Significant variation exists in outcomes reported in clinical trials related to maternal and neonatal care. Variation in outcome definitions and measurement limits accurate conclusions regarding safety, and clinical effectiveness of maternity-related treatments, interventions, and care procedures.
Previous work in the area of Womens Health conducted by Duffy and colleagues in 2017 identified 49 core outcome set registry records and four completed COS, three maternity specific. Lack of a formal quality assessment tool inhibited the ability to draw conclusions regarding whether appropriate methods had been used to develop the COS.
Outcome generation represents the first step in the standardisation of outcomes. Once a COS is agreed, it is then important to determine how the outcomes included in the set should be defined and measured. Without harmonisation of how to measurement outcomes, ongoing variation may continue. Currently little is known regarding concordance of outcomes, definitions or measurement between similar maternity and newborn COS.
This review build on previous work to identify all maternity and neonatal core outcome sets. It is anticipated that many of the ongoing projects identified by Duffy will now be complete. Further, the recent publication of minimum standards for COS development offers the opportunity to formally assess COS.
(1) To evaluate the quality of maternity and neonatal core outcome sets, and
(2) Develop a baseline for maternity and neonatal care COS standard of development
(1) Do maternity and neonatal COS meet minimum standards for development?
(2) What is the extent of concordance in regard to maternal and neonatal outcomes recommended between COS?
Valerie Slavin 1,2 RM MSc
Debra K Creedy 1 RN PhD
Jenny Gamble 1 RM PhD
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.
- Systematic review of core outcome sets
- Systematic review
The systematic review methods will be informed by published systematic reviews identifying potential core outcome sets related to general and women's health.
This review falls outside the scope of PROSPERO.
The protocol will be submitted to an online journal prior to conducting the search.
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.
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.
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.
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
Each included study will be assessed against COS-STAD minimum standards.
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.