Objectives Physical rehabilitation is a complex process, and trials of rehabilitation interventions are increasing in number but often report null results. This study aimed to establish treatment success rates in physical rehabilitation trials funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) programme and examine any relationship between treatment success and the quality of intervention development work undertaken.
Design This is a mixed methods study.
Setting This study was conducted in the UK.
Methods The NIHR HTA portfolio was searched for all completed definitive randomised controlled trials of physical rehabilitation interventions from inception to July 2016. Treatment success was categorised according to criteria developed by Djulbegovic and colleagues. Detailed textual data regarding any intervention development work were extracted from trial reports and supporting publications and informed the development of quality ratings. Mixed methods integrative analysis was undertaken to explore the relationship between quantitative and qualitative data using joint displays.
Results Fifteen trials were included in the review. Five reported a definitive finding, four of which were in favour of the ‘new’ intervention. Eight trials reported a true negative (no difference) outcome. Integrative analysis indicated those with lower quality intervention development work were less likely to report treatment success.
Conclusions Despite much effort and funding, most physical rehabilitation trials report equivocal findings. Greater focus on high quality intervention development may reduce the likelihood of a null result in the definitive trial, alongside high quality trial methods and conduct.
- randomised controlled trials
- intervention development
- mixed methods
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Contributors VAG: conception and design, data collection, analysis and interpretation, drafting and approving the manuscript; JJH: design, data collection, analysis and interpretation, drafting and approving the manuscript; JAF: data collection, analysis, revising and approving the manuscript; KF: data collection, revising and approving the manuscript; CP: data collection, revising and approving the manuscript; DAR: conception, revising and approving the manuscript.
Funding This study was not funded.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available.
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