Seven patient-reported outcome measures (PROMs) for hidradenitis suppurativa (HS) have met current quality standards for clinical and research use, although further validation is needed to improve reliability, according to a recent systematic review and meta-analysis.

Although dermatology-specific instruments are commonly used in HS clinical trials, they may underestimate disease burden and be less responsive to change than disease-specific measures, the researchers said, adding that as HS-specific measures vary in quality, identifying the most robustly validated instruments is essential.

Published in JAMA Dermatology, this study evaluated the development quality and psychometric properties of HS-specific PROMs using the Consensus-based Standards for the Selection of Health Measurement Instrument (COSMIN) framework.

MEDLINE, Embase and PubMed were searched from inception to 23 October 2025 for English-language studies reporting the development or validation of HS-specific PROMs, with generic dermatology instruments excluded.

Of 504 records screened, 26 studies met the inclusion criteria, including 14 development studies and 12 validation studies. Two independent reviewers extracted data, assessed risk of bias using the COSMIN checklist, and graded the quality of evidence using COSMIN-modified GRADE methodology.

Where feasible, random-effects meta-analysis was conducted to pool measures of internal consistency and construct validity.

The included studies reported data from 5,811 patients with HS. Participant ages ranged from a median of 33.9 years (range 25–41) to a mean of 46.9 years (standard deviation 14.1).

Strongest psychometric performance in HS

A total of 15 HS-specific PROMs were identified, including 10 health-related quality-of-life instruments, four symptom-focused measures and one treatment-benefit instrument.

Of the 15 identified PROMs, 14 showed sufficient content validity, but only eight met the highest standards for rigorous instrument development. The 17-item Hidradenitis Suppurativa Quality of Life instrument (HiSQOL-17) had the strongest overall psychometric performance.

The random-effects meta-analysis showed high internal consistency (pooled Cronbach's α=0.94) and strong construct validity (pooled Pearson r=0.84; pooled Spearman r=0.88), although there was substantial heterogeneity.

Of the seven PROMs formally assessed for internal consistency, only two met the COSMIN criteria for sufficiency. The others were rated as indeterminate due to limited or low-quality evidence of unidimensionality. Test–retest reliability was sufficient for nine PROMs and responsiveness was sufficient for five. Notably, none of the included studies evaluated measurement error.

PROMs for clinical and research use

Along with HiSQOL-17, six other PROMs met the criteria for clinical and research use, according to COSMIN recommendations: the Hidradenitis Odor and Drainage Scale, known as HODS; HIDRAdisk; the Patient Benefit Index for Hidradenitis Suppurativa, or PBI-HS; the Patient Global Assessment for Hidradenitis Suppurativa-specific Health-related Quality of Life, or PtGA-HS; the Hidradenitis Suppurativa Burden of Disease tool, known as HSBOD, and the Hidradenitis Suppurativa Symptoms and Impacts Daily Diary, or HSSID.

High statistical heterogeneity across multiple pooled analyses reduced confidence in some summary estimates, and the small number of eligible studies per instrument limited the potential for subgroup analyses. Furthermore, none of the included studies assessed measurement error or feasibility, and cross-language measurement invariance was not formally tested, even when translated instruments were available.

The authors further cautioned that all PROMs were developed and evaluated using traditional psychometric approaches, without the application of modern methods, which may have constrained the depth of validation.

The findings support the use of a limited number of well-validated HS-specific PROMs, particularly HiSQOL-17, in clinical trials and routine care. However, the authors noted that further high-quality psychometric validation, including assessment of measurement error, feasibility and cross-cultural performance, is needed to strengthen the measurement of patient-centred outcomes and promote standardisation in HS research.

Previous research found that almost 60% of patients with HS reported that their quality of life was extremely or very much impaired.

Reference
Tarafdar N et al. Hidradenitis Suppurativa Patient-Reported Outcome Measures. A Systematic Review and Meta-Analysis. JAMA Dermatol 2026; Jan 28:e2555644.