Using qualitative methods in pilot and feasibility trials to inform recruitment and retention processes in full-scale randomised trials: a qualitative evidence synthesis.
Using qualitative methods in pilot and feasibility trials to inform recruitment and retention processes in full-scale randomised trials: a qualitative evidence synthesis.
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DOI：
10.1136/bmjopen-2021-055521
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发表时间：
2022-04-18
期刊：
影响因子：
2.9
通讯作者：
Gillies, Katie
中科院分区：
文献类型：
--
作者：
Elfeky, Adel;Treweek, Shaun;Hannes, Karin;Bruhn, Hanne;Fraser, Cynthia;Gillies, Katie
系统回顾已发表的试验前定性研究，并探讨其研究结果如何用于为全面试验中的招募和保留过程提供信息。
采用主题分析进行定性证据综合。
我们对数据库进行了全面搜索，包括国际学位论文摘要、护理及相关健康文献累积索引数据库（CINAHL）、荷兰医学文摘数据库（Embase）、医学文献分析与检索系统在线数据库（MEDLINE）、社会学文摘数据库和心理学信息数据库（PsycINFO）。我们纳入了截至2018年3月所有关于临床试验中招募和保留的试验前定性数据报告。
两位作者使用预先定义的数据提取表独立提取数据，该表格涵盖研究目的、设计、方法学途径和主要发现，包括招募和/或保留的障碍及促进因素。综合采用托马斯和哈登的主题综合方法，并按照《提高定性研究综合报告的透明度指南》进行报告。使用推荐分级评估、制定与评价——定性研究综述证据的可信度方法评估可信度。
纳入了2010年至2017年期间来自三个不同国家的35篇论文（与31项可行性研究相关）。所有研究都嵌入在试点或可行性研究中，为后续全面试验的设计方面提供信息。确定了12个主题作为招募障碍，3个主题作为招募促进因素。确定了2个主题作为保留障碍，没有确定保留促进因素。可行性或试点试验中的定性研究结果往往未明确与未来或计划中的全面试验拟采用的招募和保留策略的改变相关联。
许多试验团队进行试验前定性工作，目的是改善未来全面试验中的招募和保留情况。此类工作的报告中，仅有略多于一半的报告没有清楚表明其研究结果将如何改变未来试验的招募和保留策略。试验前工作的范围需要扩大，不仅要寻找问题，还要寻找可能有帮助的因素，并在保留方面投入更多时间。
To systematically review published pretrial qualitative research studies and explore how their findings were used to inform recruitment and retention processes in full-scale trials. Qualitative evidence synthesis using thematic analysis. We conducted a comprehensive search of databases; Dissertation Abstracts International, CINAHL, Embase, MEDLINE, Sociological Abstracts and PsycINFO. We included all reports of pretrial qualitative data on recruitment and retention in clinical trials up to March 2018. Two authors independently extracted data using a predefined data extraction form that captured study aims, design, methodological approach and main findings, including barriers and facilitators to recruitment and or retention. The synthesis was undertaken using Thomas and Harden’s thematic synthesis method and reported following the Enhancing Transparency in Reporting the Synthesis of Qualitative Research guidelines. Confidence was assessed using Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research approach. Thirty-five papers (connected to 31 feasibility studies) from three different countries, published between 2010 and 2017 were included. All studies were embedded in pilot or feasibility studies to inform design aspects in preparation for a subsequent full-scale trial. Twelve themes were identified as recruitment barriers and three as recruitment facilitators. Two themes were identified as barriers for retention and none as retention facilitators. The findings from qualitative research in feasibility or pilot trials are often not explicitly linked to proposed changes to the recruitment and retention strategies to be used in the future or planned full-scale trial. Many trial teams do pretrial qualitative work with the aim of improving recruitment and retention in future full-scale trials. Just over half of all reports of such work do not clearly show how their findings will change the recruitment and retention strategy of the future trial. The scope of pretrial work needs to expand beyond looking for problems and also look for what might help and spend more time on retention.
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DOI：
10.1186/s13012-015-0263-8
发表时间：
2015-05-23
期刊：
Implementation science : IS
影响因子：
--
作者：
Blekken LE;Nakrem S;Gjeilo KH;Norton C;Mørkved S;Vinsnes AG
通讯作者：
Vinsnes AG
影响因子：
2.5
作者：
Aventin Á;Lohan M;Maguire L;Clarke M
通讯作者：
Clarke M
影响因子：
1.7
作者：
Baldeh T;MacDonald T;Kosa SD;Lawson DO;Stalteri R;Olaiya OR;Alotaibi A;Thabane L;Mbuagbaw L
通讯作者：
Mbuagbaw L
影响因子：
3.6
作者：
Campbell, R.;Pound, P.;Donovan, J.
通讯作者：
Donovan, J.
影响因子：
2.5
作者：
Hennessy, Marita;Hunter, Andrew;Houghton, Catherine
通讯作者：
Houghton, Catherine