A systematic review of discontinued trials suggested that most reasons for recruitment failure were preventable

被引:139
作者
Briel, Matthias [1 ,2 ]
Olu, Kelechi Kalu [1 ]
von Elm, Erik [3 ]
Kasenda, Benjamin [1 ,4 ]
Alturki, Reem [1 ]
Agarwal, Arnav [2 ]
Bhatnagar, Neera [2 ]
Schandelmaier, Stefan [1 ,2 ]
机构
[1] Univ Basel Hosp, Basel Inst Clin Epidemiol & Biostat, Dept Clin Res, Spitalstr 12, CH-4031 Basel, Switzerland
[2] McMaster Univ, Dept Clin Epidemiol & Biostat, 1280 Main St West, Hamilton, ON L8S 4K1, Canada
[3] Univ Lausanne Hosp, Inst Social & Prevent Med IUMSP, Cochrane Switzerland, Route Corniche 10, CH-1010 Lausanne, Switzerland
[4] Univ Basel Hosp, Dept Oncol, Petersgraben 4, CH-4031 Basel, Switzerland
基金
瑞士国家科学基金会;
关键词
Randomized controlled trials as topic; Early termination of clinical trials; Poor recruitment; Reasons for recruitment failure; Reporting quality; Systematic review; RANDOMIZED CONTROLLED-TRIALS; CLINICAL-TRIALS; PRIMARY-CARE; BARRIERS; PARTICIPATION; CANCER; CHALLENGES; RETENTION; ATTITUDES;
D O I
10.1016/j.jclinepi.2016.07.016
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Objective: To collect and classify reported reasons for recruitment failure in discontinued randomized controlled trials (RCTs) and to assess reporting quality. Methods: We systematically searched MEDLINE and EMBASE (2010-2014) and a previous cohort of RCTs for published RCTs reporting trial discontinuation due to poor recruitment. Teams of two investigators selected eligible RCTs working independently and extracted information using standardized forms. We used an iterative approach to classify reasons for poor recruitment. Results: We included 172 RCTs discontinued due to poor recruitment (including 26 conference abstracts and 63 industry funded RCTs). Of those, 131 (76%) reported one or more reasons for discontinuation due to poor recruitment. We identified 28 different reasons for recruitment failure; most frequently mentioned were overestimation of prevalence of eligible participants and prejudiced views of recruiters and participants on trial interventions. Few RCTs reported relevant details about the recruitment process such as how eligible participants were identified, the number of patients assessed for eligibility, and who actually recruited participants. Conclusion: Our classification could serve as a checklist to assist investigators in the planning of RCTs. Most reasons for recruitment failure seem preventable with a pilot study that applies the planned informed consent procedure. (C) 2016 Elsevier Inc. All rights reserved.
引用
收藏
页码:8 / 15
页数:8
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