Determination of the minimal important difference for inspiratory muscle strength in people with severe and very severe COPD

Objective Inspiratory muscle training is recommended for people with chronic obstructive pulmonary disease (COPD) with inspiratory muscle weakness. Clinical interpretation of changes in inspiratory muscle strength could be helped by the determination of cut-off values. The aim of this study was to estimate the minimal important difference for inspiratory muscle strength assessed with maximal inspiratory pressure (MIP) in people with COPD. Design Post hoc analysis of a randomized controlled trial (EMI2 study) including people with severe to very severe COPD undergoing a pulmonary rehabilitation program was conducted. The determination of the minimal important difference was realized using both anchor-based and distribution-based methods. Setting The study includes patients admitted to the rehabilitation program unit of the Centre Hospitalier des Pays de Morlaix (Morlaix, France) between March 5, 2014 and September 8, 2016. Participants Seventy-three people with severe to very severe COPD (age 62.2 +/- 8.0 years, forced expiratory volume in 1 s 36.4 +/- 9.5% of theoretical) were analyzed. Intervention Patients followed a standardized pulmonary rehabilitation program 5 days a week for 4 weeks. The program included aerobic training, ground-based outdoor walking training, and strengthening of lower and upper limb muscles. Main measures At the end of the pulmonary rehabilitation program, MIP improved by 14.8 +/- 14.9 cmH(2)O (p < 0.05). Regarding the anchor-based method, only the modified Medical Research Council was selected as an appropriate anchor. The receiver operating characteristic curve analysis reported a minimal important difference of 13.5 cmH(2)O (sensibility: 75% specificity: 67.5%). Using distribution-based methods, the estimate of minimal important difference was 7.9 cmH(2)O (standard error of measurement method) and 10.9 cmH(2)O (size effect method). Results The estimations proposed by this study ranged from 7.9 to 13.5 cmH(2)O. Conclusions The measurement of minimal important difference is a simple tool for assessing the changes of inspiratory muscle strength during a pulmonary rehabilitation program. We propose a minimal important difference of 13.5 cmH(2)O for the improvement of MIP. Further studies are needed to confirm this estimation. ClinicalTrials.gov identifier: NCT02074813