制定中西医结合临床试验评估心血管疾病临床安全性结局的核心结局集：研究方案。

Developing a core outcome set for assessing clinical safety outcomes of cardiovascular diseases in clinical trials of integrated traditional Chinese medicine and Western medicine: study protocol.

机构信息

Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.

出版信息

Trials. 2022 Mar 28;23(1):239. doi: 10.1186/s13063-022-06166-3.

DOI:10.1186/s13063-022-06166-3

PMID:35346338

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8962576/

Abstract

BACKGROUND

Integrative medicine is commonly used in China. Researchers prefer to report efficacy outcomes rather than safety outcomes in clinical trials; thus, evidence regarding safety in integrative medicine is unclear. Developing a core outcome set (COS) for safety outcomes is necessary. In this study, a representative example of the methodology for developing COS to assess safety outcomes of cardiovascular diseases in clinical trials investigating integrated medicine will be developed.

METHODS AND ANALYSIS

Safety information will be extracted from package inserts and through systematic reviews of treatments for cardiovascular diseases (including angina pectoris, myocardial infarction, heart failure, arrhythmia, and hypertension) to develop an extensive list of safety outcomes, which will then be categorized according to whether subjective or objective outcomes. Questionnaires for clinician-reported safety outcomes and patient-reported safety outcomes will be developed. Two rounds of the Delphi survey will then be conducted for different stakeholders (traditional Chinese medicine clinicians and researchers in cardiovascular diseases, Western medicine clinicians and researchers in cardiovascular diseases, integrated medicine clinicians and researchers of cardiovascular diseases, pharmacologists, methodologists of evidence-based medicine, and patients). After round 2 of the Delphi analysis, a face-to-face consensus meeting will be held to determine the final COS for assessing safety outcomes in cardiovascular diseases.

DISCUSSION

A COS for safety outcomes in cardiovascular diseases may improve the consistency of reporting results and will help identify potential bias of selective reporting in the future.

TRIAL REGISTRATION

This study was registered in the Core Outcome Measures in Effectiveness Trials database as study 1564 .

摘要

背景

整合医学在中国被广泛应用。研究人员在临床试验中更倾向于报告疗效结果而不是安全性结果；因此，整合医学安全性方面的证据尚不清楚。制定一个安全性结局的核心结局集（COS）是必要的。本研究将开发一种代表性的方法，用于开发针对心血管疾病综合医学临床试验安全性结局的 COS。

方法和分析

将从药品说明书和心血管疾病（包括心绞痛、心肌梗死、心力衰竭、心律失常和高血压）治疗的系统评价中提取安全性信息，以开发广泛的安全性结局清单，然后根据主观或客观结局对其进行分类。将制定临床医生报告的安全性结局和患者报告的安全性结局的调查问卷。然后，将针对不同利益相关者（心血管疾病的中医临床医生和研究人员、心血管疾病的西医临床医生和研究人员、心血管疾病的整合医学临床医生和研究人员、药理学家、循证医学方法学家和患者）进行两轮 Delphi 调查。在第二轮 Delphi 分析后，将举行面对面的共识会议，以确定心血管疾病安全性结局的最终 COS。