Introduction
Variation in outcomes reported in maternity-related clinical trials and practice stifles data synthesis and contributes to ineffective or harmful treatments and interventions. Variation can be addressed using core outcome sets (COSs), minimum agreed sets of outcomes that should be measured and reported in all clinical trials in a specific area of health or health care. This scoping review identified studies that developed maternity-related COSs; evaluated the extent, scope, quality, and consistency of outcomes across similar COSs; and identified current gaps in evidence.
Methods
A multifaceted search of 2 COS registers (Core Outcome Measures in Effectiveness Trials, Core Outcomes in Women's and Newborn Health), the International Consortium for Health Outcomes Measurement website, electronic databases (MEDLINE, Embase, CINAHL), and hand search was conducted. Published, English-language studies describing maternal and neonatal COSs for any health condition and published from inception to January 2020 were included. COS development process was evaluated against recently published COS Standards for Development: scope, stakeholder involvement, and consensus process.
Results
Thirty-two articles relating to 26 COSs were included (maternal: 18 articles that addressed 17 COSs; neonatal: 14 articles that addressed 9 COSs) and covered a range of obstetric and neonatal conditions. COSs were published between 2006 and 2020, 58% since 2017. Maternal COSs included more outcomes (median, 17; range, 50) than neonatal COSs (median, 8; range, 20). Overlap in COSs was seen for maternity care and gestational diabetes. Overlap in outcomes was seen across similar COSs, which were mostly inconsistent or poorly defined. No included COS met all minimum standards for development. Two COSs extended recommendations for how and when to measure outcomes.
Discussion
Growth in COS development in the last 3 years signifies increasing commitment to address variation and improve data synthesis. Although the quality of the development process has improved in the last 3 years, there is a need for improvement. This article presents an urgent need to minimize overlap in outcomes and standardize outcome measurement, case definitions, and timing of measurement between COSs.
Valerie Slavin 1,2 RM MSc
valerie.slavin@griffithuni.edu.au
Debra K Creedy 1 RN PhD
d.creedy@griffith.edu.au
Jenny Gamble 1 RM PhD
j.gamble@griffith.edu.au
Author affiliations
1 Transforming Maternity Care Collaborative, School of Nursing & Midwifery, Griffith University, Logan Campus, University Drive, Meadowbrook, Qld, 4131, Australia;
2 Women, Newborn & Children’s Services, Gold Coast University Hospital, 1 Hospital Boulevard, Southport, Qld, 4215, Australia.
Disease Category: Neonatal care, Pregnancy & childbirth
Disease Name: Neonatal care, Maternity care
Age Range: Unknown
Sex: Either
Nature of Intervention: Any
- None
- Systematic review of core outcome sets
- Systematic review
Methods:
The systematic review methods will be informed by published systematic reviews identifying potential core outcome sets related to general and women's health.
Protocol registration:
This review falls outside the scope of PROSPERO.
The protocol will be submitted to an online journal prior to conducting the search.
Inclusion criteria:
All published COS or standard sets relevant to maternity and neonatal outcomes.
Population: pregnant or postpartum participants (up to 12 months postpartum) of any age, or neonates/infants (up to 12 months of age), with any health condition in any setting which assesses outcomes related to maternal and neonatal care.
Search methods:
We will conduct a search of COS Registries, standard set developers, electronic data bases, and conduct a hand search.
Registries include COMET and CROWN
ICHOM standard sets will be reviewed for inclusion
MEDLINE, EMBASE and CINAHL databases will be reviewed.
Search terms are guided by previous reviews. No date limits are applied. English language papers will be included.
Selection process:
Title and abstract will be screened for all identified papers.
Full text will be reviewed for all studies meeting or possibly meeting inclusion criteria
Papers will be screened by 1 reviewer. Ten percent of included and excluded papers will be reviewed by a second reviewer. Discrepancies will be discussed with and resolved by a third reviewer.
Data extraction
Purposely developed data extraction forms will be completed for each included paper. Related protocols and systematic reviews will also be sought to maximise information regarding COS development and to compare compliance/deviation.
Data will be extracted for:
author(s), year of publication, type of publication (open access), COMET registration number, type of core outcome set (defined on COMET), funder, CROWN registration.
• each item as defined on COS-STAR statement 37 (18 items) (Table 1)
• each item as defined on COS-STAD (11 items) 5
• List of outcomes
• List of Domains
• Recommendation for outcome definition
• Recommendations for outcome measurement
• Recommendations for measurement timing
• Plan for further work regarding definition, measurement, timing
Quality assessment:
Each included study will be assessed against COS-STAD minimum standards.
Results:
Findings will be described descriptively using text and tables. For comparison purposes to evaluate progress in COS development, current findings will be compared to the findings of previous systematic reviews for all identified core outcome sets and those related to women’s and newborn health.