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Sample records for clinical assessment protocol

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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...

  6. 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

  7. 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

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

    Science.gov (United States)

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

    2009-01-01

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

  9. 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.

  10. Establishing treatment protocols for clinical mastitis.

    Science.gov (United States)

    Roberson, Jerry R

    2003-03-01

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

  11. 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

  12. 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.

  13. 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.

  14. [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.

  15. 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.

  16. Gamma camera performance: technical assessment protocol

    International Nuclear Information System (INIS)

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

    1996-01-01

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

  17. Gamma camera performance: technical assessment protocol

    Energy Technology Data Exchange (ETDEWEB)

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

    1996-12-31

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

  18. Welfare Quality assessment protocol for laying hens = Welfare Quality assessment protocol voor leghennen

    NARCIS (Netherlands)

    Niekerk, van T.G.C.M.; Gunnink, H.; Reenen, van C.G.

    2012-01-01

    Results of a study on the Welfare Quality® assessment protocol for laying hens. It reports the development of the integration of welfare assessment as scores per criteria as well as simplification of the Welfare Quality® assessment protocol. Results are given from assessment of 122 farms.

  19. 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.

  20. 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.

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

    Science.gov (United States)

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

    2018-04-09

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

  2. 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

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

    Science.gov (United States)

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

    2015-12-01

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

  4. Quality assessment in in vivo NMR spectroscopy: IV. A multicentre trial of test objects and protocols for performance assessment in clinical NMR spectroscopy

    DEFF Research Database (Denmark)

    Keevil, S.F.; Barbiroli, B; Collins, D.J.

    1995-01-01

    implemented on commercially available MR systems at ten sites in Europe. At each site, a number of parameters devised by the Concerted Action were measured using prototype test objects. Some of these parameters related to the quality of localisation and others to the overall performance of the spectrometer...... in the development of the Concerted Action's final recommendations for MRS performance assessment, and demonstrate that such assessment provides valuable information in the comparison of spectroscopy data from different sites and in the development of new localisation sequences, and provides a means of quality...... assurance in MRS...

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2011-09-01

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

  7. Protocol for the Quick Clinical study: a randomised controlled trial to assess the impact of an online evidence retrieval system on decision-making in general practice

    Directory of Open Access Journals (Sweden)

    Kidd Michael R

    2006-08-01

    Full Text Available Abstract Background Online information retrieval systems have the potential to improve patient care but there are few comparative studies of the impact of online evidence on clinicians' decision-making behaviour in routine clinical work. Methods/design A randomized controlled parallel design is employed to assess the effectiveness of an online evidence retrieval system, Quick Clinical (QC in improving clinical decision-making processes in general practice. Eligible clinicians are randomised either to receive access or not to receive access to QC in their consulting rooms for 12 months. Participants complete pre- and post trial surveys. Two-hundred general practitioners are recruited. Participants must be registered to practice in Australia, have a computer with Internet access in their consulting room and use electronic prescribing. Clinicians planning to retire or move to another practice within 12 months or participating in any other clinical trial involving electronic extraction of prescriptions data are excluded from the study. The primary end-points for the study is clinician acceptance and use of QC and the resulting change in decision-making behaviour. The study will examine prescribing patterns related to frequently prescribed medications where there has been a recent significant shift in recommendations regarding their use based upon new evidence. Secondary outcome measures include self-reported changes in diagnosis, patient education, prescriptions written, investigations and referrals. Discussion A trial under experimental conditions is an effective way of examining the impact of using QC in routine general practice consultations.

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

    Directory of Open Access Journals (Sweden)

    Rousseau Michel

    2011-03-01

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

  9. 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.

  10. 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

  11. The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women.

    Science.gov (United States)

    Duval, Karine; Langlois, Marie-France; Carranza-Mamane, Belina; Pesant, Marie-Hélène; Hivert, Marie-France; Poder, Thomas G; Lavoie, Hélène B; Ainmelk, Youssef; St-Cyr Tribble, Denise; Laredo, Sheila; Greenblatt, Ellen; Sagle, Margaret; Waddell, Guy; Belisle, Serge; Riverin, Daniel; Jean-Denis, Farrah; Belan, Matea; Baillargeon, Jean-Patrice

    2015-01-01

    Obesity in infertile women increases the costs of fertility treatments, reduces their effectiveness and increases significantly the risks of many complications of pregnancy and for the newborn. Studies suggest that even a modest loss of 5-10 % of body weight can restore ovulation. However, there are gaps in knowledge regarding the benefits and cost-effectiveness of a lifestyle modification program targeting obese infertile women and integrated into the fertility clinics. This study will evaluate clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women. We hypothesize that the intervention will: 1) improve fertility, efficacy of fertility treatments, and health of mothers and their children; and 2) reduce the cost per live birth, including costs of fertility treatments and pregnancy outcomes. Obese infertile women (age: 18-40 years; BMI ≥30 kg/m(2) or ≥27 kg/m(2) with polycystic ovary syndrome) will be randomised to either a lifestyle intervention followed by standard fertility treatments after 6 months if no conception has been achieved (intervention group) or standard fertility treatments only (control group). The intervention and/or follow-up will last for a maximum of 18 months or up to the end of pregnancy. Evaluation visits will be planned every 6 months where different outcome measures will be assessed. The primary outcome will be live-birth rates at 18 months. The secondary outcomes will be sub-divided into four categories: lifestyle and anthropometric, fertility, pregnancy complications, and neonatal outcomes. Outcomes and costs will be also compared to similar women seen in three fertility clinics across Canada. Qualitative data will also be collected from both professionals and obese infertile women. This study will generate new knowledge about the implementation, impacts and costs of a lifestyle management program in obese infertile women. This information

  12. 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.

  13. 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/

  14. 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.)

  15. 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.

  16. The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women

    OpenAIRE

    Duval, Karine; Langlois, Marie-France; Carranza-Mamane, Belina; Pesant, Marie-H?l?ne; Hivert, Marie-France; Poder, Thomas G.; Lavoie, H?l?ne B.; Ainmelk, Youssef; St-Cyr Tribble, Denise; Laredo, Sheila; Greenblatt, Ellen; Sagle, Margaret; Waddell, Guy; Belisle, Serge; Riverin, Daniel

    2015-01-01

    Background Obesity in infertile women increases the costs of fertility treatments, reduces their effectiveness and increases significantly the risks of many complications of pregnancy and for the newborn. Studies suggest that even a modest loss of 5?10?% of body weight can restore ovulation. However, there are gaps in knowledge regarding the benefits and cost-effectiveness of a lifestyle modification program targeting obese infertile women and integrated into the fertility clinics. This study...

  17. 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

  18. 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

  19. 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

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

    Science.gov (United States)

    Spina, Ana Lúcia; Crespo, Agrício Nubiato

    2017-03-01

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

  1. Classification and clinical assessment

    Directory of Open Access Journals (Sweden)

    F. Cantini

    2012-06-01

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

  2. Clinical assessment of blood glucose homeostasis in horses: comparison of a continuous glucose monitoring system with a combined intravenous glucose and insulin test protocol.

    Science.gov (United States)

    Johnson, P J; Wiedmeyer, C E; LaCarrubba, A; Messer, N T; Dingfelder, H A; Cogswell, A M; Amorim, J R R; Ganjam, V K

    2011-01-01

    The combined glucose-insulin test (CGIT) is helpful for evaluating insulin sensitivity. A continuous glucose monitoring system (CGMS) reports changes in interstitial glucose concentrations as they occur in the blood. Use of the CGMS minimizes animal contact and may be useful when performing a CGIT. Results obtained using a CGMS are useful for the evaluation of glucose responses during the evaluation of insulin sensitivity in equids. Seven mature, obese ponies. Ponies were equipped with CGMS for determination of interstitial glucose concentrations. Glucose (150 mg/kg, i.v.) and insulin (0.1 U/kg, i.v.) were administered and blood glucose concentrations determined at (minutes after time zero) 1, 5, 15, 25, 35, 45, 60, 75, 90, 105, and 120 with a hand-held glucometer. Blood chemistry results were compared with simultaneously obtained results using CGMS. Concordance coefficients determined for comparison of blood glucose concentrations determined by a hand-held glucometer and those determined by CGMS after the zero time point were 0.623, 0.764, 0.834, 0.854, and 0.818 (for delays of 0, 5, 10, 15, and 20 minutes, respectively). Interstitial glucose concentrations obtained by the CGMS compared favorably to blood glucose concentrations. CGMS may be useful for assessment of glucose dynamics in the CGIT. Copyright © 2010 by the American College of Veterinary Internal Medicine.

  3. 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

  4. Tools for Performance Assessment of OLSR Protocol

    Directory of Open Access Journals (Sweden)

    Makoto Ikeda

    2009-01-01

    Full Text Available In this paper, we evaluate the performance of Optimized Link State Routing (OLSR protocol by experimental and simulation results. The experiments are carried out by using our implemented testbed and the simulations by using ns-2 simulator. We also designed and implemented a new interface for the ad-hoc network testbed in order to make more easier the experiments. The comparison between experimental and simulation results shows that for the same parameters set, in the simulation we did not notice any packet loss. On the other hand, in the experiments we experienced packet loss because of the environment effects and traffic interference.

  5. A Protocol for Advanced Psychometric Assessment of Surveys

    Science.gov (United States)

    Squires, Janet E.; Hayduk, Leslie; Hutchinson, Alison M.; Cranley, Lisa A.; Gierl, Mark; Cummings, Greta G.; Norton, Peter G.; Estabrooks, Carole A.

    2013-01-01

    Background and Purpose. In this paper, we present a protocol for advanced psychometric assessments of surveys based on the Standards for Educational and Psychological Testing. We use the Alberta Context Tool (ACT) as an exemplar survey to which this protocol can be applied. Methods. Data mapping, acceptability, reliability, and validity are addressed. Acceptability is assessed with missing data frequencies and the time required to complete the survey. Reliability is assessed with internal consistency coefficients and information functions. A unitary approach to validity consisting of accumulating evidence based on instrument content, response processes, internal structure, and relations to other variables is taken. We also address assessing performance of survey data when aggregated to higher levels (e.g., nursing unit). Discussion. In this paper we present a protocol for advanced psychometric assessment of survey data using the Alberta Context Tool (ACT) as an exemplar survey; application of the protocol to the ACT survey is underway. Psychometric assessment of any survey is essential to obtaining reliable and valid research findings. This protocol can be adapted for use with any nursing survey. PMID:23401759

  6. 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.

  7. Development of low-dose protocols for thin-section CT assessment of cystic fibrosis in pediatric patients.

    LENUS (Irish Health Repository)

    O'Connor, Owen J

    2010-12-01

    To develop low-dose thin-section computed tomographic (CT) protocols for assessment of cystic fibrosis (CF) in pediatric patients and determine the clinical usefulness thereof compared with chest radiography.

  8. 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

  9. Harmonization of international risk assessment protocol

    International Nuclear Information System (INIS)

    Toyofuku, Hajime . E-mail toyofuku@nihs.go.jp

    2006-01-01

    For over centuries developments in food production and new food safety management systems in most developed countries have been perceived by many to be efficient in the prevention of food-borne disease. Nevertheless a number of problems remain dominant, one of these being the high level of food-borne microbiological disease which seems, for some pathogens, to have increased over the last decades. The development of an interdisciplinary approach with direct interaction between surveillance and risk analysis systems is described as a potential basis for improved prevention of food-borne disease. Quantitative microbiological risk assessment is a relatively new scientific approach, able to link data from food within the entire food chain and the various data on human disease to provide a clear estimation of risk. Today food safety is one of the WHOs top eleven priorities; the Organization calls for more systematic and aggressive steps to be taken to reduce significantly the risk of microbiological food-borne diseases. Dealing with this challenge is one of the major challenges for the 21st century in regard to food safety, implying a significant re-direction of food microbiology efforts in many parts of the world

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

    Science.gov (United States)

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

  11. 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.

  12. 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.

  13. A shortened protocol for assessing cognitive bias in rats.

    Science.gov (United States)

    Brydges, Nichola M; Hall, Lynsey

    2017-07-15

    Reliable measurement of affective state in animals is a significant goal of animal welfare. Such measurements would also improve the validity of pre-clinical mental health research which relies on animal models. However, at present, affective states in animals are inaccessible to direct measurement. In humans, changes in cognitive processing can give reliable indications of emotional state. Therefore, similar techniques are increasingly being used to gain proxy measures of affective states in animals. In particular, the 'cognitive bias' assay has gained popularity in recent years. Major disadvantages of this technique include length of time taken for animals to acquire the task (typically several weeks), negative experiences associated with task training, and issues of motivation. Here we present a shortened cognitive bias protocol using only positive reinforcers which must actively be responded to. The protocol took an average of 4days to complete, and produced similar results to previous, longer methods (minimum 30days). Specifically, rats housed in standard laboratory conditions demonstrated negative cognitive biases when presented with ambiguous stimuli, and took longer to make a decision when faced with an ambiguous stimulus. Compared to previous methods, this protocol is significantly shorter (average 4days vs. minimum 30days), utilises only positive reinforcers to avoid inducing negative affective states, and requires active responses to all cues, avoiding potential confounds of motivational state. We have successfully developed a shortened cognitive bias protocol, suitable for use with laboratory rats. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

  14. 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.

  15. 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.

  16. 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)

  17. 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.

  18. A proposed protocol for remote control of automated assessment devices

    International Nuclear Information System (INIS)

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

    1996-01-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

  20. The clinical assessment of impulsivity

    Directory of Open Access Journals (Sweden)

    Nagesh Brahmavar Pai

    2018-01-01

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

  1. 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

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

    Science.gov (United States)

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

    2018-02-01

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

  3. 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

  4. A novel cognitive palatability assessment protocol for dogs.

    Science.gov (United States)

    Araujo, J A; Milgram, N W

    2004-07-01

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

  5. 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

  6. To assess whether indoor residual spraying can provide additional protection against clinical malaria over current best practice of long-lasting insecticidal mosquito nets in The Gambia: study protocol for a two-armed cluster-randomised trial

    Directory of Open Access Journals (Sweden)

    Parker David

    2011-06-01

    Full Text Available Abstract Background Recently, there has been mounting interest in scaling-up vector control against malaria in Africa. It needs to be determined if indoor residual spraying (IRS with DDT will provide significant marginal protection against malaria over current best practice of long-lasting insecticidal nets (LLINs and prompt treatment in a controlled trial, given that DDT is currently the most persistent insecticide for IRS. Methods A 2 armed cluster-randomised controlled trial will be conducted to assess whether DDT IRS and LLINs combined provide better protection against clinical malaria in children than LLINs alone in rural Gambia. Each cluster will be a village, or a group of small adjacent villages; all clusters will receive LLINs and half will receive IRS in addition. Study children, aged 6 months to 13 years, will be enrolled from all clusters and followed for clinical malaria using passive case detection to estimate malaria incidence for 2 malaria transmission seasons in 2010 and 2011. This will be the primary endpoint. Exposure to malaria parasites will be assessed using light and exit traps followed by detection of Anopheles gambiae species and sporozoite infection. Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection and the prevalence of anaemia. Discussion Practical issues concerning intervention implementation, as well as the potential benefits and risks of the study, are discussed. Trial Registration ISRCTN01738840 - Spraying And Nets Towards malaria Elimination (SANTE

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

    International Nuclear Information System (INIS)

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

    2004-01-01

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

  8. Protocol of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project: formal consensus method for the development of guidelines for standardised time-to-event endpoints' definitions in cancer clinical trials.

    Science.gov (United States)

    Bellera, Carine A; Pulido, Marina; Gourgou, Sophie; Collette, Laurence; Doussau, Adélaïde; Kramar, Andrew; Dabakuyo, Tienhan Sandrine; Ouali, Monia; Auperin, Anne; Filleron, Thomas; Fortpied, Catherine; Le Tourneau, Christophe; Paoletti, Xavier; Mauer, Murielle; Mathoulin-Pélissier, Simone; Bonnetain, Franck

    2013-03-01

    In randomised phase III cancer clinical trials, the most objectively defined and only validated time-to-event endpoint is overall survival (OS). The appearance of new types of treatments and the multiplication of lines of treatment have resulted in the use of surrogate endpoints for overall survival such as progression-free survival (PFS), or time-to-treatment failure. Their development is strongly influenced by the necessity of reducing clinical trial duration, cost and number of patients. However, while these endpoints are frequently used, they are often poorly defined and definitions can differ between trials which may limit their use as primary endpoints. Moreover, this variability of definitions can impact on the trial's results by affecting estimation of treatments' effects. The aim of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project is to provide recommendations for standardised definitions of time-to-event endpoints in randomised cancer clinical trials. We will use a formal consensus methodology based on experts' opinions which will be obtained in a systematic manner. Definitions will be independently developed for several cancer sites, including pancreatic, breast, head and neck and colon cancer, as well as sarcomas and gastrointestinal stromal tumours (GISTs). The DATECAN project should lead to the elaboration of recommendations that can then be used as guidelines by researchers participating in clinical trials. This process should lead to a standardisation of the definitions of commonly used time-to-event endpoints, enabling appropriate comparisons of future trials' results. Copyright © 2012 Elsevier Ltd. All rights reserved.

  9. Protocol for physical assessment in patients with fibromyalgia syndrome.

    Science.gov (United States)

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

    2014-01-01

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

  10. 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.

  11. [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.

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

    Science.gov (United States)

    Schill, Melissa T.; And Others

    1996-01-01

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

  13. 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.

  14. 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.

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

    Science.gov (United States)

    Koo, M; Sabaté, A; Magalló, P; García, M A; Domínguez, J; de Lama, M E; López, S

    2011-11-01

    To assess conservative treatment of splenic injury due to trauma, following a protocol for computed tomography (CT) and angiographic embolization. To quantify the predictive value of CT for detecting bleeding and need for embolization. The care protocol developed by the multidisciplinary team consisted of angiography with embolization of lesions revealed by contrast extravasation under CT as well as embolization of grade III-V injuries observed, or grade I-II injuries causing hemodynamic instability and/or need for blood transfusion. We collected data on demographic variables, injury severity score (ISS), angiographic findings, and injuries revealed by CT. Pre-protocol and post-protocol outcomes were compared. The sensitivity and specificity of CT findings were calculated for all patients who required angiographic embolization. Forty-four and 30 angiographies were performed in the pre- and post-protocol periods, respectively. The mean (SD) ISSs in the two periods were 25 (11) and 26 (12), respectively. A total of 24 (54%) embolizations were performed in the pre-protocol period and 28 (98%) after implementation of the protocol. Two and 7 embolizations involved the spleen in the 2 periods, respectively; abdominal laparotomies numbered 32 and 25, respectively, and 10 (31%) vs 4 (16%) splenectomies were performed. The specificity and sensitivity values for contrast extravasation found on CT and followed by embolization were 77.7% and 79.5%. The implementation of this multidisciplinary protocol using CT imaging and angiographic embolization led to a decrease in the number of splenectomies. The protocol allows us to take a more conservative treatment approach.

  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

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

  17. Preclinical experimental stress studies: protocols, assessment and comparison.

    Science.gov (United States)

    Bali, Anjana; Jaggi, Amteshwar Singh

    2015-01-05

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2007-03-01

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

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

    Directory of Open Access Journals (Sweden)

    Hamed Jelodar

    2014-03-01

    Full Text Available Routing Protocols are underlying principles in networks like internet, transport and mobile. Routing Protocols include a series of rules and algorithms that consider routing metric and select the best way for sending healthy data packets from origin to destination. Dynamic routing protocol compatible to topology has a changeable state. RIP and OSPF are dynamic routing protocol that we consider criteria like convergence and sending protocols traffic assessment RIP first version and OSPF second version. By the test we have done on OPNET stimulation we understood that the OSPF protocol was more efficient than RIP protocol.

  2. Assessing the effectiveness of a patient-centred computer-based clinic intervention, Health-E You/Salud iTu, to reduce health disparities in unintended pregnancies among Hispanic adolescents: study protocol for a cluster randomised control trial.

