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Sample records for standard clinical protocols

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

    Science.gov (United States)

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

    2015-12-01

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

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

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    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.

  3. 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.

  4. Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials

    NARCIS (Netherlands)

    B.M. Ellingson (Benjamin M.); M. Bendszus (Martin); J. Boxerman (Jerrold); D. Barboriak (Daniel); B.J. Erickson (Bradley J.); M. Smits (Marion); S.J. Nelson (Sarah J.); E. Gerstner (Elizabeth); B. Alexander (Brian); G. Goldmacher (Gregory); W. Wick (Wolfgang); M.A. Vogelbaum (Michael); M. Weller (Michael); E. Galanis (Evanthia); J. Kalpathy-Cramer (Jayashree); L. Shankar; P. Jacobs (Paula); W.B. Pope (Whitney B.); D. Yang (Dewen); C. Chung (Caroline); R.H. Knopp; S. Cha (Soonme); M.J. van den Bent (Martin); S.M. Chang (Susan); W.K. Al Yung; T.F. Cloughesy (Timothy F.); P.Y. Wen (Patrick Y.); M.R. Gilbert (Mark R.); A. Whitney (Andrew); D. Sandak (David); A. Musella (Al); C. Haynes (Chas); M. Wallace (Max); D.F. Arons (David F.); A. Kingston (Ann)

    2015-01-01

    textabstractA recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss

  5. 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.

  6. 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.

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

    Directory of Open Access Journals (Sweden)

    de Bie Rob A

    2010-06-01

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

  8. 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

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

    Directory of Open Access Journals (Sweden)

    V.I. Tkachenko

    2014-10-01

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

  10. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY PROTOCOL FOR STANDARDIZED PRODUCTION OF CLINICAL PRACTICE GUIDELINES, ALGORITHMS, AND CHECKLISTS - 2017 UPDATE.

    Science.gov (United States)

    Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Camacho, Pauline; Correa, Ricardo; Figaro, M Kathleen; Garber, Jeffrey R; Jasim, Sina; Pantalone, Kevin M; Trence, Dace; Upala, Sikarin

    2017-08-01

    Clinical practice guideline (CPG), clinical practice algorithm (CPA), and clinical checklist (CC, collectively CPGAC) development is a high priority of the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE). This 2017 update in CPG development consists of (1) a paradigm change wherein first, environmental scans identify important clinical issues and needs, second, CPA construction focuses on these clinical issues and needs, and third, CPG provide CPA node/edge-specific scientific substantiation and appended CC; (2) inclusion of new technical semantic and numerical descriptors for evidence types, subjective factors, and qualifiers; and (3) incorporation of patient-centered care components such as economics and transcultural adaptations, as well as implementation, validation, and evaluation strategies. This third point highlights the dominating factors of personal finances, governmental influences, and third-party payer dictates on CPGAC implementation, which ultimately impact CPGAC development. The AACE/ACE guidelines for the CPGAC program is a successful and ongoing iterative exercise to optimize endocrine care in a changing and challenging healthcare environment. AACE = American Association of Clinical Endocrinologists ACC = American College of Cardiology ACE = American College of Endocrinology ASeRT = ACE Scientific Referencing Team BEL = best evidence level CC = clinical checklist CPA = clinical practice algorithm CPG = clinical practice guideline CPGAC = clinical practice guideline, algorithm, and checklist EBM = evidence-based medicine EHR = electronic health record EL = evidence level G4GAC = Guidelines for Guidelines, Algorithms, and Checklists GAC = guidelines, algorithms, and checklists HCP = healthcare professional(s) POEMS = patient-oriented evidence that matters PRCT = prospective randomized controlled trial.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2014-10-15

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

  12. [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.

  13. Clinical trials of CCLSG L874 and I874 protocols without cranial irradiation for standard-risk acute lymphoblastic leukemia in childhood

    International Nuclear Information System (INIS)

    Koizumi, Shoichi; Fujimoto, Takeo; Tsurusawa, Masahito

    1992-01-01

    In the CCLSG-874 protocol for children with low-risk (LR) and intermediate-risk (IR) acute lymphoblastic leukemia (ALL), two regimens with or without cranial irradiation (CI) were compared with respect to their ability to prevent central nervous system (CNS) leukemia and to improve overall outcome of ALL. From 1987 to 1990, 82 and 109 evaluable patients were registered into L874 and I874 protocols for LR and IR patients, respectively. All responders to induction therapy were randomized to treatment with 18 Gy of CI plus intrathecal methotrexate (MTX it) or to treatment with high-dose MTX plus MTX it. Patients were then treated with standard maintenance regimens of L874 and I874. At a median follow-up of 39 months (range 14-58 months) there was no difference in the rate of hematologic relapse between the CI group and MTX group. The rate of CNS relapse in the MTX group seemed to be higher (3 of 39 in L874 and 2 of 54 in I874) than that in the CI group (1 of 43 in L874 and 0 of 55 in I874), but these data were not statistically significant. The rates of 4-year event-free survival (EFS) in L874 were 81.1±7.6% (mean±SE) and 75.2±7.9% (ns) for the CI and MTX group, respectively, and the rates of EFS in I874 were 70.0±13.6% and 70.0±9.0% (ns) for the CI and MTX group, respectively. These data suggest that MTX alone may be as effective as CI to prolong disease-free survival in LR and IR ALL although further continuous studies are needed. Analysis of serial CCLSG protocols for ALL from 1981 revealed that the rate of EFS of ALL allover including all risk groups has gradually been increasing from 44.2±3.6% for 811 protocol and 53.1±3.5% for 841 to 65.5±3.6% for the present 874 protocol. (author)

  14. Establishing treatment protocols for clinical mastitis.

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    Roberson, Jerry R

    2003-03-01

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

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

    DEFF Research Database (Denmark)

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

    2018-01-01

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

  16. The development of standard operating protocols for paediatric radiology

    International Nuclear Information System (INIS)

    Hardwick, J.; Mencik, C.; McLaren, C.; Young, C.; Scadden, S.; Mashford, P.; McHugh, K.; Beckett, M.; Calvert, M.; Marsden, P.J.

    2001-01-01

    This paper describes how the requirement for operating protocols for standard radiological practice was expanded to provide a comprehensive aide to the operator conducting a medical exposure. The protocols adopted now include justification criteria, patient preparation, radiographic technique, standard exposure charts, diagnostic reference levels and image quality criteria. In total, the protocols have been welcomed as a tool for ensuring that medical exposures are properly optimised. (author)

  17. From Expert Protocols to Standardized Management of Infectious Diseases.

    Science.gov (United States)

    Lagier, Jean-Christophe; Aubry, Camille; Delord, Marion; Michelet, Pierre; Tissot-Dupont, Hervé; Million, Matthieu; Brouqui, Philippe; Raoult, Didier; Parola, Philippe

    2017-08-15

    We report here 4 examples of management of infectious diseases (IDs) at the University Hospital Institute Méditerranée Infection in Marseille, France, to illustrate the value of expert protocols feeding standardized management of IDs. First, we describe our experience on Q fever and Tropheryma whipplei infection management based on in vitro data and clinical outcome. Second, we describe our management-based approach for the treatment of infective endocarditis, leading to a strong reduction of mortality rate. Third, we report our use of fecal microbiota transplantation to face severe Clostridium difficile infections and to perform decolonization of patients colonized by emerging highly resistant bacteria. Finally, we present the standardized management of the main acute infections in patients admitted in the emergency department, promoting antibiotics by oral route, checking compliance with the protocol, and avoiding the unnecessary use of intravenous and urinary tract catheters. Overall, the standardization of the management is the keystone to reduce both mortality and morbidity related to IDs. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

  18. Pelvic Muscle Rehabilitation: A Standardized Protocol for Pelvic Floor Dysfunction

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    Rodrigo Pedraza

    2014-01-01

    Full Text Available Introduction. Pelvic floor dysfunction syndromes present with voiding, sexual, and anorectal disturbances, which may be associated with one another, resulting in complex presentation. Thus, an integrated diagnosis and management approach may be required. Pelvic muscle rehabilitation (PMR is a noninvasive modality involving cognitive reeducation, modification, and retraining of the pelvic floor and associated musculature. We describe our standardized PMR protocol for the management of pelvic floor dysfunction syndromes. Pelvic Muscle Rehabilitation Program. The diagnostic assessment includes electromyography and manometry analyzed in 4 phases: (1 initial baseline phase; (2 rapid contraction phase; (3 tonic contraction and endurance phase; and (4 late baseline phase. This evaluation is performed at the onset of every session. PMR management consists of 6 possible therapeutic modalities, employed depending on the diagnostic evaluation: (1 down-training; (2 accessory muscle isolation; (3 discrimination training; (4 muscle strengthening; (5 endurance training; and (6 electrical stimulation. Eight to ten sessions are performed at one-week intervals with integration of home exercises and lifestyle modifications. Conclusions. The PMR protocol offers a standardized approach to diagnose and manage pelvic floor dysfunction syndromes with potential advantages over traditional biofeedback, involving additional interventions and a continuous pelvic floor assessment with management modifications over the clinical course.

  19. Comparison of test protocols for standard room/corner tests

    Science.gov (United States)

    R. H. White; M. A. Dietenberger; H. Tran; O. Grexa; L. Richardson; K. Sumathipala; M. Janssens

    1998-01-01

    As part of international efforts to evaluate alternative reaction-to-fire tests, several series of room/comer tests have been conducted. This paper reviews the overall results of related projects in which different test protocols for standard room/corner tests were used. Differences in the test protocols involved two options for the ignition burner scenario and whether...

  20. Standardized training in nurse model travel clinics.

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    Sofarelli, Theresa A; Ricks, Jane H; Anand, Rahul; Hale, Devon C

    2011-01-01

    International travel plays a significant role in the emergence and redistribution of major human diseases. The importance of travel medicine clinics for preventing morbidity and mortality has been increasingly appreciated, although few studies have thus far examined the management and staff training strategies that result in successful travel-clinic operations. Here, we describe an example of travel-clinic operation and management coordinated through the University of Utah School of Medicine, Division of Infectious Diseases. This program, which involves eight separate clinics distributed statewide, functions both to provide patient consult and care services, as well as medical provider training and continuing medical education (CME). Initial training, the use of standardized forms and protocols, routine chart reviews and monthly continuing education meetings are the distinguishing attributes of this program. An Infectious Disease team consisting of one medical doctor (MD) and a physician assistant (PA) act as consultants to travel nurses who comprise the majority of clinic staff. Eight clinics distributed throughout the state of Utah serve approximately 6,000 travelers a year. Pre-travel medical services are provided by 11 nurses, including 10 registered nurses (RNs) and 1 licensed practical nurse (LPN). This trained nursing staff receives continuing travel medical education and participate in the training of new providers. All nurses have completed a full training program and 7 of the 11 (64%) of clinic nursing staff serve more than 10 patients a week. Quality assurance measures show that approximately 0.5% of charts reviewed contain a vaccine or prescription error which require patient notification for correction. Using an initial training program, standardized patient intake forms, vaccine and prescription protocols, preprinted prescriptions, and regular CME, highly trained nurses at travel clinics are able to provide standardized pre-travel care to

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

    Science.gov (United States)

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

    2018-05-01

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

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

    Directory of Open Access Journals (Sweden)

    Roy Jean-Sébastien

    2011-01-01

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

  3. 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

  4. Clinical quality standards for radiotherapy

    Science.gov (United States)

    2012-01-01

    Aim of the study The technological progress that is currently being witnessed in the areas of diagnostic imaging, treatment planning systems and therapeutic equipment has caused radiotherapy to become a high-tech and interdisciplinary domain involving staff of various backgrounds. This allows steady improvement in therapy results, but at the same time makes the diagnostic, imaging and therapeutic processes more complex and complicated, requiring every stage of those processes to be planned, organized, controlled and improved so as to assure high quality of services provided. The aim of this paper is to present clinical quality standards for radiotherapy as developed by the author. Material and methods In order to develop the quality standards, a comparative analysis was performed between European and Polish legal acts adopted in the period of 1980-2006 and the universal industrial ISO 9001:2008 standard, defining requirements for quality management systems, and relevant articles published in 1984-2009 were reviewed, including applicable guidelines and recommendations of American, international, European and Polish bodies, such as the American Association of Physicists in Medicine (AAPM), the European Society for Radiotherapy & Oncology (ESTRO), the International Atomic Energy Agency (IAEA), and the Organisation of European Cancer Institutes (OECI) on quality assurance and management in radiotherapy. Results As a result, 352 quality standards for radiotherapy were developed and categorized into the following three groups: 1 – organizational standards; 2 – physico-technical standards and 3 – clinical standards. Conclusion Proposed clinical quality standards for radiotherapy can be used by any institution using ionizing radiation for medical purposes. However, standards are of value only if they are implemented, reviewed, audited and improved, and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:23788854

  5. Telemetry Standards, IRIG Standard 106-17, Chapter 22, Network Based Protocol Suite

    Science.gov (United States)

    2017-07-01

    requirements. 22.2 Network Access Layer 22.2.1 Physical Layer Connectors and cable media should meet the electrical or optical properties required by the...Telemetry Standards, IRIG Standard 106-17 Chapter 22, July 2017 i CHAPTER 22 Network -Based Protocol Suite Acronyms...iii Chapter 22. Network -Based Protocol Suite

  6. 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

  7. A Novel Process Audit for Standardized Perioperative Handoff Protocols.

    Science.gov (United States)

    Pallekonda, Vinay; Scholl, Adam T; McKelvey, George M; Amhaz, Hassan; Essa, Deanna; Narreddy, Spurthy; Tan, Jens; Templonuevo, Mark; Ramirez, Sasha; Petrovic, Michelle A

    2017-11-01

    A perioperative handoff protocol provides a standardized delivery of communication during a handoff that occurs from the operating room to the postanestheisa care unit or ICU. The protocol's success is dependent, in part, on its continued proper use over time. A novel process audit was developed to help ensure that a perioperative handoff protocol is used accurately and appropriately over time. The Audit Observation Form is used for the Audit Phase of the process audit, while the Audit Averages Form is used for the Data Analysis Phase. Employing minimal resources and using quantitative methods, the process audit provides the necessary means to evaluate the proper execution of any perioperative handoff protocol. Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.

  8. The Virtual Insect Brain protocol: creating and comparing standardized neuroanatomy

    Directory of Open Access Journals (Sweden)

    Schindelin Johannes E

    2006-12-01

    Full Text Available Abstract Background In the fly Drosophila melanogaster, new genetic, physiological, molecular and behavioral techniques for the functional analysis of the brain are rapidly accumulating. These diverse investigations on the function of the insect brain use gene expression patterns that can be visualized and provide the means for manipulating groups of neurons as a common ground. To take advantage of these patterns one needs to know their typical anatomy. Results This paper describes the Virtual Insect Brain (VIB protocol, a script suite for the quantitative assessment, comparison, and presentation of neuroanatomical data. It is based on the 3D-reconstruction and visualization software Amira, version 3.x (Mercury Inc. 1. Besides its backbone, a standardization procedure which aligns individual 3D images (series of virtual sections obtained by confocal microscopy to a common coordinate system and computes average intensities for each voxel (volume pixel the VIB protocol provides an elaborate data management system for data administration. The VIB protocol facilitates direct comparison of gene expression patterns and describes their interindividual variability. It provides volumetry of brain regions and helps to characterize the phenotypes of brain structure mutants. Using the VIB protocol does not require any programming skills since all operations are carried out at an intuitively usable graphical user interface. Although the VIB protocol has been developed for the standardization of Drosophila neuroanatomy, the program structure can be used for the standardization of other 3D structures as well. Conclusion Standardizing brains and gene expression patterns is a new approach to biological shape and its variability. The VIB protocol provides a first set of tools supporting this endeavor in Drosophila. The script suite is freely available at http://www.neurofly.de2

  9. The Virtual Insect Brain protocol: creating and comparing standardized neuroanatomy

    Science.gov (United States)

    Jenett, Arnim; Schindelin, Johannes E; Heisenberg, Martin

    2006-01-01

    Background In the fly Drosophila melanogaster, new genetic, physiological, molecular and behavioral techniques for the functional analysis of the brain are rapidly accumulating. These diverse investigations on the function of the insect brain use gene expression patterns that can be visualized and provide the means for manipulating groups of neurons as a common ground. To take advantage of these patterns one needs to know their typical anatomy. Results This paper describes the Virtual Insect Brain (VIB) protocol, a script suite for the quantitative assessment, comparison, and presentation of neuroanatomical data. It is based on the 3D-reconstruction and visualization software Amira, version 3.x (Mercury Inc.) [1]. Besides its backbone, a standardization procedure which aligns individual 3D images (series of virtual sections obtained by confocal microscopy) to a common coordinate system and computes average intensities for each voxel (volume pixel) the VIB protocol provides an elaborate data management system for data administration. The VIB protocol facilitates direct comparison of gene expression patterns and describes their interindividual variability. It provides volumetry of brain regions and helps to characterize the phenotypes of brain structure mutants. Using the VIB protocol does not require any programming skills since all operations are carried out at an intuitively usable graphical user interface. Although the VIB protocol has been developed for the standardization of Drosophila neuroanatomy, the program structure can be used for the standardization of other 3D structures as well. Conclusion Standardizing brains and gene expression patterns is a new approach to biological shape and its variability. The VIB protocol provides a first set of tools supporting this endeavor in Drosophila. The script suite is freely available at [2] PMID:17196102

  10. Biocoder: A programming language for standardizing and automating biology protocols.

    Science.gov (United States)

    Ananthanarayanan, Vaishnavi; Thies, William

    2010-11-08

    Published descriptions of biology protocols are often ambiguous and incomplete, making them difficult to replicate in other laboratories. However, there is increasing benefit to formalizing the descriptions of protocols, as laboratory automation systems (such as microfluidic chips) are becoming increasingly capable of executing them. Our goal in this paper is to improve both the reproducibility and automation of biology experiments by using a programming language to express the precise series of steps taken. We have developed BioCoder, a C++ library that enables biologists to express the exact steps needed to execute a protocol. In addition to being suitable for automation, BioCoder converts the code into a readable, English-language description for use by biologists. We have implemented over 65 protocols in BioCoder; the most complex of these was successfully executed by a biologist in the laboratory using BioCoder as the only reference. We argue that BioCoder exposes and resolves ambiguities in existing protocols, and could provide the software foundations for future automation platforms. BioCoder is freely available for download at http://research.microsoft.com/en-us/um/india/projects/biocoder/. BioCoder represents the first practical programming system for standardizing and automating biology protocols. Our vision is to change the way that experimental methods are communicated: rather than publishing a written account of the protocols used, researchers will simply publish the code. Our experience suggests that this practice is tractable and offers many benefits. We invite other researchers to leverage BioCoder to improve the precision and completeness of their protocols, and also to adapt and extend BioCoder to new domains.

  11. Comparison of 3- and 20-Gradient Direction Diffusion-Weighted Imaging in a Clinical Subacute Cohort of Patients with Transient Ischemic Attack: Application of Standard Vendor Protocols for Lesion Detection and Final Infarct Size Projection

    Directory of Open Access Journals (Sweden)

    Inger Havsteen

    2017-12-01

    Full Text Available ObjectiveDiffusion tensor imaging may aid brain ischemia assessment but is more time consuming than conventional diffusion-weighted imaging (DWI. We compared 3-gradient direction DWI (3DWI and 20-gradient direction DWI (20DWI standard vendor protocols in a hospital-based prospective cohort of patients with transient ischemic attack (TIA for lesion detection, lesion brightness, predictability of persisting infarction, and final infarct size.MethodsWe performed 3T-magnetic resonance imaging including diffusion and T2-fluid attenuated inversion recovery (FLAIR within 72 h and 8 weeks after ictus. Qualitative lesion brightness was assessed by visual inspection. We measured lesion area and brightness with manual regions of interest and compared with homologous normal tissue.Results117 patients with clinical TIA showed 78 DWI lesions. 2 lesions showed only on 3DWI. No lesions were uniquely 20DWI positive. 3DWI was visually brightest for 34 lesions. 12 lesions were brightest on 20DWI. The median 3DWI lesion area was larger for lesions equally bright, or brightest on 20DWI [median (IQR 39 (18–95 versus 18 (10–34 mm2, P = 0.007]. 3DWI showed highest measured relative lesion signal intensity [median (IQR 0.77 (0.48–1.17 versus 0.58 (0.34–0.81, P = 0.0006]. 3DWI relative lesion signal intensity was not correlated to absolute signal intensity, but 20DWI performed less well for low-contrast lesions. 3DWI lesion size was an independent predictor of persistent infarction. 3-gradient direction apparent diffusion coefficient areas were closest to 8-week FLAIR infarct size.Conclusion3DWI detected more lesions and had higher relative lesion SI than 20DWI. 20DWI appeared blurred and did not add information.Clinical Trial Registrationhttp://www.clinicaltrials.gov. Unique Identifier NCT01531946.

  12. Protocol Standards for Reporting Video Data in Academic Journals.

    Science.gov (United States)

    Rowland, Pamela A; Ignacio, Romeo C; de Moya, Marc A

    2016-04-01

    Editors of biomedical journals have estimated that a majority (40%-90%) of studies published in scientific journals cannot be replicated, even though an inherent principle of publication is that others should be able to replicate and build on published claims. Each journal sets its own protocols for establishing "quality" in articles, yet over the past 50 years, few journals in any field--especially medical education--have specified protocols for reporting the use of video data in research. The authors found that technical and industry-driven aspects of video recording, as well as a lack of standardization and reporting requirements by research journals, have led to major limitations in the ability to assess or reproduce video data used in research. Specific variables in the videotaping process (e.g., camera angle), which can be changed or be modified, affect the quality of recorded data, leading to major reporting errors and, in turn, unreliable conclusions. As more data are now in the form of digital videos, the historical lack of reporting standards makes it increasingly difficult to accurately replicate medical educational studies. Reproducibility is especially important as the medical education community considers setting national high-stakes standards in medicine and surgery based on video data. The authors of this Perspective provide basic protocol standards for investigators and journals using video data in research publications so as to allow for reproducibility.

  13. 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

  14. Industrial wireless sensor networks applications, protocols, and standards

    CERN Document Server

    Güngör, V Çagri

    2013-01-01

    The collaborative nature of industrial wireless sensor networks (IWSNs) brings several advantages over traditional wired industrial monitoring and control systems, including self-organization, rapid deployment, flexibility, and inherent intelligent processing. In this regard, IWSNs play a vital role in creating more reliable, efficient, and productive industrial systems, thus improving companies' competitiveness in the marketplace. Industrial Wireless Sensor Networks: Applications, Protocols, and Standards examines the current state of the art in industrial wireless sensor networks and outline

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

    International Nuclear Information System (INIS)

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

    2010-01-01

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

  16. 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

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

    Science.gov (United States)

    Salimi, Negar; Jolanta, Aleksejūnienė; Edwin, Yen; Angelina, Loo

    2018-01-01

    To develop a standardized all-encompassing protocol for the assessment of cleft lip and palate patients with clinical and research implications. Electronic database searches were conducted and 13 major cleft centers worldwide were contacted in order to prepare for the development of the protocol. In preparation, the available evidence was reviewed and potential fistula-related risk determinants from 4 different domains were identified. No standardized protocol for the assessment of cleft patients could be found in any of the electronic database searches that were conducted. Interviews with representatives from several major centers revealed that the majority of centers do not have a standardized comprehensive strategy for the reporting and follow-up of cleft lip and palate patients. The protocol was developed and consisted of the following domains of determinants: (1) the sociodemographic domain, (2) the cleft defect domain, (3) the surgery domain, and (4) the fistula domain. The proposed protocol has the potential to enhance the quality of patient care by ensuring that multiple patient-related aspects are consistently reported. It may also facilitate future multicenter research, which could contribute to the reduction of fistula occurrence in cleft lip and palate patients.

  18. Effects of tailored neck-shoulder pain treatment based on a decision model guided by clinical assessments and standardized functional tests. A study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Björklund Martin

    2012-05-01

    Full Text Available Abstract Background A major problem with rehabilitation interventions for neck pain is that the condition may have multiple causes, thus a single treatment approach is seldom efficient. The present study protocol outlines a single blinded randomised controlled trial evaluating the effect of tailored treatment for neck-shoulder pain. The treatment is based on a decision model guided by standardized clinical assessment and functional tests with cut-off values. Our main hypothesis is that the tailored treatment has better short, intermediate and long-term effects than either non-tailored treatment or treatment-as-usual (TAU on pain and function. We sub-sequentially hypothesize that tailored and non-tailored treatment both have better effect than TAU. Methods/Design 120 working women with minimum six weeks of nonspecific neck-shoulder pain aged 20–65, are allocated by minimisation with the factors age, duration of pain, pain intensity and disability in to the groups tailored treatment (T, non-tailored treatment (NT or treatment-as-usual (TAU. Treatment is given to the groups T and NT for 11 weeks (27 sessions evenly distributed. An extensive presentation of the tests and treatment decision model is provided. The main treatment components are manual therapy, cranio-cervical flexion exercise and strength training, EMG-biofeedback training, treatment for cervicogenic headache, neck motor control training. A decision algorithm based on the baseline assessment determines the treatment components given to each participant of T- and NT-groups. Primary outcome measures are physical functioning (Neck Disability Index and average pain intensity last week (Numeric Rating Scale. Secondary outcomes are general improvement (Patient Global Impression of Change scale, symptoms (Profile Fitness Mapping neck questionnaire, capacity to work in the last 6 weeks (quality and quantity and pressure pain threshold of m. trapezius. Primary and secondary outcomes will

  19. Standards-Based Wireless Sensor Networking Protocols for Spaceflight Applications

    Science.gov (United States)

    Wagner, Raymond S.

    2010-01-01

    Wireless sensor networks (WSNs) have the capacity to revolutionize data gathering in both spaceflight and terrestrial applications. WSNs provide a huge advantage over traditional, wired instrumentation since they do not require wiring trunks to connect sensors to a central hub. This allows for easy sensor installation in hard to reach locations, easy expansion of the number of sensors or sensing modalities, and reduction in both system cost and weight. While this technology offers unprecedented flexibility and adaptability, implementing it in practice is not without its difficulties. Recent advances in standards-based WSN protocols for industrial control applications have come a long way to solving many of the challenges facing practical WSN deployments. In this paper, we will overview two of the more promising candidates - WirelessHART from the HART Communication Foundation and ISA100.11a from the International Society of Automation - and present the architecture for a new standards-based sensor node for networking and applications research.

  20. 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.

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

    Science.gov (United States)

    Masi, Massimiliano; Pugliese, Rosario; Tiezzi, Francesco

    2012-12-01

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

  2. Improving treatment times for patients with in-hospital stroke using a standardized protocol.

    Science.gov (United States)

    Koge, Junpei; Matsumoto, Shoji; Nakahara, Ichiro; Ishii, Akira; Hatano, Taketo; Sadamasa, Nobutake; Kai, Yasutoshi; Ando, Mitsushige; Saka, Makoto; Chihara, Hideo; Takita, Wataru; Tokunaga, Keisuke; Kamata, Takahiko; Nishi, Hidehisa; Hashimoto, Tetsuya; Tsujimoto, Atsushi; Kira, Jun-Ichi; Nagata, Izumi

    2017-10-15

    Previous reports have shown significant delays in treatment of in-hospital stroke (IHS). We developed and implemented our IHS alert protocol in April 2014. We aimed to determine the influence of implementation of our IHS alert protocol. Our implementation processes comprise the following four main steps: IHS protocol development, workshops for hospital staff to learn about the protocol, preparation of standardized IHS treatment kits, and obtaining feedback in a monthly hospital staff conference. We retrospectively compared protocol metrics and clinical outcomes of patients with IHS treated with intravenous thrombolysis and/or endovascular therapy between before (January 2008-March 2014) and after implementation (April 2014-December 2016). Fifty-five patients were included (pre, 25; post, 30). After the implementation, significant reductions occurred in the median time from stroke recognition to evaluation by a neurologist (30 vs. 13.5min, pvs. 26.5min, pvs. 16min, p=0.02). The median time from first neuroimaging to endovascular therapy had a tendency to decrease (75 vs. 53min, p=0.08). There were no differences in the favorable outcomes (modified Rankin scale score of 0-2) at discharge or the incidence of symptomatic intracranial hemorrhage between the two periods. Our IHS alert protocol implementation saved time in treating patients with IHS without compromising safety. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Standardized protocol for artery-only fingertip replantation.

    Science.gov (United States)

    Buntic, Rudolf F; Brooks, Darrell

    2010-09-01

    Artery-only fingertip replantation can be reliable if low-resistance flow through the replant is maintained until venous outflow is restored naturally. Injuring the tip of the replant to promote ongoing bleeding augmented with anticoagulation usually accomplishes this; however, such management results in prolonged hospitalization. In this study, we analyzed the outcomes of artery-only fingertip replantation using a standardized postoperative protocol consisting of dextran-40, heparin, and leech therapy. Between 2001 and 2008, we performed 19 artery-only fingertip replants for 17 patients. All patients had the replanted nail plate removed and received intravenous dextran-40, heparin, and aspirin to promote fingertip bleeding and vascular outflow. Anticoagulation was titrated to promote a controlled bleed until physiologic venous outflow was restored by neovascularization. We used medicinal leeches and mechanical heparin scrubbing for acute decongestion. By postoperative day 6, bleeding was no longer promoted. We initiated fluorescent dye perfusion studies to assess circulatory competence and direct further anticoagulant intervention if necessary. The absence of bleeding associated with an initial rise followed by an appropriate fall in fluorescent dye concentration would trigger a weaning of anticoagulation. All of the 19 replants survived. The average length of hospital stay was 9 days (range, 7-17 d). Eleven patients received blood transfusions. The average transfusion was 1.8 units (range, 0-9 units). All patients were happy with the decision to replant, and the cosmetic result. A protocol that promotes temporary, controlled bleeding from the fingertip is protective of artery-only replants distal to the distal interphalangeal joint until physiologic venous outflow is restored. The protocol described is both safe and reliable. The patient should be informed that such replant attempts may result in the need for transfusions and extended hospital stays, factors that

  4. Standardization of a Videofluoroscopic Swallow Study Protocol to Investigate Dysphagia in Dogs.

    Science.gov (United States)

    Harris, R A; Grobman, M E; Allen, M J; Schachtel, J; Rawson, N E; Bennett, B; Ledyayev, J; Hopewell, B; Coates, J R; Reinero, C R; Lever, T E

    2017-03-01

    Videofluoroscopic swallow study (VFSS) is the gold standard for diagnosis of dysphagia in veterinary medicine but lacks standardized protocols that emulate physiologic feeding practices. Age impacts swallow function in humans but has not been evaluated by VFSS in dogs. To develop a protocol with custom kennels designed to allow free-feeding of 3 optimized formulations of contrast media and diets that address limitations of current VFSS protocols. We hypothesized that dogs evaluated by a free-feeding VFSS protocol would show differences in objective swallow metrics based on age. Healthy juvenile, adult, and geriatric dogs (n = 24). Prospective, experimental study. Custom kennels were developed to maintain natural feeding behaviors during VFSS. Three food consistencies (thin liquid, pureed food, and dry kibble) were formulated with either iohexol or barium to maximize palatability and voluntary prehension. Dogs were evaluated by 16 swallow metrics and compared across age groups. Development of a standardized VFSS protocol resulted in successful collection of swallow data in healthy dogs. No significant differences in swallow metrics were observed among age groups. Substantial variability was observed in healthy dogs when evaluated under these physiologic conditions. Features typically attributed to pathologic states, such as gastric reflux, were seen in healthy dogs. Development of a VFSS protocol that reflects natural feeding practices may allow emulation of physiology resulting in clinical signs of dysphagia. Age did not result in significant changes in swallow metrics, but additional studies are needed, particularly in light of substantial normal variation. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

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

    Science.gov (United States)

    Elitsur, Yoram; Balfaqih, Yaslam; Preston, Deborah

    2018-04-01

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

  6. Raising standards in clinical research

    DEFF Research Database (Denmark)

    Ohmann, C.; Canham, S.; Demotes, J.

    2017-01-01

    The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were c...

  7. Improving post-stroke dysphagia outcomes through a standardized and multidisciplinary protocol: an exploratory cohort study.

    Science.gov (United States)

    Gandolfi, Marialuisa; Smania, Nicola; Bisoffi, Giulia; Squaquara, Teresa; Zuccher, Paola; Mazzucco, Sara

    2014-12-01

    Stroke is a major cause of dysphagia. Few studies to date have reported on standardized multidisciplinary protocolized approaches to the management of post-stroke dysphagia. The aim of this retrospective cohort study was to evaluate the impact of a standardized multidisciplinary protocol on clinical outcomes in patients with post-stroke dysphagia. We performed retrospective chart reviews of patients with post-stroke dysphagia admitted to the neurological ward of Verona University Hospital from 2004 to 2008. Outcomes after usual treatment for dysphagia (T- group) were compared versus outcomes after treatment under a standardized diagnostic and rehabilitative multidisciplinary protocol (T+ group). Outcome measures were death, pneumonia on X-ray, need for respiratory support, and proportion of patients on tube feeding at discharge. Of the 378 patients admitted with stroke, 84 had dysphagia and were enrolled in the study. A significantly lower risk of in-hospital death (odds ratio [OR] 0.20 [0.53-0.78]), pneumonia (OR 0.33 [0.10-1.03]), need for respiratory support (OR 0.48 [0.14-1.66]), and tube feeding at discharge (OR 0.30 [0.09-0.91]) was recorded for the T+ group (N = 39) as compared to the T- group (N = 45). The adjusted OR showed no difference between the two groups for in-hospital death and tube feeding at discharge. Use of a standardized multidisciplinary protocolized approach to the management of post-stroke dysphagia may significantly reduce rates of aspiration pneumonia, in-hospital mortality, and tube feeding in dysphagic stroke survivors. Consistent with the study's exploratory purposes, our findings suggest that the multidisciplinary protocol applied in this study offers an effective model of management of post-stroke dysphagia.

  8. 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.

  9. The need for LWR metrology standardization: the imec roughness protocol

    Science.gov (United States)

    Lorusso, Gian Francesco; Sutani, Takumichi; Rutigliani, Vito; van Roey, Frieda; Moussa, Alain; Charley, Anne-Laure; Mack, Chris; Naulleau, Patrick; Constantoudis, Vassilios; Ikota, Masami; Ishimoto, Toru; Koshihara, Shunsuke

    2018-03-01

    As semiconductor technology keeps moving forward, undeterred by the many challenges ahead, one specific deliverable is capturing the attention of many experts in the field: Line Width Roughness (LWR) specifications are expected to be less than 2nm in the near term, and to drop below 1nm in just a few years. This is a daunting challenge and engineers throughout the industry are trying to meet these targets using every means at their disposal. However, although current efforts are surely admirable, we believe they are not enough. The fact is that a specification has a meaning only if there is an agreed methodology to verify if the criterion is met or not. Such a standardization is critical in any field of science and technology and the question that we need to ask ourselves today is whether we have a standardized LWR metrology or not. In other words, if a single reference sample were provided, would everyone measuring it get reasonably comparable results? We came to realize that this is not the case and that the observed spread in the results throughout the industry is quite large. In our opinion, this makes the comparison of LWR data among institutions, or to a specification, very difficult. In this paper, we report the spread of measured LWR data across the semiconductor industry. We investigate the impact of image acquisition, measurement algorithm, and frequency analysis parameters on LWR metrology. We review critically some of the International Technology Roadmap for Semiconductors (ITRS) metrology guidelines (such as measurement box length larger than 2μm and the need to correct for SEM noise). We compare the SEM roughness results to AFM measurements. Finally, we propose a standardized LWR measurement protocol - the imec Roughness Protocol (iRP) - intended to ensure that every time LWR measurements are compared (from various sources or to specifications), the comparison is sensible and sound. We deeply believe that the industry is at a point where it is

  10. Evaluation of Dogs with Border Collie Collapse, Including Response to Two Standardized Strenuous Exercise Protocols.

    Science.gov (United States)

    Taylor, Susan; Shmon, Cindy; Su, Lillian; Epp, Tasha; Minor, Katie; Mickelson, James; Patterson, Edward; Shelton, G Diane

    2016-01-01

    Clinical and metabolic variables were evaluated in 13 dogs with border collie collapse (BCC) before, during, and following completion of standardized strenuous exercise protocols. Six dogs participated in a ball-retrieving protocol, and seven dogs participated in a sheep-herding protocol. Findings were compared with 16 normal border collies participating in the same exercise protocols (11 retrieving, five herding). Twelve dogs with BCC developed abnormal mentation and/or an abnormal gait during evaluation. All dogs had post-exercise elevations in rectal temperature, pulse rate, arterial blood pH, PaO2, and lactate, and decreased PaCO2 and bicarbonate, as expected with strenuous exercise, but there were no significant differences between BCC dogs and normal dogs. Electrocardiography demonstrated sinus tachycardia in all dogs following exercise. Needle electromyography was normal, and evaluation of muscle biopsy cryosections using a standard panel of histochemical stains and reactions did not reveal a reason for collapse in 10 dogs with BCC in which these tests were performed. Genetic testing excluded the dynamin-1 related exercise-induced collapse mutation and the V547A malignant hyperthermia mutation as the cause of BCC. Common reasons for exercise intolerance were eliminated. Although a genetic basis is suspected, the cause of collapse in BCC was not determined.

  11. 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.

  12. Implementing Home Health Standards in Clinical Practice.

    Science.gov (United States)

    Gorski, Lisa A

    2016-02-01

    In 1986, the American Nurses Association (ANA) published the first Standards of Home Health Practice. Revised in 1992 and expanded in 1999 to become Home Health Nursing: Scope and Standards of Practice, it was revised in 2008 and again in 2014. In the 2014 edition, there are 6 standards of home healthcare nursing practice and 10 standards of professional performance for home healthcare nursing. The focus of this article is to describe the home healthcare standards and to provide guidance for implementation in clinical practice. It is strongly encouraged that home healthcare administrators, educators, and staff obtain a copy of the standards and fully read this essential home healthcare resource.

  13. The impact of a new standard labor protocol on maternal and neonatal outcomes.

    Science.gov (United States)

    Wang, Dingran; Ye, Shenglong; Tao, Liyuan; Wang, Yongqing

    2017-12-01

    To analyze the clinical outcomes following the implementation of a new standard labor procedure. This was a retrospective analysis that included a study group consisting of patients managed based on a new standard labor protocol and a control group comprising patients managed under an old standard labor protocol. The following maternal and perinatal outcomes were compared in the two groups: the indications for a cesarean section and the incidence of cesarean section, postpartum hemorrhage, fetal distress, neonatal asphyxia and pediatric intervention. We also compared the average number of days spent in the hospital, the incidence of medical disputes and hospitalization expenses. The cesarean section rates for the study and control groups were 19.29% (401/2079) and 33.53% (753/2246), respectively (P labor, fetal distress and intrapartum fever; the percentages of each indication were significantly different from those of the control group (P labor protocol reduced the cesarean section rate without negatively impacting maternal and neonatal outcomes. In practice, bed turnover and the hospital utilization rate should be better controlled, patient-doctor communication should be strengthened and the quality of obstetrical service should be improved.

  14. Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pontes, Caridad; Gratacós, Jordi; Torres, Ferran; Avendaño, Cristina; Sanz, Jesús; Vallano, Antoni; Juanola, Xavier; de Miguel, Eugenio; Sanmartí, Raimon; Calvo, Gonzalo

    2015-08-20

    Dose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice. To address this issue the Spanish Society of Rheumatology (SER) and Spanish Society of Clinical Pharmacology (SEFC) designed a 3-year multicenter, randomized, open-label, controlled clinical trial (2 years for inclusion and 1 year of follow-up). The study is expected to include 190 patients with axial spondyloarthritis on stable maintenance treatment (≥4 months) with any anti-TNF agent at doses recommended in the summary of product characteristics. Patients will be randomized to either a dose reduction arm or maintenance of the dosing regimen as per the official labelling recommendations. Randomization will be stratified according to the anti-TNF agent received before study inclusion. Patient follow-up, visit schedule, and examinations will be maintained as per normal clinical practice recommendations according to SER guidelines. The study aims to test the hypothesis of noninferiority of the dose reduction strategy compared with standard treatment. The first patients were recruited in July 2012, and study completion is scheduled for the end of April 2015. The REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical decision now made empirically. The study results may help inform clinical decisions relevant to both patients and healthcare decision makers. EudraCT 2011-005871-18 (21 December 2011).

  15. Using generalizability theory to develop clinical assessment protocols.

    Science.gov (United States)

    Preuss, Richard A

    2013-04-01

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

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

    Science.gov (United States)

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

    2016-04-01

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

  17. Data distribution architecture based on standard real time protocol

    International Nuclear Information System (INIS)

    Castro, R.; Vega, J.; Pereira, A.; Portas, A.

    2009-01-01

    Data distribution architecture (DDAR) has been designed conforming to new requirements, taking into account the type of data that is going to be generated from experiments in International Thermonuclear Experimental Reactor (ITER). The main goal of this architecture is to implement a system that is able to manage on line all data that is being generated by an experiment, supporting its distribution for: processing, storing, analysing or visualizing. The first objective is to have a distribution architecture that supports long pulse experiments (even hours). The described system is able to distribute, using real time protocol (RTP), stored data or live data generated while the experiment is running. It enables researchers to access data on line instead of waiting for the end of the experiment. Other important objective is scalability, so the presented architecture can easily grow based on actual necessities, simplifying estimation and design tasks. A third important objective is security. In this sense, the architecture is based on standards, so complete security mechanisms can be applied, from secure transmission solutions until elaborated access control policies, and it is full compatible with multi-organization federation systems as PAPI or Shibboleth.

