Cooper Cindy, O'Cathain Alicia, Hind Danny, Adamson Joy, Lawton Julia, Baird Wendy
Sheffield Clinical Trials Research Unit, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S14DA, United Kingdom.
Medical Care Research Unit, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S14DA, United Kingdom.
Contemp Clin Trials. 2014 Jul;38(2):338-43. doi: 10.1016/j.cct.2014.06.002. Epub 2014 Jun 14.
The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: We make recommendations for improving the management of qualitative research within CTUs.
在随机对照试验（RCT）中或与之同时运用定性研究的价值正越来越被广泛接受。定性研究可与试点或完整的RCT同时开展，以了解所测试干预措施的可行性和可接受性，或改进试验实施过程。英国的临床试验单位（CTU）管理着大量的RCT，并且越来越多地管理定性研究或与CTU外部的定性研究人员合作。CTU开始明确管理这一过程，例如，通过使用设计和实施与试验相关的定性研究的标准操作程序。我们回顾了英国临床研究协作组织（UKCRC）注册的两个CTU与RCT同时开展定性研究的经验。借鉴从15项研究中获得的经验，我们确定了定性研究可能破坏RCT成功完成或科学完整性的可能性。我们表明，向试验团队成员或其他人员反馈中期或最终定性研究结果，尤其是在试验进行期间报告定性研究结果时，可能会出现潜在问题。这些问题包括：我们就改进CTU内定性研究的管理提出了建议。