    Science.gov (United States)

    Tebb, Kathleen P; Rodriguez, Felicia; Pollack, Lance M; Trieu, Sang Leng; Hwang, Loris; Puffer, Maryjane; Adams, Sally; Ozer, Elizabeth M; Brindis, Claire D

    2018-01-10

    Teen pregnancy rates in the USA remain higher than any other industrialised nation, and pregnancies among Hispanic adolescents are disproportionately high. Computer-based interventions represent a promising approach to address sexual health and contraceptive use disparities. Preliminary findings have demonstrated that the Health-E You/Salud iTu, computer application (app) is feasible to implement, acceptable to Latina adolescents and improves sexual health knowledge and interest in selecting an effective contraceptive method when used in conjunction with a healthcare visit. The app is now ready for efficacy testing. The purpose of this manuscript is to describe patient-centred approaches used both in developing and testing the Health-E You app and to present the research methods used to evaluate its effectiveness in improving intentions to use an effective method of contraception as well as actual contraceptive use. This study is designed to assess the effectiveness of a patient-centred computer-based clinic intervention, Health-E You/Salud  iTu, on its ability to reduce health disparities in unintended pregnancies among Latina adolescent girls. This study uses a cluster randomised control trial design in which 18 school-based health centers from the Los Angeles Unified School District were randomly assigned, at equal chance, to either the intervention ( Health-E You app) or control group. Analyses will examine differences between the control and intervention group's knowledge of and attitudes towards contraceptive use, receipt of contraception at the clinic visit and self-reported use of contraception at 3-month and 6-month follow-ups. The study began enrolling participants in August 2016, and a total of 1400 participants (700 per treatment group) are expected to be enrolled by March 2018. Ethics approval was obtained through the University of California, San Francisco Institutional Review Board. Results of this trial will be submitted for publication in peer

  3. 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.

  4. Study protocol: cluster randomised controlled trial to assess the clinical and cost effectiveness of a staff training intervention in inpatient mental health rehabilitation units in increasing service users' engagement in activities.

    Science.gov (United States)

    Killaspy, Helen; Cook, Sarah; Mundy, Tim; Craig, Thomas; Holloway, Frank; Leavey, Gerard; Marston, Louise; McCrone, Paul; Koeser, Leonardo; Arbuthnott, Maurice; Omar, Rumana Z; King, Michael

    2013-08-28

    This study focuses on people with complex and severe mental health problems who require inpatient rehabilitation. The majority have a diagnosis of schizophrenia whose recovery has been delayed due to non-response to first-line treatments, cognitive impairment, negative symptoms and co-existing problems such as substance misuse. These problems contribute to major impairments in social and everyday functioning necessitating lengthy admissions and high support needs on discharge to the community. Engagement in structured activities reduces negative symptoms of psychosis and may lead to improvement in function, but no trials have been conducted to test the efficacy of interventions that aim to achieve this. This study aims to investigate the clinical and cost-effectiveness of a staff training intervention to increase service users' engagement in activities. This is a single-blind, two-arm cluster randomised controlled trial involving 40 inpatient mental health rehabilitation units across England. Units are randomised on an equal basis to receive either standard care or a "hands-on", manualised staff training programme comprising three distinct phases (predisposing, enabling and reinforcing) delivered by a small team of psychiatrists, occupational therapists, service users and activity workers. The primary outcome is service user engagement in activities 12 months after randomisation, assessed using a standardised measure. Secondary outcomes include social functioning and costs and cost-effectiveness of care. The study will provide much needed evidence for a practical staff training intervention that has potential to improve service user functioning, reducing the need for hospital treatment and supporting successful community discharge. The trial is registered with Current Controlled Trials (Ref ISRCTN25898179).

  5. Body surface area adapted iopromide 300 mg/ml versus 370 mg/ml contrast medium injection protocol: Influence on quantitative and clinical assessment in combined PET/CT

    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); Apitzsch, Jonas [RWTH Aachen University Hospital, Department of Diagnostic and Interventional Radiology, Pauwelsstraße 30, 52074 Aachen (Germany); Lensing, Carina [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Kuhl, Christiane K. [RWTH Aachen University Hospital, Department of Diagnostic and Interventional Radiology, Pauwelsstraße 30, 52074 Aachen (Germany); Pietsch, Hubertus [Bayer Pharma AG, Müllerstrasse 178, 13353 Berlin (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)

    2013-12-01

    Purpose: To investigate the quantitative and qualitative differences between combined positron emission tomography and computed X-ray tomography (PET/CT) enhanced with contrast medium with either an iodine concentration 300 mg/ml or 370 mg/ml. Materials and methods: 120 consecutive patients scheduled for F-18-Fluorodeoxyglucose (FDG) PET/CT were included. The first (second) 60 patients received contrast medium with 300 (370) mg iodine/ml. Intravenous injection protocols were adapted for an identical iodine delivery rate (1.3 mg/s) and body surface area (BSA) adapted iodine dose (22.26 g I/m{sup 2}). Maximum and mean standardized uptake values (SUV{sub max}; SUV{sub mean}) and contrast enhancement (HU) were determined in the ascending aorta, the abdominal aorta, the inferior vena cava, the portal vein, the liver and the right kidney in the venous contrast medium phase. PET data were evaluated visually for the presence of malignancy and image quality. Results: Both media caused significantly higher values for HU, SUV{sub mean} and SUV{sub max} for the enhanced PET/CT than the non-enhanced one (all p < 0.01). There were no significant differences in the degree of increase of HU, SUV{sub mean} and SUV{sub max} between the two contrast media at any anatomic site (all p > 0.05). Visual evaluation of lesions showed no differences between contrast and non-contrast PET/CT or between the two different contrast media (p = 0.77). Conclusion: When using a constant iodine delivery rate and total iodine dose in a BSA adapted injection protocol, there are no quantitative or qualitative differences in either CT or PET between contrast media with an iodine concentration of 300 mg/ml and 370 mg/ml, respectively.

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

    Science.gov (United States)

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

    2015-01-01

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

  7. 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.

  8. 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

  9. ComOn Coaching: Study protocol of a randomized controlled trial to assess the effect of a varied number of coaching sessions on transfer into clinical practice following communication skills training.

    Science.gov (United States)

    Niglio de Figueiredo, Marcelo; Rudolph, Bärbel; Rodolph, Bärbel; Bylund, Carma L; Goelz, Tanja; Heußner, Pia; Sattel, Heribert; Fritzsche, Kurt; Wuensch, Alexander

    2015-07-07

    Communication skills training has proven to be an effective means to enhance communication of health care professionals in oncology. These effects are well studied in standardized settings. The question of transferring these skills into clinical consultations remains open. We build up on a previous developed training concept consisting of a workshop and coaching. This training achieved a medium effect size in two studies with standardized patients. In the current study, we expanded and manualized the coaching concept, and we will evaluate effects of a varied number of coaching sessions on real clinical consultations. Our aim is to determine how much coaching oncologists need to transfer communication skills into clinical practice. Physicians of two German medical centers will participate in a workshop for communication skills and will be randomized to either a group with one coaching session or a group with four coaching sessions following the workshop. The participation is voluntary and the physicians will receive medical education points. Consultations held by the participating physicians with actual patients who gave their informed consent will be filmed at three time points. These consultations will be evaluated by blinded raters using a checklist based on the training content (primary outcome). Secondary outcomes will be the self-evaluated communication competence by physicians and an evaluation of the consultations by both physicians and patients. We will evaluate our communication training concept on three levels - rater, physician and patient - and concentrate on the transfer of communication skills into real life situations. As we emphasize the external validity in this study design, limitations will be expected due to heterogeneity of data. With this study we aim to gain data on how to improve communication skills training that will result in better patient outcomes. German Clinical Trials Register DRKS00004385 .

  10. Assessing student clinical learning experiences.

    Science.gov (United States)

    Nehyba, Katrine; Miller, Susan; Connaughton, Joanne; Singer, Barbara

    2017-08-01

    This article describes the use of an activity worksheet and questionnaire to investigate the learning experience of students on clinical placement. The worksheet measures the amount of time students spend in different learning activities, and the questionnaire explores student satisfaction and preferred learning activities. An activity worksheet and questionnaire … investigate[d] the learning experiences of students on clinical placement METHODS: The activity worksheet and questionnaire were used in a cohort pilot study of physiotherapy students on clinical placement. The activity worksheet provides details of the amount of time students engage in a range of clinical and non-clinical tasks while on placement, such as time spent treating patients, working individually, working with their peers and engaging in reflective practice. In combination with the questionnaire results, it allows clinicians to gain an understanding of the clinical learning environment experienced by their students. The data collected using these tools provide a description of the students' activities while undertaking the clinical placement. This information may guide the refinement of the clinical experience, and offers an opportunity to individualise learning activities to match students' needs and preferences. © 2016 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

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

    Science.gov (United States)

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

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

  12. 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.

  13. Settleability assessment protocol for anaerobic granular sludge and ...

    African Journals Online (AJOL)

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

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

    DEFF Research Database (Denmark)

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

    2006-01-01

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

  15. 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.

  16. 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

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

    Science.gov (United States)

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

    2003-01-01

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

  18. 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

  19. 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.

  20. 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

  1. 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.

  2. 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...

  3. 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.

  4. 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...

  5. Developing a guiding protocol for the moderation of summative assessments.

    OpenAIRE

    McGuire, W.; Raaper, R.

    2016-01-01

    According to literature, assessment moderation is a process for assuring ‘valid, fair and reliable’ assessment outcomes but also consistency of applied marking criteria. While being an important area in assessment, moderation is often referred as an ‘under researched area of higher education’. The School of Education in the University of Glasgow, like many other academic units in the UK and internationally, adopts a range of approaches to moderating assessment within any one programme and acr...

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

    Science.gov (United States)

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

    2017-09-24

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

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

    Science.gov (United States)

    Chiara, Matteo; Pavesi, Giulio

    2017-01-01

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

  8. Assessment of paediatric clinical audit.

    LENUS (Irish Health Repository)

    Perrem, L M

    2012-02-01

    Consultant paediatricians in Ireland were surveyed to evaluate their perceptions of the hospital audit environment and assess their involvement in the audit process. Eighty nine (77%) replied of whom 66 (74%) had an audit department and 23 (26%) did not. Sixteen (18%) felt their hospital was well resourced for audit and 25 (28%) felt the culture was very positive but only 1 (1%) had protected time. For 61 (69%) consultants audit was very important with 38 (43%) being very actively involved in the process. The most frequent trigger for audit was non consultant hospital doctor (NCHD) career development, cited by 77 (87%). The new Professional Competence Scheme and the National Quality and Risk Management Standards will require the deficiencies identified in this survey be addressed.

  9. 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

  10. 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.

  11. 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).

  12. 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.

  13. 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.

  14. Clinical application of Assessment of Parenting Competencies (APC)

    DEFF Research Database (Denmark)

    Jacobsen, Stine Lindahl

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

  15. 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.

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

    Science.gov (United States)

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

    2017-11-01

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

  17. 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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

  20. The California Multimedia Risk Assessment Protocol for Alternative Fuels

    Science.gov (United States)

    Hatch, T.; Ginn, T. R.; McKone, T. E.; Rice, D. W.

    2013-12-01

    Any new fuel in California requires approval by the state agencies overseeing human and environmental health. In order to provide a systematic evaluation of new fuel impacts, California now requires a multimedia risk assessment (MMRA) for fuel approval. The fuel MMRA involves all relevant state agencies including: the California Air Resources Board (CARB), the State Water Resources Control Board (SWRCB), the Office of Environmental Health Hazards Assessment (OEHHA), and the Department of Toxic Substances Control (DTSC) overseen by the California Environmental Protection Agency (CalEPA). The lead agency for MMRAs is the CARB. The original law requiring a multimedia assessment is California Health and Safety Code 43830.8. In addition, the low carbon fuel standard (LCFS), the Global Warming Solutions Act (AB32), and the Verified Diesel Emission Control Strategy (VDECS) have provisions that can require a multimedia assessment. In this presentation, I give an overview of the California multimedia risk assessment (MMRA) for new fuels that has been recently developed and applied to several alternative fuels. The objective of the California MMRA is to assess risk of potential impacts of new fuels to multiple environmental media including: air, water, and soil. Attainment of this objective involves many challenges, including varying levels of uncertainty, relative comparison of incommensurate risk factors, and differing levels of priority assigned to risk factors. The MMRA is based on a strategy of relative risk assessment and flexible accommodation of distinct and diverse fuel formulations. The approach is tiered by design, in order to allow for sequentially more sophisticated investigations as knowledge gaps are identified and re-prioritized by the ongoing research. The assessment also involves peer review in order to provide coupling between risk assessment and stakeholder investment, as well as constructive or confrontational feedback. The multimedia assessment

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

    Science.gov (United States)

    Fellenz, Martin R.

    2006-01-01

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

  2. Energy and Process Assessment Protocol for Industrial Buildings

    Science.gov (United States)

    2007-05-01

    condenser surfaces of fouling 6.31 Raise evaporator or lower condenser water temperature 6.2 Optimize chiller sequencing 6.33 Use two-speed or...F increase in CHW supply setpoint the chiller compression motor load will DECREASE 1.5 percent. This is a zero cost ECO. 3.5 Decrease Conden. CTW...energy assessments, universities conducting energy assessment, and Energy Service Performance Contractors) perform Industrial and Energy Optimization

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

    Directory of Open Access Journals (Sweden)

    Dustin Ryan Osborne

    2015-05-01

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

  4. 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...

  5. Protocol to assess covering products for roofing slates

    Directory of Open Access Journals (Sweden)

    De la Horra, R.

    2008-06-01

    Full Text Available Spain is a world-wide leader in roofing slate production, quarriying more than 600,000 tons of slate of great quality and generating around 300 euros million in sales each year. However, an enormous quantity of slate plates is considered as a low quality product or discarded every year as waste. The application of protective products on roofing slate tiles helps to commercialise slate with higher oxidation rates, reducing wastes and environmental problems. The present protocol serves to evaluate the new protective products that are now used by slate producers. A combination of three technological tests is proposed here, along with a visual questionnaire to grant quality indices. Each test is oriented to clarify critical properties for the future use of the roofing slate, as follows: (i Thermal cycles were used to determine the oxidation rate of iron sulphides; (ii Slate behaviour in acid urban atmospheres was interpreted by exposition of slate tiles to SO2 gas; (iii Effectiveness of the protective layer under saline corrosion and solar radiation was obtained by exposition to saline fog and UV-irradiation. Physico-chemical tests have been performed in the Technological Centre of the Slate (Orense, Spain whereas the chemical-structural characterizations of natural, impregnated and altered slate plates were carried out by X-ray diffraction and optical and electronic microscopy in the University of Santiago de Compostela (NW Spain. The quantitative analyses of the alteration grades have been determined using a freeware program (IMAGEJ on the scanned images of roofing slate tiles. The protocol here presented has been experienced with the more important protective slate products nowadays, i.e., siloxanes, organic resins and polyurethanes.España es líder mundial en producción de pizarras de techar; la producción supera las 600.000 toneladas de pizarra de gran calidad, suponiendo mas de 300 millones euros. La aplicación de la pizarra con productos

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

    Science.gov (United States)

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

    2017-01-18

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

  7. 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.

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Brandon A. Gaudiano

    2015-07-01

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

  10. Toward an HRD Auditing Protocol: Assessing HRD Risk Management Practices

    Science.gov (United States)

    Clardy, Alan

    2004-01-01

    Even though HRD-related programs and activities carry risks that should be monitored and assessed, there is little literature on how auditing applies to the HRD function; the existing literature on the topic defines HRD auditing in widely different ways. The nature of risk for organizational process is discussed, followed by a review of the…

  11. OCONUS Compliance Assessment Protocols - Qatar (Army Version) (CD-ROM)

    National Research Council Canada - National Science Library

    Krooks, David A

    2004-01-01

    ...: 1 CD-ROM; 4 3/4 in.; 578 KB. ABSTRACT: This environmental compliance assessment manual is based on the Final Governing Standards for Environmental Security of United States Forces in the State of Qatar, 21 May 1999, and the Overseas...

  12. 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

  13. 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.

  14. Implementing an Assessment Clinic in a Residential PTSD Program

    Directory of Open Access Journals (Sweden)

    Joan McDowell

    2014-08-01

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

  15. Assessing the clinical probability of pulmonary embolism

    International Nuclear Information System (INIS)

    Miniati, M.; Pistolesi, M.

    2001-01-01

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

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

    Science.gov (United States)

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

    2004-01-01

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

  17. Setting pass scores for clinical skills assessment.

    Science.gov (United States)

    Liu, Min; Liu, Keh-Min

    2008-12-01

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

  18. Setting Pass Scores for Clinical Skills Assessment

    Directory of Open Access Journals (Sweden)

    Min Liu

    2008-12-01

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

  19. 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.

  20. Assessing clinical competency in the health sciences

    Science.gov (United States)

    Panzarella, Karen Joanne

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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. Formative assessment promotes learning in undergraduate clinical ...

    African Journals Online (AJOL)

    Introduction. Clinical clerkships, typically situated in environments lacking educational structure, form the backbone of undergraduate medical training. The imperative to develop strategies that enhance learning in this context is apparent. This study explored the impact of longitudinal bedside formative assessment on ...

  8. Personality Assessment Use by Clinical Neuropsychologists

    Science.gov (United States)

    Smith, Steven R.; Gorske, Tad T.; Wiggins, Chauntel; Little, Jessica A.

    2010-01-01

    The present study is an exploration of the personality assessment practices of clinical neuropsychologists. Professional members of the National Academy of Neuropsychology and the International Neuropsychological Society (N = 404) were surveyed to examine use of several forms of personality, behavior, and emotional function measures. Results…

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

    Science.gov (United States)

    Scheller, A; Rask, B

    1993-04-01

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

  10. Triangular model integrating clinical teaching and assessment.

    Science.gov (United States)

    Abdelaziz, Adel; Koshak, Emad

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Arash Mohagheghi

    2017-01-01

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

  12. 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

  13. 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

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

    Science.gov (United States)

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

    2016-06-01

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

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

    Directory of Open Access Journals (Sweden)

    Monica Battini

    2015-09-01

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

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

    DEFF Research Database (Denmark)

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

    2012-01-01

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

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

    NARCIS (Netherlands)

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Ana Cristina Coelho Dal Rio

    2007-12-01

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

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

    Directory of Open Access Journals (Sweden)

    de Courten Maximilian

    2006-02-01

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

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

    International Nuclear Information System (INIS)

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

    2006-01-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

  4. 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.

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

    Directory of Open Access Journals (Sweden)

    V.L. dos Santos Alves

    2015-05-01

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

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

    Science.gov (United States)

    Roberts, Laura Weiss; Kim, Jane Paik

    2014-09-01

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

  7. Risk assessment instruments in clinical practice.

    Science.gov (United States)

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

    2012-04-01

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

  8. 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.

  9. Triangular model integrating clinical teaching and assessment

    Directory of Open Access Journals (Sweden)

    Abdelaziz A

    2014-03-01

    Full Text Available Adel Abdelaziz,1,2 Emad Koshak3 1Medical Education Development Unit, Faculty of Medicine, Al Baha University, Al Baha, Saudi Arabia; 2Medical Education Department, Faculty of Medicine, Suez Canal University, Egypt; 3Dean and Internal Medicine Department, Faculty of Medicine, Al Baha University, Al Baha, Saudi Arabia Abstract: Structuring clinical teaching is a challenge facing medical education curriculum designers. A variety of instructional methods on different domains of learning are indicated to accommodate different learning styles. Conventional methods of clinical teaching, like training in ambulatory care settings, are prone to the factor of coincidence in having varieties of patient presentations. Accordingly, alternative methods of instruction are indicated to compensate for the deficiencies of these conventional methods. This paper presents an initiative that can be used to design a checklist as a blueprint to guide appropriate selection and implementation of teaching/learning and assessment methods in each of the educational courses and modules based on educational objectives. Three categories of instructional methods were identified, and within each a variety of methods were included. These categories are classroom-type settings, health services-based settings, and community service-based settings. Such categories have framed our triangular model of clinical teaching and assessment. Keywords: curriculum development, teaching, learning, assessment, apprenticeship, community-based settings, health service-based settings

  10. 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.

  11. 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

  12. [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.

