VA New England Mental Illness Research and Education Center, VA Connecticut Healthcare System (116A-4), 950 Campbell Avenue, Building 36, West Haven, CT, 06516, USA.
Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
Psychiatr Q. 2018 Mar;89(1):141-155. doi: 10.1007/s11126-017-9522-y.
This study sought to determine the minimal clinically important difference (MCID) for two frequently used measures of symptom severity in Post-Traumatic Stress Disorder: the Clinician Administered PTSD Scale (CAPS) and the PTSD Symptom Checklist (PCL). Data from a randomized clinical trial of antipsychotic medication in military-related treatment-resistant PTSD (N= 267) included assessments 4 times over 26 weeks. Methods for estimating the MCID were based on both the anchor-based approach, using the Clinical Global Impressions (CGI) severity and improvement scales, rated by both clinicians and patients; and the distribution-based approach (based on standardized z-scores). Severity and change scores on the CAPS and PCL were converted to z-scores and compared across CGI levels using analysis of variance. The average difference in CAPS z-scores between each of three CGI levels between "moderate" to "severe" and from "no change" to "much improved" was 0.758 for clinician CGI ratings and 0.525 for patient CGI ratings and were similar for the PCL (0.483 and 0.471) with all differences significant at p<.0001). Clinically meaningful CAPS and PCL severity and change z-scores range between 0.5-0.8 standard deviations. The MCID estimates suggested here provide an empirical basis for determining whether statistically significant changes in CAPS and PCL scores are clinically meaningful.
本研究旨在确定创伤后应激障碍两种常用症状严重程度评估工具的最小临床差异(MCID):临床医生管理 PTSD 量表(CAPS)和 PTSD 症状清单(PCL)。这项针对与军事相关的、治疗抵抗性 PTSD 的抗精神病药物的随机临床试验(N=267)的数据包括 26 周内的 4 次评估。MCID 的估计方法基于锚定方法,使用临床总体印象(CGI)严重程度和改善量表,由临床医生和患者进行评定;以及分布方法(基于标准化 z 分数)。CAPS 和 PCL 的严重程度和变化分数转换为 z 分数,并使用方差分析比较 CGI 水平。在 CAPS 中,与“中度”到“重度”相比,从“无变化”到“明显改善”,临床医生 CGI 评定的 z 分数平均差异为 0.758,患者 CGI 评定的 z 分数平均差异为 0.525,PCL 的差异也相似(0.483 和 0.471),所有差异均在 p<.0001 时有统计学意义。有意义的 CAPS 和 PCL 严重程度和变化 z 分数范围在 0.5-0.8 个标准差之间。这里提出的 MCID 估计值为确定 CAPS 和 PCL 评分的统计学显著变化是否具有临床意义提供了实证基础。