Development of a core outcome set for clinical trials in facial aging: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2104-3) contains supplementary material, which is available to authorized users.

Core Outcome Set for Actinic Keratosis Clinical Trials

“…Outcomes with scores less than 6.5 in both groups or that achieved less than 70% consensus among patient and physician stakeholders were excluded from consideration for inclusion in the COS. These cutoffs for consensus were based on other COS publications 13,18,[25][26][27] and were chosen a priori.…”

Core outcome sets and core outcome measures: a primer

“…Two international organizations based in Europe, the core outcome measures in effectiveness trials (COMET) [2,3] initiative and the Cochrane skin-core outcome set initiative (CSG-COUSIN) [4,5] have been instrumental in pioneering and refining the process for creating core outcome sets (COS). In short, this requires: (1) identifying a disease or condition for which a COS may be useful; (2) registering this COS as "in process" on online indices supported by both organizations to ensure transparency and avoid unnecessary duplication of effort by another similarly motivated group; (3) creating a roadmap or protocol for COS development, and possibly publishing this [6][7][8][9]; (4) conducting a literature review to develop a comprehensive long list of all outcomes that have previously been measured by investigators studying this disease or condition; (5) asking a diverse, international group of stakeholders of various types (physicians from numerous medical specialties, patients, non-physician medical personnel, regulators, epidemiologists and methodologists, industry representatives, etc.) to add any additional outcomes; (6) empowering a steering committee to edit the long list and remove duplicates; (7) performing a multi-round Delphi exercise with both patients and physicians to further cull the long list; (8) presenting the results of the Delphi at an in-person consensus meeting; (9) adopting a final short list of core outcomes, usually no more than 5-7; (10) publishing the results of the COS development process [10].…”

A Step Toward Standardizing Clinical Trials of Actinic Keratosis

“…To advance standardized outcomes in the field of dermatology, the Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) Steering Committee was formed to specifically focus on developing core outcome sets for dermatologic conditions. This committee has succeeded in overseeing the characterization of core outcome sets for various conditions, including basal cell carcinoma, squamous cell carcinoma, rosacea, facial aging, and now actinic keratosis. The conceptual framework of the method used by these studies was proposed by the Core Outcome Measures in Effectiveness Trials Initiative and the Cochrane Skin Group Core Outcomes Set Initiative methods group.…”