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经皮冠状动脉介入治疗后冠心病患者EQ-5D-5L的反应性及最小临床重要差异:一项纵向研究

Responsiveness and minimal clinically important difference of EQ-5D-5L in patients with coronary heart disease after percutaneous coronary intervention: A longitudinal study.

作者信息

Zheng Yu, Dou Lei, Fu Qiang, Li Shunping

机构信息

Center for Health Management and Policy Research, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.

NHC Key Lab of Health Economics and Policy Research (Shandong University), Jinan, Shandong, China.

出版信息

Front Cardiovasc Med. 2023 Mar 9;10:1074969. doi: 10.3389/fcvm.2023.1074969. eCollection 2023.

Abstract

BACKGROUND

Although the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) has been validated in various diseases, no empirical study has evaluated the responsiveness and minimal clinically important difference (MCID) of the instrument in patients with coronary heart disease (CHD), which limits the interpretability and clinical application of EQ-5D-5L. Therefore, this study aimed to determine the responsiveness and MCID of EQ-5D-5L in patients with CHD who underwent percutaneous coronary intervention (PCI) and identify the relationship between the MCID values and minimal detectable change (MDC).

METHODS

Patients with CHD were recruited for this longitudinal study at the Tianjin Medical University's General Hospital in China. At baseline and 4 weeks after PCI, participants completed the EQ-5D-5L and Seattle Angina Questionnaire (SAQ). Additionally, we used the effect size (ES) to assess the responsiveness of EQ-5D-5L. The anchor-based, distribution-based, and instrument-based methods were used in this study to calculate the MCID estimates. The MCID estimates to MDC ratios were computed at the individual and group levels at a 95% CI.

RESULTS

Seventy-five patients with CHD completed the survey at both baseline and follow-up. The EQ-5D-5L health state utility (HSU) improved by 0.125 at follow-up compared with baseline. The ES of EQ-5D HSU was 0.850 in all patients and 1.152 in those who improved, indicating large responsiveness. The average (range) MCID value of the EQ-5D-5L HSU was 0.071 (0.052-0.098). These values can only be used to determine whether the change in scores were clinically meaningful at the group level.

CONCLUSION

EQ-5D-5L has large responsiveness among CHD patients after undergoing PCI surgery. Future studies should focus on calculating the responsiveness and MCID for deterioration and examining the health changes at the individual level in CHD patients.

摘要

背景

尽管欧洲五维健康量表五水平版本(EQ - 5D - 5L)已在多种疾病中得到验证,但尚无实证研究评估该工具在冠心病(CHD)患者中的反应度及最小临床重要差异(MCID),这限制了EQ - 5D - 5L的可解释性和临床应用。因此,本研究旨在确定接受经皮冠状动脉介入治疗(PCI)的CHD患者中EQ - 5D - 5L的反应度和MCID,并确定MCID值与最小可检测变化(MDC)之间的关系。

方法

在中国天津医科大学总医院招募CHD患者进行这项纵向研究。在基线和PCI术后4周,参与者完成EQ - 5D - 5L和西雅图心绞痛问卷(SAQ)。此外,我们使用效应量(ES)来评估EQ - 5D - 5L的反应度。本研究采用基于锚定法、基于分布法和基于工具法来计算MCID估计值。在个体和组水平上以95%置信区间计算MCID估计值与MDC的比值。

结果

75例CHD患者在基线和随访时均完成了调查。与基线相比,随访时EQ - 5D - 5L健康状态效用(HSU)提高了0.125。所有患者中EQ - 5D HSU的ES为0.850,改善患者中为1.152,表明反应度较大。EQ - 5D - 5L HSU的平均(范围)MCID值为0.071(0.052 - 0.098)。这些值仅可用于确定组水平上分数变化是否具有临床意义。

结论

EQ - 5D - 5L在接受PCI手术的CHD患者中具有较大反应度。未来研究应侧重于计算病情恶化的反应度和MCID,并在CHD患者个体水平上检查健康变化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ef7/10034178/b99b4dee5a6f/fcvm-10-1074969-g001.jpg

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