Development of the Adult Vulvar Lichen Sclerosus Severity Scale-A Delphi Consensus Exercise for Item Generation.

OBJECTIVE

To generate a list of items through international expert consensus consisting of both symptoms and clinical signs for inclusion in an adult vulvar lichen sclerosus severity scale.

METHODS

This study was carried out as a three-stage Delphi consensus exercise. After an extensive literature review, any items used to determine disease severity in previous clinical trials were compiled into a survey. The Delphi participants were recruited from the International Society for the Study of Vulvovaginal Disease most of whom were gynecologists and in practice for more than 20 years. Participants were asked to rate the importance of these items. Consensus was defined as 75% agreeing that an item was very important or essential toward determining disease severity. Participants were also asked to indicate preferred method of measurement for these items.

RESULTS

Of approximately 400 members of the International Society for the Study of Vulvovaginal Disease, 66 participated in the study. Of the 14 symptoms presented, 7 reached consensus for inclusion. Of the 23 signs presented, 11 reached consensus for inclusion and 1 reached consensus for exclusion. Of the six architectural changes presented, all six reached consensus for inclusion. No consensus was reached regarding method of measurement for any of the symptoms and signs that reached consensus for inclusion.

CONCLUSION

International consensus was reached for a variety of items for use in an adult vulvar lichen sclerosus severity scale that will be further developed and tested. Ideally, this scale will be used in clinical practice and in research to allow for high-quality trials.