COMET Initiative | Core Measurement Set for Hyperemesis Gravidarum Research

Core Measurement Set for Hyperemesis Gravidarum Research

A core outcome set (COS) for hyperemesis gravidarum (HG) exists, aimed at standardizing outcome reporting in trials on HG, but practice variation persists in instruments used to measure the outcomes in the COS. Harmonization of the outcome measurement instruments (OMIs) will result in more standardized reporting and ultimately result in more high-level evidence through the possibility of meta-analysis. The present study aims to produce a core measurement set, a consensus-based set, to inform how the outcomes included in the COS should be measured in all future trials.

Contributors

L.A.W. Jansen, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands, Department of Obstetrics and Gynecology, Amphia Hospital, Breda, the Netherlands.
L.M. van der Minnen, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherland.
R.C. Painter, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
I.J. Grooten, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
J van 't Hooft, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Further Study Information

Current Stage: Ongoing
Date: March 2021 - January 2023
Funding source(s): This study will be partly funded by a grant received from the Bikkja Trust. The Bikkja Trust is a charitable fund focused on the severe pregnancy complication hyperemesis gravidarum.

Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Hyperemesis gravidarum

Target Population

Age Range: 15 - 60

Sex: Female

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Researchers

Study Type

- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Interview
- Literature review
- Systematic review

This study will make use of a mix methods approach, including a systematic review, quality assessment of OMIs, and an international stakeholder consultation round. We will use the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines to develop methodology for the present study.