Rosacea Core Domain Set for Clinical Trials and Practice
Authors: McKenzie A. Dirr, Areeba Ahmed, Daniel I. Schlessinger, Misha Haq, Victoria Shi, Eric Koza, Melissa Ma, Rachel E. Christensen, Sarah A. Ibrahim, Jochen Schmitt, Lena Johannsen, Yuka Asai, Hilary E. Baldwin, Enzo Berardesca, Brian Berman, Ana Carolina Vieira, Anna L. Chien, David E. Cohen, James Q. Del Rosso, Jacquelyn Dosal, Lynn A. Drake, Steven R. Feldman, Alan B. Fleischer, Adam Friedman, Emmy Graber, Julie C. Harper, Yolanda R. Helfrich, Gregor B. Jemec, Sandra M. Johnson, Rajani Katta, Peter Lio, Lisa E. Maier, George Martin, Arielle R. Nagler, Isaac M. Neuhaus, Melis Palamar, Lawrence C. Parish, Theodore Rosen, Stephen P. Shumack, James A. Solomon, Emil A. Tanghetti, Guy F. Webster, Allison Weinkle, Jonathan S. Weiss, Edward J. Wladis, Ian A. Maher, Joseph F. Sobanko, Todd V. Cartee, Brian A. Cahn, Murad Alam, Bianca Y. Kang, Sanjana Iyengar, Noor Anvery, Erkan Alpsoy, Anthony Bewley, Clio Dessinioti, Alexander Egeberg, Burhan Engin, Harald P. M. Gollnick, Dimitrios Ioannides, Hei Sung Kim, Elizabeth Lazaridou, Ji Li, Hester Gail Lim, Giuseppe Micali, Clivia Maria Moraes de Oliveira, Lucero Noguera-Morel, Aurora Parodi, Markus Reinholz, Dae Hun Suh, Qiuning Sun, Esther J van Zuuren, Uwe Wollina, Youwen Zhou, Catherine Zip, Emily Poon, Ross Pearlman
Journal: JAMA Dermatology (2024)

Importance Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.