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

Citation

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: 
http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42017077375

Review question

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.

Searches

(1) Cochrane Central Register of Controlled Trials (CENTRAL)
(2) Embase
(3) MEDLINE from inception to September 2017.

Limitations:
Human subjects only

Search strategy

Types of study to be included

Randomised Controlled Trials.

Condition or domain being studied

Childbirth trauma.

Participants/population

Women.

Intervention(s), exposure(s)

Treatments for childbirth trauma.

Comparator(s)/control

Different forms of intervention

Context

Selection criteria:
Randomised trials evaluating the efficacy and safety of different techniques in the management of perineal lacerations.

Primary outcome(s)

Review of reported outcomes and outcome measures

Pain, wound complications, incontinence, quality of life parameters etc.

Secondary outcome(s)

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

Multivariate analysis.

Contact details for further information

Stergios Doumouchtsis
sdoum@yahoo.com

Organisational affiliation of the review

CHORUS: An International Collaboration for Harmonising Research, Outcomes and Standards In Urogynaecology and Women's Health

i-chorus.org

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

Funding sources/sponsors

None

Conflicts of interest

None known

Language

English

Country

England

Published protocol

Stage of review

Review_Completed_published

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

https://www.ncbi.nlm.nih.gov/PubMed/30009461

https://doi.org/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

 
Core Outcome SetsPaul Andrew