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

    Science.gov (United States)

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

    2016-05-01

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

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

    Science.gov (United States)

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

    2012-03-01

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

  15. 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

  16. Radiation dosimetry assessment of routine CT scanning protocols used in Western Australia

    International Nuclear Information System (INIS)

    Moorin, Rachael E; Forsyth, Rene; Gibson, David J; Fox, Richard

    2013-01-01

    Technical data on local CT practice in Western Australia were collected for five major CT providers using a self-completed questionnaire. The CTDIvol DLP and effective dose for each protocol were obtained and providers were ranked according to radiation burden for each clinical scenario. The mean, median, 75th percentile and standard deviation were calculated for both effective dose and DLP for each scenario and these values were compared with published data. CT utilisation data were used to estimate the attributable radiation dose to the WA population and the potential change in population annual effective dose according to the protocol used was estimated. We found that wide variations in technique and radiation dose exist across providers for similar examinations, producing a higher radiation burden than reported internationally. As expected, the CT protocol used dramatically affects the radiation dose received, and this has a significant effect on annual population dose. This study highlights the need for recognition and understanding of both the degree of variation in radiation dose across providers and the relatively high radiation burden afforded by protocols in use in Western Australia so that necessary dialogue can be launched for practitioner consensus on appropriate diagnostic reference levels in CT scanning. (paper)

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

    Science.gov (United States)

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

    2017-09-01

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

  18. Formative assessment of GP trainees' clinical skills.

    Science.gov (United States)

    Wiener-Ogilvie, Sharon; Begg, Drummond

    2012-03-01

    Clinical skill assessment (CSA) has been an integral part of the Royal College of General Practitioners' membership examination (MRCGP) since 2008. It is an expensive, high-stakes examination with first time pass rates ranging from 76.4 to 81.3. In this paper we describe the South East Scotland Deanery, NHS Education Scotland, pilot of a formative clinical skills assessment (fCSA) using the principles of formative assessment and OSCE. The purpose of the study was to assess the acceptability of the fCSA and to examine whether trainees, identified during the fCSA as 'at risk of failing the MRCGP CSA exam', are more likely to fail the MRCGP CSA exam later on in the year. Trainees were assessed in four clinical skills stations under exam conditions. After each station they were given verbal feedback and subsequently both trainee and their trainer received written feedback. We assessed the value of the exercise through written feedback from trainees and trainers. Each trainee's performance in fCSA was triangulated with trainer assessment to identify 'flagged trainees'. We compared flagged and non-flagged trainees' performance in MRCGP CSA. Both trainees and trainers highly rated the fCSA. Overall 97% of non-flagged trainees have passed the RCGP CSA exam by May of that year in comparison to 80% of flagged trainees who have passed the RCGP CSA (P = 0.005). Trainers and trainees rated the fCSA as excellent and useful. We were able to demonstrate that the fCSA can be used to identify those trainees likely to fail the RCGP CSA. Contrary to reservations about the potential to demoralise trainees, the fCSA was viewed as a useful and a positive experience by both trainees and trainers. In addition, we suggest that feedback from fCSA was useful in triggering appropriate educational interventions. Early intervention with trainees who are predicted to fail the CSA has the potential to reduce deaneries overall fail rate. Preventing one trainee failure could save over £30 000.

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

    Science.gov (United States)

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

    2017-01-01

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

  20. Clinical risk assessment in intensive care unit

    Directory of Open Access Journals (Sweden)

    Saeed Asefzadeh

    2013-01-01

    Full Text Available Background: Clinical risk management focuses on improving the quality and safety of health care services by identifying the circumstances and opportunities that put patients at risk of harm and acting to prevent or control those risks. The goal of this study is to identify and assess the failure modes in the ICU of Qazvin′s Social Security Hospital (Razi Hospital through Failure Mode and Effect Analysis (FMEA. Methods: This was a qualitative-quantitative research by Focus Discussion Group (FDG performed in Qazvin Province, Iran during 2011. The study population included all individuals and owners who are familiar with the process in ICU. Sampling method was purposeful and the FDG group members were selected by the researcher. The research instrument was standard worksheet that has been used by several researchers. Data was analyzed by FMEA technique. Results: Forty eight clinical errors and failure modes identified, results showed that the highest risk probability number (RPN was in respiratory care "Ventilator′s alarm malfunction (no alarm" with the score 288, and the lowest was in gastrointestinal "not washing the NG-Tube" with the score 8. Conclusions: Many of the identified errors can be prevented by group members. Clinical risk assessment and management is the key to delivery of effective health care.

  1. 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

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

    Directory of Open Access Journals (Sweden)

    Natacha Alves de Oliveira

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Guilherme Malafaia

    2008-12-01

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

  4. [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.

  5. 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.)

  6. 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.

  7. 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.)

  8. 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

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

    Science.gov (United States)

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

    2009-01-01

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

  10. Assessment of macrophage migration inhibitory factor in humans: protocol for accurate and reproducible levels.

    Science.gov (United States)

    Sobierajski, Julia; Hendgen-Cotta, Ulrike B; Luedike, Peter; Stock, Pia; Rammos, Christos; Meyer, Christian; Kraemer, Sandra; Stoppe, Christian; Bernhagen, Jürgen; Kelm, Malte; Rassaf, Tienush

    2013-10-01

    The analytical validation of a possible biomarker is the first step in the long translational process from basic science to clinical routine. Although the chemokine-like cytokine macrophage migration inhibitory factor (MIF) has been investigated intensively in experimental approaches to various disease conditions, its transition into clinical research is just at the very beginning. Because of its presence in preformed storage pools, MIF is the first cytokine to be released under various stimulation conditions. In the first proof-of-concept studies, MIF levels correlated with the severity and outcome of various disease states. In a recent small study with acute coronary syndrome patients, elevation of MIF was described as a new factor for risk assessment. When these studies are compared, not only MIF levels in diseased patients differ, but also MIF levels in healthy control groups are inconsistent. Blood MIF concentrations in control groups vary between 0.56 and 95.6 ng/ml, corresponding to a 170-fold difference. MIF concentrations in blood were analyzed by ELISA. Other than the influence of this approach due to method-based variations, the impact of preanalytical processing on MIF concentrations is unclear and has not been systematically studied yet. Before large randomized studies are performed to determine the impact of circulating MIF on prognosis and outcome and before MIF is characterized as a diagnostic marker, an accurate protocol for the determination of reproducible MIF levels needs to be validated. In this study, the measurement of MIF in the blood of healthy volunteers was investigated focusing on the potential influence of critical preanalytical factors such as anticoagulants, storage conditions, freeze/thaw stability, hemolysis, and dilution. We show how to avoid pitfalls in the measurement of MIF and that MIF concentrations are highly susceptible to preanalytical factors. MIF serum concentrations are higher than plasma concentrations and show broader

  11. 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

  12. 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.

  13. 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.

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

    DEFF Research Database (Denmark)

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

    2013-01-01

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

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

    International Nuclear Information System (INIS)

    Gautier, Celia

    2012-01-01

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

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

    Science.gov (United States)

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

    2015-08-06

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

  17. 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

  18. 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

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

    DEFF Research Database (Denmark)

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

    1995-01-01

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

  20. 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…

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

    Science.gov (United States)

    Zhou, Leming; Bao, Jie; Parmanto, Bambang

    2017-08-01

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

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

    International Nuclear Information System (INIS)

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

    2014-01-01

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

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

    OpenAIRE

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

    2017-01-01

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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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).

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

    African Journals Online (AJOL)

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

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

    Science.gov (United States)

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

    2011-02-21

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

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

    Science.gov (United States)

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

    2018-01-24

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

  13. 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

  14. 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

  15. 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

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

    International Nuclear Information System (INIS)

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

    2013-01-01

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

  17. The development and evaluation of an internal workplace violence risk assessment protocol: one organization's experience.

    Science.gov (United States)

    Heitt, Michael C; Tamburo, Melissa Back

    2005-01-01

    The creation and development of a Risk Assessment Team at a large urban university is presented as a case study, with particular focus on the role the Employee Assistance Program (EAP) plays in the multidisciplinary team. The structure of the team and differing roles and responsibilities of members will be discussed. A specific protocol for addressing incidents will be introduced, along with changes in the team ' response over time. Major lessons learned will be presented, as well as the challenges the team faces today, and discussion of areas for future research and evaluation.

  18. 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.

  19. Assessment of Clinical Criteria for Sepsis

    Science.gov (United States)

    Seymour, Christopher W.; Liu, Vincent X.; Iwashyna, Theodore J.; Brunkhorst, Frank M.; Rea, Thomas D.; Scherag, André; Rubenfeld, Gordon; Kahn, Jeremy M.; Shankar-Hari, Manu; Singer, Mervyn; Deutschman, Clifford S.; Escobar, Gabriel J.; Angus, Derek C.

    2016-01-01

    IMPORTANCE The Third International Consensus Definitions Task Force defined sepsis as “life-threatening organ dysfunction due to a dysregulated host response to infection.” The performance of clinical criteria for this sepsis definition is unknown. OBJECTIVE To evaluate the validity of clinical criteria to identify patients with suspected infection who are at risk of sepsis. DESIGN, SETTINGS, AND POPULATION Among 1.3 million electronic health record encounters from January 1, 2010, to December 31, 2012, at 12 hospitals in southwestern Pennsylvania, we identified those with suspected infection in whom to compare criteria. Confirmatory analyses were performed in 4 data sets of 706 399 out-of-hospital and hospital encounters at 165 US and non-US hospitals ranging from January 1, 2008, until December 31, 2013. EXPOSURES Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score, systemic inflammatory response syndrome (SIRS) criteria, Logistic Organ Dysfunction System (LODS) score, and a new model derived using multivariable logistic regression in a split sample, the quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) score (range, 0–3 points, with 1 point each for systolic hypotension [≤100 mm Hg], tachypnea [≥22/min], or altered mentation). MAIN OUTCOMES AND MEASURES For construct validity, pairwise agreement was assessed. For predictive validity, the discrimination for outcomes (primary: in-hospital mortality; secondary: in-hospital mortality or intensive care unit [ICU] length of stay ≥3 days) more common in sepsis than uncomplicated infection was determined. Results were expressed as the fold change in outcome over deciles of baseline risk of death and area under the receiver operating characteristic curve (AUROC). RESULTS In the primary cohort, 148 907 encounters had suspected infection (n = 74 453 derivation; n = 74 454 validation), of whom 6347 (4%) died. Among ICU encounters in the validation cohort (n = 7932 with suspected

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

    Science.gov (United States)

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

    2017-10-30

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

  1. Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD-'Assessing QbTest Utility in ADHD' (AQUA): a randomised controlled trial.

    Science.gov (United States)

    Hall, Charlotte L; Walker, Gemma M; Valentine, Althea Z; Guo, Boliang; Kaylor-Hughes, Catherine; James, Marilyn; Daley, David; Sayal, Kapil; Hollis, Chris

    2014-12-01

    The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current 'gold standard' ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome. This multisite randomised controlled trial will recruit young people (aged 6-17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice. The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young

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

    Science.gov (United States)

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

    2012-11-15

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

  3. 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.

  4. 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.

  5. Experimental protocol to assess the tourism vehicles accessibility based on heart rate and access time measurements

    Energy Technology Data Exchange (ETDEWEB)

    Alcala Fazio, E.; Alvarez Fernandez, N.

    2016-07-01

    The objective of the Project is to define an experimental protocol for the accessibility assessment of the transport vehicles, by analysing the evolution of the effort and time variables consumed by a target group –Persons of Reduced Mobility (PMRs). This protocol consisted in tests of accessibility on a sample of 6 passenger cars (class M1) by 8 elderly people carrying a heart rate monitor, and whose access manoeuvres were recorded by video cameras. Based on the Hilloskorpi et al. [1] model and by developing a method of truncation of the heart rate (HR) tests records - eliminating the component of the work biologically needed by the organism to keep its basal metabolic rate from the work each person performed – it was possible to evaluate how much energy each individual invested in each access manoeuver. Immediately after each test, and after the whole round of vehicles, each participant was surveyed for a subjective assessment of the difficulty of accessing to the cars. According to each of the above results, the HR objective measurements and the subjective opinion about the ease of access experienced by each individual, the vehicles were ranked by order of accessibility to the front and rear seats. The result of both rankings showed the orders of the similar vehicles, the potential of the method and a fair closeness between its results and the subjective, but real and unequivocal, judgments of the participants. (Author)

  6. Improving mental health care transitions for children and youth: a protocol to implement and evaluate an emergency department clinical pathway.

    Science.gov (United States)

    Jabbour, Mona; Reid, S; Polihronis, C; Cloutier, P; Gardner, W; Kennedy, A; Gray, C; Zemek, R; Pajer, K; Barrowman, N; Cappelli, M

    2016-07-07

    While the emergency department (ED) is often a first point of entry for children and youth with mental health (MH) concerns, there is a limited capacity to respond to MH needs in this setting. Child MH systems are typically fragmented among multiple ministries, organizations, and providers. Communication among these groups is often poor, resulting in gaps, particularly in transitions of care, for this vulnerable population. The evidence-based Emergency Department Mental Health Clinical Pathway (EDMHCP) was created with two main goals: (1) to guide risk assessment and disposition decision-making for children and youth presenting to the ED with MH concerns and (2) to provide a streamlined transition to follow-up services with community MH agencies (CMHAs) and other providers. The purpose of this paper is to describe our study protocol to implement and evaluate the EDMHCP. This mixed methods health services research project will involve implementation and evaluation of the EDMHCP in four exemplar ED-CMHA dyads. The Theoretical Domains Framework will be used to develop a tailored intervention strategy to implement the EDMHCP. A multiple baseline study design and interrupted time-series analysis will be used to determine if the EDMHCP has improved health care utilization, medical management of the MH problems, and health sector coordination. The primary process outcome will be the proportion of patients with MH-specific recommendations documented in the health record. The primary service outcome will be the proportion of patients receiving the EDMHCP-recommended follow-up at 24-h or at 7 days. Data sources will include qualitative interviews, health record audits, administrative databases, and patient surveys. A concurrent process evaluation will be conducted to assess the degree of variability and fidelity in implementation across the sites. This paper presents a novel model for measuring the effects of the EDMHCP. Our development process will identify how the EDMHCP

  7. Parents as Agents of Change (PAC in pediatric weight management: The protocol for the PAC randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ball Geoff D C

    2012-08-01

    Full Text Available Abstract Background There is an urgent need to develop and evaluate weight management interventions to address childhood obesity. Recent research suggests that interventions designed for parents exclusively, which have been named parents as agents of change (PAC approaches, have yielded positive outcomes for managing pediatric obesity. To date, no research has combined a PAC intervention approach with cognitive behavioural therapy (CBT to examine whether these combined elements enhance intervention effectiveness. This paper describes the protocol our team is using to examine two PAC-based interventions for pediatric weight management. We hypothesize that children with obesity whose parents complete a CBT-based PAC intervention will achieve greater reductions in adiposity and improvements in cardiometabolic risk factors, lifestyle behaviours, and psychosocial outcomes than children whose parents complete a psycho-education-based PAC intervention (PEP. Methods/Design This study is a pragmatic, two-armed, parallel, single-blinded, superiority, randomized clinical trial. The primary objective is to examine the differential effects of a CBT-based PAC vs PEP-based PAC intervention on children’s BMI z-score (primary outcome. Secondary objectives are to assess intervention-mediated changes in cardiometabolic, lifestyle, and psychosocial variables in children and parents. Both interventions are similar in frequency of contact, session duration, group facilitation, lifestyle behaviour goals, and educational content. However, the interventions differ insofar as the CBT-based intervention incorporates theory-based concepts to help parents link their thoughts, feelings, and behaviours; these cognitive activities are enabled by group leaders who possess formal training in CBT. Mothers and fathers of children (8–12 years of age; BMI ≥85th percentile are eligible to participate if they are proficient in English (written and spoken and agree for at least

  8. 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

  9. Clinical Research: A Psychotherapeutic Assessment Model for Siblings in Care

    Science.gov (United States)

    Hindle, Debbie

    2007-01-01

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

  10. 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

  11. Assessment of hospital pharmacists' clinical knowledge and ...

    African Journals Online (AJOL)

    reproduction in any medium, provided the original work is properly credited. ... drug use, which improves the quality of life. ... balance of clinical knowledge, practical skills, ... Ethical approval ... plans, clinical decision making, and finding the.

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

    Science.gov (United States)

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

    2018-01-01

    The study aim was to evaluate if continual patient position monitoring, taking into account self-turns and clinician-assisted turns, would increase the percentage of time a patient's position changed at least every 2 hr. While patient turning has clinical benefits, current models to help staff remember to turn patients, such as "turn clocks" and timers, have not resulted in high compliance with turning protocols. In addition, reminders are based on arbitrary 2-hr windows (such as turning on "even" hours) rather than on individual patient activity, including self-turns. This is a first inpatient, non-randomized, pre-/postintervention study. Data collection occurred from May 2013-February 2014 on a 39-bed medical unit in a community hospital. Baseline patient turning data were recorded by a sensor; however, the patient data were not displayed at the nurses' station to establish compliance with the hospital's turning protocol. Postintervention, patient position information was wirelessly displayed on nurses' station computer monitors in real time. A Student t test was used to compare baseline to postintervention "mean time in compliance." Data from 138 patients ( N  =   7,854 hr of monitoring) were collected. The baseline phase yielded 4,322 hr of position monitoring data and the postintervention phase yielded 3,532 hr of data. Statistically significant improvement was demonstrated in the percentage of time a patient's position changed at least every 2 hr from baseline to postintervention.

  13. Assessment of Active Video Gaming Using Adapted Controllers by Individuals With Physical Disabilities: A Protocol.

    Science.gov (United States)

    Malone, Laurie A; Padalabalanarayanan, Sangeetha; McCroskey, Justin; Thirumalai, Mohanraj

    2017-06-16

    collected during an initial 20-minute baseline, followed by 40 minutes of game play. The controller (balance board or gaming mat) played was randomly selected. A set of games was played for 10 minutes, followed by 5 minutes of rest, and then another set of games was played for 10 minutes, followed by rest. Quality of game play was observed and documented for each set. During rest, the participant completed questions regarding enjoyment. Following the same procedures, the participant then played the two sets of games using the other version (off-the-shelf or adapted) of the controller. The entire procedure was repeated during Visit 3 with the controller that was not played. Enrollment began in February 2016 and ended in September 2016. Study results will be reported in late 2017. We hypothesized that the adapted versions of the Wii Fit balance board and gaming mat would produce greater quality of game play, enjoyment, and energy expenditure in persons with mobility impairments compared to off-the-shelf versions. ClinicalTrials.gov NCT02994199; https://clinicaltrials.gov/ct2/show/NCT02994199 (Archived by WebCite at http://www.webcitation.org/6qpPszPJ7). ©Laurie A Malone, Sangeetha Padalabalanarayanan, Justin McCroskey, Mohanraj Thirumalai. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.06.2017.

  14. 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

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

    International Nuclear Information System (INIS)

    2000-11-01

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

  16. 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.

  17. 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.

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

    Science.gov (United States)

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

    2017-08-11

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

  19. 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

  20. 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

  1. A real-time, quantitative PCR protocol for assessing the relative parasitemia of Leucocytozoon in waterfowl

    Science.gov (United States)

    Smith, Matthew M.; Schmutz, Joel A.; Apelgren, Chloe; Ramey, Andy M.

    2015-01-01

    Microscopic examination of blood smears can be effective at diagnosing and quantifying hematozoa infections. However, this method requires highly trained observers, is time consuming, and may be inaccurate for detection of infections at low levels of parasitemia. To develop a molecular methodology for identifying and quantifying Leucocytozoon parasite infection in wild waterfowl (Anseriformes), we designed a real-time, quantitative PCR protocol to amplify Leucocytozoon mitochondrial DNA using TaqMan fluorogenic probes and validated our methodology using blood samples collected from waterfowl in interior Alaska during late summer and autumn (n = 105). By comparing our qPCR results to those derived from a widely used nested PCR protocol, we determined that our assay showed high levels of sensitivity (91%) and specificity (100%) in detecting Leucocytozoon DNA from host blood samples. Additionally, results of a linear regression revealed significant correlation between the raw measure of parasitemia produced by our qPCR assay (Ct values) and numbers of parasites observed on blood smears (R2 = 0.694, P = 0.003), indicating that our assay can reliably determine the relative parasitemia levels among samples. This methodology provides a powerful new tool for studies assessing effects of haemosporidian infection in wild avian species.

  2. 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

    to subjects treated in the control group. Outcomes The primary outcome is the Alzheimer’s Disease Cooperative Studies Group Activities of Daily Living Scale; secondary outcome measures are two performance-based measures including the Short Physical Performance Battery and Short Portable Sarcopenia Measure. Outcome assessments for both the caregiver-reported scale and subjects’ physical performance scales are completed in the subject’s home. Randomization Eligible patient-care giver dyads will be stratified by clinic type and block randomized with a computer developed randomization scheme using a 1:1 allocation ratio. Blinding Single blinded. Research assistants completing the outcome assessments were blinded to the subjects’ treatment group. Trial status Ongoing ClinicalTrial.Gov identifier NCT01314950; date of completed registration 10 March 2011; date first patient randomized 9 March 2011

  3. 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

  4. WHY DO YOU NEED TO USE A CARIES RISK ASSESSMENT PROTOCOL TO PROVIDE AN EFFECTIVE CARIES PREVENTIVE REGIME?

    Science.gov (United States)

    Afuakwah, Charles; Welbury, Richard

    2015-11-01

    Clinical guidelines recommend an individual is given a caries risk status based on analysis of defined clinical and social criteria before implementing a tailored preventive plan. Improve documentation of caries risk assessment (CRA) in a general dental practice setting, using a systems-based approach to quality improvement methods. Investigate the impact of quality improvement efforts on subsequent design and delivery of preventive care. Identify barriers to delivery of CRA and provision of preventive care. Data for patients aged 0-16 years was collected over two cycles using standard audit methodology. The first cycle was a retrospective analysis (n = 400) using random sampling. The second cycle a prospective analysis (n = 513) using consecutive sampling over a 15-week period. Five staff meetings with feedback occurred between cycles. In cycle one, no specific CRA system was identified. CRA status was not stated widely, risk factors were not analysed and there was variation with respect to the prescription and delivery of preventive strategies. These discrepancies were demonstrable for all four participating dentists and at all ages. In cycle two, 100% recorded CRA. All risk factors were analysed and individual caries risk was correctly annotated. There was 100% compliance with the protocol for preventive plans. The use of CRA improved documentation of caries risk status. This has improved subsequent prescription of age specific evidence-based preventive care appropriate to the risk status of that individual. Barriers were identified to the delivery of CRA and the provision of comprehensive preventive care by the dentists and other healthcare professionals.

