中药或西药治疗非瓣膜性心房颤动的临床试验结局报告：系统评价。

Outcome reporting from clinical trials of non-valvular atrial fibrillation treated with traditional Chinese medicine or Western medicine: a systematic review.

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.

Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China

出版信息

BMJ Open. 2019 Aug 30;9(8):e028803. doi: 10.1136/bmjopen-2018-028803.

DOI:10.1136/bmjopen-2018-028803

PMID:31471437

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6720335/

Abstract

OBJECTIVES

To examine variation in outcomes, outcome measurement instruments (OMIs) and measurement times in clinical trials of non-valvular atrial fibrillation (NVAF) and to identify outcomes for prioritisation in developing a core outcome set (COS) in this field.

DESIGN

This study was a systematic review.

DATA SOURCES

Clinical trials published between January 2015 and March 2019 were obtained from PubMed, the Cochrane Library, Web of Science, Wanfang Database, the China National Knowledge Infrastructure and SinoMed.

ELIGIBILITY CRITERIA

Randomised controlled trials (RCTs) and observational studies were considered. Interventions included traditional Chinese medicine and Western medicine. The required treatment duration or follow-up time was ≥4 weeks. The required sample size was ≥30 and≥50 in each group in RCTs and observational studies, respectively. We excluded trials that aimed to investigate the outcome of complications of NVAF, to assess the mechanisms or pharmacokinetics, or for which full text could not be acquired.

DATA EXTRACTION AND SYNTHESIS

The general information and outcomes, OMIs and measurement times were extracted. The methodological and outcome reporting quality were assessed. The results were analysed by descriptive analysis.

RESULTS

A total of 218 articles were included from 25 255 articles. For clinical trials of antiarrhythmic therapy, 69 outcomes from 16 outcome domains were reported, and 28 (31.82%, 28/88) outcomes were reported only once; the most frequently reported outcome was ultrasonic cardiogram. Thirty-one outcomes (44.93%, 31/69) were provided definitions or OMIs; the outcome measurement times ranged from 1 to 20 with a median of 3. For clinical trials of anticoagulation therapy, 82 outcomes from 18 outcome domains were reported; 38 (29.23%, 38/130) outcomes were reported only once. The most frequently reported outcome was ischaemic stroke. Forty (48.78%, 40/82) outcomes were provided OMIs or definitions; and the outcome measurement times ranged from 1 to 27 with a median of 8.

CONCLUSION

Outcome reporting in NVAF is inconsistent. Thus, developing a COS that can be used in clinical trials is necessary.

摘要

目的

研究非瓣膜性心房颤动（NVAF）临床试验中结局、结局测量工具（OMI）和测量时间的变化，并确定该领域制定核心结局集（COS）的优先结局。

设计

本研究为系统评价。

数据来源

从 PubMed、Cochrane 图书馆、Web of Science、万方数据库、中国知识基础设施和 SinoMed 检索 2015 年 1 月至 2019 年 3 月发表的 NVAF 临床试验。

入选标准

纳入随机对照试验（RCT）和观察性研究。干预措施包括中药和西药。所需治疗持续时间或随访时间≥4 周。RCT 和观察性研究每组所需样本量分别≥30 和≥50。排除旨在调查 NVAF 并发症结局、评估机制或药代动力学或无法获取全文的试验。

数据提取和综合

提取一般信息和结局、OMI 和测量时间。评估方法学和结局报告质量。采用描述性分析对结果进行分析。

结果

从 25255 篇文章中总共纳入 218 篇文章。抗心律失常治疗的临床试验中，16 个结局领域报告了 69 个结局，其中 28 个（31.82%，28/88）结局仅报告了 1 次；最常报告的结局是超声心动图。31 个结局（44.93%，31/69）提供了定义或 OMI；结局测量时间从 1 到 20，中位数为 3。抗凝治疗的临床试验中，18 个结局领域报告了 82 个结局，其中 38 个（29.23%，38/130）结局仅报告了 1 次。最常报告的结局是缺血性卒中。40 个结局（48.78%，40/82）提供了 OMI 或定义；结局测量时间从 1 到 27，中位数为 8。