JAMA dermatology · 2026
Hidradenitis Suppurativa Patient-Reported Outcome Measures: A Systematic Review and Meta-Analysis.
СтатьяСистематический обзорМетаанализПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Tarafdar Nawar, Varambally Meghna, Karimi Nima, Akuffo-Addo Edgar, Ingram John R, Piguet Vincent
Аннотация
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.
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.