  5. 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.

  6. MENTAL AND PSYCHOMOTOR RETARDATION IN EARLY CHILDHOOD: Overview and development of a protocol for neuropsychological assessment.

    Directory of Open Access Journals (Sweden)

    María del Mar Sánchez-Joya

    2010-12-01

    Full Text Available Introduction: The last decades have brought great advances in the understanding of child neurodevelopment and knowledge of cognitive processes that occur in the brain from an early age. As a result and thanks to the large number of standardized and scientifically guaranteed neuropsychological tests that are available today, we can assess and diagnose with high specificity, deficits or delays in the acquisition of cognitive functions. Besides, it allows knowing the strengths or normality points of children with various pathologies. Objective: To present the concepts and a neuropsychological assessment protocol for mental retardation, pervasive developmental disorder and psychomotor retardation. Development: First, the authors present a general model of neuropsychological assessment in childhood. Second, he concept, classification and aetiology of mental retardation is revised and it is proposed a neuropsychological profile. Finally, the paradigms of pervasive developmental disorder and psychomotor retardation are shown. Conclusion: Based on standardized and validated test for child neuropsychological assessment, children cognitive disorders can be accurately identified to plan each child's cognitive stimulation, and thus optimize the results of the therapy.

  7. Assessment of hospital pharmacists' clinical knowledge and ...

    African Journals Online (AJOL)

    Purpose: To evaluate hospital pharmacists' clinical knowledge and practical skill levels for pharmaceutical care. Methods: A quasi-experimental prospective longitudinal study design was used to evaluate the level of clinical skills with problem-based learning (PBL) sessions. Pharmacists' in three different government ...

  8. 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.

  9. A protocol to assess cell cycle and apoptosis in human and mouse pluripotent cells

    Directory of Open Access Journals (Sweden)

    Edel Michael J

    2011-04-01

    Full Text Available Abstract Embryonic stem cells (ESC and induced pluripotent stem cells (iPSCs present a great opportunity to treat and model human disease as a cell replacement therapy. There is a growing pressure to understand better the signal transduction pathways regulating pluripotency and self-renewal of these special cells in order to deliver a safe and reliable cell based therapy in the near future. Many signal transduction pathways converge on two major cell functions associated with self-renewal and pluripotency: control of the cell cycle and apoptosis, although a standard method is lacking across the field. Here we present a detailed protocol to assess the cell cycle and apoptosis of ESC and iPSCs as a single reference point offering an easy to use standard approach across the field.

  10. Quantitative assessment of in-solution digestion efficiency identifies optimal protocols for unbiased protein analysis

    DEFF Research Database (Denmark)

    Leon, Ileana R; Schwämmle, Veit; Jensen, Ole N

    2013-01-01

    a combination of qualitative and quantitative LC-MS/MS methods and statistical data analysis. In contrast to previous studies we employed both standard qualitative as well as data-independent quantitative workflows to systematically assess trypsin digestion efficiency and bias using mitochondrial protein...... conditions (buffer, RapiGest, deoxycholate, urea), and two methods for removal of detergents prior to analysis of peptides (acid precipitation or phase separation with ethyl acetate). Our data-independent quantitative LC-MS/MS workflow quantified over 3700 distinct peptides with 96% completeness between all...... protocols and replicates, with an average 40% protein sequence coverage and an average of 11 peptides identified per protein. Systematic quantitative and statistical analysis of physicochemical parameters demonstrated that deoxycholate-assisted in-solution digestion combined with phase transfer allows...

  11. Clinical Skills Assessment in the Twenty-First Century.

    Science.gov (United States)

    Elder, Andrew

    2018-05-01

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

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

    Science.gov (United States)

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

    2014-06-25

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

  13. 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.

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

    Science.gov (United States)

    Ensminger; McCold; Webb

    1999-07-01

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

  15. 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.

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

    Science.gov (United States)

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

    2018-02-01

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

  17. 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.

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

    Directory of Open Access Journals (Sweden)

    Sílvia Marlene Monteiro Teixeira

    2016-06-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

  20. 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.)

  1. 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.)

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

    Science.gov (United States)

    Harrison, Gill

    2015-02-01

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

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

    Directory of Open Access Journals (Sweden)

    Jafar Kolahi

    2015-01-01

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

  4. Clinical Music Study Quality Assessment Scale (MUSIQUAS)

    NARCIS (Netherlands)

    Jaschke, A.C.; Eggermont, L.H.P.; Scherder, E.J.A.; Shippton, M.; Hiomonides, I.

    2013-01-01

    AIMS Quality assessment of studies is essential for the understanding and application of these in systematic reviews and meta analyses, the two “gold standards” of medical sciences. Publications in scientific journals have extensively used assessment scales to address poor methodological quality,

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

    Science.gov (United States)

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

    2009-01-01

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

  6. 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.

  7. Adapting a rapid river assessment protocols to be used by elementary school children

    Directory of Open Access Journals (Sweden)

    Guilherme Malafaia

    2012-12-01

    Full Text Available The present study aimed to adapt a rapid river assessment protocols (RAP to be used by elementary school children. The study was conducted in Ipameri, GO and the RAP was adapted for the evaluation of streams in the Cerrado biome. Based on two protocol models, the developed RAP included: physical parameters that affect the functioning of streams, language adapted to the educational level of elementary school and the presence of drawings that could facilitate the field application of RAP by the students. For consolidation of the adapted instrument, it was offered a monitoring workshop to 95 students from two public education institutions, and developed an analysis and interpretation of the pattern of responses obtained during the practical step of the workshop. The Bartlett and Levene tests revealed no statistical differences between the response patterns of the students, allowing to infer that the developed RAP was understandable by the evaluators. The application of the RAP was fast (20 to 40 minutes and the students reported that the developed instrument helped them to familiarize with environmental issues. In addition, the monitoring workshop helped them to understand the instrument and the available illustrations facilitated the field evaluation. In addition, the students concluded that they have become aware of the issues related to the water resource preservation and also that participation in the environmental monitoring workshop allowed the appropriation of knowledge about the river system functioning. It was concluded that adapted RAP has been proved to be a useful and interesting tool for using in environmental education projects and programs.

  8. Study protocol: Mother and Infant Nutritional Assessment (MINA) cohort study in Qatar and Lebanon.

    Science.gov (United States)

    Naja, Farah; Nasreddine, Lara; Al Thani, Al Anoud; Yunis, Khaled; Clinton, Michael; Nassar, Anwar; Farhat Jarrar, Sara; Moghames, Patricia; Ghazeeri, Ghina; Rahman, Sajjad; Al-Chetachi, Walaa; Sadoun, Eman; Lubbad, Nibal; Bashwar, Zelaikha; Bawadi, Hiba; Hwalla, Nahla

    2016-05-04

    The Middle East and North Africa region harbors significant proportions of stunting and wasting coupled with surging rates of non-communicable diseases (NCDs). Recent evidence identified nutrition during the first 1000 days of life as a common denominator not only for optimal growth but also for curbing the risk of NCDs later in life. The main objective of this manuscript is to describe the protocol of the first cohort in the region to investigate the association of nutrition imbalances early in life with birth outcomes, growth patterns, as well as early determinants of non-communicable diseases. More specifically the cohort aims to 1) examine the effects of maternal and early child nutrition and lifestyle characteristics on birth outcomes and growth patterns and 2) develop evidence-based nutrition and lifestyle guidelines for pregnant women and young children. A multidisciplinary team of researchers was established from governmental and private academic and health sectors in Lebanon and Qatar to launch the Mother and Infant Nutritional Assessment 3-year cohort study. Pregnant women (n = 250 from Beirut, n = 250 from Doha) in their first trimester are recruited from healthcare centers in Beirut, Lebanon and Doha, Qatar. Participants are interviewed three times during pregnancy (once every trimester) and seven times at and after delivery (when the child is 4, 6, 9, 12, 18, and 24 months old). Delivery and birth data is obtained from hospital records. Data collection includes maternal socio-demographic and lifestyle characteristics, dietary intake, anthropometric measurements, and household food security data. For biochemical assessment of various indicators of nutritional status, a blood sample is obtained from women during their first trimester. Breastfeeding and complementary feeding practices, dietary intake, as well as anthropometric measurements of children are also examined. The Delphi technique will be used for the development of the nutrition and lifestyle

  9. Clinical Considerations in the Assessment of Adolescent Chemical Dependency.

    Science.gov (United States)

    Winters, Ken

    1990-01-01

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

  10. Relationships of Functional Tests Following ACL Reconstruction: Exploratory Factor Analyses of the Lower Extremity Assessment Protocol.

    Science.gov (United States)

    DiFabio, Melissa; Slater, Lindsay V; Norte, Grant; Goetschius, John; Hart, Joseph M; Hertel, Jay

    2018-03-01

    After ACL reconstruction (ACLR), deficits are often assessed using a variety of functional tests, which can be time consuming. It is unknown whether these tests provide redundant or unique information. To explore relationships between components of a battery of functional tests, the Lower Extremity Assessment Protocol (LEAP) was created to aid in developing the most informative, concise battery of tests for evaluating ACLR patients. Descriptive, cross-sectional. Laboratory. 76 ACLR patients (6.86±3.07 months postoperative) and 54 healthy participants. Isokinetic knee flexion and extension at 90 and 180 degrees/second, maximal voluntary isometric contraction for knee extension and flexion, single leg balance, 4 hopping tasks (single, triple, crossover, and 6-meter timed hop), and a bilateral drop vertical jump that was scored with the Landing Error Scoring System (LESS). Peak torque, average torque, average power, total work, fatigue indices, center of pressure area and velocity, hop distance and time, and LESS score. A series of factor analyses were conducted to assess grouping of functional tests on the LEAP for each limb in the ACLR and healthy groups and limb symmetry indices (LSI) for both groups. Correlations were run between measures that loaded on retained factors. Isokinetic and isometric strength tests for knee flexion and extension, hopping, balance, and fatigue index were identified as unique factors for all limbs. The LESS score loaded with various factors across the different limbs. The healthy group LSI analysis produced more factors than the ACLR LSI analysis. Individual measures within each factor had moderate to strong correlations. Isokinetic and isometric strength, hopping, balance, and fatigue index provided unique information. Within each category of measures, not all tests may need to be included for a comprehensive functional assessment of ACLR patients due to the high amount of shared variance between them.

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

    Science.gov (United States)

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

    2017-06-01

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

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

    Science.gov (United States)

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

    2018-03-01

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

  13. 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

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

    Science.gov (United States)

    Murden, Robert A; Unroe, Kathleen

    2005-08-01

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

  15. 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

  16. 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.

  17. 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

  18. 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

  19. Evaluating holistic needs assessment in outpatient cancer care--a randomised controlled trial: the study protocol.

    Science.gov (United States)

    Snowden, Austyn; Young, Jenny; White, Craig; Murray, Esther; Richard, Claude; Lussier, Marie-Therese; MacArthur, Ewan; Storey, Dawn; Schipani, Stefano; Wheatley, Duncan; McMahon, Jeremy; Ross, Elaine

    2015-05-11

    People living with and beyond cancer are vulnerable to a number of physical, functional and psychological issues. Undertaking a holistic needs assessment (HNA) is one way to support a structured discussion of patients' needs within a clinical consultation. However, there is little evidence on how HNA impacts on the dynamics of the clinical consultation. This study aims to establish (1) how HNA affects the type of conversation that goes on during a clinical consultation and (2) how these putative changes impact on shared decision-making and self-efficacy. The study is hosted by 10 outpatient oncology clinics in the West of Scotland and South West England. Participants are patients with a diagnosis of head and neck, breast, urological, gynaecological and colorectal cancer who have received treatment for their cancer. Patients are randomised to an intervention or control group. The control group entails standard care--routine consultation between the patient and clinician. In the intervention group, the patient completes a holistic needs assessment prior to consultation. The completed assessment is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and preponderance of initiative (PI) within the consultation. The secondary outcome measures are shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater patient participation within the consultation, and that shared decision-making and feelings of self-efficacy will increase as a function of the intervention. This study has been given a favourable opinion by the West of Scotland Research Ethics Committee and NHS Research & Development. Study findings will be disseminated through peer-reviewed publications and conference attendance. Clinical Trials.gov NCT02274701. Published by the BMJ Publishing Group Limited. For

  20. [Clinical tools for assessing hair loss].

    Science.gov (United States)

    del Marmol, V; Jouanique, C

    2004-09-01

    The complaint of hair loss is quite frequent but merits close attention because it can be very stressful to the patient. A simple examination will allow in most cases to define the origin of the hair loss and reassure the patient rapidly as to its likely evolution if it is reversible. The examination must take into account the medical, chirurgical, gynaecological and dietary antecedents and the cosmetic habits. These elements must be situated in time and complemented by a clinical examination to define the loss as diffuse or localised and in the latter case, expose scar damage. The clinical examination will be associated with a trichogram and in certain cases with a biopsy or a squam prelevement. Further, the blood can be analysed for different metabolically and hormonal elements. Finally, the treatments already administered must be known in order to identify the beneficial and secondary effects, which will allow the definition of a new treatment, if required.

  1. A bespoke mobile application for the longitudinal assessment of depression and mood during pregnancy: protocol of a feasibility study.

    Science.gov (United States)

    Marcano Belisario, Jose Salvador; Doherty, Kevin; O'Donoghue, John; Ramchandani, Paul; Majeed, Azeem; Doherty, Gavin; Morrison, Cecily; Car, Josip

    2017-05-29

    Depression is a common mental health disorder during pregnancy, with important consequences for mothers and their children. Despite this, it goes undiagnosed and untreated in many women attending antenatal care. Smartphones could help support the prompt identification of antenatal depression in this setting. In addition, these devices enable the implementation of ecological momentary assessment techniques, which could be used to assess how mood is experienced during pregnancy. With this study, we will assess the feasibility of using a bespoke mobile application (app) running on participants' own handsets for the longitudinal (6 months) monitoring of antenatal mood and screening of depression. We will use a randomised controlled study design to compare two types of assessment strategies: retrospective + momentary (consisting of the Edinburgh Postnatal Depression Scale plus five momentary and two contextual questions), and retrospective (consisting of the Edinburgh Postnatal Depression Scale only). We will assess the impact that these strategies have on participant adherence to a prespecified sampling protocol, dropout rates and timeliness of data completion. We will evaluate differences in acceptance of the technology through a short quantitative survey and open-ended questions. We will also assess the potential effect that momentary assessments could have on retrospective data. We will attempt to identify any patterns in app usage through the analysis of log data. This study has been reviewed and approved by the National Research Ethics Service Committee South East Coast-Surrey on 15 April 2016 as a notice of substantial amendment to the original submission (9 July 2015) under the Research Ethics Committee (REC) reference 15/LO/0977. This study is being sponsored by Imperial College London under the reference number 15IC2687 and has been included in the UK Clinical Research Network Study Portfolio under the Central Portfolio Management System number 19280. The

  2. Differences in quantitative assessment of myocardial scar and gray zone by LGE-CMR imaging using established gray zone protocols.

    Science.gov (United States)

    Mesubi, Olurotimi; Ego-Osuala, Kelechi; Jeudy, Jean; Purtilo, James; Synowski, Stephen; Abutaleb, Ameer; Niekoop, Michelle; Abdulghani, Mohammed; Asoglu, Ramazan; See, Vincent; Saliaris, Anastasios; Shorofsky, Stephen; Dickfeld, Timm

    2015-02-01

    Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) imaging is the gold standard for myocardial scar evaluation. Heterogeneous areas of scar ('gray zone'), may serve as arrhythmogenic substrate. Various gray zone protocols have been correlated to clinical outcomes and ventricular tachycardia channels. This study assessed the quantitative differences in gray zone and scar core sizes as defined by previously validated signal intensity (SI) threshold algorithms. High quality LGE-CMR images performed in 41 cardiomyopathy patients [ischemic (33) or non-ischemic (8)] were analyzed using previously validated SI threshold methods [Full Width at Half Maximum (FWHM), n-standard deviation (NSD) and modified-FWHM]. Myocardial scar was defined as scar core and gray zone using SI thresholds based on these methods. Scar core, gray zone and total scar sizes were then computed and compared among these models. The median gray zone mass was 2-3 times larger with FWHM (15 g, IQR: 8-26 g) compared to NSD or modified-FWHM (5 g, IQR: 3-9 g; and 8 g. IQR: 6-12 g respectively, p zone extent (percentage of total scar that was gray zone) also varied significantly among the three methods, 51 % (IQR: 42-61 %), 17 % (IQR: 11-21 %) versus 38 % (IQR: 33-43 %) for FWHM, NSD and modified-FWHM respectively (p zone and scar core. Infarct core and total myocardial scar mass also differ using these methods. Further evaluation of the most accurate quantification method is needed.

  3. A Novel Protocol to Assess Acclimation Rate in Bos taurus Heifers during Yard Weaning

    Directory of Open Access Journals (Sweden)

    Jessica E. Monk

    2018-04-01

    Full Text Available The speed with which animals acclimate to a new environment could be an important measure of ability to cope with management induced stress. This study developed a measure of acclimation rate in a group of 50 Bos taurus heifers during yard weaning over nine days. We recorded the time and order in which heifers moved through a novel funnel structure into a feeding yard daily. We hypothesised that addition of an obstacle at the entrance would increase the time it took heifers to move through the funnel, but that they would acclimate to the obstacle over a three-day period. The change in latency to move through could then be used as a measure of acclimation rate. We hypothesised that individuals which acclimated to obstacles at a faster rate might display favourable temperament as assessed by flight time. All heifers took longer to move through the funnel after a novel object was introduced, then latency decreased over the following two days while the object was present. This indicates the protocol could be useful for measuring acclimation rate at a group level. Individual acclimation rate variables, measured as change in times and orders of heifers between test days, did not appear to have any consistent relationships with flight time or weight change during or post-weaning (p > 0.05. We concluded that the protocol was inappropriate for assessing acclimation rate at an individual level, due to social effects while testing heifers as a group. Heifers which were consistently one of the first 20 to move through the funnel had a significantly greater average weight 5 and 10 months post-weaning (345 ± 9 kg and 518 ± 10 kg respectively than heifers which were consistently one of the last 20 through the funnel (311 ± 8 kg and 484 ± 8 kg respectively; p < 0.001. This may indicate order of movement through the funnel was related to feeding motivation or another aspect of temperament not reflected by flight time.

  4. 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

  5. Psychological Assessment Training in Clinical Psychology Doctoral Programs.

    Science.gov (United States)

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

    2017-01-01

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

  6. Clinical Assessment Applications of Ambulatory Biosensors

    Science.gov (United States)

    Haynes, Stephen N.; Yoshioka, Dawn T.

    2007-01-01

    Ambulatory biosensor assessment includes a diverse set of rapidly developing and increasingly technologically sophisticated strategies to acquire minimally disruptive measures of physiological and motor variables of persons in their natural environments. Numerous studies have measured cardiovascular variables, physical activity, and biochemicals…

  7. Assessment of Safety and Effectiveness of the Extracorporeal Continuous-Flow Ventricular Assist Device (BR16010) Use as a Bridge-to-Decision Therapy for Severe Heart Failure or Refractory Cardiogenic Shock: Study Protocol for Single-Arm Non-randomized, Uncontrolled, and Investigator-Initiated Clinical Trial.

