Saggaf Moaath M, Liu Kathy, Ho George, Anastakis Emily E, Baltzer Heather
Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Toronto, Toronto, ON, Canada.
Hand Program, Department of Surgery, Toronto Western Hospital, University Health Network, Toronto, ON, Canada.
Plast Surg (Oakv). 2024 Aug;32(3):374-383. doi: 10.1177/22925503221141707. Epub 2022 Dec 4.
The aim of this study was to assess the sex differences in enrollment into clinical trials for Dupuytren's disease (DD), treatment efficacy, and complications. Three databases were searched; Ovid MEDLINE, Ovid EMBASE, and EBSCO CINAHL. Included studies were clinical trials on adult patients with DD. Exclusion criteria were non-English studies and other study designs. Two independent reviewers completed abstract screening, full-text review, and data extraction. The number and percentage of studies that reported ad hoc analyses for sex differences in treatment efficacy, tolerability, and complications were reported. A meta-analysis was performed on the proportion of female participants enrolled in clinical trials for DD. A total of 3172 references were screened, and 59 studies were identified for full-text review. We identified 28 clinical trials for DD of which none reported secondary analyses for sex differences. Only 2 trials discussed sex differences in complications, and one trial reported sex differences in tolerability. The proportion of female participants in the meta-analysis was 19.5% [95% CI: 16.1-23.0%]. Sex differences in the clinical trials for DD are not widely considered in clinical trials despite their critical role. Males and females do not have equal representation in clinical trials for DD. Future studies should account for sex differences in the design and the analysis of clinical trials.
本研究的目的是评估在掌腱膜挛缩症（DD）临床试验中的性别差异、治疗效果和并发症。检索了三个数据库：Ovid MEDLINE、Ovid EMBASE和EBSCO CINAHL。纳入的研究为针对成年DD患者的临床试验。排除标准为非英文研究和其他研究设计。两名独立评审员完成了摘要筛选、全文评审和数据提取。报告了针对治疗效果、耐受性和并发症性别差异进行特设分析的研究数量及百分比。对DD临床试验中女性参与者的比例进行了荟萃分析。共筛选了3172篇参考文献，确定了59项研究进行全文评审。我们确定了28项DD临床试验，其中没有一项报告性别差异的二次分析。只有2项试验讨论了并发症方面的性别差异，1项试验报告了耐受性方面的性别差异。荟萃分析中女性参与者的比例为19.5%[95%CI：16.1 - 23.0%]。尽管性别差异在DD临床试验中起着关键作用，但在临床试验中并未得到广泛考虑。在DD临床试验中，男性和女性的代表性并不平等。未来的研究应在临床试验的设计和分析中考虑性别差异。
