Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life
Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life
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DOI：
10.1097/00005650-199905000-00006
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发表时间：
1999-05-01
期刊：
影响因子：
3
通讯作者：
Wolinsky, FD
中科院分区：
文献类型：
--
作者：
Wyrwich, KW;Nienaber, NA;Wolinsky, FD
OBJECTIVE.比较测量标准误（SEM）与健康相关生活质量评价中临床相关个体内变化的既定标准。随机对照试验数据的次要分析。605名有心脏病史的门诊病人参加了一个主要的学术医疗中心的普通医学诊所。基线和随访访谈包括慢性心力衰竭问卷（CHQ）和SF-36的修订版。确定了与CHQ上最小临床重要差异（MCID）的既定标准对应的SEM值。使用相同的SEM标准探索SF-36的个体变化。在所有CHQ维度上，该人群中的单SEM变化与患者驱动的MCID标准完全一致（加权kappas（0.87; P < 0.001））。CHQ维度和SF-36子量表之间改善、保持稳定或下降（由单SEM标准定义）的门诊患者分布基本一致。应在其他健康相关生活质量工具中探索使用SEM评价个体患者变化，并建立临床相关差异的标准。只有这样才能确定是否可以一致地应用一个SEM标准作为有临床意义的变化的代表。
OBJECTIVE. TO compare the standard error of measurement (SEM) with established standards for clinically relevant intra-individual change in an evaluation of health-related quality of life.DESIGN. Secondary analysis of data from a randomized controlled trial.SUBJECTS. Six hundred and five outpatients with a history of cardiac problems attending the general medicine clinics of a major academic medical center.MEASURES. Baseline and follow-up interviews included a modified version of the Chronic Heart Failure Questionnaire (CHQ) and the SF-36. The SEM values corresponding to established standards for minimal clinically important differences (MCIDs) on the CHQ were determined. Individual change on the SF-36 was explored using the same SEM criterion.RESULTS. One-SEM changes in this population corresponded well to the patient-driven MCID standards on all CHQ dimensions (weighted kappas (0.87; P < 0.001). The distributions of outpatients who improved, remained stable, or declined (defined by the one-SEM criterion) were generally consistent between CHQ dimensions and SF-36 subscales.CONCLUSIONS. The use of the SEM to evaluate individual patient change should be explored among other health-related quality of life instruments with established standards for clinically relevant differences. Only then can it be determined whether the one-SEM criterion can be consistently applied as a proxy for clinically meaningful change.