| 1. |
- 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. - : Alcohol Research Documentation, Inc.. - 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.
|
|
| 2. |
- 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 Research Documentation, Inc.. - 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.
|
|
| 3. |
- 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. - : Alcohol Research Documentation, Inc.. - 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.
|
|
| 4. |
- Ugarte-Gil, Manuel Francisco, et al.
(författare)
-
Impact of glucocorticoids on the incidence of lupus-related major organ damage : A systematic literature review and meta-regression analysis of longitudinal observational studies
- 2021
-
Ingår i: Lupus Science and Medicine. - : BMJ. - 2053-8790. ; 8:1
-
Forskningsöversikt (refereegranskat)abstract
- Objective In systemic lupus erythematosus (SLE), disease activity and glucocorticoid (GC) exposure are known to contribute to irreversible organ damage. We aimed to examine the association between GC exposure and organ damage occurrence. Methods We conducted a literature search (PubMed (Medline), Embase and Cochrane January 1966-October 2021). We identified original longitudinal observational studies reporting GC exposure as the proportion of users and/or GC use with dose information as well as the occurrence of new major organ damage as defined in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index. Meta-regression analyses were performed. Reviews, case-reports and studies with <5 years of follow-up, <50 patients, different outcomes and special populations were excluded. Results We selected 49 articles including 16 224 patients, 14 755 (90.9%) female with a mean age and disease duration of 35.1 years and of 37.1 months. The mean follow-up time was 104.9 months. For individual damage items, the average daily GC dose was associated with the occurrence of overall cardiovascular events and with osteoporosis with fractures. A higher average cumulative dose adjusted (or not)/number of follow-up years and a higher proportion of patients on GC were associated with the occurrence of osteonecrosis. Conclusions We confirm associations of GC use with three specific damage items. In treating patients with SLE, our aim should be to maximise the efficacy of GC and to minimise their harms.
|
|
