Asthma & Airway Centre, University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada.
COPD. 2013 Apr;10(2):243-9. doi: 10.3109/15412555.2012.733463. Epub 2013 Mar 20.
Frequent exacerbations of COPD are associated with accelerated loss of lung function, declining health status, increased mortality, and increased health care costs. Thus, a key objective in the management of COPD is preventing exacerbations or at least reducing their number and severity. When new interventions are examined, their value is sometimes assessed in reference to the minimal clinically important difference (MCID), a theoretical construct that may be defined and estimated numerically in several different ways. There have been limited attempts to calculate the MCID for COPD exacerbations but a figure of 20% reduction in exacerbation frequency is occasionally cited as the "established" MCID from a single manuscript reviewing six clinical trials. Our review suggests that defining and calculating the MCID for COPD exacerbations is problematic, not only because the methodology around developing endpoints for MCIDs is inconsistent, but because the impact of exacerbation reduction is likely to be influenced dramatically by the definitions of exacerbation severity used and the population's baseline status. Reference to current literature shows that at least one other estimate for exacerbation MCID as low as 4%. MCID is sometimes estimated by expert consensus; a review of articles used to shape COPD guidelines shows frequent reference to articles in which interventions yielded exacerbation differences as low as 11%. We find no evidence of an established MCID but suggest that interventions reducing exacerbations by as little as 11% appear to be regarded widely as clinically important.
COPD 频繁发作与肺功能加速丧失、健康状况恶化、死亡率增加和医疗保健费用增加有关。因此,COPD 管理的一个关键目标是预防发作,或至少减少发作的次数和严重程度。当检查新的干预措施时,其价值有时参考最小临床重要差异(MCID)来评估,这是一个理论概念,可以通过几种不同的方式进行定义和数值估计。已经有一些有限的尝试来计算 COPD 发作的 MCID,但偶尔会引用一个数字,即从一篇综述六项临床试验的文献中得出的 20%的发作频率降低,作为“既定”MCID。我们的综述表明,定义和计算 COPD 发作的 MCID 存在问题,不仅因为用于开发 MCID 终点的方法不一致,而且因为减轻发作的影响可能会因使用的发作严重程度定义和人群的基线状况而受到极大影响。参考当前文献表明,至少还有另一个估计值为 4%的发作 MCID。MCID 有时通过专家共识来估计;对用于制定 COPD 指南的文章进行综述表明,经常参考干预措施仅产生 11%差异的文章。我们没有发现既定 MCID 的证据,但建议,降低发作频率低至 11%的干预措施似乎被广泛认为具有临床重要性。