Are patient-reported outcome measures (PROMs) commonly used in acne and rosacea randomized clinical trials (RCTs)?
In this systematic review of 206 RCTs, 53% of rosacea and acne trials included at least 1 PROM. Only 7% of the RCTs analyzed included a PROM as a primary outcome.
This systematic review found that PROMs often were not included in acne and rosacea RCTs and were rarely included as a primary outcome measure; increasing inclusion of patient-centered outcomes in RCTs can ensure that the patient’s perspective is captured during development of new treatments, and research is needed on improving incorporation of PROMs in RCTs.
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 (RCTs). Although patient-reported outcome measures (PROMs) are a valuable tool to capture the patient perspective, little is known about use of PROMs in RCTs on acne and rosacea.
To characterize the use of PROMs in RCTs on acne and rosacea.
A systematic literature search was conducted using the search terms acne vulgaris and rosacea in the following databases: MEDLINE through PubMed, Embase, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. A modified search hedge for RCTs from the McGill Library was applied. All phase 2, 3, and 4 RCTs published between December 31, 2011, through December 31, 2021, that evaluated the efficacy and safety of therapies for acne and rosacea vs any comparator were eligible for inclusion.
A total of 2461 publications describing RCTs were identified, of which 206 RCTs met the inclusion criteria (163 trials [79%] on acne and 43 [21%] on rosacea). At least 1 PROM was used in 53% of trials (110) included; PROM use was more common in rosacea RCTs (67% [n = 29]) compared with acne RCTs (50% [n = 81]). At least 1 dermatology-specific (13% [n = 27]) or disease-specific (14% [n = 28]) PROM was included in the RCTs analyzed. Only 7% of trials (14) included a PROM as a primary outcome measure. There was no statistically significant increase in PROM inclusion over the study period (11 of 21 trials in 2011 vs 5 of 12 trials in 2021).
Conclusions and Relevance
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.
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Accepted for Publication: July 26, 2022.
Published Online: October 26, 2022. doi:10.1001/jamadermatol.2022.3911
Corresponding Author: John S. Barbieri, MD, MBA, Department of Dermatology, Brigham and Women’s Hospital, 41 Avenue Louis Pasteur, Boston, MA 02115 (email@example.com).
Author Contributions: Ms Ly and Mr Miller had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Ms Ly and Mr Miller contributed equally to this study.
Concept and design: Ly, Miller, Mostaghimi, Barbieri.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Ly, Miller, Tong, Blake, Barbieri.
Critical revision of the manuscript for important intellectual content: Ly, Miller, Mostaghimi, Barbieri.
Statistical analysis: Ly, Miller, Barbieri.
Administrative, technical, or material support: Miller, Blake, Mostaghimi.
Supervision: Mostaghimi, Barbieri.
Conflict of Interest Disclosures: Dr Mostaghimi reported receiving personal fees from hims & hers, Figure Co, ACOM, Digital Diagnostics, Concert, Pfizer, Eli Lilly and Company, AbbVie, Equillium, and Boehringer Ingelheim outside the submitted work; and serves as an Associate Editor for JAMA Dermatology. Dr Barbieri serves as an Associate Editor for JAMA Dermatology. No other disclosures were reported.
Disclaimer: Drs Mostaghimi and Barbieri are Associate Editors of JAMA Dermatology but were not involved in any of the decisions regarding review of the manuscript or its acceptance.
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