  18. Data distribution architecture based on standard real time protocol

    Energy Technology Data Exchange (ETDEWEB)

    Castro, R. [Asociacion EURATOM/CIEMAT para Fusion, Avda. Complutense No. 22, 28040 Madrid (Spain)], E-mail: rodrigo.castro@ciemat.es; Vega, J.; Pereira, A.; Portas, A. [Asociacion EURATOM/CIEMAT para Fusion, Avda. Complutense No. 22, 28040 Madrid (Spain)

    2009-06-15

    Data distribution architecture (DDAR) has been designed conforming to new requirements, taking into account the type of data that is going to be generated from experiments in International Thermonuclear Experimental Reactor (ITER). The main goal of this architecture is to implement a system that is able to manage on line all data that is being generated by an experiment, supporting its distribution for: processing, storing, analysing or visualizing. The first objective is to have a distribution architecture that supports long pulse experiments (even hours). The described system is able to distribute, using real time protocol (RTP), stored data or live data generated while the experiment is running. It enables researchers to access data on line instead of waiting for the end of the experiment. Other important objective is scalability, so the presented architecture can easily grow based on actual necessities, simplifying estimation and design tasks. A third important objective is security. In this sense, the architecture is based on standards, so complete security mechanisms can be applied, from secure transmission solutions until elaborated access control policies, and it is full compatible with multi-organization federation systems as PAPI or Shibboleth.

  19. 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.

  20. Effect of a Standardized Protocol of Antibiotic Therapy on Surgical Site Infection after Laparoscopic Surgery for Complicated Appendicitis.

    Science.gov (United States)

    Park, Hyoung-Chul; Kim, Min Jeong; Lee, Bong Hwa

    Although it is accepted that complicated appendicitis requires antibiotic therapy to prevent post-operative surgical infections, consensus protocols on the duration and regimens of treatment are not well established. This study aimed to compare the outcome of post-operative infectious complications in patients receiving old non-standardized and new standard antibiotic protocols, involving either 5 or 10 days of treatment, respectively. We enrolled 1,343 patients who underwent laparoscopic surgery for complicated appendicitis between January 2009 and December 2014. At the beginning of the new protocol, the patients were divided into two groups; 10 days of various antibiotic regimens (between January 2009 and June 2012, called the non-standardized protocol; n = 730) and five days of cefuroxime and metronidazole regimen (between July 2012 and December 2014; standardized protocol; n = 613). We compared the clinical outcomes, including surgical site infection (SSI) (superficial and deep organ/space infections) in the two groups. The standardized protocol group had a slightly shorter operative time (67 vs. 69 min), a shorter hospital stay (5 vs. 5.4 d), and lower medical cost (US$1,564 vs. US$1,654). Otherwise, there was no difference between the groups. No differences were found in the non-standardized and standard protocol groups with regard to the rate of superficial infection (10.3% vs. 12.7%; p = 0.488) or deep organ/space infection (2.3% vs. 2.1%; p = 0.797). In patients undergoing laparoscopic surgery for complicated appendicitis, five days of cefuroxime and metronidazole did not lead to more SSIs, and it decreased the medical costs compared with non-standardized antibiotic regimens.

  1. Protocol for Usability Testing and Validation of the ISO Draft International Standard 19223 for Lung Ventilators

    Science.gov (United States)

    2017-01-01

    Background Clinicians, such as respiratory therapists and physicians, are often required to set up pieces of medical equipment that use inconsistent terminology. Current lung ventilator terminology that is used by different manufacturers contributes to the risk of usage errors, and in turn the risk of ventilator-associated lung injuries and other conditions. Human factors and communication issues are often associated with ventilator-related sentinel events, and inconsistent ventilator terminology compounds these issues. This paper describes our proposed protocol, which will be implemented at the University of Waterloo, Canada when this project is externally funded. Objective We propose to determine whether a standardized vocabulary improves the ease of use, safety, and utility as it relates to the usability of medical devices, compared to legacy medical devices from multiple manufacturers, which use different terms. Methods We hypothesize that usage errors by clinicians will be lower when standardization is consistently applied by all manufacturers. The proposed study will experimentally examine the impact of standardized nomenclature on performance declines in the use of an unfamiliar ventilator product in clinically relevant scenarios. Participants will be respiratory therapy practitioners and trainees, and we propose studying approximately 60 participants. Results The work reported here is in the proposal phase. Once the protocol is implemented, we will report the results in a follow-up paper. Conclusions The proposed study will help us better understand the effects of standardization on medical device usability. The study will also help identify any terms in the International Organization for Standardization (ISO) Draft International Standard (DIS) 19223 that may be associated with recurrent errors. Amendments to the standard will be proposed if recurrent errors are identified. This report contributes a protocol that can be used to assess the effect of

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

    Science.gov (United States)

    Mather, Carey; Jensen, Sanne; Cummings, Elizabeth

    2017-01-01

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

  3. 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

  4. 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

  5. Development of a standard communication protocol for an emergency situation management in nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Man Cheol, E-mail: charleskim@kaeri.re.k [Integrated Risk Assessment Center, Korea Atomic Energy Research Institute, 150, Deokjin-dong, Yuseong-gu, Daejeon 305-353 (Korea, Republic of); Park, Jinkyun; Jung, Wondea [Integrated Risk Assessment Center, Korea Atomic Energy Research Institute, 150, Deokjin-dong, Yuseong-gu, Daejeon 305-353 (Korea, Republic of); Kim, Hanjeom; Kim, Yoon Joong [YGN Nuclear Power Division Training Center, Korea Hydro and Nuclear Power Company, 517 Kyemari, Hongnong-eup, Yeongkwang-gun, Chonnam 513-880 (Korea, Republic of)

    2010-06-15

    Correct communication between main control room (MCR) operators is an important factor in the management of emergency situations in nuclear power plants (NPPs). For this reason, a standard communication protocol for the management of emergency situations in NPPs has been developed, with the basic direction of enhancing the safety of NPPs and the standardization of communication protocols. To validate the newly developed standard communication protocol, validation experiments with 10 licensed NPP MCR operator teams was performed. From the validation experiments, it was found that the use of the standard communication protocol required more time, but it can contribute to the enhancement of the safety of NPPs by an operators' better grasp of the safety-related parameters and a more efficient and clearer communication between NPP operators, while imposing little additional workloads on the NPP MCR operators. The standard communication protocol is expected to be used to train existing NPP MCR operators without much aversion, as well as new operators.

  6. A Standard Mutual Authentication Protocol for Cloud Computing Based Health Care System.

    Science.gov (United States)

    Mohit, Prerna; Amin, Ruhul; Karati, Arijit; Biswas, G P; Khan, Muhammad Khurram

    2017-04-01

    Telecare Medical Information System (TMIS) supports a standard platform to the patient for getting necessary medical treatment from the doctor(s) via Internet communication. Security protection is important for medical records (data) of the patients because of very sensitive information. Besides, patient anonymity is another most important property, which must be protected. Most recently, Chiou et al. suggested an authentication protocol for TMIS by utilizing the concept of cloud environment. They claimed that their protocol is patient anonymous and well security protected. We reviewed their protocol and found that it is completely insecure against patient anonymity. Further, the same protocol is not protected against mobile device stolen attack. In order to improve security level and complexity, we design a light weight authentication protocol for the same environment. Our security analysis ensures resilience of all possible security attacks. The performance of our protocol is relatively standard in comparison with the related previous research.

  7. International Standardization of the Clinical Dosimetry of Beta Radiation Brachytherapy Sources: Progress of an ISO Standard

    Science.gov (United States)

    Soares, Christopher

    2006-03-01

    In 2004 a new work item proposal (NWIP) was accepted by the International Organization for Standardization (ISO) Technical Committee 85 (TC85 -- Nuclear Energy), Subcommittee 2 (Radiation Protection) for the development of a standard for the clinical dosimetry of beta radiation sources used for brachytherapy. To develop this standard, a new Working Group (WG 22 - Ionizing Radiation Dosimetry and Protocols in Medical Applications) was formed. The standard is based on the work of an ad-hoc working group initiated by the Dosimetry task group of the Deutsches Insitiut für Normung (DIN). Initially the work was geared mainly towards the needs of intravascular brachytherapy, but with the decline of this application, more focus has been placed on the challenges of accurate dosimetry for the concave eye plaques used to treat ocular melanoma. Guidance is given for dosimetry formalisms, reference data to be used, calibrations, measurement methods, modeling, uncertainty determinations, treatment planning and reporting, and clinical quality control. The document is currently undergoing review by the ISO member bodies for acceptance as a Committee Draft (CD) with publication of the final standard expected by 2007. There are opportunities for other ISO standards for medical dosimetry within the framework of WG22.

  8. Protocol Interoperability Between DDN and ISO (Defense Data Network and International Organization for Standardization) Protocols

    Science.gov (United States)

    1988-08-01

    services and protocols above the transport layer are usually implemented as user- callable utilities on the host computers, it is desirable to offer them...Networks, Prentice-hall, New Jersey, 1987 [ BOND 87] Bond , John, "Parallel-Processing Concepts Finally Come together in Real Systems", Computer Design

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

    Science.gov (United States)

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

    2017-01-01

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

  10. An approach to standardization of urine sediment analysis via suggestion of a common manual protocol.

    Science.gov (United States)

    Ko, Dae-Hyun; Ji, Misuk; Kim, Sollip; Cho, Eun-Jung; Lee, Woochang; Yun, Yeo-Min; Chun, Sail; Min, Won-Ki

    2016-01-01

    The results of urine sediment analysis have been reported semiquantitatively. However, as recent guidelines recommend quantitative reporting of urine sediment, and with the development of automated urine sediment analyzers, there is an increasing need for quantitative analysis of urine sediment. Here, we developed a protocol for urine sediment analysis and quantified the results. Based on questionnaires, various reports, guidelines, and experimental results, we developed a protocol for urine sediment analysis. The results of this new protocol were compared with those obtained with a standardized chamber and an automated sediment analyzer. Reference intervals were also estimated using new protocol. We developed a protocol with centrifugation at 400 g for 5 min, with the average concentration factor of 30. The correlation between quantitative results of urine sediment analysis, the standardized chamber, and the automated sediment analyzer were generally good. The conversion factor derived from the new protocol showed a better fit with the results of manual count than the default conversion factor in the automated sediment analyzer. We developed a protocol for manual urine sediment analysis to quantitatively report the results. This protocol may provide a mean for standardization of urine sediment analysis.

  11. Age and gender leucocytes variances and references values generated using the standardized ONE-Study protocol

    DEFF Research Database (Denmark)

    Kverneland, Anders H.; Streitz, Mathias; Geissler, Edward

    2016-01-01

    blood flow cytometry. The performance of our protocols was challenged here by profiling samples from healthy volunteers to reveal age- and gender-dependent differences and to establish a standardized reference cohort for use in clinical trials. Whole blood samples from two different cohorts were...... analyzed (first cohort: n = 52, second cohort: n = 46, both 20–84 years with equal gender distribution). The second cohort was run as a validation cohort by a different operator. The “ONE Study” panels were applied to analyze expression of >30 different surface markers to enumerate proportional...... cohort. Thus, we have proven the utility of our strategy and generated reproducible reference ranges accounting for age- and gender-dependent differences, which are crucial for a better patient monitoring and individualized therapy....

  12. 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.

  13. Comparing Short Dental Implants to Standard Dental Implants: Protocol for a Systematic Review.

    Science.gov (United States)

    Rokn, Amir Reza; Keshtkar, Abbasali; Monzavi, Abbas; Hashemi, Kazem; Bitaraf, Tahereh

    2018-01-18

    Short dental implants have been proposed as a simpler, cheaper, and faster alternative for the rehabilitation of atrophic edentulous areas to avoid the disadvantages of surgical techniques for increasing bone volume. This review will compare short implants (4 to 8 mm) to standard implants (larger than 8 mm) in edentulous jaws, evaluating on the basis of marginal bone loss (MBL), survival rate, complications, and prosthesis failure. We will electronically search for randomized controlled trials comparing short dental implants to standard dental implants in the following databases: PubMed, Web of Science, EMBASE, Scopus, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov with English language restrictions. We will manually search the reference lists of relevant reviews and the included articles in this review. The following journals will also be searched: European Journal of Oral Implantology, Clinical Oral Implants Research, and Clinical Implant Dentistry and Related Research. Two reviewers will independently perform the study selection, data extraction and quality assessment (using the Cochrane Collaboration tool) of included studies. All meta-analysis procedures including appropriate effect size combination, sub-group analysis, meta-regression, assessing publication or reporting bias will be performed using Stata (Statacorp, TEXAS) version 12.1. Short implant effectiveness will be assessed using the mean difference of MBL in terms of weighted mean difference (WMD) and standardized mean difference (SMD) using Cohen's method. The combined effect size measures in addition to the related 95% confidence intervals will be estimated by a fixed effect model. The heterogeneity of the related effect size will be assessed using a Q Cochrane test and I2 measure. The MBL will be presented by a standardized mean difference with a 95% confidence interval. The survival rate of implants, prostheses failures, and complications will be reported using a risk

  14. Assessing impacts of roads: application of a standard assessment protocol

    Science.gov (United States)

    Duniway, Michael C.; Herrick, Jeffrey E.

    2013-01-01

    Adaptive management of road networks depends on timely data that accurately reflect the impacts those systems are having on ecosystem processes and associated services. In the absence of reliable data, land managers are left with little more than observations and perceptions to support management decisions of road-associated disturbances. Roads can negatively impact the soil, hydrologic, plant, and animal processes on which virtually all ecosystem services depend. The Interpreting Indicators of Rangeland Health (IIRH) protocol is a qualitative method that has been demonstrated to be effective in characterizing impacts of roads. The goal of this study were to develop, describe, and test an approach for using IIRH to systematically evaluate road impacts across large, diverse arid and semiarid landscapes. We developed a stratified random sampling approach to plot selection based on ecological potential, road inventory data, and image interpretation of road impacts. The test application on a semiarid landscape in southern New Mexico, United States, demonstrates that the approach developed is sensitive to road impacts across a broad range of ecological sites but that not all the types of stratification were useful. Ecological site and road inventory strata accounted for significant variability in the functioning of ecological processes but stratification based on apparent impact did not. Analysis of the repeatability of IIRH applied to road plots indicates that the method is repeatable but consensus evaluations based on multiple observers should be used to minimize risk of bias. Landscape-scale analysis of impacts by roads of contrasting designs (maintained dirt or gravel roads vs. non- or infrequently maintained roads) suggests that future travel management plans for the study area should consider concentrating traffic on fewer roads that are well designed and maintained. Application of the approach by land managers will likely provide important insights into

  15. Standardized cardiovascular magnetic resonance imaging (CMR protocols, society for cardiovascular magnetic resonance: board of trustees task force on standardized protocols

    Directory of Open Access Journals (Sweden)

    Kim Raymond J

    2008-07-01

    Full Text Available Index 1. General techniques 1.1. Stress and safety equipment 1.2. Left ventricular (LV structure and function module 1.3. Right ventricular (RV structure and function module 1.4. Gadolinium dosing module. 1.5. First pass perfusion 1.6. Late gadolinium enhancement (LGE 2. Disease specific protocols 2.1. Ischemic heart disease 2.1.1. Acute myocardial infarction (MI 2.1.2. Chronic ischemic heart disease and viability 2.1.3. Dobutamine stress 2.1.4. Adenosine stress perfusion 2.2. Angiography: 2.2.1. Peripheral magnetic resonance angiography (MRA 2.2.2. Thoracic MRA 2.2.3. Anomalous coronary arteries 2.2.4. Pulmonary vein evaluation 2.3. Other 2.3.1. Non-ischemic cardiomyopathy 2.3.2. Arrhythmogenic right ventricular cardiomyopathy (ARVC 2.3.3. Congenital heart disease 2.3.4. Valvular heart disease 2.3.5. Pericardial disease 2.3.6. Masses

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

    Directory of Open Access Journals (Sweden)

    Mostafa Alavi-Moghaddam

    2016-12-01

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

  17. Asynchronous transfer mode and Local Area Network emulation standards, protocols, and security implications

    OpenAIRE

    Kirwin, John P.

    1999-01-01

    A complex networking technology called Asynchronous Transfer Mode (ATM) and a networking protocol called Local Area Network Emulation (LANE) are being integrated into many naval networks without any security-driven naval configuration guidelines. No single publication is available that describes security issues of data delivery and signaling relating to the transition of Ethernet to LANE and ATM. The thesis' focus is to provide: (1) an overview and security analysis of standardized protocols ...

  18. 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.

  19. Managing orthopedics and neurosciences costs through standard treatment protocols.

    Science.gov (United States)

    McGinnity, E S; Pluth, T E

    1994-06-01

    can provide substantial revenue as well as the opportunity to achieve a "center of excellence" competitive position in a managed care environment. This Special Report outlines the process and advantages of managing costs and quality of care strategically, that is, in a manner which helps these programs meet internal cost and clinical goals while responding to market situations. The hospital, physicians, and patients all benefit as costs are reduced, quality is enhanced, and the service line's competitive position is strengthened.

  20. Emotional assistance in thalassaemia: pilot implementation of a standard protocol

    Directory of Open Access Journals (Sweden)

    M.T. Veit

    2011-12-01

    Full Text Available This study aims to describe the creation process of standard procedures to make possible multicentre studies related to emotional aspects of thalassaemic patients, their families and caregivers; and the pilot phase of the routine implementation. The objectives defined to perform this goal are: i develop routines to assess and manage/treat emotional issues; ii adjust the ABRASTA - Brazilian Association of Thalassaemia computer system to the input of collected data and its compilation; iii conduct a pilot implementation of the routines; iv discuss the whole process and propose next steps. Forty patients were assisted following the above mentioned routines of psychological evaluation, follow-up assistance and management of specific emotional issues. Conclusions are that the routines are adequate to enable multicenter research to compare findings and develop specific interventions to Thalassaemia patients, their families and caregivers; information gathered through them is an important means of supporting medical doctors and other members of the professional team, both in the therapeutic planning and in the communication process with patients and families; finally, considering the nature of the information, psychologists and psychiatrists are the most indicated professionals to perform the assessment and the interventions related to emotional issues, due to their professional background, training and specific skills that allow a free and candid communication with the patients and their families. 本研究旨在描述标准程序的创造过程,来进行关于地中海贫血患者、其家属和照顾者情感方面可能的多中心研究;以及例程实施的试点阶段。 为实现此目的而定下的目标有: 1)制定例程评估和管理/处理情感问题;2)调整巴西地中海贫血病协会(ABRASTA)计算机系统, 输入收集到的数据并对其进行编辑;3)对例程进行试点实施;4)讨论整个过

  1. Inter-laboratory variation in DNA damage using a standard comet assay protocol

    DEFF Research Database (Denmark)

    Forchhammer, Lykke; Ersson, Clara; Loft, Steffen

    2012-01-01

    determined the baseline level of DNA strand breaks (SBs)/alkaline labile sites and formamidopyrimidine DNA glycosylase (FPG)-sensitive sites in coded samples of mononuclear blood cells (MNBCs) from healthy volunteers. There were technical problems in seven laboratories in adopting the standard protocol...... analysed by the standard protocol. The SBs and FPG-sensitive sites were measured in the same experiment, indicating that the large spread in the latter lesions was the main reason for the reduced inter-laboratory variation. However, it remains worrying that half of the participating laboratories obtained...

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

    Directory of Open Access Journals (Sweden)

    Salaheddin Sharif

    2017-03-01

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

  3. Protocol of the COSMIN study: COnsensus-based Standards for the selection of health Measurement INstruments

    Directory of Open Access Journals (Sweden)

    Patrick DL

    2006-01-01

    Full Text Available Abstract Background Choosing an adequate measurement instrument depends on the proposed use of the instrument, the concept to be measured, the measurement properties (e.g. internal consistency, reproducibility, content and construct validity, responsiveness, and interpretability, the requirements, the burden for subjects, and costs of the available instruments. As far as measurement properties are concerned, there are no sufficiently specific standards for the evaluation of measurement properties of instruments to measure health status, and also no explicit criteria for what constitutes good measurement properties. In this paper we describe the protocol for the COSMIN study, the objective of which is to develop a checklist that contains COnsensus-based Standards for the selection of health Measurement INstruments, including explicit criteria for satisfying these standards. We will focus on evaluative health related patient-reported outcomes (HR-PROs, i.e. patient-reported health measurement instruments used in a longitudinal design as an outcome measure, excluding health care related PROs, such as satisfaction with care or adherence. The COSMIN standards will be made available in the form of an easily applicable checklist. Method An international Delphi study will be performed to reach consensus on which and how measurement properties should be assessed, and on criteria for good measurement properties. Two sources of input will be used for the Delphi study: (1 a systematic review of properties, standards and criteria of measurement properties found in systematic reviews of measurement instruments, and (2 an additional literature search of methodological articles presenting a comprehensive checklist of standards and criteria. The Delphi study will consist of four (written Delphi rounds, with approximately 30 expert panel members with different backgrounds in clinical medicine, biostatistics, psychology, and epidemiology. The final checklist will

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

    Directory of Open Access Journals (Sweden)

    Migdacelys Arboláez Estrada.

    2007-04-01

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

  5. A standardized imaging protocol for the endoscopic prediction of dysplasia within sessile serrated polyps (with video).

    Science.gov (United States)

    Tate, David J; Jayanna, Mahesh; Awadie, Halim; Desomer, Lobke; Lee, Ralph; Heitman, Steven J; Sidhu, Mayenaaz; Goodrick, Kathleen; Burgess, Nicholas G; Mahajan, Hema; McLeod, Duncan; Bourke, Michael J

    2018-01-01

    Dysplasia within sessile serrated polyps (SSPs) is difficult to detect and may be mistaken for an adenoma, risking incomplete resection of the background serrated tissue, and is strongly implicated in interval cancer after colonoscopy. The use of endoscopic imaging to detect dysplasia within SSPs has not been systematically studied. Consecutively detected SSPs ≥8 mm in size were evaluated by using a standardized imaging protocol at a tertiary-care endoscopy center over 3 years. Lesions suspected as SSPs were analyzed with high-definition white light then narrow-band imaging. A demarcated area with a neoplastic pit pattern (Kudo type III/IV, NICE type II) was sought among the serrated tissue. If this was detected, the lesion was labeled dysplastic (sessile serrated polyp with dysplasia); if not, it was labeled non-dysplastic (sessile serrated polyp without dysplasia). Histopathology was reviewed by 2 blinded specialist GI pathologists. A total of 141 SSPs were assessed in 83 patients. Median lesion size was 15.0 mm (interquartile range 10-20), and 54.6% were in the right side of the colon. Endoscopic evidence of dysplasia was detected in 36 of 141 (25.5%) SSPs; of these, 5 of 36 (13.9%) lacked dysplasia at histopathology. Two of 105 (1.9%) endoscopically designated non-dysplastic SSPs had dysplasia at histopathology. Endoscopic imaging, therefore, had an accuracy of 95.0% (95% confidence interval [CI], 90.1%-97.6%) and a negative predictive value of 98.1% (95% CI, 92.6%-99.7%) for detection of dysplasia within SSPs. Dysplasia within SSPs can be detected accurately by using a simple, broadly applicable endoscopic imaging protocol that allows complete resection. Independent validation of this protocol and its dissemination to the wider endoscopic community may have a significant impact on rates of interval cancer. (Clinical trial registration number: NCT03100552.). Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All

  6. Dual-energy CT workflow: multi-institutional consensus on standardization of abdominopelvic MDCT protocols.

    Science.gov (United States)

    Patel, Bhavik N; Alexander, Lauren; Allen, Brian; Berland, Lincoln; Borhani, Amir; Mileto, Achille; Moreno, Courtney; Morgan, Desiree; Sahani, Dushyant; Shuman, William; Tamm, Eric; Tublin, Mitchell; Yeh, Benjamin; Marin, Daniele

    2017-03-01

    To standardize workflow for dual-energy computed tomography (DECT) involving common abdominopelvic exam protocols. 9 institutions (4 rsDECT, 1 dsDECT, 4 both) with 32 participants [average # years (range) in practice and DECT experience, 12.3 (1-35) and 4.6 (1-14), respectively] filled out a single survey (n = 9). A five-point agreement scale (0, 1, 2, 3, 4-contra-, not, mildly, moderately, strongly indicated, respectively) and utilization scale (0-not performing and shouldn't; 1-performing but not clinically useful; 2-performing but not sure if clinically useful; 3-not performing it but would like to; 4-performing and clinically useful) were used. Consensus was considered with a score of ≥2.5. Survey results were discussed over three separate live webinar sessions. 5/9 (56%) institutions exclude large patients from DECT. 2 (40%) use weight, 2 (40%) use transverse dimension, and 1 (20%) uses both. 7/9 (78%) use 50 keV for low and 70 keV for medium monochromatic reconstructed images. DECT is indicated for dual liver [agreement score (AS) 3.78; utilization score (US) 3.22] and dual pancreas in the arterial phase (AS 3.78; US 3.11), mesenteric ischemia/gastrointestinal bleeding in both the arterial and venous phases (AS 2.89; US 2.79), RCC exams in the arterial phase (AS 3.33; US 2.78), and CT urography in the nephrographic phase (AS 3.11; US 2.89). DECT for renal stone and certain single-phase exams is indicated (AS 3.00). DECT is indicated during the arterial phase for multiphasic abdominal exams, nephrographic phase for CTU, and for certain single-phase and renal stone exams.

  7. 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

  8. Wireless networking for the dental office: current wireless standards and security protocols.

    Science.gov (United States)

    Mupparapu, Muralidhar; Arora, Sarika

    2004-11-15

    Digital radiography has gained immense popularity in dentistry today in spite of the early difficulty for the profession to embrace the technology. The transition from film to digital has been happening at a faster pace in the fields of Orthodontics, Oral Surgery, Endodontics, Periodontics, and other specialties where the radiographic images (periapical, bitewing, panoramic, cephalometric, and skull radiographs) are being acquired digitally, stored within a server locally, and eventually accessed for diagnostic purposes, along with the rest of the patient data via the patient management software (PMS). A review of the literature shows the diagnostic performance of digital radiography is at least comparable to or even better than that of conventional radiography. Similarly, other digital diagnostic tools like caries detectors, cephalometric analysis software, and digital scanners were used for many years for the diagnosis and treatment planning purposes. The introduction of wireless charged-coupled device (CCD) sensors in early 2004 (Schick Technologies, Long Island City, NY) has moved digital radiography a step further into the wireless era. As with any emerging technology, there are concerns that should be looked into before adapting to the wireless environment. Foremost is the network security involved in the installation and usage of these wireless networks. This article deals with the existing standards and choices in wireless technologies that are available for implementation within a contemporary dental office. The network security protocols that protect the patient data and boost the efficiency of modern day dental clinics are enumerated.

  9. A standard protocol for describing individual-based and agent-based models

    Science.gov (United States)

    Grimm, Volker; Berger, Uta; Bastiansen, Finn; Eliassen, Sigrunn; Ginot, Vincent; Giske, Jarl; Goss-Custard, John; Grand, Tamara; Heinz, Simone K.; Huse, Geir; Huth, Andreas; Jepsen, Jane U.; Jorgensen, Christian; Mooij, Wolf M.; Muller, Birgit; Pe'er, Guy; Piou, Cyril; Railsback, Steven F.; Robbins, Andrew M.; Robbins, Martha M.; Rossmanith, Eva; Ruger, Nadja; Strand, Espen; Souissi, Sami; Stillman, Richard A.; Vabo, Rune; Visser, Ute; DeAngelis, Donald L.

    2006-01-01

    Simulation models that describe autonomous individual organisms (individual based models, IBM) or agents (agent-based models, ABM) have become a widely used tool, not only in ecology, but also in many other disciplines dealing with complex systems made up of autonomous entities. However, there is no standard protocol for describing such simulation models, which can make them difficult to understand and to duplicate. This paper presents a proposed standard protocol, ODD, for describing IBMs and ABMs, developed and tested by 28 modellers who cover a wide range of fields within ecology. This protocol consists of three blocks (Overview, Design concepts, and Details), which are subdivided into seven elements: Purpose, State variables and scales, Process overview and scheduling, Design concepts, Initialization, Input, and Submodels. We explain which aspects of a model should be described in each element, and we present an example to illustrate the protocol in use. In addition, 19 examples are available in an Online Appendix. We consider ODD as a first step for establishing a more detailed common format of the description of IBMs and ABMs. Once initiated, the protocol will hopefully evolve as it becomes used by a sufficiently large proportion of modellers.

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

    Science.gov (United States)

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

    2017-09-01

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

  11. Normalization of cortical thickness measurements across different T1 magnetic resonance imaging protocols by novel W-Score standardization.

    Science.gov (United States)

    Chung, Jinyong; Yoo, Kwangsun; Lee, Peter; Kim, Chan Mi; Roh, Jee Hoon; Park, Ji Eun; Kim, Sang Joon; Seo, Sang Won; Shin, Jeong-Hyeon; Seong, Joon-Kyung; Jeong, Yong

    2017-10-01

    The use of different 3D T1-weighted magnetic resonance (T1 MR) imaging protocols induces image incompatibility across multicenter studies, negating the many advantages of multicenter studies. A few methods have been developed to address this problem, but significant image incompatibility still remains. Thus, we developed a novel and convenient method to improve image compatibility. W-score standardization creates quality reference values by using a healthy group to obtain normalized disease values. We developed a protocol-specific w-score standardization to control the protocol effect, which is applied to each protocol separately. We used three data sets. In dataset 1, brain T1 MR images of normal controls (NC) and patients with Alzheimer's disease (AD) from two centers, acquired with different T1 MR protocols, were used (Protocol 1 and 2, n = 45/group). In dataset 2, data from six subjects, who underwent MRI with two different protocols (Protocol 1 and 2), were used with different repetition times, echo times, and slice thicknesses. In dataset 3, T1 MR images from a large number of healthy normal controls (Protocol 1: n = 148, Protocol 2: n = 343) were collected for w-score standardization. The protocol effect and disease effect on subjects' cortical thickness were analyzed before and after the application of protocol-specific w-score standardization. As expected, different protocols resulted in differing cortical thickness measurements in both NC and AD subjects. Different measurements were obtained for the same subject when imaged with different protocols. Multivariate pattern difference between measurements was observed between the protocols. Classification accuracy between two protocols was nearly 90%. After applying protocol-specific w-score standardization, the differences between the protocols substantially decreased. Most importantly, protocol-specific w-score standardization reduced both univariate and multivariate differences in the images while

  12. 42 CFR 493.1457 - Standard; Clinical consultant responsibilities.

    Science.gov (United States)

    2010-10-01

    ... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing High Complexity Testing § 493.1457 Standard; Clinical consultant... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant responsibilities. 493...

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

    Science.gov (United States)

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

    2013-01-01

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

  14. 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.

  15. 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

  16. 42 CFR 493.1419 - Standard; Clinical consultant responsibilities.

    Science.gov (United States)

    2010-10-01

    ... Testing Laboratories Performing Moderate Complexity Testing § 493.1419 Standard; Clinical consultant... clinical consultation to the laboratory's clients; (b) Be available to assist the laboratory's clients in... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant responsibilities. 493...

  17. Beyond communication: the role of standardized protocols in a changing health care environment.

    Science.gov (United States)

    Vardaman, James M; Cornell, Paul; Gondo, Maria B; Amis, John M; Townsend-Gervis, Mary; Thetford, Carol

    2012-01-01

    Communication errors have grave consequences in health care settings. The situation-background-assessment-recommendation (SBAR) protocol has been theorized to improve communication by creating a common language between nurses and physicians in acute care situations. This practice is gaining acceptance across the health care field. However, as yet, there has been little investigation of the ways in which SBAR may have an impact on how health care professionals operate beyond the creation of a common language. The purposes of the study were to explore the implementation of the SBAR protocol and investigate the potential impact of SBAR on the day-to-day experiences of nurses. We performed a qualitative case study of 2 hospitals that were implementing the SBAR protocol. We collected data from 80 semistructured interviews with nurses, nurse manager, and physicians; observation of nursing and other hospital activities; and documents that pertained to the implementation of the SBAR protocol. Data were analyzed using a thematic approach. Our analysis revealed 4 dimensions of impact that SBAR has beyond its use as a communication tool: schema formation, development of legitimacy, development of social capital, and reinforcement of dominant logics. The results indicate that SBAR may function as more than a tool to standardize communication among nurses and physicians. Rather, the findings indicate that SBAR may aid in schema development that allows rapid decision making by nurses, provide social capital and legitimacy for less-tenured nurses, and reinforce a move toward standardization in the nursing profession. Our findings further suggest that standardized protocols such as SBAR may be a cost-effective method for hospital managers and administrators to accelerate the socialization of nurses, particularly new hires.

  18. 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

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

    Science.gov (United States)

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

    2013-10-21

    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

  20. 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

  1. 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

  2. Adaptive behaviors of experts in following standard protocol in trauma management: implications for developing flexible guidelines.

    Science.gov (United States)

    Vankipuram, Mithra; Ghaemmaghami, Vafa; Patel, Vimla L

    2012-01-01

    Critical care environments are complex and dynamic. To adapt to such environments, clinicians may be required to make alterations to their workflows resulting in deviations from standard procedures. In this work, deviations from standards in trauma critical care are studied. Thirty trauma cases were observed in a Level 1 trauma center. Activities tracked were compared to the Advance Trauma Life Support standard to determine (i) if deviations had occurred, (ii) type of deviations and (iii) whether deviations were initiated by individuals or collaboratively by the team. Results show that expert clinicians deviated to innovate, while deviations of novices result mostly in error. Experts' well developed knowledge allows for flexibility and adaptiveness in dealing with standards, resulting in innovative deviations while minimizing errors made. Providing informatics solution, in such a setting, would mean that standard protocols would have be flexible enough to "learn" from new knowledge, yet provide strong support for the trainees.

  3. Non operative management of blunt splenic trauma: a prospective evaluation of a standardized treatment protocol.

    Science.gov (United States)

    Brillantino, A; Iacobellis, F; Robustelli, U; Villamaina, E; Maglione, F; Colletti, O; De Palma, M; Paladino, F; Noschese, G

    2016-10-01

    The advantages of the conservative approach for major spleen injuries are still debated. This study was designed to evaluate the safety and effectiveness of NOM in the treatment of minor (grade I-II according with the American Association for the Surgery of Trauma; AAST) and severe (AAST grade III-V) blunt splenic trauma, following a standardized treatment protocol. All the hemodynamically stable patients with computer tomography (CT) diagnosis of blunt splenic trauma underwent NOM, which included strict clinical and laboratory observation, 48-72 h contrast-enhanced ultrasonography (CEUS) follow-up and splenic angioembolization, performed both in patients with admission CT evidence of vascular injuries and in patients with falling hematocrit during observation. 87 patients [32 (36.7 %) women and 55 (63.2 %) men, median age 34 (range 14-68)] were included. Of these, 28 patients (32.1 %) had grade I, 22 patients (25.2 %) grade II, 20 patients (22.9 %) grade III, 11 patients (12.6 %) grade IV and 6 patients (6.8 %) grade V injuries. The overall success rate of NOM was 95.4 % (82/87). There was no significant difference in the success rate between the patients with different splenic injuries grade. Of 24 patients that had undergone angioembolization, 22 (91.6 %) showed high splenic injury grade. The success rate of embolization was 91.6 % (22/24). No major complications were observed. The minor complications (2 pleural effusions, 1 pancreatic fistula and 2 splenic abscesses) were successfully treated by EAUS or CT guided drainage. The non operative management of blunt splenic trauma, according to our protocol, represents a safe and effective treatment for both minor and severe injuries, achieving an overall success rate of 95 %. The angiographic study could be indicated both in patients with CT evidence of vascular injuries and in patients with high-grade splenic injuries, regardless of CT findings.

  4. A Standardized and Reproducible Urine Preparation Protocol for Cancer Biomarkers Discovery

    Directory of Open Access Journals (Sweden)

    Julia Beretov

    2014-01-01

    Full Text Available A suitable and standardized protein purification technique is essential to maintain consistency and to allow data comparison between proteomic studies for urine biomarker discovery. Ultimately, efforts should be made to standardize urine preparation protocols. The aim of this study was to develop an optimal analytical protocol to achieve maximal protein yield and to ensure that this method was applicable to examine urine protein patterns that distinguish disease and disease-free states. In this pilot study, we compared seven different urine sample preparation methods to remove salts, and to precipitate and isolate urinary proteins. Sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE profiles showed that the sequential preparation of urinary proteins by combining acetone and trichloroacetic acid (TCA alongside high speed centrifugation (HSC provided the best separation, and retained the most urinary proteins. Therefore, this approach is the preferred method for all further urine protein analysis.

  5. 42 CFR 493.1276 - Standard: Clinical cytogenetics.

    Science.gov (United States)

    2010-10-01

    ... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1276 Standard: Clinical cytogenetics. (a) The laboratory must have policies and procedures for ensuring accurate and reliable patient specimen identification during the process...

  6. Use of a Microprocessor to Implement an ADCCP Protocol (Federal Standard 1003).

    Science.gov (United States)

    1980-07-01

    results of other studies, to evaluate the operational and economic impact of incorporating various options in Federal Standard 1003. The effort...the LSI interface and the microprocessor; the LSI chip deposits bytes in its buffer as the producer, and the MPU reads this data as the consumer...on the interface between the MPU and the LSI protocol chip. This requires two main processes to be running at the same time--transmit and receive. The

  7. Standard protocol for evaluation of environmental transfer factors around NPP sites

    International Nuclear Information System (INIS)

    Hegde, A.G.; Verma, P.C.; Rao, D.D.

    2009-01-01

    This document presents the standard procedures for evaluation of site specific environmental transfer factors around NPP sites. The scope of this document is to provide standard protocol to be followed for evaluation of environmental transfer factors around NPP sites. The studies on transfer factors are being carried out at various NPP sites under DAE-BRNS projects for evaluation of site specific transfer factors for radionuclides released from power plants. This document contains a common methodology in terms of sampling, processing, measurements and analysis of elemental/radionuclides, while keeping the site specific requirements also in place. (author)

  8. Standard protocol for conducting pre-operational environmental surveillance around nuclear facilities

    Energy Technology Data Exchange (ETDEWEB)

    Hegde, A G; Verma, P C; Rajan, M P [Health Safety and Environment Group, Bhabha Atomic Research Centre, Mumbai (India)

    2009-02-15

    This document presents the standard procedures for evaluation of site specific environmental transfer factors around NPP sites. The scope of this document is to provide standard protocol to be followed for conducting pre-operational environmental surveillance around nuclear facilities. Such surveillances have been proposed to be carried out by university professionals under DAE-BRNS projects. This document contains a common methodology in terms of sampling, processing, measurements and analysis of elemental/radionuclides, while keeping the site specific requirements also in place. (author)

  9. Standard protocol for conducting pre-operational environmental surveillance around nuclear facilities

    International Nuclear Information System (INIS)

    Hegde, A.G.; Verma, P.C.; Rajan, M.P.

    2009-02-01

    This document presents the standard procedures for evaluation of site specific environmental transfer factors around NPP sites. The scope of this document is to provide standard protocol to be followed for conducting pre-operational environmental surveillance around nuclear facilities. Such surveillances have been proposed to be carried out by university professionals under DAE-BRNS projects. This document contains a common methodology in terms of sampling, processing, measurements and analysis of elemental/radionuclides, while keeping the site specific requirements also in place. (author)

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

    Science.gov (United States)

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

    2018-05-15

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

  11. Why standard brain-computer interface (BCI) training protocols should be changed: an experimental study

    Science.gov (United States)

    Jeunet, Camille; Jahanpour, Emilie; Lotte, Fabien

    2016-06-01

    Objective. While promising, electroencephaloraphy based brain-computer interfaces (BCIs) are barely used due to their lack of reliability: 15% to 30% of users are unable to control a BCI. Standard training protocols may be partly responsible as they do not satisfy recommendations from psychology. Our main objective was to determine in practice to what extent standard training protocols impact users’ motor imagery based BCI (MI-BCI) control performance. Approach. We performed two experiments. The first consisted in evaluating the efficiency of a standard BCI training protocol for the acquisition of non-BCI related skills in a BCI-free context, which enabled us to rule out the possible impact of BCIs on the training outcome. Thus, participants (N = 54) were asked to perform simple motor tasks. The second experiment was aimed at measuring the correlations between motor tasks and MI-BCI performance. The ten best and ten worst performers of the first study were recruited for an MI-BCI experiment during which they had to learn to perform two MI tasks. We also assessed users’ spatial ability and pre-training μ rhythm amplitude, as both have been related to MI-BCI performance in the literature. Main results. Around 17% of the participants were unable to learn to perform the motor tasks, which is close to the BCI illiteracy rate. This suggests that standard training protocols are suboptimal for skill teaching. No correlation was found between motor tasks and MI-BCI performance. However, spatial ability played an important role in MI-BCI performance. In addition, once the spatial ability covariable had been controlled for, using an ANCOVA, it appeared that participants who faced difficulty during the first experiment improved during the second while the others did not. Significance. These studies suggest that (1) standard MI-BCI training protocols are suboptimal for skill teaching, (2) spatial ability is confirmed as impacting on MI-BCI performance, and (3) when faced

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

    Science.gov (United States)

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

    2016-03-01

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

  13. 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.

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

    Science.gov (United States)

    Zardouz, Shawn; Shi, Lei; Leung, Albert

    2016-01-01

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

  15. 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

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

    Science.gov (United States)

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

    2018-02-06

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

  17. Difficulties in Controlling Mobilization Pain Using a Standardized Patient-Controlled Analgesia Protocol in Burns

    OpenAIRE

    Nilsson, Andreas; Kalman, Sigga; Arvidsson, Anders; Sjöberg, Folke

    2011-01-01

    The aim of this study was to evaluate pain relief for patients with burns during rest and mobilization with morphine according to a standard protocol for patient-controlled analgesia (PCA). Eighteen patients with a mean (SD) burned TBSA% of 26 (20) were studied for 10 days. Using a numeric rating scale (NRS, 0 = no pain and 10 = unbearable pain), patients were asked to estimate their acceptable and worst experienced pain by specifying a number on a scale and at what point they would like addi...

  18. Standardized Duplex Ultrasound-Based Protocol for Early Diagnosis of Transplant Renal Artery Stenosis: Results of a Single-Institution Retrospective Cohort Study

    Directory of Open Access Journals (Sweden)

    Vincenzo Li Marzi

    2018-01-01

    Full Text Available Transplant renal artery stenosis (TRAS is the most frequent vascular complication after kidney transplantation (KT and has been associated with potentially reversible refractory hypertension, graft dysfunction, and reduced patient survival. The aim of the study is to describe the outcomes of a standardized Duplex Ultrasound- (DU- based screening protocol for early diagnosis of TRAS and for selection of patients potentially requiring endovascular intervention. We retrospectively reviewed our prospectively collected database of KT from January 1998 to select patients diagnosed with TRAS. The follow-up protocol was based on a risk-adapted, dynamic subdivision of eligible KT patients in different risk categories (RC with different protocol strategies (PS. Of 598 patients included in the study, 52 (9% patients had hemodynamically significant TRAS and underwent percutaneous angioplasty (PTA and stent placement. Technical and clinical success rates were 97% and 90%, respectively. 7 cases of restenosis were recorded at follow-up and treated with re-PTA plus stenting. Both DU imaging and clinical parameters improved after stent placement. Prospective high-quality studies are needed to test the efficacy and safety of our protocol in larger series. Accurate trial design and standardized reporting of patient outcomes will be key to address the current clinical needs.