    Science.gov (United States)

    Fukushima, Norihide; Tatsumi, Eisuke; Seguchi, Osamu; Takewa, Yoshiaki; Hamasaki, Toshimitsu; Onda, Kaori; Yamamoto, Haruko; Hayashi, Teruyuki; Fujita, Tomoyuki; Kobayashi, Junjiro

    2018-06-08

    The management of heart failure patients presenting in a moribund state remains challenging, despite significant advances in the field of ventricular assist systems. Bridge to decision involves using temporary devices to stabilize the hemodynamic state of such patients while further assessment is performed and a decision can be made regarding patient management. The purpose of this study (NCVC-BTD_01, National Cerebral and Cardiovascular Center-Bridge to Dicision_01) is to assess the safety and effectiveness of the newly developed extracorporeal continuous-flow ventricular assist system employing a disposable centrifugal pump with a hydrodynamically levitated bearing (BR16010) use as a bridge-to-decision therapy for patients with severe heart failure or refractory cardiogenic shock. NCVC-BTD_01 is a single-center, single-arm, open-label, exploratory, medical device, investigator-initiated clinical study. It is conducted at the National Cerebral and Cardiovascular Center in Japan. A total of nine patients will be enrolled in the study. The study was planned using Simon's minimax two-stage phase design. The primary endpoint is a composite of survival free of device-related serious adverse events and complications during device support. For left ventricular assistance, withdrawal of a trial device due to cardiac function recovery or exchange to other ventricular assist devices (VADs) for the purpose of bridge to transplantation (BTT) during 30 days after implantation will be considered study successes. For right ventricular assistance, withdrawal of tal device due to right ventricular function recovery within 30 days after implantation will be considered a study success. Secondary objectives include changes in brain natriuretic peptide levels (7 days after implantation of a trial device and the day of withdrawal of a trial device), period of mechanical ventricular support, changes in left ventricular ejection fraction (7 days after implantation of a trial device

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

    Science.gov (United States)

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

    2011-01-01

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

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

    International Nuclear Information System (INIS)

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

    2003-01-01

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

  10. Clinical experimental stress studies: methods and assessment.

    Science.gov (United States)

    Bali, Anjana; Jaggi, Amteshwar Singh

    2015-01-01

    Stress is a state of threatened homeostasis during which a variety of adaptive processes are activated to produce physiological and behavioral changes. Stress induction methods are pivotal for understanding these physiological or pathophysiological changes in the body in response to stress. Furthermore, these methods are also important for the development of novel pharmacological agents for stress management. The well-described methods to induce stress in humans include the cold pressor test, Trier Social Stress Test, Montreal Imaging Stress Task, Maastricht Acute Stress Test, CO2 challenge test, Stroop test, Paced Auditory Serial Addition Task, noise stress, and Mannheim Multicomponent Stress Test. Stress assessment in humans is done by measuring biochemical markers such as cortisol, cortisol awakening response, dexamethasone suppression test, salivary α-amylase, plasma/urinary norepinephrine, norepinephrine spillover rate, and interleukins. Physiological and behavioral changes such as galvanic skin response, heart rate variability, pupil size, and muscle and/or skin sympathetic nerve activity (microneurography) and cardiovascular parameters such as heart rate, blood pressure, and self-reported anxiety are also monitored to assess stress response. This present review describes these commonly employed methods to induce stress in humans along with stress assessment methods.

  11. Conceptual Models and Guidelines for Clinical Assessment of Financial Capacity.

    Science.gov (United States)

    Marson, Daniel

    2016-09-01

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

  12. 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

  13. Protocol to assess the neurophysiology associated with multi-segmental postural coordination

    International Nuclear Information System (INIS)

    Lomond, Karen V; Henry, Sharon M; Jacobs, Jesse V; Hitt, Juvena R; Horak, Fay B; Cohen, Rajal G; Schwartz, Daniel; Dumas, Julie A; Naylor, Magdalena R; Watts, Richard; DeSarno, Michael J

    2013-01-01

    Anticipatory postural adjustments (APAs) stabilize potential disturbances to posture caused by movement. Impaired APAs are common with disease and injury. Brain functions associated with generating APAs remain uncertain due to a lack of paired tasks that require similar limb motion from similar postural orientations, but differ in eliciting an APA while also being compatible with brain imaging techniques (e.g., functional magnetic resonance imaging; fMRI). This study developed fMRI-compatible tasks differentiated by the presence or absence of APAs during leg movement. Eighteen healthy subjects performed two leg movement tasks, supported leg raise (SLR) and unsupported leg raise (ULR), to elicit isolated limb motion (no APA) versus multi-segmental coordination patterns (including APA), respectively. Ground reaction forces under the feet and electromyographic activation amplitudes were assessed to determine the coordination strategy elicited for each task. Results demonstrated that the ULR task elicited a multi-segmental coordination that was either minimized or absent in the SLR task, indicating that it would serve as an adequate control task for fMRI protocols. A pilot study with a single subject performing each task in an MRI scanner demonstrated minimal head movement in both tasks and brain activation patterns consistent with an isolated limb movement for the SLR task versus multi-segmental postural coordination for the ULR task. (note)

  14. Comparative assessment of various lipid extraction protocols and optimization of transesterification process for microalgal biodiesel production.

    Science.gov (United States)

    Mandal, Shovon; Patnaik, Reeza; Singh, Amit Kumar; Mallick, Nirupama

    2013-01-01

    Biodiesel, using microalgae as feedstocks, is being explored as the most potent form of alternative diesel fuel for sustainable economic development. A comparative assessment of various protocols for microalgal lipid extraction was carried out using five green algae, six blue-green algae and two diatom species treated with different single and binary solvents both at room temperature and using a soxhlet. Lipid recovery was maximum with chloroform-methanol in the soxhlet extractor. Pretreatments ofbiomass, such as sonication, homogenization, bead-beating, lyophilization, autoclaving, microwave treatment and osmotic shock did not register any significant rise in lipid recovery. As lipid recovery using chloroform-methanol at room temperature demonstrated a marginally lower value than that obtained under the soxhlet extractor, on economical point of view, the former is recommended for microalgal total lipid extraction. Transesterification process enhances the quality of biodiesel. Experiments were designed to determine the effects of catalyst type and quantity, methanol to oil ratio, reaction temperature and time on the transesterification process using response surface methodology. Fatty acid methyl ester yield reached up to 91% with methanol:HCl:oil molar ratio of 82:4:1 at 65 degrees C for 6.4h reaction time. The biodiesel yield relative to the weight of the oil was found to be 69%.

  15. Improvement of isometric dorsiflexion protocol for assessment of tibialis anterior muscle strength☆

    Science.gov (United States)

    Siddiqi, Ariba; Arjunan, Sridhar P.; Kumar, Dinesh

    2015-01-01

    It is important to accurately estimate the electromyogram (EMG)/force relationship of triceps surae (TS) muscle for detecting strength deficit of tibalis anterior (TA) muscle. In literature, the protocol for recording EMG and force of dorsiflexion have been described, and the necessity for immobilizing the ankle has been explained. However, there is a significant variability of the results among researchers even though they report the fixation of the ankle. We have determined that toe extension can cause significant variation in the dorsiflexion force and EMG of TS and this can occur despite following the current guidelines which require immobilizing the ankle. The results also show that there was a large increase in the variability of the force and the RMS of EMG of TS when the toes were not strapped compared with when they were strapped. Thus, with the current guidelines, where there are no instructions regarding the necessity of strapping the toes, the EMG/force relationship of TS could be incorrect and give an inaccurate assessment of the dorsiflexor TA strength. In summary, • Current methodology to estimate the dorsiflexor TA strength with respect to the TS activity, emphasizing on ankle immobilization is insufficient to prevent large variability in the measurements. • Toe extension during dorsiflexion was found to be one source of variability in estimating the TA strength. • It is recommended that guidelines for recording force and EMG from TA and TS muscles should require the strapping of the toes along with the need for immobilizing the ankle. PMID:26150978

  16. Improvement of isometric dorsiflexion protocol for assessment of tibialis anterior muscle strength.

    Science.gov (United States)

    Siddiqi, Ariba; Arjunan, Sridhar P; Kumar, Dinesh

    2015-01-01

    It is important to accurately estimate the electromyogram (EMG)/force relationship of triceps surae (TS) muscle for detecting strength deficit of tibalis anterior (TA) muscle. In literature, the protocol for recording EMG and force of dorsiflexion have been described, and the necessity for immobilizing the ankle has been explained. However, there is a significant variability of the results among researchers even though they report the fixation of the ankle. We have determined that toe extension can cause significant variation in the dorsiflexion force and EMG of TS and this can occur despite following the current guidelines which require immobilizing the ankle. The results also show that there was a large increase in the variability of the force and the RMS of EMG of TS when the toes were not strapped compared with when they were strapped. Thus, with the current guidelines, where there are no instructions regarding the necessity of strapping the toes, the EMG/force relationship of TS could be incorrect and give an inaccurate assessment of the dorsiflexor TA strength. In summary, •Current methodology to estimate the dorsiflexor TA strength with respect to the TS activity, emphasizing on ankle immobilization is insufficient to prevent large variability in the measurements.•Toe extension during dorsiflexion was found to be one source of variability in estimating the TA strength.•It is recommended that guidelines for recording force and EMG from TA and TS muscles should require the strapping of the toes along with the need for immobilizing the ankle.

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

    NARCIS (Netherlands)

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

    2015-01-01

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

  18. Clinical Significance: a Therapeutic Approach Topsychological Assessment in Treatment Planning

    Directory of Open Access Journals (Sweden)

    Afolabi Olusegun Emmanuel

    2015-06-01

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

  19. Receptive and expressive English language assessments used for young children: a scoping review protocol.

    Science.gov (United States)

    McIntyre, Laureen J; Hellsten, Laurie-Ann M; Bidonde, Julia; Boden, Catherine; Doi, Carolyn

    2017-04-04

    The majority of a child's language development occurs in the first 5 years of life when brain development is most rapid. There are significant long-term benefits to supporting all children's language and literacy development such as maximizing their developmental potential (i.e., cognitive, linguistic, social-emotional), when children are experiencing a critical period of development (i.e., early childhood to 9 years of age). A variety of people play a significant role in supporting children's language development, including parents, guardians, family members, educators, and/or speech-language pathologists. Speech-language pathologists and educators are the professionals who predominantly support children's language development in order for them to become effective communicators and lay the foundation for later developing literacy skills (i.e., reading and writing skills). Therefore, these professionals need formal and informal assessments that provide them information on a child's understanding and/or use of the increasingly complex aspects of language in order to identify and support the receptive and expressive language learning needs of diverse children during their early learning experiences (i.e., aged 1.5 to 9 years). However, evidence on what methods and tools are being used is lacking. The authors will carry out a scoping review of the literature to identify studies and map the receptive and expressive English language assessment methods and tools that have been published and used since 1980. Arksey and O'Malley's (2005) six-stage approach to conducting a scoping review was drawn upon to design the protocol for this investigation: (1) identifying the research question; (2) identifying relevant studies; (3) study selection; (4) charting the data; (5) collating, summarizing, and reporting the results; and (6) consultation. This information will help these professionals identify and select appropriate assessment methods or tools that can be used to support

  20. Assessing Cognitive behavioural Therapy in Irritable Bowel (ACTIB): protocol for a randomised controlled trial of clinical-effectiveness and cost-effectiveness of therapist delivered cognitive behavioural therapy and web-based self-management in irritable bowel syndrome in adults.

    Science.gov (United States)

    Everitt, Hazel; Landau, Sabine; Little, Paul; Bishop, Felicity L; McCrone, Paul; O'Reilly, Gilly; Coleman, Nicholas; Logan, Robert; Chalder, Trudie; Moss-Morris, Rona

    2015-07-15

    Irritable bowel syndrome (IBS) affects 10-22% of the UK population, with England's annual National Health Service (NHS) costs amounting to more than £200 million. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many people suffer ongoing symptoms. Cognitive behaviour therapy (CBT) and self-management can be helpful, but availability is limited. To determine the clinical- and cost-effectiveness of therapist delivered cognitive behavioural therapy (TCBT) and web-based CBT self-management (WBCBT) in IBS, 495 participants with refractory IBS will be randomised to TCBT plus treatment as usual (TAU); WBCBT plus TAU; or TAU alone. The two CBT programmes have similar content. However, TCBT consists of six, 60 min telephone CBT sessions with a therapist over 9 weeks, at home, and two 'booster' 1 hour follow-up phone calls at 4 and 8 months (8 h therapist contact time). WBCBT consists of access to a previously developed and piloted WBCBT management programme (Regul8) and three 30 min therapist telephone sessions over 9 weeks, at home, and two 'booster' 30 min follow-up phone calls at 4 and 8 months (2½ h therapist contact time). Clinical effectiveness will be assessed by examining the difference between arms in the IBS Symptom Severity Score (IBS SSS) and Work and Social Adjustment Scale (WASAS) at 12 months from randomisation. Cost-effectiveness will combine measures of resource use with the IBS SSS at 12 months and quality-adjusted life years. This trial has full ethical approval. It will be disseminated via peer reviewed publications and conference presentations. The results will enable clinicians, patients and health service planners to make informed decisions regarding the management of IBS with CBT. ISRCTN44427879. Published by the BMJ Publishing Group Limited. For permission to

  1. Paracetamol (Acetaminophen) in stroke 2 (PAIS 2): protocol for a randomized, placebo-controlled, double-blind clinical trial to assess the effect of high-dose paracetamol on functional outcome in patients with acute stroke and a body temperature of 36.5 °C or above.

    Science.gov (United States)

    de Ridder, Inger R; de Jong, Frank Jan; den Hertog, Heleen M; Lingsma, Hester F; van Gemert, H Maarten A; Schreuder, A H C M L Tobien; Ruitenberg, Annemieke; Maasland, E Lisette; Saxena, Ritu; Oomes, Peter; van Tuijl, Jordie; Koudstaal, Peter J; Kappelle, L Jaap; Algra, Ale; van der Worp, H Bart; Dippel, Diederik W J

    2015-04-01

    In the first hours after stroke onset, subfebrile temperatures and fever have been associated with poor functional outcome. In the first Paracetamol (Acetaminophen) in Stroke trial, a randomized clinical trial of 1400 patients with acute stroke, patients who were treated with high-dose paracetamol showed more improvement on the modified Rankin Scale at three-months than patients treated with placebo, but this difference was not statistically significant. In the 661 patients with a baseline body temperature of 37.0 °C or above, treatment with paracetamol increased the odds of functional improvement (odds ratio 1.43; 95% confidence interval: 1.02-1.97). This relation was also found in the patients with a body temperature of 36.5 °C or higher (odds ratio 1.31; 95% confidence interval 1.01-1.68). These findings need confirmation. The study aims to assess the effect of high-dose paracetamol in patients with acute stroke and a body temperature of 36.5 °C or above on functional outcome. The Paracetamol (Acetaminophen) In Stroke 2 trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial. We use a power of 85% to detect a significant difference in the scores on the modified Rankin Scale of the paracetamol group compared with the placebo group at a level of significance of 0.05 and assume a treatment effect of 7%. Fifteen-hundred patients with acute ischemic stroke or intracerebral hemorrhage and a body temperature of 36.5 °C or above will be included within 12 h of symptom onset. Patients will be treated with paracetamol in a daily dose of six-grams or matching placebo for three consecutive days. The Paracetamol (Acetaminophen) In Stroke 2 trial has been registered as NTR2365 in The Netherlands Trial Register. The primary outcome will be improvement on the modified Rankin Scale at three-months as analyzed by ordinal logistic regression. If high-dose paracetamol will be proven effective, a simple, safe, and extremely cheap therapy will be

  2. Comparison of low- and ultralow-dose computed tomography protocols for quantitative lung and airway assessment.

    Science.gov (United States)

    Hammond, Emily; Sloan, Chelsea; Newell, John D; Sieren, Jered P; Saylor, Melissa; Vidal, Craig; Hogue, Shayna; De Stefano, Frank; Sieren, Alexa; Hoffman, Eric A; Sieren, Jessica C

    2017-09-01

    Quantitative computed tomography (CT) measures are increasingly being developed and used to characterize lung disease. With recent advances in CT technologies, we sought to evaluate the quantitative accuracy of lung imaging at low- and ultralow-radiation doses with the use of iterative reconstruction (IR), tube current modulation (TCM), and spectral shaping. We investigated the effect of five independent CT protocols reconstructed with IR on quantitative airway measures and global lung measures using an in vivo large animal model as a human subject surrogate. A control protocol was chosen (NIH-SPIROMICS + TCM) and five independent protocols investigating TCM, low- and ultralow-radiation dose, and spectral shaping. For all scans, quantitative global parenchymal measurements (mean, median and standard deviation of the parenchymal HU, along with measures of emphysema) and global airway measurements (number of segmented airways and pi10) were generated. In addition, selected individual airway measurements (minor and major inner diameter, wall thickness, inner and outer area, inner and outer perimeter, wall area fraction, and inner equivalent circle diameter) were evaluated. Comparisons were made between control and target protocols using difference and repeatability measures. Estimated CT volume dose index (CTDIvol) across all protocols ranged from 7.32 mGy to 0.32 mGy. Low- and ultralow-dose protocols required more manual editing and resolved fewer airway branches; yet, comparable pi10 whole lung measures were observed across all protocols. Similar trends in acquired parenchymal and airway measurements were observed across all protocols, with increased measurement differences using the ultralow-dose protocols. However, for small airways (1.9 ± 0.2 mm) and medium airways (5.7 ± 0.4 mm), the measurement differences across all protocols were comparable to the control protocol repeatability across breath holds. Diameters, wall thickness, wall area fraction

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-07-01

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

  4. 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.

  5. 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...

  6. 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.

  7. 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

  8. Clinical Assessment of Mineral Trioxide Aggregate in the Treatment ...

    African Journals Online (AJOL)

    2017-05-22

    May 22, 2017 ... (OH)2 (n = 49) or MTA (n = 51) and restored with composite resin in 73 patients. Periapical ... Clinical Assessment of Mineral Trioxide Aggregate in the Treatment of .... materials, light-cured glass ionomer cement base (Riva.

  9. Clinical assessment of suspected child physical abuse

    International Nuclear Information System (INIS)

    Rohrer, T.

    2009-01-01

    Violence against children has many faces. Child physical abuse, neglect, sexual abuse and interparental violence can cause acute and permanent damage and affect children's development and their life plans in the long term. In industrialized nations almost 1 child in 10 is affected. Up to 10% of child physical abuse cases involve the central nervous system with 80% of these cases occurring during the first year of life. Worldwide more than 50,000 children die as a result of violence, abuse and neglect every year, according to the United Nations Children's Fund UNICEF. In Germany, there are about 120 cases of non-accidental head injury per year. In addition to the officially known cases there is a large grey area for all forms of violence. Recognition of these cases and the provision of help for the victims require an appropriate suspicion and understanding of the pertinent pathophysiology. Suspicion must be based on a well-documented medical history and multidisciplinary diagnostic assessment. Medical confidentiality prevents the disclosure of such information making early detection networks and guidelines for collaboration absolutely indispensable. (orig.) [de

  10. 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.

  11. 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.

  12. Voice Over Internet Protocol Testbed Design for Non-Intrusive, Objective Voice Quality Assessment

    National Research Council Canada - National Science Library

    Manka, David L

    2007-01-01

    Voice over Internet Protocol (VoIP) is an emerging technology with the potential to assist the United States Marine Corps in solving communication challenges stemming from modern operational concepts...

  13. 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.

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

    Directory of Open Access Journals (Sweden)

    Olufunmilola K. Odukoya, BPharm, MS

    2012-01-01

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

  15. A feeding protocol for delivery of agents to assess development in Varroa mites.

    Directory of Open Access Journals (Sweden)

    Ana R Cabrera

    Full Text Available A novel feeding protocol for delivery of bio-active agents to Varroa mites was developed by providing mites with honey bee larva hemolymph supplemented with cultured insect cells and selected materials delivered on a fibrous cotton substrate. Mites were starved, fed on treated hemolymph to deliver selected agents and then returned to bee larvae. Transcript levels of two reference genes, actin and glyceraldehyde 3-phosphate dehydrogenase (GAPDH, as well as for nine selected genes involved in reproductive processes showed that the starvation and feeding protocol periods did not pose a high level of stress to the mites as transcript levels remained comparable between phoretic mites and those completing the protocol. The feeding protocol was used to deliver molecules such as hormone analogs or plasmids. Mites fed with Tebufenozide, an ecdysone analog, had higher transcript levels of shade than untreated or solvent treated mites. In order to extend this feeding protocol, cultured insect cells were incorporated to a final ratio of 1 part cells and 2 parts hemolymph. Although supplementation with Bombyx mori Bm5 cells increased the amount of hemolymph consumed per mite, there was a significant decrease in the percentage of mites that fed and survived. On the other hand, Drosophila melanogaster S2 cells reduced significantly the percentage of mites that fed and survived as well as the amount of hemolymph consumed. The feeding protocol provides a dynamic platform with which to challenge the Varroa mite to establish efficacy of control agents for this devastating honey bee pest.

