Monash Nursing and Midwifery, Monash University, Clayton, Victoria, Australia.
Discipline of Surgery, School of Medicine, Faculty of Health, Clinical School, University of Tasmania, Hobart, Tasmania, Australia.
Int Wound J. 2018 Dec;15(6):880-892. doi: 10.1111/iwj.12940. Epub 2018 Jun 21.
Randomised controlled trials represent the gold standard in intervention efficacy evaluation. However, suboptimal recruitment affects completion and the power of a therapeutic trial in detecting treatment differences. We conducted a systematic review to examine the barriers and enablers to patient recruitment for randomised controlled trials on chronic wound treatment. Review registration was under PROSPERO 2017:CRD42017062438. We conducted a systematic search of Ovid MEDLINE, EBSCOhost CINAHL, Ovid Cochrane Library, Ovid EMBASE, and Ovid PsycINFO databases in June 2017 for chronic wound treatment randomised controlled trials. Twenty-seven randomised controlled trials or qualitative studies met the inclusion criteria. Among the 24 randomised controlled trials, 21 were assessed as low quality in relation to recruitment, and 3 were assessed as high quality. All 27 studies reported barriers to recruitment in chronic wound randomised controlled trials. The reported barriers to recruitment were: study-related, patient-related, clinician-related, health system-related, and/or operational-related. No study reported recruitment enablers. To enhance randomised controlled trial recruitment, we propose the need for improved integration of research and clinical practice. To alleviate the problems arising from inadequate reporting of randomised controlled trials, the Consolidated Standards of Reporting Trials Statement could include an additional item on recruitment barriers. This approach will allow for increased awareness of the potential barriers to recruitment for Randomised controlled trials (RCTs) in both wound management and other health care research.
随机对照试验是干预疗效评估的金标准。然而，招募效果不佳会影响试验的完成和治疗差异的检测能力。我们进行了一项系统评价，以考察影响慢性伤口治疗随机对照试验患者招募的障碍和促进因素。本研究已在 PROSPERO 2017 系统注册，注册号为 CRD42017062438。我们于 2017 年 6 月对 Ovid MEDLINE、EBSCOhost CINAHL、Ovid Cochrane 图书馆、Ovid EMBASE 和 Ovid PsycINFO 数据库进行了系统检索，以获取有关慢性伤口治疗的随机对照试验。共有 27 项随机对照试验或定性研究符合纳入标准。在 24 项随机对照试验中，有 21 项在招募方面被评估为低质量，3 项被评估为高质量。所有 27 项研究均报告了慢性伤口随机对照试验招募存在障碍。报告的招募障碍包括：研究相关、患者相关、临床医生相关、卫生系统相关和/或操作性相关。没有研究报告招募促进因素。为了提高随机对照试验的招募率，我们建议需要更好地将研究和临床实践相结合。为了缓解随机对照试验报告不充分所带来的问题，CONSORT 声明可以增加关于招募障碍的额外条目。这种方法将提高人们对随机对照试验（RCTs）在伤口管理和其他医疗保健研究中招募潜在障碍的认识。
