Perceived study-induced influence on the control group in a randomized controlled trial evaluating a complex intervention to promote psychosocial well-being after stroke: a process evaluation

Trials

Margrete Mangset¹  Unni Sveen²  Line K. Bragstad³  Sanne Angel⁴  Lena Aadal⁵  Anne S. Evju⁶  Gabriele Kitzmüller⁶  Berit Arnesveen Bronken⁷  Randi Martinsen⁷  Kari J. Kvigne⁸  Ellen Gabrielsen Hjelle⁹  Marit Kirkevold^1,10 

[1] Department of Geriatric Medicine, Oslo University Hospital, Ullevaal, P.O. Box 4956, 0424, Oslo, Nydalen, Norway;Department of Geriatric Medicine, Oslo University Hospital, Ullevaal, P.O. Box 4956, 0424, Oslo, Nydalen, Norway;Oslo Metropolitan University, P.O. Box 4, St. Olavs plass, 0130, Oslo, Norway;Department of Geriatric Medicine, Oslo University Hospital, Ullevaal, P.O. Box 4956, 0424, Oslo, Nydalen, Norway;University of Oslo, P.O. Box 1130, 0318, Oslo, Blindern, Norway;Institute of Health and Society and Research Center for Habilitation and Rehabilitation Services and Models (CHARM), University of Oslo, P.O. Box 1130, 0318, Oslo, Blindern, Norway;Department of Public Health – Research Unit for Nursing and Healthcare, Department of Science in Nursing, Aarhus University, 8000, Aarhus, Denmark;Faculty of Health Sciences and Social Care, Molde University College, P.O. Box 2110, NO-6402, Molde, Norway;Faculty of Health Sciences and Social Care, Molde University College, P.O. Box 2110, NO-6402, Molde, Norway;Hammel Neurorehabilitation Centre and University Research Clinic, 8450, Hammel, Denmark;Department of Clinical Medicine, Aarhus University, C, 8000, Aarhus, Denmark;Faculty of Health Sciences, Department of Health and Care Sciences, UiT The Arctic University of Norway, P.O. Box 385, 8505, Narvik, Norway;Inland Norway University of Applied Sciences, P.B. 400, 2418, Elverum, Norway;Inland Norway University of Applied Sciences, P.B. 400, 2418, Elverum, Norway;The Faculty of Nursing and Health Sciences, Nord University, P.B. 1490, 8049, Bodø, Norway;University of Oslo, P.O. Box 1130, 0318, Oslo, Blindern, Norway;Institute of Health and Society and Research Center for Habilitation and Rehabilitation Services and Models (CHARM), University of Oslo, P.O. Box 1130, 0318, Oslo, Blindern, Norway;University of Oslo, P.O. Box 1130, 0318, Oslo, Blindern, Norway;Oslo Metropolitan University, P.O. Box 4, St. Olavs plass, 0130, Oslo, Norway;

关键词: Bias;    Complex interventions;    Control groups;    Process evaluation;    Research design;    RCT (randomized controlled trials);    Rehabilitation research;    Stroke;    Usual care;   

DOI  :  10.1186/s13063-021-05765-w

来源: Springer

【 摘 要 】

BackgroundA 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.MethodsFifteen participants in the control group of a multicenter stroke rehabilitation trial participated in narrative semi-structured interviews. Ricoeur’s interpretation theory guided the analysis.ResultsThe 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.ConclusionsRCT 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.Trial registrationClinicalTrials.gov NCT02338869. Registered on October 4, 2014

【 授权许可】

CC BY