WorldWideScience

Sample records for clinical protocols

  1. Establishing treatment protocols for clinical mastitis.

    Science.gov (United States)

    Roberson, Jerry R

    2003-03-01

    Each farm has a unique mix of mastitis pathogens and management procedures that have evolved over time. The herd veterinarian should work with the manager/owner to systematically develop treatment protocols that meet the needs and management of the farm. To establish a mastitis treatment protocol, it is necessary to develop a system to routinely identify clinical mastitis cases, develop a herd-specific severity level assessment system, manage the clinical mastitis cases based on severity level and culture result (when available), avoid antibiotic residues, and monitor the success of the system and alter the protocol as necessary.

  2. Colon cleansing protocol in children: research conditions vs. clinical practice.

    Science.gov (United States)

    Elitsur, Yoram; Balfaqih, Yaslam; Preston, Deborah

    2018-04-01

     Colon preparation rates are the limiting factor for a successful diagnostic colonoscopy in children. Different colon cleansing protocols have been published for use in children. Unfortunately, the applicability of those published research protocols has not been formally evaluated in routine clinical practice. We investigated the success rate of our previously published colon cleansing protocol as utilized in our clinical practice.  This was a retrospective study. In the clinical practice, the colon cleansing protocol included PEG-3350 at a dose of 2 g/kg/day plus Dulcolax (Bisacodyl, Boehringer Ingelheim, TX USA) 5 mg/day for 2 days. Adequate colon preparation was graded between 1 - 5, as previously described, and grade ≥ 4.0 was considered an adequate preparation. Patients were instructed to complete a questionnaire that included PEG-3350 dose, number of stools per day, consistency of each stool, and side effects (vomiting, abdominal pain). Clinical and endoscopic results were compared between the protocol under research conditions and routine practice.  The success rate of the colon preparation in our clinical practice was similar to the results observed under our research protocol (75 % vs. 73.6 %). Moreover, the total number of stools, stool consistency, and the intubation rate of the terminal ileum were also similar. We concluded, that in our experience, the colon cleansing protocol used under research conditions was effective and appropriate for use in routine clinical practice.  We recommend testing each new protocol under the routine conditions of clinical practice to confirm its applicability for general practitioners.

  3. SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

    Science.gov (United States)

    Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

    2015-12-01

    The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

  4. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

    Science.gov (United States)

    Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

    2016-04-01

    A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  5. Evaluating Protocol Lifecycle Time Intervals in HIV/AIDS Clinical Trials

    Science.gov (United States)

    Schouten, Jeffrey T.; Dixon, Dennis; Varghese, Suresh; Cope, Marie T.; Marci, Joe; Kagan, Jonathan M.

    2014-01-01

    Background Identifying efficacious interventions for the prevention and treatment of human diseases depends on the efficient development and implementation of controlled clinical trials. Essential to reducing the time and burden of completing the clinical trial lifecycle is determining which aspects take the longest, delay other stages, and may lead to better resource utilization without diminishing scientific quality, safety, or the protection of human subjects. Purpose In this study we modeled time-to-event data to explore relationships between clinical trial protocol development and implementation times, as well as identify potential correlates of prolonged development and implementation. Methods We obtained time interval and participant accrual data from 111 interventional clinical trials initiated between 2006 and 2011 by NIH’s HIV/AIDS Clinical Trials Networks. We determined the time (in days) required to complete defined phases of clinical trial protocol development and implementation. Kaplan-Meier estimates were used to assess the rates at which protocols reached specified terminal events, stratified by study purpose (therapeutic, prevention) and phase group (pilot/phase I, phase II, and phase III/ IV). We also examined several potential correlates to prolonged development and implementation intervals. Results Even though phase grouping did not determine development or implementation times of either therapeutic or prevention studies, overall we observed wide variation in protocol development times. Moreover, we detected a trend toward phase III/IV therapeutic protocols exhibiting longer developmental (median 2 ½ years) and implementation times (>3years). We also found that protocols exceeding the median number of days for completing the development interval had significantly longer implementation. Limitations The use of a relatively small set of protocols may have limited our ability to detect differences across phase groupings. Some timing effects

  6. Using generalizability theory to develop clinical assessment protocols.

    Science.gov (United States)

    Preuss, Richard A

    2013-04-01

    Clinical assessment protocols must produce data that are reliable, with a clinically attainable minimal detectable change (MDC). In a reliability study, generalizability theory has 2 advantages over classical test theory. These advantages provide information that allows assessment protocols to be adjusted to match individual patient profiles. First, generalizability theory allows the user to simultaneously consider multiple sources of measurement error variance (facets). Second, it allows the user to generalize the findings of the main study across the different study facets and to recalculate the reliability and MDC based on different combinations of facet conditions. In doing so, clinical assessment protocols can be chosen based on minimizing the number of measures that must be taken to achieve a realistic MDC, using repeated measures to minimize the MDC, or simply based on the combination that best allows the clinician to monitor an individual patient's progress over a specified period of time.

  7. A critical analysis of a locally agreed protocol for clinical practice

    International Nuclear Information System (INIS)

    Owen, A.; Hogg, P.; Nightingale, J.

    2004-01-01

    Within the traditional scope of radiographic practice (including advanced practice) there is a need to demonstrate effective patient care and management. Such practice should be set within a context of appropriate evidence and should also reflect peer practice. In order to achieve such practice the use of protocols is encouraged. Effective protocols can maximise care and management by minimising inter- and intra-professional variation; they can also allow for detailed procedural records to be kept in case of legal claims. However, whilst literature exists to encourage the use of protocols there is little published material available to indicate how to create, manage and archive them. This article uses an analytical approach to propose a suitable method for protocol creation and archival, it also offers suggestions on the scope and content of a protocol. To achieve this an existing clinical protocol for radiographer reporting barium enemas is analysed to draw out the general issues. Proposals for protocol creation, management, and archival were identified. The clinical practice described or inferred in the protocol should be drawn from evidence, such evidence could include peer-reviewed material, national standards and peer practice. The protocol should include an explanation of how to proceed when the radiographers reach the limit of their ability. It should refer to the initial training required to undertake the clinical duties as well as the on-going continual professional updating required to maintain competence. Audit of practice should be indicated, including the preferred audit methodology, and associated with this should be a clear statement about standards and what to do if standards are not adequately met. Protocols should be archived, in a paper-based form, for lengthy periods in case of legal claims. On the archived protocol the date it was in clinical use should be included

  8. Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis

    Directory of Open Access Journals (Sweden)

    Ali Ather

    2012-10-01

    Full Text Available Abstract Background Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. Methods The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists’ clinical judgment and maintaining consistency with a prior pilot study. Results The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. Conclusions The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. Trial registration Clinicaltrials.gov NCT00970008 (18 August 2009

  9. Clinical Simulation: A Protocol for Evaluation of Mobile Technology.

    Science.gov (United States)

    Mather, Carey; Jensen, Sanne; Cummings, Elizabeth

    2017-01-01

    For mobile technology to be accepted at point of care in healthcare environments there is a need to demonstrate benefits whilst ameliorating the risks and challenges. To provide a standardised approach to evaluation of mobile technology a simulation protocol was developed to provide guidance for its use in healthcare environments. Simulated conditions provide the opportunity to assess intended and unintended consequences and identify potential workarounds when using technology. The protocol can also be used to demonstrate the importance of the development of digital professionalism by end-users prior to students entering the clinical practice setting. The mobile technology protocol was adapted from a health information systems protocol developed and used at the ITX Lab, Denmark for use in other simulation laboratories. Use case scenarios were developed to enable evaluation of mobile technology for mobile learning of nurses, nurse supervisors, students and patients. The scenarios can be used in a range of simulated environments including hospital bedside, outpatient clinic or community settings. A case study exemplar of a nurse and patient is included to demonstrate how the mobile technology protocol can be applied.

  10. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

    Science.gov (United States)

    Chan, An-Wen; Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleza-Jeric, Karmela; Laupacis, Andreas; Moher, David

    2013-01-08

    High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

  11. Blockchain protocols in clinical trials: Transparency and traceability of consent

    Science.gov (United States)

    Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

    2018-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be

  12. Blockchain protocols in clinical trials: Transparency and traceability of consent.

    Science.gov (United States)

    Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

    2017-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a

  13. A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement.

    Science.gov (United States)

    Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

    2018-05-15

    To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.

  14. How to write a surgical clinical research protocol: literature review and practical guide.

    Science.gov (United States)

    Rosenthal, Rachel; Schäfer, Juliane; Briel, Matthias; Bucher, Heiner C; Oertli, Daniel; Dell-Kuster, Salome

    2014-02-01

    The study protocol is the core document of every clinical research project. Clinical research in studies involving surgical interventions presents some specific challenges, which need to be accounted for and described in the study protocol. The aim of this review is to provide a practical guide for developing a clinical study protocol for surgical interventions with a focus on methodologic issues. On the basis of an in-depth literature search of methodologic literature and on some cardinal published surgical trials and observational studies, the authors provides a 10-step guide for developing a clinical study protocol in surgery. This practical guide outlines key methodologic issues important when planning an ethically and scientifically sound research project involving surgical interventions, with the ultimate goal of providing high-level evidence relevant for health care decision making in surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. Building a protocol expressway: the case of Mayo Clinic Cancer Center.

    Science.gov (United States)

    McJoynt, Terre A; Hirzallah, Muhanad A; Satele, Daniel V; Pitzen, Jason H; Alberts, Steven R; Rajkumar, S Vincent

    2009-08-10

    Inconsistencies and errors resulting from nonstandard processes, together with redundancies, rework, and excess workload, lead to extended time frames for clinical trial protocol development. This results in dissatisfaction among sponsors, investigators, and staff and restricts the availability of novel treatment options for patients. A team of experts from Mayo Clinic formed, including Protocol Development Unit staff and management from the three Mayo Clinic campuses (Florida, Minnesota, and Arizona), a systems and procedures analyst, a quality office analyst, and two physician members to address the identified deficiencies. The current-state process was intensively reviewed, and improvement steps were taken to accelerate the development and approval of cancer-related clinical trials. The primary goal was to decrease the time from receipt of a new protocol through submission to an approving authority, such as the National Cancer Institute or institutional review board. Using the Define, Measure, Analyze, Improve, Control (DMAIC) framework infused with Lean waste-reduction methodologies, areas were identified for improvement, including enhancing first-time quality and processing new studies on a first-in/first-out basis. The project was successful in improving the mean turnaround time for internally authored protocols (P Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes.

  16. Conducting Clinically Based Intimate Partner Violence Research: Safety Protocol Recommendations.

    Science.gov (United States)

    Anderson, Jocelyn C; Glass, Nancy E; Campbell, Jacquelyn C

    Maintaining safety is of utmost importance during research involving participants who have experienced intimate partner violence (IPV). Limited guidance on safety protocols to protect participants is available, particularly information related to technology-based approaches to informed consent, data collection, and contacting participants during the course of a study. The purpose of the article is to provide details on the safety protocol developed and utilized with women receiving care at an urban HIV clinic and who were taking part in an observational study of IPV, mental health symptoms, and substance abuse and their relationship to HIV treatment adherence. The protocol presents the technological strategies to promote safety and allow autonomy in participant decision-making throughout the research process, including Voice over Internet Protocol telephone numbers, and tablet-based eligibility screening and data collection. Protocols for management of participants at risk for suicide and/or intimate partner homicide that included automated high-risk messaging to participants and research staff and facilitated disclosure of risk to clinical staff based on participant preferences are discussed. Use of technology and partnership with clinic staff helped to provide an environment where research regarding IPV could be conducted without undue burden or risk to participants. Utilizing tablet-based survey administration provided multiple practical and safety benefits for participants. Most women who screened into high-risk categories for suicide or intimate partner homicide did not choose to have their results shared with their healthcare providers, indicating the importance of allowing participants control over information sharing whenever possible.

  17. Comparison of IAEA protocols for clinical electron beam dosimetry

    International Nuclear Information System (INIS)

    Novotny, J.; Soukup, M.

    2002-01-01

    In most beam calibration protocols so far used in clinical practice, the method recommended for the determination of absorbed dose to water in high-energy electron beams is based on either an exposure or an air kerma calibration factor of an ionisation chamber in a C0 60 gamma-ray or 2 MV x-ray beam. These protocols are complex and the overall uncertainty in the absorbed dose to water under reference conditions is about 3-4%. The new generation of protocols, namely IAEA TRS 398, are based on absorbed dose-to-water standards in photon beams from Co 60 and accelerator beams. The possible errors in absorbed dose determination in reference conditions in practical clinical dosimetry caused by replacement of TRS 277 and TRS 381 protocols for a new TRS 398 protocol were carefully studied for clinical electron beams in energy range 6-20 MeV. All measurements were performed on Varian CLINAC 2100 C linear accelerator. The electron beam energy ranged from 6 to 20 MeV. Basically three different detectors were used for measurements: PTW Roos plane-parallel ionization chamber, calibrated PTW 30002 Farmer type, ionization, Scanditronix electron diode detector. Measurements of central axis percentage depth doses were made by diode using Wellhoefer WP700 beam scanner in 40 cm x 40 cm x 50 cm water phantom. A reference chamber or semiconductor diode mounted on electron treatment cone was used to correct beam output variations for a chamber or diode measurements during scanning. Absolute dose measurements were carried out with Roos plane-parallel chamber connected to PTW UNIDOS electrometer always for preselected number of monitor units. In a new IAEA dosimetry protocol clinical reference dosimetry for electron beam is performed at depth of d ref = 0.6R 50 - 0.1 [cm] instead of d max as in previous ones. To check the stability of electron beams for energy and to establish d ref and standard deviation for reference depth position, the depth dose curves obtained during the quality

  18. The Interface of Clinical Decision-Making With Study Protocols for Knowledge Translation From a Walking Recovery Trial.

    Science.gov (United States)

    Hershberg, Julie A; Rose, Dorian K; Tilson, Julie K; Brutsch, Bettina; Correa, Anita; Gallichio, Joann; McLeod, Molly; Moore, Craig; Wu, Sam; Duncan, Pamela W; Behrman, Andrea L

    2017-01-01

    Despite efforts to translate knowledge into clinical practice, barriers often arise in adapting the strict protocols of a randomized, controlled trial (RCT) to the individual patient. The Locomotor Experience Applied Post-Stroke (LEAPS) RCT demonstrated equal effectiveness of 2 intervention protocols for walking recovery poststroke; both protocols were more effective than usual care physical therapy. The purpose of this article was to provide knowledge-translation tools to facilitate implementation of the LEAPS RCT protocols into clinical practice. Participants from 2 of the trial's intervention arms: (1) early Locomotor Training Program (LTP) and (2) Home Exercise Program (HEP) were chosen for case presentation. The two cases illustrate how the protocols are used in synergy with individual patient presentations and clinical expertise. Decision algorithms and guidelines for progression represent the interface between implementation of an RCT standardized intervention protocol and clinical decision-making. In each case, the participant presents with a distinct clinical challenge that the therapist addresses by integrating the participant's unique presentation with the therapist's expertise while maintaining fidelity to the LEAPS protocol. Both participants progressed through an increasingly challenging intervention despite their own unique presentation. Decision algorithms and exercise progression for the LTP and HEP protocols facilitate translation of the RCT protocol to the real world of clinical practice. The two case examples to facilitate translation of the LEAPS RCT into clinical practice by enhancing understanding of the protocols, their progression, and their application to individual participants.Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A147).

  19. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

    Science.gov (United States)

    Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

    2018-02-06

    Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n

  20. Fall risk screening protocol for older hearing clinic patients.

    Science.gov (United States)

    Criter, Robin E; Honaker, Julie A

    2017-10-01

    The primary purposes of this study were (1) to describe measures that may contrast audiology patients who fall from those who do not fall and (2) to evaluate the clinical performance of measures that could be easily used for fall risk screening in a mainstream audiology hearing clinic. Cross-sectional study Study sample: Thirty-six community-dwelling audiology patient participants and 27 community-dwelling non-audiology patients over 60 years of age. The Hearing Handicap Inventory for the Elderly (HHIE) most accurately identified patients with a recent fall (sensitivity: 76.0%), while the Dizziness Handicap Inventory (DHI) most accurately identified patients without a recent fall (specificity: 90.9%). A combination of measures used in a protocol-including HHIE, DHI, number of medications, and the Timed Up and Go test-resulted in good, accurate identification of patients with or without a recent history of falls (92.0% sensitivity, 100% specificity). This study reports good sensitivity and excellent specificity for identifying patients with and without a recent history of falls when measures were combined into a screening protocol. Despite previously reported barriers, effective fall risk screenings may be performed in hearing clinic settings with measures often readily accessible to audiologists.

  1. How to design and write a clinical research protocol in Cosmetic Dermatology*

    Science.gov (United States)

    Bagatin, Ediléia; Miot, Helio A.

    2013-01-01

    Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

  2. Pregnancy outcome of “delayed start” GnRH antagonist protocol versus GnRH antagonist protocol in poor responders: A clinical trial study

    Directory of Open Access Journals (Sweden)

    Abbas Aflatoonian

    2017-08-01

    Full Text Available Background: Management of poor-responding patients is still major challenge in assisted reproductive techniques (ART. Delayed-start GnRH antagonist protocol is recommended to these patients, but little is known in this regards. Objective: The goal of this study was assessment of delayed-start GnRH antagonist protocol in poor responders, and in vitro fertilization (IVF outcomes. Materials and Methods: This randomized clinical trial included sixty infertile women with Bologna criteria for ovarian poor responders who were candidate for IVF. In case group (n=30, delayed-start GnRH antagonist protocol administered estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation with gonadotropin. Control group (n=30 treated with estrogen priming antagonist protocol. Finally, endometrial thickness, the rates of oocytes maturation, , embryo formation, and pregnancy were compared between two groups. Results: Rates of implantation, chemical, clinical, and ongoing pregnancy in delayed-start cycles were higher although was not statistically significant. Endometrial thickness was significantly higher in case group. There were no statistically significant differences in the rates of oocyte maturation, embryo formation, and IVF outcomes between two groups. Conclusion: There is no significant difference between delayed-start GnRH antagonist protocol versus GnRH antagonist protocol.

  3. [Computerized clinical protocol for occlusion].

    Science.gov (United States)

    Salsench, J; Ferrer, J; Nogueras, J

    1988-11-01

    In making a protocol it is necessary that all members of the team who are going to collect information have the same unity of criterion about the different variables that compose it. The drawing up of this document is as much or more necessary than the protocol itself. In this work we all data collected in the protocol and we give the explanations of each concept.

  4. Feasibility of Automatic Extraction of Electronic Health Data to Evaluate a Status Epilepticus Clinical Protocol.

    Science.gov (United States)

    Hafeez, Baria; Paolicchi, Juliann; Pon, Steven; Howell, Joy D; Grinspan, Zachary M

    2016-05-01

    Status epilepticus is a common neurologic emergency in children. Pediatric medical centers often develop protocols to standardize care. Widespread adoption of electronic health records by hospitals affords the opportunity for clinicians to rapidly, and electronically evaluate protocol adherence. We reviewed the clinical data of a small sample of 7 children with status epilepticus, in order to (1) qualitatively determine the feasibility of automated data extraction and (2) demonstrate a timeline-style visualization of each patient's first 24 hours of care. Qualitatively, our observations indicate that most clinical data are well labeled in structured fields within the electronic health record, though some important information, particularly electroencephalography (EEG) data, may require manual abstraction. We conclude that a visualization that clarifies a patient's clinical course can be automatically created using the patient's electronic clinical data, supplemented with some manually abstracted data. Future work could use this timeline to evaluate adherence to status epilepticus clinical protocols. © The Author(s) 2015.

  5. Economic evaluation of a clinical protocol for diagnosing emergency patients with suspected pulmonary embolism

    Directory of Open Access Journals (Sweden)

    Wolfe Rory

    2006-06-01

    Full Text Available Abstract Background The objective of this paper is to estimate the amount of cost-savings to the Australian health care system from implementing an evidence-based clinical protocol for diagnosing emergency patients with suspected pulmonary embolism (PE at the Emergency department of a Victorian public hospital with 50,000 presentations in 2001–2002. Methods A cost-minimisation study used the data collected in a controlled clinical trial of a clinical protocol for diagnosing patients with suspected PE. Thenumber and type of diagnostic tests in a historic cohort of 185 randomly selected patients, who presented to the emergency department with suspectedPE during an eight month period prior to the clinical trial (January 2002 -August 2002 were compared with the number and type of diagnostic tests in745 patients, who presented to the emergency department with suspected PE from November 2002 to August 2003. Current Medicare fees per test were usedas unit costs to calculate the mean aggregated cost of diagnostic investigation per patient in both study groups. A t-test was used to estimate the statistical significance of the difference in the cost of resources used for diagnosing PE in the control and in the intervention group. Results The trial demonstrated that diagnosing PE using an evidence-based clinical protocol was as effective as the existing clinical practice. The clinical protocol offers the advantage of reducing the use of diagnostic imaging, resulting in an average cost savings of at least $59.30 per patient. Conclusion Extrapolating the observed cost-savings of $59.30 per patient to the wholeof Australia could potentially result in annual savings between $3.1 million to $3.7 million.

  6. [Clinical outcomes and economic analysis of two ovulation induction protocols in patients undergoing repeated IVF/ICSI cycles].

    Science.gov (United States)

    Chen, Xiao; Geng, Ling; Li, Hong

    2014-04-01

    To compare the clinical outcomes and cost-effectiveness of luteal phase down-regulation with gonadotrophin-releasing hormone (GnRH) agonist protocol and GnRH antagonist protocol in patients undergoing repeated in vitro fertilization and intracytoplasmic sperm injection (IVF-ICSI) cycles. A retrospective analysis of clinical outcomes and costs was conducted among 198 patients undergoing repeated IVF-ICSI cycles, including 109 receiving luteal phase down-regulation with GnRH agonist protocol (group A) and 89 receiving GnRH antagonist protocol (group B). The numbers of oocytes retrieved and good embryos, clinical pregnancy rate, abortion rate, the live birth rate, mean total cost, and the cost-effective ratio were compared between the two groups. In patients undergoing repeated IVF-ICSI cycles, the two protocols produced no significant differences in the number of good embryos, clinical pregnancy rate, abortion rate, or twin pregnancy rate. Compared with group B, group A had better clinical outcomes though this difference was not statistically significant. The number of retrieved oocytes was significantly greater and live birth rate significantly higher in group A than in group B (9.13=4.98 vs 7.11=4.74, and 20.2% vs 9.0%, respectively). Compared with group B, group A had higher mean total cost per cycle but lower costs for each oocyte retrieved (2729.11 vs 3038.60 RMB yuan), each good embryo (8867.19 vs 9644.85 RMB yuan), each clinical pregnancy (77598.06 vs 96139.85 RMB yuan). For patients undergoing repeated IVF/ICSI cycle, luteal phase down-regulation with GnRH agonist protocol produces good clinical outcomes with also good cost-effectiveness in spite an unsatisfactory ovarian reserve.

  7. Integrating usability testing and think-aloud protocol analysis with "near-live" clinical simulations in evaluating clinical decision support.

    Science.gov (United States)

    Li, Alice C; Kannry, Joseph L; Kushniruk, Andre; Chrimes, Dillon; McGinn, Thomas G; Edonyabo, Daniel; Mann, Devin M

    2012-11-01

    Usability evaluations can improve the usability and workflow integration of clinical decision support (CDS). Traditional usability testing using scripted scenarios with think-aloud protocol analysis provide a useful but incomplete assessment of how new CDS tools interact with users and clinical workflow. "Near-live" clinical simulations are a newer usability evaluation tool that more closely mimics clinical workflow and that allows for a complementary evaluation of CDS usability as well as impact on workflow. This study employed two phases of testing a new CDS tool that embedded clinical prediction rules (an evidence-based medicine tool) into primary care workflow within a commercial electronic health record. Phase I applied usability testing involving "think-aloud" protocol analysis of 8 primary care providers encountering several scripted clinical scenarios. Phase II used "near-live" clinical simulations of 8 providers interacting with video clips of standardized trained patient actors enacting the clinical scenario. In both phases, all sessions were audiotaped and had screen-capture software activated for onscreen recordings. Transcripts were coded using qualitative analysis methods. In Phase I, the impact of the CDS on navigation and workflow were associated with the largest volume of negative comments (accounting for over 90% of user raised issues) while the overall usability and the content of the CDS were associated with the most positive comments. However, usability had a positive-to-negative comment ratio of only 0.93 reflecting mixed perceptions about the usability of the CDS. In Phase II, the duration of encounters with simulated patients was approximately 12 min with 71% of the clinical prediction rules being activated after half of the visit had already elapsed. Upon activation, providers accepted the CDS tool pathway 82% of times offered and completed all of its elements in 53% of all simulation cases. Only 12.2% of encounter time was spent using the

  8. Hearing screening procedures and protocols in use at immunisation clinics in South Africa

    Directory of Open Access Journals (Sweden)

    Luisa Petrocchi-Bartal

    2014-12-01

    Full Text Available Background: There exists a need for context-relevant research aimed at facilitating the efficacious provision of early hearing detection and intervention services in South Africa. Objectives: This study aimed to determine the hearing screening procedures and protocols as well as referral protocols in use at maternal child woman’s health (MCWH immunisation clinics in South Africa. Method: Thirty primary health care immunisation clinic managers or acting managers were interviewed in two South African sample groups. An exploratory, non-experimental,qualitative research design was employed incorporating both quantitative and qualitative information. An interview using a questionnaire was administered with all participants. The questionnaire encompassed areas such as work contexts, hearing screening contexts and information management systems, as well as quality control measures in place at these clinics.Content analysis was then used to code emergent themes into specific categories. Frequency calculations of these themes were calculated and results described qualitatively. Results: No primary health care (PHC clinics placed within the identified sites provided formalised new-born/infant hearing screening and none of these facilities had equipment to do so. Most sites attributed the lack of formalised hearing screening to budgetary and human resource issues, staff training in particular. Non-formalised hearing screening protocols in place demonstrated inconsistencies in application across districts and none complied with Health Professions Council of South Africa (HPCSA clinic guidelines or any international guidelines. Conclusion: Results from the current study have assisted in identifying procedural and logistical assets and barriers to implementation of HPCSA clinic guidelines for early hearing detection and intervention (EHDI at immunisation clinics in South Africa.

  9. Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation

    Energy Technology Data Exchange (ETDEWEB)

    Driscoll, B. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9 (Canada); Keller, H. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9, Canada and Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2 (Canada); Jaffray, D.; Coolens, C. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9 (Canada); Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2 (Canada); Techna Institute, University Health Network, 124-100 College Street, Toronto, Ontario M5G 1L5 (Canada)

    2013-08-15

    Purpose: Credentialing can have an impact on whether or not a clinical trial produces useful quality data that is comparable between various institutions and scanners. With the recent increase of dynamic contrast enhanced-computed tomography (DCE-CT) usage as a companion biomarker in clinical trials, effective quality assurance, and control methods are required to ensure there is minimal deviation in the results between different scanners and protocols at various institutions. This paper attempts to address this problem by utilizing a dynamic flow imaging phantom to develop and evaluate a DCE-CT quality assurance (QA) protocol.Methods: A previously designed flow phantom, capable of producing predictable and reproducible time concentration curves from contrast injection was fully validated and then utilized to design a DCE-CT QA protocol. The QA protocol involved a set of quantitative metrics including injected and total mass error, as well as goodness of fit comparison to the known truth concentration curves. An additional region of interest (ROI) sensitivity analysis was also developed to provide additional details on intrascanner variability and determine appropriate ROI sizes for quantitative analysis. Both the QA protocol and ROI sensitivity analysis were utilized to test variations in DCE-CT results using different imaging parameters (tube voltage and current) as well as alternate reconstruction methods and imaging techniques. The developed QA protocol and ROI sensitivity analysis was then applied at three institutions that were part of clinical trial involving DCE-CT and results were compared.Results: The inherent specificity of robustness of the phantom was determined through calculation of the total intraday variability and determined to be less than 2.2 ± 1.1% (total calculated output contrast mass error) with a goodness of fit (R{sup 2}) of greater than 0.99 ± 0.0035 (n= 10). The DCE-CT QA protocol was capable of detecting significant deviations from

  10. Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

    Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

  11. Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.We assembled a cohort of clinical studies approved 2000-2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects.Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71% were completed according to protocol, 128 (16% discontinued and 42 (5% are still ongoing; for 61 (8% there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48-0.55. Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48% protocols and in 205 (49% of the publications. In most published studies (339; 81% this information corresponded between protocol and publication. Most studies were published in English (367; 88%; some in German (25; 6% or both languages (27; 6%. The local investigators were listed as (co-authors in the publications corresponding to 259 (62% studies.Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are likely wasted as neither health care

  12. A proposed protocol for hand and table sanitizing in chiropractic clinics and education institutions

    Science.gov (United States)

    Evans, Marion Willard; Ramcharan, Michael; Floyd, Rod; Globe, Gary; Ndetan, Harrison; Williams, Ronald; Ivie, Ronald

    2009-01-01

    Abstract Objective By nature, chiropractic is a hands-on profession using manipulation applied to the joints with direct skin-to-skin contacts. Chiropractic tables are designed with a face piece to accommodate the prone patient's head in a neutral position and hand rests to allow for relaxed shoulders and upper spine so treatment is facilitated. The purpose of this article is to present a proposed guideline for hand and treatment table surface sanitizing for the chiropractic profession that is evidence-based and can easily be adopted by teaching institutions and doctors in the field. Methods A review of the chiropractic literature demonstrated that pathogenic microbes are present on treatment tables in teaching clinics at multiple facilities, yet no standardized protocols exist in the United States regarding table sanitizing and hand hygiene in chiropractic clinics or education institutions. This article reviews the scientific literature on the subject by using several search engines, databases, and specific reviews of documents pertaining to the topic including existing general guidelines. Results The literature has several existing guidelines that the authors used to develop a proposed protocol for hand and table sanitizing specific to the chiropractic profession. Recommendations were developed and are presented on hand hygiene and table sanitizing procedures that could lower the risk of infection for both clinical personnel and patients in chiropractic facilities. Conclusion This article offers a protocol for hand and table sanitizing in chiropractic clinics and education institutions. The chiropractic profession should consider adoption of these or similar measures and disseminate them to teaching clinics, institutions, and private practitioners. PMID:19646384

  13. Registered nurses' clinical reasoning in home healthcare clinical practice: A think-aloud study with protocol analysis.

    Science.gov (United States)

    Johnsen, Hege Mari; Slettebø, Åshild; Fossum, Mariann

    2016-05-01

    The home healthcare context can be unpredictable and complex, and requires registered nurses with a high level of clinical reasoning skills and professional autonomy. Thus, additional knowledge about registered nurses' clinical reasoning performance during patient home care is required. The aim of this study is to describe the cognitive processes and thinking strategies used by recently graduated registered nurses while caring for patients in home healthcare clinical practice. An exploratory qualitative think-aloud design with protocol analysis was used. Home healthcare visits to patients with stroke, diabetes, and chronic obstructive pulmonary disease in seven healthcare districts in southern Norway. A purposeful sample of eight registered nurses with one year of experience. Each nurse was interviewed using the concurrent think-aloud technique in three different patient home healthcare clinical practice visits. A total of 24 home healthcare visits occurred. Follow-up interviews were conducted with each participant. The think-aloud sessions were transcribed and analysed using three-step protocol analysis. Recently graduated registered nurses focused on both general nursing concepts and concepts specific to the domains required and tasks provided in home healthcare services as well as for different patient groups. Additionally, participants used several assertion types, cognitive processes, and thinking strategies. Our results showed that recently graduated registered nurses used both simple and complex cognitive processes involving both inductive and deductive reasoning. However, their reasoning was more reactive than proactive. The results may contribute to nursing practice in terms of developing effective nursing education programmes. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Defining robustness protocols: a method to include and evaluate robustness in clinical plans

    International Nuclear Information System (INIS)

    McGowan, S E; Albertini, F; Lomax, A J; Thomas, S J

    2015-01-01

    We aim to define a site-specific robustness protocol to be used during the clinical plan evaluation process. Plan robustness of 16 skull base IMPT plans to systematic range and random set-up errors have been retrospectively and systematically analysed. This was determined by calculating the error-bar dose distribution (ebDD) for all the plans and by defining some metrics used to define protocols aiding the plan assessment. Additionally, an example of how to clinically use the defined robustness database is given whereby a plan with sub-optimal brainstem robustness was identified. The advantage of using different beam arrangements to improve the plan robustness was analysed. Using the ebDD it was found range errors had a smaller effect on dose distribution than the corresponding set-up error in a single fraction, and that organs at risk were most robust to the range errors, whereas the target was more robust to set-up errors. A database was created to aid planners in terms of plan robustness aims in these volumes. This resulted in the definition of site-specific robustness protocols. The use of robustness constraints allowed for the identification of a specific patient that may have benefited from a treatment of greater individuality. A new beam arrangement showed to be preferential when balancing conformality and robustness for this case. The ebDD and error-bar volume histogram proved effective in analysing plan robustness. The process of retrospective analysis could be used to establish site-specific robustness planning protocols in proton therapy. These protocols allow the planner to determine plans that, although delivering a dosimetrically adequate dose distribution, have resulted in sub-optimal robustness to these uncertainties. For these cases the use of different beam start conditions may improve the plan robustness to set-up and range uncertainties. (paper)

  15. Defining robustness protocols: a method to include and evaluate robustness in clinical plans

    Science.gov (United States)

    McGowan, S. E.; Albertini, F.; Thomas, S. J.; Lomax, A. J.

    2015-04-01

    We aim to define a site-specific robustness protocol to be used during the clinical plan evaluation process. Plan robustness of 16 skull base IMPT plans to systematic range and random set-up errors have been retrospectively and systematically analysed. This was determined by calculating the error-bar dose distribution (ebDD) for all the plans and by defining some metrics used to define protocols aiding the plan assessment. Additionally, an example of how to clinically use the defined robustness database is given whereby a plan with sub-optimal brainstem robustness was identified. The advantage of using different beam arrangements to improve the plan robustness was analysed. Using the ebDD it was found range errors had a smaller effect on dose distribution than the corresponding set-up error in a single fraction, and that organs at risk were most robust to the range errors, whereas the target was more robust to set-up errors. A database was created to aid planners in terms of plan robustness aims in these volumes. This resulted in the definition of site-specific robustness protocols. The use of robustness constraints allowed for the identification of a specific patient that may have benefited from a treatment of greater individuality. A new beam arrangement showed to be preferential when balancing conformality and robustness for this case. The ebDD and error-bar volume histogram proved effective in analysing plan robustness. The process of retrospective analysis could be used to establish site-specific robustness planning protocols in proton therapy. These protocols allow the planner to determine plans that, although delivering a dosimetrically adequate dose distribution, have resulted in sub-optimal robustness to these uncertainties. For these cases the use of different beam start conditions may improve the plan robustness to set-up and range uncertainties.

  16. Dynamic whole body PET parametric imaging: I. Concept, acquisition protocol optimization and clinical application

    Science.gov (United States)

    Karakatsanis, Nicolas A.; Lodge, Martin A.; Tahari, Abdel K.; Zhou, Y.; Wahl, Richard L.; Rahmim, Arman

    2013-01-01

    Static whole body PET/CT, employing the standardized uptake value (SUV), is considered the standard clinical approach to diagnosis and treatment response monitoring for a wide range of oncologic malignancies. Alternative PET protocols involving dynamic acquisition of temporal images have been implemented in the research setting, allowing quantification of tracer dynamics, an important capability for tumor characterization and treatment response monitoring. Nonetheless, dynamic protocols have been confined to single bed-coverage limiting the axial field-of-view to ~15–20 cm, and have not been translated to the routine clinical context of whole-body PET imaging for the inspection of disseminated disease. Here, we pursue a transition to dynamic whole body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. We investigate solutions to address the challenges of: (i) long acquisitions, (ii) small number of dynamic frames per bed, and (iii) non-invasive quantification of kinetics in the plasma. In the present study, a novel dynamic (4D) whole body PET acquisition protocol of ~45min total length is presented, composed of (i) an initial 6-min dynamic PET scan (24 frames) over the heart, followed by (ii) a sequence of multi-pass multi-bed PET scans (6 passes x 7 bed positions, each scanned for 45sec). Standard Patlak linear graphical analysis modeling was employed, coupled with image-derived plasma input function measurements. Ordinary least squares (OLS) Patlak estimation was used as the baseline regression method to quantify the physiological parameters of tracer uptake rate Ki and total blood distribution volume V on an individual voxel basis. Extensive Monte Carlo simulation studies, using a wide set of published kinetic FDG parameters and GATE and XCAT platforms, were conducted to optimize the acquisition protocol from a range of 10 different clinically

  17. Dynamic whole-body PET parametric imaging: I. Concept, acquisition protocol optimization and clinical application.

    Science.gov (United States)

    Karakatsanis, Nicolas A; Lodge, Martin A; Tahari, Abdel K; Zhou, Y; Wahl, Richard L; Rahmim, Arman

    2013-10-21

    Static whole-body PET/CT, employing the standardized uptake value (SUV), is considered the standard clinical approach to diagnosis and treatment response monitoring for a wide range of oncologic malignancies. Alternative PET protocols involving dynamic acquisition of temporal images have been implemented in the research setting, allowing quantification of tracer dynamics, an important capability for tumor characterization and treatment response monitoring. Nonetheless, dynamic protocols have been confined to single-bed-coverage limiting the axial field-of-view to ~15-20 cm, and have not been translated to the routine clinical context of whole-body PET imaging for the inspection of disseminated disease. Here, we pursue a transition to dynamic whole-body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. We investigate solutions to address the challenges of: (i) long acquisitions, (ii) small number of dynamic frames per bed, and (iii) non-invasive quantification of kinetics in the plasma. In the present study, a novel dynamic (4D) whole-body PET acquisition protocol of ~45 min total length is presented, composed of (i) an initial 6 min dynamic PET scan (24 frames) over the heart, followed by (ii) a sequence of multi-pass multi-bed PET scans (six passes × seven bed positions, each scanned for 45 s). Standard Patlak linear graphical analysis modeling was employed, coupled with image-derived plasma input function measurements. Ordinary least squares Patlak estimation was used as the baseline regression method to quantify the physiological parameters of tracer uptake rate Ki and total blood distribution volume V on an individual voxel basis. Extensive Monte Carlo simulation studies, using a wide set of published kinetic FDG parameters and GATE and XCAT platforms, were conducted to optimize the acquisition protocol from a range of ten different clinically

  18. Dynamic whole-body PET parametric imaging: I. Concept, acquisition protocol optimization and clinical application

    International Nuclear Information System (INIS)

    Karakatsanis, Nicolas A; Lodge, Martin A; Tahari, Abdel K; Zhou, Y; Wahl, Richard L; Rahmim, Arman

    2013-01-01

    Static whole-body PET/CT, employing the standardized uptake value (SUV), is considered the standard clinical approach to diagnosis and treatment response monitoring for a wide range of oncologic malignancies. Alternative PET protocols involving dynamic acquisition of temporal images have been implemented in the research setting, allowing quantification of tracer dynamics, an important capability for tumor characterization and treatment response monitoring. Nonetheless, dynamic protocols have been confined to single-bed-coverage limiting the axial field-of-view to ∼15–20 cm, and have not been translated to the routine clinical context of whole-body PET imaging for the inspection of disseminated disease. Here, we pursue a transition to dynamic whole-body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. We investigate solutions to address the challenges of: (i) long acquisitions, (ii) small number of dynamic frames per bed, and (iii) non-invasive quantification of kinetics in the plasma. In the present study, a novel dynamic (4D) whole-body PET acquisition protocol of ∼45 min total length is presented, composed of (i) an initial 6 min dynamic PET scan (24 frames) over the heart, followed by (ii) a sequence of multi-pass multi-bed PET scans (six passes × seven bed positions, each scanned for 45 s). Standard Patlak linear graphical analysis modeling was employed, coupled with image-derived plasma input function measurements. Ordinary least squares Patlak estimation was used as the baseline regression method to quantify the physiological parameters of tracer uptake rate K i and total blood distribution volume V on an individual voxel basis. Extensive Monte Carlo simulation studies, using a wide set of published kinetic FDG parameters and GATE and XCAT platforms, were conducted to optimize the acquisition protocol from a range of ten different

  19. Dynamic whole-body PET parametric imaging: I. Concept, acquisition protocol optimization and clinical application

    Science.gov (United States)

    Karakatsanis, Nicolas A.; Lodge, Martin A.; Tahari, Abdel K.; Zhou, Y.; Wahl, Richard L.; Rahmim, Arman

    2013-10-01

    Static whole-body PET/CT, employing the standardized uptake value (SUV), is considered the standard clinical approach to diagnosis and treatment response monitoring for a wide range of oncologic malignancies. Alternative PET protocols involving dynamic acquisition of temporal images have been implemented in the research setting, allowing quantification of tracer dynamics, an important capability for tumor characterization and treatment response monitoring. Nonetheless, dynamic protocols have been confined to single-bed-coverage limiting the axial field-of-view to ˜15-20 cm, and have not been translated to the routine clinical context of whole-body PET imaging for the inspection of disseminated disease. Here, we pursue a transition to dynamic whole-body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. We investigate solutions to address the challenges of: (i) long acquisitions, (ii) small number of dynamic frames per bed, and (iii) non-invasive quantification of kinetics in the plasma. In the present study, a novel dynamic (4D) whole-body PET acquisition protocol of ˜45 min total length is presented, composed of (i) an initial 6 min dynamic PET scan (24 frames) over the heart, followed by (ii) a sequence of multi-pass multi-bed PET scans (six passes × seven bed positions, each scanned for 45 s). Standard Patlak linear graphical analysis modeling was employed, coupled with image-derived plasma input function measurements. Ordinary least squares Patlak estimation was used as the baseline regression method to quantify the physiological parameters of tracer uptake rate Ki and total blood distribution volume V on an individual voxel basis. Extensive Monte Carlo simulation studies, using a wide set of published kinetic FDG parameters and GATE and XCAT platforms, were conducted to optimize the acquisition protocol from a range of ten different clinically

  20. Effects of triploidy incidence on clinical outcomes for IVF-ET cycles in different ovarian stimulation protocols.

    Science.gov (United States)

    Li, Mingzhao; Xue, Xia; Zhang, Silin; Li, Wei; Zhao, Xiaoli; Ren, Wenjuan; Shi, Juanzi

    2015-10-01

    To discuss the relationship between triploidy incidence and clinical outcomes of embryos derived from normally fertilized oocytes from the same cohort for in vitro fertilization-embryo transfer (IVF-ET) cycles in different ovarian stimulation protocol. This study included 2070 in vitro fertilization (IVF) cycles with long-term protocol, 802 IVF cycles with ultra short-term protocol and 508 IVF-D (in vitro fertilization by donor semen) cycles with long-term protocol from January 2013 to September 2014. According to the different 3PN rate, patients were divided into three groups as follows: Group 1 included patients with 0% 3PN zygotes, Group 2 included patients with 1-25% 3PN zygotes and Group 3 included patients with >25% 3PN zygotes. female age, no. of retrieved oocytes, normal fertilization rate, day-3 grade I + II embryos rate, day-3 grade I + II + III embryos rate, implantation rate, pregnancy rate and early abortion rate. Triploidy cycle incidence rate in IVF and IVF-D cycles with long-term protocol were significantly higher than in IVF cycles with ultra short-term protocol (p  0.05). In three protocols, normal fertilization rate in 3PN = 0% and 3PN = 1-25% groups were significantly higher compared to 3PN > 25% group (p cycles with long-term protocol, the day-3 grade I + II embryos, implantation and pregnancy rate in 3PN > 25% group were significantly lower than other two groups (p  0.05). In IVF cycles with ultra short-term protocol, there were no significant differences found in day-3 grade I + II embryos, day-3 grade I + II + III embryos, implantation, pregnancy and early abortion rate (p > 0.05). In IVF-D cycles with long-term protocol, the day-3 grade I + II embryos, day-3 grade I + II + III embryos and implantation rate in 3PN > 25% group were significantly lower than other two groups (p  0.05). We observed that high proportion of triploid zygotes made a negative effect on

  1. [Development of clinical trial education program for pharmaceutical science students through small group discussion and role-playing using protocol].

    Science.gov (United States)

    Imakyure, Osamu; Shuto, Hideki; Nishikawa, Fumi; Hagiwara, Yoshifuka; Inoue, Sachiko; Koyanagi, Taeko; Hirakawa, Masaaki; Kataoka, Yasufumi

    2010-08-01

    The acquirement of basic knowledge of clinical trials and professional attitude in their practices is a general instructional objective in the Model Core Curriculum for Pharmaceutical Education. Unfortunately, the previous program of clinical trial education was not effective in the acquirement of a professional attitude in their practices. Then, we developed the new clinical trial education program using protocol through small group discussion (SGD) and roll-playing. Our program consists of 7 steps of practical training. In step 1, the students find some problems after presentation of the protocol including case and prescription. In step 2, they analyse the extracted problems and share the information obtained in SGD. In steps 3 and 5, five clinical case scenarios are presented to the students and they discuss which case is suitable for entry to the clinical trial or which case corresponds to the discontinuance criteria in the present designed protocol. In steps 4 and 6, the roll-playing is performed by teachers and students as doctors and clinical research coordinators (CRC) respectively. Further, we conducted a trial practice based on this program for the students. In the student's self-evaluation into five grades, the average score of the skill acquisition level in each step was 3.8-4.7 grade. Our clinical trial education program could be effective in educating the candidates for CRC or clinical pharmacists.

  2. P-02: Echocardiography Has Low Clinical Efficacy of Libyan Screening Protocol in Athletes

    Directory of Open Access Journals (Sweden)

    Salaheddin Sharif

    2017-03-01

    Full Text Available INTRODUCTIONPre-participation screening has been largely accepted as a means to identify those athletes at risk of cardiovascular diseases which are responsible for sudden cardiac death. The objectives of athlete screening are to reduce injuries and prevent sudden. However, there is no single commonly adopted protocol to screen athletes. Although the European Society of Cardiology and the American Heart Association recommend the routine screening of athletes to prevent sudden death, there is significant disagreement regarding use 12 lead ECG. FIFA has recommend the inclusion of an Echocardiography (ECHO in screening protocol.PURPOSEExplore the debate regarding differences between European and the USA pre-participation screening protocol for sudden death while also considering pre-competition medical assessment protocol used by the Libyan Football Federation. To provide evidence based recommendations on the best protocol to be used for pre-participation screening, and thus to standardize the screening method.MATERIALS and METHOD1236 male athletic received a medical history, general physical examination, cardiovascular and musculoskeletal examination, 12 lead ECG, blood laboratory test, and echocardiography.FINDINGS1235 athletics were found to be eligible to participate in sport and were given a full medical clearance. One athletic was diagnosed with second degree heart block by ECG while his medical history, physical examination, echocardiograph, and blood test were normal.DISCUSSIONEchocardiography alone do did not identify pathological condition and using echocardiography is still controversial and clinically not effective in young athletesCONCLUSIONThe Screening protocol should include a combination of medical history, physical examination and ECG due to the high sensitivity found, and thus it was able to identify all athletes at risk for the disease.

  3. Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis.

    Science.gov (United States)

    Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

    2018-01-01

    The concept of the risk-based approach has been introduced as an effort to secure the quality of clinical trials. In the risk-based approach, identification and evaluation of risk in advance are considered important. For recently completed clinical trials, we investigated the relationship between study characteristics and protocol deviations leading to the exclusion of subjects from Per Protocol Set (PPS) efficacy analysis. New drugs approved in Japan in the fiscal year 2014-2015 were targeted in the research. The reasons for excluding subjects from the PPS efficacy analysis were described in 102 trials out of 492 in the summary of new drug application documents, which was publicly disclosed after the drug's regulatory approval. The author extracted these reasons along with the numbers of the cases and the study characteristics of each clinical trial. Then, the direct comparison, univariate regression analysis, and multivariate regression analysis was carried out based on the exclusion rate. The study characteristics for which exclusion of subjects from the PPS efficacy analysis were frequently observed was multiregional clinical trials in study region; inhalant and external use in administration route; Anti-infective for systemic use; Respiratory system, Dermatologicals, and Nervous system in therapeutic drug under the Anatomical Therapeutic Chemical Classification. In the multivariate regression analysis, the clinical trial variables of inhalant, Respiratory system, or Dermatologicals were selected as study characteristics leading to a higher exclusion rate. The characteristics of the clinical trial that is likely to cause protocol deviations that will affect efficacy analysis were suggested. These studies should be considered for specific attention and priority observation in the trial protocol or its monitoring plan and execution, such as a clear description of inclusion/exclusion criteria in the protocol, development of training materials to site staff, and

  4. Remotely-Supervised Transcranial Direct Current Stimulation (tDCS for Clinical Trials: Guidelines for Technology and Protocols

    Directory of Open Access Journals (Sweden)

    Leigh E Charvet

    2015-03-01

    Full Text Available The effect of transcranial direct current stimulation (tDCS is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: 1 training of staff in tDCS treatment and supervision, 2 assessment of the user’s capability to participate in tDCS remotely, 3 ongoing training procedures and materials including assessments of the user and/or caregiver, 4 simple and fail-safe electrode preparation techniques and tDCS headgear, 5 strict dose control for each session, 6 ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol, with corresponding corrective steps as required, 7 monitoring for treatment-emergent adverse effects, 8 guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population’s level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.

  5. Towards a clinically relevant lentiviral transduction protocol for primary human CD34 hematopoietic stem/progenitor cells.

    Directory of Open Access Journals (Sweden)

    Michelle Millington

    2009-07-01

    Full Text Available Hematopoietic stem cells (HSC, in particular mobilized peripheral blood stem cells, represent an attractive target for cell and gene therapy. Efficient gene delivery into these target cells without compromising self-renewal and multi-potency is crucial for the success of gene therapy. We investigated factors involved in the ex vivo transduction of CD34(+ HSCs in order to develop a clinically relevant transduction protocol for gene delivery. Specifically sought was a protocol that allows for efficient transduction with minimal ex vivo manipulation without serum or other reagents of animal origin.Using commercially available G-CSF mobilized peripheral blood (PB CD34(+ cells as the most clinically relevant target, we systematically examined factors including the use of serum, cytokine combinations, pre-stimulation time, multiplicity of infection (MOI, transduction duration and the use of spinoculation and/or retronectin. A self-inactivating lentiviral vector (SIN-LV carrying enhanced green fluorescent protein (GFP was used as the gene delivery vehicle. HSCs were monitored for transduction efficiency, surface marker expression and cellular function. We were able to demonstrate that efficient gene transduction can be achieved with minimal ex vivo manipulation while maintaining the cellular function of transduced HSCs without serum or other reagents of animal origin.This study helps to better define factors relevant towards developing a standard clinical protocol for the delivery of SIN-LV into CD34(+ cells.

  6. DIRECT PULP CAPPING IN TREATMENT OF REVERSIBLE PULPITIS IN PRIMARY TEETH- CLINICAL PROTOCOL

    Directory of Open Access Journals (Sweden)

    Nina Milcheva

    2016-10-01

    Full Text Available The pulp of primary teeth is identical morphologically and physiologically to that of permanent teeth and it is capable to answer to pathological stimuli by producing tertiary dentin. When the inflammation of the pulp is in its reversible stage vital methods of treatment are indicated in order to stimulate the healing processes in it and protect its vitality. In Bulgaria the most popular method of treatment of inflammation diseases of the pulp in primary dentition is the mortal amputation. The biological way of treatment is not very common even in cases where there are indications for it. Purpose: The aim of this paper is to present the approbated by us protocol for application of direct pulp capping for treatment of reversible pulpitis in primary teeth. Material and methods: On the base of world experience and our contemporary meta- analysis of the researches published in the last 15 years concerning the problems of diagnostics. We determined clinical and radiographic diagnostic criteria for reversible pulpitis in primary teeth and indications for application of direct pulp capping as a method of treatment. We give clinical steps for application of the method and summarized the clinical and radiographic criteria for success after treatment. Results/conclusion: We gather all the information for applying direct pulp cappingfor treatment of reversible pulpitis in primary dentition. We offer the method of direct pulp capping as a clinical protocol “step by step” and illustrated by scheme which can be useful for students and dentists in their everyday practice.

  7. Development and implementation of intranasal naloxone opioid overdose response protocol at a homeless health clinic.

    Science.gov (United States)

    Dahlem, Chin Hwa Y; Horstman, Molly J; Williams, Brent C

    2016-01-01

    To describe the development, implementation, and preliminary evaluation of Opioid Overdose Response Protocol using intranasal (IN) naloxone in a homeless shelter. Opioid Overdose Response Protocol and training curriculum were developed using the Massachusetts Department of Public Health Opioid Overdose Education and Naloxone Distribution (OEND) flow chart, the American Heart Association (AHA) simplified adult basic life support algorithm, and resources through Harms Reduction Coalition. Intranasal naloxone offers a safe and effective method for opioid reversal. To combat the rising incidence of opioid overdose, IN naloxone should be made available at homeless shelters and other facilities with high frequency of opioid overdose, including the training of appropriate staff. This project has demonstrated the effective training and implementation of an Opioid Overdose Response Protocol, based on feedback received from cardiopulmonary resuscitation (CPR) trained nonhealthcare staff. Nurse practitioners (NPs), with our focus on patient care, prevention, and education, are well suited to the deployment of this life-saving protocol. NPs are in critical positions to integrate opioid overdose prevention education and provide naloxone rescue kits in clinical practices. ©2015 American Association of Nurse Practitioners.

  8. Matrix-assisted laser desorption/ionization-time of flight mass spectrometry: protocol standardization and database expansion for rapid identification of clinically important molds.

    Science.gov (United States)

    Paul, Saikat; Singh, Pankaj; Rudramurthy, Shivaprakash M; Chakrabarti, Arunaloke; Ghosh, Anup K

    2017-12-01

    To standardize the matrix-assisted laser desorption ionization-time of flight mass spectrometry protocols and expansion of existing Bruker Biotyper database for mold identification. Four different sample preparation methods (protocol A, B, C and D) were evaluated. On analyzing each protein extraction method, reliable identification and best log scores were achieved through protocol D. The same protocol was used to identify 153 clinical isolates. Of these 153, 123 (80.3%) were accurately identified by using existing database and remaining 30 (19.7%) were not identified due to unavailability in database. On inclusion of missing main spectrum profile in existing database, all 153 isolates were identified. Matrix-assisted laser desorption ionization-time of flight mass spectrometry can be used for routine identification of clinically important molds.

  9. Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

    Science.gov (United States)

    Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J

    2015-10-01

    Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. Published by Elsevier Inc.

  10. Baseline demographics, clinical features, and treatment protocols of 240 patients with optic neuropathy: experiences from a neuro-ophthalmological clinic in the Aegean region of Turkey.

    Science.gov (United States)

    Karti, Omer; Karti, Dilek Top; Kilic, İlay Hilal; Gokcay, Figen; Celebisoy, Nese

    2017-12-19

    To analyze the demographic patterns, clinical characteristics, and treatment protocols of optic neuropathies. The hospital data of patients with optic neuropathy admitted to the Department of Neuro-ophthalmology in a tertiary referral center in Turkey between January 2010 to January 2017 were retrospectively analyzed. Demographic patterns, clinical features, treatment protocols, and the natural disease courses were assessed. The total number of patients with optic neuropathy seen over this period was 240, which consist of 43 with idiopathic optic neuritis (17.9%), 40 with multiple sclerosis-related optic neuritis (16.7%), 12 with chronic relapsing inflammatory optic neuritis (5.0%), 12 with atypical optic neuritis (5.0%), 11 with neuromyelitis optica spectrum disorders-related optic neuritis (4.6%), 90 with non-arteritic ischemic optic neuropathy (37.5%), 4 with arteritic ischemic optic neuropathy (1.7%), 10 with traumatic optic neuropathy (4.1%), 6 with compressive optic neuropathy (2.5%), and 12 with mitochondrial optic neuropathy [9 with toxic optic neuropathy (3.7%) and 3 with Leber's hereditary optic neuropathy (1.2%)]. There were 101 males (42%) and 139 females (58%). The mean age was 43.34 ± 15.86 years. This study reported the demographics, clinical characteristics, and treatment protocols of optic neuropathies in a neuro-ophthalmology specialty clinic at a tertiary referral center in Turkey during the past decade. The data may be useful in assessing the global status of optic neuropathies.

  11. A Typology for Modeling Processes in Clinical Guidelines and Protocols

    Science.gov (United States)

    Tu, Samson W.; Musen, Mark A.

    We analyzed the graphical representations that are used by various guideline-modeling methods to express process information embodied in clinical guidelines and protocols. From this analysis, we distilled four modeling formalisms and the processes they typically model: (1) flowcharts for capturing problem-solving processes, (2) disease-state maps that link decision points in managing patient problems over time, (3) plans that specify sequences of activities that contribute toward a goal, (4) workflow specifications that model care processes in an organization. We characterized the four approaches and showed that each captures some aspect of what a guideline may specify. We believe that a general guideline-modeling system must provide explicit representation for each type of process.

  12. Giving voice to study volunteers: comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research.

    Science.gov (United States)

    Roberts, Laura Weiss; Kim, Jane Paik

    2014-09-01

    Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical

  13. A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom.

    Science.gov (United States)

    Barbosa, Alexandre Naime; Boyer, Leslie; Chippaux, Jean-Philippe; Medolago, Natalia Bronzatto; Caramori, Carlos Antonio; Paixão, Ariane Gomes; Poli, João Paulo Vasconcelos; Mendes, Mônica Bannwart; Dos Santos, Lucilene Delazari; Ferreira, Rui Seabra; Barraviera, Benedito

    2017-01-01

    Envenomation caused by multiple stings from Africanized honeybees Apis mellifera constitutes a public health problem in the Americas. In 2015, the Brazilian Ministry of Health reported 13,597 accidents (incidence of seven cases per 100,000 inhabitants) with 39 deaths (lethality of 0.25%). The toxins present in the venom, which include melittin and phospholipase A 2 , cause lesions in diverse organs and systems that may be fatal. As there has been no specific treatment to date, management has been symptomatic and supportive only. In order to evaluate the safety and neutralizing capacity of a new apilic antivenom, as well as to confirm its lowest effective dose, a clinical protocol was developed to be applied in a multicenter, non-randomized and open phase I/II clinical trial. Twenty participants with more than five stings, aged more than 18 years, of both sexes, who have not previously received the heterologous serum against bee stings, will be included for 24 months. The proposed dose was based on the antivenom neutralizing capacity and the number of stings. Treatment will be administered only in a hospital environment and the participants will be evaluated for a period up to 30 days after discharge for clinical and laboratory follow-up. This protocol, approved by the Brazilian regulatory agencies for ethics (National Commission for Ethics on Research - CONEP) and sanitation (National Health Surveillance Agency - ANVISA), is a guideline constituted by specific, adjuvant, symptomatic and complementary treatments, in addition to basic orientations for conducting a clinical trial involving heterologous sera. This is the first clinical trial protocol designed specifically to evaluate the preliminary efficacy and safety of a new antivenom against stings from the Africanized honeybee Apis mellifera . The results will support future studies to confirm a new treatment for massive bee attack that has a large impact on public health in the Americas.

  14. A feasible repetitive transcranial magnetic stimulation clinical protocol in migraine prevention.

    Science.gov (United States)

    Zardouz, Shawn; Shi, Lei; Leung, Albert

    2016-01-01

    This case series was conducted to determine the clinical feasibility of a repetitive transcranial magnetic stimulation protocol for the prevention of migraine (with and without aura). Five patients with migraines underwent five repetitive transcranial magnetic stimulation sessions separated in 1- to 2-week intervals for a period of 2 months at a single tertiary medical center. Repetitive transcranial magnetic stimulation was applied to the left motor cortex with 2000 pulses (20 trains with 1s inter-train interval) delivered per session, at a frequency of 10 Hz and 80% resting motor threshold. Pre- and post-treatment numerical rating pain scales were collected, and percent reductions in intensity, frequency, and duration were generated. An average decrease in 37.8%, 32.1%, and 31.2% were noted in the intensity, frequency, and duration of migraines post-repetitive transcranial magnetic stimulation, respectively. A mean decrease in 1.9±1.0 (numerical rating pain scale ± standard deviation; range: 0.4-2.8) in headache intensity scores was noted after the repetitive transcranial magnetic stimulation sessions. The tested repetitive transcranial magnetic stimulation protocol is a well-tolerated, safe, and effective method for migraine prevention.

  15. SU-F-R-06: Traumatic Brachial Plexus Injury Imaging, Developing a Coherent Clinical Protocol From Literature Review Through Practice

    International Nuclear Information System (INIS)

    Wu, D; France, E; Lambert, J; Hinkle, J

    2016-01-01

    Purpose: Medical Physics teams can now play a critical role to help plan and provide studied approaches for traumatic brachial plexus MR imaging (tbpMRI). This is especially important for coordination with uncommon applications, since it is challenging to select the right modality, parameters, and train technologists on the essential components. For this work, we started with a review of the medical literature, performed crossover/volunteer studies to bring tbpMRI to practice with greater image QC and protocol management. Methods: To the best of our knowledge, we reviewed the known searchable domain for tbpMRI. We found 69 total articles since 2000. Articles were evaluated with our published protocol for literature management (LIMES3). Two physicists and two radiologists condensed the information from all articles into a knowledgebase. Results: The initial literature demonstrated great heterogeneity, which was a sign that this area needed greater consistency. Despite inconsistency and imprecision, we extracted the most relevant targets using our long-term experience with protocol development in MSK. We ran volunteers on six different magnets of various field strengths with multiple receiver coils, and rebuilt a coherent protocol for tbpMRI. Our radiologists rated LIMES3 work as superior. We have received referrals from the ER and have conducted four patient evaluations. Conclusion: Traumatic brachial plexus MRI has great possible benefits for patients. This work supports the complexity of tbpMRI scanning. As this is rarely performed, it requires a more diligent protocol workflow, coordination of caregivers, and education within multiple clinical departments. Choosing the correct imaging exam can be critical, as patients can have significant neuropathy and/or paralysis. The LIMES3 protocol is well liked at our institution, and forms the cornerstone of understanding for our work. Our literature management led to a better clinical protocol creation despite the diffuse

  16. SU-F-R-06: Traumatic Brachial Plexus Injury Imaging, Developing a Coherent Clinical Protocol From Literature Review Through Practice

    Energy Technology Data Exchange (ETDEWEB)

    Wu, D; France, E; Lambert, J; Hinkle, J [The University of Oklahoma Health Sciences Center, Oklahoma City, OK (United States)

    2016-06-15

    Purpose: Medical Physics teams can now play a critical role to help plan and provide studied approaches for traumatic brachial plexus MR imaging (tbpMRI). This is especially important for coordination with uncommon applications, since it is challenging to select the right modality, parameters, and train technologists on the essential components. For this work, we started with a review of the medical literature, performed crossover/volunteer studies to bring tbpMRI to practice with greater image QC and protocol management. Methods: To the best of our knowledge, we reviewed the known searchable domain for tbpMRI. We found 69 total articles since 2000. Articles were evaluated with our published protocol for literature management (LIMES3). Two physicists and two radiologists condensed the information from all articles into a knowledgebase. Results: The initial literature demonstrated great heterogeneity, which was a sign that this area needed greater consistency. Despite inconsistency and imprecision, we extracted the most relevant targets using our long-term experience with protocol development in MSK. We ran volunteers on six different magnets of various field strengths with multiple receiver coils, and rebuilt a coherent protocol for tbpMRI. Our radiologists rated LIMES3 work as superior. We have received referrals from the ER and have conducted four patient evaluations. Conclusion: Traumatic brachial plexus MRI has great possible benefits for patients. This work supports the complexity of tbpMRI scanning. As this is rarely performed, it requires a more diligent protocol workflow, coordination of caregivers, and education within multiple clinical departments. Choosing the correct imaging exam can be critical, as patients can have significant neuropathy and/or paralysis. The LIMES3 protocol is well liked at our institution, and forms the cornerstone of understanding for our work. Our literature management led to a better clinical protocol creation despite the diffuse

  17. Blockchain protocols in clinical trials: Transparency and traceability of consent [version 5; referees: 1 approved, 2 approved with reservations, 2 not approved

    Directory of Open Access Journals (Sweden)

    Mehdi Benchoufi

    2018-02-01

    Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security

  18. Blockchain protocols in clinical trials: Transparency and traceability of consent [version 4; referees: 1 approved, 2 approved with reservations, 2 not approved

    Directory of Open Access Journals (Sweden)

    Mehdi Benchoufi

    2017-12-01

    Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security

  19. Clinical outcome comparison of immediate blanket treatment versus a delayed pathogen-based treatment protocol for clinical mastitis in a New York dairy herd.

    Science.gov (United States)

    Vasquez, A K; Nydam, D V; Capel, M B; Eicker, S; Virkler, P D

    2017-04-01

    The purpose was to compare immediate intramammary antimicrobial treatment of all cases of clinical mastitis with a selective treatment protocol based on 24-h culture results. The study was conducted at a 3,500-cow commercial farm in New York. Using a randomized design, mild to moderate clinical mastitis cases were assigned to either the blanket therapy or pathogen-based therapy group. Cows in the blanket therapy group received immediate on-label intramammary treatment with ceftiofur hydrochloride for 5 d. Upon receipt of 24 h culture results, cows in the pathogen-based group followed a protocol automatically assigned via Dairy Comp 305 (Valley Agricultural Software, Tulare, CA): Staphylococcus spp., Streptococcus spp., or Enterococcus spp. were administered on-label intramammary treatment with cephapirin sodium for 1 d. Others, including cows with no-growth or gram-negative results, received no treatment. A total of 725 cases of clinical mastitis were observed; 114 cows were not enrolled due to severity. An additional 122 cases did not meet inclusion criteria. Distribution of treatments for the 489 qualifying events was equal between groups (pathogen-based, n = 246; blanket, n = 243). The proportions of cases assigned to the blanket and pathogen-based groups that received intramammary therapy were 100 and 32%, respectively. No significant differences existed between blanket therapy and pathogen-based therapy in days to clinical cure; means were 4.8 and 4.5 d, respectively. The difference in post-event milk production between groups was not statistically significant (blanket therapy = 34.7 kg; pathogen-based = 35.4 kg). No differences were observed in test-day linear scores between groups; least squares means of linear scores was 4.3 for pathogen-based cows and 4.2 for blanket therapy cows. Odds of survival 30 d postenrollment was similar between groups (odds ratio of pathogen-based = 1.6; 95% confidence interval: 0.7-3.7) as was odds of survival to 60 d (odds ratio

  20. Clinical Trials

    Medline Plus

    Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

  1. Clinical dosimetry in molecular radiotherapy: protocol optimization and clinical implementation

    International Nuclear Information System (INIS)

    Ferrer, Ludovic

    2011-01-01

    Molecular radiotherapy (mrt) consists in destructing tumour targets by radiolabelled vectors. This nuclear medicine specialty is being considered with increasing interest for example via the success achieved in the treatment of non-Hodgkin lymphomas by radioimmunotherapy. One of the keys of mrt optimization relies on the personalising of absorbed doses delivered to the patient: This is required to ascertain that irradiation is focused on tumour cells while keeping surrounding healthy tissue irradiation at an acceptable - non-toxic - level. Radiation dose evaluation in mrt requires in one hand, the spatial and temporal localization of injected radioactive sources by scintigraphic imaging, and on a second hand, the knowledge of the emitted radiation propagating media, given by CT imaging. Global accuracy relies on the accuracy of each of the steps that contribute to clinical dosimetry. There is no reference, standardized dosimetric protocol to date. Due to heterogeneous implementations, evaluation of the accuracy of the absorbed dose is a difficult task. In this thesis, we developed and evaluated different dosimetric approaches that allow us to find a relationship between the absorbed dose to the bone marrow and haematological toxicity. Besides, we built a scientific project, called DosiTest, which aims at evaluating the impact of the various step that contribute to the realization of a dosimetric study, by means of a virtual multicentric comparison based on Monte-Carlo modelling. (author) [fr

  2. A Randomized Trial of Comparing the Efficacy of Two Neurofeedback Protocols for Treatment of Clinical and Cognitive Symptoms of ADHD: Theta Suppression/Beta Enhancement and Theta Suppression/Alpha Enhancement

    Directory of Open Access Journals (Sweden)

    Arash Mohagheghi

    2017-01-01

    Full Text Available Introduction. Neurofeedback (NF is an adjuvant or alternative therapy for children with Attention Deficit Hyperactivity Disorder (ADHD. This study intended to compare the efficacy of two different NF protocols on clinical and cognitive symptoms of ADHD. Materials and Methods. In this clinical trial, sixty children with ADHD aged 7 to 10 years old were randomly grouped to receive two different NF treatments (theta suppression/beta enhancement protocol and theta suppression/alpha enhancement protocol. Clinical and cognitive assessments were conducted prior to and following the treatment and also after an eight-week follow-up. Results. Both protocols alleviated the symptoms of ADHD in general (p<0.001, hyperactivity (p<0.001, inattention (p<0.001, and omission errors (p<0.001; however, they did not affect the oppositional and impulsive scales nor commission errors. These effects were maintained after an eight-week intervention-free period. The only significant difference between the two NF protocols was that high-frequency alpha enhancement protocol performed better in suppressing omission errors (p<0.001. Conclusion. The two NF protocols with theta suppression/beta enhancement and theta suppression/alpha enhancement have considerable and comparable effect on clinical symptoms of ADHD. Alpha enhancement protocol was more effective in suppressing omission errors.

  3. Automation in an addiction treatment research clinic: computerised contingency management, ecological momentary assessment and a protocol workflow system.

    Science.gov (United States)

    Vahabzadeh, Massoud; Lin, Jia-Ling; Mezghanni, Mustapha; Epstein, David H; Preston, Kenzie L

    2009-01-01

    A challenge in treatment research is the necessity of adhering to protocol and regulatory strictures while maintaining flexibility to meet patients' treatment needs and to accommodate variations among protocols. Another challenge is the acquisition of large amounts of data in an occasionally hectic environment, along with the provision of seamless methods for exporting, mining and querying the data. We have automated several major functions of our outpatient treatment research clinic for studies in drug abuse and dependence. Here we describe three such specialised applications: the Automated Contingency Management (ACM) system for the delivery of behavioural interventions, the transactional electronic diary (TED) system for the management of behavioural assessments and the Protocol Workflow System (PWS) for computerised workflow automation and guidance of each participant's daily clinic activities. These modules are integrated into our larger information system to enable data sharing in real time among authorised staff. ACM and the TED have each permitted us to conduct research that was not previously possible. In addition, the time to data analysis at the end of each study is substantially shorter. With the implementation of the PWS, we have been able to manage a research clinic with an 80 patient capacity, having an annual average of 18,000 patient visits and 7300 urine collections with a research staff of five. Finally, automated data management has considerably enhanced our ability to monitor and summarise participant safety data for research oversight. When developed in consultation with end users, automation in treatment research clinics can enable more efficient operations, better communication among staff and expansions in research methods.

  4. Clinical outcomes and cost effectiveness of accelerated diagnostic protocol in a chest pain center compared with routine care of patients with chest pain.

    Science.gov (United States)

    Asher, Elad; Reuveni, Haim; Shlomo, Nir; Gerber, Yariv; Beigel, Roy; Narodetski, Michael; Eldar, Michael; Or, Jacob; Hod, Hanoch; Shamiss, Arie; Matetzky, Shlomi

    2015-01-01

    The aim of this study was to compare in patients presenting with acute chest pain the clinical outcomes and cost-effectiveness of an accelerated diagnostic protocol utilizing contemporary technology in a chest pain unit versus routine care in an internal medicine department. Hospital and 90-day course were prospectively studied in 585 consecutive low-moderate risk acute chest pain patients, of whom 304 were investigated in a designated chest pain center using a pre-specified accelerated diagnostic protocol, while 281 underwent routine care in an internal medicine ward. Hospitalization was longer in the routine care compared with the accelerated diagnostic protocol group (pdiagnostic protocol patients (98%) vs. 57 (20%) routine care patients underwent non-invasive testing, (pdiagnostic imaging testing was performed in 125 (44%) and 26 (9%) patients in the routine care and accelerated diagnostic protocol patients, respectively (pdiagnostic protocol patients compared with those receiving routine care was associated with a lower incidence of readmissions for chest pain [8 (3%) vs. 24 (9%), pdiagnostic protocol remained a predictor of lower acute coronary syndromes and readmissions after propensity score analysis [OR = 0.28 (CI 95% 0.14-0.59)]. Cost per patient was similar in both groups [($2510 vs. $2703 for the accelerated diagnostic protocol and routine care group, respectively, (p = 0.9)]. An accelerated diagnostic protocol is clinically superior and as cost effective as routine in acute chest pain patients, and may save time and resources.

  5. Relationships of clinical protocols and reconstruction kernels with image quality and radiation dose in a 128-slice CT scanner: Study with an anthropomorphic and water phantom

    International Nuclear Information System (INIS)

    Paul, Jijo; Krauss, B.; Banckwitz, R.; Maentele, W.; Bauer, R.W.; Vogl, T.J.

    2012-01-01

    Research highlights: ► Clinical protocol, reconstruction kernel, reconstructed slice thickness, phantom diameter or the density of material it contains directly affects the image quality of DSCT. ► Dual energy protocol shows the lowest DLP compared to all other protocols examined. ► Dual-energy fused images show excellent image quality and the noise is same as that of single- or high-pitch mode protocol images. ► Advanced CT technology improves image quality and considerably reduce radiation dose. ► An important finding is the comparatively higher DLP of the dual-source high-pitch protocol compared to other single- or dual-energy protocols. - Abstract: Purpose: The aim of this study was to explore the relationship of scanning parameters (clinical protocols), reconstruction kernels and slice thickness with image quality and radiation dose in a DSCT. Materials and methods: The chest of an anthropomorphic phantom was scanned on a DSCT scanner (Siemens Somatom Definition flash) using different clinical protocols, including single- and dual-energy modes. Four scan protocols were investigated: 1) single-source 120 kV, 110 mA s, 2) single-source 100 kV, 180 mA s, 3) high-pitch 120 kV, 130 mA s and 4) dual-energy with 100/Sn140 kV, eff.mA s 89, 76. The automatic exposure control was switched off for all the scans and the CTDIvol selected was in between 7.12 and 7.37 mGy. The raw data were reconstructed using the reconstruction kernels B31f, B80f and B70f, and slice thicknesses were 1.0 mm and 5.0 mm. Finally, the same parameters and procedures were used for the scanning of water phantom. Friedman test and Wilcoxon-Matched-Pair test were used for statistical analysis. Results: The DLP based on the given CTDIvol values showed significantly lower exposure for protocol 4, when compared to protocol 1 (percent difference 5.18%), protocol 2 (percent diff. 4.51%), and protocol 3 (percent diff. 8.81%). The highest change in Hounsfield Units was observed with dual

  6. Standardized terminology for clinical trial protocols based on top-level ontological categories.

    Science.gov (United States)

    Heller, B; Herre, H; Lippoldt, K; Loeffler, M

    2004-01-01

    This paper describes a new method for the ontologically based standardization of concepts with regard to the quality assurance of clinical trial protocols. We developed a data dictionary for medical and trial-specific terms in which concepts and relations are defined context-dependently. The data dictionary is provided to different medical research networks by means of the software tool Onto-Builder via the internet. The data dictionary is based on domain-specific ontologies and the top-level ontology of GOL. The concepts and relations described in the data dictionary are represented in natural language, semi-formally or formally according to their use.

  7. Clinical applicability and cutoff values for an unstructured neuropsychological assessment protocol for older adults with low formal education.

    Science.gov (United States)

    de Paula, Jonas Jardim; Bertola, Laiss; Ávila, Rafaela Teixeira; Moreira, Lafaiete; Coutinho, Gabriel; de Moraes, Edgar Nunes; Bicalho, Maria Aparecida Camargos; Nicolato, Rodrigo; Diniz, Breno Satler; Malloy-Diniz, Leandro Fernandes

    2013-01-01

    The neuropsychological exam plays a central role in the assessment of elderly patients with cognitive complaints. It is particularly relevant to differentiate patients with mild dementia from those subjects with mild cognitive impairment. Formal education is a critical factor in neuropsychological performance; however, there are few studies that evaluated the psychometric properties, especially criterion related validity, neuropsychological tests for patients with low formal education. The present study aims to investigate the validity of an unstructured neuropsychological assessment protocol for this population and develop cutoff values for clinical use. A protocol composed by the Rey-Auditory Verbal Learning Test, Frontal Assessment Battery, Category and Letter Fluency, Stick Design Test, Clock Drawing Test, Digit Span, Token Test and TN-LIN was administered to 274 older adults (96 normal aging, 85 mild cognitive impairment and 93 mild Alzheimer`s disease) with predominantly low formal education. Factor analysis showed a four factor structure related to Executive Functions, Language/Semantic Memory, Episodic Memory and Visuospatial Abilities, accounting for 65% of explained variance. Most of the tests showed a good sensitivity and specificity to differentiate the diagnostic groups. The neuropsychological protocol showed a significant ecological validity as 3 of the cognitive factors explained 31% of the variance on Instrumental Activities of Daily Living. The study presents evidence of the construct, criteria and ecological validity for this protocol. The neuropsychological tests and the proposed cutoff values might be used for the clinical assessment of older adults with low formal education.

