Global Harmonization of Morphological Definitions in Hidradenitis Suppurativa for a Proposed Glossary

Abstract

and definitions are vital for identification of lesion types in the clinical trial setting and communication about the condition. For hidradenitis suppurativa (HS), morphological definitions have been proposed by different groups, representing various regions of the world, but no international consensus has been reached regarding such definitions. A lack of globally harmonized terminology and definitions may contribute to poor-quality data collection in clinical trials as well as poor communication among clinicians, investigators, and patients. OBJECTIVE To establish and validate consensus definitions for typical morphological findings for HS lesions.METHODS This study was conducted from August 2019 to August 2020. A Delphi study technique was used to assess agreement and then resolve disagreement on HS terminology among international experts. After an initial preparation phase, the process consisted of 3 rounds. In each round, participants reviewed preliminary definitions and rated them as "keep, with no changes," "keep, with changes," or "remove." Eight HS primary lesions, including papule, pustule, nodule, plaque, ulcer, abscess, comedo, and tunnel, were selected because they are most frequently used in HS clinician-reported outcome measures. The initial definitions were based on extant literature, and modifications were made between rounds based on qualitative thematic analysis of open-ended responses or discussion. Consensus was defined as greater than 70% to accept a definition. Consensus stability across rounds was defined as less than 15% change in agreement. Reliability was evaluated using the Gwet agreement coefficient. Validation was based on assessment of face validity and stability across rounds.RESULTS A total of 31 experts participated. All 8 HS primary lesion definitions achieved greater than 70% consensus by Delphi round 3. Stability was achieved for papule, pustule, and abscess. The Gwet agreement coefficient increased from 0.49 (95% CI, 0.26-0.71) in round 1 to 0.78 (95% CI, 0.64-0.92) in round 3. Face validity was supported by expert endorsement to keep terms in survey responses. Previously unmeasured variation among clinicians' definition of tunnels was identified, and consensus was achieved.CONCLUSIONS AND RELEVANCE An international group of experts agreed on definitions for morphological features of HS lesions frequently included in HS clinical trials. These international consensus terms and definitions are needed to support consistency of lesion identification and quantification in clinical trials.

The Genomic Architecture of Hidradenitis Suppurativa—A Systematic Review

“…Notwithstanding, the limited number of studies investigating HS by whole exome sequencing, and to a lesser extent by whole genome sequencing, show promising results and highlight the need for patients at the extreme ends of the HS phenotypic spectrum to be identified and prioritized for rare variant screening. To this end, phenotypic evaluation and categorization criteria need to be standardized to facilitate their use and interpretation in clinical care settings ( Daxhelet et al, 2020 ; Frew et al, 2021 ).…”

Assessing severity, treatment response, and phenotype in HS

“…As yet, no single staging, outcome‐measurement, or phenotyping schema has proven to be far superior to the others in clinical practice, and very few studies have mapped currently proposed phenotypes to either outcome or clinical response to therapy, limiting their real‐world utility. Part of the challenge in the development of these tools has been poorly delineated definitions of key terms needed to assess disease burden, though efforts at standardization are now being made that should pay dividends in future studies 51 . Efforts to develop a core outcome set for clinical trials by the HiSTORIC group will hopefully also lead to the development of further improved outcome measures 52 .…”

“…Without studies. 51 Efforts to develop a core outcome set for clinical trials by the HiSTORIC group will hopefully also lead to the development of further improved outcome measures. 52 It is vital for the astute dermatologist to remain abreast of these developments in the field to ensure the best possible care for those suffering from this debilitating disease.…”

Surgical management of hidradenitis suppurativa: A review of techniques, data, and future directions

“…The intrafollicular contents that extrude and then seed into the surrounding tissue generate a robust inflammatory process that spreads to the adjacent area. This inflammation and subsequent healing lead to the formation of subcutaneous tunnels 2 . When left untreated, HS progresses to irreversible structural changes in the skin.…”

“…This inflammation and subsequent healing lead to the formation of subcutaneous tunnels. 2 When left untreated, HS progresses to irreversible structural changes in the skin. As such, HS presents with immense quality of life impairment, which often exceeds other chronic diseases and has far-reaching systemic comorbidities and complications.…”