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Only 7% of trials included a patient-reported outcome measure as a primary outcome measure.
Investigators have analyzed how many studies involving patients with acne and rosacea and patient-reported outcome measures (PROM).
A team, led by Sophia Ly, BA, College of Medicine, University of Arkansas for Medical Sciences, characterized the use of patient-reported outcome measures in randomized clinical trials on patients with acne and rosacea.
“Acne and rosacea have substantial implications for quality of life, and it is therefore important to ensure the patient’s voice is being captured in pivotal randomized clinical trials,” the authors wrote.
There is currently not much known about the use of patient-reported outcome measures in randomized clinical trials on patients with acne and rosacea.
In the systematic literature review, the investigators searched various databases for phase 2, 3, and 4 acne vulgaris and rosacea studies between December 31, 2011 and December 31, 2021 that evaluated the efficacy and safety of treatments for the diseases with any comparator.
The investigators identified 2461 studies, 206 of which met the inclusion criteria. This included 163 trials on acne and 43 trials on rosacea.
In 53% (n = 110) of the studies there was at least 1 patient reported outcome measure used. Specically, more rosacea studies used patient-reported outcome measures (67%; n = 29). This was compared to 50% (n = 81) of trials in acne with patient-reported outcome measures.
There was also 27 (13%) dermatology-specific and 28 (14%) disease-specific patient-reported outcome measures included in the analysis, but only 7% (n = 14) of trials included a patient-reported outcome measure as a primary outcome measure.
Finally, there was no statistically signficiant increase in patient-reported outcome measure inclusion over the entire study period (11 of 21 trials in 2011 vs. 5 of 12 trials in 2021).
“In this systematic review, PROMs were included in approximately one-half of acne and rosacea RCTs performed over the study period,” the authors wrote. “In this systematic review, PROMs were included in approximately one-half of acne and rosacea RCTs performed over the study period. In addition, PROMs were rarely used as a primary outcome measure, and inclusion of PROMs has not increased substantially over the past 10 years. Increasing use of PROMs in RCTs can ensure that the patient’s perspective is captured during the development of new treatments for acne and rosacea.”
The study, “Use of Patient-Reported Outcomes in Acne Vulgaris and Rosacea Clinical Trials From 2011 to 2021,” was published online in JAMA Dermatology.