Outcome reporting in cardio-obstetrics studies: A systematic review

IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Chelsea Hall MD , Anna Shishkina MD , Robin Thurman FRANZCOG , Rizwana Ashraf MD , Ankita Pal MD , Daphne Horn , Anish Keepanasseril MRCPI , Rohan D'Souza MD, PhD, FRCOG
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引用次数: 0

Abstract

Background

Although considerable variation in the reporting and definition of outcomes in cardio-obstetrics studies is acknowledged, the extent of this variation has not been documented. The primary objective of this systematic review was to highlight this variation and inform the development of a Core Outcome Set for studies on Cardiac disease in Pregnancy (COSCarP).

Methods

Medline, Embase, Web of Science and Cochrane Central databases were searched from 1980 to 2018 to identify all English-language publications on pregnancy and heart disease. Title/abstract screening and data extraction which included details on the study, patient population, and all reported outcomes, was performed in duplicate by 2 reviewers. As the aim of the review was to identify variation in outcome reporting, risk-of-bias assessment was not performed. The study protocol was registered on PROSPERO (CRD42016038218).

Results

The final analysis included 422 cardio-obstetric studies. Maternal mortality or survival were reported in 232/422 studies, with inconsistency in terms of cause of death (all-cause [n = 65], cardiac [n = 55] or obstetric [n = 10]) or timeframe (ranging from in-hospital mortality [n = 11] to mortality 5 years following pregnancy). In 95/232 (41%) studies, the cause and timeframe were not specified. Similar inconsistencies in reporting and definitions were noted for outcomes such as heart failure (n = 298), perinatal loss (n = 296), fetal growth (n = 221), bleeding (n = 205), arrhythmias (n = 202), preterm birth (n = 191), thromboembolism (n = 153) and hypertensive disorders (n = 122). Functioning / life-impact and adverse effects of treatment were sparingly reported in published cardio-obstetric studies.

Conclusions

This systematic review hopes to create awareness among cardio-obstetrics teams about the inconsistencies in reporting and defining outcomes which makes it difficult to compare studies and perform meta-analyses. COSCarP which is being developed through international consensus between patients and care-providers will provide cardio-obstetrics teams with a minimal set of outcomes to be reported in future cardio-obstetrics studies.
关于患有心脏病的孕妇的研究结果报告:系统综述:妊娠与心脏病研究的结果。
背景:众所周知,产科心脏病研究的结果报告和定义存在很大差异,但这种差异的程度尚未记录在案。本系统综述的主要目的是强调这种差异,并为妊娠期心脏病研究核心结果集(COSCarP)的制定提供依据:检索了 1980 年至 2018 年期间的 Medline、Embase、Web of Science 和 Cochrane Central 数据库,以确定所有关于妊娠和心脏病的英文出版物。标题/摘要筛选和数据提取包括研究细节、患者人群和所有报告结果,由两名审稿人重复进行。由于综述的目的是确定结果报告中的差异,因此没有进行偏倚风险评估。研究方案已在 PROSPERO(CRD42016038218)上注册:最终分析包括 422 项心外科产科研究。232/422项研究报告了孕产妇死亡率或存活率,但在死亡原因[全因(n=65)、心脏(n=55)或产科(n=10)]或时间范围(从院内死亡(n=11)到妊娠后5年死亡)方面存在不一致。有 95/232 项研究(41%)未说明死亡原因和时间范围。心力衰竭(298 例)、围产期损失(296 例)、胎儿发育(221 例)、出血(205 例)、心律失常(202 例)、早产(191 例)、血栓栓塞(153 例)和高血压疾病(122 例)等结果的报告和定义也存在类似的不一致。心血管产科研究中很少报道治疗对功能/生活的影响和不良反应:本系统性综述希望能让心肺产科团队认识到,由于结果的报告和定义不一致,因此很难对研究进行比较和荟萃分析。COSCarP是通过患者和医疗服务提供者之间的国际共识制定的,它将为心外科产科团队提供一套最基本的结果,供今后的心外科产科研究报告使用。
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
American heart journal
American heart journal 医学-心血管系统
CiteScore
8.20
自引率
2.10%
发文量
214
审稿时长
38 days
期刊介绍: The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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