Patient-Reported Outcome Measures for Health-Related Quality of Life in Patients With Acne Vulgaris: A Systematic Review of Measure Development and Measurement Properties.

IMPORTANCE

Multiple patient-reported outcome measures (PROMs) for health-related quality of life (HRQoL) exist for patients with acne. However, little is known about the content validity and other measurement properties of these PROMs.

OBJECTIVE

To systematically review PROMs for HRQoL in adults or adolescents with acne.

DATA SOURCES

Eligible studies were extracted from PubMed and Embase (OVID).

STUDY SELECTION

Full-text articles published in English or Spanish on development, pilot, or validation studies for acne-specific, dermatology-specific, or generic HRQoL PROMs were included. Development studies included original development studies, even if not studied in acne patients per Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) recommendations. If a study included several diagnoses, the majority (ie, over 50%) of patients must have acne or acne-specific subgroup analyses must be available. Abstract and full-text screening was performed by 2 independent reviewers.

DATA EXTRACTION AND SYNTHESIS

Two independent reviewers assessed study quality applying the COSMIN checklist and extracted and analyzed the data. For each distinctive PROM, quality of evidence was graded by measurement property.

MAIN OUTCOMES AND MEASURES

PROM properties (target population, domains, recall period, development language), PROM development and pilot studies, content validity (relevance, comprehensiveness, comprehensibility), and remaining measurement properties (structural validity, internal consistency, cross-cultural validity, reliability, measurement error, criterion validity, construct validity, and responsiveness). Quality of evidence was assigned for each measurement property of included PROMs. An overall recommendation level was assigned based on content validity and quality of the evidence of measurement properties.

RESULTS

We identified 54 acne PROM development or validation studies for 10 acne-specific PROMs, 6 dermatology-specific PROMs, and 5 generic PROMs. Few PROMs had studies for responsiveness. The only acne-specific PROMs with sufficient evidence for content validity were the CompAQ and Acne-Q. Based on available evidence, the Acne-Q and CompAQ can be recommended for use in acne clinical studies.

CONCLUSIONS AND RELEVANCE

Two PROMs can currently be recommended for use in acne clinical studies: the Acne-Q and CompAQ. 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.