Resumo Introdução: Dermatofitoses constituem as infecções fúngicas da pele, cabelo e unha mais comuns em seres humanos, acometendo cerca de 20% da população mundial e todas as faixas etárias. Objetivos: Analisar características clínicas, epidemiológicas e terapêuticas de pacientes com dermatofitoses atendidos num serviço de referência em dermatologia geral e tropical na região da Amazônia Brasileira. Métodos: Foram analisados 75 prontuários do período de janeiro de 2016 a janeiro de 2020, cujos dados sobre formas clínicas, tratamento e recorrência foram coletados em protocolo próprio dos pesquisadores. Foi utilizado o teste Qui-quadrado de aderência na análise estatística e para a tomada de decisão adotou-se p < 0,05. Resultados: Houve predomínio do sexo feminino, média de 49 anos de idade, e em 28% dos casos observaram-se mais de 10 lesões no mesmo indivíduo. O principal tipo de dermatofitose foi onicomicose em adultos, seguida por Tinea capitis (24%) na faixa etária pediátrica (média 11,39 anos). De forma geral, idosos (37,33%) e crianças (26,67%) foram os mais atingidos. Optou-se, na maioria dos casos, pelo tratamento com medicações tópicas e sistémicas combinadas, sendo a griseofulvina e a terbinafina as mais prescritas para o tratamento sistêmico e a ciclopirox olamina o principal tópico prescrito (36%). Apesar de 77,3% dos pacientes terem comparecido em consulta subsequente, 25,33% recidivaram em menos de um ano. Conclusão: Os dados analisados ressaltam a importância do diagnóstico e tratamento precoce das dermatofitoses, sobretudo em idades extremas —faixa etária pediátrica e idosos— além de destacar a importância ativa das medidas não farmacológicas na viabilização da redução de recidivas e morbilidade aos pacientes.

Abstract Introduction: Dermatophytosis is the most common fungal infection of the skin, hair, and nails in humans. It affects about 20% of the world's population in all age groups. Objectives: To analyze clinical, epidemiological, and therapeutic characteristics of patients diagnosed with dermatophytosis treated at a general and tropical dermatology reference service in the Brazilian Amazon region. Methods: We analyzed 75 medical records from January 2016 to January 2020, with a researchers' protocol to collect data on clinical forms, treatment, and recurrence. Statistical analysis used the chi-square test of adherence, and p < 0.05 was considered statistically significant. Results: There was a female predominance, mean age of 49 years and 28% of patients had more than 10 lesions. The dominant type of dermatophytosis was onychomycosis in adults, followed by Tinea capitis (24%) in the pediatric group (mean 11.39 years). The elderly (37.33%) and children (26.67%) were the most affected. In most cases, treatment with combined topical and systemic medications was chosen. Griseofulvin and terbinafine were the most prescribed for systemic treatment and ciclopirox olamine was the main prescribed topic (36%). Although 77.3% of the patients attended a follow-up appointment, 25.33% relapsed in less than one year. Conclusion: The analyzed data emphasizes the importance of early diagnosis and treatment of dermatophytosis, especially in the extreme age group —pediatric and elderly age groups— besides the active importance of non-pharmacological measures to reduce recurrences and morbidity for patients.

