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  4. Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia.
 
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Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia.
File(s)
Duffy_et_al-2017-BJOG-_An_International_Journal_of_Obstetrics_&_Gynaecology (1).pdf (584.47 KB)
Accepted version
Author(s)
Duffy, J
Hirsch, M
Kawsar, A
Gale, C
Pealing, L
more
Type
Journal Article
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.
Date Issued
2017-06-14
Date Acceptance
2017-04-05
Citation
BJOG: An International Journal of Obstetrics and Gynaecology, 2017, 124 (12), pp.1829-1839
URI
http://hdl.handle.net/10044/1/48530
DOI
10.1111/1471-0528.14702
ISSN
1470-0328
Publisher
Wiley
Start Page
1829
End Page
1839
Journal / Book Title
BJOG: An International Journal of Obstetrics and Gynaecology
Volume
124
Issue
12
Copyright Statement
© 2017 Royal College of Obstetricians and Gynaecologists. This is the accepted version of the following article: Duffy JMN, Hirsch M, Kawsar A, Gale C, Pealing L, Plana MN, Showell M, Williamson PR, Khan KS, Ziebland S, McManus RJ. Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia. BJOG 2017; https://doi.org/10.1111/1471-0528.14702, which has been published in final form at https://dx.doi.org/10.1111/1471-0528.14702
Sponsor
National Institute for Health Research
Medical Research Council
Grant Number
NIHR-CTF-2014-03-02
MR/N008405/1
Subjects
Core outcome set
outcome reporting bias
pre-eclampsia
systematic review
iHOPE: International Collaboration to Harmonise Outcomes in Pre-Eclampsia
11 Medical And Health Sciences
Obstetrics & Reproductive Medicine
Publication Status
Published
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