Hidradenitis suppurativa patient-reported outcome measures

Tarafdar, Nawar, Varambally, Meghna, Karimi, Nima, Akuffo-Addo, Edgar, Ingram, John R. ORCID: https://orcid.org/0000-0002-5257-1142 and Piguet, Vincent 2026. Hidradenitis suppurativa patient-reported outcome measures. JAMA Dermatology 10.1001/jamadermatol.2025.5644

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Abstract

Importance Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder with high psychosocial burden. Despite growing use of patient-reported outcome measures (PROMs) in HS trials, variance in quality and validation of existing instruments remains to be studied. Objective To systematically review HS-specific PROMs using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) framework, evaluating development quality and psychometric evidence, and to perform a meta-analysis of key properties to summarize the evidence base and provide recommendations for clinical and research use. Data Sources MEDLINE, Embase, and PubMed were searched from inception to October 23, 2025, for English-language studies. Study Selection Articles describing the development or validation of HS-specific PROMs that evaluated at least 1 psychometric property were included. Generic instruments (eg, Dermatology Life Quality Index, pain numeric rating scale) were excluded. Screening was conducted by 2 independent reviewers. Data Extraction and Synthesis Two reviewers independently extracted data, appraised risk of bias with the COSMIN checklist, and graded quality of evidence using COSMIN-modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Random-effects meta-analysis pooled Cronbach α and correlation coefficients; heterogeneity was quantified using I2. Main Outcomes and Measures COSMIN-guided appraisal and graded quality of evidence of PROM measurement properties, including content validity, structural validity, internal consistency, reliability, responsiveness, and measurement error. Results Of 504 records screened, 26 studies (14 developmental, 12 validation) met the criteria (total number of patients across 26 studies was 5811; age ranged from median 33.9 [range, 25-41] to mean [SD] 46.9 [14.1] years), identifying 15 unique HS-specific PROMs (10 health-related quality of life, 4 symptom, 1 treatment benefit). Fourteen achieved sufficient content validity and 8 met the highest standards for rigorous instrument development. Meta-analysis demonstrated strong internal consistency and construct validity for the 17-item Hidradenitis Suppurativa Quality of Life (HiSQOL-17) PROM (pooled Cronbach α = 0.94; I2 = 81.3%; pooled Pearson r = 0.84; I2 = 74%; pooled Spearman r = 0.88, I2 = 29%). Of 7 evaluated PROMs, 2 displayed sufficient internal consistency. The remainder were indeterminate due to absent or low-quality evidence for unidimensionality. Test-retest reliability was sufficient in 9 PROMs, and responsiveness was rated sufficient in 5. No studies evaluated measurement error. Seven PROMs met COSMIN criteria for recommendation. Conclusions and Relevance In this study, 7 PROMs demonstrated sufficiency of both content validity and either internal consistency or another relevant measurement property (formative instruments). Further research is needed to strengthen the validation of HS-specific instruments.

Item Type:	Article
Date Type:	Published Online
Status:	In Press
Schools:	Schools > Medicine
Additional Information:	RRS policy applied
Publisher:	American Medical Association
ISSN:	2168-6068
Date of First Compliant Deposit:	29 January 2026
Date of Acceptance:	28 January 2026
Last Modified:	30 Jan 2026 10:30
URI:	https://orca.cardiff.ac.uk/id/eprint/184272

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