A core outcome set for pre-eclampsia research: an international consensus development study

J. M.N. Duffy; A. E. Cairns; D. Richards-Doran; J. van 't Hooft; C. Gale; M. Brown; L. C. Chappell; W. A. Grobman; R. Fitzpatrick; S. A. Karumanchi; A. Khalil; D. N. Lucas; L. A. Magee; B. W. Mol; M. Stark; S. Thangaratinam; M. J. Wilson; P. von Dadelszen; P. R. Williamson; S. Ziebland; R. J. McManus

doi:10.1111/1471-0528.16319

A core outcome set for pre-eclampsia research: an international consensus development study

J. M.N. Duffy^*, A. E. Cairns, D. Richards-Doran, J. van 't Hooft, C. Gale, M. Brown, L. C. Chappell, W. A. Grobman, R. Fitzpatrick, S. A. Karumanchi, A. Khalil, D. N. Lucas, L. A. Magee, B. W. Mol, M. Stark, S. Thangaratinam, M. J. Wilson, P. von Dadelszen, P. R. Williamson, S. ZieblandR. J. McManus

^*Corresponding author for this work

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Abstract

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: @HOPEoutcomes 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia @jamesmnduffy.

Original language	English
Pages (from-to)	1516-1526
Number of pages	11
Journal	BJOG: An International Journal of Obstetrics and Gynaecology
Volume	127
Issue number	12
Early online date	21 Jun 2020
DOIs	https://doi.org/10.1111/1471-0528.16319
Publication status	Published - Nov 2020

Bibliographical note

Funding
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 con-duct of the study, the collection, management, analysis or interpretation of data or the manuscript preparation.
Acknowledgements
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.

Keywords

Consensus development study
core outcome set
modified Delphi method
modified nominal group technique
outcome reporting bias
pre-eclampsia
TRIALS
RECOMMENDATIONS
GUIDELINES
PROTOCOL

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Duffy, J. M. N., Cairns, A. E., Richards-Doran, D., van 't Hooft, J., Gale, C., Brown, M., Chappell, L. C., Grobman, W. A., Fitzpatrick, R., Karumanchi, S. A., Khalil, A., Lucas, D. N., Magee, L. A., Mol, B. W., Stark, M., Thangaratinam, S., Wilson, M. J., von Dadelszen, P., Williamson, P. R., ... McManus, R. J. (2020). A core outcome set for pre-eclampsia research: an international consensus development study. BJOG: An International Journal of Obstetrics and Gynaecology, 127(12), 1516-1526. https://doi.org/10.1111/1471-0528.16319

Duffy, JMN, Cairns, AE, Richards-Doran, D, van 't Hooft, J, Gale, C, Brown, M, Chappell, LC, Grobman, WA, Fitzpatrick, R, Karumanchi, SA, Khalil, A, Lucas, DN, Magee, LA, Mol, BW, Stark, M, Thangaratinam, S, Wilson, MJ, von Dadelszen, P, Williamson, PR, Ziebland, S & McManus, RJ 2020, 'A core outcome set for pre-eclampsia research: an international consensus development study', BJOG: An International Journal of Obstetrics and Gynaecology, vol. 127, no. 12, pp. 1516-1526. https://doi.org/10.1111/1471-0528.16319

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title = "A core outcome set for pre-eclampsia research: an international consensus development study",

abstract = "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: @HOPEoutcomes 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia @jamesmnduffy.",

keywords = "Consensus development study, core outcome set, modified Delphi method, modified nominal group technique, outcome reporting bias, pre-eclampsia, TRIALS, RECOMMENDATIONS, GUIDELINES, PROTOCOL",

author = "Duffy, {J. M.N.} and Cairns, {A. E.} and D. Richards-Doran and {van 't Hooft}, J. and C. Gale and M. Brown and Chappell, {L. C.} and Grobman, {W. A.} and R. Fitzpatrick and Karumanchi, {S. A.} and A. Khalil and Lucas, {D. N.} and Magee, {L. A.} and Mol, {B. W.} and M. Stark and S. Thangaratinam and Wilson, {M. J.} and {von Dadelszen}, P. and Williamson, {P. R.} and S. Ziebland and McManus, {R. J.}",

note = "Funding 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 con-duct of the study, the collection, management, analysis or interpretation of data or the manuscript preparation. Acknowledgements 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{\textquoteright}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{\textquoteright}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.",

year = "2020",

month = nov,

doi = "10.1111/1471-0528.16319",

language = "English",

volume = "127",

pages = "1516--1526",

journal = "BJOG: An International Journal of Obstetrics and Gynaecology",

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TY - JOUR

T1 - A core outcome set for pre-eclampsia research

T2 - an international consensus development study

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.

N1 - Funding 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 con-duct of the study, the collection, management, analysis or interpretation of data or the manuscript preparation. Acknowledgements 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.

PY - 2020/11

Y1 - 2020/11

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: @HOPEoutcomes 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia @jamesmnduffy.

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: @HOPEoutcomes 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia @jamesmnduffy.

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KW - modified nominal group technique

KW - outcome reporting bias

KW - pre-eclampsia

KW - TRIALS

KW - RECOMMENDATIONS

KW - GUIDELINES

KW - PROTOCOL

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ER -

A core outcome set for pre-eclampsia research: an international consensus development study

Abstract

Bibliographical note

Keywords

UN SDGs

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