Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, Morlaix, France.
Inserm, Univ Brest, CHRU Brest, UMR 1304, GETBO, Brest, France.
Clin Rehabil. 2023 Nov;37(11):1521-1532. doi: 10.1177/02692155231174124. Epub 2023 May 15.
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.
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.
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.
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.
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.
At the end of the pulmonary rehabilitation program, MIP improved by 14.8 ± 14.9 cmHO (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 cmHO (sensibility: 75% specificity: 67.5%). Using distribution-based methods, the estimate of minimal important difference was 7.9 cmHO (standard error of measurement method) and 10.9 cmHO (size effect method).
The estimations proposed by this study ranged from 7.9 to 13.5 cmHO.
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 cmHO for the improvement of MIP. Further studies are needed to confirm this estimation.ClinicalTrials.gov identifier: NCT02074813.
吸气肌训练适用于存在吸气肌无力的慢性阻塞性肺疾病（COPD）患者。通过确定临界值，可以帮助临床解释吸气肌力量变化。本研究的目的是评估使用最大吸气压力（MIP）评估 COPD 患者的吸气肌力量的最小有意义差异。
对一项包括严重至极重度 COPD 患者的随机对照试验（EMI2 研究）进行了事后分析，这些患者正在接受肺康复计划。使用基于锚定和基于分布的方法来确定最小有意义差异。
该研究包括 2014 年 3 月 5 日至 2016 年 9 月 8 日期间在法国莫尔莱中心医院康复计划科就诊的患者。
分析了 73 名严重至极重度 COPD 患者（年龄 62.2±8.0 岁，1 秒用力呼气量占预计值的 36.4±9.5%）。
患者每周 5 天接受标准化肺康复计划，为期 4 周。该方案包括有氧运动、地面室外步行训练以及上下肢肌肉力量训练。
肺康复计划结束时，MIP 增加了 14.8±14.9 cmH2O（p<0.05）。基于锚定方法，仅选择改良的医学研究委员会作为合适的锚。受试者工作特征曲线分析报告最小有意义差异为 13.5 cmH2O（敏感性：75%，特异性：67.5%）。使用基于分布的方法，最小有意义差异的估计值分别为 7.9 cmH2O（测量误差法）和 10.9 cmH2O（效应量法）。
本研究提出的估计值范围在 7.9 至 13.5 cmH2O 之间。
最小有意义差异的测量是评估肺康复计划期间吸气肌力量变化的简单工具。我们提出 MIP 改善 13.5 cmH2O 为最小有意义差异。需要进一步的研究来证实这一估计。临床试验.gov 标识符：NCT02074813。
