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

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

��= 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.

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

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

Systematic Review Protocol for the IRIS Chloroform Assessment (Inhalation) (Preliminary Assessment Materials)

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In January 2018, EPA released the Systematic Review Protocol for the IRIS Chloroform Assessment (Inhalation). As part of developing a draft IRIS assessment, EPA presents a methods document, referred to as the protocol, for conducting a chemical-specific systematic revie...

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.

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.

Characterizing College Science Assessments: The Three-Dimensional Learning Assessment Protocol

Science.gov (United States)

Underwood, Sonia M.; Matz, Rebecca L.; Posey, Lynmarie A.; Carmel, Justin H.; Caballero, Marcos D.; Fata-Hartley, Cori L.; Ebert-May, Diane; Jardeleza, Sarah E.; Cooper, Melanie M.

2016-01-01

Many calls to improve science education in college and university settings have focused on improving instructor pedagogy. Meanwhile, science education at the K-12 level is undergoing significant changes as a result of the emphasis on scientific and engineering practices, crosscutting concepts, and disciplinary core ideas. This framework of “three-dimensional learning” is based on the literature about how people learn science and how we can help students put their knowledge to use. Recently, similar changes are underway in higher education by incorporating three-dimensional learning into college science courses. As these transformations move forward, it will become important to assess three-dimensional learning both to align assessments with the learning environment, and to assess the extent of the transformations. In this paper we introduce the Three-Dimensional Learning Assessment Protocol (3D-LAP), which is designed to characterize and support the development of assessment tasks in biology, chemistry, and physics that align with transformation efforts. We describe the development process used by our interdisciplinary team, discuss the validity and reliability of the protocol, and provide evidence that the protocol can distinguish between assessments that have the potential to elicit evidence of three-dimensional learning and those that do not. PMID:27606671

Characterizing College Science Assessments: The Three-Dimensional Learning Assessment Protocol.

Science.gov (United States)

Laverty, James T; Underwood, Sonia M; Matz, Rebecca L; Posey, Lynmarie A; Carmel, Justin H; Caballero, Marcos D; Fata-Hartley, Cori L; Ebert-May, Diane; Jardeleza, Sarah E; Cooper, Melanie M

2016-01-01

Many calls to improve science education in college and university settings have focused on improving instructor pedagogy. Meanwhile, science education at the K-12 level is undergoing significant changes as a result of the emphasis on scientific and engineering practices, crosscutting concepts, and disciplinary core ideas. This framework of "three-dimensional learning" is based on the literature about how people learn science and how we can help students put their knowledge to use. Recently, similar changes are underway in higher education by incorporating three-dimensional learning into college science courses. As these transformations move forward, it will become important to assess three-dimensional learning both to align assessments with the learning environment, and to assess the extent of the transformations. In this paper we introduce the Three-Dimensional Learning Assessment Protocol (3D-LAP), which is designed to characterize and support the development of assessment tasks in biology, chemistry, and physics that align with transformation efforts. We describe the development process used by our interdisciplinary team, discuss the validity and reliability of the protocol, and provide evidence that the protocol can distinguish between assessments that have the potential to elicit evidence of three-dimensional learning and those that do not.

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.

Dual-Task Assessment Protocols in Concussion Assessment: A Systematic Literature Review.

Science.gov (United States)

Kleiner, Michelle; Wong, Lynne; Dubé, Alexandra; Wnuk, Katie; Hunter, Susan W; Graham, Laura J

2018-02-01

Study Design Systematic review. Background When assessed in isolation, balance and neurocognitive testing may not be sufficiently responsive to capture changes that occur with concussion. Normal daily activities require simultaneous cognitive and physical demands. Therefore, a dual-task assessment paradigm should be considered to identify performance deficits. Objectives To evaluate the literature and to identify dual-task testing protocols associated with changes in gait after concussion. Methods A systematic review of articles of individuals with concussion who underwent dual-task testing with a combination of motor and cognitive tasks was conducted. The AMED, CINAHL, Embase, PsycINFO, PubMed, Scopus, SPORTDiscus, and Web of Science databases and gray literature were searched from inception to January 29, 2017. Title and abstract, full-text, and quality review and data abstraction were performed by 2 independent reviewers. Results Twenty-four articles met the inclusion criteria. Eleven articles reported decreased gait velocity and increased medial-lateral displacement for individuals with concussion during dual-task conditions. Overall, included articles were of poor to moderate methodological quality. Fifteen articles used the same participants and data sets, creating a threat to validity and limiting the ability to make conclusions. Conclusion A deterioration in gait performance during dual-task testing is present among people with concussion. Specific recommendations for the use of a dual-task protocol to assess individuals with suspected concussion injury in a clinical setting have yet to be determined. J Orthop Sports Phys Ther 2018;48(2):87-103. Epub 7 Nov 2017. doi:10.2519/jospt.2018.7432.

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

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

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.

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

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.

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.

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.

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.

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.

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

Clinical application of Assessment of Parenting Competencies (APC)

DEFF Research Database (Denmark)

Jacobsen, Stine Lindahl

This paper is part of a symposium on music therapy with families with Kirsi Tuomi as Chair. It revolves around the clinical application of a new music therapy assessment model on parent-child interaction and parenting competencies. APC was developed for emotional neglected children and their pare......This paper is part of a symposium on music therapy with families with Kirsi Tuomi as Chair. It revolves around the clinical application of a new music therapy assessment model on parent-child interaction and parenting competencies. APC was developed for emotional neglected children......, child somatic hospitals, centers for refuges and other populations where it would be clinical relevant to assess the parent-child interaction. APC is an observational and improvisational based assessment model evaluating dyads of parent and child (child age range is 5-12). It produces information...... (numbers, graphs, and descriptions) of parent-child interaction and parenting competencies including nonverbal communication, level of attunement in the dyad, and level of emotional support from the parent. It is based on video analysis and a fixed assessment protocol. It was developed through a completed...

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)

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.

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

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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

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

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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).

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...

A routine PET/CT protocol with simple calculations for assessing cardiac amyloid using 18F-Florbetapir

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Dustin Ryan Osborne

2015-05-01

Full Text Available Introduction: Cardiac amyloidosis is a rare condition characterized by the deposition of well-structured protein fibrils, proteoglycans, and serum proteins as amyloid. Recent work has shown that it may be possible to use 18F-Florbetapir to image cardiac amyloidosis. Current methods for assessment include invasive biopsy techniques. This work enhances foundational work by Dorbala et al. by developing a routine imaging and analysis protocol using 18F-Florbetapir for cardiac amyloid assessment.Methods: Ten patients, 3 healthy controls and 7 amyloid positive patients, were imaged using 18F-Florbetapir to assess cardiac amyloid burden. Four of the patients also were imaged using 82Rb-Chloride to evaluate possible 18F-Florbetapir retention because of reduced myocardial blood flow. Quantitative methods using modeling, SUVs and SUV ratios were used to define a new streamlined clinical imaging protocol that could be used routinely and provide patient stratification.Results: Quantitative analysis of 18F-Florbetapir cardiac amyloid data were compiled from a 20 minute listmode protocol with data histogrammed into two static images at 0-5 minutes and, 10-15 min or 15-20 min. Data analysis indicated the use of SUVs or ratios of SUVs calculated from regions draw in the septal wall were adequate in identification of all healthy controls from amyloid positive patients in this small cohort. Additionally, we found that it may be possible to use this method to differentiate patients suffering from AL vs. TTR amyloid.Conclusions: This work builds on the seminal work by Dorbala et Al. by describing a short 18F-Florbetapir imaging protocol that is suitable for routine clinical use and uses a simple method for quantitative analysis of cardiac amyloid disease.

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

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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.

ASSESSMENT OF RIP-V1 AND OSPF-V2 PROTOCOL WITH CONSIDERATION OF CONVERGENCE CRITERIA AND SENDING PROTOCOLS TRAFFIC

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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.

Unified Protocol for psychiatric and psychological assessment of candidates for transplantation of organs and tissues, PSI-CAT.

Science.gov (United States)

Fidel Kinori, Sara Guila; Alcántara Tadeo, Antonio; Castan Campanera, Esther; Costa Requena, Gemma; Diez Quevedo, Crisanto; Lligoña Garreta, Anna; Lopez Lazcano, Ana; Martínez del Pozo, Montserrat; Rangil Muñoz, Teresa; Peri Nogués, Josep María

2015-01-01

Transplantation is the treatment option that offers improved survival and quality of life as compared to organ failure. Psychiatric and psychological aspects of transplant candidates are important, especially in the pre-assessment stage, as the influence of these factors can hinder post-surgical outcome in both the implanted organ survival and the quality of life of the transplanted person. Of particular importance, are the factors related to pathology due to substance use, psychopathology, and psychosocial support. There are currently few guidelines on the correct evaluation of patients eligible for these complex procedures. Nineteen psychiatrists and clinical psychologists from six public hospitals in Catalonia conducted a systematic consensus to determine the design of a Unified Protocol psychological and psychiatric evaluation. An annual work plan was implemented, during which; the objectives were defined, a literature review was conducted, the inclusion and exclusion criteria were discussed, questionnaires were selected, and a structured interview was developed. With the implementation of the work plan, the Assessment Protocol presented in this article was designed. systematic work and improving cooperation between psychiatrists and clinical psychologists, has led to homogeneity and consensus on a unified evaluation protocol. Copyright © 2013 SEP y SEPB. Published by Elsevier España. All rights reserved.

Development of pig welfare assessment protocol integrating animal-, environment-, and management-based measures.

Science.gov (United States)

Renggaman, Anriansyah; Choi, Hong L; Sudiarto, Sartika Ia; Alasaarela, Laura; Nam, Ok S

2015-01-01

Due to increased interest in animal welfare, there is now a need for a comprehensive assessment protocol to be used in intensive pig farming systems. There are two current welfare assessment protocols for pigs: Welfare Quality® Assessment Protocols (applicable in the Europe Union), that mostly focuses on animal-based measures, and the Swine Welfare Assurance Program (applicable in the United States), that mostly focuses on management- and environment-based measures. In certain cases, however, animal-based measures might not be adequate for properly assessing pig welfare status. Similarly, welfare assessment that relies only on environment- and management-based measures might not represent the actual welfare status of pigs. Therefore, the objective of this paper was to develop a new welfare protocol by integrating animal-, environment-, and management-based measures. The background for selection of certain welfare criteria and modification of the scoring systems from existing welfare assessment protocols are described. The developed pig welfare assessment protocol consists of 17 criteria that are related to four main principles of welfare (good feeding, good housing, good health, and appropriate behavior). Good feeding, good housing, and good health were assessed using a 3-point scale: 0 (good welfare), 1 (moderate welfare), and 2 (poor welfare). In certain cases, only a 2-point scale was used: 0 (certain condition is present) or 2 (certain condition is absent). Appropriate behavior was assessed by scan sampling of positive and negative social behaviors based on qualitative behavior assessment and human-animal relationship tests. Modification of the body condition score into a 3-point scale revealed pigs with a moderate body condition (score 1). Moreover, additional criteria such as feed quality confirmed that farms had moderate (score 1) or poor feed quality (score 2), especially those farms located in a high relative humidity region. The developed protocol can be

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

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.

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

Simplifying the Welfare Quality® assessment protocol for broiler chicken welfare.

Science.gov (United States)

de Jong, I C; Hindle, V A; Butterworth, A; Engel, B; Ferrari, P; Gunnink, H; Perez Moya, T; Tuyttens, F A M; van Reenen, C G

2016-01-01

Welfare Quality(®) (WQ) assessment protocols place the emphasis on animal-based measures as an indicator for animal welfare. Stakeholders, however, emphasize that a reduction in the time taken to complete the protocol is essential to improve practical applicability. We studied the potential for reduction in time to complete the WQ broiler assessment protocol and present some modifications to the protocol correcting a few errors in the original calculations. Data was used from 180 flocks assessed on-farm and 150 flocks assessed at the slaughter plant. Correlations between variables were calculated, and where correlation was moderate, meaningful and promising (in terms of time reduction), simplification was considered using one variable predicted from another variable. Correlation analysis revealed a promising correlation between severe hock burn and gait scores on-farm. Therefore, prediction of gait scores using hock burn scores was studied further as a possible simplification strategy (strategy 1). Measurements of footpad dermatitis, hock burn, cleanliness and gait score on-farm correlated moderately to highly with slaughter plant measurements of footpad dermatitis and/or hock burn, supporting substitution of on-farm measurements with slaughter plant data. A simplification analysis was performed using footpad dermatitis, hock burn, cleanliness and gait scores measured on-farm predicted from slaughter plant measurements of footpad dermatitis and hock burn (strategy 2). Simplification strategies were compared with the full assessment protocol. Close agreement was found between the full protocol and both simplification strategies although large confidence intervals were found for specificity of the simplified models. It is concluded that the proposed simplification strategies are encouraging; strategy 1 can reduce the time to complete the on-farm assessment by ~1 h (25% to 33% reduction) and strategy 2 can reduce on-farm assessment time by ~2 h (50% to 67% reduction

Developmental trajectories of infants and toddlers with good initial presentation following moderate or severe traumatic brain injury: a pilot clinical assessment project.

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Pomerleau, Geneviève; Hurteau, Anne-Marie; Parent, Line; Doucet, Katrine; Corbin-Berrigan, Laurie-Ann; Gagnon, Isabelle

2012-01-01

The purpose of this study was to review the feasibility and usefulness of instituting a clinical protocol of scheduled assessments for children after a moderate or severe traumatic brain injury (TBI) sustained before the age of 2 years and showing no immediate deficits at hospital discharge, as well as to explore the early developmental trajectories of these children. Exploratory analytical cohort study. Pediatric Trauma Center Out-patient services. 31 children were followed within the clinical protocol of scheduled assessments. The protocol included an immediate post-injury clinical assessment of infants who sustained a TBI and follow-up assessments at the ages of 9 months, 18 months (if injured prior to that age), 30 months, and 42 months. Domains assessed at each scheduled visit included hearing, speech and language, motor performance, personal social abilities, and adaptive behaviors. Clinicians reported few difficulties with scheduling or administering the assessments, maintaining a 67% participation rate at the end of the follow-up period, thus demonstrating the feasibility of the protocol in this population. Scores on the majority of formal tests showed high variability and 15-20% of children presented with clinically significant motor and/or language delays. By 42 months of age, difficulties with adaptive behavior and personal social abilities were identified in our sample of children when compared to published norms. Qualitative clinical findings from professionals identified between 25-50% of children with potential attentional difficulties throughout the follow-up period. Findings from this study demonstrate the feasibility of implementing a clinical protocol of assessment for infants and toddlers who sustain a TBI before the age of 2 years and present with no impairments at the time of discharge from hospital. Developmental problems in this population appear to be easier to identify later in the toddler years as opposed to immediately following the TBI

Self-care assessment as an indicator for clinical supervision in nursing

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Sílvia Marlene Monteiro Teixeira

2016-06-01

Full Text Available Objective: to evaluate the needs of clinical supervision for nurses to assess the degree of dependence on self-care and planning of nursing interventions. Methods: analytical study, cross-cutting nature, collecting data from a sample of 110 patients. Results: it was shown the differences in the identification of the degree of dependence between registers and experts, as well as the selection of operations for each self-care and failures to the original assessment of the filling level (no evaluation self-care/no identification of the degree of dependence. Conclusion: there were gaps in the nursing process; they have proposed strategies such as clinical supervision sessions, training, case studies, protocols and guidance documents, to be included in a clinical supervision in nursing model.

Automation of CT-based haemorrhagic stroke assessment for improved clinical outcomes: study protocol and design.

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Chinda, Betty; Medvedev, George; Siu, William; Ester, Martin; Arab, Ali; Gu, Tao; Moreno, Sylvain; D'Arcy, Ryan C N; Song, Xiaowei

2018-04-19

Haemorrhagic stroke is of significant healthcare concern due to its association with high mortality and lasting impact on the survivors' quality of life. Treatment decisions and clinical outcomes depend strongly on the size, spread and location of the haematoma. Non-contrast CT (NCCT) is the primary neuroimaging modality for haematoma assessment in haemorrhagic stroke diagnosis. Current procedures do not allow convenient NCCT-based haemorrhage volume calculation in clinical settings, while research-based approaches are yet to be tested for clinical utility; there is a demonstrated need for developing effective solutions. The project under review investigates the development of an automatic NCCT-based haematoma computation tool in support of accurate quantification of haematoma volumes. Several existing research methods for haematoma volume estimation are studied. Selected methods are tested using NCCT images of patients diagnosed with acute haemorrhagic stroke. For inter-rater and intrarater reliability evaluation, different raters will analyse haemorrhage volumes independently. The efficiency with respect to time of haematoma volume assessments will be examined to compare with the results from routine clinical evaluations and planimetry assessment that are known to be more accurate. The project will target the development of an enhanced solution by adapting existing methods and integrating machine learning algorithms. NCCT-based information of brain haemorrhage (eg, size, volume, location) and other relevant information (eg, age, sex, risk factor, comorbidities) will be used in relation to clinical outcomes with future project development. Validity and reliability of the solution will be examined for potential clinical utility. The project including procedures for deidentification of NCCT data has been ethically approved. The study involves secondary use of existing data and does not require new consent of participation. The team consists of clinical neuroimaging

[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.

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

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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.

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.

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

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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.

Implementation of the Welfare Quality broiler assessment protocol – final report : overview of outcome-based measurement of broiler welfare and a general discussion on the Welfare Quality broiler assessment protocol

NARCIS (Netherlands)

Jong, de I.C.; Gunnink, H.; Hindle, V.A.

2015-01-01

In the current report, two topics related to our study on the implementation of the Welfare Quality® broiler assessment protocol are discussed. First, animal-based measures for broiler welfare, currently included in the Welfare Quality® broiler assessment protocol, are discussed with respect to

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

[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.

Validity of partial protocols to assess the prevalence of periodontal outcomes and associated sociodemographic and behavior factors in adolescents and young adults.

Science.gov (United States)

Peres, Marco A; Peres, Karen G; Cascaes, Andreia M; Correa, Marcos B; Demarco, Flávio F; Hallal, Pedro C; Horta, Bernardo L; Gigante, Denise P; Menezes, Ana B

2012-03-01

Most studies comparing prevalence of periodontal disease and risk factors by using partial protocols were performed in adult populations, with several studies being conducted in clinical settings. The aim of this study is to assess the accuracy of partial protocols in estimating the prevalence of periodontal outcomes in adolescents and young adults from two population-based birth cohorts from Pelotas, Brazil, and to assess differences in the estimation and strength of the effect measures when partial protocols are adopted compared to full-mouth examination. Gingival bleeding at probing among adolescents (n = 339) and young adults (n = 720) and dental calculus and periodontal probing depth among young adults were assessed using full-mouth examinations and four partial protocols: Ramfjord teeth (RT), community periodontal index (CPI), and two random diagonal quadrants (1 and 3, 2 and 4). Socioeconomic, demographic, and periodontal health-related variables were also collected. Sensitivity, absolute and relative bias, and inflation factors were calculated. Prevalence ratio for each periodontal outcome for the risk factors was estimated. Two diagonal quadrants showed better accuracy; RT had the worst, whereas CPI presented an intermediate pattern when compared to full-mouth examination. For bleeding assessment in adolescence, RT and CPI underestimated by 18.4% and 16.2%, respectively, the true outcome prevalence, whereas among young adults, all partial protocols underestimated the prevalence. All partial protocols presented similar magnitude of association measures for all investigated periodontal potential risk factors. Two diagonal quadrants protocol may be effective in identifying the risk factors for the most relevant periodontal outcomes in adolescence and in young adulthood.

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.

Preoperative vestibular assessment protocol of cochlear implant surgery: an analytical descriptive study.

Science.gov (United States)

Bittar, Roseli Saraiva Moreira; Sato, Eduardo Setsuo; Ribeiro, Douglas Jósimo Silva; Tsuji, Robinson Koji

Cochlear implants are undeniably an effective method for the recovery of hearing function in patients with hearing loss. To describe the preoperative vestibular assessment protocol in subjects who will be submitted to cochlear implants. Our institutional protocol provides the vestibular diagnosis through six simple tests: Romberg and Fukuda tests, assessment for spontaneous nystagmus, Head Impulse Test, evaluation for Head Shaking Nystagmus and caloric test. 21 patients were evaluated with a mean age of 42.75±14.38 years. Only 28% of the sample had all normal test results. The presence of asymmetric vestibular information was documented through the caloric test in 32% of the sample and spontaneous nystagmus was an important clue for the diagnosis. Bilateral vestibular areflexia was present in four subjects, unilateral arreflexia in three and bilateral hyporeflexia in two. The Head Impulse Test was a significant indicator for the diagnosis of areflexia in the tested ear (p=0.0001). The sensitized Romberg test using a foam pad was able to diagnose severe vestibular function impairment (p=0.003). The six clinical tests were able to identify the presence or absence of vestibular function and function asymmetry between the ears of the same individual. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

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...

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

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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

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

[Multidisciplinary protocol for computed tomography imaging and angiographic embolization of splenic injury due to trauma: assessment of pre-protocol and post-protocol outcomes].

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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.

Evaluation of Quality Assessment Protocols for High Throughput Genome Resequencing Data.

Science.gov (United States)

Chiara, Matteo; Pavesi, Giulio

2017-01-01

Large-scale initiatives aiming to recover the complete sequence of thousands of human genomes are currently being undertaken worldwide, concurring to the generation of a comprehensive catalog of human genetic variation. The ultimate and most ambitious goal of human population scale genomics is the characterization of the so-called human "variome," through the identification of causal mutations or haplotypes. Several research institutions worldwide currently use genotyping assays based on Next-Generation Sequencing (NGS) for diagnostics and clinical screenings, and the widespread application of such technologies promises major revolutions in medical science. Bioinformatic analysis of human resequencing data is one of the main factors limiting the effectiveness and general applicability of NGS for clinical studies. The requirement for multiple tools, to be combined in dedicated protocols in order to accommodate different types of data (gene panels, exomes, or whole genomes) and the high variability of the data makes difficult the establishment of a ultimate strategy of general use. While there already exist several studies comparing sensitivity and accuracy of bioinformatic pipelines for the identification of single nucleotide variants from resequencing data, little is known about the impact of quality assessment and reads pre-processing strategies. In this work we discuss major strengths and limitations of the various genome resequencing protocols are currently used in molecular diagnostics and for the discovery of novel disease-causing mutations. By taking advantage of publicly available data we devise and suggest a series of best practices for the pre-processing of the data that consistently improve the outcome of genotyping with minimal impacts on computational costs.

Exploring a New Simulation Approach to Improve Clinical Reasoning Teaching and Assessment: Randomized Trial Protocol.

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Pennaforte, Thomas; Moussa, Ahmed; Loye, Nathalie; Charlin, Bernard; Audétat, Marie-Claude

2016-02-17

Helping trainees develop appropriate clinical reasoning abilities is a challenging goal in an environment where clinical situations are marked by high levels of complexity and unpredictability. The benefit of simulation-based education to assess clinical reasoning skills has rarely been reported. More specifically, it is unclear if clinical reasoning is better acquired if the instructor's input occurs entirely after or is integrated during the scenario. Based on educational principles of the dual-process theory of clinical reasoning, a new simulation approach called simulation with iterative discussions (SID) is introduced. The instructor interrupts the flow of the scenario at three key moments of the reasoning process (data gathering, integration, and confirmation). After each stop, the scenario is continued where it was interrupted. Finally, a brief general debriefing ends the session. System-1 process of clinical reasoning is assessed by verbalization during management of the case, and System-2 during the iterative discussions without providing feedback. The aim of this study is to evaluate the effectiveness of Simulation with Iterative Discussions versus the classical approach of simulation in developing reasoning skills of General Pediatrics and Neonatal-Perinatal Medicine residents. This will be a prospective exploratory, randomized study conducted at Sainte-Justine hospital in Montreal, Qc, between January and March 2016. All post-graduate year (PGY) 1 to 6 residents will be invited to complete one SID or classical simulation 30 minutes audio video-recorded complex high-fidelity simulations covering a similar neonatology topic. Pre- and post-simulation questionnaires will be completed and a semistructured interview will be conducted after each simulation. Data analyses will use SPSS and NVivo softwares. This study is in its preliminary stages and the results are expected to be made available by April, 2016. This will be the first study to explore a new

A novel cognitive palatability assessment protocol for dogs.

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Araujo, J A; Milgram, N W

2004-07-01

Assessment of canine palatability is important for both the pet food and pharmaceutical industries; however, the current palatability assessment protocols are limited in their utility. The most common technique, the two-pan test, does not control for the satiating effects of food and may not be useful for long-term palatability analysis because nutritional or caloric characteristics of the diets may interfere with the results. Furthermore, the large quantities of foods consumed may be detrimental to the health of animals that do not self-limit their food intake. The purpose of this study was to determine whether a cognitive protocol could be used to determine food palatability in dogs. Five beagle dogs were trained on a three-choice object-discrimination learning task. After establishing object preferences, the preferred object was associated with no reward, a second object was associated with the dog's normal laboratory diet (Purina Agribrands Canine Lab Chow No. 5006; Agribrands Purina Canada, Inc., Woodstock, ON, Canada), and the third object was associated with a commercial (Hill's P/D; Hill's Pet Nutrition Inc., Topeka, KS) diet. In the discrimination-training phase, dogs were trained until they learned to avoid the no-reward object. They were subsequently given an additional 20 test sessions, which were used to determine food preference. In the reversal phase, which involved reversal learning, the object-food associations were modified, such that the object that was previously associated with Hill's P/D diet was now associated with the normal laboratory diet and vice versa. Once the dogs learned to avoid the no-reward object, they were tested for an additional 20 sessions. All subjects learned to avoid the no-reward object during the initial learning, and the number of choices to the object associated with the Hill's P/D diet was greater than the number of choices to the objects associated with the dry laboratory diet (P food-choice associations were reversed

A CAD system and quality assurance protocol for bone age assessment utilizing digital hand atlas

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Gertych, Arakadiusz; Zhang, Aifeng; Ferrara, Benjamin; Liu, Brent J.

2007-03-01

Determination of bone age assessment (BAA) in pediatric radiology is a task based on detailed analysis of patient's left hand X-ray. The current standard utilized in clinical practice relies on a subjective comparison of the hand with patterns in the book atlas. The computerized approach to BAA (CBAA) utilizes automatic analysis of the regions of interest in the hand image. This procedure is followed by extraction of quantitative features sensitive to skeletal development that are further converted to a bone age value utilizing knowledge from the digital hand atlas (DHA). This also allows providing BAA results resembling current clinical approach. All developed methodologies have been combined into one CAD module with a graphical user interface (GUI). CBAA can also improve the statistical and analytical accuracy based on a clinical work-flow analysis. For this purpose a quality assurance protocol (QAP) has been developed. Implementation of the QAP helped to make the CAD more robust and find images that cannot meet conditions required by DHA standards. Moreover, the entire CAD-DHA system may gain further benefits if clinical acquisition protocol is modified. The goal of this study is to present the performance improvement of the overall CAD-DHA system with QAP and the comparison of the CAD results with chronological age of 1390 normal subjects from the DHA. The CAD workstation can process images from local image database or from a PACS server.

