PROMs for Health-Related Quality of Life in Patients With Acne

The Acne-Q and CompAQ are the only 2 patient-reported outcome measures (PROMs) for health-related quality of life (HRQOL) for patients with acne vulgaris that can be endorsed for application in clinical studies, according to findings from a systematic review published in the Journal of the American Medical Association Dermatology. No PROMs have sufficient evidence on all measurement properties or content validity,

PROMs can play an important role in assessing HRQOL in patients with inflammatory skin disorders with potential profound effects on quality of life, such as severe acne. To be appropriate for clinical practice or acne research, such instruments need to be evaluated for content validity and measurement properties. Reviewers sought to identify HRQOL PROMs for adults and adolescents with acne and evaluate the quality of measurement properties and methodology.

They conducted a systematic review of PubMed and Embase databases examining full-text articles on validation, pilot, or development studies for generic, acne-specific, or dermatology-specific HRQOL PROMs published in Spanish or English. They evaluated PROM properties (development language, recall period, domains, target population), PROM content validity (comprehensibility, comprehensiveness, relevance), and additional measurement properties (construct validity, responsiveness, criterion validity, measurement error, reliability, internal consistency, cross-cultural validity, and structural validity).

Reviewers found 54 acne PROM validation or development studies for 5 generic PROMs, 6 dermatology-specific PROMs, and 10 acne-specific PROMs. PROMs with studies for responsiveness were scarce, the researchers found. Only 2 acne-specific PROMs (Acne-Q and CompAQ) had sufficient evidence for content validity.

Investigators acknowledged that review limitations included the ability to only assess aspects of studies that were reported; they believe methodology details may be missing in many previous studies, the subjectivity in the risk for bias checklist, FDA guidance for HRQOL instruments focusing on design for clinical trials so possibly missing significant design considerations from a clinical point of view, significant reviewer bias, the possibility that significant validation, pilot, or development studies were not included, and measurement error and cross-cultural validity were not assessed.

Reviewers concluded that 2 PROMs, Acne-Q and CompAQ, could be recommended for use in clinical studies involving acne. They noted, “Evidence on content validity and other measurement properties were lacking for all PROMs; further research investigating the quality of remaining acne-specific, dermatology-specific, and generic HRQoL PROMs is required to recommend their use.”

Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Hopkins ZH, Thiboutot D, Homsi HA, Perez-Chada LM, Barbieri JS. Patient-reported outcome measures for health-related quality of life in patients with acne vulgaris: A systematic review of measure development and measurement properties. JAMA Dermatol. Published online June 22, 2022. doi:10.1001/jamadermatol.2022.2260