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

    Science.gov (United States)

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

    2014-01-01

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

  20. South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

    Science.gov (United States)

    Essack, Zaynab; Wassenaar, Douglas R

    2018-04-01

    HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

  1. Standard Operational Protocols in professional nursing practice: use, weaknesses and potentialities.

    Science.gov (United States)

    Sales, Camila Balsero; Bernardes, Andrea; Gabriel, Carmen Silvia; Brito, Maria de Fátima Paiva; Moura, André Almeida de; Zanetti, Ariane Cristina Barboza

    2018-01-01

    to evaluate the use of Standard Operational Protocols (SOPs) in the professional practice of the nursing team based on the theoretical framework of Donabedian, as well as to identify the weaknesses and potentialities from its implementation. Evaluative research, with quantitative approach performed with nursing professionals working in the Health Units of a city of São Paulo, composed of two stages: document analysis and subsequent application of a questionnaire to nursing professionals. A total of 247 nursing professionals participated and reported changes in the way the interventions were performed. The main weaknesses were the small number of professionals, inadequate physical structure and lack of materials. Among the potentialities were: the standardization of materials and concern of the manager and professional related to patient safety. The reassessment of SOPs is necessary, as well as the adoption of a strategy of permanent education of professionals aiming at improving the quality of care provided.

  2. Standard Operational Protocols in professional nursing practice: use, weaknesses and potentialities

    Directory of Open Access Journals (Sweden)

    Camila Balsero Sales

    Full Text Available ABSTRACT Objective: to evaluate the use of Standard Operational Protocols (SOPs in the professional practice of the nursing team based on the theoretical framework of Donabedian, as well as to identify the weaknesses and potentialities from its implementation. Method: Evaluative research, with quantitative approach performed with nursing professionals working in the Health Units of a city of São Paulo, composed of two stages: document analysis and subsequent application of a questionnaire to nursing professionals. Results: A total of 247 nursing professionals participated and reported changes in the way the interventions were performed. The main weaknesses were the small number of professionals, inadequate physical structure and lack of materials. Among the potentialities were: the standardization of materials and concern of the manager and professional related to patient safety. Conclusion: The reassessment of SOPs is necessary, as well as the adoption of a strategy of permanent education of professionals aiming at improving the quality of care provided.

  3. Multiparametric multidetector computed tomography scanning on suspicion of hyperacute ischemic stroke: validating a standardized protocol

    Directory of Open Access Journals (Sweden)

    Felipe Torres Pacheco

    2013-06-01

    Full Text Available Multidetector computed tomography (MDCT scanning has enabled the early diagnosis of hyperacute brain ischemia. We aimed at validating a standardized protocol to read and report MDCT techniques in a series of adult patients. The inter-observer agreement among the trained examiners was tested, and their results were compared with a standard reading. No false positives were observed, and an almost perfect agreement (Kappa>0.81 was documented when the CT angiography (CTA and cerebral perfusion CT (CPCT map data were added to the noncontrast CT (NCCT analysis. The inter-observer agreement was higher for highly trained readers, corroborating the need for specific training to interpret these modern techniques. The authors recommend adding CTA and CPCT to the NCCT analysis in order to clarify the global analysis of structural and hemodynamic brain abnormalities. Our structured report is suitable as a script for the reproducible analysis of the MDCT of patients on suspicion of ischemic stroke.

  4. Standardized communication protocol for BAS (IEIEJ/p); BAS hyojun interface shiyo (IEIEJ/p)

    Energy Technology Data Exchange (ETDEWEB)

    Toyoda, T. [Hitachi Building System Co. Ltd., Tokyo (Japan)

    2000-10-05

    For the BEMS user, to construct his BEMS tinder the multiple vendors environment is very beneficial because he could choice the most appropriate vendor among many vendors about every subsystem for the view point of technique and cost at any time. The effective tool which makes the BEMS tinder the multiple environment possible is the BACnet protocol which had developed and been standardized by ANSI/ASHRAE of U.S.. Institute of Electrical Installation Engineers-of Japan (IEIEJ) offers IEIEJ/p based on BACnet as IEIEJ's standard which is added the function of autonomous decentralized control to enhance the BEMS reliability to fit the Japanese multiple vendors environment, In this paper I present the outline of it's specification and feature of IEIEJ/p. (author)

  5. Difficulties in controlling mobilization pain using a standardized patient-controlled analgesia protocol in burns.

    Science.gov (United States)

    Nilsson, Andreas; Kalman, Sigga; Sonesson, Lena Karin; Arvidsson, Anders; Sjöberg, Folke

    2011-01-01

    The aim of this study was to evaluate pain relief for patients with burns during rest and mobilization with morphine according to a standard protocol for patient-controlled analgesia (PCA). Eighteen patients with a mean (SD) burned TBSA% of 26 (20) were studied for 10 days. Using a numeric rating scale (NRS, 0 = no pain and 10 = unbearable pain), patients were asked to estimate their acceptable and worst experienced pain by specifying a number on a scale and at what point they would like additional analgesics. Patients were allowed free access to morphine with a PCA pump device. Bolus doses were set according to age, (100 - age)/24 = bolus dose (mg), and 6 minutes lockout time. Degrees of pain, morphine requirements, doses delivered and demanded, oral intake of food, and antiemetics given were used as endpoints. Acceptable pain (mean [SD]) was estimated to be 3.8 (1.3) on the NRS, and additional treatment was considered necessary at scores of 4.3 (1.6) or more. NRS at rest was 2.7 (2.2) and during mobilization 4.7 (2.6). Required mean morphine per day was 81 (15) mg, and the number of doses requested increased during the first 6 days after the burn. The authors found no correlation between dose of morphine required and any other variables. Background pain can be controlled adequately with a standard PCA protocol. During mobilization, the pain experienced was too intense, despite having the already high doses of morphine increased. The present protocol must be refined further to provide analgesia adequate to cover mobilization as well.

  6. A Standardized Shift Handover Protocol: Improving Nurses’ Safe Practice in Intensive Care Units

    Directory of Open Access Journals (Sweden)

    Javad Malekzadeh

    2013-08-01

    Full Text Available Introduction: For maintaining the continuity of care and improving the quality of care, effective inter-shift information communication is necessary. Any handover error can endanger patient safety. Despite the importance of shift handover, there is no standard handover protocol in our healthcare settings. Methods In this one-group pretest-posttest quasi-experimental study conducted in spring and summer of 2011, we recruited a convenience sample of 56 ICU nurses. The Nurses’ Safe Practice Evaluation Checklist was used for data collection. The Content Validity Index and the inter-rater correlation coefficient of the checklist was 0.92 and 89, respectively. We employed the SPSS 11.5 software and the Mc Nemar and paired-samples t test for data analysis. Results: Study findings revealed that nurses’ mean score on the Safe Practice Evaluation Checklist increased significantly from 11.6 (2.7 to 17.0 (1.8 (P < 0.001. Conclusion: using a standard handover protocol for communicating patient’s needs and information improves nurses’ safe practice in the area of basic nursing care.

  7. Outcomes of Optimized over Standard Protocol of Rabbit Antithymocyte Globulin for Severe Aplastic Anemia: A Single-Center Experience

    Science.gov (United States)

    Ge, Meili; Shao, Yingqi; Huang, Jinbo; Huang, Zhendong; Zhang, Jing; Nie, Neng; Zheng, Yizhou

    2013-01-01

    Background Previous reports showed that outcome of rabbit antithymocyte globulin (rATG) was not satisfactory as the first-line therapy for severe aplastic anemia (SAA). We explored a modifying schedule of administration of rATG. Design and Methods Outcomes of a cohort of 175 SAA patients, including 51 patients administered with standard protocol (3.55 mg/kg/d for 5 days) and 124 cases with optimized protocol (1.97 mg/kg/d for 9 days) of rATG plus cyclosporine (CSA), were analyzed retrospectively. Results Of all 175 patients, response rates at 3 and 6 months were 36.6% and 56.0%, respectively. 51 cases received standard protocol had poor responses at 3 (25.5%) and 6 months (41.2%). However, 124 patients received optimized protocol had better responses at 3 (41.1%, P = 0.14) and 6 (62.1%, P = 0.01). Higher incidences of infection (57.1% versus 37.9%, P = 0.02) and early mortality (17.9% versus 0.8%, P<0.001) occurred in patients received standard protocol compared with optimized protocol. The 5-year overall survival in favor of the optimized over standard rATG protocol (76.0% versus. 50.3%, P<0.001) was observed. By multivariate analysis, optimized protocol (RR = 2.21, P = 0.04), response at 3 months (RR = 10.31, P = 0.03) and shorter interval (<23 days) between diagnosis and initial dose of rATG (RR = 5.35, P = 0.002) were independent favorable predictors of overall survival. Conclusions Optimized instead of standard rATG protocol in combination with CSA remained efficacious as a first-line immunosuppressive regimen for SAA. PMID:23554855

  8. 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.

  9. Comparison of a fast 5-min knee MRI protocol with a standard knee MRI protocol. A multi-institutional multi-reader study

    Energy Technology Data Exchange (ETDEWEB)

    FitzGerald Alaia, Erin; Beltran, Luis S.; Garwood, Elisabeth; Burke, Christopher J.; Gyftopoulos, Soterios [NYU Langone Medical Center, Department of Radiology, Musculoskeletal Division, New York, NY (United States); Benedick, Alex [Case Western Reserve University, School of Medicine, Cleveland, OH (United States); Obuchowski, Nancy A. [Cleveland Clinic, Department of Quantitative Health Sciences, Cleveland, OH (United States); Polster, Joshua M.; Schils, Jean; Subhas, Naveen [Cleveland Clinic, Department of Radiology, Musculoskeletal Division, Cleveland, OH (United States); Chang, I. Yuan Joseph [Texas Scottish Rite Hospital for Children, Dallas, TX (United States)

    2018-01-15

    To compare diagnostic performance of a 5-min knee MRI protocol to that of a standard knee MRI. One hundred 3 T (100 patients, mean 38.8 years) and 50 1.5 T (46 patients, mean 46.4 years) MRIs, consisting of 5 fast, 2D multi-planar fast-spin-echo (FSE) sequences and five standard multiplanar FSE sequences, from two academic centers (1/2015-1/2016), were retrospectively reviewed by four musculoskeletal radiologists. Agreement between fast and standard (interprotocol agreement) and between standard (intraprotocol agreement) readings for meniscal, ligamentous, chondral, and bone pathology was compared for interchangeability. Frequency of major findings, sensitivity, and specificity was also tested for each protocol. Interprotocol agreement using fast MRI was similar to intraprotocol agreement with standard MRI (83.0-99.5%), with no excess disagreement (≤ 1.2; 95% CI, -4.2 to 3.8%), across all structures. Frequency of major findings (1.1-22.4% across structures) on fast and standard MRI was not significantly different (p ≥ 0.215), except more ACL tears on fast MRI (p = 0.021) and more cartilage defects on standard MRI (p < 0.001). Sensitivities (59-100%) and specificities (73-99%) of fast and standard MRI were not significantly different for meniscal and ligament tears (95% CI for difference, -0.08-0.08). For cartilage defects, fast MRI was slightly less sensitive (95% CI for difference, -0.125 to -0.01) but slightly more specific (95% CI for difference, 0.01-0.5) than standard MRI. A fast 5-min MRI protocol is interchangeable with and has similar accuracy to a standard knee MRI for evaluating internal derangement of the knee. (orig.)

  10. Comparison of a fast 5-min knee MRI protocol with a standard knee MRI protocol. A multi-institutional multi-reader study

    International Nuclear Information System (INIS)

    FitzGerald Alaia, Erin; Beltran, Luis S.; Garwood, Elisabeth; Burke, Christopher J.; Gyftopoulos, Soterios; Benedick, Alex; Obuchowski, Nancy A.; Polster, Joshua M.; Schils, Jean; Subhas, Naveen; Chang, I. Yuan Joseph

    2018-01-01

    To compare diagnostic performance of a 5-min knee MRI protocol to that of a standard knee MRI. One hundred 3 T (100 patients, mean 38.8 years) and 50 1.5 T (46 patients, mean 46.4 years) MRIs, consisting of 5 fast, 2D multi-planar fast-spin-echo (FSE) sequences and five standard multiplanar FSE sequences, from two academic centers (1/2015-1/2016), were retrospectively reviewed by four musculoskeletal radiologists. Agreement between fast and standard (interprotocol agreement) and between standard (intraprotocol agreement) readings for meniscal, ligamentous, chondral, and bone pathology was compared for interchangeability. Frequency of major findings, sensitivity, and specificity was also tested for each protocol. Interprotocol agreement using fast MRI was similar to intraprotocol agreement with standard MRI (83.0-99.5%), with no excess disagreement (≤ 1.2; 95% CI, -4.2 to 3.8%), across all structures. Frequency of major findings (1.1-22.4% across structures) on fast and standard MRI was not significantly different (p ≥ 0.215), except more ACL tears on fast MRI (p = 0.021) and more cartilage defects on standard MRI (p < 0.001). Sensitivities (59-100%) and specificities (73-99%) of fast and standard MRI were not significantly different for meniscal and ligament tears (95% CI for difference, -0.08-0.08). For cartilage defects, fast MRI was slightly less sensitive (95% CI for difference, -0.125 to -0.01) but slightly more specific (95% CI for difference, 0.01-0.5) than standard MRI. A fast 5-min MRI protocol is interchangeable with and has similar accuracy to a standard knee MRI for evaluating internal derangement of the knee. (orig.)

  11. [Possible relation between clinical guidelines and legal standard of medicine].

    Science.gov (United States)

    Furukawa, Toshiharu; Kitagawa, Yuko

    2010-10-01

    Legal standard of medicine is not equal across the all kinds of medical institutions. Each medical institution is required its respective standard of medicine in which its doctors are expected to have studied medical informations, which have been spread among medical institutions with similar characteristics. Therefore, in principle, clinical guidelines for the treatment of a disease formed by public committees do not directly become the medical standards of respective disease treatment. However, doctors would be legally required to practice medicine with reference to the clinical guidelines because medical informations, mediated by internet or many kinds of media, have been spread very fast to all medical institutions these days. Moreover, doctors would be required to inform their patients of non-standardized new treatments, even if such treatments are not listed in clinical guidelines in case patients have special concern about new treat-

  12. The effect of a standardized protocol for iron supplementation to blood donors low in hemoglobin concentration.

    Science.gov (United States)

    Magnussen, Karin; Bork, Nanna; Asmussen, Lisa

    2008-04-01

    Iron deficiency leading to low hemoglobin concentration (cHb) is a common problem for blood donors as well as for blood banks. A standardized protocol offering iron supplementation based on P-ferritin determination may help to reduce the problem and retain donors. This was a prospective study where 879 blood donors, presenting with cHb at or below the limit of acceptance for donation, were included. The predonation cHb result was read after donation. The donors received 50 iron tablets (JernC or Ferrochel, 100 or 25 mg elemental iron, respectively), and samples for P-ferritin, mean corpuscular volume, and control of cHb were secured. Based on a P-ferritin level of less than 60 microg per L, 20 iron tablets were offered after all following donations. Mean cHb was 7.6 mmol per L (122 g/L) and 8.2 mmol per L (132 g/L) in women and men, respectively. In 80 percent of the women and 48 percent of the men, iron stores were low (P-ferritin protocol offering iron supplementation and simple oral and written advice based on P-ferritin measurements is effective in normalizing cHb and retaining donors presenting with cHb at or below the limit of acceptance for donation.

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

    Directory of Open Access Journals (Sweden)

    Michelle Millington

    2009-07-01

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

  14. Impact of a standardized nurse observation protocol including MEWS after Intensive Care Unit discharge.

    Science.gov (United States)

    De Meester, K; Das, T; Hellemans, K; Verbrugghe, W; Jorens, P G; Verpooten, G A; Van Bogaert, P

    2013-02-01

    Analysis of in-hospital mortality after serious adverse events (SAE's) in our hospital showed the need for more frequent observation in medical and surgical wards. We hypothesized that the incidence of SAE's could be decreased by introducing a standard nurse observation protocol. To investigate the effect of a standard nurse observation protocol implementing the Modified Early Warning Score (MEWS) and a color graphic observation chart. Pre- and post-intervention study by analysis of patients records for a 5-day period after Intensive Care Unit (ICU) discharge to 14 medical and surgical wards before (n=530) and after (n=509) the intervention. For the total study population the mean Patient Observation Frequency Per Nursing Shift (POFPNS) during the 5-day period after ICU discharge increased from .9993 (95% C.I. .9637-1.0350) in the pre-intervention period to 1.0732 (95% C.I. 1.0362-1.1101) (p=.005) in the post-intervention period. There was an increased risk of a SAE in patients with MEWS 4 or higher in the present nursing shift (HR 8.25; 95% C.I. 2.88-23.62) and the previous nursing shift (HR 12.83;95% C.I. 4.45-36.99). There was an absolute risk reduction for SAE's within 120h after ICU discharge of 2.2% (95% C.I. -0.4-4.67%) from 5.7% to 3.5%. The intervention had a positive impact on the observation frequency. MEWS had a predictive value for SAE's in patients after ICU discharge. The drop in SAE's was substantial but did not reach statistical significance. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  15. Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study.

    Science.gov (United States)

    Brehmer, Jess L; Husband, Jeffrey B

    2014-10-01

    There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocols for distal radial fractures treated with open reduction and internal fixation (ORIF). The purpose of this study was to compare the early postoperative outcomes (at zero to twelve weeks postoperatively) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a standard rehabilitation protocol following ORIF for a distal radial fracture. We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a standard protocol. From November 2007 to November 2010, eighty-one patients with an unstable distal radial fracture were prospectively randomized to follow either an accelerated or a standard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture. Both groups began with gentle active range of motion at three to five days postoperatively. At two weeks, the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises, whereas the standard group initiated passive range of motion and strengthening at six weeks postoperatively. Patients were assessed at three to five days, two weeks, three weeks, four weeks, six weeks, eight weeks, twelve weeks, and six months postoperatively. Outcomes included Disabilities of the Arm, Shoulder and Hand (DASH) scores (primary outcome) and measurements of wrist flexion/extension, supination, pronation, grip strength, and palmar pinch. The patients in the accelerated group had better mobility, strength, and DASH scores at the early postoperative time points (zero to eight weeks postoperatively) compared with the patients in the standard rehabilitation group. The difference between the groups was both clinically relevant and statistically significant. Patients who follow an accelerated rehabilitation

  16. Standardizing serum 25-hydroxyvitamin D data from four Nordic population samples using the Vitamin D Standardization Program protocols: Shedding new light on vitamin D status in Nordic individuals

    DEFF Research Database (Denmark)

    Cashman, Kevin D; Dowling, Kirsten G; Škrabáková, Zuzana

    2015-01-01

    for the European Union are of variable quality making it difficult to estimate the prevalence of vitamin D deficiency across member states. As a consequence of the widespread, method-related differences in measurements of serum 25(OH)D concentrations, the Vitamin D Standardization Program (VDSP) developed...... protocols for standardizing existing serum 25(OH)D data from national surveys around the world. The objective of the present work was to apply the VDSP protocols to existing serum 25(OH)D data from a Danish, a Norwegian, and a Finnish population-based health survey and from a Danish randomized controlled...

  17. Organizational, technical, physical and clinical quality standards for radiotherapy

    Science.gov (United States)

    Bogusz-Czerniewicz, Marta; Kaźmierczak, Daniel

    2012-01-01

    Background Indisputably, radiotherapy has become an entirely interdisciplinary specialty. This situation requires efficient planning, verification, monitoring, quality control and constant improvement of all aspects of service delivery, referring both to patients’ (including diagnosis, prescription and method of treatment, its justification, realization and follow up) and organizational, technical and physics matters. Aim The aim of this work was to develop technical, physics and clinical quality standards for radiotherapy. This paper presents chosen standards for each of the aforementioned category. Materials and methods For the development of quality standards the comparison analysis of EU and Polish acts of law passed between 1980 and 2010 was conducted, the universal industrial ISO norm 9001:2008 referring to quality management system was reviewed. Recommendations of this norm were completed with detailed quality standards based on the author's 11 year work experience and the review of articles on quality assurance and quality control standards for radiotherapy published between 1984 and 2009 and the review of current recommendations and guidelines of American, International, European and National bodies (associations, societies, agencies such as AAPM, ESTRO, IAEA, and OECI) for quality assurance and quality management in radiotherapy. Results As a result 352 quality standards for radiotherapy were developed and categorized into the following three groups: (1) organizational standards, (2) physics and technical standards and (3) clinical standards. Conclusions Proposed quality standards for radiotherapy, can be used by any institution using ionizing radiation for medical procedures. Nevertheless standards are only of value if they are implemented, reviewed, audited and improved and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:24377023

  18. [Accreditation of clinical laboratories based on ISO standards].

    Science.gov (United States)

    Kawai, Tadashi

    2004-11-01

    International Organization for Standardization (ISO) have published two international standards (IS) to be used for accreditation of clinical laboratories; ISO/IEC 17025:1999 and ISO 15189:2003. Any laboratory accreditation body must satisfy the requirements stated in ISO/IEC Guide 58. In order to maintain the quality of the laboratory accreditation bodies worldwide, the International Laboratory Accreditation Cooperation (ILAC) has established the mutual recognition arrangement (MRA). In Japan, the International Accreditation Japan (IAJapan) and the Japan Accreditation Board for Conformity Assessment (JAB) are the members of the ILAC/MRA group. In 2003, the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the JAB have established the Development Committee of Clinical Laboratory Accreditation Program (CLAP), in order to establish the CLAP, probably starting in 2005.

  19. 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

  20. Anthropometric protocols for the construction of new international fetal and newborn growth standards: the INTERGROWTH-21st Project.

    Science.gov (United States)

    Cheikh Ismail, L; Knight, H E; Bhutta, Z; Chumlea, W C

    2013-09-01

    The primary aim of the INTERGROWTH-21(st) Project is to construct new, prescriptive standards describing optimal fetal and preterm postnatal growth. The anthropometric measurements include the head circumference, recumbent length and weight of the infants, and the stature and weight of the parents. In such a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes, in detail, the selection of anthropometric personnel, equipment, and measurement and calibration protocols used to construct the new standards. Implementing these protocols at each study site ensures that the anthropometric data are of the highest quality to construct the international standards. © 2013 Royal College of Obstetricians and Gynaecologists.

  1. Methodological Study to Develop Standard Operational Protocol on Oral Drug Administration for Children.

    Science.gov (United States)

    Bijarania, Sunil Kumar; Saini, Sushma Kumari; Verma, Sanjay; Kaur, Sukhwinder

    2017-05-01

    To develop standard operational protocol (SOP) on oral drug administration and checklist to assess the implementation of the developed SOP. In this prospective methodological study, SOPs were developed in five phases. In the first phase, the preliminary draft of SOPs and checklists were prepared based on literature review, assessment of current practices and focus group discussion (FGD) with bedside working nurses. In the second phase, content validity was checked with the help of Delphi technique (12 experts). Total four drafts were prepared in stages and necessary modifications were made as per suggestions after each Delphi round. Fourth Delphi round was performed after conducting a pilot study. In the fourth phase, all bedside nurses were trained as per SOPs and asked to practice accordingly and observation of thirty oral drug administrations in children was done to check reliability of checklists for implementation of SOPs. In Phase-V, 7 FGDs were conducted with bedside nurses to assess the effectiveness of SOPs. The Content Validity Index (CVI) of SOP and checklists was 99.77%. Overall standardized Cronbach's alpha was calculated as 0.94. All the nurses felt that the SOP is useful. Valid and feasible SOP for drug administration to children through oral route along with valid and reliable checklist were developed. It is recommended to use this document for drug administration to children.

  2. Standardization and Optimization of Computed Tomography Protocols to Achieve Low-Dose

    Science.gov (United States)

    Chin, Cynthia; Cody, Dianna D.; Gupta, Rajiv; Hess, Christopher P.; Kalra, Mannudeep K.; Kofler, James M.; Krishnam, Mayil S.; Einstein, Andrew J.

    2014-01-01

    The increase in radiation exposure due to CT scans has been of growing concern in recent years. CT scanners differ in their capabilities and various indications require unique protocols, but there remains room for standardization and optimization. In this paper we summarize approaches to reduce dose, as discussed in lectures comprising the first session of the 2013 UCSF Virtual Symposium on Radiation Safety in Computed Tomography. The experience of scanning at low dose in different body regions, for both diagnostic and interventional CT procedures, is addressed. An essential primary step is justifying the medical need for each scan. General guiding principles for reducing dose include tailoring a scan to a patient, minimizing scan length, use of tube current modulation and minimizing tube current, minimizing-tube potential, iterative reconstruction, and periodic review of CT studies. Organized efforts for standardization have been spearheaded by professional societies such as the American Association of Physicists in Medicine. Finally, all team members should demonstrate an awareness of the importance of minimizing dose. PMID:24589403

  3. Enhancing translation: guidelines for standard pre-clinical experiments in mdx mice.

    Science.gov (United States)

    Willmann, Raffaella; De Luca, Annamaria; Benatar, Michael; Grounds, Miranda; Dubach, Judith; Raymackers, Jean-Marc; Nagaraju, Kanneboyina

    2012-01-01

    Duchenne Muscular Dystrophy is an X-linked disorder that affects boys and leads to muscle wasting and death due to cardiac involvement and respiratory complications. The cause is the absence of dystrophin, a large structural protein indispensable for muscle cell function and viability. The mdx mouse has become the standard animal model for pre-clinical evaluation of potential therapeutic treatments. Recent years have seen a rapid increase in the number of experimental compounds being evaluated in the mdx mouse. There is, however, much variability in the design of these pre-clinical experimental studies. This has made it difficult to interpret and compare published data from different laboratories and to evaluate the potential of a treatment for application to patients. The authors therefore propose the introduction of a standard study design for the mdx mouse model. Several aspects, including animal care, sampling times and choice of tissues, as well as recommended endpoints and methodologies are addressed and, for each aspect, a standard procedure is proposed. Testing of all new molecules/drugs using a widely accepted and agreed upon standard experimental protocol would greatly improve the power of pre-clinical experimentations and help identifying promising therapies for the translation into clinical trials for boys with Duchenne Muscular Dystrophy. Copyright © 2011 Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

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

    2017-06-01

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

  5. Is a New Protocol for Acute Lymphoblastic Leukemia Research or Standard Therapy?

    NARCIS (Netherlands)

    Dekking, SAS; van der Graaf, R; de Vries, Martine; Bierings, MB; van Delden, JJM; Kodish, Eric; Lantos, John

    2015-01-01

    In the United States, doctors generally develop new cancer chemotherapy for children by testing innovative chemotherapy protocols against existing protocols in prospective randomized trials. In the Netherlands, children with leukemia are treated by protocols that are agreed upon by the Dutch

  6. 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.

  7. An Advanced Encryption Standard Powered Mutual Authentication Protocol Based on Elliptic Curve Cryptography for RFID, Proven on WISP

    Directory of Open Access Journals (Sweden)

    Alaauldin Ibrahim

    2017-01-01

    Full Text Available Information in patients’ medical histories is subject to various security and privacy concerns. Meanwhile, any modification or error in a patient’s medical data may cause serious or even fatal harm. To protect and transfer this valuable and sensitive information in a secure manner, radio-frequency identification (RFID technology has been widely adopted in healthcare systems and is being deployed in many hospitals. In this paper, we propose a mutual authentication protocol for RFID tags based on elliptic curve cryptography and advanced encryption standard. Unlike existing authentication protocols, which only send the tag ID securely, the proposed protocol could also send the valuable data stored in the tag in an encrypted pattern. The proposed protocol is not simply a theoretical construct; it has been coded and tested on an experimental RFID tag. The proposed scheme achieves mutual authentication in just two steps and satisfies all the essential security requirements of RFID-based healthcare systems.

  8. Defining standardized protocols for determining the efficacy of a postmilking teat disinfectant following experimental exposure of teats to mastitis pathogens.

    Science.gov (United States)

    Schukken, Y H; Rauch, B J; Morelli, J

    2013-04-01

    The objective of this paper was to define standardized protocols for determining the efficacy of a postmilking teat disinfectant following experimental exposure of teats to both Staphylococcus aureus and Streptococcus agalactiae. The standardized protocols describe the selection of cows and herds and define the critical points in performing experimental exposure, performing bacterial culture, evaluating the culture results, and finally performing statistical analyses and reporting of the results. The protocols define both negative control and positive control trials. For negative control trials, the protocol states that an efficacy of reducing new intramammary infections (IMI) of at least 40% is required for a teat disinfectant to be considered effective. For positive control trials, noninferiority to a control disinfectant with a published efficacy of reducing new IMI of at least 70% is required. Sample sizes for both negative and positive control trials are calculated. Positive control trials are expected to require a large trial size. Statistical analysis methods are defined and, in the proposed methods, the rate of IMI may be analyzed using generalized linear mixed models. The efficacy of the test product can be evaluated while controlling for important covariates and confounders in the trial. Finally, standards for reporting are defined and reporting considerations are discussed. The use of the defined protocol is shown through presentation of the results of a recent trial of a test product against a negative control. Copyright © 2013 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Wolfe Rory

    2006-06-01

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

  10. 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

  11. Epidemiological cut-off values for Flavobacterium psychrophilum MIC data generated by a standard test protocol.

    Science.gov (United States)

    Smith, P; Endris, R; Kronvall, G; Thomas, V; Verner-Jeffreys, D; Wilhelm, C; Dalsgaard, I

    2016-02-01

    Epidemiological cut-off values were developed for application to antibiotic susceptibility data for Flavobacterium psychrophilum generated by standard CLSI test protocols. The MIC values for ten antibiotic agents against Flavobacterium psychrophilum were determined in two laboratories. For five antibiotics, the data sets were of sufficient quality and quantity to allow the setting of valid epidemiological cut-off values. For these agents, the cut-off values, calculated by the application of the statistically based normalized resistance interpretation method, were ≤16 mg L(-1) for erythromycin, ≤2 mg L(-1) for florfenicol, ≤0.025 mg L(-1) for oxolinic acid (OXO), ≤0.125 mg L(-1) for oxytetracycline and ≤20 (1/19) mg L(-1) for trimethoprim/sulphamethoxazole. For ampicillin and amoxicillin, the majority of putative wild-type observations were 'off scale', and therefore, statistically valid cut-off values could not be calculated. For ormetoprim/sulphadimethoxine, the data were excessively diverse and a valid cut-off could not be determined. For flumequine, the putative wild-type data were extremely skewed, and for enrofloxacin, there was inadequate separation in the MIC values for putative wild-type and non-wild-type strains. It is argued that the adoption of OXO as a class representative for the quinolone group would be a valid method of determining susceptibilities to these agents. © 2014 John Wiley & Sons Ltd.

  12. Thromboelastometry versus standard coagulation tests versus restrictive protocol to guide blood transfusion prior to central venous catheterization in cirrhosis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Rocha, Leonardo Lima; Pessoa, Camila Menezes Souza; Neto, Ary Serpa; do Prado, Rogerio Ruscitto; Silva, Eliezer; de Almeida, Marcio Dias; Correa, Thiago Domingos

    2017-02-27

    Liver failure patients have traditionally been empirically transfused prior to invasive procedures. Blood transfusion is associated with immunologic and nonimmunologic reactions, increased risk of adverse outcomes and high costs. Scientific evidence supporting empirical transfusion is lacking, and the best approach for blood transfusion prior to invasive procedures in cirrhotic patients has not been established so far. The aim of this study is to compare three transfusion strategies (routine coagulation test-guided - ordinary or restrictive, or thromboelastometry-guided) prior to central venous catheterization in critically ill patients with cirrhosis. Design and setting: a double-blinded, parallel-group, single-center, randomized controlled clinical trial in a tertiary private hospital in São Paulo, Brazil. adults (aged 18 years or older) admitted to the intensive care unit with cirrhosis and an indication for central venous line insertion. Patients will be randomly assigned to three groups for blood transfusion strategy prior to central venous catheterization: standard coagulation tests-based, thromboelastometry-based, or restrictive. The primary efficacy endpoint will be the proportion of patients transfused with any blood product prior to central venous catheterization. The primary safety endpoint will be the incidence of major bleeding. Secondary endpoints will be the proportion of transfusion of fresh frozen plasma, platelets and cryoprecipitate; infused volume of blood products; hemoglobin and hematocrit before and after the procedure; intensive care unit and hospital length of stay; 28-day and hospital mortality; incidence of minor bleeding; transfusion-related adverse reactions; and cost analysis. This study will evaluate three strategies to guide blood transfusion prior to central venous line placement in severely ill patients with cirrhosis. We hypothesized that thromboelastometry-based and/or restrictive protocols are safe and would significantly

  13. 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

  14. The evolution of a clinical database: from local to standardized clinical languages.

    OpenAIRE

    Prophet, C. M.

    2000-01-01

    For more than twenty years, the University of Iowa Hospitals and Clinics Nursing Informatics (UIHC NI) has been developing a clinical database to support patient care planning and documentation in the INFORMM NIS (Information Network for Online Retrieval & Medical Management Nursing Information System). Beginning in 1992, the database content was revised to standardize orders and to incorporate the Standardized Nursing Languages (SNLs) of the North American Nursing Diagnosis Association (NAND...

  15. 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.

  16. Standardized Representation of Clinical Study Data Dictionaries with CIMI Archetypes.

    Science.gov (United States)

    Sharma, Deepak K; Solbrig, Harold R; Prud'hommeaux, Eric; Pathak, Jyotishman; Jiang, Guoqian

    2016-01-01

    Researchers commonly use a tabular format to describe and represent clinical study data. The lack of standardization of data dictionary's metadata elements presents challenges for their harmonization for similar studies and impedes interoperability outside the local context. We propose that representing data dictionaries in the form of standardized archetypes can help to overcome this problem. The Archetype Modeling Language (AML) as developed by the Clinical Information Modeling Initiative (CIMI) can serve as a common format for the representation of data dictionary models. We mapped three different data dictionaries (identified from dbGAP, PheKB and TCGA) onto AML archetypes by aligning dictionary variable definitions with the AML archetype elements. The near complete alignment of data dictionaries helped map them into valid AML models that captured all data dictionary model metadata. The outcome of the work would help subject matter experts harmonize data models for quality, semantic interoperability and better downstream data integration.

  17. Network Coding to Enhance Standard Routing Protocols in Wireless Mesh Networks

    DEFF Research Database (Denmark)

    Pahlevani, Peyman; Roetter, Daniel Enrique Lucani; Fitzek, Frank

    2013-01-01

    This paper introduces a design and simulation of a locally optimized network coding protocol, called PlayNCool, for wireless mesh networks. PlayN-Cool is easy to implement and compatible with existing routing protocols and devices. This allows the system to gain from network coding capabilities i...

  18. 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.

  19. Integrated monitoring: Setting new standards for the next decade of clinical trial practice

    Directory of Open Access Journals (Sweden)

    Kamala Rai

    2011-01-01

    Full Text Available The new age clinical research professional is now geared toward an "integrated monitoring" approach. A number of critical activities at the site level and at the sponsor′s organization need convergence to harness rich dividends in early study start and quick close of the study. The field monitor needs full integration to ensure standard of care, train the site in protocol, select the right site, ensure regulatory support, ensure excellent project management skills, coach, support the logistics team, manage the vendor, ensure good documentation practices, develop patient recruitment and retention, lean the applicable process, as well as ensure effective site management amongst the myriad activities assigned toward developing the drug in the clinic.

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

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  1. 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.

  2. Shortened screening method for phosphorus fractionation in sediments A complementary approach to the standards, measurements and testing harmonised protocol

    International Nuclear Information System (INIS)

    Pardo, Patricia; Rauret, Gemma; Lopez-Sanchez, Jose Fermin

    2004-01-01

    The SMT protocol, a sediment phosphorus fractionation method harmonised and validated in the frame of the standards, measurements and testing (SMT) programme (European Commission), establishes five fractions of phosphorus according to their extractability. The determination of phosphate extracted is carried out spectrophotometrically. This protocol has been applied to 11 sediments of different origin and characteristics and the phosphorus extracted in each fraction was determined not only by UV-Vis spectrophotometry, but also by inductively coupled plasma-atomic emission spectrometry. The use of these two determination techniques allowed the differentiation between phosphorus that was present in the extracts as soluble reactive phosphorus and as total phosphorus. From the comparison of data obtained with both determination techniques a shortened screening method, for a quick evaluation of the magnitude and importance of the fractions given by the SMT protocol, is proposed and validated using two certified reference materials

  3. Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Bennell, Kim L; Rini, Christine; Keefe, Francis; French, Simon; Nelligan, Rachel; Kasza, Jessica; Forbes, Andrew; Dobson, Fiona; Abbott, J Haxby; Dalwood, Andrew; Vicenzino, Bill; Harris, Anthony; Hinman, Rana S

    2015-10-01

    Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction. The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist-instructed home exercise leads to greater reductions in pain and improvements in function. An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted. The study will be conducted in a community setting. The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA. Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention. Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks. A self-reported diagnosis of persistent hip pain will be used. The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist-instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative

  4. 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)

  5. 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.

  6. The effect of the introduction of a standard monitoring protocol on ...

    African Journals Online (AJOL)

    2011-03-07

    Mar 7, 2011 ... management protocol had had any effect on the metabolic and nonmetabolic .... Ages were not recorded. ..... of happiness and wealth.14 Three-quarters of the girls associated ... Information on lifestyle and advice to reduce.

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

    Directory of Open Access Journals (Sweden)

    Peter Fairbairn

    2015-01-01

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

  8. Optimization of Saanen sperm genes amplification: evaluation of standardized protocols in genetically uncharacterized rural goats reared under a subtropical environment.

    Science.gov (United States)

    Barbour, Elie K; Saade, Maya F; Sleiman, Fawwak T; Hamadeh, Shady K; Mouneimne, Youssef; Kassaifi, Zeina; Kayali, Ghazi; Harakeh, Steve; Jaber, Lina S; Shaib, Houssam A

    2012-10-01

    The purpose of this research is to optimize quantitatively the amplification of specific sperm genes in reference genomically characterized Saanen goat and to evaluate the standardized protocols applicability on sperms of uncharacterized genome of rural goats reared under subtropical environment for inclusion in future selection programs. The optimization of the protocols in Saanen sperms included three production genes (growth hormone (GH) exons 2, 3, and 4, αS1-casein (CSN1S1), and α-lactalbumin) and two health genes (MHC class II DRB and prion (PrP)). The optimization was based on varying the primers concentrations and the inclusion of a PCR cosolvent (Triton X). The impact of the studied variables on statistically significant increase in the yield of amplicons was noticed in four out of five (80%) optimized protocols, namely in those related to GH, CSN1S1, α-lactalbumin, and PrP genes (P 0.05). The applicability of the optimized protocols of Saanen sperm genes on amplification of uncharacterized rural goat sperms revealed a 100% success in tested individuals for amplification of GH, CSN1S1, α-lactalbumin, and MHC class II DRB genes and a 75% success for the PrP gene. The significant success in applicability of the Saanen quantitatively optimized protocols to other uncharacterized genome of rural goats allows for their inclusion in future selection, targeting the sustainability of this farming system in a subtropical environment and the improvement of the farmers livelihood.

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

    Directory of Open Access Journals (Sweden)

    Abbas Aflatoonian

    2017-08-01

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

  10. Standards and Protocols for Digital Libraries Dijital Kütüphanelerde Standartlar ve Protokoller

    Directory of Open Access Journals (Sweden)

    Mehmet Emin Küçük

    2003-06-01

    Full Text Available New paradigms have been emerged in the field of librarianship and publishing with the developments in electronic environment, and rapid increase in electronically archived information and its acquisition and retrieval. While libraries show more interest in electronic information, publishers' current tendency is towards production of electronic information. In addition to the acquisition of electronic information, libraries have begun to digitise some of the holdings which do not present copyright problems. Economies provided by digitised information in terms of archiving, sharing and retrieval as well as the users' requirements are the basic motivation for digitisation. However, digital library standards have vital roles in performing effective library cooperation and interoperability between the systems. In this descriptive study, "the most commonly" confronted standards in digital library applications are being examined and evaluated under the following headings; (i record structure standards, (ii encoding standards, and (iii communication standards and protocols. However, metadata standards which can be categorised in record structure standards are not included since the matters are well studied in several papers in Turkish. Elektronik ortamdaki gelişmeler ve elektronik ortamda depolanan bilginin artmasıyla bilginin sağlanması, depolanması ve erişimi konularında önemli değişiklikler meydana gelmiş, yayıncılık ve kütüphanecilikte yeni paradigmaların oluşmasına neden olmuştur. Yayıncılar kaynakları elektronik ortamda üretme eğilimi göstermeye başlarken kütüphaneler de elektronik kaynaklara daha çok ilgi gösterir olmuşlardır. Elektronik ortamda üretilen kaynakların sağlanmasının yanı sıra, bir dizi kütüphane, dermelerinde bulunan ve telif sorunu olmayan materyali dijitalle sürerek kullanıcılarının hizmetine sunmaya başlamıştır. Dijital ortamda bilginin çok daha rahat depolanması, payla

  11. 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.

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

    International Nuclear Information System (INIS)

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

    2013-01-01

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

  13. Bridging the gap in complementary and alternative medicine research: manualization as a means of promoting standardization and flexibility of treatment in clinical trials of acupuncture.

