手部类风湿关节炎患者中SF-12、SF-6D、EQ-5D及密歇根手部结果问卷的实证评估
An empirical evaluation of the SF-12, SF-6D, EQ-5D and Michigan Hand Outcome Questionnaire in patients with rheumatoid arthritis of the hand.
作者信息
Dritsaki Melina, Petrou Stavros, Williams Mark, Lamb Sarah E
机构信息
Nuffield Department of Orthopaedic Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
出版信息
Health Qual Life Outcomes. 2017 Jan 24;15(1):20. doi: 10.1186/s12955-016-0584-6.
BACKGROUND
The aim of this study was to assess the psychometric properties, namely acceptability, validity, reliability, interpretability and responsiveness of the EuroQol EQ-5D (EQ-5D visual analogue (VAS) and EQ-5D (utility)), Short Form 12 Dimensions (SF-12), SF-6D and Michigan Hand Outcome Questionnaire (MHQ) in patients with rheumatoid arthritis (RA) of the hand.
METHODS
The empirical investigation was based upon data from a randomised controlled trial of 488 adults with rheumatoid arthritis who had pain and dysfunction of the hands and/or wrists. Participants completed the EQ-5D, SF-12 and MHQ at baseline and at 4 and 12 months follow up. Acceptability was measured using completion rates over time; construct validity using the "known groups" approach, based on pain troublesomeness; convergent validity using spearman's rho correlation (ρ); reliability using internal consistency (Cronbach's alpha); interpretability using minimal important differences (MID); and responsiveness using effect sizes and standardised response means (SRM) stratified by level of self-rated improvement in hand and wrist function or level of self-rated benefit and satisfaction from trial treatments.
RESULTS
At baseline, the study population had a mean age of 62.4 years, a mean MHQ score of 52.1 and included 76% women. The EQ-5D (utility) had the highest completion rates across time points. All instruments discriminated between pre-specified groups based on pain troublesomeness. Convergent validity analysis indicated that the MHQ score correlated strongly with the EQ-5D (ρ = 0.65) and SF-6D (ρ = 0.63) utility scores. The MHQ was most responsive at detecting change in indicators of RA pain severity between baseline and 4 months, whilst minimal important differences varied considerably across PROMs.
CONCLUSIONS
The instruments evaluated in this study displayed varying psychometric properties in the context of RA of the hand. The selection of a preferred instrument in evaluative studies should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purposes.
背景
本研究旨在评估欧洲五维度健康量表（EQ-5D，包括EQ-5D视觉模拟量表（VAS）和EQ-5D效用值）、简明健康调查问卷12维度版（SF-12）、SF-6D以及密歇根手部结果问卷（MHQ）在手部类风湿关节炎（RA）患者中的心理测量学特性，即可接受性、有效性、可靠性、可解释性和反应性。
方法
实证研究基于一项针对488例患有手部和/或腕部疼痛及功能障碍的类风湿关节炎成年患者的随机对照试验数据。参与者在基线、4个月和12个月随访时完成EQ-5D、SF-12和MHQ。可接受性通过不同时间点的完成率来衡量；结构效度采用基于疼痛困扰程度的“已知组”方法；收敛效度采用斯皮尔曼等级相关系数（ρ）；可靠性采用内部一致性（克朗巴哈系数）；可解释性采用最小有意义差异（MID）；反应性采用效应量和标准化反应均值（SRM），根据手部和腕部功能的自评改善水平或试验治疗的自评获益和满意度水平进行分层。
结果
在基线时，研究人群的平均年龄为62.4岁，平均MHQ评分为52.1，其中76%为女性。EQ-5D（效用值）在各时间点的完成率最高。所有工具均能根据疼痛困扰程度区分预先指定的组。收敛效度分析表明，MHQ评分与EQ-5D（ρ = 0.65）和SF-6D（ρ = 0.63）效用评分密切相关。MHQ在检测基线至4个月期间RA疼痛严重程度指标的变化方面反应最为灵敏，而最小有意义差异在不同患者报告结局测量指标中差异很大。
结论
本研究中评估的工具在手部RA背景下表现出不同的心理测量学特性。在评估研究中选择首选工具最终应取决于对个体心理测量学特性的相对重视程度以及对用于经济评估目的的健康效用值生成的重视程度。
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