The aim of this study was to validate pictogram subtitles and analyze the understanding of pictograms taken from the United States Pharmacopeia Dispensing Information (USP-DI). The subtitles of 25 pictograms from the USP-DI were translated and retro-translated, and the generated subtitles were compared by two committees of judges to evaluate semantic and cultural equivalence. Semantic validity was analyzed by submitting the translated subtitles to a convenience sample of 23 elderly people in Aracaju-SE (Brazil). Additionally, 15 of the 81 USP-DI pictograms were presented to participants individually, without subtitles and in random order, to analyze participants' understanding of them. The process of cross-cultural translation and validation resulted in a Portuguese version of each pictogram's subtitle. Changes in grammatical structure were applied to some items. Twelve subtitles showed less than 80% concordance of interpretation between judges, and were modified. The semantic validation phase indicated that four participants had difficulty understanding one particular subtitle. The analysis of understanding phase indicated that only one pictogram met the criterion for acceptable understanding established by ISO 3864. The Brazilian Portuguese version of pictogram subtitles from the USP-DI presents cross-cultural equivalency with the original English version. Most of the USP-DI pictograms assessed in the present study were not well understood by participants. The pictograms that did not meet the comprehension criteria are being redrawn in ways specific to the local culture.
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