  16. 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

  17. Weight Care Project: Health professionals' attitudes and ability to assess body weight status - Study protocol

    LENUS (Irish Health Repository)

    Moorhead, Anne

    2011-03-31

    Abstract Background Health professionals working in primary care and public health have opportunities to address body weight status issues with their patients through face-to-face contact. The objectives of this all-Ireland project are: 1. to assess the attitudes, current practices\\/behaviours and knowledge of key health professional groups on body weight status; 2. to assess the health professional groups\\' ability to identify body weight status in both adults and children. The health professional groups are: (a) community related public health nurses; (b) school public health nurses; (c) GPs and practice nurses (primary care); and (d) occupational health nurses (workplace) from both Northern Ireland and the Republic of Ireland. Methods\\/Design This all-Ireland multi-disciplinary project follows a mixed methods approach using both quantitative and qualitative methodologies, and consists of four components: 1. Literature review - to explore the role of health professionals in managing obesity through spontaneous intervention in a variety of health promotion settings. 2. Telephone interviews and focus groups - to gain an in-depth insight into the views of health professionals in assessing body weight status. 3. Survey (primarily online but also paper-based) - to determine the attitudes, current practices\\/behaviours and knowledge of health professionals in assessing body weight status. 4. Online evaluation study - an online interactive programme will be developed to assess health professionals\\' ability to identify the body weight status of adults and children. Discussion This project will assess and report the attitudes, current practices\\/behaviours and knowledge of key health professional groups within Northern Ireland and the Republic of Ireland on body weight status, and their ability to identify body weight status in both adults and children. The results of this project will generate recommendations for clinical practice in managing obesity, which may

  18. Weight Care Project: Health professionals' attitudes and ability to assess body weight status - Study protocol

    Directory of Open Access Journals (Sweden)

    Murphy Kathy

    2011-03-01

    Full Text Available Abstract Background Health professionals working in primary care and public health have opportunities to address body weight status issues with their patients through face-to-face contact. The objectives of this all-Ireland project are: 1. to assess the attitudes, current practices/behaviours and knowledge of key health professional groups on body weight status; 2. to assess the health professional groups' ability to identify body weight status in both adults and children. The health professional groups are: (a community related public health nurses; (b school public health nurses; (c GPs and practice nurses (primary care; and (d occupational health nurses (workplace from both Northern Ireland and the Republic of Ireland. Methods/Design This all-Ireland multi-disciplinary project follows a mixed methods approach using both quantitative and qualitative methodologies, and consists of four components: 1. Literature review - to explore the role of health professionals in managing obesity through spontaneous intervention in a variety of health promotion settings. 2. Telephone interviews and focus groups - to gain an in-depth insight into the views of health professionals in assessing body weight status. 3. Survey (primarily online but also paper-based - to determine the attitudes, current practices/behaviours and knowledge of health professionals in assessing body weight status. 4. Online evaluation study - an online interactive programme will be developed to assess health professionals' ability to identify the body weight status of adults and children. Discussion This project will assess and report the attitudes, current practices/behaviours and knowledge of key health professional groups within Northern Ireland and the Republic of Ireland on body weight status, and their ability to identify body weight status in both adults and children. The results of this project will generate recommendations for clinical practice in managing obesity, which may

  19. Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Jabbour, Mona; Curran, Janet; Scott, Shannon D; Guttman, Astrid; Rotter, Thomas; Ducharme, Francine M; Lougheed, M Diane; McNaughton-Filion, M Louise; Newton, Amanda; Shafir, Mark; Paprica, Alison; Klassen, Terry; Taljaard, Monica; Grimshaw, Jeremy; Johnson, David W

    2013-05-22

    evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits. This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways. ClinicalTrials.gov: NCT01815710.

  20. 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...

  1. Automated Clinical Assessment from Smart home-based Behavior Data

    Science.gov (United States)

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

    2016-01-01

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

  2. PErineal Assessment and Repair Longitudinal Study (PEARLS: protocol for a matched pair cluster trial

    Directory of Open Access Journals (Sweden)

    Thomas Peter W

    2010-02-01

    Full Text Available Abstract Background The Perineal Assessment and Repair Longitudinal Study (PEARLS is a national clinical quality improvement initiative designed to improve the assessment and management of perineal trauma. Perineal trauma affects around 85% of women who have a vaginal birth in the UK each year and millions more world-wide. Continuous suturing techniques compared with traditional interrupted methods are more effective in reducing pain and postnatal morbidity, however they are not widely used by clinicians despite recommendations of evidence based national clinical guidelines. Perineal suturing skills and postnatal management of trauma remain highly variable within and between maternity units in the UK as well as worldwide. Implementation of a standardised training package to support effective perineal management practices could reduce perineal pain and other related postnatal morbidity for a substantial number of women. Methods/Design PEARLS is a matched pair cluster trial, which is being conducted in maternity units across the UK. Units within a matched pair will be randomised to implement the study intervention either early or late in the study period. The intervention will include the cascading of a multi-professional training package to enhance midwifery and obstetric skills in the assessment, repair and postnatal management of perineal trauma. Women who have had an episiotomy or second degree perineal tear will be eligible for recruitment. Prior to developing the intervention and deciding on study outcomes, a Delphi survey and a consensus conference were held to identify what women, who previously suffered perineal trauma during childbirth, considered to be important outcomes for them. Findings from this preliminary work (which will be reported elsewhere and other outcomes including women's experiences of perineal pain and pain on activity, breastfeeding uptake and duration and psychological well-being as assessed using the Edinburgh

  3. 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

  4. 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.

  5. 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.

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

    Science.gov (United States)

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

    2013-02-01

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

  7. 'PhysioDirect' telephone assessment and advice services for physiotherapy: protocol for a pragmatic randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hopper Cherida

    2009-08-01

    Full Text Available Abstract Background Providing timely access to physiotherapy has long been a problem for the National Health Service in the United Kingdom. In an attempt to improve access some physiotherapy services have introduced a new treatment pathway known as PhysioDirect. Physiotherapists offer initial assessment and advice by telephone, supported by computerised algorithms, and patients are sent written self-management and exercise advice by post. They are invited for face-to-face treatment only when necessary. Although several such services have been developed, there is no robust evidence regarding clinical and cost-effectiveness, nor the acceptability of PhysioDirect. Methods/Design This protocol describes a multi-centre pragmatic individually randomised trial, with nested qualitative research. The aim is to determine the effectiveness, cost-effectiveness, and acceptability of PhysioDirect compared with usual models of physiotherapy based on patients going onto a waiting list and receiving face-to-face care. PhysioDirect services will be established in four areas in England. Adult patients in these areas with musculoskeletal problems who refer themselves or are referred by a primary care practitioner for physiotherapy will be invited to participate in the trial. About 1875 consenting patients will be randomised in a 2:1 ratio to PhysioDirect or usual care. Data about outcome measures will be collected at baseline and 6 weeks and 6 months after randomisation. The primary outcome is clinical improvement at 6 months; secondary outcomes include cost, waiting times, time lost from work and usual activities, patient satisfaction and preference. The impact of PhysioDirect on patients in different age-groups and with different conditions will also be examined. Incremental cost-effectiveness will be assessed in terms of quality adjusted life years in relation to cost. Qualitative methods will be used to explore factors associated with the success or failure of

  8. Validation of a clinical assessment tool for spinal anaesthesia.

    LENUS (Irish Health Repository)

    Breen, D

    2011-07-01

    There is a need for a procedure-specific means of assessment of clinical performance in anaesthesia. The aim of this study was to devise a tool for assessing the performance of spinal anaesthesia, which has both content and construct validity.

  9. The Fertility Assessment and Counselling Clinic - does the concept work?

    DEFF Research Database (Denmark)

    Petersen, Kathrine Birch; Maltesen, Thomas; Forman, Julie L.

    2017-01-01

    INTRODUCTION: The Fertility Assessment and Counselling (FAC) Clinic was initiated to provide women information about their current fertility status to prevent infertility and smaller families than desired. The aim was to study the predictive value of a risk assessment score based on known fertili...

  10. Protocol for a cohort study of adolescent mental health service users with a nested cluster randomised controlled trial to assess the clinical and cost-effectiveness of managed transition in improving transitions from child to adult mental health services (the MILESTONE study)

    DEFF Research Database (Denmark)

    Singh, Swaran P.; Tuomainen, Helena; Girolamo, Giovanni De

    2017-01-01

    of 840 participants randomised in a 1:2 intervention to control are required, providing 89% power to detect a difference in HoNOSCA score of 0.30 SD. The addition of 210 recruits for the cohort study ensures sufficient power for studying predictors, resulting in 1050 participants and an approximate 1...... Healthcare) study evaluates the longitudinal course and outcomes of adolescents approaching the transition boundary (TB) of their CAMHS and determines the effectiveness of the model of managed transition in improving outcomes, compared with usual care. Methods and analysis This is a cohort study......:3 randomisation. Ethics and dissemination The study protocol was approved by the UK National Research Ethics Service (15/WM/0052) and equivalent ethics boards in participating countries. Results will be reported at conferences, in peer-reviewed publications and to all relevant stakeholder groups. Trial...

  11. 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.

  12. Risk of Deep vein thrombosis in neurosurgery: State of the art on prophylaxis protocols and best clinical practices.

    Science.gov (United States)

    Ganau, Mario; Prisco, Lara; Cebula, Helene; Todeschi, Julien; Abid, Houssem; Ligarotti, Gianfranco; Pop, Raoul; Proust, Francois; Chibbaro, Salvatore

    2017-11-01

    To analytically discuss some protocols in Deep vein thrombosis (DVT)/pulmonary Embolism (PE) prophylaxis currently use in Neurosurgical Departments around the world. Analysis of the prophylaxis protocols in the English literature: An analytical and narrative review of literature concerning DVT prophylaxis protocols in Neurosurgery have been conducted by a PubMed search (back to 1978). 80 abstracts were reviewed, and 74 articles were extracted. The majority of DVT seems to develop within the first week after a neurosurgical procedure, and a linear correlation between the duration of surgery and DVT occurrence has been highlighted. The incidence of DVT seems greater for cranial (7.7%) than spinal procedures (1.5%). Although intermittent pneumatic compression (IPC) devices provided adequate reduction of DVT/PE in some cranial and combined cranial/spinal series, low-dose subcutaneous unfractionated heparin (UFH) or low molecular-weight heparin (LMWH) further reduced the incidence, not always of DVT, but of PE. Nevertheless, low-dose heparin-based prophylaxis in cranial and spinal series risks minor and major postoperative haemorrhages: 2-4% in cranial series, 3.4% minor and 3.4% major haemorrhages in combined cranial/spinal series, and a 0.7% incidence of major/minor haemorrhages in spinal series. This analysis showed that currently most of the articles are represented by case series and case reports. As long as clear guidelines will not be defined and universally applied to this diverse group of patients, any prophylaxis for DVT and PE should be tailored to the individual patient with cautious assessment of benefits versus risks. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. 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.

  14. 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.

  15. Clinical reasoning in nursing: teaching strategies and assessment tools

    Directory of Open Access Journals (Sweden)

    Emília Campos de Carvalho

    Full Text Available ABSTRACT Objective: To present the concept and development of teaching strategies and the assessment tools regarding clinical reasoning for accurate practice. Method: This is a theoretical reflection based on scientific studies. Results: Comprehension of the essential concepts of the thought process and its articulation with the different teaching strategies and the assessment tools which has allowed presenting ways to improve the process of diagnostic or therapeutic clinical reasoning. Conclusion: The use of new strategies and assessment tools should be encouraged in order to contribute to the development of skills that lead to safe and effective decision making.

  16. Assessment of a sequential extraction protocol by examining solution chemistry and mineralogical evolution

    Science.gov (United States)

    Maubec, Nicolas; Pauwels, Hélène; Noël, Hervé; Bourrat, Xavier

    2015-04-01

    Knowledge of the behavior of heavy metals, such as copper and zinc in sediments, is a key factor to improve the management of rivers. The mobility of these metals, which may be harmful to the environment, depends directly on their concentration and speciation , which in turn depend on physico-chemical parameters such as mineralogy of the sediment fraction, pH, redox potential, salinity etc ... (Anderson et al., 2000; Sterckeman et al., 2004; Van Oort et al., 2008). Several methods based on chemical extractions are currently applied to assess the behavior of heavy metals in soils and sediments. Among them, sequential extraction procedure is widely used in soil and sediment science and provides details about the origin, biological and physicochemical availability, mobilization and transports of trace metals elements. It is based on the use of a series of extracting reagents to extract selectively heavy metals according to their association within the solid phase (Cornu and Clozel, 2000) including the following different fraction : exchangeable, bound to carbonates, associated to oxides (reducible fraction), linked to organic matter and sulfides (oxidizable fraction) as well as silicate minerals so called residual fraction (Hickey and Kittrick, 1984; Tessier et al., 1979). Consequently sequential extraction method is expected to simulate a lot of potential natural and anthropogenic modifications of environmental conditions (Arey et al., 1999; Brannon and Patrick, 1987; Hickey and Kittrick, 1984; La Force et al., 1999; Tessier et al., 1979). For three decades, a large number of protocols has been proposed, characterized by specific reagents and experimental conditions (concentrations, number of steps, extraction orders and solid/solution ratio) (Das et al., 1995; Gomez Ariza et al., 2000; Quevauviller et al., 1994; Rauret, 1998; Tack and Verloo, 1995), but it appeared that several of them suffer from a lack of selectivity of applied reagents: besides target ones, some

  17. Large observer variation of clinical assessment of dyspnoeic wheezing children.

    Science.gov (United States)

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

    2015-07-01

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

  18. Assessment of cerebrospinal fluid system dynamics : novel infusion protocol, mathematical modelling and parameter estimation for hydrocephalus investigations

    OpenAIRE

    Andersson, Kennet

    2011-01-01

    Patients with idiopathic normal pressure hydrocephalus (INPH) have a disturbance in the cerebrospinal fluid (CSF) system. The treatment is neurosurgical – a shunt is placed in the CSF system. The infusion test is used to assess CSF system dynamics and to aid in the selection of patients that will benefit from shunt surgery. The infusion test can be divided into three parts: a mathematical model, an infusion protocol and a parameter estimation method. A non-linear differential equation is used...

  19. 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.

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Science.gov (United States)

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

    2018-04-01

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

  3. Interaction between cytokine gene polymorphisms and the effect of physical exercise on clinical and inflammatory parameters in older women: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pereira, Daniele S; Queiroz, Bárbara Z; Mateo, Elvis C C; Assumpção, Alexandra M; Felício, Diogo C; Miranda, Aline S; Anjos, Daniela M C; Jesus-Moraleida, Fabianna; Dias, Rosângela C; Pereira, Danielle A G; Teixeira, Antônio L; Pereira, Leani S M

    2012-08-08

    Aging is associated with chronic low-grade inflammatory activity with an elevation of cytokine levels. An association between regular physical activity and reduction of blood levels of anti-inflammatory cytokines is demonstrated in the literature pointing to an anti-inflammatory effect related to exercise. However, there is no consensus regarding which type of exercise and which parameters are the most appropriate to influence inflammatory markers. Evidence indicates that the single nucleotide polymorphism (SNP) can influence the synthesis of those cytokines affecting their production. The design of this study is a randomized controlled trial. The aim of this study is to investigate the interaction between the cytokine genes SNP and the effect of physical activity on older women. The main outcomes are: serum levels of sTNFR-1, sTNFR-2, interleukin (IL)-6, IL-10, measured by the ELISA method; genotyping of tumor necrosis factor- (TNF)-alpha (rs1800629), IL6 (rs1800795), IL10 (rs1800896) by the TaqMan Method (Applied Biosystems, Foster City, CA, USA); and physical performance assessed by Timed Up and Go and 10-Meter Walk Tests. Secondary outcomes include: Geriatric Depression Scale, Perceived Stress Scaleand aerobic capacity, assessed by the six-minute walk; and lower limb muscle strength, using an isokinetic dinamometer (Biodex Medical Systems, Inc., Shirley, NY,USA). Both exercise protocols will be performed three times a week for 10 weeks, 30 sessions in total. Investigating the interaction between genetic factors and exercise effects of both protocols of exercise on the levels of inflammatory cytokine levels can contribute to guide clinical practice related to treatment and prevention of functional changes due to chronic inflammatory activity in older adults. This approach could develop new perspectives on preventive and treatment proposals in physical therapy and in the management of the older patient. (ReBEC) RBR9v9cwf.

  4. Interaction between cytokine gene polymorphisms and the effect of physical exercise on clinical and inflammatory parameters in older women: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pereira Daniele S

    2012-08-01

    Full Text Available Abstract Background Aging is associated with chronic low-grade inflammatory activity with an elevation of cytokine levels. An association between regular physical activity and reduction of blood levels of anti-inflammatory cytokines is demonstrated in the literature pointing to an anti-inflammatory effect related to exercise. However, there is no consensus regarding which type of exercise and which parameters are the most appropriate to influence inflammatory markers. Evidence indicates that the single nucleotide polymorphism (SNP can influence the synthesis of those cytokines affecting their production. Methods/Design The design of this study is a randomized controlled trial. The aim of this study is to investigate the interaction between the cytokine genes SNP and the effect of physical activity on older women. The main outcomes are: serum levels of sTNFR-1, sTNFR-2, interleukin (IL-6, IL-10, measured by the ELISA method; genotyping of tumor necrosis factor- (TNF-alpha (rs1800629, IL6 (rs1800795, IL10 (rs1800896 by the TaqMan Method (Applied Biosystems, Foster City, CA, USA; and physical performance assessed by Timed Up and Go and 10-Meter Walk Tests. Secondary outcomes include: Geriatric Depression Scale, Perceived Stress Scaleand aerobic capacity, assessed by the six-minute walk; and lower limb muscle strength, using an isokinetic dinamometer (Biodex Medical Systems, Inc., Shirley, NY,USA. Both exercise protocols will be performed three times a week for 10 weeks, 30 sessions in total. Discussion Investigating the interaction between genetic factors and exercise effects of both protocols of exercise on the levels of inflammatory cytokine levels can contribute to guide clinical practice related to treatment and prevention of functional changes due to chronic inflammatory activity in older adults. This approach could develop new perspectives on preventive and treatment proposals in physical therapy and in the management of the older patient

  5. Control protocol: large scale implementation at the CERN PS complex - a first assessment

    International Nuclear Information System (INIS)

    Abie, H.; Benincasa, G.; Coudert, G.; Davydenko, Y.; Dehavay, C.; Gavaggio, R.; Gelato, G.; Heinze, W.; Legras, M.; Lustig, H.; Merard, L.; Pearson, T.; Strubin, P.; Tedesco, J.

    1994-01-01

    The Control Protocol is a model-based, uniform access procedure from a control system to accelerator equipment. It was proposed at CERN about 5 years ago and prototypes were developed in the following years. More recently, this procedure has been finalized and implemented at a large scale in the PS Complex. More than 300 pieces of equipment are now using this protocol in normal operation and another 300 are under implementation. These include power converters, vacuum systems, beam instrumentation devices, RF equipment, etc. This paper describes how the single general procedure is applied to the different kinds of equipment. The advantages obtained are also discussed. ((orig.))

  6. The clinical and molecular genetic approach to Duchenne and Becker muscular dystrophy : an updated protocol

    NARCIS (Netherlands)

    vanEssen, AJ; Kneppers, ALJ; vanderHout, AH; Scheffer, H; Ginjaar, IB; tenKate, LP; vanOmmen, GJB; Buys, CHCM; Bakker, E

    1997-01-01

    Detection of large rearrangements in the dystrophin gene in Duchenne and Becker muscular dystrophy is possible in about 65-70% of patients by Southern blotting or multiplex PCR. Subsequently, carrier detection is possible by assessing the intensity of relevant bands, but preferably by a

  7. 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.

  8. Assessment of acquired capability for suicide in clinical practice.

    Science.gov (United States)

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

    2016-12-01

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

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

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  10. Discovering biomarkers for antidepressant response: protocol from the Canadian biomarker integration network in depression (CAN-BIND) and clinical characteristics of the first patient cohort.