  8. Automation in an Addiction Treatment Research Clinic: Computerized Contingency Management, Ecological Momentary Assessment, and a Protocol Workflow System

    Science.gov (United States)

    Vahabzadeh, Massoud; Lin, Jia-Ling; Mezghanni, Mustapha; Epstein, David H.; Preston, Kenzie L.

    2009-01-01

    Issues A challenge in treatment research is the necessity of adhering to protocol and regulatory strictures while maintaining flexibility to meet patients’ treatment needs and accommodate variations among protocols. Another challenge is the acquisition of large amounts of data in an occasionally hectic environment, along with provision of seamless methods for exporting, mining, and querying the data. Approach We have automated several major functions of our outpatient treatment research clinic for studies in drug abuse and dependence. Here we describe three such specialized applications: the Automated Contingency Management (ACM) system for delivery of behavioral interventions, the Transactional Electronic Diary (TED) system for management of behavioral assessments, and the Protocol Workflow System (PWS) for computerized workflow automation and guidance of each participant’s daily clinic activities. These modules are integrated into our larger information system to enable data sharing in real time among authorized staff. Key Findings ACM and TED have each permitted us to conduct research that was not previously possible. In addition, the time to data analysis at the end of each study is substantially shorter. With the implementation of the PWS, we have been able to manage a research clinic with an 80-patient capacity having an annual average of 18,000 patient-visits and 7,300 urine collections with a research staff of five. Finally, automated data management has considerably enhanced our ability to monitor and summarize participant-safety data for research oversight. Implications and conclusion When developed in consultation with end users, automation in treatment-research clinics can enable more efficient operations, better communication among staff, and expansions in research methods. PMID:19320669

  9. MR efficiency using automated MRI-desktop eProtocol

    Science.gov (United States)

    Gao, Fei; Xu, Yanzhe; Panda, Anshuman; Zhang, Min; Hanson, James; Su, Congzhe; Wu, Teresa; Pavlicek, William; James, Judy R.

    2017-03-01

    MRI protocols are instruction sheets that radiology technologists use in routine clinical practice for guidance (e.g., slice position, acquisition parameters etc.). In Mayo Clinic Arizona (MCA), there are over 900 MR protocols (ranging across neuro, body, cardiac, breast etc.) which makes maintaining and updating the protocol instructions a labor intensive effort. The task is even more challenging given different vendors (Siemens, GE etc.). This is a universal problem faced by all the hospitals and/or medical research institutions. To increase the efficiency of the MR practice, we designed and implemented a web-based platform (eProtocol) to automate the management of MRI protocols. It is built upon a database that automatically extracts protocol information from DICOM compliant images and provides a user-friendly interface to the technologists to create, edit and update the protocols. Advanced operations such as protocol migrations from scanner to scanner and capability to upload Multimedia content were also implemented. To the best of our knowledge, eProtocol is the first MR protocol automated management tool used clinically. It is expected that this platform will significantly improve the radiology operations efficiency including better image quality and exam consistency, fewer repeat examinations and less acquisition errors. These protocols instructions will be readily available to the technologists during scans. In addition, this web-based platform can be extended to other imaging modalities such as CT, Mammography, and Interventional Radiology and different vendors for imaging protocol management.

  10. Blockchain protocols in clinical trials: Transparency and traceability of consent [version 3; referees: 1 approved, 2 approved with reservations, 1 not approved

    Directory of Open Access Journals (Sweden)

    Mehdi Benchoufi

    2017-07-01

    Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain; thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each revision of the protocol, consent was sought again. We obtained a single document, in a standard open format, that accounted for the whole consent collection process: timestamped consent status with regards to each version of the protocol. This document cannot be corrupted, and can be checked on any dedicated public website. It should be considered as a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened in order to remove the need for third parties, here the trial stakeholders, and give participative control to the peer-to-peer users. In the future, we think that the complex data flow of a clinical trial can be tracked using Blockchain, that a blockchain core functionality, named Smart Contract, could help prevent clinical trial events not to happen in the right chronological order: for example including patients before they consented or analysing case report forms data before freezing the database

  11. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Benjamin Kasenda

    2016-06-01

    Full Text Available Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i the existence and types of publication agreements in trial protocols, (ii the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii the frequency of co-authorship by industry employees.We used a retrospective cohort of randomized clinical trials (RCTs based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5% mentioned an agreement regarding publication of results. Of these 456, 393 (86.2% documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6% agreements were without constraints of publication. The remaining 24 (5.3% protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0% trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]. Of 71 agreements reported in publications, 52 (73.2% were concordant with those documented in the protocol. In 14 of 37 (37.8% publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements.Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do

  12. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

    Science.gov (United States)

    Kasenda, Benjamin; von Elm, Erik; You, John J.; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J.; Stegert, Mihaela; Olu, Kelechi K.; Tikkinen, Kari A. O.; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M.; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

    2016-01-01

    Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on

  13. Varied Search Protocols Lead to Clinically Relevant Results. A review of: Patel, Manesh R., Connie M. Schardt, Linda L. Sanders, and Sheri A. Keitz. “Randomized Trial for Answers to Clinical Questions: Evaluating a Pre‐Appraised Versus a MEDLINE Search Protocol.” Journal of the Medical Library Association 94.4 (2006: 382‐6.

    Directory of Open Access Journals (Sweden)

    Marcy L. Brown

    2008-03-01

    Full Text Available Objective – To determine the success rate of electronic resources for answering clinical questions by comparing speed, validity, and applicability of two different protocols for searching the medical literature.Design – Randomized trial with results judged by blinded panel.Setting – Duke University Medical Center in Durham, North Carolina, United States ofAmerica.Subjects – Thirty‐two 2nd and 3rd year internal medicine residents on an eight week general medicine rotation at the Duke University Medical Center.Methods – Two search protocols were developed:Protocol A: Participants searched MEDLINE first, and then searched pre‐appraised resources if needed.Protocol B: Participants searched pre‐appraised resources first, which included UpToDate, ACP JournalClub, Cochrane Database of Systematic Reviews, and DARE. The residents then searched MEDLINE if an answer could not be found in the 66 initial group of pre‐appraised resources. Residents were randomised by computer-assisted block order into four blocks of eight residents each. Two blocks were assigned to Protocol A, and two to Protocol B. Each day, residents developed at least one clinical question related to caring for patients. The questions were transcribed onto pocket-sized cards, with the answer sought later using the assigned protocol. If answers weren’t found using either protocol, searches were permitted in other available resources. When an article that answered a question was found, the resident recorded basic information about the question and the answer as well as the time required to find the answer (less than five minutes; between five and ten minutes; or more than ten minutes. Residents were to select answers that were “methodologically sound and clinically important” (384. Ten faculty members formally trained in evidence‐based medicine (EBM reviewed a subset of therapy‐related questions and answers. The reviewers, who were blinded to the search protocols

  14. Clinical protocol levels are required in laboratory animal surgery when using medical devices: experiences with ureteral replacement surgery in goats.

    Science.gov (United States)

    de Jonge, Paul K J D; Sloff, Marije; Janke, Heinz P; Kortmann, Barbara B M; de Gier, Robert P E; Geutjes, Paul J; Oosterwijk, Egbert; Feitz, Wout F J

    2017-10-01

    It is common to test medical devices in large animal studies that are or could also be used in humans. In this short report we describe the use of a ureteral J-stent for the evaluation of biodegradable tubular constructs for tissue reconstruction, and the regeneration of ureters in Saanen goats. Similarly to a previous study in pigs, the ureteral J-stent was blindly inserted until some resistance was met. During evaluation of the goats after three months, perforation of the renal cortex by the stent was observed in four out of seven animals. These results indicated that blind stent placement was not possible in goats. In four new goats, clinical protocols were followed using X-ray and iodinated contrast fluids to visualize the kidney and stent during stent placement. With this adaptation the stents were successfully placed in the kidneys of these four new goats with minimal additional effort. It is likely that other groups in other fields ran into similar problems that could have been avoided by following clinical protocols. Therefore, we would like to stress the importance of following clinical protocols when using medical devices in animals to prevent unnecessary suffering and to reduce the number of animals needed.

  15. PROPOSAL OF GUIDELINE FOR CLINICAL TRIAL PROTOCOLS WITH HERBAL DRUGS

    Directory of Open Access Journals (Sweden)

    Migdacelys Arboláez Estrada.

    2007-04-01

    Full Text Available SUMMARYCuba has extensive experience about herbal drugs, however only a few products get to the clinical phase of drug development. Our objective was to design new guidelines for clinical trials with herbal drugs.A detailed bibliographic search about regulatory aspects about clinical trials in Cuba and the world was done for development of the guideline. The guideline's proposed format includes: 1 Index, including the classification of the content. 2 Summary, 3 Fifteen chapters, related to the clinical trials. The guideline also propose the inclusion of annexes.A new guideline containing 15 chapters allows for writing more clear and detailed clinical trial protocols. The guideline contains the information required to guide the research staff who is interested in the validation of herbal drugs pharmacological activations from the perspective of clinical trials. RESUMEN Cuba tiene experiencia extensa sobre plantas medicinales, aunque solo algunos productos llegan a una fase clínica del desarrollo. Nuestro objetivo fué diseñar una nueva guía para ensayos clínicos con plantas medicinales.Hemos realizado una detallada búsqueda bibliográfica sobre aspectos reguladores de ensayos clínicos en Cuba y el resto del mundo para el desarrollo de la guía. El formato propuesto de la guia incluye: 1 Índice, incluyendo la clasificación de los contenidos. 2 Resumen, 3 Quince capítulos, relacionados con los ensayos clínicos. La guía también propone la inclusión de anexos.La nueva guía que contiene 15 capítulos que orientan la redacción de protocolos de ensayos clínicos más claros y más detallados. La guía contiene la información requerida para orientar al personal investigador interesado en la validación de la actividad farmacológica de las plantas medicinales desde la perspectiva de los ensayos clínicos.

  16. Barriers and strategies for the clinical translation of advanced orthopaedic tissue engineering protocols.

    Science.gov (United States)

    Madry, H; Alini, M; Stoddart, M J; Evans, C; Miclau, T; Steiner, S

    2014-05-06

    Research in orthopaedic tissue engineering has intensified over the last decade and new protocols continue to emerge. The clinical translation of these new applications, however, remains associated with a number of obstacles. This report highlights the major issues that impede the clinical translation of advanced tissue engineering concepts, discusses strategies to overcome these barriers, and examines the need to increase incentives for translational strategies. The statements are based on presentations and discussions held at the AO Foundation-sponsored symposium "Where Science meets Clinics 2013" held at the Congress Center in Davos, Switzerland, in September, 2013. The event organisers convened a diverse group of over one hundred stakeholders involved in clinical translation of orthopaedic tissue engineering, including scientists, clinicians, healthcare industry professionals and regulatory agency representatives. A major point that emerged from the discussions was that there continues to be a critical need for early trans-disciplinary communication and collaboration in the development and execution of research approaches. Equally importantly was the need to address the shortage of sustained funding programs for multidisciplinary teams conducting translational research. Such detailed discussions between experts contribute towards the development of a roadmap to more successfully advance the clinical translation of novel tissue engineering concepts and ultimately improve patient care in orthopaedic and trauma surgery.

  17. Barriers and strategies for the clinical translation of advanced orthopaedic tissue engineering protocols

    Directory of Open Access Journals (Sweden)

    H Madry

    2014-05-01

    Full Text Available Research in orthopaedic tissue engineering has intensified over the last decade and new protocols continue to emerge. The clinical translation of these new applications, however, remains associated with a number of obstacles. This report highlights the major issues that impede the clinical translation of advanced tissue engineering concepts, discusses strategies to overcome these barriers, and examines the need to increase incentives for translational strategies. The statements are based on presentations and discussions held at the AO Foundation-sponsored symposium "Where Science meets Clinics 2013" held at the Congress Center in Davos, Switzerland, in September, 2013. The event organisers convened a diverse group of over one hundred stakeholders involved in clinical translation of orthopaedic tissue engineering, including scientists, clinicians, healthcare industry professionals and regulatory agency representatives. A major point that emerged from the discussions was that there continues to be a critical need for early trans-disciplinary communication and collaboration in the development and execution of research approaches. Equally importantly was the need to address the shortage of sustained funding programs for multidisciplinary teams conducting translational research. Such detailed discussions between experts contribute towards the development of a roadmap to more successfully advance the clinical translation of novel tissue engineering concepts and ultimately improve patient care in orthopaedic and trauma surgery.

  18. Economic comparison of common treatment protocols and J5 vaccination for clinical mastitis in dairy herds using optimized culling decisions.

    Science.gov (United States)

    Kessels, J A; Cha, E; Johnson, S K; Welcome, F L; Kristensen, A R; Gröhn, Y T

    2016-05-01

    This study used an existing dynamic optimization model to compare costs of common treatment protocols and J5 vaccination for clinical mastitis in US dairy herds. Clinical mastitis is an infection of the mammary gland causing major economic losses in dairy herds due to reduced milk production, reduced conception, and increased risk of mortality and culling for infected cows. Treatment protocols were developed to reflect common practices in dairy herds. These included targeted therapy following pathogen identification, and therapy without pathogen identification using a broad-spectrum antimicrobial or treating with the cheapest treatment option. The cost-benefit of J5 vaccination was also estimated. Effects of treatment were accounted for as changes in treatment costs, milk loss due to mastitis, milk discarded due to treatment, and mortality. Following ineffective treatments, secondary decisions included extending the current treatment, alternative treatment, discontinuing treatment, and pathogen identification followed by recommended treatment. Average net returns for treatment protocols and vaccination were generated using an existing dynamic programming model. This model incorporates cow and pathogen characteristics to optimize management decisions to treat, inseminate, or cull cows. Of the treatment protocols where 100% of cows received recommended treatment, pathogen-specific identification followed by recommended therapy yielded the highest average net returns per cow per year. Out of all treatment scenarios, the highest net returns were achieved with selecting the cheapest treatment option and discontinuing treatment, or alternate treatment with a similar spectrum therapy; however, this may not account for the full consequences of giving nonrecommended therapies to cows with clinical mastitis. Vaccination increased average net returns in all scenarios. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  19. Sensitivity Analysis of Per-Protocol Time-to-Event Treatment Efficacy in Randomized Clinical Trials

    Science.gov (United States)

    Gilbert, Peter B.; Shepherd, Bryan E.; Hudgens, Michael G.

    2013-01-01

    Summary Assessing per-protocol treatment effcacy on a time-to-event endpoint is a common objective of randomized clinical trials. The typical analysis uses the same method employed for the intention-to-treat analysis (e.g., standard survival analysis) applied to the subgroup meeting protocol adherence criteria. However, due to potential post-randomization selection bias, this analysis may mislead about treatment efficacy. Moreover, while there is extensive literature on methods for assessing causal treatment effects in compliers, these methods do not apply to a common class of trials where a) the primary objective compares survival curves, b) it is inconceivable to assign participants to be adherent and event-free before adherence is measured, and c) the exclusion restriction assumption fails to hold. HIV vaccine efficacy trials including the recent RV144 trial exemplify this class, because many primary endpoints (e.g., HIV infections) occur before adherence is measured, and nonadherent subjects who receive some of the planned immunizations may be partially protected. Therefore, we develop methods for assessing per-protocol treatment efficacy for this problem class, considering three causal estimands of interest. Because these estimands are not identifiable from the observable data, we develop nonparametric bounds and semiparametric sensitivity analysis methods that yield estimated ignorance and uncertainty intervals. The methods are applied to RV144. PMID:24187408

  20. The Dysphagia in Stroke Protocol Reduces Aspiration Pneumonia in Patients with Dysphagia Following Acute Stroke: a Clinical Audit.

    Science.gov (United States)

    Perry, Sarah E; Miles, Anna; Fink, John N; Huckabee, Maggie-Lee

    2018-03-30

    Cough reflex testing has been evaluated as a component of the clinical swallowing assessment as a means of identifying patients at risk of aspiration during swallowing. A previous study by our research group found good sensitivity and specificity of the cough reflex test for identifying patients at risk of aspiration post-stroke, yet its use did not decrease pneumonia rates, contrary to previous reports. The aim of this study was to expand on our earlier work by implementing a clinical management protocol incorporating cough reflex testing within the same healthcare setting and compare patient outcomes to those from the original study and to evaluate clinical outcomes in patients with acute stroke who were managed using the Dysphagia in Stroke Protocol (DiSP). Secondarily, to compare those outcomes to historical data prior to implementation of the DiSP. This clinical audit measured outcomes from 284 patients with acute stroke managed per the DiSP, which guides use of videofluoroscopic swallowing study and patient management based on clinical exam with cough reflex testing. Data from our previous trial were included for comparison of pre- and post-DiSP patient outcomes. Data collection took place between November 2012 and April 2016 at four urban hospitals within New Zealand. Following implementation of the DiSP, the rate of aspiration pneumonia (10%) was substantially lower than the pre-DiSP rate (28%), with no pneumonia readmissions within 3 months. Pneumonia-related mortality was unchanged. By 3 months, 81% of the patients were on a normal diet and 67% had returned home, compared to pre-DiSP outcomes of 55% and 55% respectively. Previous work has suggested that simply implementing cough reflex testing in dysphagia management may not be sufficient to improve patient outcomes. The present study adds to this picture by suggesting that the true variable of influence may be the way in which the results of the test are applied to patient care. There is a strong case

  1. Low-dose single acquisition rest 99mTc/stress 201Tl myocardial perfusion SPECT protocol: phantom studies and clinical validation

    International Nuclear Information System (INIS)

    Dey, Thomas; Backus, Barbra E.; Romijn, R.Leo; Wieczorek, Herfried; Verzijlbergen, J.F.

    2014-01-01

    We developed and tested a single acquisition rest 99m Tc-sestamibi/stress 201 Tl dual isotope protocol (SDI) with the intention of improving the clinical workflow and patient comfort of myocardial perfusion single photon emission computed tomography (SPECT). The technical feasibility of SDI was evaluated by a series of anthropomorphic phantom studies on a standard SPECT camera. The attenuation map was created by a moving transmission line source. Iterative reconstruction including attenuation correction, resolution recovery and Monte Carlo simulation of scatter was used for simultaneous reconstruction of dual tracer distribution. For clinical evaluation, patient studies were compared to stress 99m Tc and rest 99m Tc reference images acquired in a 2-day protocol. Clinical follow-up examinations like coronary angiography (CAG) and fractional flow reserve (FFR) were included in the assessment if available. Phantom studies demonstrated the technical feasibility of SDI. Artificial lesions inserted in the phantom mimicking ischaemia could be clearly identified. In 51/53 patients, the image quality was adequate for clinical evaluation. For the remaining two obese patients with body mass index > 32 the injected 201 Tl dose of 74 MBq was insufficient for clinical assessment. In answer to this the 201 Tl dose was adapted for obese patients in the rest of the study. In 31 patients, SDI and 99m Tc reference images resulted in equivalent clinical assessment. Significant differences were found in 20 patients. In 18 of these 20 patients additional examinations were available. In 15 patients the diagnosis based on the SDI images was confirmed by the results of CAG or FFR. In these patients the SDI images were more accurate than the 99m Tc reference study. In three patients minor ischaemic lesions were detected by SDI but were not confirmed by CAG. In one of these cases this was probably caused by pronounced apical thinning. For two patients no relevant clinical follow

  2. Impact of using a local protocol in preoperative testing: blind randomized clinical trial.

    Science.gov (United States)

    Santos, Mônica Loureiro; Iglesias, Antônio Carlos

    2017-01-01

    to evaluate the impact of the use of a local protocol of preoperative test requests in reducing the number of exams requested and in the occurrence of changes in surgical anesthetic management and perioperative complications. we conducted a randomized, blinded clinical trial at the Gaffrée and Guinle University Hospital with 405 patients candidates for elective surgery randomly divided into two groups, according to the practice of requesting preoperative exams: a group with non-selectively requested exams and a protocol group with exams requested according to the study protocol. Studied exams: complete blood count, coagulogram, glycemia, electrolytes, urea and creatinine, ECG and chest X-ray. Primary outcomes: changes in surgical anesthetic management caused by abnormal exams, reduction of the number of exams requested after the use of the protocol and perioperative complications. there was a significant difference (pgrupos segundo a prática de solicitação de exames pré-operatórios: grupo Rotina com exames solicitados de maneira não seletiva e grupo Protocolo com exames solicitados de acordo com o protocolo em estudo. Exames em estudo: hemograma, coagulograma, glicemia, eletrólitos, ureia e creatinina, ECG e radiografia de tórax. Desfechos primários: alterações na conduta anestésico-cirúrgica motivadas por exames anormais, redução do número de exames solicitados após o uso do protocolo e complicações perioperatórias. foi observada diferença significativa (pgrupos (14,9% x 29,1%) e redução de 57,3% no número de exames pedidos entre os dois grupos (pgrupos. Na análise multivariada hemograma e coagulograma foram os únicos exames capazes de modificar a conduta anestésico-cirúrgica. o protocolo proposto foi efetivo em eliminar um quantitativo significativo de exames complementares sem indicação clínica, sem que houvesse aumento na morbidade e mortalidades perioperatórias.

  3. [Effect of a multidisciplinar protocol on the clinical results obtained after bariatric surgery].

    Science.gov (United States)

    Cánovas Gaillemin, B; Sastre Martos, J; Moreno Segura, G; Llamazares Iglesias, O; Familiar Casado, C; Abad de Castro, S; López Pardo, R; Sánchez-Cabezudo Muñoz, M A

    2011-01-01

    Bariatric surgery has been shown to be an effective therapy for weight loss in patients with severe obesity, and the implementation of a multidisciplinar management protocol is recommended. To assess the usefulness of the implementation of a management protocol in obesity surgery based on the Spanish Consensus Document of the SEEDO. Retrospective comparative study of the outcomes in patients previously operated (51 patients) and after the implementation of the protocol (66 patients). The following data were gathered: anthropometry, pre-and post-surgery comorbidities, post-surgical nutritional and surgical complications, validated Quality of Life questionnaire, and dietary habits. Withdrawals (l7.6%) and alcoholism (5.8%) were higher in patients pre- versus post-implementation of the protocol (4.5% vs. 3%, respectively), the differences being statistically significant. The mortality rate was 2% in the pre-protocol group and 0% in the postprotocol group. The dietary habits were better in the post-protocol group, the pre-protocol group presenting a higher percentage of feeding-behavior disorders (5.1%) although not reaching a statistical significance. The improvement in quality of life was higher in the post-protocol group for all items, but only reaching statistical significance in sexual activity (p = 0.004). In the pre-protocol group, 70.5% of the patients had more than one nutritional complication vs. 32.8% in the post-protocol group (p 50% in 81.3% in the pre-protocol group vs. 74.8% in the pos-protocol group) or the comorbidities. Bariatric surgery achieves excellent outcomes in weight loss, comorbidities, and quality of life, but presents nutritional, surgical, and psychiatric complications that require a protocol-based and multidisciplinary approach. Our protocol improves the outcomes regarding the withdrawal rates, feeding-behavior disorders, dietary habits, nutritional complications, and quality of life.

  4. Validation of the Tensoval Duo Control II blood pressure monitor for clinic use and self-measurement according to the British Hypertension Society protocol and the European Society of Hypertension International Protocol Revision 2010.

    Science.gov (United States)

    de Greeff, Annemarie; Shennan, Andrew H

    2013-06-01

    The Tensoval Duo Control II is an automated upper arm device that uses a combination of oscillometric and auscultatory technology to determine blood pressure noninvasively. The accuracy of this device was assessed according to the British Hypertension Society (BHS) protocol and the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in an adult population. Ethical approval was obtained. Eighty-five and 33 adult individuals, respectively, were recruited to fulfil the requirements of each protocol. Trained observers took nine sequential same-arm measurements alternating between a mercury sphygmomanometer and the device. The device had to achieve at least a B grade for both systolic and diastolic pressures to pass the BHS protocol and had to fulfil the criteria of all three phases of the ESH-IP2 protocol to receive recommendation. The device achieved an A/A grading for the BHS protocol and passed all three phases of the ESH-IP2 protocol. The mean difference±SD for the BHS/ESH protocols, respectively, was -1.8±6.5/-0.7±5.7 mmHg for systolic pressure and 1.9±5.1/2.4±4.5 mmHg for diastolic pressure. The device maintained its A/A grading throughout the low-pressure, medium-pressure and high-pressure ranges. The Tensoval Duo Control II device is recommended for clinical and home use according to both the BHS and the ESH-IP2 standard.

  5. A clinical protocol to increase chewing and assess mastication in children with feeding disorders.

    Science.gov (United States)

    Volkert, Valerie M; Peterson, Kathryn M; Zeleny, Jason R; Piazza, Cathleen C

    2014-09-01

    Children with feeding disorders often cannot or do not chew when presented with table food. Children with chewing deficits also often swallow the bite before masticating it appropriately, which we will refer to as early swallowing. In the current study, we evaluated a clinical protocol to increase chews per bite, assess mastication, and eliminate early swallowing with three children with feeding disorders. The current study adds to a small body of literature on chewing and mastication of children with feeding disorders. Suggestions for future research are also discussed. © The Author(s) 2014.

  6. Glenoid version by CT scan: an analysis of clinical measurement error and introduction of a protocol to reduce variability

    Energy Technology Data Exchange (ETDEWEB)

    Bunt, Fabian van de [VU University Medical Center, Amsterdam (Netherlands); Pearl, Michael L.; Lee, Eric K.; Peng, Lauren; Didomenico, Paul [Kaiser Permanente, Los Angeles, CA (United States)

    2015-11-15

    Recent studies have challenged the accuracy of conventional measurements of glenoid version. Variability in the orientation of the scapula from individual anatomical differences and patient positioning, combined with differences in observer measurement practices, have been identified as sources of variability. The purpose of this study was to explore the utility and reliability of clinically available software that allows manipulation of three-dimensional images in order to bridge the variance between clinical and anatomic version in a clinical setting. Twenty CT scans of normal glenoids of patients who had proximal humerus fractures were measured for version. Four reviewers first measured version in a conventional manner (clinical version), measurements were made again (anatomic version) after employing a protocol for reformatting the CT data to align the coronal and sagittal planes with the superior-inferior axis of the glenoid, and the scapular body, respectively. The average value of clinical retroversion for all reviewers and all subjects was -1.4 (range, -16 to 21 ), as compared to -3.2 (range, -21 to 6 ) when measured from reformatted images. The mean difference between anatomical and clinical version was 1.9 ± 5.6 but ranged on individual measurements from -13 to 26 . In no instance did all four observers choose the same image slice from the sequence of images. This study confirmed the variation in glenoid version dependent on scapular orientation previously identified in other studies using scapular models, and presents a clinically accessible protocol to correct for scapular orientation from the patient's CT data. (orig.)

  7. Glenoid version by CT scan: an analysis of clinical measurement error and introduction of a protocol to reduce variability

    International Nuclear Information System (INIS)

    Bunt, Fabian van de; Pearl, Michael L.; Lee, Eric K.; Peng, Lauren; Didomenico, Paul

    2015-01-01

    Recent studies have challenged the accuracy of conventional measurements of glenoid version. Variability in the orientation of the scapula from individual anatomical differences and patient positioning, combined with differences in observer measurement practices, have been identified as sources of variability. The purpose of this study was to explore the utility and reliability of clinically available software that allows manipulation of three-dimensional images in order to bridge the variance between clinical and anatomic version in a clinical setting. Twenty CT scans of normal glenoids of patients who had proximal humerus fractures were measured for version. Four reviewers first measured version in a conventional manner (clinical version), measurements were made again (anatomic version) after employing a protocol for reformatting the CT data to align the coronal and sagittal planes with the superior-inferior axis of the glenoid, and the scapular body, respectively. The average value of clinical retroversion for all reviewers and all subjects was -1.4 (range, -16 to 21 ), as compared to -3.2 (range, -21 to 6 ) when measured from reformatted images. The mean difference between anatomical and clinical version was 1.9 ± 5.6 but ranged on individual measurements from -13 to 26 . In no instance did all four observers choose the same image slice from the sequence of images. This study confirmed the variation in glenoid version dependent on scapular orientation previously identified in other studies using scapular models, and presents a clinically accessible protocol to correct for scapular orientation from the patient's CT data. (orig.)

  8. SPECT/CT workflow and imaging protocols

    Energy Technology Data Exchange (ETDEWEB)

    Beckers, Catherine [University Hospital of Liege, Division of Nuclear Medicine and Oncological Imaging, Department of Medical Physics, Liege (Belgium); Hustinx, Roland [University Hospital of Liege, Division of Nuclear Medicine and Oncological Imaging, Department of Medical Physics, Liege (Belgium); Domaine Universitaire du Sart Tilman, Service de Medecine Nucleaire et Imagerie Oncologique, CHU de Liege, Liege (Belgium)

    2014-05-15

    Introducing a hybrid imaging method such as single photon emission computed tomography (SPECT)/CT greatly alters the routine in the nuclear medicine department. It requires designing new workflow processes and the revision of original scheduling process and imaging protocols. In addition, the imaging protocol should be adapted for each individual patient, so that performing CT is fully justified and the CT procedure is fully tailored to address the clinical issue. Such refinements often occur before the procedure is started but may be required at some intermediate stage of the procedure. Furthermore, SPECT/CT leads in many instances to a new partnership with the radiology department. This article presents practical advice and highlights the key clinical elements which need to be considered to help understand the workflow process of SPECT/CT and optimise imaging protocols. The workflow process using SPECT/CT is complex in particular because of its bimodal character, the large spectrum of stakeholders, the multiplicity of their activities at various time points and the need for real-time decision-making. With help from analytical tools developed for quality assessment, the workflow process using SPECT/CT may be separated into related, but independent steps, each with its specific human and material resources to use as inputs or outputs. This helps identify factors that could contribute to failure in routine clinical practice. At each step of the process, practical aspects to optimise imaging procedure and protocols are developed. A decision-making algorithm for justifying each CT indication as well as the appropriateness of each CT protocol is the cornerstone of routine clinical practice using SPECT/CT. In conclusion, implementing hybrid SPECT/CT imaging requires new ways of working. It is highly rewarding from a clinical perspective, but it also proves to be a daily challenge in terms of management. (orig.)

  9. SPECT/CT workflow and imaging protocols

    International Nuclear Information System (INIS)

    Beckers, Catherine; Hustinx, Roland

    2014-01-01

    Introducing a hybrid imaging method such as single photon emission computed tomography (SPECT)/CT greatly alters the routine in the nuclear medicine department. It requires designing new workflow processes and the revision of original scheduling process and imaging protocols. In addition, the imaging protocol should be adapted for each individual patient, so that performing CT is fully justified and the CT procedure is fully tailored to address the clinical issue. Such refinements often occur before the procedure is started but may be required at some intermediate stage of the procedure. Furthermore, SPECT/CT leads in many instances to a new partnership with the radiology department. This article presents practical advice and highlights the key clinical elements which need to be considered to help understand the workflow process of SPECT/CT and optimise imaging protocols. The workflow process using SPECT/CT is complex in particular because of its bimodal character, the large spectrum of stakeholders, the multiplicity of their activities at various time points and the need for real-time decision-making. With help from analytical tools developed for quality assessment, the workflow process using SPECT/CT may be separated into related, but independent steps, each with its specific human and material resources to use as inputs or outputs. This helps identify factors that could contribute to failure in routine clinical practice. At each step of the process, practical aspects to optimise imaging procedure and protocols are developed. A decision-making algorithm for justifying each CT indication as well as the appropriateness of each CT protocol is the cornerstone of routine clinical practice using SPECT/CT. In conclusion, implementing hybrid SPECT/CT imaging requires new ways of working. It is highly rewarding from a clinical perspective, but it also proves to be a daily challenge in terms of management. (orig.)

  10. EORTC recommended protocol for melanoma sentinel lymph node sectioning misclassifies up to 50% of the patients compared with complete step sectioning. Danish Society for Pathological Anatomy and Clinical Cytology

    DEFF Research Database (Denmark)

    Riber-Hansen, Rikke; Hastrup, N; Clemmensen, O.

    2010-01-01

    EORTC recommended protocol for melanoma sentinel lymph node sectioning misclassifies up to 50% of the patients compared with complete step sectioning. Danish Society for Pathological Anatomy and Clinical Cytology......EORTC recommended protocol for melanoma sentinel lymph node sectioning misclassifies up to 50% of the patients compared with complete step sectioning. Danish Society for Pathological Anatomy and Clinical Cytology...

  11. BRIDG: a domain information model for translational and clinical protocol-driven research.

    Science.gov (United States)

    Becnel, Lauren B; Hastak, Smita; Ver Hoef, Wendy; Milius, Robert P; Slack, MaryAnn; Wold, Diane; Glickman, Michael L; Brodsky, Boris; Jaffe, Charles; Kush, Rebecca; Helton, Edward

    2017-09-01

    It is critical to integrate and analyze data from biological, translational, and clinical studies with data from health systems; however, electronic artifacts are stored in thousands of disparate systems that are often unable to readily exchange data. To facilitate meaningful data exchange, a model that presents a common understanding of biomedical research concepts and their relationships with health care semantics is required. The Biomedical Research Integrated Domain Group (BRIDG) domain information model fulfills this need. Software systems created from BRIDG have shared meaning "baked in," enabling interoperability among disparate systems. For nearly 10 years, the Clinical Data Standards Interchange Consortium, the National Cancer Institute, the US Food and Drug Administration, and Health Level 7 International have been key stakeholders in developing BRIDG. BRIDG is an open-source Unified Modeling Language-class model developed through use cases and harmonization with other models. With its 4+ releases, BRIDG includes clinical and now translational research concepts in its Common, Protocol Representation, Study Conduct, Adverse Events, Regulatory, Statistical Analysis, Experiment, Biospecimen, and Molecular Biology subdomains. The model is a Clinical Data Standards Interchange Consortium, Health Level 7 International, and International Standards Organization standard that has been utilized in national and international standards-based software development projects. It will continue to mature and evolve in the areas of clinical imaging, pathology, ontology, and vocabulary support. BRIDG 4.1.1 and prior releases are freely available at https://bridgmodel.nci.nih.gov . © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  12. Protocol Adherence for Severe Sepsis and Septic Shock Management in the Emergency Department; a Clinical Audit

    Directory of Open Access Journals (Sweden)

    Mostafa Alavi-Moghaddam

    2016-12-01

    Full Text Available Introduction: Although significant development in the field of medicine is achieved, sepsis is still a major issue threatening humans’ lives. This study was aimed to audit the management of severe sepsis and septic shock patients in emergency department (ED according to the present standard guidelines.Method: This is a prospective audit on approaching adult septic patients who were admitted to ED. The audit checklist was created based on the protocols of Surviving Sepsis Campaign and British Royal College recommendations. The mean knowledge score and the compliance rate of studied measures regarding standard protocols were calculated using SPSS version 21.Results: 30 emergency medicine residents were audited (63.3% male. The mean knowledge score of studied residents regarding standard guidelines were 5.07 ± 1.78 (IQR = 2 in pre education and 8.17 ± 1.31 (IQR = 85 in post education phase (p < 0.001. There was excellent compliance with standard in 4 (22% studied measures, good in 2 (11%, fair in 1 (6%, weak in 2 (11%, and poor in 9 (50%. 64% of poor compliance measures correlated to therapeutic factors. After training, score of 5 measures including checking vital signs in < 20 minute, central vein pressure measurement in < 1 hour, blood culture request, administration of vasopressor agents, and high flow O2 therapy were improved clinically, but not statistically.Conclusion: The protocol adherence in management of severe sepsis and septic shock for urine output measurement, central venous pressure monitoring, administration of inotrope agents, blood transfusion, intravenous antibiotic and hydration therapy, and high flow O2 delivery were disappointingly low. It seems training workshops and implementation of Clinical audit can improve residents’ adherence to current standard guidelines regarding severe sepsis and septic shock.

  13. Clinical benefits of incorporating doxycycline into a canine heartworm treatment protocol.

    Science.gov (United States)

    Nelson, C Thomas; Myrick, Elizabeth S; Nelson, Thomas A

    2017-11-09

    The objective of heartworm treatment is to improve the clinical condition of the patient and to eliminate pre-cardiac, juvenile, and adult worm stages with minimal complications. Pulmonary thromboembolisms are an inevitable consequence of worm death and can result in severe pulmonary reactions and even death of the patient. To minimize these reactions, various treatment protocols involving melarsomine, the only adulticidal drug approved by the US Food and Drug Administrations (FDA), in conjunction with macrocyclic lactone heartworm preventives and glucocorticosteroids have been advocated. The discovery of the bacterial endosymbiont Wolbachia in Dirofilaria immitis has led to several experimental studies examining the effects of administering doxycycline to reduce or eliminate Wolbachia organism. These studies have shown a decrease in gross and microscopic pathology of pulmonary parenchyma in experimental heartworm infections pretreated with doxycycline before melarsomine administration. Electronic medical records from a large veterinary practice in northeast Alabama were searched to identify dogs treated for heartworms with melarsomine from January 2005 through December 2012. The search was refined further to select for dogs that met the following criteria: 1) received two or three doses of ivermectin heartworm preventive prior to melarsomine injections, 2) received one injection of melarsomine followed by two injections 4 to 8 weeks later, and 3) were treated with prednisone following melarsomine injections. The dogs were then divided into those that also were treated with doxycycline 10 mg/kg BID for 4 weeks (Group A, n = 47) and those that did not receive doxycycline (Group B, n = 47). The medical notes of all 94 cases were then reviewed for comments concerning coughing, dyspnea, or hemoptysis in the history, physical exam template, or from telephone conversations with clients the week following each visit. Any dog that died within one year of treatment

  14. Clinical benefits of incorporating doxycycline into a canine heartworm treatment protocol

    Directory of Open Access Journals (Sweden)

    C. Thomas Nelson

    2017-11-01

    Full Text Available Abstract Background The objective of heartworm treatment is to improve the clinical condition of the patient and to eliminate pre-cardiac, juvenile, and adult worm stages with minimal complications. Pulmonary thromboembolisms are an inevitable consequence of worm death and can result in severe pulmonary reactions and even death of the patient. To minimize these reactions, various treatment protocols involving melarsomine, the only adulticidal drug approved by the US Food and Drug Administrations (FDA, in conjunction with macrocyclic lactone heartworm preventives and glucocorticosteroids have been advocated. The discovery of the bacterial endosymbiont Wolbachia in Dirofilaria immitis has led to several experimental studies examining the effects of administering doxycycline to reduce or eliminate Wolbachia organism. These studies have shown a decrease in gross and microscopic pathology of pulmonary parenchyma in experimental heartworm infections pretreated with doxycycline before melarsomine administration. Methods Electronic medical records from a large veterinary practice in northeast Alabama were searched to identify dogs treated for heartworms with melarsomine from January 2005 through December 2012. The search was refined further to select for dogs that met the following criteria: 1 received two or three doses of ivermectin heartworm preventive prior to melarsomine injections, 2 received one injection of melarsomine followed by two injections 4 to 8 weeks later, and 3 were treated with prednisone following melarsomine injections. The dogs were then divided into those that also were treated with doxycycline 10 mg/kg BID for 4 weeks (Group A, n = 47 and those that did not receive doxycycline (Group B, n = 47. The medical notes of all 94 cases were then reviewed for comments concerning coughing, dyspnea, or hemoptysis in the history, physical exam template, or from telephone conversations with clients the week following each visit. Any

  15. The studsvik BNCT project: structure and the proposed protocols

    International Nuclear Information System (INIS)

    Capala, J.; Stenstam, B.H.; Skoeld, K.; Henriksson, R.; Salford, L.; Carlsson, J.

    2000-01-01

    The BNCT facility at Studsvik is now ready for clinical trials. Scientific operations of the Studsvik BNCT project are overseen by the Scientific Advisory Board comprised of representatives of all major universities in Sweden. Furthermore, special task groups for clinical and preclinical studies have been formed to facilitate collaboration with academia and to assure the quality of the research. Proposed clinical Phase II trials for glioblastoma are sponsored by the Swedish National Neuro-Oncology Group and, initially, will involve two protocols: Protocol no.1. BNCT for glioblastoma patients who have not received any therapy other than surgery (including stereotactic biopsy only). Protocol no.2. BNCT as a palliative treatment for patients with recurrent glioblastoma following conventional therapies or BNCT. In both protocols, BPA, administered by a 6 hour i.v. infusion, will be used as the boron delivery agent. (author)

  16. Blockchain protocols in clinical trials: Transparency and traceability of consent [version 3; referees: 1 approved, 2 approved with reservations, 1 not approved

    OpenAIRE

    Mehdi Benchoufi; Raphael Porcher; Philippe Ravaud

    2017-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a...

  17. Multisite Semiautomated Clinical Data Repository for Duplication 15q Syndrome: Study Protocol and Early Uses.

    Science.gov (United States)

    Ajayi, Oluwaseun Jessica; Smith, Ebony Jeannae; Viangteeravat, Teeradache; Huang, Eunice Y; Nagisetty, Naga Satya V Rao; Urraca, Nora; Lusk, Laina; Finucane, Brenda; Arkilo, Dimitrios; Young, Jennifer; Jeste, Shafali; Thibert, Ronald; Reiter, Lawrence T

    2017-10-18

    Chromosome 15q11.2-q13.1 duplication syndrome (Dup15q syndrome) is a rare disorder caused by duplications of chromosome 15q11.2-q13.1, resulting in a wide range of developmental disabilities in affected individuals. The Dup15q Alliance is an organization that provides family support and promotes research to improve the quality of life of patients living with Dup15q syndrome. Because of the low prevalence of this condition, the establishment of a single research repository would have been difficult and more time consuming without collaboration across multiple institutions. The goal of this project is to establish a national deidentified database with clinical and survey information on individuals diagnosed with Dup15q syndrome. The development of a multiclinic site repository for clinical and survey data on individuals with Dup15q syndrome was initiated and supported by the Dup15q Alliance. Using collaborative workflows, communication protocols, and stakeholder engagement tools, a comprehensive database of patient-centered information was built. We successfully established a self-report populating, centralized repository for Dup15q syndrome research. This repository also resulted in the development of standardized instruments that can be used for other studies relating to developmental disorders. By standardizing the data collection instruments, it allows us integrate our data with other national databases, such as the National Database for Autism Research. A substantial portion of the data collected from the questionnaires was facilitated through direct engagement of participants and their families. This allowed for a more complete set of information to be collected with a minimal turnaround time. We developed a repository that can efficiently be mined for shared clinical phenotypes observed at multiple clinic sites and used as a springboard for future clinical and basic research studies. ©Oluwaseun Jessica Ajayi, Ebony Jeannae Smith, Teeradache Viangteeravat

  18. Full-mouth disinfection as a therapeutic protocol for type-2 diabetic subjects with chronic periodontitis: twelve-month clinical outcomes: a randomized controlled clinical trial.

    Science.gov (United States)

    Santos, Vanessa R; Lima, Jadson A; Miranda, Tamires S; Gonçalves, Tiago E D; Figueiredo, Luciene C; Faveri, Marcelo; Duarte, Poliana M

    2013-02-01

    The aim of this randomized controlled clinical trial was to evaluate the clinical effects of chlorhexidine (CHX) application in a full-mouth disinfection (FMD) protocol in poorly controlled type-2 diabetic subjects with generalized chronic periodontitis. Thirty-eight subjects were randomly assigned into FMD group (n=19): full-mouth scaling and root planing (FMSRP) within 24 h + local application of CHX gel + CHX rinses for 60 days or Control group (n = 19): FMSRP within 24 h + local application of placebo gel + placebo rinses for 60 days. Clinical parameters, glycated haemoglobin and fasting plasma glucose were assessed at baseline, 3, 6 and 12 months post-therapies. All clinical parameters improved significantly at 3, 6 and 12 months post-therapies for both groups (p clinical parameters, and glycemic condition at any time-point (p > 0.05). The treatments did not differ with respect to clinical parameters, including the primary outcome variable (i.e. changes in clinical attachment level in deep pockets), for up to 12 months post-treatments. © 2012 John Wiley & Sons A/S.

  19. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40

    Science.gov (United States)

    Boone, Margaret; Brown, Nancy J.; Moon, Mary A.; Schuman, Deborah J.; Thomas, Josephine; Wright, Denise L.

    2004-01-01

    This Treatment Improvement Protocol (TIP) addresses the clinical use of buprenorphine in the treatment of opioid addiction. TIPs are best-practice guidelines for the treatment of substance use disorders that make the latest research in substance abuse treatment available to counselors and educators. The content was generated by a panel of experts…

  20. Clinical outcomes and mortality before and after implementation of a pediatric sepsis protocol in a limited resource setting: A retrospective cohort study in Bangladesh.

    Directory of Open Access Journals (Sweden)

    Teresa Bleakly Kortz

    Full Text Available Pediatric sepsis has a high mortality rate in limited resource settings. Sepsis protocols have been shown to be a cost-effective strategy to improve morbidity and mortality in a variety of populations and settings. At Dhaka Hospital in Bangladesh, mortality from pediatric sepsis in high-risk children previously approached 60%, which prompted the implementation of an evidenced-based protocol in 2010. The clinical effectiveness of this protocol had not been measured. We hypothesized that implementation of a pediatric sepsis protocol improved clinical outcomes, including reducing mortality and length of hospital stay.This was a retrospective cohort study of children 1-59 months old with a diagnosis of sepsis, severe sepsis or septic shock admitted to Dhaka Hospital from 10/25/2009-10/25/2011. The primary outcome was inpatient mortality pre- and post-protocol implementation. Secondary outcomes included fluid overload, heart failure, respiratory insufficiency, length of hospital stay, and protocol compliance, as measured by antibiotic and fluid bolus administration within 60 minutes of hospital presentation.404 patients were identified by a key-word search of the electronic medical record; 328 patients with a primary diagnosis of sepsis, severe sepsis, or septic shock were included (143 pre- and185 post-protocol in the analysis. Pre- and post-protocol mortality were similar and not statistically significant (32.17% vs. 34.59%, p = 0.72. The adjusted odds ratio (AOR for post-protocol mortality was 1.55 (95% CI, 0.88-2.71. The odds for developing fluid overload were significantly higher post-protocol (AOR 3.45, 95% CI, 2.04-5.85, as were the odds of developing heart failure (AOR 4.52, 95% CI, 1.43-14.29 and having a longer median length of stay (AOR 1.81, 95% CI 1.10-2.96. There was no statistically significant difference in respiratory insufficiency (pre- 65.7% vs. post- 70.3%, p = 0.4 or antibiotic administration between the cohorts (pre- 16.08% vs

  1. Digital correction of magnification in pelvic x rays for preoperative planning of hip joint replacements: Theoretical development and clinical results of a new protocol

    International Nuclear Information System (INIS)

    The, B.; Diercks, R.L.; Stewart, R.E.; Ooijen, P.M.A. van; Horn, J.R. van

    2005-01-01

    The introduction of digital radiological facilities leads to the necessity of digital preoperative planning, which is an essential part of joint replacement surgery. To avoid errors in the preparation and execution of hip surgery, reliable correction of the magnification of the projected hip is a prerequisite. So far, no validated method exists to accomplish this. We present validated geometrical models of the x-ray projection of spheres, relevant for the calibration procedure to correct for the radiographic magnification. With help of these models a new calibration protocol was developed. The validity and precision of this procedure was determined in clinical practice. Magnification factors could be predicted with a maximal margin of error of 1.5%. The new calibration protocol is valid and reliable. The clinical tests revealed that correction of magnification has a 95% margin of error of -3% to +3%. Future research might clarify if a strict calibration protocol, as presented in this study, results in more accurate preoperative planning of hip joint replacements

  2. Clinical Experience With Image-Guided Radiotherapy in an Accelerated Partial Breast Intensity-Modulated Radiotherapy Protocol

    International Nuclear Information System (INIS)

    Leonard, Charles E.; Tallhamer, Michael M.S.; Johnson, Tim; Hunter, Kari C.M.D.; Howell, Kathryn; Kercher, Jane; Widener, Jodi; Kaske, Terese; Paul, Devchand; Sedlacek, Scot; Carter, Dennis L.

    2010-01-01

    Purpose: To explore the feasibility of fiducial markers for the use of image-guided radiotherapy (IGRT) in an accelerated partial breast intensity modulated radiotherapy protocol. Methods and Materials: Nineteen patients consented to an institutional review board approved protocol of accelerated partial breast intensity-modulated radiotherapy with fiducial marker placement and treatment with IGRT. Patients (1 patient with bilateral breast cancer; 20 total breasts) underwent ultrasound guided implantation of three 1.2- x 3-mm gold markers placed around the surgical cavity. For each patient, table shifts (inferior/superior, right/left lateral, and anterior/posterior) and minimum, maximum, mean error with standard deviation were recorded for each of the 10 BID treatments. The dose contribution of daily orthogonal films was also examined. Results: All IGRT patients underwent successful marker placement. In all, 200 IGRT treatment sessions were performed. The average vector displacement was 4 mm (range, 2-7 mm). The average superior/inferior shift was 2 mm (range, 0-5 mm), the average lateral shift was 2 mm (range, 1-4 mm), and the average anterior/posterior shift was 3 mm (range, 1 5 mm). Conclusions: This study shows that the use of IGRT can be successfully used in an accelerated partial breast intensity-modulated radiotherapy protocol. The authors believe that this technique has increased daily treatment accuracy and permitted reduction in the margin added to the clinical target volume to form the planning target volume.

  3. Low-dose single acquisition rest {sup 99m}Tc/stress {sup 201}Tl myocardial perfusion SPECT protocol: phantom studies and clinical validation

    Energy Technology Data Exchange (ETDEWEB)

    Dey, Thomas [RWTH Aachen University, Institute of Imaging and Computer Vision, Aachen (Germany); Backus, Barbra E.; Romijn, R.Leo [St. Antonius Hospital, Department of Nuclear Medicine, Nieuwegein (Netherlands); Wieczorek, Herfried [Philips Research, Eindhoven (Netherlands); Verzijlbergen, J.F. [St. Antonius Hospital, Department of Nuclear Medicine, Nieuwegein (Netherlands); Erasmus Medical Center, Department of Nuclear Medicine, Rotterdam (Netherlands)

    2014-03-15

    We developed and tested a single acquisition rest {sup 99m}Tc-sestamibi/stress {sup 201}Tl dual isotope protocol (SDI) with the intention of improving the clinical workflow and patient comfort of myocardial perfusion single photon emission computed tomography (SPECT). The technical feasibility of SDI was evaluated by a series of anthropomorphic phantom studies on a standard SPECT camera. The attenuation map was created by a moving transmission line source. Iterative reconstruction including attenuation correction, resolution recovery and Monte Carlo simulation of scatter was used for simultaneous reconstruction of dual tracer distribution. For clinical evaluation, patient studies were compared to stress {sup 99m}Tc and rest {sup 99m}Tc reference images acquired in a 2-day protocol. Clinical follow-up examinations like coronary angiography (CAG) and fractional flow reserve (FFR) were included in the assessment if available. Phantom studies demonstrated the technical feasibility of SDI. Artificial lesions inserted in the phantom mimicking ischaemia could be clearly identified. In 51/53 patients, the image quality was adequate for clinical evaluation. For the remaining two obese patients with body mass index > 32 the injected {sup 201}Tl dose of 74 MBq was insufficient for clinical assessment. In answer to this the {sup 201}Tl dose was adapted for obese patients in the rest of the study. In 31 patients, SDI and {sup 99m}Tc reference images resulted in equivalent clinical assessment. Significant differences were found in 20 patients. In 18 of these 20 patients additional examinations were available. In 15 patients the diagnosis based on the SDI images was confirmed by the results of CAG or FFR. In these patients the SDI images were more accurate than the {sup 99m}Tc reference study. In three patients minor ischaemic lesions were detected by SDI but were not confirmed by CAG. In one of these cases this was probably caused by pronounced apical thinning. For two patients

  4. Translational study of obesity management using the Diabetes Prevention Program "Group Lifestyle Balance" in primary care clinics and public hospitals from Mexico: study protocol

    Directory of Open Access Journals (Sweden)

    Rolando Giovanni Díaz-Zavala

    2017-12-01

    Full Text Available Introduction: Obesity is the main modifiable risk factor for the development of chronic diseases in Mexico. Several randomized controlled trials have shown that intensive lifestyle programs are efficacious for the management of obesity. These programs include frequent sessions (14 or more contacts in the first 6 months focused on diet and physical activity and use a behavior change protocol. However, most Mexican primary care clinics and public hospitals apply traditional treatments for obesity management with limited results on weight loss. The purpose of the study is to evaluate the effectiveness of the Diabetes Prevention Program (DPP “Group Lifestyle Balance” for weight loss among adults with overweight and obesity from baseline to 6 months and from baseline to 12 months in primary care clinics and public hospitals from Sonora, Mexico. Material and Methods: This is a translational, multi-center, non-controlled, 6 and 12-month follow-up clinical study with a pre-test and post-test design. Healthcare providers from two primary care clinics, two hospitals and one university clinic will be trained with the DPP protocol to implement on their patients with overweight and obesity. Body weight, body mass index, waist circumference, systolic and diastolic blood pressure, depression, quality of life and stress scales will be measured in participants receiving the program at baseline, 6 and 12 months. Biochemical parameters will be measured at baseline and 12 months. The primary outcome is the change in body weight at 6 and 12 months. Discussion: This study will provide scientific evidence of the effectiveness of the DPP protocol as a model for obesity management in real world clinical practice among the adult Mexican population.

  5. Clinical benefits after the implementation of a multimodal perioperative protocol in elderly patients.

    Science.gov (United States)

    Aguilar-Nascimento, José Eduardo de; Salomão, Alberto Bicudo; Caporossi, Cervantes; Diniz, Breno Nadaf

    2010-01-01

    Multimodal protocol of perioperative care may enhance recovery after surgery. Based on evidence these new routines of perioperative care changed conventional prescriptions in surgery. To evaluate the results of a multimodal protocol (ACERTO protocol) in elderly patients. Non-randomized historical cohort study was performed at the surgical ward of a tertiary university hospital. One hundred seventeen patients aged 60 and older were submitted to elective abdominal operations under either conventional (n = 42; conventional group, January 2004-June 2005) or a fast-track perioperative protocol named ACERTO (n = 75; ACERTO group, July 2005-December 2007). Main endpoints were preoperative fasting time, postoperative day of re-feeding, volume of intravenous fluids, length of hospital stay and morbidity. The implantation of the ACERTO protocol was followed by a decrease in both preoperative fasting (15 [8-20] vs 4 [2-20] hours, P<0.001) and postoperative day of refeeding (1st [1st-10th] vs 0 [0-5th] PO day; P<0.01), and intravenous fluids (10.7 [2.5-57.5] vs 2.5 [0.5-82] L, P<0.001). The changing of protocols reduced the mean length of hospital stay by 4 days (6[1-43] vs 2[1-97] days; P = 0.002) and surgical site infection rate by 85.7% (19%; 8/42 vs 2.7%; 2/75, P<0.001; relative risk = 1.20; 95% confidence interval = 1.03-1.39). Per-protocol analysis showed that hospital stay in major operations diminished only in patients who completed the protocol (P<0.01). The implementation of multidisciplinary routines of the ACERTO protocol diminished both hospitalization and surgical site infection in elderly patients submitted to abdominal operations.

  6. The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

    Science.gov (United States)

    Homedes, Núria; Ugalde, Antonio

    2015-06-01

    To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  7. A protocol for classifying normal- and flat-arched foot posture for research studies using clinical and radiographic measurements

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2009-07-01

    Full Text Available Abstract Background There are several clinical and radiological methods available to classify foot posture in research, however there is no clear strategy for selecting the most appropriate measurements. Therefore, the aim of this study was to develop a foot screening protocol to distinguish between participants with normal- and flat-arched feet who would then subsequently be recruited into a series of laboratory-based gait studies. Methods The foot posture of ninety-one asymptomatic young adults was assessed using two clinical measurements (normalised navicular height and arch index and four radiological measurements taken from antero-posterior and lateral x-rays (talus-second metatarsal angle, talo-navicular coverage angle, calcaneal inclination angle and calcaneal-first metatarsal angle. Normative foot posture values were taken from the literature and used to recruit participants with normal-arched feet. Data from these participants were subsequently used to define the boundary between normal- and flat-arched feet. This information was then used to recruit participants with flat-arched feet. The relationship between the clinical and radiographic measures of foot posture was also explored. Results Thirty-two participants were recruited to the normal-arched study, 31 qualified for the flat-arched study and 28 participants were classified as having neither normal- or flat-arched feet and were not suitable for either study. The values obtained from the two clinical and four radiological measurements established two clearly defined foot posture groups. Correlations among clinical and radiological measures were significant (p r = 0.24 to 0.70. Interestingly, the clinical measures were more strongly associated with the radiographic angles obtained from the lateral view. Conclusion This foot screening protocol provides a coherent strategy for researchers planning to recruit participants with normal- and flat-arched feet. However, further research is

  8. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

    2016-01-01

    BACKGROUND: Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe......Med and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about...

  9. Comparison of the ultrashort gonadotropin-releasing hormone agonist-antagonist protocol with microdose flare -up protocol in poor responders: a preliminary study.

    Science.gov (United States)

    Berker, Bülent; Duvan, Candan İltemir; Kaya, Cemil; Aytaç, Ruşen; Satıroğlu, Hakan

    2010-01-01

    To determine the potential effect of the ultrashort gonadotropin-releasing hormone (GnRH) agonist/GnRH antagonist protocol versus the microdose GnRH agonist protocol in poor responders undergoing intracytoplasmic sperm injection (ICSI). The patients in the Agonist-Antagonist Group (n=41) were administered the ultrashort GnRH-agonist/ antagonist protocol, while the patients in the Microdose Group (n=41) were stimulated according to the microdose flare-up protocol. The mean number of mature oocytes retrieved was the primary outcome measure. Fertilization rate, implantation rate per embryo and clinical pregnancy rates were secondary outcome measures. There was no differenc between the mean number of mature oocytes retrieved in the two groups. There were also no statistical differences between the two groups in terms of peak serum E2 level, canceled cycles, endometrial thickness on hCG day, number of 2 pronucleus and number of embryos transferred. However, the total gonadotropin consumption and duration of stimulation were significantly higher with the Agonist-Antagonist Group compared with the Microdose Group. The implantation and clinical pregnancy rates were similar between the two groups. Despite the high dose of gonadotropin consumption and longer duration of stimulation with the ultrashort GnRH agonist/ antagonist protocol, it seems that the Agonist-Antagonist Protocol is not inferior to the microdose protocol in poor responders undergoing ICSI.

  10. Effectiveness of a Nintendo Wii balance board exercise programme on standing balance of children with cerebral palsy: A randomised clinical trial protocol

    OpenAIRE

    Valeska Gatica-Rojas; Ricardo Cartes-Velásquez; Eduardo Guzmán-Muñoz; Guillermo Méndez-Rebolledo; Alex Soto-Poblete; Ana Carolina Pacheco-Espinoza; Carlos Amigo-Mendoza; M. Eliana Albornoz-Verdugo; Edith Elgueta-Cancino

    2017-01-01

    Background: Patients with cerebral palsy (CP) typically receive limited physical therapy services. However, the Nintendo Wii system offers a simple and affordable mode of virtual reality therapy. There are no clinical trials assessing the Nintendo Wii balance board for improving standing balance in CP. Methods: This randomised clinical trial will evaluate the effectiveness of an 18-session/six-week protocol using Wii therapy (W-t) compared with conventional therapy (C-t) in Chilean CP pati...

  11. Shoulder muscle endurance: the development of a standardized and reliable protocol

    Directory of Open Access Journals (Sweden)

    Roy Jean-Sébastien

    2011-01-01

    Full Text Available Abstract Background Shoulder muscle fatigue has been proposed as a possible link to explain the association between repetitive arm use and the development of rotator cuff disorders. To our knowledge, no standardized clinical endurance protocol has been developed to evaluate the effects of muscle fatigue on shoulder function. Such a test could improve clinical examination of individuals with shoulder disorders. Therefore, the purpose of this study was to establish a reliable protocol for objective assessment of shoulder muscle endurance. Methods An endurance protocol was developed on a stationary dynamometer (Biodex System 3. The endurance protocol was performed in isotonic mode with the resistance set at 50% of each subject's peak torque as measured for shoulder external (ER and internal rotation (IR. Each subject performed 60 continuous repetitions of IR/ER rotation. The endurance protocol was performed by 36 healthy individuals on two separate occasions at least two days apart. Maximal isometric shoulder strength tests were performed before and after the fatigue protocol to evaluate the effects of the endurance protocol and its reliability. Paired t-tests were used to evaluate the reduction in shoulder strength due to the protocol, while intraclass correlation coefficients (ICC and minimal detectable change (MDC were used to evaluate its reliability. Results Maximal isometric strength was significantly decreased after the endurance protocol (P 0.84. Conclusions Changes in muscular performance observed during and after the muscular endurance protocol suggests that the protocol did result in muscular fatigue. Furthermore, this study established that the resultant effects of fatigue of the proposed isotonic protocol were reproducible over time. The protocol was performed without difficulty by all volunteers and took less than 10 minutes to perform, suggesting that it might be feasible for clinical practice. This protocol could be used to induce

  12. Safety of a clinical surveillance protocol with 3- and 6-week warfarin prophylaxis after total joint arthroplasty.

    Science.gov (United States)

    Goldstein, W M; Jimenez, M L; Bailie, D S; Wall, R; Branson, J

    2001-07-01

    The charts of 1869 patients were reviewed for the occurrence of deep venous thrombosis (DVT) and pulmonary embolism after total hip or knee arthroplasty. Prophylaxis consisted of 3 (group 1; n=1235) or 6 (group 2; n=634) weeks low-dose warfarin, pneumatic compression boots worn by patients in the hospital, mobilization on the first postoperative day, and a clinical surveillance protocol. Venous ultrasound or ventilation/perfusion lung scintigraphy (V/Q) was performed only if patients became symptomatic. patients. Twenty-three (1.8%) patients were positive for DVT. Ventilation/perfusion lung scintigraphy was performed on 25 patients, and 5 (0.4%) patients were positive for pulmonary embolism. In group 2, 117 patients were evaluated for DVT, and 19 (3%) patients had positive results determined by ultrasound. Twenty-five patients were evaluated with V/Q and only 1 (0.16%) patient was positive for pulmonary embolism. No patient developed a fatal pulmonary embolism or postphlebitic syndrome. This prophylaxis protocol is an efficient and cost-effective method for the prevention of significant events after surgery.

  13. Barriers and enablers to implementing clinical treatment protocols for fever, hyperglycaemia, and swallowing dysfunction in the Quality in Acute Stroke Care (QASC) Project--a mixed methods study.

    Science.gov (United States)

    Dale, Simeon; Levi, Christopher; Ward, Jeanette; Grimshaw, Jeremy M; Jammali-Blasi, Asmara; D'Este, Catherine; Griffiths, Rhonda; Quinn, Clare; Evans, Malcolm; Cadilhac, Dominique; Cheung, N Wah; Middleton, Sandy

    2015-02-01

    The Quality in Acute Stroke Care (QASC) trial evaluated systematic implementation of clinical treatment protocols to manage fever, sugar, and swallow (FeSS protocols) in acute stroke care. This cluster-randomised controlled trial was conducted in 19 stroke units in Australia. To describe perceived barriers and enablers preimplementation to the introduction of the FeSS protocols and, postimplementation, to determine which of these barriers eventuated as actual barriers. Preimplementation: Workshops were held at the intervention stroke units (n = 10). The first workshop involved senior clinicians who identified perceived barriers and enablers to implementation of the protocols, the second workshop involved bedside clinicians. Postimplementation, an online survey with stroke champions from intervention sites was conducted. A total of 111 clinicians attended the preimplementation workshops, identifying 22 barriers covering four main themes: (a) need for new policies, (b) limited workforce (capacity), (c) lack of equipment, and (d) education and logistics of training staff. Preimplementation enablers identified were: support by clinical champions, medical staff, nursing management and allied health staff; easy adaptation of current protocols, care-plans, and local policies; and presence of specialist stroke unit staff. Postimplementation, only five of the 22 barriers identified preimplementation were reported as actual barriers to adoption of the FeSS protocols, namely, no previous use of insulin infusions; hyperglycaemic protocols could not be commenced without written orders; medical staff reluctance to use the ASSIST swallowing screening tool; poor level of engagement of medical staff; and doctors' unawareness of the trial. The process of identifying barriers and enablers preimplementation allowed staff to take ownership and to address barriers and plan for change. As only five of the 22 barriers identified preimplementation were reported to be actual barriers at

  14. Use of protocol and evaluation of postoperative residual curarization incidence in the absence of intraoperative acceleromyography - Randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Filipe Nadir Caparica Santos

    Full Text Available Abstract Objective Evaluate the incidence of postoperative residual curarization (PORC in the post-anesthesia care unit (PACU after the use of protocol and absence of intraoperative acceleromyography (AMG. Methods Randomized clinical trial with 122 patients allocated into two groups (protocol and control. Protocol group received initial and additional doses of rocuronium (0.6 mg·kg-1 and 10 mg, respectively; the use of rocuronium was avoided in the final 45 min; blockade reversal with neostigmine (50 µg·kg-1; time ≥15 min between reversion and extubation. Control: initial and additional doses of rocuronium, blockade reversal, neostigmine dose, and extubation time, all at the discretion of the anesthesiologist. AMG was used in the PACU and PORC considered at T4/T1 ratio <1.0. Results The incidence of PORC was lower in protocol group than in control group (25% vs. 45.2%, p = 0.02. In control group, total dose of rocuronium was higher in patients with PORC than without PORC (0.43 vs. 0.35 mg·kg-1·h-1, p = 0.03 and the time interval between the last administration of rocuronium and neostigmine was lower (75.0 vs. 101.0 min, p < 0.01. In protocol group, there was no difference regarding the analyzed parameters (with PORC vs. without PORC. Considering the entire study population and the presence or absence of PORC, total dose of rocuronium was higher in patients with PORC (0.42 vs. 0.31 mg·kg-1·h-1, p = 0.01, while the time interval between the last administration of rocuronium and neostigmine was lower (72.5 vs. 99.0 min, p ≤ 0.01. Conclusion The proposed systematization reduced PORC incidence in PACU in the absence of intraoperative AMG.

  15. A Systematic Review Protocol on the Use of Online Learning versus Blended Learning for Teaching Clinical Skills to Undergraduate Health Professional Students

    Science.gov (United States)

    McCutcheon, Karen; Lohan, Maria; Traynor, Marian

    2016-01-01

    Aim: This paper is a review protocol that will be used to identify, critically appraise and synthesise the best current evidence relating to the use of online learning and blended learning approaches in teaching clinical skills in undergraduate health professionals. Background: Although previous systematic reviews on online learning vs. face to…

  16. Effectiveness of oxaliplatin desensitization protocols.

    Science.gov (United States)

    Cortijo-Cascajares, Susana; Nacle-López, Inmaculada; García-Escobar, Ignacio; Aguilella-Vizcaíno, María José; Herreros-de-Tejada, Alberto; Cortés-Funes Castro, Hernán; Calleja-Hernández, Miguel-Ángel

    2013-03-01

    Hypersensitivity reaction (HSR) to antineoplastic drugs can force doctors to stop treatment and seek other alternatives. These alternatives may be less effective, not as well tolerated and/or more expensive. Another option is to use desensitization protocols that induce a temporary state of tolerance by gradually administering small quantities of the antineoplastic drug until the therapeutic dosage is reached. The aim of this study is to assess the effectiveness of oxaliplatin desensitization protocols. A retrospective observational study was carried out between January 2006 and May 2011. The inclusion criteria were patients undergoing chemotherapy treatment with oxaliplatin who had developed an HSR to the drug and who were candidates for continuing the treatment using a desensitization protocol. The patients' clinical records were reviewed and variables were gathered relating to the patient, the treatment, the HSR, and the desensitization protocol administered. The data were analysed using version 18.0 of the statistics program SPSS. A total of 53 desensitization protocols were administered to 21 patients. In 89 % of these cases, no new reactions occurred while the drug was being administered. New reactions of mild severity only occurred in 11 % of cases, and none of these reactions were severe enough for treatment to be stopped. All patients were able to complete the desensitization protocol. This study confirms that oxaliplatin desensitization protocols are safe and effective and allow patients to continue with the treatment that initially caused an HSR.

  17. Effective dose comparison between protocols stitched and usual protocols in dental cone beam CT for complete arcade

    International Nuclear Information System (INIS)

    Soares, M. R.; Maia, A. F.; Batista, W. O. G.; Lara, P. A.

    2014-08-01

    To visualization a complete dental radiology dental lives together with two separate proposals: [1] protocols diameter encompassing the entire arch (single) or [2] protocol with multiple fields of view (Fov) which together encompass the entire arch (stitched Fov s). The objective of this study is to evaluate effective dose values in examination protocols for all dental arcade available in different outfits with these two options. For this, a female anthropomorphic phantom manufactured by Radiology Support Devices twenty six thermoluminescent dosimeters inserted in relevant bodies and positions was used. Irradiate the simulator in the clinical conditions. The protocols were averaged and compared: [a] 14.0 cm x 8.5 cm and [b] 8.5 cm x 8.5 cm (Gendex Tomography GXCB 500), [c] protocol stitched for jaw combination of three volumes of 5.0 cm x 3.7 cm (Kodak 9000 3D scanner) [d] protocol stitched Fov s 5.0 cm x 8.0 cm (Planmeca Pro Max 3D) and [e] single technical Fov 14 cm x 8 cm (i-CAT Classical). Our results for the effective dose were: a range between 43.1 and 111.1 micro Sv for technical single Fov and 44.5 and 236.2 for technical stitched Fov s. The protocol presented the highest estimated effective dose was [d] and showed that lowest index was registered [a]. These results demonstrate that the protocol stitched Fov generated in Kodak 9000 3D machine applied the upper dental arch has practically equal value effective dose obtained by protocol extended diameter of, [a], which evaluates in a single image upper and lower arcade. It also demonstrates that the protocol [d] gives an estimate of five times higher than the protocol [a]. Thus, we conclude that in practical terms the protocol [c] stitched Fov s, not presents dosimetric advantages over other protocols. (Author)

  18. Effective dose comparison between protocols stitched and usual protocols in dental cone beam CT for complete arcade

    Energy Technology Data Exchange (ETDEWEB)

    Soares, M. R.; Maia, A. F. [Universidade Federal de Sergipe, Departamento de Fisica, Cidade Universitaria Prof. Jose Aloisio de Campos, Marechal Rondon s/n, Jardim Rosa Elze, 49-100000 Sao Cristovao, Sergipe (Brazil); Batista, W. O. G. [Instituto Federal da Bahia, Rua Emidio dos Santos s/n, Barbalho, Salvador, 40301015 Bahia (Brazil); Lara, P. A., E-mail: wilsonottobatista@gmail.com [Instituto de Pesquisas Energeticas e Nucleares / CNEN, Av. Lineu Prestes 2242, Cidade Universitaria, 05508-000 Sao Paulo (Brazil)

    2014-08-15

    To visualization a complete dental radiology dental lives together with two separate proposals: [1] protocols diameter encompassing the entire arch (single) or [2] protocol with multiple fields of view (Fov) which together encompass the entire arch (stitched Fov s). The objective of this study is to evaluate effective dose values in examination protocols for all dental arcade available in different outfits with these two options. For this, a female anthropomorphic phantom manufactured by Radiology Support Devices twenty six thermoluminescent dosimeters inserted in relevant bodies and positions was used. Irradiate the simulator in the clinical conditions. The protocols were averaged and compared: [a] 14.0 cm x 8.5 cm and [b] 8.5 cm x 8.5 cm (Gendex Tomography GXCB 500), [c] protocol stitched for jaw combination of three volumes of 5.0 cm x 3.7 cm (Kodak 9000 3D scanner) [d] protocol stitched Fov s 5.0 cm x 8.0 cm (Planmeca Pro Max 3D) and [e] single technical Fov 14 cm x 8 cm (i-CAT Classical). Our results for the effective dose were: a range between 43.1 and 111.1 micro Sv for technical single Fov and 44.5 and 236.2 for technical stitched Fov s. The protocol presented the highest estimated effective dose was [d] and showed that lowest index was registered [a]. These results demonstrate that the protocol stitched Fov generated in Kodak 9000 3D machine applied the upper dental arch has practically equal value effective dose obtained by protocol extended diameter of, [a], which evaluates in a single image upper and lower arcade. It also demonstrates that the protocol [d] gives an estimate of five times higher than the protocol [a]. Thus, we conclude that in practical terms the protocol [c] stitched Fov s, not presents dosimetric advantages over other protocols. (Author)

  19. A randomized trial of microdose leuprolide acetate protocol versus luteal phase ganirelix protocol in predicted poor responders.

    Science.gov (United States)

    DiLuigi, Andrea J; Engmann, Lawrence; Schmidt, David W; Benadiva, Claudio A; Nulsen, John C

    2011-06-30

    We performed a randomized trial to compare IVF outcomes in 54 poor responder patients undergoing a microdose leuprolide acetate (LA) protocol or a GnRH antagonist protocol incorporating a luteal phase E(2) patch and GnRH antagonist in the preceding menstrual cycle. Cancellation rates, number of oocytes retrieved, clinical pregnancy rates (PR), and ongoing PRs were similar between the two groups. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  20. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

    Directory of Open Access Journals (Sweden)

    Jeppe Bennekou Schroll

    2016-08-01

    Full Text Available Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials.We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal, which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of

  1. I-123 IBZM-SPECT: improved acquisition protocol with HR-collimator

    International Nuclear Information System (INIS)

    Sandrock, D.; Ivancevic, V.; Dopichaj-Menge, U.; Gruber, D.; Munz, D.

    2002-01-01

    Aim: Aim of this study was to evaluate the impact of different acquisition and reconstruction protocols on the quality of SPECT diagnostics with I-123 IBZM in patients with diseases of the dopaminergic system. Material and Methods: Overall, 30 patients (19 men, 11 women, aged 22 - 80 years) were studied with SPECT after i.v. injection of 5 mCi (185 MBq) I-123 IBZM. Acquisition was performed 60 min p.i. (protocol A) using a medium energy collimator, a 64 x 64 matrix, 64 projections, step and shoot technique, 5.6 0 and 20 seconds per step with a MultiSPECT2 double-head gamma camera (Siemens). Immediately afterwards, a second acquisition (protocol B, 90 min p.i.) using a high resolution collimator, a 128 x 128 matrix, 60 projections, step and shoot technique, 3 0 and 30 seconds per step was performed. The reconstruction was done in filtered backprojection technique and a Butterworth filter of order 7, in protocol A using a cutoff of 0.5 and in protocol B of 0.4. Finally, the net count ratios of the basal ganglia to the frontal lobe(s) were calculated and compared with the clinical diagnosis. Results: The visual analysis yielded - as expected -a better image quality for protocol B (concordant impression of 3 independent observers) with more accurate delineation of the basal ganglia. The count ratios with protocol B were (mean) 0.19 higher (equivalent to 13 %) than with protocol A. In the group of patients with count ratios > 1.55 there was the highest (and significant) difference between protocols A and B with (mean count ratio difference) 0.32 (equivalent to 20 %). Protocol B also allowed a better differentiation between patients clinically staged normal and abnormal. In patients with unilateral disease, this difference between normal and abnormal was more prominent (in comparison to the contralateral side as well as compared to the reference value [1.5]). The comparison of the count ratios with the clinical data revealed 7 patients with borderline results with

  2. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study.

    Science.gov (United States)

    Lauzier, F; Adhikari, N K; Seely, A; Koo, K K Y; Belley-Côté, E P; Burns, K E A; Cook, D J; D'Aragon, F; Rochwerg, B; Kho, M E; Oczkowksi, S J W; Duan, E H; Meade, M O; Day, A G; Lamontagne, F

    2017-07-17

    The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated with between-arm separation, if it can be measured.

