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中文腰痛患者 EQ-5D-5L 与 SF-6D 的头对头比较。

A head-to-head comparison of EQ-5D-5 L and SF-6D in Chinese patients with low back pain.

机构信息

College of Business Administration, Shenyang Pharmaceutical University, Shenyang, China.

Department of orthopedics, The General Hospital of Shenyang Military Area Command, Shenyang, China.

出版信息

Health Qual Life Outcomes. 2019 Apr 11;17(1):57. doi: 10.1186/s12955-019-1137-6.

Abstract

BACKGROUND

The comparative performance of the 3-level EuroQol 5-dimension and Short Form 6-dimension (SF-6D) has been investigated in patients with low back pain (LBP). The aim of this study was to explore the performance including agreement, convergent validity as well as known-groups validity of the 5-level EuroQol 5-dimension (EQ-5D-5 L) and SF-6D in Chinese patients with LBP.

METHODS

Individuals with LBP were recruited from a large tertiary hospital in China. All subjects were interviewed using a standardized questionnaire including the EQ-5D-5 L, 36-item Short Form Health Survey (SF-36), the Oswestry questionnaire and socio-demographic questions from June 2017 to October 2017. Agreement was evaluated by intra-class correlation coefficients (ICCs) and Bland-Altman plots. Spearman's rank correlation coefficients were applied to assess convergent validity. For known-groups validity, the Mann-Whitney U test or Kruskal-Wallis H test were used, effect size (ES) and relative efficiency (RE) were also reported. The efficiency of detecting clinically relevant differences was measured by receiver operating characteristic (ROC) curves between pre-specified groups based on Oswestry disability index (ODI), ES and RE statistics were also reported.

RESULTS

Two hundred seventy-two LBP patients (age 38.1, 38% female) took part in the study. Agreement between the EQ-5D-5 L and the SF-6D was good (ICC 0.661) but with systematic discrepancy in the Bland-Altman plots. In terms of convergent validity, most priori assumptions were more related to EQ-5D-5 L than SF-6D, but MCS derived from SF-36 was more associated with SF-6D. EQ-5D-5 L demonstrated better performance for most groups except location and general health grouped by the general assessment of health item from SF-36. Furthermore, when we applied ODI as external indicator of health status, the area under the ROC curve for EQ-5D-5 L was larger than that for the SF-6D (0.892, 95% CI 0.853 to 0.931 versus 0.822, 95% CI 0.771 to 0.873), the effect size was 0.63 for EQ-5D-5 L and 0.44 for SF-6D, and it was proved that EQ-5D-5 L was 42% more efficient than SF-6D at detecting differences measured by ODI.

CONCLUSIONS

Both EQ-5D-5 L and SF-6D are valid measures for LBP patients. Even though these two measures had good agreement, they cannot be used interchangeably. The EQ-5D-5 L was superior to the SF-6D in Chinese low back pain patients in this research, with stronger correlation to ODI and better known-groups validity. Further study needs to evaluate other factors, such as responsiveness and reliability.

摘要

背景

在腰痛(LBP)患者中,已经研究了 3 级 EuroQol 5 维度和简短形式 6 维度(SF-6D)的比较性能。本研究的目的是探讨包括一致性、收敛有效性以及中国 LBP 患者的 5 级 EuroQol 5 维度(EQ-5D-5L)和 SF-6D 的已知组有效性。

方法

从中国一家大型三级医院招募了腰痛患者。所有患者均于 2017 年 6 月至 2017 年 10 月期间通过标准化问卷进行采访,问卷包括 EQ-5D-5L、36 项简短健康调查问卷(SF-36)、Oswestry 问卷和社会人口统计学问题。使用组内相关系数(ICC)和 Bland-Altman 图评估一致性。Spearman 秩相关系数用于评估收敛有效性。对于已知组有效性,使用 Mann-Whitney U 检验或 Kruskal-Wallis H 检验,还报告了效果量(ES)和相对效率(RE)。根据 Oswestry 残疾指数(ODI),基于 ROC 曲线在预定义组之间测量检测临床相关差异的效率,还报告了 ES 和 RE 统计数据。

结果

272 名腰痛患者(年龄 38.1,38%为女性)参加了这项研究。EQ-5D-5L 和 SF-6D 之间的一致性很好(ICC 0.661),但在 Bland-Altman 图中存在系统差异。就收敛有效性而言,大多数先验假设与 EQ-5D-5L 更相关,而不是 SF-6D,但 SF-36 中的 MCS 与 SF-6D 更相关。EQ-5D-5L 除了 SF-36 的一般健康评估项目中按位置和一般健康分组的项目外,在大多数组中表现更好。此外,当我们将 ODI 用作健康状况的外部指标时,EQ-5D-5L 的 ROC 曲线下面积大于 SF-6D(0.892,95%CI 0.853 至 0.931 与 0.822,95%CI 0.771 至 0.873),效果量为 0.63 为 EQ-5D-5L,SF-6D 为 0.44,证明 EQ-5D-5L 在检测 ODI 测量的差异时比 SF-6D 更有效 42%。

结论

EQ-5D-5L 和 SF-6D 都是腰痛患者的有效测量方法。尽管这两种方法具有良好的一致性,但它们不能互换使用。在这项研究中,EQ-5D-5L 比 SF-6D 更能在腰痛患者中发挥作用,与 ODI 的相关性更强,已知组的有效性也更强。需要进一步研究评估其他因素,如反应性和可靠性。

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