COMET Initiative | Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia

Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia

BACKGROUND: Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. OBJECTIVES: To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. SEARCH STRATEGY: Randomised trials were identified by searching bibliographical databases from inception to January 2016. SELECTION CRITERIA: Randomised controlled trials. DATA COLLECTION AND ANALYSIS: We systematically extracted and categorised outcome reporting. MAIN RESULTS: Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. CONCLUSIONS: Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues. TWEETABLE ABSTRACT: Future #preeclampsia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy International Prospective Register of Systematic Reviews: CRD42015015529; www.crd.york.ac.uk/PROSPERO/display_record.aspID=CRD42015015529.

Contributors

Duffy, J. Hirsch, M. Kawsar, A. Gale, C. Pealing, L. Plana, M. N. Showell, M. Williamson, P. R. Khan, K. S. Ziebland, S. McManus, R. J.

Publication

Journal: BJOG
Volume: 124
Issue: 12
Pages: 1829 - 1839
Year: 2017
DOI: 10.1111/1471-0528.14702

Further Study Information

Current Stage: Completed
Date:
Funding source(s): This report is independent research arising from a doctoralfellowship (DRF-2014-07-051) supported by the NationalInstitute for Health Research. Dr Chris Gale was supportedduring this study by a National Institute for Health ResearchClinical Trials Fellowship (NIHR-CTF-2014-03-02) and aMedical Research Council Clinician Scientist Fellowship(MR/N008405/1). Prof Richard McManus is supported by aNational Institute for Health Research Professorship (NIHR-RP-R2-12-015) and the National Institute for HealthResearch Collaboration for Leadership in Applied HealthResearch and Care Oxford. Prof Sue Ziebland is an NIHRSenior Investigator.

Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Gestational hypertension, Hypertensive disorders in pregnancy, Pre-eclampsia

Target Population

Age Range: Unknown

Sex: Female

Nature of Intervention: Any

Stakeholders Involved

- None

Study Type

- Systematic review of outcome measures/measurement instruments

Method(s)

- Systematic review