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动脉血运重建试验中冠状动脉搭桥术后患者报告结局的最小临床重要差异。

Minimal clinically important differences in patient-reported outcomes after coronary artery bypass surgery in the arterial revascularization trial.

作者信息

Masterson Creber Ruth, Dimagli Arnaldo, Niño de Rivera Stephanie, Russell David, Gerry Stephen, Lees Belinda, Guazzelli Alice, Flather Marcus, Taggart David P, Gray Alastair, Gaudino Mario

机构信息

Columbia University School of Nursing, New York, NY, USA.

Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA.

出版信息

Eur J Cardiothorac Surg. 2024 Jul 1;66(1). doi: 10.1093/ejcts/ezae208.

DOI:10.1093/ejcts/ezae208
PMID:38845077
Abstract

OBJECTIVES

This article identifies minimal clinically important differences (MCIDs) in quality of life (QoL) measures among patients who had coronary artery bypass grafting (CABG) and were enrolled in the arterial revascularization trial (ART).

METHODS AND RESULTS

The European Quality of Life-5 Dimensions (EQ-5D) and the Short Form Health Survey 36-Item (SF-36) physical component (PC) and mental component (MC) scores were recorded at baseline, 5 years and 10 years in ART. The MCIDs were calculated as changes in QoL scores anchored to 1-class improvement in the New York Heart Association functional class and Canadian Cardiovascular Society scale at 5 years. Cox proportional hazard models were used to evaluate associations between MCIDs and mortality. Patient cohorts were examined for the SF-36 PC (N = 2671), SF-36 MC (N = 2815) and EQ-5D (N = 2943) measures, respectively. All QoL scores significantly improved after CABG compared to baseline. When anchored to the New York Heart Association, the MCID at 5 years was 17 (95% confidence interval: 17-20) for SF-36 PC, 14 (14-17) for the SF-36 MC and 0.12 (0.12-0.15) for EQ-5D. Using the Canadian Cardiovascular Society scale as an anchor, the MCID at 5 years was 15 (15-17) for the SF-36 PC, 12 (13-15) for the SF-36 MC and 0.12 (0.11-0.14) for the EQ-5D. The MCIDs for SF-36 PC and EQ-5D at 5 years were associated with a lower risk of mortality at the 10-year follow-up point after surgery.

CONCLUSIONS

MCIDs for CABG patients have been identified. These thresholds may have direct clinical applications in monitoring patients during follow-up and in designing new trials that include QoL as a primary study outcome.

CLINICAL TRIAL REGISTRATION NUMBER

ISRCTN46552265.

摘要

目的

本文确定了接受冠状动脉搭桥术(CABG)并参加动脉血运重建试验(ART)的患者在生活质量(QoL)测量中的最小临床重要差异(MCID)。

方法与结果

在ART中,于基线、5年和10年记录欧洲五维健康量表(EQ - 5D)以及简短健康调查36项量表(SF - 36)的身体成分(PC)和心理成分(MC)得分。MCID通过将生活质量得分的变化锚定到纽约心脏协会功能分级和加拿大心血管学会量表在5年时1级的改善情况来计算。采用Cox比例风险模型评估MCID与死亡率之间的关联。分别对SF - 36 PC(N = 2671)、SF - 36 MC(N = 2815)和EQ - 5D(N = 2943)测量的患者队列进行了研究。与基线相比,CABG术后所有生活质量得分均显著改善。以纽约心脏协会为锚定标准时,5年时SF - 36 PC的MCID为17(95%置信区间:17 - 20),SF - 36 MC为14(14 - 17),EQ - 5D为0.12(0.12 - 0.15)。以加拿大心血管学会量表为锚定标准时,5年时SF - 36 PC的MCID为15(15 - 17),SF - 36 MC为12(13 - 15),EQ - 5D为0.12(0.11 - 0.14)。5年时SF - 36 PC和EQ - 5D的MCID与术后10年随访时较低的死亡风险相关。

结论

已确定CABG患者的MCID。这些阈值可能在随访期间监测患者以及设计将生活质量作为主要研究结果的新试验中有直接的临床应用。

临床试验注册号

ISRCTN46552265。

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