    Science.gov (United States)

    Schnyer, Rosa N; Allen, John J B

    2002-10-01

    An important methodological challenge encountered in acupuncture clinical research involves the design of treatment protocols that help ensure standardization and replicability while allowing for the necessary flexibility to tailor treatments to each individual. Manualization of protocols used in clinical trials of acupuncture and other traditionally-based complementary and alternative medicine (CAM) systems facilitates the systematic delivery of replicable and standardized, yet individually-tailored treatments. To facilitate high-quality CAM acupuncture research by outlining a method for the systematic design and implementation of protocols used in CAM clinical trials based on the concept of treatment manualization. A series of treatment manuals was developed to systematically articulate the Chinese medical theoretical and clinical framework for a given Western-defined illness, to increase the quality and consistency of treatment, and to standardize the technical aspects of the protocol. In all, three manuals were developed for National Institutes of Health (NIH)-funded clinical trials of acupuncture for depression, spasticity in cerebral palsy, and repetitive stress injury. In Part I, the rationale underlying these manuals and the challenges encountered in creating them are discussed, and qualitative assessments of their utility are provided. In Part II, a methodology to develop treatment manuals for use in clinical trials is detailed, and examples are given. A treatment manual provides a precise way to train and supervise practitioners, enable evaluation of conformity and competence, facilitate the training process, and increase the ability to identify the active therapeutic ingredients in clinical trials of acupuncture.

  14. Summary Report Panel 1: The Need for Protocols and Standards in Research on Underwater Noise Impacts on Marine Life.

    Science.gov (United States)

    Erbe, Christine; Ainslie, Michael A; de Jong, Christ A F; Racca, Roberto; Stocker, Michael

    2016-01-01

    As concern about anthropogenic noise and its impacts on marine fauna is increasing around the globe, data are being compared across populations, species, noise sources, geographic regions, and time. However, much of the raw and processed data are not comparable due to differences in measurement methodology, analysis and reporting, and a lack of metadata. Common protocols and more formal, international standards are needed to ensure the effectiveness of research, conservation, regulation and practice, and unambiguous communication of information and ideas. Developing standards takes time and effort, is largely driven by a few expert volunteers, and would benefit from stakeholders' contribution and support.

  15. A Web Resource for Standardized Benchmark Datasets, Metrics, and Rosetta Protocols for Macromolecular Modeling and Design.

    Directory of Open Access Journals (Sweden)

    Shane Ó Conchúir

    Full Text Available The development and validation of computational macromolecular modeling and design methods depend on suitable benchmark datasets and informative metrics for comparing protocols. In addition, if a method is intended to be adopted broadly in diverse biological applications, there needs to be information on appropriate parameters for each protocol, as well as metrics describing the expected accuracy compared to experimental data. In certain disciplines, there exist established benchmarks and public resources where experts in a particular methodology are encouraged to supply their most efficient implementation of each particular benchmark. We aim to provide such a resource for protocols in macromolecular modeling and design. We present a freely accessible web resource (https://kortemmelab.ucsf.edu/benchmarks to guide the development of protocols for protein modeling and design. The site provides benchmark datasets and metrics to compare the performance of a variety of modeling protocols using different computational sampling methods and energy functions, providing a "best practice" set of parameters for each method. Each benchmark has an associated downloadable benchmark capture archive containing the input files, analysis scripts, and tutorials for running the benchmark. The captures may be run with any suitable modeling method; we supply command lines for running the benchmarks using the Rosetta software suite. We have compiled initial benchmarks for the resource spanning three key areas: prediction of energetic effects of mutations, protein design, and protein structure prediction, each with associated state-of-the-art modeling protocols. With the help of the wider macromolecular modeling community, we hope to expand the variety of benchmarks included on the website and continue to evaluate new iterations of current methods as they become available.

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

    Directory of Open Access Journals (Sweden)

    Nina Milcheva

    2016-10-01

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

  17. Report on the results of the FY1999 standardization for new standard interface protocol for electrical measuring use; 1999 nendo shinki sangyo ikusei sokkogata kokusai hyojun kaihatsu jigyo seika hokokusho. Denki keisokukiyo shinhyojun interface purotokoru no hyojunka

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-03-01

    The purpose of this project is to create a new protocol for electric measuring instruments that use a built-in the Universal Serial Bus (USB) interface which is no incorporated in PCs. This new interface will replace the existing GPIB interface (IEEE-488), which is currently used in electric measuring instruments as standard interface. Our goal is to create a protocol that will provide the same data rate as GPIB and better connectivity. To evaluate our new protocol, we create virtual instruments using evaluation boards for USB chips, as well as software, and performed transfer tests to isolate and solve problems found in the tests. We will make the protocol and the software available for general use, and register the protocol as a standard to the USB Developer's Forum, a body that manages USB standards, to make it as a de facto standard. Ultimately we are aiming at making it an international standard. (NEDO)

  18. Psychometric Properties of a Standardized Observation Protocol to Quantify Pediatric Physical Therapy Actions

    NARCIS (Netherlands)

    Sonderer, Patrizia; Ziegler, Schirin Akhbari; Oertle, Barbara Gressbach; Meichtry, Andre; Hadders-Algra, Mijna

    Purpose: Pediatric physical therapy (PPT) is characterized by heterogeneity. This blurs the evaluation of effective components of PPT. The Groningen Observation Protocol (GOP) was developed to quantify contents of PPT. This study assesses the reliability and completeness of the GOP. Methods: Sixty

  19. 75 FR 4323 - Additional Quantitative Fit-testing Protocols for the Respiratory Protection Standard

    Science.gov (United States)

    2010-01-27

    ...-mask and full face piece respirators are normally considered two different types of air purifying... article published in a peer-reviewed industrial-hygiene journal describing the protocol and explaining how... article from an industrial- hygiene journal describing the accuracy and reliability of these proposed...

  20. Understanding implementation processes of clinical pathways and clinical practice guidelines in pediatric contexts: a study protocol

    Directory of Open Access Journals (Sweden)

    Scott Shannon D

    2011-12-01

    Full Text Available Abstract Background Canada is among the most prosperous nations in the world, yet the health and wellness outcomes of Canadian children are surprisingly poor. There is some evidence to suggest that these poor health outcomes are partly due to clinical practice variation, which can stem from failure to apply the best available research evidence in clinical practice, otherwise known as knowledge translation (KT. Surprisingly, clinical practice variation, even for common acute paediatric conditions, is pervasive. Clinical practice variation results in unnecessary medical treatments, increased suffering, and increased healthcare costs. This study focuses on improving health outcomes for common paediatric acute health concerns by evaluating strategies that improve KT and reduce clinical practice variation. Design/Methods Using a multiple case study design, qualitative and quantitative data will be collected from four emergency departments in western Canada. Data sources will include: pre- and post-implementation focus group data from multidisciplinary healthcare professionals; individual interviews with the local champions, KT intervention providers, and unit/site leaders/managers; Alberta Context Tool (ACT survey data; and aggregated patient outcome data. Qualitative and quantitative data will be systematically triangulated, and matrices will be built to do cross-case comparison. Explanations will be built about the success or lack of success of the clinical practice guidelines (CPG and clinical pathways (CPs uptake based upon the cross-case comparisons. Significance This study will generate new knowledge about the potential causal mechanisms and factors which shape implementation. Future studies will track the impact of the CPG/CPs implementation on children's health outcome, and healthcare costs.

  1. 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

  2. Analysis of 855 upper extremity fistulas created using a standard protocol: the role of graft extension to achieve functional status.

    Science.gov (United States)

    Allan, Bassan J; Perez, Enrique R; Tabbara, Marwan

    2013-06-01

    The Fistula First Breakthrough Initiative (FFBI) has been one of the most important national programs to help achieve considerable improvements in the care of patients on chronic hemodialysis. FFBI has helped place guidelines to push practitioners to reduce the use of tunneled central venous catheters and to increase the rate of arteriovenous fistula use in patients requiring chronic hemodialysis access. However, despite current guidelines, no specific protocols exist for the creation and management of autogenous arteriovenous fistulas and outcomes at most centers are below national benchmarks. In this study, we examine the effectiveness of a standard protocol used at our institution for the creation of autogenous upper extremity fistulas for hemodialysis access in achieving early cannulation and early removal of tunneled dialysis catheters. Our review encompasses 855 consecutive autogenous fistulas created over a 10-year period. Our findings suggest that the use of a standard protocol for creation and management of autogenous fistulas can help increase the rate of functional accesses over national benchmarks. Additionally, extension/conversion of malfunctioning fistulas to grafts appears to be an excellent method to expedite removal of a tunneled dialysis catheter with concomitant preservation of a fistula.

  3. 78 FR 45096 - Standards for Business Practices and Communication Protocols for Public Utilities

    Science.gov (United States)

    2013-07-26

    ... Related to Terms, Definition and 24 Acronyms 6. Commission Proposal 24 D. Implementation 24 III. Notice of... between the two markets \\5\\ and re-organized and revised definitions to create a standard set of terms, definitions and acronyms applicable to all NAESB WEQ standards.\\6\\ NAESB states that the Version 003 Standards...

  4. 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...

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

    Science.gov (United States)

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

    2014-09-01

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

  6. Multiparametric prostate MRI: technical conduct, standardized report and clinical use.

    Science.gov (United States)

    Manfredi, Matteo; Mele, Fabrizio; Garrou, Diletta; Walz, Jochen; Fütterer, Jurgen J; Russo, Filippo; Vassallo, Lorenzo; Villers, Arnauld; Emberton, Mark; Valerio, Massimo

    2018-02-01

    Multiparametric prostate MRI (mp-MRI) is an emerging imaging modality for diagnosis, characterization, staging, and treatment planning of prostate cancer (PCa). The technique, results reporting, and its role in clinical practice have been the subject of significant development over the last decade. Although mp-MRI is not yet routinely used in the diagnostic pathway, almost all urological guidelines have emphasized the potential role of mp-MRI in several aspects of PCa management. Moreover, new MRI sequences and scanning techniques are currently under evaluation to improve the diagnostic accuracy of mp-MRI. This review presents an overview of mp-MRI, summarizing the technical applications, the standardized reporting systems used, and their current roles in various stages of PCa management. Finally, this critical review also reports the main limitations and future perspectives of the technique.

  7. 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.

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

    NARCIS (Netherlands)

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

    2012-01-01

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

  9. INTERGROWTH-21st Gestational Dating and Fetal and Newborn Growth Standards in Peri-Urban Nairobi, Kenya: Quasi-Experimental Implementation Study Protocol.

    Science.gov (United States)

    Millar, Kathryn; Patel, Suha; Munson, Meghan; Vesel, Linda; Subbiah, Shalini; Jones, Rachel M; Little, Sarah; Papageorghiou, Aris T; Villar, Jose; Wegner, Mary Nell; Pearson, Nick; Muigai, Faith; Ongeti, Catherine; Langer, Ana

    2018-06-22

    The burden of preterm birth, fetal growth impairment, and associated neonatal deaths disproportionately falls on low- and middle-income countries where modern obstetric tools are not available to date pregnancies and monitor fetal growth accurately. The INTERGROWTH-21 st gestational dating, fetal growth monitoring, and newborn size at birth standards make this possible. To scale up the INTERGROWTH-21 st standards, it is essential to assess the feasibility and acceptability of their implementation and their effect on clinical decision-making in a low-resource clinical setting. This study protocol describes a pre-post, quasi-experimental implementation study of the standards at Jacaranda Health, a maternity hospital in peri-urban Nairobi, Kenya. All women with viable fetuses receiving antenatal and delivery services, their resulting newborns, and the clinicians caring for them from March 2016 to March 2018 are included. The study comprises a 12-month preimplementation phase, a 12-month implementation phase, and a 5-month post-implementation phase to be completed in August 2018. Quantitative clinical and qualitative data collected during the preimplementation and implementation phases will be assessed. A clinician survey was administered eight months into the implementation phase, month 20 of the study. Implementation outcomes include quantitative and qualitative analyses of feasibility, acceptability, adoption, appropriateness, fidelity, and penetration of the standards. Clinical outcomes include appropriateness of referral and effect of the standards on clinical care and decision-making. Descriptive analyses will be conducted, and comparisons will be made between pre- and postimplementation outcomes. Qualitative data will be analyzed using thematic coding and compared across time. The study was approved by the Amref Ethics and Scientific Review Committee (Kenya) and the Harvard University Institutional Review Board. Study results will be shared with stakeholders

  10. A protocol using coho salmon to monitor Tongass National Forest Land and Resource Management Plan standards and guidelines for fish habitat.

    Science.gov (United States)

    M.D. Bryant; Trent McDonald; R. Aho; B.E. Wright; Michelle Bourassa Stahl

    2008-01-01

    We describe a protocol to monitor the effectiveness of the Tongass Land Management Plan (TLMP) management standards for maintaining fish habitat. The protocol uses juvenile coho salmon (Oncorhynchus kisutch) in small tributary streams in forested watersheds. We used a 3-year pilot study to develop detailed methods to estimate juvenile salmonid...

  11. Radiotherapy for pediatric brain tumors: Standard of care, current clinical trials, and new directions

    International Nuclear Information System (INIS)

    Kun, Larry E.

    1996-01-01

    cooperative group trials will be presented with reference to data re surgical, radiotherapeutic, and chemotherapeutic components of modern therapy. The outcome of supratentorial malignant gliomas and classical brainstem gliomas remains unacceptable; data from recent studies and planned protocols will be presented to highlight current treatment standards. The impact of tumor extent and resectability in ependymoma and craniopharyngioma will be reviewed to emphasize current practice, clinical investigations, and evolving debate regarding the role of radiation therapy and introduction of precision techniques. The rationale for recommended radiation volume(s) for intracranial germinomas will be reviewed, as well as recent data and proposed studies addressing combined chemoradiation for germ cell tumors. Recognizing the unique risk:benefit ration in treating infants and young children with both low grade and malignant brain tumors, the indications for radiation therapy, timing, and potential modifications of therapy will be highlighted

  12. Establishment and intra-/inter-laboratory validation of a standard protocol of reactive oxygen species assay for chemical photosafety evaluation.

    Science.gov (United States)

    Onoue, Satomi; Hosoi, Kazuhiro; Wakuri, Shinobu; Iwase, Yumiko; Yamamoto, Toshinobu; Matsuoka, Naoko; Nakamura, Kazuichi; Toda, Tsuguto; Takagi, Hironori; Osaki, Naoto; Matsumoto, Yasuhiro; Kawakami, Satoru; Seto, Yoshiki; Kato, Masashi; Yamada, Shizuo; Ohno, Yasuo; Kojima, Hajime

    2013-11-01

    A reactive oxygen species (ROS) assay was previously developed for photosafety evaluation of pharmaceuticals, and the present multi-center study aimed to establish and validate a standard protocol for ROS assay. In three participating laboratories, two standards and 42 coded chemicals, including 23 phototoxins and 19 nonphototoxic drugs/chemicals, were assessed by the ROS assay according to the standardized protocol. Most phototoxins tended to generate singlet oxygen and/or superoxide under UV-vis exposure, but nonphototoxic chemicals were less photoreactive. In the ROS assay on quinine (200 µm), a typical phototoxic drug, the intra- and inter-day precisions (coefficient of variation; CV) were found to be 1.5-7.4% and 1.7-9.3%, respectively. The inter-laboratory CV for quinine averaged 15.4% for singlet oxygen and 17.0% for superoxide. The ROS assay on 42 coded chemicals (200 µm) provided no false negative predictions upon previously defined criteria as compared with the in vitro/in vivo phototoxicity, although several false positives appeared. Outcomes from the validation study were indicative of satisfactory transferability, intra- and inter-laboratory variability, and predictive capacity of the ROS assay. Copyright © 2012 John Wiley & Sons, Ltd.

  13. SESOTHO trial ("Switch Either near Suppression Or THOusand") - switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL: protocol of a multicenter, parallel-group, open-label, randomized clinical trial in Lesotho, Southern Africa.

    Science.gov (United States)

    Amstutz, Alain; Nsakala, Bienvenu Lengo; Vanobberghen, Fiona; Muhairwe, Josephine; Glass, Tracy Renée; Achieng, Beatrice; Sepeka, Mamorena; Tlali, Katleho; Sao, Lebohang; Thin, Kyaw; Klimkait, Thomas; Battegay, Manuel; Labhardt, Niklaus Daniel

    2018-02-12

    The World Health Organization (WHO) recommends viral load (VL) measurement as the preferred monitoring strategy for HIV-infected individuals on antiretroviral therapy (ART) in resource-limited settings. The new WHO guidelines 2016 continue to define virologic failure as two consecutive VL ≥1000 copies/mL (at least 3 months apart) despite good adherence, triggering switch to second-line therapy. However, the threshold of 1000 copies/mL for defining virologic failure is based on low-quality evidence. Observational studies have shown that individuals with low-level viremia (measurable but below 1000 copies/mL) are at increased risk for accumulation of resistance mutations and subsequent virologic failure. The SESOTHO trial assesses a lower threshold for switch to second-line ART in patients with sustained unsuppressed VL. In this multicenter, parallel-group, open-label, randomized controlled trial conducted in Lesotho, patients on first-line ART with two consecutive unsuppressed VL measurements ≥100 copies/mL, where the second VL is between 100 and 999 copies/mL, will either be switched to second-line ART immediately (intervention group) or not be switched (standard of care, according to WHO guidelines). The primary endpoint is viral resuppression (VL < 50 copies/mL) 9 months after randomization. We will enrol 80 patients, giving us 90% power to detect a difference of 35% in viral resuppression between the groups (assuming two-sided 5% alpha error). For our primary analysis, we will use a modified intention-to-treat set, with those lost to care, death, or crossed over considered failure to resuppress, and using logistic regression models adjusted for the prespecified stratification variables. The SESOTHO trial challenges the current WHO guidelines, assessing an alternative, lower VL threshold for patients with unsuppressed VL on first-line ART. This trial will provide data to inform future WHO guidelines on VL thresholds to recommend switch to second-line ART

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

    Directory of Open Access Journals (Sweden)

    Benjamin Kasenda

    2016-06-01

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

  15. 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

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

    Science.gov (United States)

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

    2014-05-06

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

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

    Directory of Open Access Journals (Sweden)

    H Madry

    2014-05-01

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

  18. Aligning research assessment in the Humanities to the national Standard Evaluation Protocol Challenges and developments in the Dutch research landscape

    Energy Technology Data Exchange (ETDEWEB)

    Prins, A.; Spaapen, J.; Van Vree, F

    2016-07-01

    The purpose of this session is a debate about innovation in comprehensive methods for the assessment of humanities research. Input will come from preliminary outcomes of an ongoing project in the Netherlands to find adequate indicators for humanities research that will fit in the national Standard Evaluation Protocol. The project includes processes of ‘bottom up’ data collection (that is, with input coming from the research community) and discussion with Humanities researchers, investigating the specific characteristics of publication and communication cultures in the Humanities, and the prospects for the use of quantitative and qualitative indicators. (Author)

  19. Clinical and radiological instability following standard fenestration discectomy

    Directory of Open Access Journals (Sweden)

    Mascarenhas Amrithlal

    2009-01-01

    signs of instability are seen even in asymptomatic patients and so are not as reliable as clinical signs of instability. Standard fenestration discectomy does not destabilize the spine more than microdiscectomy.

  20. Complications are reduced with a protocol to standardize timing of fixation based on response to resuscitation.

    Science.gov (United States)

    Vallier, Heather A; Moore, Timothy A; Como, John J; Wilczewski, Patricia A; Steinmetz, Michael P; Wagner, Karl G; Smith, Charles E; Wang, Xiao-Feng; Dolenc, Andrea J

    2015-10-01

    Our group developed a protocol, entitled Early Appropriate Care (EAC), to determine timing of definitive fracture fixation based on presence and severity of metabolic acidosis. We hypothesized that utilization of EAC would result in fewer complications than a historical cohort and that EAC patients with definitive fixation within 36 h would have fewer complications than those treated at a later time. Three hundred thirty-five patients with mean age 39.2 years and mean Injury Severity Score (ISS) 26.9 and 380 fractures of the femur (n = 173), pelvic ring (n = 71), acetabulum (n = 57), and/or spine (n = 79) were prospectively evaluated. The EAC protocol recommended definitive fixation within 36 h if lactate <4.0 mmol/L, pH ≥7.25, or base excess (BE) ≥-5.5 mmol/L. Complications including infections, sepsis, DVT, organ failure, pneumonia, acute respiratory distress syndrome (ARDS), and pulmonary embolism (PE) were identified and compared for early and delayed patients and with a historical cohort. All 335 patients achieved the desired level of resuscitation within 36 h of injury. Two hundred sixty-nine (80%) were treated within 36 h, and 66 had protocol violations, treated on a delayed basis, due to surgeon choice in 71%. Complications occurred in 16.3% of patients fixed within 36 h and in 33.3% of delayed patients (p = 0.0009). Hospital and ICU stays were shorter in the early group: 9.5 versus 17.3 days and 4.4 versus 11.6 days, respectively, both p < 0.0001. This group of patients when compared with a historical cohort of 1443 similar patients with 1745 fractures had fewer complications (16.3 versus 22.1%, p = 0.017) and shorter length of stay (LOS) (p = 0.018). Our EAC protocol recommends definitive fixation within 36 h in resuscitated patients. Early fixation was associated with fewer complications and shorter LOS. The EAC recommendations are safe and effective for the majority of severely injured patients with mechanically

  1. [Food Security in Europe: comparison between the "Hygiene Package" and the British Retail Consortium (BRC) & International Food Standard (IFS) protocols].

    Science.gov (United States)

    Stilo, A; Parisi, S; Delia, S; Anastasi, F; Bruno, G; Laganà, P

    2009-01-01

    The birth of Hygiene Package and of the Reg. CE no 2073/2005 in the food production field signalled a change in Italy. This process started in Italy in 1997 with the legislative decree no 155 on Self-control but in reality, it was implemented in the UK in 1990 with the promulgation of the Food Safety Act. This legal act was influenced by some basic rules corresponding to the application of HACCP standards. Since 1990 the British chains of distribution (Retailers) have involved all aspects of the food line in this type of responsibility. Due to this growing awareness for a need for greater regulation, a protocol, edited by British Retail Consortium was created in 1998. This protocol acted as a "stamp" of approval for food products and it is now known as the BRC Global Food Standard. In July 2008, this protocol became effective in its fifth version. After the birth of BRC, also French and German Retailers have established a standard practically equivalent and perhaps more pertinent to safety food, that is International Food Standard (IFS). The new approach is specific to the food field and strictly applies criteria which will ensure "safety, quality and legality" of food products, similarly to ISO 22000:2005 (mainly based on BRC & IFS past experiences). New standards aim to create a sort of green list with fully "proper and fit" Suppliers only, because of comprehensible exigencies of Retailers. It is expected, as we have shown, that Auditor authorities who are responsible for ensuring that inspections are now carried out like the Hygiene Package, will find these new standards useful. The advantages of streamlining this system is that it will allow enterprises to diligently enforce food safety practices without fear of upset or legal consequence, to improve the quality (HACCP) of management & traceability system; to restrict wastes, reprocessing and withdrawal of products. However some discordances about the interpretation of certain sub-field norms (e.g., water

  2. The Application of Standards and Recommendations to Clinical Ethics Consultation in Practice: An Evaluation at German Hospitals.

    Science.gov (United States)

    Schochow, Maximilian; Rubeis, Giovanni; Steger, Florian

    2017-06-01

    The executive board of the Academy for Ethics in Medicine (AEM) and two AEM working groups formulated standards and recommendations for clinical ethics consultation in 2010, 2011, and 2013. These guidelines comply with the international standards like those set by the American Society for Bioethics and Humanities. There is no empirical data available yet that could indicate whether these standards and recommendations have been implemented in German hospitals. This desideratum is addressed in the present study. We contacted 1.858 German hospitals between September 2013 and January 2014. A follow-up survey was conducted between October 2014 and January 2015. The data of the initial survey and the follow-up survey were merged and evaluated. The statements of the participants were compared with the standards and recommendations. The standards of the AEM concerning the tasks of clinical ethics consultation (including ethics consultation, ethics training and the establishment of policy guidelines) are employed by a majority of participants of the study. Almost all of these participants document their consultation activities by means of protocols or entries in the patient file. There are deviations from the recommendations of the AEM working groups regarding the drafting of statutes, activity reports, and financial support. The activities of clinical ethics consultation predominantly comply with the standards of the AEM and recommendations for the documentation. The recommendations for evaluation should be improved in practice. This applies particularly for activity reports in order to evaluate the activities. Internal evaluation could take place accordingly.

  3. [Protocol for the study of bone tumours and standardization of pathology reports].

    Science.gov (United States)

    Machado, Isidro; Pozo, José Juan; Marcilla, David; Cruz, Julia; Tardío, Juan C; Astudillo, Aurora; Bagué, Sílvia

    Primary bone neoplasms represent a rare and heterogeneous group of mesenchymal tumours. The prevalence of benign and malignant tumours varies; the latter (sarcomas) account for less than 0.2% of all malignant tumours. Primary bone neoplasms are usually diagnosed and classified according to the criteria established and published by the World Health Organization (WHO 2013). These criteria are a result of advances in molecular pathology, which complements the histopathological diagnosis. Bone tumours should be diagnosed and treated in referral centers by a multidisciplinary team including pathologists, radiologists, orthopedic surgeons and oncologists. We analyzed different national and international protocols in order to provide a guide of recommendations for the improvement of pathological evaluation and management of bone tumours. We include specific recommendations for the pre-analytical, analytical, and post-analytical phases, as well as protocols for gross and microscopic pathology. Copyright © 2016 Sociedad Española de Anatomía Patológica. Publicado por Elsevier España, S.L.U. All rights reserved.

  4. Handbook of Carbon Offset Programs. Trading Systems, Funds, Protocols and Standards

    Energy Technology Data Exchange (ETDEWEB)

    Kollmuss, Anja; Lazarus, Michael; Lee, Carrie; Polycarp, Clifford (SEI-US (United States)); LeFranc, Maurice (US EPA (United States))

    2010-03-15

    Greenhouse gas (GHG) offsets have long been promoted as an important element of a comprehensive climate policy approach. Offset programs can reduce the overall cost of achieving a given emission goal by enabling emission reductions to occur where costs are lower. Offsets have the potential to deliver sustainability co-benefits, through technology development and transfer. They can also develop human and institutional capacity for reducing emissions in sectors and locations not included in a cap and trade or a mandatory government policy. However, offsets can pose a risk to the environmental integrity of climate actions, especially if issues surrounding additionality, permanence, leakage, quantification and verification are not adequately addressed. The challenge is to design offset programs and policies that can maximize their potential benefits while minimizing their potential risks. This handbook provides a systematic and comprehensive review of existing offset programs. It looks are what offsets are, how offset mechanisms function, and the successes and pitfalls they have encountered. Coverage includes offset programs across the full swath of applications including mandatory and voluntary systems, government regulated and private markets, carbon offset funds, and accounting and reporting protocols such as the WBCSD/WRI GHG Protocol and ISO 14064. Learning from the successes and failures of these programs will be essential to crafting effective climate policy. A reference for regulators, policy makers, business leaders and NGOs concerned with the design and operation of GHG offset programs world-wide

  5. Standard echocardiography versus handheld echocardiography for the detection of subclinical rheumatic heart disease: protocol for a systematic review.

    Science.gov (United States)

    Telford, Lisa H; Abdullahi, Leila H; Ochodo, Eleanor A; Zühlke, Liesl J; Engel, Mark E

    2018-02-10

    Rheumatic heart disease (RHD) is a preventable and treatable chronic condition which persists in many developing countries largely affecting impoverished populations. Handheld echocardiography presents an opportunity to address the need for more cost-effective methods of diagnosing RHD in developing countries, where the disease continues to carry high rates of morbidity and mortality. Preliminary studies have demonstrated moderate sensitivity as well as high specificity and diagnostic odds for detecting RHD in asymptomatic patients. We describe a protocol for a systematic review on the diagnostic performance of handheld echocardiography compared to standard echocardiography using the 2012 World Heart Federation criteria for diagnosing subclinical RHD. Electronic databases including PubMed, Scopus, Web of Science and EBSCOhost as well as reference lists and citations of relevant articles will be searched from 2012 to date using a predefined strategy incorporating a combination of Medical Subject Heading terms and keywords. The methodological validity and quality of studies deemed eligible for inclusion will be assessed against review specific Quality Assessment of Diagnostic Accuracy Studies 2 criteria and information on metrics of diagnostic accuracy and demographics extracted. Forest plots of sensitivity and specificity as well as scatter plots in receiver operating characteristic (ROC) space will be used to investigate heterogeneity. If possible, a meta-analysis will be conducted to produce summary results of sensitivity and specificity using the Hierarchical Summary ROC method. In addition, a sensitivity analysis will be conducted to investigate the effect of studies with a high risk of bias. Ethics approval is not required for this systematic review of previously published literature. The planned review will provide a summary of the diagnostic accuracy of handheld echocardiography. Results may feed into evidence-based guidelines and should the findings of this

  6. Introduction of a standardized multimodality image protocol for navigation-guided surgery of suspected low-grade gliomas.

    Science.gov (United States)

    Mert, Aygül; Kiesel, Barbara; Wöhrer, Adelheid; Martínez-Moreno, Mauricio; Minchev, Georgi; Furtner, Julia; Knosp, Engelbert; Wolfsberger, Stefan; Widhalm, Georg

    2015-01-01

    OBJECT Surgery of suspected low-grade gliomas (LGGs) poses a special challenge for neurosurgeons due to their diffusely infiltrative growth and histopathological heterogeneity. Consequently, neuronavigation with multimodality imaging data, such as structural and metabolic data, fiber tracking, and 3D brain visualization, has been proposed to optimize surgery. However, currently no standardized protocol has been established for multimodality imaging data in modern glioma surgery. The aim of this study was therefore to define a specific protocol for multimodality imaging and navigation for suspected LGG. METHODS Fifty-one patients who underwent surgery for a diffusely infiltrating glioma with nonsignificant contrast enhancement on MRI and available multimodality imaging data were included. In the first 40 patients with glioma, the authors retrospectively reviewed the imaging data, including structural MRI (contrast-enhanced T1-weighted, T2-weighted, and FLAIR sequences), metabolic images derived from PET, or MR spectroscopy chemical shift imaging, fiber tracking, and 3D brain surface/vessel visualization, to define standardized image settings and specific indications for each imaging modality. The feasibility and surgical relevance of this new protocol was subsequently prospectively investigated during surgery with the assistance of an advanced electromagnetic navigation system in the remaining 11 patients. Furthermore, specific surgical outcome parameters, including the extent of resection, histological analysis of the metabolic hotspot, presence of a new postoperative neurological deficit, and intraoperative accuracy of 3D brain visualization models, were assessed in each of these patients. RESULTS After reviewing these first 40 cases of glioma, the authors defined a specific protocol with standardized image settings and specific indications that allows for optimal and simultaneous visualization of structural and metabolic data, fiber tracking, and 3D brain

  7. Is the standard compliance check protocol a valid measure of the accessibility of tobacco to underage smokers?

    Science.gov (United States)

    DiFranza, J.; Savageau, J.; Bouchard, J.

    2001-01-01

    OBJECTIVE—To determine if the standard compliance check protocol is a valid measure of the experience of underage smokers when purchasing tobacco in unfamiliar communities.
SETTING—160 tobacco outlets in eight Massachusetts communities where underage tobacco sales laws are vigorously enforced.
PROCEDURE—Completed purchase rates were compared between underage smokers who behaved normally and inexperienced non-smoking youths who were not allowed to lie or present proof of age (ID).
RESULTS—The "smoker protocol" increased the likelihood of a sale nearly sixfold over that for the non-smokers (odds ratio (OR) 5.7, 95% confidence interval (CI) 1.5 to 22). When the youths presented an ID with an underage birth date, the odds of a completed sale increased dramatically (OR 27, 95% CI 3.4 to 212). Clerks judged to be under 21 years of age were seven times more likely to make an illegal sale (OR 7.6, 95% CI 2.4 to 24.0).
CONCLUSIONS—Commonly used compliance check protocols are too artificial to reflect accurately the experience of underage smokers. The validity of compliance checks might be improved by having youths present ID, and by employing either tobacco users, or non-tobacco users who are sufficiently experienced to mimic the self confidence exhibited by tobacco users in this situation. Consideration should be given to prohibiting the sale of tobacco by individuals under 21 years of age.


Keywords: compliance check protocol; underage smokers PMID:11544386

  8. Clinical standard of neurosurgical disorder. (9) Disturbance of consciousness

    International Nuclear Information System (INIS)

    Ohta, Tomio

    2009-01-01

    Functional diagnosis of consciousness disturbance (CD) in acute and chronic stages is becoming more important along with the progress of morphological diagnosis by CT and MRI at the stroke and brain lesion. Here described and discussed are the definition of consciousness and unconsciousness, cause and scoring of CD by various scaling and clinical significance of the scale for therapy. The author's definition for consciousness is based on patients' self identity and orientation. The above CD is essentially caused by the increased intracranial pressure, which is evaluable by imaging as the increase is derived from the herniation by tumor or edema mainly through transtentorial (uncal, hippocampal) and/or foraminal (cerebellar tonsillar) pathways. Scaling of CD stands on three factors of validity, reliability and feasibility, of which standards of JCS (Japan coma scale) and GCS (Glasgow coma scale) have been widely employed. In discussion of merit/demerit of JCS and GCS, the author et al. have proposed a new scale ECS (emergency coma scale) with 3 levels of digit code for patient's response and behavior under CD. Therapeutic outcome is greatly affected by acute CD levels evaluable by scaling, in which awakening/alertness relates with mortality, and local symptom/consciousness, with morbidity. ECS is now globally getting around. (K.T.)

  9. Psychometric Properties of a Standardized Observation Protocol to Quantify Pediatric Physical Therapy Actions.

    Science.gov (United States)

    Sonderer, Patrizia; Akhbari Ziegler, Schirin; Gressbach Oertle, Barbara; Meichtry, André; Hadders-Algra, Mijna

    2017-07-01

    Pediatric physical therapy (PPT) is characterized by heterogeneity. This blurs the evaluation of effective components of PPT. The Groningen Observation Protocol (GOP) was developed to quantify contents of PPT. This study assesses the reliability and completeness of the GOP. Sixty infant PPT sessions were video-taped. Two random samples of 10 videos were used to determine interrater and intrarater reliability using interclass correlation coefficients (ICCs) with 95% confidence intervals. Completeness of GOP 2.0 was based on 60 videos. Interrater reliability of quantifying PPT actions was excellent (ICC, 0.75-1.0) in 71% and sufficient to good (ICC, 0.4-0.74) in 24% of PPT actions. Intrarater reliability was excellent in 94% and sufficient to good in 6% of PPT actions. Completeness was good for greater than 90% of PPT actions. GOP 2.0 has good reliability and completeness. After appropriate training, it is a useful tool to quantify PPT for children with developmental disorders.

  10. Control protocol: the proposed new CERN standard access procedure to accelerator equipment

    International Nuclear Information System (INIS)

    Baribaud, G.; Barnett, I.; Benincasa, G.

    1992-01-01

    Control protocol provides a normalized access procedure for equipment of the same kind from a control system. Modelisation and the subsequent identification of functionalities with their parameters, variables and attributes have now been carried out at CERN for representative families of devices. ISO specifications, such as the ASN.1 metalanguage for data structure representation and MMS definitions and services have, to some extent, been introduced in the design for generality and compatibility with external world. The final product of this design is totally independent of the control systems and permits object oriented implementations in any controls frame. The present paper describes the different phases of the project with a short overview of the various implementations under development at CERN. (author)

  11. Recommended protocol for standardization in collecting and interpreting radiological environmental data

    International Nuclear Information System (INIS)

    Denham, D.H.; Kathren, R.L.

    1989-02-01

    Current reductions in ''allowable'' levels of radiation and radioactive materials in the environment and an increased public awareness of naturally occurring radioactive materials have reinforced the need for consistency in evaluating the radiological environment. A key concern is the identification and interpretation of environmental levels of radiation and radioactive materials resulting from nuclear facility operations. If these levels can be detected and their source(s) identified, then corrective actions can be taken to eliminate or greatly reduce the environmental impacts of the facility operations. In this paper we address the lack of definitive guidance necessary to determine incremental levels of significance (or insignificance), and we propose a series of protocols to achieve more consistent collection and interpretation of radiological environmental data. 8 refs

  12. Reproducibility of microbial mutagenicity assays. I. Tests with Salmonella typhimurium and Escherichia coli using a standardized protocol

    International Nuclear Information System (INIS)

    Dunkel, V.C.; Zeiger, E.; Brusick, D.; McCoy, E.; McGregor, D.; Mortelmans, K.; Rosenkranz, H.S.; Simmon, V.F.

    1984-01-01

    The Salmonella/microsome test developed by Ames and his coworkers has been widely used in the evaluation of chemicals for genotoxic potential. Although the value of this assay is well recognized, there have been no comprehensive studies on the interlaboratory reproducibility of the method using a standardized protocol. A program was therefore initiated to compare the results obtained in four laboratories from testing a series of coded mutagens and nonmutagens using a standardized protocol. Additional objectives of this study were to compare male Fisher 344 rat, B6C3F1 mouse, and Syrian hamster liver S-9 preparations for the activation of chemicals; to compare Aroclor 1254-induced liver S-9 from all three species with the corresponding non-induced liver S-9's; and to compare the response of Escherichia coli WP-2 uvrA with the Salmonella typhimurium tester strains recommended by Ames. Since a primary use of in vitro microbial mutagenesis tests is the identification of potential carcinogens by their mutagenicity, the authors decided to compare the animal species and strains used by the National Cancer Institute/National Toxicology Program (NCI/NTP) for animal carcinogenicity studies

  13. Metabolomics Workbench: An international repository for metabolomics data and metadata, metabolite standards, protocols, tutorials and training, and analysis tools.

    Science.gov (United States)

    Sud, Manish; Fahy, Eoin; Cotter, Dawn; Azam, Kenan; Vadivelu, Ilango; Burant, Charles; Edison, Arthur; Fiehn, Oliver; Higashi, Richard; Nair, K Sreekumaran; Sumner, Susan; Subramaniam, Shankar

    2016-01-04

    The Metabolomics Workbench, available at www.metabolomicsworkbench.org, is a public repository for metabolomics metadata and experimental data spanning various species and experimental platforms, metabolite standards, metabolite structures, protocols, tutorials, and training material and other educational resources. It provides a computational platform to integrate, analyze, track, deposit and disseminate large volumes of heterogeneous data from a wide variety of metabolomics studies including mass spectrometry (MS) and nuclear magnetic resonance spectrometry (NMR) data spanning over 20 different species covering all the major taxonomic categories including humans and other mammals, plants, insects, invertebrates and microorganisms. Additionally, a number of protocols are provided for a range of metabolite classes, sample types, and both MS and NMR-based studies, along with a metabolite structure database. The metabolites characterized in the studies available on the Metabolomics Workbench are linked to chemical structures in the metabolite structure database to facilitate comparative analysis across studies. The Metabolomics Workbench, part of the data coordinating effort of the National Institute of Health (NIH) Common Fund's Metabolomics Program, provides data from the Common Fund's Metabolomics Resource Cores, metabolite standards, and analysis tools to the wider metabolomics community and seeks data depositions from metabolomics researchers across the world. © The Author(s) 2015. Published by Oxford University Press on behalf of Nucleic Acids Research.

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

    Directory of Open Access Journals (Sweden)

    Johan W van Neck

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

  15. National Mesothelioma Virtual Bank: A standard based biospecimen and clinical data resource to enhance translational research

    Directory of Open Access Journals (Sweden)

    Valdivieso Federico A

    2008-08-01

    Full Text Available Abstract Background Advances in translational research have led to the need for well characterized biospecimens for research. The National Mesothelioma Virtual Bank is an initiative which collects annotated datasets relevant to human mesothelioma to develop an enterprising biospecimen resource to fulfill researchers' need. Methods The National Mesothelioma Virtual Bank architecture is based on three major components: (a common data elements (based on College of American Pathologists protocol and National North American Association of Central Cancer Registries standards, (b clinical and epidemiologic data annotation, and (c data query tools. These tools work interoperably to standardize the entire process of annotation. The National Mesothelioma Virtual Bank tool is based upon the caTISSUE Clinical Annotation Engine, developed by the University of Pittsburgh in cooperation with the Cancer Biomedical Informatics Grid™ (caBIG™, see http://cabig.nci.nih.gov. This application provides a web-based system for annotating, importing and searching mesothelioma cases. The underlying information model is constructed utilizing Unified Modeling Language class diagrams, hierarchical relationships and Enterprise Architect software. Result The database provides researchers real-time access to richly annotated specimens and integral information related to mesothelioma. The data disclosed is tightly regulated depending upon users' authorization and depending on the participating institute that is amenable to the local Institutional Review Board and regulation committee reviews. Conclusion The National Mesothelioma Virtual Bank currently has over 600 annotated cases available for researchers that include paraffin embedded tissues, tissue microarrays, serum and genomic DNA. The National Mesothelioma Virtual Bank is a virtual biospecimen registry with robust translational biomedical informatics support to facilitate basic science, clinical, and translational

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

    Science.gov (United States)

    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.

  17. Standardization of 8-color flow cytometry across different flow cytometer instruments: A feasibility study in clinical laboratories in Switzerland.

    Science.gov (United States)

    Glier, Hana; Heijnen, Ingmar; Hauwel, Mathieu; Dirks, Jan; Quarroz, Stéphane; Lehmann, Thomas; Rovo, Alicia; Arn, Kornelius; Matthes, Thomas; Hogan, Cassandra; Keller, Peter; Dudkiewicz, Ewa; Stüssi, Georg; Fernandez, Paula

    2017-07-29

    The EuroFlow Consortium developed a fully standardized flow cytometric approach from instrument settings, through antibody panel, reagents and sample preparation protocols, to data acquisition and analysis. The Swiss Cytometry Society (SCS) promoted a study to evaluate the feasibility of using such standardized measurements of 8-color data across two different flow cytometry platforms - Becton Dickinson (BD) FACSCanto II and Beckman Coulter (BC) Navios, aiming at increasing reproducibility and inter-laboratory comparability of immunophenotypic data in clinical laboratories in Switzerland. The study was performed in two phases, i.e. a learning phase (round 1) and an analytical phase (rounds 2 and 3) consisting of a total of three rounds. Overall, 10 laboratories using BD FACSCanto II (n=6) or BC Navios (n=4) flow cytometers participated. Each laboratory measured peripheral blood samples from healthy donors stained with a uniform antibody panel of reagents - EuroFlow Lymphoid Screening Tube (LST) - applying the EuroFlow standardized protocols for instrument setup and sample preparation (www.EuroFlow.org). All data files were analyzed centrally and median fluorescence intensity (MedFI) values for individual markers on defined lymphocyte subsets were recorded; variability from reference MedFI values was assessed using performance scores. Data troubleshooting and discussion of the results with the participants followed after each round at SCS meetings. The results of the learning phase demonstrated that standardized instrument setup and data acquisition are feasible in routine clinical laboratories without previous experience with EuroFlow. During the analytical phase, highly comparable data were obtained at the different laboratories using either BD FACSCanto II or BC Navios. The coefficient of variation of MedFI for 7 of 11 markers performed repeatedly below 30%. In the last study round, 89% of participants scored over 90% MedFI values within the acceptance criteria

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

    Science.gov (United States)

    Santos, Mônica Loureiro; Iglesias, Antônio Carlos

    2017-01-01

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

  19. [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.