RESUMO Introdução: A psoríase é uma doença crónica inflamatória multissistêmica com diversas comorbidades, entre elas estão os transtornos de ansiedade e de depressão. Metodologia: Avaliar a prevalência de ansiedade e depressão, respectivamente pelos questionários GAD-7 and PHQ-9 em relação com variáveis socio-demográficas e formas de tratamento. Resultados: Foram avaliados 90 pacientes (56 do género feminino), 41 pacientes (45,56%) utilizavam apenas tratamento tópico, 28 pacientes (31,11%) utilizavam metotrexato via oral e 21 (23,33%) utilizavam imunobiológicos (agentes anti-TNF-alfa). Observou-se que 47 pacientes dos avaliados (52,23%) apresentaram algum grau de depressão (leve, moderado ou severo) e que 53 pacientes (58,89%) apresentaram algum grau de transtorno de ansiedade (leve, moderado ou severo). Não houve relação estatística significante entre o quadro de ansiedade e de depressão e o score PASI, assim como a faixa etária, a empregabilidade ou a escolaridade. Houve associação estatística entre o quadro psiquiátrico e o género feminino (p<0,0001) e menor prevalência de depressão (p=0,0336) com o uso de imunobiológicos. Conclusão: Os achados ratificam os achados encontrados na literatura, nos quais o quadro psiquiátrico possui também uma ampla associação com a fisiopatogenia inflamatória da psoríase, em especial em relação ao TNF-alfa, de modo que terapias anti-TNF possam vir a ser uma alternativa para o tratamento de depressão ou de transtornos de ansiedade associados à psoríase.

ABSTRACT Introduction: Psoriasis is a chronic inflammatory multisystemic disease with several comorbidities, namely anxiety and depression disorders. Methods: In this study, the prevalence of these psychiatric entities was investigated by the PHQ-9 and GAD-7 questionnaries and related to the socio-demographic variables and to the forms of clinical treatment. Results: A total of 90 patients (56 females) were analyzed. Of these, 41 patients (45.56%) used topical treatment only, 28 patients (31.11%) used oral methotrexate and 21 patients (23.33%) used immunobiological agents (anti-TNF-alfa agents). It was observed that 47 patients (52.23%) presented some degree of depression (mild, moderate or severe) and 53 patients (58.89%) presented some degree of anxiety disorder (mild, moderate or severe). There was no statistical relationship between the anxiety and depression scores and the PASI score, as well as age, employability or schooling. There was a statistical association between psychiatric comorbidities and the female gender (p <0.0001). It was also observed a lower prevalence of depression (p = 0.0336) on patients using immunobiological treatments. Conclusion: The findings confirm published data, showing association of psychiatric conditions with psoriasis, especially in relation to TNF-alpha, so that anti-TNF therapies may become an alternative for the treatment of depression or anxiety disorders associated with psoriasis.

ABSTRACT A 37-year-old male patient, Fitzpatrick skin phototype IV, a student living in Belem, Amazon region, in 2015 had a confirmed diagnosis of acquired immunodeficiency virus (HIV) infection, but did not initiate antiretroviral treatment at his own option. Three years after the diagnosis, erythematous maculae appeared on the dorsum of the nose with rapid progression to the entire face, with posterior diffuse infiltration and appearance of nodules on the chin and shoulder. In December 2018, the patient presented with exacerbation of the condition with an increase in infiltrated violaceous plaques and disseminated violaceous nodules. A histopathological biopsy of the skin was performed, confirming the diagnosis of angiomatoid proliferation suggestive of Kaposi’s sarcoma (KS), with an important dissemination of this disease to the noble organs. In addition, it is important to note that he only started antiretroviral therapy (ART) after the exacerbation of Kaposi (December 2018). In such cases, chemotherapy associated with ART is crucial for the treatment and follow-up of the patient, since Kaposi’s sarcoma develops relatively low in patients who do not have immunodeficiency.

