Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia.
BJOG
; 124(12): 1829-1839, 2017 Nov.
Article
in En
| MEDLINE
| ID: mdl-28432737
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 ANDANALYSIS:
We systematically extracted and categorised outcome reporting. MAINRESULTS:
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 childhoodoutcomes:
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pre-Eclampsia
/
Randomized Controlled Trials as Topic
Type of study:
Clinical_trials
/
Prognostic_studies
/
Systematic_reviews
Limits:
Female
/
Humans
/
Newborn
/
Pregnancy
Language:
En
Journal:
BJOG
Journal subject:
GINECOLOGIA
/
OBSTETRICIA
Year:
2017
Type:
Article
Affiliation country:
United kingdom