Establishing core outcome sets in the management of childbirth trauma. A systematic review on variations of reported outcomes and development of protocol for core outcome sets in childbirth trauma
Stergios Doumouchtsis, Vasilios Pergialiotis
Stergios Doumouchtsis, Vasilios Pergialiotis. Establishing core outcome sets in the management of childbirth trauma. A systematic review on variations of reported outcomes and development of protocol for core outcome sets in childbirth trauma.
PROSPERO 2017 CRD42017077375 Available from:
The aim is to review the outcomes and outcome measures reported in randomized controlled trials and their relationship with methodological quality, year of publication, commercial funding, and journal impact factor.
(1) Cochrane Central Register of Controlled Trials (CENTRAL)
(3) MEDLINE from inception to September 2017.
Human subjects only
Types of study to be included
Randomised Controlled Trials.
Condition or domain being studied
Treatments for childbirth trauma.
Different forms of intervention
Randomised trials evaluating the efficacy and safety of different techniques in the management of perineal lacerations.
Review of reported outcomes and outcome measures
Pain, wound complications, incontinence, quality of life parameters etc.
Relationship of outcomes and outcome measures with methodological quality, year of publication, commercial funding, and journal impact factor.
Data extraction (selection and coding)
Two researchers independently assessed studies for inclusion, evaluated methodological quality and extracted relevant data.
Risk of bias (quality) assessment
Methodological quality: Jadad score; range, 1-5
Strategy for data synthesis
The Spearman's rho correlation and the multivariate linear regression analysis using the backward stepwise model were used for analysis.
Analysis of subgroups or subsets
Contact details for further information
Organisational affiliation of the review
CHORUS: An International Collaboration for Harmonising Research, Outcomes and Standards In Urogynaecology and Women's Health
Review team members and their organisational affiliations
Professor Stergios Doumouchtsis. Epsom and St Helier University Hospitals NHS Trust, St George's University of London, University of Athens Medical School, CHORUS
Dr Vasilios Pergialiotis. University of Athens, CHORUS
Anticipated or actual start date
03 April 2017
Anticipated completion date
20 October 2017
Conflicts of interest
Stage of review
Details of final report/publication(s)
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.
Pergialiotis V, Durnea C, Elfituri A, Duffy JMN, Doumouchtsis SK; International Collaboration for Harmonising Outcomes, Research, and Standards in Urogynaecology and Women's Health (CHORUS).
BJOG. 2018 Jul 16. doi: 10.1111/1471-0528.15408
Subject index terms status
Subject indexing assigned by CRD
Subject index terms
Birth Injuries; Delphi Technique; Humans; Research Design
Date of registration in PROSPERO
20 October 2017
Date of publication of this version
01 August 2018
Stage of review at time of this submission
Stage / Started / Completed
Preliminary searches / Yes / Yes
Piloting of the study selection process / Yes / Yes
Formal screening of search results against eligibility criteria / Yes / Yes
Data extraction / Yes / Yes
Risk of bias (quality) assessment / Yes / Yes
Data analysis / Yes / Yes