Department of Geriatric Medicine, Oslo University Hospital, Ullevaal, P.O. Box 4956, 0424, Oslo, Nydalen, Norway.
Faculty of Health Sciences, Department of Health and Care Sciences, UiT The Arctic University of Norway, P.O. Box 385, 8505, Narvik, Norway.
Trials. 2021 Nov 27;22(1):850. doi: 10.1186/s13063-021-05765-w.
A commonly applied control condition in trials evaluating complex interventions in rehabilitation research is "usual care." The main challenge is to ensure that the control group receives genuine usual care as delivered in everyday clinical practice. The assessment interviews and dialogues with the data collectors may influence the control group participants' reflections on their condition and adjustments. This represents a threat to the internal validity of the trial. Thus, the aim of this study was to explore the perceived study-induced influence of assessment interviews on the adjustment of the members of a control group in a randomized clinical trial. The aim of the trial was to test a dialogue-based psychosocial intervention aiming at promoting the psychosocial well-being and adjustment of stroke survivors.
Fifteen participants in the control group of a multicenter stroke rehabilitation trial participated in narrative semi-structured interviews. Ricoeur's interpretation theory guided the analysis.
The perceived study-induced influence of the assessment interviews on the adjustment process of members of the control group varied considerably. The results demonstrated that the assessment interviews facilitated some participants' feelings of control and their ability to cope. Other participants' statements indicate that they relied on their existing personal capacity to cope and adjust and that the assessment interviews did not make any difference either on their coping ability or on their process of adjustment. Five themes were identified that described the perceived study-induced influence of the assessment interviews in the control group. The themes illustrated that the assessments served as a safety net, enhanced awareness and understanding, encouraged seeking support, allowed the opportunity to vent disappointment, or did not make any difference either way.
RCT assessment interviews may influence the adjustment process and represent a serious problem in measuring interventions over time in trials of complex interventions in rehabilitation research. To uphold rigor and stringency, the usual care control conditions should be thoroughly assessed and described. Informing participants only about the treatment they were allocated to receive might counteract the potential to dilute the difference between the two arms of the trial.
ClinicalTrials.gov NCT02338869. Registered on October 4, 2014.
在康复研究中评估复杂干预措施的试验中，常用的对照条件是“常规护理”。主要挑战是确保对照组接受真正的常规护理，就像在日常临床实践中提供的那样。评估访谈和与数据收集者的对话可能会影响对照组参与者对自身状况的反思和调整。这对试验的内部有效性构成了威胁。因此，本研究旨在探讨评估访谈对随机临床试验中对照组成员调整的感知研究影响。该试验的目的是测试一种基于对话的心理社会干预措施，旨在促进中风幸存者的心理社会幸福感和调整。
参加多中心中风康复试验的对照组的 15 名参与者参加了叙事半结构化访谈。里克尔的解释理论指导了分析。
评估访谈对对照组成员调整过程的感知研究影响差异很大。结果表明，评估访谈促进了一些参与者的控制感和应对能力。其他参与者的陈述表明，他们依赖于自己现有的应对和调整能力，评估访谈对他们的应对能力或调整过程没有任何影响。确定了五个主题，描述了评估访谈对对照组的感知研究影响。这些主题表明，评估作为安全网，增强了意识和理解，鼓励寻求支持，允许发泄失望，或者没有任何影响。
RCT 评估访谈可能会影响调整过程，并且是在康复研究中复杂干预措施试验中随时间测量干预措施的一个严重问题。为了保持严谨性，应彻底评估和描述常规护理对照条件。仅告知参与者他们接受的治疗可能会抵消潜在的稀释试验两个臂之间差异的可能性。
ClinicalTrials.gov NCT02338869。于 2014 年 10 月 4 日注册。
