Core Outcome Measures in Effectiveness Trials

Progressing towards core outcomes for maternal and perinatal clinical trials and reviews

General Information

Abstract:
Background

As defined by the Core Outcome Measures in Effectiveness Trials (COMET) initiative, core outcome sets (COS) are an agreed minimum set of outcomes to be measured and reported in randomised controlled trials (RCTs) in a specific area, making it easier for results to be compared, contrasted and combined. We assessed progress made towards COS for maternal and perinatal RCTs and reviews.
Method

We searched the COMET Database (12/11/2016), limiting to the health areas ‘Pregnancy and Childbirth’ and ‘Neonatal Care’, and extracted information related to scope and methodology of relevant COS studies. We searched the Cochrane Database of Systematic Reviews (12/11/2016) using the term ‘core outcome*’, limiting to ‘Pregnancy and Childbirth’ and ‘Neonatal’ protocols and reviews.
Results

We identified 46 COS studies in the ‘Pregnancy and Childbirth’ area, and 15 focused on ‘Neonatal Care,’ predominately planned or ongoing and being led by investigators in Europe and North America. Scope of the COS varies greatly, from COS for studies in ‘pregnant women requiting ventilation’ to ‘neonatal care’ generally. Commonly COS development is involving a systematic review of outcomes in relevant trials, followed by Delphi surveys and a final consensus meeting. To date, only 2% (15/890) of Cochrane Pregnancy and Childbirth and Neonatal protocols or reviews make reference to a COS.
Conclusions

In order to increase value and reduce waste in future research, there is now an urgent need for international engagement in maternal and perinatal COS development. Methodological research and guidance to support COS development, reporting and implementation is required.

Authors:
Emily Shepherd, Philippa Middleton, Caroline Crowther

Publication

Journal:
Journal of Paediatrics and Child Health
Volume:
53
Issue:
S2
Pages:
-
Year:
2017
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Child health

Disease Name
Maternity care
Perinatal

Target Population

Age Range
-

Sex
Unknown


Nature / type of Intervention
Any

Method(s)

Systematic review

Stakeholders Involved

Unknown

Study Type

Systematic review of outcomes measured in trials

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