1 North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK.
2 Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.
Clin Trials. 2018 Dec;15(6):533-542. doi: 10.1177/1740774518796156. Epub 2018 Aug 31.
Recruiting the target number of participants within the pre-specified time frame agreed with funders remains a common challenge in the completion of a successful clinical trial and addressing this is an important methodological priority. While there is growing research around recruitment, navigating this literature to support an evidence-based approach remains difficult. The Online resource for Recruitment Research in Clinical triAls project aims to create an online searchable database of recruitment research to improve access to existing evidence and to identify gaps for future research.
MEDLINE (Ovid), Scopus, Cochrane Database of Systematic Reviews and Cochrane Methodology Register, Science Citation Index Expanded and Social Sciences Citation Index within the ISI Web of Science and Education Resources Information Center were searched in January 2015. Search strategy results were screened by title and abstract, and full text obtained for potentially eligible articles. Studies reporting or evaluating strategies, interventions or methods used to recruit patients were included along with case reports and studies exploring reasons for patient participation or non-participation. Eligible articles were categorised as systematic reviews, nested randomised controlled trials and other designs evaluating the effects of recruitment strategies (Level 1); studies that report the use of recruitment strategies without an evaluation of impact (Level 2); or articles reporting factors affecting recruitment without presenting a particular recruitment strategy (Level 3). Articles were also assigned to 1, or more, of 42 predefined recruitment domains grouped under 6 categories.
More than 60,000 records were retrieved by the search, resulting in 56,030 unique titles and abstracts for screening, with a further 23 found through hand searches. A total of 4570 full text articles were checked; 2804 were eligible. Six percent of the included articles evaluated the effectiveness of a recruitment strategy (Level 1), with most of these assessing aspects of participant information, either its method of delivery (33%) or its content and format (28%).
Recruitment to clinical trials remains a common challenge and an important area for future research. The online resource for Recruitment Research in Clinical triAls project provides a searchable, online database of research relevant to recruitment. The project has identified the need for researchers to evaluate their recruitment strategies to improve the evidence base and broaden the narrow focus of existing research to help meet the complex challenges faced by those recruiting to clinical trials.
在与资助者商定的预先指定时间框架内招募到目标数量的参与者仍然是成功完成临床试验的常见挑战，解决这个问题是一个重要的方法学优先事项。虽然关于招募的研究越来越多，但要在文献中找到支持循证方法的内容仍然很困难。临床试验招募研究在线资源项目旨在创建一个在线可搜索的招募研究数据库，以提高对现有证据的访问，并确定未来研究的空白。
2015 年 1 月，在 MEDLINE（Ovid）、Scopus、Cochrane 系统评价数据库和 Cochrane 方法学登记册、科学引文索引扩展版和科学引文索引社会科学版（ISI Web of Science）以及教育资源信息中心进行了检索。通过标题和摘要筛选了检索结果，对可能符合条件的文章获取全文。纳入了报告或评估招募患者的策略、干预措施或方法的研究，以及探索患者参与或不参与原因的病例报告和研究。符合条件的文章被归类为系统评价、嵌套随机对照试验和其他评估招募策略效果的设计（一级）；报告使用招募策略但未评估影响的研究（二级）；或报告影响招募的因素而不提出特定招募策略的文章（三级）。文章还被分配到 6 个类别下的 42 个预先定义的招募领域中的 1 个或多个领域。
搜索共检索到超过 60,000 条记录，筛选出 56,030 个独特的标题和摘要，通过手工搜索又发现了 23 个。共检查了 4570 篇全文文章，其中 2804 篇符合条件。纳入的文章有 6%评估了招募策略的有效性（一级），其中大多数评估了参与者信息的方面，要么是其传递方法（33%），要么是其内容和格式（28%）。
临床试验的招募仍然是一个常见的挑战，也是未来研究的一个重要领域。临床试验招募研究在线资源项目提供了一个可搜索的在线数据库，其中包含与招募相关的研究。该项目已经确定，研究人员需要评估他们的招募策略，以提高证据基础，并拓宽现有研究的狭隘重点，以帮助应对临床试验招募所面临的复杂挑战。
