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. 2024 Jun 1;160(6):658-666.
doi: 10.1001/jamadermatol.2024.0636.

Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement

McKenzie A Dirr  1 , Areeba Ahmed  1 , Daniel I Schlessinger  1 , Misha Haq  1 , Victoria Shi  1 , Eric Koza  1 , Melissa Ma  1 , Rachel E Christensen  1 , Sarah A Ibrahim  1 , Jochen Schmitt  2 , Lena Johannsen  2 , Yuka Asai  3 , Hilary E Baldwin  4 , Enzo Berardesca  5 , Brian Berman  6 , Ana Carolina Vieira  7 , Anna L Chien  8 , David E Cohen  9 , James Q Del Rosso  10 , Jacquelyn Dosal  11 , Lynn A Drake  12 , Steven R Feldman  13 , Alan B Fleischer Jr  14 , Adam Friedman  15   16 , Emmy Graber  17 , Julie C Harper  18 , Yolanda R Helfrich  19 , Gregor B Jemec  20 , Sandra M Johnson  21 , Rajani Katta  22 , Peter Lio  23 , Lisa E Maier  24 , George Martin  25 , Arielle R Nagler  26 , Isaac M Neuhaus  27 , Melis Palamar  28 , Lawrence C Parish  29 , Theodore Rosen  30 , Stephen P Shumack  31 , James A Solomon  32   33 , Emil A Tanghetti  34 , Guy F Webster  35 , Allison Weinkle  36 , Jonathan S Weiss  37 , Edward J Wladis  38 , Ian A Maher  39 , Joseph F Sobanko  40 , Todd V Cartee  41 , Brian A Cahn  42 , Murad Alam  1 ; IMPROVED-COS Rosacea Working Group; Bianca Y Kang  1 , Sanjana Iyengar  1 , Noor Anvery  1 , Erkan Alpsoy  43 , Anthony Bewley  44 , Clio Dessinioti  45 , Alexander Egeberg  46 , Burhan Engin  47 , Harald P M Gollnick  48 , Dimitrios Ioannides  49 , Hei Sung Kim  50 , Elizabeth Lazaridou  51 , Ji Li  52 , Hester Gail Lim  53 , Giuseppe Micali  54 , Clivia Maria Moraes de Oliveira  55 , Lucero Noguera-Morel  56 , Aurora Parodi  57 , Markus Reinholz  58 , Dae Hun Suh  59 , Qiuning Sun  60 , Esther J van Zuuren  61 , Uwe Wollina  62 , Youwen Zhou  63 , Catherine Zip  64 , Emily Poon  1 , Ross Pearlman  1
Affiliations

Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement

McKenzie A Dirr et al. JAMA Dermatol. .

Abstract

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.

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