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 A
AU - Fitzpatrick, Ray
AU - Ananth Karumanchi, S.
AU - Lucas, Nuala
AU - Magee, Laura
AU - Mol, Ben
AU - Stark, Michael
AU - Thangaratinam, Shakila
AU - Wilson, Mathew
AU - von Dadelszen, Peter
N1 - Funding Information:
The study is independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the National Institute for Health Research (NIHR). CG was supported by an NIHR Clinical Trials Fellowship (NIHR-CTF-2014-03-02) and a Medical Research Council (MRC) Clinician Scientist Fellowship (MR/N008405/1). SZ is a NIHR Senior Investigator. RJM is supported by a NIHR Professorship (NIHR-RP-R2-12-015) and the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the UK Department of Health. We would like to thank Carla Betts, Dawn Evans, Caroline Jordan, Sam Monaghan, Dan Richards-Doran, Nicola Small, and Clare Wickings at the Nuffield Department of Primary Care Health Sciences, University of Oxford, for administrative, technical, and material support; Tracy Holtham and Rehan Khan at the Women's Health Research Unit, Queen Mary, University of London for administrative, technical support, and subject-specific expertise; and David Mills for administrative and material support.
Funding Information:
The study is independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the NaD鸀onal InsD鸀tute for Health Research (NIHR). CG was supported by an NIHR Clinical Trials Fellowship (NIHR-CTF-2014-03-02) and a Medical Research Council (MRC) Clinician ScienD鸀st Fellowship (MR/N008405/1). SZ is a NIHR Senior InvesD鸀gator. RJM is supported by a NIHR Professorship (NIHR-RP-R2-12-015) and the NIHR CollaboraD鸀on for Leadership in Applied Health Research and Care Oxford. The views expressed in this pub-licaD鸀on are those of the authors and not necessarily those of the
Publisher Copyright:
© 2017 International Federation of Gynecology and Obstetrics
PY - 2017/12
Y1 - 2017/12
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.
AB - 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.
KW - Core outcome sets
KW - Maternal
KW - Newborn
KW - Outcome reporting bias
KW - Pre-eclampsia
KW - Randomized controlled trials
KW - Systematic review
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U2 - 10.1002/ijgo.12298
DO - 10.1002/ijgo.12298
M3 - Review article
C2 - 28803445
AN - SCOPUS:85028937355
VL - 139
SP - 262
EP - 267
JO - International Journal of Gynecology and Obstetrics
JF - International Journal of Gynecology and Obstetrics
SN - 0020-7292
IS - 3
ER -