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      Development and Validation Clinician and Patient Reported Photonumeric Scales to Assess Buttocks Cellulite Severity

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          Abstract

          Supplemental Digital Content is Available in the Text.

          BACKGROUND

          The Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported PCSS (PR-PCSS) are newly developed tools for assessing cellulite severity.

          OBJECTIVE

          To report on the reliability, validity, and ability to detect a change in cellulite severity on the buttocks of adult women with the CR-PCSS and PR-PCSS.

          MATERIALS AND METHODS

          Content validity of both scales was established through concept elicitation and cognitive interviews. Test–retest reliability was evaluated, and intra-rater (both scales) and inter-rater (CR-PCSS only) reliability were estimated using intraclass correlation coefficients (ICCs) for agreement and consistency. Ability to detect a change was determined using the Subject–Global Aesthetic Improvement Scale (GAIS) or Investigator-GAIS as anchors.

          RESULTS

          For the CR-PCSS ( n = 6) at baseline and Day 2, the mean interrater ICCs were ≥0.70 and mean intrarater ICCs (95% confidence interval [CI]) were ≥0.81 (0.72–0.90) for both buttocks. For the PR-PCSS ( n = 99) at baseline and Day 14, the mean test–retest reliability ICCs (95% CI) were ≥0.86 (0.79–0.91) for both buttocks. A clinically meaningful change was 1.0 point on the PR-PCSS and 1.0 on the CR-PCSS.

          CONCLUSION

          The CR-PCSS and PR-PCSS reliably assess cellulite severity of the buttocks and can detect a clinically meaningful change after treatment for cellulite.

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          Most cited references24

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          A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research.

          Intraclass correlation coefficient (ICC) is a widely used reliability index in test-retest, intrarater, and interrater reliability analyses. This article introduces the basic concept of ICC in the content of reliability analysis.
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            Developing criteria for establishing interrater reliability of specific items: applications to assessment of adaptive behavior.

            A set of criteria based upon biostatistical considerations for determining the interrater reliability of specific adaptive behavior items in a given setting was presented. The advantages and limitations of extant statistical assessment procedures were discussed. Also, a set of guidelines for differentiating type of adaptive behavior that are statistically reliable from those that are reliable in a clinical or practical sense was delineated. Data sets were presented throughout in order to illustrate the advantages of recommended statistical procedures over other available ones.
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              Recommendations for evaluating the validity of quality of life claims for labeling and promotion.

              The pharmaceutical industry, the medical device industry, and national regulatory agencies such as the United States Food and Drug Administration (FDA) are faced with a number of difficult issues related to the development and evaluation of health-related quality of life (HRQL) claims for product labeling and promotion. This paper outlines some of the unique challenges of HRQL research and makes recommendations for assuring that claims are based on the results of rigorous studies designed and conducted according to accepted scientific principles and practices. Standards of evidence for HRQL are discussed in terms of research design and methodology, instrumentation, statistical analysis, and interpretation. Examples are provided to highlight important points. The paper concludes with a brief discussion of future trends in HRQL outcomes evaluation.
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                Author and article information

                Journal
                Dermatol Surg
                Dermatol Surg
                ds
                Dermatologic Surgery
                Lippincott Williams & Wilkins (Philadelphia, PA )
                1076-0512
                1524-4725
                December 2020
                29 September 2020
                : 46
                : 12
                : 1628-1635
                Affiliations
                [* ]AboutSkin Dermatology and DermSurgery, PC, Greenwood Village, Colorado;
                []Dermatology, University of California, Irvine, California;
                []Department of Dermatology, Weill Cornell Medical College, Cornell University, New York, New York;
                [§ ]Endo Pharmaceuticals, Inc., Malvern, Pennsylvania;
                []Evidera, Bethesda, Maryland;
                []Department of Anesthesiology, University of North Carolina, Chapel Hill, North Carolina;
                [# ]Cosmetic Laser Dermatology: A West Dermatology Company and Volunteer Clinical Professor of Dermatology, University of California, San Diego, California
                Author notes
                Address correspondence and reprint requests to: Joel L. Cohen, MD, AboutSkin Dermatology and DermSurgery, PC, 5340 South Quebec Street, Suite 300, Greenwood Village, CO 80111, or e-mail: jcohenderm@ 123456yahoo.com
                Article
                ds-01003-2019 00036
                10.1097/DSS.0000000000002756
                7685927
                33009069
                4338c4a5-0d93-47bc-89ac-42fafb266801
                Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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