  20. 75 FR 20901 - Standards for Business Practices and Communication Protocols for Public Utilities

    Science.gov (United States)

    2010-04-22

    ... verify demand response products in wholesale markets administered by the ISOs and RTOs.\\13\\ \\13\\ Phase I... contends that the ISOs and RTOs are in a better position to develop these standards, due to regional... providers, ISOs, RTOs, public utilities and trade groups. 27. The continued cooperation and efforts of all...

  1. A standardized conjugation protocol to asses antibiotic resistance transfer between lactococcal species

    DEFF Research Database (Denmark)

    Lampkowska, Joanna; Feld, Louise; Monaghan, Aine

    2008-01-01

    Optimal conditions and a standardized method for conjugation between two model lactococcal strains, Lactococcus lactis SH4174 (pAM beta 1-containing, erythromycin resistant donor) and L. lactis Bu2-60 (plasmid-free, erythromycin sensitive recipient), were developed and tested in a inter-laborator...

  2. A standardized conjugation protocol to assess antibiotic resistance transfer between lactococcal species

    NARCIS (Netherlands)

    Lampkowska, J.; Feld, L.; Monaghan, A.; Toomey, N.; Schjørring, S.; Jacobsen, B.; Voet, van der H.; Andersen, S.R.; Bolton, D.; Aarts, H.J.M.; Krogfelt, K.A.; Wilcks, A.; Bardowski, J.K.

    2008-01-01

    Optimal conditions and a standardized method for conjugation between two model lactococcal strains, Lactococcus lactis SH4174 (pAMbeta1-containing, erythromycin resistant donor) and L. lactis Bu2-60 (plasmid-free, erythromycin sensitive recipient), were developed and tested in a inter-laboratory

  3. Spray Drift Reduction Evaluations of Spray Nozzles Using a Standardized Testing Protocol

    Science.gov (United States)

    2010-07-01

    Drop Size Characteristics in a Spray Using Optical Nonimaging Light-Scattering Instruments,” Annual Book of ASTM Standards, Vol. 14-02, ASTM...Test Method for Determining Liquid Drop Size Characteristics in a Spray Using Optical Non- imaging Light-Scattering Instruments 22. AGDISP Model

  4. Protocol - realist and meta-narrative evidence synthesis: Evolving Standards (RAMESES

    Directory of Open Access Journals (Sweden)

    Westhorp Gill

    2011-08-01

    Full Text Available Abstract Background There is growing interest in theory-driven, qualitative and mixed-method approaches to systematic review as an alternative to (or to extend and supplement conventional Cochrane-style reviews. These approaches offer the potential to expand the knowledge base in policy-relevant areas - for example by explaining the success, failure or mixed fortunes of complex interventions. However, the quality of such reviews can be difficult to assess. This study aims to produce methodological guidance, publication standards and training resources for those seeking to use the realist and/or meta-narrative approach to systematic review. Methods/design We will: [a] collate and summarise existing literature on the principles of good practice in realist and meta-narrative systematic review; [b] consider the extent to which these principles have been followed by published and in-progress reviews, thereby identifying how rigour may be lost and how existing methods could be improved; [c] using an online Delphi method with an interdisciplinary panel of experts from academia and policy, produce a draft set of methodological steps and publication standards; [d] produce training materials with learning outcomes linked to these steps; [e] pilot these standards and training materials prospectively on real reviews-in-progress, capturing methodological and other challenges as they arise; [f] synthesise expert input, evidence review and real-time problem analysis into more definitive guidance and standards; [g] disseminate outputs to audiences in academia and policy. The outputs of the study will be threefold: 1. Quality standards and methodological guidance for realist and meta-narrative reviews for use by researchers, research sponsors, students and supervisors 2. A 'RAMESES' (Realist and Meta-review Evidence Synthesis: Evolving Standards statement (comparable to CONSORT or PRISMA of publication standards for such reviews, published in an open

  5. A Review of Offset Programs: Trading Systems, Funds, Protocols, Standards and Retailers

    Energy Technology Data Exchange (ETDEWEB)

    Kollmuss, Anja; Lazarus, Michael; Lee, Carrie; Polycarp, Clifford

    2008-11-15

    Carbon or greenhouse gas (GHG) offsets have long been promoted as an important element of a comprehensive climate policy approach. Offset programs can reduce the overall cost of achieving a given emission goal by enabling emission reductions to occur where costs are lower. Furthermore, offsets have the potential to deliver sustainability co-benefits, spurred through technology development and transfer, and to develop human and institutional capacity for reducing emissions in sectors and locations not included in a cap and trade or a mandatory government policy. However, offsets can pose a risk to the environmental integrity of climate actions, especially if issues surrounding additionality, permanence, leakage, quantification and verification are not adequately addressed. The challenge for policymakers is clear: to design offset programs and policies that can maximize their potential benefits while minimizing their potential risks. The goal of this review is to provide an up-to-date analysis and synthesis of the most influential offset programs and activities, to reflect on lessons learned, and thus to inform participants and designers of current and future offset programs. Our intention is to periodically update this review to stay abreast of ongoing developments, and to develop a website portal to make this information more accessible. This version targets programs that meet one or more of the following criteria: - a significant volume of credit transactions occurring or anticipated; - an established set of rules or protocols - path-breaking, novel or otherwise notable initiatives or important lessons learned

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

    Science.gov (United States)

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

    2012-11-01

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

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

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

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

  8. A consensus protocol for the standardization of cerebrospinal fluid collection and biobanking

    DEFF Research Database (Denmark)

    Teunissen, C E; Petzold, A; Bennett, J L

    2009-01-01

    There is a long history of research into body fluid biomarkers in neurodegenerative and neuroinflammatory diseases. However, only a few biomarkers in CSF are being used in clinical practice. One of the most critical factors in CSF biomarker research is the inadequate powering of studies because o...

  9. Standard protocol for demographic and epidemiological survey to be carried out for nuclear facilities

    Energy Technology Data Exchange (ETDEWEB)

    Joshi, M L; Datta, D; Singh, Jitendra; Sardhi, I V; Verma, P C [Health Physics Division, Bhabha Atomic Research Centre, Mumbai (India)

    2007-11-15

    This document presents the standard procedures for conducting demographic and epidemiological studies for nuclear facilities. These studies are required to be carried out to prepare baseline data, the impact of the facility and the risk factors for the population residing in the vicinity of facility. This document includes the basic elements of these type surveys, their methodology and statistical analysis of the data collected during demographic and epidemiological surveillance. (author)

  10. Standard protocol for demographic and epidemiological survey to be carried out for nuclear facilities

    International Nuclear Information System (INIS)

    Joshi, M.L.; Datta, D.; Singh, Jitendra; Sardhi, I.V.; Verma, P.C.

    2007-11-01

    This document presents the standard procedures for conducting demographic and epidemiological studies for nuclear facilities. These studies are required to be carried out to prepare baseline data, the impact of the facility and the risk factors for the population residing in the vicinity of facility. This document includes the basic elements of these type surveys, their methodology and statistical analysis of the data collected during demographic and epidemiological surveillance. (author)

  11. Clinical transfusion practice update: haemovigilance, complications, patient blood management and national standards.

    Science.gov (United States)

    Engelbrecht, Sunelle; Wood, Erica M; Cole-Sinclair, Merrole F

    2013-09-16

    Blood transfusion is not without risk. Although the risks of HIV and hepatitis transmission have diminished, haemovigilance programs highlight that other significant transfusion hazards remain. Sepsis from bacterial contamination is the most common residual infectious hazard in developed countries, and events due to clerical error are problematic. Unnecessary transfusions should be avoided. New national guidelines on patient blood management (PBM) emphasise holistic approaches, including strategies to reduce transfusion requirements. Perioperative PBM should incorporate preoperative haemoglobin and medication optimisation, intraoperative blood conservation, and consideration of restrictive postoperative transfusion and cell-salvage techniques. When massive transfusion is required, hospitals should implement massive transfusion protocols. These protocols reduce mortality, improve communication and facilitate adequate provision of blood products. They should include multidisciplinary team involvement and guidelines for use of blood components and adjunctive agents. Although fresh frozen plasma to red blood cell and platelet to red blood cell ratios of ≥ 1 : 2 appear to reduce mortality in trauma patients who receive massive transfusion, there is insufficient evidence to recommend specific ratios. Systematic reviews have found no significant benefit of recombinant activated factor VII in critical bleeding, and an increase in thromboembolic events; specialist haematology advice is therefore recommended when considering use of this agent. The National Safety and Quality Health Service Standards address use of blood and blood products, and provide important transfusion principles for adoption by all clinicians. Storage of red cells in additive solution results in changes, known as the "storage lesion", and studies to determine the clinical effect of the age of blood at transfusion are ongoing.

  12. A fixed protocol for outpatient clinic routines in the care of patients with severe renal failure.

    Science.gov (United States)

    Hadimeri, Henrik; Frisenette-Fich, Carsten; Deurell, Sven-Ingemar; Svensson, Lars; Carlsson-Bjering, Lena; Fernström, Anders; Almroth, Gabriel; Melander, Stefan; Haarhaus, Mattias; Andersson, Per-Olof; Cassel, Agneta; Mauritz, Nils-Johan; Ståhl-Nilsson, Agneta; Wilske, Jan; Nordström, Kataryna; Oruda, Pavel; Eriksson, Marie; Larsson, Annelie Inghilesi; Stegmayr, Bernd

    2013-07-01

    The primary aim of this study was to assess whether a fixed protocol, using a specially trained team, for intermediate follow-up to fulfillment of guideline targets is non-inferior to conventional follow-up in the care of uraemic patients. A secondary aim was to investigate possible impact on patient outcome. The cohort comprised 424 patients from seven centers. Inclusion criteria were either serum creatinine exceeding 200 µmol/l or calculated clearance below 30 ml/min, representing CKD 4 or 5a. Six centers followed a standardized protocol (group 1). One center provided controls (group 2). The study design was prospective and interventional. The variables measured were blood hemoglobin, bicarbonate, calcium, phosphate, intact parathyroid hormone, albumin, renal function variables, blood pressure and RAAS blockade. The number of patients achieving the set goals was analyzed as a time trend to determine if the intervention resulted in an improvement. At baseline, group 1 had significantly lower GFR and higher serum creatinine, calcium, phosphate, calcium × phosphate product and bicarbonate, lower mean arterial pressure (MAP), systolic blood pressures and less use of RAAS. During the intervention, group 1 improved in the direction of guidelines for blood hemoglobin, albumin, bicarbonate and MAP. Outcome of secondary endpoints gave a risk of death of 30% in both groups, while the risk of renal replacement therapy was higher in group 1. However, the time to renal replacement therapy was significantly shorter in the intervention group, indicating that other variables than guideline achievements are important for the patient.

  13. Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial

    Science.gov (United States)

    Parkin, Patricia C; Willan, Andrew R; Schuh, Suzanne

    2011-01-01

    Objective To determine if rapid rather than standard intravenous rehydration results in improved hydration and clinical outcomes when administered to children with gastroenteritis. Design Single centre, two arm, parallel randomised pragmatic controlled trial. Blocked randomisation stratified by site. Participants, caregivers, outcome assessors, investigators, and statisticians were blinded to the treatment assignment. Setting Paediatric emergency department in a tertiary care centre in Toronto, Canada. Participants 226 children aged 3 months to 11 years; complete follow-up was obtained on 223 (99%). Eligible children were aged over 90 days, had a diagnosis of dehydration secondary to gastroenteritis, had not responded to oral rehydration, and had been prescribed intravenous rehydration. Children were excluded if they weighed less than 5 kg or more than 33 kg, required fluid restriction, had a suspected surgical condition, or had an insurmountable language barrier. Children were also excluded if they had a history of a chronic systemic disease, abdominal surgery, bilious or bloody vomit, hypotension, or hypoglycaemia or hyperglycaemia. Interventions Rapid (60 mL/kg) or standard (20 mL/kg) rehydration with 0.9% saline over an hour; subsequent fluids administered according to protocol. Main outcome measures Primary outcome: clinical rehydration, assessed with a validated scale, two hours after the start of treatment. Secondary outcomes: prolonged treatment, mean clinical dehydration scores over the four hour study period, time to discharge, repeat visits to emergency department, adequate oral intake, and physician’s comfort with discharge. Data from all randomised patients were included in an intention to treat analysis. Results 114 patients were randomised to rapid rehydration and 112 to standard. One child was withdrawn because of severe hyponatraemia at baseline. There was no evidence of a difference between the rapid and standard rehydration groups in the

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

    Science.gov (United States)

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

    2010-08-01

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

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

    International Nuclear Information System (INIS)

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

    2001-01-01

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

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

    International Nuclear Information System (INIS)

    Gomes, Mafalda; Matias, Alexandra; Macedo, Filipe

    2015-01-01

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

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

    Science.gov (United States)

    Gomes, Mafalda; Matias, Alexandra; Macedo, Filipe

    2015-12-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2015-12-15

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

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

    International Nuclear Information System (INIS)

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

    1995-01-01

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

  20. [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.

  1. Early Appropriate Care: A Protocol to Standardize Resuscitation Assessment and to Expedite Fracture Care Reduces Hospital Stay and Enhances Revenue.

    Science.gov (United States)

    Vallier, Heather A; Dolenc, Andrea J; Moore, Timothy A

    2016-06-01

    We hypothesized that a standardized protocol for fracture care would enhance revenue by reducing complications and length of stay. Prospective consecutive series. Level 1 trauma center. Two hundread and fifty-three adult patients with a mean age of 40.7 years and mean Injury Severity Score of 26.0. Femur, pelvis, or spine fractures treated surgically. Hospital and professional charges and collections were analyzed. Fixation was defined as early (<36 hours) or delayed. Complications and hospital stay were recorded. Mean charges were US $180,145 with a mean of US $66,871 collected (37%). The revenue multiplier was US $59,882/$6989 (8.57), indicating hospital collection of US $8.57 for every professional dollar, less than half of which went to orthopaedic surgeons. Delayed fracture care was associated with more intensive care unit (4.5 vs. 9.4) and total hospital days (9.4 vs. 15.3), with mean loss of actual revenue US $6380/patient delayed (n = 47), because of the costs of longer length of stay. Complications were associated with the highest expenses: mean of US $291,846 charges and US $101,005 collections, with facility collections decreased by 5.1%. An uncomplicated course of care was associated with the most favorable total collections: (US $60,017/$158,454 = 38%) and the shortest mean stay (8.7 days). Facility collections were nearly 9 times more than professional collections. Delayed fixation was associated with more complications, and facility collections decreased 5% with a complication. Furthermore, delayed fixation was associated with longer hospital stay, accounting for US $300K more in actual costs during the study. A standardized protocol to expedite definitive fixation enhances the profitability of the trauma service line. Economic Level IV. See Instructions for Authors for a complete description of levels of evidence.

  2. Standardization of a Protocol for Obtaining Platelet Rich Plasma from blood Donors; a Tool for Tissue Regeneration Procedures.

    Science.gov (United States)

    Gómez, Lina Andrea; Escobar, Magally; Peñuela, Oscar

    2015-01-01

    To develop a protocol for obtaining autologous platelet rich plasma in healthy individuals and to determine the concentration of five major growth factors before platelet activation. This protocol could be integrated into the guidelines of good clinical practice and research in regenerative medicine. Platelet rich plasma was isolated by centrifugation from 38 healthy men and 42 women ranging from 18 to 59 years old. The platelet count and quantification of growth factors were analyzed in eighty samples, stratified for age and gender of the donor. Analyses were performed using parametric the t-test or Pearson's analysis for non-parametric distribution. P platelet counts from 1.6 to 4.9 times (mean = 2.8). There was no correlation between platelet concentration and the level of the following growth factors: VEGF-D (r = 0.009, p = 0.4105), VEGF-A (r = 0.0068, p = 0.953), PDGF subunit AA (p = 0.3618; r = 0.1047), PDGF-BB (p = 0.5936; r = 0.6095). In the same way, there was no correlation between donor gender and growth factor concentrations. Only TGF-β concentration was correlated to platelet concentration (r = 0.3163, p = 0.0175). The procedure used allowed us to make preparations rich in platelets, low in leukocytes and red blood cells, and sterile. Our results showed biological variations in content of growth factors in PRP. The factors influencing these results should be further studied.

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

    Science.gov (United States)

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

    2015-10-01

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

  4. Guidelines for Standard Photography in Gross and Clinical Anatomy

    Science.gov (United States)

    Barut, Cagatay; Ertilav, Hakan

    2011-01-01

    Photography has a widespread usage in medicine and anatomy. In this review, authors focused on the usage of photography in gross and clinical anatomy. Photography in gross and clinical anatomy is not only essential for accurate documentation of morphological findings but also important in sharing knowledge and experience. Photographs of cadavers…

  5. 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

  6. 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

  7. 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…

  8. Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment

    Directory of Open Access Journals (Sweden)

    Rosiana Estéfane da Silva

    Full Text Available BACKGROUND Despite its recognised toxicity, antimonial therapy continues to be the first-line drug for cutaneous leishmaniasis (CL treatment. Intralesional administration of meglumine antimoniate (MA represents an alternative that could reduce the systemic absorption of the drug and its side effects. OBJECTIVES This study aims to validate the standard operational procedure (SOP for the intralesional infiltration of MA for CL therapy as the first step before the assessment of efficacy and safety related to the procedure. METHODS The SOP was created based on 21 trials retrieved from the literature, direct monitoring of the procedure and consultation with experts. This script was submitted to a formal computer-aided inspection to identify readability, clarity, omission, redundancy and unnecessary information (content validation. For criterion and construct validations, the influence of critical condition changes (compliance with the instructions and professional experience on outcome conformity (saturation status achievement, tolerability (pain referred and safety (bleeding were assessed. FINDINGS The median procedure length was 12 minutes and in 72% of them, patients classified the pain as mild. The bleeding was also classified as mild in 96.6% of the procedures. Full compliance with the SOP was observed in 66% of infiltrations. Despite this, in 100% of the inspected procedures, lesion saturation was observed at the end of infiltration, which means that it tolerates some degree of modification in its execution (robustness without prejudice to the result. CONCLUSIONS The procedure is reproducible and can be used by professionals without previous training with high success and safety rates.

  9. Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment.

    Science.gov (United States)

    Silva, Rosiana Estéfane da; Carvalho, Janaína de Pina; Ramalho, Dario Brock; Senna, Maria Camilo Ribeiro De; Moreira, Hugo Silva Assis; Rabello, Ana; Cota, Erika; Cota, Gláucia

    2018-02-01

    BACKGROUND Despite its recognised toxicity, antimonial therapy continues to be the first-line drug for cutaneous leishmaniasis (CL) treatment. Intralesional administration of meglumine antimoniate (MA) represents an alternative that could reduce the systemic absorption of the drug and its side effects. OBJECTIVES This study aims to validate the standard operational procedure (SOP) for the intralesional infiltration of MA for CL therapy as the first step before the assessment of efficacy and safety related to the procedure. METHODS The SOP was created based on 21 trials retrieved from the literature, direct monitoring of the procedure and consultation with experts. This script was submitted to a formal computer-aided inspection to identify readability, clarity, omission, redundancy and unnecessary information (content validation). For criterion and construct validations, the influence of critical condition changes (compliance with the instructions and professional experience) on outcome conformity (saturation status achievement), tolerability (pain referred) and safety (bleeding) were assessed. FINDINGS The median procedure length was 12 minutes and in 72% of them, patients classified the pain as mild. The bleeding was also classified as mild in 96.6% of the procedures. Full compliance with the SOP was observed in 66% of infiltrations. Despite this, in 100% of the inspected procedures, lesion saturation was observed at the end of infiltration, which means that it tolerates some degree of modification in its execution (robustness) without prejudice to the result. CONCLUSIONS The procedure is reproducible and can be used by professionals without previous training with high success and safety rates.

  10. The international protocol for the dosimetry of external radiotherapy beams based on standards of absorbed dose to water

    International Nuclear Information System (INIS)

    Andreo, P.

    2001-01-01

    An International Code of Practice (CoP, or dosimetry protocol) for external beam radiotherapy dosimetry based on standards of absorbed dose to water has been published by the IAEA on behalf of IAEA, WHO, PAHO and ESTRO. The CoP provides a systematic and internationally unified approach for the determination of the absorbed dose to water in reference conditions with radiotherapy beams. The development of absorbed-dose-to-water standards for high-energy photons and electrons offers the possibility of reducing the uncertainty in the dosimetry of radiotherapy beams. Many laboratories already provide calibrations at the radiation quality of 60Co gamma-rays and some have extended calibrations to high-energy photon and electron beams. The dosimetry of kilovoltage x-rays, as well as that of proton and ion beams can also be based on these standards. Thus, a coherent dosimetry system based on the same formalism is achieved for practically all radiotherapy beams. The practical use of the CoP as simple. The document is formed by a set of different CoPs for each radiation type, which include detailed procedures and worksheets. All CoPs are based on ND,w chamber calibrations at a reference beam quality Qo, together with radiation beam quality correction factors kQ preferably measured directly for the user's chamber in a standards laboratory. Calculated values of kQ are provided together with their uncertainty estimates. Beam quality specifiers are 60Co, TPR20,10 (high-energy photons), R50 (electrons), HVL and kV (x-rays) and Rres (protons and ions) [es

  11. 76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

    Science.gov (United States)

    2011-08-19

    ... clinical trials of therapeutic drugs and biological products. The draft guidance describes standards... important imaging endpoint is used in a clinical trial of a therapeutic drug or biological product... Services to the Chairman of [[Page 51994

  12. 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

  13. 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

  14. Making the Case for Standards of Conduct in Clinical Training

    Science.gov (United States)

    Homrich, Alicia M.; DeLorenzi, Leigh D.; Bloom, Zachary D.; Godbee, Brandi

    2014-01-01

    The authors examined a proposed set of standards for the personal and professional conduct of counseling trainees. Eighty-two counselor educators and supervisors from programs accredited by the Council for Accreditation of Counseling and Related Educational Programs ranked 55 behaviors divided across 3 categories (i.e., professional,…

  15. 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.

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

    Science.gov (United States)

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

    2016-07-01

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

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

    Directory of Open Access Journals (Sweden)

    Kappelle L Jaap

    2008-11-01

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

  18. The Cardiology Audit and Registration Data Standards (CARDS), European data standards for clinical cardiology practice

    NARCIS (Netherlands)

    M.R. Flynn (Rachel); C. Barrett (Conor); F.G. Cosio (Francisco); A.K. Gitt (Anselm); L.C. Wallentin (Lars); P. Kearney (Peter); M. Lonergan (Moira); E. Shelley (Emer); M.L. Simoons (Maarten)

    2005-01-01

    textabstractAIMS: Systematic registration of data from clinical practice is important for clinical care, local, national and international registries, and audit. Data to be collected for these different purposes should be harmonized. Therefore, during Ireland's Presidency of the European Union (EU)

  19. Using Semantic Web technologies for the generation of domain-specific templates to support clinical study metadata standards.

    Science.gov (United States)

    Jiang, Guoqian; Evans, Julie; Endle, Cory M; Solbrig, Harold R; Chute, Christopher G

    2016-01-01

    The Biomedical Research Integrated Domain Group (BRIDG) model is a formal domain analysis model for protocol-driven biomedical research, and serves as a semantic foundation for application and message development in the standards developing organizations (SDOs). The increasing sophistication and complexity of the BRIDG model requires new approaches to the management and utilization of the underlying semantics to harmonize domain-specific standards. The objective of this study is to develop and evaluate a Semantic Web-based approach that integrates the BRIDG model with ISO 21090 data types to generate domain-specific templates to support clinical study metadata standards development. We developed a template generation and visualization system based on an open source Resource Description Framework (RDF) store backend, a SmartGWT-based web user interface, and a "mind map" based tool for the visualization of generated domain-specific templates. We also developed a RESTful Web Service informed by the Clinical Information Modeling Initiative (CIMI) reference model for access to the generated domain-specific templates. A preliminary usability study is performed and all reviewers (n = 3) had very positive responses for the evaluation questions in terms of the usability and the capability of meeting the system requirements (with the average score of 4.6). Semantic Web technologies provide a scalable infrastructure and have great potential to enable computable semantic interoperability of models in the intersection of health care and clinical research.

  20. 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.

  1. The place of clinical features and standard chest radiography in ...

    African Journals Online (AJOL)

    One hundred and five primary mediastinal masses were seen between 1975 and 1998, at the Cardiothoracic surgical Unit of the University College Hospital Ibadan. These were studied to establish the importance of clinical features and plain chest radiography in preoperative evaluation of these masses. The sources of ...

  2. 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

  3. 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

  4. The role of the standard EEG in clinical psychiatry.

    LENUS (Irish Health Repository)

    O'Sullivan, S S

    2012-02-03

    BACKGROUND: The EEG is a commonly requested test on patients attending psychiatric services, predominantly to investigate for a possible organic brain syndrome causing behavioural changes. AIMS: To assess referrals for EEG from psychiatric services in comparison with those from other sources. We determine which clinical factors were associated with an abnormal EEG in patients referred from psychiatric sources. METHODS: A retrospective review of EEG requests in a 1-year period was performed. Analysis of referral reasons for psychiatric patients was undertaken, and outcome of patients referred from psychiatric services post-EEG was reviewed. RESULTS: One thousand four hundred and seventy EEGs were reviewed, of which 91 (6.2%) were referred from psychiatry. Neurology service referrals had detection rates of abnormal EEGs of 27%, with psychiatric referrals having the lowest abnormality detection rate of 17.6% (p < 0.1). In psychiatric-referred patients the only significant predictors found of an abnormal EEG were a known history of epilepsy (p < 0.001), being on clozapine (p < 0.05), and a possible convulsive seizure (RR = 6.51). Follow-up data of 53 patients did not reveal a significant clinical impact of EEG results on patient management. CONCLUSIONS: Many patients are referred for EEG from psychiatric sources despite a relatively low index of suspicion of an organic brain disorders, based on reasons for referral documented, with an unsurprising low clinical yield.

  5. Pragmatic, consensus-based minimum standards and structured interview to guide the selection and development of cancer support group leaders: a protocol paper.

    Science.gov (United States)

    Pomery, Amanda; Schofield, Penelope; Xhilaga, Miranda; Gough, Karla

    2017-06-30

    Across the globe, peer support groups have emerged as a community-led approach to accessing support and connecting with others with cancer experiences. Little is known about qualities required to lead a peer support group or how to determine suitability for the role. Organisations providing assistance to cancer support groups and their leaders are currently operating independently, without a standard national framework or published guidelines. This protocol describes the methods that will be used to generate pragmatic consensus-based minimum standards and an accessible structured interview with user manual to guide the selection and development of cancer support group leaders. We will: (A) identify and collate peer-reviewed literature that describes qualities of support group leaders through a systematic review; (B) content analyse eligible documents for information relevant to requisite knowledge, skills and attributes of group leaders generally and specifically to cancer support groups; (C) use an online reactive Delphi method with an interdisciplinary panel of experts to produce a clear, suitable, relevant and appropriate structured interview comprising a set of agreed questions with behaviourally anchored rating scales; (D) produce a user manual to facilitate standard delivery of the structured interview; (E) pilot the structured interview to improve clinical utility; and (F) field test the structured interview to develop a rational scoring model and provide a summary of existing group leader qualities. The study is approved by the Department Human Ethics Advisory Group of The University of Melbourne. The study is based on voluntary participation and informed written consent, with participants able to withdraw at any time. The results will be disseminated at research conferences and peer review journals. Presentations and free access to the developed structured interview and user manual will be available to cancer agencies. © Article author(s) (or their

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

    Science.gov (United States)

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

    2014-10-01

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

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

    Science.gov (United States)

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

    2010-01-01

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

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

    Science.gov (United States)

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

    2018-01-09

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

  9. "Heidelberg standard examination" and "Heidelberg standard procedures" - Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education.

    Science.gov (United States)

    Nikendei, C; Ganschow, P; Groener, J B; Huwendiek, S; Köchel, A; Köhl-Hackert, N; Pjontek, R; Rodrian, J; Scheibe, F; Stadler, A-K; Steiner, T; Stiepak, J; Tabatabai, J; Utz, A; Kadmon, M

    2016-01-01

    The competent physical examination of patients and the safe and professional implementation of clinical procedures constitute essential components of medical practice in nearly all areas of medicine. The central objective of the projects "Heidelberg standard examination" and "Heidelberg standard procedures", which were initiated by students, was to establish uniform interdisciplinary standards for physical examination and clinical procedures, and to distribute them in coordination with all clinical disciplines at the Heidelberg University Hospital. The presented project report illuminates the background of the initiative and its methodological implementation. Moreover, it describes the multimedia documentation in the form of pocketbooks and a multimedia internet-based platform, as well as the integration into the curriculum. The project presentation aims to provide orientation and action guidelines to facilitate similar processes in other faculties.

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

    Science.gov (United States)

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

    2012-10-01

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

  11. Group differences in physician responses to handheld presentation of clinical evidence: a verbal protocol analysis

    Directory of Open Access Journals (Sweden)

    Pavlovic Nada J

    2007-07-01

    Full Text Available Abstract Background To identify individual differences in physicians' needs for the presentation of evidence resources and preferences for mobile devices. Methods Within-groups analysis of responses to semi-structured interviews. Interviews consisted of using prototypes in response to task-based scenarios. The prototypes were implemented on two different form factors: a tablet style PC and a pocketPC. Participants were from three user groups: general internists, family physicians and medicine residents, and from two different settings: urban and semi-urban. Verbal protocol analysis, which consists of coding utterances, was conducted on the transcripts of the testing sessions. Statistical relationships were investigated between staff physicians' and residents' background variables, self-reported experiences with the interfaces, and verbal code frequencies. Results 47 physicians were recruited from general internal medicine, family practice clinics and a residency training program. The mean age of participants was 42.6 years. Physician specialty had a greater effect on device and information-presentation preferences than gender, age, setting or previous technical experience. Family physicians preferred the screen size of the tablet computer and were less concerned about its portability. Residents liked the screen size of the tablet, but preferred the portability of the pocketPC. Internists liked the portability of the pocketPC, but saw less advantage to the large screen of the tablet computer (F[2,44] = 4.94, p = .012. Conclusion Different types of physicians have different needs and preferences for evidence-based resources and handheld devices. This study shows how user testing can be incorporated into the process of design to inform group-based customization.

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

    Science.gov (United States)

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

    2013-01-01

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

  13. Laparoscopic colorectal surgery in learning curve: Role of implementation of a standardized technique and recovery protocol. A cohort study

    Science.gov (United States)

    Luglio, Gaetano; De Palma, Giovanni Domenico; Tarquini, Rachele; Giglio, Mariano Cesare; Sollazzo, Viviana; Esposito, Emanuela; Spadarella, Emanuela; Peltrini, Roberto; Liccardo, Filomena; Bucci, Luigi

    2015-01-01

    Background Despite the proven benefits, laparoscopic colorectal surgery is still under utilized among surgeons. A steep learning is one of the causes of its limited adoption. Aim of the study is to determine the feasibility and morbidity rate after laparoscopic colorectal surgery in a single institution, “learning curve” experience, implementing a well standardized operative technique and recovery protocol. Methods The first 50 patients treated laparoscopically were included. All the procedures were performed by a trainee surgeon, supervised by a consultant surgeon, according to the principle of complete mesocolic excision with central vascular ligation or TME. Patients underwent a fast track recovery programme. Recovery parameters, short-term outcomes, morbidity and mortality have been assessed. Results Type of resections: 20 left side resections, 8 right side resections, 14 low anterior resection/TME, 5 total colectomy and IRA, 3 total panproctocolectomy and pouch. Mean operative time: 227 min; mean number of lymph-nodes: 18.7. Conversion rate: 8%. Mean time to flatus: 1.3 days; Mean time to solid stool: 2.3 days. Mean length of hospital stay: 7.2 days. Overall morbidity: 24%; major morbidity (Dindo–Clavien III): 4%. No anastomotic leak, no mortality, no 30-days readmission. Conclusion Proper laparoscopic colorectal surgery is safe and leads to excellent results in terms of recovery and short term outcomes, even in a learning curve setting. Key factors for better outcomes and shortening the learning curve seem to be the adoption of a standardized technique and training model along with the strict supervision of an expert colorectal surgeon. PMID:25859386

  14. Development of job standards for clinical nutrition therapy for dyslipidemia patients.

    Science.gov (United States)

    Kang, Min-Jae; Seo, Jung-Sook; Kim, Eun-Mi; Park, Mi-Sun; Woo, Mi-Hye; Ju, Dal-Lae; Wie, Gyung-Ah; Lee, Song-Mi; Cha, Jin-A; Sohn, Cheong-Min

    2015-04-01

    Dyslipidemia has significantly contributed to the increase of death and morbidity rates related to cardiovascular diseases. Clinical nutrition service provided by dietitians has been reported to have a positive effect on relief of medical symptoms or reducing the further medical costs. However, there is a lack of researches to identify key competencies and job standard for clinical dietitians to care patients with dyslipidemia. Therefore, the purpose of this study was to analyze the job components of clinical dietitian and develop the standard for professional practice to provide effective nutrition management for dyslipidemia patients. The current status of clinical nutrition therapy for dyslipidemia patients in hospitals with 300 or more beds was studied. After duty tasks and task elements of nutrition care process for dyslipidemia clinical dietitians were developed by developing a curriculum (DACUM) analysis method. The developed job standards were pretested in order to evaluate job performance, difficulty, and job standards. As a result, the job standard included four jobs, 18 tasks, and 53 task elements, and specific job description includes 73 basic services and 26 recommended services. When clinical dietitians managing dyslipidemia patients performed their practice according to this job standard for 30 patients the job performance rate was 68.3%. Therefore, the job standards of clinical dietitians for clinical nutrition service for dyslipidemia patients proposed in this study can be effectively used by hospitals.

  15. A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

    Science.gov (United States)

    Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

    2013-01-01

    Background If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. PMID:21429960

  16. Data for improvement and clinical excellence: protocol for an audit with feedback intervention in long-term care

    Directory of Open Access Journals (Sweden)

    Schalm Corinne

    2010-10-01

    Full Text Available Abstract Background There is considerable evidence about the effectiveness of audit coupled with feedback, although few audit with feedback interventions have been conducted in long-term care (LTC settings to date. In general, the effects have been found to be modest at best, although in settings where there has been little history of audit and feedback, the effects may be greater, at least initially. The primary purpose of the Data for Improvement and Clinical Excellence (DICE Long-Term Care project is to assess the effects of an audit with feedback intervention delivered monthly over 13 months in four LTC facilities. The research questions we addressed are: 1. What effects do feedback reports have on processes and outcomes over time? 2. How do different provider groups in LTC and home care respond to feedback reports based on data targeted at improving quality of care? Methods/design The research team conducting this study comprises researchers and decision makers in continuing care in the province of Alberta, Canada. The intervention consists of monthly feedback reports in nine LTC units in four facilities in Edmonton, Alberta. Data for the feedback reports comes from the Resident Assessment Instrument Minimum Data Set (RAI version 2.0, a standardized instrument mandated for use in LTC facilities throughout Alberta. Feedback reports consist of one page, front and back, presenting both graphic and textual information. Reports are delivered to all staff working in the four LTC facilities. The primary evaluation uses a controlled interrupted time series design both adjusted and unadjusted for covariates. The concurrent process evaluation uses observation and self-report to assess uptake of the feedback reports. Following the project phase described in this protocol, a similar intervention will be conducted in home care settings in Alberta. Depending on project findings, if they are judged useful by decision makers participating in this research

  17. Data for improvement and clinical excellence: protocol for an audit with feedback intervention in long-term care.

    Science.gov (United States)

    Sales, Anne E; Schalm, Corinne

    2010-10-13

    There is considerable evidence about the effectiveness of audit coupled with feedback, although few audit with feedback interventions have been conducted in long-term care (LTC) settings to date. In general, the effects have been found to be modest at best, although in settings where there has been little history of audit and feedback, the effects may be greater, at least initially. The primary purpose of the Data for Improvement and Clinical Excellence (DICE) Long-Term Care project is to assess the effects of an audit with feedback intervention delivered monthly over 13 months in four LTC facilities. The research questions we addressed are:1. What effects do feedback reports have on processes and outcomes over time?2. How do different provider groups in LTC and home care respond to feedback reports based on data targeted at improving quality of care? The research team conducting this study comprises researchers and decision makers in continuing care in the province of Alberta, Canada. The intervention consists of monthly feedback reports in nine LTC units in four facilities in Edmonton, Alberta. Data for the feedback reports comes from the Resident Assessment Instrument Minimum Data Set (RAI) version 2.0, a standardized instrument mandated for use in LTC facilities throughout Alberta. Feedback reports consist of one page, front and back, presenting both graphic and textual information. Reports are delivered to all staff working in the four LTC facilities. The primary evaluation uses a controlled interrupted time series design both adjusted and unadjusted for covariates. The concurrent process evaluation uses observation and self-report to assess uptake of the feedback reports. Following the project phase described in this protocol, a similar intervention will be conducted in home care settings in Alberta. Depending on project findings, if they are judged useful by decision makers participating in this research team, we plan dissemination and spread of the feedback

  18. Inter-rater and intra-rater reliability of a clinical protocol for measuring turnout in collegiate dancers.

    Science.gov (United States)

    Greene, Amanda; Lasner, Andrea; Deu, Rajwinder; Oliphant, Seth; Johnson, Kenneth

    2018-02-02

    Reliable methods of measuring turnout in dancers and comparing active turnout (used in class) with functional (uncompensated) turnout are needed. Authors have suggested measurement techniques but there is no clinically useful, easily reproducible technique with established inter-rater and intra-rater reliability. We adapted a technique based on previous research, which is easily reproducible. We hypothesized excellent inter-rater and intra-rater reliability between experienced physical therapists (PTs) and a briefly trained faculty member from a university's department of dance. Thirty-two participants were recruited from the same dance department. Dancers' active and functional turnout was measured by each rater. We found that our technique for measuring active and functional turnout has excellent inter-rater and intra-rater reliability when performed by two experienced PTs and by one briefly trained university-level dance faculty member. For active turnout, inter-rater reliability was 0.78 among all raters and 0.82 among only the PT raters; intra-rater reliability was 0.82 among all raters and 0.85 among only the PT raters. For functional turnout, inter-rater reliability was 0.86 among all raters and 0.88 among only the PT raters; intra-rater reliability was 0.87 among all raters and 0.88 among only the PT raters. The measurement technique described provides a standardized protocol with excellent inter-rater and intra-rater reliability when performed by experienced PTs or by a briefly trained university-level dance faculty member.

  19. Standardized Patients Provide a Reliable Assessment of Athletic Training Students' Clinical Skills

    Science.gov (United States)

    Armstrong, Kirk J.; Jarriel, Amanda J.

    2016-01-01

    Context: Providing students reliable objective feedback regarding their clinical performance is of great value for ongoing clinical skill assessment. Since a standardized patient (SP) is trained to consistently portray the case, students can be assessed and receive immediate feedback within the same clinical encounter; however, no research, to our…

  20. 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.

  1. A clinical investigation of motivation to change standards and cognitions about failure in perfectionism.

    Science.gov (United States)

    Egan, Sarah J; Piek, Jan P; Dyck, Murray J; Rees, Clare S; Hagger, Martin S

    2013-10-01

    Clinical perfectionism is a transdiagnostic process that has been found to maintain eating disorders, anxiety disorders and depression. Cognitive behavioural models explaining the maintenance of clinical perfectionism emphasize the contribution of dichotomous thinking and resetting standards higher following both success and failure in meeting their goals. There has been a paucity of research examining the predictions of the models and motivation to change perfectionism. Motivation to change is important as individuals with clinical perfectionism often report many perceived benefits of their perfectionism; they are, therefore, likely to be ambivalent regarding changing perfectionism. The aim was to compare qualitative responses regarding questions about motivation to change standards and cognitions regarding failure to meet a personal standard in two contrasting groups with high and low negative perfectionism. Negative perfectionism refers to concern over not meeting personal standards. A clinical group with a range of axis 1 diagnoses who were elevated on negative perfectionism were compared to a group of athletes who were low on negative perfectionism. Results indicated that the clinical group perceived many negative consequences of their perfectionism. They also, however, reported numerous benefits and the majority stated that they would prefer not to change their perfectionism. The clinical group also reported dichotomous thinking and preferring to either keep standards the same or reset standards higher following failure, whilst the athlete group reported they would keep standards the same or set them lower. The findings support predictions of the cognitive behavioural model of clinical perfectionism.

  2. 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.

  3. A collaborative study on a Nordic standard protocol for detection and enumeration of thermotolerant Campylobacter in food (NMKL 119, 3. Ed., 2007)

    DEFF Research Database (Denmark)

    Rosenquist, Hanne; Bengtsson, Anja; Hansen, Tina Beck

    2007-01-01

    A Nordic standard protocol for detection and enumeration of thermotolerant Campylobacter in food has been elaborated (NMKL 119, 3. Ed., 2007). Performance and precision characteristics of this protocol were evaluated in a collaborative study with participation of 14 laboratories from seven European...... jejuni (SLV-542). Expected concentrations (95% C.I.) (cfu g(-1) or ml(-1)) of both strains in matrices were 0.6-1.4 and 23-60 for qualitative detection, and 0.6-1.4; 23-60; and 420-1200 for semi-quantitative detection. For quantitative determination, the expected concentrations of C. jejuni/C. coli were...

  4. Clinical practice guidelines: 2004 standards, options and recommendations for the management of patient with adenocarcinoma of the stomach - radiotherapy

    International Nuclear Information System (INIS)

    Ychou, M.; Duffour, J.; Lemanski, C.; Masson, B.; Gory-Delabaere, G.; Bosquet, L.; Blanc, P.; Giovannini, M.; Monge, G.; Guillemin, F.; Marchal, F.; Conroy, T.; Merrouche, Y.; Adenis, A.; Bosset, J.F.; Bouche, O.; Pezet, D.; Triboulet, J.P.

