Quality of core outcome sets in maternal and newborn health – a systematic review protocol

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.

Review aims:
(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

Research questions:
(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?

Protocol submitted for publication: 16th January 2020
SR submitted for publication: 9th March 2020


Valerie Slavin 1,2 RM MSc

Debra K Creedy 1 RN PhD

Jenny Gamble 1 RM PhD

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.

Further Study Information

Current Stage: Completed – pending publication
Date: January 2020 - March 2020
Funding source(s): This review is supported by a PhD Scholarship awarded by Griffith University, Australia.

Health Area

Disease Category: Neonatal care, Pregnancy & childbirth

Disease Name: Neonatal care, Maternity care

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- None

Study Type

- 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.

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.

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.

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