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Sífilis é uma infecção sexualmente transmissível (IST) que sinaliza a necessidade de efetivas políticas públicas devido ao aumento de casos na última década. Dessa forma, o objetivo do trabalho é descrever a incidência de sífilis no estado do Rio de Janeiro e no município de Seropédica. Métodos: foi realizado um estudo descritivo, com abordagem quantitativa. A coleta dos dados foi realizada por meio do Sistema de Informação de Agravos de Notificação (Sinan), referentes ao município de Seropédica e ao estado do Rio de Janeiro, no período de 2010 a 2022. Resultados: foram identificados 105.138, 79.609 e 42.819 casos de sífilis adquirida, em gestantes e congênita, respectivamente, no estado do Rio de Janeiro e 187, 140 e 79 casos de sífilis adquirida, em gestantes e congênita, respectivamente, no município de Seropédica. Foi observado uma incidência maior para sífilis adquirida entre homens em comparação com mulheres tanto no estado do Rio de Janeiro (62.719 versus 42.346) quanto no município de Seropédica (110 versus 77). Houve um aumento nas taxas de incidência de sífilis no estado do Rio de Janeiro e no município de Seropédica ao longo dos anos. Conclusão: a sífilis segue sendo uma doença com alta incidência no território do Rio de Janeiro. Nesse sentido, é importante elaborar estratégias em saúde pública mais efetivas às pessoas acometidas por tal infecção.

Syphilis is a sexually transmitted infection (STI) that signals the need for effective public policies due to the increase in cases in the last decade. Thus, the aim of this study is to describe the incidence of syphilis in the state of Rio de Janeiro and in the municipality of Seropédica. Methods: a descriptive study with a quantitative approach was carried out. Data collection was performed through the Sistema de Informação de Agravos de Notificação (Sinan), referring to the municipality of Seropédica and the state of Rio de Janeiro, from 2010 to 2022. Results: overall, 105.138, 79.609 and 42.819 cases of acquired syphilis, in pregnant women, and congenital syphilis, respectively, were identified in the state of Rio de Janeiro, and 187, 140, and 79 cases of acquired syphilis, in pregnant women, and congenital syphilis, respectively, were identified in the municipality of Seropédica. A higher incidence of acquired syphilis was observed among men compared to women both in the state of Rio de Janeiro (62.719 versus 42.346) and in the municipality of Seropédica (110 versus 77). There has been an increase in the incidence rates of syphilis in the state of Rio de Janeiro and the municipality of Seropédica over the years. Conclusion: syphilis continues to be a disease with a high incidence in the territory of Rio de Janeiro. In this sense, it is important to develop more effective public health strategies for people affected by this infection.

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O aplicativo móvel CalcVAN foi desenvolvido para auxiliar os profissionais de saúde para otimizar as doses de vancomicina em pacientes hospitalizados. Porém, é imprescindível avaliar a sua usabilidade antes de disponibilizá-lo para prática clínica. Assim, o objetivo do estudo é avaliar a usabilidade do aplicativo móvel na perspectiva dos profissionais de saúde. Trata-se de um estudo descritivo, de avaliação heurística da usabilidade de um aplicativo móvel. Foram convidados profissionais da área de saúde com expertise no tema de gerenciamento de antimicrobianos e vancomicina. O instrumento validado Smartphone Usability questionnaiRE (SURE) foi utilizado para mensuração da usabilidade por meio de um questionário on-line. Vinte e um especialistas participaram do estudo, com média de idade de 32,6 anos, sendo a maioria de mulheres (n = 14, 66,7%), profissionais farmacêuticos (n = 13, 61,9%), com pós-graduação lato sensu (n = 10, 47,6%), que trabalhavam em hospitais públicos ou privados (n = 15, 71,4%) e com média de experiência em 9,7 anos. Com base na interpretação dos resultados obtidos pelo instrumento SURE, a média de usabilidade geral do CalcVAN foi de 83 pontos, com escore menor de 78 e maior de 90 pontos. O teste de usabilidade foi enquadrado nos dois últimos níveis, 70 e 80, onde os profissionais de saúde passaram a concordar fortemente e totalmente, indicando que o aplicativo móvel apresenta uma usabilidade satisfatória. O CalcVAN atingiu uma usabilidade satisfatória e atende as necessidades e exigências dos profissionais de saúde, mostrando--se eficiente para realizar as funções propostas.

The CalcVAN app was developed to assist healthcare professionals in optimizing vancomycin doses for hospitalized patients. However, the usability test before making it available for clinical practice is essential. Therefore, the study aims to evaluate the usability of the app from the perspective of health professionals. A descriptive study, a heuristic evaluation of the usability of a mobile application was conducted. Healthcare professionals with expertise in antimicrobial management and vancomycin were invited to participate. The validated Smartphone Usability questionnaiRE (SURE) was used to measure usability through an online questionnaire. Twenty-one experts participated in the study, with a mean age of 32.6 years, mostly of them women (n = 14, 66.7%), pharmacists (n = 13, 61.9%), with postgraduate education (n = 10, 47.6%), working in private or public hospitals (n = 15, 71.4%), and a mean experience of 9.7 years. Overall usability score for CalcVAN was 83 points, ranging from a minimum of 78 to a maximum of 90 points. The usability test registered within the last two levels, 70 and 80, with users expressing strongly and fully agreed, indicating that the app demonstrates satisfactory usability. CalcVAN achieved satisfactory usability, fulfilling the needs and requirements of health professionals, proving to be efficient in performing the intended functions.