    Science.gov (United States)

    Lam, Raymond W; Milev, Roumen; Rotzinger, Susan; Andreazza, Ana C; Blier, Pierre; Brenner, Colleen; Daskalakis, Zafiris J; Dharsee, Moyez; Downar, Jonathan; Evans, Kenneth R; Farzan, Faranak; Foster, Jane A; Frey, Benicio N; Geraci, Joseph; Giacobbe, Peter; Feilotter, Harriet E; Hall, Geoffrey B; Harkness, Kate L; Hassel, Stefanie; Ismail, Zahinoor; Leri, Francesco; Liotti, Mario; MacQueen, Glenda M; McAndrews, Mary Pat; Minuzzi, Luciano; Müller, Daniel J; Parikh, Sagar V; Placenza, Franca M; Quilty, Lena C; Ravindran, Arun V; Salomons, Tim V; Soares, Claudio N; Strother, Stephen C; Turecki, Gustavo; Vaccarino, Anthony L; Vila-Rodriguez, Fidel; Kennedy, Sidney H

    2016-04-16

    Major Depressive Disorder (MDD) is among the most prevalent and disabling medical conditions worldwide. Identification of clinical and biological markers ("biomarkers") of treatment response could personalize clinical decisions and lead to better outcomes. This paper describes the aims, design, and methods of a discovery study of biomarkers in antidepressant treatment response, conducted by the Canadian Biomarker Integration Network in Depression (CAN-BIND). The CAN-BIND research program investigates and identifies biomarkers that help to predict outcomes in patients with MDD treated with antidepressant medication. The primary objective of this initial study (known as CAN-BIND-1) is to identify individual and integrated neuroimaging, electrophysiological, molecular, and clinical predictors of response to sequential antidepressant monotherapy and adjunctive therapy in MDD. CAN-BIND-1 is a multisite initiative involving 6 academic health centres working collaboratively with other universities and research centres. In the 16-week protocol, patients with MDD are treated with a first-line antidepressant (escitalopram 10-20 mg/d) that, if clinically warranted after eight weeks, is augmented with an evidence-based, add-on medication (aripiprazole 2-10 mg/d). Comprehensive datasets are obtained using clinical rating scales; behavioural, dimensional, and functioning/quality of life measures; neurocognitive testing; genomic, genetic, and proteomic profiling from blood samples; combined structural and functional magnetic resonance imaging; and electroencephalography. De-identified data from all sites are aggregated within a secure neuroinformatics platform for data integration, management, storage, and analyses. Statistical analyses will include multivariate and machine-learning techniques to identify predictors, moderators, and mediators of treatment response. From June 2013 to February 2015, a cohort of 134 participants (85 outpatients with MDD and 49 healthy participants

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

    Science.gov (United States)

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

    2015-02-01

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

  12. Cognitive Assessment of Elderly Inpatients: A Clinical Audit

    Directory of Open Access Journals (Sweden)

    Elizabeth Shermon

    2015-01-01

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

  13. 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.)

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

    Science.gov (United States)

    Chabeli, M M

    2002-08-01

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

  15. Protocol Analysis of Group Problem Solving in Mathematics: A Cognitive-Metacognitive Framework for Assessment.

    Science.gov (United States)

    Artzt, Alice F.; Armour-Thomas, Eleanor

    The roles of cognition and metacognition were examined in the mathematical problem-solving behaviors of students as they worked in small groups. As an outcome, a framework that links the literature of cognitive science and mathematical problem solving was developed for protocol analysis of mathematical problem solving. Within this framework, each…

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

    Science.gov (United States)

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

    2015-05-01

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

  17. The Copenhagen Standardised MRI protocol to assess the pubic symphysis and adductor regions of athletes

    DEFF Research Database (Denmark)

    Branci, Sonia; Thorborg, Kristian; Bech, Birthe Højlund

    2015-01-01

    radiologists developed an 11-element MRI evaluation protocol defined according to precise criteria and illustrated in a pictorial atlas. Eighty-six male athletes (soccer players and non-soccer players) underwent standardised 3 Tesla MRI of the pelvis. Two external musculoskeletal radiologists were trained...

  18. Progress towards more uniform assessment and reporting of soil disturbance for operations, research, and sustainability protocols.

    Science.gov (United States)

    Michael P. Curran; Richard E. Miller; Steven W. Howes; Douglas G. Maynard; Thomas A. Terry; Ronald L. Heninger; Thomas Niemann; Ken van Rees; Robert F. Powers; Stephen H. Schoenholtz

    2005-01-01

    International protocols, such as those of the Montreal Process (MP), specify desired outcomes without specifying the process and components required to attain those outcomes. We suggest that the process and its components are critical to achieve desired outcomes. We discuss recent progress in northwestern North America, on three topics that will facilitate development...

  19. Agricultural Soil Spectral Response and Properties Assessment: Effects of Measurement Protocol and Data Mining Technique

    Directory of Open Access Journals (Sweden)

    Asa Gholizadeh

    2017-10-01

    Full Text Available Soil spectroscopy has shown to be a fast, cost-effective, environmentally friendly, non-destructive, reproducible and repeatable analytical technique. Soil components, as well as types of instruments, protocols, sampling methods, sample preparation, spectral acquisition techniques and analytical algorithms have a combined influence on the final performance. Therefore, it is important to characterize these differences and to introduce an effective approach in order to minimize the technical factors that alter reflectance spectra and consequent prediction. To quantify this alteration, a joint project between Czech University of Life Sciences Prague (CULS and Tel-Aviv University (TAU was conducted to estimate Cox, pH-H2O, pH-KCl and selected forms of Fe and Mn. Two different soil spectral measurement protocols and two data mining techniques were used to examine seventy-eight soil samples from five agricultural areas in different parts of the Czech Republic. Spectral measurements at both laboratories were made using different ASD spectroradiometers. The CULS protocol was based on employing a contact probe (CP spectral measurement scheme, while the TAU protocol was carried out using a CP measurement method, accompanied with the internal soil standard (ISS procedure. Two spectral datasets, acquired from different protocols, were both analyzed using partial least square regression (PLSR technique as well as the PARACUDA II®, a new data mining engine for optimizing PLSR models. The results showed that spectra based on the CULS setup (non-ISS demonstrated significantly higher albedo intensity and reflectance values relative to the TAU setup with ISS. However, the majority of statistics using the TAU protocol was not noticeably better than the CULS spectra. The paper also highlighted that under both measurement protocols, the PARACUDA II® engine proved to be a powerful tool for providing better results than PLSR. Such initiative is not only a way to

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

    Science.gov (United States)

    Thomas V. Dietsch

    2005-01-01

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

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

    DEFF Research Database (Denmark)

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

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    George R Bergus

    2010-11-01

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

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

    Directory of Open Access Journals (Sweden)

    Pantelić Ivana

    2018-01-01

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

  4. Videofluoroscopic assessment of dysphagia: A questionnaire survey of protocols, roles and responsibilities of radiology and speech and language therapy personnel

    International Nuclear Information System (INIS)

    Power, Maxine; Laasch, Hans-Ulrich; Kasthuri, Ram S.; Nicholson, David A.; Hamdy, Shaheen

    2006-01-01

    Videofluoroscopy (VF) is the 'gold standard' assessment for oropharyngeal dysphagia and radiographers are beginning to direct this examination independently, yet little is known about the roles and responsibilities of the core professions of radiology and speech and language therapy and their practice in this examination. Aim: To evaluate VF practice and identify the roles and responsibilities of radiology and speech and language therapy personnel. Materials and methods: A questionnaire was developed and distributed to speech and language therapists (SALT) and radiologists via national special interest networks. Information regarding protocols, test materials, supervision, radiation protection and training was obtained. Results: One hundred and thirteen questionnaires were completed, 83% of respondents had more than 5 years service. Most were carrying out VF on an 'ad hoc' basis with only 32% participating in more than 6 assessments per month. There was no consensus on protocol and 41% chose to thicken barium solutions by adding more barium sulphate powder, potentially predisposing patients to complications. Over 50% of SALTs had received one day post-graduate training in VF, whereas, only one radiologist had specific VF training. Conclusion: Despite its importance in determining the feeding route for patients, VF is carried out infrequently by most clinicians and protocols vary widely. Moreover, intra- and inter-disciplinary training and supervision is minimal. More work is needed to develop standard guidelines, to improve the quality of the examination and its reproducibility

  5. Large-scale hydrological simulations using the soil water assessment tool, protocol development, and application in the danube basin.

    Science.gov (United States)

    Pagliero, Liliana; Bouraoui, Fayçal; Willems, Patrick; Diels, Jan

    2014-01-01

    The Water Framework Directive of the European Union requires member states to achieve good ecological status of all water bodies. A harmonized pan-European assessment of water resources availability and quality, as affected by various management options, is necessary for a successful implementation of European environmental legislation. In this context, we developed a methodology to predict surface water flow at the pan-European scale using available datasets. Among the hydrological models available, the Soil Water Assessment Tool was selected because its characteristics make it suitable for large-scale applications with limited data requirements. This paper presents the results for the Danube pilot basin. The Danube Basin is one of the largest European watersheds, covering approximately 803,000 km and portions of 14 countries. The modeling data used included land use and management information, a detailed soil parameters map, and high-resolution climate data. The Danube Basin was divided into 4663 subwatersheds of an average size of 179 km. A modeling protocol is proposed to cope with the problems of hydrological regionalization from gauged to ungauged watersheds and overparameterization and identifiability, which are usually present during calibration. The protocol involves a cluster analysis for the determination of hydrological regions and multiobjective calibration using a combination of manual and automated calibration. The proposed protocol was successfully implemented, with the modeled discharges capturing well the overall hydrological behavior of the basin. Copyright © by the American Society of Agronomy, Crop Science Society of America, and Soil Science Society of America, Inc.

  6. 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.

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

    International Nuclear Information System (INIS)

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

    2011-01-01

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

  8. Clinically assessed mediolateral knee motion: impact on gait

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  9. Effect of different financial competing interest statements on readers' perceptions of clinical educational articles: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Schroter, Sara; Pakpoor, Julia; Morris, Julie; Chew, Mabel; Godlee, Fiona

    2016-06-10

    Financial ties with industry are varied and common among academics, doctors and institutions. Clinical educational articles are intended to guide patient care and convey authors' own interpretation of selected data. Author biases in educational articles tend to be less visible to readers compared to those in research papers. Little is known about which types of competing interest statements affect readers' interpretation of the credibility of these articles. This study aims to investigate how different competing interest statements in educational articles affect clinical readers' perceptions of the articles. 2040 doctors who are members of the British Medical Association (BMA) and receive a copy of the British Medical Journal (The BMJ) each week will be randomly selected and invited by an email to participate in the study. They will be randomised to receive 1 of 2 Clinical Reviews, each with 1 of 4 possible competing interest statements. Versions of each review will be identical except for permutations of the competing interest statement. Study participants will be asked to read their article and complete an online questionnaire. The questionnaire will ask participants to rate their confidence in the conclusions drawn in the article, the importance of the article, their level of interest in the article and their likeliness to change their practice from the article. Factorial analyses of variance and analyses of covariance will be carried out to assess the impact of the type of competing interest statement and Clinical Review on level of confidence, importance, interest and likeliness to change practice. The study protocol, questionnaire and letter of invitation to participants have been reviewed by members of The BMJ's Ethics Committee for ethical concerns. The trial results will be disseminated to participants and published in a peer-reviewed journal. NCT02548312; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already

  10. Liver iron concentration quantification by MRI: are recommended protocols accurate enough for clinical practice?

    International Nuclear Information System (INIS)

    Castiella, Agustin; Zapata, Eva Mia; Alustiza, Jose M.; Emparanza, Jose I.; Costero, Belen; Diez, Maria I.

    2011-01-01

    To assess the accuracy of quantification of liver iron concentration (LIC) by MRI using the Rennes University (URennes) algorithm. In the overall study period 1999-2006 the LIC in 171 patients was calculated with the URennes model and the results were compared with LIC measured by liver biopsy. The biopsy showed that 107 patients had no overload, 38 moderate overload and 26 high overload. The correlation between MRI and biopsy was r = 0.86. MRI correctly classified 105 patients according to the various levels of LIC. Diagnostic accuracy was 61.4%, with a tendency to overestimate overload: 43% of patients with no overload were diagnosed as having overload, and 44.7% of patients with moderate overload were diagnosed as having high overload. The sensitivity of the URennes method for high overload was 92.3%, and the specificity for the absence of overload was 57.0%. MRI values greater than 170 μmol Fe/g revealed a positive predictive value (PPV) for haemochromatosis of 100% (n = 18); concentrations below 60 μmol Fe/g had a negative predictive value (NPV) of 100% for haemochromatosis (n = 101). The diagnosis in 44 patients with intermediate values remained uncertain. The assessment of LIC with the URennes method was useful in 74.3% of the patients to rule out or to diagnose high iron overload. The method has a tendency to overestimate overload, which limits its diagnostic performance. (orig.)

  11. Liver iron concentration quantification by MRI: are recommended protocols accurate enough for clinical practice?

    Energy Technology Data Exchange (ETDEWEB)

    Castiella, Agustin; Zapata, Eva M. [Mendaro Hospital, Gastroenterology Service, Mendaro (Spain); Alustiza, Jose M. [Osatek Donostia, Radiology Service, Donostia (Spain); Emparanza, Jose I. [Donostia Hospital CASPe, CIBER-ESP, Clinical Epidemiology Unit, Donostia (Spain); Costero, Belen [Principe de Asturias Hospital, Gastroenterology Service, Alcala de Henares (Spain); Diez, Maria I. [Principe de Asturias Hospital, Radiology Service, Alcala de Henares (Spain)

    2011-01-15

    To assess the accuracy of quantification of liver iron concentration (LIC) by MRI using the Rennes University (URennes) algorithm. In the overall study period 1999-2006 the LIC in 171 patients was calculated with the URennes model and the results were compared with LIC measured by liver biopsy. The biopsy showed that 107 patients had no overload, 38 moderate overload and 26 high overload. The correlation between MRI and biopsy was r = 0.86. MRI correctly classified 105 patients according to the various levels of LIC. Diagnostic accuracy was 61.4%, with a tendency to overestimate overload: 43% of patients with no overload were diagnosed as having overload, and 44.7% of patients with moderate overload were diagnosed as having high overload. The sensitivity of the URennes method for high overload was 92.3%, and the specificity for the absence of overload was 57.0%. MRI values greater than 170 {mu}mol Fe/g revealed a positive predictive value (PPV) for haemochromatosis of 100% (n = 18); concentrations below 60 {mu}mol Fe/g had a negative predictive value (NPV) of 100% for haemochromatosis (n = 101). The diagnosis in 44 patients with intermediate values remained uncertain. The assessment of LIC with the URennes method was useful in 74.3% of the patients to rule out or to diagnose high iron overload. The method has a tendency to overestimate overload, which limits its diagnostic performance. (orig.)

  12. Using dreams to assess clinical change during treatment.

    Science.gov (United States)

    Glucksman, Myron L; Kramer, Milton

    2004-01-01

    This article describes several studies that examine the relationship between the manifest content of selected dreams reported by patients and their clinical progress during psychoanalytic and psychodynamically oriented treatment. There are a number of elements that dreaming and psychotherapy have in common: affect regulation; conflict resolution; problem-solving; self-awareness; mastery and adaptation. Four different studies examined the relationship between the manifest content of selected dreams and clinical progress during treatment. In each study, the ratings of manifest content and clinical progress by independent observers were rank-ordered and compared. In three of the four studies there was a significant correlation between the rankings of manifest content and the rankings of clinical progress. This finding suggests that the manifest content of dreams can be used as an independent variable to assess clinical progress during psychoanalytic and psychodynamically oriented treatment.

  13. Outcomes assessment of dental hygiene clinical teaching workshops.

    Science.gov (United States)

    Wallace, Juanita S; Infante, Taline D

    2008-10-01

    Faculty development courses related to acquiring clinical teaching skills in the health professions are limited. Consequently, the Department of Dental Hygiene at the University of Texas Health Science Center at San Antonio conducted a series of clinical teaching workshops to address clinical teaching methodology. The goal of these workshops was to promote a problem-solving learning atmosphere for dental hygiene faculty to acquire and share sound clinical teaching strategies. To determine the value of the annual workshops on clinical teaching and evaluation, a web-based qualitative program assessment was developed using software by Survey Tracker. Four open-ended questions were designed to elicit perceptions regarding what significant changes in teaching strategies were achieved, what barriers or challenges were encountered in making these changes, and what strategies were used to overcome the barriers. The assessment was sent to dental hygiene educators representing thirty-eight dental hygiene programs who had participated in two or more of these workshops. Twenty-eight programs provided collective responses to the questions, and the narrative data were analyzed, using a qualitative methodology. Responses revealed that programs had made productive changes to their clinical education curricula and the information gained from the workshops had a positive effect on clinical teaching.

  14. 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

  15. 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

  16. Chronic pelvic pain syndrome: role of a thorough clinical assessment.

    Science.gov (United States)

    Quaghebeur, Jörgen; Wyndaele, Jean-Jacques

    2015-04-01

    Chronic pelvic pain syndrome (CPPS) presents with a variety of symptoms affecting multiple systems. There is no universal treatment that can be given to all patients with CPPS. The results of treatment depend greatly on an accurate diagnosis. A thorough clinical assessment, including a "four-step plan", should include paying special attention to the musculoskeletal system. This assessment is not difficult to perform and provides valuable information on possible muscular problems and neuropathy.

  17. Effectiveness of oxaliplatin desensitization protocols.

    Science.gov (United States)

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

    2013-03-01

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

  18. Structured assessment of microsurgery skills in the clinical setting.

    Science.gov (United States)

    Chan, WoanYi; Niranjan, Niri; Ramakrishnan, Venkat

    2010-08-01

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

  19. Do pressure ulcer risk assessment scales improve clinical practice?

    Directory of Open Access Journals (Sweden)

    Jan Kottner

    2010-07-01

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

  20. 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

  1. 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.

  2. Caries risk assessment tool and prevention protocol for public health nurses in mother and child health centers, Israel.

    Science.gov (United States)

    Natapov, Lena; Dekel-Markovich, Dan; Granit-Palmon, Hadas; Aflalo, Efrat; Zusman, Shlomo Paul

    2018-01-01

    Dental caries is the most prevalent chronic disease in children. Caries risk assessment tools enable the dentists, physicians, and nondental health care providers to assess the individual's risk. Intervention by nurses in primary care settings can contribute to the establishment of oral health habits and prevention of dental disease. In Israel, Mother and Child Health Centers provide free preventive services for pregnant women and children by public health nurses. A caries prevention program in health centers started in 2015. Nurses underwent special training regarding caries prevention. A customized Caries Risk Assessment tool and Prevention Protocol for nurses, based on the AAPD tool, was introduced. A two-step evaluation was conducted which included a questionnaire and in-depth phone interviews. Twenty-eight (out of 46) health centers returned a completed questionnaire. Most nurses believed that oral health preventive services should be incorporated into their daily work. In the in-depth phone interviews, nurses stated that the integration of the program into their busy daily schedule was realistic and appropriate. The lack of specific dental module for computer program was mentioned as an implementation difficulty. The wide use of our tool by nurses supports its simplicity and feasibility which enables quick calculation and informed decision making. The nurses readily embraced the tool and it became an integral part of their toolkit. We provide public health nurses with a caries risk assessment tool and prevention protocol thus integrating oral health into general health of infants and toddlers. © 2017 Wiley Periodicals, Inc.

  3. 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 regions, a major challenge was represented by the need of skills and instruments to address psychosocial issues of people with diabetes. The BENCH-D study allows a field testing of benchmarking activities focused on clinical and patient-centred indicators.

  4. Assessment of clinical residents' needs for ten educational subjects

    Directory of Open Access Journals (Sweden)

    Mansour Razavi

    2002-04-01

    Full Text Available Background Fulfilling the learners' "real needs" will improve medical education. There are subjects that are necessary for any clinical residents not considering their field of specialty. Among the subjects ten seems to be the most important: research methodology and data analysis, computer-based programs, medical recording, cardiopulmonary and cerebral resuscitation, clinical teaching programs, communication skills, clinical ethics, laboratory examinations, reporting special diseases and death certification, and prescription. Purpose This cross-sectional study assessed educational needs of clinical residents for ten educational subjects. Methods A questionnaire prepared by board faculty members consisted of 10 close-ended questions, and one open­ ended question was distributed among 1307 residents from 22 clinical disciplines, who registered for preboard or promotion exam in June 2000. Results Among the subjects three were the most needed: computer-based programs 149 (60%, data collecting system 606 (49%, and clinical ethics 643 (46%. The prescription standard was the least required 177(13%. Conclusion Complementary training courses on these subjects can be an answer to the clinical residents needs. Keywords : research methodology, computer in medicine, cpr, clinical teaching methods, communication in medicine, medical ethics, laboratory ordering, disease coding system, death certificate, prescription writing

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

    Science.gov (United States)

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

    2018-03-01

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

  6. 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

  7. 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…

  8. An approach to the clinical assessment and management of ...

    African Journals Online (AJOL)

    Syncope, defined as a brief loss of consciousness due to an abrupt fall in cerebral perfusion, remains a frequent reason for medical presentation. The goals of the clinical assessment of a patient with syncope are twofold: (i) to identify the precise cause in order to implement a mechanism-specific and effective therapeutic ...

  9. Clinical Evaluation of a Novel and Mobile Autism Risk Assessment

    Science.gov (United States)

    Duda, Marlena; Daniels, Jena; Wall, Dennis P.

