PROJECT SUMMARY The overarching goal of this proposal is to enhance the quality of clinical trials in hidradenitis suppurativa (HS) and to improve the current outcome measures for assessing treatment response by incorporating valid and reliable outcome measures of periodic worsening, or flares, of HS. This work is significant because it addresses an outcome deemed crucial by HS researchers and patients; will be the first to develop valid and reliable outcome measures for HS flare; and generate data on flare frequency and severity from an observational study in order to inform future study design. This work is innovative because it seeks to refine and expand the current paradigm for outcome assessment for HS to include flare activity, long-term control, and minimal disease activity, which are assessed in other chronic inflammatory diseases that periodically worsen. The overarching goal of this study is to develop, validate, and longitudinally assess criteria for flare in HS. This project will test the central hypothesis that HS flare can be validly and reliably measured using patient- and clinician-reported outcome measures. Two aims are proposed: 1) Validate the patient-reported Hidradenitis Suppurativa Quality of Life (HiSQOL) insturment for longitudinal HS flare assessment; 2) Validate the clinician-reported Severity and Area Score for Hidradenitis (SASH) instrument for longitudinal HS flare assessment. We will address these aims in prospective observational cohort studies incorporated into a quaternary HS referral clinic with an integrated patient registry where patients with HS will receive standard of care management. This study will address key gaps in our knowledge and approach, ultimately leading to effective clinical trials that include outcomes for HS that change the disease course. We have an established team of investigators with experience in HS clinical trials and outcome measure development and validation. All of our data is stored in a robust prospective database, with experience performing the necessary data entry, data extraction and analysis. The knowledge gained from the proposal will be invaluable to future clinical trials in HS.
|Effective start/end date||4/1/21 → 3/31/22|