Abstract
BackgroundRosacea 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.Methods/designThis 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).DiscussionThis 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1554-3) contains supplementary material, which is available to authorized users.
Highlights
Rosacea is a chronic inflammatory disorder affecting millions of individuals worldwide
This study aims to develop a core outcome set to guide assessment in clinical trials of rosacea
In order to minimize duplication, this study has been registered with the Core Outcome Measures in Effectiveness Trials (COMET) and CSG-COUSIN organizations so researchers are aware of our ongoing efforts and may participate if interested
Summary
There is currently no COS relevant to clinical trials of rosacea. With a lack of standardization in outcomes assessed, the potential for reporting bias exists. Selection of outcomes is crucial for properly comparing and evaluating the effectiveness of different treatment interventions. The proposed COS for rosacea aims to reduce the inconsistency of outcomes and outcome measurements across relevant trials. Through the use of COSs, we hope to hasten refinement and adoption of therapies for rosacea that address factors important to key stakeholders, patients and physicians. Trial status The development of the COS is active and ongoing in its initial phase of outcome extraction. Completed checklist of the study protocol for the development of a core outcome set. Completed checklist of the study protocol for the development of a core outcome set. (DOCX 47 kb)
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