College of Business Administration, Shenyang Pharmaceutical University, Shenyang, China.
Department of orthopedics, The General Hospital of Shenyang Military Area Command, Shenyang, China.
Health Qual Life Outcomes. 2019 Apr 11;17(1):57. doi: 10.1186/s12955-019-1137-6.
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.
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.
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.
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.
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。
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。
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%。
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。