ABSTRACT BACKGROUND: Package leaflets of medicines need to be intelligible, but tools for their evaluation are scarce. OBJECTIVE: To validate a new tool for assessing subjects’ satisfaction with medicine package leaflets (LiS-RPL). DESIGN AND SETTING: Cross-sectional descriptive study conducted in two regions of Portugal (Lisbon and Centre). METHODS: 503 participants (53.1% male) were selected according to convenience and homogenously distributed into three groups: 1 to 6; 7 to 12; and > 12 years of schooling. LiS-RPL was developed based on international regulation guidelines and was initially composed of 14 items. Twelve package leaflets were tested. Dimensionality calculations included: exploratory factor analysis and minimum rank factor analysis; Kaiser-Meyer-Olkin index and Bartlett’s sphericity test to assess matrix adequacy for exploratory factor analysis; exploratory bifactor analysis with Schmid-Leiman solution to detect possible existence of a broad second-order factor; and Bentler’s Simplicity Index and Loading Simplicity Index to assess factor simplicity. Diverse coefficients were calculated to assess reliability. RESULTS: Minimum rank factor analysis detected a two-factor or single-factor structure. Exploratory factor analysis with 12 items showed a two-factor structure, explaining 69.11% of the variance. These items were strongly correlated with each other (r = 0.80). Schmid-Leiman: all items seemed to represent the general factor (loadings above 0.50), which was 76.4% of the extracted variance. Simplicity indices were good (percentile 99): Bentler’s Simplicity Index of 0.99 and Loading Simplicity Index of 0.48. Internal consistency indexes indicated good reliability. LiS-RPL was shown to be homogenous. CONCLUSION: LiS-RPL is a validated tool for evaluating subjects’ satisfaction with medicine package leaflets.

Abstract: Background: Kaposi’s sarcoma (KS) is a rare neoplasm with indolent progression. Since 1981, the Kaposi’s sarcoma epidemic has increased as co-infection with HIV. Objectives: The study aimed to identify the clinical and demographic characteristics and therapeutic approaches in HIV/AIDS patients in a regional referral hospital. Methods: We analyzed the medical records of 51 patients with histopathological diagnosis of Kaposi’s sarcoma hospitalized at Hospital Universitário João de Barros Barreto (HUJBB) from 2004 to 2015. Results: The study sample consisted of individuals 15 to 44 years of age (80.4%), male (80.4%), single (86.3%), and residing in Greater Metropolitan Belém, Pará State, Brazil. The primary skin lesions identified at diagnosis were violaceous macules (45%) and violaceous papules (25%). Visceral involvement was seen in 62.7%, mainly affecting the stomach (75%). The most frequent treatment regimen was 2 NRTI + NNRTI, and 60.8% were referred to chemotherapy. Study limitations: We assumed that more patients had been admitted to hospital without histopathological confirmation or with pathology reports from other services, so that the current study probably underestimated the number of KS cases. Conclusion: Although the cutaneous manifestations in most of these patients were non-exuberant skin lesions like macules and papules, many already showed visceral involvement. Meticulous screening of these patients is thus mandatory, even if the skin lesions are subtle and localized.

RESUMO Objetivos: Relatar as manifestações oculares observadas em pacientes com psoríase atendidos no Ambulatório de Dermatologia da X e encaminhados ao Y, no período de outubro de 2013 a agosto de 2014. Métodos: A amostra foi constituída por um grupo composto por 43 pacientes com psoríase e um grupo controle com 86 pacientes sem psoríase. Foi realizada uma entrevista clínica com dados epidemiológicos, aspectos clínicos da doença e terapia empregada, sendo todas as informações registradas em protocolo próprio. Posteriormente, realizou-se o exame dermatológico, no qual foi avaliado o índice de gravidade da Psoríase por área (PASI) e índice dermatológico de qualidade de vida (DLQI), e o exame oftalmológico completo, incluindo: Acuidade Visual, Biomicroscopia, Tonometria, Fundoscopia, Teste de Schirmer I, Tempo de Ruptura do Filme Lacrimal (TBUT), rosa bengala, índice de doença da superfície ocular (OSDI) e exames para glaucoma. Resultados: Observou-se que nos pacientes com psoríase houve frequência estatisticamente maior de envolvimento ocular, como olho seco (16,28%), provável olho seco (32,56%) e blefarite (16,28%). Além disso, os valores do rosa bengala e do OSDI apresentaram-se mais alterados nos pacientes com psoríase (p<0,05). Conclusão: Dessa forma, sugere-se que esses pacientes realizem exames oftalmológicos periódicos, já que as manifestações oculares podem progredir sem sintomatologia e ocorrer independentemente de fatores de risco.

