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