Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials
Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials
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DOI：
10.1016/j.jad.2020.01.101
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发表时间：
2020-04-01
影响因子：
6.6
通讯作者：
Monahan, Patrick O.
中科院分区：
文献类型：
--
作者：
Kroenke, Kurt;Stump, Timothy E.;Monahan, Patrick O.
背景资料：患者报告结果测量信息系统（PROMIS）量表越来越多地用于测量研究和实践中的症状。本研究的目的是确定最低限度的重要差异（MID）和严重程度阈值（cut-points）为四个固定长度的PROMIS抑郁scales.Methods：研究样本是成人参与者在三个随机临床试验（N=651）。MID估计使用多个分布和锚为基础的方法，包括评估患者健康问卷（PHQ-9）和PROMIS抑郁scores.Results之间的对应关系：最好的MID估计是一个PROMIS抑郁症的T-得分为3.5点，大多数方法产生的MID在3至4点的范围内，在所有三个样本。所有四个PROMIS量表的MID估计值相似。PHQ-9 1分变化相当于PROMIS 1.25分T评分变化。PROMIS的T-分数为55，60，65，和70似乎是合理的阈值为轻度，中度，中度严重，和重度depressions.Limitations：研究样本主要是男性退伍军人与慢性疼痛（2试验）或以前中风（1试验）。结论：3 ~ 4分的T分是PROMIS抑郁量表的合理MID，可用于临床和研究中评估治疗效果，也可用于计算临床试验的样本量。严重程度临界点可以帮助解释治疗决策的评分和行动阈值的含义。
Background: Patient Reported Outcomes Measurement Information Systems (PROMIS) scales are increasingly being used to measure symptoms in research and practice. The purpose of this study was to determine the minimally important difference (MID) and severity thresholds (cut-points) for the four fixed-length PROMIS depression scales.Methods: The study sample was adult participants in three randomized clinical trials (N=651). MID was estimated using multiple distribution- and anchor-based approaches including assessing correspondence between Patient Health Questionnaire (PHQ-9) and PROMIS depression scores.Results: The best MID estimate was a PROMIS depression T-score of 3.5 points with most methods producing an MID in the 3 to 4 point range across all three samples. MID estimates were similar for all four PROMIS scales. A PHQ-9 1-point change equated to a PROMIS 1.25-point T-score change. PROMIS T-scores of 55, 60, 65, and 70 appeared to be reasonable thresholds for mild, moderate, moderately severe, and severe depression, respectively.Limitations: The study sample was predominantly male veterans with either chronic pain (2 trials) or previous stroke (1 trial). The severity of depression was mild to moderate.Conclusion: A T-score of 3 to 4 points is a reasonable MID for PROMIS depression scales and can be used to assess treatment effects in both practice and research as well to calculate sample sizes for clinical trials. Severity cut-points can help interpret the meaning of scores and action thresholds for treatment decisions.