Abstract
BackgroundFacial aging is a concern for many patients. Wrinkles, loss of volume, and discoloration are common physical manifestations of aging skin. Genetic heritage, prior ultraviolet light exposure, and Fitzpatrick skin type may be associated with the rate and type of facial aging. Although many clinical trials assess the correlates of skin aging, there is heterogeneity in the outcomes assessed, which limits the quality of evaluation and comparison of treatment modalities. To address the inconsistency in outcomes, in this project we will develop a core set of outcomes that are to be evaluated in all clinical trials relevant to facial aging.Methods/designA long list of measureable outcomes will be created from four sources: (1) systematic medical literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Two rounds of Delphi processes with homogeneous groups of physicians and patients will be performed to prioritize and condense the list. At a consensus meeting attended by physicians, patients, and stakeholders, outcomes will be further condensed on the basis of participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. Subsequent to this, specific measures will be selected or created to assess these outcomes.DiscussionThe aim of this study is to develop a core outcome set and relevant measures for clinical trials relevant to facial aging. We hope to improve the reliability and consistency of outcome reporting of skin aging, thereby enabling improved evaluation of treatment efficacy and patient satisfaction.Trial registrationCore Outcome Measures in Effectiveness Trials (COMET) Initiative, accessible at http://www.comet-initiative.org/studies/details/737. Core Outcomes Set Initiative, (CSG-COUSIN) accessible at https://www.uniklinikum-dresden.de/de/das-klinikum/universitaetscentren/zegv/cousin/meet-the-teams/project-groups/core-outcome-set-for-the-appearance-of-facial-aging. Protocol version date is 28 July 2016.
Highlights
Facial aging is a concern for many patients
The aim of this study is to develop a core outcome set and relevant measures for clinical trials relevant to facial aging
Because physical attractiveness is strongly correlated with self-esteem and quality of life, aging of the skin is an important concern encountered in dermatology [4,5,6]
Summary
COSs have been proposed as a solution to selective outcome reporting. There is currently no COS relevant to clinical trials of facial aging. The proposed study will incorporate the opinions of patients, physicians, and other key stakeholders to create such a set to eliminate the inconsistency of outcomes and outcome measurements examined across relevant trials. Through the use of COSs, we hope to improve research trials and clinical practice. Trial status The development of the COS is active and ongoing in its initial phase of outcome extraction. Additional file in Dermatologic Surgery; SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials
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