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类风湿关节炎前瞻性观察研究中患者报告结局测量信息系统(PROMIS)20项身体功能简表的反应性及最小重要差异

Responsiveness and minimally important difference for the patient-reported outcomes measurement information system (PROMIS) 20-item physical functioning short form in a prospective observational study of rheumatoid arthritis.

作者信息

Hays Ron D, Spritzer Karen L, Fries James F, Krishnan Eswar

机构信息

Department of Medicine, UCLA Division of General Internal Medicine & Health Services Research, Los Angeles, California, USA RAND, Santa Monica, California, USA.

Department of Medicine, UCLA Division of General Internal Medicine & Health Services Research, Los Angeles, California, USA.

出版信息

Ann Rheum Dis. 2015 Jan;74(1):104-7. doi: 10.1136/annrheumdis-2013-204053. Epub 2013 Oct 4.

Abstract

OBJECTIVE

To estimate responsiveness (sensitivity to change) and minimally important difference (MID) for the Patient-Reported Outcomes Measurement Information System (PROMIS) 20-item physical functioning scale (PROMIS PF-20).

METHODS

The PROMIS PF-20, short form 36 (SF-36) physical functioning scale, and Health Assessment Questionnaire (HAQ) were administered at baseline, and 6 and 12 months later to a sample of 451 persons with rheumatoid arthritis. A retrospective change (anchor) item was administered at the 12-month follow-up. We estimated responsiveness between 12 months and baseline, and between 12 months and 6 months using one-way analysis of variance F-statistics. We estimated the MID for the PROMIS PF-20 using prospective change for people reporting getting 'a little better' or 'a little worse' on the anchor item.

RESULTS

F-statistics for prospective change on the PROMIS PF-20, SF-36 and HAQ by the anchor item over 12 and 6 months (in parentheses) were 16.64 (14.98), 12.20 (7.92) and 10.36 (12.90), respectively. The MID for the PROMIS PF-20 was 2 points (about 0.20 of an SD).

CONCLUSIONS

The PROMIS PF-20 is more responsive than two widely used ('legacy') measures. The MID is a small effect size. The measure can be useful for assessing physical functioning in clinical trials and observational studies.

摘要

目的

评估患者报告结局测量信息系统(PROMIS)20项身体功能量表(PROMIS PF - 20)的反应度(对变化的敏感性)和最小重要差异(MID)。

方法

对451名类风湿关节炎患者样本在基线、6个月和12个月时分别施测PROMIS PF - 20、简短形式36(SF - 36)身体功能量表和健康评估问卷(HAQ)。在12个月随访时施测一项回顾性变化(锚定)项目。我们使用单因素方差分析F统计量估计12个月与基线之间以及12个月与6个月之间的反应度。我们使用在锚定项目上报告“稍有好转”或“稍有恶化”的人群的前瞻性变化来估计PROMIS PF - 20的MID。

结果

PROMIS PF - 20、SF - 36和HAQ在12个月和6个月(括号内)由锚定项目得出的前瞻性变化的F统计量分别为16.64(14.98)、12.20(7.92)和10.36(12.90)。PROMIS PF - 20的MID为2分(约为标准差的0.20)。

结论

PROMIS PF - 20比另外两种广泛使用的(“传统”)测量方法反应度更高。MID是一个小效应量。该测量方法可用于评估临床试验和观察性研究中的身体功能。

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