Maximum exercise as an outcome in COPD: minimal clinically important difference.
Maximum exercise as an outcome in COPD: minimal clinically important difference.
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最大程度的运动作为慢性阻塞性肺病的结果：临床上的重要差异最小。
作者：
Sutherland,ERand;Make,BarryJ
体力活动受限在慢性阻塞性肺疾病（COPD）患者的综合症状中起着核心作用，运动能力的改善是COPD治疗反应的关键结果。最大运动能力测试有助于评估运动的生理机制，并允许量化的限制程度。本文利用国家肺气肿治疗试验的已发表数据，研究重度肺气肿患者最大运动能力的最小临床重要差异（MCID）。分布和意见为基础的方法被用来估计MCID。专家临床医生的意见产生了10瓦的值作为最大运动能力变化的MCID。基线标准差和误差数据产生了10.5瓦的基于一半标准差的估计和4.2瓦的基于标准误差的估计。在随机接受药物治疗的受试者中，药物治疗后最大运动能力的平均（± SD）24个月变化为− 9.2 ± 1.2瓦，而在随机接受肺减容手术的受试者中，最大运动能力的平均24个月变化为1.7 ± 17.7瓦，两组之间的平均差异为10.9瓦。24个月后，随机接受药物治疗与手术治疗的受试者之间观察到的最大运动能力差异符合MCID的意见和分布估计。需要进一步的研究来开发和验证MCID对COPD患者最大运动能力和其他关键临床结局的估计。
Limitation of physical activity occupies a central role in the symptom complex of patients with chronic obstructive pulmonary disease (COPD), and improvement in exercise capacity is a key outcome of response to COPD therapy. Maximum exercise capacity testing facilitates assessment of physiologic mechanisms of exercise and allows quantitation of the degree of limitation. This manuscript utilizes published data from the National Emphysema Treatment Trial to investigate the minimal clinically important difference (MCID) in maximum exercise capacity in patients with severe emphysema. Distribution- and opinion-based methods were used to estimate MCID. Expert clinician opinion yielded a value of 10 Watts as the MCID for change in maximum exercise capacity. Baseline standard deviation and error data yielded a one-half standard deviation-based estimate of 10.5 Watts and a standard error-based estimate of 4.2 Watts. In subjects randomized to medical therapy, the mean ( ± SD) 24-month change in maximum exercise capacity following medical therapy was − 9.2 ± 1.2 Watts, whereas among those randomized to lung volume reduction surgery, mean 24-month change in maximum exercise capacity was 1.7 ± 17.7 Watts, with a mean difference between the groups of 10.9 Watts. The observed difference in maximum exercise capacity after 24 months between subjects randomized to medical versus surgical therapy conforms to both opinion- and distribution-based estimates of MCID. Further investigation is needed to develop and validate estimates of MCID for maximum exercise capacity and other key clinical outcomes in COPD.