Health Services Research Unit, University of Aberdeen, Aberdeen, UK
Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
BMJ Open. 2022 May 31;12(5):e054459. doi: 10.1136/bmjopen-2021-054459.
Our objective was to determine the extent to which current evidence from long-term randomised controlled trials (RCTs) of weight management is generalisable and applicable to underserved adult groups with obesity (body mass index (BMI) ≥35 kg/m).
Descriptive analysis of 131 RCTs, published after 1990-May 2017 with ≥1 year of follow-up, included in a systematic review of long-term weight management interventions for adults with BMI ≥35 kg/m (the REBALANCE Project). Studies were identified from MEDLINE, EMBASE, PsychINFO, SCI, CENTRAL and from hand searching. Reporting of trial inclusion and exclusion criteria, trial recruitment strategies, baseline characteristics and outcomes were analysed using a predefined list of characteristics informed by the PROGRESS (Place of residence, Race/ethnicity/culture/language, Occupation, Gender/sex, Religion, Education, Socioeconomic status, Social capital)-Plus framework and the UK Equality Act 2010.
Few (6.1%) trials reported adapting recruitment to appeal to underserved groups. 10.0% reported culturally adapting their trial materials. Only 6.1% of trials gave any justification for their exclusion criteria, yet over half excluded participation for age or mental health reasons. Just over half (58%) of the trials reported participants' race or ethnicity, and one-fifth reported socioeconomic status. Where outcomes were reported for underserved groups, the most common analysis was by sex (47.3%), followed by race or ethnicity (16.8%). 3.1% of trials reported outcomes according to socioeconomic status.
Although we were limited by poor trial reporting, our results indicate inadequate representation of people most at risk of obesity. Guidance for considering underserved groups may improve the appropriateness of research and inform greater engagement with health and social care services.
National Institute for Health Research Health Technology Assessment Programme (project number: 15/09/04).
CRD42016040190.
本研究旨在确定当前肥胖成年人(体重指数(BMI)≥35kg/m²)长期随机对照试验(RCT)的证据的普遍性和适用性程度。
对 1990 年 5 月至 2017 年 5 月期间发表的 131 项长期体重管理干预成年人 BMI≥35kg/m²的 RCT(REBALANCE 项目)进行描述性分析。这些研究是从 MEDLINE、EMBASE、PsychINFO、SCI、CENTRAL 和手工检索中确定的。使用基于 PROGRESS(居住地、种族/民族/文化/语言、职业、性别/性别、宗教、教育、社会经济地位、社会资本)-Plus 框架和英国 2010 年平等法案的预先确定的特征清单,分析了试验纳入和排除标准、试验招募策略、基线特征和结局的报告情况。
很少(6.1%)的试验报告称其招募策略是为了吸引服务不足的人群。10.0%的试验报告称其试验材料进行了文化适应。只有 6.1%的试验对其排除标准进行了任何解释,但超过一半的试验因年龄或心理健康原因排除了参与者。超过一半(58%)的试验报告了参与者的种族或民族,五分之一报告了社会经济地位。在报告了服务不足人群的结局的试验中,最常见的分析是按性别(47.3%),其次是种族或民族(16.8%)。3.1%的试验根据社会经济地位报告了结局。
尽管我们受到试验报告不佳的限制,但我们的结果表明,肥胖风险最高的人群代表性不足。考虑服务不足人群的指导意见可能会提高研究的适当性,并为更好地参与卫生和社会保健服务提供信息。
英国国家卫生研究院卫生技术评估计划(项目编号:15/09/04)。
PROSPERO 注册号:CRD42016040190。