  3. The influence of different contrast medium concentrations and injection protocols on quantitative and clinical assessment of FDG–PET/CT in lung cancer

    Energy Technology Data Exchange (ETDEWEB)

    Verburg, Frederik A., E-mail: fverburg@ukaachen.de [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Maastricht University Medical Center, Department of Nuclear Medicine, P. Debyelaan 25, 6229 HX Maastricht (Netherlands); Kuhl, Christiane K. [RWTH Aachen University Hospital, Department of Diagnostic and Interventional Radiology, Pauwelsstraße 30, 52074 Aachen (Germany); Pietsch, Hubertus [Bayer Pharma AG, Berlin, Müllerstrasse 178, 13353 Berlin (Germany); Palmowski, Moritz [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Mottaghy, Felix M. [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Maastricht University Medical Center, Department of Nuclear Medicine, P. Debyelaan 25, 6229 HX Maastricht (Netherlands); Behrendt, Florian F. [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany)

    2013-10-01

    Objectives: To compare the effects of two different contrast medium concentrations for use in computed X-ray tomography (CT) employing two different injection protocols on positron emission tomography (PET) reconstruction in combined 2-{sup 18}F-desoxyglucose (FDG) PET/CT in patients with a suspicion of lung cancer. Methods: 120 patients with a suspicion of lung cancer were enrolled prospectively. PET images were reconstructed with the non-enhanced and venous phase contrast CT obtained after injection of iopromide 300 mg/ml or 370 mg/ml using either a fixed-dose or a body surface area adapted injection protocol. Maximum and mean standardized uptake values (SUVmax and SUVmean) and contrast enhancement (HU) were determined in the subclavian vein, ascending aorta, abdominal aorta, inferior vena cava, portal vein, liver and kidney and in the suspicious lung lesion. PET data were evaluated visually for the presence of malignancy and image quality. Results: At none of the sites a significant difference in the extent of the contrast enhancement between the four different protocols was found. However, the variability of the contrast enhancement at several anatomical sites was significantly greater in the fixed dose groups than in the BSA groups for both contrast medium concentrations. At none of the sites a significant difference was found in the extent of the SUVmax and SUVmean increase as a result of the use of the venous phase contrast enhanced CT for attenuation. Visual clinical evaluation of lesions showed no differences between contrast and non-contrast PET/CT (P = 0.32). Conclusions: Contrast enhanced CT for attenuation correction in combined PET/CT in lung cancer affects neither the clinical assessment nor image quality of the PET-images. A body surface adapted contrast medium protocol reduces the interpatient variability in contrast enhancement.

  4. Clinical outcome of one-third-dose depot triptorelin is the same as half-dose depot triptorelin in the long protocol of controlled ovarian stimulation

    Directory of Open Access Journals (Sweden)

    Yu Li

    2012-01-01

    Full Text Available Objective: Appropriate dosage of the long-acting depot gonadotrophin releasing hormone (GnRH agonist has not been determined in long protocol for IVF, and one-third-dose depot triptorelin was compared with half-dose in a luteal long protocol of in-vitro fertilization/ intra cytoplasmic sperm injection (IVF/ICSI treatment in this study. Materials and Methods: This is a prospective, randomized, open clinical trial. 100 patients were randomized into two groups. Group I received one-third-dose (1.25 mg depot triptorelin. Group II received half-dose (1.87 mg. The clinical and experimental parameters were compared between the two groups. Results: There was no premature luteinizing hormone (LH surge in both groups. On Day 3-5 of menstrual cycle after down-regulation, fewer patients showed low-level LH (<1.0 IU/L and estradiol (<30 pg/mL in group I (P <0.05. There were fewer oocytes retrieved (P =0.086, fewer total embryos and available embryos for cryopreservation in Group I (P <0.05, while good-quality embryo rate was higher in group I (P <0.05. The length and dose of ovarian stimulation was lower in Group I, but not significantly. The clinical pregnancy (52% versus 40%, implantation (48% versus 37.5%, delivery (46% versus 32%, or live birth (42% versus 32% rates and the abortion (8% versus 20% rates showed no significant differences. Conclusion: Depot triptorelin 1.25 mg can be successfully used with reduced pituitary suppression and lower cost in a long protocol for in-vitro fertilization.

  5. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study

    Directory of Open Access Journals (Sweden)

    F. Lauzier

    2017-07-01

    Full Text Available Abstract Background The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Discussion Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75–80 mmHg versus lower (60–65 mmHg mean arterial pressure (MAP targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. Conclusions In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated

  6. Protocol-based care: the standardisation of decision-making?

    Science.gov (United States)

    Rycroft-Malone, Jo; Fontenla, Marina; Seers, Kate; Bick, Debra

    2009-05-01

    To explore how protocol-based care affects clinical decision-making. In the context of evidence-based practice, protocol-based care is a mechanism for facilitating the standardisation of care and streamlining decision-making through rationalising the information with which to make judgements and ultimately decisions. However, whether protocol-based care does, in the reality of practice, standardise decision-making is unknown. This paper reports on a study that explored the impact of protocol-based care on nurses' decision-making. Theoretically informed by realistic evaluation and the promoting action on research implementation in health services framework, a case study design using ethnographic methods was used. Two sites were purposively sampled; a diabetic and endocrine unit and a cardiac medical unit. Within each site, data collection included observation, postobservation semi-structured interviews with staff and patients, field notes, feedback sessions and document review. Data were inductively and thematically analysed. Decisions made by nurses in both sites were varied according to many different and interacting factors. While several standardised care approaches were available for use, in reality, a variety of information sources informed decision-making. The primary approach to knowledge exchange and acquisition was person-to-person; decision-making was a social activity. Rarely were standardised care approaches obviously referred to; nurses described following a mental flowchart, not necessarily linked to a particular guideline or protocol. When standardised care approaches were used, it was reported that they were used flexibly and particularised. While the logic of protocol-based care is algorithmic, in the reality of clinical practice, other sources of information supported nurses' decision-making process. This has significant implications for the political goal of standardisation. The successful implementation and judicious use of tools such as

  7. Postoperative vaginal cuff irradiation using high dose rate remote afterloading: a Phase II clinical protocol

    International Nuclear Information System (INIS)

    Noyes, William R.; Bastin, Kenneth; Edwards, Scott A.; Buchler, Dolores A.; Stitt, Judith A.; Thomadsen, Bruce R.; Fowler, Jack F.; Kinsella, Timothy J.

    1995-01-01

    Purpose: In September 1989, a postoperative Phase II high dose rate (HDR) brachytherapy protocol was started for International Federation of Gynecology and Obstetrics (FIGO) Stage I endometrial adenocarcinoma. This review reports the overall survival, local control, and complication rates for the initial 63 patients treated in this Phase II study. Methods and Materials: High dose rate brachytherapy was delivered using an Iridium-192 HDR remote afterloader. Sixty-three patients were entered into the Phase II protocol, each receiving two vaginal cuff treatments 1 week apart (range 4-12 days) with vaginal ovoids (diameter 2.0-3.0 cm). No patient received adjuvant external beam radiation. A dose of 32.4 Gy in two fractions was prescribed to the ovoid surface in 63 patients. The first three patients treated at our institution received 15, 16.2, and 29 Gy, respectively, to determine acute effects. Results: At a median follow-up of 1.6 years (range 0.75-4.3 years) no patient has developed a vaginal cuff recurrence. One regional recurrence (1.6%) occurred at 1.2 years at the pelvic side wall. This patient is alive and without evidence of disease 7 months after completion of salvage irradiation, which resulted in the only vaginal stenosis (1.6%). Fourteen patients (22%) experienced vaginal apex fibrosis by physical exam, which was clinically symptomatic in four patients. Two patients reported stress incontinence; however, these symptoms were noted prior to their HDR therapy. One patient died 2.4 years after HDR therapy due to cardiovascular disease without evidence of cancer at autopsy. Conclusion: Preliminary results of our phase II HDR vaginal cuff protocol for postoperative FIGO Stage IA, Grade 3 or Stage IB, Grade 1-2 patients demonstrate that 32.4 Gy in two fractions is well tolerated by the vaginal cuff mucosa. Local control appears comparable to our prior experience and others with low dose rate (LDR) brachytherapy. Additional patient accrual and further follow

  8. How to write a research protocol

    African Journals Online (AJOL)

    A research protocol is best viewed as a key to open the gates between the researcher and ... studies will be quantitative designs and these form the focus of this paper. ..... applied to the underlying clinical problem addressed by the study.

  9. Adoption of the children's obesity clinic's treatment (TCOCT) protocol into another Danish pediatric obesity treatment clinic

    DEFF Research Database (Denmark)

    Most, Sebastian W; Højgaard, Birgitte; Teilmann, Grete Katrine

    2015-01-01

    BACKGROUND: Treating severe childhood obesity has proven difficult with inconsistent treatment results. This study reports the results of the implementation of a childhood obesity chronic care treatment protocol. METHODS: Patients aged 5 to 18 years with a body mass index (BMI) above the 99th......, but independent of baseline BMI SDS, age, co-morbidity, SES, pubertal stage, place of referral, hours of treatment per year, and mean visit interval time. CONCLUSIONS: The systematic use of the TCOCT protocol reduced the degree of childhood obesity with acceptable retention rates with a modest time...... percentile for sex and age were eligible for inclusion. At baseline patients' height, weight, and tanner stages were measured, as well as parents' socioeconomic status (SES) and family structure. Parental weight and height were self-reported. An individualised treatment plan including numerous advices...

  10. Development of a protocol that allows safe consumption of the hypoallergenic apple cultivar Santana

    OpenAIRE

    Maas, van der, M.P.; Schenk, M.F.

    2009-01-01

    The apple (Malus ×domestica) cultivar Santana was shown to have a low allergenicity in a previously reported clinical trial. A protocol was developed to validate these results outside a clinical setting and to market the Santana as a hypoallergenic apple for large-scale consumption. This protocol was designed to ensure safe consumption of the Santana by consumers suffering from apple allergy. We tested the protocol in a pilot in 100 supermarket stores and evaluated in an internet-based survey...

  11. Risks to the fetus from diagnostic imaging during pregnancy: review and proposal of a clinical protocol

    International Nuclear Information System (INIS)

    Gomes, Mafalda; Matias, Alexandra; Macedo, Filipe

    2015-01-01

    Every day, medical practitioners face the dilemma of exposing pregnant or possibly pregnant patients to radiation from diagnostic examinations. Both doctors and patients often have questions about the risks of radiation. The most vulnerable period is between the 8th and 15th weeks of gestation. Deterministic effects like pregnancy loss, congenital malformations, growth retardation and neurobehavioral abnormalities have threshold doses above 100-200 mGy. The risk is considered negligible at 50 mGy and in reality no diagnostic examination exceeds this limit. The risk of carcinogenesis is slightly higher than in the general population. Intravenous iodinated contrast is discouraged, except in highly selected patients. Considering all the possible noxious effects of radiation exposure, measures to diminish radiation are essential and affect the fetal outcome. Nonionizing procedures should be considered whenever possible and every radiology center should have its own data analysis on fetal radiation exposure. In this review, we analyze existing literature on fetal risks due to radiation exposure, producing a clinical protocol to guide safe radiation use in a clinical setting. (orig.)

  12. Risks to the fetus from diagnostic imaging during pregnancy: review and proposal of a clinical protocol.

    Science.gov (United States)

    Gomes, Mafalda; Matias, Alexandra; Macedo, Filipe

    2015-12-01

    Every day, medical practitioners face the dilemma of exposing pregnant or possibly pregnant patients to radiation from diagnostic examinations. Both doctors and patients often have questions about the risks of radiation. The most vulnerable period is between the 8th and 15th weeks of gestation. Deterministic effects like pregnancy loss, congenital malformations, growth retardation and neurobehavioral abnormalities have threshold doses above 100-200 mGy. The risk is considered negligible at 50 mGy and in reality no diagnostic examination exceeds this limit. The risk of carcinogenesis is slightly higher than in the general population. Intravenous iodinated contrast is discouraged, except in highly selected patients. Considering all the possible noxious effects of radiation exposure, measures to diminish radiation are essential and affect the fetal outcome. Nonionizing procedures should be considered whenever possible and every radiology center should have its own data analysis on fetal radiation exposure. In this review, we analyze existing literature on fetal risks due to radiation exposure, producing a clinical protocol to guide safe radiation use in a clinical setting.

  13. Risks to the fetus from diagnostic imaging during pregnancy: review and proposal of a clinical protocol

    Energy Technology Data Exchange (ETDEWEB)

    Gomes, Mafalda; Matias, Alexandra [University of Porto, Faculty of Medicine, Porto (Portugal); Macedo, Filipe [SMIC, Porto (Portugal)

    2015-12-15

    Every day, medical practitioners face the dilemma of exposing pregnant or possibly pregnant patients to radiation from diagnostic examinations. Both doctors and patients often have questions about the risks of radiation. The most vulnerable period is between the 8th and 15th weeks of gestation. Deterministic effects like pregnancy loss, congenital malformations, growth retardation and neurobehavioral abnormalities have threshold doses above 100-200 mGy. The risk is considered negligible at 50 mGy and in reality no diagnostic examination exceeds this limit. The risk of carcinogenesis is slightly higher than in the general population. Intravenous iodinated contrast is discouraged, except in highly selected patients. Considering all the possible noxious effects of radiation exposure, measures to diminish radiation are essential and affect the fetal outcome. Nonionizing procedures should be considered whenever possible and every radiology center should have its own data analysis on fetal radiation exposure. In this review, we analyze existing literature on fetal risks due to radiation exposure, producing a clinical protocol to guide safe radiation use in a clinical setting. (orig.)

  14. An evidence based blunt trauma protocol

    NARCIS (Netherlands)

    Vugt, R. van; Kool, D.R.; Lubeek, S.F.K.; Dekker, H.M.; Brink, M.; Deunk, J.; Edwards, M.J.R.

    2013-01-01

    OBJECTIVE: Currently CT is rapidly implemented in the evaluation of trauma patients. In anticipation of a large international multicentre trial, this study's aim was to evaluate the clinical feasibility of a new diagnostic protocol, used for the primary radiological evaluation in adult blunt

  15. Publication trends of study protocols in rehabilitation.

    Science.gov (United States)

    Jesus, Tiago S; Colquhoun, Heather L

    2017-09-04

    Growing evidence points for the need to publish study protocols in the health field. To observe whether the growing interest in publishing study protocols in the broader health field has been translated into increased publications of rehabilitation study protocols. Observational study using publication data and its indexation in PubMed. Not applicable. Not applicable. PubMed was searched with appropriate combinations of Medical Subject Headings up to December 2014. The effective presence of study protocols was manually screened. Regression models analyzed the yearly growth of publications. Two-sample Z-tests analyzed whether the proportion of Systematic Reviews (SRs) and Randomized Controlled Trials (RCTs) among study protocols differed from that of the same designs for the broader rehabilitation research. Up to December 2014, 746 publications of rehabilitation study protocols were identified, with an exponential growth since 2005 (r2=0.981; p<0.001). RCT protocols were the most common among rehabilitation study protocols (83%), while RCTs were significantly more prevalent among study protocols than among the broader rehabilitation research (83% vs. 35.8%; p<0.001). For SRs, the picture was reversed: significantly less common among study protocols (2.8% vs. 9.3%; p<0.001). Funding was more often reported by rehabilitation study protocols than the broader rehabilitation research (90% vs. 53.1%; p<0.001). Rehabilitation journals published a significantly lower share of rehabilitation study protocols than they did for the broader rehabilitation research (1.8% vs.16.7%; p<0.001). Identifying the reasons for these discrepancies and reverting unwarranted disparities (e.g. low rate of publication for rehabilitation SR protocols) are likely new avenues for rehabilitation research and its publication. SRs, particularly those aggregating RCT results, are considered the best standard of evidence to guide rehabilitation clinical practice; however, that standard can be improved

  16. Variation in radiographic protocols in paediatric interventional cardiology

    International Nuclear Information System (INIS)

    McFadden, S L; Hughes, C M; Winder, R J

    2013-01-01

    The aim of this work is to determine current radiographic protocols in paediatric interventional cardiology (IC) in the UK and Ireland. To do this we investigated which imaging parameters/protocols are commonly used in IC in different hospitals, to identify if a standard technique is used and illustrate any variation in practice. A questionnaire was sent to all hospitals in the UK and Ireland which perform paediatric IC to obtain information on techniques used in each clinical department and on the range of clinical examinations performed. Ethical and research governance approval was sought from the Office for Research Ethics Committees Northern Ireland and the individual trusts. A response rate of 79% was achieved, and a wide variation in technique was found between hospitals. The main differences in technique involved variations in the use of an anti-scatter grid and the use of additional filtration to the radiation beam, frame rates for digital acquisition and pre-programmed projections/paediatric specific programming in the equipment. We conclude that there is no standard protocol for carrying out paediatric IC in the UK or Ireland. Each hospital carries out the IC procedure according to its own local protocols resulting in a wide variation in radiation dose. (paper)

  17. Variation in radiographic protocols in paediatric interventional cardiology.

    Science.gov (United States)

    McFadden, S L; Hughes, C M; Winder, R J

    2013-06-01

    The aim of this work is to determine current radiographic protocols in paediatric interventional cardiology (IC) in the UK and Ireland. To do this we investigated which imaging parameters/protocols are commonly used in IC in different hospitals, to identify if a standard technique is used and illustrate any variation in practice. A questionnaire was sent to all hospitals in the UK and Ireland which perform paediatric IC to obtain information on techniques used in each clinical department and on the range of clinical examinations performed. Ethical and research governance approval was sought from the Office for Research Ethics Committees Northern Ireland and the individual trusts. A response rate of 79% was achieved, and a wide variation in technique was found between hospitals. The main differences in technique involved variations in the use of an anti-scatter grid and the use of additional filtration to the radiation beam, frame rates for digital acquisition and pre-programmed projections/paediatric specific programming in the equipment. We conclude that there is no standard protocol for carrying out paediatric IC in the UK or Ireland. Each hospital carries out the IC procedure according to its own local protocols resulting in a wide variation in radiation dose.

  18. Use of an evidence-based protocol to screen for sleep-disordered breathing in a heart failure disease management clinic.

    Science.gov (United States)

    Garner, Shelby L; Traverse, Ramona D

    2014-01-01

    Undiagnosed and untreated sleep-disordered breathing can lead to negative health outcomes and increased utilization of health resources among patients with heart failure. The purpose of this evidence-based practice project was to implement and evaluate a new multifaceted sleep-disordered breathing screening protocol in a heart failure disease management clinic. The combined use of a symptoms questionnaire, the Epworth sleepiness scale, and overnight pulse oximetry was significantly more effective in identifying patients with a positive diagnosis of sleep-disordered breathing than using the Epworth sleepiness scale alone (P < .05).

  19. Efficacy of 2 finishing protocols in the quality of orthodontic treatment outcome.

    Science.gov (United States)

    Stock, Gregory J; McNamara, James A; Baccetti, Tiziano

    2011-11-01

    The objectives of this prospective clinical study were to evaluate the quality of treatment outcomes achieved with a complex orthodontic finishing protocol involving serpentine wires and a tooth positioner, and to compare it with the outcomes of a standard finishing protocol involving archwire bends used to detail the occlusion near the end of active treatment. The complex finishing protocol sample consisted of 34 consecutively treated patients; 1 week before debonding, their molar bands were removed, and serpentine wires were placed; this was followed by active wear of a tooth positioner for up to 1 month after debonding. The standard finishing protocol group consisted of 34 patients; their dental arches were detailed with archwire bends and vertical elastics. The objective grading system of the American Board of Orthodontics was used to quantify the quality of the finish at each time point. The Wilcoxon signed rank test was used to compare changes in the complex finishing protocol; the Mann-Whitney U test was used to compare changes between groups. The complex finishing protocol group experienced a clinically significant improvement in objective grading system scores after treatment with the positioner. Mild improvement in posterior space closure was noted after molar band removal, but no improvement in the occlusion was observed after placement of the serpentine wires. Patients managed with the complex finishing protocol also had a lower objective grading system score (14.7) at the end of active treatment than did patients undergoing the standard finishing protocol (23.0). Tooth positioners caused a clinically significant improvement in interocclusal contacts, interproximal contacts, and net objective grading system score; mild improvement in posterior band space was noted after molar band removal 1 week before debond. Copyright © 2011 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

  20. Development of software for clinical protocols in nuclear medicine. Final report for the period 21 November 1994 - 21 November 1995

    International Nuclear Information System (INIS)

    Todd-Pokropek, A.

    1996-01-01

    After two technical contracts of IAEA, a portable image processing software (PIP) has been developed and some clinical protocols for nuclear medicine studies with IBM PCs which are connected to analogue gamma cameras. In addition, a suitable front end for driving some PC/gamma camera interface cards have been successfully tested and extended. The on-line help facilities and the user interface within PIP was remarkably improved, for medical physicists as developers as well as for technologists as users for routine studies

  1. Implementation of a Rapid, Protocol-based TIA Management Pathway.

    Science.gov (United States)

    Jarhult, Susann J; Howell, Melissa L; Barnaure-Nachbar, Isabelle; Chang, Yuchiao; White, Benjamin A; Amatangelo, Mary; Brown, David F; Singhal, Aneesh B; Schwamm, Lee H; Silverman, Scott B; Goldstein, Joshua N

    2018-03-01

    Our goal was to assess whether use of a standardized clinical protocol improves efficiency for patients who present to the emergency department (ED) with symptoms of transient ischemic attack (TIA). We performed a structured, retrospective, cohort study at a large, urban, tertiary care academic center. In July 2012 this hospital implemented a standardized protocol for patients with suspected TIA. The protocol selected high-risk patients for admission and low/intermediate-risk patients to an ED observation unit for workup. Recommended workup included brain imaging, vascular imaging, cardiac monitoring, and observation. Patients were included if clinical providers determined the need for workup for TIA. We included consecutive patients presenting during a six-month period prior to protocol implementation, and those presenting between 6-12 months after implementation. Outcomes included ED length of stay (LOS), hospital LOS, use of neuroimaging, and 90-day risk of stroke or TIA. From 01/2012 to 06/2012, 130 patients were evaluated for TIA symptoms in the ED, and from 01/2013 to 06/2013, 150 patients. The final diagnosis was TIA or stroke in 45% before vs. 41% after (p=0.18). Following the intervention, the inpatient admission rate decreased from 62% to 24% (pTIA among those with final diagnosis of TIA was 3% for both periods. Implementation of a TIA protocol significantly reduced ED LOS and total hospital LOS.

  2. Magnetic resonance imaging protocols for paediatric neuroradiology

    International Nuclear Information System (INIS)

    Saunders, Dawn E.; Thompson, Clare; Gunny, Roxanne; Jones, Rod; Cox, Tim; Chong, Wui Khean

    2007-01-01

    Increasingly, radiologists are encouraged to have protocols for all imaging studies and to include imaging guidelines in care pathways set up by the referring clinicians. This is particularly advantageous in MRI where magnet time is limited and a radiologist's review of each patient's images often results in additional sequences and longer scanning times without the advantage of improvement in diagnostic ability. The difficulties of imaging small children and the challenges presented to the radiologist as the brain develops are discussed. We present our protocols for imaging the brain and spine of children based on 20 years experience of paediatric neurological MRI. The protocols are adapted to suit children under the age of 2 years, small body parts and paediatric clinical scenarios. (orig.)

  3. Development of a calibration protocol for quantitative imaging for molecular radiotherapy dosimetry

    International Nuclear Information System (INIS)

    Wevrett, J.; Fenwick, A.; Scuffham, J.; Nisbet, A.

    2017-01-01

    Within the field of molecular radiotherapy, there is a significant need for standardisation in dosimetry, in both quantitative imaging and dosimetry calculations. Currently, there are a wide range of techniques used by different clinical centres and as a result there is no means to compare patient doses between centres. To help address this need, a 3 year project was funded by the European Metrology Research Programme, and a number of clinical centres were involved in the project. One of the required outcomes of the project was to develop a calibration protocol for three dimensional quantitative imaging of volumes of interest. Two radionuclides were selected as being of particular interest: iodine-131 ( 131 I, used to treat thyroid disorders) and lutetium-177 ( 177 Lu, used to treat neuroendocrine tumours). A small volume of activity within a scatter medium (water), representing a lesion within a patient body, was chosen as the calibration method. To ensure ease of use in clinical centres, an “off-the-shelf” solution was proposed – to avoid the need for in-house manufacturing. The BIODEX elliptical Jaszczak phantom and 16 ml fillable sphere were selected. The protocol was developed for use on SPECT/CT gamma cameras only, where the CT dataset would be used to correct the imaging data for attenuation of the emitted photons within the phantom. The protocol corrects for scatter of emitted photons using the triple energy window correction technique utilised by most clinical systems. A number of clinical systems were tested in the development of this protocol, covering the major manufacturers of gamma camera generally used in Europe. Initial imaging was performed with 131 I and 177 Lu at a number of clinical centres, but due to time constraints in the project, some acquisitions were performed with 177 Lu only. The protocol is relatively simplistic, and does not account for the effects of dead-time in high activity patients, the presence of background activity

  4. Development and implementation of a clinical pathway for cardiac surgery in the intensive care unit: Effects on protocol adherence.

    Science.gov (United States)

    van der Kolk, Marion; van den Boogaard, Mark; Ter Brugge-Speelman, Corine; Hol, Jeroen; Noyez, Luc; van Laarhoven, Kees; van der Hoeven, Hans; Pickkers, Peter

    2017-12-01

    Cardiac surgery (CS) is facilitated by multiple perioperative guidelines and protocols. Use of a clinical pathway (CP) may facilitate the care of these patients. This is a pre-post design study in the ICU of a tertiary referral centre. A CP for CS patients in the ICU was developed by ICU-nurses and enabled them to execute proactively predefined actions in accordance with and within the preset boundaries which were part of a variance report. A tailored implementation strategy was used. Primary outcome measure was protocol adherence above 80% on the domains of blood pressure control, action on chest tube blood loss and electrolyte control within the CP. In a 4-month period, 84 consecutive CP patients were included and compared with 162 matched control patients admitted in the year before implementation; 3 patients were excluded. Propensity score was used as matching parameter. CP patients were more likely to receive early adequate treatment for derangements in electrolytes (96% vs 47%, P blueprint for the implementation and use of a CP in low-volume high complex surgery. © 2017 John Wiley & Sons, Ltd.

  5. Comparison of a new whole-body continuous-table-movement protocol versus a standard whole-body MR protocol for the assessment of multiple myeloma

    International Nuclear Information System (INIS)

    Weckbach, S.; Michaely, H.J.; Schoenberg, S.O.; Dinter, D.J.; Stemmer, A.

    2010-01-01

    To evaluate a whole body (WB) continuous-table-movement (CTM) MR protocol for the assessment of multiple myeloma (MM) in comparison to a step-by-step WB protocol. Eighteen patients with MM were examined at 1.5T using a WB CTM protocol (axial T2-w fs BLADE, T1-w GRE sequence) and a step-by-step WB protocol including coronal/sagittal T1-w SE and STIR sequences as reference. Protocol time was assessed. Image quality, artefacts, liver/spleen assessability, and the ability to depict bone marrow lesions less than or greater than 1 cm as well as diffuse infiltration and soft tissue lesions were rated. Potential changes in the Durie and Salmon Plus stage and the detectability of complications were assessed. Mean protocol time was 6:38 min (CTM) compared to 24:32 min (standard). Image quality was comparable. Artefacts were more prominent using the CTM protocol (P = 0.0039). Organ assessability was better using the CTM protocol (P < 0.001). Depiction of bone marrow and soft tissue lesions was identical without a staging shift. Vertebral fractures were not detected using the CTM protocol. The new protocol allows a higher patient throughput and facilitates the depiction of extramedullary lesions. However, as long as vertebral fractures are not detectable, the protocol cannot be safely used for clinical routine without the acquisition of an additional sagittal sequence. (orig.)

  6. Revised Recommendations of the Consortium of MS Centers Task Force for a Standardized MRI Protocol and Clinical Guidelines for the Diagnosis and Follow-Up of Multiple Sclerosis

    Science.gov (United States)

    Traboulsee, A.; Simon, J.H.; Stone, L.; Fisher, E.; Jones, D.E.; Malhotra, A.; Newsome, S.D.; Oh, J.; Reich, D.S.; Richert, N.; Rammohan, K.; Khan, O.; Radue, E.-W.; Ford, C.; Halper, J.; Li, D.

    2016-01-01

    SUMMARY An international group of neurologists and radiologists developed revised guidelines for standardized brain and spinal cord MR imaging for the diagnosis and follow-up of MS. A brain MR imaging with gadolinium is recommended for the diagnosis of MS. A spinal cord MR imaging is recommended if the brain MR imaging is nondiagnostic or if the presenting symptoms are at the level of the spinal cord. A follow-up brain MR imaging with gadolinium is recommended to demonstrate dissemination in time and ongoing clinically silent disease activity while on treatment, to evaluate unexpected clinical worsening, to re-assess the original diagnosis, and as a new baseline before starting or modifying therapy. A routine brain MR imaging should be considered every 6 months to 2 years for all patients with relapsing MS. The brain MR imaging protocol includes 3D T1-weighted, 3D T2-FLAIR, 3D T2-weighted, post-single-dose gadolinium-enhanced T1-weighted sequences, and a DWI sequence. The progressive multifocal leukoencephalopathy surveillance protocol includes FLAIR and DWI sequences only. The spinal cord MR imaging protocol includes sagittal T1-weighted and proton attenuation, STIR or phase-sensitive inversion recovery, axial T2- or T2*-weighted imaging through suspicious lesions, and, in some cases, postcontrast gadolinium-enhanced T1-weighted imaging. The clinical question being addressed should be provided in the requisition for the MR imaging. The radiology report should be descriptive, with results referenced to previous studies. MR imaging studies should be permanently retained and available. The current revision incorporates new clinical information and imaging techniques that have become more available. PMID:26564433

  7. Clinical Trials

    Medline Plus

    Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

  9. International Study to Predict Optimized Treatment for Depression (iSPOT-D, a randomized clinical trial: rationale and protocol

    Directory of Open Access Journals (Sweden)

    Cooper Nicholas J

    2011-01-01

    Full Text Available Abstract Background Clinically useful treatment moderators of Major Depressive Disorder (MDD have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65 from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls. Study-eligible patients are antidepressant medication (ADM naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary. Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D ClinicalTrials.gov Identifier

  10. Aging of monolithic zirconia dental prostheses: Protocol for a 5-year prospective clinical study using ex vivo analyses.

    Science.gov (United States)

    Koenig, Vinciane; Wulfman, Claudine P; Derbanne, Mathieu A; Dupont, Nathalie M; Le Goff, Stéphane O; Tang, Mie-Leng; Seidel, Laurence; Dewael, Thibaut Y; Vanheusden, Alain J; Mainjot, Amélie K

    2016-12-15

    Recent introduction of computer-aided design/computer-aided manufacturing (CAD/CAM) monolithic zirconia dental prostheses raises the issue of material low thermal degradation (LTD), a well-known problem with zirconia hip prostheses. This phenomenon could be accentuated by masticatory mechanical stress. Until now zirconia LTD process has only been studied in vitro . This work introduces an original protocol to evaluate LTD process of monolithic zirconia prostheses in the oral environment and to study their general clinical behavior, notably in terms of wear. 101 posterior monolithic zirconia tooth elements (molars and premolars) are included in a 5-year prospective clinical trial. On each element, several areas between 1 and 2 mm 2 (6 on molars, 4 on premolars) are determined on restoration surface: areas submitted or non-submitted to mastication mechanical stress, glazed or non-glazed. Before prosthesis placement, ex vivo analyses regarding LTD and wear are performed using Raman spectroscopy, SEM imagery and 3D laser profilometry. After placement, restorations are clinically evaluated following criteria of the World Dental Federation (FDI), complemented by the analysis of fracture clinical risk factors. Two independent examiners perform the evaluations. Clinical evaluation and ex vivo analyses are carried out after 6 months and then each year for up to 5 years. For clinicians and patients, the results of this trial will justify the use of monolithic zirconia restorations in dental practice. For researchers, the originality of a clinical study including ex vivo analyses of material aging will provide important data regarding zirconia properties.Trial registration: ClinicalTrials.gov Identifier: NCT02150226.

  11. Impact of a pain protocol including hypnosis in major burns.

    Science.gov (United States)

    Berger, Mette M; Davadant, Maryse; Marin, Christian; Wasserfallen, Jean-Blaise; Pinget, Christophe; Maravic, Philippe; Koch, Nathalie; Raffoul, Wassim; Chiolero, René L

    2010-08-01

    Pain is a major issue after burns even when large doses of opioids are prescribed. The study focused on the impact of a pain protocol using hypnosis on pain intensity, anxiety, clinical course, and costs. All patients admitted to the ICU, aged >18 years, with an ICU stay >24h, accepting to try hypnosis, and treated according to standardized pain protocol were included. Pain was scaled on the Visual Analog Scale (VAS) (mean of daily multiple recordings), and basal and procedural opioid doses were recorded. Clinical outcome and economical data were retrieved from hospital charts and information system, respectively. Treated patients were matched with controls for sex, age, and the burned surface area. Forty patients were admitted from 2006 to 2007: 17 met exclusion criteria, leaving 23 patients, who were matched with 23 historical controls. Altogether patients were 36+/-14 years old and burned 27+/-15%BSA. The first hypnosis session was performed after a median of 9 days. The protocol resulted in the early delivery of higher opioid doses/24h (ppatient. A pain protocol including hypnosis reduced pain intensity, improved opioid efficiency, reduced anxiety, improved wound outcome while reducing costs. The protocol guided use of opioids improved patient care without side effects, while hypnosis had significant psychological benefits.

  12. Comparison of the effect of two endodontic irrigation protocols on the elimination of bacteria from root canal system: a prospective, randomized clinical trial.

    Science.gov (United States)

    Beus, Christopher; Safavi, Kamran; Stratton, Jeffrey; Kaufman, Blythe

    2012-11-01

    The purpose of this prospective, randomized clinical study was to compare the results of a nonactivated single-irrigation protocol (NAI) that used only 1% NaOCl with a passive ultrasonic multi-irrigation protocol (PUI) that used 1% NaOCl, 17% ethylenediaminetetraacetic acid, and 2% chlorhexidine in rendering canals bacteria free. In addition, the effect of a second-visit instrumentation after intra-appointment calcium hydroxide (CaOH(2)) was also evaluated in bacterial elimination. Fifty patients were recruited with a posterior tooth requiring primary endodontic treatment of apical periodontitis. Standard nonsurgical endodontic therapy was performed on both groups in a 2-visit approach by using calcium hydroxide intracanal medicament. Teeth were randomly treated with the NAI or PUI protocols in the first visit after complete instrumentation. Bacterial cultures were obtained at 4 periods during treatment from the canals: (1) before instrumentation, (2) after irrigation protocol, (3) after CaOH(2) medication, and (4) before obturation. Statistical analysis was performed on data by using the Fisher exact test and multivariate analysis. NAI and PUI rendered canals 80% and 84% bacteria free, respectively, at the end of the first visit. After CaOH(2) medication the total sample (NAI + PUI) had increased to 87% bacteria free, and the second-visit instrumentation resulted in a total of 91% bacteria free. These differences were not significant (P > .05). There was no statistical difference between irrigation methods. Each protocol resulted in a high frequency of negative cultures. This high frequency of negative cultures obtained in 1 visit is most likely related to an increased volume and depth of irrigation compared with previously reported protocols. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  13. Computationally Developed Sham Stimulation Protocol for Multichannel Desynchronizing Stimulation

    Directory of Open Access Journals (Sweden)

    Magteld Zeitler

    2018-05-01

    Full Text Available A characteristic pattern of abnormal brain activity is abnormally strong neuronal synchronization, as found in several brain disorders, such as tinnitus, Parkinson's disease, and epilepsy. As observed in several diseases, different therapeutic interventions may induce a placebo effect that may be strong and hinder reliable clinical evaluations. Hence, to distinguish between specific, neuromodulation-induced effects and unspecific, placebo effects, it is important to mimic the therapeutic procedure as precisely as possibly, thereby providing controls that actually lack specific effects. Coordinated Reset (CR stimulation has been developed to specifically counteract abnormally strong synchronization by desynchronization. CR is a spatio-temporally patterned multichannel stimulation which reduces the extent of coincident neuronal activity and aims at an anti-kindling, i.e., an unlearning of both synaptic connectivity and neuronal synchrony. Apart from acute desynchronizing effects, CR may cause sustained, long-lasting desynchronizing effects, as already demonstrated in pre-clinical and clinical proof of concept studies. In this computational study, we set out to computationally develop a sham stimulation protocol for multichannel desynchronizing stimulation. To this end, we compare acute effects and long-lasting effects of six different spatio-temporally patterned stimulation protocols, including three variants of CR, using a no-stimulation condition as additional control. This is to provide an inventory of different stimulation algorithms with similar fundamental stimulation parameters (e.g., mean stimulation rates but qualitatively different acute and/or long-lasting effects. Stimulation protocols sharing basic parameters, but inducing nevertheless completely different or even no acute effects and/or after-effects, might serve as controls to validate the specific effects of particular desynchronizing protocols such as CR. In particular, based on

  14. Medical guidelines for the patient: introducing the life assistance protocols.

    Science.gov (United States)

    Domínguez, David; Fernández, Carlos; Meneu, Teresa; Mocholí, Juan Bautista; Serafin, Riccardo

    2008-01-01

    This paper introduces our preliminary results in the modeling of Life Assistance Protocols, a new vision of medical guidelines and protocols through the lenses of p-Health. In this context the patient's role in the process is emphasized, the actions to be performed less defined and not only clinical situations considered, but also healthier lifestyle promotion processes accounted for, where the person's preferences and motivations play a key role. We propose a complete framework, balancing on classical clinical guideline models and covering both the theoretical and the practical aspects of the problem, describing it from conceptualization to the execution environment.

  15. Extraction protocols for orthodontic treatment: A retrospective study

    Directory of Open Access Journals (Sweden)

    Vaishnevi N Thirunavukkarasu

    2016-01-01

    Full Text Available Background and Objectives: Various extraction protocols have been followed for successful orthodontic treatment. The purpose of this study was to evaluate the extraction protocols in patients who had previously undergone orthodontic treatment and also who had reported for continuing orthodontic treatment from other clinics. Materials and Methods: One hundred thirty eight patients who registered for orthodontic treatment at the Faculty of Dentistry were divided into 10 extraction protocols based on the Orthodontic treatment protocol given by Janson et al. and were evaluated for statistical significance. Results: The descriptive statistics of the study revealed a total of 40 (29% patients in protocol 1, 43 (31.2% in protocol 2, 18 (13% in protocol 3, 16 (11.6% in protocol 5, and 12 (8.7% in Type 3 category of protocol 9. The Type 3 category in protocol 9 was statistically significant compared to other studies. Midline shift and collapse of the arch form were noticed in these individuals. Conclusion: Extraction of permanent teeth such as canine and lateral incisors without rational reasons could have devastating consequences on the entire occlusion. The percentage of cases wherein extraction of permanent teeth in the crowded region was adopted as a treatment option instead of orthodontic treatment is still prevalent in dental practice. The shortage of orthodontists in Malaysia, the long waiting period, and lack of subjective need for orthodontic treatment at an earlier age group were the reasons for the patient's to choose extraction of the mal-aligned teeth such as the maxillary canine or maxillary lateral incisors.

  16. Clinical protocol for conducting a bone scintigraphy subsequent SPECT/CT examination

    International Nuclear Information System (INIS)

    Jovanovska, A.; Dimcheva, M.; Doldurova, M.

    2013-01-01

    Full text: Introduction: Like any nuclear medicine study, bone scintigraphy is a diagnostic procedure associated with intravenous injection of a radioactive isotope with low activity - radiopharmaceutical. But recently in clinical practice hybrid imaging methods such as SPECT/ CT (Single Photon Emission Tomography - Computed Tomography) has necessitated, as they provide comprehensive information about the function and structure of the studied organ. Materials and methods: In the Department of Nuclear Medicine in The Specialized Hospital for Active Treatment of Oncology Diseases in Sofia it is installed a two-detector SPECT/CT gamma camera Siemens Symbia T2, on which the whole range of nuclear medicine studies in oncology practice is held: bone scintigraphy, 99mTc - MIBI scintigraphy, Lymphoscintigraphy, somatostatin receptor scintigraphy, tireostsintigraphy with 131I/99mTc, dynamic nephroscintgraphy etc. The working algorithm upon choosing the clinical protocols, and setting the parameters for scanning are complied with the requirements and recommendations established by the nuclear medicine standard. The presented are results from studies of patients when after whole body bone scintigraphy, an additional SPECT/CT study was conducted for more accurate diagnostic and interpretation of the results. Results: Practical introduction of hybrid imaging methods require from technicians besides knowledge in working with radioactive sources and practical skills such as: the selection of the matrix size, number of projections, choice of trajectory - circular or elliptical, set the appropriate degree of rotation of the detector (180 or 360). Particularly important in the processing of MR images is the appropriate choice of algorithm of reconstruction: filtered backprojection or iterative reconstruction methods. In MR images processing there is no rule for the optimal filter, which is why the quality of the reconstructed image depends primarily on the experience of the operator

  17. Thinking in clinical nursing practice: a study of critical care nurses' thinking applying the think-aloud, protocol analysis method.

    Science.gov (United States)

    Han, Kyung-Ja; Kim, Hesook Suzie; Kim, Mae-Ja; Hong, Kyung-Ja; Park, Sungae; Yun, Soon-Nyoung; Song, Misoon; Jung, Yoenyi; Kim, Haewon; Kim, Dong-Oak Debbie; Choi, Heejung; Kim, Kyungae

    2007-06-01

    The purpose of the paper is to discover the patterns and processes of decision-making in clinical nursing practice. A set of think-aloud data from five critical care nurses during 40 to 50 minutes of caregiving in intensive care units were obtained and analyzed by applying the procedures recommended by Ericsson and Simon for protocol analysis. Four thinking processes before acting were identified to constitute various sorts of thoughts in which the nurses were engaged during patient care: reviewing, validation, consideration, rationalization, and action. In addition, three patterns of sequential streaming of thinking (short, intermediate, long) were identified to reveal various ways the nurses dealt with clinical situations involving nursing tasks and responsibilities. This study specifies the initial categories of thoughts for each of the processes and various patterns with which these processes are sequentially combined, providing insights into the ways nurses think about problems and address their concerns. The findings suggest that the thinking in clinical practice involves more than focused decision-making and reasoning, and needs to be examined from a broader perspective.

  18. Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

    Science.gov (United States)

    Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

    2017-06-01

    The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

  19. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

    Science.gov (United States)

    Furberg, Robert D; Ortiz, Alexa M; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-06-27

    Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

  20. Radiotherapy QA of the DAHANCA 19 protocol

    DEFF Research Database (Denmark)

    Samsøe, E.; Andersen, E.; Hansen, C. R.

    2015-01-01

    Purpose/Objective: It has been demonstrated that nonadherence to protocol-specified radiotherapy (RT) requirements is associated with reduced survival, local control and potentially increased toxicity [1]. Thus, quality assurance (QA) of RT is important when evaluating the results of clinical...

  1. Development of a Decision Support System to Predict Physicians' Rehabilitation Protocols for Patients with Knee Osteoarthritis

    Science.gov (United States)

    Hawamdeh, Ziad M.; Alshraideh, Mohammad A.; Al-Ajlouni, Jihad M.; Salah, Imad K.; Holm, Margo B.; Otom, Ali H.

    2012-01-01

    To design a medical decision support system (MDSS) that would accurately predict the rehabilitation protocols prescribed by the physicians for patients with knee osteoarthritis (OA) using only their demographic and clinical characteristics. The demographic and clinical variables for 170 patients receiving one of three treatment protocols for knee…

  2. [Chinese Protocol of Diagnosis and Treatment of Colorectal Cancer].

    Science.gov (United States)

    2018-04-01

    Colorectal cancer is one of the most common malignant tumors in China. In 2012 one million thirty six thousand cases of colorectal cancer were diagnosed all over the world, two hundred fifty three thousand cases were diagnosed in China (accounted for 18.6%). China has the largest number of new cases of colorectal cancer in the world. Colorectal cancer has becoming a serious threat of Chinese residents' health. In 2010, the National Ministry of Health organized colorectal cancer expertise of the Chinese Medical Association to write the "Chinese Protocol of Diagnosis and Treatment of Colorectal Cancer" (2010edition), and publish it publicly. In recent years, the National Health and Family Planning Commission has organized experts to revised the protocol 2 times: the first time in 2015, the second time in 2017. The revised part of "Chinese Protocol of Diagnosis and Treatment of Colorectal Cancer" (2017 edition) involves new progress in the field of imaging examination, pathological evaluation, surgery, chemotherpy and radiotherapy. The 2017 edition of the protocol not only referred to the contents of the international guidelines, but also combined with the specific national conditions and clinical practice in China, and also included many evidence-based clinical data in China recently. The 2017 edition of the protocol would further promote the standardization of diagnosis and treatment of colorectal cancer in China, improve the survival and prognosis of patients, and benefit millions of patients with colorectal cancer and their families.

  3. Simplified protocol for clinical-grade tumor-infiltrating lymphocyte manufacturing with use of the Wave bioreactor

    DEFF Research Database (Denmark)

    Donia, Marco; Larsen, Signe Møllebæk; Met, Ozcan

    2014-01-01

    , a practical and simple protocol of TIL manufacturing with the use of a closed-system bioreactor was developed and implemented at our institution. RESULTS: This protocol enabled significant work load reduction during the most labor-intense step of TIL expansion, and allowed generation of high-quality TIL...

  4. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded

  5. Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    de Bie Rob A

    2010-06-01

    Full Text Available Abstract Background Shoulder impingement syndrome is a common musculoskeletal complaint leading to significant reduction of health and disability. Physiotherapy is often the first choice of treatment although its effectiveness is still under debate. Systematic reviews in this field highlight the need for more high quality trials to investigate the effectiveness of physiotherapy interventions in patients with subacromial impingement syndrome. Methods/Design This randomized controlled trial will investigate the effectiveness of individualized physiotherapy in patients presenting with clinical signs and symptoms of subacromial impingement, involving 90 participants aged 18-75. Participants are recruited from outpatient physiotherapy clinics, general practitioners, and orthopaedic surgeons in Germany. Eligible participants will be randomly allocated to either individualized physiotherapy or to a standard exercise protocol using central randomization. The control group will perform the standard exercise protocol aiming to restore muscular deficits in strength, mobility, and coordination of the rotator cuff and the shoulder girdle muscles to unload the subacromial space during active movements. Participants of the intervention group will perform the standard exercise protocol as a home program, and will additionally be treated with individualized physiotherapy based on clinical examination results, and guided by a decision tree. After the intervention phase both groups will continue their home program for another 7 weeks. Outcome will be measured at 5 weeks and at 3 and 12 months after inclusion using the shoulder pain and disability index and patients' global impression of change, the generic patient-specific scale, the average weekly pain score, and patient satisfaction with treatment. Additionally, the fear avoidance beliefs questionnaire, the pain catastrophizing scale, and patients' expectancies of treatment effect are assessed. Participants

  6. Comparison of two imaging protocols for acute stroke: unenhanced cranial CT versus a multimodality cranial CT protocol with perfusion imaging

    International Nuclear Information System (INIS)

    Langer, R. D.; Gorkom, K. Neidl van.; Kaabi, Ho Al.; Torab, F.; Czechowski, J.; Nagi, M.; Ashish, G. M.

    2007-01-01

    Full text: The aim of the study was to validate a multimodality cranial computed tomography (CCT) protocol for patients with acute stroke in the United Arab Emirates as a basic imaging procedure for a stroke unit. Therefore, a comparative study was conducted between two groups: retrospective, historical group 1 with early unenhanced CCT and prospective group 2 undergoing a multimodality CCT protocol. Follow-up unenhanced CCT >48 h served as gold standard in both groups. Group 1: Early unenhanced CCT of 50 patients were evaluated retrospectively, using Alberta Stroke Program Early CT Score, and compared with the definite infarction on follow-up CCT. Group 2: 50 patients underwent multimodality CCT (unenhanced CCT, perfusion studies: cerebral blood flow, cerebral blood volume, mean transit time and CT angiography) <8 h after clinical onset and follow-up studies. Modified National Institute of Health Stroke Scale was used clinically in both groups. Group 1 showed 38 men, 12 women, clinical onset 2-8 h before CCT and modified National Institute of Health Stroke Scale 0-28. Group 2 included 38 men, 12 women, onset 3-8 h before CCT, modified National Institute of Health Stroke Scale 0-28. Sensitivity was 58.3% in group 1 and 84.2% in group 2. Computed tomography angiography detected nine intracranial occlusions/stenoses. The higher sensitivity of the multimodality CCT protocol justifies its use as a basic diagnostic tool for the set-up of a first-stroke unit in the United Arab Emirates

  7. Improving biofeedback for the treatment of fecal incontinence in women: implementation of a standardized multi-site manometric biofeedback protocol.

    Science.gov (United States)

    Markland, A D; Jelovsek, J E; Whitehead, W E; Newman, D K; Andy, U U; Dyer, K; Harm-Ernandes, I; Cichowski, S; McCormick, J; Rardin, C; Sutkin, G; Shaffer, A; Meikle, S

    2017-01-01

    Standardized training and clinical protocols using biofeedback for the treatment of fecal incontinence (FI) are important for clinical care. Our primary aims were to develop, implement, and evaluate adherence to a standardized protocol for manometric biofeedback to treat FI. In a Pelvic Floor Disorders Network (PFDN) trial, participants were enrolled from eight PFDN clinical centers across the United States. A team of clinical and equipment experts developed biofeedback software on a novel tablet computer platform for conducting standardized anorectal manometry with separate manometric biofeedback protocols for improving anorectal muscle strength, sensation, and urge resistance. The training protocol also included education on bowel function, anal sphincter exercises, and bowel diary monitoring. Study interventionists completed online training prior to attending a centralized, standardized certification course. For the certification, expert trainers assessed the ability of the interventionists to perform the protocol components for a paid volunteer who acted as a standardized patient. Postcertification, the trainers audited interventionists during trial implementation to improve protocol adherence. Twenty-four interventionists attended the in-person training and certification, including 46% advanced practice registered nurses (11/24), 50% (12/24) physical therapists, and 4% physician assistants (1/24). Trainers performed audio audits for 88% (21/24), representing 84 audited visits. All certified interventionists met or exceeded the prespecified 80% pass rate for the audit process, with an average passing rate of 93%. A biofeedback protocol can be successfully imparted to experienced pelvic floor health care providers from various disciplines. Our process promoted high adherence to a standard protocol and is applicable to many clinical settings. © 2016 John Wiley & Sons Ltd.

  8. WE-E-304-00: Implementing SBRT Protocols

    International Nuclear Information System (INIS)

    2015-01-01

    SBRT is having a dramatic impact on radiation therapy of early-stage, locally advanced cancers. A number of national protocols have been and are being developed to assess the clinical efficacy of SBRT for various anatomical sites, such as lung and spine. Physics credentialing for participating and implementation of trial protocols involve a broad spectrum of requirements from image guidance, motion management, to planning technology and dosimetric constrains. For radiation facilities that do not have extensive experiences in SBRT treatment and protocol credentialing, these complex processes of credentialing and implementation could be very challenging and, sometimes, may lead to ineffective even unsuccessful execution of these processes. In this proposal, we will provide comprehensive review of some current SBRT protocols, explain the requirements and their underline rationales, illustrate representative failed and successful experiences, related to SBRT credentialing, and discuss strategies for effective SBRT credentialing and implementation. Learning Objectives: Understand requirements and challenges of SBRT credentailing and implentation Discuss processes and strategies of effective SBRT credentailing Discuss practical considerations, potential pitfalls and solutions of SBRT implentation

  9. WE-E-304-00: Implementing SBRT Protocols

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2015-06-15

    SBRT is having a dramatic impact on radiation therapy of early-stage, locally advanced cancers. A number of national protocols have been and are being developed to assess the clinical efficacy of SBRT for various anatomical sites, such as lung and spine. Physics credentialing for participating and implementation of trial protocols involve a broad spectrum of requirements from image guidance, motion management, to planning technology and dosimetric constrains. For radiation facilities that do not have extensive experiences in SBRT treatment and protocol credentialing, these complex processes of credentialing and implementation could be very challenging and, sometimes, may lead to ineffective even unsuccessful execution of these processes. In this proposal, we will provide comprehensive review of some current SBRT protocols, explain the requirements and their underline rationales, illustrate representative failed and successful experiences, related to SBRT credentialing, and discuss strategies for effective SBRT credentialing and implementation. Learning Objectives: Understand requirements and challenges of SBRT credentailing and implentation Discuss processes and strategies of effective SBRT credentailing Discuss practical considerations, potential pitfalls and solutions of SBRT implentation.

  10. Protocol for Bone Augmentation with Simultaneous Early Implant Placement: A Retrospective Multicenter Clinical Study

    Directory of Open Access Journals (Sweden)

    Peter Fairbairn

    2015-01-01

    Full Text Available Purpose. To present a novel protocol for alveolar bone regeneration in parallel to early implant placement. Methods. 497 patients in need of extraction and early implant placement with simultaneous bone augmentation were treated in a period of 10 years. In all patients the same specific method was followed and grafting was performed utilizing in situ hardening fully resorbable alloplastic grafting materials consisting of β-tricalcium phosphate and calcium sulfate. The protocol involved atraumatic extraction, implant placement after 4 weeks with simultaneous bone augmentation, and loading of the implant 12 weeks after placement and grafting. Follow-up periods ranged from 6 months to 10 years (mean of 4 years. Results. A total of 601 postextraction sites were rehabilitated in 497 patients utilizing the novel protocol. Three implants failed before loading and three implants failed one year after loading, leaving an overall survival rate of 99.0%. Conclusions. This standardized protocol allows successful long-term functional results regarding alveolar bone regeneration and implant rehabilitation. The concept of placing the implant 4 weeks after extraction, augmenting the bone around the implant utilizing fully resorbable, biomechanically stable, alloplastic materials, and loading the implant at 12 weeks seems to offer advantages when compared with traditional treatment modalities.

  11. A simple method for estimating the effective dose in dental CT. Conversion factors and calculation for a clinical low-dose protocol

    International Nuclear Information System (INIS)

    Homolka, P.; Kudler, H.; Nowotny, R.; Gahleitner, A.; Wien Univ.

    2001-01-01

    An easily appliable method to estimate effective dose including in its definition the high radio-sensitivity of the salivary glands from dental computed tomography is presented. Effective doses were calculated for a markedly dose reduced dental CT protocol as well as for standard settings. Data are compared with effective doses from the literature obtained with other modalities frequently used in dental care. Methods: Conversion factors based on the weighted Computed Tomography Dose Index were derived from published data to calculate effective dose values for various CT exposure settings. Results: Conversion factors determined can be used for clinically used kVp settings and prefiltrations. With reduced tube current an effective dose for a CT examination of the maxilla of 22 μSv can be achieved, which compares to values typically obtained with panoramic radiography (26 μSv). A CT scan of the mandible, respectively, gives 123 μSv comparable to a full mouth survey with intraoral films (150 μSv). Conclusion: For standard CT scan protocols of the mandible, effective doses exceed 600 μSv. Hence, low dose protocols for dental CT should be considered whenever feasable, especially for paediatric patients. If hard tissue diagnoses is performed, the potential of dose reduction is significant despite the higher image noise levels as readability is still adequate. (orig.) [de

  12. CPM Test-Retest Reliability: "Standard" vs "Single Test-Stimulus" Protocols.

    Science.gov (United States)

    Granovsky, Yelena; Miller-Barmak, Adi; Goldstein, Oren; Sprecher, Elliot; Yarnitsky, David

    2016-03-01

    Assessment of pain inhibitory mechanisms using conditioned pain modulation (CPM) is relevant clinically in prediction of pain and analgesic efficacy. Our objective is to provide necessary estimates of intersession CPM reliability, to enable transformation of the CPM paradigm into a clinical tool. Two cohorts of young healthy subjects (N = 65) participated in two dual-session studies. In Study I, a Bath-Thermode CPM protocol was used, with hot water immersion and contact heat as conditioning- and test-stimuli, respectively, in a classical parallel CPM design introducing test-stimulus first, and then the conditioning- and repeated test-stimuli in parallel. Study II consisted of two CPM protocols: 1) Two-Thermodes, one for each of the stimuli, in the same parallel design as above, and 2) single test-stimulus (STS) protocol with a single administration of a contact heat test-stimulus, partially overlapped in time by a remote shorter contact heat as conditioning stimulus. Test-retest reliability was assessed within 3-7 days. The STS-CPM had superior reliability intraclass correlation (ICC 2 ,: 1  = 0.59) over Bath-Thermode (ICC 2 ,: 1  = 0.34) or Two-Thermodes (ICC 2 ,: 1  = 0.21) protocols. The hand immersion conditioning pain had higher reliability than thermode pain (ICC 2 ,: 1  = 0.76 vs ICC 2 ,: 1  = 0.16). Conditioned test-stimulus pain scores were of good (ICC 2 ,: 1  = 0.62) or fair (ICC 2 ,: 1  = 0.43) reliability for the Bath-Thermode and the STS, respectively, but not for the Two-Thermodes protocol (ICC 2 ,: 1  = 0.20). The newly developed STS-CPM paradigm was more reliable than other CPM protocols tested here, and should be further investigated for its clinical relevance. It appears that large contact size of the conditioning-stimulus and use of single rather than dual test-stimulus pain contribute to augmentation of CPM reliability. © 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e

  13. CareTrack Kids—part 1. Assessing the appropriateness of healthcare delivered to Australian children: study protocol for clinical indicator development

    Science.gov (United States)

    Wiles, Louise K; Hooper, Tamara D; Hibbert, Peter D; White, Les; Mealing, Nicole; Jaffe, Adam; Cowell, Christopher T; Runciman, William B; Goldstein, Stan; Hallahan, Andrew R; Wakefield, John G; Murphy, Elisabeth; Lau, Annie; Wheaton, Gavin; Williams, Helena M; Hughes, Clifford; Braithwaite, Jeffrey

    2015-01-01

    Introduction Despite the widespread availability of clinical guidelines, considerable gaps remain between the care that is recommended (appropriate care) and the care provided. This protocol describes a research methodology to develop clinical indicators for appropriate care for common paediatric conditions. Methods and analysis We will identify conditions amenable to population-level appropriateness of care research and develop clinical indicators for each condition. Candidate conditions have been identified from published research; burden of disease, prevalence and frequency of presentation data; and quality of care priority lists. Clinical indicators will be developed through searches of national and international guidelines, and formatted with explicit criteria for inclusion, exclusion, time frame and setting. Experts will review the indicators using a wiki-based approach and modified Delphi process. A formative evaluation of the wiki process will be undertaken. Ethics and dissemination Human Research Ethics Committee approvals have been received from Sydney Children's Hospital Network, Children's Health Queensland Hospital and Health Service, and the Women's and Children's Health Network (South Australia). Applications are under review with Macquarie University and the Royal Australian College of General Practitioners. We will submit the results of the study to relevant journals and offer national and international presentations. PMID:25854976

  14. How blockchain-timestamped protocols could improve the trustworthiness of medical science.

    Science.gov (United States)

    Irving, Greg; Holden, John

    2016-01-01

    Trust in scientific research is diminished by evidence that data are being manipulated. Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research. Methods for using blockchain to provide proof of pre-specified endpoints in clinical trial protocols were first reported by Carlisle. We wished to empirically test such an approach using a clinical trial protocol where outcome switching has previously been reported. Here we confirm the use of blockchain as a low cost, independently verifiable method to audit and confirm the reliability of scientific studies.

  15. From protocol to published report

    DEFF Research Database (Denmark)

    Berendt, Louise; Callréus, Torbjörn; Petersen, Lene Grejs

    2016-01-01

    and published reports of academic clinical drug trials. METHODS: A comparison was made between study protocols and their corresponding published reports. We assessed the overall consistency, which was defined as the absence of discrepancy regarding study type (categorized as either exploratory or confirmatory...... in 1999, 2001, and 2003, 95 of which fulfilled the eligibility criteria and had at least one corresponding published report reporting data on trial subjects. Overall consistency was observed in 39% of the trials (95% CI: 29 to 49%). Randomized controlled trials (RCTs) constituted 72% (95% CI: 63 to 81......%) of the sample, and 87% (95% CI: 80 to 94%) of the trials were hospital based. CONCLUSIONS: Overall consistency between protocols and their corresponding published reports was low. Motivators for the inconsistencies are unknown but do not seem restricted to economic incentives....

  16. Recovery and functional activity of mononuclear bone marrow and peripheral blood cells after different cell isolation protocols used in clinical trials for cell therapy after acute myocardial infarction

    NARCIS (Netherlands)

    van Beem, Rachel T.; Hirsch, Alexander; Lommerse, Ingrid M.; Zwaginga, Jaap Jan; Noort, Willy A.; Biemond, Bart J.; Piek, Jan J.; van der Schoot, C. Ellen; Voermans, Carlijn

    2008-01-01

    AIMS: Clinical trials showed contradictory results in functional recovery after intracoronary infusion of autologous mononuclear (bone marrow) cells in patients with acute myocardial infarction. A recent study suggests that this might be related to the isolation protocol used. In The Netherlands, a

  17. Multi-disciplinary clinical protocol for the diagnosis of bulbar amyotrophic lateral sclerosis.

    Science.gov (United States)

    Chiaramonte, Rita; Di Luciano, Carmela; Chiaramonte, Ignazio; Serra, Agostino; Bonfiglio, Marco

    2018-04-23

    The objective of this study was to examine the role of different specialists in the diagnosis of amyotrophic lateral sclerosis (ALS), to understand changes in verbal expression and phonation, respiratory dynamics and swallowing that occurred rapidly over a short period of time. 22 patients with bulbar ALS were submitted for voice assessment, ENT evaluation, Multi-Dimensional Voice Program (MDVP), spectrogram, electroglottography, fiberoptic endoscopic evaluation of swallowing. In the early stage of the disease, the oral tract and velopharyngeal port were involved. Three months after the initial symptoms, most of the patients presented hoarseness, breathy voice, dysarthria, pitch modulation problems and difficulties in pronunciation of explosive, velar and lingual consonants. Values of MDVP were altered. Spectrogram showed an additional formant, due to nasal resonance. Electroglottography showed periodic oscillation of the vocal folds only during short vocal cycle. Swallowing was characterized by weakness and incoordination of oro-pharyngeal muscles with penetration or aspiration. A specific multidisciplinary clinical protocol was designed to report vocal parameters and swallowing disorders that changed more quickly in bulbar ALS patients. Furthermore, the patients were stratified according to involvement of pharyngeal structures, and severity index. Copyright © 2018 Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. Publicado por Elsevier España, S.L.U. All rights reserved.

  18. Determining the Optimal Protocol for Measuring an Albuminuria Class Transition in Clinical Trials in Diabetic Kidney Disease

    DEFF Research Database (Denmark)

    Kröpelin, Tobias F; de Zeeuw, Dick; Remuzzi, Giuseppe

    2016-01-01

    Albuminuria class transition (normo- to micro- to macroalbuminuria) is used as an intermediate end point to assess renoprotective drug efficacy. However, definitions of such class transition vary between trials. To determine the most optimal protocol, we evaluated the approaches used in four...... effect increased (decreased precision) with stricter end point definitions, resulting in a loss of statistical significance. In conclusion, the optimal albuminuria transition end point for use in drug intervention trials can be determined with a single urine collection for albuminuria assessment per...... clinical trials testing the effect of renin-angiotensin-aldosterone system intervention on albuminuria class transition in patients with diabetes: the BENEDICT, the DIRECT, the ALTITUDE, and the IRMA-2 Trial. The definition of albuminuria class transition used in each trial differed from the definitions...

  19. Alcohol handrubbing and chlorhexidine handwashing protocols for routine hospital practice: A randomized clinical trial of protocol efficacy and time effectiveness

    NARCIS (Netherlands)

    Chow, Angela; Arah, Onyebuchi A.; Chan, Siew-Pang; Poh, Bee-Fong; Krishnan, Prabha; Ng, Woei-Kian; Choudhury, Saugata; Chan, Joey; Ang, Brenda

    2012-01-01

    Background: The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend the use of alcohol handrubs to prevent health care-associated infections. However, the efficacy and time effectiveness of different alcohol handrubbing protocols have yet to be

  20. Improving the quality of perinatal mental health: a health visitor-led protocol.

    Science.gov (United States)

    Lewis, Anne; Ilot, Irene; Lekka, Chrysanthi; Oluboyede, Yemi

    2011-02-01

    The mental health of mothers is of significant concern to community practitioners. This paper reports on a case study exploring the success factors of a well established, health visitor-led protocol to identify and treat women with mild to moderate depression. Data were collected through interviews with a purposive sample of 12 community practitioners, a focus group of four health visitors and observation of a multidisciplinary steering group meeting. The protocol was described as an evidence-based tool and safety net that could be used flexibly to support clinical judgments and tailored to individual needs. Success factors included frontline clinician engagement and ownership, continuity of leadership to drive development and maintain momentum, comprehensive and on-going staff training, and strategic support for the protocol as a quality indicator at a time of organisational change. Quality and clinical leadership are continuing policy priorities. The protocol enabled frontline staff to lead a service innovation, providing a standardised multiprofessional approach to women's mental health needs through effective support, advice and treatment that can be measured and quality assured.

  1. The effect of personalized versus standard patient protocols for radiostereometric analysis (RSA)

    DEFF Research Database (Denmark)

    Muharemovic, O; Troelsen, A; Thomsen, M G

    2018-01-01

    INTRODUCTION: Increasing pressure in the clinic requires a more standardized approach to radiostereometric analysis (RSA) imaging. The aim of this study was to investigate whether implementation of personalized RSA patient protocols could increase image quality and decrease examination time...... imaging. Radiographers in the control group used a standard RSA protocol. RESULTS: At three months, radiographers in the case group significantly reduced (p .... No significant improvements were found in the control group at any time point. CONCLUSION: There is strong evidence that personalized RSA patient protocols have a positive effect on image quality and radiation dose savings. Implementation of personal patient protocols as a RSA standard will contribute...

  2. A Practice-Based Evaluation of Distress Screening Protocol Adherence and Medical Service Utilization.

    Science.gov (United States)

    Zebrack, Brad; Kayser, Karen; Bybee, Deborah; Padgett, Lynne; Sundstrom, Laura; Jobin, Chad; Oktay, Julianne

    2017-07-01

    Background: This study examined the extent to which cancer programs demonstrated adherence to their own prescribed screening protocol, and whether adherence to that protocol was associated with medical service utilization. The hypothesis is that higher rates of service utilization are associated with lower rates of adherence to screening protocols. Methods: Oncology social workers at Commission on Cancer-accredited cancer programs reviewed electronic health records (EHRs) in their respective cancer programs during a 2-month period in 2014. Rates of overall adherence to a prescribed distress screening protocol were calculated based on documentation in the EHR that screening adherence and an appropriate clinical response had occurred. We examined documentation of emergency department (ED) use and hospitalization within 2 months after the screening visit. Results: Review of 8,409 EHRs across 55 cancer centers indicated that the overall adherence rate to screening protocols was 62.7%. The highest rates of adherence were observed in Community Cancer Programs (76.3%) and the lowest rates were in NCI-designated Cancer Centers (43.3%). Rates of medical service utilization were significantly higher than expected when overall protocol adherence was lacking. After controlling for patient and institutional characteristics, risk ratios for ED use (0.82) and hospitalization (0.81) suggest that when overall protocol adherence was documented, 18% to 19% fewer patients used these medical services. Conclusions: The observed associations between a mandated psychosocial care protocol and medical service utilization suggest opportunities for operational efficiencies and costs savings. Further investigations of protocol integrity, as well as the clinical care models by which psychosocial care is delivered, are warranted. Copyright © 2017 by the National Comprehensive Cancer Network.

  3. Assessment of Grade of Dysphonia and Correlation With Quality of Life Protocol.

    Science.gov (United States)

    Spina, Ana Lúcia; Crespo, Agrício Nubiato

    2017-03-01

    The main objective of this study is to check the correlation between vocal self-assessment and results of the Voice-Related Quality of Life (V-RQOL) protocol, and whether there is a correlation between perceptual vocal assessment made by voice therapists and the results from the V-RQOL protocol. The study included 245 subjects with vocal complaints. This was a prospective analytical clinical study. Vocal perceptual assessment of each subject with dysphonia was made by three voice therapists, followed by self-assessment made by the subjects themselves, and the application of the V-RQOL protocol. The results have shown poor level of agreement between vocal assessment made by the voice therapists and self-assessment made by the subjects. The statistical analysis indicated that the results of V-RQOL protocol showed significant correlation with the vocal assessment made by the voice therapists and the self-assessment by the subjects. The agreement between the assessments was low and variable; age, gender, professional voice use, and clinical laryngoscopic diagnosis did not influence the agreement level. Protocol V-RQOL is sensitive to vocal assessment made by the voice therapists and self-assessment made by the patient. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  4. An Hourly Dose-Escalation Desensitization Protocol for Aspirin-Exacerbated Respiratory Disease.

    Science.gov (United States)

    Chen, Justin R; Buchmiller, Brett L; Khan, David A

    2015-01-01

    Aspirin desensitization followed by maintenance therapy effectively improves symptom control in patients with aspirin exacerbated respiratory disease (AERD). The majority of current desensitization protocols use 3-hour dosing intervals and often require 2 to 3 days to complete. We evaluated hourly dose escalations in a subset of patients with chronic rhinosinusitis, nasal polyps, and asthma who historically reacted to aspirin within 1 hour or were avoiding aspirin with the goal of developing a safe and efficient desensitization protocol. Fifty-seven aspirin desensitizations were performed under the hourly protocol. All patients had refractory nasal polyposis as an indication for aspirin desensitization. The clinical characteristics of each subject were analyzed in relation to aspects of his or her reactions during the procedure. Ninety-eight percent of study patients were successfully treated under the hourly protocol, including those with a history of severe reactions and intubation. None required further medication than is available in an outpatient allergy clinic. A total of 96% of reactors recorded a bronchial or naso-ocular reaction within 1 hour of the preceding dose. Of the total patients on this protocol, 40% were able to complete the procedure in a single day, and 60% within 2 days. Patients with AERD who have a history of symptoms less than 1 hour after aspirin exposure can be safely desensitized with a 1-hour dose-escalation protocol that can often be completed in a single day. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  5. Physical Therapy Protocol After Hip Arthroscopy: Clinical Guidelines Supported by 2-Year Outcomes.

    Science.gov (United States)

    Domb, Benjamin G; Sgroi, Terrance A; VanDevender, Jeremy C

    2016-07-01

    Femoroacetabular impingement (FAI) was first described by Ganz in 2003 and is a significant cause of decreased function and mobility. Femoroacetabular impingement must be treated in an individualized, goal-oriented, stepwise fashion. This protocol was developed with biomechanical considerations of soft tissue and bony structures surrounding the hip joint. The PubMed database was searched for scientific and review articles from the years 2000 to 2015 utilizing the search terms: hip rehabilitation, femoroacetabular impingement, and arthroscopy. Clinical review. Level 5. Five hundred ninety-five of 738 patients were available for follow-up showing improvement from preoperative to 2-year follow-up of 61.29 to 82.02 for modified Harris Hip Score (mHHS), 62.79 to 83.04 for Hip Outcome Score-Activities of Daily Living (HOS-ADL), 40.96 to 70.07 for Hip Outcome Score-Sport-Specific Subscale (HOS-SSS), and 57.97 to 80.41 for Non-Arthritic Hip Score (NAHS); visual analog scale (VAS) scores decreased from 5.86 preoperatively to 2.94 postoperatively. Following a structured, criteria-based program, appropriate patients undergoing hip arthroscopy may achieve excellent outcomes and return to full independent activities of daily living as well as sport. © 2016 The Author(s).

  6. A Quasi-Experimental, Before-After Trial Examining the Impact of an Emergency Department Mechanical Ventilator Protocol on Clinical Outcomes and Lung-Protective Ventilation in Acute Respiratory Distress Syndrome.

    Science.gov (United States)

    Fuller, Brian M; Ferguson, Ian T; Mohr, Nicholas M; Drewry, Anne M; Palmer, Christopher; Wessman, Brian T; Ablordeppey, Enyo; Keeperman, Jacob; Stephens, Robert J; Briscoe, Cristopher C; Kolomiets, Angelina A; Hotchkiss, Richard S; Kollef, Marin H

    2017-04-01

    To evaluate the impact of an emergency department mechanical ventilation protocol on clinical outcomes and adherence to lung-protective ventilation in patients with acute respiratory distress syndrome. Quasi-experimental, before-after trial. Emergency department and ICUs of an academic center. Mechanically ventilated emergency department patients experiencing acute respiratory distress syndrome while in the emergency department or after admission to the ICU. An emergency department ventilator protocol which targeted variables in need of quality improvement, as identified by prior work: 1) lung-protective tidal volume, 2) appropriate setting of positive end-expiratory pressure, 3) oxygen weaning, and 4) head-of-bed elevation. A total of 229 patients (186 preintervention group, 43 intervention group) were studied. In the emergency department, the intervention was associated with significant changes (p protective ventilation from 11.1% to 61.5%, p value of less than 0.01. The intervention was associated with a reduction in mortality from 54.8% to 39.5% (odds ratio, 0.38; 95% CI, 0.17-0.83; p = 0.02) and a 3.9 day increase in ventilator-free days, p value equals to 0.01. This before-after study of mechanically ventilated patients with acute respiratory distress syndrome demonstrates that implementing a mechanical ventilator protocol in the emergency department is feasible and associated with improved clinical outcomes.

  7. Comparison of mild and microdose GnRH agonist flare protocols on IVF outcome in poor responders.

    Science.gov (United States)

    Karimzadeh, Mohammad Ali; Mashayekhy, Mehri; Mohammadian, Farnaz; Moghaddam, Fatemeh Mansoori

    2011-05-01

    To compare the IVF outcome of clomiphene citrate/gonadotropin/antagonist (mild protocol) and microdose GnRH agonist flare protocols for poor responders undergoing in vitro fertilization. 159 poor responder patients were randomized and ovarian stimulation was performed with clomiphene citrate, gonadotropin and antagonist (group I) or microdose GnRH agonist flare (group II) protocols. Main outcome was clinical pregnancy rate and secondary outcomes were doses of gonadotropin administration and duration of stimulation. There were no significant differences in age, causes of infertility, basal FSH, BMI, duration of infertility, E(2) level on the day of hCG injection in both groups. Although the cancellation, fertilization, and clinical pregnancy rates were similar in both groups, the endometrial thickness, number of retrieved oocytes, mature oocytes and implantation rate were significantly higher in mild protocol. The doses of gonadotropin administration and duration of stimulation were significantly lower in mild protocol. We recommend mild protocol in assisted reproductive technology cycles for poor responders based on our results regarding less doses of used gonadotropin and a shorter duration of stimulation.

  8. Protocol Implementation Generator

    DEFF Research Database (Denmark)

    Carvalho Quaresma, Jose Nuno; Probst, Christian W.

    2010-01-01

    Users expect communication systems to guarantee, amongst others, privacy and integrity of their data. These can be ensured by using well-established protocols; the best protocol, however, is useless if not all parties involved in a communication have a correct implementation of the protocol and a...... Generator framework based on the LySatool and a translator from the LySa language into C or Java....... necessary tools. In this paper, we present the Protocol Implementation Generator (PiG), a framework that can be used to add protocol generation to protocol negotiation, or to easily share and implement new protocols throughout a network. PiG enables the sharing, verification, and translation...

  9. Protocol of specific health monitoring: ionizing radiation, 11 years later

    International Nuclear Information System (INIS)

    Castillejo Puertas, F. M.

    2016-01-01

    Since the approval on November 11 t h 2003 of the Protocol of Specific Health Monitoring for Workers Exposed to Ionizing Radiation a study has been carried out to discover its effectiveness. These areas were examined: the daily practice od accupational medicine and, in particular, its specific task in the application of the different clinical/labour criteria for workers exposed to ionizing radiation or at risk of radioactive contamination; the degree of its uses as well as the updates and improvements. For that purpose, a descriptive bibliographic revision has been used for the last 11 years. The results revealed the lack of updates of the Protocol as well as the few usable objective criteria, when the clinical/labour aptitudes are reflected upon. (Author)

  10. Follow-up care, surveillance protocol, and secondary prevention measures for survivors of colorectal cancer: American Society of Clinical Oncology clinical practice guideline endorsement.

