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- Shorter, Gillian W., et al.
(författare)
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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
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Ingår i: Journal of Studies on Alcohol and Drugs. - : Alcohol Research Documentation, Inc.. - 1937-1888 .- 1938-4114. ; 80:3, s. 299-309
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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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| 2. |
- Shorter, Gillian W., et al.
(författare)
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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
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Ingår i: Journal of Studies on Alcohol and Drugs. - : Alcohol Research Documentation, Inc.. - 1937-1888 .- 1938-4114. ; 82:5, s. 638-646
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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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| 3. |
- Shorter, Gillian W., et al.
(författare)
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The Variability of Outcomes Used in Efficacy and Effectiveness Trials of Alcohol Brief Interventions : A Systematic Review
- 2019
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Ingår i: Journal of Studies on Alcohol and Drugs. - : Alcohol Research Documentation, Inc.. - 1937-1888 .- 1938-4114. ; 80:3, s. 286-298
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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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| 5. |
- Bendtsen, Marcus, et al.
(författare)
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The Effect of Question Order on Outcomes in the Core Outcome Set for Brief Alcohol Interventions Among Online Help-Seekers: Protocol for a Factorial Randomized Trial
- 2020
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Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 9:11
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Tidskriftsartikel (refereegranskat)abstract
- Background: A core outcome set (COS) for trials and evaluations of the effectiveness and efficacy of alcohol brief interventions (ABIs) has recently been established through international consensus to address the variability of outcomes evaluated. Objective: This is a protocol for studies to assess if there are order effects among the questions included in the COS. Methods: The 10 items of the COS are organized into 4 clusters. A factorial design will be used with 24 arms, where each arm represents 1 order of the 4 clusters. Individuals searching online for help will be asked to complete a questionnaire, and consenting participants will be randomized to 1 of the 24 arms (double-blind with equal allocation). Participants will be included if they are 18 years or older. The primary analyses will (1) estimate how the order of the clusters of outcomes affects how participants respond and (2) investigate patterns of abandonment of the questionnaire. Results: Data collection is expected to commence in November 2020. A Bayesian group sequential design will be used with interim analyses planned for every 50 participants completing the questionnaire Data collection will end no more than 24 months after commencement, and the results are expected to be published no later than December 2023. Conclusions: Homogenizing the outcomes evaluated in studies of ABIs is important to support synthesis, and the COS is an important step toward this goal. Determining whether there may be issues with the COS question order may improve confidence in using it and speed up its dissemination in the research community We encourage others to adopt the protocol as a study within their trial as they adopt the ORBITAL (Outcome Reporting in Brief Intervention Trials: Alcohol) COS to build a worldwide repository and provide materials to support such analysis.
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| 6. |
- Bendtsen, Marcus, et al.
(författare)
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The effect of question order on outcomes in the orbital core outcome set for alcohol brief interventions among online help-seekers (QOBCOS): Findings from a randomised factorial trial
- 2023
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Ingår i: Digital Health. - : SAGE PUBLICATIONS LTD. - 2055-2076. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- ObjectiveA core outcome set (COS) has been developed in alcohol brief intervention (ABI) research through international consensus. This study aimed to estimate order effects among questions in the COS. MethodsIndividuals aged 18 or older who searched online for alcohol-related help were invited to complete the COS. The order of questions was randomised following a factorial design. Primary outcomes were order effects among the COS items and patterns of attrition. ResultsBetween 21/10/2020 and 26/11/2020, we randomised 7334 participants, of which 5256 responded to at least one question and were available for analyses. Current non-drinkers were excluded. We found evidence of higher self-reported average consumption and odds of harmful and hazardous drinking was found among those who first answered questions on recent consumption and impact of alcohol use. Lower self-reported recent consumption was found among those first asked about average consumption. Quality of life (QoL) was reported lower among those who first responded to when questions on impact of alcohol use were asked first, which in turn was lower among those who first answered question on when average consumption and QoL were asked first. Attrition was lowest when average consumption was asked first, and highest when QoL or impact of alcohol use was asked first. Median completion time for the COS was 4.3 min. ConclusionsQuestion order affects outcomes and attrition. If the aim is to minimize attrition, consumption measures should be asked before QoL and impact of alcohol use; however, this order impacts self-reported alcohol consumption and so researchers should be guided by study priorities. At a minimum, all participants should be asked the same questions in the same order.
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