A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia
File(s)
Accepted version
Author(s)
Type
Journal Article
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.
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.
Date Issued
2017-09-07
Date Acceptance
2017-08-13
Citation
International Journal of Gynecology and Obstetrics, 2017, 139 (3), pp.262-267
ISSN
0020-7292
Publisher
Wiley
Start Page
262
End Page
267
Journal / Book Title
International Journal of Gynecology and Obstetrics
Volume
139
Issue
3
Copyright Statement
This is the peer reviewed version of the following article: Duffy, J. M.N., Hirsch, M., Gale, C., Pealing, L., Kawsar, A., Showell, M., Williamson, P. R., Khan, K. S., Ziebland, S., McManus, R. J. and the International Collaboration to Harmonize Outcomes for Pre-eclampsia (iHOPE) (2017), A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia. Int J Gynecol Obstet. doi:10.1002/ijgo.12298, which has been published in final form at https://dx.doi.org/10.1002/ijgo.12298. This article may be used for non-commercial purposes in accordance With Wiley Terms and Conditions for self-archiving.
Sponsor
Medical Research Council
Grant Number
MR/N008405/1
Subjects
Core outcome sets
Maternal
Newborn
Outcome reporting bias
Pre-eclampsia
Randomized controlled trials
Systematic review
International Collaboration to Harmonize Outcomes for Pre-eclampsia (iHOPE)
1114 Paediatrics And Reproductive Medicine
Obstetrics & Reproductive Medicine
Publication Status
Published
Date Publish Online
2017-08-13