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.

An Experimental Protocol for Assessing the Performance of New Ultrasound Probes Based on CMUT Technology in Application to Brain Imaging.

Science.gov (United States)

Matrone, Giulia; Ramalli, Alessandro; Savoia, Alessandro Stuart; Quaglia, Fabio; Castellazzi, Gloria; Morbini, Patrizia; Piastra, Marco

2017-09-24

The possibility to perform an early and repeatable assessment of imaging performance is fundamental in the design and development process of new ultrasound (US) probes. Particularly, a more realistic analysis with application-specific imaging targets can be extremely valuable to assess the expected performance of US probes in their potential clinical field of application. The experimental protocol presented in this work was purposely designed to provide an application-specific assessment procedure for newly-developed US probe prototypes based on Capacitive Micromachined Ultrasonic Transducer (CMUT) technology in relation to brain imaging. The protocol combines the use of a bovine brain fixed in formalin as the imaging target, which ensures both realism and repeatability of the described procedures, and of neuronavigation techniques borrowed from neurosurgery. The US probe is in fact connected to a motion tracking system which acquires position data and enables the superposition of US images to reference Magnetic Resonance (MR) images of the brain. This provides a means for human experts to perform a visual qualitative assessment of the US probe imaging performance and to compare acquisitions made with different probes. Moreover, the protocol relies on the use of a complete and open research and development system for US image acquisition, i.e. the Ultrasound Advanced Open Platform (ULA-OP) scanner. The manuscript describes in detail the instruments and procedures involved in the protocol, in particular for the calibration, image acquisition and registration of US and MR images. The obtained results prove the effectiveness of the overall protocol presented, which is entirely open (within the limits of the instrumentation involved), repeatable, and covers the entire set of acquisition and processing activities for US images.

An Assessment Protocol for Selective Mutism: Analogue Assessment Using Parents as Facilitators.

Science.gov (United States)

Schill, Melissa T.; And Others

1996-01-01

Assesses protocol for conducting a functional analysis of maintaining variables for children with selective mutism. A parent was trained in and later applied various behavior strategies designed to increase speech in an eight-year-old girl with selective mutism. Parent and child ratings of treatment were positive. Presents implications for future…

WelFur - mink: development of on-farm welfare assessment protocols for mink

DEFF Research Database (Denmark)

Møller, Steen Henrik; Hansen, Steffen W; Rousing, Tine

2012-01-01

European Fur Breeder's Association initiated the "WelFur" project in 2009 in order to develop a welfare assessment protocol for mink and fox farms after the Welfare Quality® standards. The assessment is based on four welfare principles (Good feeding, good housing, good health and appropriate beha...... mink production seasons: Winter, spring, and autumn, in order to cover the life cycle of mink and proved feasible for a one-day visit.......European Fur Breeder's Association initiated the "WelFur" project in 2009 in order to develop a welfare assessment protocol for mink and fox farms after the Welfare Quality® standards. The assessment is based on four welfare principles (Good feeding, good housing, good health and appropriate...

Assessing health systems for type 1 diabetes in sub-Saharan Africa: developing a 'Rapid Assessment Protocol for Insulin Access'

Directory of Open Access Journals (Sweden)

de Courten Maximilian

2006-02-01

Full Text Available Abstract Background In order to improve the health of people with Type 1 diabetes in developing countries, a clear analysis of the constraints to insulin access and diabetes care is needed. We developed a Rapid Assessment Protocol for Insulin Access, comprising a series of questionnaires as well as a protocol for the gathering of other data through site visits, discussions, and document reviews. Methods The Rapid Assessment Protocol for Insulin Access draws on the principles of Rapid Assessment Protocols which have been developed and implemented in several different areas. This protocol was adapted through a thorough literature review on diabetes, chronic condition management and medicine supply in developing countries. A visit to three countries in sub-Saharan Africa and meetings with different experts in the field of diabetes helped refine the questionnaires. Following the development of the questionnaires these were tested with various people familiar with diabetes and/or healthcare in developing countries. The Protocol was piloted in Mozambique then refined and had two further iterations in Zambia and Mali. Translations of questionnaires were made into local languages when necessary, with back translation to ensure precision. Results In each country the protocol was implemented in 3 areas – the capital city, a large urban centre and a predominantly rural area and their respective surroundings. Interviews were carried out by local teams trained on how to use the tool. Data was then collected and entered into a database for analysis. Conclusion The Rapid Assessment Protocol for Insulin Access was developed to provide a situational analysis of Type 1 diabetes, in order to make recommendations to the national Ministries of Health and Diabetes Associations. It provided valuable information on patients' access to insulin, syringes, monitoring and care. It was thus able to sketch a picture of the health care system with regards to its ability to

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

Assessment of blinding success among dental implant clinical trials: A systematic review

Directory of Open Access Journals (Sweden)

Jafar Kolahi

2015-01-01

Full Text Available Introduction: It is widely believed that blinding is a cornerstone of randomized clinical trials and that significant bias may result from unsuccessful blinding. However, it is not enough to claim that a clinical trial is single- or double-blinded and that assessment of the success of blinding is ideal. The aim of this study was to evaluate the prevalence of assessment of blinding success among dental implant clinical trials and to introduce methods of blinding assessment to the implant research community. Methods: In November 2014, PubMed was searched by blinded and experienced researchers with the query "implant AND (blindFNx01 OR maskFNx01" using the following filters: (1 Article type: clinical trial; (2 Journal categories: dental journals; (3 Field: title/abstract. Consequently, title/abstract was reviewed in all relevant articles to find any attempt to assess the success of blinding in dental implant clinical trials. Results: The PubMed search results yielded 86 clinical trials. The point of interest is that when "blindFNx01 OR maskFNx01" was deleted from the query, the number of results increased to 1688 clinical trials. This shows that only 5% of dental implant clinical trials tried to use blinding. Disappointingly, we could not find any dental implant clinical trial reporting any attempt to assess the success of blinding. Conclusion: The current status of turning a blind eye to unblinding in dental implant clinical trials is not tolerable and needs to be improved. Researchers, protocol reviewers, local ethical committees, journal reviewers, and editors should make a concerted effort to incorporate, report, and publish such information to understand its potential impact on study results.

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.

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.

Importance of Standardized DXA Protocol for Assessing Physique Changes in Athletes.

Science.gov (United States)

Nana, Alisa; Slater, Gary J; Hopkins, Will G; Halson, Shona L; Martin, David T; West, Nicholas P; Burke, Louise M

2016-06-01

The implications of undertaking DXA scans using best practice protocols (subjects fasted and rested) or a less precise but more practical protocol in assessing chronic changes in body composition following training and a specialized recovery technique were investigated. Twenty-one male cyclists completed an overload training program, in which they were randomized to four sessions per week of either cold water immersion therapy or control groups. Whole-body DXA scans were undertaken with best practice protocol (Best) or random activity protocol (Random) at baseline, after 3 weeks of overload training, and after a 2-week taper. Magnitudes of changes in total, lean and fat mass from baseline-overload, overload-taper and baseline-taper were assessed by standardization (Δmean/SD). The standard deviations of change scores for total and fat-free soft tissue mass (FFST) from Random scans (2-3%) were approximately double those observed in the Best (1-2%), owing to extra random errors associated with Random scans at baseline. There was little difference in change scores for fat mass. The effect of cold water immersion therapy on baseline-taper changes in FFST was possibly harmful (-0.7%; 90% confidence limits ±1.2%) with Best scans but unclear with Random scans (0.9%; ±2.0%). Both protocols gave similar possibly harmful effects of cold water immersion therapy on changes in fat mass (6.9%; ±13.5% and 5.5%; ±14.3%, respectively). An interesting effect of cold water immersion therapy on training-induced changes in body composition might have been missed with a less precise scanning protocol. DXA scans should be undertaken with Best.

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

On-FarmWelfare Assessment Protocol for Adult Dairy Goats in Intensive Production Systems

Directory of Open Access Journals (Sweden)

Monica Battini

2015-09-01

Full Text Available Within the European AWIN project, a protocol for assessing dairy goats’ welfareon the farm was developed. Starting from a literature review, a prototype includinganimal-based indicators covering four welfare principles and 12 welfare criteria was set up.The prototype was tested in 60 farms for validity, reliability, and feasibility. After testing theprototype, a two-level assessment protocol was proposed in order to increase acceptabilityamong stakeholders. The first level offers a more general overview of the welfare status,based on group assessment of a few indicators (e.g., hair coat condition, latency to thefirst contact test, severe lameness, Qualitative Behavior Assessment, with no or minimalhandling of goats and short assessment time required. The second level starts if welfareAnimals 2015, 5 935problems are encountered in the first level and adds a comprehensive and detailed individualevaluation (e.g., Body Condition Score, udder asymmetry, overgrown claws, supported byan effective sampling strategy. The assessment can be carried out using the AWIN Goatapp. The app results in a clear visual output, which provides positive feedback on welfareconditions in comparison with a benchmark of a reference population. The protocol maybe a valuable tool for both veterinarians and technicians and a self-assessment instrumentfor farmers.

[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.

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.

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.)

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.)

Comparative assessment of different recycling methods of orthodontic brackets for clinical use.

Science.gov (United States)

de Oliveira Correia, Ayla M; de Souza Matos, Felipe; Pilli Jóias, Renata; de Mello Rode, Sigmar; Cesar, Paulo F; Paranhos, Luiz R

2017-06-01

This study aimed to assess bond strength of the resin/bracket interface, under in-vitro shear stress, of metal brackets recycled by different clinical protocols. Sixty stainless steel orthodontic brackets were bonded on acrylic resin. The Transbond XT™ resin was applied at the base of the bracket aided by a matrix, obtaining 1 mm of thickness, and photoactivated with a LED device (40 s; 500 mW/cm2). Samples were randomly divided into four groups (N.=15) according to the reconditioning/recycling protocol: aluminum oxide (AO) 90 µm; hydrofluoric acid 60 s (HA60); hydrofluoric acid 120 s (HA120); hydrofluoric acid 60 s + silane (HA60S). After recycling, the resin was applied at the base of the bracket for shear testing in a universal testing machine (0.5 mm/min). After reconditioning/recycling, the surfaces were analyzed by Scanning Electron Microscopy. Data obtained after the shear test were subjected to ANOVA and Tukey's test (Porthodontic brackets when compared to the other protocols. The reconditioning technique with 10% hydrofluoric acid followed by the application of silane bonding agent may be used as an alternative protocol.

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.

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

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

A Systematic Review to Uncover a Universal Protocol for Accuracy Assessment of 3-Dimensional Virtually Planned Orthognathic Surgery.

Science.gov (United States)

Gaber, Ramy M; Shaheen, Eman; Falter, Bart; Araya, Sebastian; Politis, Constantinus; Swennen, Gwen R J; Jacobs, Reinhilde

2017-11-01

The aim of this study was to systematically review methods used for assessing the accuracy of 3-dimensional virtually planned orthognathic surgery in an attempt to reach an objective assessment protocol that could be universally used. A systematic review of the currently available literature, published until September 12, 2016, was conducted using PubMed as the primary search engine. We performed secondary searches using the Cochrane Database, clinical trial registries, Google Scholar, and Embase, as well as a bibliography search. Included articles were required to have stated clearly that 3-dimensional virtual planning was used and accuracy assessment performed, along with validation of the planning and/or assessment method. Descriptive statistics and quality assessment of included articles were performed. The initial search yielded 1,461 studies. Only 7 studies were included in our review. An important variability was found regarding methods used for 1) accuracy assessment of virtually planned orthognathic surgery or 2) validation of the tools used. Included studies were of moderate quality; reviewers' agreement regarding quality was calculated to be 0.5 using the Cohen κ test. On the basis of the findings of this review, it is evident that the literature lacks consensus regarding accuracy assessment. Hence, a protocol is suggested for accuracy assessment of virtually planned orthognathic surgery with the lowest margin of error. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Assessing Clinical Trial-Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool.

Science.gov (United States)

Good, Marjorie J; Hurley, Patricia; Woo, Kaitlin M; Szczepanek, Connie; Stewart, Teresa; Robert, Nicholas; Lyss, Alan; Gönen, Mithat; Lilenbaum, Rogerio

2016-05-01

Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial-associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Community-based research programs were recruited to collect and enter clinical trial-associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings. Copyright © 2016 by American Society of Clinical Oncology.

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...

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

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

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

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

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

A proposed protocol for remote control of automated assessment devices

International Nuclear Information System (INIS)

Kissock, P.S.; Pritchard, D.A.

1996-01-01

Systems and devices that are controlled remotely are becoming more common in security systems in the US Air Force and other government agencies to provide protection of valuable assets. These systems reduce the number of needed personnel while still providing a high level of protection. However, each remotely controlled device usually has its own communication protocol. This limits the ability to change devices without changing the system that provides the communications control to the device. Sandia is pursuing a standard protocol that can be used to communicate with the different devices currently in use, or may be used in the future, in the US Air Force and other government agencies throughout the security community. Devices to be controlled include intelligent pan/tilt mounts, day/night video cameras, thermal imaging cameras, and remote data processors. Important features of this protocol include the ability to send messages of varying length, identify the sender, and more importantly, control remote data processors. This paper describes the proposed public domain protocol, features, and examples of use. The authors hope to elicit comments from security technology developers regarding format and use of remotely controlled automated assessment devices

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.

Quantitative echocardiographic measures in the assessment of single ventricle function post-Fontan: Incorporation into routine clinical practice.

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Rios, Rodrigo; Ginde, Salil; Saudek, David; Loomba, Rohit S; Stelter, Jessica; Frommelt, Peter

2017-01-01

Quantitative echocardiographic measurements of single ventricular (SV) function have not been incorporated into routine clinical practice. A clinical protocol, which included quantitative measurements of SV deformation (global circumferential and longitudinal strain and strain rate), standard deviation of time to peak systolic strain, myocardial performance index (MPI), dP/dT from an atrioventricular valve regurgitant jet, and superior mesenteric artery resistance index, was instituted for all patients with a history of Fontan procedure undergoing echocardiography. All measures were performed real time during clinically indicated studies and were included in clinical reports. A total of 100 consecutive patients (mean age = 11.95±6.8 years, range 17 months-31.3 years) completed the protocol between September 1, 2014 to April 29, 2015. Deformation measures were completed in 100% of the studies, MPI in 93%, dP/dT in 55%, and superior mesenteric artery Doppler in 82%. The studies were reviewed to assess for efficiency in completing the protocol. The average time for image acquisition was 27.4±8.8 (range 10-62 minutes). The average time to perform deformation measures was 10.8±5.5 minutes (range 5-35 minutes) and time from beginning of imaging to report completion was 53.4±13.7 minutes (range 27-107 minutes). There was excellent inter-observer reliability when deformation indices were blindly repeated. Patients with a single left ventricle had significantly higher circumferential strain and strain rate, longitudinal strain and strain rate, and dP/dT compared to a single right ventricle. There were no differences in quantitative indices of ventricular function between patients 10 years post-Fontan. Advanced quantitative assessment of SV function post-Fontan can be consistently and efficiently performed real time during clinically indicated echocardiograms with excellent reliability. © 2016, Wiley Periodicals, Inc.

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

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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

Diagnosing subtle palatal anomalies: Validation of video-analysis and assessment protocol for diagnosing occult submucous cleft palate.

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Rourke, Ryan; Weinberg, Seth M; Marazita, Mary L; Jabbour, Noel

2017-09-01

Submucous cleft palate (SMCP) classically involves bifid uvula, zona pellucida, and notched hard palate. However, patients may present with more subtle anatomic abnormalities. The ability to detect these abnormalities is important for surgeons managing velopharyngeal dysfunction (VPD) or considering adenoidectomy. Validate an assessment protocol for diagnosis of occult submucous cleft palate (OSMCP) and identify physical examination features present in patients with OSMCP in the relaxed and activated palate positions. Study participants included patients referred to a pediatric VPD clinic with concern for hypernasality or SMCP. Using an appropriately encrypted iPod touch, transoral video was obtained for each patient with the palate in the relaxed and activated positions. The videos were reviewed by two otolaryngologists in normal speed and slow-motion, as needed, and a questionnaire was completed by each reviewer pertaining to the anatomy and function of the palate. 47 patients, with an average age of 4.6 years, were included in the study over a one-year period. Four videos were unusable due to incomplete view of the palate. The most common palatal abnormality noted was OSMCP, diagnosed by each reviewer in 26/43 and 30/43 patients respectively. Using the assessment protocol, agreement on palatal diagnosis was 83.7% (kappa = 0.68), indicating substantial agreement, with the most prevalent anatomic features being vaulted palate elevation (96%) and visible notching of hard palate (75%). The diagnosis of subtle palatal anomalies is difficult and can be subjective. Using the proposed video-analysis method and assessment protocol may improve reliability of diagnosis of OSMCP. Copyright © 2017 Elsevier B.V. All rights reserved.

Students' Assessment and Self-assessment of Nursing Clinical Faculty Competencies: Important Feedback in Clinical Education?

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Lovrić, Robert; Prlić, Nada; Zec, Davor; Pušeljić, Silvija; Žvanut, Boštjan

2015-01-01

The students' assessment of clinical faculty competencies and the faculty members' self-assessment can provide important information about nursing clinical education. The aim of this study was to identify the differences between the students' assessment of the clinical faculty member's competencies and the faculty member's self-assessment. These differences can reveal interesting insights relevant for improving clinical practice.

Quantitative assessment of inter-clinician variability of target volume delineation for medulloblastoma: quality assurance for the SIOP PNET 4 trial protocol

International Nuclear Information System (INIS)

Coles, Charlotte E.; Hoole, Andrew C.F.; Harden, Susan V; Burnet, Neil G.; Twyman, Nicola; Taylor, Roger E.; Kortmann, Rolf D.; Williams, Michael V.

2003-01-01

Background and purpose: To assess inter-clinician variability amongst specialist paediatric radiation oncologists in delineating clinical target volumes for treating medulloblastoma as a quality assurance exercise prior to the introduction of the SIOP PNET 4 trial protocol of conformal radiotherapy to the posterior fossa and tumour bed. Patients and methods: Participants from 17 UK centres attended an educational meeting and then completed a clinical planning exercise to outline: (1) the whole posterior fossa and (2) the tumour bed. Quantitative analysis of the volumes, lengths, spatial positioning and axial planes for each individual was carried out and variation between individuals analysed. Results: Outlining of the posterior fossa was reasonably consistent, although most variation was seen in defining the superior border of the tentorium. A major difference was the decision whether or not to include the post-surgical meningocoele in the clinical target volume (CTV). The CTV for the tumour bed was under treated by all participants due to lack of inclusion of pre-operative tumour extent. Conclusions: This exercise demonstrated several ambiguities in the draft protocol and highlighted particular areas of inter-clinician variation. Consequently the protocol was revised and improved to take account of these findings. We recommend that planning exercises, in conjunction with education and training, should be implemented before the start of any new radiotherapy trial. In the future, the use of image transfer will allow prospective peer review of target volumes before treatment commences. These measures are essential to ensure that alterations in clinical practice are achieved in a uniform way

Implementing an Assessment Clinic in a Residential PTSD Program

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Joan McDowell

2014-08-01

Full Text Available Creating useful treatment plans can help improve services to consumers of mental health services. As more evidence-based practices are implemented, deciding what treatment, at what time, for whom becomes an important factor in facilitating positive outcomes. Readiness for trauma-focused treatments for Posttraumatic Stress Disorder (PTSD such as Cognitive Processing Therapy or Prolonged Exposure Therapy may influence whether an individual can successfully complete either protocol. In addition, components of adjunctive therapies such as Acceptance and Commitment Therapy or Dialectical Behavior Therapy may be useful in moving a particular patient toward readiness and successful completion of treatment. Psychological assessment adds valuable data to inform these types of treatment decisions. This paper describes the implementation of a psychological assessment clinic in a residential PTSD treatment setting. Barriers to implementation, use of the data, and Veterans’ reactions to the feedback provided to them are included.

Assessing health systems for type 1 diabetes in sub-Saharan Africa: developing a 'Rapid Assessment Protocol for Insulin Access'

DEFF Research Database (Denmark)

Beran, David; Yudkin, John S; de Courten, Maximilian

2006-01-01

In order to improve the health of people with Type 1 diabetes in developing countries, a clear analysis of the constraints to insulin access and diabetes care is needed. We developed a Rapid Assessment Protocol for Insulin Access, comprising a series of questionnaires as well as a protocol...... for the gathering of other data through site visits, discussions, and document reviews....

A protocol for the health and fitness assessment of NBA players.

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Scheller, A; Rask, B

1993-04-01

The assessment of the health and fitness of elite basketball players should be a multidisciplinary process. We have described an organized, efficient, and comprehensive protocol for preseason physical evaluations that could be used at the university as well as professional level.

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

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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.

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic.

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Hilton, Lara; Elfenbaum, Pamela; Jain, Shamini; Sprengel, Meredith; Jonas, Wayne B

2018-03-01

The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies.

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

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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

Assessment of scapular positioning and function as future effect measure of shoulder interventions – an inter-examiner reliability study of the clinical assessment methods

DEFF Research Database (Denmark)

Larsen, Camilla Marie; Eshøj, Henrik; Ingwersen, Kim Gordon

2015-01-01

Assessment of scapular positioning and function as future effect measure of shoulder interventions – an inter-examiner reliability study of the clinical assessment methods Eshøj H1, Ingwersen KG1, Larsen CM1, 2, Søgaard K1, Juul-Kristensen B1, 3 1 University of Southern Denmark, Institute of Sports...... only been tested for intra-examiner reliability. The objective was to investigate the inter-examiner reliability of an extended battery of clinical tests for assessing scapular positioning and function. Methods A standardized three-phase protocol for clinical reliability studies was conducted...... coefficients (ICC) and kappa values were interpreted as: 0.0-0.40 (poor); 0.40-0.75 (fair to good); and 0.75-1.00 (good to excellent). Results A total of 41 subjects (23 males, yrs 25±9), were recruited among adult overhead athletes from the municipality of Odense, DK. Prevalence of the index condition was 54...

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

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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.

Portfolio assessment and evaluation: implications and guidelines for clinical nursing education.

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Chabeli, M M

2002-08-01

With the advent of Outcomes-Based Education in South Africa, the quality of nursing education is debatable, especially with regard to the assessment and evaluation of clinical nursing education, which is complex and renders the validity and reliability of the methods used questionable. This paper seeks to explore and describe the use of portfolio assessment and evaluation, its implications and guidelines for its effective use in nursing education. Firstly, the concepts of assessment, evaluation, portfolio and alternative methods of evaluation are defined. Secondly, a comparison of the characteristics of the old (traditional) methods and the new alternative methods of evaluation is made. Thirdly, through deductive analysis, synthesis and inference, implications and guidelines for the effective use of portfolio assessment and evaluation are described. In view of the qualitative, descriptive and exploratory nature of the study, a focus group interview with twenty students following a post-basic degree at a university in Gauteng regarding their perceptions on the use of portfolio assessment and evaluation method in clinical nursing education was used. A descriptive method of qualitative data analysis of open coding in accordance with Tesch's protocol (in Creswell 1994:155) was used. Resultant implications and guidelines were conceptualised and described within the existing theoretical framework. Principles of trustworthiness were maintained as described by (Lincoln & Guba 1985:290-327). Ethical considerations were in accordance with DENOSA's standards of research (1998:7).

Quality assessment in in vivo NMR spectroscopy: V. Multicentre evaluation of prototype test objects and protocols for performance assessment in small bore MRS equipment

DEFF Research Database (Denmark)

Howe, F.A.; Canese, R; Podo, F

1995-01-01

This paper reports the results of multicentre studies aimed at designing, constructing, and evaluating prototype test objects for performance assessment in small-bore MRS systems, by utilizing the test protocols already proposed by the EEC COMAC-BME Concerted Action for clinical MRS equipment...... using ISIS as volume localization sequence in 31P MRS. The results suggested the interest of adopting some of these prototypes for improving the comparison of spectroscopy data obtained from different sites, for providing useful means of quality assurance in experimental MRS, and facilitating....... Three classes of test objects were considered: (1) a multicompartment test object for 31P MRS measurements performed with slice-selective sequences; (2) a two-compartment test object for volume-selection 1H MRS; and (3) two-compartment test objects for assessing the performance of experimental systems...

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.

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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

Feasibility of an intracranial EEG-fMRI protocol at 3T: risk assessment and image quality.

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Boucousis, Shannon M; Beers, Craig A; Cunningham, Cameron J B; Gaxiola-Valdez, Ismael; Pittman, Daniel J; Goodyear, Bradley G; Federico, Paolo

2012-11-15

Integrating intracranial EEG (iEEG) with functional MRI (iEEG-fMRI) may help elucidate mechanisms underlying the generation of seizures. However, the introduction of iEEG electrodes in the MR environment has inherent risk and data quality implications that require consideration prior to clinical use. Previous studies of subdural and depth electrodes have confirmed low risk under specific circumstances at 1.5T and 3T. However, no studies have assessed risk and image quality related to the feasibility of a full iEEG-fMRI protocol. To this end, commercially available platinum subdural grid/strip electrodes (4×5 grid or 1×8 strip) and 4 or 6-contact depth electrodes were secured to the surface of a custom-made phantom mimicking the conductivity of the human brain. Electrode displacement, temperature increase of electrodes and surrounding phantom material, and voltage fluctuations in electrode contacts were measured in a GE Discovery MR750 3T MR scanner during a variety of imaging sequences, typical of an iEEG-fMRI protocol. An electrode grid was also used to quantify the spatial extent of susceptibility artifact. The spatial extent of susceptibility artifact in the presence of an electrode was also assessed for typical imaging parameters that maximize BOLD sensitivity at 3T (TR=1500 ms; TE=30 ms; slice thickness=4mm; matrix=64×64; field-of-view=24 cm). Under standard conditions, all electrodes exhibited no measurable displacement and no clinically significant temperature increase (2.0°C) that in some cases exceeded 10°C. Induced voltages in the frequency range that could elicit neuronal stimulation (<10 kHz) were well below the threshold of 100 mV. fMRI signal intensity was significantly reduced within 20mm of the electrodes for the imaging parameters used in this study. Thus, for the conditions tested, a full iEEG-fMRI protocol poses a low risk at 3T; however, fMRI sensitivity may be reduced immediately adjacent to the electrodes. In addition, high SAR sequences

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

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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

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

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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

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.

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

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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.

An assessment of care provided by a public sector STD clinic in Cape Town.

