Evidence map›Paper›PMID 34838094›Full record

Trial reportTrials2021

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.

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 and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02338869 (Psycho-Social Well Being Following Stroke - A Randomized Controlled Trial), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02338869 nacompletednot on this map

Psycho-Social Well Being Following Stroke - A Randomized Controlled Trial

TypeinterventionalSponsorUniversity of OsloRan2014 to 2018Enrolled322ConditionsStrokeArmsDialogue-based psychosocial rehabilitation
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 3 countries.

Margrete MangsetDepartment of Geriatric Medicine, Oslo University Hospital, Ullevaal, P.O. Box 4956, 0424, Oslo, Nydalen, Norway. margrete.mangset@medisin.uio.no.ORCID http://orcid.org/0000-0002-4005-1430
Gabriele KitzmüllerFaculty of Health Sciences, Department of Health and Care Sciences, UiT The Arctic University of Norway, P.O. Box 385, 8505, Narvik, Norway.ORCID https://orcid.org/0000-0002-8528-6137
Anne S EvjuFaculty of Health Sciences, Department of Health and Care Sciences, UiT The Arctic University of Norway, P.O. Box 385, 8505, Narvik, Norway.
Sanne AngelDepartment of Public Health - Research Unit for Nursing and Healthcare, Department of Science in Nursing, Aarhus University, 8000, Aarhus, Denmark.
Lena AadalFaculty of Health Sciences and Social Care, Molde University College, P.O. Box 2110, NO-6402, Molde, Norway.
Randi MartinsenInland Norway University of Applied Sciences, P.B. 400, 2418, Elverum, Norway.
Berit Arnesveen BronkenInland Norway University of Applied Sciences, P.B. 400, 2418, Elverum, Norway.
Kari J KvigneInland Norway University of Applied Sciences, P.B. 400, 2418, Elverum, Norway.
Line K BragstadDepartment of Geriatric Medicine, Oslo University Hospital, Ullevaal, P.O. Box 4956, 0424, Oslo, Nydalen, Norway.ORCID https://orcid.org/0000-0002-9645-3770
Ellen Gabrielsen HjelleUniversity of Oslo, P.O. Box 1130, 0318, Oslo, Blindern, Norway.
Unni SveenDepartment of Geriatric Medicine, Oslo University Hospital, Ullevaal, P.O. Box 4956, 0424, Oslo, Nydalen, Norway.
Marit KirkevoldUniversity of Oslo, P.O. Box 1130, 0318, Oslo, Blindern, Norway.
Oslo University Hospital · NOMolde University College · NOUiT The Arctic University of Norway · NOUniversity of Inland Norway · NONord University · NOOsloMet – Oslo Metropolitan University · NOUniversity of Oslo · NO

Funding

Helse Sør-Øst RHF 2013086the European Union Seventh 532 Framework Program 609020
6 · The paper itself

Abstract

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.

Indexed as

StrokeStroke RehabilitationAdaptation, PsychologicalControl GroupsHumansQuality of LifeBiasComplex interventionsControl groupsProcess evaluationRCT (randomized controlled trials)Rehabilitation researchResearch designStrokeUsual care

Identifiers

PMID34838094
PMCPMC8627040
OpenAlexW3214785779

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.