Abstract
Background: An evaluation of outcome reporting is required to develop a core outcome set. Objectives: To assess primary outcomes and outcome measure reporting in pre-eclampsia trials. Search strategy: Five online databases were searched from inception to January 2016 using terms including “preeclampsia” and “randomized controlled trial”. Selection criteria: Randomized controlled trials evaluating treatments for pre-eclampsia published in any language were included. Data collection and analysis: Primary outcomes and data on outcome measure reporting were systematically extracted and categorized. Main results: Overall, 79 randomized trials including data from 31 615 women were included. Of those, 38 (48%) reported 35 different primary outcomes; 28 were maternal outcomes and seven were fetal/neonatal outcomes. Three randomized trials reported composite outcomes, incorporating between six and nine outcome components. The method of definition or measurement was infrequently or poorly reported. Even when outcomes were consistent across trials, different methods of definition or measurement were frequently described. Conclusions: In randomized trials evaluating interventions for pre-eclampsia, critical information related to the primary outcome, including definition and measurement, is regularly omitted. Developing a core outcome set for pre-eclampsia trials would help to inform primary outcome selection and outcome measure reporting.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 262-267 |
| Number of pages | 6 |
| Journal | International Journal of Gynecology and Obstetrics |
| Volume | 139 |
| Issue number | 3 |
| DOIs | |
| State | Published - Dec 2017 |
Funding
The study is independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the NaD\u9E00onal InsD\u9E00tute for Health Research (NIHR). CG was supported by an NIHR Clinical Trials Fellowship (NIHR-CTF-2014-03-02) and a Medical Research Council (MRC) Clinician ScienD\u9E00st Fellowship (MR/N008405/1). SZ is a NIHR Senior InvesD\u9E00gator. RJM is supported by a NIHR Professorship (NIHR-RP-R2-12-015) and the NIHR CollaboraD\u9E00on for Leadership in Applied Health Research and Care Oxford. The views expressed in this pub-licaD\u9E00on are those of the authors and not necessarily those of the The study is independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the National Institute for Health Research (NIHR). CG was supported by an NIHR Clinical Trials Fellowship (NIHR-CTF-2014-03-02) and a Medical Research Council (MRC) Clinician Scientist Fellowship (MR/N008405/1). SZ is a NIHR Senior Investigator. RJM is supported by a NIHR Professorship (NIHR-RP-R2-12-015) and the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the UK Department of Health. We would like to thank Carla Betts, Dawn Evans, Caroline Jordan, Sam Monaghan, Dan Richards-Doran, Nicola Small, and Clare Wickings at the Nuffield Department of Primary Care Health Sciences, University of Oxford, for administrative, technical, and material support; Tracy Holtham and Rehan Khan at the Women's Health Research Unit, Queen Mary, University of London for administrative, technical support, and subject-specific expertise; and David Mills for administrative and material support.
Keywords
- Core outcome sets
- Maternal
- Newborn
- Outcome reporting bias
- Pre-eclampsia
- Randomized controlled trials
- Systematic review
ASJC Scopus subject areas
- Obstetrics and Gynecology