INTRODUCTION
Clinical trials are undertaken in a range of settings and populations to
support evidence-based practice.(1) The reporting of standardised
outcome measures facilitates comparisons between trials.(2) Outcome
selection however varies widely between trials and few outcomes reflect
the perspectives of and are directly relevant to trial participants.(3)
The development of Core Outcome Sets (COS) has been encouraged to
address these issues, identifying minimum outcomes recommended for
routine measurement and reporting in clinical trials and systematic
reviews in shared areas, whilst allowing researchers to add further
outcomes to address specific questions.(2) Core outcome sets include
outcomes, or domains, to be measured in clinical trials, and
recommendations for which instruments should be used, and when, to
quantify domains.(4, 5)
The Core Outcome Measures for Effectiveness Trials (COMET) initiative,
established in 2010, supports COS developers by providing methodological
guidelines and hosting a repository of COS studies.(6-8) Guidelines
recommend consensus science methods engaging diverse stakeholders
including health professionals, researchers and patients, aiming to
improve the inclusion of patient centred outcomes, reduce selective
outcome reporting and facilitate prospective analysis.(2, 9, 10) The
process typically involves 6 stages: (1) defining COS scope (2) COMET
registration, avoiding duplication (3) protocol development (4)
systematic review of outcome measures followed by Delphi process to
refine core outcomes (5) implementation.
Over 80 specialty journals, including BJOG: An InternationalJournal of Obstetrics and Gynaecology , have come together within
the Core Outcomes in Women’s and Newborn Health (CROWN) initiative to
support researchers to develop, disseminate, and implement COS.(11, 12)
As interest has grown in this area, variable quality has been noted in
the development and reporting of COS.(9) In response, standards have
been developed through Delphi processes with COS developers, journal
editors and patient and public representatives. These propose minimum
expectations for methodological and reporting quality for COS, promoting
research integrity and transparency.(13) The Core Outcome
Set-STAndardised Protocol (COS-STAP) specify protocol methods,(13) the
Core Outcome Set STAndards for Development (COS-STAD) identifies
methodological standards,(14) and the Core Outcome Set STAndards for
Reporting (COS-STAR) identifies reporting standards of completed
COS.(15)
A review of the COMET and CROWN databases in 2017 identified COS
development studies relevant to women’s and newborn health.(11) Since
then, there has been rapid expansion of the COMET database and the
introduction of quality standards.(13-15) The aim of this study was to
review women’s and newborn health COS registered with the COMET or CROWN
initiative, evaluate methodological and reporting quality and consider
how COS development may be improved.