ABSTRACT Purpose: We aimed to report the ocular manifestations observed in patients with psoriasis. Methods: Patients were included and referred to our ophthalmology clinic from dermatology clinics of Universidade do Estado do Pará between October 2013 and August 2014. Clinical interviews were conducted to identify relevant epidemiological data, clinical features, and treatment details, and data were recorded using the same protocol. Subsequent dermatological examinations were performed and disease severity was rated using the Psoriasis Area and Severity Index and the Dermatological Life Quality Index. Complete eye examination was conducted, including visual acuity, biomicroscopy, tonometry, fundoscopy, Schirmer I test, tear breakup time, rose bengal staining, ocular surface disease index, and glaucoma tests. Results: In total, we included 43 patients with psoriasis and 86 controls. Patients with psoriasis had statistically higher incidences of dry eye (16.28%), likely dry eye (32.56%), and blepharitis (16.28%). Furthermore, the rose bengal and ocular surface disease tests were more abnormal in patients with psoriasis (p<0.05). Conclusions: Patients with psoriasis should undergo regular eye exams, regardless of risk factors, to monitor for the progression of symptomatic or asymptomatic ocular manifestations.

Abstract: Cutaneous lymphomas are classified according to their cellular origin into T-cell lymphoma and B-cell lymphoma. The annual incidence rate is 0.3 per 100,000 population. We report a case of a 56-year-old male patient who presented with a two-month history of nodules of varying sizes, some ulcerated, on the face, abdomen, and upper limbs. Histopathological examination and immunohistochemical study confirmed the diagnosis of primary cutaneous centrofollicular lymphoma. Studies have shown an increased incidence of non-Hodgkin lymphomas in the last decade. We report an infrequent case that should be kept as a differential diagnosis of patients with nodules and cutaneous papules.

RESUMO Objetivo: Avaliar o impacto da dermatite atópica na qualidade de vida de pacientes pediátricos de 5 a 16 anos e seus responsáveis, atendidos no serviço de dermatologia da Universidade do Estado do Pará (UEPA) em 2015. Métodos: Estudo transversal de 51 pacientes juntamente com seus responsáveis, aos quais foram aplicados dois questionários de qualidade de vida, o Escore da Qualidade de Vida na Dermatologia Infantil (CDLQI) e o Impacto da Dermatite Atópica na Família (DFI). Para avaliar a gravidade da doença, os pesquisadores aplicaram o índice de Severity Scoring of Atopic Dermatitis (SCORAD). A correlação linear de Pearson foi aplicada para averiguar a correspondência entre os instrumentos CDLQI, DFI e SCORAD, e o coeficiente de contingência C para avaliar a associação entre as variáveis qualitativas. Considerou-se significante p<0,05. Resultados: Dos pacientes, 55% pertenciam ao sexo feminino. A idade média foi de 9.5±3.2 anos, e 41% tinha renda familiar de até um salário-mínimo. A média dos escores foi de 5.4±5.1 para o CDLQI, 6.6±4.5 para o DFI e 28.3±19.8 para o SCORAD. Atestou-se correlação altamente significante entre os escores CDLQI, DFI e SCORAD pela correlação linear de Pearson (p<0.001). Conclusões: A dermatite atópica afeta a qualidade de vida tanto das crianças quanto de seus responsáveis, o que indica a importância de inserir o estudo da qualidade de vida de forma complementar à avaliação clínica dos pacientes.

ABSTRACT Objective: To evaluate the impact of atopic dermatitis on the quality of life of pediatric patients in the age group of 5-16 years, and their parents, assisted at the Dermatology Department of Universidade do Estado do Pará in 2015. Methods: A cross-sectional study including 51 patients and their guardians, to whom two questionnaires about the quality of life were applied, the Children’s Dermatology Life Quality Index (CDLQI) and the Dermatitis Family Impact (DFI). To evaluate the severity of the disease, the researchers applied the Severity Scoring of Atopic Dermatitis (SCORAD) index. The Pearson Product-Moment Correlation Coefficient (PPMCC) evaluated the correlation between CDLQI, DFI, SCORAD, and the contingency coefficient C evaluated the association between the qualitative variables, considering p<0.05 significant. Results: Of the patients, 55% were female. The average age was 9.5±3.2 years, and 41% had family income up ≤1 minimum wage. The average score was 5.4±5.1 for CDLQI, 6.6±4.5 for DFI, and 28.3±19.8 for SCORAD. The correlation among the scores CDLQI, DFI, and SCORAD was significant by the PPMCC (p<0,001). Conclusions: Atopic dermatitis affects the quality of life of both children and their guardians, and indicates the importance of including the study of quality of life as a complement to clinical evaluation.

