Development of a core outcome set for treatment studies of provoked vestibulodynia

Provoked vestibulodynia (PVD) (localised provoked vulvodynia) is a condition characterised by pain in the vestibular region of the vulva. In June 2021 Swedish Agency for Health Technology Assessment and Assessment of Social Service (SBU) published a Health technology assessment (HTA) focusing on diagnosis and treatment of the condition https://www.sbu.se/326e. One result from the report was the need for a Core Outcome Set (COS) for treatment studies on this condition. To date no relevant ongoing or available COS is available. This study will aim to identify a core outcome set that can be used in future trials of the treatment of PVD, improving the consistency of research in this clinical area.

Contributors

• Christel Hellberg (Principal investigator, SBU)
• Marie Österberg (Investigator, SBU)
• Ann Kristine Jonsson (Information specialist, SBU)
• Maria Ahlberg (Project Assistant, SBU)
• Sofia Tranæus (Project director, SBU)
• Nina Bohm-Starke (Clinical expert, MD, Associate professor, Karolinska Institutet)
• Caroline Pukall (Clinical expert, Professor, McGill University)
• Susanna Kempe (Patient representative)

Further Study Information

Current Stage: Ongoing
Date: February 2022 - June 2023
Funding source(s): SBU


Health Area

Disease Category: Gynaecology

Disease Name: Provoked vestibulodynia

Target Population

Age Range: 18 - 44

Sex: Female

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Funders
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Literature review
- Nominal group technique (NGT)
- Survey

This study will include an assessment of outcomes that have previously been reported in research. This list of outcomes will be used in a two round Delphi survey with multiple stakeholders, for example patients with PVD, relatives of those with PVD, clinicians and researchers within the field. In the first Delphi round we will ask all participants to score the outcome list using a 9-point Likert scale. They will also be given the opportunity to add any outcomes they think are missing from the list. The second round involves presentation of scores according to stakeholder groups and the opportunity for participants to rescore outcomes. A final consensus meeting will be held with some representatives from all stakeholder groups, to agree on a final set of core outcomes.

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