Science.gov (United States)

Mathews, C; van Rensburg, A; Schierhout, G; Coetzee, N; Lombard, C J; Fehler, H G; Ballard, R C

1998-11-01

A study was undertaken in a Cape Town public sector STD clinic to evaluate the content and quality of care provided since it has been recognized that appropriate improvements in the management of conventional sexually transmitted diseases (STDs), including provision of correct therapy, health education, condom promotion and partner notification, could result in a reduced incidence of HIV infection. Our objectives were to assess patients' needs for health education and to assess the quality of STD management in terms of health education, condom promotion, partner notification, the validity of the clinical diagnoses and the adequacy of the treatments prescribed. The study subjects were sampled systematically, according to their gender. Patients included in the study were given a standardized interview and their clinical records reviewed. Specimens were collected for laboratory investigations. For each STD detected, the treatment was defined as adequate if drugs currently known to be active against that infection were prescribed. One hundred and seventy men and 161 women were included in the study (median age: females 22 years, males 26 years). While almost all patients believed their STD may have been caused by unprotected sexual intercourse, many also believed it may have been caused by other factors, such as bewitchment with traditional medicine. Only 21% of male and 37% of female patients received any education about STD transmission during the clinic visit, and only 25% of male and 36% of female patients received education about condom use. As a result of the low sensitivity of the clinicians' diagnoses, 16% of men and 61% of women left the clinic with at least one infection inadequately treated. The majority of patients were not receiving education for the prevention of STDs including HIV. Many were not receiving adequate treatment for their infections. The introduction of a syndromic management protocol in this setting would substantially reduce the proportion

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

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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.

Assessment of auditory skills in 140 cochlear implant children using the EARS protocol.

Science.gov (United States)

Sainz, Manuel; Skarzynski, Henryk; Allum, John H J; Helms, Jan; Rivas, Adriana; Martin, Jane; Zorowka, Patrick Georg; Phillips, Lucy; Delauney, Joseph; Brockmeyer, Steffi Johanna; Kompis, Martin; Korolewa, Inna; Albegger, Klaus; Zwirner, Petra; Van De Heyning, Paul; D'Haese, Patrick

2003-01-01

Auditory performance of cochlear implant (CI) children was assessed with the Listening Progress Profile (LiP) and the Monosyllabic-Trochee-Polysyllabic-Word Test (MTP) following the EARS protocol. Additionally, the 'initial drop' phenomenon, a recently reported decrease of auditory performance occurring immediately after first fitting, was investigated. Patients were 140 prelingually deafened children from various clinics and centers worldwide implanted with a MEDEL COMBI 40/40+. Analysis of LiP data showed a significant increase after 1 month of CI use compared to preoperative scores (p < 0.01). No initial decrease was observed with this test. Analysis of MTP data revealed a significant improvement of word recognition after 6 months (p < 0.01), with a significant temporary decrease after initial fitting (p < 0.01). With both tests, children's auditory skills improved up to 2 years. Amount of improvement was negatively correlated with age at implantation. Copyright 2003 S. Karger AG, Basel

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)

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

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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

Reliability and criterion validity of an observation protocol for working technique assessments in cash register work.

Science.gov (United States)

Palm, Peter; Josephson, Malin; Mathiassen, Svend Erik; Kjellberg, Katarina

2016-06-01

We evaluated the intra- and inter-observer reliability and criterion validity of an observation protocol, developed in an iterative process involving practicing ergonomists, for assessment of working technique during cash register work for the purpose of preventing upper extremity symptoms. Two ergonomists independently assessed 17 15-min videos of cash register work on two occasions each, as a basis for examining reliability. Criterion validity was assessed by comparing these assessments with meticulous video-based analyses by researchers. Intra-observer reliability was acceptable (i.e. proportional agreement >0.7 and kappa >0.4) for 10/10 questions. Inter-observer reliability was acceptable for only 3/10 questions. An acceptable inter-observer reliability combined with an acceptable criterion validity was obtained only for one working technique aspect, 'Quality of movements'. Thus, major elements of the cashiers' working technique could not be assessed with an acceptable accuracy from short periods of observations by one observer, such as often desired by practitioners. Practitioner Summary: We examined an observation protocol for assessing working technique in cash register work. It was feasible in use, but inter-observer reliability and criterion validity were generally not acceptable when working technique aspects were assessed from short periods of work. We recommend the protocol to be used for educational purposes only.

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.

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.

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

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....

Accuracy of Dose Calibrators for 68Ga PET Imaging: Unexpected Findings in a Multicenter Clinical Pretrial Assessment.

Science.gov (United States)

Bailey, Dale L; Hofman, Michael S; Forwood, Nicholas J; O'Keefe, Graeme J; Scott, Andrew M; van Wyngaardt, Winifred M; Howe, Bonnie; Kovacev, Olga; Francis, Roslyn J

2018-04-01

We report the discovery of a systematic miscalibration during the work-up process for site validation of a multicenter clinical PET imaging trial using 68 Ga, which manifested as a consistent and reproducible underestimation in the quantitative accuracy (assessed by SUV) of a range of PET systems from different manufacturers at several different facilities around Australia. Methods: Sites were asked to follow a strict preparation protocol to create a radioactive phantom with 68 Ga to be imaged using a standard clinical protocol before commencing imaging in the trial. All sites had routinely used 68 Ga for clinical PET imaging for many years. The reconstructed image data were transferred to an imaging core laboratory for analysis, along with information about ancillary equipment such as the radionuclide dose calibrator. Fourteen PET systems were assessed from 10 nuclear medicine facilities in Australia, with the aim for each PET system being to produce images within 5% of the true SUV. Results: At initial testing, 10 of the 14 PET systems underestimated the SUV by 15% on average (range, 13%-23%). Multiple PET systems at one site, from two different manufacturers, were all similarly affected, suggesting a common cause. We eventually identified an incorrect factory-shipped dose calibrator setting from a single manufacturer as being the cause. The calibrator setting for 68 Ga was subsequently adjusted by the users so that the reconstructed images produced accurate values. Conclusion: PET imaging involves a chain of measurements and calibrations to produce accurate quantitative performance. Testing of the entire chain is simple, however, and should form part of any quality assurance program or prequalifying site assessment before commencing a quantitative imaging trial or clinical imaging. © 2018 by the Society of Nuclear Medicine and Molecular Imaging.

Toward Fairness in Assessing Student Groupwork: A Protocol for Peer Evaluation of Individual Contributions

Science.gov (United States)

Fellenz, Martin R.

2006-01-01

A key challenge for management instructors using graded groupwork with students is to find ways to maximize student learning from group projects while ensuring fair and accurate assessment methods. This article presents the Groupwork Peer-Evaluation Protocol (GPEP) that enables the assessment of individual contributions to graded student…

The clinical assessment of impulsivity

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Nagesh Brahmavar Pai

2018-01-01

Full Text Available The term impulsivity is often used to describe behavior that is both spontaneous and detrimental. Impulsivity is multidimensional and derives from personality, general psychopathology as well as specific mental disorders. Thus, the construct of impulsivity is important as it is associated with numerous mental disorders as well as socially deviant behaviors ranging from behaviors targeted towards others such as aggression, to behaviors targeted toward oneself, for example, self-harm and suicide. As a clinical construct impulsivity is highly predictive of poor prognosis thus further emphasizing its clinical relevance. Therefore, the need exists for impulsivity to be clinically assessed and this assessment should take place at the same time as the assessment of risk. As risk and impulsivity are interrelated and interact. Although there are existing self-report rating scales for trait-based impulsivity, a dearth exists in regards to assessment of impulsivity in clinical practice that is focused and pragmatic. Thus, a pragmatic rubric to guide the individualized assessment of impulsivity in a clinical population is proposed. The quadrants espoused will assist both with the formulation of questions and categorization of responses to determine the most appropriate interventions for the client.

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.

Rivers rapid assessment protocols and insertion of society in monitoring of water resources

Directory of Open Access Journals (Sweden)

Guilherme Malafaia

2008-12-01

Full Text Available The degradation of water resources has been detected and changes both institutional and in the legislation have been demanded. The careless use of rivers has ecological changes as direct consequence, causing serious modifications in the landscape and fluvial regime, besides altering the availability of habitats and the trophic composition of the aquatic environment. Pressed by this scenario, scientists have been developing assessment methods that are efficient both for the evaluation itself and for supporting decision taking in the environmental management processes. In this perspective, the objective of this study is to present the Rapid River Assessment Protocols (RAPs and to emphasize how these protocols can promote the community participation in water resources monitoring. The RAPs can used to evaluate in an integrated form the characteristics of a river section according to the conservation or degradation condition of the fluvial environment and it is characterized by its economic viability and easy applicability. In regions with poor financial resources and serious problems of water quality, the RAPs can be used in environmental management programs. By using these protocols, the integration of the community in water resources monitoring generates data which represent the quality of fluvial ecosystems throughout time, without requesting high costs or specialized professionals. The RAPs in a simplified but not simplistic tool, which can be used in activities that aim at promoting a quick and reliable assessment of the “health” of a river.

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.

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.

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.

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

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.

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

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

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

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

Clinical trials radiotherapy treatment plan review software : is this the first quantified assessment

International Nuclear Information System (INIS)

Hatton, J.A.; Cornes, D.A.

2011-01-01

Full text: Clinical trials require robust quality assurance (QA) procedures to ensure commonality of all treatments, with independent reviews to assess compliance with trial protocols. All clinical trials tools, including QA software, require testing for validity and reliability. enabling inter- and intra-trial comparison. Unlike clinical radiotherapy treatment planning (RTP) systems, review software has no published guidelines. This study describes the design and development of a test suite to quantify the performance of review software in TROG clinical trials. Test areas are image handling and reconstruction; geometric accuracy; dosimetric accuracy; dose-volume histogram (DVH) calculation; display of plan parameters. TROG have developed tests for commissioning plan review software, assessed with SWAN 2.3, and CMS Elekta FocalPro. While image handling tests were based on published guidelines for RTP systems, dosimetric tests used the TROG QA case review requirements. Treatment plans represented systems of all manufacturers (Pinnacle, Eclipse, Xio and Oncentra) used in Australasian centres. The test suite identified areas for SW A software development, including the DVH algorithm, changed to reduce calculation time. Results, in Fig. I, for known volumes of varying shapes and sizes, demonstrate differences between SWAN 2.1 and 2.3 when compared with Eclipse. Liaison with SWAN programmers enabled re-instatement of 2.1 algorithm. The test suite has quantified the RTP review software, prioritised areas for development with the programmers, and improved the user experience.

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

Selective effects of different fatigue protocols on the function of upper body muscles assessed through the force-velocity relationship.

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García-Ramos, Amador; Torrejón, Alejandro; Feriche, Belén; Morales-Artacho, Antonio J; Pérez-Castilla, Alejandro; Padial, Paulino; Jaric, Slobodan

2018-02-01

This study explored the feasibility of the force-velocity relationship (F-V) to detect the acute effects of different fatigue protocols on the selective changes of the maximal capacities of upper body muscles to produce force, velocity, and power. After determining the bench press one-repetition maximum (1RM), participants' F-V relationships were assessed during the bench press throw exercise on five separate sessions after performing one of the following fatiguing protocols: 60%1RM failure, 60%1RM non-failure, 80%1RM failure, 80%1RM non-failure, and no-fatigue. In the non-failure protocols, participants performed half the maximum number of repetitions than in their respective failure protocols. The main findings revealed that (1) all F-V relationships were highly linear (median r = 0.997 and r = 0.982 for averaged across participants and individual data, respectively), (2) the fatiguing protocols were ranked based on the magnitude of power loss as follows: 60%1RM failure > 80%1RM failure > 60%1RM non-failure > 80%1RM non-failure, while (3) the assessed maximum force and velocity outputs showed a particularly prominent reduction in the protocols based on the lowest and highest levels of fatigue (i.e., 80%1RM non-failure and 60%1RM failure), respectively. The results support the use of F-V to assess the effects of fatigue on the distinctive capacities of the muscles to produce force, velocity, and power output while performing multi-joint tasks, while the assessed maximum force and velocity capacities showed a particularly prominent reduction in the protocols based on the lowest and highest levels of fatigue (i.e., 80%1RM non-failure and 60%1RM failure), respectively.

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 ...

STOPDVTs: Development and testing of a clinical assessment tool to guide nursing assessment of postoperative patients for Deep Vein Thrombosis.

Science.gov (United States)

O'Brien, Alanna; Redley, Bernice; Wood, Beverley; Botti, Mari; Hutchinson, Anastasia F

2018-03-01

To develop and test a clinical tool to guide nurses' assessment of postoperative patients for Deep Vein Thrombosis. Preventing venous thromboembolism in hospitalised patients is an international patient safety priority. Despite high-level evidence for optimal venous thromboembolism prophylaxis, implementation is inconsistent and the incidence of Deep Vein Thrombosis remains high. A two-stage sequential multi-method design was used. In stage 1, the STOPDVTs tool was developed using a review of the literature and focus groups with local clinical experts. Stage 2 involved pilot testing the tool with 38 surgical nurses who conducted repeated assessments on a prospective sample of 50 postoperative orthopaedic patients. Stage 1: The focus group members who were members of the nursing leadership team agreed on eight local and systemic signs and symptoms that should be included in a nursing patient assessment tool for early Deep Vein Thrombosis. Local symptoms were pain in the limbs, calf swelling and tightness, changes in the affected limb's skin temperature. Systemic signs included in the tool were as follows: increased shortness of breath, increased respiratory and heart rates, and decreased oxygen saturation. Stage 2: The STOPDVTs tool had acceptable face and content validity, the agreement between the expert nurse and surgical nurses on assessments of individual signs and symptoms varied between 44%-94%. Surgical nurses were less likely than the expert nurse to identify signs indicative of Deep Vein Thrombosis. Despite finding the STOPDVTs clinical assessment tool was a useful guide for nursing assessment, surgical nurses often underestimated the potential importance of clinical signs. The findings reveal a gap in nursing knowledge and skill in assessing for Deep Vein Thrombosis in postoperative orthopaedic patients. This study identified a possible risk to patient safety related to under-recognition of the signs and symptoms of possible Deep Vein Thrombosis (DVT) in

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

Transient ischaemic attacks clinics provide equivalent and more efficient care than early in-hospital assessment.

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Martínez-Martínez, M M; Martínez-Sánchez, P; Fuentes, B; Cazorla-García, R; Ruiz-Ares, G; Correas-Callero, E; Lara-Lara, M; Díez-Tejedor, E

2013-02-01

Clinics for early management of transient ischaemic attacks (TIAs) have been developed in some stroke centres, resulting in reduced recurrence rates compared to appointment-based outpatient management, thus saving on hospitalization. We analysed the care process, recurrence rates and economic impact of the first year of work in our early-management TIA clinic and compared these with our previous in-hospital study protocols for low- and moderate-risk TIA patients. This was a prospective evaluation of the management of low- to moderate-risk TIA patients, comparing a new TIA clinic model (2010) with a previous hospitalization model (2009). Demographic data, vascular risk factor profiles, diagnostic test performance, secondary prevention measures, final aetiological diagnoses and cerebrovascular recurrences at 7 and 90 days were compared between in-hospital and TIA clinic assessed patients. We also carried out an economic comparison of the costs of each model's process. Two hundred and eleven low- to moderate-risk TIA patients were included, of whom 40.8% were hospitalized. There were no differences between the TIA clinic assessed and in-hospital assessed patients in terms of risk factor diagnosis and secondary prevention measures. The stroke recurrence rate (2.4% vs. 1.2%; P = 0.65) was low and similar for both groups (CI 95%, 0.214-20.436; P = 0.52). Cost per patient was €393.28 for clinic versus €1931.18 for in-hospital management. Outpatient management resulted in a 77.8% reduction in hospitalizations. Transient ischaemic attacks clinics are efficient for the early management of low- to moderate-risk TIA patients compared to in-hospital assessment, with no higher recurrence rates and at almost one-fifth the cost. © 2012 The Author(s) European Journal of Neurology © 2012 EFNS.

Protocol for physical assessment in patients with fibromyalgia syndrome.

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dos Santos, Michele R; Moro, Claudia M C; Vosgerau, Dilmeire S R

2014-01-01

Fibromyalgia syndrome (FMS) is a chronic disease that causes pain and fatigue, presenting a negative impact on quality of life. Exercise helps maintaining physical fitness and influences directly on the improvement of quality of life. Develop a protocol for health-related physical fitness assessment of patients with FMS with tests that are feasible and appropriate for this population. An exploratory and analytical literature review was performed, seeking to determine the tests used by the scientific community. With this in mind, we performed a literature revision through the use of virtual libraries databases: PubMed, Bireme, Banco de Teses e Dissertações da Capes and Biblioteca Digital Brasileira de Teses e Dissertações, published in between 1992-2012. A variety of tests was found; the following, by number of citations, stood out: Body Mass Index (BMI) and bioimpedance; 6-minute walk; handgrip strength (dynamometer, 1RM [Repetition Maximum]); Sit and reach and Shoulder flexibility; Foot Up and Go, and Flamingo balance. These are the tests that should make up the protocol for the physical evaluation of FMS patients, emphasizing their ease of use.

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

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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.

[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.

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

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.

Non-invasive Assessments of Subjective and Objective Recovery Characteristics Following an Exhaustive Jump Protocol

Science.gov (United States)

Hohenauer, Erich; Clarys, Peter; Baeyens, Jean-Pierre; Clijsen, Ron

2017-01-01

Fast recovery after strenuous exercise is important in sports and is often studied via cryotherapy applications. Cryotherapy has a significant vasoconstrictive effect, which seems to be the leading factor in its effectiveness. The resulting enhanced recovery can be measured by using both objective and subjective parameters. Two commonly measured subjective characteristics of recovery are delayed-onset muscle soreness (DOMS) and ratings of perceived exertion (RPE). Two important objective recovery characteristics are countermovement jump (CMJ) performance and peak power output (PPO). Here, we provide a detailed protocol to induce muscular exhaustion of the frontal thighs with a self-paced, 3 x 30 countermovement jump protocol (30-s rest between each set). This randomized controlled trial protocol explains how to perform local cryotherapy cuff application (+ 8 °C for 20 min) and thermoneutral cuff application (+ 32 °C for 20 min) on both thighs as two possible post-exercise recovery modalities. Finally, we provide a non-invasive protocol to measure the effects of these two recovery modalities on subjective (i.e., DOMS of both frontal thighs and RPE) and objective recovery (i.e., CMJ and PPO) characteristics 24, 48, and 72 h post-application. The advantage of this method is that it provides a tool for researchers or coaches to induce muscular exhaustion, without using any expensive devices; to implement local cooling strategies; and to measure both subjective and objective recovery, without using invasive methods. Limitations of this protocol are that the 30 s rest period between sets is very short, and the cardiovascular demand is very high. Future studies may find the assessment of maximum voluntary contractions to be a more sensitive assessment of muscular exhaustion compared to CMJs. PMID:28654037

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

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

Using Brain Activation (nir-HEG/Q-EEG) and Execution Measures (CPTs) in a ADHD Assessment Protocol.

Science.gov (United States)

Areces, Debora; Cueli, Marisol; García, Trinidad; González-Castro, Paloma; Rodríguez, Celestino

2018-04-01

Attention Deficit Hyperactivity Disorder (ADHD) is a problem that impacts academic performance and has serious consequences that result in difficulties in scholastic, social and familial contexts. One of the most common problems in the identification of this disorder relates to the apparent over diagnosis of the disorder due to the absence of global protocols for assessment. The research group of School Learning, Difficulties and Academic Performance (ADIR) from the University of Oviedo, has developed a complete protocol that suggests the existence of certain patterns of cortical activation and executive control for identifying ADHD more objectively. This protocol takes into consideration some of the hypothetical determinants of ADHD, including the relationship between activation of selected areas of the brain, and differences in performance on various aspects of executive functioning such as omissions, commissions or response times, using innovative tools of Continuous Performance Testing (based on Virtual Reality CPT and Traditional CPT) and brain activation measures (two different tools, based on Hemoencephalography- nirHEG; and Quantified Electroencephalography --Q-EEG, respectively). This model of assessment aims to provide an effective assessment of ADHD symptomatology in order to design an accurate intervention and make appropriate recommendations for parents and teachers.

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.

Preclinical experimental stress studies: protocols, assessment and comparison.

Science.gov (United States)

Bali, Anjana; Jaggi, Amteshwar Singh

2015-01-05

Stress is a state of threatened homeostasis during which a variety of adaptive processes are activated to produce physiological and behavioral changes. Preclinical models are pivotal for understanding these physiological or pathophysiological changes in the body in response to stress. Furthermore, these models are also important for the development of novel pharmacological agents for stress management. The well described preclinical stress models include immobilization, restraint, electric foot shock and social isolation stress. Stress assessment in animals is done at the behavioral level using open field, social interaction, hole board test; at the biochemical level by measuring plasma corticosterone and ACTH; at the physiological level by measuring food intake, body weight, adrenal gland weight and gastric ulceration. Furthermore the comparison between different stressors including electric foot shock, immobilization and cold stressor is described in terms of intensity, hormonal release, protein changes in brain, adaptation and sleep pattern. This present review describes these preclinical stress protocols, and stress assessment at different levels. Copyright © 2014 Elsevier B.V. All rights reserved.

A protocol for comprehensive assessment of bulbar dysfunction in amyotrophic lateral sclerosis (ALS).

Science.gov (United States)

Yunusova, Yana; Green, Jordan R; Wang, Jun; Pattee, Gary; Zinman, Lorne

2011-02-21

Improved methods for assessing bulbar impairment are necessary for expediting diagnosis of bulbar dysfunction in ALS, for predicting disease progression across speech subsystems, and for addressing the critical need for sensitive outcome measures for ongoing experimental treatment trials. To address this need, we are obtaining longitudinal profiles of bulbar impairment in 100 individuals based on a comprehensive instrumentation-based assessment that yield objective measures. Using instrumental approaches to quantify speech-related behaviors is very important in a field that has primarily relied on subjective, auditory-perceptual forms of speech assessment(1). Our assessment protocol measures performance across all of the speech subsystems, which include respiratory, phonatory (laryngeal), resonatory (velopharyngeal), and articulatory. The articulatory subsystem is divided into the facial components (jaw and lip), and the tongue. Prior research has suggested that each speech subsystem responds differently to neurological diseases such as ALS. The current protocol is designed to test the performance of each speech subsystem as independently from other subsystems as possible. The speech subsystems are evaluated in the context of more global changes to speech performance. These speech system level variables include speaking rate and intelligibility of speech. The protocol requires specialized instrumentation, and commercial and custom software. The respiratory, phonatory, and resonatory subsystems are evaluated using pressure-flow (aerodynamic) and acoustic methods. The articulatory subsystem is assessed using 3D motion tracking techniques. The objective measures that are used to quantify bulbar impairment have been well established in the speech literature and show sensitivity to changes in bulbar function with disease progression. The result of the assessment is a comprehensive, across-subsystem performance profile for each participant. The profile, when compared to

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.

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

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.

A protocol for lifetime energy and environmental impact assessment of building insulation materials

International Nuclear Information System (INIS)

Shrestha, Som S.; Biswas, Kaushik; Desjarlais, Andre O.

2014-01-01

This article describes a proposed protocol that is intended to provide a comprehensive list of factors to be considered in evaluating the direct and indirect environmental impacts of building insulation materials, as well as detailed descriptions of standardized calculation methodologies to determine those impacts. The energy and environmental impacts of insulation materials can generally be divided into two categories: (1) direct impact due to the embodied energy of the insulation materials and other factors and (2) indirect or environmental impacts avoided as a result of reduced building energy use due to addition of insulation. Standards and product category rules exist, which provide guidelines about the life cycle assessment (LCA) of materials, including building insulation products. However, critical reviews have suggested that these standards fail to provide complete guidance to LCA studies and suffer from ambiguities regarding the determination of the environmental impacts of building insulation and other products. The focus of the assessment protocol described here is to identify all factors that contribute to the total energy and environmental impacts of different building insulation products and, more importantly, provide standardized determination methods that will allow comparison of different insulation material types. Further, the intent is not to replace current LCA standards but to provide a well-defined, easy-to-use comparison method for insulation materials using existing LCA guidelines. - Highlights: • We proposed a protocol to evaluate the environmental impacts of insulation materials. • The protocol considers all life cycle stages of an insulation material. • Both the direct environmental impacts and the indirect impacts are defined. • Standardized calculation methods for the ‘avoided operational energy’ is defined. • Standardized calculation methods for the ‘avoided environmental impact’ is defined

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

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

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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

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

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

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.

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.

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.

Clinical outcomes assessment in clinical trials to assess treatment of femoroacetabular impingement

DEFF Research Database (Denmark)

Harris-Hayes, Marcie; McDonough, Christine M; Leunig, Michael

2013-01-01

Patient-reported outcome measures are an important component of outcomes assessment in clinical trials to assess the treatment of femoroacetabular impingement (FAI). This review of disease-specific measures and instruments used to assess the generic quality of life and physical activity levels...... developed recently and have not been established in the literature. Although currently used generic and activity-level measures have limitations, as well, they should be considered, depending on the specific goals of the study. Additional research is needed to assess the properties of these measures fully...

PROPOSAL OF GUIDELINE FOR CLINICAL TRIAL PROTOCOLS WITH HERBAL DRUGS

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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.

Halitose: proposta de um protocolo de avaliação Halitosis: an assessment protocol proposal

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Ana Cristina Coelho Dal Rio

2007-12-01

the authors’ personal experiences, adopting an evidence-based anamnesis. RESULTS: There are many causes of halitosis and most of them are related to the oral cavity; others are related to otolaryngologic and respiratory diseases. Gastrointestinal diseases, liver/renal impairment and other metabolic syndromes are less frequent, but also important causes of halitosis. CONCLUSION: There are important costs involved in halitosis assessment and treatment, including medical appointments, specialist assessment, and complementary tests. Such costs would be minimized by adopting a protocol of evidence-based anamnesis and a flowchart for a rational clinical investigation.

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

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

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.

Tulsa 1000: a naturalistic study protocol for multilevel assessment and outcome prediction in a large psychiatric sample.

Science.gov (United States)

Victor, Teresa A; Khalsa, Sahib S; Simmons, W Kyle; Feinstein, Justin S; Savitz, Jonathan; Aupperle, Robin L; Yeh, Hung-Wen; Bodurka, Jerzy; Paulus, Martin P

2018-01-24

Although neuroscience has made tremendous progress towards understanding the basic neural circuitry underlying important processes such as attention, memory and emotion, little progress has been made in applying these insights to psychiatric populations to make clinically meaningful treatment predictions. The overall aim of the Tulsa 1000 (T-1000) study is to use the NIMH Research Domain Criteria framework in order to establish a robust and reliable dimensional set of variables that quantifies the positive and negative valence, cognition and arousal domains, including interoception, to generate clinically useful treatment predictions. The T-1000 is a naturalistic study that will recruit, assess and longitudinally follow 1000 participants, including healthy controls and treatment-seeking individuals with mood, anxiety, substance use and eating disorders. Each participant will undergo interview, behavioural, biomarker and neuroimaging assessments over the course of 1 year. The study goal is to determine how disorders of affect, substance use and eating behaviour organise across different levels of analysis (molecules, genes, cells, neural circuits, physiology, behaviour and self-report) to predict symptom severity, treatment outcome and long-term prognosis. The data will be used to generate computational models based on Bayesian statistics. The final end point of this multilevel latent variable analysis will be standardised assessments that can be developed into clinical tools to help clinicians predict outcomes and select the best intervention for each individual, thereby reducing the burden of mental disorders, and taking psychiatry a step closer towards personalised medicine. Ethical approval was obtained from Western Institutional Review Board screening protocol #20101611. The dissemination plan includes informing health professionals of results for clinical practice, submitting results to journals for peer-reviewed publication, presenting results at national

Protocols for the Investigation of Information Processing in Human Assessment of Fundamental Movement Skills.

