Core Outcome Measures in Effectiveness Trials

Evaluating interventions for informed consent for surgery

General Information

Summary:
Outcome reporting in trials of interventions to improve the informed consent process for surgery is heterogeneous meaning comparisons between interventions and meaningful synthesis of data is limited. A core outcome set could address these issues and also reduce outcome selection and reporting bias.

Contributors:
Mr. Liam Convie (PI) Ulster Hospital Dundonald
Professor Mike Clarke.(Supervisor) MRC Research Methodologies Hub, Queen's University Belfast
Mr. Scott McCain - Ulster Hospital Dundonald
Mr Jeffrey Campbell - Ulster Hospital Dundonald
Mr. Stephen Kirk - Ulster Hospital Dundonald

Further Study Information

Current Stage:
Planning
Date:
September 2017 - August 2018
Funding source(s):
None

Health Area

Disease Category
Other

Disease Name
Informed Consent for Surgery

Target Population

Age Range
16 - 110

Sex
Either


Nature / type of Intervention
Other

Method(s)

Consensus meeting
Delphi process
Interview
Systematic review

As per the COMET guidelines we will conduct a systematic review of published research to develop a list of all outcomes measured in consent research to date.

Next a group of stakeholders will be invited to participate in semi-structured interviews to explore their views on the outcomes identified by the systematic review. Participants will also be asked to suggest additional outcome measures that may be important in measuring informed consent but have not yet been considered or used in the published literature.

The final list of outcomes generated from the systematic review and interviews will form the basis for a Delphi survey distributed to international stakeholders in order to refine the items.

Finally, two web-based consensus meetings will be conducted in order to reach consensus on items deemed to be equivocal following the Delphi survey and to agree on the final core outcome set.


Stakeholders Involved

Clinical experts
Consumers (patients)
Ethicists
Researchers
Medico-Legal Solicitors

Study Type

COS for clinical trials or clinical research

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