Minimum Clinically Important Difference in the Positive and Negative Syndrome Scale With Data From the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)

Minimum Clinically Important Difference in the Positive and Negative Syndrome Scale With Data From the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)
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DOI:
10.4088/jcp.11m07162
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发表时间:
2012-04-01
影响因子:
5.3
通讯作者:
Rosenheck, Robert A.
Rosenheck, Robert A.
中科院分区:
医学2区
文献类型:
--
作者:
Hermes, Eric D. A.;Sokoloff, Daniel;Rosenheck, Robert A.

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背景:建立阳性与阴性证候量表(PANSS)的最小临床重要差异对于解释使用该量表进行的研究和临床工作具有重要意义。方法:本研究采用锚定法和分布法两种方法,通过使用一项针对精神分裂症患者的大型多中心试验——临床抗精神病药物干预有效性试验(CATIE)精神分裂症试验的数据,估计PANSS的最小临床重要差异。通过使用等位数方法,来自1442个人的数据将PANSS分数与临床医生和患者在临床总体印象量表(CGI)上的评分联系起来。数据还用于调查测量标准误差(SEM)的大小,提供最小临床重要差异的另一种估计。结果:横断面,临床评定的cgi -疾病严重程度评分为1到7,PANSS评分分别为32.4、42.2、57.5、74.5、93.0、110.9和131.0。使用该量表的PANSS评分的最小临床重要差异相当于基线的15.3分(34.0%)变化。PANSS的扫描电镜(SEM)为1.96,与基线相比变化了16.5分(36.2%)。PANSS评分高于中位数的亚样本的最小临床重要差异比基线评分较低的样本高38%。以患者评价的CGI为锚点,CGI评分1 ~ 4分时,PANSS评分较高,最小临床重要差异较低,为11.2分(24.6%)。结论:长期疗效试验的最小临床重要差异估计与先前短期疗效试验的结果一致。最小临床重要差异估计可以帮助临床医生和研究人员设计未来的研究,并解释未来研究和临床工作中的治疗变化。临床精神病学杂志2012;73(4):526-532 (C)版权所有2012年医师研究生出版社
Context: Establishing the minimum clinically important difference in the Positive and Negative Syndrome Scale (PANSS) is important to the interpretation of the research and clinical work conducted with this scale.Method:This study employed both anchor-based and distributive methods to estimate the minimum clinically important difference for the PANSS by using data from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial, a large, multicenter trial for patients with schizophrenia. By using an equipercentile method, data from 1,442 individuals linked PANSS scores with both clinician and patient ratings on the Clinical Global Impressions scale (CGI). Data were also used to investigate the magnitude of the standard error of measurement (SEM), offering another estimate of the minimum clinically important difference.Results: Cross-sectional, clinician-rated CGI-Severity of illness scores of 1 through 7 linked to PANSS scores of 32.4, 42.2, 57.5, 74.5, 93.0, 110.9, and 131.0, respectively. The minimum clinically important difference for PANSS scores using this scale equaled a 15.3-point (34.0%) change from baseline. A 1.96 SEM on the PANSS corresponded to a 16.5-point (36.2%) change from baseline, The minimum clinically important difference for a subsample with above-median baseline PANSS scores was 38% higher than a sample with lower baseline scores. With the patient-rated CGI as the anchor, PANSS scores were higher for CGI scores of 1 through 4, and the minimum clinically important difference was lower, 11.2 points (24.6%).Conclusion: Minimum clinically important difference estimates from a longer-term effectiveness trial were consistent with previous efforts from shorter-term efficacy trials. Minimum clinically important difference estimates can help clinicians and researchers design future studies and interpret treatment change in future research and clinical work. J Clin Psychiatry 2012;73(4):526-532 (C) Copyright 2012 Physicians Postgraduate Press, Inc.