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

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.

Tweetable abstract: 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.

Keywords: Core outcome set; outcome reporting bias; pre-eclampsia; systematic review.