Outcome Reporting in Studies on Pregnant Women With Cardiac Disease: A Systematic Review [30Q]

INTRODUCTION: To systematically review the literature for reported outcomes is studies on pregnant women with cardiac disease. METHODS: A search strategy was designed for Medline, Embase, Web of Science and Cochrane Central databases from 1980 to 2015 to identify all experimental and observational studies in pregnant women with cardiac disease. The search was limited to studies describing five patients or more, studies in the English language and excluded conference abstracts. As the intent was to describe reported outcomes, authors were not contacted for clarifications, the grey literature was not searched and no risk of bias assessment was performed. RESULTS: 3118 titles and abstracts were reviewed and 327 studies were included in this review, stratified under valvular heart disease (78), all cardiac disease (75), cardiomyopathies (68), complex congenital heart disease (49), cardiac interventions in pregnancy (35) and others including aortopathies and arrhythmias (22). There was large variation in the number and nature of reported outcomes. The most commonly reported maternal outcomes included: maternal mortality (n=169), thrombo-embolism (n=118), and mode of delivery (n=190). The most commonly reported fetal/neonatal outcomes included: preterm birth (n=143), miscarriage/abortion (n=119) and neonatal death (n=100). Proportions of studies that provided definitions for outcomes varied, and definitions were highly inconsistent between studies. CONCLUSION: Meta-analysis of studies involving pregnant women with cardiac disease requires consistency in the reporting and defining of outcomes for meaningful clinical conclusions to be drawn. To address this issue, a core outcome set, a standardized set of outcomes obtained through consensus between relevant stakeholders, is urgently required.