    2016-01-01

    The Mobile Autism Risk Assessment (MARA) is a new, electronically administered, 7-question autism spectrum disorder (ASD) screen to triage those at highest risk for ASD. Children 16 months-17 years (N = 222) were screened during their first visit in a developmental-behavioral pediatric clinic. MARA scores were compared to diagnosis from the…

  10. Evidence-Based Clinical Voice Assessment: A Systematic Review

    Science.gov (United States)

    Roy, Nelson; Barkmeier-Kraemer, Julie; Eadie, Tanya; Sivasankar, M. Preeti; Mehta, Daryush; Paul, Diane; Hillman, Robert

    2013-01-01

    Purpose: To determine what research evidence exists to support the use of voice measures in the clinical assessment of patients with voice disorders. Method: The American Speech-Language-Hearing Association (ASHA) National Center for Evidence-Based Practice in Communication Disorders staff searched 29 databases for peer-reviewed English-language…

  11. A randomised clinical trial of a comprehensive exercise program for chronic whiplash: trial protocol

    Directory of Open Access Journals (Sweden)

    Latimer Jane

    2009-12-01

    Full Text Available Abstract Background Whiplash is the most common injury following a motor vehicle accident. Approximately 60% of people suffer persistent pain and disability six months post injury. Two forms of exercise; specific motor relearning exercises and graded activity, have been found to be effective treatments for this condition. Although the effect sizes for these exercise programs, individually, are modest, pilot data suggest much larger effects on pain and disability are achieved when these two treatments are combined. The aim of this study is to investigate the effectiveness and cost-effectiveness of this comprehensive exercise approach for chronic whiplash. Methods/Design A multicentre randomised controlled trial will be conducted. One hundred and seventy-six participants with chronic grade I to II whiplash will be recruited in Sydney and Brisbane, Australia. All participants will receive an educational booklet on whiplash and in addition, those randomised to the comprehensive exercise group (specific motor relearning and graded activity exercises will receive 20 progressive and individually-tailored, 1 hour exercise sessions over a 12 week period (specific motor relearning exercises: 8 sessions over 4 weeks; graded activity: 12 sessions over 8 weeks. The primary outcome to be assessed is pain intensity. Other outcomes of interest include disability, health-related quality of life and health service utilisation. Outcomes will be measured at baseline, 14 weeks, 6 months and 12 months by an assessor who is blinded to the group allocation of the subjects. Recruitment is due to commence in late 2009. Discussion The successful completion of this trial will provide evidence on the effectiveness and cost-effectiveness of a simple treatment for the management of chronic whiplash. Trial registration ACTRN12609000825257

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

    Science.gov (United States)

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

    2018-03-14

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

  13. The accountability of clinical education: its definition and assessment.

    Science.gov (United States)

    Murray, E; Gruppen, L; Catton, P; Hays, R; Woolliscroft, J O

    2000-10-01

    Medical education is not exempt from increasing societal expectations of accountability. Competition for financial resources requires medical educators to demonstrate cost-effective educational practice; health care practitioners, the products of medical education programmes, must meet increasing standards of professionalism; the culture of evidence-based medicine demands an evaluation of the effect educational programmes have on health care and service delivery. Educators cannot demonstrate that graduates possess the required attributes, or that their programmes have the desired impact on health care without appropriate assessment tools and measures of outcome. To determine to what extent currently available assessment approaches can measure potentially relevant medical education outcomes addressing practitioner performance, health care delivery and population health, in order to highlight areas in need of research and development. Illustrative publications about desirable professional behaviour were synthesized to obtain examples of required competencies and health outcomes. A MEDLINE search for available assessment tools and measures of health outcome was performed. There are extensive tools for assessing clinical skills and knowledge. Some work has been done on the use of professional judgement for assessing professional behaviours; scholarship; and multiprofessional team working; but much more is needed. Very little literature exists on assessing group attributes of professionals, such as clinical governance, evidence-based practice and workforce allocation, and even less on examining individual patient or population health indices. The challenge facing medical educators is to develop new tools, many of which will rely on professional judgement, for assessing these broader competencies and outcomes.

  14. Caries assessment: establishing mathematical link of clinical and benchtop method

    Science.gov (United States)

    Amaechi, Bennett T.

    2009-02-01

    It is well established that the development of new technologies for early detection and quantitative monitoring of dental caries at its early stage could provide health and economic benefits ranging from timely preventive interventions to reduction of the time required for clinical trials of anti-caries agents. However, the new technologies currently used in clinical setting cannot assess and monitor caries using the actual mineral concentration within the lesion, while a laboratory-based microcomputed tomography (MCT) has been shown to possess this capability. Thus we envision the establishment of mathematical equations relating the measurements of each of the clinical technologies to that of MCT will enable the mineral concentration of lesions detected and assessed in clinical practice to be extrapolated from the equation, and this will facilitate preventitive care in dentistry to lower treatment cost. We utilize MCT and the two prominent clinical caries assessment devices (Quantitative Light-induced Fluorescence [QLF] and Diagnodent) to longitudinally monitor the development of caries in a continuous flow mixed-organisms biofilm model (artificial mouth), and then used the collected data to establish mathematical equation relating the measurements of each of the clinical technologies to that of MCT. A linear correlation was observed between the measurements of MicroCT and that of QLF and Diagnodent. Thus mineral density in a carious lesion detected and measured using QLF or Diagnodent can be extrapolated using the developed equation. This highlights the usefulness of MCT for monitoring the progress of an early caries being treated with therapeutic agents in clinical practice or trials.

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

    Directory of Open Access Journals (Sweden)

    Daria Tashyreva

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

  16. 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

  17. COPD management: role of symptom assessment in routine clinical practice

    Science.gov (United States)

    van der Molen, Thys; Miravitlles, Marc; Kocks, Janwillem WH

    2013-01-01

    Patients with chronic obstructive pulmonary disease (COPD) present with a variety of symptoms that significantly impair health-related quality of life. Despite this, COPD treatment and its management are mainly based on lung function assessments. There is increasing evidence that conventional lung function measures alone do not correlate well with COPD symptoms and their associated impact on patients’ everyday lives. Instead, symptoms should be assessed routinely, preferably by using patient-centered questionnaires that provide a more accurate guide to the actual burden of COPD. Numerous questionnaires have been developed in an attempt to find a simple and reliable tool to use in everyday clinical practice. In this paper, we review three such patient-reported questionnaires recommended by the latest Global Initiative for Chronic Obstructive Lung Disease guidelines, ie, the modified Medical Research Council questionnaire, the clinical COPD questionnaire, and the COPD Assessment Test, as well as other symptom-specific questionnaires that are currently being developed. PMID:24143085

  18. 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.

  19. 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

  20. 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.

  1. 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

  2. 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

  3. 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

  4. Effect of Rapid Maxillary Expansion on Glenoid Fossa and Condyle-Fossa Relationship in Growing Patients (MEGP): Study Protocol for a Controlled Clinical Trial

    Science.gov (United States)

    Ghoussoub, Mona Sayegh; Rifai, Khaldoun; Garcia, Robert; Sleilaty, Ghassan

    2018-01-01

    Aims and Objectives: Rapid maxillary expansion (RME) is an orthodontic nonsurgical procedure aiming at increasing the width of the maxilla by opening mainly the intermaxillary suture in patients presenting a transverse maxillary skeletal deficiency. The objectives of the current prospective controlled clinical and radiographic study are to evaluate the hypothesis that RME in growing patients will result in radiographic changes at the level of interglenoid fossa distance, condyle-fossa relationship, and nasal cavity widths compared to the group who received no treatment initially and served as untreated control. Materials and Methods: In this prospective controlled clinical and radiographic study, forty healthy growing patients selected from a school-based population following a large screening campaign, ranging in age between 8 and 13 years, presenting a maxillary constriction with bilateral crossbite, and candidates for RME are being recruited. The first group will include participants willing to undergo treatment (n = 25) and the other group will include those inclined to postpone (n = 15). Results: The primary outcome is to compare radiologically the interglenoid fossa distance and the condyle-fossa relationship; nasal cavity width will be a secondary outcome. A multivariable analysis of Covariance model will be used, with the assessment of the time by group interaction, using age as covariate. The project protocol was reviewed and approved by the Ethics Committee of the Lebanese University, National Institute in Lebanon (CUEMB process number 31/04/2015). The study is funded by the Lebanese University and Centre National de Recherche Scientifique, Lebanon (Number: 652 on 14/04/2016). Conclusion: This prospective controlled clinical trial will give information about the effect of RME on the glenoid fossa and condyle-fossa relationship and its impact on the nasal cavity width. Trial Registration: Retrospectively registered in BioMed Central (DOI10.1186/ISRCTN

  5. Telephone follow-up by nurse following total knee arthroplasty - protocol for a randomized clinical trial (NCT01771315)

    DEFF Research Database (Denmark)

    Szöts, Kirsten; Konradsen, Hanne; Solgaard, Søren

    2014-01-01

    to the orthopaedic outpatient clinic during the rehabilitation period. METHOD/DESIGN: The design is a randomized un-blinded parallel group clinical trial conducted at the Department of Orthopaedic Surgery, Gentofte Hospital, the Capital Region of Denmark. In total, 116 patients will be allocated by an external...... are structured by key subjects relevant to assess the health status according to the VIPS-model (the Swedish acronym for the concepts Well-being, Integrity, Prevention and Safety). The content of the consultations can vary according to the patients´ individual situations and needs. All consultations...... of life, general self-efficacy and the number of acute visits to the orthopaedic outpatient clinic. DISCUSSION: The result of this trial is expected to provide new knowledge to support the development of targeted and effective follow-up after total knee arthroplasty in order to improve the patients...

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

    Directory of Open Access Journals (Sweden)

    Timothy J. Cleary

    2012-01-01

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

  7. 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)

  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. Sharing Annotated Audio Recordings of Clinic Visits With Patients-Development of the Open Recording Automated Logging System (ORALS): Study Protocol.

    Science.gov (United States)

    Barr, Paul J; Dannenberg, Michelle D; Ganoe, Craig H; Haslett, William; Faill, Rebecca; Hassanpour, Saeed; Das, Amar; Arend, Roger; Masel, Meredith C; Piper, Sheryl; Reicher, Haley; Ryan, James; Elwyn, Glyn

    2017-07-06

    Providing patients with recordings of their clinic visits enhances patient and family engagement, yet few organizations routinely offer recordings. Challenges exist for organizations and patients, including data safety and navigating lengthy recordings. A secure system that allows patients to easily navigate recordings may be a solution. The aim of this project is to develop and test an interoperable system to facilitate routine recording, the Open Recording Automated Logging System (ORALS), with the aim of increasing patient and family engagement. ORALS will consist of (1) technically proficient software using automated machine learning technology to enable accurate and automatic tagging of in-clinic audio recordings (tagging involves identifying elements of the clinic visit most important to patients [eg, treatment plan] on the recording) and (2) a secure, easy-to-use Web interface enabling the upload and accurate linkage of recordings to patients, which can be accessed at home. We will use a mixed methods approach to develop and formatively test ORALS in 4 iterative stages: case study of pioneer clinics where recordings are currently offered to patients, ORALS design and user experience testing, ORALS software and user interface development, and rapid cycle testing of ORALS in a primary care clinic, assessing impact on patient and family engagement. Dartmouth's Informatics Collaboratory for Design, Development and Dissemination team, patients, patient partners, caregivers, and clinicians will assist in developing ORALS. We will implement a publication plan that includes a final project report and articles for peer-reviewed journals. In addition to this work, we will regularly report on our progress using popular relevant Tweet chats and online using our website, www.openrecordings.org. We will disseminate our work at relevant conferences (eg, Academy Health, Health Datapalooza, and the Institute for Healthcare Improvement Quality Forums). Finally, Iora Health, a

  11. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol

    Directory of Open Access Journals (Sweden)

    Fukuoka Yoshimi

    2011-12-01

    Full Text Available Abstract Background Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. Methods A randomized controlled trial (RCT with three arms; 1 PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention, 2 REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention, and 3 CONTROL (pedometer only, but no intervention will be conducted. A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary, immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. Discussion If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral

  12. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol.

    Science.gov (United States)

    Fukuoka, Yoshimi; Komatsu, Judith; Suarez, Larry; Vittinghoff, Eric; Haskell, William; Noorishad, Tina; Pham, Kristin

    2011-12-14

    Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education) randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. A randomized controlled trial (RCT) with three arms; 1) PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention), 2) REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention), and 3) CONTROL (pedometer only, but no intervention will be conducted). A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary), immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral sciences and mHealth. ClinicalTrials.gov#:NCTO1280812.

  13. Health Literacy Assessment in an Otolaryngology Clinic Population.

    Science.gov (United States)

    Megwalu, Uchechukwu C; Lee, Jennifer Y

    2016-12-01

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

  14. Protocol for assessing maternal, environmental and epigenetic risk factors for dental caries in children.

    Science.gov (United States)

    Fernando, Surani; Speicher, David J; Bakr, Mahmoud M; Benton, Miles C; Lea, Rodney A; Scuffham, Paul A; Mihala, Gabor; Johnson, Newell W

    2015-12-29

    Expenditure on dental and oral health services in Australia is $3.4 billion AUD annually. This is the sixth highest health cost and accounts for 7 % of total national health expenditure. Approximately 49 % of Australian children aged 6 years have caries experience in their deciduous teeth and this is rising. The aetiology of dental caries involves a complex interplay of individual, behavioural, social, economic, political and environmental conditions, and there is increasing interest in genetic predisposition and epigenetic modification. The Oral Health Sub-study; a cross sectional study of a birth cohort began in November 2012 by examining mothers and their children who were six years old by the time of initiation of the study, which is ongoing. Data from detailed questionnaires of families from birth onwards and data on mothers' knowledge, attitudes and practices towards oral health collected at the time of clinical examination are used. Subjects' height, weight and mid-waist circumference are taken and Body Mass Index (BMI) computed, using an electronic Bio-Impedance balance. Dental caries experience is scored using the International Caries Detection and Assessment System (ICDAS). Saliva is collected for physiological measures. Salivary Deoxyribose Nucleic Acid (DNA) is extracted for genetic studies including epigenetics using the SeqCap Epi Enrichment Kit. Targets of interest are being confirmed by pyrosequencing to identify potential epigenetic markers of caries risk. This study will examine a wide range of potential determinants for childhood dental caries and evaluate inter-relationships amongst them. The findings will provide an evidence base to plan and implement improved preventive strategies.

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

    Science.gov (United States)

    Armitage-Chan, Elizabeth

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

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

    Science.gov (United States)

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

    1998-11-01

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

  17. Clinical assessment of transthoracic echocardiography skills: a generalizability study

    DEFF Research Database (Denmark)

    Nielsen, Dorte Guldbrand; O'Neill, Lotte; Jensen, Signe

    2015-01-01

    Context: Transthoracic echocardiography (TTE) is a widely used cardiac imaging technique that all cardiologists should be able to perform competently. Traditionally, TTE competence has been assessed by unstructured observation or in test situations separated from daily clinical practice. An objec......Context: Transthoracic echocardiography (TTE) is a widely used cardiac imaging technique that all cardiologists should be able to perform competently. Traditionally, TTE competence has been assessed by unstructured observation or in test situations separated from daily clinical practice....... An objective assessment instrument for TTE technical proficiency including a global rating score and a checklist score has previously been shown reliability and validity in a standardised setting. Objectives: As clinical test situations typically have several sources of error giving rise to variance in scores......, a more thorough examination of the generalizability of the test scores is needed. Methods Nine physicians performed a TTE scan on the same three patients. Then, two raters rated all 27 TTE scans using the TTE technical assessment in a fully crossed generalizability study. Estimated variance components...

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

    DEFF Research Database (Denmark)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

  20. Evolutions in clinical reasoning assessment: The Evolving Script Concordance Test.

    Science.gov (United States)

    Cooke, Suzette; Lemay, Jean-François; Beran, Tanya

    2017-08-01

    Script concordance testing (SCT) is a method of assessment of clinical reasoning. We developed a new type of SCT case design, the evolving SCT (E-SCT), whereby the patient's clinical story is "evolving" and with thoughtful integration of new information at each stage, decisions related to clinical decision-making become increasingly clear. We aimed to: (1) determine whether an E-SCT could differentiate clinical reasoning ability among junior residents (JR), senior residents (SR), and pediatricians, (2) evaluate the reliability of an E-SCT, and (3) obtain qualitative feedback from participants to help inform the potential acceptability of the E-SCT. A 12-case E-SCT, embedded within a 24-case pediatric SCT (PaedSCT), was administered to 91 pediatric residents (JR: n = 50; SR: n = 41). A total of 21 pediatricians served on the panel of experts (POE). A one-way analysis of variance (ANOVA) was conducted across the levels of experience. Participants' feedback on the E-SCT was obtained with a post-test survey and analyzed using two methods: percentage preference and thematic analysis. Statistical differences existed across levels of training: F = 19.31 (df = 2); p decision-making process. The E-SCT demonstrated very good reliability and was effective in distinguishing clinical reasoning ability across three levels of experience. Participants found the E-SCT engaging and representative of real-life clinical reasoning and decision-making processes. We suggest that further refinement and utilization of the evolving style case will enhance SCT as a robust, engaging, and relevant method for the assessment of clinical reasoning.

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

    Science.gov (United States)

    McCarthy, Bridie; Murphy, Siobhan

    2008-04-01

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

  2. Hypersensitivity and desensitization to antineoplastic agents: outcomes of 189 procedures with a new short protocol and novel diagnostic tools assessment.

    Science.gov (United States)

    Madrigal-Burgaleta, R; Berges-Gimeno, M P; Angel-Pereira, D; Ferreiro-Monteagudo, R; Guillen-Ponce, C; Pueyo, C; Gomez de Salazar, E; Alvarez-Cuesta, E

    2013-07-01

    Desensitization to antineoplastic agents is becoming a standard of care. Efforts to establish and improve these techniques are being made at many institutions. Our aims are to evaluate a new rapid desensitization protocol designed to be shorter (approximately 4 h) and safer (reducing hazardous drugs exposure risks) and to assess the oxaliplatin-specific immunoglobulin E (IgE) as a novel diagnostic tool. Prospective, observational, longitudinal study with patients who, for a 1-year period, suffered reactions to antineoplastic agents and were referred to the Desensitization Program at Ramon y Cajal University Hospital (RCUH). Patients were included or excluded as desensitization candidates after anamnesis, skin testing, risk assessment, and graded challenge. Specific IgE was determined in oxaliplatin-reactive patients. Candidate patients were desensitized using the new RCUH rapid desensitization protocol. Of 189 intravenous rapid desensitizations, 188 were successfully accomplished in the 23 patients who met inclusion criteria for desensitization (of 58 referred patients). No breakthrough reactions occurred in 94% of desensitizations, and most breakthrough reactions were mild. In 10 oxaliplatin-reactive patients, 38 desensitizations were successfully accomplished. Sensitivity for oxaliplatin-specific IgE was 38% (0.35UI/l cutoff point) and 54% (0.10UI/l cutoff point); specificity was 100% for both cutoff points. In the hands of a Desensitization Program, managed by drug desensitization experts, this new protocol has proven an effective therapeutic tool for hypersensitivity to several antineoplastic agents (oxaliplatin, carboplatin, paclitaxel, docetaxel, cyclophosphamide, and rituximab); moreover, it improves safety handling of hazardous drugs. We report the first large series of oxaliplatin desensitizations. Oxaliplatin-specific IgE determination could be helpful. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

    DEFF Research Database (Denmark)

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

    2010-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Marcy L. Brown

    2008-03-01

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

  5. The Assessment of Military Multitasking Performance: Validation of a Dual-Task and Multitask Protocol

    Science.gov (United States)

    2014-08-01

    multitasks using healthy control and SM with diagnosed mTBI. Approach: Inter-rater reliability and assessment of training requirements for expert...developers piloted the revised multitask assessment in a healthy population to assess IRR. Given the an- ticipated variability in task performance between...1 AD_________________ Award Number: Contract W81XWH-12-2-0070 TITLE: Annual Report: The Assessment of Military Multitasking

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

    Science.gov (United States)

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

    2015-08-25

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

  7. Initial Readability Assessment of Clinical Trial Eligibility Criteria

    Science.gov (United States)

    Kang, Tian; Elhadad, Noémie; Weng, Chunhua

    2015-01-01

    Various search engines are available to clinical trial seekers. However, it remains unknown how comprehensible clinical trial eligibility criteria used for recruitment are to a lay audience. This study initially investigated this problem. Readability of eligibility criteria was assessed according to (i) shallow and lexical characteristics through the use of an established, generic readability metric; (ii) syntactic characteristics through natural language processing techniques; and (iii) health terminological characteristics through an automated comparison to technical and lay health texts. We further stratified clinical trials according to various study characteristics (e.g., source country or study type) to understand potential factors influencing readability. Mainly caused by frequent use of technical jargons, a college reading level was found to be necessary to understand eligibility criteria text, a level much higher than the average literacy level of the general American population. The use of technical jargons should be minimized to simplify eligibility criteria text. PMID:26958204