title: Development of a core outcome set for clinical trials in rosacea: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.
abstract: Rosacea is a chronic inflammatory disorder affecting millions of individuals worldwide. Diagnosis is based on signs and symptoms with management and treatment aimed to suppress inflammatory lesions, erythema, and telangiectasia. While many clinical trials of rosacea exist, the lack of consensus in outcome reporting across all trials poses a concern. Proper evaluation and comparison of treatment modalities is challenging. In order to address the inconsistencies present, this project aims to determine a core set of outcomes which should be evaluated in all clinical trials of rosacea.
  
  
  
  This project will utilize a methodology similar to previous core outcome set research. A long list of outcomes will be extracted over four phases: (1) systematic literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Potential outcomes will be examined by the Steering Committee to provide further insight. The Delphi process will then be performed to prioritize and condense the list of outcomes generated. Two homogenous groups of physicians and patients will participate in two consecutive rounds of Delphi surveys. A consensus meeting, composed of physicians, patients, and stakeholders, will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. For the duration of the study, we will be in collaboration with both the Core Outcome Measures in Effectiveness Trials (COMET) and Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN).
  
  
  
  This study aims to develop a core outcome set to guide assessment in clinical trials of rosacea. The end-goal is to improve the reliability and consistency of outcome reporting, thereby allowing sufficient evaluation of treatment effectiveness and patient satisfaction.
authors: Department of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
authors: Sanjana
authors: S
authors: Iyengar
authors: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors: Paula R
authors: PR
authors: Williamson
authors: Centre for Evidence-Based Healthcare, Medical Faculty Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
authors: Jochen
authors: J
authors: Schmitt
authors: Centre for Evidence-Based Healthcare, Medical Faculty Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
authors: Lena
authors: L
authors: Johannsen
authors: Department of Dermatology, Saint Louis University School of Medicine, St. Louis, MO, USA.
authors: Ian A
authors: IA
authors: Maher
authors: Department of Dermatology, University of Pennsylvania, Philadelphia, PA, USA.|Division of Dermatologic Surgery, University of Pennsylvania, Philadelphia, PA, USA.
authors: Joseph F
authors: JF
authors: Sobanko
authors: Department of Dermatology, Penn State Hershey Dermatology, Hershey, PA, USA.
authors: Todd V
authors: TV
authors: Cartee
authors: Department of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
authors: Daniel
authors: D
authors: Schlessinger
authors: Department of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
authors: Emily
authors: E
authors: Poon
authors: Department of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA. m-alam@northwestern.edu.|Department of Otolaryngology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. m-alam@northwestern.edu.|Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. m-alam@northwestern.edu.
authors: Murad
authors: M
authors: Alam
mesh_terms: D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D003697:Delphi Technique; D006801:Humans; D063868:Patient Outcome Assessment; D018802:Patient-Centered Care; D012393:Rosacea / Q000628:therapy*; D000078202:Systematic Reviews as Topic; D016896:Treatment Outcome
keywords: Consensus; Core outcome set; Delphi; Rosacea; Stakeholders; Systematic review