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.
Chelsea Hall, Anna Shishkina, Robin Thurman, Rizwana Ashraf, Ankita Pal, Daphne Horn, Anish Keepanasseril, Rohan D’Souza,
Disease Category: Heart & circulation, Pregnancy & childbirth
Disease Name: Cardiovascular Disease
Age Range: 18 - 55
Sex: Female
Nature of Intervention: Any
- None
- Systematic review of outcomes measured in trials
- Systematic review