Accepted Manuscript. The readability of ipledge program patient education materials. Rachel Howard, BS, Gideon Smith, MD, PhD

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1 Accepted Manuscript The readability of ipledge program patient education materials Rachel Howard, BS, Gideon Smith, MD, PhD PII: S (18)30834-X DOI: /j.jaad Reference: YMJD To appear in: Journal of the American Academy of Dermatology Received Date: 14 May 2018 Accepted Date: 16 May 2018 Please cite this article as: Howard R, Smith G, The readability of ipledge program patient education materials, 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: Research Letters Title: The readability of ipledge program patient education materials Rachel Howard, BS 1, Gideon Smith, MD, PhD 1 1 UNC Center for Pharmacogenomics and Individualized Therapy, 120 Mason Farm Rd, Chapel Hill, NC Mass General Hospital of Harvard Medical School, 50 Staniford Street, Suite 200, Boston, MA Corresponding author: Rachel Howard, BS 120 Mason Farm Rd Chapel Hill, NC Telephone: (919) howardrm@ .unc.edu Funding sources: None Conflicts of Interest: None declared. Manuscript word count: 493 words References: 3 Figures: 1 Supplementary figures: 0 Tables: 1 Supplementary tables: 0 Keywords: ipledge; patient education; readability; isotretinoin; acne; dermatology

3 Body of manuscript Patient education is fundamental to successful therapeutic management. 1 However, adequate education is contingent upon a patient s ability to comprehend materials provided. It is recommended that patient materials be at a 6th grade level, representative of the national average reading level. It is vital that these recommendations are carefully considered when designing patient education materials, as poor comprehension can adversely affect outcomes, adherence and overall quality of life. 2 The ipledge program has been instituted to prevent on-therapy pregnancies. However, it has been shown that pregnancy rates among ipledge participants still remain unchanged at approximately 2.7 isotretinoin-exposed pregnancies per 1000 treatment courses. 3 Here we evaluate the ipledge patient education materials for readability to see if this may be one contributor to the failure of this system and an opportunity for improvement. The ipledge brochure and ipledge consent agreement were downloaded from the ipledge website and the written text components were extracted from these materials. Analysis was conducted via a readability software package utilizing standard formulas for Flesch-Kincaid grade level, Gunning-Fog score, Coleman-Liau, SMOG index, and Automated Readability Index. Mean reading grade level ranged from 9.88 to for the ipledge patient education materials (Table 1). The first page of the ipledge brochure was graded the most readable among the sources examined; however, it is presented at a challenging reading level of grade If patients cannot comprehend the first page, it is unlikely they will continue reading. The brochure in entirety was graded at a mean reading level of Thus, there is still no improvement of reading ease should the patient continue reading the brochure. The ipledge consent agreement proved to be the most inaccessible, with a

4 reading level of grade This is of great concern because failure to provide readable, comprehendible patient education materials can hinder patient compliance and thus health outcomes Both the brochure and consent agreement failed to meet the suggested reading level of grade 6 (Figure 1). This readability assessment only examined educational materials of the ipledge program. There may be other useful, more readable patient education materials for isotretinoin use. However, many providers are likely using ipledge resources as their only patient materials. This analysis demonstrates the necessity for either improvement in these resources, or provision of alternate more accessible documents by dermatologists. In addition, the consent process requires patient understanding to be valid, and this suggests the ipledge materials do not meet this standard. All ipledge materials examined in this study exceeded the recommended readability level of grade 6. These results support the need to evaluate ipledge and consider revision of the materials, especially the consent agreement. While the ipledge program strived to prevent on-therapy pregnancies, the program appears to have failed in achieving this despite expensive lab testing, visits and mandated burden on the health system, providers and patients. It is therefore our duty to understand that failure and target ways to improve it. Here we identify one possible explanation and a clear target for change.

5 References 1. Lagger, Grégoire, Zoltan Pataky, and Alain Golay Efficacy of therapeutic patient education in chronic diseases and obesity. Patient Education and Counseling 79 (3): Hadden K, Prince LY, Schnaekel A, Couch CG, Stephenson JM, Wyrick TO. Readability of Patient Education Materials in Hand Surgery and Health Literacy Best Practices for Improvement. J Hand Surg Am. 2016;41(8): Shin J, Cheetham TC, Wong L, et al. The impact of the ipledge program on isotretinoin fetal exposure in an integrated health care system. J Am Acad Dermatol. 2011;65(6):

6 Figure legend Figure 1. Mean reading grade level scores of ipledge program patient educational brochure and ipledge consent agreement. Table legend Table 1. Readability scores and overall mean reading grade level scores of ipledge program patient educational brochure and ipledge consent agreement ipledge Brochure, ipledge Brochure ipledge Consent First Page Character count ,701 5,604 Word count 180 4,103 1,167 Sentence count Characters per word Syllables per word Words per sentence Flesch reading score Flesch-Kincaid grade level Gunning-Fog score Coleman-Liau SMOG index Automated readability index Mean grade level Source program.com/docum program.com/docum ohrms/dockets/ac/07 ents/patient%20intro %20Broch_ p df ents/patient%20intro %20Broch_ p df /briefing/ b1-15- addendumsponsor.pdf

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