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    Core Outcome Set for Actinic Keratosis Clinical Trials

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    Author
    Reynolds, Kelly A
    Schlessinger, Daniel I
    Vasic, Jelena
    Iyengar, Sanjana
    Qaseem, Yaqoob
    Behshad, Ramona
    DeHoratius, Danielle M
    Denes, Pablo
    Drucker, Aaron M
    Dzubow, Leonard M
    Etzkorn, Jeremy R
    Harwood, Catherine
    Kim, John Y S
    Lee, Erica H
    Lissner, Gary S
    Marghoob, Ashfaq A
    Matin, Rubeta N
    Mattox, Adam
    Mittal, Bharat B
    Thomas, J Regan
    Zhou, Xiaolong Alan
    Zloty, David
    Schmitt, Jochen
    Kirkham, Jamie
    Poon, Emily
    Sobanko, Joseph F
    Cartee, Todd V
    Maher, Ian A
    Alam, Murad
    Show allShow less
    Affiliation
    Univ Arizona, Coll Med, Div Dermatol
    Issue Date
    2020-01-15
    
    Metadata
    Show full item record
    Publisher
    AMER MEDICAL ASSOC
    Citation
    Reynolds KA, Schlessinger DI, Vasic J, et al. Core Outcome Set for Actinic Keratosis Clinical Trials. JAMA Dermatol. 2020;156(3):326–333. doi:10.1001/jamadermatol.2019.4212
    Journal
    JAMA DERMATOLOGY
    Rights
    Copyright © 2020 American Medical Association. All rights reserved.
    Collection Information
    This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.
    Abstract
    Question What are the most important outcomes to report in clinical trials on actinic keratosis? Findings In this survey study including physician and patient stakeholders (33 in round 1 and 29 in round 2), a consensus was reached regarding a core set of 6 of 137 outcomes and domains of actinic keratosis: complete clearance of actinic keratoses, percentage of actinic keratoses cleared, severity of adverse events, patient perspective on effectiveness, patient-reported future treatment preference, and rate of recurrence. Meaning In studies of treatment of actinic keratosis, the recommended core outcomes should be reported as a minimum to facilitate comparison of results across studies. This survey study assesses the most important outcomes to report in clinical trials on actinic keratosis based on Delphi surveys completed by physician and patient stakeholders. Importance Although various treatments have been found in clinical trials to be effective in treating actinic keratosis (AK), researchers often report different outcomes. Heterogeneous outcome reporting precludes the comparison of results across studies and impedes the synthesis of treatment effectiveness in systematic reviews. Objective To establish an international core outcome set for all clinical studies on AK treatment using systematic literature review and a Delphi consensus process. Evidence Review Survey study with a formal consensus process. The keywords actinic keratosis and treatment were searched in PubMed, Embase, CINAHL, and the Cochrane Library to identify English-language studies investigating AK treatments published between January 1, 1980, and July 13, 2015. Physician and patient stakeholders were nominated to participate in Delphi surveys by the Measurement of Priority Outcome Variables in Dermatologic Surgery Steering Committee members. All participants from the first round were invited to participate in the second round. Outcomes reported in randomized controlled clinical trials on AK treatment were rated via web-based e-Delphi consensus surveys. Stakeholders were asked to assess the relative importance of each outcome in 2 Delphi survey rounds. Outcomes were provisionally included, pending the final consensus conference, if at least 70% of patient or physician stakeholders rated the outcome as critically important in 1 or both Delphi rounds and the outcome received a mean score of 7.5 from either stakeholder group. Data analysis was performed from November 5, 2018, to February 27, 2019. Findings A total of 516 outcomes were identified by reviewing the literature and surveying key stakeholder groups. After deduplication and combination of similar outcomes, 137 of the 516 outcomes were included in the Delphi surveys. Twenty-one physicians and 12 patients participated in round 1 of the eDelphi survey, with 17 physicians (81%) retained and 12 patients (100%) retained in round 2. Of the 137 candidate outcomes, 9 met a priori Delphi consensus criteria, and 6 were included in the final outcomes set after a consensus meeting: complete clearance of AKs, percentage of AKs cleared, severity of adverse events, patient perspective on effectiveness, patient-reported future treatment preference, and recurrence rate. It was recommended that treatment response be assessed at 2 to 4 months and recurrence at 6 to 12 months, with the AK rate of progression to cutaneous squamous cell carcinoma reported whenever long-term follow-up was possible. Conclusions and Relevance Consensus was reached regarding a core outcome set for AK trials. Further research may help determine the specific outcome measures used to assess each of these outcomes.
    Note
    12 month embargo; published online: 15 January 2020
    ISSN
    2168-6068
    PubMed ID
    31939999
    DOI
    10.1001/jamadermatol.2019.4212
    Version
    Final published version
    ae974a485f413a2113503eed53cd6c53
    10.1001/jamadermatol.2019.4212
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    UA Faculty Publications

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