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Power of Outcome Measurements to Detect Clinically Significant Changes in Pulmonary Rehabilitation of Patients With COPD^*

^* From the Pulmonary and Critical Care Division (Drs. de Torres, Pinto-Plata, and Celli), St. Elizabeth’s Medical Center, Boston; Pulmonary and Critical Care Division (Dr. Ingenito), Brigham and Women’s Hospital, Boston; Pulmonary and Critical Care Division (Dr. Bagley), Lahey Clinic, Boston; and Pulmonary and Critical Care Division (Dr. Gray), University of Massachusetts Medical Center, Boston; and Harvard School of Medicine (Dr. Berger), Boston, MA.

Correspondence to: Bartolome Celli, MD, FCCP, St. Elizabeth’s Medical Center, Pulmonary and Critical Care Division, 736 Cambridge St, Boston, MA 02135-2997; e-mail: bcelli{at}semc.org

Study objectives: Several validated instruments are used to measure outcomes, such as exercise performance, dyspnea, and health-related quality of life after pulmonary rehabilitation (PR) in patients with COPD. However, no study has simultaneously compared the responsiveness of the most frequently used outcome measurements after PR. We designed this study to investigate the capacity of several of the most frequently used outcome measurements to detect changes after PR in a population of patients with severe COPD who qualified for lung volume reduction surgery.

Design, patients, and interventions: We evaluated 37 patients with severe COPD (FEV₁ < 40%) before and after 6 to 8 weeks of outpatient PR. The following frequently used tools were evaluated: the 6-min walk distance (6MWD); functional dyspnea with the Medical Research Council (MRC) scale; baseline and transitional dyspnea index (BDI/TDI); resting and 6MWD visual analog scale (VAS); quality of life with a generic tool (the Short Form-36 [SF-36]); and two disease-specific tools, the Chronic Respiratory Disease Questionnaire (CRQ) and the St. George’s Respiratory Questionnaire (SGRQ).

Results: After PR, mean ± SD 6MWD increased in 33 of 37 patients (89%), from 285 ± 97 to 343 ± 92 m (p = 0.009). Improvements were seen also in the MRC scale in 23 of 37 patients (62%; from 2.27 ± 0.8 to 1.86 ± 0.6; p = 0.01); in CRQ dyspnea in 25 of 37 patients (67%; from 3.25 ± 0.9 to 3.90 ± 1.4; p = 0.02); in CRQ mastery in 22 of 37 patients (60%; from 4.37 ± 1.4 to 5.14 ± 1.3; p = 0.01); and in BDI/TDI functional in 24 of 37 patients (64%; from 1.4 ± 0.8 to 0.7 ± 1.1; p = 0.002). There were smaller improvements in the SGRQ in 18 of 37 patients (48%) and in the SF-36 in 19 of 37 patients (51%), but they were not statistically significant. There were good correlations between the dyspnea components of all the tools. The 6MWD change did not correlate with the changes in the other outcomes. Clinically significant changes in the values for those outcome tools were detected in > 50% of patients for the BDI/TDI, 29% of patients for the MRC scale, in 37% of patients for the 6MWD, in 48% of patients for the VAS at peak exercise, in > 50% of patients for the CRQ, and in 40% of patients for the SGRQ.

Conclusions: We conclude that the VAS peak exercise, BDI/TDI, and CRQ adequately reflect the beneficial effects of PR. The 6MWD evaluates a unique domain not related to quality of life. Due to their simplicity and sensitivity, VAS at peak exercise, 6MWD, and CRQ may be the best practical tools to evaluate responsiveness to PR.

Key Words: COPD • pulmonary rehabilitation • quality of life

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