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参与随机对照试验的招募障碍和促进因素:定性视角。

Barriers and facilitators to participant recruitment to randomised controlled trials: A qualitative perspective.

机构信息

Monash Nursing and Midwifery, Monash University, Clayton, Victoria, Australia.

出版信息

Int Wound J. 2018 Dec;15(6):929-942. doi: 10.1111/iwj.12950. Epub 2018 Jul 5.

Abstract

Low recruitment rates for randomised controlled trials (RCTs) are a common issue. Information on barriers and facilitators to recruitment for RCTs may inform researchers on how to improve the recruitment rate. The aim of this qualitative project was to identify barriers and facilitators to participant recruitment for a randomised double-blinded placebo-controlled trial on the clinical effectiveness of aspirin as an adjunct to compression therapy in healing chronic venous leg ulcers. We have conducted interviews with health professionals and project workers to understand their perspective on low recruitment rate, barriers to, and facilitators of recruitment. NVivo 11 software was used for data management and coding. Thematic analysis was applied as a method of data analysis. Although strict recruitment criteria were the main barrier, there were other recruitment barriers that should be considered when planning RCTs. We have further developed a framework of factors influencing the recruitment rate. The main recruitment barriers, including study-related, participant-related, practitioner-related, collaboration-related, ethics-related, practice-related, and health system-related barriers, should be considered for inclusion in the "Other Information" section of Consolidated Standards of Reporting Trials Statement to improve the quality of reporting and ensure the strategic planning of future RCTs.

摘要

随机对照试验(RCT)的招募率低是一个常见问题。有关招募RCT 的障碍和促进因素的信息可以为研究人员提供如何提高招募率的信息。本定性项目的目的是确定一项关于阿司匹林作为慢性静脉性腿部溃疡的压缩治疗辅助疗法的临床效果的随机双盲安慰剂对照试验的参与者招募的障碍和促进因素。我们对卫生专业人员和项目工作人员进行了访谈,以了解他们对低招募率、招募障碍和促进因素的看法。使用 NVivo 11 软件进行数据管理和编码。主题分析被用作数据分析的方法。尽管严格的招募标准是主要障碍,但在计划 RCT 时还应考虑其他招募障碍。我们进一步制定了影响招募率的因素框架。主要的招募障碍,包括与研究相关、与参与者相关、与从业者相关、与合作相关、与伦理相关、与实践相关和与卫生系统相关的障碍,应考虑包含在 CONSORT 声明的“其他信息”部分中,以提高报告质量并确保未来 RCT 的战略规划。

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