Science.gov (United States)

Ward, Brodie J; Thornton, Ashleigh; Lay, Brendan; Rosenberg, Michael

2017-01-01

Fundamental movement skill (FMS) assessment remains an important tool in classifying individuals' level of FMS proficiency. The collection of FMS performances for assessment and monitoring has remained unchanged over the last few decades, but new motion capture technologies offer opportunities to automate this process. To achieve this, a greater understanding of the human process of movement skill assessment is required. The authors present the rationale and protocols of a project in which they aim to investigate the visual search patterns and information extraction employed by human assessors during FMS assessment, as well as the implementation of the Kinect system for FMS capture.

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.

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.

Discriminating real victims from feigners of psychological injury in gender violence: Validating a protocol for forensic setting

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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.

Nursing intervention protocol for adult patients experiencing chronic low back pain

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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.

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.

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.

Assessment and clinical factors associated with pain in patients undergoing transrectal prostate biopsy.

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Gómez-Gómez, E; Ramírez, M; Gómez-Ferrer, A; Rubio-Briones, J; Iborra, I; J Carrasco-Valiente; Campos, J P; Ruiz-García, J; Requena-Tapia, M J; Solsona, E

2015-09-01

To quantify the degree of pain experienced by patients who undergo ultrasound-guided transrectal prostate biopsy in standard clinical practice and assess the clinical factors associated with increased pain. Analysis of a multicenter series of patients with prostate biopsy according to standard clinical practice. The biopsy was performed transrectally with a protocol of local anesthesia on the posterolateral nerve bundle. The pain was assessed at 20minutes into the procedure using the visual analog scale (0-10). The degree of pain was analyzed, and the association was studied using a univariate/multivariate analysis of selected clinical variables and the degree of pain. A total of 1188 patients with a median age of 64 years were analyzed. Thirty percent of the biopsies were diagnosed with a tumor. The median pain score was 2, with 65% of the patients reporting a pain score ≤2. The multivariate analysis showed that the prostate volume (RR, 1.34; 95% CI 1.01-1.77; P=.04), having a previous biopsy (RR, 2.25; 95% CI 1.44-3.52; P<.01), age (RR, .63; 95% CI .47-.85; P<.01) and feel palpation (RR, 1.95; 95% CI 1.28-2.96; P<.01) were factors independently associated with greater pain during the procedure. Transrectal biopsy with local anesthesia is a relatively painless technique. Factors such as age, a previous biopsy, pain on being touched and prostate volume were associated with the presence of greater pain during the procedure. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

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

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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

Assessment of cardiorespiratory fitness using submaximal protocol in older adults with mood disorder and Parkinson's disease

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Natacha Alves de Oliveira

2013-01-01

Full Text Available BACKGROUND: Evidence has shown benefits for mental health through aerobic training oriented in percentage of VO2max, indicating the importance of this variable for clinical practice. OBJECTIVE: To validate a method for estimating VO2max using a submaximal protocol in elderly patients with clinically diagnosis as major depressive disorder (MDD and Parkinson's disease (PD. METHODS: The sample comprised 18 patients (64.22 ± 9.92 years with MDD (n = 7 and with PD (n = 11. Three evaluations were performed: I disease staging, II direct measurement of VO2max and III submaximal exercise test. Linear regression was performed to verify the accuracy of estimation in VO2max established in ergospirometry and the predicted VO2max from the submaximal test measurement. We also analyzed the correlation between the Bland-Altman procedures. RESULTS: The regression analysis showed that VO2max values estimated by submaximal protocol associated with the VO2max measured, both in absolute values (R² = 0.65; SEE = 0.26; p < 0.001 and the relative (R² = 0.56; SEE = 3.70; p < 0.001. The Bland-Altman plots for analysis of agreement of showed a good correlation between the two measures. DISCUSSION: The VO2max predicted by submaximal protocol demonstrated satisfactory criterion validity and simple execution compared to ergospirometry.

Protocol for development and validation of a context-appropriate tool for assessing organisational readiness for change in primary health clinics in South Africa.

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Brooke-Sumner, Carrie; Sorsdahl, Katherine; Lombard, Carl; Petersen-Williams, Petal; Myers, Bronwyn

2018-04-09

A large treatment gap for common mental disorders (such as depression) exists in South Africa. Comorbidity with other chronic diseases, including HIV and diseases of lifestyle, is an increasing public health concern globally. Currently, primary health facilities as points of care for those with chronic disease provide limited services for common mental disorders. Assessing organisational readiness for change (ORC) towards adopting health innovations (such as mental health services) using contextually appropriate measures is needed to facilitate implementation of these services. This study aims to investigate the validity of the Texas Christian University Organisational Readiness for Change (TCU-ORC) scale in the South African context. Subsequently, we will develop a shortened version of this scale. This study is nested within Project MIND, a multiyear randomised controlled trial that is testing two different approaches for integrating counselling for common mental disorders into chronic disease care. Although the modified, contextually appropriate ORC measure resulting from the proposed study will be developed in the context of integrating mental health into primary healthcare services, the potential for the tool to be generalised to further understanding barriers to any change being implemented in primary care settings is high. We will establish internal consistency (Cronbach's alpha coefficients), test-retest reliability (intraclass correlation coefficient) and construct validity of the long-form TCU-ORC questionnaire. Survey data will be collected from 288 clinical, management and operational staff from 24 primary health facilities where the Project MIND trial is implemented. A modified Delphi approach will assess the content validity of the TCU-ORC items and identify areas for potential adaptation and item reduction. Ethical approval has been granted by the South African Medical Research Council (Protocol ID EC004-2-2015, amendment of 20 August 2017). Results

A Standardized Protocol for the Prospective Follow-Up of Cleft Lip and Palate Patients.

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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.

Clinical assessment of scapular positioning in musicians: an intertester reliability study.

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Struyf, Filip; Nijs, Jo; De Coninck, Kris; Giunta, Marco; Mottram, Sarah; Meeusen, Romain

2009-01-01

The reliability of the measurement of the distance between the posterior border of the acromion and the wall and the reliability of the modified lateral scapular slide test have not been studied. Overall, the reliability of the clinical tools used to assess scapular positioning has not been studied in musicians. To examine the intertester reliability of scapular observation and 2 clinical tests for the assessment of scapular positioning in musicians. Intertester reliability study. University research laboratory. Thirty healthy student musicians at a single university. Two assessors performed a standardized observation protocol, the measurement of the distance between the posterior border of the acromion and the wall, and the modified lateral scapular slide test. Each assessor was blinded to the other's findings. The intertester reliability coefficients (kappa) for the observation in relaxed position, during unloaded movement, and during loaded movement were 0.41, 0.63, and 0.36, respectively. The kappa values for the observation of tilting and winging at rest were 0.48 and 0.42, respectively; during unloaded movement, the kappa values were 0.52 and 0.78, respectively; and with a 1-kg load, the kappa values were 0.24 and 0.50, respectively. The intraclass correlation coefficient (ICC) of the measurement of the acromial distance was 0.72 in relaxed position and 0.75 with the participant actively retracting both shoulders. The ICCs for the modified lateral scapular slide test varied between 0.63 and 0.58. Our results demonstrated that the modified lateral scapular slide test was not a reliable tool to assess scapular positioning in these participants. Our data indicated that scapular observation in the relaxed position and during unloaded abduction in the frontal plane was a reliable assessment tool. The reliability of the measurement of the distance between the posterior border of the acromion and the wall in healthy musicians was moderate.

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

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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.)

Development of a waste management protocol based on assessment of knowledge and practice of healthcare personnel in surgical departments.

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Mostafa, Gehan M A; Shazly, Mona M; Sherief, Wafaa I

2009-01-01

Good healthcare waste management in a hospital depends on a dedicated waste management team, good administration, careful planning, sound organization, underpinning legislation, adequate financing, and full participation by trained staff. Hence, waste management protocols must be convenient and sensible. To assess the knowledge and practice related to waste management among doctors, nurses, and housekeepers in the surgical departments at Al-Mansoura University Hospital, and to design and validate a waste management protocol for the health team in these settings. This cross-sectional study was carried out in the eight surgical departments at Al-Mansoura University Hospital. All health care personnel and their assistants were included: 38 doctors, 106 nurses, and 56 housekeepers. Two groups of jury were included for experts' opinions validation of the developed protocol, one from academia (30 members) and the other from service providers (30 members). Data were collected using a self-administered knowledge questionnaire for nurses and doctors, and an interview questionnaire for housekeepers. Observation checklists were used for assessment of performance. The researchers developed the first draft of the waste management protocol according to the results of the analysis of the data collected in the assessment phase. Then, the protocol was presented to the jury group for validation, and then was implemented. Only 27.4% of the nurses, 32.1% of the housekeepers, and 36.8% of the doctors had satisfactory knowledge. Concerning practice, 18.9% of the nurses, 7.1% of the housekeepers, and none of the doctors had adequate practice. Nurses' knowledge score had a statistically significant weak positive correlation with the attendance of training courses (r=0.23, pwaste management. The knowledge among nurses is positively affected by attendance of training programs. Based on the findings, a protocol for healthcare waste management was developed and validated. It is recommended to

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

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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

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

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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.

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

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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.

Assessing the clinical utility of combined movement examination in symptomatic degenerative lumbar spondylosis.

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Monie, A P; Price, R I; Lind, C R P; Singer, K P

2015-07-01

The aim of this study is to report the development and validation of a low back computer-aided combined movement examination protocol in normal individuals and record treatment outcomes of cases with symptomatic degenerative lumbar spondylosis. Test-retest, following intervention. Self-report assessments and combined movement examination were used to record composite spinal motion, before and following neurosurgical and pain medicine interventions. 151 normal individuals aged from 20 years to 69 years were assessed using combined movement examination between L1 and S1 spinal levels to establish a reference range. Cases with degenerative low back pain and sciatica were assessed before and after therapeutic interventions with combined movement examination and a battery of self-report pain and disability questionnaires. Change scores for combined movement examination and all outcome measures were derived. Computer-aided combined movement examination validation and intraclass correlation coefficient with 95% confidence interval and least significant change scores indicated acceptable reliability of combined movement examination when recording lumbar movement in normal subjects. In both clinical cases lumbar spine movement restrictions corresponded with self-report scores for pain and disability. Post-intervention outcomes all showed significant improvement, particularly in the most restricted combined movement examination direction. This study provides normative reference data for combined movement examination that may inform future clinical studies of the technique as a convenient objective surrogate for important clinical outcomes in lumbar degenerative spondylosis. It can be used with good reliability, may be well tolerated by individuals in pain and appears to change in concert with validated measures of lumbar spinal pain, functional limitation and quality of life. Copyright © 2015 Elsevier Ltd. All rights reserved.

Assessing undergraduate nursing students in clinical practice: do preceptors use assessment strategies?

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McCarthy, Bridie; Murphy, Siobhan

2008-04-01

Health care organisations such as the World Health Organisation (WHO) and An Bord Altranais (ABA, The Irish Nursing Registration Board) demand higher standards of new graduate nurses than heretofore. This is in conjunction with the implementation of degree programmes for undergraduate nurse education. These organisations stipulate that graduates must be well-educated, accountable, and can demonstrate the skills of a safe, caring and competent decision-making practitioner. The Bachelor of Science (BSc) four-year degree programme for undergraduate nurse education was introduced in Ireland in 2002, and is provided in universities and colleges of higher education throughout The Republic of Ireland. During the implementation process, each university and college of higher education developed a range of assessment strategies to clinically assess students. Preceptor nurses were subsequently assigned the responsibility of clinically assessing students, a remit previously undertaken by Clinical Ward/Unit Nurse Managers. Preceptors are qualified nurses, working in clinical units who are specially prepared to support BSc students during clinical placements. The purpose of this study was to explore to what extent preceptor nurses use the devised assessment strategies to clinically assess BSc students in one university in The Republic of Ireland. Data were collected by using a questionnaire distributed to all known preceptors in General, Psychiatric and Intellectual Disability nursing, during year four of the first cycle of the BSc programme. Findings from this descriptive study revealed that many preceptors were inexperienced, did not fully comprehend the assessment process and were not applying all of the recommended assessment strategies when assessing students in clinical practice. In light of these findings suggestions are made in the context of further research, management and education.

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.)

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.)

Systematic Review Protocol to Assess the Effectiveness of Usability Questionnaires in mHealth App Studies.

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Zhou, Leming; Bao, Jie; Parmanto, Bambang

2017-08-01

Usability questionnaires have a wide use in mobile health (mHealth) app usability studies. However, no systematic review has been conducted for assessing the effectiveness of these questionnaires. This paper describes a protocol for conducting a systematic review of published questionnaire-based mHealth app usability studies. In this systematic review, we will select recently published (2008-2017) articles from peer-reviewed journals and conferences that describe mHealth app usability studies and implement at least one usability questionnaire. The search strategy will include terms such as "mobile app" and "usability." Multiple databases such as PubMed, CINAHL, IEEE Xplore, ACM Digital Library, and INSPEC will be searched. There will be 2 independent reviewers in charge of screening titles and abstracts as well as determining those articles that should be included for a full-text review. The third reviewer will act as a mediator between the other 2 reviewers. Moreover, a data extraction form will be created and used during the full article data analysis. Notably, the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines will be followed in reporting this protocol. A preliminary search produced 1271 articles, 40 of which are duplicate records. The inclusion-exclusion criteria are being strictly followed in performing the ongoing study selection. Usability questionnaires are an important tool in mHealth app usability studies. This review will summarize the usability questionnaires used in published research articles while assessing the efficacy of these questionnaires in determining the usability of mHealth apps. ©Leming Zhou, Jie Bao, Bambang Parmanto. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.08.2017.

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

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.

Professional practice assessment. Pertinence of positron emission tomography clinical indications in oncology

International Nuclear Information System (INIS)

Le Stanc, E.; Tainturier, C.; Swaenepoel, J.

2009-01-01

Introduction As part of the health care quality and safety policy in France, Professional Practice Assessment (P.P.A.) are mandatory in the health services 'certification' process. We present our study regarding the pertinence of Positron Emission Tomography (PET) indications in oncology. Materials and methods A multidisciplinary task group used the Quick Audit method with two rounds of 100 request forms each. The assessment list of criteria comprised four items of decreasing relevance grading the PET scans clinical indications, which were derived from the three French published guidelines (S.O.R. [F.N.C.L.C.C]., 'Guide du bon usage des examens d'imagerie medicale' [S.F.R.-S.F.M.N.], 'Guide pour la redaction de protocoles pour la TEP au F.D.G. en cancerologie' [S.F.M.N.]) and five additional items: clinical information, patient's body weight, previous treatments dates, diabetes, claustrophobia. Results The first round showed that 68% of the requested scans corresponded to the two most relevant groups of indications (S.O.R. Standards and Options). The request forms were correctly filled in regarding the clinical information, but this was not the case for the other items we tested. Several actions were conducted: dedicated PET request form, availability of the S.O.R. on the hospital intranet, boost of the referring physicians awareness during the multidisciplinary oncology meetings (Reunions de Concertation Pluridisciplinaires RCP). The second round showed a better pertinence of the PET scans indications (75% versus 68%); the patient's body weight was more frequently mentioned on the request form. Discussion This study is an example of P.P.A. in our discipline. It led to an improvement of the oncologic PET scans clinical indications in our hospital. This work is pursued in everyday discussion with the referring clinicians, especially during the RCP. (authors)

Assessing Professionalism: A Theoretical Framework for Defining Clinical Rotation Assessment Criteria.

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Armitage-Chan, Elizabeth

Although widely accepted as an important graduate competence, professionalism is a challenging outcome to define and assess. Clinical rotations provide an excellent opportunity to develop student professionalism through the use of experiential learning and effective feedback, but without appropriate theoretical frameworks, clinical teachers may find it difficult to identify appropriate learning outcomes. The adage "I know it when I see it" is unhelpful in providing feedback and guidance for student improvement, and criteria that are more specifically defined would help students direct their own development. This study sought first to identify how clinical faculty in one institution currently assess professionalism, using retrospective analysis of material obtained in undergraduate teaching and faculty development sessions. Subsequently, a faculty workshop was held in which a round-table type discussion sought to develop these ideas and identify how professionalism assessment could be improved. The output of this session was a theoretical framework for teaching and assessing professionalism, providing example assessment criteria and ideas for clinical teaching. This includes categories such as client and colleague interaction, respect and trust, recognition of limitations, and understanding of different professional identities. Each category includes detailed descriptions of the knowledge, skills, and behaviors expected of students in these areas. The criteria were determined by engaging faculty in the development of the framework, and therefore they should represent a focused development of criteria already used to assess professionalism, and not a novel and unfamiliar set of assessment guidelines. The faculty-led nature of this framework is expected to facilitate implementation in clinical teaching.

Histomorphometric assessment of bone necrosis produced by two cryosurgery protocols using liquid nitrogen: an experimental study on rat femurs.

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Costa, Fábio Wildson Gurgel; Brito, Gerly Anne de Castro; Pessoa, Rosana Maria Andrade; Studart-Soares, Eduardo Costa

2011-01-01

The aim of this study was to evaluate the effects of liquid nitrogen cryosurgery on the femoral diaphysis of rats. The femoral diaphyses of 42 Wistar rats were exposed to three local and sequential applications of liquid nitrogen for 1 or 2 min, intercalated with periods of 5 min of passive thawing. The animals were sacrificed after 1, 2, 4 and 12 weeks and the specimens obtained were processed and analyzed histomorphometrically. The depth and extent of peak bone necrosis were 124.509 µm and 2087.094 µm for the 1-min protocol, respectively, and 436.424 µm and 12046.426 µm for the 2-min protocol. Peak necrosis was observed in the second experimental week with both cryotherapy protocols. The present results indicate that the 2-min protocol produced more marked bone necrosis than the 1-min protocol. Although our results cannot be entirely extrapolated to clinical practice, they contribute to the understanding of the behavior of bone tissue submitted to different cycles of liquid nitrogen freezing and may serve as a basis for new studies.

Using systematically observed clinical encounters (SOCEs to assess medical students’ skills in clinical settings

Directory of Open Access Journals (Sweden)

George R Bergus

2010-11-01

Full Text Available George R Bergus1–3, Jerold C Woodhead4, Clarence D Kreiter2,51Performance Based Assessment Program, Office of Student Affairs and Curriculum, 2Department of Family Medicine, 3Department of Psychiatry, 4Department of Pediatrics, 5Office of Consultation and Research in Medical Education, Roy J and Lucille A Carver College of Medicine, The University of Iowa, Iowa City, IA, USAIntroduction: The Objective Structured Clinical Examination (OSCE is widely used to assess the clinical performance of medical students. However, concerns related to cost, availability, and validity, have led educators to investigate alternatives to the OSCE. Some alternatives involve assessing students while they provide care to patients – the mini-CEX (mini-Clinical Evaluation Exercise and the Long Case are examples. We investigated the psychometrics of systematically observed clinical encounters (SOCEs, in which physicians are supplemented by lay trained observers, as a means of assessing the clinical performances of medical students.Methods: During the pediatrics clerkship at the University of Iowa, trained lay observers assessed the communication skills of third-year medical students using a communication checklist while the students interviewed and examined pediatric patients. Students then verbally presented their findings to faculty, who assessed students’ clinical skills using a standardized form. The reliability of the combined communication and clinical skills scores was calculated using generalizability theory.Results: Fifty-one medical students completed 199 observed patient encounters. The mean combined clinical and communication skills score (out of a maximum 45 points was 40.8 (standard deviation 3.3. The calculated reliability of the SOCE scores, using generalizability theory, from 10 observed patient encounters was 0.81. Students reported receiving helpful feedback from faculty after 97% of their observed clinical encounters.Conclusion: The SOCE can

Psychological Assessment Training in Clinical Psychology Doctoral Programs.

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Mihura, Joni L; Roy, Manali; Graceffo, Robert A

2017-01-01

We surveyed American Psychological Association-accredited clinical psychology doctoral programs' (n = 83) training in psychological assessment-specifically, their coverage of various assessment topics and tests in courses and practica, and whether the training was optional or required. We report results overall and separately per training model (clinical science, scientist-practitioner, and practitioner-focused). Overall, our results suggest that psychological assessment training is as active, or even more active, than in previous years. Areas of increased emphasis include clinical interviewing and psychometrics; multimethod, outcomes, health, and collaborative or therapeutic assessment; and different types of cognitive and self-report personality tests. All or almost all practice-focused programs offered training with the Thematic Apperception Test and Rorschach compared to about half of the scientist-practitioner programs and a third of the clinical science programs. Although almost all programs reported teaching multimethod assessment, what constitutes different methods of assessing psychopathology should be clarified in future studies because many programs appear to rely on one method-self-report (especially clinical science programs). Although doctoral programs covered many assessment topics and tests in didactic courses, there appears to be a shortage of program-run opportunities for students to obtain applied assessment training. Finally, we encourage doctoral programs to be familiar with (a) internships' assessment expectations and opportunities, (b) the professional guidelines for assessment training, and (c) the American Psychological Association's requirements for preinternship assessment competencies.

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...

77 FR 14531 - Proposed Collection; Comment Request; Web-Based Assessment of the NHLBI Clinical Studies Support...

Science.gov (United States)

2012-03-12

... (PRCs) have become an important quality standard in clinical trials and research involving human... study protocols developed under NHLBI funded Clinical Trial Networks. These committees are composed of... research areas. The NHLBI is charged with ensuring the highest quality of each Institute-funded clinical...

Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system.

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Saposnik, G; Mamdani, M; Bayley, M; Thorpe, K E; Hall, J; Cohen, L G; Teasell, R

2010-02-01

Evidence suggests that increasing intensity of rehabilitation results in better motor recovery. Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation. EVREST was designed to evaluate feasibility, safety and efficacy of using the Nintendo Wii gaming virtual reality (VRWii) technology to improve arm recovery in stroke patients. Pilot randomized study comparing, VRWii versus recreational therapy (RT) in patients receiving standard rehabilitation within six months of stroke with a motor deficit of > or =3 on the Chedoke-McMaster Scale (arm). In this study we expect to randomize 20 patients. All participants (age 18-85) will receive customary rehabilitative treatment consistent of a standardized protocol (eight sessions, 60 min each, over a two-week period). The primary feasibility outcome is the total time receiving the intervention. The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit. From November, 2008 to September, 2009 21 patients were randomized to VRWii or RT. Mean age, 61 (range 41-83) years. Mean time from stroke onset 25 (range 10-56) days. EVREST is the first randomized parallel controlled trial assessing the feasibility, safety, and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation. The results of this study will serve as the basis for a larger multicentre trial. ClinicalTrials.gov registration# NTC692523.

A Field-Based Testing Protocol for Assessing Gross Motor Skills in Preschool Children: The Children's Activity and Movement in Preschool Study Motor Skills Protocol

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Williams, Harriet G.; Pfeiffer, Karin A.; Dowda, Marsha; Jeter, Chevy; Jones, Shaverra; Pate, Russell R.

2009-01-01

The purpose of this study was to develop a valid and reliable tool for use in assessing motor skills in preschool children in field-based settings. The development of the Children's Activity and Movement in Preschool Study Motor Skills Protocol included evidence of its reliability and validity for use in field-based environments as part of large…

Satellite Communications Using Commercial Protocols

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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.

Adapting a rapid assessment protocol to environmentally assess palm swamp (Veredas) springs in the Cerrado biome, Brazil.

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Guimarães, Ariane; de Lima Rodrigues, Aline Sueli; Malafaia, Guilherme

2017-10-30

The exploitation and degradation of natural environments exert intense pressure on important ecosystems worldwide. Thus, it is necessary developing or adapting assessment methods to monitor environmental changes and to generate results to be applied to environmental management programs. The Brazilian Veredas (phytophysiognomies typical to the Cerrado biome) are threatened by several human activities; thus, the aim of the present study is to adapt a rapid assessment protocol (RAP) to be applied to Veredas springs, by using the upper course of the Vai-e-Vem stream watershed (Ipameri County, Goiás State, Brazil). Therefore, several springs in the study site were visited and 11 of them were considered Veredas springs. After the RAP was adapted, the instrument was validated and used to environmentally assess the springs in order to demonstrate its applicability. The present study has provided an instrument of option to monitor Veredas springs.

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

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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

PROFILE: Environmental Impact Assessment Under the National Environmental Policy Act and the Protocol on Environmental Protection to the Antarctic Treaty.

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Ensminger; McCold; Webb

1999-07-01

/ Antarctica has been set aside by the international community for protection as a natural reserve and a place for scientific research. Through the Antarctic Treaty of 1961, the signing nations agreed to cooperate in protecting the antarctic environment, in conducting scientific studies, and in abstaining from the exercise of territorial claims. The 1991 signing of the Protocol on Environmental Protection to the Antarctic Treaty (Protocol) by representatives of the 26 nations comprising the Antarctic Treaty Consultative Parties (Parties) significantly strengthened environmental protection measures for the continent. The Protocol required ratification by each of the governments individually prior to official implementation. The US government ratified the Protocol by passage of the Antarctic Science, Tourism, and Conservation Act of 1997. Japan completed the process by ratifying the Protocol on December 15, 1997. US government actions undertaken in Antarctica are subject to the requirements of both the Protocol and the US National Environmental Policy Act (NEPA). There are differences in the scope and intent of the Protocol and NEPA; however, both require environmental impact assessment (EIA) as part of the planning process for proposed actions that have the potential for environmental impacts. In this paper we describe the two instruments and highlight key similarities and differences with particular attention to EIA. Through this comparison of the EIA requirements of NEPA and the Protocol, we show how the requirements of each can be used in concert to provide enhanced environmental protection for the antarctic environment. NEPA applies only to actions of the US government; therefore, because NEPA includes certain desirable attributes that have been refined and clarified through numerous court cases, and because the Protocol is just entering implementation internationally, some recommendations are made for strengthening the procedural requirements of the Protocol

Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol.

