Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review

作者：Katie Biggs, Caroline Dix, Frances Shiely, Shaun Treweek, Victoria Shepherd, J. Athene Lane, Heidi Green, Talia Isaacs, Andrew Willis, Cindy Cooper · 发表于：NIHR Open Research · 年份：2024 · DOI：10.3310/nihropenres.13524.1 · 被引用次数：7 · 研究领域：Ethics in Clinical Research、Mental Health and Patient Involvement、Race, Genetics, and Society

Background: Participants in clinical trials often do not reflect the populations that could benefit from the treatments being investigated. There are known barriers to trial participation for under-served groups, but limited evidence on strategies to alleviate these barriers to improve representation. This scoping review aimed to identify effective interventions and design features that improve the representation `of under-served groups in trials, focusing on the UK and Ireland. Methods: We included methodological research studies that reported interventions to improve representation of ethnic minority groups, socioeconomically disadvantaged groups, older people, or those with impaired capacity to consent to randomised controlled trials, conducted in the UK and Ireland, published between 2000-2021. Systematic searches were conducted in November 2021 and data were independently extracted by two authors and narratively synthesised. Results: Seven studies were included: one randomised controlled study embedded in five trials, one mixed-methods study, and five studies reporting 'lessons learnt' from one trial. We categorised the 47 reported interventions or strategies into nine broad themes: Recruitment sites, recruitment settings, community engagement, and communication with participants, incentives, inclusion criteria, flexibility, patient documentation, and the consent process. Only 28/47 interventions were evaluated, 23 of which were comparison of recruitment pathways.The ran...