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

Women & Children's Health

Research output: Contribution to journal › Article › peer-review

76 Citations (Scopus)

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: 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.].

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
DOIs	https://doi.org/10.1111/1471-0528.16319
Publication status	Published - 1 Nov 2020

Keywords

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

UN SDGs

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

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10.1111/1471-0528.16319

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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

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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: 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.].",

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

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.}",

year = "2020",

month = nov,

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doi = "10.1111/1471-0528.16319",

language = "English",

volume = "127",

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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

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.

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

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U2 - 10.1111/1471-0528.16319

DO - 10.1111/1471-0528.16319

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AN - SCOPUS:85087149699

SN - 1470-0328

VL - 127

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JO - BJOG: An International Journal of Obstetrics and Gynaecology

JF - BJOG: An International Journal of Obstetrics and Gynaecology

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ER -

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

Abstract

Keywords

UN SDGs

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