Vulvovaginal disease is a neglected area of women's health. The purpose of this initiative is to develop internationally accepted core outcome measures for trials into the treatment of vulvovaginal conditions.
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 (1) (core journal for the International Society for Study of Vulval Disease, ISSVD) and subsequent editorial(2).
This initiative intends to coordinate the development of Core Outcome Sets 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 have an overall membership which represents a wide range of stakeholders including clinicians, nurses, patients, regulatory bodies and journal editors. We will form working groups for each of the disease categories within the membership. A central Executive Committee will coordinate the overall project, ensure methodological quality across the workgroups and make key decisions.
We will use consensus methods to 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.
Currently, workstreams exist for lichen sclerosus (CORALS – Core Outcomes for Research in Lichen Sclerosus, led by Dr Simpson) and vulvodynia (led by Professor Foster).
The initiative is registered with COMET, CROWN and CS-COUSIN (http://cs-cousin.org/)
References:
1. Andrews J. Lower Anogenital Tract Disease Therapy Outcomes, COMET, and CROWN: Call for Research Submissions. J Low Genit Tract Dis. 2015;19(4):275-7
2. Foster DC, Stockdale CK, Simpson R, Kirtschig G. Core Outcome Sets for Clinical Trials and Observational Studies in Vulvovaginal Disease. J Low Genit Tract Dis. 2017;21(3):163-5
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.
Disease Category: Other
Disease Name: Vulval skin disorders, Vulvar lichen sclerosus, Vulvodynia
Age Range: 0 - 100
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Journal editors
- Methodologists
- Patient/ support group representatives
- Researchers
- Pharmaceutical industry representatives
- Policy makers
- Regulatory agency representatives
- Service commissioners
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review
- Semi structured discussion
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.