    Science.gov (United States)

    Meyerhardt, Jeffrey A; Mangu, Pamela B; Flynn, Patrick J; Korde, Larissa; Loprinzi, Charles L; Minsky, Bruce D; Petrelli, Nicholas J; Ryan, Kim; Schrag, Deborah H; Wong, Sandra L; Benson, Al B

    2013-12-10

    The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing recent clinical practice guidelines that have been developed by other professional organizations. The Cancer Care Ontario (CCO) Guideline on Follow-up Care, Surveillance Protocol, and Secondary Prevention Measures for Survivors of Colorectal Cancer was reviewed by ASCO for methodologic rigor and considered for endorsement. The ASCO Panel concurred with the CCO recommendations and recommended endorsement, with the addition of several qualifying statements. Surveillance should be guided by presumed risk of recurrence and functional status of the patient (important within the first 2 to 4 years). Medical history, physical examination, and carcinoembryonic antigen testing should be performed every 3 to 6 months for 5 years. Patients at higher risk of recurrence should be considered for testing in the more frequent end of the range. A computed tomography scan (abdominal and chest) is recommended annually for 3 years, in most cases. Positron emission tomography scans should not be used for surveillance outside of a clinical trial. A surveillance colonoscopy should be performed 1 year after the initial surgery and then every 5 years, dictated by the findings of the previous one. If a colonoscopy was not preformed before diagnosis, it should be done after completion of adjuvant therapy (before 1 year). Secondary prevention (maintaining a healthy body weight and active lifestyle) is recommended. If a patient is not a candidate for surgery or systemic therapy because of severe comorbid conditions, surveillance tests should not be performed. A treatment plan from the specialist should have clear directions on appropriate follow-up by a nonspecialist.

  11. Comprehensive small animal imaging strategies on a clinical 3 T dedicated head MR-scanner; adapted methods and sequence protocols in CNS pathologies.

    Directory of Open Access Journals (Sweden)

    Deepu R Pillai

    Full Text Available BACKGROUND: Small animal models of human diseases are an indispensable aspect of pre-clinical research. Being dynamic, most pathologies demand extensive longitudinal monitoring to understand disease mechanisms, drug efficacy and side effects. These considerations often demand the concomitant development of monitoring systems with sufficient temporal and spatial resolution. METHODOLOGY AND RESULTS: This study attempts to configure and optimize a clinical 3 Tesla magnetic resonance scanner to facilitate imaging of small animal central nervous system pathologies. The hardware of the scanner was complemented by a custom-built, 4-channel phased array coil system. Extensive modification of standard sequence protocols was carried out based on tissue relaxometric calculations. Proton density differences between the gray and white matter of the rodent spinal cord along with transverse relaxation due to magnetic susceptibility differences at the cortex and striatum of both rats and mice demonstrated statistically significant differences. The employed parallel imaging reconstruction algorithms had distinct properties dependent on the sequence type and in the presence of the contrast agent. The attempt to morphologically phenotype a normal healthy rat brain in multiple planes delineated a number of anatomical regions, and all the clinically relevant sequels following acute cerebral ischemia could be adequately characterized. Changes in blood-brain-barrier permeability following ischemia-reperfusion were also apparent at a later time. Typical characteristics of intra-cerebral haemorrhage at acute and chronic stages were also visualized up to one month. Two models of rodent spinal cord injury were adequately characterized and closely mimicked the results of histological studies. In the employed rodent animal handling system a mouse model of glioblastoma was also studied with unequivocal results. CONCLUSIONS: The implemented customizations including extensive

  12. Comprehensive Small Animal Imaging Strategies on a Clinical 3 T Dedicated Head MR-Scanner; Adapted Methods and Sequence Protocols in CNS Pathologies

    Science.gov (United States)

    Pillai, Deepu R.; Heidemann, Robin M.; Lanz, Titus; Dittmar, Michael S.; Sandner, Beatrice; Beier, Christoph P.; Weidner, Norbert; Greenlee, Mark W.; Schuierer, Gerhard; Bogdahn, Ulrich; Schlachetzki, Felix

    2011-01-01

    Background Small animal models of human diseases are an indispensable aspect of pre-clinical research. Being dynamic, most pathologies demand extensive longitudinal monitoring to understand disease mechanisms, drug efficacy and side effects. These considerations often demand the concomitant development of monitoring systems with sufficient temporal and spatial resolution. Methodology and Results This study attempts to configure and optimize a clinical 3 Tesla magnetic resonance scanner to facilitate imaging of small animal central nervous system pathologies. The hardware of the scanner was complemented by a custom-built, 4-channel phased array coil system. Extensive modification of standard sequence protocols was carried out based on tissue relaxometric calculations. Proton density differences between the gray and white matter of the rodent spinal cord along with transverse relaxation due to magnetic susceptibility differences at the cortex and striatum of both rats and mice demonstrated statistically significant differences. The employed parallel imaging reconstruction algorithms had distinct properties dependent on the sequence type and in the presence of the contrast agent. The attempt to morphologically phenotype a normal healthy rat brain in multiple planes delineated a number of anatomical regions, and all the clinically relevant sequels following acute cerebral ischemia could be adequately characterized. Changes in blood-brain-barrier permeability following ischemia-reperfusion were also apparent at a later time. Typical characteristics of intra-cerebral haemorrhage at acute and chronic stages were also visualized up to one month. Two models of rodent spinal cord injury were adequately characterized and closely mimicked the results of histological studies. In the employed rodent animal handling system a mouse model of glioblastoma was also studied with unequivocal results. Conclusions The implemented customizations including extensive sequence protocol

  13. Adherence to, and outcomes of, a galactomannan screening protocol in high-risk hematology patients.

    Science.gov (United States)

    Harricharan, S; Biederman, K; Bombassaro, A M; Lazo-Langner, A; Elsayed, S; Fulford, A; Delport, J A; Xenocostas, A

    2018-04-01

    A twice-weekly galactomannan (gm) screening protocol was implemented in high-risk hematology inpatients. Study objectives were to determine adherence to the protocol, use of selected resources, and patient outcomes. This retrospective cohort study compared outcomes of interest before and after implementation of gm screening. Adults undergoing matched related allogeneic hematopoietic stem-cell transplantation or induction chemotherapy for acute leukemia were eligible. Patients could be enrolled more than once and were evaluated as episodes. Adherence to the gm protocol was assessed in post-implementation episodes. Use of broad-spectrum antifungals (bsafs), consultations (infectious diseases, respirology), and diagnostic procedures (computed tomography imaging, bronchoalveolar lavage) were compared between phases, as were the patient outcomes of all-cause mortality and clinical success (alive and not taking a bsaf). Of 182 episodes consecutively screened, 70 per phase were enrolled. Clinical characteristics and duration of assessment were similar for the phases. Full or partial adherence to the protocol was observed in 61 post-implementation episodes (87%), with full adherence in 40 episodes (57%). More episodes in the pre-implementation phase than in the post-implementation phase involved receipt of bsafs, consultations, and diagnostics (27% vs. 7%, p = 0.02; 46% vs. 26%, p = 0.014; and 46% vs. 31%, p = 0.083 respectively). Although mortality was similar in the two phases, clinical success at the final assessment was observed in fewer pre-implementation than post-implementation episodes (79% vs. 98%, p < 0.001). Implementation of a gm screening protocol was feasible and associated with significantly fewer episodes involving receipt of bsafs and consultations, and with significantly more episodes showing clinical success.

  14. Vertical Protocol Composition

    DEFF Research Database (Denmark)

    Groß, Thomas; Mödersheim, Sebastian Alexander

    2011-01-01

    The security of key exchange and secure channel protocols, such as TLS, has been studied intensively. However, only few works have considered what happens when the established keys are actually used—to run some protocol securely over the established “channel”. We call this a vertical protocol.......e., that the combination cannot introduce attacks that the individual protocols in isolation do not have. In this work, we prove a composability result in the symbolic model that allows for arbitrary vertical composition (including self-composition). It holds for protocols from any suite of channel and application...

  15. Minimal stimulation protocol using letrozole versus microdose flare up GnRH agonist protocol in women with poor ovarian response undergoing ICSI.

    Science.gov (United States)

    Mohsen, Iman Abdel; El Din, Rasha Ezz

    2013-02-01

    To compare the IVF outcomes of letrozole/antagonist and microdose GnRH agonist flare up protocols in poor ovarian responders undergoing intracytoplasmic sperm injection. A randomized controlled trial was performed in patients with one or more previous failed IVF cycles in which four or less oocytes were retrieved when the gonadotrophin starting dose was at least 300 IU/day. Sixty patients were randomized by computer-generated list to receive either letrozole/antagonist (mild stimulation) n = 30 or GnRH-a protocol (microdose flare) n = 30. Both groups were similar with respect to background and hormonal characteristics (age, duration of infertility, BMI, FSH, LH and E2). The clinical pregnancy rate per cycle was similar in both groups (13.3 vs. 16.6%; OR = 0.769; 95% CI = 0.185, 3.198). The doses of used gonadotropins and the number of stimulation days were significantly lower in the letrozole/antagonist protocol. The peak E2 level on the day of hCG, the endometrial thickness, the retrieved oocytes, the number of fertilized oocytes, the number of transferred embryos and the cancellation rate were statistically similar in both groups. The letrozole/antagonist protocol is a cost-effective and patient-friendly protocol that may be used in poor ovarian responders for IVF/ICSI.

  16. Validation of the Pangao PG-800B5 for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010.

    Science.gov (United States)

    Chen, Wan; Zeng, Zhaolin; Li, Lizhi; Wan, Xiaofen; Wan, Yi

    2014-10-01

    This study aimed to validate the Pangao PG-800B5 upper arm blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. A total of 33 participants, 16 men and 17 women, were included in the device evaluation. The protocol requirements were followed precisely. The mean age of the participants was 56.4±21.0 years (range 22-84 years). The mean systolic blood pressure was 143.6±25.5 mmHg (range 98-188 mmHg), the mean diastolic blood pressure was 85.7±17.2 mmHg (range 49-125 mmHg), and the mean arm circumference was 26.1±2.2 cm (range 23-32 cm). On average, the device overestimated the systolic blood pressure by 0.9±4.2 mmHg and diastolic blood pressure by 0.7±4.5 mmHg. The device passed all requirements, fulfilling the standards of the protocol. Therefore, the Pangao PG-800B5 upper arm blood pressure monitor can be recommended for clinical use and self-measurement in an adult population.

  17. Comparison of mRNA splicing assay protocols across multiple laboratories: recommendations for best practice in standardized clinical testing.

    Science.gov (United States)

    Whiley, Phillip J; de la Hoya, Miguel; Thomassen, Mads; Becker, Alexandra; Brandão, Rita; Pedersen, Inge Sokilde; Montagna, Marco; Menéndez, Mireia; Quiles, Francisco; Gutiérrez-Enríquez, Sara; De Leeneer, Kim; Tenés, Anna; Montalban, Gemma; Tserpelis, Demis; Yoshimatsu, Toshio; Tirapo, Carole; Raponi, Michela; Caldes, Trinidad; Blanco, Ana; Santamariña, Marta; Guidugli, Lucia; de Garibay, Gorka Ruiz; Wong, Ming; Tancredi, Mariella; Fachal, Laura; Ding, Yuan Chun; Kruse, Torben; Lattimore, Vanessa; Kwong, Ava; Chan, Tsun Leung; Colombo, Mara; De Vecchi, Giovanni; Caligo, Maria; Baralle, Diana; Lázaro, Conxi; Couch, Fergus; Radice, Paolo; Southey, Melissa C; Neuhausen, Susan; Houdayer, Claude; Fackenthal, Jim; Hansen, Thomas Van Overeem; Vega, Ana; Diez, Orland; Blok, Rien; Claes, Kathleen; Wappenschmidt, Barbara; Walker, Logan; Spurdle, Amanda B; Brown, Melissa A

    2014-02-01

    Accurate evaluation of unclassified sequence variants in cancer predisposition genes is essential for clinical management and depends on a multifactorial analysis of clinical, genetic, pathologic, and bioinformatic variables and assays of transcript length and abundance. The integrity of assay data in turn relies on appropriate assay design, interpretation, and reporting. We conducted a multicenter investigation to compare mRNA splicing assay protocols used by members of the ENIGMA (Evidence-Based Network for the Interpretation of Germline Mutant Alleles) consortium. We compared similarities and differences in results derived from analysis of a panel of breast cancer 1, early onset (BRCA1) and breast cancer 2, early onset (BRCA2) gene variants known to alter splicing (BRCA1: c.135-1G>T, c.591C>T, c.594-2A>C, c.671-2A>G, and c.5467+5G>C and BRCA2: c.426-12_8delGTTTT, c.7988A>T, c.8632+1G>A, and c.9501+3A>T). Differences in protocols were then assessed to determine which elements were critical in reliable assay design. PCR primer design strategies, PCR conditions, and product detection methods, combined with a prior knowledge of expected alternative transcripts, were the key factors for accurate splicing assay results. For example, because of the position of primers and PCR extension times, several isoforms associated with BRCA1, c.594-2A>C and c.671-2A>G, were not detected by many sites. Variation was most evident for the detection of low-abundance transcripts (e.g., BRCA2 c.8632+1G>A Δ19,20 and BRCA1 c.135-1G>T Δ5q and Δ3). Detection of low-abundance transcripts was sometimes addressed by using more analytically sensitive detection methods (e.g., BRCA2 c.426-12_8delGTTTT ins18bp). We provide recommendations for best practice and raise key issues to consider when designing mRNA assays for evaluation of unclassified sequence variants.

  18. Protocol for a randomised controlled trial for Reducing Arthritis Fatigue by clinical Teams (RAFT) using cognitive-behavioural approaches.

    Science.gov (United States)

    Hewlett, S; Ambler, N; Almeida, C; Blair, P S; Choy, E; Dures, E; Hammond, A; Hollingworth, W; Kirwan, J; Plummer, Z; Rooke, C; Thorn, J; Tomkinson, K; Pollock, J

    2015-08-06

    will be submitted to the National Institute for Health and Care Excellence, Clinical Commissioning Groups and all UK rheumatology departments. 52709998; Protocol v3 09.02.2015. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  19. Optimized workflow and imaging protocols for whole-body oncologic PET/MRI.

    Science.gov (United States)

    Ishii, Shirou; Hara, Takamitsu; Nanbu, Takeyuki; Suenaga, Hiroki; Sugawara, Shigeyasu; Kuroiwa, Daichi; Sekino, Hirofumi; Miyajima, Masayuki; Kubo, Hitoshi; Oriuchi, Noboru; Ito, Hiroshi

    2016-11-01

    Although PET/MRI has the advantages of a simultaneous acquisition of PET and MRI, high soft-tissue contrast of the MRI images, and reduction of radiation exposure, its low profitability and long acquisition time are significant problems in clinical settings. Thus, MRI protocols that meet oncological purposes need to be used in order to reduce examination time while securing detectability. Currently, half-Fourier acquisition single-shot turbo spin echo and 3D-T1 volumetric interpolated breath-hold examination may be the most commonly used sequences for whole-body imaging due to their shorter acquisition time and higher diagnostic accuracy. Although there have been several reports that adding diffusion weighted image (DWI) to PET/MRI protocol has had no effect on tumor detection to date, in cases of liver, kidney, bladder, and prostate cancer, the use of DWI may be beneficial in detecting lesions. Another possible option is to scan each region with different MRI sequences instead of scanning the whole body using one sequence continuously. We herein report a workflow and imaging protocols for whole-body oncologic PET/MRI using an integrated system in the clinical routine, designed for the detection, for example by cancer screening, of metastatic lesions, in order to help future users optimize their workflow and imaging protocols.

  20. The evaluation of MRI protocols for the quantification of adiposity in the obese

    International Nuclear Information System (INIS)

    Tagami, Hirotaka; Taki, Tomomi; Ueoro, Kouichi

    1998-01-01

    Obesity is a recognized risk factor for the development of diseases such as atherosclerosis, diabetes mellitus and hypertension. The individual risk of the obesity can not be evaluated merely by the body weight or body mass index. The fat distribution is a key to evaluate it. So far, the MRI protocols in the literature tested for the evaluation of the fat distribution were spin-echo and inversion-recovery images. We tested both protocols and couldn't get good images basically due to motion artifacts. Therefore, the field-echo (FE) protocol, a rapid scan protocol, was evaluated. The transverse fat distributions at umbilical level of 8 male obese volunteers were examined with MRI FE protocol and X-ray computed tomography (CT). The excellent images were obtained with FE protocol and correlation with CT images was also satisfactory. The FE protocols for the evaluation of the fat distribution is of use and reasonable tool for the clinical usage. (author)

  1. Data-driven CT protocol review and management—experience from a large academic hospital.

    Science.gov (United States)

    Zhang, Da; Savage, Cristy A; Li, Xinhua; Liu, Bob

    2015-03-01

    Protocol review plays a critical role in CT quality assurance, but large numbers of protocols and inconsistent protocol names on scanners and in exam records make thorough protocol review formidable. In this investigation, we report on a data-driven cataloging process that can be used to assist in the reviewing and management of CT protocols. We collected lists of scanner protocols, as well as 18 months of recent exam records, for 10 clinical scanners. We developed computer algorithms to automatically deconstruct the protocol names on the scanner and in the exam records into core names and descriptive components. Based on the core names, we were able to group the scanner protocols into a much smaller set of "core protocols," and to easily link exam records with the scanner protocols. We calculated the percentage of usage for each core protocol, from which the most heavily used protocols were identified. From the percentage-of-usage data, we found that, on average, 18, 33, and 49 core protocols per scanner covered 80%, 90%, and 95%, respectively, of all exams. These numbers are one order of magnitude smaller than the typical numbers of protocols that are loaded on a scanner (200-300, as reported in the literature). Duplicated, outdated, and rarely used protocols on the scanners were easily pinpointed in the cataloging process. The data-driven cataloging process can facilitate the task of protocol review. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  2. GnRH antagonist versus long agonist protocols in IVF

    DEFF Research Database (Denmark)

    Lambalk, C B; Banga, F R; Huirne, J A

    2017-01-01

    BACKGROUND: Most reviews of IVF ovarian stimulation protocols have insufficiently accounted for various patient populations, such as ovulatory women, women with polycystic ovary syndrome (PCOS) or women with poor ovarian response, and have included studies in which the agonist or antagonist...... was not the only variable between the compared study arms. OBJECTIVE AND RATIONALE: The aim of the current study was to compare GnRH antagonist protocols versus standard long agonist protocols in couples undergoing IVF or ICSI, while accounting for various patient populations and treatment schedules. SEARCH...... in couples undergoing IVF or ICSI. The primary outcome was ongoing pregnancy rate. Secondary outcomes were: live birth rate, clinical pregnancy rate, number of oocytes retrieved and safety with regard to ovarian hyperstimulation syndrome (OHSS). Separate comparisons were performed for the general IVF...

  3. Magnetic resonance imaging protocols for examination of the neurocranium at 3 T.

    Science.gov (United States)

    Schwindt, W; Kugel, H; Bachmann, R; Kloska, S; Allkemper, T; Maintz, D; Pfleiderer, B; Tombach, B; Heindel, W

    2003-09-01

    The increasing availability of high-field (3 T) MR scanners requires adapting and optimizing clinical imaging protocols to exploit the theoretically higher signal-to-noise ratio (SNR) of the higher field strength. Our aim was to establish reliable and stable protocols meeting the clinical demands for imaging the neurocranium at 3 T. Two hundred patients with a broad range of indications received an examination of the neurocranium with an appropriate assortment of imaging techniques at 3 T. Several imaging parameters were optimized. Keeping scan times comparable to those at 1.5 T we increased spatial resolution. Contrast-enhanced and non-enhanced T1-weighted imaging was best applying gradient-echo and inversion recovery (rather than spin-echo) techniques, respectively. For fluid-attenuated inversion recovery (FLAIR) imaging a TE of 120 ms yielded optimum contrast-to-noise ratio (CNR). High-resolution isotropic 3D data sets were acquired within reasonable scan times. Some artifacts were pronounced, but generally imaging profited from the higher SNR. We present a set of optimized examination protocols for neuroimaging at 3 T, which proved to be reliable in a clinical routine setting.

  4. Magnetic resonance imaging protocols for examination of the neurocranium at 3 T

    Energy Technology Data Exchange (ETDEWEB)

    Schwindt, W.; Kugel, H.; Bachmann, R.; Kloska, S.; Allkemper, T.; Maintz, D.; Pfleiderer, B.; Tombach, B.; Heindel, W. [Institut fuer Klinische Radiologie, Universitaetsklinikum Muenster, Albert-Schweitzer-Strasse 33, 48129, Muenster (Germany)

    2003-09-01

    The increasing availability of high-field (3 T) MR scanners requires adapting and optimizing clinical imaging protocols to exploit the theoretically higher signal-to-noise ratio (SNR) of the higher field strength. Our aim was to establish reliable and stable protocols meeting the clinical demands for imaging the neurocranium at 3 T. Two hundred patients with a broad range of indications received an examination of the neurocranium with an appropriate assortment of imaging techniques at 3 T. Several imaging parameters were optimized. Keeping scan times comparable to those at 1.5 T we increased spatial resolution. Contrast-enhanced and non-enhanced T1-weighted imaging was best applying gradient-echo and inversion recovery (rather than spin-echo) techniques, respectively. For fluid-attenuated inversion recovery (FLAIR) imaging a TE of 120 ms yielded optimum contrast-to-noise ratio (CNR). High-resolution isotropic 3D data sets were acquired within reasonable scan times. Some artifacts were pronounced, but generally imaging profited from the higher SNR. We present a set of optimized examination protocols for neuroimaging at 3 T, which proved to be reliable in a clinical routine setting. (orig.)

  5. Magnetic resonance imaging protocols for examination of the neurocranium at 3 T

    International Nuclear Information System (INIS)

    Schwindt, W.; Kugel, H.; Bachmann, R.; Kloska, S.; Allkemper, T.; Maintz, D.; Pfleiderer, B.; Tombach, B.; Heindel, W.

    2003-01-01

    The increasing availability of high-field (3 T) MR scanners requires adapting and optimizing clinical imaging protocols to exploit the theoretically higher signal-to-noise ratio (SNR) of the higher field strength. Our aim was to establish reliable and stable protocols meeting the clinical demands for imaging the neurocranium at 3 T. Two hundred patients with a broad range of indications received an examination of the neurocranium with an appropriate assortment of imaging techniques at 3 T. Several imaging parameters were optimized. Keeping scan times comparable to those at 1.5 T we increased spatial resolution. Contrast-enhanced and non-enhanced T1-weighted imaging was best applying gradient-echo and inversion recovery (rather than spin-echo) techniques, respectively. For fluid-attenuated inversion recovery (FLAIR) imaging a TE of 120 ms yielded optimum contrast-to-noise ratio (CNR). High-resolution isotropic 3D data sets were acquired within reasonable scan times. Some artifacts were pronounced, but generally imaging profited from the higher SNR. We present a set of optimized examination protocols for neuroimaging at 3 T, which proved to be reliable in a clinical routine setting. (orig.)

  6. Comprehensive brachytherapy physical and clinical aspects

    CERN Document Server

    Baltas, Dimos; Meigooni, Ali S; Hoskin, Peter J

    2013-01-01

    Modern brachytherapy is one of the most important oncological treatment modalities requiring an integrated approach that utilizes new technologies, advanced clinical imaging facilities, and a thorough understanding of the radiobiological effects on different tissues, the principles of physics, dosimetry techniques and protocols, and clinical expertise. A complete overview of the field, Comprehensive Brachytherapy: Physical and Clinical Aspects is a landmark publication, presenting a detailed account of the underlying physics, design, and implementation of the techniques, along with practical guidance for practitioners. Bridging the gap between research and application, this single source brings together the technological basis, radiation dosimetry, quality assurance, and fundamentals of brachytherapy. In addition, it presents discussion of the most recent clinical practice in brachytherapy including prostate, gynecology, breast, and other clinical treatment sites. Along with exploring new clinical protocols, ...

  7. The utilization of Clinical Protocols and Therapeutic Guidelines and the rationalization of judicialization for the right to health

    Directory of Open Access Journals (Sweden)

    Clarice Seixas Duarte

    2017-08-01

    Full Text Available The article analyzes the adoption of the Clinical Protocols and Therapeutic Guidelines (CPTGs as an objective measure to be used by the courts in cases where the purpose is to offer positive benefits in terms of realization of the right to health. Such a benchmark can assist the judge in the task of deciding the legal situation of medication supplies, guaranteeing the prevalence of rationality as outlined in the formulation of related public policies and, consequently, the use of technical-political arguments in the distribution of healthcare goods and resources. However, this is not an absolute parameter, and the content of the CPTGs may be questioned, even judicially. With this, judicial action is used as an instrument of democratization and social control among public choices, which can impact health policy itself.

  8. Utility of CT after sonography for suspected appendicitis in children: integration of a clinical scoring system with a staged imaging protocol.

    Science.gov (United States)

    Srinivasan, Abhay; Servaes, Sabah; Peña, Andrès; Darge, Kassa

    2015-02-01

    To improve diagnosis of pediatric appendicitis, many institutions have implemented a staged imaging protocol utilizing ultrasonography (US) first and then computed tomography (CT). A substantial number of children with suspected appendicitis undergo CT after US, and the efficient and accurate diagnosis of pediatric appendicitis continues to be challenging. The objective of the study is to characterize the utility of CT following US for diagnosis of pediatric appendicitis, in conjunction with a clinical appendicitis score (AS). Imaging studies of children with suspected appendicitis who underwent CT after US in an imaging protocol were retrospectively reviewed by three radiologists in consensus. Chart review derived the AS (range 0-10) and obtained the patient diagnosis and disposition, and an AS was applied to each patient. Clinical and radiologic data were analyzed to assess the yield of CT after US. Studies of 211 children (mean age 11.3 years) were included. The positive threshold for AS was determined to be 6 out of 10. When AS and US were concordant (N = 140), the sensitivity and specificity of US were similar to CT. When AS and US were discordant (N = 71) and also when AS ≥ 6 (N = 84), subsequent CT showed superior sensitivity and specificity to US alone. In the subset where US showed neither the appendix nor inflammatory change in the right lower quadrant (126/211, 60 % of scans), when AS 6 (kg/year, P < 0.001) and after-hours (1700 -0730 hours) performance of US (P < 0.001). Results suggest that the appendicitis score has utility in guiding an imaging protocol and support the contention that non-visualization of the appendix on US is not intrinsically non-diagnostic. There was little benefit to additional CT when AS < 6 and US did not show the appendix or evidence of inflammation; this would have avoided CT in 140/211 (66 %) patients. CT demonstrated benefit when AS ≥ 6, suggesting that cases with AS ≥ 6 and

  9. Long-term impact of pre-operative physical rehabilitation protocol on the 6-min walk test of patients with adolescent idiopathic scoliosis: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    V.L. dos Santos Alves

    2015-05-01

    Full Text Available Background: Monitored physical activities in patients with adolescent idiopathic scoliosis (AIS have been shown to improve physical performance, endurance and cardiopulmonary function and may be assessed by the 6-min walk test (6MWT. We aimed to evaluate the long-term results of the 6MWT after a rehabilitation protocol employed before surgical correction for AIS. Methods: This prospective randomized clinical trial studied the impact of a 4-month pre-operative physical rehabilitation protocol on post-operative cardiopulmonary function and physical endurance, by using the 6MWT, in patients with AIS submitted to surgical correction, comparing them to matched controls without physical rehabilitation. Studied variables were heart and respiratory rate, systolic and diastolic blood pressure, peripheral blood oxygen saturation, Borg score, and distance walked. Patients were assessed at baseline, after 4 months of rehabilitation, and 3, 6 and 12 months post-operatively. Results: A total of 50 patients with AIS were included in the study and allocated blindly, by simple randomization, into either one of the two groups, with 25 patients each: study group (pre-operative physical rehabilitation and control group. The physical rehabilitation protocol promoted significant progressive improvement in heart and respiratory rate, peripheral blood oxygen saturation, distance walked, and level of effort assessed by the Borg scale after surgery. Conclusions: Post-surgical recovery, evaluated by 6MWT, was significantly better in patients who underwent a 4-month pre-operative physical rehabilitation protocol. Keywords: Scoliosis, Exercise, Exercise movement techniques, Exercise therapy, Exercise test

  10. Medical management of early pregnancy failure (EPF): a retrospective analysis of a combined protocol of mifepristone and misoprostol used in clinical practice.

    Science.gov (United States)

    Colleselli, Valeria; Schreiber, Courtney A; D'Costa, Elisabeth; Mangesius, Stephanie; Wildt, Ludwig; Seeber, Beata E

    2014-06-01

    To evaluate the efficacy of a combined protocol of mifepristone and misoprostol in the management of early pregnancy failure (EPF) and the average time to expulsion of tissue and rate of side effects. Retrospective chart review of all consecutive women treated with primary medical management for EPF at our institution from 2006 to 2012. 168 patients were included in the present study. The overall success rate, defined as the absence of the need for surgical intervention, was 61 % and did not differ by calendar year. There was no difference in success rate grouped by diagnosis [intrauterine embryonic/fetal demise (IUED/IUFD) vs. anembryonic gestation; p = 0.30] or gestational age (800 μg (68 vs. 50 %, p = 0.029). Of the possible predictive factors of success, only the dose of misoprostol required was a significant independent negative predictor. Mean and median time to tissue expulsion after the first dose of misoprostol were 8.4 and 5.5 h, respectively. The incidence of side effects was low with no blood transfusions required. The success rate in this study is markedly below published data. This can possibly be attributed to retrospective study design, allowing for physician subjectivity and patients' wishes in the absence of strict study requirements. The protocol was well tolerated with a paucity of side effects. We make suggestions for enhancing success rates in the clinical setting by optimizing medication protocols, establishing precise treatment guidelines and training physicians in the accurate interpretation of treatment outcomes.

  11. [Comparision of in vitro maturation applied in PCOS and non-PCOS patients undergo stimulated and unstimulated protocols].

    Science.gov (United States)

    Wang, Peiyu; Zhao, Junzhao; Jin, Congcong; Yu, Rong; Lin, Jia; Zhu, Ruru; Wu, Yonggen

    2014-12-01

    To compare the laboratory and clinical results between unstimulated in vitro maturation (IVM) and IVM converted from in vitro fertilization (IVF) in polycystic ovarian syndrome (PCOS) and non-PCOS patients. We divided 591 IVM cycles in the First Affiliated Hospital of Wenzhou Medical Univesity from Jan. 2008 to Dec. 2013 into 4 groups: group A1B1, PCOS patients underwent unstimulated IVM protocol, 240 cycles; group A1B2, PCOS patients underwent IVM converted from conventional stimulated IVF protocol, 153 cycles; group A2B1, non-PCOS patients underwent unstimutlated IVM protocol, 103 cycles; group A2B2, non-PCOS patient underwent IVM converted from conventional stimulated IVF protocol, 95 cycles. Multiple linear regression method and binary logistic regression method were used to assess the influence of PCOS and protocols for IVM on laboratory and clinical outcomes. The mean number of oocytes retrieved was positively related with PCOS [partial regression coefficient (B) = 3.37, P PCOS and IVM converted from IVF (B = 0.08, P = 0.010; B = 0.09, P = 0.001), as well as implantation rate related with them (B = 0.07, P = 0.010; B = 0.10, P PCOS and IVM converted from IVF improved hCG positive (hCG>10 U/L) rate (OR = 1.636, 95%CI: 1.113-2.204, P PCOS condition and protocol used (P > 0.05). PCOS and IVM converted from IVF protocol improved the high-quality embryo rate, implantation rate, hCG positive rate and clinical pregnancy rate. IVM converted from IVF protocol reduced the spontaneous abortion rate. PCOS patients may be more suitable for the IVM treatment. No matter PCOS or non-PCOS patients, IVM converted from IVF protocol had better pregnancy outcome than that of unstimulated cycle.

  12. Adherence to guidelines and protocols in the prehospital and emergency department setting : A systematic review

    NARCIS (Netherlands)

    Theo van Achterberg; S. Meijer; M. Verhofstad; Joke Mintjes; Lilian Vloet

    2011-01-01

    A gap between guidelines or protocols and clinical practice often exists, which may result in patients not receiving appropriate care. Therefore, the objectives of this systematic review were (1) to give an overview of professionals’ adherence to (inter)national guidelines and protocols in the

  13. Adherence to guidelines and protocols in the prehospital and emergency care setting: a systematic review

    NARCIS (Netherlands)

    Ebben, R.H.A.; Vloet, L.C.M.; Verhofstad, M.H.J.; Meijer, S.; Groot, J. de; Achterberg, T. van

    2013-01-01

    A gap between guidelines or protocols and clinical practice often exists, which may result in patients not receiving appropriate care. Therefore, the objectives of this systematic review were (1) to give an overview of professionals' adherence to (inter)national guidelines and protocols in the

  14. Dysphonia risk screening protocol

    Science.gov (United States)

    Nemr, Katia; Simões-Zenari, Marcia; da Trindade Duarte, João Marcos; Lobrigate, Karen Elena; Bagatini, Flavia Alves

    2016-01-01

    OBJECTIVE: To propose and test the applicability of a dysphonia risk screening protocol with score calculation in individuals with and without dysphonia. METHOD: This descriptive cross-sectional study included 365 individuals (41 children, 142 adult women, 91 adult men and 91 seniors) divided into a dysphonic group and a non-dysphonic group. The protocol consisted of 18 questions and a score was calculated using a 10-cm visual analog scale. The measured value on the visual analog scale was added to the overall score, along with other partial scores. Speech samples allowed for analysis/assessment of the overall degree of vocal deviation and initial definition of the respective groups and after six months, the separation of the groups was confirmed using an acoustic analysis. RESULTS: The mean total scores were different between the groups in all samples. Values ranged between 37.0 and 57.85 in the dysphonic group and between 12.95 and 19.28 in the non-dysphonic group, with overall means of 46.09 and 15.55, respectively. High sensitivity and specificity were demonstrated when discriminating between the groups with the following cut-off points: 22.50 (children), 29.25 (adult women), 22.75 (adult men), and 27.10 (seniors). CONCLUSION: The protocol demonstrated high sensitivity and specificity in differentiating groups of individuals with and without dysphonia in different sample groups and is thus an effective instrument for use in voice clinics. PMID:27074171

  15. Dysphonia risk screening protocol

    Directory of Open Access Journals (Sweden)

    Katia Nemr

    2016-03-01

    Full Text Available OBJECTIVE: To propose and test the applicability of a dysphonia risk screening protocol with score calculation in individuals with and without dysphonia. METHOD: This descriptive cross-sectional study included 365 individuals (41 children, 142 adult women, 91 adult men and 91 seniors divided into a dysphonic group and a non-dysphonic group. The protocol consisted of 18 questions and a score was calculated using a 10-cm visual analog scale. The measured value on the visual analog scale was added to the overall score, along with other partial scores. Speech samples allowed for analysis/assessment of the overall degree of vocal deviation and initial definition of the respective groups and after six months, the separation of the groups was confirmed using an acoustic analysis. RESULTS: The mean total scores were different between the groups in all samples. Values ranged between 37.0 and 57.85 in the dysphonic group and between 12.95 and 19.28 in the non-dysphonic group, with overall means of 46.09 and 15.55, respectively. High sensitivity and specificity were demonstrated when discriminating between the groups with the following cut-off points: 22.50 (children, 29.25 (adult women, 22.75 (adult men, and 27.10 (seniors. CONCLUSION: The protocol demonstrated high sensitivity and specificity in differentiating groups of individuals with and without dysphonia in different sample groups and is thus an effective instrument for use in voice clinics.

  16. Local administration of enriched mononuclear cells, platelets and zoledronic acid for preventing collapse of the femoral head in the early stage of osteonecrosis: study protocol for a prospective randomized parallel-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Ning Ma

    2016-01-01

    Trial registration: ClinicalTrial.gov identifier: NCT02721940. Written approval for this protocol was obtained from the ethics committee of the Chinese PLA General Hospital in China (approval No. S2015-082-01.

  17. How blockchain-timestamped protocols could improve the trustworthiness of medical science [version 3; referees: 3 approved

    OpenAIRE

    Greg Irving; John Holden

    2017-01-01

    Trust in scientific research is diminished by evidence that data are being manipulated. Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research. Methods for using blockchain to provide proof of pre-specified endpoints in clinical trial protocols were first reported by Carlisle.?We wished to empirically test such an approach using a clinical trial protocol where outcome switching has previously been reported. Here w...

  18. Analysis of the Implementation of Standardized Clinical Protocol «Diabetes Mellitus Type 2» by Quality Indicators in Institutions of Kyiv Region

    Directory of Open Access Journals (Sweden)

    V.I. Tkachenko

    2014-10-01

    Full Text Available In Ukraine, a standardized clinical protocol (SCP to provide medical care in diabetes mellitus type 2 (order of the Ministry of Healthcare of Ukraine dated 21.12.2012 № 1118, which identifies 4 quality indicators, is being implemented. The objective of research — to analyze the implementation of SCP based on monitoring of quality indicators in the institutions of the Kyiv region. Materials and Methods. Technique for assessing the quality of diabetes care, one element of which is the monitoring of quality indicators specified in SCP, has been developed and applied. Collection and analysis of information was carried out by forms of primary records № 025/030 and 030/o, forms of statistical reporting № 12 and 20. Statistical analysis was performed using Excel 2007, SPSS. Results. Today, primary health care institutions in Kyiv region developed local protocols that confirms the implementation of the first quality indicator, in accordance with the desired level of the indicator value by SCP. The second indicator — the percentage of patients who were defined the level of glycated hemoglobin in the reporting period amounted to 12.2 %, which is higher than in 2012 (8.84 %, but remains low. The third quality indicator — the percentage of patients who were admitted to hospital for diabetes mellitus and its complications during the reporting period amounted to 15.01 %, while in 2012 it stood at 8.66 %. For comparison, this figure in 2007 was 9.37 %. Conclusions. The quality of care at an early stage of implementation is not enough, partly due to the lack of awareness by physicians of major provisions of the protocol, lack of equipment, the need of payment by a patient for medical services specified in the protocol, lack of doctors’ understanding of the characteristics of different types of medical and technological documents and difficulties in the development and implementation of local protocols, particularly. The obtained results are

  19. Cost effectiveness of a protocol using palivizumab in preterm infants

    Directory of Open Access Journals (Sweden)

    Yolanda Hernández-Gago

    2017-03-01

    Full Text Available Objective: The main objective was to evaluate the cost-effectiveness of protocol use of palivizumab in premature established by consensus in our Hospital comparing it based on the recommendations of various Scientific Societies. As a secondary objective risk factors and severity of hospitalized patients attending the established protocol in our Hospital were analyzed. Methods: The study period was 4 seasons with the expanded protocol (retrospective data versus 2 with restricted or agreed protocol (prospective data. The perspective of the study was the Health System, including the costs of hospitalization and palivizumab our center. The calculation of the effectiveness was determined with the admission rate of premature patients stratified by weeks of gestational age <29, <32; and <35. For the analysis of risk factors and severity in patients admitted seasons with the new protocol are collected prospectively clinical data and environmental and social factors. Results: In the range of gestational age <29 years old and <32 greater effectiveness of the extended protocol was not demonstrated against the consensus. Only more effective for EG <35 in the accumulated data and comparing seasons 12/13 and 08/09 to 13/14 for individual data was observed. This range has an associated incremental cost effectiveness ratio of € 53 250,07 (range: € 14 793,39 to € 90 446,47 for singles data and € 50 525,53 (€ 28 688.22 to € 211 575,65 for accumulated. The establishment of this protocol in our center meant an average saving per season € 169 911,51. A cost- effectiveness of the extended protocol appropriate relationship is found if the cost of palivizumab per patient was less than € 1 206,67 (calculated for maximum use of the vial and a higher rate of hospitalization of 9.21%. Children entering the season with the new protocol (season 12/13 and 13/14 are 63.4% in children under 3 months and 90% are term infants who do not belong to any population at

  20. Nutritional adequacy of a novel human milk fortifier from donkey milk in feeding preterm infants: study protocol of a randomized controlled clinical trial.

    Science.gov (United States)

    Coscia, Alessandra; Bertino, Enrico; Tonetto, Paola; Peila, Chiara; Cresi, Francesco; Arslanoglu, Sertac; Moro, Guido E; Spada, Elena; Milani, Silvano; Giribaldi, Marzia; Antoniazzi, Sara; Conti, Amedeo; Cavallarin, Laura

    2018-01-09

    Fortification of human milk is a standard practice for feeding very low birth weight infants. However, preterm infants often still experience suboptimal growth and feeding intolerance. New fortification strategies and different commercially available fortifiers have been developed. Commercially available fortifiers are constituted by a blend of ingredients from different sources, including plant oils and bovine milk proteins, thus presenting remarkable differences in the quality of macronutrients with respect to human milk. Based on the consideration that donkey milk has been suggested as a valid alternative for children allergic to cow's milk proteins, due to its biochemical similarity to human milk, we hypothesized that donkey milk could be a suitable ingredient for developing an innovative human milk fortifier. The aim of the study is to evaluate feeding tolerance, growth and clinical short and long-term outcomes in a population of preterm infants fed with a novel multi-component fortifier and a protein concentrate derived from donkey milk, in comparison to an analogous population fed with traditional fortifier and protein supplement containing bovine milk proteins. The study has been designed as a randomized, controlled, single-blind clinical trial. Infants born milk-based multicomponent fortifier and protein supplement, or a combination of a novel multicomponent fortifier and protein supplement derived from donkey milk. The fortification protocol followed is the same for the two groups, and the two diets were designed to be isoproteic and isocaloric. Weight, length and head circumference are measured; feeding tolerance is assessed by a standardized protocol. The occurrence of sepsis, necrotizing enterocolitis and adverse effects are monitored. This is the first clinical study investigating the use of a human milk fortifier derived from donkey milk for the nutrition of preterm infants. If donkey milk derived products will be shown to improve the feeding

  1. Improvements in Clinical Trials Information Will Improve the Reproductive Health and Fertility of Cancer Patients.

    Science.gov (United States)

    Dauti, Angela; Gerstl, Brigitte; Chong, Serena; Chisholm, Orin; Anazodo, Antoinette

    2017-06-01

    There are a number of barriers that result in cancer patients not being referred for oncofertility care, which include knowledge about reproductive risks of antineoplastic agents. Without this information, clinicians do not always make recommendations for oncofertility care. The objective of this study was to describe the level of reproductive information and recommendations that clinicians have available in clinical trial protocols regarding oncofertility management and follow-up, and the information that patients may receive in clinical trials patient information sheets or consent forms. A literature review of the 71 antineoplastic drugs included in the 68 clinical trial protocols showed that 68% of the antineoplastic drugs had gonadotoxic animal data, 32% had gonadotoxic human data, 83% had teratogenic animal data, and 32% had teratogenic human data. When the clinical trial protocols were reviewed, only 22% of the protocols reported the teratogenic risks and 32% of the protocols reported the gonadotoxic risk. Only 56% of phase 3 protocols had gonadotoxic information and 13% of phase 3 protocols had teratogenic information. Nine percent of the protocols provided fertility preservation recommendations and 4% provided reproductive information in the follow-up and survivorship period. Twenty-six percent had a section in the clinical trials protocol, which identified oncofertility information easily. When gonadotoxic and teratogenic effects of treatment were known, they were not consistently included in the clinical trial protocols and the lack of data for new drugs was not reported. Very few protocols gave recommendations for oncofertility management and follow-up following the completion of cancer treatment. The research team proposes a number of recommendations that should be required for clinicians and pharmaceutical companies developing new trials.

  2. Microdose gonadotropin-releasing hormone agonist flare-up protocol versus multiple dose gonadotropin-releasing hormone antagonist protocol in poor responders undergoing intracytoplasmic sperm injection-embryo transfer cycle.

    Science.gov (United States)

    Kahraman, Korhan; Berker, Bulent; Atabekoglu, Cem Somer; Sonmezer, Murat; Cetinkaya, Esra; Aytac, Rusen; Satiroglu, Hakan

    2009-06-01

    To compare the efficacy of microdose GnRH agonist (GnRH-a) flare-up and multiple dose GnRH antagonist protocols in patients who have a poor response to a long luteal GnRH-a protocol. Prospective, randomized, clinical study. University hospital. Forty-two poor responder patients undergoing intracytoplasmic sperm injection (ICSI)-embryo transfer cycle. Twenty-one patients received microdose leuprolide acetate (LA) (50 microg twice daily) starting on the second day of withdrawal bleeding. The other 21 patients received 0.25 mg of cetrorelix daily when the leading follicle reached 14 mm in diameter. Serum E(2) levels, number of growing follicles and mature oocytes, embryo quality, dose of gonadotropin used, cancellation, fertilization, implantation rate and pregnancy rate (PR). The mean serum E(2) concentration on the day of hCG administration was significantly higher in the microdose GnRH-a group than in the GnRH antagonist group (1,904 vs. 1,362 pg/mL). The clinical PRs per started cycle of microdose GnRH-a and GnRH antagonist groups were 14.2% and 9.5%, respectively. There were no statistically significant differences in the other ovulation induction characteristics, fertilization and implantation rates. Microdose GnRH-a flare-up protocol and multiple dose GnRH antagonist protocol seem to have similar efficacy in improving treatment outcomes of poor responder patients.

  3. Three-stage treatment protocol for recalcitrant distal femoral nonunion.

    Science.gov (United States)

    Ma, Ching-Hou; Chiu, Yen-Chun; Tu, Yuan-Kun; Yen, Cheng-Yo; Wu, Chin-Hsien

    2017-04-01

    In this study, we proposed a three-stage treatment protocol for recalcitrant distal femoral nonunion and aimed to analyze the clinical results. We retrospective reviewed 12 consecutive patients with recalcitrant distal femoral nonunion undergoing our three-stage treatment protocol from January 2010 to December 2014 in our institute. The three-stage treatment protocol comprised debridement of the nonunion site, lengthening to eliminate leg length discrepancy, deformity correction, stabilization with a locked plate, filling of the defect with cement spacer for inducing membrane formation, and bone reconstruction using a cancellous bone autograft (Masquelet technique) or free vascularized fibular bone graft. The bone union time, wound complication, lower limbs alignment, amount of lengthening, knee range of motion, and functional outcomes were evaluated. Osseous union with angular deformity lengthening was 5.88 cm (range 3.5-12 cm). Excellent or good outcomes were obtained in 9 patients. Although the current study involved only a small number of patients and the intervention comprised three stages, we believe that such a protocol may be a valuable alternative for the treatment of recalcitrant distal femoral nonunion.

  4. Comparative effectiveness of family problem-solving therapy (F-PST for adolescents after traumatic brain injury: Protocol for a randomized, multicenter, clinical trial

    Directory of Open Access Journals (Sweden)

    Brad G. Kurowski

    2018-06-01

    Full Text Available Introduction: The objective of this manuscript is to describe the methodology that will be used to test the comparative effectiveness, feasibility, and acceptability of three formats of family problem solving therapy (F-PST for improving functional outcomes of complicated mild to severe adolescent TBI. Methods: Three-arm comparative effectiveness, randomized clinical trial (RCT design. We describe the protocol of a three-arm RCT comparing the effectiveness of three modalities of F-PST to reduce executive dysfunction and behavior problems following TBI in adolescence. The RCT will compare the relative effectiveness among face-to-face; online and self-directed; and therapist-supported online modes of treatment. Ethics and dissemination: It is anticipated that findings from this work will inform future clinical care practices, with implications for treatment of other patient populations of youth with psychological symptoms arising from neurological conditions. Institutional review board approval will be obtained from all sites prior to commencement of the study. Clinical Trials Registration: NCT:02368366, Keywords: Pediatric traumatic brain injury, Telehealth, Problem solving, Behavior, Executive function

  5. Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol

    Directory of Open Access Journals (Sweden)

    Pérula-de-Torres LuisÁ

    2012-10-01

    Full Text Available Abstract Background Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. Methods/design An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group. As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group. Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis. Discussion If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. Trial registration The study is registered as NCT01291953 (ClinicalTrials.gob

  6. Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol.

    Science.gov (United States)

    Pérula-de-Torres, Luis Á; Martínez-Adell, Miguel Á; González-Blanco, Virginia; Baena-Díez, José M; Martín-Rioboó, Enrique; Parras-Rejano, Juan M; González-Lama, Jesús; Martín-Alvarez, Remedios; Ruiz-Moral, Roger; Fernández-García, José Á; Pérez-Díaz, Modesto; Ruiz-de-Castroviejo, Joaquin; Pérula-de-Torres, Carlos; Valero-Martín, Antonio; Roldán-Villalobos, Ana; Criado-Larumbe, Margarita; Burdoy-Joaquín, Emili; Coma-Solé, Montserrat; Cervera-León, Mercè; Cuixart-Costa, Lluís

    2012-10-30

    Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. The study is registered as NCT01291953 (ClinicalTrials.gob).

  7. Quantifying and visualizing site performance in clinical trials

    OpenAIRE

    Eric Yang; Christopher O'Donovan; JodiLyn Phillips; Leone Atkinson; Krishnendu Ghosh; Dimitris K. Agrafiotis

    2018-01-01

    Background: One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitively, the historical track record of a site is one of the strongest predictors of its future performance; however, issues such as data availability and wide differences in protocol complexity can co...

  8. Desensitization protocols and their outcome.

    Science.gov (United States)

    Marfo, Kwaku; Lu, Amy; Ling, Min; Akalin, Enver

    2011-04-01

    In the last decade, transplantation across previously incompatible barriers has increasingly become popular because of organ donor shortage, availability of better methods of detecting and characterizing anti-HLA antibodies, ease of diagnosis, better understanding of antibody-mediated rejection, and the availability of effective regimens. This review summarizes all manuscripts published since the first publication in 2000 on desensitized patients and discusses clinical outcomes including acute and chronic antibody-mediated rejection rate, the new agents available, kidney paired exchange programs, and the future directions in sensitized patients. There were 21 studies published between 2000 and 2010, involving 725 patients with donor-specific anti-HLA antibodies (DSAs) who underwent kidney transplantation with different desensitization protocols. All studies were single center and retrospective. The patient and graft survival were 95% and 86%, respectively, at a 2-year median follow-up. Despite acceptable short-term patient and graft survivals, acute rejection rate was 36% and acute antibody-mediated rejection rate was 28%, which is significantly higher than in nonsensitized patients. Recent studies with longer follow-up of those patients raised concerns about long-term success of desensitization protocols. The studies utilizing protocol biopsies in desensitized patients also reported higher subclinical and chronic antibody-mediated rejection. An association between the strength of DSAs determined by median fluorescence intensity values of Luminex single-antigen beads and risk of rejection was observed. Two new agents, bortezomib, a proteasome inhibitor, and eculizumab, an anti-complement C5 antibody, were recently introduced to desensitization protocols. An alternative intervention is kidney paired exchange, which should be considered first for sensitized patients. © 2011 by the American Society of Nephrology

  9. Optimised low-dose multidetector CT protocol for children with cranial deformity

    Energy Technology Data Exchange (ETDEWEB)

    Vazquez, Jose Luis [Complejo Hospitalario Universitario de Vigo, Department of Radiology, Vigo, Pontevedra (Spain); Pombar, Miguel Angel [Complejo Hospitalario Universitario de Santiago, Department of Radiophysics, Santiago de Compostela, La Coruna (Spain); Pumar, Jose Manuel [Complejo Hospitalario Universitario de Santiago, Department of Radiology, Santiago de Compostela, La Coruna (Spain); Campo, Victor Miguel del [Complejo Hospitalario Universitario de Vigo, Department of Public Health, Vigo, Pontevedra (Spain)

    2013-08-15

    To present an optimised low-dose multidetector computed tomography (MDCT) protocol for the study of children with cranial deformity. Ninety-one consecutive MDCT studies were performed in 80 children. Studies were performed with either our standard head CT protocol (group 1, n = 20) or a low-dose cranial deformity protocol (groups 2 and 3). Group 2 (n = 38), initial, and group 3 (n = 33), final and more optimised. All studies were performed in the same 64-MDCT equipment. Cranial deformity protocol was gradationally optimised decreasing kVp, limiting mA range, using automatic exposure control (AEC) and increasing the noise index (NI). Image quality was assessed. Dose indicators such us CT dose index volume (CTDIvol), dose-length product (DLP) and effective dose (E) were used. The optimised low-dose protocol reached the following values: 80 kVp, mA range: 50-150 and NI = 23. We achieved a maximum dose reduction of 10-22 times in the 1- to 12-month-old cranium in regard to the 2004 European guidelines for MDCT. A low-dose MDCT protocol that may be used as the first diagnostic imaging option in clinically selected patients with skull abnormalities. (orig.)

  10. Hyperbaric oxygen therapy for wound healing in diabetic rats: Varying efficacy after a clinically-based protocol.

    Directory of Open Access Journals (Sweden)

    Johan W van Neck

    Full Text Available Hyperbaric oxygen therapy (HBOT is a clinical treatment in which a patient breathes pure oxygen for a limited period of time at an increased pressure. Although this therapy has been used for decades to assist wound healing, its efficacy for many conditions is unproven and its mechanism of action is not yet fully clarified. This study investigated the effects of HBOT on wound healing using a diabetes-impaired pressure ulcer rat model. Seven weeks after streptozotocin-induced diabetes in rats (n = 55, a pressure ulcer was created on dorsal skin. Subsequently, animals received HBOT during 6 weeks following a standard clinical protocol (HBOT group with varying endpoints up to 42 days post-wounding versus controls without HBOT. Capillary venous oxygen saturation (SO2 showed a significant increase in the HBOT group on day 24; however, this increase was significant at this time point only. The quantity of hemoglobin in the micro-blood vessels (rHB showed a significant decrease in the HBOT group on days 21 and 42, and showed a trend to decrease on day 31. Blood flow in the microcirculation showed a significant increase on days 17, 21 and 31 but a significant decrease on days 24 and 28. Inflammation scoring showed significantly decreased CD68 counts in the HBOT group on day 42, but not in the early stages of wound healing. Animals in the HBOT group showed a trend for an increase in mean wound breaking strength on day 42.

  11. Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board

    Directory of Open Access Journals (Sweden)

    Isabelle Gautier

    2017-08-01

    Full Text Available Abstract Background There is a great need for high quality clinical research for children. The European Pediatric Regulation aimed to improve the quality of clinical trials in order to increase the availability of treatments for children. The main purpose of this study was to assess the evolution of both the number and the quality of pediatric trial protocols that were submitted to a French Institutional Review Board (IRB00009118 before and after the initiation of the EU Pediatric Regulation. Methods All protocols submitted to the IRB00009118 between 2003 and 2014 and conducting research on subjects under eighteen years of age were eligible. The quality of randomized clinical trials was assessed according to the guidelines developed by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR Network and ranked using the Jadad score. Results Out of 622 protocols submitted to the Institutional Review Board (IRB, 21% (133/622 included children. Among these 133 pediatric protocols, the number of submitted pediatric protocols doubled between the two studied periods. From 2003 to 2008, 47 protocols including 21 institutionally sponsored were submitted to the IRB and from 2009 until 2014, 86 protocols including 48 institutionally sponsored were submitted. No significant trend was observed on the quality of RCTs. The overall median score of RCTs on the Jadad scale was high (3.5, 70.0% of protocols had a Jadad score ≥ 3, and 30.0% had a score < 3. Conclusion Following the EU Pediatric Regulation, the number of pediatric protocols submitted to the IRB00009118 tends to increase, but no change was noticed regarding their quality.

  12. A protocol proposition of cell therapy for the treatment of chronic obstructive pulmonary disease.

    Science.gov (United States)

    Ribeiro-Paes, J T; Stessuk, T; Marcelino, M; Faria, C; Marinelli, T; Ribeiro-Paes, M J

    2014-01-01

    The main feature of pulmonary emphysema is airflow obstruction resulting from the destruction of the alveolar walls distal to the terminal bronchioles. Existing clinical approaches have improved and extended the quality of life of emphysema patients. However, no treatment currently exists that can change the disease course and cure the patient. The different therapeutic approaches that are available aim to increase survival and/or enhance the quality of life of emphysema patients. In this context, cell therapy is a promising therapeutic approach with great potential for degenerative pulmonary diseases. In this protocol proposition, all patients will be submitted to laboratory tests, such as evaluation of heart and lung function and routine examinations. Stem cells will be harvested by means of 10 punctures on each anterior iliac crest, collecting a total volume of 200mL bone marrow. After preparation, separation, counting and labeling (optional) of the mononuclear cells, the patients will receive an intravenous infusion from the pool of Bone Marrow Mononuclear Cells (BMMC). This article proposes a rational and safe clinical cellular therapy protocol which has the potential for developing new projects and can serve as a methodological reference for formulating clinical application protocols related to the use of cellular therapy in COPD. This study protocol was submitted and approved by the Brazilian National Committee of Ethics in Research (CONEP - Brazil) registration number 14764. It is also registered in ClinicalTrials.gov (NCT01110252). Copyright © 2013 Sociedade Portuguesa de Pneumologia. Published by Elsevier España. All rights reserved.

  13. Reduction in Wound Complications After Total Ankle Arthroplasty Using a Compression Wrap Protocol.

    Science.gov (United States)

    Schipper, Oliver N; Hsu, Andrew R; Haddad, Steven L

    2015-12-01

    The purpose of this study was to evaluate the clinical differences in wound complications after total ankle arthroplasty (TAA) between a cohort of patients that received a compression wrap protocol and a historical control group treated with cast immobilization. Patient charts and postoperative wound pictures were reviewed for 42 patients who underwent a compression wrap protocol and 50 patients who underwent circumferential casting after primary TAA from 2008 to 2013. A blinded reviewer graded each wound using a novel postoperative wound classification system, and recorded whether the wound was completely healed by or after 3 months. A second blinded review was performed to determine intraobserver reliability. Mean patient age was 55 years (range, 24-80) and all patients had at least 6-month follow-up. There were significantly more total wound complications (P = .02) and mild wound complications (P = .02) in the casted group compared to the compression wrap group. There were no significant differences in the number of moderate and severe complications between each group. A significantly higher proportion of TAA incisions took longer than 3 months to heal in the casted group (P = .02). Based on our clinical experience with postoperative wound care after TAA, use of a compression wrap protocol was safe and effective at reducing wound-related complications, and well tolerated by patients. Further prospective, randomized clinical trials are warranted to evaluate the utility and cost-effectiveness of a compression wrap protocol after TAA. © The Author(s) 2015.

  14. Comparison of microdose GnRH agonist protocol with GnRH antagonist / letrazole protocol in patients with poor ovarian response

    Directory of Open Access Journals (Sweden)

    Yiğit Çakıroğlu

    2013-09-01

    Full Text Available Objective: To compare microdose GnRH agonist (MDL protocol with GnRH antagonist/letrazole (AL protocol in patients with poor ovarian response. Design: Randomised clinical trial. Setting: Kocaeli University Assisted Reproductive Centre Interventions: POR was diagnosed according to ESHRE Bologna criteria in case of presence of 2 out of 3 criteria. In the MDL group (n=27, 40µg/0.2 cc subcutaneous leuprolid acetate was given two times a day starting on the first day of menstrual cycle. On the second day of the cycle, gonadotrophin stimulation was started at 450-600 IU and/or 150 IU human menopausal gonadotrophin (hMG along with leuprolid. In the AL group (n=28, 5 mg letrazole was given for 5 days starting on the second day of the spontaneous cycle and after the 5th day of the cycle, 450-600 IU and/or 150 IU hMG was given. Main Outcome Measures: To compare the outcomes of MDL protocol with AL protocol in patients with poor ovarian response. Results: Stimulation days, total gonadotrophin dose (IU, peak E2 (pg/ml levels, and endometrial thickness were found to be statistically significantly lower in the AL group. While no cases of cycle cancellation was detected in the MDL group, statistically significantly higher rates of cycle cancellation (%35.7, p<0.001 was detected in the AL group. No statistically significant differences were detected in total oocyte numbers (3.7±2.9 vs 2.7±2.2, number of transferred embryos (1.4±0.5 vs 1.4±1.9, pregnancy rates (3/27 (%11.1 vs 2/28 (%7.1 and implantation rates (3/36 (%8.3 vs 2/22 (%9.1 in between the groups. Comment: Although AL protocol is not superior to MDL protocol in poor ovarian response patients, it may be used as an alternative protocol.

  15. The effect of personalized versus standard patient protocols for radiostereometric analysis (RSA).

    Science.gov (United States)

    Muharemovic, O; Troelsen, A; Thomsen, M G; Kallemose, T; Gosvig, K K

    2018-05-01

    Increasing pressure in the clinic requires a more standardized approach to radiostereometric analysis (RSA) imaging. The aim of this study was to investigate whether implementation of personalized RSA patient protocols could increase image quality and decrease examination time and the number of exposure repetitions. Forty patients undergoing primary total hip arthroplasty were equally randomized to either a case or a control group. Radiographers in the case group were assisted by personalized patient protocols containing information about each patient's post-operative RSA imaging. Radiographers in the control group used a standard RSA protocol. At three months, radiographers in the case group significantly reduced (p RSA patient protocols have a positive effect on image quality and radiation dose savings. Implementation of personal patient protocols as a RSA standard will contribute to the reduction of examination time, thus ensuring a cost benefit for department and patient safety. Copyright © 2017 The College of Radiographers. Published by Elsevier Ltd. All rights reserved.

  16. Who needs inpatient detox? Development and implementation of a hospitalist protocol for the evaluation of patients for alcohol detoxification.

    Science.gov (United States)

    Stephens, John R; Liles, E Allen; Dancel, Ria; Gilchrist, Michael; Kirsch, Jonathan; DeWalt, Darren A

    2014-04-01

    Clinicians caring for patients seeking alcohol detoxification face many challenges, including lack of evidence-based guidelines for treatment and high recidivism rates. To develop a standardized protocol for determining which alcohol dependent patients seeking detoxification need inpatient versus outpatient treatment, and to study the protocol's implementation. Review of best evidence by ad hoc task force and subsequent creation of standardized protocol. Prospective observational evaluation of initial protocol implementation. Patients presenting for alcohol detoxification. Development and implementation of a protocol for evaluation and treatment of patients requesting alcohol detoxification. Number of admissions per month with primary alcohol related diagnosis (DRG), 30-day readmission rate, and length of stay, all measured before and after protocol implementation. We identified one randomized clinical trial and three cohort studies to inform the choice of inpatient versus outpatient detoxification, along with one prior protocol in this population, and combined that data with clinical experience to create an institutional protocol. After implementation, the average number of alcohol related admissions was 15.9 per month, compared with 18.9 per month before implementation (p = 0.037). There was no difference in readmission rate or length of stay. Creation and utilization of a protocol led to standardization of care for patients requesting detoxification from alcohol. Initial evaluation of protocol implementation showed a decrease in number of admissions.

  17. Standardized CT protocols and nomenclature: better, but not yet there

    Energy Technology Data Exchange (ETDEWEB)

    Singh, Sarabjeet; Kalra, Mannudeep K. [Harvard Medical School, Department of Radiology, Massachusetts General Hospital, Boston, MA (United States)

    2014-10-15

    Radiation dose associated with CT is an important safety concern in patient care, especially in children. Technical advancements in multidetector-row CT scanner technology offer several advantages for clinical applications; these advancements have considerably increased CT utilization and enhanced the complexity of CT scanning protocols. Furthermore there are several scan manufacturers spearheading these technical advancements, leading to different commercial names causing confusion among the users, especially at imaging sites with scanners from different vendors. Several scientific studies and the National Council on Radiation Protection and Measurements (NCRP) have shown variation in CT radiation doses for same body region and similar scanning protocols. Therefore there is a need for standardization of scanning protocols and nomenclature of scan parameters. The following material reviews the status and challenges in standardization of CT scanning and nomenclature. (orig.)

  18. Development and validation of a remote home safety protocol.

    Science.gov (United States)

    Romero, Sergio; Lee, Mi Jung; Simic, Ivana; Levy, Charles; Sanford, Jon

    2018-02-01

    Environmental assessments and subsequent modifications conducted by healthcare professionals can enhance home safety and promote independent living. However, travel time, expense and the availability of qualified professionals can limit the broad application of this intervention. Remote technology has the potential to increase access to home safety evaluations. This study describes the development and validation of a remote home safety protocol that can be used by a caregiver of an elderly person to video-record their home environment for later viewing and evaluation by a trained professional. The protocol was developed based on literature reviews and evaluations from clinical and content experts. Cognitive interviews were conducted with a group of six caregivers to validate the protocol. The final protocol included step-by-step directions to record indoor and outdoor areas of the home. The validation process resulted in modifications related to safety, clarity of the protocol, readability, visual appearance, technical descriptions and usability. Our final protocol includes detailed instructions that a caregiver should be able to follow to record a home environment for subsequent evaluation by a home safety professional. Implications for Rehabilitation The results of this study have several implications for rehabilitation practice The remote home safety evaluation protocol can potentially improve access to rehabilitation services for clients in remote areas and prevent unnecessary delays for needed care. Using our protocol, a patient's caregiver can partner with therapists to quickly and efficiently evaluate a patient's home before they are released from the hospital. Caregiver narration, which reflects a caregiver's own perspective, is critical to evaluating home safety. In-home safety evaluations, currently not available to all who need them due to access barriers, can enhance a patient's independence and provide a safer home environment.

  19. From clinical practice guidelines, to clinical guidance in practice - implications for design of computerized guidance

    DEFF Research Database (Denmark)

    Lyng, Karen Marie

    2010-01-01

    an extensive application of what we have named second order guiding artifacts. The deployed protocols underwent a local adaptation and transformation process when initiated. The protocols were adapted to match the local resources and transformed into several activity specific second order guiding artifacts....... The transformation from protocols was executed according to a standard operating procedure. Each activity type had a standardized template ensuring uniformity across second order guiding artifacts within a clinic. The guiding artifacts were multi-functional and a wide variety of standardized graphical attributes...

  20. Data acquisition for a patient-directed intervention protocol in the dynamic intensive care unit setting.

    Science.gov (United States)

    Chlan, Linda; Patterson, Robert P; Heiderscheit, Annie

    2011-07-01

    Methods to easily, accurately, and efficiently obtain data in an ICU-based clinical trial can be challenging in this high-tech setting. Patient medical status and the dynamic nature of this clinical setting further complicate data collection. The purpose of this paper is to describe the modifications of commercially available headphones and the application of a data logging device to capture frequency and length of protocol use (music listening or headphones only for noise cancellation) without burdening participants or busy ICU nurses. With the automatic capture of protocol use by research participants, there have been no instances of lost data for this clinical trial. Copyright © 2011 Elsevier Inc. All rights reserved.

  1. Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients

    Directory of Open Access Journals (Sweden)

    Villafranca Alex

    2009-11-01

    Full Text Available Abstract Background Awareness with explicit recall of intra-operative events is a rare and distressing complication that may lead to severe psychological symptoms. Candidate depth of anesthesia monitors have been developed, partly with the aim of preventing this complication. Despite conflicting results from clinical trials and the lack of incisive validation, such monitors have enjoyed widespread clinical adoption, in particular the bispectral index. The American Society of Anesthesiologists has called for adequately powered and rigorously designed clinical trials to determine whether the use of such monitors decreases the incidence of awareness in various settings. The aim of this study is to determine with increased precision whether incorporating the bispectral index into a structured general anesthesia protocol decreases the incidence of awareness with explicit recall among a subset of surgical patients at increased risk for awareness and scheduled to receive an inhalation gas-based general anesthetic. Methods/Design BAG-RECALL is a multi-center, randomized, controlled clinical trial, in which 6,000 patients are being assigned to bispectral index-guided anesthesia (target range, 40 to 60 or end-tidal anesthetic gas-guided anesthesia (target range, 0.7 to 1.3 age-adjusted minimum alveolar concentration. Postoperatively, patients are being assessed for explicit recall at two intervals (0 to 72 hours, and 30 days after extubation. The primary outcome of the trial is awareness with explicit recall. Secondary outcomes include postoperative mortality, psychological symptoms, intensive care and hospital length of stay, average anesthetic gas administration, postoperative pain and nausea and vomiting, duration of stay in the recovery area, intra-operative dreaming, and postoperative delirium. Discussion This trial has been designed to complement two other clinical trials: B-Unaware and MACS (ClinicalTrials.gov numbers, NCT00281489 and NCT00689091

  2. Identification of a research protocol to study orthodontic tooth movement

    Directory of Open Access Journals (Sweden)

    Annalisa Dichicco

    2014-06-01

    Full Text Available Aim: The orthodontic movement is associated with a process of tissue remodeling together with the release of several chemical mediators in periodontal tissues. Each mediator is a potential marker of tooth movement and expresses biological processes as: tissue inflammation and bone remodeling. Different amounts of every mediator are present in several tissues and fluids of the oral cavity. Therefore, there are different methods that allow sampling with several degrees of invasiveness. Chemical mediators are also substances of different molecular nature, and multiple kind of analysis methods allow detection. The purpose of this study was to draft the best research protocol for an optimal study on orthodontic movement efficiency. Methods: An analysis of the international literature have been made, to identify the gold standard of each aspect of the protocol: type of mediator, source and method of sampling and analysis method. Results: From the analysis of the international literature was created an original research protocol for the study and the assessment of the orthodontic movement, by using the biomarkers of the tooth movement. Conclusions: The protocol created is based on the choice of the gold standard of every aspect already analyzed in the literature and in existing protocols for the monitoring of orthodontic tooth movement through the markers of tooth movement. Clinical trials re required for the evaluation and validation of the protocol created.

  3. A randomized controlled clinical trial evaluating quality of life when using a simple acupressure protocol in women with primary dysmenorrhea.

    Science.gov (United States)

    Bazarganipour, Fatemeh; Taghavi, Seyed-Abdolvahab; Allan, Helen; Hosseini, Nazafarin; Khosravi, Ahmad; Asadi, Rahimeh; Salari, Shohreh; Dehghani, Raziyeh; Jamshidi, Zahra; Rezaei, Marziyeh; Saberian, Mansoreh; Javedan, Fatemeh; Salari, Zahra; Miri, Fahimeh

    2017-10-01

    To evaluate a simple acupressure protocol in LIV3 and LI4 acupoints in women with primary dysmenorrhea. This paper reports a randomized, single blinded clinical trial. 90 young women with dysmenorrhea were recruited to three groups to receive 20min acupressure every day in either LIV3 or LI4, or placebo points. Acupressure was timed five days before menstruation for three successive menstrual cycles. On menstruation, each participant completed the Wong Baker faces pain scale, and the quality of life short form -12 (QOL SF-12). Intensity and duration of pain between the three groups in the second and third cycles during the intervention (pdysmenorrhea, and improve the QOL. Registration ID in IRCT: IRCT2016052428038N1. Copyright © 2017. Published by Elsevier Ltd.

  4. Implementation of a Rapid, Protocol-based TIA Management Pathway

    Directory of Open Access Journals (Sweden)

    Susann J. Jarhult

    2018-02-01

    Full Text Available Introduction: Our goal was to assess whether use of a standardized clinical protocol improves efficiency for patients who present to the emergency department (ED with symptoms of transient ischemic attack (TIA. Methods: We performed a structured, retrospective, cohort study at a large, urban, tertiary care academic center. In July 2012 this hospital implemented a standardized protocol for patients with suspected TIA. The protocol selected high-risk patients for admission and low/intermediate-risk patients to an ED observation unit for workup. Recommended workup included brain imaging, vascular imaging, cardiac monitoring, and observation. Patients were included if clinical providers determined the need for workup for TIA. We included consecutive patients presenting during a six-month period prior to protocol implementation, and those presenting between 6–12 months after implementation. Outcomes included ED length of stay (LOS, hospital LOS, use of neuroimaging, and 90-day risk of stroke or TIA. Results: From 01/2012 to 06/2012, 130 patients were evaluated for TIA symptoms in the ED, and from 01/2013 to 06/2013, 150 patients. The final diagnosis was TIA or stroke in 45% before vs. 41% after (p=0.18. Following the intervention, the inpatient admission rate decreased from 62% to 24% (p<0.001, median ED LOS decreased by 1.2 hours (5.7 to 4.9 hours, p=0.027, and median total hospital LOS from 29.4 hours to 23.1 hours (p=0.019. The proportion of patients receiving head computed tomography (CT went from 68% to 58% (p=0.087; brain magnetic resonance (MR imaging from 83% to 88%, (p=0.44 neck CT angiography from 32% to 22% (p=0.039; and neck MR angiography from 61% to 72% (p=0.046. Ninety-day stroke or recurrent TIA among those with final diagnosis of TIA was 3% for both periods. Conclusion: Implementation of a TIA protocol significantly reduced ED LOS and total hospital LOS.

  5. Evaluation of an adult insulin infusion protocol at an academic medical center.

    Science.gov (United States)

    Petrov, Katerina I; Burns, Tammy L; Drincic, Andjela

    2012-05-01

    Acknowledging evidence of possible detrimental effects of tightly controlled blood glucose levels, the American Association of Clinical Endocrinologists and the American Diabetes Association published a consensus statement recommending less strict control for most diabetic patients. As a result of these recommendations, our academic center at Creighton University Medical Center revised its adult insulin infusion protocol to target blood glucose levels ranging from 120 to 180 mg/dL for regular (standard) glycemic control and 80 to 120 mg/dL for tight control; previous targets had ranged from 80 to 180 mg/dL and 70 to 110 mg/dL, respectively. The primary objective was to evaluate the time that blood glucose values were within the target range for patients receiving the new protocol, compared with patients receiving the previous protocol. Our study was designed to evaluate the effectiveness and safety of the revised protocol. Using a retrospective chart review, we collected data for 4 months from patients on the old insulin protocol (May to August 2009) and for 4 months from patients on the new protocol (September to December 2009). Secondary endpoints included the number of hypoglycemic episodes (blood glucose below 70 mg/dL) and severe hypoglycemic episodes (blood glucose 40 mg/dL or lower) experienced by patients receiving the new insulin protocol compared with those receiving the former protocol. Patient characteristics were similar at baseline. Blood glucose values stayed within the target range for a significantly shorter time with the new protocol than with the former protocol (44.6% vs. 56.8%, respectively; P protocol. No statistically significant differences in hypoglycemia were observed after the protocol was changed. Hypoglycemia occurred in 31% of the former-protocol patients compared with 18% of the revised-protocol patients. Severe hypoglycemia was experienced by 2.1% of patients on the old protocol and by 3.1% of patients on the new protocol. Rates of

  6. Analyzing the effect of routing protocols on media access control protocols in radio networks

    Energy Technology Data Exchange (ETDEWEB)

    Barrett, C. L. (Christopher L.); Drozda, M. (Martin); Marathe, A. (Achla); Marathe, M. V. (Madhav V.)

    2002-01-01

    We study the effect of routing protocols on the performance of media access control (MAC) protocols in wireless radio networks. Three well known MAC protocols: 802.11, CSMA, and MACA are considered. Similarly three recently proposed routing protocols: AODV, DSR and LAR scheme 1 are considered. The experimental analysis was carried out using GloMoSim: a tool for simulating wireless networks. The main focus of our experiments was to study how the routing protocols affect the performance of the MAC protocols when the underlying network and traffic parameters are varied. The performance of the protocols was measured w.r.t. five important parameters: (i) number of received packets, (ii) average latency of each packet, (iii) throughput (iv) long term fairness and (v) number of control packets at the MAC layer level. Our results show that combinations of routing and MAC protocols yield varying performance under varying network topology and traffic situations. The result has an important implication; no combination of routing protocol and MAC protocol is the best over all situations. Also, the performance analysis of protocols at a given level in the protocol stack needs to be studied not locally in isolation but as a part of the complete protocol stack. A novel aspect of our work is the use of statistical technique, ANOVA (Analysis of Variance) to characterize the effect of routing protocols on MAC protocols. This technique is of independent interest and can be utilized in several other simulation and empirical studies.

  7. TH-E-209-00: Radiation Dose Monitoring and Protocol Management

    International Nuclear Information System (INIS)

    2016-01-01

    Radiation dose monitoring solutions have opened up new opportunities for medical physicists to be more involved in modern clinical radiology practices. In particular, with the help of comprehensive radiation dose data, data-driven protocol management and informed case follow up are now feasible. Significant challenges remain however and the problems faced by medical physicists are highly heterogeneous. Imaging systems from multiple vendors and a wide range of vintages co-exist in the same department and employ data communication protocols that are not fully standardized or implemented making harmonization complex. Many different solutions for radiation dose monitoring have been implemented by imaging facilities over the past few years. Such systems are based on commercial software, home-grown IT solutions, manual PACS data dumping, etc., and diverse pathways can be used to bring the data to impact clinical practice. The speakers will share their experiences with creating or tailoring radiation dose monitoring/management systems and procedures over the past few years, which vary significantly in design and scope. Topics to cover: (1) fluoroscopic dose monitoring and high radiation event handling from a large academic hospital; (2) dose monitoring and protocol optimization in pediatric radiology; and (3) development of a home-grown IT solution and dose data analysis framework. Learning Objectives: Describe the scope and range of radiation dose monitoring and protocol management in a modern radiology practice Review examples of data available from a variety of systems and how it managed and conveyed. Reflect on the role of the physicist in radiation dose awareness.

