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  1. Article ; Online: Protocol for development of a core outcome set for clinical trials in melasma

    Jamie J Kirkham / Murad Alam / Jochen Schmitt / Sarah A Ibrahim / Bianca Y Kang / Daniel I Schlessinger / Sarah G Chiren / Jennifer C Tang / Emily Poon / Ian A Maher / Joseph F Sobanko / Todd V Cartee

    BMJ Open, Vol 12, Iss

    2022  Volume 2

    Keywords Medicine ; R
    Language English
    Publishing date 2022-02-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Development of a core outcome set for clinical trials in squamous cell carcinoma

    Daniel I. Schlessinger / Sanjana Iyengar / Arianna F. Yanes / Sarah G. Chiren / Victoria Godinez-Puig / Brian R. Chen / Anastasia O. Kurta / Jochen Schmitt / Stefanie Deckert / Karina C. Furlan / Emily Poon / Todd V. Cartee / Ian A. Maher / Murad Alam / Joseph F. Sobanko

    Trials, Vol 18, Iss 1, Pp 1-

    study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

    2017  Volume 6

    Abstract: Abstract Background Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The ... ...

    Abstract Abstract Background Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The outcome heterogeneity and reporting bias of these studies leave clinicians unable to accurately compare studies. Core outcome sets (COSs) are an agreed minimum set of outcomes recommended to be measured and reported in all clinical trials of a given condition or disease. Although COSs are under development for several dermatologic conditions, work has yet to be done to identify core outcomes specific for SCC. Methods/design Outcome extraction for COS generation will occur via four methods: (1) systematic literature review; (2) patient interviews; (3) other published sources; and (4) input from stakeholders in medicine, pharmacy, and other relevant industries. The list of outcomes will be revaluated by the Measuring PRiority Outcome Variables via Excellence in Dermatologic surgery (IMPROVED) Steering Committee. Delphi processes will be performed separately by expert clinicians and patients to condense the list of outcomes generated. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. At the end of the meeting, members will vote and decide on a final recommended set of core outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) organization and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN) will serve as advisers throughout the COS generation process. Discussion Comparison of clinical trials via systematic reviews and meta-analyses is facilitated when investigators study outcomes that are relevant and similar. The aim of this project is to develop a COS to guide use for future clinical trials.
    Keywords Core outcome set ; Delphi ; Consensus ; Stakeholders ; Squamous cell carcinoma ; Systematic review ; Medicine (General) ; R5-920
    Subject code 310
    Language English
    Publishing date 2017-07-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Development of a core outcome set for clinical trials in facial aging

    Daniel I. Schlessinger / Sanjana Iyengar / Arianna F. Yanes / Jill K. Henley / Hovik J. Ashchyan / Anastasia O. Kurta / Payal M. Patel / Umar A. Sheikh / Matthew J. Franklin / Courtney C. Hanna / Brian R. Chen / Sarah G. Chiren / Jochen Schmitt / Stefanie Deckert / Karina C. Furlan / Emily Poon / Ian A. Maher / Todd V. Cartee / Joseph F. Sobanko /
    Murad Alam

    Trials, Vol 18, Iss 1, Pp 1-

    study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

    2017  Volume 6

    Abstract: Abstract Background Facial 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 ...

    Abstract Abstract Background Facial 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/design A 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. Discussion The 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 registration Core 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 ...
    Keywords Core outcome set ; Delphi ; Consensus ; Stakeholders ; Aging ; Systematic review ; Medicine (General) ; R5-920
    Subject code 616
    Language English
    Publishing date 2017-08-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Development of a core outcome set for clinical trials in basal cell carcinoma

    Daniel I. Schlessinger / Sanjana Iyengar / Arianna F. Yanes / Jake M. Lazaroff / Victoria Godinez-Puig / Brian R. Chen / Anastasia O. Kurta / Jill K. Henley / Sarah G. Chiren / Karina C. Furlan / Jochen Schmitt / Stefanie Deckert / Emily Poon / Joseph F. Sobanko / Todd V. Cartee / Murad Alam / Ian A. Maher

    Trials, Vol 18, Iss 1, Pp 1-

    study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

    2017  Volume 6

    Abstract: Abstract Background Basal cell carcinoma is the most common skin cancer worldwide. Treatment options include both surgical and topical modalities. Although risk of metastasis is low, basal cell carcinoma can be invasive and infiltrate important ... ...

    Abstract Abstract Background Basal cell carcinoma is the most common skin cancer worldwide. Treatment options include both surgical and topical modalities. Although risk of metastasis is low, basal cell carcinoma can be invasive and infiltrate important underlying structures such as bone or cartilage. While many clinical trials examining therapies for basal cell carcinoma 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 basal cell carcinoma. Methods/design Outcomes will be extracted over four phases: (1) a systematic literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Potential outcomes will then be examined by the Steering Committee, who may add or remove outcomes. The Delphi process will then be performed to condense the list of outcomes generated. Two rounds of Delphi surveys will be performed with two groups of participants – physicians and patients. A consensus meeting with relevant 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) initiative and the Cochrane Skin Group – Core Outcome Set Initiative (CSG-COUSIN). Discussion This study aims to develop a core outcome set to guide assessment in clinical trials on basal cell carcinoma. The end-goal is to improve the consistency of outcome reporting and allow proper evaluation of treatment effectiveness.
    Keywords Core outcome set ; Delphi ; Consensus ; Stakeholders ; Basal cell carcinoma ; Systematic review ; Medicine (General) ; R5-920
    Subject code 616
    Language English
    Publishing date 2017-10-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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