Background: There is an inconsistency in treatment outcomes used in clinical trials for provoked vestibulodynia (PVD), which makes it impossible to compare the effects of different interventions.
Aim: In this study, we completed the first step in creating a core outcome set (COS), defining what outcomes should be measured in clinical trials for PVD.
Methods: Identification of outcomes used in studies was done by extracting data from clinical trials in a recently published systematic review and via review of clinical trials for PVD registered on ClinicalTrials.gov. The COS process consisted of 2 rounds of Delphi surveys and a consensus meeting, during which the final COS was decided through a modified nominal group technique.
Outcomes: Consensus on what outcomes to include in a COS for PVD.
Results: Forty scientific articles and 92 study protocols were reviewed for outcomes. Of those, 36 articles and 25 protocols were eligible, resulting in 402 outcomes, which were then categorized into 63 unique outcomes. Participants consisted of patients, relatives/partners of
patients, health care professionals, and researchers. Out of 463 who registered for participation, 319 and 213 responded to the first and second surveys, respectively. The consensus meeting consisted of 18 members and resulted in 6 outcomes for the COS to be measured in all treatment
trials regardless of intervention: insertional pain (nonsexual), insertional pain (sexual), provoked vulvar pain by pressure/contact, pain-related interference on one’s life, pain interference on sexual life, and sexual function.
Clinical Implications: Critical outcomes to be measured in clinical trials will allow for accurate comparison of outcomes across treatment interventions and provide solid treatment recommendations.
Strengths and Limitations: The major strengths of the study are the adherence to methodological recommendations and the intentional focus on aspects of diversity of participating stakeholders (eg, status such as patients with lived experience and researchers, inclusiveness with respect to sexual identity), the latter of which will allow for broader application and relevance of the COS. Among the limitations of the study are the low
rate of participants outside North America and Europe and the lower response rate (about 50%) for the second Delphi survey.
Conclusion: In this international project, patients, health care professionals, and researchers have decided what critical outcomes are to be used in future clinical trials for PVD. Before the COS can be fully implemented, there is also a need to decide on how and preferably when the outcomes should be measured.
In this study, we completed the first step in creating a core outcome set (COS), defining what outcomes should be measured in clinical trials for PVD.
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, Queen’s University)
• Susanna Kempe (Patient representative)
Disease Category: Gynaecology
Disease Name: Provoked vestibulodynia
Age Range: 18 - 44
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Funders
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Researchers
- COS for clinical trials or clinical research
- 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.