(032) Development of a Core Outcome Set for Provoked Vestibulodynia
Authors: Pukall C , Bohm-starke N , Kempe S , Hellberg C , Ahlberg M , Osterberg M , Jonsson A K , Tranaeus S 
Published: May 2023

Abstract

Introduction
The literature on vulvodynia treatment is heterogeneous in terms of intervention type, study quality, and outcome measures. A systematic review (SR) of vulvodynia treatments was recently published focusing on randomized controlled trials (RCTs) and non-RCTs for provoked vestibulodynia (PVD, a vulvodynia subtype). The authors of the SR concluded that most studies had very low certainty of evidence, which limited the ability to draw conclusions about intervention efficacy. In addition, the authors noted a large degree of heterogeneity in outcome measures, which limited the ability to conduct a meta-analysis, and they recommended that future studies incorporate a core outcome set (COS, an agreed-upon standardized set of outcomes that should be assessed and reported, as a minimum, in all clinical trials in specific areas of health or healthcare) so that results from future clinical trials of PVD can be combined and evaluated.

Objective
To establish a COS for PVD.

Methods
The Project Management Team of the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) consists of vulvodynia researchers/clinicians, a patient partner, and health technology methodologists. Since March 2022, the team has conducted a literature review and extracted all outcomes from the PVD treatment literature (as of 1990 for published studies, and no date limit for the clinical trials database). Sixty-six outcomes (e.g., pain during intercourse, sexual function) have been identified. To conduct a two round Delphi survey with multiple stakeholders, registration for participation in the study (ongoing) has been open to a variety of stakeholders: people with current or past lived experience of PVD, relatives of those with lived experience of PVD, healthcare practitioners, researchers, and others (e.g., leaders of patient or funding organizations). Participants who register will provide background information to ensure representativeness of stakeholder identification and sociodemographic status (e.g., country of residence, gender), after which they will be asked to participate in the first survey. The first survey asks participants to rate each of the outcomes on a 9-point scale (from outcome is not important to outcome is critical to include and should always be measured in treatment studies) and to list any outcomes that should be included but were missed. In the second survey, the outcomes with the highest ranks from the first survey and all new outcomes will be presented to the participants, and they will be asked to rate them. Then, a virtual consensus meeting will be held with some members from all stakeholder groups to discuss the highest ranked outcomes and to decide which ones to include in the core outcome set.

Results
We will report on interim progress of the COS for PVD.

Conclusions
The results of this study will contribute critical information to standardize outcome reporting across PVD treatment studies so that stakeholders can directly compare the effectiveness of different interventions, identify clinically relevant outcomes, and reduce the risk of reporting bias. In addition, they will allow for the generation of consistent data for meta-analyses.

Disclosure
No