@article{Duffy:2017:10.1111/1471-0528.14702,
author = {Duffy, J and Hirsch, M and Kawsar, A and Gale, C and Pealing, L and Plana, MN and Showell, M and Williamson, PR and Khan, KS and Ziebland, S and McManus, RJ and iHOPE, International Collaboration to Harmonise Outcomes in Pre-Eclampsia},
doi = {10.1111/1471-0528.14702},
journal = {BJOG: An International Journal of Obstetrics and Gynaecology},
pages = {1829--1839},
title = {Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia.},
url = {http://dx.doi.org/10.1111/1471-0528.14702},
volume = {124},
year = {2017}
}

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TY  - JOUR
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.
AU  - Duffy,J
AU  - Hirsch,M
AU  - Kawsar,A
AU  - Gale,C
AU  - Pealing,L
AU  - Plana,MN
AU  - Showell,M
AU  - Williamson,PR
AU  - Khan,KS
AU  - Ziebland,S
AU  - McManus,RJ
AU  - iHOPE,International Collaboration to Harmonise Outcomes in Pre-Eclampsia
DO  - 10.1111/1471-0528.14702
EP  - 1839
PY  - 2017///
SN  - 1470-0328
SP  - 1829
TI  - Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia.
T2  - BJOG: An International Journal of Obstetrics and Gynaecology
UR  - http://dx.doi.org/10.1111/1471-0528.14702
UR  - http://hdl.handle.net/10044/1/48530
VL  - 124
ER  - 

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