Response to Authors Concern for Mischaracterization of Referenced Publications

Transcription

1 Accepted Manuscript Response to Authors Concern for Mischaracterization of Referenced Publications Catherine C. Motosko, BS, George A. Zakhem, BS, Anna K. Ault, BA, Laura L. Kimberly, MSW, MBE, M David Gothard, MS, Roger S. Ho, MD, MS, MPH, Alexes Hazen, MD PII: S (18) DOI: /j.jaad Reference: YMJD To appear in: Journal of the American Academy of Dermatology Received Date: 20 July 2018 Revised Date: 26 July 2018 Accepted Date: 30 July 2018 Please cite this article as: Motosko CC, Zakhem GA, Ault AK, Kimberly LL, Gothard MD, Ho RS, Hazen A, Response to Authors Concern for Mischaracterization of Referenced Publications, Journal of the American Academy of Dermatology (2018), doi: /j.jaad This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

2 Article Type: Letters: Notes & Comments Title: Response to Authors Concern for Mischaracterization of Referenced Publications Catherine C Motosko, BS 1,2, George A Zakhem, BS 1,2, Anna K Ault, BA 1, Laura L Kimberly, MSW, MBE 1, M David Gothard MS 3, Roger S Ho, MD, MS, MPH 2, Alexes Hazen, MD 1 1 Hansjörg Wyss Department of Plastic Surgery, NYU Langone Health, New York, NY 2 Ronald O. Perelman Department of Dermatology, NYU Langone Health, New York, NY 3 Biostats Inc., East Canton, OH Corresponding Author: Alexes Hazen, M.D. Hansjörg Wyss Department of Plastic Surgery, NYU Langone Health st Avenue New York, NY Telephone: Alexes.Hazen@nyumc.org Funding sources: None IRB approval status: NA Conflicts of interest: None to disclose Manuscript word count: 474 words [excluding capsule summary, abstract, references, figures, and tables] Abstract word count: 0 Capsule summary word count: 0 Figures: 0 Supplementary figures: 0 Tables: 0 Supplementary tables: 0 Attachments: None Keywords: ethics, general dermatology, cosmetics

3 Dear Editor, Like several other studies, we adapted Boutron and colleagues s 1 methodology to evaluate spin in a selection of articles that reported significant findings. Spin tactics alter the interpretation of results through incomplete reporting of data, inaccurate discussion of results, or inappropriate statistical analysis. While we would not presume to question the intent of Farris and colleagues, both papers included in our analysis employed the above tactics. We thank Farris and colleagues for noting a typographical error in the pre-print draft of our manuscript this typo has already been addressed in the final proof; however, the transcriptional error was not relevant to the point exemplified by the quote. The passage highlights the inappropriate reporting of results as percent changes from baseline a spin tactic used in both manuscripts that can inaccurately convey a higher magnitude of findings. Their reporting in the absence of raw scores can give the appearance of more impactful results. 2 Because percent improvement at the final time point is unreported, the reader must rely on an unsupported claim that the active group was statistically superior. Although Farris and colleagues assert visualization techniques were used only to demonstrate visible changes, this contradicts both papers. 2,3 Digital Photography and Silicone Replicas replica techniques are listed under Efficacy and Safety Assessments, 2,3 and, per their methods, image analysis was applied to each replica. 3 Yet, the results of these analyses are unreported, while significant results are implied with statements like...demonstrated improvement...that corresponded to the visual changes seen in clinical photographs. 3 Moreover, although almost all subjects in the active group reported antiaging benefits, 3 the results of the placebo group s self-assessment are absent, and comparative analysis was not performed. Failure to report these findings might lead the reader to question whether other results were unreported. Farris and colleagues also state that their statistical analyses were appropriate because they found significant changes in clinically graded parameters; however, their analysis is flawed. Both studies failed

4 to account for baseline variation between groups, and although the authors state the issue of multiplicity has no practical impact for the interpretation of these studies, multiplicity can occur from multiple testing of within-group changes at multiple time points. These issues can be avoided if a repeated measure ANOVA approach or type I error adjustment is used when multiple measures are taken in the same units and compared for equality within and between groups multiple times. Finally, we agree that the cosmetic nature of these studies imparts an inherent challenge for standardized, objective assessment of skin quality; however, validated tools do exist that were developed in accordance with FDA requirements. 4 Although we appreciate the opportunity to address concerns raised by Farris and colleagues, we would like to emphasize that our study was performed to highlight the need to address the root causes of spin and elevate the quality of research, not to criticize specific authors.

5 References: 1. Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. Jama. 2010;303(20): Farris PK, Edison BL, Weinkauf RL, Green BA. A novel, volumizing cosmetic formulation significantly improves the appearance of target Glabellar lines, nasolabial folds, and crow's feet in a double-blind, vehicle-controlled clinical trial. Journal of drugs in dermatology : JDD. 2014;13(1): Farris PK, Edison BL, Brouda I, Weinkauf RL, Green BA. A high-potency, multimechanism skin care regimen provides significant antiaging effects: results from a double-blind, vehiclecontrolled clinical trial. Journal of drugs in dermatology : JDD. 2012;11(12): Donofrio L, Carruthers A, Hardas B, et al. Development and Validation of a Photonumeric Scale for Evaluation of Facial Skin Texture. Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al]. 2016;42 Suppl 1:S219-s226.