학술논문

Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia.
Document Type
Journal Article
Source
BJOG: An International Journal of Obstetrics & Gynaecology. Nov2017, Vol. 124 Issue 12, p1829-1839. 11p. 1 Diagram, 3 Charts.
Subject
*PREECLAMPSIA
*HEALTH outcome assessment
*MATERNAL mortality
*RANDOMIZED controlled trials
*FOLLOW-up studies (Medicine)
*THERAPEUTICS
*CLINICAL trials
*INFANT mortality
*SYSTEMATIC reviews
*TREATMENT effectiveness
Language
ISSN
1470-0328
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. [ABSTRACT FROM AUTHOR]