Core Outcome Measures in Effectiveness Trials

Developing a core outcome set for rectal prolapse surgery

General Information

Summary:
There is significant heterogeneity in the outcomes measured in studies assessing the effectiveness of surgical interventions for rectal prolapse. An agreed set of core-outcomes will improve the consistency of the outcomes of clinical trials focusing on rectal prolapse.

The objective of this project is to formulate and disseminate a core outcome set that can be used in future studies on rectal prolapse, to increase the homogeneity of outcome reporting and ensure all key outcomes are considered.

Contributors:
Principal investigator -
Mr Janindra Warusavitarne
Consultant surgeon
St. Mark's hospital
Watford road, Harrow

Further Study Information

Current Stage:
Ongoing
Date:
October 2018 - September 2019
Funding source(s):
No funding sources

Health Area

Disease Category
Gastroenterology

Disease Name
Rectal prolapse

Target Population

Age Range
18 - 90

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Consensus meeting
Delphi process
Interview
Systematic review

Stage 1 Identifying Potential Outcomes
A systematic review will be conducted looking at all prospective studies, cohort studies, case control studies and case series, to identify the number and types of outcomes measured by each study, the timing of the measurements and the schedule.
An inventory of the outcomes will be formulated using the outcomes identified above.

Stage 2 Determining Core Outcomes
A Delphi methodology will be followed involving all stakeholders. Using the inventory of outcomes, 3 rounds of consensus measurement and consensus development will be conducted. Each round will include scoring of outcomes on a Likert scale. Feedback on the scoring will be provided before the subsequent rounds.

Stage 3 Determining How Core Outcomes Should be Measured
Once a set of core outcomes are identified, the precise instrument to use for the measurement will also be agreed upon. The sensitivity, acceptability and feasibility of the available instruments will be considered prior to agreement.
Once the outcomes and the instruments are agreed upon, a document including the results will be circulated to all stake holders. The core outcome set will be appropriately modified with the feedback.


Stakeholders Involved

Clinical experts
Conference participants
Pharmaceutical industry representatives
Policy makers
Researchers
Service users

Study Type

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

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