背景:患病率存在显著的种族和性别差异,诊断,和外周动脉疾病(PAD)的结果。然而,评估PAD治疗的临床试验通常缺乏代表性的患者群体.本系统综述旨在总结下肢血管内介入治疗PAD的临床试验中的人口统计学表现和招募策略。
方法:遵循2020年系统审查和荟萃分析(PRISMA)指南的首选报告项目,我们搜索了多个来源(Medline,EMBASE,科克伦,Clinicaltrials.gov,WHO临床试验登记)用于随机对照试验(RCTs),RCT协议,以及2012年1月至2022年12月期间进行的随机对照试验的同行评审期刊出版物。描述性分析用于总结试验特征,出版物或研究方案特征,以及人口特征的报告。使用元回归来探索人口学特征与某些试验特征之间的关联。
结果:共确定2,374条记录。其中,59符合纳入标准,由35项试验组成,14出版物和10个协议。有关人口代表性的信息经常丢失。虽然所有14篇试验出版物都报告了年龄和性别,只有4人报告了种族/民族,没有人报告社会经济或婚姻状况。此外,只有4篇出版物报告了按人口统计学特征分类的临床结局.Meta回归分析显示,参加非欧洲试验的女性(36%)比参加欧洲试验的女性(30%)多6%。
结论:本综述的发现强调了潜在的问题,这些问题可能会影响应用于真实世界人群的下肢PADRCT研究结果的可靠性和外部有效性。解决这些问题对于提高PAD领域临床试验结果的普遍性和影响力至关重要。最终改善代表性不足人群患者的临床结局。
背景:系统评价方法发表在国际系统评价前瞻性注册(PROSPERO:CRD42022378304)上。
BACKGROUND: Significant race and sex disparities exist in the prevalence, diagnosis, and outcomes of peripheral artery disease (PAD). However, clinical trials evaluating treatments for PAD often lack representative patient populations. This systematic review aims to summarize the demographic representation and enrollment strategies in clinical trials of lower-extremity endovascular interventions for PAD.
METHODS: Following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched multiple sources (Medline, EMBASE, Cochrane, Clinicaltrials.gov, WHO clinical trial registry) for randomized controlled trials (RCTs), RCT protocols, and peer-reviewed journal publications of RCTs conducted between January 2012 and December 2022. Descriptive analysis was used to summarize trial characteristics, publication or study protocol characteristics, and the reporting of demographic characteristics. Meta-regression was used to explore associations between demographic characteristics and certain trial characteristics.
RESULTS: A total of 2,374 records were identified. Of these, 59 met the inclusion criteria, consisting of 35 trials, 14 publications, and 10 protocols. Information regarding demographic representation was frequently missing. While all 14 trial publications reported age and sex, only 4 reported race/ethnicity, and none reported socioeconomic or marital status. Additionally, only 4 publications reported clinical outcomes by demographic characteristics. Meta-regression analysis revealed that 6% more women were enrolled in non-European trials (36%) than in European trials (30%).
CONCLUSIONS: The findings of this review highlight potential issues that may compromise the reliability and external validity of study findings in lower-extremity PAD RCTs when applied to the real-world population. Addressing these issues is crucial to enhance the generalizability and impact of clinical trial results in the field of PAD, ultimately leading to improved clinical outcomes for patients in underrepresented populations.
BACKGROUND: The systematic review methodology was published in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022378304).