Ninomiya Maya Morton, Hiemstra Jenna, Nicholson Emma, Isaac Kathryn V
Department of Kinesiology and Health Sciences, University of Waterloo, Waterloo, ON, Canada.
Division of Plastic Surgery, Department of Surgery, University of British Columbia, 2221 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada.
World J Surg. 2023 Nov;47(11):2659-2667. doi: 10.1007/s00268-023-07124-z. Epub 2023 Aug 17.
Due to the complex nature of surgical randomized controlled trials (RCTs), reaching target recruitment can be challenging. The primary objective was to report on characteristics of successful pilot surgical and perioperative RCTs and the methodological strategies implemented to optimize recruitment. The secondary objective was to provide recommendations for successful recruitment strategies for future surgical RCTs. Ovid MEDLINE, Ovid EMBASE, and Web of Science (via Ovid) databases were searched from 2012 to 2022. This review included surgical and perioperative pilot studies that met their recruitment targets. Study and recruitment characteristics were summarized, and potential relationships between study design and recruitment rate were assessed. Optimized recruitment strategies were extracted when reported. Of 4156 total articles identified, 255 underwent full-text screening, and 52 articles were included. Of the included pilot studies, 21% (n = 11) did not indicate a target sample size or recruitment rate. Recruitment methods were minimally reported in pilot studies for perioperative or surgical RCTs. Strategies to optimize recruitment included internal iterative evaluations of the recorded recruitment appointments and staged introduction of the study. Recruitment rate was not associated with invasiveness of intervention or burden of participation. Patient involvement is absent from current reports on methodological design and offers valuable opportunity to optimize recruitment. Recruitment strategies in perioperative and surgical RCTs can be optimized with iterative qualitative evaluation of the recruitment methods with input from the interdisciplinary research team.
由于外科随机对照试验(RCT)的性质复杂,达到目标招募人数可能具有挑战性。主要目的是报告成功的外科手术及围手术期RCT试点研究的特征以及为优化招募而实施的方法策略。次要目的是为未来的外科RCT提供成功招募策略的建议。检索了2012年至2022年期间的Ovid MEDLINE、Ovid EMBASE和Web of Science(通过Ovid)数据库。本综述纳入了达到招募目标的外科手术及围手术期试点研究。总结了研究和招募特征,并评估了研究设计与招募率之间的潜在关系。如有报道,提取优化后的招募策略。在总共识别出的4156篇文章中,255篇进行了全文筛选,52篇文章被纳入。在纳入的试点研究中,21%(n = 11)未表明目标样本量或招募率。围手术期或外科RCT的试点研究中对招募方法的报道极少。优化招募的策略包括对记录的招募预约进行内部迭代评估以及分阶段介绍研究。招募率与干预的侵入性或参与负担无关。目前关于方法设计的报告中缺乏患者参与,而这为优化招募提供了宝贵机会。围手术期和外科RCT的招募策略可以通过跨学科研究团队的投入对招募方法进行迭代定性评估来优化。