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Sökning: WFRF:(Bray Jeremy W.)

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1.
  • Brownstein, Catherine A., et al. (författare)
  • An international effort towards developing standards for best practices in analysis, interpretation and reporting of clinical genome sequencing results in the CLARITY Challenge
  • 2014
  • Ingår i: Genome Biology. - 1465-6906 .- 1474-760X. ; 15:3, s. R53-
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: There is tremendous potential for genome sequencing to improve clinical diagnosis and care once it becomes routinely accessible, but this will require formalizing research methods into clinical best practices in the areas of sequence data generation, analysis, interpretation and reporting. The CLARITY Challenge was designed to spur convergence in methods for diagnosing genetic disease starting from clinical case history and genome sequencing data. DNA samples were obtained from three families with heritable genetic disorders and genomic sequence data were donated by sequencing platform vendors. The challenge was to analyze and interpret these data with the goals of identifying disease-causing variants and reporting the findings in a clinically useful format. Participating contestant groups were solicited broadly, and an independent panel of judges evaluated their performance. Results: A total of 30 international groups were engaged. The entries reveal a general convergence of practices on most elements of the analysis and interpretation process. However, even given this commonality of approach, only two groups identified the consensus candidate variants in all disease cases, demonstrating a need for consistent fine-tuning of the generally accepted methods. There was greater diversity of the final clinical report content and in the patient consenting process, demonstrating that these areas require additional exploration and standardization. Conclusions: The CLARITY Challenge provides a comprehensive assessment of current practices for using genome sequencing to diagnose and report genetic diseases. There is remarkable convergence in bioinformatic techniques, but medical interpretation and reporting are areas that require further development by many groups.
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2.
  • Ademuyiwa, Adesoji O., et al. (författare)
  • Determinants of morbidity and mortality following emergency abdominal surgery in children in low-income and middle-income countries
  • 2016
  • Ingår i: BMJ Global Health. - : BMJ Publishing Group Ltd. - 2059-7908. ; 1:4
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Child health is a key priority on the global health agenda, yet the provision of essential and emergency surgery in children is patchy in resource-poor regions. This study was aimed to determine the mortality risk for emergency abdominal paediatric surgery in low-income countries globally.Methods: Multicentre, international, prospective, cohort study. Self-selected surgical units performing emergency abdominal surgery submitted prespecified data for consecutive children aged <16 years during a 2-week period between July and December 2014. The United Nation's Human Development Index (HDI) was used to stratify countries. The main outcome measure was 30-day postoperative mortality, analysed by multilevel logistic regression.Results: This study included 1409 patients from 253 centres in 43 countries; 282 children were under 2 years of age. Among them, 265 (18.8%) were from low-HDI, 450 (31.9%) from middle-HDI and 694 (49.3%) from high-HDI countries. The most common operations performed were appendectomy, small bowel resection, pyloromyotomy and correction of intussusception. After adjustment for patient and hospital risk factors, child mortality at 30 days was significantly higher in low-HDI (adjusted OR 7.14 (95% CI 2.52 to 20.23), p<0.001) and middle-HDI (4.42 (1.44 to 13.56), p=0.009) countries compared with high-HDI countries, translating to 40 excess deaths per 1000 procedures performed.Conclusions: Adjusted mortality in children following emergency abdominal surgery may be as high as 7 times greater in low-HDI and middle-HDI countries compared with high-HDI countries. Effective provision of emergency essential surgery should be a key priority for global child health agendas.
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3.
  • Shorter, Gillian W., et al. (författare)
  • Prioritization of Outcomes in Efficacy and Effectiveness of Alcohol Brief Intervention Trials : International Multi-Stakeholder e-Delphi Consensus Study to Inform a Core Outcome Set
  • 2019
  • Ingår i: Journal of Studies on Alcohol and Drugs. - 1937-1888 .- 1938-4114. ; 80:3, s. 299-309
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective:Outcomes used in alcohol brief intervention trials vary considerably. Achieving consensus about key outcomes can enhance evidence synthesis and improve healthcare guidelines. This international, e-Delphi study sought to prioritize outcomes for alcohol brief intervention trials as part of a larger program of work develop an alcohol brief intervention core outcome set.Method:In total, 150 registrants from 19 countries, representing researchers, policymakers, and patients, participated in a two-round e-Delphi study. In Round 1, participants (n = 137) rated 86 outcomes, derived from a review of the literature and a patient and public involvement panel, by importance. In Round 2, participants (n = 114) received feedback on importance ratings for each outcome, and a reminder of their personal rating, before rating the outcomes for importance a second time. Seven additional outcomes suggested in Round 1 were added to the Round 2 questionnaire. We defined consensus a priori as 70% agreement across all stakeholder groups.Results:Seven consumption outcomes met inclusion criteria: typical frequency, typical quantity, frequency of heavy drinking, alcohol-related problems, weekly drinks, at-risk drinking, and combined consumption measures. Others meeting the threshold were alcohol-related injury, quality of life, readiness to change, and intervention fidelity.Conclusions:This is the first international e-Delphi study to identify and prioritize outcomes for use in alcohol brief intervention trials. The use and reporting of outcomes in future alcohol brief intervention trials should improve evidence synthesis in systematic reviews and meta-analyses. Further work is required to refine these outcomes into a core outcome set that includes guidance for measurement of outcomes.
