Alavi A, Hamzavi IH, Baradaran S, Mathias SD, Colwell HH, Song M, and Han C. 27630 Assessing signs and symptoms of hidradenitis suppurativa from the patient perspective. J Am Acad Dermatol 2021; 85(3):AB157.
J Am Acad Dermatol
Background: Qualitative research was conducted to develop a patient reported outcome (PRO) measure assessing symptoms/signs of hidradenitis suppurativa (HS), the HS Symptom Diary (HSSD).
Methods: Concept elicitation (CE) and combined CE/cognitive debriefing (CD) interviews were conducted with adult patients with moderate-to-severe HS from 5 dermatology practices in North America. The CE portion of the interview sought to fully understand important concepts of HS. Subjects then completed the draft HSSD, and answered questions to evaluate its content, clarity, and relevance. Revisions were made iteratively to the HSSD. The study received institutional review board approval; subjects provided written informed consent.
Results: 36 subjects were interviewed [6 = CE and 30 = CE/CD, 65% female; mean age = 39]. The most commonly reported lesion locations were armpits (81%), groin (75%), or under the breasts (31%). Subjects reported pain (100%), drainage (100%), itching (100%), swelling/ inflammation (94%), odor (86%), tenderness (81%), heat (64%), and pressure (64%) related to their lesions. The most bothersome symptoms were pain (94%), drainage (50%), swelling/inflammation (42%), and itching (33%). Pain was the most difficult symptom to manage (53%). In general, respondents were able to paraphrase each item and found the content to be clear and relevant. The final HSSD, developed as a daily diary with a 24-hour recall period, contains 8 items evaluating severity of each symptom/sign using an 11-point numeric rating scale. A 7-day version was also developed.
Conclusion: Content validity of the HSSD in patients with moderate-to-severe HS has been demonstrated. Its measurement properties will be assessed using data from upcoming clinical studies.