Evidence map›Paper›PMID 31443735›Full record

ArticleTrials2019

Hope and despair: a qualitative exploration of the experiences and impact of trial processes in a rehabilitation trial.

Meriel Norris, Leon Poltawski, Raff Calitri, Anthony I Shepherd, Sarah G Dean, ReTrain Team

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02429180 (Community-based Rehabilitation Training After Stroke), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT02429180 phase1completednot on this map

Community-based Rehabilitation Training After Stroke: a Pilot Randomised Controlled Trial

TypeinterventionalSponsorUniversity of ExeterRan2015 to 2016Enrolled48ConditionsStrokeArmsRehabilitation
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

6 authors.

Meriel NorrisCollege of Health and Life Sciences, Brunel University London, Uxbridge, UB8 3PH, UK. Meriel.norris@brunel.ac.uk.ORCID http://orcid.org/0000-0001-7779-5612
Leon PoltawskiUniversity of Exeter Medical School, Exeter, EX1 2LU, UK.
Raff CalitriUniversity of Exeter Medical School, Exeter, EX1 2LU, UK.
Anthony I ShepherdDepartment of Sport and Exercise Science, University of Portsmouth, Portsmouth, PO1 2ER, UK.
Sarah G DeanUniversity of Exeter Medical School, Exeter, EX1 2LU, UK.
ReTrain Team

Funding

The stroke association TSA 2014-03
6 · The paper itself

Abstract

backgroundUnanticipated responses by research participants can influence randomised controlled trials (RCTs) in multiple ways, many of which are poorly understood. This study used qualitative interviews as part of an embedded process evaluation to explore the impact participants may have on the study, but also unintended impacts the study may have on them.

aimThe aim of the study was to explore participants' experiences and the impact of trial involvement in a pilot RCT in order to inform the designing and delivery of a definitive RCT.

methodsIn-depth interviews with 20 participants (10 in the intervention and 10 in the control group) enrolled in a stroke rehabilitation pilot trial. A modified framework approach was used to analyse transcripts.

resultsParticipation in the study was motivated partly by a desperation to receive further rehabilitation after discharge. Responses to allocation to the control group included an increased commitment to self-treatment, and negative psychological consequences were also described. Accounts of participants in both control and intervention groups challenge the presumption that they were neutral, or in equipoise, regarding group allocation prior to consenting to randomisation.

conclusionsConsidering and exploring participant and participation effects, particularly in the control group, highlights numerous issues in the interpretation of trial studies, as well as the in ethics of RCTs more generally. While suggestions for a definitive trial design are given, further research is required to investigate the significant implications these findings may have for trial design, monitoring and funding.

trial registrationClinicalTrials.gov, NCT02429180 . Registered on 29 April/2015.

Indexed as

Health BehaviorHealth Knowledge, Attitudes, PracticeHopeStroke RehabilitationAgedAged, 80 and overAltruismFemaleHumansMaleMiddle AgedMotivationPilot ProjectsQualitative ResearchRandomized Controlled Trials as TopicResearch SubjectsEquipoiseQualitativeRandomisationRehabilitationStrokeTrial design

Identifiers

PMID31443735
PMCPMC6708169

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.