  8. TH-E-209-00: Radiation Dose Monitoring and Protocol Management

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2016-06-15

    Radiation dose monitoring solutions have opened up new opportunities for medical physicists to be more involved in modern clinical radiology practices. In particular, with the help of comprehensive radiation dose data, data-driven protocol management and informed case follow up are now feasible. Significant challenges remain however and the problems faced by medical physicists are highly heterogeneous. Imaging systems from multiple vendors and a wide range of vintages co-exist in the same department and employ data communication protocols that are not fully standardized or implemented making harmonization complex. Many different solutions for radiation dose monitoring have been implemented by imaging facilities over the past few years. Such systems are based on commercial software, home-grown IT solutions, manual PACS data dumping, etc., and diverse pathways can be used to bring the data to impact clinical practice. The speakers will share their experiences with creating or tailoring radiation dose monitoring/management systems and procedures over the past few years, which vary significantly in design and scope. Topics to cover: (1) fluoroscopic dose monitoring and high radiation event handling from a large academic hospital; (2) dose monitoring and protocol optimization in pediatric radiology; and (3) development of a home-grown IT solution and dose data analysis framework. Learning Objectives: Describe the scope and range of radiation dose monitoring and protocol management in a modern radiology practice Review examples of data available from a variety of systems and how it managed and conveyed. Reflect on the role of the physicist in radiation dose awareness.

  9. Anti-Mullerian hormone-tailored stimulation protocols improve outcomes whilst reducing adverse effects and costs of IVF.

    Science.gov (United States)

    Yates, A P; Rustamov, O; Roberts, S A; Lim, H Y N; Pemberton, P W; Smith, A; Nardo, L G

    2011-09-01

    Anti-Müllerian hormone (AMH) is increasingly used to quantify ovarian reserve, but it has not yet realized its full clinical potential in assisted reproduction technology. We investigated the possible benefits of using novel, stratified ovarian hyperstimulation protocols, tailored to individual AMH levels, compared with conventional stimulation. Retrospective data were collected from 769 women (first cycle of IVF, using fresh embryos), in a UK tertiary care unit: 346 women using conventional stimulation protocols; 423 women treated under new AMH-tailored protocols. Embryo transfer rates increased significantly (79-87%: P= 0.002) after the introduction of AMH-tailored stimulation protocols. Pregnancy rate per cycle started and live birth rate also increased significantly compared with conventionally treated women (17.9-27.7%, P= 0.002 and 15.9-23.9%, P = 0.007, respectively). Moreover, in the AMH group, the incidence of the ovarian hyperstimulation syndrome (OHSS) fell significantly (6.9-2.3%, P = 0.002) and failed fertilization fell from 7.8 to 4.5%. The cost of fertility drug treatment fell by 29% per patient and the overall cost of clinical management of OHSS fell by 43% in the AMH group. GnRH antagonist protocols, introduced as part of AMH-tailored treatment, may have contributed to the observed improvements: however, within the AMH-tailored group, the live birth rate was not significantly different between agonist and antagonist-treated groups. Although large, prospective, multicentre studies are indicated, we have clearly demonstrated that individualized, AMH-guided, controlled ovarian hyperstimulation protocols significantly improved positive clinical outcomes, reduced the incidence of complications and reduced the financial burden associated with assisted reproduction.

  10. Development of clinical application of radiation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Mi Sook; Yoo, Seoung Yul; Yoo, Hyung Jun [and others

    2000-04-01

    The aim is to develop the clinical radiation therapy techniques, which increase local control and cure rate of cancer. The contents were 1. technique of stereotactic radiotherapy 2. technique of intraoperative radiation therapy(IORT) 3. technique of fractionated radiotherapy 4. technique of 3D conformal therapy 5. chemoradiotherapy in lung cancer, rectal cancer and biliopancreatic cancer 6. network based information communication system of radiation oncology 7. animal studies for the best application of chemoradiotherapy and for elucidating mechanism of slide effect in radiotherapy. The results were 1. completion of quality assurance protocol, frame and mounting system 2. completion of applicator of IORT 3. clinical protocol of fractionated radiotherapy 4. clinical protocol of 3D conformal therapy for brain, head and neck, breast and lung cancer 5. completion of multimodality treatment protocol for lung, rectal and biliopancreatic cancer 6. completion of database system for patient information and simulation image 7. standardization of estimation for radiation induced pneumonitis in animal model. Future plans are (1) developed fractionated stereotactic radiotherapy system will be commercialized (2) developed applicator of brachytherapy for IORT will be commercialized (3) 3D conformal therapy will increase local control rate for brain tumor and decrease complications such as zerostomia after treatment for nasopharygeal cancer (4) training manpower and skills for randomized clinical trial (5) suggest possibility of clinical usefulness of oral 5-fluorouracil (6) to provide basic technique for electric chart (7) promote developing database system for image information (8) also in view of double edge sword effect of NO, it is possible to modify the NO production from irradiation to increase the tolerance to radiation.

  11. Development of clinical application of radiation

    International Nuclear Information System (INIS)

    Kim, Mi Sook; Yoo, Seoung Yul; Yoo, Hyung Jun

    2000-04-01

    The aim is to develop the clinical radiation therapy techniques, which increase local control and cure rate of cancer. The contents were 1. technique of stereotactic radiotherapy 2. technique of intraoperative radiation therapy(IORT) 3. technique of fractionated radiotherapy 4. technique of 3D conformal therapy 5. chemoradiotherapy in lung cancer, rectal cancer and biliopancreatic cancer 6. network based information communication system of radiation oncology 7. animal studies for the best application of chemoradiotherapy and for elucidating mechanism of slide effect in radiotherapy. The results were 1. completion of quality assurance protocol, frame and mounting system 2. completion of applicator of IORT 3. clinical protocol of fractionated radiotherapy 4. clinical protocol of 3D conformal therapy for brain, head and neck, breast and lung cancer 5. completion of multimodality treatment protocol for lung, rectal and biliopancreatic cancer 6. completion of database system for patient information and simulation image 7. standardization of estimation for radiation induced pneumonitis in animal model. Future plans are 1) developed fractionated stereotactic radiotherapy system will be commercialized 2) developed applicator of brachytherapy for IORT will be commercialized 3) 3D conformal therapy will increase local control rate for brain tumor and decrease complications such as zerostomia after treatment for nasopharygeal cancer 4) training manpower and skills for randomized clinical trial 5) suggest possibility of clinical usefulness of oral 5-fluorouracil 6) to provide basic technique for electric chart 7) promote developing database system for image information 8) also in view of double edge sword effect of NO, it is possible to modify the NO production from irradiation to increase the tolerance to radiation

  12. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol.

    Science.gov (United States)

    Klonoff, David C; Lias, Courtney; Beck, Stayce; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A; Arreaza-Rubin, Guillermo; Burk, Robert D; Kowalski, Aaron; Little, Randie; Nichols, James; Petersen, Matt; Rawlings, Kelly; Sacks, David B; Sampson, Eric; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert; Vesper, Hubert W

    2016-05-01

    Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled "Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program" is attached as supplementary material. This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market. © 2015 Diabetes Technology Society.

  13. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol

    Science.gov (United States)

    Klonoff, David C.; Lias, Courtney; Beck, Stayce; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A.; Arreaza-Rubin, Guillermo; Burk, Robert D.; Kowalski, Aaron; Little, Randie; Nichols, James; Petersen, Matt; Rawlings, Kelly; Sacks, David B.; Sampson, Eric; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert; Vesper, Hubert W.

    2015-01-01

    Background: Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. Methods: The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. Results: A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled “Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program” is attached as supplementary material. Conclusion: This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market. PMID:26481642

  14. Clinical and immunological evaluation of anti-apoptosis protein, survivin-derived peptide vaccine in phase I clinical study for patients with advanced or recurrent breast cancer

    Directory of Open Access Journals (Sweden)

    Asanuma Hiroko

    2008-05-01

    Full Text Available Abstract Background We previously reported that survivin-2B, a splicing variant of survivin, was expressed in various types of tumors and that survivin-2B peptide might serve as a potent immunogenic cancer vaccine. The objective of this study was to examine the toxicity of and to clinically and immunologically evaluate survivin-2B peptide in a phase I clinical study for patients with advanced or recurrent breast cancer. Methods We set up two protocols. In the first protocol, 10 patients were vaccinated with escalating doses (0.1–1.0 mg of survivin-2B peptide alone 4 times every 2 weeks. In the second protocol, 4 patients were vaccinated with the peptide at a dose of 1.0 mg mixed with IFA 4 times every 2 weeks. Results In the first protocol, no adverse events were observed during or after vaccination. In the second protocol, two patients had induration at the injection site. One patient had general malaise (grade 1, and another had general malaise (grade 1 and fever (grade 1. Peptide vaccination was well tolerated in all patients. In the first protocol, tumor marker levels increased in 8 patients, slightly decreased in 1 patient and were within the normal range during this clinical trial in 1 patient. With regard to tumor size, two patients were considered to have stable disease (SD. Immunologically, in 3 of the 10 patients (30%, an increase of the peptide-specific CTL frequency was detected. In the second protocol, an increase of the peptide-specific CTL frequency was detected in all 4 patients (100%, although there were no significant beneficial clinical responses. ELISPOT assay showed peptide-specific IFN-γ responses in 2 patients in whom the peptide-specific CTL frequency in tetramer staining also was increased in both protocols. Conclusion This phase I clinical study revealed that survivin-2B peptide vaccination was well tolerated. The vaccination with survivin-2B peptide mixed with IFA increased the frequency of peptide-specific CTL more

  15. Inspiratory muscle training in pediatrics: main indications and technical characteristics of the protocols

    Directory of Open Access Journals (Sweden)

    Cristhiele Tais Woszezenki

    Full Text Available Abstract Introduction: Inspiratory muscle training (IMT is a resource widely used in pediatrics. However, there is great variability in relation to the characteristics of the protocols used. Objective: To identify the main clinical conditions and IMT protocols used in the pediatric age group. Methods: Integrative review of the literature by searching on Pubmed, Scielo, PEDro and EMBASE databases using the following strategy: threshold OR inspiratory muscle training OR muscle endurance OR muscle resistance OR endurance training OR maximal inspiratory pressure AND respiratory muscle. We have selected clinical trials that performed IMT in children and adolescents (0 to 18 years old, with a clinical diagnosis, and published in English, Portuguese and Spanish. Results: 17 studies were included. From these, 11 underwent IMT in patients with some neuromuscular disorder, being Duchenne Muscular Dystrophy the most common. The selected articles included a total sample of 327 participants. As for the characteristics of the protocols, 7 performed strength training, 5 endurance and 5 strength and endurance. The training load ranged from 30 to 80% of maximal inspiratory pressure. Moreover, 8 studies performed IMT twice daily and the session duration and the training period varied between 10 and 30 minutes, and from 3 weeks to 24 months, respectively. Conclusion: The IMT was used more frequently in patients with some neuromuscular disorder. Although there is no consensus as to the characteristics of the protocols, the choice of the load should take into account the purpose of IMT and the disease severity.

  16. [Professional divers: analysis of critical issues and proposal of a health protocol for work fitness].

    Science.gov (United States)

    Pedata, Paola; Corvino, Anna Rita; Napolitano, Raffaele Carmine; Garzillo, Elpidio Maria; Furfaro, Ciro; Lamberti, Monica

    2016-01-20

    From many years now, thanks to the development of modern diving techniques, there has been a rapid spread of diving activities everywhere. In fact, divers are ever more numerous both among the Armed Forces and civilians who dive for work, like fishing, biological research and archeology. The aim of the study was to propose a health protocol for work fitness of professional divers keeping in mind the peculiar work activity, existing Italian legislation that is almost out of date and the technical and scientific evolution in this occupational field. We performed an analysis of the most frequently occurring diseases among professional divers and of the clinical investigation and imaging techniques used for work fitness assessment of professional divers. From analysis of the health protocol recommended by D.M. 13 January 1979 (Ministerial Decree), that is most used by occupational health physician, several critical issues emerged. Very often the clinical investigation and imaging techniques still used are almost obsolete, ignoring the execution of simple and inexpensive investigations that are more useful for work fitness assessment. Considering the out-dated legislation concerning diving disciplines, it is necessary to draw up a common health protocol that takes into account clinical and scientific knowledge and skills acquired in this area. This protocol's aim is to propose a useful tool for occupational health physicians who work in this sector.

  17. Clinical Implementation of an Online Adaptive Plan-of-the-Day Protocol for Nonrigid Motion Management in Locally Advanced Cervical Cancer IMRT

    Energy Technology Data Exchange (ETDEWEB)

    Heijkoop, Sabrina T., E-mail: s.heijkoop@erasmusmc.nl; Langerak, Thomas R.; Quint, Sandra; Bondar, Luiza; Mens, Jan Willem M.; Heijmen, Ben J.M.; Hoogeman, Mischa S.

    2014-11-01

    Purpose: To evaluate the clinical implementation of an online adaptive plan-of-the-day protocol for nonrigid target motion management in locally advanced cervical cancer intensity modulated radiation therapy (IMRT). Methods and Materials: Each of the 64 patients had four markers implanted in the vaginal fornix to verify the position of the cervix during treatment. Full and empty bladder computed tomography (CT) scans were acquired prior to treatment to build a bladder volume-dependent cervix-uterus motion model for establishment of the plan library. In the first phase of clinical implementation, the library consisted of one IMRT plan based on a single model-predicted internal target volume (mpITV), covering the target for the whole pretreatment observed bladder volume range, and a 3D conformal radiation therapy (3DCRT) motion-robust backup plan based on the same mpITV. The planning target volume (PTV) combined the ITV and nodal clinical target volume (CTV), expanded with a 1-cm margin. In the second phase, for patients showing >2.5-cm bladder-induced cervix-uterus motion during planning, two IMRT plans were constructed, based on mpITVs for empty-to-half-full and half-full-to-full bladder. In both phases, a daily cone beam CT (CBCT) scan was acquired to first position the patient based on bony anatomy and nodal targets and then select the appropriate plan. Daily post-treatment CBCT was used to verify plan selection. Results: Twenty-four and 40 patients were included in the first and second phase, respectively. In the second phase, 11 patients had two IMRT plans. Overall, an IMRT plan was used in 82.4% of fractions. The main reasons for selecting the motion-robust backup plan were uterus outside the PTV (27.5%) and markers outside their margin (21.3%). In patients with two IMRT plans, the half-full-to-full bladder plan was selected on average in 45% of the first 12 fractions, which was reduced to 35% in the last treatment fractions. Conclusions: The implemented

  18. Comparison of luteal estradiol patch and gonadotropin-releasing hormone antagonist suppression protocol before gonadotropin stimulation versus microdose gonadotropin-releasing hormone agonist protocol for patients with a history of poor in vitro fertilization outcomes.

    Science.gov (United States)

    Weitzman, Vanessa N; Engmann, Lawrence; DiLuigi, Andrea; Maier, Donald; Nulsen, John; Benadiva, Claudio

    2009-07-01

    To compare IVF outcomes in poor-responder patients undergoing stimulation after luteal phase E(2) patch/GnRH antagonist (LPG) protocol versus microdose GnRH agonist protocol. Retrospective analysis. University-based IVF center. Forty-five women undergoing ovarian stimulation for IVF using the LPG protocol were compared with 76 women stimulated with the microdose GnRH agonist protocol from May 2005 to April 2006. Cancellation rate, number of oocytes retrieved, and clinical pregnancy rates. The mean number of oocytes (9.1 +/- 4.1 vs. 8.9 +/- 4.3) and mature oocytes (6.7 +/- 3.5 vs. 6.8 +/- 3.1) retrieved were similar, as were the fertilization rates (70.0% +/- 24.2% vs. 69.9% +/- 21.5%) and the number of embryos transferred (2.5 +/- 1.1 vs. 2.7 +/- 1.3). The cancellation rate was not significantly different between the groups (13/45, 28.9% vs. 23/76, 30.3%). Likewise, there were no significant differences among the implantation rate (15.0% vs. 12.5%), clinical pregnancy rate (43.3% vs. 45.1%), and ongoing pregnancy rate per transfer (33.3% vs. 26.0%) between both groups. This study demonstrates that the use of an E(2) patch and a GnRH antagonist during the preceding luteal phase in patients with a history of failed cycles can provide similar IVF outcomes when compared with the microdose GnRH agonist protocol.

  19. Security analysis of standards-driven communication protocols for healthcare scenarios.

    Science.gov (United States)

    Masi, Massimiliano; Pugliese, Rosario; Tiezzi, Francesco

    2012-12-01

    The importance of the Electronic Health Record (EHR), that stores all healthcare-related data belonging to a patient, has been recognised in recent years by governments, institutions and industry. Initiatives like the Integrating the Healthcare Enterprise (IHE) have been developed for the definition of standard methodologies for secure and interoperable EHR exchanges among clinics and hospitals. Using the requisites specified by these initiatives, many large scale projects have been set up for enabling healthcare professionals to handle patients' EHRs. The success of applications developed in these contexts crucially depends on ensuring such security properties as confidentiality, authentication, and authorization. In this paper, we first propose a communication protocol, based on the IHE specifications, for authenticating healthcare professionals and assuring patients' safety. By means of a formal analysis carried out by using the specification language COWS and the model checker CMC, we reveal a security flaw in the protocol thus demonstrating that to simply adopt the international standards does not guarantee the absence of such type of flaws. We then propose how to emend the IHE specifications and modify the protocol accordingly. Finally, we show how to tailor our protocol for application to more critical scenarios with no assumptions on the communication channels. To demonstrate feasibility and effectiveness of our protocols we have fully implemented them.

  20. Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial.

    Science.gov (United States)

    van der Heijden, Amber A W A; de Bruijne, Martine C; Feenstra, Talitha L; Dekker, Jacqueline M; Baan, Caroline A; Bosmans, Judith E; Bot, Sandra D M; Donker, Gé A; Nijpels, Giel

    2014-06-25

    The increasing prevalence of diabetes is associated with increased health care use and costs. Innovations to improve the quality of care, manage the increasing demand for health care and control the growth of health care costs are needed. The aim of this study is to evaluate the care process and costs of managed, protocolized and usual care for type 2 diabetes patients from a societal perspective. In two distinct regions of the Netherlands, both managed and protocolized diabetes care were implemented. Managed care was characterized by centralized organization, coordination, responsibility and centralized annual assessment. Protocolized care had a partly centralized organizational structure. Usual care was characterized by a decentralized organizational structure. Using a quasi-experimental control group pretest-posttest design, the care process (guideline adherence) and costs were compared between managed (n = 253), protocolized (n = 197), and usual care (n = 333). We made a distinction between direct health care costs, direct non-health care costs and indirect costs. Multivariate regression models were used to estimate differences in costs adjusted for confounding factors. Because of the skewed distribution of the costs, bootstrapping methods (5000 replications) with a bias-corrected and accelerated approach were used to estimate 95% confidence intervals (CI) around the differences in costs. Compared to usual and protocolized care, in managed care more patients were treated according to diabetes guidelines. Secondary health care use was higher in patients under usual care compared to managed and protocolized care. Compared to usual care, direct costs were significantly lower in managed care (€-1.181 (95% CI: -2.597 to -334)) while indirect costs were higher (€ 758 (95% CI: -353 to 2.701), although not significant. Direct, indirect and total costs were lower in protocolized care compared to usual care (though not significantly). Compared to usual care, managed

  1. Standardisation of neonatal clinical practice.

    Science.gov (United States)

    Bhutta, Z A; Giuliani, F; Haroon, A; Knight, H E; Albernaz, E; Batra, M; Bhat, B; Bertino, E; McCormick, K; Ochieng, R; Rajan, V; Ruyan, P; Cheikh Ismail, L; Paul, V

    2013-09-01

    The International Fetal and Newborn Growth Consortium for the 21(st) Century (INTERGROWTH-21(st) ) is a large-scale, population-based, multicentre project involving health institutions from eight geographically diverse countries, which aims to assess fetal, newborn and preterm growth under optimal conditions. Given the multicentre nature of the project and the expected number of preterm births, it is vital that all centres follow the same standardised clinical care protocols to assess and manage preterm infants, so as to ensure maximum validity of the resulting standards as indicators of growth and nutrition with minimal confounding. Moreover, it is well known that evidence-based clinical practice guidelines can reduce the delivery of inappropriate care and support the introduction of new knowledge into clinical practice. The INTERGROWTH-21(st) Neonatal Group produced an operations manual, which reflects the consensus reached by members of the group regarding standardised definitions of neonatal morbidities and the minimum standards of care to be provided by all centres taking part in the project. The operational definitions and summary management protocols were developed by consensus through a Delphi process based on systematic reviews of relevant guidelines and management protocols by authoritative bodies. This paper describes the process of developing the Basic Neonatal Care Manual, as well as the morbidity definitions and standardised neonatal care protocols applied across all the INTERGROWTH-21(st) participating centres. Finally, thoughts about implementation strategies are presented. © 2013 Royal College of Obstetricians and Gynaecologists.

  2. An investigation into the bacterial contamination of goniolenses in use in clinical practice.

    Science.gov (United States)

    Grundon, Rachael; Scurrell, Emma; Mould, John; Hayton-Lee, Emma; Heinrich, Christine

    2017-12-18

    Objectives To report the incidence and evaluate the clinical significance of goniolens bacterial contamination in clinical use in dogs with three different usage protocols and one with an added cleaning protocol. Animals Studied and Methods Three groups of twenty dogs undergoing gonioscopy at a private practice in the UK had the goniolenses swabbed for bacteriology culture and identification prior to placement on the cornea. Three protocols of lens use, with 2 different types of goniolens, were studied. One protocol was then repeated with 21 dogs with a lens cleaning protocol prior to storage. Results Low levels of bacterial contamination were found in all 3 initial groups (10-15%). No correlation was found between usage protocol used and rate of contamination and no correlation was found between length of storage between use and contamination. All bacteria cultured were considered naturally occurring commensals for the canine eye and environment. The group with a cleaning protocol had a 4.7% contamination rate. This was not statistically different from the non-cleaning groups. Conclusions The rate of bacterial contamination of goniolenses in clinical practice is low and the bacterial contaminants consist of commensal bacteria, unlikely to be of detriment to the eye. Minimal contamination of the goniolenses was found and this did not appear to be of clinical significance. The introduction of a simple cleaning protocol did not produce a statistically significant reduction in bacterial contamination. © 2017 American College of Veterinary Ophthalmologists.

  3. Gamma camera performance: technical assessment protocol

    International Nuclear Information System (INIS)

    Bolster, A.A.; Waddington, W.A.

    1996-01-01

    This protocol addresses the performance assessment of single and dual headed gamma cameras. No attempt is made to assess the performance of any associated computing systems. Evaluations are usually performed on a gamma camera commercially available within the United Kingdom and recently installed at a clinical site. In consultation with the manufacturer, GCAT selects the site and liaises with local staff to arrange a mutually convenient time for assessment. The manufacturer is encouraged to have a representative present during the evaluation. Three to four days are typically required for the evaluation team to perform the necessary measurements. When access time is limited, the team will modify the protocol to test the camera as thoroughly as possible. Data are acquired on the camera's computer system and are subsequently transferred to the independent GCAT computer system for analysis. This transfer from site computer to the independent system is effected via a hardware interface and Interfile data transfer. (author)

  4. Gamma camera performance: technical assessment protocol

    Energy Technology Data Exchange (ETDEWEB)

    Bolster, A.A. [West Glasgow Hospitals NHS Trust, London (United Kingdom). Dept. of Clinical Physics; Waddington, W.A. [University College London Hospitals NHS Trust, London (United Kingdom). Inst. of Nuclear Medicine

    1996-12-31

    This protocol addresses the performance assessment of single and dual headed gamma cameras. No attempt is made to assess the performance of any associated computing systems. Evaluations are usually performed on a gamma camera commercially available within the United Kingdom and recently installed at a clinical site. In consultation with the manufacturer, GCAT selects the site and liaises with local staff to arrange a mutually convenient time for assessment. The manufacturer is encouraged to have a representative present during the evaluation. Three to four days are typically required for the evaluation team to perform the necessary measurements. When access time is limited, the team will modify the protocol to test the camera as thoroughly as possible. Data are acquired on the camera`s computer system and are subsequently transferred to the independent GCAT computer system for analysis. This transfer from site computer to the independent system is effected via a hardware interface and Interfile data transfer. (author).

  5. Conventional and advanced implant treatment in the type II diabetic patient: surgical protocol and long-term clinical results.

    Science.gov (United States)

    Tawil, Georges; Younan, Roland; Azar, Pierre; Sleilati, Ghassan

    2008-01-01

    To investigate the effect of type-2 diabetes on implant survival and complication rate. Prospective study enrolling type-2 diabetic patients suffering from edentulism, having a mean perioperative HbA1c level of 7.2%, and compliant with a maintenance program. All the patients underwent dental and periodontal examinations and had laboratory testing for HbA1c, fasting plasma glucose, blood lipids, and microalbuminuria. Nondiabetic patients matched for implant treatment indication served as controls. The influence of clinical diabetes-related factors and periodontal parameters (Plaque Index, bleeding on probing, probing depth) on implant survival were assessed via univariate then multivariate methods. Forty-five diabetic patients, followed for 1 to 12 years, mean age 64.7 years, received 255 implants: 143 following a classical protocol and 112 in cases of sinus floor elevation, immediate loading, and guided bone regeneration. Forty-five nondiabetic control patients received 244 implants: 142 following a classical protocol and 102 in cases of advanced surgery. Implant survival following conventional or advanced implant therapy was not statistically different between the well-controlled (HbA1c diabetic group was 97.2% (control 98.8%) and was not significantly different for age, gender, diabetes duration, smoking, or type of hypoglycemic therapy. The mean peri-implant bone loss was 0.41 +/- 0.58 mm (control, 0.49 +/- 0.64 mm). PI and BOP fairly correlated with postoperative complications. HbA1c was the only multivariate independent factor affecting the complication rate (P = .04). No statistically significant difference was found for patients (P = .81) or for implants (P = .66) for the advanced surgery cases or the conventional approach in diabetic patients compared to nondiabetic patients.

  6. Evaluation and Adaptation of a Laboratory-Based cDNA Library Preparation Protocol for Retrospective Sequencing of Archived MicroRNAs from up to 35-Year-Old Clinical FFPE Specimens.

    Science.gov (United States)

    Loudig, Olivier; Wang, Tao; Ye, Kenny; Lin, Juan; Wang, Yihong; Ramnauth, Andrew; Liu, Christina; Stark, Azadeh; Chitale, Dhananjay; Greenlee, Robert; Multerer, Deborah; Honda, Stacey; Daida, Yihe; Spencer Feigelson, Heather; Glass, Andrew; Couch, Fergus J; Rohan, Thomas; Ben-Dov, Iddo Z

    2017-03-14

    Formalin-fixed paraffin-embedded (FFPE) specimens, when used in conjunction with patient clinical data history, represent an invaluable resource for molecular studies of cancer. Even though nucleic acids extracted from archived FFPE tissues are degraded, their molecular analysis has become possible. In this study, we optimized a laboratory-based next-generation sequencing barcoded cDNA library preparation protocol for analysis of small RNAs recovered from archived FFPE tissues. Using matched fresh and FFPE specimens, we evaluated the robustness and reproducibility of our optimized approach, as well as its applicability to archived clinical specimens stored for up to 35 years. We then evaluated this cDNA library preparation protocol by performing a miRNA expression analysis of archived breast ductal carcinoma in situ (DCIS) specimens, selected for their relation to the risk of subsequent breast cancer development and obtained from six different institutions. Our analyses identified six miRNAs (miR-29a, miR-221, miR-375, miR-184, miR-363, miR-455-5p) differentially expressed between DCIS lesions from women who subsequently developed an invasive breast cancer (cases) and women who did not develop invasive breast cancer within the same time interval (control). Our thorough evaluation and application of this laboratory-based miRNA sequencing analysis indicates that the preparation of small RNA cDNA libraries can reliably be performed on older, archived, clinically-classified specimens.

  7. Cognitive Hypnotherapy as a Transdiagnostic Protocol for Emotional Disorders.

    Science.gov (United States)

    Alladin, Assen; Amundson, Jon

    2016-01-01

    This article describes cognitive hypnotherapy (CH), an integrative treatment that provides an evidence-based framework for synthesizing clinical practice and research. CH combines hypnotherapy with cognitive-behavior therapy in the management of emotional disorders. This blended version of clinical practice meets criteria for an assimilative model of integrative psychotherapy, which incorporates both theory and empirical findings. Issues related to (a) additive effect of hypnosis in treatment, (b) transdiagnostic consideration, and (c) unified treatment protocols in the treatment of emotional disorders are considered in light of cognitive hypnotherapy.

  8. A Comparison Between Inter-Asterisk eXchange Protocol and Jingle Protocol: Session Time

    Directory of Open Access Journals (Sweden)

    H. S. Haj Aliwi

    2016-08-01

    Full Text Available Over the last few years, many multimedia conferencing and Voice over Internet Protocol (VoIP applications have been developed due to the use of signaling protocols in providing video, audio and text chatting services between at least two participants. This paper compares between two widely common signaling protocols: InterAsterisk eXchange Protocol (IAX and the extension of the eXtensible Messaging and Presence Protocol (Jingle in terms of delay time during call setup, call teardown, and media sessions.

  9. Combined positron emission tomography/computed tomography (PET/CT) for clinical oncology: technical aspects and acquisition protocols

    International Nuclear Information System (INIS)

    Beyer, T.

    2004-01-01

    Combined PET/CT imaging is a non-invasive means of reviewing both, the anatomy and the molecular pathways of a patient during a quasi-simultaneous examination. Since the introduction of the prototype PET/CT in 1998 a rapid development of this imaging technology is being witnessed. The incorporation of fast PET detector technology into PET/CT designs and the routine use of the CT transmission images for attenuation correction of the PET allow for anato-metabolic whole-body examinations to be completed in less than 30 min. Thus, PET/CT imaging offers a logistical advantage to both, the patient and the clinicians since the two complementary exams - whenever clinically indicated - can be performed almost at the same time and a single integrated report can be created. Nevertheless, a number of pit-falls, primarily from the use of CT-based attenuation correction, have been identified and are being addressed through optimized acquisition protocols. It is fair to say, that PET/CT has been integrated in the diagnostic imaging arena, and in many cases has led to a close collaboration between different, yet complementary diagnostic and therapeutic medical disciplines. (orig.)

  10. Results of a multicenter prospective clinical study in Japan for evaluating efficacy and safety of desensitization protocol based on rituximab in ABO-incompatible kidney transplantation.

    Science.gov (United States)

    Takahashi, Kota; Saito, Kazuhide; Takahara, Shiro; Fuchinoue, Shohei; Yagisawa, Takashi; Aikawa, Atsushi; Watarai, Yoshihiko; Yoshimura, Norio; Tanabe, Kazunari; Morozumi, Kunio; Shimazu, Motohide

    2017-08-01

    Deceased organ donations are rare in Japan, with most kidney transplants performed from a limited number of living donors. Researchers have thus developed highly successful ABO-incompatible transplantation procedures, emphasizing preoperative desensitization and postoperative immunosuppression. A recent open-label, single-arm, multicenter clinical study prospectively examined the efficacy and safety of rituximab/mycophenolate mofetil desensitization in ABO-incompatible kidney transplantation without splenectomy. Mycophenolate mofetil and low dose steroid were started 28 days pretransplant, followed by two doses of rituximab 375 mg/m 2 at day -14 and day -1, and postoperative immunosuppression with tacrolimus or ciclosporin and basiliximab. The primary endpoint was the non-occurrence rate of acute antibody-mediated rejection. Patient survival and graft survival were monitored for 1 year posttransplant. Eighteen patients received rituximab and underwent ABO-incompatible kidney transplantation. CD19-positive peripheral B cell count decreased rapidly after the first rituximab infusion and recovered gradually after week 36. The desensitization protocol was tolerable, and most rituximab-related infusion reactions were mild. No anti-A/B antibody-mediated rejection occurred with this series. One patient developed anti-HLA antibody-mediated rejection (Banff 07 type II) on day 2, which was successfully managed. Patient and graft survival were both 100 % after 1 year. Our desensitization protocol was confirmed to be clinically effective and with acceptable toxicities for ABO-I-KTx (University Hospital Medical Information Network Registration Number: UMIN000006635).

  11. Neuroimaging in dementia and Alzheimer's disease: Current protocols and practice in the Republic of Ireland

    International Nuclear Information System (INIS)

    Kelly, I.; Butler, M.-L.; Ciblis, A.; McNulty, J.P.

    2016-01-01

    Introduction: Neuroimaging plays an essential supportive role in the diagnosis of dementia, assisting in establishing the dementia subtype(s). This has significant value in both treatment and care decisions and has important implications for prognosis. This study aims to explore the development and nature of neuroimaging protocols currently used in the assessment of dementia and Alzheimer's disease (AD). Methods: An online questionnaire was designed and distributed to lead radiography personnel working in computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) departments (n = 94) in both hospital-based and out-patient imaging centres in the Republic of Ireland. Results: Response rates for each modality ranged from 42 to 44%. CT, MRI, and PET were used to specifically diagnose dementia or AD by 43%, 40% and 50% of responding centres respectively. Of these, dementia-specific neuroimaging protocols were utilised in 33%, 50% and 100% of CT, MRI and PET centres respectively, with the remainder using either standard or other non-specific protocols. Both radiologists and clinical specialist radiographers participated in the development of the majority of protocols. The Royal College of Radiologists (RCR) guidelines were most commonly referenced as informing protocol development, however, none of the MRI respondents were able to identify any guidelines used to inform MR protocol development. Conclusion: Currently there is no consensus in Ireland on optimal dementia/AD neuroimaging protocols, particularly for PET and MRI. Similarly the use of validated and published guidelines to inform protocols is not universal. - Highlights: • We examined the nature of neuroimaging protocols for dementia and Alzheimer's disease in Ireland. • Dementia or Alzheimer's disease-specific protocols were used by between 33 and 100% of centres depending on modality. • Stated dementia-specific protocols were identical for CT whereas

  12. Usefulness of an injectable anaesthetic protocol for semen collection through urethral catheterisation in domestic cats.

    Science.gov (United States)

    Pisu, Maria Carmela; Ponzio, Patrizia; Rovella, Chiara; Baravalle, Michela; Veronesi, Maria Cristina

    2017-10-01

    Objectives Although less often requested in comparison with dogs, the collection of semen in cats can be necessary for artificial insemination, for semen evaluation in tom cats used for breeding and for semen storage. Urethral catheterisation after pharmacological induction with medetomidine has proved to be useful for the collection of semen in domestic cats. However, most of the previously used protocols require the administration of high doses of medetomidine that can increase the risk of side effects, especially on the cardiovascular system. In routine clinical practice, one safe and useful injectable anaesthetic protocol for short-term clinical investigations or surgery in cats involves premedication with low intramuscular doses of dexmedetomidine with methadone, followed by intravenous propofol bolus injection. We aimed to assess the usefulness of this injectable anaesthetic protocol for semen collection, via urethral catheterisation, in domestic cats. Methods The study was performed on 38 purebred, adult cats, during the breeding season, and semen was collected via urethral catheterisation using an injectable anaesthesia protocol with methadone (0.2 mg/kg) and dexmedetomidine (5 µg/kg) premedication, followed by induction with propofol. Results The anaesthetic protocol used in the present study allowed the collection of large-volume semen samples, characterised by good parameters and without side effects. Conclusions and relevance The results from the present study suggest that the injectable anaesthetic protocol using methadone and dexmedetomidine premedication, followed by induction with propofol, could be suitable and safe for the collection of a good-quality semen sample, via urethral catheterisation, in domestic cats. It can therefore be used as an alternative to previous medetomidine-based sedation protocols.

  13. Polyethylene glycol 3350 based colon cleaning protocol: 2 d vs 4 d head to head comparison.

    Science.gov (United States)

    Elitsur, Rotem; Butcher, Lisa; Vicki, Lund; Elitsur, Yoram

    2013-04-16

    To compare between 2 and 4 d colon cleansing protocols. Children who were scheduled for colonoscopy procedure (2010-2012) for various medical reasons, were recruited from the pediatric gastroenterology clinic at Marshall University School of Medicine, Huntington, WV. Exclusion criteria were patients who were allergic to the medication used in the protocols [polyethylene glycol (PEG) 3350, Bisacodyl], or children with metabolic or renal diseases. Two PEG 3350 protocols for 4 d (A) and 2 d (B) were prescribed as previously described. A questionnaire describing the volume of PEG consumed, clinical data, and side effects were recorded. Colon preparation was graded by two observers according to previously described method. Rate of adequate colon preparation. A total of 78 patients were considered for final calculation (group A: 40, group B: 38). Age and stool consistency at the last day was comparable in both groups, but the number of stools/day was significantly higher in group B (P = 0.001). Adequate colon preparation was reached in 57.5% (A) and 73.6% (B), respectively (P = 0.206). Side effects were minimal and comparable in both groups. There was no difference in children's age, stool characteristics, or side effects between the children with adequate or inadequate colon preparation. Correlation and agreement between observers was excellent (Pearson correlation = 0.972, kappa = 1.0). No difference between protocols was observed, but the 2 d protocol was superior for its shorter time. Direct comparison between different colon cleansing protocols is crucial in order to establish the "gold standard" protocol for children.

  14. Validation of the Andon KD595 for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

    Science.gov (United States)

    Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

    2016-04-01

    This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor Andon KD595 for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using the standard mercury sphygmomanometer and the Andon KD595 device. Ninety-nine pairs of comparisons were obtained from 33 participants for analysis. The KD595 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10, and 15 mmHg was 72/99, 93/99, and 96/99, respectively, for SBP and 72/99, 96/99, and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. A total of 28 and 25 participants had at least two of the three device-observer differences within 5 mmHg (required≥24) for SBP and DBP, respectively. The number of participants without device-observer difference within 5 mmHg was two for SBP and two for DBP (required≤3). The Andon upper arm blood pressure monitor KD595 has passed the International Protocol requirements and it can be recommended for clinical use and self-measurement in adults.

  15. Validation of the Andon KD5031 for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

    Science.gov (United States)

    Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

    2016-10-01

    This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor Andon KD5031 for home BP monitoring according to the European Society of Hypertension International Protocol revision 2010. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using the standard mercury sphygmomanometer and the Andon KD5031 device. Ninety-nine pairs of comparisons were obtained from 33 participants for analysis. The KD5031 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10, and 15 mmHg was 66/99, 93/99, and 98/99, respectively, for SBP and 72/99, 94/99, and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. Twenty-six participants for both SBP and DBP had at least two of the three device-observer differences within 5 mmHg (required ≥24). The number of participants without a device-observer difference within 5 mmHg was one for SBP and three for DBP (required ≤3). The Andon upper arm BP monitor KD5031 has passed the International Protocol requirements, and it can be recommended for clinical use and self-measurement in adults.

  16. Measuring outcomes in children's rehabilitation: a decision protocol.

    Science.gov (United States)

    Law, M; King, G; Russell, D; MacKinnon, E; Hurley, P; Murphy, C

    1999-06-01

    To develop and test the feasibility and clinical utility of a computerized self-directed software program designed to enable service providers in children's rehabilitation to make decisions about the most appropriate outcome measures to use in client and program evaluation. A before-and-after design was used to test the feasibility and initial impact of the decision-making outcome software in improving knowledge and use of clinical outcome measures. A children's rehabilitation center in a city of 50,000. All service providers in the children's rehabilitation center. Disciplines represented included early childhood education, occupational therapy, physical therapy, speech and language pathology, audiology, social work, and psychology. Using a conceptual framework based on the International Classification of Impairment, Disability, and Handicap (ICIDH), an outcome measurement decision-making protocol was developed. The decision-making protocol was computerized in an educational software program with an attached database of critically appraised measures. Participants learned about outcome measures through the program and selected outcome measures that met their specifications. The computer software was tested for feasibility in the children's rehabilitation center for 6 months. Knowledge and use of clinical outcome measures were determined before and after the feasibility testing using a survey of all service providers currently at the centre and audits of 30 randomly selected rehabilitation records (at pretest, posttest, and follow-up). Service providers indicated that the outcomes software was easy to follow and believed that the use of the ICIDH framework helped them in making decisions about selecting outcome measures. Results of the survey indicated that there were significant changes in the service providers' level of comfort with selecting measures and knowing what measures were available. Use of outcome measures as identified through the audit did not change

  17. Impact of Sleep Telemedicine Protocol in Management of Sleep Apnea: A 5-Year VA Experience.

    Science.gov (United States)

    Baig, Mirza M; Antonescu-Turcu, Andrea; Ratarasarn, Kavita

    2016-05-01

    There is growing evidence that demonstrates an important role for telemedicine technologies in enhancing healthcare delivery. A comprehensive sleep telemedicine protocol was implemented at the Veterans Administration Medical Center (VAMC), Milwaukee, WI, in 2008 in an effort to improve access to sleep specialty care. The telemedicine protocol relied heavily on sleep specialist interventions based on chart review (electronic consult [e-consult]). This was done in response to long wait time for sleep clinic visits as well as delayed sleep study appointments. Since 2008 all consults are screened by sleep service to determine the next step in intervention. Based on chart review, the following steps are undertaken: (1) eligibility for portable versus in-lab sleep study is determined, and a sleep study order is placed accordingly, (2) positive airway pressure (PAP) therapy is prescribed for confirmed sleep apnea, and (3) need for in-person evaluation in the sleep clinic is determined, and the visit is scheduled. This study summarizes the 5-year trend in various aspects of access to sleep care after implementation of sleep telemedicine protocol at the Milwaukee VAMC. This is a retrospective system efficiency study. The electronic medical record was interrogated 5 years after starting the sleep telemedicine protocol to study annual trends in the following outcomes: (1) interval between sleep consult and prescription of PAP equipment, (2) total sleep consults, and (3) sleep clinic wait time. Two part-time sleep physicians provided sleep-related care at the Milwaukee VAMC between 2008 and 2012. During this period, the interval between sleep consult and PAP prescription decreased from ≥60 days to ≤7 days. This occurred in spite of an increase in total sleep consults and sleep studies. There was also a significant increase in data downloads, indicating overall improved follow-up. There was no change in clinic wait time of ≥60 days. Implementation of a sleep telemedicine

  18. The French dosimetry protocol

    International Nuclear Information System (INIS)

    Dutreix, A.

    1985-01-01

    After a general introduction the protocol is divided in five sections dealing with: determination of the quality of X-ray, γ-ray and electron beams; the measuring instrument; calibration of the reference instrument; determination of the reference absorbed dose in the user's beams; determination of the absorbed dose in water at other points, in other conditions. The French protocol is not essentially different from the Nordic protocol and it is based on the experience gained in using both the American and the Nordic protocols. Therefore, only the main difference with the published protocols are discussed. (Auth.)

  19. How blockchain-timestamped protocols could improve the trustworthiness of medical science [version 3; referees: 3 approved

    Directory of Open Access Journals (Sweden)

    Greg Irving

    2017-03-01

    Full Text Available Trust in scientific research is diminished by evidence that data are being manipulated. Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research. Methods for using blockchain to provide proof of pre-specified endpoints in clinical trial protocols were first reported by Carlisle. We wished to empirically test such an approach using a clinical trial protocol where outcome switching has previously been reported. Here we confirm the use of blockchain as a low cost, independently verifiable method to audit and confirm the reliability of scientific studies.

  20. How blockchain-timestamped protocols could improve the trustworthiness of medical science [version 2; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Greg Irving

    2016-05-01

    Full Text Available Trust in scientific research is diminished by evidence that data are being manipulated. Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research. Methods for using blockchain to provide proof of pre-specified endpoints in clinical trial protocols were first reported by Carlisle. We wished to empirically test such an approach using a clinical trial protocol where outcome switching has previously been reported. Here we confirm the use of blockchain as a low cost, independently verifiable method to audit and confirm the reliability of scientific studies.

  1. WE-E-304-02: Implementing SBRT Protocols: A NRG CIRO Perspective

    International Nuclear Information System (INIS)

    Xiao, Y.

    2015-01-01

    SBRT is having a dramatic impact on radiation therapy of early-stage, locally advanced cancers. A number of national protocols have been and are being developed to assess the clinical efficacy of SBRT for various anatomical sites, such as lung and spine. Physics credentialing for participating and implementation of trial protocols involve a broad spectrum of requirements from image guidance, motion management, to planning technology and dosimetric constrains. For radiation facilities that do not have extensive experiences in SBRT treatment and protocol credentialing, these complex processes of credentialing and implementation could be very challenging and, sometimes, may lead to ineffective even unsuccessful execution of these processes. In this proposal, we will provide comprehensive review of some current SBRT protocols, explain the requirements and their underline rationales, illustrate representative failed and successful experiences, related to SBRT credentialing, and discuss strategies for effective SBRT credentialing and implementation. Learning Objectives: Understand requirements and challenges of SBRT credentailing and implentation Discuss processes and strategies of effective SBRT credentailing Discuss practical considerations, potential pitfalls and solutions of SBRT implentation

  2. WE-E-304-02: Implementing SBRT Protocols: A NRG CIRO Perspective

    Energy Technology Data Exchange (ETDEWEB)

    Xiao, Y. [Thomas Jefferson University, Philadelphia, PA (United States)

    2015-06-15

    SBRT is having a dramatic impact on radiation therapy of early-stage, locally advanced cancers. A number of national protocols have been and are being developed to assess the clinical efficacy of SBRT for various anatomical sites, such as lung and spine. Physics credentialing for participating and implementation of trial protocols involve a broad spectrum of requirements from image guidance, motion management, to planning technology and dosimetric constrains. For radiation facilities that do not have extensive experiences in SBRT treatment and protocol credentialing, these complex processes of credentialing and implementation could be very challenging and, sometimes, may lead to ineffective even unsuccessful execution of these processes. In this proposal, we will provide comprehensive review of some current SBRT protocols, explain the requirements and their underline rationales, illustrate representative failed and successful experiences, related to SBRT credentialing, and discuss strategies for effective SBRT credentialing and implementation. Learning Objectives: Understand requirements and challenges of SBRT credentailing and implentation Discuss processes and strategies of effective SBRT credentailing Discuss practical considerations, potential pitfalls and solutions of SBRT implentation.

  3. Biologic comparison of partial breast irradiation protocols

    International Nuclear Information System (INIS)

    Rosenstein, Barry S.; Lymberis, Stella C.; Formenti, Silvia C.

    2004-01-01

    Purpose: To analyze the dose/fractionation schedules currently used in ongoing clinical trials of partial breast irradiation (PBI) by comparing their biologically effective dose (BED) values to those of three standard whole breast protocols commonly used after segmental mastectomy in the treatment of breast cancer. Methods and materials: The BED equation derived from the linear-quadratic model for radiation-induced cell killing was used to calculate the BEDs for three commonly used whole breast radiotherapy regimens, in addition to a variety of external beam radiotherapy, as well as high-dose-rate and low-dose-rate brachytherapy, PBI protocols. Results: The BED values of most PBI protocols resulted in tumor control BEDs roughly equivalent to a 50-Gy standard treatment, but consistently lower than the BEDs for regimens in which the tumor bed receives a total dose of either 60 Gy or 66 Gy. The BED values calculated for the acute radiation responses of erythema and desquamation were nearly all lower for the PBI schedules, and the late-response BEDs for most PBI regimens were in a similar range to the BEDs for the standard treatments. Conclusion: Biologically effective dose modeling raises the concern that inadequate doses might be delivered by PBI to ensure optimal in-field tumor control

  4. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

    Science.gov (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

    2016-03-22

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

  5. Protocol optimization in chest CT scans of child

    Energy Technology Data Exchange (ETDEWEB)

    Abrao L, L. T.; Amaral de O, F.; Prata M, A. [Biomedical Engineering Center, Centro Federal de Educacao Tecnologica de Minas Gerais, 30421-169, Belo Horizonte, Minas Gerais (Brazil); Bustos F, M., E-mail: luanaabrao@gmail.com [Universidad Federal de Minas Gerais, Department of Nuclear Engineering, Av. Pres. Antonio Carlos 6627, Pampulha, 31270-901 Belo Horizonte, Minas Gerais (Brazil)

    2017-10-15

    The dissemination of Computed Tomography (CT), a radiodiagnostic technique, has significant increase in the patient dose. In the last years, this technique has shown a high growth due to clinical cases of medical emergencies, neoplasm and pediatric traumas. Dose measurement is important to correlate with the deleterious effects of radiation on the organism and radiation future effects is related with stochastic risks due to tissue radiosensitivity, allied to the life expectancy of the child. In this work, a cylindrical phantom, representing an adult chest made of polymethylmethacrylate (PMMA), was used and a new born chest phantom with a shape oblong was developed based on the dimensions of a typical newborn. In a Ge CT scanner, Discovery model, with 64 channels, the central slice of the phantoms were irradiated successively in order to obtain dose measurements using an ionizing pencil camera. Based in the measurements, dose index was calculated (CTDI{sub vol}). The radiological service chest protocol using a voltage of 120 kV was used for scanning 10 cm of the central area of the adult and newborn phantom, in helical mode. An acquisition of images was performed using this radiological service chest protocol to compare with the protocol optimized. In the newborn phantom was also used protocols optimized using a voltage of 120 and 80 kV. The voltage of 80 kV has the lowest dose index for the pediatric object phantom. This work allowed the comparison between absorbed dose variations by the pediatric phantom changing the X-ray tube supply voltage. This dose variation has shown how important is specific protocols for children. (Author)

  6. Protocol optimization in chest CT scans of child

    International Nuclear Information System (INIS)

    Abrao L, L. T.; Amaral de O, F.; Prata M, A.; Bustos F, M.

    2017-10-01

    The dissemination of Computed Tomography (CT), a radiodiagnostic technique, has significant increase in the patient dose. In the last years, this technique has shown a high growth due to clinical cases of medical emergencies, neoplasm and pediatric traumas. Dose measurement is important to correlate with the deleterious effects of radiation on the organism and radiation future effects is related with stochastic risks due to tissue radiosensitivity, allied to the life expectancy of the child. In this work, a cylindrical phantom, representing an adult chest made of polymethylmethacrylate (PMMA), was used and a new born chest phantom with a shape oblong was developed based on the dimensions of a typical newborn. In a Ge CT scanner, Discovery model, with 64 channels, the central slice of the phantoms were irradiated successively in order to obtain dose measurements using an ionizing pencil camera. Based in the measurements, dose index was calculated (CTDI vol ). The radiological service chest protocol using a voltage of 120 kV was used for scanning 10 cm of the central area of the adult and newborn phantom, in helical mode. An acquisition of images was performed using this radiological service chest protocol to compare with the protocol optimized. In the newborn phantom was also used protocols optimized using a voltage of 120 and 80 kV. The voltage of 80 kV has the lowest dose index for the pediatric object phantom. This work allowed the comparison between absorbed dose variations by the pediatric phantom changing the X-ray tube supply voltage. This dose variation has shown how important is specific protocols for children. (Author)

  7. Pre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! Study): protocol for a pragmatic clinical trial at public healthcare clinics in Brazil.

    Science.gov (United States)

    Grangeiro, Alexandre; Couto, Márcia Thereza; Peres, Maria Fernanda; Luiz, Olinda; Zucchi, Eliana Miura; de Castilho, Euclides Ayres; Estevam, Denize Lotufo; Alencar, Rosa; Wolffenbüttel, Karina; Escuder, Maria Mercedes; Calazans, Gabriela; Ferraz, Dulce; Arruda, Érico; Corrêa, Maria da Gloria; Amaral, Fabiana Rezende; Santos, Juliane Cardoso Villela; Alvarez, Vivian Salles; Kietzmann, Tiago

    2015-08-25

    Few results from programmes based on combination prevention methods are available. We propose to analyse the degree of protection provided by postexposure prophylaxis (PEP) for consensual sexual activity at healthcare clinics, its compensatory effects on sexual behaviour; and the effectiveness of combination prevention methods and pre-exposure prophylaxis (PrEP), compared with exclusively using traditional methods. A total of 3200 individuals aged 16 years or older presenting for PEP at 5 sexually transmitted disease (STD)/HIV clinics in 3 regions of Brazil will be allocated to one of two groups: the PEP group-individuals who come to the clinic within 72 h after a sexual exposure and start PEP; and the non-PEP group-individuals who come after 72 h but within 30 days of exposure and do not start PEP. Clinical follow-up will be conducted initially for 6 months and comprise educational interventions based on information and counselling for using prevention methods, including PrEP. In the second study phase, individuals who remain HIV negative will be regrouped according to the reported use of prevention methods and observed for 18 months: only traditional methods; combined methods; and PrEP. Effectiveness will be analysed according to the incidence of HIV, syphilis and hepatitis B and C and protected sexual behaviour. A structured questionnaire will be administered to participants at baseline and every 6 months thereafter. Qualitative methods will be employed to provide a comprehensive understanding of PEP-seeking behaviour, preventive choices and exposure to HIV. This study will be conducted in accordance with the resolution of the School of Medicine Research Ethics Commission of Universidade de São Paulo (protocol no. 251/14). The databases will be available for specific studies, after management committee approval. Findings will be presented to researchers, health managers and civil society members by means of newspapers, electronic media and scientific journals

  8. The HPA photon protocol and proposed electron protocol

    International Nuclear Information System (INIS)

    Pitchford, W.G.

    1985-01-01

    The Hospital Physicists Association (HPA) photon dosimetry protocol has been produced and was published in 1983. Revised values of some components of Csub(lambda) and refinements introduced into the theory in the last few years have enabled new Csub(lambda) values to be produced. The proposed HPA electron protocol is at present in draft form and will be published shortly. Both protocels are discussed. (Auth.)

  9. Suicide Risk Protocols: Addressing the Needs of High Risk Youths Identified through Suicide Prevention Efforts and in Clinical Settings

    Science.gov (United States)

    Heilbron, Nicole; Goldston, David; Walrath, Christine; Rodi, Michael; McKeon, Richard

    2013-01-01

    Several agencies have emphasized the importance of establishing clear protocols or procedures to address the needs of youths who are identified as suicidal through suicide prevention programs or in emergency department settings. What constitutes optimal guidelines for developing and implementing such protocols, however, is unclear. At the request…

  10. A Higher-Calorie Refeeding Protocol Does Not Increase Adverse Outcomes in Adult Patients with Eating Disorders.

    Science.gov (United States)

    Matthews, Kylie; Hill, Jan; Jeffrey, Shane; Patterson, Susan; Davis, Amanda; Ward, Warren; Palmer, Michelle; Capra, Sandra

    2018-04-12

    Patients with eating disorders (EDs) are often considered a high-risk population to refeed. Current research advises using "start low, go slow" refeeding methods (∼1,000 kcal/day, advancing ∼500 kcal/day every 3 to 4 days) in adult patients with severe EDs to prevent the development of refeeding syndrome (RFS), typically characterized by decreases in serum electrolyte levels and fluid shifts. To compare the incidence of RFS and related outcomes using a low-calorie protocol (LC) (1,000 kcal) or a higher-calorie protocol (HC) (1,500 kcal) in medically compromised adult patients with EDs. This was a retrospective pre-test-post-test study. One hundred and nineteen participants with EDs, medically admitted to a tertiary hospital in Brisbane, Australia, between December 2010 and January 2017, were included (LC: n=26, HC: n=93). The HC refeeding protocol was implemented in September 2013. Differences in prevalence of electrolyte disturbances, hypoglycemia, edema, and RFS diagnoses were examined. χ 2 tests, Kruskal-Wallis H test, analysis of variance, and independent t tests were used to compare data between the two protocols. Descriptors were similar between groups (LC: 28±9 years, 96% female, 85% with anorexia nervosa, 31% admitted primarily because of clinical symptoms of exacerbated ED vs HC: 27±9 years, 97% female, 84% with anorexia nervosa, 44% admitted primarily because of clinical symptoms of exacerbated ED, P>0.05). Participants refed using the LC protocol had higher incidence rates of hypoglycemia (LC: 31% vs HC: 10%, P=0.012), with no statistical or clinical differences in electrolyte disturbances (LC: 65% vs HC: 45%, P=0.079), edema (LC: 8% vs HC: 6%, P=0.722) or diagnosed RFS (LC: 4% vs HC: 1%, P=0.391). A higher-calorie refeeding protocol appears to be safe, with no differences in rates of electrolyte disturbances or clinically diagnosed RFS and a lower incidence of hypoglycemia. Future research examining higher-calorie intakes, similar to those

  11. Geographic variation in lumbar diskectomy: a protocol for evaluation.

    Science.gov (United States)

    Barron, M; Kazandjian, V A

    1992-03-01

    In 1989 the Maryland Hospital Association (MHA) began developing a protocol related to lumbar diskectomy, a procedure with widely reported geographic variation in its use. The MHA's Laminectomy Advisory Committee drafted three criteria for performance of lumbar diskectomy and also developed a data-collection instrument with which the eight hospitals participating in a pilot study could abstract the necessary data from medical records. Both individual hospital and aggregate results showed wide variation in compliance with the criteria. These findings suggest research and development activities such as refinement of the data-collection instrument, use of the protocol for bench-marking, further investigation of clinical and other determinants of rate variation, and study of the effect of new diagnostic technology on utilization rates for this procedure.

  12. Effective dose comparison between stitched and single FOV in CBCT protocols for complete dental arcade

    International Nuclear Information System (INIS)

    Soares, Maria Rosangela; Batista, Wilson Otto; Antonio, Patricia Lara de; Caldas, Linda V.E.; Maia, Ana F.

    2015-01-01

    Objective: The objective of this study was to assess and compare protocols with a single field of view and multiple stitched field of view with a similar clinical purpose by means of effective dose value. Materials and methods: Measurements of absorbed dose were performed with thermoluminescent dosemeters inserted in the position of organs/tissues of a female anthropomorphic phantom and from these values the effective dose was calculated, utilizing weighting factor tissue-ICRP 103 (2007). Results: The results obtained in this study for effective dose are within the range of 43.1 µSv and 111.5 µSv for equipment using protocols with single FOV and in the range of 44.5 µSv and 236.2 µSv for equipments that using protocols with stitched field of view. Conclusions: In terms of the value of effective dose, stitched FOV protocols do not have any advantage over the single field of view protocols. This results suggest the necessity for knowledge of the exposure parameters and effective dose values associated with each image protocol. - Highlights: • The study relies on the comparison of two protocols with similar goals of CBCT: stitched protocols and single protocols. • The stitched FOV protocol is more specific and it is good option when want imaging only of some dental units. • In relation the effective dose, single FOV protocols presents advantage over the stitched FOV protocols. • Know the exposure parameters and effective dose values associated with each image protocol is necessity for request the best CBCT tomographic image

  13. Implementing an ultrasound-based protocol for diagnosingappendicitis while maintaining diagnostic accuracy

    International Nuclear Information System (INIS)

    Van Atta, Angela J.; Baskin, Henry J.; Maves, Connie K.; Dansie, David M.; Rollins, Michael D.; Bolte, Robert G.; Mundorff, Michael B.; Andrews, Seth P.

    2015-01-01

    The use of ultrasound to diagnose appendicitis in children is well-documented but not universally employed outside of pediatric academic centers, especially in the United States. Various obstacles make it difficult for institutions and radiologists to abandon a successful and accurate CT-based imaging protocol in favor of a US-based protocol. To describe how we overcame barriers to implementing a US-based appendicitis protocol among a large group of nonacademic private-practice pediatric radiologists while maintaining diagnostic accuracy and decreasing medical costs. A multidisciplinary team of physicians (pediatric surgery, pediatric emergency medicine and pediatric radiology) approved an imaging protocol using US as the primary modality to evaluate suspected appendicitis with CT for equivocal cases. The protocol addressed potential bias against US and accommodated for institutional limitations of radiologist and sonographer experience and availability. Radiologists coded US reports according to the probability of appendicitis. Radiology reports were compared with clinical outcomes to assess diagnostic accuracy. During the study period, physicians from each group were apprised of the interim US protocol accuracy results. Problematic cases were discussed openly. A total of 512 children were enrolled and underwent US for evaluation of appendicitis over a 30-month period. Diagnostic accuracy was comparable to published results for combined US/CT protocols. Comparing the first 12 months to the last 12 months of the study period, the proportion of children achieving an unequivocal US result increased from 30% (51/169) to 53% (149/282) and the proportion of children undergoing surgery based solely on US findings increased from 55% (23/42) to 84% (92/109). Overall, 63% (325/512) of patients in the protocol did not require a CT. Total patient costs were reduced by $30,182 annually. We overcame several barriers to implementing a US protocol. During the study period our

  14. Implementing an ultrasound-based protocol for diagnosingappendicitis while maintaining diagnostic accuracy

    Energy Technology Data Exchange (ETDEWEB)

    Van Atta, Angela J. [University of Utah School of Medicine, Salt Lake City, UT (United States); Baskin, Henry J.; Maves, Connie K.; Dansie, David M. [Primary Children' s Hospital, Department of Radiology, Salt Lake City, UT (United States); Rollins, Michael D. [University of Utah School of Medicine, Department of Surgery, Division of Pediatric Surgery, Salt Lake City, UT (United States); Bolte, Robert G. [University of Utah School of Medicine, Department of Pediatrics, Division of Pediatric Emergency Medicine, Salt Lake City, UT (United States); Mundorff, Michael B.; Andrews, Seth P. [Primary Children' s Hospital, Systems Improvement, Salt Lake City, UT (United States)

    2015-05-01

    The use of ultrasound to diagnose appendicitis in children is well-documented but not universally employed outside of pediatric academic centers, especially in the United States. Various obstacles make it difficult for institutions and radiologists to abandon a successful and accurate CT-based imaging protocol in favor of a US-based protocol. To describe how we overcame barriers to implementing a US-based appendicitis protocol among a large group of nonacademic private-practice pediatric radiologists while maintaining diagnostic accuracy and decreasing medical costs. A multidisciplinary team of physicians (pediatric surgery, pediatric emergency medicine and pediatric radiology) approved an imaging protocol using US as the primary modality to evaluate suspected appendicitis with CT for equivocal cases. The protocol addressed potential bias against US and accommodated for institutional limitations of radiologist and sonographer experience and availability. Radiologists coded US reports according to the probability of appendicitis. Radiology reports were compared with clinical outcomes to assess diagnostic accuracy. During the study period, physicians from each group were apprised of the interim US protocol accuracy results. Problematic cases were discussed openly. A total of 512 children were enrolled and underwent US for evaluation of appendicitis over a 30-month period. Diagnostic accuracy was comparable to published results for combined US/CT protocols. Comparing the first 12 months to the last 12 months of the study period, the proportion of children achieving an unequivocal US result increased from 30% (51/169) to 53% (149/282) and the proportion of children undergoing surgery based solely on US findings increased from 55% (23/42) to 84% (92/109). Overall, 63% (325/512) of patients in the protocol did not require a CT. Total patient costs were reduced by $30,182 annually. We overcame several barriers to implementing a US protocol. During the study period our

  15. Satellite Communications Using Commercial Protocols

    Science.gov (United States)

    Ivancic, William D.; Griner, James H.; Dimond, Robert; Frantz, Brian D.; Kachmar, Brian; Shell, Dan

    2000-01-01

    NASA Glenn Research Center has been working with industry, academia, and other government agencies in assessing commercial communications protocols for satellite and space-based applications. In addition, NASA Glenn has been developing and advocating new satellite-friendly modifications to existing communications protocol standards. This paper summarizes recent research into the applicability of various commercial standard protocols for use over satellite and space- based communications networks as well as expectations for future protocol development. It serves as a reference point from which the detailed work can be readily accessed. Areas that will be addressed include asynchronous-transfer-mode quality of service; completed and ongoing work of the Internet Engineering Task Force; data-link-layer protocol development for unidirectional link routing; and protocols for aeronautical applications, including mobile Internet protocol routing for wireless/mobile hosts and the aeronautical telecommunications network protocol.

  16. Security Protocols in a Nutshell

    OpenAIRE

    Toorani, Mohsen

    2016-01-01

    Security protocols are building blocks in secure communications. They deploy some security mechanisms to provide certain security services. Security protocols are considered abstract when analyzed, but they can have extra vulnerabilities when implemented. This manuscript provides a holistic study on security protocols. It reviews foundations of security protocols, taxonomy of attacks on security protocols and their implementations, and different methods and models for security analysis of pro...

  17. A comparison of national and international megavoltage calibration protocols

    International Nuclear Information System (INIS)

    Almond, P.R.

    1985-01-01

    Almond lists, describes and compares the following radiation therapy dosimetry protocols and standards of the following groups: Deutsches Institut fuer Normung (DIN), Nordic Association of Clinical Physics (NACP), National Council on Radiation Protection and Measurements (NCRP), Hospital Physicists Association (HPA), American Association of Physics in Medicine (AAPM), Bureau National de Metrologie (BNM), and the Sociedad Espanola de fisica Medica (SEFM)

  18. Microdose flare-up vs. flexible-multidose GnRH antagonist protocols for poor responder patients who underwent ICSI.

    Science.gov (United States)

    Esinler, I

    2014-01-01

    To compare the performance of microdose flare-up (MF) and flexible-multidose gonadotropin-releasing hormone (GnRH) antagonist protocols in poor responder patients who underwent intracytoplasmic sperm injection (ICSI). One hundred and 12 consecutive patients (217 cycles) suspected to have poor ovarian response were enrolled. Group 1 (MF GnRH agonist group) constituted 64 patients (135 cycles) who underwent MF GnRH agonist protocol. Group 2 (flexible-multidose GnRH antagonist group) constituted 48 patients (82 cycles) who underwent flexible-multidose GnRH antagonist protocol. The duration of stimulation (d) (11.5 +/- 2.1 vs. 10.4 +/- 2.7, p or = seven blastomeres and < 10% fragmentation at day 3 (35.9% vs. 65.1%, p < 0.05) were significantly lower in Group 1 when compared to Group 2. The number of embryos transferred (2.2 +/- 1.3 vs. 2.4 +/- 0.9), the clinical pregnancy per embryo transfer (16.3% vs. 25.8%), and the implantation rate (8.6% vs. 12.2%) were comparable between groups. Although the flexible-multidose GnRH antagonist protocol produced better oocyte and embryo parameters, the clinical pregnancy rate and the implantation rates were comparable between the flexible-multidose GnRH antagonist and MF protocols in poor responder patients.

  19. Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial.

    Science.gov (United States)

    Kim, Mikyung; Kim, Jung-Eun; Lee, Hye-Yoon; Kim, Ae-Ran; Park, Hyo-Ju; Kwon, O-Jin; Kim, Bo-Kyung; Cho, Jung Hyo; Kim, Joo-Hee

    2017-08-11

    Although insomnia is one of the most prevalent and disturbing symptoms among patients with cancer, it has not been properly managed. Electroacupuncture (EA) has received attention as a promising intervention for insomnia, and a few previous studies have reported that this intervention may be beneficial for treating insomnia in patients with cancer. The aim of this pilot study is to explore the feasibility and preliminary effectiveness of EA on the sleep disturbance of patients with cancer with insomnia using a subjective method, patient-reported questionnaires and an objective tool, actigraphy, to measure the quality of sleep. This is a study protocol for a randomised, three-arm, multicentre, pilot clinical trial. A total of 45 patients with cancer who have continuous insomnia related to cancer treatment or cancer itself will be randomly allocated to an EA group, sham EA group or usual care group in equal proportions. The EA group will receive 10 sessions of EA treatment over 4 weeks. The sham EA group will receive sham EA at non-acupoints using non-penetrating Streitberger acupuncture needles with mock EA. The usual care group will not receive EA treatment. All participants will be provided a brochure on the management of sleep disorders regardless of their group assignment. The primary outcome measure is the mean change in the insomnia severity index from the baseline to week 5. Information related to sleep quality will also be obtained through the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Participants will complete the trial by visiting the research centre at week 9 for follow-up assessment. This study protocol was approved by the institutional review boards of each research centre. Written informed consent will be obtained from all participants. The result of this study will be published in peer-reviewed journals or presented at academic conferences. KCT0002162; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated

  20. Microdose Flare-up Gonadotropin-releasing Hormone (GnRH) Agonist Versus GnRH Antagonist Protocols in Poor Ovarian Responders Undergoing Intracytoplasmic Sperm Injection.

    Science.gov (United States)

    Boza, Aysen; Cakar, Erbil; Boza, Barıs; Api, Murat; Kayatas, Semra; Sofuoglu, Kenan

    2016-01-01

    Microdose flare-up GnRH agonist and GnRH antagonist have become more popular in the management of poor ovarian responders (POR) in recent years; however, the optimal protocol for POR patients undergoing in vitro fertilization has still been a challenge. In this observational study design, two hundred forty four poor ovarian responders were retrospectively evaluated for their response to GnRH agonist protocol (group-1, n=135) or GnRH antagonist protocol (group-2, n=109). Clinical pregnancy rate was the primary end point and was compared between the groups. Student t-test, Mann Whitney U test and χ (2)-test were used to compare the groups. The pmicrodose flare-up protocol has favorable outcomes with respect to the number of oocytes retrieved and implantation rate; nevertheless, the clinical pregnancy rate was found to be similar in comparison to GnRH antagonist protocol in poor ovarian responders. GnRH antagonist protocol appears to be promising with significantly lower gonadotropin requirement and lower treatment cost in poor ovarian responders.

  1. Business protocol in integrated Europe

    OpenAIRE

    Pavelová, Nina

    2009-01-01

    The first chapter devotes to definitions of basic terms such as protocol or business protocol, to differences between protocol and etiquette, and between social etiquette and business etiquette. The second chapter focuses on the factors influencing the European business protocol. The third chapter is devoted to the etiquette of business protocol in the European countries. It touches the topics such as punctuality and planning of business appointment, greeting, business cards, dress and appear...

  2. The clinical management of awake bruxism.

    Science.gov (United States)

    Goldstein, Ronald E; Auclair Clark, Wendy

    2017-06-01

    Awake bruxism is a common clinical condition that often goes undetected, often leading to pain or damaged teeth and restorations. The authors searched electronic databases regarding the treatment and effects of awake bruxism compared with those of sleep bruxism. The authors used the search terms diurnal bruxism and oral parafunction. The authors combined information from relevant literature with clinical experience to establish a recommended protocol for diagnosis and treatment. The authors found articles regarding the diagnosis and treatment of bruxism. The authors combined information from the articles with a review of clinical cases to establish a treatment protocol for awake bruxism. Literature and clinical experience indicate a lack of patient awareness and, thus, underreporting of awake bruxism. As a result, myriad dental consequences can occur from bruxism. The authors propose a need for increased awareness, for both patients and professionals, particularly of the number of conditions related to awake bruxism. Clinicians should look for clinical signs and symptoms of awake bruxism and use minimally invasive treatment modalities. Copyright © 2017 American Dental Association. Published by Elsevier Inc. All rights reserved.

  3. EOS microdose protocol for the radiological follow-up of adolescent idiopathic scoliosis.

    Science.gov (United States)

    Ilharreborde, Brice; Ferrero, Emmanuelle; Alison, Marianne; Mazda, Keyvan

    2016-02-01

    Imaging plays a key role in adolescent idiopathic scoliosis (AIS) to determine the prognosis and accordingly define the best therapeutic strategy to follow. Conventional radiographs with ionizing radiation have been associated with 1-2 % increased lifetime risk of developing cancer in children, and physicians, therefore, need a sensitive but harmless way to explore patients at risk, according to the "as low as reasonably achievable" concept. The EOS system (EOS imaging, Paris, France) is available in routine clinical use since 2007, and allows 3D reconstructions of the trunk in standing position with significant radiation reduction. With recent technical advances, further dose reduction can be obtained, but at the cost of image quality that might alter the reliability of 3D reconstructions. The aim of the present study was to analyze the reproducibility of a "microdose" protocol, and evaluate its use in clinical practice. 32 consecutive patients followed for AIS were prospectively included. Biplanar radiographs were obtained with the EOS system according to the new microdose protocol. From the microdose images obtained, three experienced operators performed 3D reconstructions, two times for each subject in a random order (total, 192 reconstructions). The intraoperator repeatability and interoperator reproducibility were evaluated, as recommended by the International Organization for Standardization, for the most clinically relevant 3D radiological parameters. The identification of the required anatomical landmarks for the "fast spine" reconstruction process was possible in all cases. None of the patients required a second acquisition for 3D analysis. Mean time for reconstruction was 5 ± 2 min. The intraoperator repeatability was better than interoperator reproducibility for all parameters, with values ranging between 3° and 8° for frontal and sagittal spinal parameters, and between 1° and 8° for pelvic measurements. The agreement was very good for all clinical

  4. A robust ECC based mutual authentication protocol with anonymity for session initiation protocol.

    Science.gov (United States)

    Mehmood, Zahid; Chen, Gongliang; Li, Jianhua; Li, Linsen; Alzahrani, Bander

    2017-01-01

    Over the past few years, Session Initiation Protocol (SIP) is found as a substantial application-layer protocol for the multimedia services. It is extensively used for managing, altering, terminating and distributing the multimedia sessions. Authentication plays a pivotal role in SIP environment. Currently, Lu et al. presented an authentication protocol for SIP and profess that newly proposed protocol is protected against all the familiar attacks. However, the detailed analysis describes that the Lu et al.'s protocol is exposed against server masquerading attack and user's masquerading attack. Moreover, it also fails to protect the user's identity as well as it possesses incorrect login and authentication phase. In order to establish a suitable and efficient protocol, having ability to overcome all these discrepancies, a robust ECC-based novel mutual authentication mechanism with anonymity for SIP is presented in this manuscript. The improved protocol contains an explicit parameter for user to cope the issues of security and correctness and is found to be more secure and relatively effective to protect the user's privacy, user's masquerading and server masquerading as it is verified through the comprehensive formal and informal security analysis.

  5. A robust ECC based mutual authentication protocol with anonymity for session initiation protocol.

    Directory of Open Access Journals (Sweden)

    Zahid Mehmood

    Full Text Available Over the past few years, Session Initiation Protocol (SIP is found as a substantial application-layer protocol for the multimedia services. It is extensively used for managing, altering, terminating and distributing the multimedia sessions. Authentication plays a pivotal role in SIP environment. Currently, Lu et al. presented an authentication protocol for SIP and profess that newly proposed protocol is protected against all the familiar attacks. However, the detailed analysis describes that the Lu et al.'s protocol is exposed against server masquerading attack and user's masquerading attack. Moreover, it also fails to protect the user's identity as well as it possesses incorrect login and authentication phase. In order to establish a suitable and efficient protocol, having ability to overcome all these discrepancies, a robust ECC-based novel mutual authentication mechanism with anonymity for SIP is presented in this manuscript. The improved protocol contains an explicit parameter for user to cope the issues of security and correctness and is found to be more secure and relatively effective to protect the user's privacy, user's masquerading and server masquerading as it is verified through the comprehensive formal and informal security analysis.

  6. Correction: PAIS: paracetamol (acetaminophen in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480

    Directory of Open Access Journals (Sweden)

    Kappelle L Jaap

    2008-11-01

    Full Text Available Abstract Background The Paracetamol (Acetaminophen In Stroke (PAIS study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever. The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis. Methods Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial. Conclusion The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power. Trial Registration Current Controlled Trials [ISCRTN74418480

  7. Enhanced Recovery After Surgery Protocols in Major Urologic Surgery

    Directory of Open Access Journals (Sweden)

    Natalija Vukovic

    2018-04-01

    Full Text Available The purpose of the reviewThe analysis of the components of enhanced recovery after surgery (ERAS protocols in urologic surgery.Recent findingsERAS protocols has been studied for over 20 years in different surgical procedures, mostly in colorectal surgery. The concept of improving patient care and reducing postoperative complications was also applied to major urologic surgery and especially procedure of radical cystectomy. This procedure is technically challenging, due to a major surgical resection and high postoperative complication rate that may reach 65%. Several clinical pathways were introduced to improve perioperative course and reduce the length of hospital stay. These protocols differ from ERAS modalities in other surgeries. The reasons for this are longer operative time, increased risk of perioperative transfusion and infection, and urinary diversion achieved using transposed intestinal segments. Previous studies in this area analyzed the need for mechanical bowel preparation, postoperative nasogastric tube decompression, as well as the duration of urinary drainage. Furthermore, the attention has also been drawn to perioperative fluid optimization, pain management, and bowel function.SummaryNotwithstanding partial resemblance between the pathways in major urologic surgery and other pelvic surgeries, there are still scarce guidelines for ERAS protocols in urology, which is why further studies should assess the importance of preoperative medical optimization, implementation of thoracic epidural anesthesia and analgesia, and perioperative nutritional management.

