SynthesisClinical trials (London, England)2025
Optimising adherence to inpatient rehabilitation trial protocols: A mixed-methods systematic review.
Synthesis in Clinical trials (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07484958 (Co-designing a Toolkit to Optimise Adherence to Inpatient Stroke Rehabilitation Trial Protocols), which is not on this map. Not yet cited in PubMed.
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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.
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.
Co-designing a Toolkit to Optimise Adherence to Inpatient Stroke Rehabilitation Trial Protocols
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe results of rehabilitation clinical trials can be negatively affected by adherence to trial protocols. Adherence is multi-factorial, but studies often look at adherence factors separately. Therefore, a systematic review to appraise and synthesise the evidence is warranted to determine the barriers, facilitators and predictors associated with adherence to inpatient rehabilitation trial protocols, whether and how factors interact with one another, and how adherence to rehabilitation protocols can be optimised.
methodsA mixed-methods systematic review was conducted and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Databases searched were PubMed (Ovid), EMBASE (Ovid), MEDLINE (Ovid), CINAHL (Ovid), PsycINFO (Ovid), Cochrane Library, Health Technology Assessment Database, Web of Science and grey literature up to April 2024. A cohesive, integrated methodology was employed, leveraging the Consolidated Framework for Implementation Research (CFIR) 2.0, to transform, synthesise and integrate data from various methodologies to address the review objectives.
resultsTwenty-seven studies met the inclusion criteria (randomised controlled trials, qualitative studies related to randomised controlled trials or mixed-methods). Most of the studies were in stroke (n = 17), but other studies included neurological, respiratory, cardiovascular, post-surgical, osteoarthritis and elderly medical. Multiple factors affecting adherence protocols were identified. Adherence was measured in various ways, and setting pre-specified adherence levels was uncommon.
conclusionAdherence to inpatient rehabilitation trial protocols is multi-dimensional and multi-factorial. Consensus of adherence measurement and interpretation of adherence levels is needed to make meaningful comparisons between trials. A standardised approach, including adopting a traffic light system, would enable trialists to implement changes mid-trial or stop the trial to avoid research waste. Adopting approaches from behavioural science in the design and conduct of inpatient rehabilitation trials may overcome some of the behavioural barriers identified and optimise adherence for those delivering and receiving the intervention. REVIEW REGISTRATION: Prospective Register of Systematic Reviews, registration number CRD42021270121.
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