Introduction
A core outcome set (COS) represents an agreed set of outcomes that
should be measured and reported, as a minimum, in all clinical trials in
a specific area of health or health care,1 and can be
used in other research and clinical audit.2 COS
development and implementation is supported by the Core Outcome Measures
in Effectiveness Trials (COMET) Initiative. Launched in 2010, COMET
collates and stimulates the development and application of agreed
standardised COS by maintaining a publicly available, searchable
database of published and ongoing COS.3 The Core
Outcomes in Women’s and Newborn Health (CROWN) Initiative strongly
supports the development and dissemination of COS within women’s health
research.4
With over 330 published COS developed in several health disciplines
since 1981,5 COS related to maternal and neonatal care
has seen slower development. In a 2017 systematic review, Duffy and
colleagues identified only four published COS related to women’s and
newborn health, three of which related to pregnancy and
childbirth.6 To be effective, COS must be developed
using rigorous methods that reflect outcomes important to patients and
other stakeholders.7 The recent minimum standards for
COS development (Core Outcome Set-STAndards for Development: COS-STAD)
facilitates the assessment of whether a COS has been developed using a
reasonable approach.8 Core outcome set methodology is
however in its infancy, and advancements in methodologic standards are
likely in the future.9 To evaluate progress, a
baseline of methodological rigor is required to inform future maternal
and neonatal COS development.
To date, little attention has been paid to the harmonisation of outcomes
between similar COS. Without harmonisation of definitions, measures and
timing, there is a danger that heterogeneity and research wastage will
continue. The aim of the current study was to evaluate maternal and
neonatal COS against available standards of development. The current
study is guided by the following research questions:
- Do existing completed maternal and neonatal core outcome sets meet
minimum standards for development?
- What is the extent of concordance between core outcome sets?