Effective dose 50 method as the minimal clinically important difference: Evidence from depression trials.
Effective dose 50 method as the minimal clinically important difference: Evidence from depression trials.
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DOI：
10.1016/j.jclinepi.2021.04.002
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发表时间：
2021-09
影响因子：
7.2
通讯作者：
Button KS
中科院分区：
文献类型：
--
作者：
Bauer-Staeb C;Kounali DZ;Welton NJ;Griffith E;Wiles NJ;Lewis G;Faraway JJ;Button KS
以前关于抑郁症和焦虑症的最小临床重要差异（MCID）的研究是基于人口平均值。本研究旨在确定基线严重程度范围内的MCID。本分析使用了来自2项抑郁症随机对照试验（n = 1，122）的次要数据，以校准PHQ-9和GAD-7的总体变化评级。MCID定义为患者“感觉更好”的概率为50%时的评分变化，考虑到其基线严重程度，称为有效剂量50（ED 50）。MCID估计值取决于基线严重程度，范围从非常轻度的无变化到PHQ-9的14分（52%）和GAD-7的高达10分（48%）（非常高的严重程度）。PHQ-9和GAD-7的平均MCID估计值分别为3.7分（23%）和3.3分（28%）。ED 50方法生成了基线严重程度范围内的MCID估计值，提供了更高的精确度，但相对于群体平均估计值，其代价是更高的复杂性。这对治疗和临床实践的评估具有重要意义，用户可以使用这些结果根据基线严重程度为特定人群定制MCID。
Previous research on the minimal clinically important difference (MCID) for depression and anxiety is based on population averages. The present study aimed to identify the MCID across the spectrum of baseline severity. The present analysis used secondary data from 2 randomized controlled trials for depression (n = 1,122) to calibrate the Global Rating of Change with the PHQ–9 and GAD–7. The MCID was defined as a change in scores corresponding to a 50% probability of patients "feeling better", given their baseline severity, referred to as Effective Dose 50 (ED50). MCID estimates depended on baseline severity and ranged from no change for very mild up to 14 points (52%) on the PHQ–9 and up to 10 points (48%) on the GAD–7 for very high severity. The average MCID estimates were 3.7 points (23%) and 3.3 (28%) for the PHQ–9 and GAD–7 respectively. The ED50 method generates MCID estimates across the spectrum of baseline severity, offering greater precision but at the cost of greater complexity relative to population average estimates. This has important implications for evaluations of treatments and clinical practice where users can use these results to tailor the MCID to specific populations according to baseline severities.
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