ResumoEntre outros requisitos regulatórios, o nome dos medicamentos de marca deve ser composto por um único nome e não integrar abreviaturas para evitar erros de medicação. Os objetivos do estudo foram: investigar a adequação de um grupo de nomes de medicamentos de marca portugueses à regulação farmacêutica do mesmo País; identificar as suas características linguísticas básicas e comparar essas características e a sua frequência com valores de referência da língua corrente ou informal. Foi selecionada uma amostra de 474 nomes. Os nomes foram analisados com recurso a métodos manuais (análise visual) e automáticos (FreP - Frequency Patterns of Phonological Objects in Portuguese e o MS word). Um número significativo de nomes (61,3%) não estava em conformidade com o sistema fonológico (relacionado com a forma sonora das palavras) e ortográfico do Português (relacionado com a forma de escrita das palavras), tinha mais de uma palavra, continha uma alta proporção padrões silábicos e acentuais raros, e incluía abreviaturas. Os resultados sugerem que alguns dos nomes das marcas medicamentos portugueses devem ser reavaliadas e os aspetos regulatórios atualizados, tendo em consideração as características específicas do sistema linguístico e ortográfico português.

AbstractAmong other regulatory requirements, medicine brands should be composed of single names without abbreviations to prevent errors in prescription of medication. The purposes of the study were to investigate the compliance of a sam ple of Portuguese medicine brand names with Portuguese pharmaceutical regulations. This includes identifying their basic linguistic characteristics and comparing these features and their frequency of occurrence with benchmark values of the colloquial or informal language. A sample of 474 brand names was selected. Names were analyzed using manual (visual analyses) and computer methods (FreP - Frequency Patterns of Phonological Objects in Portuguese and MS word). A significant number of names (61.3%) failed to comply with the Portuguese phonologic system (related to the sound of words) and/or the spelling system (related to the written form of words) contained more than one word, comprised a high proportion of infrequent syllable types or stress patterns and included abbreviations. The results suggest that some of the brand names of Portuguese medication should be reevaluated, and that regulation on this issue should be enforced and updated, taking into consideration specific linguistic and spelling codes.

Resumo Entre outros requisitos regulatórios, o nome dos medicamentos de marca deve ser composto por um único nome e não integrar abreviaturas para evitar erros de medicação. Os objetivos do estudo foram: investigar a adequação de um grupo de nomes de medicamentos de marca portugueses à regulação farmacêutica do mesmo País; identificar as suas características linguísticas básicas e comparar essas características e a sua frequência com valores de referência da língua corrente ou informal. Foi selecionada uma amostra de 474 nomes. Os nomes foram analisados com recurso a métodos manuais (análise visual) e automáticos (FreP - Frequency Patterns of Phonological Objects in Portuguese e o MS word). Um número significativo de nomes (61,3%) não estava em conformidade com o sistema fonológico (relacionado com a forma sonora das palavras) e ortográfico do Português (relacionado com a forma de escrita das palavras), tinha mais de uma palavra, continha uma alta proporção padrões silábicos e acentuais raros, e incluía abreviaturas. Os resultados sugerem que alguns dos nomes das marcas medicamentos portugueses devem ser reavaliadas e os aspetos regulatórios atualizados, tendo em consideração as características específicas do sistema linguístico e ortográfico português.

