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在中国淋巴瘤患者中,EQ-5D-5L 和 SF-6Dv2 的心理计量学性能。

Psychometric performance of EQ-5D-5L and SF-6Dv2 in patients with lymphoma in China.

机构信息

School of Public Health, Fudan University, 130 Dong An Road, Shanghai, 200032, China.

Key Lab of Health Technology Assessment, National Health Commission of the People's Republic of China (Fudan University), Shanghai, China.

出版信息

Eur J Health Econ. 2024 Dec;25(9):1471-1484. doi: 10.1007/s10198-024-01672-4. Epub 2024 Mar 7.

DOI:10.1007/s10198-024-01672-4
PMID:38451345
Abstract

AIM

To assess and compare the measurement properties of EQ-5D-5L and SF-6Dv2 among lymphoma patients in China.

METHODS

A face-to-face survey of Chinese lymphoma patients was conducted at baseline (all types) and follow-up (diffuse large B-cell). EQ-5D-5L and SF-6Dv2 health utility scores (HUSs) were calculated using the respective Chinese value sets. Ceiling effect was assessed by calculating the percentage of respondents reporting the optimal health state. Convergent validity of EQ-5D-5L and SF-6Dv2 was assessed using the Spearman rank correlation coefficient (r) with QLQ-C30 as a calibration standard. Known-groups validity of the two HUSs was evaluated by comparing their scores of patients with different conditions; and their sensitivity was further assessed in the known-groups using relative efficiency (RE). Test-retest reliability and responsiveness was tested using ICC and standardized response mean (SRM), respectively.

RESULTS

Altogether 200 patients were enrolled at baseline and 78 were followed up. No ceiling effect was found for SF-6Dv2 compared to 24.5% for EQ-5D-5L. Correlation between the two HUSs and with QLQ-C30 score was strong (r > 0.5). Each dimension of EQ-5D-5L and SF-6Dv2 had moderate or greater correlations with similar dimensions of QLQ-C30 (r > 0.35). Both EQ-5D-5L and SF-6Dv2 could only a minority known-groups, and the latter may have better sensitivity. EQ-5D-5L had better test-retest reliability (ICC = 0.939); while both of them were responsive to patients with worsened and improved clinical status.

CONCLUSIONS

EQ-5D-5L and SF-6Dv2 were found to have good convergent validity and responsiveness, while EQ-5D-5L had better test-retest reliability and higher ceiling effect. Not enough evidence indicates which of the two measures has better known-group validity and sensitivity.

摘要

目的

评估和比较 EQ-5D-5L 和 SF-6Dv2 在我国淋巴瘤患者中的测量特性。

方法

对基线(所有类型)和随访(弥漫性大 B 细胞)的中国淋巴瘤患者进行面对面调查。使用各自的中国价值集计算 EQ-5D-5L 和 SF-6Dv2 健康效用评分(HUS)。通过计算报告最佳健康状态的受访者百分比来评估上限效应。通过与 QLQ-C30 作为校准标准的 Spearman 秩相关系数(r)评估 EQ-5D-5L 和 SF-6Dv2 的收敛效度。通过比较不同情况下患者的评分评估两种 HUS 的已知组有效性;并使用相对效率(RE)在已知组中进一步评估其敏感性。使用 ICC 和标准化反应均值(SRM)分别测试测试-重测信度和反应度。

结果

共有 200 名患者在基线时入组,78 名患者进行了随访。与 EQ-5D-5L 的 24.5%相比,SF-6Dv2 没有上限效应。两种 HUS 与 QLQ-C30 评分之间的相关性很强(r>0.5)。EQ-5D-5L 和 SF-6Dv2 的每个维度与 QLQ-C30 的相似维度之间都存在中度或更大的相关性(r>0.35)。EQ-5D-5L 和 SF-6Dv2 都只能区分少数已知群体,后者可能具有更好的敏感性。EQ-5D-5L 的测试-重测信度更好(ICC=0.939);而两者都能对临床状况恶化和改善的患者产生反应。

结论

EQ-5D-5L 和 SF-6Dv2 具有良好的收敛效度和反应度,而 EQ-5D-5L 具有更好的测试-重测信度和更高的上限效应。没有足够的证据表明这两种测量方法中的哪一种具有更好的已知组有效性和敏感性。

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