    2004-01-01

    Context. - The 'Standards, Options and Recommendations' (SOR) project, started in 1993, is a collaboration between the Federation of French Cancer Centers (FNCLCC), the 20 French regional cancer centers, and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. Objectives. - To elaborate clinical practice guidelines for patients with stomach adenocarcinoma. These recommendations cover the diagnosis, treatment and follow-up of these tumors. Methods. - The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. The Standards, Options and Recommendations are thus based on the best available evidence and expert agreement. Results. - Adjuvant radiation therapy alone is not a standard treatment for patients with stomach adenocarcinoma. Adjuvant concomitant chemoradiotherapy is not a standard treatment for patients with stage II or III stomach adenocarcinoma R0, with D1 or D2 lymphadenectomy who have undergone surgery. Following surgical resection, adjuvant concomitant chemoradiotherapy should be proposed to patients without de-nutrition with a lymphadenectomy < D1 (fewer than 15 lymph nodes examined) and those with T3 and/or N+ tumours following the protocol used in the MacDonald trials (SWOG-9008) (Level of evidence B1). Adjuvant concomitant chemoradiotherapy can be administered to patients without de-nutrition with D1 or D2 lymphadenectomy and with involvement of regional lymph nodes (N2 or N3). (authors)

  5. Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - The SOSTRA trial protocol

    Directory of Open Access Journals (Sweden)

    Thomsen Per

    2011-01-01

    Full Text Available Abstract Background Children with attention deficit hyperactivity disorder (ADHD are hyperactive and impulsive, cannot maintain attention, and have difficulties with social interactions. Medical treatment may alleviate symptoms of ADHD, but seldom solves difficulties with social interactions. Social-skills training may benefit ADHD children in their social interactions. We want to examine the effects of social-skills training on difficulties related to the children's ADHD symptoms and social interactions. Methods/Design The design is randomised two-armed, parallel group, assessor-blinded trial. Children aged 8-12 years with a diagnosis of ADHD are randomised to social-skills training and parental training plus standard treatment versus standard treatment alone. A sample size calculation estimated that at least 52 children must be included to show a 4-point difference in the primary outcome on the Conners 3rd Edition subscale for 'hyperactivity-impulsivity' between the intervention group and the control group. The outcomes will be assessed 3 and 6 months after randomisation. The primary outcome measure is ADHD symptoms. The secondary outcome is social skills. Tertiary outcomes include the relationship between social skills and symptoms of ADHD, the ability to form attachment, and parents' ADHD symptoms. Discussion We hope that the results from this trial will show that the social-skills training together with medication may have a greater general effect on ADHD symptoms and social and emotional competencies than medication alone. Trial registration ClinicalTrials (NCT: NCT00937469

  6. Clinical Image Evaluation of Film Mammograms in Korea: Comparison with the ACR Standard

    International Nuclear Information System (INIS)

    Gwak, Yeon Joo; Kim, Hye Jung; Kwak, Jin Young; Son, Eun Ju; Ko, Kyung Hee; Lee, Jin Hwa; Lim, Hyo Soon; Lee, You Jin; Park, Ji Won; Shin, Kyung Min; Jang, Yun-Jin

    2013-01-01

    The goal of this study is to compare the overall quality of film mammograms taken according to the Korean standards with the American College of Radiology (ACR) standard for clinical image evaluation and to identify means of improving mammography quality in Korea. Four hundred and sixty eight sets of film mammograms were evaluated with respect to the Korean and ACR standards for clinical image evaluation. The pass and failure rates of mammograms were compared by medical facility types. Average scores in each category of the two standards were evaluated. Receiver operating characteristic curve analysis was used to identify an optimal Korean standard pass mark by taking the ACR standard as the reference standard. 93.6% (438/468) of mammograms passed the Korean standard, whereas only 80.1% (375/468) passed the ACR standard (p < 0.001). Non-radiologic private clinics had the lowest pass rate (88.1%: Korean standard, 71.8%: ACR standard) and the lowest total score (76.0) by the Korean standard. Average scores of positioning were lowest (19.3/29 by the Korean standard and 3.7/5 by the ACR standard). A cutoff score of 77.0 for the Korean standard was found to correspond to a pass level when the ACR standard was applied. We suggest that tighter regulations, such as, raising the Korean pass mark, subtracting more for severe deficiencies, or considering a very low scores in even a single category as failure, are needed to improve the quality of mammography in Korea

  7. The development of clinical document standards for semantic interoperability in china.

    Science.gov (United States)

    Yang, Peng; Pan, Feng; Liu, Danhong; Xu, Yongyong; Wan, Yi; Tu, Haibo; Tang, Xuejun; Hu, Jianping

    2011-12-01

    This study is aimed at developing a set of data groups (DGs) to be employed as reusable building blocks for the construction of the eight most common clinical documents used in China's general hospitals in order to achieve their structural and semantic standardization. The Diagnostics knowledge framework, the related approaches taken from the Health Level Seven (HL7), the Integrating the Healthcare Enterprise (IHE), and the Healthcare Information Technology Standards Panel (HITSP) and 1,487 original clinical records were considered together to form the DG architecture and data sets. The internal structure, content, and semantics of each DG were then defined by mapping each DG data set to a corresponding Clinical Document Architecture data element and matching each DG data set to the metadata in the Chinese National Health Data Dictionary. By using the DGs as reusable building blocks, standardized structures and semantics regarding the clinical documents for semantic interoperability were able to be constructed. Altogether, 5 header DGs, 48 section DGs, and 17 entry DGs were developed. Several issues regarding the DGs, including their internal structure, identifiers, data set names, definitions, length and format, data types, and value sets, were further defined. Standardized structures and semantics regarding the eight clinical documents were structured by the DGs. This approach of constructing clinical document standards using DGs is a feasible standard-driven solution useful in preparing documents possessing semantic interoperability among the disparate information systems in China. These standards need to be validated and refined through further study.

  8. Quality of dispatch-assisted cardiopulmonary resuscitation by lay rescuers following a standard protocol in Japan: an observational simulation study.

    Science.gov (United States)

    Asai, Hideki; Fukushima, Hidetada; Bolstad, Francesco; Okuchi, Kazuo

    2018-04-01

    Bystander cardiopulmonary resuscitation (CPR) is essential for improving the outcomes of sudden cardiac arrest patients. It has been reported that dispatch-assisted CPR (DACPR) accounts for more than half of the incidence of CPR undertaken by bystanders. Its quality, however, can be suboptimal. We aimed to measure the quality of DACPR using a simulation study. We recruited laypersons at a shopping mall and measured the quality of CPR carried out in our simulation. Dispatchers provided instruction in accordance with the standard DACPR protocol in Japan. Twenty-three laypersons (13 with CPR training experience within the past 2 years and 10 with no training experience) participated in this study. The median chest compression rate and depth were 106/min and 33 mm, respectively. The median time interval from placing the 119 call to the start of chest compressions was 119 s. No significant difference was found between the groups with and without training experience. However, subjects with training experience more frequently placed their hands correctly on the manikin (84.6% versus 40.0%; P = 0.026). Twelve participants (52.2%, seven in trained and five in untrained group) interrupted chest compressions for 3-18 s, because dispatchers asked if the patient started breathing or moving. This current simulation study showed that the quality of DACPR carried out by lay rescuers can be less than optimal in terms of depth, hand placement, and minimization of pauses. Further studies are required to explore better DACPR instruction methods to help lay rescuers perform CPR with optimal quality.

  9. 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.

  10. Effect of standardized training on the reliability of the Cochrane risk of bias assessment tool: a study protocol.

    Science.gov (United States)

    da Costa, Bruno R; Resta, Nina M; Beckett, Brooke; Israel-Stahre, Nicholas; Diaz, Alison; Johnston, Bradley C; Egger, Matthias; Jüni, Peter; Armijo-Olivo, Susan

    2014-12-13

    The Cochrane risk of bias (RoB) tool has been widely embraced by the systematic review community, but several studies have reported that its reliability is low. We aim to investigate whether training of raters, including objective and standardized instructions on how to assess risk of bias, can improve the reliability of this tool. We describe the methods that will be used in this investigation and present an intensive standardized training package for risk of bias assessment that could be used by contributors to the Cochrane Collaboration and other reviewers. This is a pilot study. We will first perform a systematic literature review to identify randomized clinical trials (RCTs) that will be used for risk of bias assessment. Using the identified RCTs, we will then do a randomized experiment, where raters will be allocated to two different training schemes: minimal training and intensive standardized training. We will calculate the chance-corrected weighted Kappa with 95% confidence intervals to quantify within- and between-group Kappa agreement for each of the domains of the risk of bias tool. To calculate between-group Kappa agreement, we will use risk of bias assessments from pairs of raters after resolution of disagreements. Between-group Kappa agreement will quantify the agreement between the risk of bias assessment of raters in the training groups and the risk of bias assessment of experienced raters. To compare agreement of raters under different training conditions, we will calculate differences between Kappa values with 95% confidence intervals. This study will investigate whether the reliability of the risk of bias tool can be improved by training raters using standardized instructions for risk of bias assessment. One group of inexperienced raters will receive intensive training on risk of bias assessment and the other will receive minimal training. By including a control group with minimal training, we will attempt to mimic what many review authors

  11. Effectiveness of a Rapid Lumbar Spine MRI Protocol Using 3D T2-Weighted SPACE Imaging Versus a Standard Protocol for Evaluation of Degenerative Changes of the Lumbar Spine.

    Science.gov (United States)

    Sayah, Anousheh; Jay, Ann K; Toaff, Jacob S; Makariou, Erini V; Berkowitz, Frank

    2016-09-01

    Reducing lumbar spine MRI scanning time while retaining diagnostic accuracy can benefit patients and reduce health care costs. This study compares the effectiveness of a rapid lumbar MRI protocol using 3D T2-weighted sampling perfection with application-optimized contrast with different flip-angle evolutions (SPACE) sequences with a standard MRI protocol for evaluation of lumbar spondylosis. Two hundred fifty consecutive unenhanced lumbar MRI examinations performed at 1.5 T were retrospectively reviewed. Full, rapid, and complete versions of each examination were interpreted for spondylotic changes at each lumbar level, including herniations and neural compromise. The full examination consisted of sagittal T1-weighted, T2-weighted turbo spin-echo (TSE), and STIR sequences; and axial T1- and T2-weighted TSE sequences (time, 18 minutes 40 seconds). The rapid examination consisted of sagittal T1- and T2-weighted SPACE sequences, with axial SPACE reformations (time, 8 minutes 46 seconds). The complete examination consisted of the full examination plus the T2-weighted SPACE sequence. Sensitivities and specificities of the full and rapid examinations were calculated using the complete study as the reference standard. The rapid and full studies had sensitivities of 76.0% and 69.3%, with specificities of 97.2% and 97.9%, respectively, for all degenerative processes. Rapid and full sensitivities were 68.7% and 66.3% for disk herniation, 85.2% and 81.5% for canal compromise, 82.9% and 69.1% for lateral recess compromise, and 76.9% and 69.7% for foraminal compromise, respectively. Isotropic SPACE T2-weighted imaging provides high-quality imaging of lumbar spondylosis, with multiplanar reformatting capability. Our SPACE-based rapid protocol had sensitivities and specificities for herniations and neural compromise comparable to those of the protocol without SPACE. This protocol fits within a 15-minute slot, potentially reducing costs and discomfort for a large subgroup of

  12. 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.

  13. FPGA based data-flow injection module at 10 Gbit/s reading data from network exported storage and using standard protocols

    International Nuclear Information System (INIS)

    Lemouzy, B; Garnier, J-C; Neufeld, N

    2011-01-01

    The goal of the LHCb readout upgrade is to accelerate the DAQ to 40 MHz. Such a DAQ system will certainly employ 10 Gigabit or similar technologies and might also need new networking protocols such as a customized, light-weight TCP or more specialized protocols. A test module is being implemented to be integrated in the existing LHCb infrastructure. It is a multiple 10-Gigabit traffic generator, driven by a Stratix IV FPGA, and flexible enough to generate LHCb's raw data packets. Traffic data are either internally generated or read from external storage via the network. We have implemented a light-weight industry standard protocol ATA over Ethernet (AoE) and we present an outlook of using a file-system on these network-exported disk-drivers.

  14. LHCb: FPGA based data-flow injection module at 10 Gbit/s reading data from network exported storage and using standard protocols

    CERN Multimedia

    Lemouzy, B; Garnier, J-C

    2010-01-01

    The goal of the LHCb readout upgrade is to speed up the DAQ to 40 MHz. Such a DAQ system will certainly employ 10 Gigabit or similar technologies and might also need new networking protocols such as a customized, light-weight TCP or more specialised protocols. A test module is being implemented, which integrates in the existing LHCb infrastructure. It is a multiple 10-Gigabit traffic generator, driven by a Stratix IV FPGA, which is flexibile enough to either generate LHCb's raw data packets internally or read them from external storage via the network. For reading the data we have implemented a light-weight industry standard protocol ATA over Ethernet (AoE) and we present an outlook of using a filesystem on these network-exported disk-drivers.

  15. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Directory of Open Access Journals (Sweden)

    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  16. 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.

  17. The Performance of Standardized Patients in Portraying Clinical Scenarios in Speech-Language Therapy

    Science.gov (United States)

    Hill, Anne E.; Davidson, Bronwyn J.; Theodoros, Deborah G.

    2013-01-01

    Background: Standardized patients (SPs) are frequently included in the clinical preparation of students in the health sciences. An acknowledged benefit of using SPs is the opportunity to provide a standardized method by which students can demonstrate and develop their competency. Relatively little is known, however, about the capacity of SPs to…

  18. Performance Comparison of Wireless Sensor Network Standard Protocols in an Aerospace Environment: ISA100.11a and ZigBee Pro

    Science.gov (United States)

    Wagner, Raymond S.; Barton, Richard J.

    2011-01-01

    Standards-based wireless sensor network (WSN) protocols are promising candidates for spacecraft avionics systems, offering unprecedented instrumentation flexibility and expandability. Ensuring reliable data transport is key, however, when migrating from wired to wireless data gathering systems. In this paper, we conduct a rigorous laboratory analysis of the relative performances of the ZigBee Pro and ISA100.11a protocols in a representative crewed aerospace environment. Since both operate in the 2.4 GHz radio frequency (RF) band shared by systems such as Wi-Fi, they are subject at times to potentially debilitating RF interference. We compare goodput (application-level throughput) achievable by both under varying levels of 802.11g Wi-Fi traffic. We conclude that while the simpler, more inexpensive ZigBee Pro protocol performs well under moderate levels of interference, the more complex and costly ISA100.11a protocol is needed to ensure reliable data delivery under heavier interference. This paper represents the first published, rigorous analysis of WSN protocols in an aerospace environment that we are aware of and the first published head-to-head comparison of ZigBee Pro and ISA100.11a.

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

    Science.gov (United States)

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

    2009-01-01

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

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

    Science.gov (United States)

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

    2009-01-01

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

  1. 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

  2. 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.)

  3. 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.)

  4. Personalized-Detailed Clinical Model for Data Interoperability Among Clinical Standards

    OpenAIRE

    Khan, Wajahat Ali; Hussain, Maqbool; Afzal, Muhammad; Amin, Muhammad Bilal; Saleem, Muhammad Aamir; Lee, Sungyoung

    2013-01-01

    Objective: Data interoperability among health information exchange (HIE) systems is a major concern for healthcare practitioners to enable provisioning of telemedicine-related services. Heterogeneity exists in these systems not only at the data level but also among different heterogeneous healthcare standards with which these are compliant. The relationship between healthcare organization data and different heterogeneous standards is necessary to achieve the goal of data level interoperabi...

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

    Science.gov (United States)

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

    2015-01-01

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

  6. The effect of static scanning and mobility training on mobility in people with hemianopia after stroke: A randomized controlled trial comparing standardized versus non-standardized treatment protocols

    Science.gov (United States)

    2011-01-01

    Background Visual loss following stroke impacts significantly on activities of daily living and is an independent risk factor for becoming dependent. Routinely, allied health clinicians provide training for visual field loss, mainly with eye movement based therapy. The effectiveness of the compensatory approach to rehabilitation remains inconclusive largely due to difficulty in validating functional outcome with the varied type and dosage of therapy received by an individual patient. This study aims to determine which treatment is more effective, a standardized approach or individualized therapy in patients with homonymous hemianopia post stroke. Methods/Design This study is a double-blind randomized controlled, multicenter trial. A standardised scanning rehabilitation program (Neuro Vision Technology (NVT) program) of 7 weeks at 3 times per week, is compared to individualized therapy recommended by clinicians. Discussion The results of the trial will provide information that could potentially inform the allocation of resources in visual rehabilitation post stroke. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000494033 PMID:21767413

  7. The effect of static scanning and mobility training on mobility in people with hemianopia after stroke: A randomized controlled trial comparing standardized versus non-standardized treatment protocols

    Directory of Open Access Journals (Sweden)

    George Stacey

    2011-07-01

    Full Text Available Abstract Background Visual loss following stroke impacts significantly on activities of daily living and is an independent risk factor for becoming dependent. Routinely, allied health clinicians provide training for visual field loss, mainly with eye movement based therapy. The effectiveness of the compensatory approach to rehabilitation remains inconclusive largely due to difficulty in validating functional outcome with the varied type and dosage of therapy received by an individual patient. This study aims to determine which treatment is more effective, a standardized approach or individualized therapy in patients with homonymous hemianopia post stroke. Methods/Design This study is a double-blind randomized controlled, multicenter trial. A standardised scanning rehabilitation program (Neuro Vision Technology (NVT program of 7 weeks at 3 times per week, is compared to individualized therapy recommended by clinicians. Discussion The results of the trial will provide information that could potentially inform the allocation of resources in visual rehabilitation post stroke. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000494033

  8. Standardization of a protocol to obtain genomic DNA for the quantification of 5mC in epicormics buds of Tectona grandis L.

    OpenAIRE

    Elisa Quiala; Luis Valledor; Rodrigo Hazbun; Raúl Barbón; Manuel de Feria; Maité Chávez

    2008-01-01

    The present investigation was carried out with the objective of defining an extraction and purification method that it provided deoxyribonucleic acid (DNA) appropriate to determine the percentage of 5mC in the genomic DNA of epicormics buds of Tectona grandis L. During the standardization of the protocol four methods were compared: 1 -classic based on saline shock solution with CTAB (hexadecil trimetil ammonium bromide), 2 - Kit of extraction of DNA plants DNeasy Plant Mini Kit (QIAGEN) accor...

  9. A comparative analysis of quality management standards for contract research organisations in clinical trials.

    Science.gov (United States)

    Murray, Elizabeth; McAdam, Rodney

    2007-01-01

    This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

  10. Toward Clarity in Clinical Vitamin D Status Assessment: 25(OH)D Assay Standardization.

    Science.gov (United States)

    Binkley, Neil; Carter, Graham D

    2017-12-01

    Widespread variation in 25-hydroxyvitamin D (25(OH)D) assays continues to compromise efforts to develop clinical and public health guidelines regarding vitamin D status. The Vitamin D Standardization Program helps alleviate this problem. Reference measurement procedures and standard reference materials have been developed to allow current, prospective, and retrospective standardization of 25(OH)D results. Despite advances in 25(OH)D measurement, substantial variability in clinical laboratory 25(OH)D measurement persists. Existing guidelines have not used standardized data and, as a result, it seems unlikely that consensus regarding definitions of vitamin D deficiency, inadequacy, sufficiency, and excess will soon be reached. Until evidence-based consensus is reached, a reasonable clinical approach is advocated. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Data for improvement and clinical excellence: protocol for an audit with feedback intervention in home care and supportive living.

    Science.gov (United States)

    Fraser, Kimberly D; Sales, Anne E; O'Rourke, Hannah M; Schalm, Corinne

    2012-01-18

    Although considerable evidence exists about the effectiveness of audit coupled with feedback, very few audit-with-feedback interventions have been done in either home care or supportive living settings to date. With little history of audit and feedback in home care or supportive living there is potential for greater effects, at least initially. This study extends the work of an earlier study designed to assess the effects of an audit-with-feedback intervention. It will be delivered quarterly over a one-year period in seven home care offices and 11 supportive living sites. The research questions are the same as in the first study but in a different environment. They are as follows: 1. What effects do feedback reports have on processes and outcomes over time? 2. How do different provider groups in home care and supportive living sites respond to feedback reports based on quality indicator data? The research team conducting this study includes researchers and decision makers in continuing care in the province of Alberta, Canada. The intervention consists of quarterly feedback reports in 19 home care offices and supportive living sites across Alberta. Data for the feedback reports are based on the Resident Assessment Instrument Home Care tool, a standardized instrument mandated for use in home care and supportive living environments throughout Alberta. The feedback reports consist of one page, printed front and back, presenting both graphic and textual information. Reports are delivered to all employees working in each site. The primary evaluation uses a controlled interrupted time-series design, both adjusted and unadjusted for covariates. The concurrent process evaluation includes observation, focus groups, and self-reports to assess uptake of the feedback reports. The project described in this protocol follows a similar intervention conducted in our previous study, Data for Improvement and Clinical Excellence--Long-Term Care. We will offer dissemination strategies

  12. Data for improvement and clinical excellence: protocol for an audit with feedback intervention in home care and supportive living

    Directory of Open Access Journals (Sweden)

    Fraser Kimberly D

    2012-01-01

    Full Text Available Abstract Background Although considerable evidence exists about the effectiveness of audit coupled with feedback, very few audit-with-feedback interventions have been done in either home care or supportive living settings to date. With little history of audit and feedback in home care or supportive living there is potential for greater effects, at least initially. This study extends the work of an earlier study designed to assess the effects of an audit-with-feedback intervention. It will be delivered quarterly over a one-year period in seven home care offices and 11 supportive living sites. The research questions are the same as in the first study but in a different environment. They are as follows: 1. What effects do feedback reports have on processes and outcomes over time? 2. How do different provider groups in home care and supportive living sites respond to feedback reports based on quality indicator data? Methods The research team conducting this study includes researchers and decision makers in continuing care in the province of Alberta, Canada. The intervention consists of quarterly feedback reports in 19 home care offices and supportive living sites across Alberta. Data for the feedback reports are based on the Resident Assessment Instrument Home Care tool, a standardized instrument mandated for use in home care and supportive living environments throughout Alberta. The feedback reports consist of one page, printed front and back, presenting both graphic and textual information. Reports are delivered to all employees working in each site. The primary evaluation uses a controlled interrupted time-series design, both adjusted and unadjusted for covariates. The concurrent process evaluation includes observation, focus groups, and self-reports to assess uptake of the feedback reports. The project described in this protocol follows a similar intervention conducted in our previous study, Data for Improvement and Clinical Excellence

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

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2009-07-01

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

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

    Science.gov (United States)

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

    2016-04-01

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

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

    Science.gov (United States)

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

    2016-10-01

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

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

    Directory of Open Access Journals (Sweden)

    Deepu R Pillai

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

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

    Science.gov (United States)

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

    2011-01-01

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

  18. 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

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

    International Nuclear Information System (INIS)

    Todd-Pokropek, A.

    1996-01-01

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

  20. 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

  1. Establishment of quality assessment standard for mammographic equipment: evaluation of phantom and clinical images

    International Nuclear Information System (INIS)

    Lee, Sung Hoon; Choe, Yeon Hyeon; Chung, Soo Young

    2005-01-01

    The purpose of this study was to establish a quality standard for mammographic equipment Korea and to eventually improve mammographic quality in clinics and hospitals throughout Korea by educating technicians and clinic personnel. For the phantom test and on site assessment, we visited 37 sites and examined 43 sets of mammographic equipment. Items that were examined include phantom test, radiation dose measurement, developer assessment, etc. The phantom images were assessed visually and by optical density measurements. For the clinical image assessment, clinical images from 371 sites were examined following the new Korean standard for clinical image evaluation. The items examined include labeling, positioning, contrast, exposure, artifacts, collimation among others. Quality standard of mammographic equipment was satisfied in all equipment on site visits. Average mean glandular dose was 114.9 mRad. All phantom image test scores were over 10 points (average, 10.8 points). However, optical density measurements were below 1.2 in 9 sets of equipment (20.9%). Clinical image evaluation revealed appropriate image quality in 83.5%, while images from non-radiologist clinics were adequate in 74.6% (91/122), which was the lowest score of any group. Images were satisfactory in 59.0% (219/371) based on evaluation by specialists following the new Korean standard for clinical image evaluation. Satisfactory images had a mean score of 81.7 (1 S.D. =8.9) and unsatisfactory images had a mean score of 61.9 (1 S.D = 11). The correlation coefficient between the two observers was 0.93 (ρ < 0.01) in 49 consecutive cases. The results of the phantom tests suggest that optical density measurements should be performed as part of a new quality standard for mammographic equipment. The new clinical evaluation criteria that was used in this study can be implemented with some modifications for future mammography quality control by the Korean government

  2. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    Osteoarthritis (OA) is a heterogeneous disorder. The goals of this review are (1) To stimulate use of standardized nomenclature for OA that could serve as building blocks for describing OA and defining OA phenotypes, in short to provide unifying disease concepts for a heterogeneous disorder; and ...... sophisticated definitions, terminology and tools....

  3. Subdissociative intranasal ketamine plus standard pain therapy versus standard pain therapy in the treatment of paediatric sickle cell disease vaso-occlusive crises in resource-limited settings: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Young, James R; Sawe, Hendry Robert; Mfinanga, Juma A; Nshom, Ernest; Helm, Ethan; Moore, Charity G; Runyon, Michael S; Reynolds, Stacy L

    2017-07-10

    Pediatric sickle cell disease, highly prevalent in sub-Saharan Africa, carries great morbidity and mortality risk. Limited resources and monitoring make management of acute vaso-occlusive crises challenging. This study aims to evaluate the efficacy and safety of subdissociative intranasal ketamine as a cheap, readily available and easily administered adjunct to standard pain therapy. We hypothesise that subdissociative, intranasal ketamine may significantly augment current approaches to pain management in resource-limited settings in a safe and cost-effective manner. This is a multicentred, randomised, double-blind, placebo-controlled trial enrolling children 4-16 years of age with sickle cell disease and painful vaso-occlusive pain crises. Study sites include two sub-Saharan teaching and referral hospitals with acute intake areas. All patients receive standard analgesic therapy during evaluation. Patients randomised to the treatment arm receive 1 mg/kg intranasal ketamine at onset of therapy, while placebo arm participants receive volume-matched intranasal normal saline. All participants and clinical staff are blinded to the treatment allocation. Data will be analysed on an intention-to-treat basis. Primary endpoints are changes in self-report pain scales (Faces Pain Scale-Revised) at 30, 60 and 120 minutes and rates of adverse events. Secondary endpoints include hospital length of stay, total analgesia use and quality of life assessment 2-3 weeks postintervention. The research methods for this study have been approved by the Cameroon Baptist Convention Health Board Institutional Review Board (IRB2015-07), the Tanzanian National Institute for Medical Research (NIMR/HQ/R.8a/Vol. IX/2299), Muhimbili National Hospital IRB (MNH/IRB/I/2015/14) and the Tanzanian Food and Drugs Authority (TFDA0015/CTR/0015/9). Data reports will be provided to the Data and Safety Monitoring Board (DSMB) periodically throughout the study as well as all reports of adverse events. All

  4. 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

  5. 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.

  6. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop.

    Science.gov (United States)

    Jabs, Douglas A; Nussenblatt, Robert B; Rosenbaum, James T

    2005-09-01

    To begin a process of standardizing the methods for reporting clinical data in the field of uveitis. Consensus workshop. Members of an international working group were surveyed about diagnostic terminology, inflammation grading schema, and outcome measures, and the results used to develop a series of proposals to better standardize the use of these entities. Small groups employed nominal group techniques to achieve consensus on several of these issues. The group affirmed that an anatomic classification of uveitis should be used as a framework for subsequent work on diagnostic criteria for specific uveitic syndromes, and that the classification of uveitis entities should be on the basis of the location of the inflammation and not on the presence of structural complications. Issues regarding the use of the terms "intermediate uveitis," "pars planitis," "panuveitis," and descriptors of the onset and course of the uveitis were addressed. The following were adopted: standardized grading schema for anterior chamber cells, anterior chamber flare, and for vitreous haze; standardized methods of recording structural complications of uveitis; standardized definitions of outcomes, including "inactive" inflammation, "improvement'; and "worsening" of the inflammation, and "corticosteroid sparing," and standardized guidelines for reporting visual acuity outcomes. A process of standardizing the approach to reporting clinical data in uveitis research has begun, and several terms have been standardized.

  7. Validation of the Konsung QD217A for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

    Science.gov (United States)

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

    2015-08-01

    This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor Konsung QD217A for home BP monitoring according to the European Society of Hypertension International Protocol revision 2010. Three trained observers validated the performance of these devices by comparing the measurements obtained from these devices with those taken using a standard mercury sphygmomanometer. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using a standard mercury sphygmomanometer and the Konsung QD217A device. A total of 99 pairs of comparisons were obtained from 33 participants. The QD217A device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10 and 15 mmHg was 70/99, 92/99 and 96/99, respectively, for SBP and 80/99, 94/99 and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. A total of 27 and 31 participants for SBP and DBP, respectively, showed at least two of the three device-observers differences within 5 mmHg (required≥24). The number of participants without device-observer difference within 5 mmHg was one for SBP and one for DBP (required≤3). The Konsung upper arm BP monitor QD217A has passed the International Protocol requirements and it can be recommended for clinical use and self-measurement in adults. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

  8. Minimum reporting standards for clinical research on groin pain in athletes

    DEFF Research Database (Denmark)

    Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M

    2015-01-01

    Groin pain in athletes is a priority area for sports physiotherapy and sports medicine research. Heterogeneous studies with low methodological quality dominate research related to groin pain in athletes. Low-quality studies undermine the external validity of research findings and limit the ability...... to generalise findings to the target patient population. Minimum reporting standards for research on groin pain in athletes are overdue. We propose a set of minimum reporting standards based on best available evidence to be utilised in future research on groin pain in athletes. Minimum reporting standards...... are provided in relation to: (1) study methodology, (2) study participants and injury history, (3) clinical examination, (4) clinical assessment and (5) radiology. Adherence to these minimum reporting standards will strengthen the quality and transparency of research conducted on groin pain in athletes...

  9. 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.

  10. 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

  11. A review of standardized patients in clinical education: Implications for speech-language pathology programs.

    Science.gov (United States)

    Hill, Anne E; Davidson, Bronwyn J; Theodoros, Deborah G

    2010-06-01

    The use of standardized patients has been reported as a viable addition to traditional models of professional practice education in medicine, nursing and allied health programs. Educational programs rely on the inclusion of work-integrated learning components in order to graduate competent practitioners. Allied health programs world-wide have reported increasing difficulty in attaining sufficient traditional placements for students within the workplace. In response to this, allied health professionals are challenged to be innovative and problem-solving in the development and maintenance of clinical education placements and to consider potential alternative learning opportunities for students. Whilst there is a bank of literature describing the use of standardized patients in medicine and nursing, reports of its use in speech-language pathology clinical education are limited. Therefore, this paper aims to (1) provide a review of literature reporting on the use of standardized patients within medical and allied health professions with particular reference to use in speech-language pathology, (2) discuss methodological and practical issues involved in establishing and maintaining a standardized patient program and (3) identify future directions for research and clinical programs using standardized patients to build foundation clinical skills such as communication, interpersonal interaction and interviewing.

  12. Providing support to nursing students in the clinical environment: a nursing standard requirement.

    Science.gov (United States)

    Anderson, Carina; Moxham, Lorna; Broadbent, Marc

    2016-10-01

    This discussion paper poses the question 'What enables or deters Registered Nurses to take up their professional responsibility to support undergraduate nursing students through the provision of clinical education?'. Embedded within many nursing standards are expectations that Registered Nurses provide support and professional development to undergraduate nursing students undertaking clinical placements. Expectations within nursing standards that Registered Nurses provide support and professional development to nursing students are important because nursing students depend on Registered Nurses to help them to become competent practitioners. Contributing factors that enable and deter Registered Nurses from fulfilling this expectation to support nursing students in their clinical learning include; workloads, preparedness for the teaching role, confidence in teaching and awareness of the competency requirement to support students. Factors exist which can enable or deter Registered Nurses from carrying out the licence requirement to provide clinical education and support to nursing students.

  13. Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

    Science.gov (United States)

    Landgrebe, Michael; Azevedo, Andréia; Baguley, David; Bauer, Carol; Cacace, Anthony; Coelho, Claudia; Dornhoffer, John; Figueiredo, Ricardo; Flor, Herta; Hajak, Goeran; van de Heyning, Paul; Hiller, Wolfgang; Khedr, Eman; Kleinjung, Tobias; Koller, Michael; Lainez, Jose Miguel; Londero, Alain; Martin, William H.; Mennemeier, Mark; Piccirillo, Jay; De Ridder, Dirk; Rupprecht, Rainer; Searchfield, Grant; Vanneste, Sven; Zeman, Florian; Langguth, Berthold

    2013-01-01

    Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus. PMID:22789414

  14. Publication trends of study protocols in rehabilitation.

    Science.gov (United States)

    Jesus, Tiago S; Colquhoun, Heather L

    2017-09-04

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

  15. [The challenges of standardization in clinical diagnostic laboratories of medical organizations].

    Science.gov (United States)

    Men'shikov, V V

    2013-04-01

    The generalized data concerning the conditions of application of regulations of national standards in clinical diagnostic laboratories of medical organizations is presented. The primary information was provided by 14 regions of 6 federal administrative okrugs of Russia. The causes of challenges of application of requirements of standards are presented. They are mostly related with insufficient financial support, lacking of manpower, difficulties with reagents supply, inadequate technical maintenance of devices and absence of support of administration of medical organizations. The recommendations are formulated concerning the necessity of publishing the document of Minzdrav of Russia to determine the need in application of standards in laboratory practice.

  16. Clinical utility of a complete diagnostic protocol for the ocular evaluation of free-living raptors.

    Science.gov (United States)

    Labelle, Amber L; Whittington, Julia K; Breaux, Carrie B; Labelle, Philippe; Mitchell, Mark A; Zarfoss, Mitzi K; Schmidt, Stephanie A; Hamor, Ralph E

    2012-01-01

      To describe a protocol for the examination of free-living raptors and report the ophthalmic examination findings of seven raptor species native to central Illinois, namely the barred owl, Cooper's hawk, eastern screech owl, great horned owl, American kestrel, red-tailed hawk, and turkey vulture and to determine if the findings relative to visual prognosis affected eligibility for future release.   Seventy-nine free-living raptors.   Under manual restraint, complete ophthalmic examination including slit-lamp biomicroscopy and indirect funduscopy, applanation tonometry, rebound tonometry, ocular morphometrics, B-mode ultrasound, and electroretinography (ERG) were performed on each bird. Histopathology of enucleated globes was performed after euthanasia or death in selected cases.   The examination protocol was easily performed using manual restraint alone on all birds. Ocular lesions were detected in 48.1% of birds, with 47.3% affected unilaterally and 52.6% affected bilaterally. Ocular lesions were considered to be vision threatening in 29.0% of the unilaterally affected birds and 29.0% of the bilaterally affected birds. The most common case outcomes were discharge from hospital to rehabilitation facility (45.6%) followed by euthanasia (43.0%). The presence of an ocular lesion or a vision-threatening ocular lesion was not significantly associated with outcome. Reference ranges are reported for B-mode ultrasound, ocular morphometrics, and horizontal corneal diameter in all species.   Complete ophthalmic examination can be supplemented by the use of ocular morphometrics, ultrasound, and ERG in the manually restrained raptor. These advanced diagnostic techniques may be useful in developing more objective criteria for evaluating eligibility for release following rehabilitation of free-living birds of prey. © 2011 American College of Veterinary Ophthalmologists.

  17. Intra-rater and inter-rater reliability of the standardized ultrasound protocol for assessing subacromial structures

    DEFF Research Database (Denmark)

    Hougs Kjær, Birgitte; Ellegaard, Karen; Wieland, Ina

    2017-01-01

    BACKGROUND: US-examinations related to shoulder impingement (SI) often vary due to methodological differences, examiner positions, transducers, and recording parameters. Reliable US protocols for examination of different structures related to shoulder impingement are therefore needed. OBJECTIVES...... of the supraspinatus tendon (SUPRA) and subacromial subdeltoid (SASD) bursa in two imaging positions, and the acromial humeral distance (AHD) in one position. Additionally, agreement on dynamic impingement (DI) examination was performed. The intra- and inter-rater reliability was carried out on the same day...

  18. Diversity in clinical management and protocols for the treatment of major bleeding trauma patients across European level I Trauma Centres

    DEFF Research Database (Denmark)

    Schäfer, Nadine; Driessen, Arne; Fröhlich, Matthias

    2015-01-01

    according to clinical assessment in combination with laboratory signs of achieved haemostasis. The severity of coagulopathy and shock is mostly assessed via standard coagulation tests and partially used extended viscoelastic tests. All centres have implemented the immediate use of tranexamic acid. Initial...

  19. Performance evaluation of working standard NE2581 in comparison with reference standard NE2561 in the determination of absorbed dose to water using IAEA, HPA, NACP, AAPM, NCRP and ICRU protocols

    International Nuclear Information System (INIS)

    Dolah, M.T.; Supian Samat; Taiman Kadni

    2001-01-01

    The aim of this study was to evaluate the performance of NE 2581 in comparison with NE 2561 in the determination of the absorbed dose to water in a γ-ray beam using IAEA, HPA, NACP, AAPM, NCRP and ICRU protocols. 13 exposures of the γ-ray beams were used. This number of exposures yielded 26 chamber rate readings for NE 2581 (N=13) and for NE 2561 (N=13). From the 13 NE 2581 readings, 78 absorbed dose to water values were calculated for the IAEA (N=13), HPA (N=13), NACP (N=13), AAPM (N=13), NCRP (N=13) and ICRU (N=13) protocols. Similarly, from the 13 NE 2561 readings, 78 absorbed dose to water values were calculated for IAEA (N=13), HPA (N=13), NACP (N=13), AAPM (N=13), NCRP (N=13) and ICRU (N=13) protocols. From these 156 (=78 x 2) absorbed dose to water values, 78 percentage deviations between the NE 2581 and NE 2561 results were calculated for IAEA (N=13), HPA (N=13), NACP (N=13), AAPM (N=13), NCRP (N=13) and ICRU (N=13) protocols. For a single protocol, the mean μ and standard error σ+s+e of the percentage deviations (N=13) were calculated. results obtained in terms of [protocol, μ ± σ se ] were [IAEA,1.55 ± 0.12], [HPA, 0.98 ± 0.12], [NACP, 1.93 ± 0.12], [AAPM, -0.06 ± 0.12], [NCRP, 0.97 ± 0.12], [ICRU, 0.97 ± 0.12]. It can be seen that the range of percentage deviations is from -0.06 to 1.93. As the quoted IAEA acceptable limit of deviation is ± 3.0%, it was concluded that the working standard NE 2581 chamber has shown acceptable performance. In addition, the use of the AAPM protocol has enable NE 2581 to show a performance that is very similar like NE 2561. (Author)

  20. Incorporating Standardized Colleague Simulations in a Clinical Assessment Course and Evaluating the Impact on Interprofessional Communication.

    Science.gov (United States)

    Shrader, Sarah; Dunn, Brianne; Blake, Elizabeth; Phillips, Cynthia

    2015-05-25

    To determine the impact of incorporating standardized colleague simulations on pharmacy students' confidence and interprofessional communication skills. Four simulations using standardized colleagues portraying attending physicians in inpatient and outpatient settings were integrated into a required course. Pharmacy students interacted with the standardized colleagues using the Situation, Background, Assessment, Request/Recommendation (SBAR) communication technique and were evaluated on providing recommendations while on simulated inpatient rounds and in an outpatient clinic. Additionally, changes in student attitudes and confidence toward interprofessional communication were assessed with a survey before and after the standardized colleague simulations. One hundred seventy-one pharmacy students participated in the simulations. Student interprofessional communication skills improved after each simulation. Student confidence with interprofessional communication in both inpatient and outpatient settings significantly improved. Incorporation of simulations using standardized colleagues improves interprofessional communication skills and self-confidence of pharmacy students.

  1. Co-Designing Mobile Apps to Assist in Clinical Nursing Education: A Study Protocol.

    Science.gov (United States)

    O'Connor, Siobhan; Andrews, Tom

    2016-01-01

    Mobile applications (apps) to train health professionals is gaining momentum as the benefits of mobile learning (mLearning) are becoming apparent in complex clinical environments. However, most educational apps are generic, off-the-shelf pieces of software that do not take into consideration the unique needs of nursing students. The proposed study will apply a user-centred design process to create a tailored mobile app for nursing students to learn and apply clinical skills in practice. The app will be piloted and evaluated to understand how nursing students use mobile technology in clinical settings to support their learning and educational needs.

