Core Outcome Measures in Effectiveness Trials

Defining core outcomes for clinical trials of heavy menstrual bleeding A Core Outcome sets for Gynaecological conditions (COGS) project

General Information

HMB is one of the most common reasons for referral to secondary care and affects up to 1 in 5 women of reproductive age (2) thus it is a common condition which has a large impact on women’s physical, psychological and social wellbeing (3-5) and an economic impact due to time taken away from employment and cost to the NHS (6;7). There are many different treatments for HMB including hormonal, medical and surgical interventions. Our aim is to develop a COS which covers all aspects of the condition.

Dr Natalie A.M. Cooper, Queen Mary University of London

Professor Khalid Khan, Queen Mary University of London

Collaborators / co-researchers:
Dr Carol Rivas, University of Southampton
Dr Thulasi Setty, Obstetrics and Gynaecology trainee, London

Further Study Information

Current Stage:
November 2015 - November 2017
Funding source(s):
The Academy of Medical Sciences Starter Grant

Health Area

Disease Category

Disease Name
Heavy menstrual bleeding

Target Population

Age Range
13 - 50


Nature / type of Intervention


Consensus meeting
Delphi process
Literature review
Semi structured discussion

Methodology which engages all key stakeholders (clinicians, patients, charities), will be used to develop each of the COS. Systematic reviews of the literature and patient workshops will be conducted to identify potential core outcomes. A Delphi survey of all relevant stakeholders will then be used to reach consensus regarding outcomes to be included in the core set, which will be subsequently refined through fact-to-face consensus discussions. The final core outcome set will be disseminated via publication.

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Service providers

Study Type

COS for clinical trials or clinical research

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