A core outcome set for hyperemesis gravidarum research: an international consensus study

Objective
To develop a core outcome set for trials on the treatment of hyperemesis gravidarum (HG).

Design
Identification of outcomes is followed by a modified Delphi survey combined with a consensus development meeting and a consultation round.

Setting
An international web-based survey combined with a consensus development meeting.

Population
Stakeholders including researchers; women with lived experience of HG and their families; obstetric health professionals; and other health professionals.

Methods
We used systematic review, semi-structured patient interviews, closed group sessions and Steering Committee input to identify potential core outcomes. We conducted two web-based survey rounds, followed by a face-to-face consensus development meeting and a web-based consultation round.

Main outcome measures
A core outcome set for research on HG.

Results
Fifty-six potential outcomes were identified. The modified Delphi process was completed by 125 stakeholders, the consensus development meeting by 20 stakeholders and the consultation round by 96 stakeholders. Consensus was reached in ten domains on 24 outcomes: nausea; vomiting; inability to tolerate oral fluids or food; dehydration; weight difference; electrolyte imbalance; intravenous fluid treatment; use of medication for hyperemesis gravidarum; hospital treatment; treatment compliance; patient satisfaction; daily functioning; maternal physical or mental or emotional wellbeing; short- and long-term adverse effects of treatment; maternal death; pregnancy complications; considering or actually terminating a wanted pregnancy; preterm birth; small for gestational age; congenital anomalies; neonatal morbidity and offspring death).

Conclusions
This core outcome set will help standardise outcome reporting in HG trials.

Tweetable abstract
A core outcome set for treatment of hyperemesis gravidarum in order to create high-quality evidence.

Contributors

LAW Jansen
MH Koot
J van‘t Hooft
CR Dean
JMN Duffy
W Ganzevoort
N Gauw
BY Goes
J Rodenburg
TJ Roseboom
RC Painter
IJ Grooten

Publication

Journal: BJOG: An International Journal of Obstetrics and Gynaecology
Volume:
Issue:
Pages: -
Year: 2020
DOI: 10.1111/1471-0528.16227

Further Study Information

Current Stage: Completed
Date: December 2015 - 2016
Funding source(s): None


Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Hyperemesis gravidarum

Target Population

Age Range: Unknown

Sex: Female

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Systematic review
- Interview

We used systematic review, semi-structured patient interviews, closed group sessions, and Steering Committee input to identify potential core outcomes. We conducted two web-based survey rounds, followed by a face-to-face consensus development meeting and a web-based consultation round.