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