Core Outcome Measures in Effectiveness Trials

Forming Core Outcome Sets to Unify Studies on Domestic Violence and Abuse (FoCUS DVA)

General Information

Summary:
Domestic violence and abuse (DVA) affects one in four women and is a major public health issue costing the NHS £1.7 billion per year. Recent Cochrane reviews highlight that synthesizing evidence on addressing DVA in healthcare settings is limited due to enormous variation in the measurement of effectiveness of intervention. One solution is the development of a ‘core outcome set’ (COS). This works seeks to develop a core outcome set for (a) screening interventions on DVA and (b) advocacy interventions on DVA. This will be achieved via systematic review, stakeholder engagement, qualitative interviews with survivors, and a 2-stage Delphi process .

Please email n.pathak@qmul.ac.uk for a copy of the protocol.

Contributors:
Principal Investigator:

Dr Neha Pathak
NIHR Academic Clinical Fellow in Obstetrics & Gynaecology
Queen Mary University of London

Co-investigators/Educational Supervisors:

Professor Khalid Khan
Professor of Women’s Health & Epidemiology
Queen Mary University of London

Professor Gene Feder
Professor of Primary Care
University of Bristol

Dr Claudia Garcia-Moreno
Medical Officer Adolescents and At-Risk Populations
World Health Organisation

Further Study Information

Current Stage:
Ongoing
Date:
January 2016 - 2017
Funding source(s):
Barts Health Charity

Health Area

Disease Category
Other

Disease Name
Domestic violence and abuse
Intimate partner violence

Target Population

Age Range
-

Sex
Female


Nature / type of Intervention
Complex intervention

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Systematic review

Phase 1 Identifying Potential Outcomes and Measures

(A): Systematic Review
Literature searches will identify any study evaluating complex interventions for DVA in healthcare settings looking at (a) screening (b) advocacy. A systematic review of the study reports trial reports will catalogue outcomes and outcome measures.

(B): Qualitative Patient Interviews
Patients and survivors of DVA will be recruited through DVA charities and a research network of 17 hospitals in London to take part in focus groups and semi-structured interviews. Interview questions will be developed in consultation with patient representatives and guided by the literature review. Thematic content analysis will identify potential core outcomes.

(C): Outcome Inventory:
A comprehensive inventory of outcomes identified by the literature review and qualitative patient interviews will be developed prior to entering into the Delphi process.

Phase 2 Determining Core Outcomes

(A) Delphi methodology:
All stakeholders will be invited to participate in a 2 stage Delphi process process which assesses the extent of agreement (consensus measurement) and then resolves disagreement (consensus development).
(B): Stakeholder and Steering Group Consultation:
A draft document summarising the background information, methodology, and results will be circulated and presented to stakeholders and steering group. Feedback will be collated, reviewed, and incorporated into the finalised core outcome set prior to distribution.

Phase 3 Determining How Core Outcome Measures

(A): Quality Assessment:
Once core outcomes have been agreed it is important to determine how they should be measured. An assessment framework (truth, discrimination, feasibility) will assess the quality of potential outcome measures. High quality outcome measures will be incorporated into the core outcome set.

(B): Stakeholder and Steering Group Consultation:
A draft document summarising the background information, methodology, and results will be circulated and presented to stakeholders and steering group.
Phase 4 Dissemination

The project is being completed in association with the CROWN Initiative (Core Outcomes in Women’s Health). The finalised core outcome sets will be published via simultaneous publication in journals endorsing CROWN.


Stakeholders Involved

Charities
Clinical experts
Governmental agencies
Patient/ support group representatives
Researchers
Service commissioners
Service providers
Service users

Study Type

COS for clinical trials or clinical research
COS for practice
Recommended outcome measures (measurement)

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