Conclusion
Methodological and reporting standards of OG COSs should be further
improved.
Registration number : 1581
(http://www.comet-initiative.org/Studies/Details/1581).
Keywords: Core outcome set; Obstetrics; Gynecology; Research
methodology; COS; Report methodology
Tweetable abstract: Methodological and reporting standards of
obstetrics and gynecology core outcome sets COSs should be further
improved.
Introduction
Selecting outcomes that adequately reflect relevant issues to patients
and health care professionals is essential when designing clinical
trials to compare the effects of different interventions
directly.1, 2 Core outcome sets (COSs) represent the
minimum important outcomes that should be measured and reported in all
research studies for a specific condition.1 The use of
high-quality COSs in clinical trials has the following benefits;
improves comparability between similar trials, reduces selective
reporting of results, increases the relevance of trial and systematic
review results,3 and enhances the quality of evidence
used in health care decision-making ultimately translates to improved
health care for patients.4 COSs are increasingly
recognized as important for the design, implementation, and reporting of
randomized trials, systematic reviews, and other forms of
research.5-7
The rapid increase in the number of COSs covering a wide range of
different health-related areas has seen the standards of COSs definition
vary considerably.6, 8-13 Previous studies have
suggested that a high-quality set of COSs should include a comprehensive
scoping process and a consensus process that involves multi-stakeholder
groups.14-16 Whether these published COSs undertook a
systematic review of existing outcomes or fully considered the views of
different stakeholder groups on the COSs, remains
unclear.17 The Core Outcome SeteSTAndards for
Development (COS-STAD) project aimed to identify those aspects of COSs
development for which minimum standards can be agreed upon and applied
regardless of the consensus method chosen. Recommendations have since
been established to improve the methodological approach for developing
COSs and help users assess the applicability of a particular
COSs.15 Additionally, the Core Outcome Set-STAndards
for Reporting (COS-STAR) statement was developed using the recommended
approach for developing medical reporting
guidelines.18 The difference between COS-STAD and
COS-STAR is that the former focuses on the principles of design
associated with COSs development, while the latter focuses on the
reporting of COSs development studies. While applying COS-STAD standards
to assess the design quality of cancer COSs, a recent pilot study
revealed that the scoping process and consensus process of cancer COSs
were not optimistic.19 Besides, none of the studies
met all the 12 standards representing the 11 minimum standards assessed.
Therefore, it is valuable to explore ways of improving the existing
standards of COSs development.
Obstetrics and gynecology (OG) is a specialty in clinical medicine that
focuses on the physiological and pathological changes of the female
reproductive system, as well as fertility
regulation.20-22 Well-developed COSs should ensure
that outcomes in OG trials reflect prioritize relevant issues to both
patients and health care professionals over other
disciplines.21-25 The primary objective of our study
is to use COS-STAD and the COS-STAR checklists to assess the
methodological and reporting standards of OG COSs. The secondary
objectives of our research include: exploring factors that affect the
quality of developed COSs standards; and exploring how to improve
baseline standards for obstetrics and gynecology COSs development.
Methods