A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse
A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse
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DOI：
10.1186/1745-6215-14-353
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发表时间：
2013-10-25
期刊：
影响因子：
2.5
通讯作者：
Sinclair, Lesley
中科院分区：
文献类型：
--
作者：
Bugge, Carol;Williams, Brian;Sinclair, Lesley
背景：当前医学研究委员会 (MRC) 关于复杂干预措施的指导主张将试点试验和可行性研究作为医疗保健干预措施开发、测试和评估分阶段方法的一部分。在本文中，我们讨论了最近一项针对盆底肌肉脱垂训练的随机对照试验 (RCT) 的可行性研究和预试验的结果（ClinicalTrials.gov：NCT01136889）。研究人员决定对可行性工作结果做出反应的方式可能会对最终试验中内部效度和外部效度之间紧张的性质和程度产生重大影响。 方法：我们使用方法论问题对可行性研究中出现的问题进行分类和分析。四个中心参与其中，目的是随机抽取 50 名女性。如果女性患有第一至第四期任何类型的脱垂，并且成功安装了子宫托，则她们符合资格。在基线、随机分组后 6 个月和 7 个月时进行邮寄问卷调查。在确定试点研究中出现的问题后，我们寻求找到潜在的解决方案，以最大限度地减少随后的解释性试验与实用性试验之间的权衡。结果：可行性研究指出了与参与者招募、干预措施的特点、参与者对干预措施的可接受性以及结果衡量相关的重大潜在问题。为了找到最少的证据来支持我们关于从可行性工作过渡到试验的决策，我们开发了一个系统流程（试点和可行性试验后决策流程 (ADePT)），随后将其用作指南。该过程旨在：1）鼓励系统地识别和评估问题和潜在的解决方案； 2）提高决策过程的透明度； 3）揭示实用性和解释性选择之间存在的紧张关系。结论：我们开发了一个过程，可以帮助研究人员尝试为未来试点和可行性随机对照试验中发现的问题找到最合适的解决方案。该过程包括三个关键步骤：决定问题类型、确定所有解决方案（无论是在干预、试验设计还是临床背景下解决）以及对这些解决方案进行系统评估。
Background: Current Medical Research Council (MRC) guidance on complex interventions advocates pilot trials and feasibility studies as part of a phased approach to the development, testing, and evaluation of healthcare interventions. In this paper we discuss the results of a recent feasibility study and pilot trial for a randomized controlled trial (RCT) of pelvic floor muscle training for prolapse (ClinicalTrials.gov: NCT01136889). The ways in which researchers decide to respond to the results of feasibility work may have significant repercussions for both the nature and degree of tension between internal and external validity in a definitive trial.Methods: We used methodological issues to classify and analyze the problems that arose in the feasibility study. Four centers participated with the aim of randomizing 50 women. Women were eligible if they had prolapse of any type, of stage I to IV, and had a pessary successfully fitted. Postal questionnaires were administered at baseline, 6 months, and 7 months post-randomization. After identifying problems arising within the pilot study we then sought to locate potential solutions that might minimize the trade-off between a subsequent explanatory versus pragmatic trial.Results: The feasibility study pointed to significant potential problems in relation to participant recruitment, features of the intervention, acceptability of the intervention to participants, and outcome measurement. Finding minimal evidence to support our decision-making regarding the transition from feasibility work to a trial, we developed a systematic process (A process for Decision-making after Pilot and feasibility Trials (ADePT)) which we subsequently used as a guide. The process sought to: 1) encourage the systematic identification and appraisal of problems and potential solutions; 2) improve the transparency of decision-making processes; and 3) reveal the tensions that exist between pragmatic and explanatory choices.Conclusions: We have developed a process that may aid researchers in their attempt to identify the most appropriate solutions to problems identified within future pilot and feasibility RCTs. The process includes three key steps: a decision about the type of problem, the identification of all solutions (whether addressed within the intervention, trial design or clinical context), and a systematic appraisal of these solutions.