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

    Science.gov (United States)

    Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

    2018-01-01

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

  3. Neurorestorative clinical application standards for the culture and quality control of olfactory ensheathing cells

    Directory of Open Access Journals (Sweden)

    Xiao J

    2017-09-01

    Full Text Available Juan Xiao,1,2 Lin Chen,3 Gengsheng Mao,1 Wenyong Gao,1,2 Ming Lu,4 Xijing He,5 Hongyun Huang1,2 On behalf of the Neurorestoratology Professional Committee of Chinese Medical Doctors Association (Chinese Association of Neurorestoratology 1Institute of Neurorestoratology, The General Hospital of Chinese People’s Armed Police Forces, Beijing, People’s Republic of China; 2Cell Therapy Center, Beijing Hongtianji Neuroscience Academy, Beijing, People’s Republic of China; 3Department of Neurosurgery, Tsinghua University Yuquan Hospital, Beijing, People’s Republic of China; 4Department of Neurosurgery, 163 Hospital of PLA (Second Affiliated Hospital of Hunan Normal University, Changsha, Hunan Province, People’s Republic of China; 5Department of Orthopedics, Second Affiliated Hospital of Xi’an Jiaotong University, Xian, Shanxi Provine, People’s Republic of China Abstract: Olfactory ensheathing cells (OECs are a novel type of glial cell that can perform and promote many neurorestorative processes in vivo after transplant. To date, dozens of preclinical and clinical studies have confirmed that OECs have unique restoring effects in animal models and human subjects with neurological degeneration or damage, such as spinal cord injury, stroke, cerebral palsy, traumatic brain injury, and motor neuron disease (amyotrophic lateral sclerosis. To ensure the safety and effectiveness of clinical applications utilizing this type of cell, it is important to standardize cell-culture and quality-control processes. Based on a comprehensive review of published clinical studies, as well as existing methods of OEC culture and quality control currently utilized by hospitals and biomedical enterprises, the Chinese Association of Neurorestoratology has developed a set of standards for the culture and quality control of olfactory ensheathing cells for use in clinical applications. These guidelines include standardized training and management procedures for

  4. Determinants of successful clinical networks: the conceptual framework and study protocol.

    Science.gov (United States)

    Haines, Mary; Brown, Bernadette; Craig, Jonathan; D'Este, Catherine; Elliott, Elizabeth; Klineberg, Emily; McInnes, Elizabeth; Middleton, Sandy; Paul, Christine; Redman, Sally; Yano, Elizabeth M

    2012-03-13

    Clinical networks are increasingly being viewed as an important strategy for increasing evidence-based practice and improving models of care, but success is variable and characteristics of networks with high impact are uncertain. This study takes advantage of the variability in the functioning and outcomes of networks supported by the Australian New South Wales (NSW) Agency for Clinical Innovation's non-mandatory model of clinical networks to investigate the factors that contribute to the success of clinical networks. The objective of this retrospective study is to examine the association between external support, organisational and program factors, and indicators of success among 19 clinical networks over a three-year period (2006-2008). The outcomes (health impact, system impact, programs implemented, engagement, user perception, and financial leverage) and explanatory factors will be collected using a web-based survey, interviews, and record review. An independent expert panel will provide judgements about the impact or extent of each network's initiatives on health and system impacts. The ratings of the expert panel will be the outcome used in multivariable analyses. Following the rating of network success, a qualitative study will be conducted to provide a more in-depth examination of the most successful networks. This is the first study to combine quantitative and qualitative methods to examine the factors that contribute to the success of clinical networks and, more generally, is the largest study of clinical networks undertaken. The adaptation of expert panel methods to rate the impacts of networks is the methodological innovation of this study. The proposed project will identify the conditions that should be established or encouraged by agencies developing clinical networks and will be of immediate use in forming strategies and programs to maximise the effectiveness of such networks.

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

    Science.gov (United States)

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

    2016-12-15

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

  6. Clinically significant discrepancies between sleep problems assessed by standard clinical tools and actigraphy

    Directory of Open Access Journals (Sweden)

    Kjersti Marie Blytt

    2017-10-01

    Full Text Available Abstract Background Sleep disturbances are widespread among nursing home (NH patients and associated with numerous negative consequences. Identifying and treating them should therefore be of high clinical priority. No prior studies have investigated the degree to which sleep disturbances as detected by actigraphy and by the sleep-related items in the Cornell Scale for Depression in Dementia (CSDD and the Neuropsychiatric Inventory – Nursing Home version (NPI-NH provide comparable results. Such knowledge is highly needed, since both questionnaires are used in clinical settings and studies use the NPI-NH sleep item to measure sleep disturbances. For this reason, insight into their relative (disadvantages is valuable. Method Cross-sectional study of 83 NH patients. Sleep was objectively measured with actigraphy for 7 days, and rated by NH staff with the sleep items in the CSDD and the NPI-NH, and results were compared. McNemar's tests were conducted to investigate whether there were significant differences between the pairs of relevant measures. Cohen's Kappa tests were used to investigate the degree of agreement between the pairs of relevant actigraphy, NPI-NH and CSDD measures. Sensitivity and specificity analyses were conducted for each of the pairs, and receiver operating characteristics (ROC curves were designed as a plot of the true positive rate against the false positive rate for the diagnostic test. Results Proxy-raters reported sleep disturbances in 20.5% of patients assessed with NPI-NH and 18.1% (difficulty falling asleep, 43.4% (multiple awakenings and 3.6% (early morning awakenings of patients had sleep disturbances assessed with CSDD. Our results showed significant differences (p<0.001 between actigraphy measures and proxy-rated sleep by the NPI-NH and CSDD. Sensitivity and specificity analyses supported these results. Conclusions Compared to actigraphy, proxy-raters clearly underreported NH patients' sleep disturbances as assessed

  7. Examining the effects of enhanced provider-patient communication on postoperative tonsillectomy pain: protocol of a randomised controlled trial performed by nurses in daily clinical care.

    Science.gov (United States)

    van Vliet, Liesbeth M; van Dulmen, Sandra; Thiel, Bram; van Deelen, Gerard W; Immerzeel, Stephanie; Godfried, Marc B; Bensing, Jozien M

    2017-11-03

    Placebo effects (true biopsychological effects not attributable to the active ingredients of medical technical interventions) can be attributed to several mechanisms, such as expectancy manipulation and empathy manipulation elicited by a provider's communication. So far, effects have primarily been shown in laboratory settings. The aim of this study is to determine the separate and combined effects of expectancy manipulation and empathy manipulation during preoperative and postoperative tonsillectomy analgesia care on clinical adult patients' outcomes. Using a two-by-two randomised controlled trial, 128 adult tonsillectomy patients will be randomly assigned to one out of four conditions differing in the level of expectancy manipulation (standard vs enhanced) and empathy manipulation (standard vs enhanced). Day care ward nurses are trained to deliver the intervention, while patients are treated via the standard analgesia protocol and hospital routines. The primary outcome, perceived pain, is measured via hospital routine by a Numeric Rating Scale, and additional prehospitalisation, perihospitalisation and posthospitalisation questionnaires are completed (until day 3, ie, 2 days after the operation). The manipulation is checked using audio recordings of nurse-patient interactions. Although communication is manipulated, the manipulations do not cross norms or values of acceptable behaviour. Standard medical care is provided. The ethical committee of the UMC Utrecht and the local OLVG hospital committee approved the study. Results will be published via (inter)national peer-reviewed journals and a lay publication. NTR5994; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. Clinical manifestations of tension pneumothorax: protocol for a systematic review and meta-analysis

    Science.gov (United States)

    2014-01-01

    Background Although health care providers utilize classically described signs and symptoms to diagnose tension pneumothorax, available literature sources differ in their descriptions of its clinical manifestations. Moreover, while the clinical manifestations of tension pneumothorax have been suggested to differ among subjects of varying respiratory status, it remains unknown if these differences are supported by clinical evidence. Thus, the primary objective of this study is to systematically describe and contrast the clinical manifestations of tension pneumothorax among patients receiving positive pressure ventilation versus those who are breathing unassisted. Methods/Design We will search electronic bibliographic databases (MEDLINE, PubMed, EMBASE, and the Cochrane Database of Systematic Reviews) and clinical trial registries from their first available date as well as personal files, identified review articles, and included article bibliographies. Two investigators will independently screen identified article titles and abstracts and select observational (cohort, case–control, and cross-sectional) studies and case reports and series that report original data on clinical manifestations of tension pneumothorax. These investigators will also independently assess risk of bias and extract data. Identified data on the clinical manifestations of tension pneumothorax will be stratified according to whether adult or pediatric study patients were receiving positive pressure ventilation or were breathing unassisted, as well as whether the two investigators independently agreed that the clinical condition of the study patient(s) aligned with a previously published tension pneumothorax working definition. These data will then be summarized using a formal narrative synthesis alongside a meta-analysis of observational studies and then case reports and series where possible. Pooled or combined estimates of the occurrence rate of clinical manifestations will be calculated using

  9. Quality standards for DNA sequence variation databases to improve clinical management under development in Australia

    Directory of Open Access Journals (Sweden)

    B. Bennetts

    2014-09-01

    Full Text Available Despite the routine nature of comparing sequence variations identified during clinical testing to database records, few databases meet quality requirements for clinical diagnostics. To address this issue, The Royal College of Pathologists of Australasia (RCPA in collaboration with the Human Genetics Society of Australasia (HGSA, and the Human Variome Project (HVP is developing standards for DNA sequence variation databases intended for use in the Australian clinical environment. The outputs of this project will be promoted to other health systems and accreditation bodies by the Human Variome Project to support the development of similar frameworks in other jurisdictions.

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

    Directory of Open Access Journals (Sweden)

    Teresa Bleakly Kortz

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

  11. European AIDS Clinical Society Second Standard of Care Meeting, Brussels 16-17 November 2016

    DEFF Research Database (Denmark)

    De Wit, S; Battegay, M; D'Arminio Monforte, A

    2018-01-01

    The European AIDS Clinical Society (EACS) organized a second meeting on Standard of Care in Europe on November 16-17 th, 2016. The aims of the meeting were to discuss and propose actions on three topics, namely: Adherence to guidelines for treatment initiation, treatment monitoring and outcomes, ...

  12. Anthropometric standardisation and quality control protocols for the construction of new, international, fetal and newborn growth standards: the INTERGROWTH-21st Project.

    Science.gov (United States)

    Cheikh Ismail, L; Knight, H E; Ohuma, E O; Hoch, L; Chumlea, W C

    2013-09-01

    The primary aim of the INTERGROWTH-21(st) Project is to construct new, prescriptive standards describing optimal fetal and preterm postnatal growth. The anthropometric measurements include the head circumference, recumbent length and weight of the infants, and the stature and weight of the parents. In such a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes in detail the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. The initial standardisation session was in Nairobi, Kenya, using newborns, which was followed by similar sessions in the eight participating study sites in Brazil, China, India, Italy, Kenya, Oman, UK and USA. The intraobserver and inter-observer technical error of measurement values for head circumference range from 0.3 to 0.4 cm, and for recumbent length from 0.3 to 0.5 cm. These standardisation protocols implemented at each study site worldwide ensure that the anthropometric data collected are of the highest quality to construct international growth standards. © 2013 Royal College of Obstetricians and Gynaecologists.

  13. 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...

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

    Science.gov (United States)

    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

  15. Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Rens Ger HMB

    2010-03-01

    Full Text Available Abstract Background Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT to provide an evidence-based training program in the use of this device. Methods/Design To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122 were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension, patients' skills to operate the CCTV, perceived (vision-related quality of life and tasks performed in daily living. Discussion The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. Trial registration http://www.trialregister.nl, identifier: NTR1031

  16. The influence of standards and clinical guidelines on prosthetic and orthotic service quality: a scoping review.

    Science.gov (United States)

    Sadeghi-Demneh, Ebrahim; Forghany, Saeed; Onmanee, Pornsuree; Trinler, Ursula; Dillon, Michael P; Baker, Richard

    2017-06-20

    Standards and guidelines are an integral part of prosthetic and orthotic service delivery in the developed world underpinned by an assumption that they lead to improved services. Implementing them has a cost, however, and that cost needs to be justified, particularly in resource-limited environments. This scoping review thus asks the question, "What is the evidence of the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics?" A structured search of three electronic databases (Medline, Scopus and Web of Science) followed by manual searching of title, abstract and full text, yielded 29 articles. Four categories of papers were identified: Descriptions and Commentaries (17 papers), Guideline Development (7), Guideline Testing (2) and Standards implementation (3). No articles were explicitly designed to assess the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics. Studies tended to be commentaries on or descriptions of guideline development, testing or implementation of standards. The literature is not sufficiently well developed to warrant the cost and effort of a systematic review. Future primary research should seek to demonstrate whether and how guidelines and standards improve the outcomes for people that require prostheses, orthoses and other assistive devices. Implications for Rehabilitation International Standards and Clinical Guidelines are now an integral part of clinical service provision in prosthetics and orthotics in the developed world. Complying with standards and guidelines has a cost and, particularly in resource-limited environments, it should be possible to justify this in terms of the resulting benefits. This scoping review concludes that there have been no previous studies designed to directly quantify the effects of implementing standards and guidelines on service delivery.

  17. Certifying a university ENT clinic using the ISO 9001:2000 international standard.

    Science.gov (United States)

    Helbig, Matthias; Helbig, Silke; Kahla-Witzsch, Heike A; Kroll, Tobias; May, Angelika

    2010-01-01

    Against statutory duties to introduce quality management systems, the increased importance of this subject has led to numerous activities in various public health institutions. Following the International Standardization Organization (ISO 9001:2000) prerequisites, Frankfurt Goethe University Hospital ENT clinic staff introduced a quality management system. This paper aims to investigate this process. Designing, planning and implementing the quality management system is described. Under the supervision of an executive quality management board, clinic quality goals were defined. Thereafter, several quality management teams performed an actual state analysis as well as developing and realising improvement proposals. Finally a quality management manual containing binding standards and working instructions concerning all patient care, research and teaching aspects was written. Successful certification by a neutral body ascertained that the clinic's quality management system conformed to current national and international standards while restructuring and reform improved procedural efficiency. The paper shows that mplementing the quality management system requires considerable effort but patients as well as staff profit considerably from the innovation. On the whole, the positive impact on structure and workflow in a specialist clinic predominates. Therefore, implementing a quality management system in all the clinic's wards and departments is recommended.

  18. Clinical results after different protocols of combined local heat and radiation

    International Nuclear Information System (INIS)

    Arcangeli, G.; Cividalli, A.; Nervi, C.; Lovisolo, G.

    1983-01-01

    Since 1977, 69 patients with 138 multiple lesions have been treated with combined radiotherapy and hyperthermia, according to 3 protocols. Firstly, radiotherapy was given following a thrice-a-day fractionation scheme of 1.5 to 2 Gy/fraction, up to 60 Gy. Hyperthermia (42.5 0 C/45 min) was applied each other day, immediately after the 2nd radiation fraction. Immediate response resulted significantly higher in the combined group (76% clearances in comparison with 46% after radiotherapy alone). Secondly, tumors received 40 Gy/8 fractions, twice a week, and hyperthermia (42.5 0 C/45 min) was applied with each radiotherapy fraction, either immediately after irradiation (simultaneously) of 4 h later (sequentially). A remarkable improvement of radiation response was obtained, especially with the simultaneous treatment. Thirdly, tumors received 30 Gy/6 fractions, twice a week. Hyperthermia (45 0 C/30 min) was applied simultaneously with each radiotherapy fraction and the surrounding skin was cooled. Complete tumor clearance was achieved in 88% lesions in comparison with 31% after radiotherapy alone. As expected, the incidence of thermal damage on uncooled skin was also increased. In conclusion, the best therapeutic ratio was obtained with low fractional radiotherapy doses and low temperature hyperthermia. (orig.) [de

  19. 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.

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

    Science.gov (United States)

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

    2017-12-01

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

  1. A scheme for the audit of scientific and technological standards in clinical nuclear medicine

    International Nuclear Information System (INIS)

    Perkins, A.C.; Jarritt, P.H.

    2002-01-01

    Aim: Audit is the process whereby the quality of a service is monitored and optimised. It forms an essential component of the quality assurance process, whether by self-assessment or by external peer review. In the UK the British Nuclear Medicine Society (BNMS) has undertaken external organisational audit of departments providing clinical nuclear medicine services. This work aimed to develop a more thorough and service specific process for the audit of scientific and technological standards in nuclear medicine. Materials and Methods: The audit process has been implemented using written audit documents to facilitate the audit procedure. A questionnaire forms part of the formal documentation for audit of the scientific and technical standards of a clinical service. Scientific and technical standards were derived from a number of sources including legal requirements, regulatory obligations, notes for guidance, peer reviewed publications and accepted good clinical practice (GCP). Results: The audit process graded the standards of an individual department according to legal or safety requirements (Grade A), good practice (Grade B) and desirable aspects of service delivery (Grade C). The standards have been allocated into eight main categories. These are: Instrumentation; Software and data protection; Electrical Safety; Mechanical Safety; Workstation Safety; The Control of Substances Hazardous to Health (COSHH); Radiation Protection; Scientific and Technical staffing levels. During the audit visit a detailed inspection of clinical and laboratory areas and department written documentation is also necessary to validate the data obtained. Conclusion: The printed scheme now provides a means for external audit or self-assessment. There should be evidence of a well-organised and safe environment for both patients and staff. Health and Safety legislation requires written local rules and these records should be available to demonstrate the standard of service provision. Other

  2. The need for international standardization in clinical beta dosimetry for brachytherapy

    International Nuclear Information System (INIS)

    Quast, U.; Boehm, J.; Kaulich, T.W.

    2002-01-01

    Beta radiation has found increasing interest in radiotherapy. Besides the curative treatment of small and medium-sized intraocular tumors by means of ophthalmic beta radiation plaques, intravascular brachytherapy has proven to successfully overcome the severe problem of restenosis after interventional treatment of arterial stenosis in coronaries and peripheral vessels in many clinical trials with a large number of patients. Prior to initiating procedures applying beta radiation in radiotherapy, however, there is a common need to specify methods for the determination and specification of the absorbed dose to water or tissue and their spatial distributions. The IAEA-TECDOC-1274 Calibration of photon and beta ray sources used in brachytherapy (2002) is a help for photon brachytherapy calibration. But, for beta seed and line sources, IAEA recommends well type ionization chambers as working standards which are far from measuring absorbed dose to water of the radiation clinically used. Although the application of such working standards seems to be more precise, large errors can occur when the medical physicist has to convert the calibration data to absorbed dose to water of the beta radiation emitted. The user must believe that the source is equally activated and that the manufacturer did not change the design and construction of the source encapsulation. With the DGMP Report 16 (2001) Guidelines for medical physical aspects of intravascular brachytherapy a very detailed code of practice is given, especially for the calibration and clinical dosimetry of intravascular beta radiation sources. As there is a global need for standardization in clinical dosimetry for intravascular brachytherapy utilizing beta radiation, the DIN-NAR, the German committee on standardization in radiology, task group dosimetry, has initiated an international adhoc working group for a new ISO work item proposal on the standardization of procedures in clinical dosimetry to guarantee reliable

  3. Medical Paraclinical Standards, Political Economy of Clinic, and Patients’ Clinical Dependency; A Critical Conversation Analysis of Clinical Counseling in South of Iran

    Science.gov (United States)

    Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

    2014-01-01

    Background: Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. Methods: The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. Results: Results show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Conclusion: Although we can’t condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can’t reduce it to instrumental and linear methods of body treatment. PMID:25349858

  4. Medical paraclinical standards, political economy of clinic, and patients' clinical dependency; a critical conversation analysis of clinical counseling in South of iran.

    Science.gov (United States)

    Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

    2014-07-01

    Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. RESULTS show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Although we can't condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can't reduce it to instrumental and linear methods of body treatment.

  5. Participation of nurses in the execution of clinical research protocol about technological innovation

    Directory of Open Access Journals (Sweden)

    Luciane Patrícia Andreani Cabral

    2015-10-01

    Full Text Available AbstractOBJECTIVETo report the nurse's experience of inclusion in interdisciplinary clinical study about technological innovation, involving people with spinal cord injury.METHODDescriptive experience report. The empirical support was based on notes about perspectives and practice of clinical research, with a multi-professional nursing, physical education, physiotherapy and engineering staff.RESULTThe qualification includes the elaboration of the document for the Ethics Committee, familiarization among the members of staff and with the studied topic, and also an immersion into English. The nurse's knowledge gave support to the uptake of participants and time adequacy for data collection, preparation and assistance of the participants during the intervention and after collection. Nursing theories and processes have contributed to reveal risky diagnoses and the plan of care. It was the nurse's role to monitor the risk of overlapping methodological strictness to the human aspect. The skills for the clinical research must be the object of learning, including students in multidisciplinary researches.CONCLUSIONTo qualify the nurse for clinical research and to potentialize its caregiver essence, some changes are needed in the educational system, professional behavior, attitude and educational assistance.

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

    Science.gov (United States)

    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

  7. New Acquisition Protocol of 18F-Choline PET/CT in Prostate Cancer Patients: Review of the Literature about Methodology and Proposal of Standardization

    Directory of Open Access Journals (Sweden)

    Sotirios Chondrogiannis

    2014-01-01

    Full Text Available Purpose. (1 To evaluate a new acquisition protocol of 18F-choline (FCH PET/CT for prostate cancer patients (PC, (2 to review acquisition 18F-choline PET/CT methodology, and (3 to propose a standardized acquisition protocol on FCH PET/CT in PC patients. Materials. 100 consecutive PC patients (mean age 70.5 years, mean PSA 21.35 ng/mL were prospectively evaluated. New protocol consisted of an early scan of the pelvis immediately after the injection of the tracer (1 bed position of 4 min followed by a whole body scan at one 1 hour. Early and 1 hour images were compared for interfering activity and pathologic findings. Results. The overall detection rate of FCH PET/CT was 64%. The early static images of the pelvis showed absence of radioactive urine in ureters, bladder, or urethra which allowed a clean evaluation of the prostatic fossae. Uptake in the prostatic region was better visualized in the early phase in 26% (7/30 of cases. Other pelvic pathologic findings (bone and lymph nodes were visualized in both early and late images. Conclusion. Early 18F-choline images improve visualization of abnormal uptake in prostate fossae. All pathologic pelvic deposits (prostate, lymph nodes, and bone were visualized in both early and late images.

  8. Implant Mandibular Overdentures Retained by Immediately Loaded Implants: A 1-Year Randomized Trial Comparing the Clinical and Radiographic Outcomes Between Mini Dental Implants and Standard-Sized Implants.

    Science.gov (United States)

    Zygogiannis, Kostas; Aartman, Irene Ha; Parsa, Azin; Tahmaseb, Ali; Wismeijer, Daniel

    The aim of this 1-year randomized trial was to evaluate and compare the clinical and radiographic performance of four immediately loaded mini dental implants (MDIs) and two immediately loaded standard-sized tissue-level (STL) implants, placed in the interforaminal region of the mandible and used to retain mandibular overdentures (IODs) in completely edentulous patients. A total of 50 completely edentulous patients wearing conventional maxillary dentures and complaining about insufficient retention of their mandibular dentures were divided into two groups; 25 patients received four MDIs and 25 patients received two STL implants. The marginal bone loss (MBL) at the mesial and distal sides of each implant was assessed by means of standardized intraoral radiographs after a period of 1 year. Implant success and survival rates were also calculated. Immediate loading was possible for all patients in the first group. In the second group, an immediate loading protocol could not be applied for 10 patients. These patients were treated with a delayed loading protocol. A mean MBL of 0.42 ± 0.56 mm for the MDIs and 0.54 ± 0.49 mm for the immediately loaded STL implants was recorded at the end of the evaluation period. There was no statistically significant difference between the MDIs and the immediately loaded STL implants. Two MDIs failed, resulting in a survival rate of 98%. The success rate was 91%. For the immediately loaded conventional implants, the survival rate was 100% and the success rate 96.7% after 1 year of function. However, in 10 patients, the immediate loading protocol could not be followed. Considering the limitations of this short-term clinical study, immediate loading of four unsplinted MDIs or two splinted STL implants to retain mandibular overdentures seems to be a feasible treatment option. The marginal bone level changes around the MDIs were well within the clinically acceptable range.

  9. Standardized cardiovascular data for clinical research, registries, and patient care: a report from the Data Standards Workgroup of the National Cardiovascular Research Infrastructure project.

    Science.gov (United States)

    Anderson, H Vernon; Weintraub, William S; Radford, Martha J; Kremers, Mark S; Roe, Matthew T; Shaw, Richard E; Pinchotti, Dana M; Tcheng, James E

    2013-05-07

    Relatively little attention has been focused on standardization of data exchange in clinical research studies and patient care activities. Both are usually managed locally using separate and generally incompatible data systems at individual hospitals or clinics. In the past decade there have been nascent efforts to create data standards for clinical research and patient care data, and to some extent these are helpful in providing a degree of uniformity. Nonetheless, these data standards generally have not been converted into accepted computer-based language structures that could permit reliable data exchange across computer networks. The National Cardiovascular Research Infrastructure (NCRI) project was initiated with a major objective of creating a model framework for standard data exchange in all clinical research, clinical registry, and patient care environments, including all electronic health records. The goal is complete syntactic and semantic interoperability. A Data Standards Workgroup was established to create or identify and then harmonize clinical definitions for a base set of standardized cardiovascular data elements that could be used in this network infrastructure. Recognizing the need for continuity with prior efforts, the Workgroup examined existing data standards sources. A basic set of 353 elements was selected. The NCRI staff then collaborated with the 2 major technical standards organizations in health care, the Clinical Data Interchange Standards Consortium and Health Level Seven International, as well as with staff from the National Cancer Institute Enterprise Vocabulary Services. Modeling and mapping were performed to represent (instantiate) the data elements in appropriate technical computer language structures for endorsement as an accepted data standard for public access and use. Fully implemented, these elements will facilitate clinical research, registry reporting, administrative reporting and regulatory compliance, and patient care

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

    Science.gov (United States)

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

    2017-10-01

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

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

    Directory of Open Access Journals (Sweden)

    Clarice Seixas Duarte

    2017-08-01

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

  12. 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...

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

    Science.gov (United States)

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

    2007-06-01

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

  14. Yoga for Health Care in Korea: A Protocol for Systematic Review of Clinical Trials

    Directory of Open Access Journals (Sweden)

    Jiae Choi

    2016-08-01

    Sixteen electronic databases will be searched from the inception of the study until January 2016. All clinical evidences that evaluate any type of yoga and any type of control in individuals with any type of condition will be eligible. The methodological quality will be assessed using the Cochrane risk of bias tool for randomized clinical trials and the Newcastle–Ottawa scale for nonrandomized studies. Two authors will independently assess each study for eligibility and the risk of bias, and then they will extract the data. With its extensive, unbiased search of the Korean literature from various databases without any language restrictions, this systematic review will be useful for both practitioners in the field of yoga research as well as for patients.

  15. Towards a Clinical Trial Protocol to Evaluate Health Information Systems: Evaluation of a Computerized System for Monitoring Tuberculosis from a Patient Perspective in Brazil.

    Science.gov (United States)

    Crepaldi, Nathalia Yukie; de Lima, Inacia Bezerra; Vicentine, Fernanda Bergamini; Rodrigues, Lídia Maria Lourençon; Sanches, Tiago Lara Michelin; Ruffino-Netto, Antonio; Alves, Domingos; Rijo, Rui Pedro Charters Lopes

    2018-05-08

    Assessment of health information systems consider different aspects of the system itself. They focus or on the professional who will use the software or on its usability or on the software engineering metrics or on financial and managerial issues. The existent approaches are very resources consuming, disconnected, and not standardized. As the software becomes more critical in the health organizations and in patients, becoming used as a medical device or a medicine, there is an urgency to identify tools and methods that can be applied in the development process. The present work is one of the steps of a broader study to identify standardized protocols to evaluate the health information systems as medicines and medical devices are evaluated by clinical trials. The goal of the present work was to evaluate the effect of the introduction of an information system for monitoring tuberculosis treatment (SISTB) in a Brazilian municipality from the patients' perspective. The Patient Satisfaction Questionnaire and the Hospital Consumer Assessment of Healthcare Providers and Systems were answered by the patients before and after the SISTB introduction, for comparison. Patients from an outpatient clinic, formed the control group, that is, at this site was not implanted the SISTB. Descriptive statistics and mixed effects model were used for data analysis. Eighty-eight interviews were conducted in the study. The questionnaire's results presented better averages after the system introduction but were not considered statistically significant. Therefore, it was not possible to associate system implantation with improved patient satisfaction. The HIS evaluation need be complete, the technical and managerial evaluation, the safety, the impact on the professionals and direct and/or indirect impact on patients are important. Developing the right tools and methods that can evaluate the software in its entirety, from the beginning of the development cycle with a normalized scale, are

  16. The need for European professional standards and the challenges facing clinical microbiology.

    Science.gov (United States)

    Humphreys, H; Nagy, E; Kahlmeter, G; Ruijs, G J H M

    2010-06-01

    Microorganisms spread across national boundaries and the professional activities of clinical (medical) microbiologists are critical in minimising their impact. Clinical microbiologists participate in many activities, e.g. diagnosis, antibiotic therapy, and there is a need for a set of professional standards for Europe with a common curriculum, to build upon the current strengths of the specialty and to facilitate the free movement of specialists within the European Union. Such standards will also better highlight the important contribution of clinical microbiologists to healthcare. There is a move to larger centralised microbiology laboratories often located off-site from an acute hospital, driven by the concentration of resources, amalgamation of services, outsourcing of diagnostics, automation, an explosion in the range of staff competencies and accreditation. Large off-site centralised microbiology laboratories are often distant to the patient and may not facilitate the early detection of microbial spread. Ultimately, the needs of patients and the public are paramount in deciding on the future direction of clinical microbiology. Potential conflicts between integration on an acute hospital site and centralisation can be resolved by a common set of professional standards and a team-based approach that puts patients first.

  17. Postimplant Dosimetry Using a Monte Carlo Dose Calculation Engine: A New Clinical Standard

    International Nuclear Information System (INIS)

    Carrier, Jean-Francois; D'Amours, Michel; Verhaegen, Frank; Reniers, Brigitte; Martin, Andre-Guy; Vigneault, Eric; Beaulieu, Luc

    2007-01-01

    Purpose: To use the Monte Carlo (MC) method as a dose calculation engine for postimplant dosimetry. To compare the results with clinically approved data for a sample of 28 patients. Two effects not taken into account by the clinical calculation, interseed attenuation and tissue composition, are being specifically investigated. Methods and Materials: An automated MC program was developed. The dose distributions were calculated for the target volume and organs at risk (OAR) for 28 patients. Additional MC techniques were developed to focus specifically on the interseed attenuation and tissue effects. Results: For the clinical target volume (CTV) D 90 parameter, the mean difference between the clinical technique and the complete MC method is 10.7 Gy, with cases reaching up to 17 Gy. For all cases, the clinical technique overestimates the deposited dose in the CTV. This overestimation is mainly from a combination of two effects: the interseed attenuation (average, 6.8 Gy) and tissue composition (average, 4.1 Gy). The deposited dose in the OARs is also overestimated in the clinical calculation. Conclusions: The clinical technique systematically overestimates the deposited dose in the prostate and in the OARs. To reduce this systematic inaccuracy, the MC method should be considered in establishing a new standard for clinical postimplant dosimetry and dose-outcome studies in a near future

  18. Concordance of mutation detection in circulating tumor DNA in early clinical trials using different blood collection protocols

    DEFF Research Database (Denmark)

    Ahlborn, Lise B.; Madsen, Mette; Jonson, Lars

    2017-01-01

    in a clinical setting. Here we investigate the concordance between standard blood collection for molecular analysis using immediate separation of plasma, compared to the use of collection tubes allowing for delayed processing. Methods: In this study, we measured the fractional abundance of tumor specific...... patients with advanced solid cancers enrolled in early clinical trials. Results: Concordance in the fractional abundance of mutations in ctDNA isolated from blood collected in either K3EDTA or BCT tubes from patients with different solid cancers was observed. Conclusions: This study indicates that BCT...... mutations (BRAF p.V600E and PIK3CA p.H1047R) in ctDNA isolated from blood samples collected in either cell-stabilizing Cell-Free DNA BCT tubes (delayed processing within 72 hours) or standard K3EDTA tubes (immediate processing within 15 minutes). Twenty-five blood sample pairs (EDTA/BCT) were collected from...

  19. Applicability Evaluation of Job Standards for Diabetes Nutritional Management by Clinical Dietitian.

    Science.gov (United States)

    Baek, Young Jin; Oh, Na Gyeong; Sohn, Cheong-Min; Woo, Mi-Hye; Lee, Seung Min; Ju, Dal Lae; Seo, Jung-Sook

    2017-04-01

    This study was conducted to evaluate applicability of job standards for diabetes nutrition management by hospital clinical dietitians. In order to promote the clinical nutrition services, it is necessary to present job standards of clinical dietitian and to actively apply these standardized tasks to the medical institution sites. The job standard of clinical dietitians for diabetic nutrition management was distributed to hospitals over 300 beds. Questionnaire was collected from 96 clinical dietitians of 40 tertiary hospitals, 47 general hospitals, and 9 hospitals. Based on each 5-point scale, the importance of overall duty was 4.4 ± 0.5, performance was 3.6 ± 0.8, and difficulty was 3.1 ± 0.7. 'Nutrition intervention' was 4.5 ± 0.5 for task importance, 'nutrition assessment' was 4.0 ± 0.7 for performance, and 'nutrition diagnosis' was 3.4 ± 0.9 for difficulty. These 3 items were high in each category. Based on the grid diagram, the tasks of both high importance and high performance were 'checking basic information,' 'checking medical history and therapy plan,' 'decision of nutritional needs,' 'supply of foods and nutrients,' and 'education of nutrition and self-management.' The tasks with high importance but low performance were 'derivation of nutrition diagnosis,' 'planning of nutrition intervention,' 'monitoring of nutrition intervention process.' The tasks of both high importance and high difficulty were 'derivation of nutrition diagnosis,' 'planning of nutrition intervention,' 'supply of foods and nutrients,' 'education of nutrition and self-management,' and 'monitoring of nutrition intervention process.' The tasks of both high performance and high difficulty were 'documentation of nutrition assessment,' 'supply of foods and nutrients,' and 'education of nutrition and self-management.'

  20. Validity Evidence and Scoring Guidelines for Standardized Patient Encounters and Patient Notes From a Multisite Study of Clinical Performance Examinations in Seven Medical Schools.

    Science.gov (United States)

    Park, Yoon Soo; Hyderi, Abbas; Heine, Nancy; May, Win; Nevins, Andrew; Lee, Ming; Bordage, Georges; Yudkowsky, Rachel

    2017-11-01

    To examine validity evidence of local graduation competency examination scores from seven medical schools using shared cases and to provide rater training protocols and guidelines for scoring patient notes (PNs). Between May and August 2016, clinical cases were developed, shared, and administered across seven medical schools (990 students participated). Raters were calibrated using training protocols, and guidelines were developed collaboratively across sites to standardize scoring. Data included scores from standardized patient encounters for history taking, physical examination, and PNs. Descriptive statistics were used to examine scores from the different assessment components. Generalizability studies (G-studies) using variance components were conducted to estimate reliability for composite scores. Validity evidence was collected for response process (rater perception), internal structure (variance components, reliability), relations to other variables (interassessment correlations), and consequences (composite score). Student performance varied by case and task. In the PNs, justification of differential diagnosis was the most discriminating task. G-studies showed that schools accounted for less than 1% of total variance; however, for the PNs, there were differences in scores for varying cases and tasks across schools, indicating a school effect. Composite score reliability was maximized when the PN was weighted between 30% and 40%. Raters preferred using case-specific scoring guidelines with clear point-scoring systems. This multisite study presents validity evidence for PN scores based on scoring rubric and case-specific scoring guidelines that offer rigor and feedback for learners. Variability in PN scores across participating sites may signal different approaches to teaching clinical reasoning among medical schools.

  1. Clinical grade purification and expansion of NK cell products for an optimized manufacturing protocol

    Directory of Open Access Journals (Sweden)

    Ulrike eKoehl

    2013-05-01

    Full Text Available Allogeneic Natural Killer (NK cells are used for adoptive immunotherapy after stem cell transplantation. In order to overcome technical limitations in NK cell purification and activation, the following study investigates the impact of different variables on NK cell recovery, cytotoxicity and T cell depletion during GMP-grade NK cell selection. 40 NK cell products were derived from 54 unstimulated donor leukaphereses using immunomagnetic CD3 T-cell depletion, followed by a CD56 cell enrichment step. For T cell depletion, either the depletion 2.1 program in single or double procedure (D2.1 1depl, n=18; D2.1 2depl, n=13 or the faster depletion 3.1 (D3.1, n=9 was used on the CliniMACS instrument. 17 purified NK cell products were activated in vitro by IL-2 for 12 days. The whole process resulted in a median number of 7.59x10e8 CD56+CD3- cells with both purity and viability of 94%, respectively. The T-cell depletion was significantly better using D2.1 1depl/2depl compared to D3.1 (log 4.6/log 4.9 vs. log 3.7; p<0.01 and double procedure in two stages led always to residual T cells below 0.1%. In contrast D3.1 was superior to D2.1 1depl/2depl with regard to recovery of CD56+CD3- NK cells (68% vs 41%/38%. Concomitant monocytes and especially IL-2 activation led to increased NK cell activity against malignant target cells compared to unstimulated NK cells, which correlated with both up-regulation of natural cytotoxicity receptors and intracellular signaling. Overall, wide variations in the NK cell expansion rate and the distribution of NK cell subpopulations were found. In conclusion, our results indicate that GMP-grade purification of NK cells might be improved by a sequential processing of T cell depletion program D2.1 and D3.1. In addition NK cell expansion protocols need to be further optimized.

  2. Standard requirements for GCP-compliant data management in multinational clinical trials

    LENUS (Irish Health Repository)

    Ohmann, Christian

    2011-03-22

    Abstract Background A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. Methods International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials. Results The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit

  3. Patient controlled sedation using a standard protocol for dressing changes in burns: patients' preference, procedural details and a preliminary safety evaluation.

    Science.gov (United States)

    Nilsson, Andreas; Steinvall, Ingrid; Bak, Zoltan; Sjöberg, Folke

    2008-11-01

    Patient controlled sedation (PCS) enables patients to titrate doses of drugs by themselves during different procedures involving pain or discomfort. We studied it in a prospective crossover design using a fixed protocol without lockout time to examine it as an alternative method of sedation for changing dressings in burned patients. Eleven patients with >10% total burn surface area (TBSA) had their dressings changed, starting with sedation by an anaesthetist (ACS). The second dressing change was done with PCS (propofol/alfentanil) and the third time the patients had to choose ACS or PCS. During the procedures, data on cardiopulmonary variables, sedation (bispectral index), pain intensity (VAS), procedural details, doses of drugs, and patients' preferences were collected to compare the two sedation techniques. The study data indicated that wound care in burned patients is feasible with a standardized PCS protocol. The patients preferred PCS to ACS on the basis of self-control, and because they had less discomfort during the recovery period. Wound care was also considered adequate by the staff during PCS. No respiratory (respiratory rate/transcutaneous PCO(2)) or cardiovascular (heart rate/blood pressure) adverse events were recorded at any time during any of the PCS procedures. The doses of propofol and alfentanil and BIS index decrease were less during PCS than ACS. Procedural pain was higher during PCS but lower after the procedure. We suggest that PCS using a standard protocol is an interesting alternative to anaesthetist-provided sedation during dressing changes. It seems effective, saves resources, is safe, and at same time is preferred by the patients. The strength of these conclusions is, however, hampered by the small size of this investigation and therefore further studies are warranted.

  4. Clinical trial or standard treatment? Shared decision making at the department of oncology

    DEFF Research Database (Denmark)

    Gregersen, Trine Ammentorp; Birkelund, Regner; Ammentorp, Jette

    2016-01-01

    Title: Clinical trial or standard treatment? Shared decision making at the department of oncology. Authors: Ph.d. student, Trine A. Gregersen. Trine.gregersen@rsyd.dk. Department of Oncology. Health Services Research Unit Lillebaelt Hospital / IRS University of Southern Denmark. Professor, Regner...... are involved in difficult treatment decisions including participation in clinical trials. The literature indicates that the decision is very often based on little knowledge about the treatment and that many patients who have consented to participate in a clinical trial are not always aware...... that they are participating in a trial. This place great demand on the healthcare providers’ ability to involve and advise patients in the decisions. The aim of this study is to investigate the characteristics of the communication when decisions about participation in clinical oncology trial are made and the patients...

  5. Visualization of the internal globus pallidus: sequence and orientation for deep brain stimulation using a standard installation protocol at 3.0 Tesla.

    Science.gov (United States)

    Nölte, Ingo S; Gerigk, Lars; Al-Zghloul, Mansour; Groden, Christoph; Kerl, Hans U

    2012-03-01

    Deep-brain stimulation (DBS) of the internal globus pallidus (GPi) has shown remarkable therapeutic benefits for treatment-resistant neurological disorders including dystonia and Parkinson's disease (PD). The success of the DBS is critically dependent on the reliable visualization of the GPi. The aim of the study was to evaluate promising 3.0 Tesla magnetic resonance imaging (MRI) methods for pre-stereotactic visualization of the GPi using a standard installation protocol. MRI at 3.0 T of nine healthy individuals and of one patient with PD was acquired (FLAIR, T1-MPRAGE, T2-SPACE, T2*-FLASH2D, susceptibility-weighted imaging mapping (SWI)). Image quality and visualization of the GPi for each sequence were assessed by two neuroradiologists independently using a 6-point scale. Axial, coronal, and sagittal planes of the T2*-FLASH2D images were compared. Inter-rater reliability, contrast-to-noise ratios (CNR) and signal-to-noise ratios (SNR) for the GPi were determined. For illustration, axial T2*-FLASH2D images were fused with a section schema of the Schaltenbrand-Wahren stereotactic atlas. The GPi was best and reliably visualized in axial and to a lesser degree on coronal T2*-FLASH2D images. No major artifacts in the GPi were observed in any of the sequences. SWI offered a significantly higher CNR for the GPi compared to standard T2-weighted imaging using the standard parameters. The fusion of the axial T2*-FLASH2D images and the atlas projected the GPi clearly in the boundaries of the section schema. Using a standard installation protocol at 3.0 T T2*-FLASH2D imaging (particularly axial view) provides optimal and reliable delineation of the GPi.

  6. [The analytical reliability of clinical laboratory information and role of the standards in its support].

    Science.gov (United States)

    Men'shikov, V V

    2012-12-01

    The article deals with the factors impacting the reliability of clinical laboratory information. The differences of qualities of laboratory analysis tools produced by various manufacturers are discussed. These characteristics are the causes of discrepancy of the results of laboratory analyses of the same analite. The role of the reference system in supporting the comparability of laboratory analysis results is demonstrated. The project of national standard is presented to regulate the requirements to standards and calibrators for analysis of qualitative and non-metrical characteristics of components of biomaterials.

