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- Wilkinson, Jack, et al.
(författare)
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Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions
- 2024
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 14:3
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions.Methods and analysis The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare.Ethics and dissemination The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.
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| 2. |
- McDonald, Matthew D., et al.
(författare)
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A systematic review examining socioeconomic factors in trials of interventions for men that report weight as an outcome
- 2022
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Ingår i: Obesity Reviews. - Chichester : John Wiley & Sons. - 1467-7881 .- 1467-789X. ; 23:7
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Forskningsöversikt (refereegranskat)abstract
- Weight management interventions designed specifically for men have become more common, but the extent to which socioeconomic factors are considered in trials of these interventions is unclear. We synthesized study characteristics, methods, and reporting of interventions with a behavioral component for men that report weight as an outcome, to establish the extent to which socioeconomic factors are considered during intervention design, conduct, and reporting. A comprehensive search was conducted on Medline, Embase, PsycINFO, and CENTRAL for studies published from January 2000 to July 2021. Thirty-six trials were included. Educational attainment (n = 24) was the most frequently reported socioeconomic characteristic, followed by working status (n = 14) and area level deprivation (n = 12). Seven studies did not report any socioeconomic characteristics. Most studies (n = 20) did not mention the socioeconomic profile of their samples in relation to study strengths or limitations. Few (n = 4) consulted with men from lower socioeconomic groups during intervention design. One study examined potential differential intervention effects across socioeconomic groups, with most not powered to do so. Recent feasibility trials (n = 3) targeting specific socioeconomic groups suggest a potential nascent towards a greater consideration of factors related to equity. To best inform public health policy related to health inequalities, greater consideration of socioeconomic factors is required in trials of men's weight management interventions. © 2022 The Authors. Obesity Reviews published by John Wiley & Sons Ltd on behalf of World Obesity Federation.
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