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Simmons, Rebecca G; Shattuck, Dominick C; Jennings, Victoria H

2017-01-18

assess pregnancy status over time. This paper outlines the protocol for this efficacy trial, following the Standard Protocol Items: Recommendations for Intervention Trials checklist, to provide an overview of the rationale, methodology, and analysis plan. Participants will be asked to provide daily sexual history data and periodically answer surveys administered through a call center or directly on their phone. Funding for the study was provided in 2013 under the United States Agency for International Development Fertility Awareness for Community Transformation project. Recruitment for the study will begin in January of 2017. The study is expected to last approximately 18 months, depending on recruitment. Findings on the study's primary outcomes are expected to be finalized by September 2018. Reproducibility and transparency, important aspects of all research, are particularly critical in developing new approaches to research design. This protocol outlines the first study to prospectively test both the efficacy (correct use) and effectiveness (actual use) of a pregnancy prevention app. This protocol and the processes it describes reflect the dynamic integration of mobile technologies, a call center, and Health Insurance Portability and Accountability Act-compliant study procedures. Future fertility app studies can build on our approaches to develop methodologies that can contribute to the evidence base around app-based methods of contraception. ClinicalTrials.gov NCT02833922; https://clinicaltrials.gov/ct2/show/NCT02833922 (Archived be WebCite at http://www.webcitation.org/6nDkr0e76). ©Rebecca G Simmons, Dominick C Shattuck, Victoria H Jennings. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.01.2017.

The Promises and Challenges of Ecological Momentary Assessment in Schizophrenia: Development of an Initial Experimental Protocol

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Brandon A. Gaudiano

2015-07-01

Full Text Available Severe mental illnesses, including schizophrenia and other psychotic-spectrum disorders, are a major cause of disability worldwide. Although efficacious pharmacological and psychosocial interventions have been developed for treating patients with schizophrenia, relapse rates are high and long-term recovery remains elusive for many individuals. Furthermore, little is still known about the underlying mechanisms of these illnesses. Thus, there is an urgent need to better understand the contextual factors that contribute to psychosis so that they can be better targeted in future interventions. Ecological Momentary Assessment (EMA is a dynamic procedure that permits the measurement of variables in natural settings in real-time through the use of brief assessments delivered via mobile electronic devices (i.e., smartphones. One advantage of EMA is that it is less subject to retrospective memory biases and highly sensitive to fluctuating environmental factors. In the current article, we describe the research-to-date using EMA to better understand fluctuating symptoms and functioning in patients with schizophrenia and other psychotic disorders and potential applications to treatment. In addition, we describe a novel EMA protocol that we have been employing to study the outcomes of patients with schizophrenia following a hospital discharge. We also report the lessons we have learned thus far using EMA methods in this challenging clinical population.

Clinical evaluation of a dose monitoring software tool based on Monte Carlo Simulation in assessment of eye lens doses for cranial CT scans

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Guberina, Nika; Suntharalingam, Saravanabavaan; Nassenstein, Kai; Forsting, Michael; Theysohn, Jens; Wetter, Axel; Ringelstein, Adrian [University Hospital Essen, Institute of Diagnostic and Interventional Radiology and Neuroradiology, Essen (Germany)

2016-10-15

The aim of this study was to verify the results of a dose monitoring software tool based on Monte Carlo Simulation (MCS) in assessment of eye lens doses for cranial CT scans. In cooperation with the Federal Office for Radiation Protection (Neuherberg, Germany), phantom measurements were performed with thermoluminescence dosimeters (TLD LiF:Mg,Ti) using cranial CT protocols: (I) CT angiography; (II) unenhanced, cranial CT scans with gantry angulation at a single and (III) without gantry angulation at a dual source CT scanner. Eye lens doses calculated by the dose monitoring tool based on MCS and assessed with TLDs were compared. Eye lens doses are summarized as follows: (I) CT angiography (a) MCS 7 mSv, (b) TLD 5 mSv; (II) unenhanced, cranial CT scan with gantry angulation, (c) MCS 45 mSv, (d) TLD 5 mSv; (III) unenhanced, cranial CT scan without gantry angulation (e) MCS 38 mSv, (f) TLD 35 mSv. Intermodality comparison shows an inaccurate calculation of eye lens doses in unenhanced cranial CT protocols at the single source CT scanner due to the disregard of gantry angulation. On the contrary, the dose monitoring tool showed an accurate calculation of eye lens doses at the dual source CT scanner without gantry angulation and for CT angiography examinations. The dose monitoring software tool based on MCS gave accurate estimates of eye lens doses in cranial CT protocols. However, knowledge of protocol and software specific influences is crucial for correct assessment of eye lens doses in routine clinical use. (orig.)

Clinical evaluation of a dose monitoring software tool based on Monte Carlo Simulation in assessment of eye lens doses for cranial CT scans

International Nuclear Information System (INIS)

Guberina, Nika; Suntharalingam, Saravanabavaan; Nassenstein, Kai; Forsting, Michael; Theysohn, Jens; Wetter, Axel; Ringelstein, Adrian

2016-01-01

The aim of this study was to verify the results of a dose monitoring software tool based on Monte Carlo Simulation (MCS) in assessment of eye lens doses for cranial CT scans. In cooperation with the Federal Office for Radiation Protection (Neuherberg, Germany), phantom measurements were performed with thermoluminescence dosimeters (TLD LiF:Mg,Ti) using cranial CT protocols: (I) CT angiography; (II) unenhanced, cranial CT scans with gantry angulation at a single and (III) without gantry angulation at a dual source CT scanner. Eye lens doses calculated by the dose monitoring tool based on MCS and assessed with TLDs were compared. Eye lens doses are summarized as follows: (I) CT angiography (a) MCS 7 mSv, (b) TLD 5 mSv; (II) unenhanced, cranial CT scan with gantry angulation, (c) MCS 45 mSv, (d) TLD 5 mSv; (III) unenhanced, cranial CT scan without gantry angulation (e) MCS 38 mSv, (f) TLD 35 mSv. Intermodality comparison shows an inaccurate calculation of eye lens doses in unenhanced cranial CT protocols at the single source CT scanner due to the disregard of gantry angulation. On the contrary, the dose monitoring tool showed an accurate calculation of eye lens doses at the dual source CT scanner without gantry angulation and for CT angiography examinations. The dose monitoring software tool based on MCS gave accurate estimates of eye lens doses in cranial CT protocols. However, knowledge of protocol and software specific influences is crucial for correct assessment of eye lens doses in routine clinical use. (orig.)

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

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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.

Developing a theory-based instrument to assess the impact of continuing professional development activities on clinical practice: a study protocol

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Rousseau Michel

2011-03-01

Full Text Available Abstract Background Continuing professional development (CPD is one of the principal means by which health professionals (i.e. primary care physicians and specialists maintain, improve, and broaden the knowledge and skills required for optimal patient care and safety. However, the lack of a widely accepted instrument to assess the impact of CPD activities on clinical practice thwarts researchers' comparisons of the effectiveness of CPD activities. Using an integrated model for the study of healthcare professionals' behaviour, our objective is to develop a theory-based, valid, reliable global instrument to assess the impact of accredited CPD activities on clinical practice. Methods Phase 1: We will analyze the instruments identified in a systematic review of factors influencing health professionals' behaviours using criteria that reflect the literature on measurement development and CPD decision makers' priorities. The outcome of this phase will be an inventory of instruments based on social cognitive theories. Phase 2: Working from this inventory, the most relevant instruments and their related items for assessing the concepts listed in the integrated model will be selected. Through an e-Delphi process, we will verify whether these instruments are acceptable, what aspects need revision, and whether important items are missing and should be added. The outcome of this phase will be a new global instrument integrating the most relevant tools to fit our integrated model of healthcare professionals' behaviour. Phase 3: Two data collections are planned: (1 a test-retest of the new instrument, including item analysis, to assess its reliability and (2 a study using the instrument before and after CPD activities with a randomly selected control group to explore the instrument's mere-measurement effect. Phase 4: We will conduct individual interviews and focus groups with key stakeholders to identify anticipated barriers and enablers for implementing the

Performance assessment of two lysis methods for direct identification of yeasts from clinical blood cultures using MALDI-TOF mass spectrometry.

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Jeddi, Fakhri; Yapo-Kouadio, Gisèle Cha; Normand, Anne-Cécile; Cassagne, Carole; Marty, Pierre; Piarroux, Renaud

2017-02-01

In cases of fungal infection of the bloodstream, rapid species identification is crucial to provide adapted therapy and thereby ameliorate patient outcome. Currently, the commercial Sepsityper kit and the sodium-dodecyl sulfate (SDS) method coupled with MALDI-TOF mass spectrometry are the most commonly reported lysis protocols for direct identification of fungi from positive blood culture vials. However, the performance of these two protocols has never been compared on clinical samples. Accordingly, we performed a two-step survey on two distinct panels of clinical positive blood culture vials to identify the most efficient protocol, establish an appropriate log score (LS) cut-off, and validate the best method. We first compared the performance of the Sepsityper and the SDS protocols on 71 clinical samples. For 69 monomicrobial samples, mass spectrometry LS values were significantly higher with the SDS protocol than with the Sepsityper method (P < .0001), especially when the best score of four deposited spots was considered. Next, we established the LS cut-off for accurate identification at 1.7, based on specimen DNA sequence data. Using this LS cut-off, 66 (95.6%) and 46 (66.6%) isolates were correctly identified at the species level with the SDS and the Sepsityper protocols, respectively. In the second arm of the survey, we validated the SDS protocol on an additional panel of 94 clinical samples. Ninety-two (98.9%) of 93 monomicrobial samples were correctly identified at the species level (median LS = 2.061). Overall, our data suggest that the SDS method yields more accurate species identification of yeasts, than the Sepsityper protocol. © The Author 2016. Published by Oxford University Press on behalf of The International Society for Human and Animal Mycology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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.

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

[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.

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

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

Assessment tools for the measurement of the self-efficacy of drug users: protocol for a systematic review.

Science.gov (United States)

Vasconcelos, Selene Cordeiro; Frazão, Iracema da Silva; Sougey, Everton Botelho; Souza, Sandra Lopes de; Silva, Tatiana de Paula Santana da; Lima, Murilo Duarte da Costa

2018-03-14

The abuse of alcohol and other drugs is a worldwide problem, the treatment of which poses a challenge to healthcare workers. This study presents a proposal for a systematic review to analyse the psychometric properties of assessment tools developed to measure the self-efficacy of drug users with regard to resisting the urge to take drugs in high-risk situations. The guiding question was based on PICOS (Population Intervention Comparator Outcome Setting), and the report of the methods of review protocol was written in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Searches will be performed in the PsycINFO, Cochrane, Pubmed, Web of Science, SCOPUS and CINAHL databases, followed by the use of the 'snowball' strategy. The inclusion criteria for the articles will be (1) assessment tool validation studies; (2) assessment tools developed to measure self-efficacy; (3) quantitative measures; (4) measures designed for use on adults; (5) data from self-reports of the participants; (6) studies involving a description of psychometric properties of the measures; and (7) studies that explain how the level of self-efficacy is scored. The search, selection and analysis will be performed by two independent reviewers. In cases of a divergence of opinion, a third reviewer will be consulted. The COSMIN checklist will be used for the appraisal of the methodological quality of the assessment tools and the certainty of the evidence in the articles (risk of bias) will be analysed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. This protocol does not require ethical approval. However, this protocol is part of the thesis entitled Drug-Taking Confidence Questionnaire for use in Brazil, presented for obtaining a doctorate in neuropsychiatry and behavioural sciences from the Federal University of Pernambuco, and has received approval from the human research ethics committee of the Federal

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.

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)

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...

The Kyoto protocol: assessment and perspectives. Towards a new regime up to the climate stake

International Nuclear Information System (INIS)

Gautier, Celia

2012-01-01

This report proposes an analysis within the context of transition of the climate regime from the 'before-2012' regime to the 'post-2020' regime. It first gives an overview of international stakes and context (lack of ambition for climate policy, perspective of an international agreement from 2020). Then, the authors recall the history and achievements of the Kyoto protocol which is the basis of the present climate policy regime. They propose an assessment of actions performed by countries during the first period of the protocol, and focus on the present climate regime elements which are to be safeguarded. They analyse the weaknesses of the present regime, and propose possible improvements for the future post-2020 climate regime

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

Cost-benefit assessment of using electronic health records data for clinical research versus current practices: Contribution of the Electronic Health Records for Clinical Research (EHR4CR) European Project.

Science.gov (United States)

Beresniak, Ariel; Schmidt, Andreas; Proeve, Johann; Bolanos, Elena; Patel, Neelam; Ammour, Nadir; Sundgren, Mats; Ericson, Mats; Karakoyun, Töresin; Coorevits, Pascal; Kalra, Dipak; De Moor, Georges; Dupont, Danielle

2016-01-01

The widespread adoption of electronic health records (EHR) provides a new opportunity to improve the efficiency of clinical research. The European EHR4CR (Electronic Health Records for Clinical Research) 4-year project has developed an innovative technological platform to enable the re-use of EHR data for clinical research. The objective of this cost-benefit assessment (CBA) is to assess the value of EHR4CR solutions compared to current practices, from the perspective of sponsors of clinical trials. A CBA model was developed using an advanced modeling approach. The costs of performing three clinical research scenarios (S) applied to a hypothetical Phase II or III oncology clinical trial workflow (reference case) were estimated under current and EHR4CR conditions, namely protocol feasibility assessment (S1), patient identification for recruitment (S2), and clinical study execution (S3). The potential benefits were calculated considering that the estimated reduction in actual person-time and costs for performing EHR4CR S1, S2, and S3 would accelerate time to market (TTM). Probabilistic sensitivity analyses using Monte Carlo simulations were conducted to manage uncertainty. Should the estimated efficiency gains achieved with the EHR4CR platform translate into faster TTM, the expected benefits for the global pharmaceutical oncology sector were estimated at €161.5m (S1), €45.7m (S2), €204.5m (S1+S2), €1906m (S3), and up to €2121.8m (S1+S2+S3) when the scenarios were used sequentially. The results suggest that optimizing clinical trial design and execution with the EHR4CR platform would generate substantial added value for pharmaceutical industry, as main sponsors of clinical trials in Europe, and beyond. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical Skills Assessment in the Twenty-First Century.

Science.gov (United States)

Elder, Andrew

2018-05-01

Clinical skills remain fundamental to the practice of medicine and form a core component of the professional identity of the physician. However, evidence exists to suggest that the practice of some clinical skills is declining, particularly in the United States. A decline in practice of any skill can lead to a decline in its teaching and assessment, with further decline in practice as a result. Consequently, assessment not only drives learning of clinical skills, but their practice. This article summarizes contemporary approaches to clinical skills assessment that, if more widely adopted, could support the maintenance and reinvigoration of bedside clinical skills. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

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.

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

Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial.

Science.gov (United States)

Wylde, Vikki; Bertram, Wendy; Beswick, Andrew D; Blom, Ashley W; Bruce, Julie; Burston, Amanda; Dennis, Jane; Garfield, Kirsty; Howells, Nicholas; Lane, Athene; McCabe, Candy; Moore, Andrew J; Noble, Sian; Peters, Tim J; Price, Andrew; Sanderson, Emily; Toms, Andrew D; Walsh, David A; White, Simon; Gooberman-Hill, Rachael

2018-02-21

Approximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care. This is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability

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

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.

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

Rheumatoid arthritis (RA) fatigue is distressing, leading to unmanageable physical and cognitive exhaustion impacting on health, leisure and work. Group cognitive-behavioural (CB) therapy delivered by a clinical psychologist demonstrated large improvements in fatigue impact. However, few rheumatology teams include a clinical psychologist, therefore, this study aims to examine whether conventional rheumatology teams can reproduce similar results, potentially widening intervention availability. This is a multicentre, randomised, controlled trial of a group CB intervention for RA fatigue self-management, delivered by local rheumatology clinical teams. 7 centres will each recruit 4 consecutive cohorts of 10-16 patients with RA (fatigue severity ≥ 6/10). After consenting, patients will have baseline assessments, then usual care (fatigue self-management booklet, discussed for 5-6 min), then be randomised into control (no action) or intervention arms. The intervention, Reducing Arthritis Fatigue by clinical Teams (RAFT) will be cofacilitated by two local rheumatology clinicians (eg, nurse/occupational therapist), who will have had brief training in CB approaches, a RAFT manual and materials, and delivered an observed practice course. Groups of 5-8 patients will attend 6 × 2 h sessions (weeks 1-6) and a 1 hr consolidation session (week 14) addressing different self-management topics and behaviours. The primary outcome is fatigue impact (26 weeks); secondary outcomes are fatigue severity, coping and multidimensional impact, quality of life, clinical and mood status (to week 104). Statistical and health economic analyses will follow a predetermined plan to establish whether the intervention is clinically and cost-effective. Effects of teaching CB skills to clinicians will be evaluated qualitatively. Approval was given by an NHS Research Ethics Committee, and participants will provide written informed consent. The copyrighted RAFT package will be freely available. Findings

WE-A-BRC-02: Lessons Learned: Clinical Trials and Operations

International Nuclear Information System (INIS)

Evans, S.

2016-01-01

Quality and safety in healthcare are inextricably linked. There are compelling data that link poor quality radiation therapy to inferior patient survival. Radiation Oncology clinical trial protocol deviations often involve incorrect target volume delineation or dosing, akin to radiotherapy incidents which also often involve partial geometric miss or improper radiation dosing. When patients with radiation protocol variations are compared to those without significant protocol variations, clinical outcome is negatively impacted. Traditionally, quality assurance in radiation oncology has been driven largely by new technological advances, and safety improvement has been driven by reactive responses to past system failures and prescriptive mandates recommended by professional organizations and promulgated by regulators. Prescriptive approaches to quality and safety alone often do not address the huge variety of process and technique used in radiation oncology. Risk-based assessments of radiotherapy processes provide a mechanism to enhance quality and safety, both for new and for established techniques. It is imperative that we explore such a paradigm shift at this time, when expectations from patients as well as providers are rising while available resources are falling. There is much we can learn from our past experiences to be applied towards the new risk-based assessments. Learning Objectives: Understand the impact of clinical and technical quality on outcomes Understand the importance of quality care in radiation oncology Learn to assess the impact of quality on clinical outcomes D. Followill, NIH Grant CA180803

Non-Intrusive Load Monitoring Assessment: Literature Review and Laboratory Protocol

Energy Technology Data Exchange (ETDEWEB)

Butner, R. Scott; Reid, Douglas J.; Hoffman, Michael G.; Sullivan, Greg; Blanchard, Jeremy

2013-07-01

To evaluate the accuracy of NILM technologies, a literature review was conducted to identify any test protocols or standardized testing approaches currently in use. The literature review indicated that no consistent conventions were currently in place for measuring the accuracy of these technologies. Consequently, PNNL developed a testing protocol and metrics to provide the basis for quantifying and analyzing the accuracy of commercially available NILM technologies. This report discusses the results of the literature review and the proposed test protocol and metrics in more detail.

Assessing clinical competency in the health sciences

Science.gov (United States)

Panzarella, Karen Joanne

To test the success of integrated curricula in schools of health sciences, meaningful measurements of student performance are required to assess clinical competency. This research project analyzed a new performance assessment tool, the Integrated Standardized Patient Examination (ISPE), for assessing clinical competency: specifically, to assess Doctor of Physical Therapy (DPT) students' clinical competence as the ability to integrate basic science knowledge with clinical communication skills. Thirty-four DPT students performed two ISPE cases, one of a patient who sustained a stroke and the other a patient with a herniated lumbar disc. Cases were portrayed by standardized patients (SPs) in a simulated clinical setting. Each case was scored by an expert evaluator in the exam room and then by one investigator and the students themselves via videotape. The SPs scored each student on an overall encounter rubric. Written feedback was obtained from all participants in the study. Acceptable reliability was demonstrated via inter-rater agreement as well as inter-rater correlations on items that used a dichotomous scale, whereas the items requiring the use of the 4-point rubric were somewhat less reliable. For the entire scale both cases had a significant correlation between the Expert-Investigator pair of raters, for the CVA case r = .547, p performances on the ISPE with other independent estimates of students' competence. The unique integration questions of the ISPE were judged to have good content validity from experts and students, suggestive that integration, a most crucial element of clinical competence, while done in the mind of the student, can be practiced, learned and assessed.

Classification and clinical assessment

Directory of Open Access Journals (Sweden)

F. Cantini

2012-06-01

Full Text Available There are at least nine classification criteria for psoriatic arthritis (PsA that have been proposed and used in clinical studies. With the exception of the ESSG and Bennett rules, all of the other criteria sets have a good performance in identifying PsA patients. As the CASPAR criteria are based on a robust study methodology, they are considered the current reference standard. However, if there seems to be no doubt that they are very good to classify PsA patients (very high specificity, they might be not sensitive enough to diagnose patients with unknown early PsA. The vast clinical heterogeneity of PsA makes its assessment very challenging. Peripheral joint involvement is measured by 78/76 joint counts, spine involvement by the instruments used for ankylosing spondylitis (AS, dactylitis by involved digit count or by the Leeds dactylitis index, enthesitis by the number of affected entheses (several indices available and psoriasis by the Psoriasis Area and Severity Index (PASI. Peripheral joint damage can be assessed by a modified van der Heijde-Sharp scoring system and axial damage by the methods used for AS or by the Psoriatic Arthritis Spondylitis Radiology Index (PASRI. As in other arthritides, global evaluation of disease activity and severity by patient and physician and assessment of disability and quality of life are widely used. Finally, composite indices that capture several clinical manifestations of PsA have been proposed and a new instrument, the Psoriatic ARthritis Disease Activity Score (PASDAS, is currently being developed.

Psoriatic arthritis: An assessment of clinical, biochemical and ...

African Journals Online (AJOL)

, epidemiological, clinical and radiological studies of South African (SA) patients are scarce. Objectives. To assess clinical, biochemical and radiological features in a single-centre SA cohort. Methods. We conducted a prospective assessment ...

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…

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.

EMS Adherence to a Pre-hospital Cervical Spine Clearance Protocol

Directory of Open Access Journals (Sweden)

Johnson, David

2001-10-01

Full Text Available Purpose: To determine the degree of adherence to a cervical spine (c-spine clearance protocol by pre-hospital Emergency Medical Services (EMS personnel by both self-assessment and receiving hospital assessment, to describe deviations from the protocol, and to determine if the rate of compliance by paramedic self-assessment differed from receiving hospital assessment. Methods: A retrospective sample of pre-hospital (consecutive series and receiving hospital (convenience sample assessments of the compliance with and appropriateness of c-spine immobilization. The c-spine clearance protocol was implemented for Orange County EMS just prior to the April-November 1999 data collection period. Results: We collected 396 pre-hospital and 162 receiving hospital data forms. From the pre-hospital data sheet. the percentage deviation from the protocol was 4.096 (16/396. Only one out of 16 cases that did not comply with the protocol was due to over immobilization (0.2%. The remaining 15 cases were under immobilized, according to protocol. Nine of the under immobilized cases (66% that should have been placed in c-spine precautions met physical assessment criteria in the protocol, while the other five cases met mechanism of injury criteria. The rate of deviations from protocol did not differ over time. The receiving hospital identified 8.0% (13/162; 6/16 over immobilized, 7/16 under immobilized of patients with deviations from the protocol; none was determined to have actual c-spine injury. Conclusion: The implementation of a pre-hospital c-spine clearance protocol in Orange County was associated with a moderate overall adherence rate (96% from the pre-hospital perspective, and 92% from the hospital perspective, p=.08 for the two evaluation methods. Most patients who deviated from protocol were under immobilized, but no c-spine injuries were missed. The rate of over immobilization was better than previously reported, implying a saving of resources.

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

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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

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

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.

Using a clinical protocol for orthognathic surgery and assessing a 3-dimensional virtual approach: current therapy.

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Quevedo, Luis A; Ruiz, Jessica V; Quevedo, Cristobal A

2011-03-01

Oral and maxillofacial surgeons who perform orthognathic surgery face major changes in their practices, and these challenges will increase in the near future, because the extraordinary advances in technology applied to our profession are not only amazing but are becoming the standard of care as they promote improved outcomes for our patients. Orthognathic surgery is one of the favorite areas of practicing within the scope of practice of an oral and maxillofacial surgeon. Our own practice in orthognathic surgery has completed over 1,000 surgeries of this type. Success is directly related to the consistency and capability of the surgical-orthodontic team to achieve predictable, stable results, and our hypothesis is that a successful result is directly related to the way we take our records and perform diagnosis and treatment planning following basic general principles. Now that we have the opportunity to plan and treat 3-dimensional (3D) problems with 3D technology, we should enter into this new era with appropriate standards to ensure better results, instead of simply enjoying these new tools, which will clearly show not only us but everyone what we do when we perform orthognathic surgery. Appropriate principles need to be taken into account when implementing this new technology. In other words, new technology is welcome, but we do not have to reinvent the wheel. The purpose of this article is to review the current protocol that we use for orthognathic surgery and compare it with published protocols that incorporate new 3D and virtual technology. This report also describes our approach to this new technology. Copyright © 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

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

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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

Biosafety assessment protocols for new organisms in New Zealand: Can they apply internationally to emerging technologies?

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Barratt, B.I.P.; Moeed, A.; Malone, L.A.

2006-01-01

An analysis of established biosafety protocols for release into the environment of exotic plants and biological control agents for weeds and arthropod pests has been carried out to determine whether such protocols can be applied to relatively new and emerging technologies intended for the primary production industries, such as transgenic plants. Example case studies are described to indicate the scope of issues considered by regulators who make decisions on new organism releases. No transgenic plants have been released to date in New Zealand, but two field test approvals are described as examples. An analysis of the biosafety protocols has shown that, while many of the risk criteria considered for decision-making by regulators are similar for all new organisms, a case-by-case examination of risks and potential impacts is required in order to fully assess risk. The value of post-release monitoring and validation of decisions made by regulators is emphasised

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

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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

Evaluation of the appropriate use of a CIWA-Ar alcohol withdrawal protocol in the general hospital setting.

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Eloma, Amanda S; Tucciarone, Jason M; Hayes, Edmund M; Bronson, Brian D

2018-01-01

The Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) is an assessment tool used to quantify alcohol withdrawal syndrome (AWS) severity and inform benzodiazepine treatment for alcohol withdrawal. To evaluate the prescribing patterns and appropriate use of the CIWA-Ar protocol in a general hospital setting, as determined by the presence or absence of documented AWS risk factors, patients' ability to communicate, and provider awareness of the CIWA-Ar order. This retrospective chart review included 118 encounters of hospitalized patients placed on a CIWA-Ar protocol during one year. The following data were collected for each encounter: patient demographics, admitting diagnosis, ability to communicate, and admission blood alcohol level; and medical specialty of the clinician ordering CIWA-Ar, documentation of the presence or absence of established AWS risk factors, specific parameters of the protocol ordered, service admitted to, provider documentation of awareness of the active protocol within 48 h of initial order, total benzodiazepine dose equivalents administered and associated adverse events. 57% of patients who started on a CIWA-Ar protocol had either zero or one documented risk factor for AWS (19% and 38% respectively). 20% had no documentation of recent alcohol use. 14% were unable to communicate. 19% of medical records lacked documentation of provider awareness of the ordered protocol. Benzodiazepine associated adverse events were documented in 15% of encounters. The judicious use of CIWA-Ar protocols in general hospitals requires mechanisms to ensure assessment of validated alcohol withdrawal risk factors, exclusion of patients who cannot communicate, and continuity of care during transitions.

The Use of Non-Variant Sites to Improve the Clinical Assessment of Whole-Genome Sequence Data.