Abstract Among other regulatory requirements, medicine brands should be composed of single names without abbreviations to prevent errors in prescription of medication. The purposes of the study were to investigate the compliance of a sam ple of Portuguese medicine brand names with Portuguese pharmaceutical regulations. This includes identifying their basic linguistic characteristics and comparing these features and their frequency of occurrence with benchmark values of the colloquial or informal language. A sample of 474 brand names was selected. Names were analyzed using manual (visual analyses) and computer methods (FreP - Frequency Patterns of Phonological Objects in Portuguese and MS word). A significant number of names (61.3%) failed to comply with the Portuguese phonologic system (related to the sound of words) and/or the spelling system (related to the written form of words) contained more than one word, comprised a high proportion of infrequent syllable types or stress patterns and included abbreviations. The results suggest that some of the brand names of Portuguese medication should be reevaluated, and that regulation on this issue should be enforced and updated, taking into consideration specific linguistic and spelling codes.

Urban mobility problems affects the vast majority of cities nowadays. Thus, systems that provide real time information to assist in planning routes and choosing the most appropriate paths are essential to make transport more effective. As an alternative solution to problems related to mobility in cities, there are the so-called Intelligent Transportation Systems (ITS) which include the Route Recommendation Systems (RRS) and methodologies for congestion prediction that combine Information and Communication Technology (ICT) with Artificial Intelligence (AI) technology to improve the quality of transport systems. In this context, this work proposes the use of pheromone-based communication for building an ITS that offers information about real time traffic flow, taking into account the mobility of vehicles and passengers and the traffic dynamics. The general goal is to provide an Android solution able to suggest users routes calculated by the hybrid algorithm between A* and pheromone mechanism. The idea is to avoid areas of heavy traffic congestion.

CONTEXTO E OBJETIVO: As bulas dos medicamentos são necessárias para a sua utilização segura. Os objetivos do presente estudo foram: 1) avaliar a adequação entre o conteúdo das bulas e as especificações da regulação farmacêutica e 2) identificar os aspectos que potencialmente possam comprometer a utilização segura dos medicamentos pelos doentes.TIPO DE ESTUDO E LOCAL: Estudo descritivo qualitativo com a inclusão de todas as bulas dos medicamentos de marca dos três grupos terapêuticos mais consumidos em Portugal, analisados no Departamento de Farmacoepidemiologia da Faculdade de Farmácia da Universidade de Lisboa.MÉTODOS: Utilização de uma checklist para recolher os dados. A checklistfoi validada por um processo de consenso entre peritos. O conteúdo de cada uma das bulas da amostra foi classificado em relação à adequação aos aspectos regulatórios obrigatórios, como a descrição das reações adversas, dose e frequência de administração, e à adequação dos aspectos regulatórios facultativos, como a frequência das reações adversas e sintomas e procedimentos em caso de sobredosagem.RESULTADOS: Foram identificadas 651 bulas. Em termos gerais, todas as bulas foram consideradas conformes em relação aos aspectos regulatórios obrigatórios. No entanto, os aspectos regulatórios opcionais foram descritos em apenas cerca de metade da amostra de bulas, o que permite a identificação de situações susceptíveis de comprometer a utilização segura dos medicamentos.CONCLUSÃO: Idealmente as metodologias de aprovação das bulas devem ser revistas e otimizadas de forma a assegurar um mínimo de informação essencial para a utilização segura dos medicamentos.

CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients.DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon.METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose).RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety.CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.

BACKGROUND: Leprosy and HIV are diseases that have a major impact on public health in Brazil. Patients coinfected with both diseases, appear to be at higher risk to develop leprosy reactions. OBJECTIVE: The aim of this study is to describe the histopathological aspects of cutaneous lesions during reactional states in a group of patients with HIV-leprosy coinfection, compared to patients with leprosy, without coinfection. METHODS: Two groups were established: group 1 comprised of 40 patients coinfected with HIV-leprosy; group 2, comprised of 107 patients with leprosy only. Patients presenting reactional states of leprosy had their lesions biopsied and comparatively evaluated. RESULTS: Reversal reaction was the most frequent feature in both groups, with dermis edema as the most common histopathological finding. Giant cells were seen in all group 1 histopathological examinations. Dermis edema was the most common finding in patients with erythema nodosum leprosum. CONCLUSION: Few histopathological differences were found in both groups, with reversal reaction as the most significant one, although this fact should be analyzed considering the predominant BT clinical form in the coinfected group and BB form in the group without HIV. Larger prospective studies in patients with HIV-leprosy coinfection are needed to confirm and broaden these results.

