Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia

Duffy, JMN, Hirsch, M, Kawsar, A, Gale, C, Pealing, L, Plana, MN, Showell, M, Williamson, PR ORCID: 0000-0001-9802-6636, Khan, KS, Ziebland, S
et al (show 1 more authors) (2017) Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia. BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY, 124 (12). pp. 1829-1839.

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<h4>Background</h4>Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting.<h4>Objectives</h4>To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia.<h4>Search strategy</h4>Randomised trials were identified by searching bibliographical databases from inception to January 2016.<h4>Selection criteria</h4>Randomised controlled trials.<h4>Data collection and analysis</h4>We systematically extracted and categorised outcome reporting.<h4>Main results</h4>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.<h4>Conclusions</h4>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.<h4>Tweetable abstract</h4>Future #preeclampsia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy International Prospective Register of Systematic Reviews: CRD42015015529; www.crd.york.ac.uk/PROSPERO/display_record.aspID=CRD42015015529.

Item Type: Article
Uncontrolled Keywords: Core outcome set, outcome reporting bias, pre-eclampsia, systematic review
Depositing User: Symplectic Admin
Date Deposited: 08 May 2017 06:27
Last Modified: 19 Jan 2023 07:04
DOI: 10.1111/1471-0528.14702
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3007275