A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia

the International Collaboration to Harmonize Outcomes for Pre-eclampsia (iHOPE), James M.N. Duffy, Martin Hirsch, Chris Gale, Louise Pealing, Anusuya Kawsar, Marian Showell, Paula R. Williamson, Khalid S. Khan, Sue Ziebland, Richard J. McManus, Janneke van ‘t Hooft, Mark Brown, William Grobman, Ray Fitzpatrick, S. Ananth Karumanchi, Nuala Lucas, Laura Magee, Ben Mol, Michael Stark & 3 others Ben Mol, Mathew Wilson, Peter von Dadelszen

Research output: Contribution to journalReview article

14 Citations (Scopus)

Abstract

Background: An evaluation of outcome reporting is required to develop a core outcome set. Objectives: To assess primary outcomes and outcome measure reporting in pre-eclampsia trials. Search strategy: Five online databases were searched from inception to January 2016 using terms including “preeclampsia” and “randomized controlled trial”. Selection criteria: Randomized controlled trials evaluating treatments for pre-eclampsia published in any language were included. Data collection and analysis: Primary outcomes and data on outcome measure reporting were systematically extracted and categorized. Main results: Overall, 79 randomized trials including data from 31 615 women were included. Of those, 38 (48%) reported 35 different primary outcomes; 28 were maternal outcomes and seven were fetal/neonatal outcomes. Three randomized trials reported composite outcomes, incorporating between six and nine outcome components. The method of definition or measurement was infrequently or poorly reported. Even when outcomes were consistent across trials, different methods of definition or measurement were frequently described. Conclusions: In randomized trials evaluating interventions for pre-eclampsia, critical information related to the primary outcome, including definition and measurement, is regularly omitted. Developing a core outcome set for pre-eclampsia trials would help to inform primary outcome selection and outcome measure reporting.

LanguageEnglish
Pages262-267
Number of pages6
JournalInternational Journal of Gynecology and Obstetrics
Volume139
Issue number3
DOIs
Publication statusPublished - 1 Jan 2017

Keywords

  • Core outcome sets
  • Maternal
  • Newborn
  • Outcome reporting bias
  • Pre-eclampsia
  • Randomized controlled trials
  • Systematic review

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

the International Collaboration to Harmonize Outcomes for Pre-eclampsia (iHOPE). / A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia. In: International Journal of Gynecology and Obstetrics. 2017 ; Vol. 139, No. 3. pp. 262-267.
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abstract = "Background: An evaluation of outcome reporting is required to develop a core outcome set. Objectives: To assess primary outcomes and outcome measure reporting in pre-eclampsia trials. Search strategy: Five online databases were searched from inception to January 2016 using terms including “preeclampsia” and “randomized controlled trial”. Selection criteria: Randomized controlled trials evaluating treatments for pre-eclampsia published in any language were included. Data collection and analysis: Primary outcomes and data on outcome measure reporting were systematically extracted and categorized. Main results: Overall, 79 randomized trials including data from 31 615 women were included. Of those, 38 (48{\%}) reported 35 different primary outcomes; 28 were maternal outcomes and seven were fetal/neonatal outcomes. Three randomized trials reported composite outcomes, incorporating between six and nine outcome components. The method of definition or measurement was infrequently or poorly reported. Even when outcomes were consistent across trials, different methods of definition or measurement were frequently described. Conclusions: In randomized trials evaluating interventions for pre-eclampsia, critical information related to the primary outcome, including definition and measurement, is regularly omitted. Developing a core outcome set for pre-eclampsia trials would help to inform primary outcome selection and outcome measure reporting.",
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A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia. / the International Collaboration to Harmonize Outcomes for Pre-eclampsia (iHOPE).

In: International Journal of Gynecology and Obstetrics, Vol. 139, No. 3, 01.01.2017, p. 262-267.

Research output: Contribution to journalReview article

TY - JOUR

T1 - A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia

AU - the International Collaboration to Harmonize Outcomes for Pre-eclampsia (iHOPE)

AU - Duffy, James M.N.

AU - Hirsch, Martin

AU - Gale, Chris

AU - Pealing, Louise

AU - Kawsar, Anusuya

AU - Showell, Marian

AU - Williamson, Paula R.

AU - Khan, Khalid S.

AU - Ziebland, Sue

AU - McManus, Richard J.

AU - van ‘t Hooft, Janneke

AU - Brown, Mark

AU - Grobman, William

AU - Fitzpatrick, Ray

AU - Ananth Karumanchi, S.

AU - Lucas, Nuala

AU - Magee, Laura

AU - Mol, Ben

AU - Stark, Michael

AU - Mol, Ben

AU - Wilson, Mathew

AU - von Dadelszen, Peter

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Background: An evaluation of outcome reporting is required to develop a core outcome set. Objectives: To assess primary outcomes and outcome measure reporting in pre-eclampsia trials. Search strategy: Five online databases were searched from inception to January 2016 using terms including “preeclampsia” and “randomized controlled trial”. Selection criteria: Randomized controlled trials evaluating treatments for pre-eclampsia published in any language were included. Data collection and analysis: Primary outcomes and data on outcome measure reporting were systematically extracted and categorized. Main results: Overall, 79 randomized trials including data from 31 615 women were included. Of those, 38 (48%) reported 35 different primary outcomes; 28 were maternal outcomes and seven were fetal/neonatal outcomes. Three randomized trials reported composite outcomes, incorporating between six and nine outcome components. The method of definition or measurement was infrequently or poorly reported. Even when outcomes were consistent across trials, different methods of definition or measurement were frequently described. Conclusions: In randomized trials evaluating interventions for pre-eclampsia, critical information related to the primary outcome, including definition and measurement, is regularly omitted. Developing a core outcome set for pre-eclampsia trials would help to inform primary outcome selection and outcome measure reporting.

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KW - Maternal

KW - Newborn

KW - Outcome reporting bias

KW - Pre-eclampsia

KW - Randomized controlled trials

KW - Systematic review

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DO - 10.1002/ijgo.12298

M3 - Review article

VL - 139

SP - 262

EP - 267

JO - International Journal of Gynecology and Obstetrics

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JF - International Journal of Gynecology and Obstetrics

SN - 0020-7292

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ER -