Core outcome sets for myocardial infarction in clinical trials of traditional Chinese medicine and Western medicine

IF 3.6 2区医学 Q1 MEDICINE, GENERAL & INTERNAL Journal of Evidence‐Based Medicine Pub Date : 2024-01-12 DOI:10.1111/jebm.12579

Ruijin Qiu, Siqi Wan, Changming Zhong, Songjie Han, Tianmai He, Ya Huang, Xuxu Wei, Meng Li, Zhiyue Guan, Xinyi Zhang, Huanlin Wu, Hongcai Shang

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Abstract

Background

Clinical trials of traditional Chinese medicine (TCM) and Western medicine showed there was heterogeneity of outcome reporting in myocardial infarction (MI). Developing a core outcome set (COS) might improve the consistency of outcome reporting in future clinical trials.

Methods

A list of outcomes was developed based on a systematic review of randomized controlled trials (RCTs) of MI and semistructured interviews with MI patients. Two rounds of Delphi survey for clinicians, researchers, journal editors, and methodologists were conducted. An online questionnaire sent to nurses. After an online consensus meeting, a COS for MI RCTs was developed.

Results

After extracted data from clinical trials and discussed, 216 outcomes were included in round 1 of the Delphi survey. Seventy-four participants completed round 1 of the Delphi survey. Sixty-five participants completed round 2 of the Delphi survey. Twenty-two nurses completed the online questionnaire. Fifteen participants attended the online consensus meeting, and 14 of them voted and determined the final COS. For all types of MI, it was recommended that left ventricular ejection fraction and quality of life be measured and reported. For acute MI, the participants in the consensus meeting recommended the following core outcomes: death from cardio-cerebrovascular disease, cardiogenic shock, heart failure, troponin I, troponin T, creatine kinase isoenzyme, Killip class, target vessel revascularization, and emergency CABG. For previous MI, recurrent MI, recurrent angina pectoris, and heart failure readmission were recommended.

Conclusions

The COS for MI in RCTs provides recommendations for clinical trials that seek to improve outcomes for patients with MI.

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中西医临床试验中心肌梗死的核心结果集。

背景：中西医临床试验显示，心肌梗死（MI）的结果报告存在异质性。制定核心结果集（COS）可提高未来临床试验结果报告的一致性：方法：根据对心肌梗死随机对照试验（RCT）的系统回顾和对心肌梗死患者的半结构式访谈，制定了一份结果列表。对临床医生、研究人员、期刊编辑和方法论专家进行了两轮德尔菲调查。向护士发送在线问卷。在线共识会议后，制定了 MI RCT 的 COS：从临床试验中提取数据并进行讨论后，216 项结果被纳入德尔菲调查的第一轮。74 位参与者完成了德尔菲调查的第一轮。65名参与者完成了德尔菲调查第二轮。22 名护士完成了在线问卷调查。15 名参与者参加了在线共识会议，其中 14 人进行了投票并确定了最终的 COS。对于所有类型的心肌梗死，建议测量并报告左心室射血分数和生活质量。对于急性心肌梗死，共识会议与会者推荐了以下核心结果：心脑血管疾病导致的死亡、心源性休克、心力衰竭、肌钙蛋白 I、肌钙蛋白 T、肌酸激酶同工酶、Killip 分级、靶血管再通术和急诊 CABG。对于既往的心肌梗死、复发性心肌梗死、复发性心绞痛和心力衰竭再入院，建议采用COS：RCT中的心肌梗死COS为旨在改善心肌梗死患者预后的临床试验提供了建议。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Evidence‐Based Medicine MEDICINE, GENERAL & INTERNAL-

CiteScore

11.20

自引率

1.40%

发文量

期刊介绍： The Journal of Evidence-Based Medicine (EMB) is an esteemed international healthcare and medical decision-making journal, dedicated to publishing groundbreaking research outcomes in evidence-based decision-making, research, practice, and education. Serving as the official English-language journal of the Cochrane China Centre and West China Hospital of Sichuan University, we eagerly welcome editorials, commentaries, and systematic reviews encompassing various topics such as clinical trials, policy, drug and patient safety, education, and knowledge translation.

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