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

Abstract Background 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...

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Autores principales: Margrete Mangset, Gabriele Kitzmüller, Anne S. Evju, Sanne Angel, Lena Aadal, Randi Martinsen, Berit Arnesveen Bronken, Kari J. Kvigne, Line K. Bragstad, Ellen Gabrielsen Hjelle, Unni Sveen, Marit Kirkevold
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spelling oai:doaj.org-article:0744bf2a99cf45f1bffd08d3469c6a582021-11-28T12:28:29ZPerceived 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 evaluation10.1186/s13063-021-05765-w1745-6215https://doaj.org/article/0744bf2a99cf45f1bffd08d3469c6a582021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05765-whttps://doaj.org/toc/1745-6215Abstract Background 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. Methods 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. Results 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. Conclusions 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. Trial registration ClinicalTrials.gov NCT02338869. Registered on October 4, 2014Margrete MangsetGabriele KitzmüllerAnne S. EvjuSanne AngelLena AadalRandi MartinsenBerit Arnesveen BronkenKari J. KvigneLine K. BragstadEllen Gabrielsen HjelleUnni SveenMarit KirkevoldBMCarticleBiasComplex interventionsControl groupsProcess evaluationResearch designRCT (randomized controlled trials)Medicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-10 (2021)
institution DOAJ
collection DOAJ
language EN
topic Bias
Complex interventions
Control groups
Process evaluation
Research design
RCT (randomized controlled trials)
Medicine (General)
R5-920
spellingShingle Bias
Complex interventions
Control groups
Process evaluation
Research design
RCT (randomized controlled trials)
Medicine (General)
R5-920
Margrete Mangset
Gabriele Kitzmüller
Anne S. Evju
Sanne Angel
Lena Aadal
Randi Martinsen
Berit Arnesveen Bronken
Kari J. Kvigne
Line K. Bragstad
Ellen Gabrielsen Hjelle
Unni Sveen
Marit Kirkevold
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
description Abstract Background 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. Methods 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. Results 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. Conclusions 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. Trial registration ClinicalTrials.gov NCT02338869. Registered on October 4, 2014
format article
author Margrete Mangset
Gabriele Kitzmüller
Anne S. Evju
Sanne Angel
Lena Aadal
Randi Martinsen
Berit Arnesveen Bronken
Kari J. Kvigne
Line K. Bragstad
Ellen Gabrielsen Hjelle
Unni Sveen
Marit Kirkevold
author_facet Margrete Mangset
Gabriele Kitzmüller
Anne S. Evju
Sanne Angel
Lena Aadal
Randi Martinsen
Berit Arnesveen Bronken
Kari J. Kvigne
Line K. Bragstad
Ellen Gabrielsen Hjelle
Unni Sveen
Marit Kirkevold
author_sort Margrete Mangset
title 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
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
publisher BMC
publishDate 2021
url https://doaj.org/article/0744bf2a99cf45f1bffd08d3469c6a58
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