  8. Penicillin allergy: optimizing diagnostic protocols, public health implications, and future research needs.

    Science.gov (United States)

    Macy, Eric

    2015-08-01

    Unverified penicillin allergy is being increasingly recognized as a public health concern. The ideal protocol for verifying true clinically significant IgE-mediated penicillin allergy needs to use only commercially available materials, be well tolerated and easy to perform in both the inpatient and outpatient settings, and minimize false-positive determinations. This review concentrates on articles published in 2013 and 2014 that present new data relating to the diagnosis and management of penicillin allergy. Penicillin allergy can be safely evaluated at this time, in patients with an appropriate clinical history of penicillin allergy, using only penicilloyl-poly-lysine and native penicillin G as skin test reagents, if an oral challenge with amoxicillin 250 mg, followed by 1 h of observation, is given to all skin test negative individuals. Millions of individuals falsely labeled with penicillin allergy need to be evaluated to safely allow them to use penicillin-class antibiotics and avoid morbidity associated with penicillin avoidance. Further research is needed to determine optimal protocol(s). There will still be a 1-2% rate of adverse reactions reported with all future therapeutic penicillin-class antibiotic use, even with optimal methods used to determine acute penicillin tolerance. Only a small minority of these new reactions will be IgE-mediated.

  9. Nursing intervention protocol for adult patients experiencing chronic low back pain

    Directory of Open Access Journals (Sweden)

    Nadia Mohamed Taha

    2015-12-01

    Full Text Available Aim: The aim of this study was to evaluate the effectiveness of a nursing intervention protocol targeting the knowledge and practice of adult patients experiencing low back pain. Design: A quasi-experimental research design. Methods: Pre-post assessment of outcome was used in this study. The study was conducted in the outpatient clinic of the physical therapy department at Zagazig University Hospital and Beni-Suef University Hospital, Egypt. Sample: 40 participants diagnosed with chronic low back pain (lasting for longer than six months. Seven of the 40 dropped out during the follow-up phase for personal or logistical reasons. Tools included sections for demographic characteristics, knowledge and practice assessment; in addition to the Oswestry Disability Index, and Visual Analogue Scale (VAS. Results: The application of an instruction protocol intervention for low back pain was effective in improving patient knowledge and practice, with associated amelioration of the severity of pain and disability among them. The effect was still apparent at the three-month follow-up. Conclusion: It is recommended that the study be replicated using a more robust randomized clinical trial design. Nonetheless, the instruction protocol with the designed booklet may be adopted as an element of the care services offered to patients suffering LBP, given the clear positive effects on patient knowledge, which would undoubtedly help them decide on the most preferential management approach.

  10. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    International Nuclear Information System (INIS)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina

    2016-01-01

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

  11. Power Saving MAC Protocols for WSNs and Optimization of S-MAC Protocol

    Directory of Open Access Journals (Sweden)

    Simarpreet Kaur

    2012-11-01

    Full Text Available Low power MAC protocols have received a lot of consideration in the last few years because of their influence on the lifetime of wireless sensor networks. Since, sensors typically operate on batteries, replacement of which is often difficult. A lot of work has been done to minimize the energy expenditure and prolong the sensor lifetime through energy efficient designs, across layers. Meanwhile, the sensor network should be able to maintain a certain throughput in order to fulfill the QoS requirements of the end user, and to ensure the constancy of the network. This paper introduces different types of MAC protocols used for WSNs and proposes S‐MAC, a Medium‐Access Control protocol designed for Wireless Sensor Networks. S‐MAC uses a few innovative techniques to reduce energy consumption and support selfconfiguration. A new protocol is suggested to improve the energy efficiency, latency and throughput of existing MAC protocol for WSNs. A modification of the protocol is then proposed to eliminate the need for some nodes to stay awake longer than the other nodes which improves the energy efficiency, latency and throughput and hence increases the life span of a wireless sensor network.

  12. TH-E-209-02: Dose Monitoring and Protocol Optimization: The Pediatric Perspective

    International Nuclear Information System (INIS)

    MacDougall, R.

    2016-01-01

    Radiation dose monitoring solutions have opened up new opportunities for medical physicists to be more involved in modern clinical radiology practices. In particular, with the help of comprehensive radiation dose data, data-driven protocol management and informed case follow up are now feasible. Significant challenges remain however and the problems faced by medical physicists are highly heterogeneous. Imaging systems from multiple vendors and a wide range of vintages co-exist in the same department and employ data communication protocols that are not fully standardized or implemented making harmonization complex. Many different solutions for radiation dose monitoring have been implemented by imaging facilities over the past few years. Such systems are based on commercial software, home-grown IT solutions, manual PACS data dumping, etc., and diverse pathways can be used to bring the data to impact clinical practice. The speakers will share their experiences with creating or tailoring radiation dose monitoring/management systems and procedures over the past few years, which vary significantly in design and scope. Topics to cover: (1) fluoroscopic dose monitoring and high radiation event handling from a large academic hospital; (2) dose monitoring and protocol optimization in pediatric radiology; and (3) development of a home-grown IT solution and dose data analysis framework. Learning Objectives: Describe the scope and range of radiation dose monitoring and protocol management in a modern radiology practice Review examples of data available from a variety of systems and how it managed and conveyed. Reflect on the role of the physicist in radiation dose awareness.

  13. TH-E-209-02: Dose Monitoring and Protocol Optimization: The Pediatric Perspective

    Energy Technology Data Exchange (ETDEWEB)

    MacDougall, R. [Boston Children’s Hospital (United States)

    2016-06-15

    Radiation dose monitoring solutions have opened up new opportunities for medical physicists to be more involved in modern clinical radiology practices. In particular, with the help of comprehensive radiation dose data, data-driven protocol management and informed case follow up are now feasible. Significant challenges remain however and the problems faced by medical physicists are highly heterogeneous. Imaging systems from multiple vendors and a wide range of vintages co-exist in the same department and employ data communication protocols that are not fully standardized or implemented making harmonization complex. Many different solutions for radiation dose monitoring have been implemented by imaging facilities over the past few years. Such systems are based on commercial software, home-grown IT solutions, manual PACS data dumping, etc., and diverse pathways can be used to bring the data to impact clinical practice. The speakers will share their experiences with creating or tailoring radiation dose monitoring/management systems and procedures over the past few years, which vary significantly in design and scope. Topics to cover: (1) fluoroscopic dose monitoring and high radiation event handling from a large academic hospital; (2) dose monitoring and protocol optimization in pediatric radiology; and (3) development of a home-grown IT solution and dose data analysis framework. Learning Objectives: Describe the scope and range of radiation dose monitoring and protocol management in a modern radiology practice Review examples of data available from a variety of systems and how it managed and conveyed. Reflect on the role of the physicist in radiation dose awareness.

  14. A protocol for identification of early bulbar signs in amyotrophic lateral sclerosis.

    Science.gov (United States)

    Ball, L J; Willis, A; Beukelman, D R; Pattee, G L

    2001-10-15

    The purpose of this project is to identify characteristics that may be of assistance in establishing the diagnosis and monitoring early progression of bulbar dysfunction in patients with Amyotrophic Lateral Sclerosis (ALS). Early identification of bulbar dysfunction would assist in clinical trials and management decisions. A database of 218 clinic visits of patients with ALS was developed and formed the basis for these analyses. As a framework for the description of our methodology, the Disablement Model [World Health Organization. WHO International classification of impairment, activity, and participation: beginner's guide. In: WHO, editor. Beta-1 draft for field trials; 1999] was utilized. Our data identified that the strongest early predictors of bulbar speech dysfunction include altered voice quality (laryngeal control), speaking rate, and communication effectiveness. A protocol for measuring these speech parameters was therefore undertaken. This paper presents the protocol used to measure these bulbar parameters.

  15. Cross-Layer Protocol as a Better Option in Wireless Mesh Network with Respect to Layered-Protocol

    OpenAIRE

    Ahmed Abdulwahab Al-Ahdal; Dr. V. P. Pawar; G. N. Shinde

    2014-01-01

    The Optimal way to improve Wireless Mesh Networks (WMNs) performance is to use a better network protocol, but whether layered-protocol design or cross-layer design is a better option to optimize protocol performance in WMNs is still an on-going research topic. In this paper, we focus on cross-layer protocol as a better option with respect to layered-protocol. The layered protocol architecture (OSI) model divides networking tasks into layers and defines a pocket of services for each layer to b...

  16. Quality of care in palliative sedation: audit and compliance monitoring of a clinical protocol.

    Science.gov (United States)

    Benitez-Rosario, Miguel Angel; Castillo-Padrós, Manuel; Garrido-Bernet, Belén; Ascanio-León, Belen

    2012-10-01

    The European Association for Palliative Care and the U.S. National Hospice and Palliative Care Organization have published statements that recommend an audit of palliative sedation practices. The aim was to assess the feasibility of a quality care project in palliative sedation. We carried out an audit of adherence to a guideline regarding palliative sedation, undertaken as a yearly assessment during two years, of a sample of patient charts. With an audit tool, the charts were evaluated as to the presence of the ethical sedation checklist, information that justified palliative sedation, patient and/or family agreement, and the appropriateness of treatment in concordance with the clinical protocol. An educational program and result feedback meetings were used as the implementation strategy. Roughly 25% of the medical charts of patients who died in the palliative care unit were evaluated, 94 in 2007 and 110 in 2008. In 2007 and 2008, 63% and 57% of the patients, respectively, whose median age was 65 years, were sedated, with a median length of two days. The main reason for sedation was agitation concomitant with respiratory failure in roughly 60% and 75% of the cases in 2007 and 2008, respectively. Agreement of the patient/family about sedation was collected from 100% of the cases. The concordance of procedures with the sedation guideline was 100% in both years. Our quality-of-care strategy was shown to obtain a higher level of compliance with the palliative sedation guideline for at least two years. Copyright © 2012 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

  17. Enhancing the Detection of Dysmorphic Red Blood Cells and Renal Tubular Epithelial Cells with a Modified Urinalysis Protocol.

    Science.gov (United States)

    Chu-Su, Yu; Shukuya, Kenichi; Yokoyama, Takashi; Lin, Wei-Chou; Chiang, Chih-Kang; Lin, Chii-Wann

    2017-01-11

    Urinary sediment is used to evaluate patients with possible urinary tract diseases. Currently, numerous protocols are applied to detect dysmorphic red blood cells (RBCs) and renal tubular epithelial cells (RTECs) in urinary sediment. However, distinct protocols are used by nephrologists and medical technologists for specimen concentration and observation, which leads to major discrepancies in the differential counts of formed elements such as dysmorphic RBCs and RTECs and might interfere with an accurate clinical diagnosis. To resolve these problems, we first tested a modified urinalysis protocol with an increased relative centrifuge force and concentration factor in 20 biopsy-confirmed glomerulonephritis patients with haematuria. We successfully improved the recovery ratio of dysmorphic RBCs in clinical specimens from 34.7% to 42.0% (P dysmorphic RBCs were detected using a bright field microscope, with results comparable to those using a standard phase contrast microscope. Finally, we applied Sternheimer stain to enhance the contrast of RTECs in the urinary sediments. We concluded that this modified urinalysis protocol significantly enhanced the quality of urinalysis.

  18. Anaerobic exercise testing in rehabilitation : A systematic review of available tests and protocols

    NARCIS (Netherlands)

    Krops, Leonie A.; Albada, Trijntje; van der Woude, Lucas H. V.; Hijmans, Juha M.; Dekker, Rienk

    Objective: Anaerobic capacity assessment in rehabilitation has received increasing scientific attention in recent years. However, anaerobic capacity is not tested consistently in clinical rehabilitation practice. This study reviews tests and protocols for anaerobic capacity in adults with various

  19. Update protocols for evaluating nuclear cardiology and management of coronary heart disease. Chilean Society of Cardiology and Cardiovascular Surgery

    International Nuclear Information System (INIS)

    Massardo, Teresa; Jaimovich, Rodrigo; Canessa, Jose; Castro, Gabriel; Soto, Juan Ramon

    2010-01-01

    Protocols are reviewed nuclear cardiology present, with emphasis on imaging studies Single photon ( S PECT ) myocardial perfusion mainly in assessment of coronary heart disease (EC). The indications and protocols used are detailed as well as the literature review relevant both to clinical use as a quality control and interpretation of studies

  20. Dental-CT: image quality and absorbed radiation dose of different scan protocols

    International Nuclear Information System (INIS)

    Schorn, C.; Alamo, L.; Funke, M.; Grabbe, E.; Visser, H.; Hermann, K.P.

    1999-01-01

    Purpose: To develop a scan protocol for dental-CT which guarantees good image quality at the lowest possible radiation dose. Methods: In an experimental investigation Dental-CT (HSA, GE, Milwaukee, USA) of the mandible of two human skeletons positioned in a water tank were performed in order to define the most advantageous scan protocol. Tube currents ranged from 40 to 200 mA and the scan technique was modified (axial mode or helical mode with pitches of 1 to 3 and corresponding increments of 0.4 to 1.0 mm). 39 patients underwent a dental-CT with decreased current (80 mA) in the helical scan mode (pitch 2, slice thickness 1 mm). Dose measurements were performed for two different scan protocols (A: axial, 130 mAs, B: helical, 80 mA, pitch 2). Results: The preliminary investigations of image quality showed only a minor effect of the applied current. For the helical scan mode, pitches of more than 2 impaired image quality. A low increment had no advantages. There were no disadvantages in clinical practice using protocol B with decreased tube current. Absorbed radiation dose of dental CT performed with protocol B was decreased to one third in comparison to protocol A. Conclusions: A scan protocol with a low tube current (e.g., 80 mA, for a rotation time of 1 s) and a helical scan mode (e.g., for a slice thickness of 1 mm with a pitch of 2 and an increment of 1 mm) is recommended for performing dental-CT. (orig.) [de

  1. Comparison of 2 intravenous insulin protocols: Glycemia variability in critically ill patients.

    Science.gov (United States)

    Gómez-Garrido, Marta; Rodilla-Fiz, Ana M; Girón-Lacasa, María; Rodríguez-Rubio, Laura; Martínez-Blázquez, Anselmo; Martínez-López, Fernando; Pardo-Ibáñez, María Dolores; Núñez-Marín, Juan M

    2017-05-01

    Glycemic variability is an independent predictor of mortality in critically ill patients. The objective of this study was to compare two intravenous insulin protocols in critically ill patients regarding the glycemic variability. This was a retrospective observational study performed by reviewing clinical records of patients from a Critical Care Unit for 4 consecutive months. First, a simpler Scale-Based Intravenous Insulin Protocol (SBIIP) was reviewed and later it was compared for the same months of the following year with a Sliding Scale-Based Intravenous Insulin Protocol (SSBIIP). All adult patients admitted to the unit during the referred months were included. Patients in whom the protocol was not adequately followed were excluded. A total of 557 patients were reviewed, of whom they had needed intravenous insulin 73 in the first group and 52 in the second group. Four and two patients were excluded in each group respectively. Glycemic variability for both day 1 (DS1) and total stay (DST) was lower in SSBIIP patients compared to SBIIP patients: SD1 34.88 vs 18.16 and SDT 36.45 vs 23.65 (P<.001). A glycemic management protocol in critically ill patients based on sliding scales decreases glycemic variability. Copyright © 2017 SEEN. Publicado por Elsevier España, S.L.U. All rights reserved.

  2. Validation of the Andon KD-5917 automatic upper arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

    Science.gov (United States)

    Guo, Wan-Gang; Li, Bing-Ling; He, Yong; Xue, Yu-Sheng; Wang, Hai-Yan; Zheng, Qiang-Sun; Xiang, Ding-Cheng

    2014-08-01

    To validate the Andon KD-5917 automatic upper arm blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. Sequential same-left-arm measurements of systolic blood pressure (SBP) and diastolic blood pressure (DBP) were obtained in 33 participants using the mercury sphygmomanometer and the test device. According to the validation protocol, 99 pairs of test device and reference blood pressure measurements (three pairs for each of the 33 participants) were obtained in the study. The device produced 73, 98, and 99 measurements within 5, 10, and 15 mmHg for SBP and 86, 98, and 99 for DBP, respectively. The mean ± SD device-observer difference was 3.07 ± 3.68 mmHg for SBP and -0.89 ± 3.72 mmHg for DBP. The number of patients with two or three of the device-observer difference within 5 mmHg was 26 for SBP and 29 for DBP, and no patient had a device-observer difference within 5 mmHg. The Andon KD-5917 automatic upper arm blood pressure monitor can be recommended for clinical use and self-measurement in an adult population on the basis of the European Society of Hypertension International Protocol revision 2010.

  3. Effect of various rinsing protocols after use of amine fluoride/stannous fluoride toothpaste on the bacterial composition of dental plaque

    NARCIS (Netherlands)

    van Loveren, C.; Gerardu, V.A.M.; Sissons, C.H.; van Bekkum, M.; ten Cate, J.M.

    2009-01-01

    This clinical study evaluated the effect of different oral hygiene protocols on the bacterial composition of dental plaque. After a 2-week period of using fluoride-free toothpaste, 30 participants followed three 1-week experimental protocols, each followed by 2-week fluoride-free washout periods in

  4. [Multidisciplinary protocol for computed tomography imaging and angiographic embolization of splenic injury due to trauma: assessment of pre-protocol and post-protocol outcomes].

    Science.gov (United States)

    Koo, M; Sabaté, A; Magalló, P; García, M A; Domínguez, J; de Lama, M E; López, S

    2011-11-01

    To assess conservative treatment of splenic injury due to trauma, following a protocol for computed tomography (CT) and angiographic embolization. To quantify the predictive value of CT for detecting bleeding and need for embolization. The care protocol developed by the multidisciplinary team consisted of angiography with embolization of lesions revealed by contrast extravasation under CT as well as embolization of grade III-V injuries observed, or grade I-II injuries causing hemodynamic instability and/or need for blood transfusion. We collected data on demographic variables, injury severity score (ISS), angiographic findings, and injuries revealed by CT. Pre-protocol and post-protocol outcomes were compared. The sensitivity and specificity of CT findings were calculated for all patients who required angiographic embolization. Forty-four and 30 angiographies were performed in the pre- and post-protocol periods, respectively. The mean (SD) ISSs in the two periods were 25 (11) and 26 (12), respectively. A total of 24 (54%) embolizations were performed in the pre-protocol period and 28 (98%) after implementation of the protocol. Two and 7 embolizations involved the spleen in the 2 periods, respectively; abdominal laparotomies numbered 32 and 25, respectively, and 10 (31%) vs 4 (16%) splenectomies were performed. The specificity and sensitivity values for contrast extravasation found on CT and followed by embolization were 77.7% and 79.5%. The implementation of this multidisciplinary protocol using CT imaging and angiographic embolization led to a decrease in the number of splenectomies. The protocol allows us to take a more conservative treatment approach.

  5. A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation (tDCS) in Multiple Sclerosis (MS).

    Science.gov (United States)

    Kasschau, Margaret; Sherman, Kathleen; Haider, Lamia; Frontario, Ariana; Shaw, Michael; Datta, Abhishek; Bikson, Marom; Charvet, Leigh

    2015-12-26

    Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses low amplitude direct currents to alter cortical excitability. With well-established safety and tolerability, tDCS has been found to have the potential to ameliorate symptoms such as depression and pain in a range of conditions as well as to enhance outcomes of cognitive and physical training. However, effects are cumulative, requiring treatments that can span weeks or months and frequent, repeated visits to the clinic. The cost in terms of time and travel is often prohibitive for many participants, and ultimately limits real-world access. Following guidelines for remote tDCS application, we propose a protocol that would allow remote (in-home) participation that uses specially-designed devices for supervised use with materials modified for patient use, and real-time monitoring through a telemedicine video conferencing platform. We have developed structured training procedures and clear, detailed instructional materials to allow for self- or proxy-administration while supervised remotely in real-time. The protocol is designed to have a series of checkpoints, addressing attendance and tolerability of the session, to be met in order to continue to the next step. The feasibility of this protocol was then piloted for clinical use in an open label study of remotely-supervised tDCS in multiple sclerosis (MS). This protocol can be widely used for clinical study of tDCS.

  6. A new testing protocol for zirconia dental implants.

    Science.gov (United States)

    Sanon, Clarisse; Chevalier, Jérôme; Douillard, Thierry; Cattani-Lorente, Maria; Scherrer, Susanne S; Gremillard, Laurent

    2015-01-01

    Based on the current lack of standards concerning zirconia dental implants, we aim at developing a protocol to validate their functionality and safety prior their clinical use. The protocol is designed to account for the specific brittle nature of ceramics and the specific behavior of zirconia in terms of phase transformation. Several types of zirconia dental implants with different surface textures (porous, alveolar, rough) were assessed. The implants were first characterized in their as-received state by Scanning Electron Microscopy (SEM), Focused Ion Beam (FIB), X-Ray Diffraction (XRD). Fracture tests following a method adapted from ISO 14801 were conducted to evaluate their initial mechanical properties. Accelerated aging was performed on the implants, and XRD monoclinic content measured directly at their surface instead of using polished samples as in ISO 13356. The implants were then characterized again after aging. Implants with an alveolar surface presented large defects. The protocol shows that such defects compromise the long-term mechanical properties. Implants with a porous surface exhibited sufficient strength but a significant sensitivity to aging. Even if associated to micro cracking clearly observed by FIB, aging did not decrease mechanical strength of the implants. As each dental implant company has its own process, all zirconia implants may behave differently, even if the starting powder is the same. Especially, surface modifications have a large influence on strength and aging resistance, which is not taken into account by the current standards. Protocols adapted from this work could be useful. Copyright © 2014 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

  7. Cryptographic Protocols:

    DEFF Research Database (Denmark)

    Geisler, Martin Joakim Bittel

    cryptography was thus concerned with message confidentiality and integrity. Modern cryptography cover a much wider range of subjects including the area of secure multiparty computation, which will be the main topic of this dissertation. Our first contribution is a new protocol for secure comparison, presented...... implemented the comparison protocol in Java and benchmarks show that is it highly competitive and practical. The biggest contribution of this dissertation is a general framework for secure multiparty computation. Instead of making new ad hoc implementations for each protocol, we want a single and extensible...... in Chapter 2. Comparisons play a key role in many systems such as online auctions and benchmarks — it is not unreasonable to say that when parties come together for a multiparty computation, it is because they want to make decisions that depend on private information. Decisions depend on comparisons. We have...

  8. Pregnancy outcome in delayed start antagonist versus microdose flare GnRH agonist protocol in poor responders undergoing IVF/ICSI: An RCT

    Directory of Open Access Journals (Sweden)

    Robab Davar

    2018-04-01

    Full Text Available Background: Over the years, many article on different aspects of pathogenesis and management of poor ovarian responders have been published but there is no clear guideline for treating themyet. Objective: This study was designated to compare the effectiveness of a delayed start protocol with gonadotropin-releasing hormone (GnRH antagonist and microdose flare-up GnRH agonist protocol in poor ovarian responders. Materials and Methods: This randomized clinical trial consisted of 100 poor ovarian responder women in assisted reproductive technologies cycles. They were divided randomly in delayed-start antagonist protocol (with estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation and microdose flare-up GnRH agonist protocol. The main outcome was clinical pregnancy rate and second outcome was the number of retrieved oocytes, mature oocytes, 2PN number, fertilization rate, and implantation rate. Results: Fertilization rate, clinical pregnancy rate, and ongoing pregnancy rates were not significantly different between the two studied protocols. Number of retrieved oocytes (5.10±3.41 vs. 3.08±2.51 with p=0.002, mature oocytes (4.32±2.69 vs. 2.34±1.80 with p=0.003, number of 2PN (3.94±1.80 vs. 2.20±1.01 with p=0.001 and implantation rate (19.40% vs. 10.30% with p=0.022 were significantly higher in delayed antagonist group. Conclusion: The delayed-start protocol can improve ovarian response in poor responders by stimulating and synchronizing follicle development

  9. Chest magnetic resonance imaging: a protocol suggestion

    Directory of Open Access Journals (Sweden)

    Bruno Hochhegger

    2015-12-01

    Full Text Available Abstract In the recent years, with the development of ultrafast sequences, magnetic resonance imaging (MRI has been established as a valuable diagnostic modality in body imaging. Because of improvements in speed and image quality, MRI is now ready for routine clinical use also in the study of pulmonary diseases. The main advantage of MRI of the lungs is its unique combination of morphological and functional assessment in a single imaging session. In this article, the authors review most technical aspects and suggest a protocol for performing chest MRI. The authors also describe the three major clinical indications for MRI of the lungs: staging of lung tumors; evaluation of pulmonary vascular diseases; and investigation of pulmonary abnormalities in patients who should not be exposed to radiation.

  10. Is gait variability reliable in older adults and Parkinson's disease? Towards an optimal testing protocol.

    Science.gov (United States)

    Galna, Brook; Lord, Sue; Rochester, Lynn

    2013-04-01

    Despite the widespread use of gait variability in research and clinical studies, testing protocols designed to optimise its reliability have not been established. This study evaluates the impact of testing protocol and pathology on the reliability of gait variability. To (i) estimate the reliability of gait variability during continuous and intermittent walking protocols in older adults and people with Parkinson's disease (PD), (ii) determine optimal number of steps for acceptable levels of reliability of gait variability and (iii) provide sample size estimates for use in clinical trials. Gait variability was measured twice, one week apart, in 27 older adults and 25 PD participants. Participants walked at their preferred pace during: (i) a continuous 2 min walk and (ii) 3 intermittent walks over a 12 m walkway. Gait variability was calculated as the within-person standard deviation for step velocity, length and width, and step, stance and swing duration. Reliability of gait variability ranged from poor to excellent (intra class correlations .041-.860; relative limits of agreement 34-89%). Gait variability was more reliable during continuous walks. Control and PD participants demonstrated similar reliability. Increasing the number of steps improved reliability, with most improvement seen across the first 30 steps. In this study, we identified testing protocols that improve the reliability of measuring gait variability. We recommend using a continuous walking protocol and to collect no fewer than 30 steps. Early PD does not appear to impact negatively on the reliability of gait variability. Copyright © 2012 Elsevier B.V. All rights reserved.

  11. The costs and cost-effectiveness of an integrated sepsis treatment protocol.

    Science.gov (United States)

    Talmor, Daniel; Greenberg, Dan; Howell, Michael D; Lisbon, Alan; Novack, Victor; Shapiro, Nathan

    2008-04-01

    Sepsis is associated with high mortality and treatment costs. International guidelines recommend the implementation of integrated sepsis protocols; however, the true cost and cost-effectiveness of these are unknown. To assess the cost-effectiveness of an integrated sepsis protocol, as compared with conventional care. Prospective cohort study of consecutive patients presenting with septic shock and enrolled in the institution's integrated sepsis protocol. Clinical and economic outcomes were compared with a historical control cohort. Beth Israel Deaconess Medical Center. Overall, 79 patients presenting to the emergency department with septic shock in the treatment cohort and 51 patients in the control group. An integrated sepsis treatment protocol incorporating empirical antibiotics, early goal-directed therapy, intensive insulin therapy, lung-protective ventilation, and consideration for drotrecogin alfa and steroid therapy. In-hospital treatment costs were collected using the hospital's detailed accounting system. The cost-effectiveness analysis was performed from the perspective of the healthcare system using a lifetime horizon. The primary end point for the cost-effectiveness analysis was the incremental cost per quality-adjusted life year gained. Mortality in the treatment group was 20.3% vs. 29.4% in the control group (p = .23). Implementing an integrated sepsis protocol resulted in a mean increase in cost of approximately $8,800 per patient, largely driven by increased intensive care unit length of stay. Life expectancy and quality-adjusted life years were higher in the treatment group; 0.78 and 0.54, respectively. The protocol was associated with an incremental cost of $11,274 per life-year saved and a cost of $16,309 per quality-adjusted life year gained. In patients with septic shock, an integrated sepsis protocol, although not cost-saving, appears to be cost-effective and compares very favorably to other commonly delivered acute care interventions.

  12. SU-E-I-68: Practical Considerations On Implementation of the Image Gently Pediatric CT Protocols

    International Nuclear Information System (INIS)

    Zhang, J; Adams, C; Lumby, C; Dillon, J; Woods, E; Richer, E

    2014-01-01

    Purpose: One limitation associated with the Image Gently pediatric CT protocols is practical implementation of the recommended manual techniques. Inconsistency as a result of different practice is a possibility among technologist. An additional concern is the added risk of data error that would result in over or underexposure. The Automatic Exposure Control (AEC) features automatically reduce radiation for children. However, they do not work efficiently for the patients of very small size and relative large size. This study aims to implement the Image Gently pediatric CT protocols in the practical setting while maintaining the use of AEC features for pediatric patients of varying size. Methods: Anthropomorphological abdomen phantoms were scanned in a CT scanner using the Image Gently pediatric protocols, the AEC technique with a fixed adult baseline, and automatic protocols with various baselines. The baselines were adjusted corresponding to patient age, weight and posterioranterior thickness to match the Image Gently pediatric CT manual techniques. CTDIvol was recorded for each examination. Image noise was measured and recorded for image quality comparison. Clinical images were evaluated by pediatric radiologists. Results: By adjusting vendor default baselines used in the automatic techniques, radiation dose and image quality can match those of the Image Gently manual techniques. In practice, this can be achieved by dividing pediatric patients into three major groups for technologist reference: infant, small child, and large child. Further division can be done but will increase the number of CT protocols. For each group, AEC can efficiently adjust acquisition techniques for children. This implementation significantly overcomes the limitation of the Image Gently manual techniques. Conclusion: Considering the effectiveness in clinical practice, Image Gently Pediatric CT protocols can be implemented in accordance with AEC techniques, with adjusted baselines, to

  13. Patient-Specific Internal Dosimetry Protocol for 131 treatment of differentiated thyroid cancer

    International Nuclear Information System (INIS)

    Deluca, G.M.; Rojo, Ana M.; Llina Fuentes, C.S.; Cabrejas, Mariana L.; Cabrejas, R.; Fadel, A.M.

    2008-01-01

    Full text: The most effective treatment against Differentiated Thyroid Cancer (DTC), in its most frequently types: papillar and follicular, is the administration of radioiodine. As a result of a multidisciplinary work, a dosimetrical protocol for radiological protection purpose has been developed that suggests the standards and formalisms for the determination of absorbed doses due to the administration of 131 I activity to DTC patients. This dosimetrical protocol takes into account individual data of each patient (age, gender, the presence or absence of metastases, physiology, physiopathology, biochemical parameters) and involves clinical aspects, the equipment that should be used and the dose assessment procedure of each treatment. Based on the Medical Internal radiation Dose (MIRD) scheme and considering the major critical organs for this therapy, the dosimetrical protocol states the 'how-to' of the following procedures, in adults and paediatric cases: 1) estimation of the red marrow dose (with/without bone metastases) to avoid mielotoxicity (200 cGy); 2) Estimation of the retention / dose rate / dose in lungs after 48 hours from the administration of radioiodine to avoid lung fibrosis; 3) Estimation of the testes dose in young male patients to avoid oligospermia; 4) Estimation of the maximum activity which can be safely administered without damaging the most critical organ for each patient; and 5) Acquisition of images and retention data from patients. This dosimetrical protocol also specifies the requirements and basic steps that should be followed, the essential information, the complementary studies and the basic equipment required to perform an appropriate internal dosimetry evaluation. To be fully implemented, the dosimetrical protocol needs the constitution of a multidisciplinary team including physicians, medical physicists and technicians. Clear instructions should be provided to the patient as his full collaboration is essential. Even though empirical

  14. Fetal MRI: techniques and protocols

    International Nuclear Information System (INIS)

    Prayer, Daniela; Brugger, Peter Christian; Prayer, Lucas

    2004-01-01

    The development of ultrafast sequences has led to a significant improvement in fetal MRI. Imaging protocols have to be adjusted to the rapidly developing fetal central nervous system (CNS) and to the clinical question. Sequence parameters must be changed to cope with the respective developmental stage, to produce images free from motion artefacts and to provide optimum visualization of the region and focus of interest. In contrast to postnatal studies, every suspect fetal CNS abnormality requires examination of the whole fetus and the extrafetal intrauterine structures including the uterus. This approach covers both aspects of fetal CNS disorders: isolated and complex malformations and cerebral lesions arising from the impaired integrity of the feto-placental unit. (orig.)

  15. Fetal MRI: techniques and protocols

    Energy Technology Data Exchange (ETDEWEB)

    Prayer, Daniela [Department of Neuroradiology, University Clinics of Radiodiagnostics, Medical University Vienna, Waehringerguertel 18-10, 1090, Vienna (Austria); Brugger, Peter Christian [Department of Anatomy, Integrative Morphology Group, Medical University Vienna (Austria); Prayer, Lucas [Diagnosezentrum Urania, Vienna (Austria)

    2004-09-01

    The development of ultrafast sequences has led to a significant improvement in fetal MRI. Imaging protocols have to be adjusted to the rapidly developing fetal central nervous system (CNS) and to the clinical question. Sequence parameters must be changed to cope with the respective developmental stage, to produce images free from motion artefacts and to provide optimum visualization of the region and focus of interest. In contrast to postnatal studies, every suspect fetal CNS abnormality requires examination of the whole fetus and the extrafetal intrauterine structures including the uterus. This approach covers both aspects of fetal CNS disorders: isolated and complex malformations and cerebral lesions arising from the impaired integrity of the feto-placental unit. (orig.)

  16. Improving treatment times for patients with in-hospital stroke using a standardized protocol.

    Science.gov (United States)

    Koge, Junpei; Matsumoto, Shoji; Nakahara, Ichiro; Ishii, Akira; Hatano, Taketo; Sadamasa, Nobutake; Kai, Yasutoshi; Ando, Mitsushige; Saka, Makoto; Chihara, Hideo; Takita, Wataru; Tokunaga, Keisuke; Kamata, Takahiko; Nishi, Hidehisa; Hashimoto, Tetsuya; Tsujimoto, Atsushi; Kira, Jun-Ichi; Nagata, Izumi

    2017-10-15

    Previous reports have shown significant delays in treatment of in-hospital stroke (IHS). We developed and implemented our IHS alert protocol in April 2014. We aimed to determine the influence of implementation of our IHS alert protocol. Our implementation processes comprise the following four main steps: IHS protocol development, workshops for hospital staff to learn about the protocol, preparation of standardized IHS treatment kits, and obtaining feedback in a monthly hospital staff conference. We retrospectively compared protocol metrics and clinical outcomes of patients with IHS treated with intravenous thrombolysis and/or endovascular therapy between before (January 2008-March 2014) and after implementation (April 2014-December 2016). Fifty-five patients were included (pre, 25; post, 30). After the implementation, significant reductions occurred in the median time from stroke recognition to evaluation by a neurologist (30 vs. 13.5min, pvs. 26.5min, pvs. 16min, p=0.02). The median time from first neuroimaging to endovascular therapy had a tendency to decrease (75 vs. 53min, p=0.08). There were no differences in the favorable outcomes (modified Rankin scale score of 0-2) at discharge or the incidence of symptomatic intracranial hemorrhage between the two periods. Our IHS alert protocol implementation saved time in treating patients with IHS without compromising safety. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. Multimode Communication Protocols Enabling Reconfigurable Radios

    Directory of Open Access Journals (Sweden)

    Berlemann Lars

    2005-01-01

    Full Text Available This paper focuses on the realization and application of a generic protocol stack for reconfigurable wireless communication systems. This focus extends the field of software-defined radios which usually concentrates on the physical layer. The generic protocol stack comprises common protocol functionality and behavior which are extended through specific parts of the targeted radio access technology. This paper considers parameterizable modules of basic protocol functions residing in the data link layer of the ISO/OSI model. System-specific functionality of the protocol software is realized through adequate parameterization and composition of the generic modules. The generic protocol stack allows an efficient realization of reconfigurable protocol software and enables a completely reconfigurable wireless communication system. It is a first step from side-by-side realized, preinstalled modes in a terminal towards a dynamic reconfigurable anymode terminal. The presented modules of the generic protocol stack can also be regarded as a toolbox for the accelerated and cost-efficient development of future communication protocols.

  18. Ancestors protocol for scalable key management

    Directory of Open Access Journals (Sweden)

    Dieter Gollmann

    2010-06-01

    Full Text Available Group key management is an important functional building block for secure multicast architecture. Thereby, it has been extensively studied in the literature. The main proposed protocol is Adaptive Clustering for Scalable Group Key Management (ASGK. According to ASGK protocol, the multicast group is divided into clusters, where each cluster consists of areas of members. Each cluster uses its own Traffic Encryption Key (TEK. These clusters are updated periodically depending on the dynamism of the members during the secure session. The modified protocol has been proposed based on ASGK with some modifications to balance the number of affected members and the encryption/decryption overhead with any number of the areas when a member joins or leaves the group. This modified protocol is called Ancestors protocol. According to Ancestors protocol, every area receives the dynamism of the members from its parents. The main objective of the modified protocol is to reduce the number of affected members during the leaving and joining members, then 1 affects n overhead would be reduced. A comparative study has been done between ASGK protocol and the modified protocol. According to the comparative results, it found that the modified protocol is always outperforming the ASGK protocol.

  19. Implementation of Quality Control Protocol in Mammography: A Serbian Experience

    International Nuclear Information System (INIS)

    Ciraj Bjelac, O.; Kosutic, D.; Arandjic, D.; Kovacevic, M.

    2008-01-01

    Mammography is method of choice for early detection of breast cancer. In Serbia, mammography is performed only clinically, although there is a long term plan to introduce mammography as screening method. Currently there are 60 mammography units in practice in Serbia, resulting with 70 000 mammographies annually. The purpose of this paper is preliminary evaluation of the mammography practice in Serbia, having in mind the annual number of examinations and fact that part of examination is performed on women without any clinical signs. For pilot implementation of Quality Control (QC) protocol in mammography, five hospitals with highest workload have been selected, representing the typical mammography practice in Serbia. Developed QC protocol, based on European guidelines for quality assurance in breast cancer screening and diagnosis, actual practice and resources, includes equipment testing and maintenance, staff training and QC management and allocation of responsibilities. Subsequently, it should be applied on the national scale. The survey demonstrated considerable variations in technical parameters that affect image quality and patients doses. Mean glandular doses ranged from 0.12 to 2.8 mGy, while reference optical density ranged from 1.2 to 2.8. Main problems were associated with film processing, viewing conditions and optical density control. The preliminary survey of mammography practice highlighted the need for optimization of radiation protection and training of operating staff, although the survey itself was very valuable learning process for all participants. Furthermore, systematic implementation of QC protocol should provide reliable performance of mammography units and maintain satisfactory image quality and keep patient doses as low as reasonably practical.(author)

  20. [New protocol combining orthodontics and implant therapy for partially edentulous adult patients. Part I: Description of the Decker protocol].

    Science.gov (United States)

    Davarpanah, K; Decker, A; Sache, M P; Deffrennes, D; Demurashvili, G; Szmukler-Moncler, S

    2014-12-01

    The treatment of adult malocclusion is usually complex and pluridisciplinary. Its prognosis is not reliable. We present a new clinical protocol to improve the management and final result. We use a specific software (Simplant®, OMS®, Materialise Dental) and its accessory modules. It allows visualization of the expected final clinical result of the orthodontic treatment. Combined with guided-surgery, it allows placing implants at the beginning of treatment in a position that is compatible with the final position. The implants serve as absolute anchorage for dental motions during the orthodontic step; it is also used to support the final prosthesis. The treatment is thus optimized and its prognosis is improved. Finally, the reversed surgical sequences shorten the treatment thus promoting the compliance of patients. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  1. Sharing Privacy Protected and Statistically Sound Clinical Research Data Using Outsourced Data Storage

    Directory of Open Access Journals (Sweden)

    Geontae Noh

    2014-01-01

    Full Text Available It is critical to scientific progress to share clinical research data stored in outsourced generally available cloud computing services. Researchers are able to obtain valuable information that they would not otherwise be able to access; however, privacy concerns arise when sharing clinical data in these outsourced publicly available data storage services. HIPAA requires researchers to deidentify private information when disclosing clinical data for research purposes and describes two available methods for doing so. Unfortunately, both techniques degrade statistical accuracy. Therefore, the need to protect privacy presents a significant problem for data sharing between hospitals and researchers. In this paper, we propose a controlled secure aggregation protocol to secure both privacy and accuracy when researchers outsource their clinical research data for sharing. Since clinical data must remain private beyond a patient’s lifetime, we take advantage of lattice-based homomorphic encryption to guarantee long-term security against quantum computing attacks. Using lattice-based homomorphic encryption, we design an aggregation protocol that aggregates outsourced ciphertexts under distinct public keys. It enables researchers to get aggregated results from outsourced ciphertexts of distinct researchers. To the best of our knowledge, our protocol is the first aggregation protocol which can aggregate ciphertexts which are encrypted with distinct public keys.

  2. Quality Assurance for Clinical Trials

    Science.gov (United States)

    Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

  3. Validation of the iHealth BP3 upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

    Science.gov (United States)

    Chen, Can; Shang, Fujun; Wang, Jiepin; Chen, Jianghong; Ji, Na; Wan, Yi

    2012-12-01

    This study aimed to evaluate the performance of the iHealth BP3 upper-arm blood pressure monitor, which is designed for clinic use and self-measurement of blood pressure using Apple touch devices as an interface. The European Society of Hypertension International Protocol (ESH-IP) revision 2010 for the validation of blood pressure measuring devices in adults was followed precisely. Ninty-nine couples of test device and reference blood pressure measurements were obtained during the study (three pairs for each of the 33 participants). The 33 participants, age 47.1±12.3 years (age range 27-69 years) and arm circumference 30.0±4.4 cm, had a mean systolic blood pressure (SBP) of 143.9±27.4 mmHg and a mean diastolic blood pressure (DBP) of 90.1±18.3 mmHg. The device passed all of the requirements fulfilling the standards of the protocol, and the mean±SD device-observer difference was 2.8±4.2 mmHg for SBP and -0.4±3.5 mmHg for DBP. According to the results of the validation study on the basis of the ESH-IP revision 2010, the iHealth BP3 can be recommended for clinic use and self-measurement in an adult population. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

  4. Should the diagnostic and therapeutic protocols for adrenal incidentalomas be changed?

    Science.gov (United States)

    Mateo-Gavira, Isabel; Vilchez-López, Francisco Javier; Larrán-Escandón, Laura; Ojeda-Schuldt, María Belén; Tinoco, Cristina López; Aguilar-Diosdado, Manuel

    2015-01-01

    The prevalence of adrenal incidentalomas is increasing with the aging of the population and the use of high resolution imaging technics. Current protocols propose a comprehensive monitoring of their functional and morphological state, but with no conclusive clinical evidence that endorses it. Retrospective study of 96 patients diagnosed with adrenal incidentaloma between 2008 and 2012. We evaluated clinical, functional and imaging at baseline and during follow-up. Initially, 9 cases were surgically removed: 4 due to hyperfunction (2 Cushing syndromes and 2 pheochromocytomas) and 5 due to size larger than 4cm. During follow-up one case of pheochromocytoma was diagnosed and another grew more than 1cm, needing surgery. In 98.86% of nonfunctional and benign lesions, there was no functional and/or morphological changes in the final evaluation. The results of our study challenge the validity of current diagnostic-therapeutic protocols of incidentalomas, which should be reassessed in prospective studies taking into account efficiency characteristics. Copyright © 2013 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  5. Understanding implementation processes of clinical pathways and clinical practice guidelines in pediatric contexts: a study protocol

    Directory of Open Access Journals (Sweden)

    Scott Shannon D

    2011-12-01

    Full Text Available Abstract Background Canada is among the most prosperous nations in the world, yet the health and wellness outcomes of Canadian children are surprisingly poor. There is some evidence to suggest that these poor health outcomes are partly due to clinical practice variation, which can stem from failure to apply the best available research evidence in clinical practice, otherwise known as knowledge translation (KT. Surprisingly, clinical practice variation, even for common acute paediatric conditions, is pervasive. Clinical practice variation results in unnecessary medical treatments, increased suffering, and increased healthcare costs. This study focuses on improving health outcomes for common paediatric acute health concerns by evaluating strategies that improve KT and reduce clinical practice variation. Design/Methods Using a multiple case study design, qualitative and quantitative data will be collected from four emergency departments in western Canada. Data sources will include: pre- and post-implementation focus group data from multidisciplinary healthcare professionals; individual interviews with the local champions, KT intervention providers, and unit/site leaders/managers; Alberta Context Tool (ACT survey data; and aggregated patient outcome data. Qualitative and quantitative data will be systematically triangulated, and matrices will be built to do cross-case comparison. Explanations will be built about the success or lack of success of the clinical practice guidelines (CPG and clinical pathways (CPs uptake based upon the cross-case comparisons. Significance This study will generate new knowledge about the potential causal mechanisms and factors which shape implementation. Future studies will track the impact of the CPG/CPs implementation on children's health outcome, and healthcare costs.

  6. Epistemic Protocols for Distributed Gossiping

    Directory of Open Access Journals (Sweden)

    Krzysztof R. Apt

    2016-06-01

    Full Text Available Gossip protocols aim at arriving, by means of point-to-point or group communications, at a situation in which all the agents know each other's secrets. We consider distributed gossip protocols which are expressed by means of epistemic logic. We provide an operational semantics of such protocols and set up an appropriate framework to argue about their correctness. Then we analyze specific protocols for complete graphs and for directed rings.

  7. Screening for Spiritual Struggle in an Adolescent Transgender Clinic: Feasibility and Acceptability.

    Science.gov (United States)

    Grossoehme, Daniel H; Teeters, Alexis; Jelinek, Sue; Dimitriou, Sophia M; Conard, Lee Ann E

    2016-01-01

    Spiritual struggles are associated with poorer health outcomes, including depression, which has higher prevalence among transgender individuals than the general population. This study's objective was to improve the quality of care in an outpatient transgender clinic by screening patients and caregivers for spiritual struggle and future intervention. The quality improvement questions addressed were whether screening for spiritual struggle was feasible and acceptable; and whether the sensitivity and specificity of the Rush Protocol were acceptable. Revision of the screening was based on cognitive interviews with the 115 adolescents and caregivers who were screened. Prevalence of spiritual struggle was 38-47%. Compared to the Negative R-COPE, the Rush Protocol screener had sensitivities of 44-80% and specificities of 60-74%. The Rush Protocol was acceptable to adolescents seen in a transgender clinic, caregivers, and clinic staff; was feasible to deliver during outpatient clinic visits, and offers a straightforward means of identifying transgender persons and caregivers experiencing spiritual struggle.

  8. Using semantics for representing experimental protocols.

    Science.gov (United States)

    Giraldo, Olga; García, Alexander; López, Federico; Corcho, Oscar

    2017-11-13

    An experimental protocol is a sequence of tasks and operations executed to perform experimental research in biological and biomedical areas, e.g. biology, genetics, immunology, neurosciences, virology. Protocols often include references to equipment, reagents, descriptions of critical steps, troubleshooting and tips, as well as any other information that researchers deem important for facilitating the reusability of the protocol. Although experimental protocols are central to reproducibility, the descriptions are often cursory. There is the need for a unified framework with respect to the syntactic structure and the semantics for representing experimental protocols. In this paper we present "SMART Protocols ontology", an ontology for representing experimental protocols. Our ontology represents the protocol as a workflow with domain specific knowledge embedded within a document. We also present the S ample I nstrument R eagent O bjective (SIRO) model, which represents the minimal common information shared across experimental protocols. SIRO was conceived in the same realm as the Patient Intervention Comparison Outcome (PICO) model that supports search, retrieval and classification purposes in evidence based medicine. We evaluate our approach against a set of competency questions modeled as SPARQL queries and processed against a set of published and unpublished protocols modeled with the SP Ontology and the SIRO model. Our approach makes it possible to answer queries such as Which protocols use tumor tissue as a sample. Improving reporting structures for experimental protocols requires collective efforts from authors, peer reviewers, editors and funding bodies. The SP Ontology is a contribution towards this goal. We build upon previous experiences and bringing together the view of researchers managing protocols in their laboratory work. Website: https://smartprotocols.github.io/ .

  9. Clinical status and philosophy of clinical care of radionuclide-treated beagles

    International Nuclear Information System (INIS)

    MacMillan, K.; Holbrook, C.; White, R.; Chrisp, C.

    1975-01-01

    A manual for therapy of beagles is reviewed. The following protocol is outlined and described: antibiotic therapy, chemotherapy for neoplasms, hormone therapy, nutritional therapy, radiation therapy, steroid therapy, and miscellaneous treatments. The manual also includes sections on diagnosis and discussions of individual cases. Tables summarizing clinical cases seen during 1974 are presented

  10. Development of low-dose protocols for thin-section CT assessment of cystic fibrosis in pediatric patients.

    LENUS (Irish Health Repository)

    O'Connor, Owen J

    2010-12-01

    To develop low-dose thin-section computed tomographic (CT) protocols for assessment of cystic fibrosis (CF) in pediatric patients and determine the clinical usefulness thereof compared with chest radiography.

  11. A Standardized Protocol for the Prospective Follow-Up of Cleft Lip and Palate Patients.

    Science.gov (United States)

    Salimi, Negar; Jolanta, Aleksejūnienė; Edwin, Yen; Angelina, Loo

    2018-01-01

    To develop a standardized all-encompassing protocol for the assessment of cleft lip and palate patients with clinical and research implications. Electronic database searches were conducted and 13 major cleft centers worldwide were contacted in order to prepare for the development of the protocol. In preparation, the available evidence was reviewed and potential fistula-related risk determinants from 4 different domains were identified. No standardized protocol for the assessment of cleft patients could be found in any of the electronic database searches that were conducted. Interviews with representatives from several major centers revealed that the majority of centers do not have a standardized comprehensive strategy for the reporting and follow-up of cleft lip and palate patients. The protocol was developed and consisted of the following domains of determinants: (1) the sociodemographic domain, (2) the cleft defect domain, (3) the surgery domain, and (4) the fistula domain. The proposed protocol has the potential to enhance the quality of patient care by ensuring that multiple patient-related aspects are consistently reported. It may also facilitate future multicenter research, which could contribute to the reduction of fistula occurrence in cleft lip and palate patients.

  12. A Robust PCR Protocol for HIV Drug Resistance Testing on Low-Level Viremia Samples

    Directory of Open Access Journals (Sweden)

    Shivani Gupta

    2017-01-01

    Full Text Available The prevalence of drug resistance (DR mutations in people with HIV-1 infection, particularly those with low-level viremia (LLV, supports the need to improve the sensitivity of amplification methods for HIV DR genotyping in order to optimize antiretroviral regimen and facilitate HIV-1 DR surveillance and relevant research. Here we report on a fully validated PCR-based protocol that achieves consistent amplification of the protease (PR and reverse transcriptase (RT regions of HIV-1 pol gene across many HIV-1 subtypes from LLV plasma samples. HIV-spiked plasma samples from the External Quality Assurance Program Oversight Laboratory (EQAPOL, covering various HIV-1 subtypes, as well as clinical specimens were used to optimize and validate the protocol. Our results demonstrate that this protocol has a broad HIV-1 subtype coverage and viral load span with high sensitivity and reproducibility. Moreover, the protocol is robust even when plasma sample volumes are limited, the HIV viral load is unknown, and/or the HIV subtype is undetermined. Thus, the protocol is applicable for the initial amplification of the HIV-1 PR and RT genes required for subsequent genotypic DR assays.

  13. Understanding protocol performance: impact of test performance.

    Science.gov (United States)

    Turner, Robert G

    2013-01-01

    This is the second of two articles that examine the factors that determine protocol performance. The objective of these articles is to provide a general understanding of protocol performance that can be used to estimate performance, establish limits on performance, decide if a protocol is justified, and ultimately select a protocol. The first article was concerned with protocol criterion and test correlation. It demonstrated the advantages and disadvantages of different criterion when all tests had the same performance. It also examined the impact of increasing test correlation on protocol performance and the characteristics of the different criteria. To examine the impact on protocol performance when individual tests in a protocol have different performance. This is evaluated for different criteria and test correlations. The results of the two articles are combined and summarized. A mathematical model is used to calculate protocol performance for different protocol criteria and test correlations when there are small to large variations in the performance of individual tests in the protocol. The performance of the individual tests that make up a protocol has a significant impact on the performance of the protocol. As expected, the better the performance of the individual tests, the better the performance of the protocol. Many of the characteristics of the different criteria are relatively independent of the variation in the performance of the individual tests. However, increasing test variation degrades some criteria advantages and causes a new disadvantage to appear. This negative impact increases as test variation increases and as more tests are added to the protocol. Best protocol performance is obtained when individual tests are uncorrelated and have the same performance. In general, the greater the variation in the performance of tests in the protocol, the more detrimental this variation is to protocol performance. Since this negative impact is increased as

  14. Country report: Italy (Chinol). Pre-clinical evaluation of a new biotin-DOTA conjugate labeled with 90Y for application in pretargeting clinical protocols

    International Nuclear Information System (INIS)

    Chinol, Marco

    2010-01-01

    In the attempt to improve the therapeutic efficacy of radiolabeled mAbs in cancer radioimmunotherapy, various studies have examined the concept of tumor pretargeting. The so called three-step pretargeting technique, employing the avidin–biotin system, was applied in phase I-II clinical trials showing low toxicity and therapeutic efficacy. The final step of the pretargeting protocols consists in the systemic injection of radiolabeled biotin. The worldwide recognized “successful association” is between 90 Y and the tetraazamacrocycle DOTA chelator chemically bound to biotin. Improvements in the structure of the biotin-DOTA conjugate have been reported by our group following a novel approach which simplified the synthetic pattern by reducing the amide group to a methylene group, thus transforming the amide into a secondary amine without affecting the length of the biotin side arm. Preliminary in-vitro experiments, previously published by our group, indicated the potential of the new conjugate. Based on our previous experience with avidin-based pre-targeting followed 90 Y-DOTA-biotin in the locoregional treatment of peritoneal carcinomatosis and malignant glioma suggested that similar radionuclide therapy might be worth investigating as a partial replacement of external beam radiotherapy in breast cancer. We have developed IART® the Intra-operative Avidination for Radionuclide Therapy that relies on the avidin-biotin binding system. In fact, the “avidination” of the anatomical area of the tumor with native avidin, directly injected by the surgeon into and around the tumor bed, provides a target for the radiolabeled biotin intravenously (iv) injected one day later. In order to optimize the overall strategy, further efforts were needed to optimize the use of the labeled new biotin conjugate and to elucidate its chemical and biological properties. In the first 18 months of this CRP, the pre-clinical evaluation of this new reduced biotinamidohexylamine

  15. Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial

    International Nuclear Information System (INIS)

    Hur, Hoon; Lee, Hyun Yong; Lee, Hyuk-Joon; Kim, Min Chan; Hyung, Woo Jin; Park, Young Kyu; Kim, Wook; Han, Sang-Uk

    2015-01-01

    Despite the well-described benefits of laparoscopic surgery such as lower operative blood loss and enhanced postoperative recovery in gastric cancer surgery, the application of laparoscopic surgery in patients with locally advanced gastric cancer (AGC) remains elusive owing to a lack of clinical evidence. Recently, the Korean Laparoscopic Surgical Society Group launched a new multicenter randomized clinical trial (RCT) to compare laparoscopic and open D2 lymphadenectomy for patients with locally AGC. Here, we introduce the protocol of this clinical trial. This trial is an investigator-initiated, randomized, controlled, parallel group, non-inferiority trial. Gastric cancer patients diagnosed with primary tumors that have invaded into the muscle propria and not into an adjacent organ (cT2–cT4a) in preoperative studies are recruited. Another criterion for recruitment is no lymph node metastasis or limited perigastric lymph node (including lymph nodes around the left gastric artery) metastasis. A total 1,050 patients in both groups are required to statistically show non-inferiority of the laparoscopic approach with respect to the primary end-point, relapse-free survival of 3 years. Secondary outcomes include postoperative morbidity and mortality, postoperative recovery, quality of life, and overall survival. Surgeons who are validated through peer-review of their surgery videos can participate in this clinical trial. This clinical trial was designed to maintain the principles of a surgical clinical trial with internal validity for participating surgeons. Through the KLASS-02 RCT, we hope to show the efficacy of laparoscopic D2 lymphadenectomy in AGC patients compared with the open procedure. ClinicalTrial.gov, https://www.clinicaltrials.gov/ct2/show/NCT01456598?term

  16. Determinants of successful clinical networks: the conceptual framework and study protocol.

    Science.gov (United States)

    Haines, Mary; Brown, Bernadette; Craig, Jonathan; D'Este, Catherine; Elliott, Elizabeth; Klineberg, Emily; McInnes, Elizabeth; Middleton, Sandy; Paul, Christine; Redman, Sally; Yano, Elizabeth M

    2012-03-13

    Clinical networks are increasingly being viewed as an important strategy for increasing evidence-based practice and improving models of care, but success is variable and characteristics of networks with high impact are uncertain. This study takes advantage of the variability in the functioning and outcomes of networks supported by the Australian New South Wales (NSW) Agency for Clinical Innovation's non-mandatory model of clinical networks to investigate the factors that contribute to the success of clinical networks. The objective of this retrospective study is to examine the association between external support, organisational and program factors, and indicators of success among 19 clinical networks over a three-year period (2006-2008). The outcomes (health impact, system impact, programs implemented, engagement, user perception, and financial leverage) and explanatory factors will be collected using a web-based survey, interviews, and record review. An independent expert panel will provide judgements about the impact or extent of each network's initiatives on health and system impacts. The ratings of the expert panel will be the outcome used in multivariable analyses. Following the rating of network success, a qualitative study will be conducted to provide a more in-depth examination of the most successful networks. This is the first study to combine quantitative and qualitative methods to examine the factors that contribute to the success of clinical networks and, more generally, is the largest study of clinical networks undertaken. The adaptation of expert panel methods to rate the impacts of networks is the methodological innovation of this study. The proposed project will identify the conditions that should be established or encouraged by agencies developing clinical networks and will be of immediate use in forming strategies and programs to maximise the effectiveness of such networks.

  17. Field validation of protocols developed to evaluate in-line mastitis detection systems.

    Science.gov (United States)

    Kamphuis, C; Dela Rue, B T; Eastwood, C R

    2016-02-01

    This paper reports on a field validation of previously developed protocols for evaluating the performance of in-line mastitis-detection systems. The protocols outlined 2 requirements of these systems: (1) to detect cows with clinical mastitis (CM) promptly and accurately to enable timely and appropriate treatment and (2) to identify cows with high somatic cell count (SCC) to manage bulk milk SCC levels. Gold standard measures, evaluation tests, performance measures, and performance targets were proposed. The current study validated the protocols on commercial dairy farms with automated in-line mastitis-detection systems using both electrical conductivity (EC) and SCC sensor systems that both monitor at whole-udder level. The protocol for requirement 1 was applied on 3 commercial farms. For requirement 2, the protocol was applied on 6 farms; 3 of them had low bulk milk SCC (128×10(3) cells/mL) and were the same farms as used for field evaluation of requirement 1. Three farms with high bulk milk SCC (270×10(3) cells/mL) were additionally enrolled. The field evaluation methodology and results were presented at a workshop including representation from 7 international suppliers of in-line mastitis-detection systems. Feedback was sought on the acceptance of standardized performance evaluation protocols and recommended refinements to the protocols. Although the methodology for requirement 1 was relatively labor intensive and required organizational skills over an extended period, no major issues were encountered during the field validation of both protocols. The validation, thus, proved the protocols to be practical. Also, no changes to the data collection process were recommended by the technology supplier representatives. However, 4 recommendations were made to refine the protocols: inclusion of an additional analysis that ignores small (low-density) clot observations in the definition of CM, extension of the time window from 4 to 5 milkings for timely alerts for CM

  18. Development of a bedside viable ultrasound protocol to quantify appendicular lean tissue mass.

    Science.gov (United States)

    Paris, Michael T; Lafleur, Benoit; Dubin, Joel A; Mourtzakis, Marina

    2017-10-01

    Ultrasound is a non-invasive and readily available tool that can be prospectively applied at the bedside to assess muscle mass in clinical settings. The four-site protocol, which images two anatomical sites on each quadriceps, may be a viable bedside method, but its ability to predict musculature has not been compared against whole-body reference methods. Our primary objectives were to (i) compare the four-site protocol's ability to predict appendicular lean tissue mass from dual-energy X-ray absorptiometry; (ii) optimize the predictability of the four-site protocol with additional anatomical muscle thicknesses and easily obtained covariates; and (iii) assess the ability of the optimized protocol to identify individuals with low lean tissue mass. This observational cross-sectional study recruited 96 university and community dwelling adults. Participants underwent ultrasound scans for assessment of muscle thickness and whole-body dual-energy X-ray absorptiometry scans for assessment of appendicular lean tissue. Ultrasound protocols included (i) the nine-site protocol, which images nine anterior and posterior muscle groups in supine and prone positions, and (ii) the four-site protocol, which images two anterior sites on each quadriceps muscle group in a supine position. The four-site protocol was strongly associated (R 2  = 0.72) with appendicular lean tissue mass, but Bland-Altman analysis displayed wide limits of agreement (-5.67, 5.67 kg). Incorporating the anterior upper arm muscle thickness, and covariates age and sex, alongside the four-site protocol, improved the association (R 2  = 0.91) with appendicular lean tissue and displayed narrower limits of agreement (-3.18, 3.18 kg). The optimized protocol demonstrated a strong ability to identify low lean tissue mass (area under the curve = 0.89). The four-site protocol can be improved with the addition of the anterior upper arm muscle thickness, sex, and age when predicting appendicular lean tissue mass

  19. Static Validation of Security Protocols

    DEFF Research Database (Denmark)

    Bodei, Chiara; Buchholtz, Mikael; Degano, P.

    2005-01-01

    We methodically expand protocol narrations into terms of a process algebra in order to specify some of the checks that need to be made in a protocol. We then apply static analysis technology to develop an automatic validation procedure for protocols. Finally, we demonstrate that these techniques ...... suffice to identify several authentication flaws in symmetric and asymmetric key protocols such as Needham-Schroeder symmetric key, Otway-Rees, Yahalom, Andrew secure RPC, Needham-Schroeder asymmetric key, and Beller-Chang-Yacobi MSR...

  20. PATIENT-CENTRED SCREENING FOR PRIMARY IMMUNODEFICIENCY, A MULTI-STAGE DIAGNOSTIC PROTOCOL DESIGNED FOR NONIMMUNOLOGISTS: 2011 UPDATE

    Directory of Open Access Journals (Sweden)

    E. de Vries

    2013-01-01

    Full Text Available Abstract. Members of the European Society for Immunodeficiencies (ESID and other colleagues have updated themulti-stage expert-opinion-based diagnostic protocol for non-immunologists incorporating newly defined primary immunodeficiency diseases (PIDs. The protocol presented here aims to increase the awareness of PIDs among doctors working in different fields. Prompt identification of PID is important for prognosis, but this may not be an easy task. The protocol therefore starts from the clinical presentation of the patient. Because PIDs may present at all ages, this protocol is aimed at both adult and paediatric physicians. The multi-stage design allows cost-effective screening for PID of the large number of potential cases in the early phases, with more expensive tests reserved for definitive classification in collaboration with a specialist in the field of immunodeficiency at a later stage.

  1. Proton Beam Therapy for Hepatocellular Carcinoma: A Comparison of Three Treatment Protocols

    Energy Technology Data Exchange (ETDEWEB)

    Mizumoto, Masashi; Okumura, Toshiyuki; Hashimoto, Takayuki [Proton Medical Research Center, University of Tsukuba, Tsukuba, Ibaraki (Japan); Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Fukuda, Kuniaki [Department of Gastroenterology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Oshiro, Yoshiko; Fukumitsu, Nobuyoshi [Proton Medical Research Center, University of Tsukuba, Tsukuba, Ibaraki (Japan); Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Abei, Masato [Department of Gastroenterology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Kawaguchi, Atsushi [Biostatistics Center, Kurume University, Fukuoka (Japan); Hayashi, Yasutaka; Ookawa, Ayako; Hashii, Haruko; Kanemoto, Ayae [Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Moritake, Takashi [Proton Medical Research Center, University of Tsukuba, Tsukuba, Ibaraki (Japan); Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Tohno, Eriko [Department of Diagnostic Radiology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Tsuboi, Koji [Proton Medical Research Center, University of Tsukuba, Tsukuba, Ibaraki (Japan); Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Sakae, Takeji [Proton Medical Research Center, University of Tsukuba, Tsukuba, Ibaraki (Japan); Sakurai, Hideyuki, E-mail: hsakurai@pmrc.tsukuba.ac.jp [Proton Medical Research Center, University of Tsukuba, Tsukuba, Ibaraki (Japan); Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki (Japan)

    2011-11-15

    Background: Our previous results for treatment of hepatocellular carcinoma (HCC) with proton beam therapy revealed excellent local control with low toxicity. Three protocols were used to avoid late complications such as gastrointestinal ulceration and bile duct stenosis. In this study, we examined the efficacy of these protocols. Methods and Materials: The subjects were 266 patients (273 HCCs) treated by proton beam therapy at University of Tsukuba between January 2001 and December 2007. Three treatment protocols (A, 66 GyE in 10 fractions; B, 72.6 GyE in 22 fractions; and C, 77 GyE in 35 fractions) were used, depending on the tumor location. Results: Of the 266 patients, 104, 95, and 60 patients were treated with protocols A, B, and C, respectively. Seven patients with double lesions underwent two different protocols. The overall survival rates after 1, 3 and 5 years were 87%, 61%, and 48%, respectively (median survival, 4.2 years). Multivariate analysis showed that better liver function, small clinical target volume, and no prior treatment (outside the irradiated field) were associated with good survival. The local control rates after 1, 3, and 5 years were 98%, 87%, and 81%, respectively. Multivariate analysis did not identify any factors associated with good local control. Conclusions: This study showed that proton beam therapy achieved good local control for HCC using each of three treatment protocols. This suggests that selection of treatment schedules based on tumor location may be used to reduce the risk of late toxicity and maintain good treatment efficacy.

  2. A class-chest for deriving transport protocols

    Energy Technology Data Exchange (ETDEWEB)

    Strayer, W.T.

    1996-10-01

    Development of new transport protocols or protocol algorithms suffers from the complexity of the environment in which they are intended to run. Modeling techniques attempt to avoid this by simulating the environment. Another approach to promoting rapid prototyping of protocols and protocol algorithms is to provide a pre-built infrastructure that is common to transport protocols, so that the focus is placed on the protocol-specific aspects. The Meta-Transport Library is a library of C++ base classes that implement or abstract out the mundane functions of a protocol, new protocol implementations are derived from base classes. The result is a fully viable user- level transport protocol implementation, with emphasis on modularity. The collection of base classes form a ``class-chest`` of tools .from which protocols can be developed and studied with as little change to a normal UNIX environment as possible.

  3. Generation of insulin-producing cells from human bone marrow-derived mesenchymal stem cells: comparison of three differentiation protocols.

    Science.gov (United States)

    Gabr, Mahmoud M; Zakaria, Mahmoud M; Refaie, Ayman F; Khater, Sherry M; Ashamallah, Sylvia A; Ismail, Amani M; El-Badri, Nagwa; Ghoneim, Mohamed A

    2014-01-01

    Many protocols were utilized for directed differentiation of mesenchymal stem cells (MSCs) to form insulin-producing cells (IPCs). We compared the relative efficiency of three differentiation protocols. Human bone marrow-derived MSCs (HBM-MSCs) were obtained from three insulin-dependent type 2 diabetic patients. Differentiation into IPCs was carried out by three protocols: conophylline-based (one-step protocol), trichostatin-A-based (two-step protocol), and β -mercaptoethanol-based (three-step protocol). At the end of differentiation, cells were evaluated by immunolabeling for insulin production, expression of pancreatic endocrine genes, and release of insulin and c-peptide in response to increasing glucose concentrations. By immunolabeling, the proportion of generated IPCs was modest ( ≃ 3%) in all the three protocols. All relevant pancreatic endocrine genes, insulin, glucagon, and somatostatin, were expressed. There was a stepwise increase in insulin and c-peptide release in response to glucose challenge, but the released amounts were low when compared with those of pancreatic islets. The yield of functional IPCs following directed differentiation of HBM-MSCs was modest and was comparable among the three tested protocols. Protocols for directed differentiation of MSCs need further optimization in order to be clinically meaningful. To this end, addition of an extracellular matrix and/or a suitable template should be attempted.

  4. Automatic Validation of Protocol Narration

    DEFF Research Database (Denmark)

    Bodei, Chiara; Buchholtz, Mikael; Degano, Pierpablo

    2003-01-01

    We perform a systematic expansion of protocol narrations into terms of a process algebra in order to make precise some of the detailed checks that need to be made in a protocol. We then apply static analysis technology to develop an automatic validation procedure for protocols. Finally, we...

  5. Transitioning HIV-Positive Adolescents to Adult Care: Lessons Learned From Twelve Adolescent Medicine Clinics.

    Science.gov (United States)

    Tanner, Amanda E; Philbin, Morgan M; DuVal, Anna; Ellen, Jonathan; Kapogiannis, Bill; Fortenberry, J Dennis

    2016-01-01

    To maximize positive health outcomes for youth with HIV as they transition from youth to adult care, clinical staff need strategies and protocols to help youth maintain clinic engagement and medication adherence. Accordingly, this paper describe transition processes across twelve clinics within the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) to provide lessons learned and inform the development of transition protocols to improve health outcomes as youth shift from adolescent to adult HIV care. During a large multi-method Care Initiative program evaluation, three annual visits were completed at each site from 2010-2012 and conducted 174 semi-structured interviews with clinical and program staff (baseline n=64, year 1 n=56, year 2=54). The results underscore the value of adhering to recent American Academy of Pediatrics (AAP) transition recommendations, including: developing formal transition protocols, preparing youth for transition, facilitating youth's connection to the adult clinic, and identifying necessary strategies for transition evaluation. Transitioning youth with HIV involves targeting individual-, provider-, and system-level factors. Acknowledging and addressing key barriers is essential for developing streamlined, comprehensive, and context-specific transition protocols. Adolescent and adult clinic involvement in transition is essential to reduce service fragmentation, provide coordinated and continuous care, and support individual and community level health. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Standardized Duplex Ultrasound-Based Protocol for Early Diagnosis of Transplant Renal Artery Stenosis: Results of a Single-Institution Retrospective Cohort Study

    Directory of Open Access Journals (Sweden)

    Vincenzo Li Marzi

    2018-01-01

    Full Text Available Transplant renal artery stenosis (TRAS is the most frequent vascular complication after kidney transplantation (KT and has been associated with potentially reversible refractory hypertension, graft dysfunction, and reduced patient survival. The aim of the study is to describe the outcomes of a standardized Duplex Ultrasound- (DU- based screening protocol for early diagnosis of TRAS and for selection of patients potentially requiring endovascular intervention. We retrospectively reviewed our prospectively collected database of KT from January 1998 to select patients diagnosed with TRAS. The follow-up protocol was based on a risk-adapted, dynamic subdivision of eligible KT patients in different risk categories (RC with different protocol strategies (PS. Of 598 patients included in the study, 52 (9% patients had hemodynamically significant TRAS and underwent percutaneous angioplasty (PTA and stent placement. Technical and clinical success rates were 97% and 90%, respectively. 7 cases of restenosis were recorded at follow-up and treated with re-PTA plus stenting. Both DU imaging and clinical parameters improved after stent placement. Prospective high-quality studies are needed to test the efficacy and safety of our protocol in larger series. Accurate trial design and standardized reporting of patient outcomes will be key to address the current clinical needs.

  7. Efficient secure two-party protocols

    CERN Document Server

    Hazay, Carmit

    2010-01-01

    The authors present a comprehensive study of efficient protocols and techniques for secure two-party computation -- both general constructions that can be used to securely compute any functionality, and protocols for specific problems of interest. The book focuses on techniques for constructing efficient protocols and proving them secure. In addition, the authors study different definitional paradigms and compare the efficiency of protocols achieved under these different definitions.The book opens with a general introduction to secure computation and then presents definitions of security for a

  8. Using Ovsynch protocol versus Cosynch protocol in dairy cows

    Directory of Open Access Journals (Sweden)

    Ion Valeriu Caraba

    2013-10-01

    Full Text Available As a research on the reproductive physiology and endocrinology surrounding the estrous cycle in dairy cattle has been compiled, several estrous synchronization programs have been developed for use with dairy cows. These include several programs that facilitate the mass breeding of all animals at a predetermined time (timed-AI rather than the detection of estrus. We studied on 15 dary cows which were synchronized by Ovsynch and Cosynch programs. The estrus response for cows in Ovsynch protocol was of 63%. Pregnancy per insemination at 60 days was of 25%. Estrus response for cow in Cosynch protocol was of 57%. Pregnancy per insemination at 60 days was of 57%. Synchronization of ovulation using Ovsynch protocols can provide an effective way to manage reproduction in lactating dairy cows by eliminating the need for estrus detection. These are really efficient management programs for TAI of dairy cows that are able to reduce both the labour costs and the extra handling to daily estrus detection and AI.

  9. Breakthrough reactions of iodinated and gadolinium contrast media after oral steroid premedication protocol.

    Science.gov (United States)

    Jingu, Akiko; Fukuda, Junya; Taketomi-Takahashi, Ayako; Tsushima, Yoshito

    2014-10-06

    Adverse reactions to iodinated and gadolinium contrast media are an important clinical issue. Although some guidelines have proposed oral steroid premedication protocols to prevent adverse reactions, some patients may have reactions to contrast media in spite of premedication (breakthrough reaction; BTR).The purpose of this study was to assess the frequency, type and severity of BTR when following an oral steroid premedication protocol. All iodinated and gadolinium contrast-enhanced radiologic examinations between August 2011 and February 2013 for which the premedication protocol was applied in our institution were assessed for BTRs. The protocol was applied to a total of 252 examinations (153 patients, ages 15-87 years; 63 males, 90 females). Of these, 152 were for prior acute adverse reactions to contrast media, 85 were for a history of bronchial asthma, and 15 were for other reasons. There were 198 contrast enhanced CTs and 54 contrast enhanced MRIs. There were nine BTR (4.5%) for iodinated contrast media, and only one BTR (1.9%) for gadolinium contrast media: eight were mild and one was moderate. No patient who had a mild index reaction (IR) had a severe BTR. Incidence of BTRs when following the premedication protocol was low. This study by no means proves the efficacy of premedication, but provides some support for following a premedication protocol to improve safety of contrast-enhanced examinations when prior adverse reactions are mild, or when there is a history of asthma.