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4.
  • Shorter, G. W., et al. (författare)
  • The ‘Outcome Reporting in Brief Intervention Trials : Alcohol’ (ORBITAL) framework: protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention
  • 2017
  • Ingår i: Trials. - 1745-6215 .- 1745-6215. ; 18
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporting guidance for its use in future trials of ABI in a range of settings.Methods/design: An international Special Interest Group was convened through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs) to inform the development of a COS for trials of ABI. ORBITAL will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This will support a multi-round Delphi study to prioritise outcomes. Delphi panellists will be drawn from a range of settings and stakeholder groups, and the Delphi study will also be used to determine if a single COS is relevant for all settings. A consensus meeting with key stakeholder representation will determine the final COS and associated guidance for its use in trials of ABI.Discussion: ORBITAL will develop a COS for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments. The standardisation of ABI outcomes and their measurement will support the ongoing development of ABI studies and a systematic synthesis of emerging research findings. We will track the extent to which the COS delivers on this promise through an exploration of the use of the guidance in the decade following COS publication.
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5.
  • Shorter, Gillian W., et al. (författare)
  • The "Outcome Reporting in Brief Intervention Trials: Alcohol" (ORBITAL) Core Outcome Set : International Consensus on Outcomes to Measure in Efficacy and Effectiveness Trials of Alcohol Brief Interventions
  • 2021
  • Ingår i: Journal of Studies on Alcohol and Drugs. - : ALCOHOL RES DOCUMENTATION INC CENT ALCOHOL STUD RUTGERS UNIV. - 1937-1888 .- 1938-4114. ; 82:5, s. 638-646
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective: The purpose of this study was to report the "Outcome Reporting in Brief Intervention Trials: Alcohol" (ORBITAL) recommended core outcome set (COS) to improve efficacy and effectiveness trials/evaluations for alcohol brief interventions (ABIs).Method: A systematic review identified 2,641 outcomes in 401 ABI articles measured by 1,560 different approaches. These outcomes were classified into outcome categories, and 150 participants from 19 countries participated in a two-round e-Delphi outcome prioritization exercise. This process prioritized 15 of 93 outcome categories for discussion at a consensus meeting of key stakeholders to decide the COS. A psychometric evaluation determined how to measure the outcomes.Results: Ten outcomes were voted into the COS at the consensus meeting: (a) typical frequency, (b) typical quantity, (c) frequency of heavy episodic drinking, (d) combined consumption measure summarizing alcohol use, (e) hazardous or harmful drinking (average consumption), (1) standard drinks consumed in the past week (recent, current consumption), (g) alcohol-related consequences, (h) alcohol-related injury, (i) use of emergency health care services (impact of alcohol use), and (j) quality of life.Conclusions: The ORBITAL COS is an international consensus standard for future ABI trials and evaluations. It can improve the synthesis of new findings, reduce redundant/selective reporting (i.e., reporting only some, usually significant outcomes), improve between-study comparisons, and enhance the relevance of trial and evaluation findings to decision makers. The COS is the recommended minimum and does not exclude oilier. additional outcomes.
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6.
  • Shorter, Gillian W., et al. (författare)
  • The Variability of Outcomes Used in Efficacy and Effectiveness Trials of Alcohol Brief Interventions : A Systematic Review
  • 2019
  • Ingår i: Journal of Studies on Alcohol and Drugs. - 1937-1888 .- 1938-4114. ; 80:3, s. 286-298
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective:The purpose of this study was to characterize recent alcohol brief intervention (ABI) efficacy and effectiveness trials, summarize outcomes, and show how variability in outcomes and reporting compromises the evidence base.Method:A systematic review and narrative synthesis of articles from 10 databases were undertaken (January 2000–November 2017); study selection represented recent, readily available publications. The National Institute of Care Excellence (NICE) Public Health Guideline 24 (Alcohol use disorders: prevention) informed ABI definitions. The review was conducted using Centre for Reviews and Dissemination (CRD) guidance and pre-registered on PROSPERO (CRD42016047185). Seven a priori specified domains were used to classify outcomes: biomarkers, alcohol-related outcomes, economic factors/resource use, health measures, life impact, intervention factors, and psychological/behavioral factors.Results:The search identified 405 trials from 401 eligible papers. In 405 trials, 2,641 separate outcomes were measured in approximately 1,560 different ways. The most common outcomes used were the number of drinks consumed in a week and frequency of heavy episodic drinking. Biomarkers were least frequently used. The most common primary outcome was weekly drinks. By trial type, the most frequent outcome in efficacy and effectiveness trials was frequency of heavy drinking.Conclusions:Consumption outcomes predominated; however, no single outcome was found in all trials. This comprehensive outcome map and methodological detail on ABI effectiveness and efficacy trials can aid decision making in future trials. There was a diversity of instruments, time points, and outcome descriptions in methods and results sections. Compliance with reporting guidance would support data synthesis and improve trial quality. This review establishes the need for a core outcome set (COS)/minimum data standard and supports the Outcome Reporting in Brief Interventions: Alcohol initiative (ORBITAL) to improve standards in the ABI field through a COS for effectiveness and efficacy randomized trials.
