Development and validation of printed educational material for isotretinoin users☆☆☆

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Dear Editor,
Acne is a dermatosis that affects approximately 80% of adolescents. 1 The treatment of the most severe forms involves the use of isotretinoin, a medication whose prescription requires strict control due to its high number of adverse effects. The use of printed educational materials during treatment with isotretinoin can increase user's adherence and satisfaction, reducing side effects and complications. 2 The present study developed an orientation manual for patients with acne who use isotretinoin and methodologically validated this material. The manual creation protocol consisted of two phases: the first phase involved the creation of educational material, based on the search for scientific articles in the databases between 1980 and 2019, using the descriptors: acne, isotretinoin, adherence, adverse effects, health education manuals. When creating the content, short phrases were used with simple, everyday language and in the active voice. In the second phase, the educational manual was evaluated in two stages: validation by judges (Brazilian dermatologists who are acne experts), and validation by the target audience (patients).
There are controversies in the literature regarding the number and qualification of the judges. Lynn recommends a minimum of five and a maximum of ten people participating in this process. 3 Pasquali points out that the number of six to twenty specialists is recommended for the validation process. 4 In the first stage, nine judges were included, following the classification system described by Joventino (2010), which requires a minimum score of five, considering the academic degree and qualification in the area of interest ( Table 1). The specialists received the free and informed consent form and a questionnaire to be completed online, adapted from Galdino's instrument (2019), containing closed questions about information included in the manual regarding the following: objectives, relevance, structure and presentation. 5 In the second stage, after    The criteria for selecting patients with acne were: age ≥14 years, isotretinoin use up to the third month of treatment, and adequate level of education for reading and understanding the material. The patients had to sign the free and informed consent form, and answer a question- The Content Validity Index (CVI) was used to perform the interpretation and analysis of the data, which measures the proportion of judges who are in agreement about the instrument and its items. 6 This method uses a Likert-type scale, with scores ranging from one to four. To assess relevance/representativeness, the answers may include 3 : 1 = not relevant, or not representative; 2 = needs further revision to be representative; 3 = needs a little revision to be representative; 4 = relevant or representative. The index is calculated by adding the sum of the agreement on the items which got scores ''3'' and ''4'' by the specialists, divided by the total number of responses. 7 Items that received a score of ''1'' or ''2'' must be reviewed or eliminated. In the case of six or more judges, an acceptable agreement rate of no less than 0.78 is recommended. 7 In the analysis of the data evaluated by the target audience, items with a minimum level of agreement of 75% were considered validated. Table 2 shows the evaluation of the manual by the judges regarding the objectives, structure, presentation and relevance of the manual. All items were validated, which conferred a Content Validity Index (CVI) of 0.88 for the proposed objectives, a CVI of 0.88 for structure and presentation and a CVI of 1.0 for relevance. There were some suggestions for changes in color, pictures and text. Table 3 shows the evaluation of the manual by the patients. Of the thirty patients, 63% were aged between 15 and 20 years; 30% between 21 and 25 years; and 6.7% between 26 and 31 years. Most patients were males (56.6%), single (93.3%), had more than ten years of schooling (56.6%), had had acne for a period of less than or equal to five years (70%), and had undergone previous treatment with oral or topical medication (56.6%).
The material was positively assessed and validated by the patients regarding all aspects: organization, style and quality of the writing and three items of motivation, with the CVI always equal or very close to 1.0. One item related to motivation had a lower CVI (0.70) and was not validated by the patients (the one that addressed whether the manual would influence behavior change during isotretinoin use). It is possible that the quality of the information provided to patients by the two Dermatology Services where the study was carried out was the cause of the non-validation of this item, since the patients had probably already received guidance on the behavior while using isotretinoin.
The 16-page manual, validated by judges and patients, is illustrated in Fig. 1, in reduced size. The project developed easy-to-understand material, written in simple language, addressing the issues necessary to guide patients in relation to isotretinoin use, based on a sample of SUS-Brasil users.

Financial support
None declared.

Authors' contributions
Letícia Santos Dexheimer: Statistical analysis; design and planning of the study; drafting and editing of the manuscript; collection, analysis, and interpretation of data; intellectual participation in the propaedeutic and therapeutic conduct of the studied cases; critical review of the literature; critical review of the manuscript.
Camila Boff: Design and planning of the study; drafting and editing of the manuscript.
Cecília Cassal: Approval of the final version of the manuscript; design and planning of the study; drafting and editing of the manuscript; effective participation in research orientation.
Renan Rangel Bonamigo: Approval of the final version of the manuscript; design and planning of the study; drafting and editing of the manuscript; effective participation in research orientation; critical review of the manuscript.