Core outcome sets in women’s and newborn health: A review,
methodological and reporting quality assessment informing
recommendations for core outcome set developers and wider stakeholders
Abstract
Background: Methodological and reporting assessment tools have been
developed which allow us to investigate the core outcome set development
process Objective: To characterise core outcome sets relevant to women’s
and newborn health and assess methodological and reporting quality.
Search Strategy: Systematic search using the Core Outcome Measures in
Effectiveness Trials (COMET) and the Core Outcomes in Women’s and
Newborn Health (CROWN) Initiative databases from inception to March
2020. Selection Criteria: Registered, progressing, and completed core
outcome sets. Data Collection and analysis: Descriptive summaries of
characteristics and results. Published protocols were assessed using the
Core Outcome Set-STAndardised Protocol Items (COS-STAP). Completed core
outcome sets were evaluated using COS-STAD (standards for development)
and COS-STAR (standards for reporting). Main Results: Eighty studies
were identified. Twenty-four studies had published a protocol; four
(17%) met all COS-STAP criteria. This was primarily due to poorly
defined steering groups and lack of discussion around the potential
impact of attrition. Thirty-nine systematic reviews characterized
inconsistency in outcome reporting. Twenty studies published a core
outcome set development process with four (20%) and three (15%)
meeting COS-STAD and COS-STAR recommendations respectively, largely due
to variation in patient involvement, outcome selection and the Delphi
process Conclusions: Future core outcome set developers should actively
engage with the methodological and reporting criteria to enhance the
quality of their studies. Clarity is also required within the assessment
guidelines as to how these issues should be adequately addressed. We
have identified 5 key areas for improvement for future core outcome set
developers and wider stakeholders