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7.
  • Tait, Brian D, et al. (författare)
  • Consensus Guidelines on the Testing and Clinical Management Issues Associated With HLA and Non-HLA Antibodies in Transplantation.
  • 2013
  • Ingår i: Transplantation. - 1534-6080. ; 95:1, s. 19-47
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: The introduction of solid-phase immunoassay (SPI) technology for the detection and characterization of human leukocyte antigen (HLA) antibodies in transplantation while providing greater sensitivity than was obtainable by complement-dependent lymphocytotoxicity (CDC) assays has resulted in a new paradigm with respect to the interpretation of donor-specific antibodies (DSA). Although the SPI assay performed on the Luminex instrument (hereafter referred to as the Luminex assay), in particular, has permitted the detection of antibodies not detectable by CDC, the clinical significance of these antibodies is incompletely understood. Nevertheless, the detection of these antibodies has led to changes in the clinical management of sensitized patients. In addition, SPI testing raises technical issues that require resolution and careful consideration when interpreting antibody results. METHODS: With this background, The Transplantation Society convened a group of laboratory and clinical experts in the field of transplantation to prepare a consensus report and make recommendations on the use of this new technology based on both published evidence and expert opinion. Three working groups were formed to address (a) the technical issues with respect to the use of this technology, (b) the interpretation of pretransplantation antibody testing in the context of various clinical settings and organ transplant types (kidney, heart, lung, liver, pancreas, intestinal, and islet cells), and (c) the application of antibody testing in the posttransplantation setting. The three groups were established in November 2011 and convened for a "Consensus Conference on Antibodies in Transplantation" in Rome, Italy, in May 2012. The deliberations of the three groups meeting independently and then together are the bases for this report. RESULTS: A comprehensive list of recommendations was prepared by each group. A summary of the key recommendations follows. Technical Group: (a) SPI must be used for the detection of pretransplantation HLA antibodies in solid organ transplant recipients and, in particular, the use of the single-antigen bead assay to detect antibodies to HLA loci, such as Cw, DQA, DPA, and DPB, which are not readily detected by other methods. (b) The use of SPI for antibody detection should be supplemented with cell-based assays to examine the correlations between the two types of assays and to establish the likelihood of a positive crossmatch (XM). (c) There must be an awareness of the technical factors that can influence the results and their clinical interpretation when using the Luminex bead technology, such as variation in antigen density and the presence of denatured antigen on the beads. Pretransplantation Group: (a) Risk categories should be established based on the antibody and the XM results obtained. (b) DSA detected by CDC and a positive XM should be avoided due to their strong association with antibody-mediated rejection and graft loss. (c) A renal transplantation can be performed in the absence of a prospective XM if single-antigen bead screening for antibodies to all class I and II HLA loci is negative. This decision, however, needs to be taken in agreement with local clinical programs and the relevant regulatory bodies. (d) The presence of DSA HLA antibodies should be avoided in heart and lung transplantation and considered a risk factor for liver, intestinal, and islet cell transplantation. Posttransplantation Group: (a) High-risk patients (i.e., desensitized or DSA positive/XM negative) should be monitored by measurement of DSA and protocol biopsies in the first 3 months after transplantation. (b) Intermediate-risk patients (history of DSA but currently negative) should be monitored for DSA within the first month. If DSA is present, a biopsy should be performed. (c) Low-risk patients (nonsensitized first transplantation) should be screened for DSA at least once 3 to 12 months after transplantation. If DSA is detected, a biopsy should be performed. In all three categories, the recommendations for subsequent treatment are based on the biopsy results. CONCLUSIONS: A comprehensive list of recommendations is provided covering the technical and pretransplantation and posttransplantation monitoring of HLA antibodies in solid organ transplantation. The recommendations are intended to provide state-of-the-art guidance in the use and clinical application of recently developed methods for HLA antibody detection when used in conjunction with traditional methods.
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