Core Outcome Measures in Effectiveness Trials

Core outcome sets for Clinical trials and Observational Studies in Vulvovaginal Disease

General Information

Summary:
Vulvovaginal disease is a neglected area of women's health. The purpose of this study is to determine a set of core outcomes to be used in trials for the treatment of vulvovaginal conditions that are acceptable to the research, clinical community and patients internationally.

There is recognition in the field of vulvovaginal disease that developing core outcome sets is a priority, as evidenced by an article from Journal of Lower Genital Tract Disease (core journal for the International Society for Study of Vulval Disease, ISSVD), which was published in October 2015.

This initiative will remain relatively broad in scope, covering a spectrum of at least three large disease categories in the field of genital disease: 1) vulvovaginal pain, 2) vulval and genital dermatoses, and 3) vulvovaginal infections.

The organisational structure will consist of an overall membership which will represent a wide range of stakeholders including clinicians, nurses, patients, regulatory bodies and journal editors. Working groups for each of the disease categories will be formed within the membership. A central Executive Committee will coordinate the overall project, ensure methodological quality across the workgroups and make key decisions.

Consensus methods will be used to cover the identified disease categories and focus on the following major aims: 1) Defining clinical conditions within each disease category; 2) Identifying core domains and subdomains within each condition, 3) Identifying and defining core outcome instruments within each domain, and 4) Development of clinical research structure for randomized clinical trials (RCTs) in the respective disease states.

Stakeholder groups will include dermatologists, gynaecologists, genitourinary medicine physicians and researchers with interest in vulvovaginal disease, patients (and their carers) and representatives of regulatory agencies and journal editors.

Contributors:
Co-leads for the project:

Dr Rosalind Simpson, Centre of Evidence Based Dermatology, University of Nottingham, U.K
Professor David Foster, Department of Obstetrics and Gynecology, University of Rochester, New York, U.S.
Dr Gudula Kirtschig, Department of Dermatology, University of Tübingen, Germany.

Further Study Information

Current Stage:
Planning
Date:
June 2017 - January 2023
Funding source(s):
None

Health Area

Disease Category
Other

Disease Name
Vulval skin disorders

Target Population

Age Range
18 - 80

Sex
Female


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Systematic review

Working groups will be formed to cover the different categories of vulvovaginal disease: Vulval inflammatory conditions, vulval pain and vulvovaginal infections.

Each group will follow the roadmap from the HOME initiative(Harmonising Outcome Measures for Eczema). If common ground between the groups is identified their results will be shared to avoid duplication of effort. An overall Executive Committee will oversee and co-ordinate the groups. Prospective registration of study protocols will occur.

1. Delphi consensus methods involving international stakeholders (including patients) to agree domains.

2. Systematic literature review: update previously published systematic review (2013) to identify outcome instruments used in trials of vulval skin conditions. Also using COSMIN guidance and a Patient-Reported Outcome Measure Filter we will perform a systematic review of published scales that have not yet been used in trials.

3. Consensus conference involving to agree core outcome instruments for each domain identified by the groups.

4. Dissemination and implementation through publication in peer reviewed journals who endorse the CROWN initiative, and presentation at relevant multidisciplinary forums.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Journal editors
Methodologists
Patient/ support group representatives
Researchers

Study Type

COS for clinical trials or clinical research

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