Optimising adherence to inpatient rehabilitation trial protocols: A mixed-methods systematic review.

Abstract

Background: The 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.

Methods: A 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.

Results: Twenty-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.

Conclusion: Adherence 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.