Rationale and design of the PRSM study: pulmonary rehabilitation or self management for chronic obstructive pulmonary disease (COPD), what is the best approach?

摘要

BACKGROUND: Pulmonary rehabilitation is only accessible by a small proportion of individuals with COPD. For the vast majority who are not able to access these programs, self management approaches may be an alternative to improve health care outcomes. METHODS: The PRSM study is a three group randomised controlled trial with individual randomisation, blinded outcome assessment, 3 monthly follow-up assessments across a 12-month period and concurrent economic evaluation. The inclusion criteria are adults with COPD. The primary outcome measure is the St George Respiratory Disease Questionnaire. Secondary outcome measures include a series of questionnaires (Frenchay Activities Index, International Physical Activity Questionnaire, the Hospital Anxiety and Depression Scale and the COPD self-efficacy scale) and two physiological measures (Forced Vital Capacity in 1-second and an incremental shuttle walk). Economic outcome measures include assessment of direct and indirect costs. The sample size of 318 patients (106 per group) is required to detect 4 point difference in the SGRQ, power 90% employing a 2 tailed alpha=0.05. RESULTS: Enrollment to start April 2008 and complete December 2010. Intention to treat analyses will be used to compare group effect. CONCLUSION: The results will provide an evidence base regarding the community management of individuals with COPD.