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

Publikation: Beitrag in FachzeitschriftÜbersichtsartikel (Review)BeigetragenBegutachtung

Beitragende

  • McKenzie A Dirr - , Feinberg School of Medicine (Autor:in)
  • Areeba Ahmed - , Feinberg School of Medicine (Autor:in)
  • Daniel I Schlessinger - , Feinberg School of Medicine (Autor:in)
  • Misha Haq - , Feinberg School of Medicine (Autor:in)
  • Victoria Shi - , Feinberg School of Medicine (Autor:in)
  • Eric Koza - , Feinberg School of Medicine (Autor:in)
  • Melissa Ma - , Feinberg School of Medicine (Autor:in)
  • Rachel E Christensen - , Feinberg School of Medicine (Autor:in)
  • Sarah A Ibrahim - , Feinberg School of Medicine (Autor:in)
  • Jochen Schmitt - , Zentrum für evidenzbasierte Gesundheitsversorgung (Autor:in)
  • Lena Johannsen - , Zentrum für Evidenzbasierte Gesundheitsversorgung (Autor:in)
  • Yuka Asai - , Queen's University Kingston (Autor:in)
  • Hilary E Baldwin - , The Acne Treatment and Research Center, Morristown, New Jersey. (Autor:in)
  • Enzo Berardesca - , University of Miami Miller School of Medicine (Autor:in)
  • Brian Berman - , University of Miami Miller School of Medicine (Autor:in)
  • Ana Carolina Vieira - , Universidade Federal Fluminense (Autor:in)
  • Anna L Chien - , Johns Hopkins Medicine (Autor:in)
  • David E Cohen - , NYU Grossman School of Medicine (Autor:in)
  • James Q Del Rosso - , JDR Dermatology Research, Las Vegas, Nevada. (Autor:in)
  • Jacquelyn Dosal - , Skin Associates of South Florida, Coral Gables. (Autor:in)
  • Lynn A Drake - , Massachusetts General Hospital (Autor:in)
  • Steven R Feldman - , Wake Forest School of Medicine (Autor:in)
  • Alan B Fleischer - , University of Cincinnati College of Medicine (Autor:in)
  • Adam Friedman - , Medizinische Universität Innsbruck (Autor:in)
  • Emmy Graber - , Northeastern University (Autor:in)
  • Julie C Harper - , Dermatology and Skin Care Center of Birmingham (Autor:in)
  • Yolanda R Helfrich - , University of Michigan Medical School (Autor:in)
  • Gregor B Jemec - , Copenhagen University Hospitals (Autor:in)
  • Sandra M Johnson - (Autor:in)
  • Rajani Katta - , McGovern Medical School (Autor:in)
  • Peter Lio - , Feinberg School of Medicine (Autor:in)
  • Lisa E Maier - , University of Washington Medical Center (Autor:in)
  • George Martin - , Dr George Martin Dermatology Associates, Kihei, Hawaii. (Autor:in)
  • Arielle R Nagler - , NYU Grossman School of Medicine (Autor:in)
  • Isaac M Neuhaus - , University of California at San Francisco (Autor:in)
  • Melis Palamar - , Ege University (Autor:in)
  • Lawrence C Parish - , Thomas Jefferson University (Autor:in)
  • Theodore Rosen - , Baylor College of Medicine (Autor:in)
  • Stephen P Shumack - , Royal North Shore Hospital (Autor:in)
  • James A Solomon - , Carle-Illinois College of Medicine (Autor:in)
  • Emil A Tanghetti - , Center for Dermatology and Laser Surgery, Sacramento, California. (Autor:in)
  • Guy F Webster - , Thomas Jefferson University (Autor:in)
  • Allison Weinkle - , Weinkle Dermatology, Bradenton, Florida. (Autor:in)
  • Jonathan S Weiss - , Gwinnett Dermatology, Snellville, Georgia. (Autor:in)
  • Edward J Wladis - , Albany Medical College (Autor:in)
  • Ian A Maher - , University of Minnesota System (Autor:in)
  • Joseph F Sobanko - , University of Pennsylvania Perelman School of Medicine (Autor:in)
  • Todd V Cartee - , Pennsylvania State College of Medicine (PSCOM) (Autor:in)
  • Brian A Cahn - , Feinberg School of Medicine (Autor:in)
  • Murad Alam - , Feinberg School of Medicine (Autor:in)

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.

Details

OriginalspracheEnglisch
Seiten (von - bis)658-666
Seitenumfang9
FachzeitschriftJAMA dermatology
Jahrgang160
Ausgabenummer6
Frühes Online-Datum24 Apr. 2024
PublikationsstatusVeröffentlicht - 1 Juni 2024
Peer-Review-StatusJa

Externe IDs

Scopus 85191839363

Schlagworte

Schlagwörter

  • Clinical Trials as Topic/standards, Consensus, Delphi Technique, Humans, Outcome Assessment, Health Care/standards, Rosacea/therapy, Treatment Outcome