Abstract
BackgroundThe rationale for commissioning community pulmonary rehabilitation programmes is based on evidence from randomised clinical trials. However, there are a number of reasons why similar programmes might be less effective outside the environment of a clinical trial. These include a less highly selected patient group and less control over the fidelity of intervention delivery. The main objective of this study was therefore to test the hypothesis that the real-world programme would have similar outcomes to an intervention delivered in the context of a clinical trial.MethodsAs part of the evaluation of an innovative community-based pulmonary rehabilitation programme (“BreathingSpace”), clinical and quality of life measures were collected before and after delivery of a rehabilitation programme. Baseline characteristics of participants and the change in symptoms and quality of life after the BreathingSpace programme were compared to measures collected in the community-based arm of a separate randomised trial of pulmonary rehabilitation.ResultsDespite differences between the BreathingSpace participants and research participants in clinical status at baseline, patient reported symptoms and quality of life measures were similar. Improvements in both symptoms and quality of life were of the same order of magnitude despite the different contexts, setting and scale of the two intervention programmes. Whilst 73% (326/448) of those considered suitable for community rehabilitation in the trial and 80% (393/491) assessed as suitable for the BreathingSpace programme agreed to participate, less than half of participants completed rehabilitation, whether in a research or “real world” setting ( 47% and 45% respectively).ConclusionThe before-after changes in outcomes seen in a “real world” community rehabilitation programme are similar in magnitude to those seen in the intervention arm of a clinical trial. However suboptimal uptake and high dropout rates from rehabilitation amongst eligible participants occurs in both clinical trials and community based programmes and must be addressed if the benefits of rehabilitation for people with chronic lung disease are to be maximised.
Highlights
The rationale for commissioning community pulmonary rehabilitation programmes is based on evidence from randomised clinical trials
The rationale for commissioning community pulmonary rehabilitation programmes is based on the results of randomised controlled trials (RCTs) in which rehabilitation has been shown to be effective and cost-effective in increasing exercise tolerance, reducing symptoms, improving quality of life and reducing hospital admissions [1,2,3]
Overall the main differences between the two programmes are those that might typically be found when comparing a randomised trial intervention and a community programme outside the context of a trial, in that the trial was designed as a “pragmatic” trial and the trial protocol and report stresses that “access to the sessions was designed to follow usual clinical practice, reflecting ‘real life’ conditions” [8], the intervention did have more restrictive inclusion criteria (MRC severity grade of 3 or greater) and a more standardised intervention (“Programmes were identical in each venue, with exercises following a protocol and a core syllabus for each of the educational aspects” [8])
Summary
The rationale for commissioning community pulmonary rehabilitation programmes is based on evidence from randomised clinical trials. There are a number of reasons why similar programmes might be less effective outside the environment of a clinical trial. These include a less highly selected patient group and less control over the fidelity of intervention delivery. The rationale for commissioning community pulmonary rehabilitation programmes is based on the results of randomised controlled trials (RCTs) in which rehabilitation has been shown to be effective and cost-effective in increasing exercise tolerance, reducing symptoms, improving quality of life and reducing hospital admissions [1,2,3]. The very nature of being observed in a trial can result in different behaviour by both patients and clinicians and potentially a different outcome (the “Hawthorne effect”) [7]
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