Rosacea Core Domain Set for Clinical Trials and Practice

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dc.authoridJemec, Gregor/0000-0002-0712-2540
dc.authoridHelfrich, Yolanda/0000-0003-4957-3910
dc.contributor.authorDirr, McKenzie A.
dc.contributor.authorAhmed, Areeba
dc.contributor.authorSchlessinger, Daniel I.
dc.contributor.authorHaq, Misha
dc.contributor.authorShi, Victoria
dc.contributor.authorKoza, Eric
dc.contributor.authorMa, Melissa
dc.date.accessioned2024-08-31T07:50:12Z
dc.date.available2024-08-31T07:50:12Z
dc.date.issued2024
dc.departmentEge Üniversitesien_US
dc.description.abstractImportance 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.en_US
dc.identifier.doi10.1001/jamadermatol.2024.0636
dc.identifier.endpage630en_US
dc.identifier.issn2168-6068
dc.identifier.issn2168-6084
dc.identifier.issue6en_US
dc.identifier.pmid38656294en_US
dc.identifier.scopus2-s2.0-85191839363en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage621en_US
dc.identifier.urihttps://doi.org/10.1001/jamadermatol.2024.0636
dc.identifier.urihttps://hdl.handle.net/11454/105145
dc.identifier.volume160en_US
dc.identifier.wosWOS:001208531800003en_US
dc.identifier.wosqualityN/Aen_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherAmer Medical Assocen_US
dc.relation.ispartofJama Dermatologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.snmz20240831_Uen_US
dc.subjectQuality-Of-Lifeen_US
dc.subjectImpacten_US
dc.subjectAcneen_US
dc.titleRosacea Core Domain Set for Clinical Trials and Practiceen_US
dc.typeReview Articleen_US

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