  7. 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

  8. EXACKTE2: Exploiting the clinical consultation as a knowledge transfer and exchange environment: a study protocol

    Directory of Open Access Journals (Sweden)

    Ouimet Mathieu

    2009-03-01

    Full Text Available Abstract Background While the evidence suggests that the way physicians provide information to patients is crucial in helping patients decide upon a course of action, the field of knowledge translation and exchange (KTE is silent about how the physician and the patient influence each other during clinical interactions and decision-making. Consequently, based on a novel relationship-centered model, EXACKTE2 (EXploiting the clinicAl Consultation as a Knowledge Transfer and Exchange Environment, this study proposes to assess how patients and physicians influence each other in consultations. Methods We will employ a cross-sectional study design involving 300 pairs of patients and family physicians from two primary care practice-based research networks. The consultation between patient and physician will be audio-taped and transcribed. Following the consultation, patients and physicians will complete a set of questionnaires based on the EXACKTE2 model. All questionnaires will be similar for patients and physicians. These questionnaires will assess the key concepts of our proposed model based on the essential elements of shared decision-making (SDM: definition and explanation of problem; presentation of options; discussion of pros and cons; clarification of patient values and preferences; discussion of patient ability and self-efficacy; presentation of doctor knowledge and recommendation; and checking and clarifying understanding. Patients will be contacted by phone two weeks later and asked to complete questionnaires on decisional regret and quality of life. The analysis will be conducted to compare the key concepts in the EXACKTE2 model between patients and physicians. It will also allow the assessment of how patients and physicians influence each other in consultations. Discussion Our proposed model, EXACKTE2, is aimed at advancing the science of KTE based on a relationship process when decision-making has to take place. It fosters a new KTE

  9. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  10. Study of the behavior of radiation detectors for mammography in standard beams using a clinical system

    International Nuclear Information System (INIS)

    Barreira, Jacqueline Sales

    2014-01-01

    A mammogram is the x-ray of the breast that allows early detection of cancer, by being able to show lesions in very small early stage. But to get an early and reliable diagnosis is necessary that the mammography unit is calibrated and working properly, otherwise there may be a loss in image produced, may lead to a false diagnosis, and possible harm to the patient. So it is important to control these devices, especially in relation to the radiation produced by them. In this project, we propose a study of the behavior of ionization chambers for mammography calibrated beam patterns in a clinical system (Philips-VMI mammography, Graph Mammo AF, which operates a range of 20 to 35 kV) from Instruments Calibration Laboratory at IPEN-CNEN/SP, with the aim of determining parameters correction approaching conditions calibration conditions for clinical use. Measurements of the parameters of the beams set in mammography using simulators acrylic specially developed for these measurements were performed in order to establish a new protocol for calibration of the ionization chambers in a clinical system rather than the industrial system, or as a complement to this. (author)

  11. Organisation and management of the first clinical trial of BNCT in Europe (EORTC Protocol 11961)

    International Nuclear Information System (INIS)

    Sauerwein, W.; Rassow, J.; Hideghety, K.; Sack, H.; Moss, R.; Stecher-Rasmussen, F.; Wolbers, J.G.

    1999-01-01

    Boron Neutron Capture Therapy is based on the ability of the isotope 10 B to capture thermal neutrons and to disintegrate instantaneously producing high LET particles. The only neutron beam available in Europe for such a treatment is based at the European High Flux Reactor HFR at Petten (The Netherlands). The European Commission, owners of the reactor, decided that the potential benefit of the facility should be opened to all European citizens and therefore insisted on a multinational approach to perform the first clinical trial in Europe on BNCT. This precondition had to be respected as well as the national laws and regulations. Together with the Dutch authorities actions were undertaken to overcome the obvious legal problems. Furthermore, the clinical trial at Petten takes place in a nuclear research reactor, which apart from being conducted in a non-hospital environment, is per se known to be dangerous. It was therefore of the utmost importance that special attention is given to safety, beyond normal rules, and to the training of staff. In itself, the trial is an unusual Phase I study, introducing a new drug with a new irradiation modality, with really an unknown dose-effect relationship. This trial must follow optimal procedures, which underscore the quality and qualified manner of performance. (orig.)

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

    Science.gov (United States)

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

    2015-08-06

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

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

    Directory of Open Access Journals (Sweden)

    Cooper Nicholas J

    2011-01-01

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

  14. WE-F-BRB-01: The Power of Ontologies and Standardized Terminologies for Capturing Clinical Knowledge

    Energy Technology Data Exchange (ETDEWEB)

    Gabriel, P. [University of Pennsylvania (United States)

    2015-06-15

    Advancements in informatics in radiotherapy are opening up opportunities to improve our ability to assess treatment plans. Models on individualizing patient dose constraints from prior patient data and shape relationships have been extensively researched and are now making their way into commercial products. New developments in knowledge based treatment planning involve understanding the impact of the radiation dosimetry on the patient. Akin to radiobiology models that have driven intensity modulated radiotherapy optimization, toxicity and outcome predictions based on treatment plans and prior patient experiences may be the next step in knowledge based planning. In order to realize these predictions, it is necessary to understand how the clinical information can be captured, structured and organized with ontologies and databases designed for recall. Large databases containing radiation dosimetry and outcomes present the opportunity to evaluate treatment plans against predictions of toxicity and disease response. Such evaluations can be based on dose volume histogram or even the full 3-dimensional dose distribution and its relation to the critical anatomy. This session will provide an understanding of ontologies and standard terminologies used to capture clinical knowledge into structured databases; How data can be organized and accessed to utilize the knowledge in planning; and examples of research and clinical efforts to incorporate that clinical knowledge into planning for improved care for our patients. Learning Objectives: Understand the role of standard terminologies, ontologies and data organization in oncology Understand methods to capture clinical toxicity and outcomes in a clinical setting Understand opportunities to learn from clinical data and its application to treatment planning Todd McNutt receives funding from Philips, Elekta and Toshiba for some of the work presented.

  15. WE-F-BRB-01: The Power of Ontologies and Standardized Terminologies for Capturing Clinical Knowledge

    International Nuclear Information System (INIS)

    Gabriel, P.

    2015-01-01

    Advancements in informatics in radiotherapy are opening up opportunities to improve our ability to assess treatment plans. Models on individualizing patient dose constraints from prior patient data and shape relationships have been extensively researched and are now making their way into commercial products. New developments in knowledge based treatment planning involve understanding the impact of the radiation dosimetry on the patient. Akin to radiobiology models that have driven intensity modulated radiotherapy optimization, toxicity and outcome predictions based on treatment plans and prior patient experiences may be the next step in knowledge based planning. In order to realize these predictions, it is necessary to understand how the clinical information can be captured, structured and organized with ontologies and databases designed for recall. Large databases containing radiation dosimetry and outcomes present the opportunity to evaluate treatment plans against predictions of toxicity and disease response. Such evaluations can be based on dose volume histogram or even the full 3-dimensional dose distribution and its relation to the critical anatomy. This session will provide an understanding of ontologies and standard terminologies used to capture clinical knowledge into structured databases; How data can be organized and accessed to utilize the knowledge in planning; and examples of research and clinical efforts to incorporate that clinical knowledge into planning for improved care for our patients. Learning Objectives: Understand the role of standard terminologies, ontologies and data organization in oncology Understand methods to capture clinical toxicity and outcomes in a clinical setting Understand opportunities to learn from clinical data and its application to treatment planning Todd McNutt receives funding from Philips, Elekta and Toshiba for some of the work presented

  16. Standardization of Data for Clinical Use and Research in Spinal Cord Injury

    DEFF Research Database (Denmark)

    Biering-Sørensen, Fin; Noonan, Vanessa K

    2016-01-01

    for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged...... to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society's International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements......Increased survival after spinal cord injury (SCI) worldwide has enhanced the need for quality data that can be compared and shared between centers, countries, as well as across research studies, to better understand how best to prevent and treat SCI. Such data should be standardized and be able...

  17. Laparoscopic colorectal surgery in learning curve: Role of implementation of a standardized technique and recovery protocol. A cohort study

    Directory of Open Access Journals (Sweden)

    Gaetano Luglio

    2015-06-01

    Conclusion: Proper laparoscopic colorectal surgery is safe and leads to excellent results in terms of recovery and short term outcomes, even in a learning curve setting. Key factors for better outcomes and shortening the learning curve seem to be the adoption of a standardized technique and training model along with the strict supervision of an expert colorectal surgeon.

  18. Innovating cystic fibrosis clinical trial designs in an era of successful standard of care therapies.

    Science.gov (United States)

    VanDevanter, Donald R; Mayer-Hamblett, Nicole

    2017-11-01

    Evolving cystic fibrosis 'standards of care' have influenced recent cystic fibrosis clinical trial designs for new therapies; care additions/improvements will require innovative trial designs to maximize feasibility and efficacy detection. Three cystic fibrosis therapeutic areas (pulmonary exacerbations, Pseudomonas aeruginosa airway infections, and reduced cystic fibrosis transmembrane conductance regulator [CFTR] protein function) differ with respect to the duration for which recognized 'standards of care' have been available. However, developers of new therapies in all the three areas are affected by similar challenges: standards of care have become so strongly entrenched that traditional placebo-controlled studies in cystic fibrosis populations likely to benefit from newer therapies have become less and less feasible. Today, patients/clinicians are more likely to entertain participation in active-comparator trial designs, that have substantial challenges of their own. Foremost among these are the selection of 'valid' active comparator(s), estimation of a comparator's current clinical efficacy (required for testing noninferiority hypotheses), and effective blinding of commercially available comparators. Recent and future cystic fibrosis clinical trial designs will have to creatively address this collateral result of successful past development of effective cystic fibrosis therapies: patients and clinicians are much less likely to accept simple, placebo-controlled studies to evaluate future therapies.

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

    Science.gov (United States)

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

    2008-01-01

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

  20. Performance Comparison of Wireless Sensor Network Standard Protocols in an Aerospace Environment: ISA100.11a and ZigBee

    Science.gov (United States)

    Wagner, Raymond S.; Barton, Richard J.

    2011-01-01

    Wireless Sensor Networks (WSNs) can provide a substantial benefit in spacecraft systems, reducing launch weight and providing unprecedented flexibility by allowing instrumentation capabilities to grow and change over time. Achieving data transport reliability on par with that of wired systems, however, can prove extremely challenging in practice. Fortunately, much progress has been made in developing standard WSN radio protocols for applications from non-critical home automation to mission-critical industrial process control. The relative performances of candidate protocols must be compared in representative aerospace environments, however, to determine their suitability for spaceflight applications. In this paper, we will present the results of a rigorous laboratory analysis of the performance of two standards-based, low power, low data rate WSN protocols: ZigBee Pro and ISA100.11a. Both are based on IEEE 802.15.4 and augment that standard's specifications to build complete, multi-hop networking stacks. ZigBee Pro targets primarily the home and office automation markets, providing an ad-hoc protocol that is computationally lightweight and easy to implement in inexpensive system-on-a-chip components. As a result of this simplicity, however, ZigBee Pro can be susceptible to radio frequency (RF) interference. ISA100.11a, on the other hand, targets the industrial process control market, providing a robust, centrally-managed protocol capable of tolerating a significant amount of RF interference. To achieve these gains, a coordinated channel hopping mechanism is employed, which entails a greater computational complexity than ZigBee and requires more sophisticated and costly hardware. To guide future aerospace deployments, we must understand how well these standards relatively perform in analog environments under expected operating conditions. Specifically, we are interested in evaluating goodput -- application level throughput -- in a representative crewed environment

  1. Personalized versus standardized dosing strategies for the treatment of childhood amblyopia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Moseley, Merrick J; Wallace, Michael P; Stephens, David A; Fielder, Alistair R; Smith, Laura C; Stewart, Catherine E

    2015-04-25

    Amblyopia is the commonest visual disorder of childhood in Western societies, affecting, predominantly, spatial visual function. Treatment typically requires a period of refractive correction ('optical treatment') followed by occlusion: covering the nonamblyopic eye with a fabric patch for varying daily durations. Recent studies have provided insight into the optimal amount of patching ('dose'), leading to the adoption of standardized dosing strategies, which, though an advance on previous ad-hoc regimens, take little account of individual patient characteristics. This trial compares the effectiveness of a standardized dosing strategy (that is, a fixed daily occlusion dose based on disease severity) with a personalized dosing strategy (derived from known treatment dose-response functions), in which an initially prescribed occlusion dose is modulated, in a systematic manner, dependent on treatment compliance. A total of 120 children aged between 3 and 8 years of age diagnosed with amblyopia in association with either anisometropia or strabismus, or both, will be randomized to receive either a standardized or a personalized occlusion dose regimen. To avoid confounding by the known benefits of refractive correction, participants will not be randomized until they have completed an optical treatment phase. The primary study objective is to determine whether, at trial endpoint, participants receiving a personalized dosing strategy require fewer hours of occlusion than those in receipt of a standardized dosing strategy. Secondary objectives are to quantify the relationship between observed changes in visual acuity (logMAR, logarithm of the Minimum Angle of Resolution) with age, amblyopia type, and severity of amblyopic visual acuity deficit. This is the first randomized controlled trial of occlusion therapy for amblyopia to compare a treatment arm representative of current best practice with an arm representative of an entirely novel treatment regimen based on statistical

  2. Simultaneous validation of the SunTech CT40 automated blood pressure measurement device by the 1993 British Hypertension Society protocol and the Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2: 2013 standard.

    Science.gov (United States)

    Polo Friz, Hernan; Punzi, Veronica; Petri, Francesco; Orlandi, Riccardo; Maggiolini, Daniele; Polo Friz, Melisa; Primitz, Laura; Vighi, Giuseppe

    2017-10-01

    This study aimed to perform a simultaneous, third-party, independent validation of the oscillometric SunTech CT40 device for blood pressure (BP) measurement, according to the 1993 protocol of the British Hypertension Society and the standard of the Association for the Advancement of Medical Instrumentation (AAMI)/the International Organization for Standardization (ISO) 81060-2:2013. Patient recruitment, study procedures, and data analysis followed the recommendations stated by the protocols. The study was approved by the institutional review board. A total of 94 participants were included, 52 (55.3%) women, mean±SD age: 63.1±18.0 years, mean±SD arm circumference: 35.0±9.0 cm. The average of observers' entry BPs was 146.9±37.2 mmHg for systolic blood pressure (SBP) and 82.2±22.1 mmHg for diastolic blood pressure (DBP). Differences between the standard measurement and the test device within 5, 10, and 15 mmHg, for the better observer, were 79.4, 96.5, and 100.0% for SBP and 82.6, 97.5, and 100.0% for DBP, respectively. The mean±SD differences between the readings obtained using the test device and those obtained by the observers (AAMI/ISO 81060-2:2013 standard criterion 1) were 0.3±5.0 mmHg (SBP) and -0.8±4.3 mmHg (DBP), and the mean±SD differences between average of reference readings and average of test device readings in each patient (criterion 2) were 0.3±3.9 and -0.8±3.5 mmHg for SBP and DBP, respectively. The CT40 BP device achieved A/A grade of the British Hypertension Society protocol and fulfilled the requirements (criteria 1 and 2) of the AAMI/ISO standard. CT40 can be recommended for BP measurement in adults.

  3. The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial.

    Science.gov (United States)

    Leslie, Wilma S; Ford, Ian; Sattar, Naveed; Hollingsworth, Kieren G; Adamson, Ashley; Sniehotta, Falko F; McCombie, Louise; Brosnahan, Naomi; Ross, Hazel; Mathers, John C; Peters, Carl; Thom, George; Barnes, Alison; Kean, Sharon; McIlvenna, Yvonne; Rodrigues, Angela; Rehackova, Lucia; Zhyzhneuskaya, Sviatlana; Taylor, Roy; Lean, Mike E J

    2016-02-16

    Despite improving evidence-based practice following clinical guidelines to optimise drug therapy, Type 2 diabetes (T2DM) still exerts a devastating toll from vascular complications and premature death. Biochemical remission of T2DM has been demonstrated with weight loss around 15kg following bariatric surgery and in several small studies of non-surgical energy-restriction treatments. The non-surgical Counterweight-Plus programme, running in Primary Care where obesity and T2DM are routinely managed, produces >15 kg weight loss in 33% of all enrolled patients. The Diabetes UK-funded Counterpoint study suggested that this should be sufficient to reverse T2DM by removing ectopic fat in liver and pancreas, restoring first-phase insulin secretion. The Diabetes Remission Clinical Trial (DiRECT) was designed to determine whether a structured, intensive, weight management programme, delivered in a routine Primary Care setting, is a viable treatment for achieving durable normoglycaemia. Other aims are to understand the mechanistic basis of remission and to identify psychological predictors of response. Cluster-randomised design with GP practice as the unit of randomisation: 280 participants from around 30 practices in Scotland and England will be allocated either to continue usual guideline-based care or to add the Counterweight-Plus weight management programme, which includes primary care nurse or dietitian delivery of 12-20weeks low calorie diet replacement, food reintroduction, and long-term weight loss maintenance. Main inclusion criteria: men and women aged 20-65 years, all ethnicities, T2DM 0-6years duration, BMI 27-45 kg/m(2). Tyneside participants will undergo Magnetic Resonance (MR) studies of pancreatic and hepatic fat, and metabolic studies to determine mechanisms underlying T2DM remission. Co-primary endpoints: weight reduction ≥ 15 kg and HbA1c <48 mmol/mol at one year. Further follow-up at 2 years. This study will establish whether a structured weight

  4. The effectiveness of a health promotion with group intervention by clinical trial. Study protocol

    Directory of Open Access Journals (Sweden)

    Campo Osaba Maria-Antonia

    2012-03-01

    Full Text Available Abstract Background The promotion of health and the interventions in community health continue to be one of the pending subjects of our health system. The most prevalent health problems (cardiovascular diseases, cancer, diabetes... are for the most part related to life habits. We propose a holistic and integral approach as the best option for tackling behavior and its determinants. The research team has elaborated the necessary educational material to realize group teaching, which we call "Health Workshops". The goal of the present study is to evaluate the effectiveness of these Health Workshops in the following terms: Health Related Quality of Life (HRQOL, incorporate and maintain a balanced diet, do physical activity regularly, maintain risk factors such as tension, weight, cholesterol within normal limits and diminish cardiovascular risk. Methods/Design Controlled and random clinical testing, comparing a group of persons who have participated in the Health Workshops with a control group of similar characteristics who have not participated in the Health Workshops. Field of study: the research is being done in Health Centers of the city of Barcelona, Spain. Population studied: The group is composed of 108 persons that are actually doing the Health Workshops, and 108 that are not and form the control group. They are assigned at random to one group or the other. Data Analysis: With Student's t-distribution test to compare the differences between numerical variables or their non parametric equivalent if the variable does not comply with the criteria of normality. (Kolmogorov-Smirnof test. Chi-square test to compare the differences between categorical variables and the Logistic Regression Model to analyze different meaningful variables by dichotomous analysis related to the intervention. Discussion The Health Workshop proposed in the present study constitutes an innovative approach in health promotion, placing the emphasis on the person's self

  5. GENetic and clinical Predictors Of treatment response in Depression: the GenPod randomised trial protocol

    Directory of Open Access Journals (Sweden)

    O'Donovan Michael

    2008-05-01

    Full Text Available Abstract Background The most effective pharmacological treatments for depression inhibit the transporters that reuptake serotonin (Selective Serotonin Reuptake Inhibitors – SSRIs and noradrenaline (Noradrenaline Reuptake Inhibitors – NaRIs into the presynaptic terminal. There is evidence to suggest that noradrenaline and serotonin enhancing drugs work through separate mechanisms to produce their clinical antidepressant action. Although most of the current evidence suggests there is little difference in overall efficacy between SSRIs and NaRIs, there are patients who respond to one class of compounds and not another. This suggests that treatment response could be predicted by genetic and/or clinical characteristics. Firstly, this study aims to investigate the influence of a polymorphism (SLC6A4 in the 5HT transporter in altering response to SSRI medication. Secondly, the study will investigate whether those with more severe depression have a better response to NaRIs than SSRIs. Methods/design The GenPod trial is a multi-centre randomised controlled trial. GPs referred patients aged between 18–74 years presenting with a new episode of depression, who did not have any medical contraindications to antidepressant medication and who had no history of psychosis or alcohol/substance abuse. Patients were interviewed to ascertain their suitability for the study. Eligible participants (with a primary diagnosis of depression according to ICD10 criteria and a Beck Depression Inventory (BDI score > 14 were randomised to receive one of two antidepressant treatments, either the SSRI Citalopram or the NaRI Reboxetine, stratified according to severity. The final number randomised to the trial was 601. Follow-up assessments took place at 2, 6 and 12 weeks following randomisation. Primary outcome was measured at 6 weeks by the BDI. Outcomes will be analysed on an intention-to-treat basis and will use multiple regression models to compare treatments

  6. A cross-platform survey of CT image quality and dose from routine abdomen protocols and a method to systematically standardize image quality.

    Science.gov (United States)

    Favazza, Christopher P; Duan, Xinhui; Zhang, Yi; Yu, Lifeng; Leng, Shuai; Kofler, James M; Bruesewitz, Michael R; McCollough, Cynthia H

    2015-11-07

    Through this investigation we developed a methodology to evaluate and standardize CT image quality from routine abdomen protocols across different manufacturers and models. The influence of manufacturer-specific automated exposure control systems on image quality was directly assessed to standardize performance across a range of patient sizes. We evaluated 16 CT scanners across our health system, including Siemens, GE, and Toshiba models. Using each practice's routine abdomen protocol, we measured spatial resolution, image noise, and scanner radiation output (CTDIvol). Axial and in-plane spatial resolutions were assessed through slice sensitivity profile (SSP) and modulation transfer function (MTF) measurements, respectively. Image noise and CTDIvol values were obtained for three different phantom sizes. SSP measurements demonstrated a bimodal distribution in slice widths: an average of 6.2  ±  0.2 mm using GE's 'Plus' mode reconstruction setting and 5.0  ±  0.1 mm for all other scanners. MTF curves were similar for all scanners. Average spatial frequencies at 50%, 10%, and 2% MTF values were 3.24  ±  0.37, 6.20  ±  0.34, and 7.84  ±  0.70 lp cm(-1), respectively. For all phantom sizes, image noise and CTDIvol varied considerably: 6.5-13.3 HU (noise) and 4.8-13.3 mGy (CTDIvol) for the smallest phantom; 9.1-18.4 HU and 9.3-28.8 mGy for the medium phantom; and 7.8-23.4 HU and 16.0-48.1 mGy for the largest phantom. Using these measurements and benchmark SSP, MTF, and image noise targets, CT image quality can be standardized across a range of patient sizes.

  7. Standardizing Umbilical Cord Mesenchymal Stromal Cells for Translation to Clinical Use: Selection of GMP-Compliant Medium and a Simplified Isolation Method

    Directory of Open Access Journals (Sweden)

    J. Robert Smith

    2016-01-01

    Full Text Available Umbilical cord derived mesenchymal stromal cells (UC-MSCs are a focus for clinical translation but standardized methods for isolation and expansion are lacking. Previously we published isolation and expansion methods for UC-MSCs which presented challenges when considering good manufacturing practices (GMP for clinical translation. Here, a new and more standardized method for isolation and expansion of UC-MSCs is described. The new method eliminates dissection of blood vessels and uses a closed-vessel dissociation following enzymatic digestion which reduces contamination risk and manipulation time. The new method produced >10 times more cells per cm of UC than our previous method. When biographical variables were compared, more UC-MSCs per gram were isolated after vaginal birth compared to Caesarian-section births, an unexpected result. UC-MSCs were expanded in medium enriched with 2%, 5%, or 10% pooled human platelet lysate (HPL eliminating the xenogeneic serum components. When the HPL concentrations were compared, media supplemented with 10% HPL had the highest growth rate, smallest cells, and the most viable cells at passage. UC-MSCs grown in 10% HPL had surface marker expression typical of MSCs, high colony forming efficiency, and could undergo trilineage differentiation. The new protocol standardizes manufacturing of UC-MSCs and enables clinical translation.

  8. Natural language processing systems for capturing and standardizing unstructured clinical information: A systematic review.

    Science.gov (United States)

    Kreimeyer, Kory; Foster, Matthew; Pandey, Abhishek; Arya, Nina; Halford, Gwendolyn; Jones, Sandra F; Forshee, Richard; Walderhaug, Mark; Botsis, Taxiarchis

    2017-09-01

    We followed a systematic approach based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses to identify existing clinical natural language processing (NLP) systems that generate structured information from unstructured free text. Seven literature databases were searched with a query combining the concepts of natural language processing and structured data capture. Two reviewers screened all records for relevance during two screening phases, and information about clinical NLP systems was collected from the final set of papers. A total of 7149 records (after removing duplicates) were retrieved and screened, and 86 were determined to fit the review criteria. These papers contained information about 71 different clinical NLP systems, which were then analyzed. The NLP systems address a wide variety of important clinical and research tasks. Certain tasks are well addressed by the existing systems, while others remain as open challenges that only a small number of systems attempt, such as extraction of temporal information or normalization of concepts to standard terminologies. This review has identified many NLP systems capable of processing clinical free text and generating structured output, and the information collected and evaluated here will be important for prioritizing development of new approaches for clinical NLP. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

    Science.gov (United States)

    Neuss, Michael N; Gilmore, Terry R; Belderson, Kristin M; Billett, Amy L; Conti-Kalchik, Tara; Harvey, Brittany E; Hendricks, Carolyn; LeFebvre, Kristine B; Mangu, Pamela B; McNiff, Kristen; Olsen, MiKaela; Schulmeister, Lisa; Von Gehr, Ann; Polovich, Martha

    2016-12-01

    Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .

  10. Hepatocellular carcinoma: From clinical practice to evidence-based treatment protocols

    Science.gov (United States)

    Galun, Danijel; Basaric, Dragan; Zuvela, Marinko; Bulajic, Predrag; Bogdanovic, Aleksandar; Bidzic, Nemanja; Milicevic, Miroslav

    2015-01-01

    Hepatocellular carcinoma (HCC) is one of the major malignant diseases in many healthcare systems. The growing number of new cases diagnosed each year is nearly equal to the number of deaths from this cancer. Worldwide, HCC is a leading cause of cancer-related deaths, as it is the fifth most common cancer and the third most important cause of cancer related death in men. Among various risk factors the two are prevailing: viral hepatitis, namely chronic hepatitis C virus is a well-established risk factor contributing to the rising incidence of HCC. The epidemic of obesity and the metabolic syndrome, not only in the United States but also in Asia, tend to become the leading cause of the long-term rise in the HCC incidence. Today, the diagnosis of HCC is established within the national surveillance programs in developed countries while the diagnosis of symptomatic, advanced stage disease still remains the characteristic of underdeveloped countries. Although many different staging systems have been developed and evaluated the Barcelona-Clinic Liver Cancer staging system has emerged as the most useful to guide HCC treatment. Treatment allocation should be decided by a multidisciplinary board involving hepatologists, pathologists, radiologists, liver surgeons and oncologists guided by personalized -based medicine. This approach is important not only to balance between different oncologic treatments strategies but also due to the complexity of the disease (chronic liver disease and the cancer) and due to the large number of potentially efficient therapies. Careful patient selection and a tailored treatment modality for every patient, either potentially curative (surgical treatment and tumor ablation) or palliative (transarterial therapy, radioembolization and medical treatment, i.e., sorafenib) is mandatory to achieve the best treatment outcome. PMID:26380652

  11. A novel telemonitoring device for improving diabetes control: protocol and results from a randomized clinical trial.

    Science.gov (United States)

    Pressman, Alice R; Kinoshita, Linda; Kirk, Susan; Barbosa, Gina Monraz; Chou, Cathy; Minkoff, Jerome

    2014-02-01

    Telemedicine is one approach to managing patients with chronic illness. Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL) levels. The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes. The device was used to transmit weekly blood glucose, weight, and BP readings to a diabetes care manager. We conducted a two-arm, parallel-comparison, single-blind, randomized controlled trial among Kaiser Permanente Northern California members 18-75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5% and 10.0%. Participants were randomly assigned to either the telemonitoring arm or the usual care arm. We observed very small, nonsignificant changes in fructosamine (telemonitoring, -54.9 μmol; usual care, -59.4 μmol) and systolic BP (telemonitoring, -6.3 mm Hg; usual care, -3.2 mm Hg) from baseline to 6 weeks in both groups. At 6 months, we observed no significant intergroup differences in change from baseline for HbA1c, fructosamine, or self-efficacy. However, LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm (-17.1 mg/dL versus -5.4 mg/dL; P=0.045). Although HbA1c improved significantly over 6 months in both groups, the difference in improvement between the groups was not significant. This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa, CA clinic. Further study in subgroups of less healthy diabetes patients is recommended.

  12. Resource utilization after introduction of a standardized clinical assessment and management plan.

    Science.gov (United States)

    Friedman, Kevin G; Rathod, Rahul H; Farias, Michael; Graham, Dionne; Powell, Andrew J; Fulton, David R; Newburger, Jane W; Colan, Steven D; Jenkins, Kathy J; Lock, James E

    2010-01-01

    A Standardized Clinical Assessment and Management Plan (SCAMP) is a novel quality improvement initiative that standardizes the assessment and management of all patients who carry a predefined diagnosis. Based on periodic review of systemically collected data the SCAMP is designed to be modified to improve its own algorithm. One of the objectives of a SCAMP is to identify and reduce resource utilization and patient care costs. We retrospectively reviewed resource utilization in the first 93 arterial switch operation (ASO) SCAMP patients and 186 age-matched control ASO patients. We compared diagnostic and laboratory testing obtained at the initial SCAMP clinic visit and control patient visits. To evaluate the effect of the SCAMP over time, the number of clinic visits per patient year and echocardiograms per patient year in historical control ASO patients were compared to the projected rates for ASO SCAMP participants. Cardiac magnetic resonance imaging (MRI), stress echocardiogram, and lipid profile utilization were higher in the initial SCAMP clinic visit group than in age-matched control patients. Total echocardiogram and lung scan usage were similar. Chest X-ray and exercise stress testing were obtained less in SCAMP patients. ASO SCAMP patients are projected to have 0.5 clinic visits and 0.5 echocardiograms per year. Historical control patients had more clinic visits (1.2 vs. 0.5 visits/patient year, P<.01) and a higher echocardiogram rate (0.92 vs. 0.5 echocardiograms/patient year, P<.01) Implementation of a SCAMP may initially lead to increased resource utilization, but over time resource utilization is projected to decrease.

  13. MASTER: a model to improve and standardize clinical breakpoints for antimicrobial susceptibility testing using forecast probabilities.

    Science.gov (United States)

    Blöchliger, Nicolas; Keller, Peter M; Böttger, Erik C; Hombach, Michael

    2017-09-01

    The procedure for setting clinical breakpoints (CBPs) for antimicrobial susceptibility has been poorly standardized with respect to population data, pharmacokinetic parameters and clinical outcome. Tools to standardize CBP setting could result in improved antibiogram forecast probabilities. We propose a model to estimate probabilities for methodological categorization errors and defined zones of methodological uncertainty (ZMUs), i.e. ranges of zone diameters that cannot reliably be classified. The impact of ZMUs on methodological error rates was used for CBP optimization. The model distinguishes theoretical true inhibition zone diameters from observed diameters, which suffer from methodological variation. True diameter distributions are described with a normal mixture model. The model was fitted to observed inhibition zone diameters of clinical Escherichia coli strains. Repeated measurements for a quality control strain were used to quantify methodological variation. For 9 of 13 antibiotics analysed, our model predicted error rates of  0.1% for ampicillin, cefoxitin, cefuroxime and amoxicillin/clavulanic acid. Increasing the susceptible CBP (cefoxitin) and introducing ZMUs (ampicillin, cefuroxime, amoxicillin/clavulanic acid) decreased error rates to < 0.1%. ZMUs contained low numbers of isolates for ampicillin and cefuroxime (3% and 6%), whereas the ZMU for amoxicillin/clavulanic acid contained 41% of all isolates and was considered not practical. We demonstrate that CBPs can be improved and standardized by minimizing methodological categorization error rates. ZMUs may be introduced if an intermediate zone is not appropriate for pharmacokinetic/pharmacodynamic or drug dosing reasons. Optimized CBPs will provide a standardized antibiotic susceptibility testing interpretation at a defined level of probability. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For

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

    NARCIS (Netherlands)

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

    2008-01-01

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

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

    Science.gov (United States)

    McCutcheon, Karen; Lohan, Maria; Traynor, Marian

    2016-01-01

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

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

    Science.gov (United States)

    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.

  17. 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...

  18. 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

  19. Whole-body magnetic resonance angiography of patients using a standard clinical scanner

    Energy Technology Data Exchange (ETDEWEB)

    Hansen, Tomas; Wikstroem, Johan; Eriksson, Mats-Ola; Lundberg, Anders; Ahlstroem, Haakan [Uppsala University Hospital, Department of Diagnostic Radiology, Uppsala (Sweden); Johansson, Lars [Uppsala University Hospital, Uppsala (Sweden); Ljungman, Christer [Uppsala University Hospital, Department of Vascular Surgery, Uppsala (Sweden); Hoogeven, Romhild [Philips Medical Systems, MR Clinical Science, Best (Netherlands)

    2006-01-01

    The purpose of this study was to evaluate the technique of whole-body magnetic resonance angiography (MRA) of patients with a standard clinical scanner. Thirty-three patients referred for stenoses, occlusions, aneurysms, assessment of patency of vascular grafts, vasculitis and vascular aplasia were examined in a 1.5-T scanner using its standard body coil. Three-dimensional sequences were acquired in four stations after administration of one intravenous injection of 40 ml conventional gadolinium contrast agent. Different vessel segments were evaluated as either diagnostic or nondiagnostic and regarding the presence of stenoses with more than 50% diameter reduction, occlusions or aneurysms. Of 923 vessel segments, 67 were not evaluable because of poor contrast filling (n=31), motion artefacts (n=20), venous overlap (n=12) and other reasons (n=4). Stenoses of more than 50%, occlusions or aneurysms were observed in 26 patients (129 segments). In nine patients additional unsuspected pathology was found. In 10 out of 14 patients (71/79 segments) there was conformity between MRA and digital subtraction angiography regarding the grade of stenosis. This study shows that whole-body MRA with a standard clinical scanner is feasible. Motion artefacts and the timing of the contrast agent through the different segments are still problems to be solved. (orig.)

  20. Audit, guidelines and standards: clinical governance for hip fracture care in Scotland.

    Science.gov (United States)

    Currie, Colin T; Hutchison, James D

    To report on experience of national-level audit, guidelines and standards for hip fracture care in Scotland. Scottish Hip Fracture Audit (from 1993) documents case-mix, process and outcomes of hip fracture care in Scotland. Evidence-based national guidelines on hip fracture care are available (1997, updated 2002). Hip fracture serves as a tracer condition by the health quality assurance authority for its work on older people, which reported in 2004. Audit data are used locally to document care and support and monitor service developments. Synergy between the guidelines and the audit provides a means of improving care locally and monitoring care nationally. External review by the quality assurance body shows to what extent guideline-based standards relating to A&E care, pre-operative delay, multidisciplinary care and audit participation are met. Three national-level initiatives on hip fracture care have delivered: Reliable and large-scale comparative information on case-mix, care and outcomes; evidence-based recommendations on care; and nationally accountable standards inspected and reported by the national health quality assurance authority. These developments are linked and synergistic, and enjoy both clinical and managerial support. They provide an evolving framework for clinical governance, with casemix-adjusted outcome assessment for hip fracture care as a next step.

  1. Comparison of size modulation and conventional standard automated perimetry with the 24-2 test protocol in glaucoma patients

    Science.gov (United States)

    Hirasawa, Kazunori; Shoji, Nobuyuki; Kasahara, Masayuki; Matsumura, Kazuhiro; Shimizu, Kimiya

    2016-05-01

    This prospective randomized study compared test results of size modulation standard automated perimetry (SM-SAP) performed with the Octopus 600 and conventional SAP (C-SAP) performed with the Humphrey Field Analyzer (HFA) in glaucoma patients. Eighty-eight eyes of 88 glaucoma patients underwent SM-SAP and C-SAP tests with the Octopus 600 24-2 Dynamic and HFA 24-2 SITA-Standard, respectively. Fovea threshold, mean defect, and square loss variance of SM-SAP were significantly correlated with the corresponding C-SAP indices (P < 0.001). The false-positive rate was slightly lower, and false-negative rate slightly higher, with SM-SAP than C-SAP (P = 0.002). Point-wise threshold values obtained with SM-SAP were moderately to strongly correlated with those obtained with C-SAP (P < 0.001). The correlation coefficients of the central zone were significantly lower than those of the middle to peripheral zone (P = 0.031). The size and depth of the visual field (VF) defect were smaller (P = 0.039) and greater (P = 0.043), respectively, on SM-SAP than on C-SAP. Although small differences were observed in VF sensitivity in the central zone, the defect size and depth and the reliability indices between SM-SAP and C-SAP, global indices of the two testing modalities were well correlated.

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

    Science.gov (United States)

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

    2017-06-01

    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. 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 patients. The C-t group will perform the typical exercises prescribed by physical therapists for 40 min each session. W-t will consist of a virtual reality training session using the Nintendo Wii balance board console for 30 min each session. The primary outcome variable is the area of centre-of-pressure (CoP) sway (CoP Sway ). The secondary outcomes are the standard deviation (SD ML ; SD AP ) and velocity (V ML ; V AP ) of CoP in the ML and AP directions. For a mean difference of 21.5 cm 2 (CoP Sway ) between the groups, we required a minimum of 16 participants in each group. Data will be collected at baseline (week 0), during the study (weeks 2 and 4), at the end of the study (week 6), and during the follow-up (weeks 8 and 10). Measurements of postural control during quiet standing for both groups will be assessed on a force platform AMTI OR67. This is the first trial that measures and compares the effects of a Nintendo Wii Balance Board exercise programme on standing balance in children with cerebral palsy compared to conventional therapy.

  3. Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

    Science.gov (United States)

    Dawson, Liza; Zwerski, Sheryl

    2015-06-01

    This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

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

    Science.gov (United States)

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

    2013-12-10

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

  5. Effectiveness of Standardized Patient Simulations in Teaching Clinical Communication Skills to Dental Students.

    Science.gov (United States)

    McKenzie, Carly T; Tilashalski, Ken R; Peterson, Dawn Taylor; White, Marjorie Lee

    2017-10-01

    The aim of this study was to investigate dental students' long-term retention of clinical communication skills learned in a second-year standardized patient simulation at one U.S. dental school. Retention was measured by students' performance with an actual patient during their fourth year. The high-fidelity simulation exercise focused on clinical communication skills took place during the spring term of the students' second year. The effect of the simulation was measured by comparing the fourth-year clinical performance of two groups: those who had participated in the simulation (intervention group; Class of 2016) and those who had not (no intervention/control group; Class of 2015). In the no intervention group, all 47 students participated; in the intervention group, 58 of 59 students participated. Both instructor assessments and students' self-assessments were used to evaluate the effectiveness of key patient interaction principles as well as comprehensive presentation of multiple treatment options. The results showed that students in the intervention group more frequently included cost during their treatment option presentation than did students in the no intervention group. The instructor ratings showed that the intervention group included all key treatment option components except duration more frequently than did the no intervention group. However, the simulation experience did not result in significantly more effective student-patient clinical communication on any of the items measured. This study presents limited evidence of the effectiveness of a standardized patient simulation to improve dental students' long-term clinical communication skills with respect to thorough presentation of treatment options to a patient.

  6. 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

  7. 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

  8. Role of oral candidiasis in TB and HIV co-infection: AIDS Clinical Trial Group Protocol A5253.

    Science.gov (United States)

    Shiboski, C H; Chen, H; Ghannoum, M A; Komarow, L; Evans, S; Mukherjee, P K; Isham, N; Katzenstein, D; Asmelash, A; Omozoarhe, A E; Gengiah, S; Allen, R; Tripathy, S; Swindells, S

    2014-06-01

    To evaluate the association between oral candidiasis and tuberculosis (TB) in human immunodeficiency virus (HIV) infected individuals in sub-Saharan Africa, and to investigate oral candidiasis as a potential tool for TB case finding. Protocol A5253 was a cross-sectional study designed to improve the diagnosis of pulmonary TB in HIV-infected adults in high TB prevalence countries. Participants received an oral examination to detect oral candidiasis. We estimated the association between TB disease and oral candidiasis using logistic regression, and sensitivity, specificity and predictive values. Of 454 participants with TB culture results enrolled in African sites, the median age was 33 years, 71% were female and the median CD4 count was 257 cells/mm(3). Fifty-four (12%) had TB disease; the prevalence of oral candidiasis was significantly higher among TB cases (35%) than among non-TB cases (16%, P oral candidiasis when controlling for CD4 count and antifungals (95%CI 1.2-4.7, P = 0.01). The sensitivity of oral candidiasis as a predictor of TB was 35% (95%CI 22-48) and the specificity 85% (95%CI 81-88). We found a strong association between oral candidiasis and TB disease, independent of CD4 count, suggesting that in resource-limited settings, oral candidiasis may provide clinical evidence for increased risk of TB and contribute to TB case finding.

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

    International Nuclear Information System (INIS)

    Beyer, T.

    2004-01-01

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

  10. Benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study: protocol, tools, and population.

    Science.gov (United States)

    Nicolucci, Antonio; Rossi, Maria C; Pellegrini, Fabio; Lucisano, Giuseppe; Pintaudi, Basilio; Gentile, Sandro; Marra, Giampiero; Skovlund, Soren E; Vespasiani, Giacomo

    2014-01-01

    In the context of the DAWN-2 initiatives, the BENCH-D Study aims to test a model of regional benchmarking to improve not only the quality of diabetes care, but also patient-centred outcomes. As part of the AMD-Annals quality improvement program, 32 diabetes clinics in 4 Italian regions extracted clinical data from electronic databases for measuring process and outcome quality indicators. A random sample of patients with type 2 diabetes filled in a questionnaire including validated instruments to assess patient-centred indicators: SF-12 Health Survey, WHO-5 Well-Being Index, Diabetes Empowerment Scale, Problem Areas in Diabetes, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Barriers to Medications, Patient Support, Diabetes Self-care Activities, and Global Satisfaction for Diabetes Treatment. Data were discussed with participants in regional meetings. Main problems, obstacles and solutions were identified through a standardized process, and a regional mandate was produced to drive the priority actions. Overall, clinical indicators on 78,854 patients have been measured; additionally, 2,390 patients filled-in the questionnaire. The regional mandates were officially launched in March 2012. Clinical and patient-centred indicators will be evaluated again after 18 months. A final assessment of clinical indicators will take place after 30 months. In the context of the BENCH-D study, a set of instruments has been validated to measure patient well-being and satisfaction with the care. In the four regional meetings, different priorities were identified, reflecting different organizational resources of the different areas. In all the regio