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Alberto Ferrarini

Full Text Available Genetic testing, which is now a routine part of clinical practice and disease management protocols, is often based on the assessment of small panels of variants or genes. On the other hand, continuous improvements in the speed and per-base costs of sequencing have now made whole exome sequencing (WES and whole genome sequencing (WGS viable strategies for targeted or complete genetic analysis, respectively. Standard WGS/WES data analytical workflows generally rely on calling of sequence variants respect to the reference genome sequence. However, the reference genome sequence contains a large number of sites represented by rare alleles, by known pathogenic alleles and by alleles strongly associated to disease by GWAS. It's thus critical, for clinical applications of WGS and WES, to interpret whether non-variant sites are homozygous for the reference allele or if the corresponding genotype cannot be reliably called. Here we show that an alternative analytical approach based on the analysis of both variant and non-variant sites from WGS data allows to genotype more than 92% of sites corresponding to known SNPs compared to 6% genotyped by standard variant analysis. These include homozygous reference sites of clinical interest, thus leading to a broad and comprehensive characterization of variation necessary to an accurate evaluation of disease risk. Altogether, our findings indicate that characterization of both variant and non-variant clinically informative sites in the genome is necessary to allow an accurate clinical assessment of a personal genome. Finally, we propose a highly efficient extended VCF (eVCF file format which allows to store genotype calls for sites of clinical interest while remaining compatible with current variant interpretation software.

Assessing clinical reasoning abilities of medical students using clinical performance examination

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Sunju Im

2016-03-01

Full Text Available Purpose: The purpose of this study is to investigate the reliability and validity of new clinical performance examination (CPX for assessing clinical reasoning skills and evaluating clinical reasoning ability of the students. Methods: Third-year medical school students (n=313 in Busan-Gyeongnam consortium in 2014 were included in the study. One of 12 stations was developed to assess clinical reasoning abilities. The scenario and checklists of the station were revised by six experts. Chief complaint of the case was rhinorrhea, accompanied by fever, headache, and vomiting. Checklists focused on identifying of the main problem and systematic approach to the problem. Students interviewed the patient and recorded subjective and objective findings, assessments, plans (SOAP note for 15 minutes. Two professors assessed students simultaneously. We performed statistical analysis on their scores and survey. Results: The Cronbach α of subject station was 0.878 and Cohen κ coefficient between graders was 0.785. Students agreed on CPX as an adequate tool to evaluate students’ performance, but some graders argued that the CPX failed to secure its validity due to their lack of understanding the case. One hundred eight students (34.5% identified essential problem early and only 58 (18.5% performed systematic history taking and physical examination. One hundred seventy-three of them (55.3% communicated correct diagnosis with the patient. Most of them had trouble in writing SOAP notes. Conclusion: To gain reliability and validity, interrater agreement should be secured. Students' clinical reasoning skills were not enough. Students need to be trained on problem identification, reasoning skills and accurate record-keeping.

Using Think Aloud Protocols to Assess E-Prescribing in Community Pharmacies

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Olufunmilola K. Odukoya, BPharm, MS

2012-01-01

Full Text Available Introduction: Think aloud protocol has rarely been used as a method of data collection in community pharmacies.Purpose: The aim of the report is to describe how think aloud protocols were used to identify issues that arise when using e-prescribing technology in pharmacies. In this paper, we report on the benefits and challenges of using think aloud protocols in pharmacies to examine the use of e-prescribing systems.Methods: Sixteen pharmacists and pharmacy technicians were recruited from seven community pharmacies in Wisconsin. Data were collected using direct observation alongside think aloud protocol. Direct observations and think aloud protocols took place between January-February, 2011. Participants were asked to verbalize their thoughts as they process electronic prescriptions.Results: Participants identified weaknesses in e-prescribing that they had previously not conceived. This created heightened awareness for vigilance when processing e-prescriptions. The main challenge with using think aloud protocols was due to interruptions in the pharmacies. Also, a few participants found it challenging to remember to continue verbalizing their thought process during think aloud sessions.Conclusion: The use of think aloud protocols as method of data collection is a new way for understanding the issues related to technology use in community pharmacy practice. Think aloud protocol was beneficial in providing objective information on e-prescribing use not solely based on pharmacist’s or technician’s opinion of the technology. This method provided detailed information on a wide variety of real time challenges with e-prescribing technology use in community pharmacies. Using this data collection method can help identify potential patient safety issues when using e-prescribing and suggestions for redesign.

Development, appraisal, validation and implementation of a consensus protocol for the assessment of cerebral amyloid angiopathy in post-mortem brain tissue

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Love, Seth; Chalmers, Katy; Ince, Paul; Esiri, Margaret; Attems, Johannes; Jellinger, Kurt; Yamada, Masahito; McCarron, Mark; Minett, Thais; Matthews, Fiona; Greenberg, Steven; Mann, David; Kehoe, Patrick Gavin

2014-01-01

In a collaboration involving 11 groups with research interests in cerebral amyloid angiopathy (CAA), we used a two-stage process to develop and in turn validate a new consensus protocol and scoring scheme for the assessment of CAA and associated vasculopathic abnormalities in post-mortem brain tissue. Stage one used an iterative Delphi-style survey to develop the consensus protocol. The resultant scoring scheme was tested on a series of digital images and paraffin sections that were circulated blind to a number of scorers. The scoring scheme and choice of staining methods were refined by open-forum discussion. The agreed protocol scored parenchymal and meningeal CAA on a 0-3 scale, capillary CAA as present/absent and vasculopathy on 0-2 scale, in the 4 cortical lobes that were scored separately. A further assessment involving three centres was then undertaken. Neuropathologists in three centres (Bristol, Oxford and Sheffield) independently scored sections from 75 cases (25 from each centre) and high inter-rater reliability was demonstrated. Stage two used the results of the three-centre assessment to validate the protocol by investigating previously described associations between APOE genotype (previously determined), and both CAA and vasculopathy. Association of capillary CAA with or without arteriolar CAA with APOE ε4 was confirmed. However APOE ε2 was also found to be a strong risk factor for the development of CAA, not only in AD but also in elderly non-demented controls. Further validation of this protocol and scoring scheme is encouraged, to aid its wider adoption to facilitate collaborative and replication studies of CAA. PMID:24754000

In silico toxicology protocols.

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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.

Development and validation of a remote home safety protocol.

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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.

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

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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.

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

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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

Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

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Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

2015-09-01

An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

The clinical assessment study of the foot (CASF: study protocol for a prospective observational study of foot pain and foot osteoarthritis in the general population

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Menz Hylton B

2011-09-01

Full Text Available Abstract Background Symptomatic osteoarthritis (OA affects approximately 10% of adults aged over 60 years. The foot joint complex is commonly affected by OA, yet there is relatively little research into OA of the foot, compared with other frequently affected sites such as the knee and hand. Existing epidemiological studies of foot OA have focussed predominantly on the first metatarsophalangeal joint at the expense of other joints. This three-year prospective population-based observational cohort study will describe the prevalence of symptomatic radiographic foot OA, relate its occurrence to symptoms, examination findings and life-style-factors, describe the natural history of foot OA, and examine how it presents to, and is diagnosed and managed in primary care. Methods All adults aged 50 years and over registered with four general practices in North Staffordshire, UK, will be invited to participate in a postal Health Survey questionnaire. Respondents to the questionnaire who indicate that they have experienced foot pain in the preceding twelve months will be invited to attend a research clinic for a detailed clinical assessment. This assessment will consist of: clinical interview; physical examination; digital photography of both feet and ankles; plain x-rays of both feet, ankles and hands; ultrasound examination of the plantar fascia; anthropometric measurement; and a further self-complete questionnaire. Follow-up will be undertaken in consenting participants by postal questionnaire at 18 months (clinic attenders only and three years (clinic attenders and survey participants, and also by review of medical records. Discussion This three-year prospective epidemiological study will combine survey data, comprehensive clinical, x-ray and ultrasound assessment, and review of primary care records to identify radiographic phenotypes of foot OA in a population of community-dwelling older adults, and describe their impact on symptoms, function and

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

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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.

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

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

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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.

Inter-observer reliability of animal-based welfare indicators included in the Animal Welfare Indicators welfare assessment protocol for dairy goats.

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Vieira, A; Battini, M; Can, E; Mattiello, S; Stilwell, G

2018-01-08

This study was conducted within the context of the Animal Welfare Indicators (AWIN) project and the underlying scientific motivation for the development of the study was the scarcity of data regarding inter-observer reliability (IOR) of welfare indicators, particularly given the importance of reliability as a further step for developing on-farm welfare assessment protocols. The objective of this study is therefore to evaluate IOR of animal-based indicators (at group and individual-level) of the AWIN welfare assessment protocol (prototype) for dairy goats. In the design of the study, two pairs of observers, one in Portugal and another in Italy, visited 10 farms each and applied the AWIN prototype protocol. Farms in both countries were visited between January and March 2014, and all the observers received the same training before the farm visits were initiated. Data collected during farm visits, and analysed in this study, include group-level and individual-level observations. The results of our study allow us to conclude that most of the group-level indicators presented the highest IOR level ('substantial', 0.85 to 0.99) in both field studies, pointing to a usable set of animal-based welfare indicators that were therefore included in the first level of the final AWIN welfare assessment protocol for dairy goats. Inter-observer reliability of individual-level indicators was lower, but the majority of them still reached 'fair to good' (0.41 to 0.75) and 'excellent' (0.76 to 1) levels. In the paper we explore reasons for the differences found in IOR between the group and individual-level indicators, including how the number of individual-level indicators to be assessed on each animal and the restraining method may have affected the results. Furthermore, we discuss the differences found in the IOR of individual-level indicators in both countries: the Portuguese pair of observers reached a higher level of IOR, when compared with the Italian observers. We argue how the

Clinical Research: A Psychotherapeutic Assessment Model for Siblings in Care

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Hindle, Debbie

2007-01-01

This paper focuses on the aspects of a qualitative research project that examines an assessment protocol for the placement of siblings in foster care and/or future adoption. A brief description of the background to the study and the research design is given. Evaluating the material from the quantitative instruments used and the psychotherapeutic…

Assessing the clinical probability of pulmonary embolism

International Nuclear Information System (INIS)

Miniati, M.; Pistolesi, M.

2001-01-01

Clinical assessment is a cornerstone of the recently validated diagnostic strategies for pulmonary embolism (PE). Although the diagnostic yield of individual symptoms, signs, and common laboratory tests is limited, the combination of these variables, either by empirical assessment or by a prediction rule, can be used to express a clinical probability of PE. The latter may serve as pretest probability to predict the probability of PE after further objective testing (posterior or post-test probability). Over the last few years, attempts have been made to develop structured prediction models for PE. In a Canadian multicenter prospective study, the clinical probability of PE was rated as low, intermediate, or high according to a model which included assessment of presenting symptoms and signs, risk factors, and presence or absence of an alternative diagnosis at least as likely as PE. Recently, a simple clinical score was developed to stratify outpatients with suspected PE into groups with low, intermediate, or high clinical probability. Logistic regression was used to predict parameters associated with PE. A score ≤ 4 identified patients with low probability of whom 10% had PE. The prevalence of PE in patients with intermediate (score 5-8) and high probability (score ≥ 9) was 38 and 81%, respectively. As opposed to the Canadian model, this clinical score is standardized. The predictor variables identified in the model, however, were derived from a database of emergency ward patients. This model may, therefore, not be valid in assessing the clinical probability of PE in inpatients. In the PISA-PED study, a clinical diagnostic algorithm was developed which rests on the identification of three relevant clinical symptoms and on their association with electrocardiographic and/or radiographic abnormalities specific for PE. Among patients who, according to the model, had been rated as having a high clinical probability, the prevalence of proven PE was 97%, while it was 3

Evaluation of an advanced pressure ulcer management protocol followed by trained wound, ostomy, and continence nurses: a non-randomized controlled trial

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Kaitani T

2015-02-01

Full Text Available Toshiko Kaitani,1 Gojiro Nakagami,2 Junko Sugama,3 Masahiro Tachi,4 Yutaka Matsuyama,5 Yoshiki Miyachi,6 Takashi Nagase,2 Yukie Takemura,7 Hiromi Sanada2 1School of Nursing, Sapporo City University, Hokkaido, Japan; 2Department of Gerontological Nursing/Wound Care Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; 3Department of Clinical Nursing, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan; 4Department of Plastic Surgery, Tohoku University Graduate School of Medicine, Miyagi, Japan; 5Department of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; 6Department of Dermatology, Kyoto University Graduate School of Medicine, Kyoto, Japan; 7Department of Nursing, Research Hospital, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan Aims and objectives: We investigated the effectiveness and safety of an advanced pressure ulcer (PU management protocol comprising 1 ultrasonography to assess the deep tissue, 2 use of a non-contact thermometer to detect critical colonization, 3 conservative sharp debridement, 4 dressing selection, 5 negative pressure wound therapy, and 6 vibration therapy in comparison with those of a conventional approach. Each protocol was followed by trained wound, ostomy, and continence nurses (WOCNs. Background: At present, there is no systematic PU management protocol for nurses that includes appropriate assessment and intervention techniques for deep tissue injury and critical colonization. In Japan, there is no such protocol that the nurses can follow without a physician’s orders. Design and methods: This was a prospective non-randomized controlled trial. Over a 3-week period, we evaluated the effectiveness of an advanced protocol by comparing the PU severity and healing on the basis of the DESIGN-R scale and presence of patients' discomfort. We recruited ten WOCNs to follow

Summative clinical competency assessment: A survey of ultrasound practitioners' views.

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Harrison, Gill

2015-02-01

Clinical competency and the assessment of core skills is a crucial element of any programme leading to an award with a clinical skills component. This has become a more prominent feature of current reports on quality health care provision. This project aimed to determine ultrasound practitioners' opinions about how best to assess clinical competency. An on-line questionnaire was sent to contacts from the Consortium for the Accreditation of Sonographic Education and details distributed at the British Medical Ultrasound Society conference in 2011. One hundred and sixteen responses were received from a range of clinical staff with an interest in ultrasound assessment. The majority of respondents suggested that competency assessments should take place in the clinical departments with or without an element of assessment at the education centre. Moderation was an important area highlighted by respondents, with 84% of respondents suggesting that two assessors were required and 66% of those stating some element of external moderation should be included. The findings suggest that respondents' preference is for some clinical competency assessments to take place on routine lists within the clinical department, assessed by two people one of which would be an external assessor. In view of recent reports relating to training and assessment of health care professionals, the ultrasound profession needs to begin the debate about how best to assess clinical competence and ensure appropriate first post-competency of anyone undertaking ultrasound examinations.

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

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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.

Risk assessment instruments in clinical practice.

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Côté, Gilles; Crocker, Anne G; Nicholls, Tonia L; Seto, Michael C

2012-04-01

To determine whether the items in one of the most widely validated instruments of violence risk assessment, the Historical-Clinical-Risk Management-20 (HCR-20), are used in review board hearings to assess the risk of violence by people found Not Criminally Responsible on account of Mental Disorder (NCRMD). This study was conducted from October 2004 to August 2006 in Quebec's sole forensic psychiatric hospital and 2 large civil psychiatric hospitals designated for the care of people declared NCRMD in the Montreal metropolitan area. The risk assessments presented by clinicians at annual review board hearings and the boards' rationale for the release or detention of people found NCRMD were contrasted with the risk assessments conducted by the research team using the HCR-20. The final sample was comprised of 96 men. Very few of the risk factors identified by prior research (HCR-20 items) were mentioned in the hearing process, whether in clinical reports, discussions during the hearing, or in the disposition justification. The findings confirm that there remains a significant gap between research evidence and risk assessment practice.

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

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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

Implementation of a Rapid, Protocol-based TIA Management Pathway

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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.

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

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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

Undergraduate nursing students' perspectives on clinical assessment at transition to practice.

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Wu, Xi Vivien; Wang, Wenru; Pua, Lay Hoon; Heng, Doreen Gek Noi; Enskär, Karin

2015-01-01

Assessment of clinical competence requires explicitly defined standards meeting the national standards of the nursing profession. This is a complex process because of the diverse nature of nursing practice. To explore the perceptions of final-year undergraduate nursing students regarding clinical assessment at transition to practice. An exploratory qualitative approach was adopted. Twenty-four students participated in three focus group discussions. Thematic analysis was conducted. Five themes emerged: the need for a valid and reliable clinical assessment tool, the need for a flexible style of reflection and specific feedback, the dynamic clinical learning environment, students' efforts in learning and assessment, and the unclear support system for preceptors. Workload, time, resource availability, adequate preparation of preceptors, and the provision of valid and reliable clinical assessment tools were deemed to influence the quality of students' clinical learning and assessment. Nursing leadership in hospitals and educational institutions has a joint responsibility in shaping the clinical learning environment and providing clinical assessments for the students.

The Localized Scleroderma Cutaneous Assessment Tool: responsiveness to change in a pediatric clinical population.

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Kelsey, Christina E; Torok, Kathryn S

2013-08-01

Lack of agreement on how to accurately capture disease outcomes in localized scleroderma (LS) has hindered the development of efficacious treatment protocols. The LS Cutaneous Assessment Tool (LoSCAT), consisting of the modified LS Skin Severity Index (mLoSSI) and the LS Damage Index, has potential for use in clinical trials. The goal of this article is to further evaluate the clinical responsiveness of the LoSCAT. Based on the modifiable nature of disease activity versus damage, we expected the mLoSSI to be responsive to change. At 2 study visits, a physician completed the LoSCAT and Physician Global Assessment (PGA) of Disease Activity and of Disease Damage for 29 patients with LS. Spearman correlations were used to examine the relationships between the change in the LoSCAT and the PGA scores. To evaluate contrasted group validity, patients were grouped according to disease activity classification and change scores of groups were compared. Minimal clinically important differences were calculated and compared with the standard error of measurement. Change in the mLoSSI score correlated strongly with change in the PGA of Disease Activity score, whereas change in the LS Damage Index score correlated weakly with change in the PGA of Disease Damage score. The mLoSSI and PGA of Disease Activity exhibited contrasted group validity. Minimal clinically important differences for the activity measures were greater than the respective standard errors of measurement. Only 2 study visits were included in analysis. This study gives further evidence that the LoSCAT, specifically the mLoSSI, is a responsive, valid measure of activity in LS and should be used in future treatment studies. Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

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

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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.

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

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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.

Enhanced Recovery After Surgery Protocols in Major Urologic Surgery

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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.

Clinical Significance: a Therapeutic Approach Topsychological Assessment in Treatment Planning

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Afolabi Olusegun Emmanuel

2015-06-01

Full Text Available Psychological assessment has long been reported as a key component of clinical psychology. This paper examines the complexities surrounding the clinical significance of therapeutic approach to treatment planning. To achieve this objective, the paper searched and used the PsycINFO and PubMed databases and the reference sections of chapters and journal articles to analysed, 1 a strong basis for the usage of therapeutic approach to psychological assessment in treatment plans, 2 explained the conceptual meaning of clinical significant change in therapeutic assessment, 3 answered some of the questions regarding practicability and the clinical significance of therapeutic approach to treatment plans, particularly during or before treatment, 4 linked therapeutic assessment to change in clients’ clinical impression, functioning and therapeutic needs 5 analysed the empirically documenting clinically significant change in therapeutic assessment. Finally, the study suggested that though therapeutic assessment is not sufficient for the systematic study of psychotherapy outcome and process, it is still consistent with both the layman and professional expectations regarding treatment outcome and also provides a precise method for classifying clients as ‘changed’ or ‘unchanged’ on the basis of clinical significance criteria.

Variability in Usual Care Mechanical Ventilation for Pediatric Acute Respiratory Distress Syndrome: Time for a Decision Support Protocol?

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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

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

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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

Development of standardized bioassay protocols for the toxicity assessment of waste, manufactured products, and effluents in Latin America: Venezuela, a Case Study

International Nuclear Information System (INIS)

Rodriquez-Grau, J.

1993-01-01

The present status of the toxicity assessment of industrial products in Latin America is well below North America/EC standards. As an example, most of Latin America regulatory laws regarding effluent discharge are still based upon concentration limits of certain major pollutants, and BOD/COD measurements; no reference is made to the necessity of aquatic bioassay toxicity data. Aware of this imperative need, the Venezuelan Petroleum Industry (PDVSA), through its R ampersand D Corporative branch (INTEVEP) gave priority to the development of standardized acute/sublethal toxicity test protocols as sound means of evaluating their products and wastes. Throughout this presentation, the Venezuelan case will be studied, showing strategies undertaken to accelerate protocol development. Results will show the assessment of 14 different protocols encompassing a variety of species of aquatic/terrestrial organisms, and a series of toxicity test endpoints including mortality, reproductive, biological and immunological measurements, most of which are currently in use or being developed. These protocols have already yielded useful results in numerous cases where toxicity assessment was required, including evaluations of effluent, oil dispersants, drilling fluids, toxic wastes, fossil fuels and newly developed products. The Venezuelan case demonstrates that the integration of Industry, Academia and Government, which is an essential part of SETAC's philosophy, is absolutely necessary for the successful advancement of environmental scientific/regulatory issues

Assessing older drivers: a primary care protocol to evaluate driving safety risk.

Science.gov (United States)

Murden, Robert A; Unroe, Kathleen

2005-08-01

Most articles on elder drivers offer either general advice, or review testing protocols that divide drivers into two distinct groups: safe or unsafe. We believe it is unreasonable to expect any testing to fully separate drivers into just these two mutually exclusive groups, so we offer a protocol for a more practical approach. This protocol can be applied by primary care physicians. We review the justification for the many steps of this protocol, which have branches that lead to identifying drivers as low risk, high risk (for accidents) or needing further evaluation. Options for further evaluation are provided.

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

The Impact of a Novel Tool for Comprehensive Assessment of Palliative Care (MPCAT) on Assessment Outcome at 6- and 12-Month Follow-Up.

LENUS (Irish Health Repository)

O'Reilly, Martina

2016-07-01

Assessment in palliative care settings should be focused, sensitive, specific, and effective to minimize discomfort to vulnerable and often highly morbid patients. This report describes the development of an admission assessment protocol for a Specialist Palliative Care Inpatient Unit and its implementation into clinical practice.

Automated Clinical Assessment from Smart home-based Behavior Data

Science.gov (United States)

Dawadi, Prafulla Nath; Cook, Diane Joyce; Schmitter-Edgecombe, Maureen

2016-01-01

Smart home technologies offer potential benefits for assisting clinicians by automating health monitoring and well-being assessment. In this paper, we examine the actual benefits of smart home-based analysis by monitoring daily behaviour in the home and predicting standard clinical assessment scores of the residents. To accomplish this goal, we propose a Clinical Assessment using Activity Behavior (CAAB) approach to model a smart home resident’s daily behavior and predict the corresponding standard clinical assessment scores. CAAB uses statistical features that describe characteristics of a resident’s daily activity performance to train machine learning algorithms that predict the clinical assessment scores. We evaluate the performance of CAAB utilizing smart home sensor data collected from 18 smart homes over two years using prediction and classification-based experiments. In the prediction-based experiments, we obtain a statistically significant correlation (r = 0.72) between CAAB-predicted and clinician-provided cognitive assessment scores and a statistically significant correlation (r = 0.45) between CAAB-predicted and clinician-provided mobility scores. Similarly, for the classification-based experiments, we find CAAB has a classification accuracy of 72% while classifying cognitive assessment scores and 76% while classifying mobility scores. These prediction and classification results suggest that it is feasible to predict standard clinical scores using smart home sensor data and learning-based data analysis. PMID:26292348

Protocol compliance and time management in blunt trauma resuscitation.

Science.gov (United States)

Spanjersberg, W R; Bergs, E A; Mushkudiani, N; Klimek, M; Schipper, I B

2009-01-01

To study advanced trauma life support (ATLS) protocol adherence prospectively in trauma resuscitation and to analyse time management of daily multidisciplinary trauma resuscitation at a level 1 trauma centre, for both moderately and severely injured patients. All victims of severe blunt trauma were consecutively included. Patients with a revised trauma score (RTS) of 12 were resuscitated by a "minor trauma" team and patients with an RTS of less than 12 were resuscitated by a "severe trauma" team. Digital video recordings were used to analyse protocol compliance and time management during initial assessment. From 1 May to 1 September 2003, 193 resuscitations were included. The "minor trauma" team assessed 119 patients, with a mean injury severity score (ISS) of 7 (range 1-45). Overall protocol compliance was 42%, ranging from 0% for thoracic percussion to 93% for thoracic auscultation. The median resuscitation time was 45.9 minutes (range 39.7-55.9). The "severe team" assessed 74 patients, with a mean ISS of 22 (range 1-59). Overall protocol compliance was 53%, ranging from 4% for thoracic percussion to 95% for thoracic auscultation. Resuscitation took 34.8 minutes median (range 21.6-44.1). Results showed the current trauma resuscitation to be ATLS-like, with sometimes very low protocol compliance rates. Timing of secondary survey and radiology and thus time efficiency remains a challenge in all trauma patients. To assess the effect of trauma resuscitation protocols on outcome, protocol adherence needs to be improved.

Predicting implementation from organizational readiness for change: a study protocol

Directory of Open Access Journals (Sweden)

Kelly P Adam

2011-07-01

Full Text Available Abstract Background There is widespread interest in measuring organizational readiness to implement evidence-based practices in clinical care. However, there are a number of challenges to validating organizational measures, including inferential bias arising from the halo effect and method bias - two threats to validity that, while well-documented by organizational scholars, are often ignored in health services research. We describe a protocol to comprehensively assess the psychometric properties of a previously developed survey, the Organizational Readiness to Change Assessment. Objectives Our objective is to conduct a comprehensive assessment of the psychometric properties of the Organizational Readiness to Change Assessment incorporating methods specifically to address threats from halo effect and method bias. Methods and Design We will conduct three sets of analyses using longitudinal, secondary data from four partner projects, each testing interventions to improve the implementation of an evidence-based clinical practice. Partner projects field the Organizational Readiness to Change Assessment at baseline (n = 208 respondents; 53 facilities, and prospectively assesses the degree to which the evidence-based practice is implemented. We will conduct predictive and concurrent validities using hierarchical linear modeling and multivariate regression, respectively. For predictive validity, the outcome is the change from baseline to follow-up in the use of the evidence-based practice. We will use intra-class correlations derived from hierarchical linear models to assess inter-rater reliability. Two partner projects will also field measures of job satisfaction for convergent and discriminant validity analyses, and will field Organizational Readiness to Change Assessment measures at follow-up for concurrent validity (n = 158 respondents; 33 facilities. Convergent and discriminant validities will test associations between organizational readiness and

Erratum: Development, appraisal, validation and implementation of a consensus protocol for the assessment of cerebral amyloid angiopathy in post-mortem brain tissue.

