TY - JOUR
T1 - Development and initial validation of the HS-IGA
T2 - a novel hidradenitis suppurativa-specific investigator global assessment for use in interventional trials
AU - Garg, Amit
AU - Zema, Carla
AU - Kim, Katherine
AU - Gao, Weihua
AU - Chen, Naijun
AU - Jemec, Gregor B E
AU - Kirby, Joslyn
AU - Thorlacius, Linnea
AU - Villumsen, Bente
AU - Ingram, John R
N1 - © 2022 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.
PY - 2022/8
Y1 - 2022/8
N2 - 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 and median lesion counts by region were largely <10 and were highest in axillary and inguinal regions. The mean and median number of regions involved were ≤ 3 for individual lesions and combinations. Regardless of lesion type, axillary and inguinal regions most influenced the HS-IGA score. Accordingly, regions were combined into a six-point IGA based on the maximum lesion number in either upper or lower body regions with a score of 0 (0-1 lesions), 1 (2-5), 2 (6-10), 3 (11-15), 4 (16-20) and 5 (≥ 20 lesions). The intraclass correlation coefficient for test-retest reliability was 0·91 (95% confidence interval 0·87-0·94). Spearman's rank order correlations (SROCs) with HS-PGA and Hidradenitis Suppurativa Clinical Response (HiSCR) were 0·73 and 0·51, respectively (P < 0·001 for both comparisons). SROCs with Dermatology Life Quality Index (DLQI), pain numerical rating scale and HS-QoL were 0·42, 0·34 and -0·25, respectively (P < 0·001 for all comparisons). HS-IGA was responsive at weeks 12 and 36. Predictive convergent validity was very good with HS-PGA (area under the curve = 0·89) and with HiSCR (area under the curve = 0·82). Predictive divergent validity was low with DLQI and HS-QoL.CONCLUSIONS: HS-IGA has moderate-to-strong psychometric properties and is simple to calculate.
AB - 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 and median lesion counts by region were largely <10 and were highest in axillary and inguinal regions. The mean and median number of regions involved were ≤ 3 for individual lesions and combinations. Regardless of lesion type, axillary and inguinal regions most influenced the HS-IGA score. Accordingly, regions were combined into a six-point IGA based on the maximum lesion number in either upper or lower body regions with a score of 0 (0-1 lesions), 1 (2-5), 2 (6-10), 3 (11-15), 4 (16-20) and 5 (≥ 20 lesions). The intraclass correlation coefficient for test-retest reliability was 0·91 (95% confidence interval 0·87-0·94). Spearman's rank order correlations (SROCs) with HS-PGA and Hidradenitis Suppurativa Clinical Response (HiSCR) were 0·73 and 0·51, respectively (P < 0·001 for both comparisons). SROCs with Dermatology Life Quality Index (DLQI), pain numerical rating scale and HS-QoL were 0·42, 0·34 and -0·25, respectively (P < 0·001 for all comparisons). HS-IGA was responsive at weeks 12 and 36. Predictive convergent validity was very good with HS-PGA (area under the curve = 0·89) and with HiSCR (area under the curve = 0·82). Predictive divergent validity was low with DLQI and HS-QoL.CONCLUSIONS: HS-IGA has moderate-to-strong psychometric properties and is simple to calculate.
KW - Clinical Trials, Phase III as Topic
KW - Hidradenitis Suppurativa/drug therapy
KW - Humans
KW - Immunoglobulin A
KW - Prostaglandins A/therapeutic use
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - Reproducibility of Results
KW - Severity of Illness Index
U2 - 10.1111/bjd.21236
DO - 10.1111/bjd.21236
M3 - Article
C2 - 35599448
SN - 0007-0963
VL - 187
SP - 203
EP - 210
JO - The British journal of dermatology
JF - The British journal of dermatology
IS - 2
ER -