  10. Breakthrough reactions of iodinated and gadolinium contrast media after oral steroid premedication protocol

    International Nuclear Information System (INIS)

    Jingu, Akiko; Fukuda, Junya; Taketomi-Takahashi, Ayako; Tsushima, Yoshito

    2014-01-01

    Adverse reactions to iodinated and gadolinium contrast media are an important clinical issue. Although some guidelines have proposed oral steroid premedication protocols to prevent adverse reactions, some patients may have reactions to contrast media in spite of premedication (breakthrough reaction; BTR). The purpose of this study was to assess the frequency, type and severity of BTR when following an oral steroid premedication protocol. All iodinated and gadolinium contrast-enhanced radiologic examinations between August 2011 and February 2013 for which the premedication protocol was applied in our institution were assessed for BTRs. The protocol was applied to a total of 252 examinations (153 patients, ages 15–87 years; 63 males, 90 females). Of these, 152 were for prior acute adverse reactions to contrast media, 85 were for a history of bronchial asthma, and 15 were for other reasons. There were 198 contrast enhanced CTs and 54 contrast enhanced MRIs. There were nine BTR (4.5%) for iodinated contrast media, and only one BTR (1.9%) for gadolinium contrast media: eight were mild and one was moderate. No patient who had a mild index reaction (IR) had a severe BTR. Incidence of BTRs when following the premedication protocol was low. This study by no means proves the efficacy of premedication, but provides some support for following a premedication protocol to improve safety of contrast-enhanced examinations when prior adverse reactions are mild, or when there is a history of asthma

  11. Community vs. Clinic-Based Modular Treatment of Children with Early-Onset ODD or CD: A Clinical Trial with 3-Year Follow-Up

    Science.gov (United States)

    Kolko, David J.; Dorn, Lorah D.; Bukstein, Oscar G.; Pardini, Dustin; Holden, Elizabeth A.; Hart, Jonathan

    2009-01-01

    This study examines the treatment outcomes of 139, 6-11 year-old, clinically referred boys and girls diagnosed with Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD) who were randomly assigned to a modular-based treatment protocol that was applied by research study clinicians either in the community (COMM) or a clinic office (CLINIC).…

  12. Group differences in physician responses to handheld presentation of clinical evidence: a verbal protocol analysis

    Directory of Open Access Journals (Sweden)

    Pavlovic Nada J

    2007-07-01

    Full Text Available Abstract Background To identify individual differences in physicians' needs for the presentation of evidence resources and preferences for mobile devices. Methods Within-groups analysis of responses to semi-structured interviews. Interviews consisted of using prototypes in response to task-based scenarios. The prototypes were implemented on two different form factors: a tablet style PC and a pocketPC. Participants were from three user groups: general internists, family physicians and medicine residents, and from two different settings: urban and semi-urban. Verbal protocol analysis, which consists of coding utterances, was conducted on the transcripts of the testing sessions. Statistical relationships were investigated between staff physicians' and residents' background variables, self-reported experiences with the interfaces, and verbal code frequencies. Results 47 physicians were recruited from general internal medicine, family practice clinics and a residency training program. The mean age of participants was 42.6 years. Physician specialty had a greater effect on device and information-presentation preferences than gender, age, setting or previous technical experience. Family physicians preferred the screen size of the tablet computer and were less concerned about its portability. Residents liked the screen size of the tablet, but preferred the portability of the pocketPC. Internists liked the portability of the pocketPC, but saw less advantage to the large screen of the tablet computer (F[2,44] = 4.94, p = .012. Conclusion Different types of physicians have different needs and preferences for evidence-based resources and handheld devices. This study shows how user testing can be incorporated into the process of design to inform group-based customization.

  13. A family of multi-party authentication protocols

    NARCIS (Netherlands)

    Cremers, C.J.F.; Mauw, S.

    2006-01-01

    We introduce a family of multi-party authentication protocols and discuss six novel protocols, which are members of this family. The first three generalize the well-known Needham-Schroeder-Lowe public-key protocol, the Needham-Schroeder private-key protocol, and the Bilateral Key Exchange protocol.

  14. Neuroimaging for non-accidental head injury in childhood: A proposed protocol

    International Nuclear Information System (INIS)

    Jaspan, T.; Griffiths, P.D.; McConachie, N.S.; Punt, J.A.G.

    2003-01-01

    Non-accidental head injury (NAHI) is a major cause of neurological disability and death during infancy. Radiological imaging plays a crucial role in evaluating craniospinal injury, both for guiding medical management and the forensic aspects of abusive trauma. The damage sustained is varied, complex and may be accompanied by an evolving pattern of brain injury secondary to a cascade of metabolic and physiological derangements. Regrettably, many cases are poorly or incompletely evaluated leading to diagnostic errors and difficulties in executing subsequent child care or criminal proceedings. It is evident, from cases referred to the authors, that imaging protocols for NAHI are lacking (or only loosely adhered to, if present) in many centres throughout the U.K. Future research in this field will also be hampered if there is a lack of consistent and reliable radiological data. There is no nationally agreed protocol for imaging NAHI. We propose such a protocol, based upon a wide experience in the medical management of child abuse and extensive involvement in the medicolegal aspects of NAHI. Jaspan, T., et al. (2003). Clinical Radiology58, 44--53

  15. Neuroimaging for non-accidental head injury in childhood: A proposed protocol

    Energy Technology Data Exchange (ETDEWEB)

    Jaspan, T.; Griffiths, P.D.; McConachie, N.S.; Punt, J.A.G

    2003-01-01

    Non-accidental head injury (NAHI) is a major cause of neurological disability and death during infancy. Radiological imaging plays a crucial role in evaluating craniospinal injury, both for guiding medical management and the forensic aspects of abusive trauma. The damage sustained is varied, complex and may be accompanied by an evolving pattern of brain injury secondary to a cascade of metabolic and physiological derangements. Regrettably, many cases are poorly or incompletely evaluated leading to diagnostic errors and difficulties in executing subsequent child care or criminal proceedings. It is evident, from cases referred to the authors, that imaging protocols for NAHI are lacking (or only loosely adhered to, if present) in many centres throughout the U.K. Future research in this field will also be hampered if there is a lack of consistent and reliable radiological data. There is no nationally agreed protocol for imaging NAHI. We propose such a protocol, based upon a wide experience in the medical management of child abuse and extensive involvement in the medicolegal aspects of NAHI. Jaspan, T., et al. (2003). Clinical Radiology58, 44--53.

  16. Evaluation of protocolized angiography in performing the interventional procedure for hepatocellular carcinoma

    International Nuclear Information System (INIS)

    Jiang Jianqiang; Shi Haibin; Liu Sheng; Yang Zhengqiang; Zhou Chungao; Zhou Weizhong

    2010-01-01

    Objective: To assess the clinical value of protocolized angiography,including the superior mesenteric artery (SMA), the celiac artery and the common hepatic artery angiography, in detecting the atypical tumor feeding arteries of hepatocellular carcinoma (HCC) during transarterial chemoembolization (TACE) procedure. Methods: The clinical data of all patients who received the initial TACE for HCC during the period of January 2005-December 2009 were collected and were retrospectively analyzed. Both the angiograms and procedure reports were reviewed. According to the angiography protocols used in interventional procedure the patients were divided into two groups. Group A included 526 patients who received the protocolized angiography, including the SMA, the celiac artery and the common hepatic artery, while Group B composed of 850 patients who underwent the routine angiography of the common hepatic artery. For all patients in both groups the atypical tumor feeding arteries were searched for when the tumor staining was incomplete. The anatomic variations of tumor feeding arteries were classified and were statistically analyzed. Results: The detection rate of tumor supply from the branches of SMA, left gastric artery, phrenic artery and celiac artery was 14.1%, 6.7%, 4.6% and 0.5% respectively in group A, while it was 8.9%, 3.3%, 2.6% and 0% respectively in group B. Significant difference in all above four detection rates existed between two groups (P 0.05). Conclusion: Compared with the conventional common hepatic arteriography during TACE, the diagnostic protocolized angiography, including the SMA, the celiac artery and the common hepatic artery, can markedly improve the detection rates of atypical tumor feeders of HCC, such as the accessory hepatic artery, which means that the tumor will be occluded more completely and be controlled more promptly. (authors)

  17. Overview of procalcitonin assays and procalcitonin-guided protocols for the management of patients with infections and sepsis.

    Science.gov (United States)

    Schuetz, Philipp; Bretscher, Celine; Bernasconi, Luca; Mueller, Beat

    2017-06-01

    Procalcitonin is a surrogate infection blood marker whose levels help estimate the likelihood of bacterial infections and correlate with their resolution. Recent trials have revealed the benefits of inclusion of procalcitonin in antibiotic stewardship protocols for initiation and discontinuation of antimicrobial therapy. Areas covered: Procalcitonin-guided antibiotic stewardship protocols have shown appreciable reductions in antibiotic use and duration of therapy in respiratory infections, sepsis, and other infections, with positive effects on clinical outcomes. Multiple fully automated and sensitive procalcitonin assays are routinely used in clinical practice. Utilization of these assays requires consideration of the clinical setting and knowledge of assay characteristics, particularly assay sensitivities, reproducibility, and performance across routinely used cut-off ranges. The authors provide an overview of the strengths and limitations of currently available procalcitonin assays and antibiotic therapy algorithms incorporating procalcitonin currently used in different clinical settings and in patients with different underlying infections. Expert commentary: Use of sensitive procalcitonin measurements in clinical algorithms can reduce antimicrobial overuse, decreasing the risk of side effects and controlling emerging bacterial multi-resistance. Before use in clinical practice, it is important to carefully assess the quality of novel PCT assays and rigorously evaluate them in target patient populations across clinically relevant cut-off ranges.

  18. A shortened protocol for assessing cognitive bias in rats.

    Science.gov (United States)

    Brydges, Nichola M; Hall, Lynsey

    2017-07-15

    Reliable measurement of affective state in animals is a significant goal of animal welfare. Such measurements would also improve the validity of pre-clinical mental health research which relies on animal models. However, at present, affective states in animals are inaccessible to direct measurement. In humans, changes in cognitive processing can give reliable indications of emotional state. Therefore, similar techniques are increasingly being used to gain proxy measures of affective states in animals. In particular, the 'cognitive bias' assay has gained popularity in recent years. Major disadvantages of this technique include length of time taken for animals to acquire the task (typically several weeks), negative experiences associated with task training, and issues of motivation. Here we present a shortened cognitive bias protocol using only positive reinforcers which must actively be responded to. The protocol took an average of 4days to complete, and produced similar results to previous, longer methods (minimum 30days). Specifically, rats housed in standard laboratory conditions demonstrated negative cognitive biases when presented with ambiguous stimuli, and took longer to make a decision when faced with an ambiguous stimulus. Compared to previous methods, this protocol is significantly shorter (average 4days vs. minimum 30days), utilises only positive reinforcers to avoid inducing negative affective states, and requires active responses to all cues, avoiding potential confounds of motivational state. We have successfully developed a shortened cognitive bias protocol, suitable for use with laboratory rats. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

  19. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

    2014-01-01

    , respectively. We also found publication bias in relation to beneficial effects. CONCLUSION: Clinical study reports contained extensive data on major harms that were unavailable in journal articles and in trial registry reports. There were inconsistencies between protocols and clinical study reports and within.......gov and the manufacturer's online clinical trial registry were searched for trial results. RESULTS: Clinical study reports fully described the primary efficacy analysis and major harms (deaths (including suicides), suicide attempts, serious adverse events, and discontinuations because of adverse events). There were minor...... clinical study reports. Clinical study reports should be used as the data source for systematic reviews of drugs, but they should first be checked against protocols and within themselves for accuracy and consistency....

  20. Conservative Treatment Protocol for Keratocystic Odontogenic Tumour: a Follow-up Study of 3 Cases

    Directory of Open Access Journals (Sweden)

    Gülsün Yildirim

    2010-07-01

    Full Text Available Background: The keratocystic odontogenic tumour is classified as a developmental cyst derived from the enamel organ or from the dental lamina. The treatment of keratocystic odontogenic tumour of the jaw remains controversial. The aim of this study was to report the outcome of our conservative treatment protocol for keratocystic odontogenic tumour.Methods: Three patients with different complaints referred to Oral and Maxillofacial Surgery Clinic, Faculty of Dentistry, Selçuk University. Initial biopsy was carried out in all patients and keratocystic odontogenic tumours was diagnosed subsequent to histopathological examination. The patients with keratocystic odontogenic tumours were treated by enucleation followed by open packing. This conservative treatment protocol was selected because of existing young aged patients. The average follow-up duration of the cases was 2 years.Results: Out of 3 cases, 2 lesions were present in mandible and 1 lesion in maxilla. There was no evidence of recurrence during follow-up. All the cases were monitored continuously with panoramic radiographs, computed tomography and clinical evaluations.Conclusions: This conservative treatment protocol for keratocystic odontogenic tumours, based on enucleation followed by open packing would be a possible choice with a view of offering low recurrence rate and low morbidity rate particularly in young patients.

  1. Use of crowdsourcing for cancer clinical trial development.

    Science.gov (United States)

    Leiter, Amanda; Sablinski, Tomasz; Diefenbach, Michael; Foster, Marc; Greenberg, Alex; Holland, John; Oh, William K; Galsky, Matthew D

    2014-10-01

    Patient and physician awareness and acceptance of trials and patient ineligibility are major cancer clinical trial accrual barriers. Yet, trials are typically conceived and designed by small teams of researchers with limited patient input. We hypothesized that through crowdsourcing, the intellectual and creative capacity of a large number of researchers, clinicians, and patients could be harnessed to improve the clinical trial design process. In this study, we evaluated the feasibility and utility of using an internet-based crowdsourcing platform to inform the design of a clinical trial exploring an antidiabetic drug, metformin, in prostate cancer. Over a six-week period, crowd-sourced input was collected from 60 physicians/researchers and 42 patients/advocates leading to several major (eg, eligibility) and minor modifications to the clinical trial protocol as originally designed. Crowdsourcing clinical trial design is feasible, adds value to the protocol development process, and may ultimately improve the efficiency of trial conduct. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  2. Clinical, Radiographic and Microbiological Evaluation of High Level Laser Therapy, a New Photodynamic Therapy Protocol, in Peri-Implantitis Treatment; a Pilot Experience

    Directory of Open Access Journals (Sweden)

    Gianluigi Caccianiga

    2016-01-01

    Full Text Available Aim. Endosseous implants are widely used to replace missing teeth but mucositis and peri-implantitis are the most frequent long-term complications related with dental implants. Removing all bacterial deposits on contaminated implant surface is very difficult due to implant surface morphology. The aim of this study was to evaluate the bactericidal potential of photodynamic therapy by using a new high level laser irradiation protocol associated with hydrogen peroxide in peri-implantitis. Materials and Methods. 10 patients affected by peri-implantitis were selected for this study. Medical history, photographic documentation, periodontal examination, and periapical radiographs were collected at baseline and 6 months after surgery. Microbiological analysis was performed with PCR Real Time. Each patient underwent nonsurgical periodontal therapy and surgery combined with photodynamic therapy according to High Level Laser Therapy protocol. Results. All peri-implant pockets were treated successfully, without having any complication and not showing significant differences in results. All clinical parameters showed an improvement, with a decrease of Plaque Index (average decrease of 65%, range 23–86%, bleeding on probing (average decrease of 66%, range 26–80%, and probing depth (average decrease of 1,6 mm, range 0,46–2,6 mm. Periapical radiographs at 6 months after surgery showed a complete radiographic filling of peri-implant defect around implants treated. Results showed a decrease of total bacterial count and of all bacterial species, except for Eikenella corrodens, 6 months after surgery. Conclusion. Photodynamic therapy using HLLT appears to be a good adjunct to surgical treatment of peri-implantitis.

  3. Validation of the Konsung QD217A for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

    Science.gov (United States)

    Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

    2015-08-01

    This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor Konsung QD217A for home BP monitoring according to the European Society of Hypertension International Protocol revision 2010. Three trained observers validated the performance of these devices by comparing the measurements obtained from these devices with those taken using a standard mercury sphygmomanometer. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using a standard mercury sphygmomanometer and the Konsung QD217A device. A total of 99 pairs of comparisons were obtained from 33 participants. The QD217A device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10 and 15 mmHg was 70/99, 92/99 and 96/99, respectively, for SBP and 80/99, 94/99 and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. A total of 27 and 31 participants for SBP and DBP, respectively, showed at least two of the three device-observers differences within 5 mmHg (required≥24). The number of participants without device-observer difference within 5 mmHg was one for SBP and one for DBP (required≤3). The Konsung upper arm BP monitor QD217A has passed the International Protocol requirements and it can be recommended for clinical use and self-measurement in adults. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

  4. Schizophrenia research participants' responses to protocol safeguards: recruitment, consent, and debriefing.

    Science.gov (United States)

    Roberts, Laura Weiss; Warner, Teddy D; Anderson, Charles T; Smithpeter, Megan V; Rogers, Melinda K

    2004-04-01

    To examine the perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing of people with schizophrenia who volunteered for research protocols. A structured interview to assess research-related views of people with schizophrenia was developed and piloted. Data collection occurred at three sites. For this analysis, we examined the subset of responses from schizophrenia patients currently enrolled in a protocol. Data from 28 schizophrenia research volunteers were analyzed. Of these, 22 were men and 11 were voluntary inpatients. Most (n=23) recalled speaking with someone before enrolling in the protocol, and most (n=26) reported trusting the person who told them about it. Participants reported a moderate understanding of their protocols. All but one person (n=27) remembered signing a consent form. Twenty-one volunteers indicated that consent forms are meant to help both the patient and the researcher. Most (n=23) reported making the enrollment decision alone, with 22 making this decision prior to reviewing the consent form. The decision was described as relatively easy. Respondents felt some pressure to enroll, with women experiencing more pressure. Debriefing practices were strongly endorsed by participants. All 28 of the volunteers wished to be informed if a health problem (i.e., "something wrong") was discovered during the protocol. The persons living with schizophrenia who were interviewed for this project expressed interesting perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing in clinical research that may help guide efforts to make research processes more attuned to participants and merit further inquiry.

  5. Detection and identification of Leishmania spp.: application of two hsp70-based PCR-RFLP protocols to clinical samples from the New World.

    Science.gov (United States)

    Montalvo, Ana M; Fraga, Jorge; Tirado, Dídier; Blandón, Gustavo; Alba, Annia; Van der Auwera, Gert; Vélez, Iván Darío; Muskus, Carlos

    2017-07-01

    Leishmaniasis is highly prevalent in New World countries, where several methods are available for detection and identification of Leishmania spp. Two hsp70-based PCR protocols (PCR-N and PCR-F) and their corresponding restriction fragment length polymorphisms (RFLP) were applied for detection and identification of Leishmania spp. in clinical samples recruited in Colombia, Guatemala, and Honduras. A total of 93 cases were studied. The samples were classified into positive or suspected of leishmaniasis according to parasitological criteria. Molecular amplification of two different hsp70 gene fragments and further RFLP analysis for identification of Leishmania species was done. The detection in parasitologically positive samples was higher using PCR-N than PCR-F. In the total of samples studied, the main species identified were Leishmania panamensis, Leishmania braziliensis, and Leishmania infantum (chagasi). Although RFLP-N was more efficient for the identification, RFLP-F is necessary for discrimination between L. panamensis and Leishmania guyanesis, of great importance in Colombia. Unexpectedly, one sample from this country revealed an RFLP pattern corresponding to Leishmania naiffi. Both molecular variants are applicable for the study of clinical samples originated in Colombia, Honduras, and Guatemala. Choosing the better tool for each setting depends on the species circulating. More studies are needed to confirm the presence of L. naiffi in Colombian territory.

  6. A Cryptographic Moving-Knife Cake-Cutting Protocol

    Directory of Open Access Journals (Sweden)

    Yoshifumi Manabe

    2012-02-01

    Full Text Available This paper proposes a cake-cutting protocol using cryptography when the cake is a heterogeneous good that is represented by an interval on a real line. Although the Dubins-Spanier moving-knife protocol with one knife achieves simple fairness, all players must execute the protocol synchronously. Thus, the protocol cannot be executed on asynchronous networks such as the Internet. We show that the moving-knife protocol can be executed asynchronously by a discrete protocol using a secure auction protocol. The number of cuts is n-1 where n is the number of players, which is the minimum.

  7. The Simplest Protocol for Oblivious Transfer

    DEFF Research Database (Denmark)

    Chou, Tung; Orlandi, Claudio

    2015-01-01

    Oblivious Transfer (OT) is the fundamental building block of cryptographic protocols. In this paper we describe the simplest and most efficient protocol for 1-out-of-n OT to date, which is obtained by tweaking the Diffie-Hellman key-exchange protocol. The protocol achieves UC-security against...... active and adaptive corruptions in the random oracle model. Due to its simplicity, the protocol is extremely efficient and it allows to perform m 1-out-of-n OTs using only: - Computation: (n+1)m+2 exponentiations (mn for the receiver, mn+2 for the sender) and - Communication: 32(m+1) bytes (for the group...... optimizations) is at least one order of magnitude faster than previous work. Category / Keywords: cryptographic protocols / Oblivious Transfer, UC Security, Elliptic Curves, Efficient Implementation...

  8. Optic neuritis in paediatric patients: Experience over 27 years and a management protocol.

    Science.gov (United States)

    Monge Galindo, L; Martínez de Morentín, A L; Pueyo Royo, V; García Iñiguez, J P; Sánchez Marco, S; López-Pisón, J; Peña-Segura, J L

    2018-03-08

    In this article, we present our experience on optic neuritis (ON) and provide a diagnostic/therapeutic protocol, intended to rule out other aetiologies (particularly infection), and a fact sheet for parents. We conducted a descriptive, retrospective study of patients with ON over a 27-year period (1990-2017). A review of the available scientific evidence was performed in order to draft the protocol and fact sheet. Our neuropaediatrics department has assessed 20,744 patients in the last 27 years, of whom 14 were diagnosed with ON: 8 had isolated ON, 1 had multiple sclerosis (MS), 1 had clinically isolated syndrome (CIS), 3 had acute disseminated encephalomyelitis, and 1 had isolated ON and a history of acute disseminated encephalomyelitis one year previously. Patients' age range was 4-13 years; 50% were boys. Eight patients were aged over 10: 7 had isolated ON and 1 had MS. Nine patients had bilateral ON, and 3 had retrobulbar ON. MRI results were normal in 7 patients and showed involvement of the optic nerve only in 2 patients and optic nerve involvement + central nervous system demyelination in 5. Thirteen patients received corticosteroids. One patient had been vaccinated against meningococcus-C the previous month. Progression was favourable, except in the patient with MS. A management protocol and fact sheet are provided. ON usually has a favourable clinical course. In children aged older than 10 years with risk factors for MS or optic neuromyelitis (hyperintensity on brain MRI, oligoclonal bands, anti-NMO antibody positivity, ON recurrence), the initiation of immunomodulatory treatment should be agreed with the neurology department. The protocol is useful for diagnostic decision-making, follow-up, and treatment of this rare disease with potentially major repercussions. The use of protocols and fact sheets is important. Copyright © 2018 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  9. A data grid for imaging-based clinical trials

    Science.gov (United States)

    Zhou, Zheng; Chao, Sander S.; Lee, Jasper; Liu, Brent; Documet, Jorge; Huang, H. K.

    2007-03-01

    Clinical trials play a crucial role in testing new drugs or devices in modern medicine. Medical imaging has also become an important tool in clinical trials because images provide a unique and fast diagnosis with visual observation and quantitative assessment. A typical imaging-based clinical trial consists of: 1) A well-defined rigorous clinical trial protocol, 2) a radiology core that has a quality control mechanism, a biostatistics component, and a server for storing and distributing data and analysis results; and 3) many field sites that generate and send image studies to the radiology core. As the number of clinical trials increases, it becomes a challenge for a radiology core servicing multiple trials to have a server robust enough to administrate and quickly distribute information to participating radiologists/clinicians worldwide. The Data Grid can satisfy the aforementioned requirements of imaging based clinical trials. In this paper, we present a Data Grid architecture for imaging-based clinical trials. A Data Grid prototype has been implemented in the Image Processing and Informatics (IPI) Laboratory at the University of Southern California to test and evaluate performance in storing trial images and analysis results for a clinical trial. The implementation methodology and evaluation protocol of the Data Grid are presented.

  10. Coded Splitting Tree Protocols

    DEFF Research Database (Denmark)

    Sørensen, Jesper Hemming; Stefanovic, Cedomir; Popovski, Petar

    2013-01-01

    This paper presents a novel approach to multiple access control called coded splitting tree protocol. The approach builds on the known tree splitting protocols, code structure and successive interference cancellation (SIC). Several instances of the tree splitting protocol are initiated, each...... instance is terminated prematurely and subsequently iterated. The combined set of leaves from all the tree instances can then be viewed as a graph code, which is decodable using belief propagation. The main design problem is determining the order of splitting, which enables successful decoding as early...

  11. Playing With Population Protocols

    Directory of Open Access Journals (Sweden)

    Xavier Koegler

    2009-06-01

    Full Text Available Population protocols have been introduced as a model of sensor networks consisting of very limited mobile agents with no control over their own movement: A collection of anonymous agents, modeled by finite automata, interact in pairs according to some rules. Predicates on the initial configurations that can be computed by such protocols have been characterized under several hypotheses. We discuss here whether and when the rules of interactions between agents can be seen as a game from game theory. We do so by discussing several basic protocols.

  12. Model Additional Protocol

    International Nuclear Information System (INIS)

    Rockwood, Laura

    2001-01-01

    Since the end of the cold war a series of events has changed the circumstances and requirements of the safeguards system. The discovery of a clandestine nuclear weapons program in Iraq, the continuing difficulty in verifying the initial report of Democratic People's Republic of Korea upon entry into force of their safeguards agreement, and the decision of the South African Government to give up its nuclear weapons program and join the Treaty on the Non-Proliferation of Nuclear Weapons have all played a role in an ambitious effort by IAEA Member States and the Secretariat to strengthen the safeguards system. A major milestone in this effort was reached in May 1997 when the IAEA Board of Governors approved a Model Protocol Additional to Safeguards Agreements. The Model Additional Protocol was negotiated over a period of less than a year by an open-ended committee of the Board involving some 70 Member States and two regional inspectorates. The IAEA is now in the process of negotiating additional protocols, State by State, and implementing them. These additional protocols will provide the IAEA with rights of access to information about all activities related to the use of nuclear material in States with comprehensive safeguards agreements and greatly expanded physical access for IAEA inspectors to confirm or verify this information. In conjunction with this, the IAEA is working on the integration of these measures with those provided for in comprehensive safeguards agreements, with a view to maximizing the effectiveness and efficiency, within available resources, the implementation of safeguards. Details concerning the Model Additional Protocol are given. (author)

  13. Asymptotic adaptive bipartite entanglement-distillation protocol

    International Nuclear Information System (INIS)

    Hostens, Erik; Dehaene, Jeroen; De Moor, Bart

    2006-01-01

    We present an asymptotic bipartite entanglement-distillation protocol that outperforms all existing asymptotic schemes. This protocol is based on the breeding protocol with the incorporation of two-way classical communication. Like breeding, the protocol starts with an infinite number of copies of a Bell-diagonal mixed state. Breeding can be carried out as successive stages of partial information extraction, yielding the same result: one bit of information is gained at the cost (measurement) of one pure Bell state pair (ebit). The basic principle of our protocol is at every stage to replace measurements on ebits by measurements on a finite number of copies, whenever there are two equiprobable outcomes. In that case, the entropy of the global state is reduced by more than one bit. Therefore, every such replacement results in an improvement of the protocol. We explain how our protocol is organized as to have as many replacements as possible. The yield is then calculated for Werner states

  14. Inter-rater and intra-rater reliability of a clinical protocol for measuring turnout in collegiate dancers.

    Science.gov (United States)

    Greene, Amanda; Lasner, Andrea; Deu, Rajwinder; Oliphant, Seth; Johnson, Kenneth

    2018-02-02

    Reliable methods of measuring turnout in dancers and comparing active turnout (used in class) with functional (uncompensated) turnout are needed. Authors have suggested measurement techniques but there is no clinically useful, easily reproducible technique with established inter-rater and intra-rater reliability. We adapted a technique based on previous research, which is easily reproducible. We hypothesized excellent inter-rater and intra-rater reliability between experienced physical therapists (PTs) and a briefly trained faculty member from a university's department of dance. Thirty-two participants were recruited from the same dance department. Dancers' active and functional turnout was measured by each rater. We found that our technique for measuring active and functional turnout has excellent inter-rater and intra-rater reliability when performed by two experienced PTs and by one briefly trained university-level dance faculty member. For active turnout, inter-rater reliability was 0.78 among all raters and 0.82 among only the PT raters; intra-rater reliability was 0.82 among all raters and 0.85 among only the PT raters. For functional turnout, inter-rater reliability was 0.86 among all raters and 0.88 among only the PT raters; intra-rater reliability was 0.87 among all raters and 0.88 among only the PT raters. The measurement technique described provides a standardized protocol with excellent inter-rater and intra-rater reliability when performed by experienced PTs or by a briefly trained university-level dance faculty member.

  15. Safety and efficacy of an intensive insulin protocol in a burn-trauma intensive care unit.

    Science.gov (United States)

    Cochran, Amalia; Davis, Lynn; Morris, Stephen E; Saffle, Jeffrey R

    2008-01-01

    Aggressive glycemic management in critically ill patients with acute burn injury or life-threatening soft-tissue infections has not been thoroughly evaluated. An intensive insulin protocol with target glucose values of less than 120 mg/dl was implemented in October 2005 in our regional Burn-Trauma intensive care unit. We reviewed our initial experience with this protocol to evaluate the safety and efficacy of aggressive glycemic control in these patient groups. Patients were placed on the intensive insulin protocol based upon the need for glycemic management during their hospitalization for burn or soft-tissue disease. Patient information prospectively collected while on protocol included all measured blood glucose values, total daily insulin use, and incidence of hypoglycemic episodes, defined as serum glucose patients (17 burns, 13 soft-tissue infections) were placed on the intensive insulin protocol during the first 16 months of use. The mean daily blood glucose level for burn patients was 115.9 mg/dl and for soft-tissue disease patients was 119.5 mg/dl. There was a 5% incidence of hypoglycemic episodes per protocol day. All hypoglycemic episodes were treated by holding the insulin infusion, and no episode had known adverse effects. Hyperglycemia in critically ill patients with burns and extensive soft-tissue disease can be effectively managed with an insulin protocol that targets blood glucose values of less than 120 mg/dl with minimal incidence of hypoglycemia. A multicenter prospective randomized trial would provide the ideal forum for evaluating clinical outcome benefits of using an intensive insulin protocol.

  16. ASCOT: a text mining-based web-service for efficient search and assisted creation of clinical trials

    Science.gov (United States)

    2012-01-01

    Clinical trials are mandatory protocols describing medical research on humans and among the most valuable sources of medical practice evidence. Searching for trials relevant to some query is laborious due to the immense number of existing protocols. Apart from search, writing new trials includes composing detailed eligibility criteria, which might be time-consuming, especially for new researchers. In this paper we present ASCOT, an efficient search application customised for clinical trials. ASCOT uses text mining and data mining methods to enrich clinical trials with metadata, that in turn serve as effective tools to narrow down search. In addition, ASCOT integrates a component for recommending eligibility criteria based on a set of selected protocols. PMID:22595088

  17. ASSESSMENT OF RIP-V1 AND OSPF-V2 PROTOCOL WITH CONSIDERATION OF CONVERGENCE CRITERIA AND SENDING PROTOCOLS TRAFFIC

    Directory of Open Access Journals (Sweden)

    Hamed Jelodar

    2014-03-01

    Full Text Available Routing Protocols are underlying principles in networks like internet, transport and mobile. Routing Protocols include a series of rules and algorithms that consider routing metric and select the best way for sending healthy data packets from origin to destination. Dynamic routing protocol compatible to topology has a changeable state. RIP and OSPF are dynamic routing protocol that we consider criteria like convergence and sending protocols traffic assessment RIP first version and OSPF second version. By the test we have done on OPNET stimulation we understood that the OSPF protocol was more efficient than RIP protocol.

  18. Objective and automated protocols for the evaluation of biomedical search engines using No Title Evaluation protocols.

    Science.gov (United States)

    Campagne, Fabien

    2008-02-29

    The evaluation of information retrieval techniques has traditionally relied on human judges to determine which documents are relevant to a query and which are not. This protocol is used in the Text Retrieval Evaluation Conference (TREC), organized annually for the past 15 years, to support the unbiased evaluation of novel information retrieval approaches. The TREC Genomics Track has recently been introduced to measure the performance of information retrieval for biomedical applications. We describe two protocols for evaluating biomedical information retrieval techniques without human relevance judgments. We call these protocols No Title Evaluation (NT Evaluation). The first protocol measures performance for focused searches, where only one relevant document exists for each query. The second protocol measures performance for queries expected to have potentially many relevant documents per query (high-recall searches). Both protocols take advantage of the clear separation of titles and abstracts found in Medline. We compare the performance obtained with these evaluation protocols to results obtained by reusing the relevance judgments produced in the 2004 and 2005 TREC Genomics Track and observe significant correlations between performance rankings generated by our approach and TREC. Spearman's correlation coefficients in the range of 0.79-0.92 are observed comparing bpref measured with NT Evaluation or with TREC evaluations. For comparison, coefficients in the range 0.86-0.94 can be observed when evaluating the same set of methods with data from two independent TREC Genomics Track evaluations. We discuss the advantages of NT Evaluation over the TRels and the data fusion evaluation protocols introduced recently. Our results suggest that the NT Evaluation protocols described here could be used to optimize some search engine parameters before human evaluation. Further research is needed to determine if NT Evaluation or variants of these protocols can fully substitute

  19. Comparison of Three Prehospital Cervical Spine Protocols for Missed Injuries

    Directory of Open Access Journals (Sweden)

    Rick Hong

    2014-07-01

    Full Text Available Introduction: We wanted to compare 3 existing emergency medical services (EMS immobilization protocols: the Prehospital Trauma Life Support (PHTLS, mechanism-based; the Domeier protocol (parallels the National Emergency X-Radiography Utilization Study [NEXUS] criteria; and the Hankins’ criteria (immobilization for patients 65 years, those with altered consciousness, focal neurologic deficit, distracting injury, or midline or paraspinal tenderness.To determine the proportion of patients who would require cervical immobilization per protocol and the number of missed cervical spine injuries, had each protocol been followed with 100% compliance. Methods: This was a cross-sectional study of patients ≥18 years transported by EMS post-traumatic mechanism to an inner city emergency department. Demographic and clinical/historical data obtained by physicians were recorded prior to radiologic imaging. Medical record review ascertained cervical spine injuries. Both physicians and EMS were blinded to the objective of the study. Results: Of 498 participants, 58% were male and mean age was 48 years. The following participants would have required cervical spine immobilization based on the respective protocol: PHTLS, 95.4% (95% CI: 93.1-96.9%; Domeier, 68.7% (95% CI: 64.5-72.6%; Hankins, 81.5% (95% CI: 77.9-84.7%. There were 18 cervical spine injuries: 12 vertebral fractures, 2 subluxations/dislocations and 4 spinal cord injuries. Compliance with each of the 3 protocols would have led to appropriate cervical spine immobilization of all injured patients. In practice, 2 injuries were missed when the PHTLS criteria were mis-applied. Conclusion: Although physician-determined presence of cervical spine immobilization criteria cannot be generalized to the findings obtained by EMS personnel, our findings suggest that the mechanism-based PHTLS criteria may result in unnecessary cervical spine immobilization without apparent benefit to injured patients. PHTLS

  20. Standardization of a Videofluoroscopic Swallow Study Protocol to Investigate Dysphagia in Dogs.

    Science.gov (United States)

    Harris, R A; Grobman, M E; Allen, M J; Schachtel, J; Rawson, N E; Bennett, B; Ledyayev, J; Hopewell, B; Coates, J R; Reinero, C R; Lever, T E

    2017-03-01

    Videofluoroscopic swallow study (VFSS) is the gold standard for diagnosis of dysphagia in veterinary medicine but lacks standardized protocols that emulate physiologic feeding practices. Age impacts swallow function in humans but has not been evaluated by VFSS in dogs. To develop a protocol with custom kennels designed to allow free-feeding of 3 optimized formulations of contrast media and diets that address limitations of current VFSS protocols. We hypothesized that dogs evaluated by a free-feeding VFSS protocol would show differences in objective swallow metrics based on age. Healthy juvenile, adult, and geriatric dogs (n = 24). Prospective, experimental study. Custom kennels were developed to maintain natural feeding behaviors during VFSS. Three food consistencies (thin liquid, pureed food, and dry kibble) were formulated with either iohexol or barium to maximize palatability and voluntary prehension. Dogs were evaluated by 16 swallow metrics and compared across age groups. Development of a standardized VFSS protocol resulted in successful collection of swallow data in healthy dogs. No significant differences in swallow metrics were observed among age groups. Substantial variability was observed in healthy dogs when evaluated under these physiologic conditions. Features typically attributed to pathologic states, such as gastric reflux, were seen in healthy dogs. Development of a VFSS protocol that reflects natural feeding practices may allow emulation of physiology resulting in clinical signs of dysphagia. Age did not result in significant changes in swallow metrics, but additional studies are needed, particularly in light of substantial normal variation. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  1. Benchmarking pediatric cranial CT protocols using a dose tracking software system: a multicenter study

    Energy Technology Data Exchange (ETDEWEB)

    Bondt, Timo de; Parizel, Paul M. [Antwerp University Hospital and University of Antwerp, Department of Radiology, Antwerp (Belgium); Mulkens, Tom [H. Hart Hospital, Department of Radiology, Lier (Belgium); Zanca, Federica [GE Healthcare, DoseWatch, Buc (France); KU Leuven, Imaging and Pathology Department, Leuven (Belgium); Pyfferoen, Lotte; Casselman, Jan W. [AZ St. Jan Brugge-Oostende AV Hospital, Department of Radiology, Brugge (Belgium)

    2017-02-15

    To benchmark regional standard practice for paediatric cranial CT-procedures in terms of radiation dose and acquisition parameters. Paediatric cranial CT-data were retrospectively collected during a 1-year period, in 3 different hospitals of the same country. A dose tracking system was used to automatically gather information. Dose (CTDI and DLP), scan length, amount of retakes and demographic data were stratified by age and clinical indication; appropriate use of child-specific protocols was assessed. In total, 296 paediatric cranial CT-procedures were collected. Although the median dose of each hospital was below national and international diagnostic reference level (DRL) for all age categories, statistically significant (p-value < 0.001) dose differences among hospitals were observed. The hospital with lowest dose levels showed smallest dose variability and used age-stratified protocols for standardizing paediatric head exams. Erroneous selection of adult protocols for children still occurred, mostly in the oldest age-group. Even though all hospitals complied with national and international DRLs, dose tracking and benchmarking showed that further dose optimization and standardization is possible by using age-stratified protocols for paediatric cranial CT. Moreover, having a dose tracking system revealed that adult protocols are still applied for paediatric CT, a practice that must be avoided. (orig.)

  2. Rehabilitation protocol for patellar tendinopathy applied among 16- to 19-year old volleyball players.

    Science.gov (United States)

    Biernat, Ryszard; Trzaskoma, Zbigniew; Trzaskoma, Lukasz; Czaprowski, Dariusz

    2014-01-01

    The aim of the study was to investigate the efficacy of rehabilitation protocol applied during competitive period for the treatment of patellar tendinopathy. A total of 28 male volleyball players were divided into two groups. Fifteen from experimental group (E) and 13 from control group (C) fulfilled the same tests 3 times: before the training program started (first measurement), after 12 weeks (second measurement) and after 24 weeks (third measurement). The above-mentioned protocol included the following: USG imagining with color Doppler function, clinical testing, pain intensity evaluation with VISA-P questionnaire, leg muscle strength and power and jumping ability measurements. The key element of the rehabilitation program was eccentric squat on decline board with additional unstable surface. The essential factor of the protocol was a set of preventive functional exercises, with focus on eccentric exercises of hamstrings. Patellar tendinopathy was observed in 18% of the tested young volleyball players. Implementation of the presented rehabilitation protocol with eccentric squat on decline board applied during sports season lowered the pain level of the young volleyball players. Presented rehabilitation protocol applied without interrupting the competitive period among young volleyball players together with functional exercises could be an effective method for the treatment of patellar tendinopathy.

  3. Radiation dosimetry assessment of routine CT scanning protocols used in Western Australia

    International Nuclear Information System (INIS)

    Moorin, Rachael E; Forsyth, Rene; Gibson, David J; Fox, Richard

    2013-01-01

    Technical data on local CT practice in Western Australia were collected for five major CT providers using a self-completed questionnaire. The CTDIvol DLP and effective dose for each protocol were obtained and providers were ranked according to radiation burden for each clinical scenario. The mean, median, 75th percentile and standard deviation were calculated for both effective dose and DLP for each scenario and these values were compared with published data. CT utilisation data were used to estimate the attributable radiation dose to the WA population and the potential change in population annual effective dose according to the protocol used was estimated. We found that wide variations in technique and radiation dose exist across providers for similar examinations, producing a higher radiation burden than reported internationally. As expected, the CT protocol used dramatically affects the radiation dose received, and this has a significant effect on annual population dose. This study highlights the need for recognition and understanding of both the degree of variation in radiation dose across providers and the relatively high radiation burden afforded by protocols in use in Western Australia so that necessary dialogue can be launched for practitioner consensus on appropriate diagnostic reference levels in CT scanning. (paper)

  4. Optimization of Protocol CT, PET-CT, whole body

    International Nuclear Information System (INIS)

    Gutierrez, Fredys Santos; Namias, Mauro

    2013-01-01

    The objective of this study was to optimize the acquisition protocols and processing existing of the CT PET/CT scanner for clinical use of Nuclear Diagnostic Center Foundation, a way to minimize the radiation dose while maintaining diagnostic image quality properly. Dosimetric data of PET / CT service were surveyed and obtained the baseline against which we compare and define strategies and modifications to develop online. We selected transaxial up to the pulmonary hilum and liver slices as the anatomical regions of interest that led to the standardization of the study

  5. Managing symptoms during cancer treatments: evaluating the implementation of evidence-informed remote support protocols

    Directory of Open Access Journals (Sweden)

    Stacey Dawn

    2012-11-01

    Full Text Available Abstract Background Management of cancer treatment-related symptoms is an important safety issue given that symptoms can become life-threatening and often occur when patients are at home. With funding from the Canadian Partnership Against Cancer, a pan-Canadian steering committee was established with representation from eight provinces to develop symptom protocols using a rigorous methodology (CAN-IMPLEMENT©. Each protocol is based on a systematic review of the literature to identify relevant clinical practice guidelines. Protocols were validated by cancer nurses from across Canada. The aim of this study is to build an effective and sustainable approach for implementing evidence-informed protocols for nurses to use when providing remote symptom assessment, triage, and guidance in self-management for patients experiencing symptoms while undergoing cancer treatments. Methods A prospective mixed-methods study design will be used. Guided by the Knowledge to Action Framework, the study will involve (a establishing an advisory knowledge user team in each of three targeted settings; (b assessing factors influencing nurses’ use of protocols using interviews/focus groups and a standardized survey instrument; (c adapting protocols for local use, ensuring fidelity of the content; (d selecting intervention strategies to overcome known barriers and implementing the protocols; (e conducting think-aloud usability testing; (f evaluating protocol use and outcomes by conducting an audit of 100 randomly selected charts at each of the three settings; and (g assessing satisfaction with remote support using symptom protocols and change in nurses’ barriers to use using survey instruments. The primary outcome is sustained use of the protocols, defined as use in 75% of the calls. Descriptive analysis will be conducted for the barriers, use of protocols, and chart audit outcomes. Content analysis will be conducted on interviews/focus groups and usability testing

  6. Country report: Italy (Chinol). Pre-clinical evaluation of a new biotin-DOTA conjugate labeled with {sup 90}Y for application in pretargeting clinical protocols

    Energy Technology Data Exchange (ETDEWEB)

    Chinol, Marco

    2010-07-01

    In the attempt to improve the therapeutic efficacy of radiolabeled mAbs in cancer radioimmunotherapy, various studies have examined the concept of tumor pretargeting. The so called three-step pretargeting technique, employing the avidin–biotin system, was applied in phase I-II clinical trials showing low toxicity and therapeutic efficacy. The final step of the pretargeting protocols consists in the systemic injection of radiolabeled biotin. The worldwide recognized “successful association” is between {sup 90}Y and the tetraazamacrocycle DOTA chelator chemically bound to biotin. Improvements in the structure of the biotin-DOTA conjugate have been reported by our group following a novel approach which simplified the synthetic pattern by reducing the amide group to a methylene group, thus transforming the amide into a secondary amine without affecting the length of the biotin side arm. Preliminary in-vitro experiments, previously published by our group, indicated the potential of the new conjugate. Based on our previous experience with avidin-based pre-targeting followed {sup 90}Y-DOTA-biotin in the locoregional treatment of peritoneal carcinomatosis and malignant glioma suggested that similar radionuclide therapy might be worth investigating as a partial replacement of external beam radiotherapy in breast cancer. We have developed IART® the Intra-operative Avidination for Radionuclide Therapy that relies on the avidin-biotin binding system. In fact, the “avidination” of the anatomical area of the tumor with native avidin, directly injected by the surgeon into and around the tumor bed, provides a target for the radiolabeled biotin intravenously (iv) injected one day later. In order to optimize the overall strategy, further efforts were needed to optimize the use of the labeled new biotin conjugate and to elucidate its chemical and biological properties. In the first 18 months of this CRP, the pre-clinical evaluation of this new reduced biotinamidohexylamine

  7. Generation of Insulin-Producing Cells from Human Bone Marrow-Derived Mesenchymal Stem Cells: Comparison of Three Differentiation Protocols

    Directory of Open Access Journals (Sweden)

    Mahmoud M. Gabr

    2014-01-01

    Full Text Available Introduction. Many protocols were utilized for directed differentiation of mesenchymal stem cells (MSCs to form insulin-producing cells (IPCs. We compared the relative efficiency of three differentiation protocols. Methods. Human bone marrow-derived MSCs (HBM-MSCs were obtained from three insulin-dependent type 2 diabetic patients. Differentiation into IPCs was carried out by three protocols: conophylline-based (one-step protocol, trichostatin-A-based (two-step protocol, and β-mercaptoethanol-based (three-step protocol. At the end of differentiation, cells were evaluated by immunolabeling for insulin production, expression of pancreatic endocrine genes, and release of insulin and c-peptide in response to increasing glucose concentrations. Results. By immunolabeling, the proportion of generated IPCs was modest (≃3% in all the three protocols. All relevant pancreatic endocrine genes, insulin, glucagon, and somatostatin, were expressed. There was a stepwise increase in insulin and c-peptide release in response to glucose challenge, but the released amounts were low when compared with those of pancreatic islets. Conclusion. The yield of functional IPCs following directed differentiation of HBM-MSCs was modest and was comparable among the three tested protocols. Protocols for directed differentiation of MSCs need further optimization in order to be clinically meaningful. To this end, addition of an extracellular matrix and/or a suitable template should be attempted.

  8. Influence of pre-anaesthetic thoracic radiographs on ASA physical status classification and anaesthetic protocols in traumatized dogs and cats

    International Nuclear Information System (INIS)

    Sigrist, N.; Mosing, M.; Iff, I.; Larenza, M.P.; Lang, J.; Spreng, D.

    2008-01-01

    The purpose of this study was to evaluate if pre-anaesthetic thoracic radiographs contribute to the anaesthetic management of trauma patients by comparing American Society of Anesthesiologists Physical Status Classification (ASA grade) with and without information from thoracic radiography findings. Case records of 157 dogs and cats being anaesthetized with or without post-traumatic, pre-anaesthetic chest radiographs were retrospectively evaluated for clinical parameters, radiographic abnormalities and anaesthetic protocol. Animals were retrospectively assigned an ASA grade. ASA grades, clinical signs of respiratory abnormalities and anaesthesia protocols were compared between animals with and without chest radiographs. The group of animals without pre-anaesthetic radiographs was anaesthetized earlier after trauma and showed less respiratory abnormalities at presentation. The retrospectively evaluated ASA grade significantly increased with the information from thoracic radiography. Animals with a higher ASA grade were less frequently mechanically ventilated. Pre-anaesthetic radiographs may provide important information to assess the ASA grade in traumatized patients and may therefore influence the anesthesia protocol

  9. Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy

    Science.gov (United States)

    Jang, Soobin; Park, Sunju; Jang, Bo-Hyoung; Park, Yu Lee; Lee, Ju Ah; Cho, Chung-Sik; Go, Ho-Yeon; Shin, Yong Cheol; Ko, Seong-Gyu

    2017-01-01

    Introduction Nicotine dependence is a disease, and tobacco use is related to 6 million deaths annually worldwide. Recently, in many countries, there has been growing interest in the use of traditional and complementary medicine (T&CM) methods, especially acupuncture, as therapeutic interventions for smoking cessation. The aim of this pilot study is to investigate the effectiveness of T&CM interventions on smoking cessation. Methods and analysis The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial. This trial will evaluate whether adding T&CM methods (ie, ear and body acupuncture, aromatherapy) to conventional cessation methods (ie, nicotine replacement therapy (NRT), counselling) increases smoking cessation rates. Forty participants over 19 years old who are capable of communicating in Korean will be recruited. They will be current smokers who meet one of the following criteria: (1) smoke more than 10 cigarettes a day, (2) smoke less than 10 cigarettes a day and previously failed to cease smoking, or (3) smoke fewer than 10 cigarettes a day and have a nicotine dependence score (Fagerstrom Test for Nicotine Dependence) of 4 points or more. The trial will consist of 4 weeks of treatment and a 20 week follow-up period. A statistician will perform the statistical analyses for both the intention-to-treat (all randomly assigned participants) and per-protocol (participants who completed the trial without any protocol deviations) data using SAS 9.1.3. Ethics and dissemination This study has been approved by the Institutional Review Board (IRB) of the Dunsan Korean Medicine Hospital of Daejeon University (IRB reference no: DJDSKH-15-BM-11–1, Protocol No. version 4.1.).The protocol will be reapproved by IRB if it requires amendment. The trial will be conducted according to the Declaration of Helsinki, 7th version (2013). This study is designed to minimise the risk to participants

  10. USA-USSR protocol

    CERN Multimedia

    1970-01-01

    On 30 November the USA Atomic Energy Commission and the USSR State Committee for the Utilization of Atomic Energy signed, in Washington, a protocol 'on carrying out of joint projects in the field of high energy physics at the accelerators of the National Accelerator Laboratory (Batavia) and the Institute for High Energy Physics (Serpukhov)'. The protocol will be in force for five years and can be extended by mutual agreement.

  11. Role of oral candidiasis in TB and HIV co-infection: AIDS Clinical Trial Group Protocol A5253.

    Science.gov (United States)

    Shiboski, C H; Chen, H; Ghannoum, M A; Komarow, L; Evans, S; Mukherjee, P K; Isham, N; Katzenstein, D; Asmelash, A; Omozoarhe, A E; Gengiah, S; Allen, R; Tripathy, S; Swindells, S

    2014-06-01

    To evaluate the association between oral candidiasis and tuberculosis (TB) in human immunodeficiency virus (HIV) infected individuals in sub-Saharan Africa, and to investigate oral candidiasis as a potential tool for TB case finding. Protocol A5253 was a cross-sectional study designed to improve the diagnosis of pulmonary TB in HIV-infected adults in high TB prevalence countries. Participants received an oral examination to detect oral candidiasis. We estimated the association between TB disease and oral candidiasis using logistic regression, and sensitivity, specificity and predictive values. Of 454 participants with TB culture results enrolled in African sites, the median age was 33 years, 71% were female and the median CD4 count was 257 cells/mm(3). Fifty-four (12%) had TB disease; the prevalence of oral candidiasis was significantly higher among TB cases (35%) than among non-TB cases (16%, P oral candidiasis when controlling for CD4 count and antifungals (95%CI 1.2-4.7, P = 0.01). The sensitivity of oral candidiasis as a predictor of TB was 35% (95%CI 22-48) and the specificity 85% (95%CI 81-88). We found a strong association between oral candidiasis and TB disease, independent of CD4 count, suggesting that in resource-limited settings, oral candidiasis may provide clinical evidence for increased risk of TB and contribute to TB case finding.

  12. Development and Pilot Implementation of a Search Protocol to Improve Patient Safety on a Psychiatric Inpatient Unit.

    Science.gov (United States)

    Abela-Dimech, Frances; Johnston, Kim; Strudwick, Gillian

    A mental health organization in Ontario, Canada, noted an increase in unsafe items entering locked inpatient units. The purpose of this project was to develop and implement a search protocol to improve patient, staff, and visitor safety by preventing unsafe items from entering a locked inpatient unit. Under the guidance of a clinical nurse specialist, an interprofessional team used the Failure Mode and Effects Analysis framework to identify what items were considered unsafe, how these unsafe items were entering the unit, and what strategies could be used to prevent these items from entering the unit. A standardized search protocol was identified as a strategy to prevent items from entering the unit. The standardized search protocol was developed and piloted on 1 unit. To support the search protocol, an interprofessional team created a poster using a mnemonic aid to educate patients, staff, and visitors about which items could not be brought onto the unit. Educational sessions on the search protocol were provided for staff. The difference between the number of incidents before and after the implementation of the search protocol was statistically significant. Safety on an inpatient unit was increased as incidents of unsafe items entering the unit decreased.

  13. 9.4 T small animal MRI using clinical components for direct translational studies.

    Science.gov (United States)

    Felder, Jörg; Celik, A Avdo; Choi, Chang-Hoon; Schwan, Stefan; Shah, N Jon

    2017-12-28

    Magnetic resonance is a major preclinical and clinical imaging modality ideally suited for longitudinal studies, e.g. in pharmacological developments. The lack of a proven platform that maintains an identical imaging protocol between preclinical and clinical platforms is solved with the construction of an animal scanner based on clinical hard- and software. A small animal magnet and gradient system were connected to a clinical MR system. Several hardware components were either modified or built in-house to achieve compatibility. The clinical software was modified to account for the different field-of-view of a preclinical MR system. The established scanner was evaluated using clinical QA protocols, and platform compatibility for translational research was verified against clinical scanners of different field strength. The constructed animal scanner operates with the majority of clinical imaging sequences. Translational research is greatly facilitated as protocols can be shared between preclinical and clinical platforms. Hence, when maintaining sequences parameters, maximum similarity between pulses played out on a human or an animal system is maintained. Coupling of a small animal magnet with a clinical MR system is a flexible, easy to use way to establish and advance translational imaging capability. It provides cost and labor efficient translational capability as no tedious sequence reprogramming between moieties is required and cross-platform compatibility of sequences facilitates multi-center studies.

  14. Bioremediation protocols

    National Research Council Canada - National Science Library

    Sheehan, David

    1997-01-01

    ..., .. . . . . .. ,. . . .. . . . . . . . .. . . . . .. . . .. . .. 3 2 Granular Nina Sludge Christiansen, Consortia lndra for Bioremediation, M. Mathrani, and Birgitte K. Ahring . 23 PART II PROTOCOLS...

  15. ATM and Internet protocol

    CERN Document Server

    Bentall, M; Turton, B

    1998-01-01

    Asynchronous Transfer Mode (ATM) is a protocol that allows data, sound and video being transferred between independent networks via ISDN links to be supplied to, and interpreted by, the various system protocols.ATM and Internet Protocol explains the working of the ATM and B-ISDN network for readers with a basic understanding of telecommunications. It provides a handy reference to everyone working with ATM who may not require the full standards in detail, but need a comprehensive guide to ATM. A substantial section is devoted to the problems of running IP over ATM and there is some discussion o

  16. Group covariant protocols for quantum string commitment

    International Nuclear Information System (INIS)

    Tsurumaru, Toyohiro

    2006-01-01

    We study the security of quantum string commitment (QSC) protocols with group covariant encoding scheme. First we consider a class of QSC protocol, which is general enough to incorporate all the QSC protocols given in the preceding literatures. Then among those protocols, we consider group covariant protocols and show that the exact upperbound on the binding condition can be calculated. Next using this result, we prove that for every irreducible representation of a finite group, there always exists a corresponding nontrivial QSC protocol which reaches a level of security impossible to achieve classically

  17. Families of quantum fingerprinting protocols

    Science.gov (United States)

    Lovitz, Benjamin; Lütkenhaus, Norbert

    2018-03-01

    We introduce several families of quantum fingerprinting protocols to evaluate the equality function on two n -bit strings in the simultaneous message passing model. The original quantum fingerprinting protocol uses a tensor product of a small number of O (logn ) -qubit high-dimensional signals [H. Buhrman et al., Phys. Rev. Lett. 87, 167902 (2001), 10.1103/PhysRevLett.87.167902], whereas a recently proposed optical protocol uses a tensor product of O (n ) single-qubit signals, while maintaining the O (logn ) information leakage of the original protocol [J. M. Arazola and N. Lütkenhaus, Phys. Rev. A 89, 062305 (2014), 10.1103/PhysRevA.89.062305]. We find a family of protocols which interpolate between the original and optical protocols while maintaining the O (logn ) information leakage, thus demonstrating a tradeoff between the number of signals sent and the dimension of each signal. There has been interest in experimental realization of the recently proposed optical protocol using coherent states [F. Xu et al., Nat. Commun. 6, 8735 (2015), 10.1038/ncomms9735; J.-Y. Guan et al., Phys. Rev. Lett. 116, 240502 (2016), 10.1103/PhysRevLett.116.240502], but as the required number of laser pulses grows linearly with the input size n , eventual challenges for the long-time stability of experimental setups arise. We find a coherent state protocol which reduces the number of signals by a factor 1/2 while also reducing the information leakage. Our reduction makes use of a simple modulation scheme in optical phase space, and we find that more complex modulation schemes are not advantageous. Using a similar technique, we improve a recently proposed coherent state protocol for evaluating the Euclidean distance between two real unit vectors [N. Kumar et al., Phys. Rev. A 95, 032337 (2017), 10.1103/PhysRevA.95.032337] by reducing the number of signals by a factor 1/2 and also reducing the information leakage.

  18. Immunosuppression for in vivo research: state-of-the-art protocols and experimental approaches

    Institute of Scientific and Technical Information of China (English)

    Rita Diehl; Fabienne Ferrara; Claudia Müller; Antje Y Dreyer; Damian D McLeod; Stephan Fricke; Johannes Boltze

    2017-01-01

    Almost every experimental treatment strategy using non-autologous cell,tissue or organ transplantation is tested in small and large animal models before clinical translation.Because these strategies require immunosuppression in most cases,immunosuppressive protocols are a key element in transplantation experiments.However,standard immunosuppressive protocols are often applied without detailed knowledge regarding their efficacy within the particular experimental setting and in the chosen model species.Optimization of such protocols is pertinent to the translation of experimental results to human patients and thus warrants further investigation.This review summarizes current knowledge regarding immunosuppressive drug classes as well as their dosages and application regimens with consideration of species-specific drug metabolization and side effects.It also summarizes contemporary knowledge of novel immunomodulatory strategies,such as the use of mesenchymal stem cells or antibodies.Thus,this review is intended to serve as a state-of-the-art compendium for researchers to refine applied experimental immunosuppression and immunomodulation strategies to enhance the predictive value of preclinical transplantation studies.

  19. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology.

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C; Hobbs, Brian P; Berry, Donald A; Pentz, Rebecca D; Tam, Alda; Hong, Waun K; Ellis, Lee M; Abbruzzese, James; Overman, Michael J

    2015-11-01

    The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P medicine, additional initiatives are needed to minimize selective reporting. © 2015 by American Society of Clinical Oncology.

  20. Team Training and Institutional Protocols to Prevent Shoulder Dystocia Complications.

    Science.gov (United States)

    Smith, Samuel

    2016-12-01

    Shoulder dystocia is an obstetrical emergency that may result in significant neonatal complications. It requires rapid recognition and a coordinated response. Standardization of care, teamwork and communication, and clinical simulation are the key components of patient safety programs in obstetrics. Simulation-based team training and institutional protocols for the management of shoulder dystocia are emerging as integral components of many labor and delivery safety initiatives because of their impact on technical skills and team performance.

  1. In-memory interconnect protocol configuration registers

    Energy Technology Data Exchange (ETDEWEB)

    Cheng, Kevin Y.; Roberts, David A.

    2017-09-19

    Systems, apparatuses, and methods for moving the interconnect protocol configuration registers into the main memory space of a node. The region of memory used for storing the interconnect protocol configuration registers may also be made cacheable to reduce the latency of accesses to the interconnect protocol configuration registers. Interconnect protocol configuration registers which are used during a startup routine may be prefetched into the host's cache to make the startup routine more efficient. The interconnect protocol configuration registers for various interconnect protocols may include one or more of device capability tables, memory-side statistics (e.g., to support two-level memory data mapping decisions), advanced memory and interconnect features such as repair resources and routing tables, prefetching hints, error correcting code (ECC) bits, lists of device capabilities, set and store base address, capability, device ID, status, configuration, capabilities, and other settings.

  2. In-memory interconnect protocol configuration registers

    Science.gov (United States)

    Cheng, Kevin Y.; Roberts, David A.

    2017-09-19

    Systems, apparatuses, and methods for moving the interconnect protocol configuration registers into the main memory space of a node. The region of memory used for storing the interconnect protocol configuration registers may also be made cacheable to reduce the latency of accesses to the interconnect protocol configuration registers. Interconnect protocol configuration registers which are used during a startup routine may be prefetched into the host's cache to make the startup routine more efficient. The interconnect protocol configuration registers for various interconnect protocols may include one or more of device capability tables, memory-side statistics (e.g., to support two-level memory data mapping decisions), advanced memory and interconnect features such as repair resources and routing tables, prefetching hints, error correcting code (ECC) bits, lists of device capabilities, set and store base address, capability, device ID, status, configuration, capabilities, and other settings.

  3. Robot training of upper limb in multiple sclerosis: comparing protocols with or without manipulative task components.

    Science.gov (United States)

    Carpinella, Ilaria; Cattaneo, Davide; Bertoni, Rita; Ferrarin, Maurizio

    2012-05-01

    In this pilot study, we compared two protocols for robot-based rehabilitation of upper limb in multiple sclerosis (MS): a protocol involving reaching tasks (RT) requiring arm transport only and a protocol requiring both objects' reaching and manipulation (RMT). Twenty-two MS subjects were assigned to RT or RMT group. Both protocols consisted of eight sessions. During RT training, subjects moved the handle of a planar robotic manipulandum toward circular targets displayed on a screen. RMT protocol required patients to reach and manipulate real objects, by moving the robotic arm equipped with a handle which left the hand free for distal tasks. In both trainings, the robot generated resistive and perturbing forces. Subjects were evaluated with clinical and instrumental tests. The results confirmed that MS patients maintained the ability to adapt to the robot-generated forces and that the rate of motor learning increased across sessions. Robot-therapy significantly reduced arm tremor and improved arm kinematics and functional ability. Compared to RT, RMT protocol induced a significantly larger improvement in movements involving grasp (improvement in Grasp ARAT sub-score: RMT 77.4%, RT 29.5%, p=0.035) but not precision grip. Future studies are needed to evaluate if longer trainings and the use of robotic handles would significantly improve also fine manipulation.

  4. Construction of an Anthropomorphic Phantom for Use in Evaluating Pediatric Airway Digital Tomosynthesis Protocols

    Directory of Open Access Journals (Sweden)

    Nima Kasraie

    2018-01-01

    Full Text Available Interpretation of radiolucent foreign bodies (FBs is a common task charged to pediatric radiologists. The use of a motion compensated technique to decrease breathing motion on images would greatly decrease overall exposure to ionizing radiation and increase access to treatment yielding a great impact on clinical care. This study reports on the methodology and materials used to construct an in-house anthropomorphic phantom for investigating image quality in digital tomosynthesis protocols for volumetric imaging of the pediatric airway. Availability and cost of possible substitute materials were considered and simplifying assumptions were made. Two different modular phantoms were assembled in coronal slab layers using materials designed to approximate a one- and three-year-old thorax at diagnostic photon energies for use with digital tomosynthesis protocols such as those offered on GE’s VolumeRAD application. Exposures were made using both phantoms with inserted food particles inside an oscillating airway. The goal of the phantom is to help evaluate (1 whether the currently used protocol is sufficient to image the airway despite breathing motion and (2 whether it is not, to find the optimal protocol by testing various commercially available protocols using this phantom. The affordable construction of the pediatric sized phantom aimed at optimizing GE’s VolumeRAD protocol for airway foreign body imaging is demonstrated in this study which can be used to test VolumeRAD’s ability to image the airways with and without a low-density foreign body within the airways.

  5. DNA repair protocols

    DEFF Research Database (Denmark)

    Bjergbæk, Lotte

    In its 3rd edition, this Methods in Molecular Biology(TM) book covers the eukaryotic response to genomic insult including advanced protocols and standard techniques in the field of DNA repair. Offers expert guidance for DNA repair, recombination, and replication. Current knowledge of the mechanisms...... that regulate DNA repair has grown significantly over the past years with technology advances such as RNA interference, advanced proteomics and microscopy as well as high throughput screens. The third edition of DNA Repair Protocols covers various aspects of the eukaryotic response to genomic insult including...... recent advanced protocols as well as standard techniques used in the field of DNA repair. Both mammalian and non-mammalian model organisms are covered in the book, and many of the techniques can be applied with only minor modifications to other systems than the one described. Written in the highly...

  6. Spontaneous swallow frequency compared with clinical screening in the identification of dysphagia in acute stroke.

    Science.gov (United States)

    Crary, Michael A; Carnaby, Giselle D; Sia, Isaac

    2014-09-01

    The aim of this study was to compare spontaneous swallow frequency analysis (SFA) with clinical screening protocols for identification of dysphagia in acute stroke. In all, 62 patients with acute stroke were evaluated for spontaneous swallow frequency rates using a validated acoustic analysis technique. Independent of SFA, these same patients received a routine nurse-administered clinical dysphagia screening as part of standard stroke care. Both screening tools were compared against a validated clinical assessment of dysphagia for acute stroke. In addition, psychometric properties of SFA were compared against published, validated clinical screening protocols. Spontaneous SFA differentiates patients with versus without dysphagia after acute stroke. Using a previously identified cut point based on swallows per minute, spontaneous SFA demonstrated superior ability to identify dysphagia cases compared with a nurse-administered clinical screening tool. In addition, spontaneous SFA demonstrated equal or superior psychometric properties to 4 validated, published clinical dysphagia screening tools. Spontaneous SFA has high potential to identify dysphagia in acute stroke with psychometric properties equal or superior to clinical screening protocols. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  7. Phase Transition in Protocols Minimizing Work Fluctuations

    Science.gov (United States)

    Solon, Alexandre P.; Horowitz, Jordan M.

    2018-05-01

    For two canonical examples of driven mesoscopic systems—a harmonically trapped Brownian particle and a quantum dot—we numerically determine the finite-time protocols that optimize the compromise between the standard deviation and the mean of the dissipated work. In the case of the oscillator, we observe a collection of protocols that smoothly trade off between average work and its fluctuations. However, for the quantum dot, we find that as we shift the weight of our optimization objective from average work to work standard deviation, there is an analog of a first-order phase transition in protocol space: two distinct protocols exchange global optimality with mixed protocols akin to phase coexistence. As a result, the two types of protocols possess qualitatively different properties and remain distinct even in the infinite duration limit: optimal-work-fluctuation protocols never coalesce with the minimal-work protocols, which therefore never become quasistatic.

  8. Generalized routing protocols for multihop relay networks

    KAUST Repository

    Khan, Fahd Ahmed

    2011-07-01

    Performance of multihop cooperative networks depends on the routing protocols employed. In this paper we propose the last-n-hop selection protocol, the dual path protocol, the forward-backward last-n-hop selection protocol and the forward-backward dual path protocol for the routing of data through multihop relay networks. The average symbol error probability performance of the schemes is analysed by simulations. It is shown that close to optimal performance can be achieved by using the last-n-hop selection protocol and its forward-backward variant. Furthermore we also compute the complexity of the protocols in terms of number of channel state information required and the number of comparisons required for routing the signal through the network. © 2011 IEEE.

  9. Discovering biomarkers for antidepressant response: protocol from the Canadian biomarker integration network in depression (CAN-BIND) and clinical characteristics of the first patient cohort.

    Science.gov (United States)

    Lam, Raymond W; Milev, Roumen; Rotzinger, Susan; Andreazza, Ana C; Blier, Pierre; Brenner, Colleen; Daskalakis, Zafiris J; Dharsee, Moyez; Downar, Jonathan; Evans, Kenneth R; Farzan, Faranak; Foster, Jane A; Frey, Benicio N; Geraci, Joseph; Giacobbe, Peter; Feilotter, Harriet E; Hall, Geoffrey B; Harkness, Kate L; Hassel, Stefanie; Ismail, Zahinoor; Leri, Francesco; Liotti, Mario; MacQueen, Glenda M; McAndrews, Mary Pat; Minuzzi, Luciano; Müller, Daniel J; Parikh, Sagar V; Placenza, Franca M; Quilty, Lena C; Ravindran, Arun V; Salomons, Tim V; Soares, Claudio N; Strother, Stephen C; Turecki, Gustavo; Vaccarino, Anthony L; Vila-Rodriguez, Fidel; Kennedy, Sidney H

    2016-04-16

    Major Depressive Disorder (MDD) is among the most prevalent and disabling medical conditions worldwide. Identification of clinical and biological markers ("biomarkers") of treatment response could personalize clinical decisions and lead to better outcomes. This paper describes the aims, design, and methods of a discovery study of biomarkers in antidepressant treatment response, conducted by the Canadian Biomarker Integration Network in Depression (CAN-BIND). The CAN-BIND research program investigates and identifies biomarkers that help to predict outcomes in patients with MDD treated with antidepressant medication. The primary objective of this initial study (known as CAN-BIND-1) is to identify individual and integrated neuroimaging, electrophysiological, molecular, and clinical predictors of response to sequential antidepressant monotherapy and adjunctive therapy in MDD. CAN-BIND-1 is a multisite initiative involving 6 academic health centres working collaboratively with other universities and research centres. In the 16-week protocol, patients with MDD are treated with a first-line antidepressant (escitalopram 10-20 mg/d) that, if clinically warranted after eight weeks, is augmented with an evidence-based, add-on medication (aripiprazole 2-10 mg/d). Comprehensive datasets are obtained using clinical rating scales; behavioural, dimensional, and functioning/quality of life measures; neurocognitive testing; genomic, genetic, and proteomic profiling from blood samples; combined structural and functional magnetic resonance imaging; and electroencephalography. De-identified data from all sites are aggregated within a secure neuroinformatics platform for data integration, management, storage, and analyses. Statistical analyses will include multivariate and machine-learning techniques to identify predictors, moderators, and mediators of treatment response. From June 2013 to February 2015, a cohort of 134 participants (85 outpatients with MDD and 49 healthy participants

  10. A process evaluation of implementing a vocational enablement protocol for employees with hearing difficulties in clinical practice

    NARCIS (Netherlands)

    Gussenhoven, A.H.M.; Singh, A.S.; Goverts, S.T.; van Til, M.; Anema, J.R.; Kramer, S.E.

    2015-01-01

    A multidisciplinary vocational rehabilitation programme, the Vocational Enablement Protocol (VEP) was developed to address the specific needs of employees with hearing difficulties. In the current study we evaluated the process of implementing the VEP in audiologic care among employees with hearing

  11. Bioinspired Security Analysis of Wireless Protocols

    DEFF Research Database (Denmark)

    Petrocchi, Marinella; Spognardi, Angelo; Santi, Paolo

    2016-01-01

    work, this paper investigates feasibility of adopting fraglets as model for specifying security protocols and analysing their properties. In particular, we give concrete sample analyses over a secure RFID protocol, showing evolution of the protocol run as chemical dynamics and simulating an adversary...

  12. Parents as Agents of Change (PAC in pediatric weight management: The protocol for the PAC randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ball Geoff D C

    2012-08-01

    Full Text Available Abstract Background There is an urgent need to develop and evaluate weight management interventions to address childhood obesity. Recent research suggests that interventions designed for parents exclusively, which have been named parents as agents of change (PAC approaches, have yielded positive outcomes for managing pediatric obesity. To date, no research has combined a PAC intervention approach with cognitive behavioural therapy (CBT to examine whether these combined elements enhance intervention effectiveness. This paper describes the protocol our team is using to examine two PAC-based interventions for pediatric weight management. We hypothesize that children with obesity whose parents complete a CBT-based PAC intervention will achieve greater reductions in adiposity and improvements in cardiometabolic risk factors, lifestyle behaviours, and psychosocial outcomes than children whose parents complete a psycho-education-based PAC intervention (PEP. Methods/Design This study is a pragmatic, two-armed, parallel, single-blinded, superiority, randomized clinical trial. The primary objective is to examine the differential effects of a CBT-based PAC vs PEP-based PAC intervention on children’s BMI z-score (primary outcome. Secondary objectives are to assess intervention-mediated changes in cardiometabolic, lifestyle, and psychosocial variables in children and parents. Both interventions are similar in frequency of contact, session duration, group facilitation, lifestyle behaviour goals, and educational content. However, the interventions differ insofar as the CBT-based intervention incorporates theory-based concepts to help parents link their thoughts, feelings, and behaviours; these cognitive activities are enabled by group leaders who possess formal training in CBT. Mothers and fathers of children (8–12 years of age; BMI ≥85th percentile are eligible to participate if they are proficient in English (written and spoken and agree for at least

  13. A security analysis of the 802.11s wireless mesh network routing protocol and its secure routing protocols.

    Science.gov (United States)

    Tan, Whye Kit; Lee, Sang-Gon; Lam, Jun Huy; Yoo, Seong-Moo

    2013-09-02

    Wireless mesh networks (WMNs) can act as a scalable backbone by connecting separate sensor networks and even by connecting WMNs to a wired network. The Hybrid Wireless Mesh Protocol (HWMP) is the default routing protocol for the 802.11s WMN. The routing protocol is one of the most important parts of the network, and it requires protection, especially in the wireless environment. The existing security protocols, such as the Broadcast Integrity Protocol (BIP), Counter with cipher block chaining message authentication code protocol (CCMP), Secure Hybrid Wireless Mesh Protocol (SHWMP), Identity Based Cryptography HWMP (IBC-HWMP), Elliptic Curve Digital Signature Algorithm HWMP (ECDSA-HWMP), and Watchdog-HWMP aim to protect the HWMP frames. In this paper, we have analyzed the vulnerabilities of the HWMP and developed security requirements to protect these identified vulnerabilities. We applied the security requirements to analyze the existing secure schemes for HWMP. The results of our analysis indicate that none of these protocols is able to satisfy all of the security requirements. We also present a quantitative complexity comparison among the protocols and an example of a security scheme for HWMP to demonstrate how the result of our research can be utilized. Our research results thus provide a tool for designing secure schemes for the HWMP.

  14. Maximally efficient protocols for direct secure quantum communication

    Energy Technology Data Exchange (ETDEWEB)

    Banerjee, Anindita [Department of Physics and Materials Science Engineering, Jaypee Institute of Information Technology, A-10, Sector-62, Noida, UP-201307 (India); Department of Physics and Center for Astroparticle Physics and Space Science, Bose Institute, Block EN, Sector V, Kolkata 700091 (India); Pathak, Anirban, E-mail: anirban.pathak@jiit.ac.in [Department of Physics and Materials Science Engineering, Jaypee Institute of Information Technology, A-10, Sector-62, Noida, UP-201307 (India); RCPTM, Joint Laboratory of Optics of Palacky University and Institute of Physics of Academy of Science of the Czech Republic, Faculty of Science, Palacky University, 17. Listopadu 12, 77146 Olomouc (Czech Republic)

    2012-10-01

    Two protocols for deterministic secure quantum communication (DSQC) using GHZ-like states have been proposed. It is shown that one of these protocols is maximally efficient and that can be modified to an equivalent protocol of quantum secure direct communication (QSDC). Security and efficiency of the proposed protocols are analyzed and compared. It is shown that dense coding is sufficient but not essential for DSQC and QSDC protocols. Maximally efficient QSDC protocols are shown to be more efficient than their DSQC counterparts. This additional efficiency arises at the cost of message transmission rate. -- Highlights: ► Two protocols for deterministic secure quantum communication (DSQC) are proposed. ► One of the above protocols is maximally efficient. ► It is modified to an equivalent protocol of quantum secure direct communication (QSDC). ► It is shown that dense coding is sufficient but not essential for DSQC and QSDC protocols. ► Efficient QSDC protocols are always more efficient than their DSQC counterparts.

