Funding
This article is adapted from a report undertaken by the SBU, who
provided funding for the study.
Keywords: Childbirth, Core outcome set, Maternal health, Obstetric care,
Pregnancy
Tweetable abstract
A systematic review of completed and ongoing Core Outcomes Sets (COS)
relating to pregnancy and childbirth by @SBU_en
Introduction
Well- designed and well conducted randomized controlled trials (RCTs)
determine the effectiveness of different interventions through unbiased
comparison of outcomes (events or endpoints). The selection of outcomes
is critical in RCT design, and trials may be regarded as “only as
credible as their outcomes”. However, outcomes may be defined in
various ways, resulting in the reporting of multiple, apparently
different outcomes across studies. This has a negative impact on
evidence synthesis, contributing to heterogeneity and research waste
(1-3).
To overcome these problems, the selection of outcomes and measurement
properties in studies need to be standardised. Described and promoted by
the Core Outcome Measures in Effectiveness Trials (COMET) initiative
group in 2010, Core Outcome Sets (COS) have increasingly been developed
for various conditions over time (2). A COS is a minimum set of outcomes
to be selected, measured, and reported in trials of a specific
condition. These are typically developed by identifying and describing
the outcomes used in current research (primary studies as well as
systematic reviews) and then allowing stakeholders to prioritize these
outcomes by using a consensus process. When a core outcome set has been
agreed on, the purpose is that researchers use it in all studies within
that condition, adding further outcomes if they wish (Figure 1). The aim
of developing and implementing COS is that the results of various
studies will be more readily comparable and collated, reinforcing the
basis of decisions, to benefit patients and healthcare personnel.
In the research fields of women’s health and neonatal health, an
international network, called CoRe Outcomes in Women’s and Newborn
health (CROWN), has been established (4). It is led by journal editors,
and aims to address the widespread, unwarranted variation in reporting
of outcomes, which makes comparison between and combination of results
across studies difficult, if not impossible.
The aim of this article was to systematically identify and describe
ongoing and completed studies prioritizing outcomes within the field of
pregnancy and childbirth.
Methods
The study consisted of a systematic literature review undertaken to
analyse and summarize ongoing and completed COS projects (including all
projects where outcomes where prioritized), within the area of obstetric
care. The literature search was conducted in June 2019. However, the
search of the COMET Initiative database was updated in January 2020.
Protocol and registration
A project plan was established a priori and registered at SBU, the
PROSPERO database (5) as well as the COMET database (6).
This systematic review was
conducted and reported in accordance with the PRISMA statement.
Eligibility criteria
The criteria for eligibility were outlined according to the PICOS model
(Population, Intervention, Comparator, Outcome and Study design) and
included the following characteristics:
Population: Pregnant women, women giving birth (labour and
delivery), women who suffer an injury or other complication related to
childbirth, women or men suffering from a mental health disorder during
pregnancy or during or after childbirth.
Intervention: No restriction.
Control: Not applicable.
Outcome: A list of outcomes included in the COS.
Study design: Ongoing or completed original studies where
outcomes were prioritized using some form of consensus. No restriction
applied to publication status.
Language: English and Scandinavian languages.