Published in:
Open Access 01-12-2013 | Research article
Is a large scale community programme as effective as a community rehabilitation programme delivered in the setting of a clinical trial?
Published in: BMC Medical Research Methodology | Issue 1/2013
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Background
The 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.
Methods
As 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.
Results
Despite 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).
Conclusion
The 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.