Science.gov (United States)

Love, Seth; Chalmers, Katy; Ince, Paul; Esiri, Margaret; Attems, Johannes; Kalaria, Raj; Jellinger, Kurt; Yamada, Masahito; McCarron, Mark; Minett, Thais; Matthews, Fiona; Greenberg, Steven; Mann, David; Kehoe, Patrick Gavin

2015-01-01

In a collaboration involving 11 groups with research interests in cerebral amyloid angiopathy (CAA), we used a two-stage process to develop and in turn validate a new consensus protocol and scoring scheme for the assessment of CAA and associated vasculopathic abnormalities in post-mortem brain tissue. Stage one used an iterative Delphi-style survey to develop the consensus protocol. The resultant scoring scheme was tested on a series of digital images and paraffin sections that were circulated blind to a number of scorers. The scoring scheme and choice of staining methods were refined by open-forum discussion. The agreed protocol scored parenchymal and meningeal CAA on a 0-3 scale, capillary CAA as present/absent and vasculopathy on 0-2 scale, in the 4 cortical lobes that were scored separately. A further assessment involving three centres was then undertaken. Neuropathologists in three centres (Bristol, Oxford and Sheffield) independently scored sections from 75 cases (25 from each centre) and high inter-rater reliability was demonstrated. Stage two used the results of the three-centre assessment to validate the protocol by investigating previously described associations between APOE genotype (previously determined), and both CAA and vasculopathy. Association of capillary CAA with or without arteriolar CAA with APOE ε4 was confirmed. However APOE ε2 was also found to be a strong risk factor for the development of CAA, not only in AD but also in elderly non-demented controls. Further validation of this protocol and scoring scheme is encouraged, to aid its wider adoption to facilitate collaborative and replication studies of CAA.[This corrects the article on p. 19 in vol. 3, PMID: 24754000.].

Puzzle test: A tool for non-analytical clinical reasoning assessment.

Science.gov (United States)

Monajemi, Alireza; Yaghmaei, Minoo

2016-01-01

Most contemporary clinical reasoning tests typically assess non-automatic thinking. Therefore, a test is needed to measure automatic reasoning or pattern recognition, which has been largely neglected in clinical reasoning tests. The Puzzle Test (PT) is dedicated to assess automatic clinical reasoning in routine situations. This test has been introduced first in 2009 by Monajemi et al in the Olympiad for Medical Sciences Students.PT is an item format that has gained acceptance in medical education, but no detailed guidelines exist for this test's format, construction and scoring. In this article, a format is described and the steps to prepare and administer valid and reliable PTs are presented. PT examines a specific clinical reasoning task: Pattern recognition. PT does not replace other clinical reasoning assessment tools. However, it complements them in strategies for assessing comprehensive clinical reasoning.

Definition of a VR-based protocol to treat social phobia.

Science.gov (United States)

Roy, S; Klinger, E; Légeron, P; Lauer, F; Chemin, I; Nugues, P

2003-08-01

Social phobia is an anxiety disorder that is accessible to two forms of treatment yielding scientifically validated results: drugs and cognitive-behavioral therapies. Graded exposure to feared social situations is fundamental to obtain an improvement of the anxious symptoms. Traditionally, exposure therapies are done either in vivo or by imagining the situations. In vivo exposure is sometimes difficult to control and many patients have some difficulties in using imagination. Virtual reality (VR) seems to bring significant advantages. It allows exposures to numerous and varied situations. This paper reports the definition of a clinical protocol whose purpose is to assess the efficiency of a VR therapy compared to a CBT and to the absence of treatment for social phobic patients. It explains the illness' diagnosis and its usual treatments. It exposes all the architecture of the study, the assessment tools, the content and unfold of the therapy sessions. It finally reports first results of a clinical trial in a between-group design in 10 patients suffering from social phobia. The virtual environments used in the treatment reproduce four situations that social phobics feel the most threatening: performance, intimacy, scrutiny and assertiveness. With the help of the therapist, the patient learns adapted cognitions and behaviors with the aim of reducing her or his anxiety in the corresponding real situations. The novelty of our work is to address a group of situations that the phobic patient is most likely to experience and to treat patients according to a precise protocol.

Setting pass scores for clinical skills assessment.

Science.gov (United States)

Liu, Min; Liu, Keh-Min

2008-12-01

In a clinical skills assessment, the decision to pass or fail an examinee should be based on the test content or on the examinees' performance. The process of deciding a pass score is known as setting a standard of the examination. This requires a properly selected panel of expert judges and a suitable standard setting method, which best fits the purpose of the examination. Six standard setting methods that are often used in clinical skills assessment are described to provide an overview of the standard setting process.

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

Auditing the use and assessing the clinical utility of microscopy as a point-of-care test for Neisseria gonorrhoeae in a Sexual Health clinic.

Science.gov (United States)

Mensforth, Sarah; Thorley, Nicola; Radcliffe, Keith

2018-02-01

We assessed whether urethral microscopy was performed as per clinic protocol for male clinic attendees reporting contact with Neisseria gonorrhoeae (GC), urethral symptoms or given a diagnosis of epididymo-orchitis (EO) over a 12-month period (9732 patients). Prevalence of gonorrhoea in the contacts, urethral symptoms and EO groups was 50, 12.7 and 1.6%, respectively. Microscopy was performed reliably for contacts (96%), those with discharge/dysuria with evidence of urethritis on examination (98%), but not those with EO (43%). We explored the clinical utility of microscopy as a point-of-care test for identifying urethral GC in each subgroup, using the APTIMA Combo 2 CT/GC nucleic acid amplification test as the comparator (1710 patients). Sensitivity of microscopy for each subgroup was good; there was no statistical difference between subgroup sensitivity using Fisher's exact test. Microscopy is valuable to ensure prompt diagnosis and contact tracing. All GC contacts were treated 'epidemiologically'; however, half of GC contacts did not have GC. Microscopy identified the majority of GC cases, including amongst contacts (71% of heterosexual contacts, 66% of contacts reporting sex with men). We propose that epidemiological treatment for GC contacts should be reconsidered on the grounds of antibiotic stewardship, favouring use of microscopy to guide treatment decisions.

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

Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project.

Science.gov (United States)

Levitan, Bennett; Getz, Kenneth; Eisenstein, Eric L; Goldberg, Michelle; Harker, Matthew; Hesterlee, Sharon; Patrick-Lake, Bray; Roberts, Jamie N; DiMasi, Joseph

2018-03-01

While patient groups, regulators, and sponsors are increasingly considering engaging with patients in the design and conduct of clinical development programs, sponsors are often reluctant to go beyond pilot programs because of uncertainty in the return on investment. We developed an approach to estimate the financial value of patient engagement. Expected net present value (ENPV) is a common technique that integrates the key business drivers of cost, time, revenue, and risk into a summary metric for project strategy and portfolio decisions. We assessed the impact of patient engagement on ENPV for a typical oncology development program entering phase 2 or phase 3. For a pre-phase 2 project, the cumulative impact of a patient engagement activity that avoids one protocol amendment and improves enrollment, adherence, and retention is an increase in net present value (NPV) of $62MM ($65MM for pre-phase 3) and an increase in ENPV of $35MM ($75MM for pre-phase 3). Compared with an investment of $100,000 in patient engagement, the NPV and ENPV increases can exceed 500-fold the investment. This ENPV increase is the equivalent of accelerating a pre-phase 2 product launch by 2½ years (1½ years for pre-phase 3). Risk-adjusted financial models can assess the impact of patient engagement. A combination of empirical data and subjective parameter estimates shows that engagement activities with the potential to avoid protocol amendments and/or improve enrollment, adherence, and retention may add considerable financial value. This approach can help sponsors assess patient engagement investment decisions.

Conceptual Models and Guidelines for Clinical Assessment of Financial Capacity.

Science.gov (United States)

Marson, Daniel

2016-09-01

The ability to manage financial affairs is a life skill of critical importance, and neuropsychologists are increasingly asked to assess financial capacity across a variety of settings. Sound clinical assessment of financial capacity requires knowledge and appreciation of applicable clinical conceptual models and principles. However, the literature has presented relatively little conceptual guidance for clinicians concerning financial capacity and its assessment. This article seeks to address this gap. The article presents six clinical models of financial capacity : (1) the early gerontological IADL model of Lawton, (2) the clinical skills model and (3) related cognitive psychological model developed by Marson and colleagues, (4) a financial decision-making model adapting earlier decisional capacity work of Appelbaum and Grisso, (5) a person-centered model of financial decision-making developed by Lichtenberg and colleagues, and (6) a recent model of financial capacity in the real world developed through the Institute of Medicine. Accompanying presentation of the models is discussion of conceptual and practical perspectives they represent for clinician assessment. Based on the models, the article concludes by presenting a series of conceptually oriented guidelines for clinical assessment of financial capacity. In summary, sound assessment of financial capacity requires knowledge and appreciation of clinical conceptual models and principles. Awareness of such models, principles and guidelines will strengthen and advance clinical assessment of financial capacity. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Pilot study: Assessing the effect of continual position monitoring technology on compliance with patient turning protocols

OpenAIRE

Schutt, Suann Cirigliano; Tarver, Christine; Pezzani, Michelle

2017-01-01

Abstract Aim The study aim was to evaluate if continual patient position monitoring, taking into account self‐turns and clinician‐assisted turns, would increase the percentage of time a patient's position changed at least every 2 hr. Background While patient turning has clinical benefits, current models to help staff remember to turn patients, such as “turn clocks” and timers, have not resulted in high compliance with turning protocols. In addition, reminders are based on arbitrary 2‐hr windo...

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

Setting Pass Scores for Clinical Skills Assessment

Directory of Open Access Journals (Sweden)

Min Liu

2008-12-01

Full Text Available In a clinical skills assessment, the decision to pass or fail an examinee should be based on the test content or on the examinees' performance. The process of deciding a pass score is known as setting a standard of the examination. This requires a properly selected panel of expert judges and a suitable standard setting method, which best fits the purpose of the examination. Six standard setting methods that are often used in clinical skills assessment are described to provide an overview of the standard setting process.

Accuracy assessment of and 111In quantification protocol using Monte Carlo simulated patients

International Nuclear Information System (INIS)

Castillo Lopez, J.; Coca, M. A.; Torres, L. A.; Gomez Facenda, A.

2013-01-01

The analyzed protocol showed a tendency to overestimate activity, revealed in the mean difference of -0.3MBq. Still, determined activity was never separated more than 10% from simulated one. Differences between calculated and simulated activity followed a Lorentzian distribution with a correlation coefficient of 0.99. The graphical interface exhibited an average difference of 0.001MBq with a standard deviation of 0.5MBq in relation to reference software. It was implemented and evaluated a methodology to perform quantitative calculations of 1 11In activity using whole body studies. Its application with a proposed graphical interface was also assessed. (Author)

Clinical Considerations in the Assessment of Adolescent Chemical Dependency.

Science.gov (United States)

Winters, Ken

1990-01-01

Discusses relevant research findings of clinical assessment of adolescent chemical dependency so that service providers can better address these concerns. Three major issues are discussed: the definition of adolescent chemical dependency, clinical domains of assessment (chemical use problem severity, precipitating and perpetuating risk factors,…

A stepwise protocol for drug permeation assessment that combines heat-separated porcine ear epidermis and vertical diffusion cells

Directory of Open Access Journals (Sweden)

Pantelić Ivana

2018-01-01

Full Text Available After decades long absence of an official consensus on the most appropriate evaluation method for in vitro skin performance of topical semisolid drugs, United States Pharmacopoeia (USP 39 finally suggested three types of testing equipment; however, all these provide data on drug release using inert synthetic membranes. Considering the need for a readily available membrane that would be more structurally similar to human skin, this paper provides a detailed protocol of a method for drug permeation assessment that uses heat-separated porcine ear epidermis and modified Franz diffusion cells. Phases that were shown to be critical for variability of the results are identified (e.g., membrane preparation, and process parameters optimized. Applicability of the method was tested on four cream samples loaded with aceclofenac as a model drug. Sample compositions were designed in such a way to provide „large“ variations (variation of the main stabilizer: natural-origin versus synthetic emulsifier and relatively „minor“ variations (co-solvent variation: none/isopropanol/glycerol. The developed protocol is a straightforward and reliable in vitro test for the evaluation of rate and extent of drug delivery into/through the skin. Moreover, this protocol may be routinely applied even in averagely equipped laboratories during formulation development or preliminary bioequivalence assessment of generic topical semisolids. [Project of the Serbian Ministry of Education, Science and Technological Development, Grant no. TR34031

A novel staining protocol for multiparameter assessment of cell heterogeneity in Phormidium populations (cyanobacteria employing fluorescent dyes.

Directory of Open Access Journals (Sweden)

Daria Tashyreva

Full Text Available Bacterial populations display high heterogeneity in viability and physiological activity at the single-cell level, especially under stressful conditions. We demonstrate a novel staining protocol for multiparameter assessment of individual cells in physiologically heterogeneous populations of cyanobacteria. The protocol employs fluorescent probes, i.e., redox dye 5-cyano-2,3-ditolyl tetrazolium chloride, 'dead cell' nucleic acid stain SYTOX Green, and DNA-specific fluorochrome 4',6-diamidino-2-phenylindole, combined with microscopy image analysis. Our method allows simultaneous estimates of cellular respiration activity, membrane and nucleoid integrity, and allows the detection of photosynthetic pigments fluorescence along with morphological observations. The staining protocol has been adjusted for, both, laboratory and natural populations of the genus Phormidium (Oscillatoriales, and tested on 4 field-collected samples and 12 laboratory strains of cyanobacteria. Based on the mentioned cellular functions we suggest classification of cells in cyanobacterial populations into four categories: (i active and intact; (ii injured but active; (iii metabolically inactive but intact; (iv inactive and injured, or dead.

A clinical assessment tool used for physiotherapy students--is it reliable?

Science.gov (United States)

Lewis, Lucy K; Stiller, Kathy; Hardy, Frances

2008-01-01

Educational institutions providing professional programs such as physiotherapy must provide high-quality student assessment procedures. To ensure that assessment is consistent, assessment tools should have an acceptable level of reliability. There is a paucity of research evaluating the reliability of clinical assessment tools used for physiotherapy students. This study evaluated the inter- and intrarater reliability of an assessment tool used for physiotherapy students during a clinical placement. Five clinical educators and one academic participated in the study. Each rater independently marked 22 student written assessments that had been completed by students after viewing a videotaped patient physiotherapy assessment. The raters repeated the marking process 7 weeks later, with the assessments provided in a randomised order. The interrater reliability (Intraclass Correlation Coefficient) for the total scores was 0.32, representing a poor level of reliability. A high level of intrarater reliability (percentage agreement) was found for the clinical educators, with a difference in section scores of one mark or less on 93.4% of occasions. Further research should be undertaken to reevaluate the reliability of this clinical assessment tool following training. The reliability of clinical assessment tools used in other areas of physiotherapy education should be formally measured rather than assumed.

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.

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

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.

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…

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.

Validation of the Preverbal Visual Assessment (PreViAs) questionnaire.

Science.gov (United States)

García-Ormaechea, Inés; González, Inmaculada; Duplá, María; Andres, Eva; Pueyo, Victoria

2014-10-01

Visual cognitive integrative functions need to be evaluated by a behavioral assessment, which requires an experienced evaluator. The Preverbal Visual Assessment (PreViAs) questionnaire was designed to evaluate these functions, both in general pediatric population or in children with high risk of visual cognitive problems, through primary caregivers' answers. We aimed to validate the PreViAs questionnaire by comparing caregiver reports with results from a comprehensive clinical protocol. A total of 220 infants (visual development, as determined by the clinical protocol. Their primary caregivers completed the PreViAs questionnaire, which consists of 30 questions related to one or more visual domains: visual attention, visual communication, visual-motor coordination, and visual processing. Questionnaire answers were compared with results of behavioral assessments performed by three pediatric ophthalmologists. Results of the clinical protocol classified 128 infants as having normal visual maturation, and 92 as having abnormal visual maturation. The specificity of PreViAs questionnaire was >80%, and sensitivity was 64%-79%. More than 80% of the infants were correctly classified, and test-retest reliability exceeded 0.9 for all domains. The PreViAs questionnaire is useful to detect abnormal visual maturation in infants from birth to 24months of age. It improves the anamnesis process in infants at risk of visual dysfunctions. Copyright © 2014. Published by Elsevier Ireland Ltd.

The utility of fecal corticosterone metabolites and animal welfare assessment protocols as predictive parameters of tumor development and animal welfare in a murine xenograft model

DEFF Research Database (Denmark)

Jacobsen, Kirsten Rosenmaj; Jørgensen, Pernille Schønning; Pipper, Christian Bressen

2013-01-01

consumption, and an animal welfare assessment (AWA) protocol revealed marked differences between control and cancer lines as the size of the tumor increased. However, only the AWA protocol was effective in predicting the tumor size and the level of fecal corticosterone metabolites (FCM). FCM levels were...

A systematic review of assessment and intervention strategies for effective clinical communication in culturally and linguistically diverse students.

Science.gov (United States)

Chan, Annie; Purcell, Alison; Power, Emma

2016-09-01

Culturally and linguistically diverse (CALD) students often experience difficulties with the clinical communication skills that are essential for successful interactions in the workplace. However, there is little evidence on the effectiveness of assessment and intervention strategies for this population. The two aims of this study were: to evaluate the effectiveness of assessment tools in identifying and describing the clinical communication difficulties of CALD health care students; and to determine whether communication programmes improved their clinical communication skills. Systematic review based on the Cochrane protocol. Articles were identified through a search of established databases using MeSH and key search terms. Studies published in English from 1990 to March 2015 were included if they described assessment strategies or a training programme for communication skills of CALD students. Studies were excluded if they did not describe implementation of a specific assessment or intervention programme. Data were extracted independently by the first author and verified by the second author. Quality was measured by the Best Evidence Medical Education guide and the Educational Interventions Critical Appraisal Tool. The Kirkpatrick hierarchy was used to measure impact. Meta-analysis was not conducted because of the heterogeneity of programme design and outcome measures. One hundred and twenty-nine articles met the criteria for full text review. Eighty-six articles were excluded. Thirteen articles addressing assessment and 30 articles reporting on communication training programmes were included in this review. Assessment tools used rubrics and rating scales effectively. Intervention studies focused on speech and language skills (n = 20), interpersonal skills (n = 7) and faculty-level support (n = 5). Although 17 studies reported positive findings on student satisfaction, only eight reported improved skills post-training. The development of effective

The challenge of objective scar colour assessment in a clinical setting: using digital photography.

Science.gov (United States)

Anderson, J C; Hallam, M-J; Nduka, C; Osorio, D

2015-08-01

Scar assessment in the clinical setting is typically impeded by a lack of quantitative data and most systems rely on subjective rating scales which are user dependant and show considerable variability between raters. The growing use of digital photography in medicine suggests a more objective approach to scar evaluation. Our objective was to determine if cameras could be of practical use for measuring colour in a clinical setting. The measurement of colour and reflectance spectra in photographs faces two difficulties: firstly the effects of variable illumination spectra, and secondly to recover accurate colour and spectral information from the sparse red, green and blue (RGB) camera signals. As a result the colour rendition is often inaccurate, and spectral information is lost. To deal with variable illumination and other factors that systematically affect all reflectance spectra ColourWorker (a method for image-based colour measurement implemented in software) calibrates the spectral responses of the camera's RGB sensors using a colour standard in the image. To make best use of the calibrated signals, it takes advantage of the fact that although a given RGB signal can be caused by an infinite number of spectra, most natural reflectance spectra vary smoothly and have predictable forms. This means given a set of examples of spectra produced by the materials of interest, it is possible to estimate the specific spectrum that produced a given RGB signal once corrected for the illumination. We describe a method for recovering spectral and chromatic information relating to surface reflectance from ordinary digital images and apply this to analyse photographs of surgical scars, taken as part of a clinical trial, in an attempt to better quantify clinical scar assessment. It should be noted the pre-existing trial protocol did not allow for a comprehensive evaluation of the accuracy of the method which would require the spectrophotometric measurement of skin regions

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

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

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)

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)

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.

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.

[New medical device hospital assessment: what kind of clinical data?].

Science.gov (United States)

Beaussier, H; Junot, H; Lancrenon, S; Faure, P

2012-01-01

Since 2003, the AP-HP medical devices committee (CODIMS) assess the therapeutic relevance of innovated medical device (MD) for the French AP-HP hospitals' group. To accomplish this task, the CODIMS asks manufacturers to bring out clinical arguments to justify the use of their MD in hospital. This work analyses retrospectively after 8years, all assessed MD until March 2011 and the scientific quality of the clinical data submitted by manufacturers to the CODIMS to purchase their MD. All MD were classed according to their certification's level (I, IIa, IIb, III, DMIA). The quality of available clinical studies (CS) provided by manufacturers for each case was assessed and classed according to five clinical relevance levels based on the evidence-based medecine standards (1-2: high methodology; 3-5: low methodology). One hundred and three MD files (80 % of class IIb and III MD) were analysed by the CODIMS (630CS). Our results highlight the lack of relevance of files that are provided to assess innovated MD: 29 files without any CS; concerning class IIb (32DMS, 221CS) and III (50, 342CS) MD, only 6 % of CS presented a correct clinical relevance level. And the situation did not get better during this assessment period. The CODIMS deplore the poor clinical relevance of files provided to assess MD (wrong comparator, inappropriate ends-points, insufficient follow-up to assess long-term security, small population studied). Future legislative developments for MD assessment are expected to improve this situation. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Interobserver reliability of the 'Welfare Quality(®) Animal Welfare Assessment Protocol for Growing Pigs'.

Science.gov (United States)

Czycholl, I; Kniese, C; Büttner, K; Beilage, E Grosse; Schrader, L; Krieter, J

2016-01-01

The present paper focuses on evaluating the interobserver reliability of the 'Welfare Quality(®) Animal Welfare Assessment Protocol for Growing Pigs'. The protocol for growing pigs mainly consists of a Qualitative Behaviour Assessment (QBA), direct behaviour observations (BO) carried out by instantaneous scan sampling and checks for different individual parameters (IP), e.g. presence of tail biting, wounds and bursitis. Three trained observers collected the data by performing 29 combined assessments, which were done at the same time and on the same animals; but they were carried out completely independent of each other. The findings were compared by the calculation of Spearman Rank Correlation Coefficients (RS), Intraclass Correlation Coefficients (ICC), Smallest Detectable Changes (SDC) and Limits of Agreements (LoA). There was no agreement found concerning the adjectives belonging to the QBA (e.g. active: RS: 0.50, ICC: 0.30, SDC: 0.38, LoA: -0.05 to 0.45; fearful: RS: 0.06, ICC: 0.0, SDC: 0.26, LoA: -0.20 to 0.30). In contrast, the BO showed good agreement (e.g. social behaviour: RS: 0.45, ICC: 0.50, SDC: 0.09, LoA: -0.09 to 0.03 use of enrichment material: RS: 0.75, ICC: 0.68, SDC: 0.06, LoA: -0.03 to 0.03). Overall, observers agreed well in the IP, e.g. tail biting (RS: 0.52, ICC: 0.88; SDC: 0.05, LoA: -0.01 to 0.02) and wounds (RS: 0.43, ICC: 0.59, SDC: 0.10, LoA: -0.09 to 0.10). The parameter bursitis showed great differences (RS: 0.10, ICC: 0.0, SDC: 0.35, LoA: -0.37 to 0.40), which can be explained by difficulties in the assessment when the animals moved around quickly or their legs were soiled. In conclusion, the interobserver reliability was good in the BO and most IP, but not for the parameter bursitis and the QBA.

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

Student´s self-assessment of clinical competence and objective clinical performance in OSCE evaluation

OpenAIRE

Jünger, J; Schellberg, D; Nikendei, C

2006-01-01

[english] Overestimating one's clinical competence can be dangerous to patient's safety. Therefore the goal of this study was to identify students with high confidence in their own clinical competence but low performance in objective assessment. 171 students in the 14 week course in internal medicine completed the clinical skills-related self-assessment expectations (SE) and were tested in a 12 station OSCE. Both measures were obtained within three days. In total we identified 16% of students...

Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease

Science.gov (United States)

Cameron, Daniel J; Johnson, Lorraine B; Maloney, Elizabeth L

2014-01-01

Evidence-based guidelines for the management of patients with Lyme disease were developed by the International Lyme and Associated Diseases Society (ILADS). The guidelines address three clinical questions – the usefulness of antibiotic prophylaxis for known tick bites, the effectiveness of erythema migrans treatment and the role of antibiotic retreatment in patients with persistent manifestations of Lyme disease. Healthcare providers who evaluate and manage patients with Lyme disease are the intended users of the new ILADS guidelines, which replace those issued in 2004 (Exp Rev Anti-infect Ther 2004;2:S1–13). These clinical practice guidelines are intended to assist clinicians by presenting evidence-based treatment recommendations, which follow the Grading of Recommendations Assessment, Development and Evaluation system. ILADS guidelines are not intended to be the sole source of guidance in managing Lyme disease and they should not be viewed as a substitute for clinical judgment nor used to establish treatment protocols. PMID:25077519

Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease.

Science.gov (United States)

Cameron, Daniel J; Johnson, Lorraine B; Maloney, Elizabeth L

2014-09-01

Evidence-based guidelines for the management of patients with Lyme disease were developed by the International Lyme and Associated Diseases Society (ILADS). The guidelines address three clinical questions - the usefulness of antibiotic prophylaxis for known tick bites, the effectiveness of erythema migrans treatment and the role of antibiotic retreatment in patients with persistent manifestations of Lyme disease. Healthcare providers who evaluate and manage patients with Lyme disease are the intended users of the new ILADS guidelines, which replace those issued in 2004 (Exp Rev Anti-infect Ther 2004;2:S1-13). These clinical practice guidelines are intended to assist clinicians by presenting evidence-based treatment recommendations, which follow the Grading of Recommendations Assessment, Development and Evaluation system. ILADS guidelines are not intended to be the sole source of guidance in managing Lyme disease and they should not be viewed as a substitute for clinical judgment nor used to establish treatment protocols.

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

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

An Argument Approach to Observation Protocol Validity

Science.gov (United States)

Bell, Courtney A.; Gitomer, Drew H.; McCaffrey, Daniel F.; Hamre, Bridget K.; Pianta, Robert C.; Qi, Yi

2012-01-01

This article develops a validity argument approach for use on observation protocols currently used to assess teacher quality for high-stakes personnel and professional development decisions. After defining the teaching quality domain, we articulate an interpretive argument for observation protocols. To illustrate the types of evidence that might…

Challenging the foundations of the clinical model of foot function: further evidence that the root model assessments fail to appropriately classify foot function.

Science.gov (United States)

Jarvis, Hannah L; Nester, Christopher J; Bowden, Peter D; Jones, Richard K

2017-01-01

The Root model of normal and abnormal foot function remains the basis for clinical foot orthotic practice globally. Our aim was to investigate the relationship between foot deformities and kinematic compensations that are the foundations of the model. A convenience sample of 140 were screened and 100 symptom free participants aged 18-45 years were invited to participate. The static biomechanical assessment described by the Root model was used to identify five foot deformities. A 6 segment foot model was used to measure foot kinematics during gait. Statistical tests compared foot kinematics between feet with and without foot deformities and correlated the degree of deformity with any compensatory motions. None of the deformities proposed by the Root model were associated with distinct differences in foot kinematics during gait when compared to those without deformities or each other. Static and dynamic parameters were not correlated. Taken as part of a wider body of evidence, the results of this study have profound implications for clinical foot health practice. We believe that the assessment protocol advocated by the Root model is no longer a suitable basis for professional practice. We recommend that clinicians stop using sub-talar neutral position during clinical assessments and stop assessing the non-weight bearing range of ankle dorsiflexion, first ray position and forefoot alignments and movement as a means of defining the associated foot deformities. The results question the relevance of the Root assessments in the prescription of foot orthoses.