OBJECTIVO Analisar a literatura sobre legibilidade das bulas dos medicamentos para uso humano.MÉTODOS Estudo de revisão sistemática, utilizando as palavras-chave “Readability and Package Leaflet” e “Readability and Package Insert”e a ferramenta de busca académica b-on, que contém diferentes bases bibliográficas. O período analisado foi entre 2008 e 2013. Foram aplicados os critérios PRISMA para redigir o relatório da revisão. Foram incluídos artigos originais de pesquisa quantitativa ou qualitativa. Os critérios de exclusão foram: artigos de opinião ou de revisão, ou escritos numa língua diferente do inglês, português, italiano, francês ou espanhol.RESULTADOS Foram identificados 202 trabalhos, dos quais 180 foram excluídos e 22 selecionados para análise: dois com profissionais de saúde, 10 com pacientes, três sobre reações adversas e sete descritivos. As bulas apresentaram diversos problemas de legibilidade, entre os quais: textos insuficientemente claros e simples, utilização de tamanhos de letra pequenos e número reduzido de ilustrações. Os principais métodos utilizados para avaliar a legibilidade das bulas foram as fórmulas e os testes de legibilidade/usabilidade. Entre as limitações metodológicas, foram identificados aspetos como o recurso a amostras pequenas, a inexistência de fórmulas de legibilidade específicas para a língua em causa, e.g., português, e a realização de testes de compreensão em grupos de pacientes sem avaliação prévia da literacia, dos conhecimentos específicos na área da saúde, das capacidades cognitivas, ou do grau de satisfação dos participantes.CONCLUSÕES Em geral, as bulas apresentaram diversos problemas de legibilidade. Adicionalmente, nesta revisão foram identificadas algumas limitações metodológicas nos estudos revistos (e.g. a participação de um número reduzido de pacientes e profissionais de saúde, a ausência da avaliação prévia da literacia, do humor ou satisfação dos participantes ou o predomínio de estudos não baseados em encenações sobre o uso de medicamentos) que deverão ser consideradas na apreciação dos resultados e contornadas em estudos futuros.

OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use.METHODS We conducted a systematic literature review between 2008 and 2013 using the keywords “Readability and Package Leaflet” and “Readability and Package Insert” in the academic search engine Biblioteca do Conhecimento Online,comprising different bibliographic resources/databases. The preferred reporting items for systematic reviews and meta-analyses criteria were applied to prepare the draft of the report. Quantitative and qualitative original studies were included. Opinion or review studies not written in English, Portuguese, Italian, French, or Spanish were excluded.RESULTS We identified 202 studies, of which 180 were excluded and 22 were enrolled [two enrolling healthcare professionals, 10 enrolling other type of participants (including patients), three focused on adverse reactions, and 7 descriptive studies]. The package leaflets presented various readability problems, such as complex and difficult to understand texts, small font size, or few illustrations. The main methods to assess the readability of the package leaflet were usability tests or legibility formulae. Limitations with these methods included reduced number of participants; lack of readability formulas specifically validated for specific languages (e.g., Portuguese); and absence of an assessment on patients literacy, health knowledge, cognitive skills, levels of satisfaction, and opinions.CONCLUSIONS Overall, the package leaflets presented various readability problems. In this review, some methodological limitations were identified, including the participation of a limited number of patients and healthcare professionals, the absence of prior assessments of participant literacy, humor or sense of satisfaction, or the predominance of studies not based on role-plays about the use of medicines. These limitations should be avoided in future studies and be considered when interpreting the results.