TY - JOUR
T1 - A core outcome set for pre-eclampsia research
T2 - an international consensus development study
AU - The International Collaboration to Harmonise Outcomes for Pre-eclampsia (iHOPE)
AU - Duffy, J. M.N.
AU - Cairns, A. E.
AU - Richards-Doran, D.
AU - van 't Hooft, J.
AU - Gale, C.
AU - Brown, M.
AU - Chappell, L. C.
AU - Grobman, W. A.
AU - Fitzpatrick, R.
AU - Karumanchi, S. A.
AU - Khalil, A.
AU - Lucas, D. N.
AU - Magee, L. A.
AU - Mol, B. W.
AU - Stark, M.
AU - Thangaratinam, S.
AU - Wilson, M. J.
AU - von Dadelszen, P.
AU - Williamson, P. R.
AU - Ziebland, S.
AU - McManus, R. J.
AU - Abalos, Edgardo J.
AU - DA, Christine C.D.
AU - AkaDr, Adebayo A.
AU - Akturk, Zekeriya
AU - Allegaert, Karel
AU - Angel-Müller, Edith
AU - Antretter, Jessica
AU - Ashdown, Helen F.
AU - Audibert, Francois
AU - Auger, Nathalie
AU - Aygun, Canan
AU - Babic, Inas
AU - Bagga, Rashmi
AU - Baker, Judith M.
AU - Bhakta, Pradipta
AU - Bhandari, Vineet
AU - Bhattacharya, Sohinee
AU - Blanker, Marco H.
AU - Bloomfield, Frank H.
AU - Bof, Anna
AU - Brennan, Siobhan M.
AU - Broekhuijsen, Kim
AU - Pipkin, Emeritus Fiona Broughton
AU - Browne, Joyce L.
AU - Browning, Roger M.
AU - Bull, Jameson W.
AU - Butt, Amina
AU - Button, Dena
AU - Erez, Offer
N1 - Funding Information:
CG received expenses to attend an educational conference from Chiesi Pharmaceuticals and his institution has received research funding from Chiesi Pharmaceuticals. SAK reports receiving research funding from Siemens, serving as a consultant to Roche and Thermo Fisher Scientific, having a financial interest in Aggamin Pharmaceuticals and holding multiple patents. AK reports being the inventor of the Hampton system. BWM reports consultancy fees from Guerbet, iGenomix, Merck KGaA and ObsEva. RJM reports research support from Omron. The remaining authors declare no competing interests. Completed disclosure of interests forms are available to view online as supporting information.
Funding Information:
This work reports independent research arising from a doctoral fellowship (DRF‐2014‐07‐051) supported by the National Institute for Health Research, Barts Charity and Elisabeth Garrett Anderson Hospital Charity Travelling Fellowship in Memory of Anne Boutwood. 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. Richard McManus, Prof. Paula Williamson and Prof. Sue Ziebland are supported by National Institute for Health Research Senior Investigator awards. Prof. Ben Mol is supported by a National Health and Medical Research Council Investigator Grant. 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 study was funded by the Barts Charity, Elisabeth Garrett Anderson Hospital Charity 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 the manuscript preparation. This work reports independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the National Institute for Health Research, Barts Charity and Elisabeth Garrett Anderson Hospital Charity Travelling Fellowship in Memory of Anne Boutwood. 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. Richard McManus, Prof. Paula Williamson and Prof. Sue Ziebland are supported by National Institute for Health Research Senior Investigator awards. Prof. Ben Mol is supported by a National Health and Medical Research Council Investigator Grant. 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 Delphi survey and consensus development meeting participants. 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, 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 Khalid Khan, Rehan Khan and Tracy Holtham for administrative and technical support or subject-specific expertise. We would like to thank David J. Mills for administrative and logistical support.
Publisher Copyright:
© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists
PY - 2020/11/1
Y1 - 2020/11/1
N2 - Objective: To develop a core outcome set for pre-eclampsia. Design: Consensus development study. Setting: International. Population: Two hundred and eight-one healthcare professionals, 41 researchers and 110 patients, representing 56 countries, participated. Methods: Modified Delphi method and Modified Nominal Group Technique. Results: A long-list of 116 potential core outcomes was developed by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting. Maternal core outcomes: death, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary oedema, acute kidney injury, liver haematoma or rupture, abruption, postpartum haemorrhage, raised liver enzymes, low platelets, admission to intensive care required, and intubation and ventilation. Offspring core outcomes: stillbirth, gestational age at delivery, birthweight, small-for-gestational-age, neonatal mortality, seizures, admission to neonatal unit required and respiratory support. Conclusions: The core outcome set for pre-eclampsia should underpin future randomised trials and systematic reviews. Such implementation should ensure that future research holds the necessary reach and relevance to inform clinical practice, enhance women's care and improve the outcomes of pregnant women and their babies. Tweetable abstract: 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia core outcomes @HOPEoutcomes @jamesmnduffy. [Correction added on 29 June 2020, after first online publication: the order has been corrected.].
AB - Objective: To develop a core outcome set for pre-eclampsia. Design: Consensus development study. Setting: International. Population: Two hundred and eight-one healthcare professionals, 41 researchers and 110 patients, representing 56 countries, participated. Methods: Modified Delphi method and Modified Nominal Group Technique. Results: A long-list of 116 potential core outcomes was developed by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting. Maternal core outcomes: death, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary oedema, acute kidney injury, liver haematoma or rupture, abruption, postpartum haemorrhage, raised liver enzymes, low platelets, admission to intensive care required, and intubation and ventilation. Offspring core outcomes: stillbirth, gestational age at delivery, birthweight, small-for-gestational-age, neonatal mortality, seizures, admission to neonatal unit required and respiratory support. Conclusions: The core outcome set for pre-eclampsia should underpin future randomised trials and systematic reviews. Such implementation should ensure that future research holds the necessary reach and relevance to inform clinical practice, enhance women's care and improve the outcomes of pregnant women and their babies. Tweetable abstract: 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia core outcomes @HOPEoutcomes @jamesmnduffy. [Correction added on 29 June 2020, after first online publication: the order has been corrected.].
KW - Consensus development study
KW - core outcome set
KW - modified Delphi method
KW - modified nominal group technique
KW - outcome reporting bias
KW - pre-eclampsia
UR - http://www.scopus.com/inward/record.url?scp=85087149699&partnerID=8YFLogxK
U2 - 10.1111/1471-0528.16319
DO - 10.1111/1471-0528.16319
M3 - Article
C2 - 32416644
AN - SCOPUS:85087149699
SN - 1470-0328
VL - 127
SP - 1516
EP - 1526
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
IS - 12
ER -