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.

A Comparison of ectoparasite infestation by chigger mite larvae (Acarina: Trombiculidae) on resident and migratory birds in Chiapas, Mexico illustrating a rapid visual assessment protocol

Science.gov (United States)

Thomas V. Dietsch

2005-01-01

This study presents a protocol developed to rapidly assess ectoparasite prevalence and intensity. Using this protocol during a mist-netting project in two different coffee agroecosystems in Chiapas, Mexico, data were collected on ectoparasitic chigger mite larvae (Acarina: Trombiculidae) found on resident and migratory birds. Surprisingly high infestation rates were...

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.

Health care access for rural youth on equal terms? A mixed methods study protocol in northern Sweden.

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Goicolea, Isabel; Carson, Dean; San Sebastian, Miguel; Christianson, Monica; Wiklund, Maria; Hurtig, Anna-Karin

2018-01-11

The purpose of this paper is to propose a protocol for researching the impact of rural youth health service strategies on health care access. There has been no published comprehensive assessment of the effectiveness of youth health strategies in rural areas, and there is no clearly articulated model of how such assessments might be conducted. The protocol described here aims to gather information to; i) Assess rural youth access to health care according to their needs, ii) Identify and understand the strategies developed in rural areas to promote youth access to health care, and iii) Propose actions for further improvement. The protocol is described with particular reference to research being undertaken in the four northernmost counties of Sweden, which contain a widely dispersed and diverse youth population. The protocol proposes qualitative and quantitative methodologies sequentially in four phases. First, to map youth access to health care according to their health care needs, including assessing horizontal equity (equal use of health care for equivalent health needs,) and vertical equity (people with greater health needs should receive more health care than those with lesser needs). Second, a multiple case study design investigates strategies developed across the region (youth clinics, internet applications, public health programs) to improve youth access to health care. Third, qualitative comparative analysis of the 24 rural municipalities in the region identifies the best combination of conditions leading to high youth access to health care. Fourth, a concept mapping study involving rural stakeholders, care providers and youth provides recommended actions to improve rural youth access to health care. The implementation of this research protocol will contribute to 1) generating knowledge that could contribute to strengthening rural youth access to health care, as well as to 2) advancing the application of mixed methods to explore access to health care.

Settleability assessment protocol for anaerobic granular sludge and ...

African Journals Online (AJOL)

The re revealed that the protocol was sufficiently sensitive to define the settleability of the sludge samples and to accurately determ their allowable upflow velocities, resultant organic loading rates, and recycling ratios according to the settleability of the gran bed. Also, a series of graphical procedures with settling tests which ...

Do pressure ulcer risk assessment scales improve clinical practice?

Directory of Open Access Journals (Sweden)

Jan Kottner

2010-07-01

Full Text Available Jan Kottner1, Katrin Balzer21Department of Nursing Science, Charité-Universitätsmedizin Berlin, Germany; 2Nursing Research Group, Institute for Social Medicine, Universitätsklinikum Schleswig-Holstein, Lübeck, GermanyAbstract: Standardized assessment instruments are deemed important for estimating pressure ulcer risk. Today, more than 40 so-called pressure ulcer risk assessment scales are available but still there is an ongoing debate about their usefulness. From a measurement point of view pressure ulcer (PU risk assessment scales have serious limitations. Empirical evidence supporting the validity of PU risk assessment scale scores is weak and obtained scores contain varying amounts of measurement error. The concept of pressure ulcer risk is strongly related to the general health status and severity of illness. A clinical impact due do the application of these scales could also not be demonstrated. It is questionable whether completion of standardized pressure ulcer risk scales in clinical practice is really needed.Keywords: Braden pressure ulcer, prevention, risk assessment, nursing assessment, predictive value, clinical effectiveness, review

Spontaneous swallow frequency compared with clinical screening in the identification of dysphagia in acute stroke.

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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.

An assessment of the economic and environmental implications for Canada of the Kyoto Protocol

International Nuclear Information System (INIS)

2000-11-01

The National Climate Change Process was launched in April 1998 to examine the feasibility and implications of Canada's commitment to the Kyoto Protocol. The Analysis Modelling Group (AMG) was designated to assess the economic and environmental consequences for Canada in achieving the target. This report summarizes the analytical approach, the assumptions, the results and the main findings of the AMG's efforts to analyse the macro-/micro-economic, social, health and environmental implications of the Kyoto Protocol. The role of the AMG was to provide policymakers with guidance on some issues such as the economic implications of different broad policy approaches, the potential costs of greater access to the Kyoto flexibility mechanisms, the sectoral and regional distributions of emissions reductions, and the degree to which Canada's competitive position could be affected by the achievement of the Protocol. The relative importance of greenhouse gas reduction was also discussed along with a review of actions that offer significant potential for emissions reductions. The AMG examined five policy packages or Paths which are differentiated by different degrees of reliance on specific measures and tradable permit systems and by the imposition of sectoral versus national targets. It was concluded that at the national level, attainment of the target results in sustained, long-term negative economic impacts. In the long run, the reduction in gross domestic product (GDP) relative to the business-as-usual case, ranges from 0 to 3 per cent depending on the path-scenario combination. It was emphasized that it is important to provide perspective on these estimates. 37 refs., 64 figs

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.)

Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED): protocol for a mixed methods feasibility study to assess the clinical utility of lower dose thyroxine in elderly hypothyroid patients: study protocol for a randomized controlled trial.

Science.gov (United States)

Wilkes, Scott; Pearce, Simon; Ryan, Vicky; Rapley, Tim; Ingoe, Lorna; Razvi, Salman

2013-03-22

The population of the UK is ageing. There is compelling evidence that thyroid stimulating hormone distribution levels increase with age. Currently, in UK clinical practice elderly hypothyroid patients are treated with levothyroxine to lower their thyroid stimulating hormone levels to a standard non-age-related range. Evidence suggests that mortality is negatively associated with thyroid stimulating hormone levels. We report the protocol of a feasibility study working towards a full-scale randomized controlled trial to test whether lower dose levothyroxine has beneficial cardiovascular outcomes in the oldest old. SORTED is a mixed methods study with three components: SORTED A: A feasibility study of a dual-center single-blinded randomized controlled trial of elderly hypothyroid patients currently treated with levothyroxine. Patients will be recruited from 20 general practices and two hospital trust endocrine units in Northumberland, Tyne and Wear. Target recruitment of 50 elderly hypothyroid patients currently treated with levothyroxine, identified in both primary and secondary care settings. Reduced dose of levothyroxine to achieve an elevated serum thyroid stimulating hormone (target range 4.1 to 8.0 mU/L) versus standard levothyroxine replacement (target range 0.4 to 4.0 mU/L). Using random permuted blocks, in a ratio of 1:1, randomization will be carried out by Newcastle Clinical Trials Unit. Study feasibility (recruitment and retention rates and medication compliance), acceptability of the trial design, assessment of mobility and falls risk, and change in cardiovascular risk factors. Qualitative study using in-depth interviews to understand patients' willingness to take part in a randomized controlled trial and participants' experience of the intervention. Retrospective cohort study of 400 treated hypothyroid patients aged 80 years or over registered in 2008 in primary care practices, studying their 4-year cardiovascular outcomes to inform the power of SORTED

Introduction of an accelerated diagnostic protocol in the assessment of emergency department patients with possible acute coronary syndrome: the Nambour Short Low-Intermediate Chest pain project.

Science.gov (United States)

George, Terry; Ashover, Sarah; Cullen, Louise; Larsen, Peter; Gibson, Jason; Bilesky, Jennifer; Coverdale, Steven; Parsonage, William

2013-08-01

Emergency physicians can feel pressured by opposing forces of clinical reality and the need to publish successful key performance indicators in an environment of increasing demands and cost containment. This is particularly relevant to management of patients with undifferentiated chest pain and possible acute coronary syndrome. Unreliability of clinical assessment and high risk of adverse outcomes for all concerned exist, yet national guidelines are at odds with efforts to reduce ED crowding and access block. We report findings from the Nambour Short Low-Intermediate Chest pain risk trial, which safely introduced an accelerated diagnostic protocol with reduced ED length of stay and high patient acceptability. Over a 7-month period, there were no major adverse cardiac events by 30 days in 19% of undifferentiated chest pain presentations with possible acute coronary syndrome discharged after normal sensitive cardiac troponin taken 2 h after presentation and scheduled to return for outpatient exercise stress test. © 2013 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

Walking adaptability after a stroke and its assessment in clinical settings.

Science.gov (United States)

Balasubramanian, Chitralakshmi K; Clark, David J; Fox, Emily J

2014-01-01

Control of walking has been described by a tripartite model consisting of stepping, equilibrium, and adaptability. This review focuses on walking adaptability, which is defined as the ability to modify walking to meet task goals and environmental demands. Walking adaptability is crucial to safe ambulation in the home and community environments and is often severely compromised after a stroke. Yet quantification of walking adaptability after stroke has received relatively little attention in the clinical setting. The objectives of this review were to examine the conceptual challenges for clinical measurement of walking adaptability and summarize the current state of clinical assessment for walking adaptability. We created nine domains of walking adaptability from dimensions of community mobility to address the conceptual challenges in measurement and reviewed performance-based clinical assessments of walking to determine if the assessments measure walking adaptability in these domains. Our literature review suggests the lack of a comprehensive well-tested clinical assessment tool for measuring walking adaptability. Accordingly, recommendations for the development of a comprehensive clinical assessment of walking adaptability after stroke have been presented. Such a clinical assessment will be essential for gauging recovery of walking adaptability with rehabilitation and for motivating novel strategies to enhance recovery of walking adaptability after stroke.

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.

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.

Beyond protocols

DEFF Research Database (Denmark)

Vanderhoeven, Sonia; Branquart, Etienne; Casaer, Jim

2017-01-01

Risk assessment tools for listing invasive alien species need to incorporate all available evidence and expertise. Beyond the wealth of protocols developed to date, we argue that the current way of performing risk analysis has several shortcomings. In particular, lack of data on ecological impact...... information on risk and the exploration of improved methods for decision making on biodiversity management. This is crucial for efficient conservation resource allocation and uptake by stakeholders and the public......., transparency and repeatability of assessments as well as the incorporation of uncertainty should all be explicitly considered. We recommend improved quality control of risk assessments through formalized peer review with clear feedback between assessors and reviewers. Alternatively, a consensus building...

ZOOM or Non-ZOOM? Assessing Spinal Cord Diffusion Tensor Imaging Protocols for Multi-Centre Studies.

Directory of Open Access Journals (Sweden)

Rebecca S Samson

Full Text Available The purpose of this study was to develop and evaluate two spinal cord (SC diffusion tensor imaging (DTI protocols, implemented at multiple sites (using scanners from two different manufacturers, one available on any clinical scanner, and one using more advanced options currently available in the research setting, and to use an automated processing method for unbiased quantification. DTI parameters are sensitive to changes in the diseased SC. However, imaging the cord can be technically challenging due to various factors including its small size, patient-related and physiological motion, and field inhomogeneities. Rapid acquisition sequences such as Echo Planar Imaging (EPI are desirable but may suffer from image distortions. We present a multi-centre comparison of two acquisition protocols implemented on scanners from two different vendors (Siemens and Philips, one using a reduced field-of-view (rFOV EPI sequence, and one only using options available on standard clinical scanners such as outer volume suppression (OVS. Automatic analysis was performed with the Spinal Cord Toolbox for unbiased and reproducible quantification of DTI metrics in the white matter. Images acquired using the rFOV sequence appear less distorted than those acquired using OVS alone. SC DTI parameter values obtained using both sequences at all sites were consistent with previous measurements made at 3T. For the same scanner manufacturer, DTI parameter inter-site SDs were smaller for the rFOV sequence compared to the OVS sequence. The higher inter-site reproducibility (for the same manufacturer and acquisition details, i.e. ZOOM data acquired at the two Philips sites of rFOV compared to the OVS sequence supports the idea that making research options such as rFOV more widely available would improve accuracy of measurements obtained in multi-centre clinical trials. Future multi-centre studies should also aim to match the rFOV technique and signal-to-noise ratios in all

Re-thinking clinical assessment: What can we learn from the medical literature?

International Nuclear Information System (INIS)

Yielder, Jill; Thompson, Andrea; De Bueger, Tracy

2012-01-01

This article explores the literature available in the field of medical education on the topic of clinical assessment, in order to suggest different ways of assessing clinical experience that may not have been considered within undergraduate radiography programmes. The medical literature is contrasted with the clinical assessment currently being used in a medical imaging programme in New Zealand, with the aim of offering suggestions that may benefit the assessment of the clinical and professional elements of radiography programmes more generally. The authors conclude that ideally students need to be assessed in the clinical domain by multiple assessors, with varied assessment methods used repeatedly over a period of time and with the provision of frequent and constructive feedback. Various methods of clinical assessment are suggested and it is emphasised that the methods selected need to be valid, reliable and psychometrically supported. This encourages an evidence-based practice approach that is supportive of on-going programme development and change.

Large observer variation of clinical assessment of dyspnoeic wheezing children.

Science.gov (United States)

Bekhof, Jolita; Reimink, Roelien; Bartels, Ine-Marije; Eggink, Hendriekje; Brand, Paul L P

2015-07-01

In children with acute dyspnoea, the assessment of severity of dyspnoea and response to treatment is often performed by different professionals, implying that knowledge of the interobserver variation of this clinical assessment is important. To determine intraobserver and interobserver variation in clinical assessment of children with dyspnoea. From September 2009 to September 2010, we recorded a convenience sample of 27 acutely wheezing children (aged 3 months-7 years) in the emergency department of a general teaching hospital in the Netherlands, on video before and after treatment with inhaled bronchodilators. These video recordings were independently assessed by nine observers scoring wheeze, prolonged expiratory phase, retractions, nasal flaring and a general assessment of dyspnoea on a Likert scale (0-10). Assessment was repeated after 2 weeks to evaluate intraobserver variation. We analysed 972 observations. Intraobserver reliability was the highest for supraclavicular retractions (κ 0.84) and moderate-to-substantial for other items (κ 0.49-0.65). Interobserver reliability was considerably worse, with κ3 points) was larger than the minimal important change (meaning that in 69% of observations a clinically important change after treatment cannot be distinguished from measurement error. Intraobserver variation is modest, and interobserver variation is large for most clinical findings in children with dyspnoea. The measurement error induced by this variation is too large to distinguish potentially clinically relevant changes in dyspnoea after treatment in two-thirds of observations. The poor interobserver reliability of clinical dyspnoea assessment in children limits its usefulness in clinical practice and research, and highlights the need to use more objective measurements in these patients. 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.

Assessment of acquired capability for suicide in clinical practice.

Science.gov (United States)

Rimkeviciene, Jurgita; Hawgood, Jacinta; O'Gorman, John; De Leo, Diego

2016-12-01

The Interpersonal Psychological Theory of suicide proposes that the interaction between Thwarted Belongingness, Perceived Burdensomeness, and Acquired Capability for Suicide (ACS) predicts proximal risk of death by suicide. Instruments to assess all three constructs are available. However, research on the validity of one of them, the acquired capability for suicide scale (ACSS), has been limited, especially in terms of its clinical relevance. This study aimed to explore the utility of the different versions of the ACSS in clinical assessment. Three versions of the scale were investigated, the full 20-item version, a 7-item version and a single item version representing self-perceived capability for suicide. In a sample of patients recruited from a clinic specialising in the treatment of suicidality and in a community sample, all versions of the ACSS were found to show reasonable levels of reliability and to correlate as expected with reports of suicidal ideation, self-harm, and attempted suicide. The item assessing self-perceived acquired capacity for suicide showed highest correlations with all levels of suicidal behaviour. However, no version of the ACSS on its own showed a capacity to indicate suicide attempts in the combined sample. It is concluded that the versions of the scale have construct validity, but their clinical utility is limited. An assessment using a single item on self-perceived ACS outperforms the full and shortened versions of ACSS in clinical settings and can be recommended with caution for clinicians interested in assessing this characteristic.

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 ...

Triangular model integrating clinical teaching and assessment.

Science.gov (United States)

Abdelaziz, Adel; Koshak, Emad

2014-01-01

Structuring clinical teaching is a challenge facing medical education curriculum designers. A variety of instructional methods on different domains of learning are indicated to accommodate different learning styles. Conventional methods of clinical teaching, like training in ambulatory care settings, are prone to the factor of coincidence in having varieties of patient presentations. Accordingly, alternative methods of instruction are indicated to compensate for the deficiencies of these conventional methods. This paper presents an initiative that can be used to design a checklist as a blueprint to guide appropriate selection and implementation of teaching/learning and assessment methods in each of the educational courses and modules based on educational objectives. Three categories of instructional methods were identified, and within each a variety of methods were included. These categories are classroom-type settings, health services-based settings, and community service-based settings. Such categories have framed our triangular model of clinical teaching and assessment.

Health Literacy Assessment in an Otolaryngology Clinic Population.

Science.gov (United States)

Megwalu, Uchechukwu C; Lee, Jennifer Y

2016-12-01

To assess health literacy in an adult tertiary care otolaryngology clinic population and to explore potential determinants of inadequate health literacy. Cross-sectional study. Tertiary care otolaryngology clinic. The study population included all adult patients treated at 3 of Stanford University's adult otolaryngology clinic sites between March 1 and 11, 2016. Data were collected via an anonymous questionnaire. Health literacy was assessed with the Brief Health Literacy Screen. Ten percent of patients had inadequate health literacy. White race (odds ratio [OR], 0.23) and having English as the primary language (OR, 0.12) were associated with adequate health literacy, while high school or lower level of education (OR, 3.2) was associated with inadequate health literacy. Age, sex, and Hispanic ethnicity were not associated with health literacy. Our study highlights the need for health literacy screening in the otolaryngology clinic setting and identifies sociodemographic risk factors for inadequate health literacy. Further studies are needed to assess the impact of health literacy on patient outcomes and to test specific interventions to address health literacy and health outcomes. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

Improved assessment of mediastinal and pulmonary pathologies in combined staging CT examinations using a fast-speed acquisition dual-source CT protocol

Energy Technology Data Exchange (ETDEWEB)

Braun, Franziska M.; Holzner, Veronica; Meinel, Felix G.; Armbruster, Marco; Brandlhuber, Martina; Ertl-Wagner, Birgit; Sommer, Wieland H. [University Hospital Munich, Institute for Clinical Radiology, Munich (Germany)

2017-12-15

To demonstrate the feasibility of fast Dual-Source CT (DSCT) and to evaluate the clinical utility in chest/abdomen/pelvis staging CT studies. 45 cancer patients with two follow-up combined chest/abdomen/pelvis staging CT examinations (maximally ±10 kV difference in tube potential) were included. The first scan had to be performed with our standard protocol (fixed pitch 0.6), the second one using a novel fast-speed DSCT protocol (fixed pitch 1.55). Effective doses (ED) were calculated, noise measurements performed. Scan times were compared, motion artefacts and the diagnostic confidence rated in consensus reading. ED for the standard and fast-speed scans was 9.1 (7.0-11.1) mSv and 9.2 (7.4-12.8) mSv, respectively (P = 0.075). Image noise was comparable (abdomen; all P > 0.05) or reduced for fast-speed CTs (trachea, P = 0.001; ascending aorta, P < 0.001). Motion artefacts of the heart/the ascending aorta (all P < 0.001) and breathing artefacts (P < 0.031) were reduced in fast DSCT. The diagnostic confidence for the evaluation of mediastinal (P < 0.001) and pulmonary (P = 0.008) pathologies was improved for fast DSCT. Fast DSCT for chest/abdomen/pelvis staging CT examinations is performed within 2 seconds scan time and eliminates relevant intrathoracic motion/breathing artefacts. Mediastinal/pulmonary pathologies can thus be assessed with high diagnostic confidence. Abdominal image quality remains excellent. (orig.)

Assessing Self-Regulation as a Cyclical, Context-Specific Phenomenon: Overview and Analysis of SRL Microanalytic Protocols

Directory of Open Access Journals (Sweden)

Timothy J. Cleary

2012-01-01

Full Text Available The primary purpose of this paper is to review relevant research related to the use of an assessment technique, called Self-Regulated Learning (SRL Microanalysis. This structured interview is grounded in social-cognitive theory and research and thus seeks to evaluate students' regulatory processes as they engage in well-defined academic or nonacademic tasks and activities. We illustrate the essential features of this contextualized assessment approach and detail a simple five-step process that researchers can use to apply this approach to their work. Example questions and administration procedures for five key self-regulation subprocesses (i.e., including goal-setting, strategic planning, monitoring, self-evaluation, and attributions are highlighted, with particular emphasis placed on causal attributions. The psychometric properties of SRL microanalytic assessment protocols and potential areas of future research are presented.

Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

Science.gov (United States)

Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

2016-01-01

Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.

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.

Assessment of neuromuscular function after different strength training protocols using tensiomyography.

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de Paula Simola, Rauno Á; Harms, Nico; Raeder, Christian; Kellmann, Michael; Meyer, Tim; Pfeiffer, Mark; Ferrauti, Alexander

2015-05-01

The purpose of the study was to analyze tensiomyography (TMG) sensitivity to changes in muscle force and neuromuscular function of the muscle rectus femoris (RF) using TMG muscle properties after 5 different lower-limb strength training protocols (multiple sets; DS = drop sets; eccentric overload; FW = flywheel; PL = plyometrics). After baseline measurements, 14 male strength trained athletes completed 1 squat training protocol per week over a 5-week period in a randomized controlled order. Maximal voluntary isometric contraction (MVIC), TMG measurements of maximal radial displacement of the muscle belly (Dm), contraction time between 10 and 90% of Dm (Tc), and mean muscle contraction velocities from the beginning until 10% (V10) and 90% of Dm (V90) were analyzed up to 0.5 (post-train), 24 (post-24), and 48 hours (post-48) after the training interventions. Significant analysis of variance main effects for measurement points were found for all TMG contractile properties and MVIC (p TMG muscle properties are sensitive to changes in muscle force, and different lower-limb strength training protocols lead to changes in neuromuscular function of RF. In addition, those protocols involving high and eccentric load and a high total time under tension may induce higher changes in TMG muscle properties.

Clinically assessed mediolateral knee motion: impact on gait

DEFF Research Database (Denmark)

Thorlund, Jonas Bloch; Creaby, Mark W; Simic, Milena

2011-01-01

Mediolateral knee movement can be assessed visually with clinical tests. A knee-medial-to-foot position is associated with an increased risk of knee injuries and pathologies. However, the implications of such findings on daily tasks are not well understood. The aim of this study was to investigat...... if a knee-medial-to-foot position assessed during a clinical test was associated with altered hip and knee joint kinematics and knee joint kinetics during gait compared with those with a knee-over-foot position....

Cognitive Assessment of Elderly Inpatients: A Clinical Audit

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Elizabeth Shermon

2015-01-01

Full Text Available Background: Comprehensive geriatric assessment including cognitive assessment results in better outcomes and quality of life through facilitating access to support and further care. The National Audit of Dementia Care revealed too few patients were being assessed for cognition and therefore failing to receive adequate care. Methods: This was a retrospective clinical audit in a district general hospital with systematic sampling of the clinical records of 50 inpatients on an elderly care ward. A descriptive analysis of the results was performed. Results: Despite guidance that cognitive assessment should be performed on admission, this was only documented in 22% of the medical notes. However, this rate improved to 56% by discharge. The most commonly used tool was the Abbreviated Mental Test (AMT 10. Assessment completion was independent of gender or social support, but only patients aged over 75 years were assessed. Of those, 75% had some level of cognitive impairment and 36.8% received a new or suspected diagnosis of dementia. Discussion: Cognitive assessment rates continue to be low. Our findings support the need for increased education regarding the importance and benefits of assessment as well as how to complete and document the assessment correctly. Conclusion: Cognitive assessment rates need to be further improved to promote better outcomes for patients with dementia.

Structured assessment of microsurgery skills in the clinical setting.

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Chan, WoanYi; Niranjan, Niri; Ramakrishnan, Venkat

2010-08-01

Microsurgery is an essential component in plastic surgery training. Competence has become an important issue in current surgical practice and training. The complexity of microsurgery requires detailed assessment and feedback on skills components. This article proposes a method of Structured Assessment of Microsurgery Skills (SAMS) in a clinical setting. Three types of assessment (i.e., modified Global Rating Score, errors list and summative rating) were incorporated to develop the SAMS method. Clinical anastomoses were recorded on videos using a digital microscope system and were rated by three consultants independently and in a blinded fashion. Fifteen clinical cases of microvascular anastomoses performed by trainees and a consultant microsurgeon were assessed using SAMS. The consultant had consistently the highest scores. Construct validity was also demonstrated by improvement of SAMS scores of microsurgery trainees. The overall inter-rater reliability was strong (alpha=0.78). The SAMS method provides both formative and summative assessment of microsurgery skills. It is demonstrated to be a valid, reliable and feasible assessment tool of operating room performance to provide systematic and comprehensive feedback as part of the learning cycle. Copyright 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

The Effectiveness of Nurse-Led Preoperative Assessment Clinics for Patients Receiving Elective Orthopaedic Surgery: A Systematic Review.

Science.gov (United States)

Sau-Man Conny, Chan; Wan-Yim, Ip

2016-12-01

Nurse-led preoperative assessment clinics (POAC) have been introduced in different specialty areas to assess and prepare patients preoperatively in order to avoid last-minute surgery cancellations. Not all patients are referred to POACs before surgery, and the benefits of nurse-led POACs are not well documented in Hong Kong. The purpose of this systemic review was to identify the best available research evidence to inform current clinical practice, guide health care decision making and promote better care. The Joanna Briggs Institute (JBI) approach for conducting systematic review of quantitative research was used. Data bases searched included all published and unpublished studies in Chinese and English. All studies with adult patients who required elective orthopaedic surgery e.g. total knee replacement, total hip replacement, reduction of fracture or reconstruction surgery etc. in a hospital or day surgery center and attended a nurse-led POAC before surgery were included. Ten studies were critically appraised. Results showed that nurse-led POACs can reduce surgery cancellation rates. These studies suggested a reduction in the rate of postoperative mortality and length of hospital stay. In addition, the level of satisfaction towards services provided was significantly high. Although POACs are being increasingly implemented worldwide, the development of clinical guidelines, pathways and protocols was advocated. The best available evidence asserted that nurses in the POAC could serve as effective coordinators, assessors and educators. The nurse-led practice optimized patients' condition before surgery and hence minimized elective surgery cancellations. Copyright © 2016 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.