Development and initial validation of the HS-IGA: a novel hidradenitis suppurativa-specific investigator global assessment for use in interventional trials.

ABSTRACT:

Background

Few validated instruments exist for use in hidradenitis suppurativa (HS) trials.

Objectives

To develop a novel HS Investigator Global Assessment (HS-IGA) and to validate its psychometric properties.

Methods

Development of HS-IGA involved discussion among stakeholders, including patients, within HISTORIC. Data from replicate phase III randomized controlled trials evaluating HS treatment were utilized. Multivariate models identified lesion type and body region as variables of importance. Classification and regression trees for ordinal responses were built. Validation included assessment of test-retest reliability, predictive validity, responsiveness and clinical meaningfulness.

Results

There were 3024 unique measurements available in PIONEER I. Mean an

SUBMITTER: Garg A 

PROVIDER: S-EPMC9542331 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature