Core Outcome Measures in Effectiveness Trials

Do we need a core outcome set for childbirth perineal trauma research? A systematic review of outcome reporting in randomised trials evaluating the management of childbirth trauma

General Information

Abstract:
BACKGROUND: Selecting appropriate outcomes to reflect both beneficial and harmful effects is a critical step in designing childbirth trauma trials. OBJECTIVE: To evaluate the outcomes and outcome measures reported in randomised controlled trials evaluating interventions for childbirth trauma. SEARCH STRATEGY: Randomised trials were identified by searching bibliographical databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE. SELECTION CRITERIA: Randomised trials evaluating the efficacy and safety of different techniques in the management of perineal lacerations. DATA COLLECTION AND ANALYSIS: Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted the relevant data. Spearman's rho correlation and multivariate linear regression analysis using the backward stepwise model were used for analysis. MAIN RESULTS: Forty-eight randomised trials, reporting data from 20 308 women, were included. Seventeen different interventions were evaluated. Included trials reported 77 different outcomes and 50 different outcome measures. Commonly reported outcomes included pain (34 trials; 70%), wound healing (20 trials; 42%), and anorectal dysfunction (16 trials, 33%). In the multivariate analysis, no relationship was demonstrated between the quality of outcome reporting and year of publication (P = 0.31), journal impact factor (P = 0.49), and methodological quality (P = 0.13). CONCLUSION: Outcome reporting in childbirth trauma research is heterogeneous. Developing, disseminating, and implementing a core outcome set in future childbirth trauma research could help address these issues. FUNDING: None. TWEETABLE ABSTRACT: Developing @coreoutcomes for childbirth trauma research could help to reduce #research waste.

Authors:
Pergialiotis, V. Durnea, C. Elfituri, A. Duffy, J. Doumouchtsis, S. K.

Publication

Journal:
BJOG
Volume:
Issue:
Pages:
-
Year:
2018
DOI:
Further Study Information

Date:
- September 2017
Funding source(s):
None

Health Area

Disease Category
Gynaecology
Pregnancy & childbirth

Disease Name
Childbirth Trauma

Target Population

Age Range
16 - 100

Sex
Female


Nature / type of Intervention
Any

Method(s)

Systematic review

Stakeholders Involved

None

Study Type

Systematic review of outcomes measured in trials

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.