Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia

iHOPE: International Collaboration to Harmonise Outcomes in Pre-Eclampsia, J. M.N. Duffy, M. Hirsch, A. Kawsar, C. Gale, L. Pealing, M. N. Plana, M. Showell, P. R. Williamson, K. S. Khan, S. Ziebland, R. J. McManus, Janneke van ‘t Hooft, Mark Brown, William Grobman, S. Karumanchi, Nuala Lucas, Laura Magee, Ben Mol, Michael Stark & 3 others Shakila Thangaratinam, Mathew Wilson, Ben Mol

Research output: Contribution to journalReview article

18 Citations (Scopus)

Abstract

Background: Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. Objectives: To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. Search strategy: Randomised trials were identified by searching bibliographical databases from inception to January 2016. Selection criteria: Randomised controlled trials. Data collection and analysis: We systematically extracted and categorised outcome reporting. Main results: Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. Conclusions: Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues. Tweetable abstract: Future #preeclampsia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy. International Prospective Register of Systematic Reviews: CRD42015015529; www.crd.york.ac.uk/PROSPERO/display_record.aspID=CRD42015015529.

LanguageEnglish
Pages1829-1839
Number of pages11
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Volume124
Issue number12
DOIs
Publication statusPublished - 1 Nov 2017

Keywords

  • Core outcome set
  • outcome reporting bias
  • pre-eclampsia
  • systematic review

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

iHOPE: International Collaboration to Harmonise Outcomes in Pre-Eclampsia. / Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia. In: BJOG: An International Journal of Obstetrics and Gynaecology. 2017 ; Vol. 124, No. 12. pp. 1829-1839.
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abstract = "Background: Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. Objectives: To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. Search strategy: Randomised trials were identified by searching bibliographical databases from inception to January 2016. Selection criteria: Randomised controlled trials. Data collection and analysis: We systematically extracted and categorised outcome reporting. Main results: Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14{\%}) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20{\%}) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54{\%}) reported fetal outcomes and 23 trials (29{\%}) reported neonatal outcomes. Twenty-eight trials (35{\%}) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8{\%}) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. Conclusions: Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues. Tweetable abstract: Future #preeclampsia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy. International Prospective Register of Systematic Reviews: CRD42015015529; www.crd.york.ac.uk/PROSPERO/display_record.aspID=CRD42015015529.",
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Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia. / iHOPE: International Collaboration to Harmonise Outcomes in Pre-Eclampsia.

In: BJOG: An International Journal of Obstetrics and Gynaecology, Vol. 124, No. 12, 01.11.2017, p. 1829-1839.

Research output: Contribution to journalReview article

TY - JOUR

T1 - Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia

AU - iHOPE: International Collaboration to Harmonise Outcomes in Pre-Eclampsia

AU - Duffy, J. M.N.

AU - Hirsch, M.

AU - Kawsar, A.

AU - Gale, C.

AU - Pealing, L.

AU - Plana, M. N.

AU - Showell, M.

AU - Williamson, P. R.

AU - Khan, K. S.

AU - Ziebland, S.

AU - McManus, R. J.

AU - van ‘t Hooft, Janneke

AU - Brown, Mark

AU - Grobman, William

AU - Karumanchi, S.

AU - Lucas, Nuala

AU - Magee, Laura

AU - Mol, Ben

AU - Stark, Michael

AU - Thangaratinam, Shakila

AU - Wilson, Mathew

AU - Mol, Ben

PY - 2017/11/1

Y1 - 2017/11/1

N2 - Background: Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. Objectives: To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. Search strategy: Randomised trials were identified by searching bibliographical databases from inception to January 2016. Selection criteria: Randomised controlled trials. Data collection and analysis: We systematically extracted and categorised outcome reporting. Main results: Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. Conclusions: Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues. Tweetable abstract: Future #preeclampsia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy. International Prospective Register of Systematic Reviews: CRD42015015529; www.crd.york.ac.uk/PROSPERO/display_record.aspID=CRD42015015529.

AB - Background: Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. Objectives: To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. Search strategy: Randomised trials were identified by searching bibliographical databases from inception to January 2016. Selection criteria: Randomised controlled trials. Data collection and analysis: We systematically extracted and categorised outcome reporting. Main results: Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. Conclusions: Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues. Tweetable abstract: Future #preeclampsia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy. International Prospective Register of Systematic Reviews: CRD42015015529; www.crd.york.ac.uk/PROSPERO/display_record.aspID=CRD42015015529.

KW - Core outcome set

KW - outcome reporting bias

KW - pre-eclampsia

KW - systematic review

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U2 - 10.1111/1471-0528.14702

DO - 10.1111/1471-0528.14702

M3 - Review article

VL - 124

SP - 1829

EP - 1839

JO - BJOG: An International Journal of Obstetrics and Gynaecology

T2 - BJOG: An International Journal of Obstetrics and Gynaecology

JF - BJOG: An International Journal of Obstetrics and Gynaecology

SN - 1470-0328

IS - 12

ER -