Abstract
Objectives:
To develop consensus definitions for the core outcome set for pre-eclampsia.
Study design:
Potential definitions for individual core outcomes were identified across four formal definition development initiatives, nine national and international guidelines, 12 Cochrane systematic reviews, and 79 randomised trials. Eighty-six definitions were entered into the consensus development meeting. Ten healthcare professionals and three researchers, including six participants who had experience of conducting research in low- and middle-income countries, participated in the consensus development process. The final core outcome set was approved by an international steering group.
Results:
Consensus definitions were developed for all core outcomes. When considering stroke, pulmonary oedema, acute kidney injury, raised liver enzymes, low platelets, birth weight, and neonatal seizures, consensus definitions were developed specifically for low- and middle-income countries because of the limited availability of diagnostic interventions including computerised tomography, chest x-ray, laboratory tests, equipment, and electroencephalogram monitoring.
Conclusions:
Consensus on measurements for the pre-eclampsia core outcome set will help to ensure consistency across future randomised trials and systematic reviews. Such standardization should make research evidence more accessible and facilitate the translation of research into clinical practice. Video abstract can be available at: www.dropbox.com/s/ftrgvrfu0u9glqd/6.%20Standardising%20definitions%20in%20teh%20pre-eclampsia%20core%20outcome%20set%3A%20a%20consensus%20development%20study.mp4?dl=0.
| Original language | English |
|---|---|
| Pages (from-to) | 208-217 |
| Number of pages | 10 |
| Journal | Pregnancy Hypertension |
| Volume | 21 |
| DOIs | |
| Publication status | Published - Jul 2020 |
Bibliographical note
Funding Information:Dr Gale has received expenses to attend an educational conference from Chiesi Pharmaceuticals and his institution has received research funding from Chiesi Pharmaceuticals. Prof Karumanchi reports serving as a consultant to Roche and Thermofisher Scientific and has a financial interest in Aggamin Pharmaceuticals. Prof Mol is a consultant for ObsEva. The remaining authors declare no competing interests.
Funding Information:
This paper reports independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the National Institute for Health Research. Dr Chris Gale was supported by a Medical Research Council Clinician Scientist Fellowship . Prof Richard McManus was supported by a National Institute for Health Research Professorship (NIHR-RP-R2-12-015) and the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care Oxford. Prof Mol is supported by a National Health and Medical Research Practitioner Fellowship (GNT1082548). Prof Richard McManus, Prof Paula Williamson, and Prof Sue Ziebland are supported by National Institute for Health Research Senior Investigator awards. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the National Institute for Health Research, or the Department of Health.
Funding Information:
This paper reports independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the National Institute for Health Research. Dr Chris Gale was supported by a Medical Research Council Clinician Scientist Fellowship. Prof Richard McManus was supported by a National Institute for Health Research Professorship (NIHR-RP-R2-12-015) and the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care Oxford. Prof Mol is supported by a National Health and Medical Research Practitioner Fellowship (GNT1082548). Prof Richard McManus, Prof Paula Williamson, and Prof Sue Ziebland are supported by National Institute for Health Research Senior Investigator awards. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the National Institute for Health Research, or the Department of Health. We would like to thank the healthcare professionals and researchers who participated in the consensus development meeting. We would like to thank the Radcliffe Women's Health Patient Participation group, Action on Pre-eclampsia, and our patient and public representatives who assisted with study design, data interpretation, and planned dissemination. We would like to thank colleagues at the Nuffield Department of Primary Care Health Sciences, University of Oxford including Jacqui Belcher, Carla Betts, Lucy Curtin, Dawn Evans, Caroline Jordan, Sarah King, Sam Monaghan, Dan Richards-Doran, Nicola Small, and Clare Wickings for administrative, technical, or material support. We would like to thank Prof. Marian Knight, Nuffield Department of Population Health, University of Oxford, for providing subject-specific expertise. We would like to thank colleagues at the Women's Health Research Unit, Queen Mary, University of London including Prof. Khalid Khan, Tracy Holtham, and Rehan Khan for administrative, technical support, or subject-specific expertise.
Funding Information:
This study was funded by the Balliol College, University of Oxford, Barts Charity, Elizabeth Garrett Anderson Hospital Charity, Royal College of Obstetricians and Gynaecologists, and National Institute for Health Research. The funders have no role in the design and conduct of the study, the collection, management, analysis, or interpretation of data, or manuscript preparation.
Publisher Copyright:
© 2020 International Society for the Study of Hypertension in Pregnancy