  15. Physical Therapy Protocols for Arthroscopic Bankart Repair.

    Science.gov (United States)

    DeFroda, Steven F; Mehta, Nabil; Owens, Brett D

    Outcomes after arthroscopic Bankart repair can be highly dependent on compliance and participation in physical therapy. Additionally, there are many variations in physician-recommended physical therapy protocols. The rehabilitation protocols of academic orthopaedic surgery departments vary widely despite the presence of consensus protocols. Descriptive epidemiology study. Level 3. Web-based arthroscopic Bankart rehabilitation protocols available online from Accreditation Council for Graduate Medical Education (ACGME)-accredited orthopaedic surgery programs were included for review. Individual protocols were reviewed to evaluate for the presence or absence of recommended therapies, goals for completion of ranges of motion, functional milestones, exercise start times, and recommended time to return to sport. Thirty protocols from 27 (16.4%) total institutions were identified out of 164 eligible for review. Overall, 9 (30%) protocols recommended an initial period of strict immobilization. Variability existed between the recommended time periods for sling immobilization (mean, 4.8 ± 1.8 weeks). The types of exercises and their start dates were also inconsistent. Goals to full passive range of motion (mean, 9.2 ± 2.8 weeks) and full active range of motion (mean, 12.2 ± 2.8 weeks) were consistent with other published protocols; however, wide ranges existed within the reviewed protocols as a whole. Only 10 protocols (33.3%) included a timeline for return to sport, and only 3 (10%) gave an estimate for return to game competition. Variation also existed when compared with the American Society of Shoulder and Elbow Therapists' (ASSET) consensus protocol. Rehabilitation protocols after arthroscopic Bankart repair were found to be highly variable. They also varied with regard to published consensus protocols. This discrepancy may lead to confusion among therapists and patients. This study highlights the importance of attending surgeons being very clear and specific with

  16. Effect of different financial competing interest statements on readers' perceptions of clinical educational articles: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Schroter, Sara; Pakpoor, Julia; Morris, Julie; Chew, Mabel; Godlee, Fiona

    2016-06-10

    Financial ties with industry are varied and common among academics, doctors and institutions. Clinical educational articles are intended to guide patient care and convey authors' own interpretation of selected data. Author biases in educational articles tend to be less visible to readers compared to those in research papers. Little is known about which types of competing interest statements affect readers' interpretation of the credibility of these articles. This study aims to investigate how different competing interest statements in educational articles affect clinical readers' perceptions of the articles. 2040 doctors who are members of the British Medical Association (BMA) and receive a copy of the British Medical Journal (The BMJ) each week will be randomly selected and invited by an email to participate in the study. They will be randomised to receive 1 of 2 Clinical Reviews, each with 1 of 4 possible competing interest statements. Versions of each review will be identical except for permutations of the competing interest statement. Study participants will be asked to read their article and complete an online questionnaire. The questionnaire will ask participants to rate their confidence in the conclusions drawn in the article, the importance of the article, their level of interest in the article and their likeliness to change their practice from the article. Factorial analyses of variance and analyses of covariance will be carried out to assess the impact of the type of competing interest statement and Clinical Review on level of confidence, importance, interest and likeliness to change practice. The study protocol, questionnaire and letter of invitation to participants have been reviewed by members of The BMJ's Ethics Committee for ethical concerns. The trial results will be disseminated to participants and published in a peer-reviewed journal. NCT02548312; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already

  17. The Network Protocol Analysis Technique in Snort

    Science.gov (United States)

    Wu, Qing-Xiu

    Network protocol analysis is a network sniffer to capture data for further analysis and understanding of the technical means necessary packets. Network sniffing is intercepted by packet assembly binary format of the original message content. In order to obtain the information contained. Required based on TCP / IP protocol stack protocol specification. Again to restore the data packets at protocol format and content in each protocol layer. Actual data transferred, as well as the application tier.

  18. A protocol for developing a clinical practice guideline for intra-articular injection for treating knee osteoarthritis

    Directory of Open Access Journals (Sweden)

    Dan Xing

    2018-01-01

    Ethics and dissemination: The protocol will provide us a roadmap to systematically develop evidence-based CPG for intra-articular injection for knee OA. The work will be disseminated electronically and in print. The guideline would be the first CPG that is developed primarily by orthopedic specialists in China and strictly based on systematic methodology.

  19. Welfare Quality assessment protocol for laying hens = Welfare Quality assessment protocol voor leghennen

    NARCIS (Netherlands)

    Niekerk, van T.G.C.M.; Gunnink, H.; Reenen, van C.G.

    2012-01-01

    Results of a study on the Welfare Quality® assessment protocol for laying hens. It reports the development of the integration of welfare assessment as scores per criteria as well as simplification of the Welfare Quality® assessment protocol. Results are given from assessment of 122 farms.

  20. Protocol Fuel Mix reporting

    International Nuclear Information System (INIS)

    2002-07-01

    The protocol in this document describes a method for an Electricity Distribution Company (EDC) to account for the fuel mix of electricity that it delivers to its customers, based on the best available information. Own production, purchase and sale of electricity, and certificates trading are taken into account. In chapter 2 the actual protocol is outlined. In the appendixes additional (supporting) information is given: (A) Dutch Standard Fuel Mix, 2000; (B) Calculation of the Dutch Standard fuel mix; (C) Procedures to estimate and benchmark the fuel mix; (D) Quality management; (E) External verification; (F) Recommendation for further development of the protocol; (G) Reporting examples

  1. Pediatric superficial scald burns--reassessment of our follow-up protocol.

    Science.gov (United States)

    Egro, Francesco M; O'Neill, Jennifer K; Briard, Robert; Cubison, Tania C S; Kay, Alan R; Estela, Catalina M; Burge, Timothy S

    2010-01-01

    The most common pediatric burn injury is a superficial scald. The current follow-up protocol for such burns includes review of the patient at 2 weeks postinjury and then 2 months later. The authors decided to review the protocol to assess the need for this second follow-up. A retrospective study reviewed the case notes of patients younger than 16 years at the time of their injury presenting with a scald over 5% TBSA. The progress of healing and scar development up to 5 years follow-up was assessed. This study showed that scalds healing within 2 weeks following injury rarely became hypertrophic. A prospective study was performed over a 10-month period. All children who suffered a superficial partial-thickness scald injury were included. At the 2-week appointment, the need for further follow-up was predicted. The accuracy of this prediction was assessed 2 months later. This study showed that an experienced member of the burns team could reliably predict at 2-week appointment those children who could be safely discharged with no subsequent need for scar management. This study suggests that it will be safe to modify the follow-up protocol, reducing the number of clinic attendances.

  2. TH-C-18A-08: A Management Tool for CT Dose Monitoring, Analysis, and Protocol Review

    International Nuclear Information System (INIS)

    Wang, J; Chan, F; Newman, B; Larson, D; Leung, A; Fleischmann, D; Molvin, L; Marsh, D; Zorich, C; Phillips, L

    2014-01-01

    Purpose: To develop a customizable tool for enterprise-wide managing of CT protocols and analyzing radiation dose information of CT exams for a variety of quality control applications Methods: All clinical CT protocols implemented on the 11 CT scanners at our institution were extracted in digital format. The original protocols had been preset by our CT management team. A commercial CT dose tracking software (DoseWatch,GE healthcare,WI) was used to collect exam information (exam date, patient age etc.), scanning parameters, and radiation doses for all CT exams. We developed a Matlab-based program (MathWorks,MA) with graphic user interface which allows to analyze the scanning protocols with the actual dose estimates, and compare the data to national (ACR,AAPM) and internal reference values for CT quality control. Results: The CT protocol review portion of our tool allows the user to look up the scanning and image reconstruction parameters of any protocol on any of the installed CT systems among about 120 protocols per scanner. In the dose analysis tool, dose information of all CT exams (from 05/2013 to 02/2014) was stratified on a protocol level, and within a protocol down to series level, i.e. each individual exposure event. This allows numerical and graphical review of dose information of any combination of scanner models, protocols and series. The key functions of the tool include: statistics of CTDI, DLP and SSDE, dose monitoring using user-set CTDI/DLP/SSDE thresholds, look-up of any CT exam dose data, and CT protocol review. Conclusion: our inhouse CT management tool provides radiologists, technologists and administration a first-hand near real-time enterprise-wide knowledge on CT dose levels of different exam types. Medical physicists use this tool to manage CT protocols, compare and optimize dose levels across different scanner models. It provides technologists feedback on CT scanning operation, and knowledge on important dose baselines and thresholds

  3. Artery-only fingertip replantations using a controlled nailbed bleeding protocol.

    Science.gov (United States)

    Erken, H Yener; Takka, Semih; Akmaz, Ibrahim

    2013-11-01

    We report our experience, treatment protocol, and 2-year follow-up results of 24 fingertip replantations treated using the artery-only technique without vein or nerve repair. We performed a retrospective review of 24 patients who had undergone fingertip replantation at the same center between 2005 and 2011. All patients in this study had complete fingertip amputation at or distal to the distal interphalangeal joint of the fingers or interphalangeal joint of the thumb. Patients with incomplete and complete amputations who had undergone vein and/or nerve repair along with artery repair were excluded. All patients received the same protocol including removal of the nail at the surgery and intravenous heparin 70 U/kg administered at the time of arterial anastomosis. After surgery, the nailbed was mechanically made to bleed with a sterile needle and mechanically scrubbed with a heparin-saline gauze. All patients received the same postoperative medical treatment protocol until physiological outflow was restored. Successful replantation was confirmed with clinical observation. Twenty-one of the 24 fingertip replantations (88%) were successful. The mean length of hospital stay was 7 days (range, 4-9 d). Fifteen of 22 patients required blood transfusion. The average amount of blood transfusion was 1.2 U (range, 0-3 U). This study shows that the described technique and protocol reconstructed circulation without vein anastomosis and with a high success rate. Furthermore, adequate sensory recovery without any nerve repair had occurred by the 2-year follow-up. Therapeutic IV. Copyright © 2013 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  4. Do Different Stimulation Protocols Effect Oocyte Quality and IVF Outcomes in IVF-ET?

    Directory of Open Access Journals (Sweden)

    Nafiye Yilmaz

    2016-04-01

    Full Text Available Aim: This study was planned to compare the effect of different stimulation protocols (hMG and uFSH on oocyte maturation and in vitro fertilization outcomes. Material and Method: Eighty-two patients admitted Ankara University Obstetrics and Gynecology Clinic- IVF Department were included in this retrospective study. All patients used long GnRH agonist protocol. Fifty-nine patients used human menopausal gonadotropin (hMG (Group 1 and 23 patients used urine derived follicle-stimulating hormone (uFSH (Group 2 for ovulation induction. Maximum follicle diameter, dominant follicle number, endometrial thickness at human chorionic gonadotropin day, duration of induction, dose of gonadotropin, oocyte number and quality, fertilization rate, embryo number and quality, pregnancy rate per cycles and transfer were reported. Results: Maximum follicle diameter, dominant follicle number, immature oocyte number were significantly higher in hMG group vs. uFSH group (p0.05. Discussion: Clinical pregnancy rate was not significantly different in hMG vs. uFSH group. In developing countries, ovarian stimulation agents should be chosen based on patient characteristics and cost.

  5. Universally composable protocols with relaxed set-up assumptions

    DEFF Research Database (Denmark)

    Barak, Boaz; Canetti, Ran; Nielsen, Jesper Buus

    2004-01-01

    A desirable goal for cryptographic protocols is to guarantee security when the protocol is composed with other protocol instances. Universally composable (UC) protocols provide this guarantee in a strong sense: A protocol remains secure even when composed concurrently with an unbounded number of ...

  6. In silico toxicology protocols.

    Science.gov (United States)

    Myatt, Glenn J; Ahlberg, Ernst; Akahori, Yumi; Allen, David; Amberg, Alexander; Anger, Lennart T; Aptula, Aynur; Auerbach, Scott; Beilke, Lisa; Bellion, Phillip; Benigni, Romualdo; Bercu, Joel; Booth, Ewan D; Bower, Dave; Brigo, Alessandro; Burden, Natalie; Cammerer, Zoryana; Cronin, Mark T D; Cross, Kevin P; Custer, Laura; Dettwiler, Magdalena; Dobo, Krista; Ford, Kevin A; Fortin, Marie C; Gad-McDonald, Samantha E; Gellatly, Nichola; Gervais, Véronique; Glover, Kyle P; Glowienke, Susanne; Van Gompel, Jacky; Gutsell, Steve; Hardy, Barry; Harvey, James S; Hillegass, Jedd; Honma, Masamitsu; Hsieh, Jui-Hua; Hsu, Chia-Wen; Hughes, Kathy; Johnson, Candice; Jolly, Robert; Jones, David; Kemper, Ray; Kenyon, Michelle O; Kim, Marlene T; Kruhlak, Naomi L; Kulkarni, Sunil A; Kümmerer, Klaus; Leavitt, Penny; Majer, Bernhard; Masten, Scott; Miller, Scott; Moser, Janet; Mumtaz, Moiz; Muster, Wolfgang; Neilson, Louise; Oprea, Tudor I; Patlewicz, Grace; Paulino, Alexandre; Lo Piparo, Elena; Powley, Mark; Quigley, Donald P; Reddy, M Vijayaraj; Richarz, Andrea-Nicole; Ruiz, Patricia; Schilter, Benoit; Serafimova, Rositsa; Simpson, Wendy; Stavitskaya, Lidiya; Stidl, Reinhard; Suarez-Rodriguez, Diana; Szabo, David T; Teasdale, Andrew; Trejo-Martin, Alejandra; Valentin, Jean-Pierre; Vuorinen, Anna; Wall, Brian A; Watts, Pete; White, Angela T; Wichard, Joerg; Witt, Kristine L; Woolley, Adam; Woolley, David; Zwickl, Craig; Hasselgren, Catrin

    2018-04-17

    The present publication surveys several applications of in silico (i.e., computational) toxicology approaches across different industries and institutions. It highlights the need to develop standardized protocols when conducting toxicity-related predictions. This contribution articulates the information needed for protocols to support in silico predictions for major toxicological endpoints of concern (e.g., genetic toxicity, carcinogenicity, acute toxicity, reproductive toxicity, developmental toxicity) across several industries and regulatory bodies. Such novel in silico toxicology (IST) protocols, when fully developed and implemented, will ensure in silico toxicological assessments are performed and evaluated in a consistent, reproducible, and well-documented manner across industries and regulatory bodies to support wider uptake and acceptance of the approaches. The development of IST protocols is an initiative developed through a collaboration among an international consortium to reflect the state-of-the-art in in silico toxicology for hazard identification and characterization. A general outline for describing the development of such protocols is included and it is based on in silico predictions and/or available experimental data for a defined series of relevant toxicological effects or mechanisms. The publication presents a novel approach for determining the reliability of in silico predictions alongside experimental data. In addition, we discuss how to determine the level of confidence in the assessment based on the relevance and reliability of the information. Copyright © 2018. Published by Elsevier Inc.

  7. Summary Report on Unconditionally Secure Protocols

    DEFF Research Database (Denmark)

    Damgård, Ivan Bjerre; Salvail, Louis; Cachin, Christian

    This document describes the state of the art snd some of the main open problems in the area of unconditionally secure cryptographic protocols. The most essential part of a cryptographic protocol is not its being secure. Imagine a cryptographic protocol which is secure, but where we do not know...... that it is secure. Such a protocol would do little in providing security. When all comes to all, cryptographic security is done for the sake of people, and the essential part of security is for people what it has always been, namely to feel secure. To feel secure employing a given cryptographic protocol we need...... to know that is is secure. I.e. we need a proof that it is secure. Today the proof of security of essentially all practically employed cryptographic protocols relies on computational assumptions. To prove that currently employed ways to communicate securely over the Internet are secure we e.g. need...

  8. Network-topology-adaptive quantum conference protocols

    International Nuclear Information System (INIS)

    Zhang Sheng; Wang Jian; Tang Chao-Jing; Zhang Quan

    2011-01-01

    As an important application of the quantum network communication, quantum multiparty conference has made multiparty secret communication possible. Previous quantum multiparty conference schemes based on quantum data encryption are insensitive to network topology. However, the topology of the quantum network significantly affects the communication efficiency, e.g., parallel transmission in a channel with limited bandwidth. We have proposed two distinctive protocols, which work in two basic network topologies with efficiency higher than the existing ones. We first present a protocol which works in the reticulate network using Greeberger—Horne—Zeilinger states and entanglement swapping. Another protocol, based on quantum multicasting with quantum data compression, which can improve the efficiency of the network, works in the star-like network. The security of our protocols is guaranteed by quantum key distribution and one-time-pad encryption. In general, the two protocols can be applied to any quantum network where the topology can be equivalently transformed to one of the two structures we propose in our protocols. (general)

  9. Analysis of agreement between cardiac risk stratification protocols applied to participants of a center for cardiac rehabilitation

    Directory of Open Access Journals (Sweden)

    Ana A. S. Santos

    2016-01-01

    Full Text Available ABSTRACT Background Cardiac risk stratification is related to the risk of the occurrence of events induced by exercise. Despite the existence of several protocols to calculate risk stratification, studies indicating that there is similarity between these protocols are still unknown. Objective To evaluate the agreement between the existing protocols on cardiac risk rating in cardiac patients. Method The records of 50 patients from a cardiac rehabilitation program were analyzed, from which the following information was extracted: age, sex, weight, height, clinical diagnosis, medical history, risk factors, associated diseases, and the results from the most recent laboratory and complementary tests performed. This information was used for risk stratification of the patients in the protocols of the American College of Sports Medicine, the Brazilian Society of Cardiology, the American Heart Association, the protocol designed by Frederic J. Pashkow, the American Association of Cardiovascular and Pulmonary Rehabilitation, the Société Française de Cardiologie, and the Sociedad Española de Cardiología. Descriptive statistics were used to characterize the sample and the analysis of agreement between the protocols was calculated using the Kappa coefficient. Differences were considered with a significance level of 5%. Results Of the 21 analyses of agreement, 12 were considered significant between the protocols used for risk classification, with nine classified as moderate and three as low. No agreements were classified as excellent. Different proportions were observed in each risk category, with significant differences between the protocols for all risk categories. Conclusion The agreements between the protocols were considered low and moderate and the risk proportions differed between protocols.

  10. Variability in Usual Care Mechanical Ventilation for Pediatric Acute Respiratory Distress Syndrome: Time for a Decision Support Protocol?

    Science.gov (United States)

    Newth, Christopher J L; Sward, Katherine A; Khemani, Robinder G; Page, Kent; Meert, Kathleen L; Carcillo, Joseph A; Shanley, Thomas P; Moler, Frank W; Pollack, Murray M; Dalton, Heidi J; Wessel, David L; Berger, John T; Berg, Robert A; Harrison, Rick E; Holubkov, Richard; Doctor, Allan; Dean, J Michael; Jenkins, Tammara L; Nicholson, Carol E

    2017-11-01

    Although pediatric intensivists philosophically embrace lung protective ventilation for acute lung injury and acute respiratory distress syndrome, we hypothesized that ventilator management varies. We assessed ventilator management by evaluating changes to ventilator settings in response to blood gases, pulse oximetry, or end-tidal CO2. We also assessed the potential impact that a pediatric mechanical ventilation protocol adapted from National Heart Lung and Blood Institute acute respiratory distress syndrome network protocols could have on reducing variability by comparing actual changes in ventilator settings to those recommended by the protocol. Prospective observational study. Eight tertiary care U.S. PICUs, October 2011 to April 2012. One hundred twenty patients (age range 17 d to 18 yr) with acute lung injury/acute respiratory distress syndrome. Two thousand hundred arterial and capillary blood gases, 3,964 oxygen saturation by pulse oximetry, and 2,757 end-tidal CO2 values were associated with 3,983 ventilator settings. Ventilation mode at study onset was pressure control 60%, volume control 19%, pressure-regulated volume control 18%, and high-frequency oscillatory ventilation 3%. Clinicians changed FIO2 by ±5 or ±10% increments every 8 hours. Positive end-expiratory pressure was limited at ~10 cm H2O as oxygenation worsened, lower than would have been recommended by the protocol. In the first 72 hours of mechanical ventilation, maximum tidal volume/kg using predicted versus actual body weight was 10.3 (8.5-12.9) (median [interquartile range]) versus 9.2 mL/kg (7.6-12.0) (p Ventilator management varies substantially in children with acute respiratory distress syndrome. Opportunities exist to minimize variability and potentially injurious ventilator settings by using a pediatric mechanical ventilation protocol offering adequately explicit instructions for given clinical situations. An accepted protocol could also reduce confounding by mechanical

  11. Sharing Annotated Audio Recordings of Clinic Visits With Patients-Development of the Open Recording Automated Logging System (ORALS): Study Protocol.

    Science.gov (United States)

    Barr, Paul J; Dannenberg, Michelle D; Ganoe, Craig H; Haslett, William; Faill, Rebecca; Hassanpour, Saeed; Das, Amar; Arend, Roger; Masel, Meredith C; Piper, Sheryl; Reicher, Haley; Ryan, James; Elwyn, Glyn

    2017-07-06

    US-wide network of primary care practices (www.iorahealth.com), has indicated a willingness to implement ORALS on a larger scale upon completion of this development project. Upon the completion of this project we will have developed a novel recording system that will be ready for large-scale testing. Our long-term goal is for ORALS to seamlessly fit into a clinic's and patient's daily routine, increasing levels of patient engagement and transparency of care. ©Paul J Barr, Michelle D Dannenberg, Craig H Ganoe, William Haslett, Rebecca Faill, Saeed Hassanpour, Amar Das, Roger Arend, Meredith C Masel, Sheryl Piper, Haley Reicher, James Ryan, Glyn Elwyn. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 06.07.2017.

  12. Benchmarking pediatric cranial CT protocols using a dose tracking software system: a multicenter study.

    Science.gov (United States)

    De Bondt, Timo; Mulkens, Tom; Zanca, Federica; Pyfferoen, Lotte; Casselman, Jan W; Parizel, Paul M

    2017-02-01

    To benchmark regional standard practice for paediatric cranial CT-procedures in terms of radiation dose and acquisition parameters. Paediatric cranial CT-data were retrospectively collected during a 1-year period, in 3 different hospitals of the same country. A dose tracking system was used to automatically gather information. Dose (CTDI and DLP), scan length, amount of retakes and demographic data were stratified by age and clinical indication; appropriate use of child-specific protocols was assessed. In total, 296 paediatric cranial CT-procedures were collected. Although the median dose of each hospital was below national and international diagnostic reference level (DRL) for all age categories, statistically significant (p-value benchmarking showed that further dose optimization and standardization is possible by using age-stratified protocols for paediatric cranial CT. Moreover, having a dose tracking system revealed that adult protocols are still applied for paediatric CT, a practice that must be avoided. • Significant differences were observed in the delivered dose between age-groups and hospitals. • Using age-adapted scanning protocols gives a nearly linear dose increase. • Sharing dose-data can be a trigger for hospitals to reduce dose levels.

  13. Optimized Protocol for Protein Extraction from the Breast Tissue that is Compatible with Two-Dimensional Gel Electrophoresis

    Directory of Open Access Journals (Sweden)

    Olena Zakharchenko

    2011-01-01

    Full Text Available Proteomics is a highly informative approach to analyze cancer-associated transformation in tissues. The main challenge to use a tissue for proteomics studies is the small sample size and difficulties to extract and preserve proteins. The choice of a buffer compatible with proteomics applications is also a challenge. Here we describe a protocol optimized for the most efficient extraction of proteins from the human breast tissue in a buffer compatible with two-dimensional gel electrophoresis (2D-GE. This protocol is based on mechanically assisted disintegration of tissues directly in the 2D-GE buffer. Our method is simple, robust and easy to apply in clinical practice. We demonstrate high quality of separation of proteins prepared according to the reported here protocol.

  14. Clinical grade adult stem cell banking.

    Science.gov (United States)

    Thirumala, Sreedhar; Goebel, W Scott; Woods, Erik J

    2009-07-01

    There has been a great deal of scientific interest recently generated by the potential therapeutic applications of adult stem cells in human care but there are several challenges regarding quality and safety in clinical applications and a number of these challenges relate to the processing and banking of these cells ex-vivo. As the number of clinical trials and the variety of adult cells used in regenerative therapy increases, safety remains a primary concern. This has inspired many nations to formulate guidelines and standards for the quality of stem cell collection, processing, testing, banking, packaging and distribution. Clinically applicable cryopreservation and banking of adult stem cells offers unique opportunities to advance the potential uses and widespread implementation of these cells in clinical applications. Most current cryopreservation protocols include animal serum proteins and potentially toxic cryoprotectant additives (CPAs) that prevent direct use of these cells in human therapeutic applications. Long term cryopreservation of adult stem cells under good manufacturing conditions using animal product free solutions is critical to the widespread clinical implementation of ex-vivo adult stem cell therapies. Furthermore, to avoid any potential cryoprotectant related complications, reduced CPA concentrations and efficient post-thaw washing to remove CPA are also desirable. The present review focuses on the current strategies and important aspects of adult stem cell banking for clinical applications. These include current good manufacturing practices (cGMPs), animal protein free freezing solutions, cryoprotectants, freezing & thawing protocols, viability assays, packaging and distribution. The importance and benefits of banking clinical grade adult stem cells are also discussed.

  15. An investigation into current protocols and radiographer opinions on contrast extravasation in Irish CT departments

    International Nuclear Information System (INIS)

    Cleary, N.; McNulty, J.P.; Foley, S.J.; Kelly, E.

    2017-01-01

    Background: Iodinated contrast extravasation is a serious complication associated with intravenous administration in radiology. Departmental protocols and the radiographer's approach on both prevention techniques and treatment will affect the prevalence of extravasation, and the eventual outcome for the patient when it does occur. Aims: To examine contrast extravasation protocols in place in Irish CT departments for alignment with European Society of Urogenital Radiology (ESUR) Guidelines (2014); to establish radiographer's opinions on contrast extravasation; and to examine radiographer adherence to protocols. Methods: Contrast extravasation protocols from a purposively selected sample of CT departments across Ireland (n = 6) were compared to ESUR guidelines, followed by an online survey of CT radiographers practicing in the participating centres. Results: All participating CT departments (n = 5) had written protocols in place. High risk patients, such as elderly or unconscious, were identified in most protocols, however, children were mentioned in just one protocol and obese patients were not specified in any. The response rate of CT radiographers was 23% (n = 24). 58% (n = 14) of respondents indicated that contrast extravasation was more likely during CTA examinations. While high levels of confidence in managing extravasation were reported, suggested treatment approaches, and confidence in same, was more variable. Clinical workload in CT departments was also identified as a factor impacting on patient care and management. Conclusion: While contrast extravasation protocols were generally in line with ESUR Guidelines, high risk patients may not be getting sufficient attention. More radiographer awareness of patient monitoring needs, particularly in busy departments with a heavy workload may also reduce extravasation risk, and improve management of same. - Highlights: • Irish protocols on contrast extravasation are generally in line with

  16. Clinical application of dosimetry in electron beam therapy

    International Nuclear Information System (INIS)

    Yoshiura, Takao

    1995-01-01

    In everyday radiotherapy we must carry out the determination of absorbed dose measurement according to JARP's protocol. We explained an outline of JARP's 1974 and 1986 protocol in electron beam therapy, and mentioned it about the matter that should examined. To use it easily in clinic, a simplified procedure based on precisely to JARP's 1986 protocol is practical, the character of this procedure settles briefly the determination of mean incident energy of electron beams and get ready to table of ionization to absorbed dose conversion factor for various ionization chamber. Also, this procedure almost not influence on the accuracy of determination. We described systematically practical procedure for requisite absorbed dose calculation in a patient in electron beam therapy. (author)

  17. e-SCP-ECG+ Protocol: An Expansion on SCP-ECG Protocol for Health Telemonitoring—Pilot Implementation

    Directory of Open Access Journals (Sweden)

    George J. Mandellos

    2010-01-01

    Full Text Available Standard Communication Protocol for Computer-assisted Electrocardiography (SCP-ECG provides standardized communication among different ECG devices and medical information systems. This paper extends the use of this protocol in order to be included in health monitoring systems. It introduces new sections into SCP-ECG structure for transferring data for positioning, allergies, and five additional biosignals: noninvasive blood pressure (NiBP, body temperature (Temp, Carbon dioxide (CO2, blood oxygen saturation (SPO2, and pulse rate. It also introduces new tags in existing sections for transferring comprehensive demographic data. The proposed enhanced version is referred to as e-SCP-ECG+ protocol. This paper also considers the pilot implementation of the new protocol as a software component in a Health Telemonitoring System.

  18. Mac protocols for cyber-physical systems

    CERN Document Server

    Xia, Feng

    2015-01-01

    This book provides a literature review of various wireless MAC protocols and techniques for achieving real-time and reliable communications in the context of cyber-physical systems (CPS). The evaluation analysis of IEEE 802.15.4 for CPS therein will give insights into configuration and optimization of critical design parameters of MAC protocols. In addition, this book also presents the design and evaluation of an adaptive MAC protocol for medical CPS, which exemplifies how to facilitate real-time and reliable communications in CPS by exploiting IEEE 802.15.4 based MAC protocols. This book wil

  19. Quantifying and visualizing site performance in clinical trials.

    Science.gov (United States)

    Yang, Eric; O'Donovan, Christopher; Phillips, JodiLyn; Atkinson, Leone; Ghosh, Krishnendu; Agrafiotis, Dimitris K

    2018-03-01

    One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitively, the historical track record of a site is one of the strongest predictors of its future performance; however, issues such as data availability and wide differences in protocol complexity can complicate interpretation. Here, we demonstrate how operational data derived from central laboratory services can provide key insights into the performance of clinical sites and help guide operational planning and site selection for new clinical trials. Our methodology uses the metadata associated with laboratory kit shipments to clinical sites (such as trial and anonymized patient identifiers, investigator names and addresses, sample collection and shipment dates, etc.) to reconstruct the complete schedule of patient visits and derive insights about the operational performance of those sites, including screening, enrollment, and drop-out rates and other quality indicators. This information can be displayed in its raw form or normalized to enable direct comparison of site performance across studies of varied design and complexity. Leveraging Covance's market leadership in central laboratory services, we have assembled a database of operational metrics that spans more than 14,000 protocols, 1400 indications, 230,000 unique investigators, and 23 million patient visits and represents a significant fraction of all clinical trials run globally in the last few years. By analyzing this historical data, we are able to assess and compare the performance of clinical investigators across a wide range of therapeutic areas and study designs. This information can be aggregated across trials and geographies to gain further insights into country and regional trends, sometimes with surprising results. The

  20. Short Review on Quantum Key Distribution Protocols.

    Science.gov (United States)

    Giampouris, Dimitris

    2017-01-01

    Cryptographic protocols and mechanisms are widely investigated under the notion of quantum computing. Quantum cryptography offers particular advantages over classical ones, whereas in some cases established protocols have to be revisited in order to maintain their functionality. The purpose of this paper is to provide the basic definitions and review the most important theoretical advancements concerning the BB84 and E91 protocols. It also aims to offer a summary on some key developments on the field of quantum key distribution, closely related with the two aforementioned protocols. The main goal of this study is to provide the necessary background information along with a thorough review on the theoretical aspects of QKD, concentrating on specific protocols. The BB84 and E91 protocols have been chosen because most other protocols are similar to these, a fact that makes them important for the general understanding of how the QKD mechanism functions.

  1. Challenges of maintaining research protocol fidelity in a clinical care setting: A qualitative study of the experiences and views of patients and staff participating in a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Farmer Andrew J

    2011-05-01

    Full Text Available Abstract Background Trial research has predominantly focused on patient and staff understandings of trial concepts and/or motivations for taking part, rather than why treatment recommendations may or may not be followed during trial delivery. This study sought to understand why there was limited attainment of the glycaemic target (HbA1c ≤6.5% among patients who participated in the Treating to Target in Type 2 Diabetes Trial (4-T. The objective was to inform interpretation of trial outcomes and provide recommendations for future trial delivery. Methods In-depth interviews were conducted with 45 patients and 21 health professionals recruited from 11 of 58 trial centres in the UK. Patients were broadly representative of those in the main trial in terms of treatment allocation, demographics and glycaemic control. Both physicians and research nurses were interviewed. Results Most patients were committed to taking insulin as recommended by 4-T staff. To avoid hypoglycaemia, patients occasionally altered or skipped insulin doses, normally in consultation with staff. Patients were usually unaware of the trial's glycaemic target. Positive staff feedback could lead patients to believe they had been 'successful' trial participants even when their HbA1c exceeded 6.5%. While some staff felt that the 4-T automated insulin dose adjustment algorithm had increased their confidence to prescribe larger insulin doses than in routine clinical practice, all described situations where they had not followed its recommendations. Staff regarded the application of a 'one size fits all' glycaemic target during the trial as contradicting routine clinical practice where they would tailor treatments to individuals. Staff also expressed concerns that 'tight' glycaemic control might impose an unacceptably high risk of hypoglycaemia, thus compromising trust and safety, especially amongst older patients. To address these concerns, staff tended to adapt the trial protocol to

  2. A protocol for a systematic review for perioperative pregabalin use

    Directory of Open Access Journals (Sweden)

    Eipe Naveen

    2012-09-01

    Full Text Available Abstract Background Perioperative pain management has recently been revolutionized with the recognition of novel mechanisms and introduction of newer drugs. Many randomized trials have studied the use of the gabapentinoid anti-epileptic, pregabalin, in acute pain. Published systematic reviews suggest that using pregabalin for perioperative pain management may decrease analgesic requirements and pain scores, at the expense of troublesome side effects. A major limitation of the extant reviews is the lack of rigorous investigation of clinical characteristics that would maximize the benefit harms ratio in favor of surgical patients. We posit that effects of pregabalin for perioperative pain management vary by the type of surgical pain model and propose this systematic review protocol to update previous systematic reviews and investigate the heterogeneity in findings across subgroups of surgical pain models. Methods/Design Using a peer-reviewed search strategy, we will search key databases for clinical trials on perioperative pregabalin use in adults. The electronic searches will be supplemented by scanning the reference lists of included studies. No limits of language, country or year will be imposed. Outcomes will include pain; use of co-analgesia, particularly opioids; enhanced recovery; and drug-related harms. We will focus on the identification of surgical models and patient characteristics that have shown benefit and adverse effects from pregabalin. Two clinical experts will independently screen the studies for inclusion using eligibility criteria established a priori. Data extracted by the reviewers will then be verified. Publication bias will be assessed, as will risk of bias using the Cochrane Risk of Bias tool. Meta-analysis and meta-regression are planned if the studies are deemed statistically, methodologically and clinically homogenous. Evidence will be graded for its strength for a select number of outcomes. Discussion We will explore

  3. An Evidence-Based Protocol for Antibiotic Use Prior to Cystoscopy Decreases Antibiotic Use without Impacting Post-Procedural Symptomatic Urinary Tract Infection Rates.

    Science.gov (United States)

    Gregg, Justin R; Bhalla, Rohan G; Cook, J Paul; Kang, Caroline; Dmochowski, Roger; Talbot, Thomas R; Barocas, Daniel A

    2018-04-01

    Symptomatic urinary tract infection is a complication of office based cystourethroscopy. Studies are mixed regarding the efficacy of antibiotic prophylaxis to prevent urinary tract infections. Our aim was to develop and evaluate an evidence-based protocol that reduces unnecessary antibiotic use while avoiding an increase in urinary tract infections. We created a clinic antibiogram based on all urology office visits performed during a 2-year period. Bacterial resistance rates, institutional risk related data and clinical guidelines were applied to create a protocol for antibiotic administration before cystourethroscopy. We then analyzed 1,245 consecutive patients without a renal transplant who underwent outpatient cystourethroscopy, including 610 after protocol initiation. Urinary tract infection rates and antibiotic use were analyzed for an association with the protocol change using the Fisher exact test. Cultures had an overall 20% rate of resistance to fluoroquinolones, representing 40% of the cultures that grew Escherichia coli. Before the protocol change 602 of 635 patients (94.8%) received a preprocedural antibiotic compared to 426 of 610 (69.9%) after protocol initiation (p urinary tract infection prior to the protocol change while 16 (2.6%) had a urinary tract infection after the change (p = 0.69). Regarding resistance, fluoroquinolone resistant organisms grew in the cultures of 12 of 19 patients (63.2%) with a urinary tract infection before the protocol change compared to 5 of 16 (31.3%) with a urinary tract infection after the change. Recent antibiotic administration, hospitalization and chronic catheterization were associated with urinary tract infection in the entire cohort (all p ≤0.01). A local antibiogram with infection related risk data effectively risk stratifies patients before cystourethroscopy, decreasing the use of antibiotics without increasing the rate of symptomatic urinary tract infection. Copyright © 2018 American Urological Association

  4. Protocol for the ostomized person in the trans-hospital and outpatient period: Integrative Review

    Directory of Open Access Journals (Sweden)

    Stella Godoy Silva Lima

    2017-06-01

    Full Text Available Objective: To review the literature about the application of the evidence-based protocol concept for clinical assessment and interventions in nursing consultation to ostomized people. Method: integrative review to increase the knowledge about stomata. A search was made in the databases BIREME, CINAHL, SCOPUS, WEB OF SCIENCE and PUBMED with descriptors Ostomy OR Colostomy OR Colonic Pouches OR Surgical Stomata OR Colorectal Neoplasms OR Colorectal Cancer AND Protocols. It was selected 21 articles in the period of 2011-2015. Results: The articles were systematized into five categories: quality of life, nursing assistance, protocols, complications and surgery. The categories are complementary and demonstrate a work carried out by a multiprofessional team. Conclusion: the themes analysis made it possible to identify the need for expansion in research that addresses specific aspects such as teaching strategies in the levels of assistance in the trans-operative, postoperative and in the outpatient phase in nursing consultations.

  5. Large family of quantum weak coin-flipping protocols

    International Nuclear Information System (INIS)

    Mochon, Carlos

    2005-01-01

    Each classical public-coin protocol for coin flipping is naturally associated with a quantum protocol for weak coin flipping. The quantum protocol is obtained by replacing classical randomness with quantum entanglement and by adding a cheat detection test in the last round that verifies the integrity of this entanglement. The set of such protocols defines a family which contains the protocol with bias 0.192 previously found by the author, as well as protocols with bias as low as 1/6 described herein. The family is analyzed by identifying a set of optimal protocols for every number of messages. In the end, tight lower bounds for the bias are obtained which prove that 1/6 is optimal for all protocols within the family

  6. Nonblocking and orphan free message logging protocols

    Science.gov (United States)

    Alvisi, Lorenzo; Hoppe, Bruce; Marzullo, Keith

    1992-12-01

    Currently existing message logging protocols demonstrate a classic pessimistic vs. optimistic tradeoff. We show that the optimistic-pessimistic tradeoff is not inherent to the problem of message logging. We construct a message-logging protocol that has the positive features of both optimistic and pessimistic protocol: our protocol prevents orphans and allows simple failure recovery; however, it requires no blocking in failure-free runs. Furthermore, this protocol does not introduce any additional message overhead as compared to one implemented for a system in which messages may be lost but processes do not crash.

  7. The Kyoto Protocol. An economic appraisal

    International Nuclear Information System (INIS)

    Grubb, M.

    2000-05-01

    This paper examines the overall economics of the Kyoto Protocol on climate change, in three main parts. The first part explores the structure of the Protocol and how this matches against classical economic criteria of an 'optimal' climate change agreement. This discussion also considers the nature of and reasons for shortcomings, and the prospects for its evolution. Given the various flexibilities in the agreement, the Kyoto Protocol is far more economically efficient in its structure than any previous global environmental agreement. The central conclusion is that, from an economic perspective, the Protocol's structure for industrialised country commitments is as good as could reasonably be expected. The second part of the paper explores more closely the economics of the commitments themselves and how they combine with the various flexibilities, briefly reviewing the available literature and using a simple spreadsheet model of how the commitments might combine with trading mechanisms under a range of assumptions. Flexibility is intrinsic and necessary, but it is argued that the allocations to Russia and Ukraine in particular mean that unlimited flexibility could render the Protocol's commitments weaker in their impacts than is economically desirable to address climate change. It is argued that, should this prove to be the case, access to the large surplus in the transition economies could be used as a control valve to limit the costs of the Protocol to within acceptable limits. Finally, the paper considers the issues of developing country involvement in the Kyoto Protocol, and the Protocol's longer-term impact and evolution, including its impact on technological evolution and dissemination and the evolution of future commitments. It is argued that taking account of such issues critically affects views of the Protocol

  8. Comparison between PRP, PRGF and PRF: lights and shadows in three similar but different protocols.

    Science.gov (United States)

    Giannini, S; Cielo, A; Bonanome, L; Rastelli, C; Derla, C; Corpaci, F; Falisi, G

    2015-01-01

    The main goal of the modern surgery is to get a low invasiveness and a high rate of clinical healing: in the last years, it has been introduced the concept of a "regenerative surgery", and many techniques has been widely described in the literature. The most used are PRP, PRGF and PRF techniques. Aim of this research is to compare the three protocol of PRP, PRF and PRGF in their essential features, so to suggest to the practitioners the best blood product to use in the regenerative surgery. Among the advantages that shows the PRF, compared to PRP and PRGF, we can cite a greater simplicity of production for the absence of manipulation that leads to a reduced possibility of alteration of the protocol due to an error of the operator. The special texture of the PRF and its biological features shows clearly an interesting surgical versatility and all the characteristics that can support a faster tissues regeneration and high-quality clinical outcomes.

  9. Comparison of microdose flare-up and antagonist multiple-dose protocols for poor-responder patients: a randomized study.

    Science.gov (United States)

    Demirol, Aygul; Gurgan, Timur

    2009-08-01

    To compare the efficacy of the microdose flare-up and multiple-dose antagonist protocols for poor-responder patients in intracytoplasmic sperm injection-ET cycles. A randomized, prospective study. Center for assisted reproductive technology in Turkey. Ninety patients with poor ovarian response in a minimum of two previous IVF cycles. All women were prospectively randomized into two groups by computer-assisted randomization. The patients in group 1 were stimulated according to the microdose flare-up protocol (n = 45), while the patients in group 2 were stimulated according to antagonist multiple-dose protocol (n = 45). The mean number of mature oocytes retrieved was the primary outcome measure, and fertilization rate, implantation rate per embryo, and clinical pregnancy rates were secondary outcome measures. The mean age of the women, the mean duration of infertility, basal FSH level, and the number of previous IVF cycles were similar in both groups. The total gonadotropin dose used was significantly higher in group 2, while the number of oocytes retrieved was significantly greater in group 1. Although the fertilization and clinical pregnancy rates were nonsignificantly higher in group 1 compared with group 2, the implantation rate was significantly higher in the microdose flare-up group than in the multiple-dose antagonist group (22% vs. 11%). The microdose flare-up protocol seems to have a better outcome in poor-responder patients, with a significantly higher mean number of mature oocytes retrieved and higher implantation rate.

  10. A magneto-motive ultrasound platform designed for pre-clinical and clinical applications

    Directory of Open Access Journals (Sweden)

    Diego Ronaldo Thomaz Sampaio

    Full Text Available Abstract Introduction Magneto-motive ultrasound (MMUS combines magnetism and ultrasound (US to detect magnetic nanoparticles in soft tissues. One type of MMUS called shear-wave dispersion magneto-motive ultrasound (SDMMUS analyzes magnetically induced shear waves (SW to quantify the elasticity and viscosity of the medium. The lack of an established presets or protocols for pre-clinical and clinical studies currently limits the use of MMUS techniques in the clinical setting. Methods This paper proposes a platform to acquire, process, and analyze MMUS and SDMMUS data integrated with a clinical ultrasound equipment. For this purpose, we developed an easy-to-use graphical user interface, written in C++/Qt4, to create an MMUS pulse sequence and collect the ultrasonic data. We designed a graphic interface written in MATLAB to process, display, and analyze the MMUS images. To exemplify how useful the platform is, we conducted two experiments, namely (i MMUS imaging to detect magnetic particles in the stomach of a rat, and (ii SDMMUS to estimate the viscoelasticity of a tissue-mimicking phantom containing a spherical target of ferrite. Results The developed software proved to be an easy-to-use platform to automate the acquisition of MMUS/SDMMUS data and image processing. In an in vivo experiment, the MMUS technique detected an area of 6.32 ± 1.32 mm2 where magnetic particles were heterogeneously distributed in the stomach of the rat. The SDMMUS method gave elasticity and viscosity values of 5.05 ± 0.18 kPa and 2.01 ± 0.09 Pa.s, respectively, for a tissue-mimicking phantom. Conclusion Implementation of an MMUS platform with addressed presets and protocols provides a step toward the clinical implementation of MMUS imaging equipment. This platform may help to localize magnetic particles and quantify the elasticity and viscosity of soft tissues, paving a way for its use in pre-clinical and clinical studies.

  11. Estimating Return on Investment in Translational Research: Methods and Protocols

    Science.gov (United States)

    Trochim, William; Dilts, David M.; Kirk, Rosalind

    2014-01-01

    Assessing the value of clinical and translational research funding on accelerating the translation of scientific knowledge is a fundamental issue faced by the National Institutes of Health and its Clinical and Translational Awards (CTSA). To address this issue, the authors propose a model for measuring the return on investment (ROI) of one key CTSA program, the clinical research unit (CRU). By estimating the economic and social inputs and outputs of this program, this model produces multiple levels of ROI: investigator, program and institutional estimates. A methodology, or evaluation protocol, is proposed to assess the value of this CTSA function, with specific objectives, methods, descriptions of the data to be collected, and how data are to be filtered, analyzed, and evaluated. This paper provides an approach CTSAs could use to assess the economic and social returns on NIH and institutional investments in these critical activities. PMID:23925706

  12. Estimating return on investment in translational research: methods and protocols.

    Science.gov (United States)

    Grazier, Kyle L; Trochim, William M; Dilts, David M; Kirk, Rosalind

    2013-12-01

    Assessing the value of clinical and translational research funding on accelerating the translation of scientific knowledge is a fundamental issue faced by the National Institutes of Health (NIH) and its Clinical and Translational Awards (CTSAs). To address this issue, the authors propose a model for measuring the return on investment (ROI) of one key CTSA program, the clinical research unit (CRU). By estimating the economic and social inputs and outputs of this program, this model produces multiple levels of ROI: investigator, program, and institutional estimates. A methodology, or evaluation protocol, is proposed to assess the value of this CTSA function, with specific objectives, methods, descriptions of the data to be collected, and how data are to be filtered, analyzed, and evaluated. This article provides an approach CTSAs could use to assess the economic and social returns on NIH and institutional investments in these critical activities.

  13. Image quality comparison between single energy and dual energy CT protocols for hepatic imaging

    International Nuclear Information System (INIS)

    Yao, Yuan; Pelc, Norbert J.; Ng, Joshua M.; Megibow, Alec J.

    2016-01-01

    Purpose: Multi-detector computed tomography (MDCT) enables volumetric scans in a single breath hold and is clinically useful for hepatic imaging. For simple tasks, conventional single energy (SE) computed tomography (CT) images acquired at the optimal tube potential are known to have better quality than dual energy (DE) blended images. However, liver imaging is complex and often requires imaging of both structures containing iodinated contrast media, where atomic number differences are the primary contrast mechanism, and other structures, where density differences are the primary contrast mechanism. Hence it is conceivable that the broad spectrum used in a dual energy acquisition may be an advantage. In this work we are interested in comparing these two imaging strategies at equal-dose and more complex settings. Methods: We developed numerical anthropomorphic phantoms to mimic realistic clinical CT scans for medium size and large size patients. MDCT images based on the defined phantoms were simulated using various SE and DE protocols at pre- and post-contrast stages. For SE CT, images from 60 kVp through 140 with 10 kVp steps were considered; for DE CT, both 80/140 and 100/140 kVp scans were simulated and linearly blended at the optimal weights. To make a fair comparison, the mAs of each scan was adjusted to match the reference radiation dose (120 kVp, 200 mAs for medium size patients and 140 kVp, 400 mAs for large size patients). Contrast-to-noise ratio (CNR) of liver against other soft tissues was used to evaluate and compare the SE and DE protocols, and multiple pre- and post-contrasted liver-tissue pairs were used to define a composite CNR. To help validate the simulation results, we conducted a small clinical study. Eighty-five 120 kVp images and 81 blended 80/140 kVp images were collected and compared through both quantitative image quality analysis and an observer study. Results: In the simulation study, we found that the CNR of pre-contrast SE image mostly

  14. Protocol for the management of psychiatric patients with psychomotor agitation.

    Science.gov (United States)

    Vieta, Eduard; Garriga, Marina; Cardete, Laura; Bernardo, Miquel; Lombraña, María; Blanch, Jordi; Catalán, Rosa; Vázquez, Mireia; Soler, Victòria; Ortuño, Noélia; Martínez-Arán, Anabel

    2017-09-08

    Psychomotor agitation (PMA) is a state of motor restlessness and mental tension that requires prompt recognition, appropriate assessment and management to minimize anxiety for the patient and reduce the risk for escalation to aggression and violence. Standardized and applicable protocols and algorithms can assist healthcare providers to identify patients at risk of PMA, achieve timely diagnosis and implement minimally invasive management strategies to ensure patient and staff safety and resolution of the episode. Spanish experts in PMA from different disciplines (psychiatrists, psychologists and nurses) convened in Barcelona for a meeting in April 2016. Based on recently issued international consensus guidelines on the standard of care for psychiatric patients with PMA, the meeting provided the opportunity to address the complexities in the assessment and management of PMA from different perspectives. The attendees worked towards producing a consensus for a unified approach to PMA according to the local standards of care and current local legislations. The draft protocol developed was reviewed and ratified by all members of the panel prior to its presentation to the Catalan Society of Psychiatry and Mental Health, the Spanish Society of Biological Psychiatry (SEPB) and the Spanish Network Centre for Research in Mental Health (CIBERSAM) for input. The final protocol and algorithms were then submitted to these organizations for endorsement. The protocol presented here provides guidance on the appropriate selection and use of pharmacological agents (inhaled/oral/IM), seclusion, and physical restraint for psychiatric patients suspected of or presenting with PMA. The protocol is applicable within the Spanish healthcare system. Implementation of the protocol and the constituent algorithms described here should ensure the best standard of care of patients at risk of PMA. Episodes of PMA could be identified earlier in their clinical course and patients could be managed in

  15. Efficacy of an extravascular lung water-driven negative fluid balance protocol.

    Science.gov (United States)

    Díaz-Rubia, L; Ramos-Sáez, S; Vázquez-Guillamet, R; Guerrero-López, F; Pino-Sánchez, F; García-Delgado, M; Gómez-Jiménez, F J; Fernández-Mondéjar, E

    2015-01-01

    To analyze the efficacy of negative fluid balance in hypoxemic patients with an elevated extravascular lung water index (EVLWI). A retrospective observational study was made. Intensive Care Unit of Virgen de las Nieves Hospital (Spain). Forty-four patients participated in the study. We analyzed our database of hypoxemic patients covering a period of 11 consecutive months. We included all hemodynamically stable and hypoxemic patients with EVLWI>9ml/kg. The protocol dictates a negative fluid balance between 500 and 1500ml/day. We analyzed the impact of this negative fluid balance strategy upon pulmonary, hemodynamic, and renal function. Demographic data, severity scores, clinical, hemodynamic, pulmonary, metabolic and renal function data. Thirty-three patients achieved negative fluid balance (NFB group) and 11 had a positive fluid balance (PFB group). In the former group, PaO2/FiO2 improved from 145 (IQR 106, 200) to 210mmHg (IQR 164, 248) (pPFB group, EVLWI also decreased from 11 (10, 14) to 10ml/kg (8, 14) at the end of the protocol (p=0.004). For these patients there were no changes in oxygenation, with a PaO2/FiO2 of 216mmHg (IQR 137, 260) at the beginning versus 205mmHg (IQR 99,257) at the end of the study (p=0.08). Three out of four hypoxic patients with elevated EVLWI tolerated the NFB protocol. In these subjects, the improvement of various analyzed physiological parameters was greater and faster than in those unable to complete the protocol. Patients who did not tolerate the protocol were usually in more severe condition, though a larger sample would be needed to detect specific characteristics of this group. Copyright © 2014 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

  16. A Simple XML Producer-Consumer Protocol

    Science.gov (United States)

    Smith, Warren; Gunter, Dan; Quesnel, Darcy; Biegel, Bryan (Technical Monitor)

    2001-01-01

    There are many different projects from government, academia, and industry that provide services for delivering events in distributed environments. The problem with these event services is that they are not general enough to support all uses and they speak different protocols so that they cannot interoperate. We require such interoperability when we, for example, wish to analyze the performance of an application in a distributed environment. Such an analysis might require performance information from the application, computer systems, networks, and scientific instruments. In this work we propose and evaluate a standard XML-based protocol for the transmission of events in distributed systems. One recent trend in government and academic research is the development and deployment of computational grids. Computational grids are large-scale distributed systems that typically consist of high-performance compute, storage, and networking resources. Examples of such computational grids are the DOE Science Grid, the NASA Information Power Grid (IPG), and the NSF Partnerships for Advanced Computing Infrastructure (PACIs). The major effort to deploy these grids is in the area of developing the software services to allow users to execute applications on these large and diverse sets of resources. These services include security, execution of remote applications, managing remote data, access to information about resources and services, and so on. There are several toolkits for providing these services such as Globus, Legion, and Condor. As part of these efforts to develop computational grids, the Global Grid Forum is working to standardize the protocols and APIs used by various grid services. This standardization will allow interoperability between the client and server software of the toolkits that are providing the grid services. The goal of the Performance Working Group of the Grid Forum is to standardize protocols and representations related to the storage and distribution of

  17. Discriminating real victims from feigners of psychological injury in gender violence: Validating a protocol for forensic setting

    Directory of Open Access Journals (Sweden)

    Ramon Arce

    2009-07-01

    Full Text Available Standard clinical assessment of psychological injury does not provide valid evidence in forensic settings, and screening of genuine from feigned complaints must be undertaken prior to the diagnosis of mental state (American Psychological Association, 2002. Whereas psychological injury is Post-traumatic Stress Disorder (PTSD, a clinical diagnosis may encompass other nosologies (e.g., depression and anxiety. The assessment of psychological injury in forensic contexts requires a multimethod approach consisting of a psychometric measure and an interview. To assess the efficacy of the multimethod approach in discriminating real from false victims, 25 real victims of gender violence and 24 feigners were assessed using a the Symptom Checklist-90-Revised (SCL-90-R, a recognition task; and a forensic clinical interview, a knowledge task. The results revealed that feigners reported more clinical symptoms on the SCL-90-R than real victims. Moreover, the feigning indicators on the SCL-90-R, GSI, PST, and PSDI were higher in feigners, but not sufficient to provide a screening test for invalidating feigning protocols. In contrast, real victims reported more clinical symptoms related to PTSD in the forensic clinical interview than feigners. Notwithstanding, in the forensic clinical interview feigners were able to feign PTSD which was not detected by the analysis of feigning strategies. The combination of both measures and their corresponding validity controls enabled the discrimination of real victims from feigners. Hence, a protocol for discriminating the psychological sequelae of real victims from feigners of gender violence is described.

  18. The Resin-Embedded Cornea Prepared Via Rapid Processing Protocol : A Good Histomorphometric Target for Clinical Investigation in Ophthalmology and Optometry

    Science.gov (United States)

    Cheah, Pike See; Mohidin, Norhani; Mohd Ali, Bariah; Maung, Myint; Latif, Azian Abdul

    2008-01-01

    This study illustrates and quantifies the changes on corneal tissue between the paraffin-embedded and resin-embedded blocks and thus, selects a better target in investigational ophthalmology and optometry via light microscopy. Corneas of two cynomolgus monkeys (Macaca fascicularis) were used in this study. The formalin-fixed cornea was prepared in paraffin block via the conventional tissue processing protocol (4-day protocol) and stained with haematoxylin and eosin. The glutaraldehyde-fixed cornea was prepared in resin block via the rapid and modified tissue processing procedure (1.2-day protocol) and stained with toluidine blue. The paraffin-embedded sample exhibits various undesired tissue damage and artifact such as thinner epithelium (due to the substantial volumic extraction from the tissue), thicker stroma layer (due to the separation of lamellae and the presence of voids) and the distorted endothelium. In contrast, the resin-embedded corneal tissue has demonstrated satisfactory corneal ultrastructural preservation. The rapid and modified tissue processing method for preparing the resin-embedded is particularly beneficial to accelerate the microscopic evaluation in ophthalmology and optometry. PMID:22570589

  19. Readjustment of abdominal computed tomography protocols in a university hospital: impact on radiation dose

    Energy Technology Data Exchange (ETDEWEB)

    Romano, Ricardo Francisco Tavares; Salvadori, Priscila Silveira; Torres, Lucas Rios; Bretas, Elisa Almeida Sathler; Bekhor, Daniel; Medeiros, Regina Bitelli; D' Ippolito, Giuseppe, E-mail: ricardo.romano@unifesp.br [Universidade Federal de Sao Paulo (EPM/UNIFESP), Sao Paulo, SP (Brazil). Escola Paulista de Medicina; Caldana, Rogerio Pedreschi [Fleury Medicina e Saude, Sao Paulo, SP (Brazil)

    2015-09-15

    Objective: To assess the reduction of estimated radiation dose in abdominal computed tomography following the implementation of new scan protocols on the basis of clinical suspicion and of adjusted images acquisition parameters. Materials and Methods: Retrospective and prospective review of reports on radiation dose from abdominal CT scans performed three months before (group A - 551 studies) and three months after (group B - 788 studies) implementation of new scan protocols proposed as a function of clinical indications. Also, the images acquisition parameters were adjusted to reduce the radiation dose at each scan phase. The groups were compared for mean number of acquisition phases, mean CTDI{sub vol} per phase, mean DLP per phase, and mean DLP per scan. Results: A significant reduction was observed for group B as regards all the analyzed aspects, as follows: 33.9%, 25.0%, 27.0% and 52.5%, respectively for number of acquisition phases, CTDI{sub vol} per phase, DLP per phase and DLP per scan (p < 0.001). Conclusion: The rational use of abdominal computed tomography scan phases based on the clinical suspicion in conjunction with the adjusted images acquisition parameters allows for a 50% reduction in the radiation dose from abdominal computed tomography scans. (author)

  20. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

    2015-01-01

    Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

  1. Principles of the new quantum cryptography protocols building

    International Nuclear Information System (INIS)

    Kurochkin, V.; Kurochkin, Yu.

    2009-01-01

    The main aim of the quantum cryptography protocols is the maximal secrecy under the conditions of the real experiment. This work presents the result of the new protocol building with the use of the secrecy maximization. While using some well-known approaches this method has allowed one to achieve completely new results in quantum cryptography. The process of the protocol elaboration develops from the standard BB84 protocol upgrading to the building of completely new protocol with arbitrary large bases number. The secrecy proofs of the elaborated protocol appear to be natural continuation of the protocol building process. This approach reveals possibility to reach extremely high parameters of the protocol. It suits both the restrictions of contemporary technologies and requirements for high bit rate while being absolutely secret

  2. A secure distributed logistic regression protocol for the detection of rare adverse drug events.

    Science.gov (United States)

    El Emam, Khaled; Samet, Saeed; Arbuckle, Luk; Tamblyn, Robyn; Earle, Craig; Kantarcioglu, Murat

    2013-05-01

    There is limited capacity to assess the comparative risks of medications after they enter the market. For rare adverse events, the pooling of data from multiple sources is necessary to have the power and sufficient population heterogeneity to detect differences in safety and effectiveness in genetic, ethnic and clinically defined subpopulations. However, combining datasets from different data custodians or jurisdictions to perform an analysis on the pooled data creates significant privacy concerns that would need to be addressed. Existing protocols for addressing these concerns can result in reduced analysis accuracy and can allow sensitive information to leak. To develop a secure distributed multi-party computation protocol for logistic regression that provides strong privacy guarantees. We developed a secure distributed logistic regression protocol using a single analysis center with multiple sites providing data. A theoretical security analysis demonstrates that the protocol is robust to plausible collusion attacks and does not allow the parties to gain new information from the data that are exchanged among them. The computational performance and accuracy of the protocol were evaluated on simulated datasets. The computational performance scales linearly as the dataset sizes increase. The addition of sites results in an exponential growth in computation time. However, for up to five sites, the time is still short and would not affect practical applications. The model parameters are the same as the results on pooled raw data analyzed in SAS, demonstrating high model accuracy. The proposed protocol and prototype system would allow the development of logistic regression models in a secure manner without requiring the sharing of personal health information. This can alleviate one of the key barriers to the establishment of large-scale post-marketing surveillance programs. We extended the secure protocol to account for correlations among patients within sites through

  3. Risk of severe ovarian hyperstimulation syndrome in GnRH antagonist versus GnRH agonist protocol

    DEFF Research Database (Denmark)

    Toftager, M.; Bogstad, J; Bryndorf, T

    2016-01-01

    interval (CI): 0.33-0.57) compared with the traditional GnRH agonist protocol. Previous trials comparing the two protocols mainly included selected patient populations, a limited number of patients and the applied OHSS criteria differed, making direct comparisons difficult. In two recent large meta...... IV, dual-centre, open-label, RCT including 1050 women allocated to either short GnRH antagonist or long GnRH agonist protocol in a 1:1 ratio and enrolled over a 5-year period using a web-based concealed randomization code. This is a superiority study designed to detect a difference in severe OHSS...... between the two arms. None of the women had undergone previous ART treatment. PARTICIPANTS/MATERIALS, SETTING, METHODS: All infertile women referred for their first IVF/ICSI at two public fertility clinics, less than 40 years of age and with no uterine malformations were asked to participate. A total...

  4. Attack strategies on quantum cryptographic protocols

    International Nuclear Information System (INIS)

    Schauer, S.; Suda, M.

    2006-01-01

    Full text: Quantum key distribution (QKD) and quantum authentication (QA) have been a topic of extensive research in the last 20 years. In course of that many attacks on QKD and QA protocols have been studied. Among these, Zhang, Lee and Guo presented an attack on a QKD protocol using entanglement swapping. Based on that strategy we take a look at other protocols to inspect how much information an adversary may get if he shares entanglement with either one or both parties. We will present some protocols where an adversary can even get full information about the key using entanglement. (author)

  5. Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy.

    Science.gov (United States)

    Jang, Soobin; Park, Sunju; Jang, Bo-Hyoung; Park, Yu Lee; Lee, Ju Ah; Cho, Chung-Sik; Go, Ho-Yeon; Shin, Yong Cheol; Ko, Seong-Gyu

    2017-06-02

    Nicotine dependence is a disease, and tobacco use is related to 6 million deaths annually worldwide. Recently, in many countries, there has been growing interest in the use of traditional and complementary medicine (T&CM) methods, especially acupuncture, as therapeutic interventions for smoking cessation. The aim of this pilot study is to investigate the effectiveness of T&CM interventions on smoking cessation. The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial. This trial will evaluate whether adding T&CM methods (ie, ear and body acupuncture, aromatherapy) to conventional cessation methods (ie, nicotine replacement therapy (NRT), counselling) increases smoking cessation rates. Forty participants over 19 years old who are capable of communicating in Korean will be recruited. They will be current smokers who meet one of the following criteria: (1) smoke more than 10 cigarettes a day, (2) smoke less than 10 cigarettes a day and previously failed to cease smoking, or (3) smoke fewer than 10 cigarettes a day and have a nicotine dependence score (Fagerstrom Test for Nicotine Dependence) of 4 points or more. The trial will consist of 4 weeks of treatment and a 20 week follow-up period. A statistician will perform the statistical analyses for both the intention-to-treat (all randomly assigned participants) and per-protocol (participants who completed the trial without any protocol deviations) data using SAS 9.1.3. This study has been approved by the Institutional Review Board (IRB) of the Dunsan Korean Medicine Hospital of Daejeon University (IRB reference no: DJDSKH-15-BM-11-1, Protocol No. version 4.1.).The protocol will be reapproved by IRB if it requires amendment. The trial will be conducted according to the Declaration of Helsinki, 7th version (2013). This study is designed to minimise the risk to participants, and the investigators will explain the study to the

  6. Network protocols and sockets

    OpenAIRE

    BALEJ, Marek

    2010-01-01

    My work will deal with network protocols and sockets and their use in programming language C#. It will therefore deal programming network applications on the platform .NET from Microsoft and instruments, which C# provides to us. There will describe the tools and methods for programming network applications, and shows a description and sample applications that work with sockets and application protocols.

  7. Validation of the Omron HEM-7320-LA, upper arm blood pressure monitor with Intelli Wrap Technology Cuff HEM-FL1 for self-measurement and clinic use according to the European Society of Hypertension International Protocol revision 2010 in the Mexican population.

    Science.gov (United States)

    Grover-Páez, Fernando; Cardona-Muñoz, Ernesto G; Cardona-Müller, David; Guzmán-Saldívar, Víctor H; Rodríguez-De la Cerda, Mariana; Jiménez-Cázarez, Mayra B; Totsuka-Sutto, Sylvia E; Alanis-Sánchez, Guillermo A; Ramos-Becerra, Carlos G

    2017-12-01

    The aim of this study was to determine the accuracy of the Omron HEM-7320-LA with Intelli Wrap technology cuff HEM-FL1 for self-measurement and clinic blood pressure (BP) measurement according to the European Society of Hypertension International Protocol revision 2010. The evaluation was performed in 39 individuals. The mean age of the participants was 47.9±14 years; systolic BP was 145.2±24.3 mmHg (range: 97-190), diastolic BP was 90.9±12.9 mmHg (range: 68-120), and arm circumference was 30.8±4 cm (range: 25-38.5). The device successfully fulfilled the established criteria of the validation protocol. The device overestimated systolic BP by 0.6±5.7 mmHg and diastolic BP by 2.2±5.1 mmHg. The specially designed cuff HEM-FL1 to cover a broad range of arm circumferences and self-placement fulfilled the requirements of the International Protocol.

  8. A consensus protocol for the determination of the threshold doses for allergenic foods: how much is too much?

    DEFF Research Database (Denmark)

    Taylor, S. L.; Hefle, S. L.; Bindslev-Jensen, C.

    2004-01-01

    Background While the ingestion of small amounts of an offending food can elicit adverse reactions in individuals with IgE-mediated food allergies, little information is known regarding these threshold doses for specific allergenic foods. While low-dose challenge trials have been conducted...... on an appreciable number of allergic individuals, a variety of different clinical protocols were used making the estimation of the threshold dose very difficult. Objective A roundtable conference was convened to develop a consensus clinical protocol for low-dose challenge trials for the estimation of threshold...... was developed for the medication status of patients entering such trials. Challenge materials must be standardized, for example, partially defatted peanut flour composed of equal amounts of the three major varieties of peanuts (Florunner, Virginia, Spanish). Challenge materials must be appropriately blinded...

  9. Effect of Cephalexin Plus Trimethoprim-Sulfamethoxazole vs Cephalexin Alone on Clinical Cure of Uncomplicated Cellulitis: A Randomized Clinical Trial.

    Science.gov (United States)

    Moran, Gregory J; Krishnadasan, Anusha; Mower, William R; Abrahamian, Fredrick M; LoVecchio, Frank; Steele, Mark T; Rothman, Richard E; Karras, David J; Hoagland, Rebecca; Pettibone, Stephanie; Talan, David A

    2017-05-23

    Emergency department visits for skin infections in the United States have increased with the emergence of methicillin-resistant Staphylococcus aureus (MRSA). For cellulitis without purulent drainage, β-hemolytic streptococci are presumed to be the predominant pathogens. It is unknown if antimicrobial regimens possessing in vitro MRSA activity provide improved outcomes compared with treatments lacking MRSA activity. To determine whether cephalexin plus trimethoprim-sulfamethoxazole yields a higher clinical cure rate of uncomplicated cellulitis than cephalexin alone. Multicenter, double-blind, randomized superiority trial in 5 US emergency departments among outpatients older than 12 years with cellulitis and no wound, purulent drainage, or abscess enrolled from April 2009 through June 2012. All participants had soft tissue ultrasound performed at the time of enrollment to exclude abscess. Final follow-up was August 2012. Cephalexin, 500 mg 4 times daily, plus trimethoprim-sulfamethoxazole, 320 mg/1600 mg twice daily, for 7 days (n = 248 participants) or cephalexin plus placebo for 7 days (n = 248 participants). The primary outcome determined a priori in the per-protocol group was clinical cure, defined as absence of these clinical failure criteria at follow-up visits: fever; increase in erythema (>25%), swelling, or tenderness (days 3-4); no decrease in erythema, swelling, or tenderness (days 8-10); and more than minimal erythema, swelling, or tenderness (days 14-21). A clinically significant difference was defined as greater than 10%. Among 500 randomized participants, 496 (99%) were included in the modified intention-to-treat analysis and 411 (82.2%) in the per-protocol analysis (median age, 40 years [range, 15-78 years]; 58.4% male; 10.9% had diabetes). Median length and width of erythema were 13.0 cm and 10.0 cm. In the per-protocol population, clinical cure occurred in 182 (83.5%) of 218 participants in the cephalexin plus trimethoprim

  10. Digital pathology in nephrology clinical trials, research, and pathology practice.

    Science.gov (United States)

    Barisoni, Laura; Hodgin, Jeffrey B

    2017-11-01

    In this review, we will discuss (i) how the recent advancements in digital technology and computational engineering are currently applied to nephropathology in the setting of clinical research, trials, and practice; (ii) the benefits of the new digital environment; (iii) how recognizing its challenges provides opportunities for transformation; and (iv) nephropathology in the upcoming era of kidney precision and predictive medicine. Recent studies highlighted how new standardized protocols facilitate the harmonization of digital pathology database infrastructure and morphologic, morphometric, and computer-aided quantitative analyses. Digital pathology enables robust protocols for clinical trials and research, with the potential to identify previously underused or unrecognized clinically useful parameters. The integration of digital pathology with molecular signatures is leading the way to establishing clinically relevant morpho-omic taxonomies of renal diseases. The introduction of digital pathology in clinical research and trials, and the progressive implementation of the modern software ecosystem, opens opportunities for the development of new predictive diagnostic paradigms and computer-aided algorithms, transforming the practice of renal disease into a modern computational science.

  11. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  12. SIP protocol model for OMNET++

    Directory of Open Access Journals (Sweden)

    Jan Kucerak

    2016-01-01

    Full Text Available The article describes our new SIP protocol implementation for the OMNeT++ simulation framework. OMNeT++ simulation framework provides an extensive support of IP related protocols, nevertheless a working SIP protocol implementation is missing. Real measurements were also done using a SIPp traffic generator and the results are compared to those obtained by our new SIP model. Since this work is a part of bigger project concerned strictly on measuring "first response times" over networks with a faulty transmission links, the actually collected statistics are focused only this way.

  13. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol

    Directory of Open Access Journals (Sweden)

    Fukuoka Yoshimi

    2011-12-01

    Full Text Available Abstract Background Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. Methods A randomized controlled trial (RCT with three arms; 1 PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention, 2 REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention, and 3 CONTROL (pedometer only, but no intervention will be conducted. A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary, immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. Discussion If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral

  14. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol.

    Science.gov (United States)

    Fukuoka, Yoshimi; Komatsu, Judith; Suarez, Larry; Vittinghoff, Eric; Haskell, William; Noorishad, Tina; Pham, Kristin

    2011-12-14

    Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education) randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. A randomized controlled trial (RCT) with three arms; 1) PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention), 2) REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention), and 3) CONTROL (pedometer only, but no intervention will be conducted). A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary), immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral sciences and mHealth. ClinicalTrials.gov#:NCTO1280812.

  15. [Fewer caesarean sections for breech presentation following external cephalic version according to a protocol in a special office visit].

    Science.gov (United States)

    Kuppens, S M I; Hasaart, T H M; van der Donk, M W P; Huibers, M; Franssen, M J; de Becker, B M J; Wijnen, H A A; Pop, V J M

    2008-06-07

    Identification of determinants affecting the outcome of external cephalic version (ECV) in breech presentation, and investigation of the impact of ECV--performed according to a standardized protocol in an outpatient clinic--on the mode of delivery. Retrospective analysis. In 2003 a standardized protocol of ECV was developed in the outpatient clinic for obstetrics of the Catharina Hospital in Eindhoven, the Netherlands; it was tested in 'version office visits'. Obstetric characteristics of all pregnant women who underwent attempts of ECV in the clinic from January 2004 until June 2006 during these sessions, and the subsequent births, were analysed. 85% of all ECVs were performed by the same hospital midwife and gynaecologist, in accordance with the protocol. ECV was successful in 96 of 209 pregnant women (46%). In 1 pregnant woman an emergency caesarean section was performed after ECV because of partial abruptio placentae. Nulliparity, incomplete breech presentation and low birth weight of the baby were associated with a lower success rate of ECV in this study. In the group with a successful ECV the percentage of caesarean deliveries was substantially lower (9 versus 83%; odds ratio: 0.21; 95% CI: 0.09-0.51). A regular team consisting of a hospital midwife and a gynaecologist working according to a standardized protocol for ECV in a case of breech presentation proved successful: the number of term breech presentations substantially diminished and therefore the percentage of caesarean sections was lower in the group in which ECV had been successful. This could have considerable impact on health care in the Netherlands in terms of reduced maternal morbidity and cost savings.

  16. SPP: A data base processor data communications protocol

    Science.gov (United States)

    Fishwick, P. A.

    1983-01-01

    The design and implementation of a data communications protocol for the Intel Data Base Processor (DBP) is defined. The protocol is termed SPP (Service Port Protocol) since it enables data transfer between the host computer and the DBP service port. The protocol implementation is extensible in that it is explicitly layered and the protocol functionality is hierarchically organized. Extensive trace and performance capabilities have been supplied with the protocol software to permit optional efficient monitoring of the data transfer between the host and the Intel data base processor. Machine independence was considered to be an important attribute during the design and implementation of SPP. The protocol source is fully commented and is included in Appendix A of this report.

  17. Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials

    NARCIS (Netherlands)

    B.M. Ellingson (Benjamin M.); M. Bendszus (Martin); J. Boxerman (Jerrold); D. Barboriak (Daniel); B.J. Erickson (Bradley J.); M. Smits (Marion); S.J. Nelson (Sarah J.); E. Gerstner (Elizabeth); B. Alexander (Brian); G. Goldmacher (Gregory); W. Wick (Wolfgang); M.A. Vogelbaum (Michael); M. Weller (Michael); E. Galanis (Evanthia); J. Kalpathy-Cramer (Jayashree); L. Shankar; P. Jacobs (Paula); W.B. Pope (Whitney B.); D. Yang (Dewen); C. Chung (Caroline); R.H. Knopp; S. Cha (Soonme); M.J. van den Bent (Martin); S.M. Chang (Susan); W.K. Al Yung; T.F. Cloughesy (Timothy F.); P.Y. Wen (Patrick Y.); M.R. Gilbert (Mark R.); A. Whitney (Andrew); D. Sandak (David); A. Musella (Al); C. Haynes (Chas); M. Wallace (Max); D.F. Arons (David F.); A. Kingston (Ann)

    2015-01-01

    textabstractA recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss

  18. Deterministic secure communication protocol without using entanglement

    OpenAIRE

    Cai, Qing-yu

    2003-01-01

    We show a deterministic secure direct communication protocol using single qubit in mixed state. The security of this protocol is based on the security proof of BB84 protocol. It can be realized with current technologies.

  19. Simulation and Evaluation of CTP and Secure-CTP Protocols

    Directory of Open Access Journals (Sweden)

    P. Pecho

    2010-04-01

    Full Text Available The paper discusses characteristics and qualities of two routing protocols – Collection Tree Protocol and its secure modification. The original protocol, as well as other protocols for wireless sensors, solves only problems of ra- dio communication and limited resources. Our design of the secure protocol tries to solve also the essential security ob- jectives. For the evaluation of properties of our protocol in large networks, a TOSSIM simulator was used. Our effort was to show the influence of the modification of the routing protocol to its behavior and quality of routing trees. We have proved that adding security into protocol design does not necessarily mean higher demands for data transfer, power consumption or worse protocol efficiency. In the paper, we manifest that security in the protocol may be achieved with low cost and may offer similar performance as the original protocol.

  20. Considerations preliminary to the application of early and immediate loading protocols in dental implantology.

    Science.gov (United States)

    Szmukler-Moncler, S; Piattelli, A; Favero, G A; Dubruille, J H

    2000-02-01

    In oral implantology, a 3-6 month stress-free healing period is presently accepted as a prerequisite to achieve bone apposition without interposition of a fibrous scar tissue. This protocol was introduced by Brånemark and co-workers in 1977. The aim of the present paper is to review the reasons that led Brånemark and collaborators to require long delayed loading periods. It is shown that the requirement for long delayed loading periods was drawn from the initiation and development periods of their original clinical trial. Demanding conditions were met involving simultaneously: 1) patients with poor bone quality and quantity, 2) non-optimized implant design, 3) short implants, 4) non-optimized surgical placement, 5) non-optimized surgical protocol and 6) biomechanically non-optimized prosthesis. Extrapolation of the requirement for long healing periods from these particular conditions to more standard situations involving refined surgical protocols and careful patient selection might be questioned. Albeit premature loading has been interpreted as inducing fibrous tissue interposition, immediate loading per se is not responsible for fibrous encapsulation. It is the excess of micromotion during the healing phase that interferes with bone repair. A threshold of tolerated micromotion exists, that is somewhere between 50 microns and 150 microns. It is suggested that loading protocols might be shortened through 2 different approaches. The first way would be to decrease stepwise the delayed loading period for free-standing implants below the presently accepted 3-6 months of healing. The second way would be to identify immediate loading protocols that are capable of keeping the amount of micromotion beneath the threshold of deleterious micromotion. Immediate loading protocols for implants-retained overdentures and fixed bridges are reviewed. It is shown that successful premature loading protocols require a careful and strict patient selection aimed to achieve the best