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BACKGROUND: Treating multiple myeloma is complex, and providing supportive care through an interdisciplinary approach is essential. AIM: To report and synthesize pharmacists' clinical activities and impact on the care of patients with multiple myeloma. METHOD: This was a scoping review that followed the PRISMA-ScR reporting recommendations. A search was conducted in PubMed, Embase, Web of Science, Scopus, and LILACS from the inception of the database until January 10th, 2024. Papers that reported pharmacists' clinical activities in the care of patients with multiple myeloma were included. Descriptive Elements of Pharmacist Intervention Characterization Tool (DEPICT) version 2 was used to characterize the pharmacists' clinical activities. The results are presented as a narrative and tabular synthesis. RESULTS: A total of 2885 records were identified, 10 of which met the inclusion criteria. Pharmacists' clinical activities related to 'direct patient care' (n = 8) and 'medication counseling, education, and training' (n = 7) were the most cited. Most were provided for patients (n = 8), by one-on-one contact (n = 9), and through face-to-face communication method (n = 8), with patient counseling being the main action taken by pharmacists (n = 7). Materials that supported pharmacists' actions were cited in five studies. Integrating pharmacists into interdisciplinary teams led to improved process, clinical, humanistic, and economic outcomes. CONCLUSION: This scoping review emphasizes pharmacists' clinical activities in improving the care of patients with multiple myeloma. There is a need to develop studies with patient-reported outcomes and comprehensive reporting of pharmacists' clinical activities to ensure reproducibility and effective implementation in clinical practice.

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Access to drugs for rare diseases constitutes a challenge to healthcare systems, especially those with public funding. This study aimed to map and summarize the criteria used by HTA agencies in different healthcare systems to evaluate reimbursement recommendations for orphan drugs. A comprehensive literature search was performed on the databases PubMed, LILACS, Scopus, and Embase and the gray literature (Google Scholar and websites of HTA agencies). Publications addressing the criteria used by HTA agencies in countries with public healthcare systems when evaluating reimbursement recommendations for orphan drugs were included. This scoping review included 23 studies published between 2014 and 2023, mostly consisting of reviews of HTA reports, guidance documents, and original articles. The criteria were mapped from 19 countries and ranked within three models of healthcare systems (National Health System, National Health Insurance, and Social Health Insurance). All models shared concerns about unmet needs and disease nature. In addition, NHS countries (e.g., United Kingdom, Sweden, and Italy) prioritized innovation and system-level impact, while SHI countries (e.g., Germany, France, the Netherlands) usually valued budget impact and employed expedited evaluation processes. This review provides a comprehensive understanding of the general tendencies of each healthcare system model in establishing differentiated criteria to address the challenges posed by the limited evidence and investment in the field of rare diseases.

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Background: Key performance indicators (KPIs) are a set of indicators that improve the quality of services provided by pharmacists. They enable the monitoring and evaluation of result progress and optimize decision-making for stakeholders. Currently, there is no systematic review regarding KPIs for pharmaceutical services. Objectives: To identify and assess the quality of KPIs developed for pharmaceutical services. Methods: A systematic review was conducted in PubMed, Scopus, EMBASE, and LILACS from the inception of the database until February 5th, 2024. Studies that developed a set of KPIs for pharmaceutical services were included. The indicators were evaluated using the Appraisal of Indicators through Research and Evaluation (AIRE) instrument. Two independent reviewers performed the study selection, data extraction, and quality assessment. Results: Fifteen studies were included. The studies were conducted in different regions, most of which were developed for clinical services in hospitals or ambulatory settings, and used similar domains for the development of KPIs such as medication review, patient safety, and patient counseling. Literature review combined with the Delphi technique was the method most used by the studies, with content validity by inter-rater agreement. Regarding methodological quality, most studies described information on the purpose, definition, and stakeholders' involvement in the set of KPIs. However, little information was observed on the strategy for risk adjustment, instructions for presenting and interpreting the indicator results, the detailed description of the numerator and denominator, evidence scientific, and the feasibility of the set of KPIs. Only one study achieved a high methodological quality in all domains of the AIRE tool. Conclusion: Our findings showed the potential of KPIs to monitor and assess pharmacy practice quality. Future studies should expand KPIs for other settings, explore validity evidence of the existing KPIs, provide detailed descriptions of evidence, formulation, and usage, and test their feasibility in daily practice.

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Background: Stakeholders and healthcare professionals have an essential role in the elimination of Hansen's Disease. Of these, pharmacists provide core services that assist the management of these patients with the supply of medicines and clinical actions. Objectives: To summarize evidence on the role of pharmacist in the management of Hansen's Disease. Methods: A literature search was performed in MEDLINE, Embase, Scopus, Web of Sciences, LILACS, and Google Scholar for studies published until September 29th, 2022 without language restriction. Studies that reported actions provided by pharmacists in the management of patients with Hansen's Disease were included. The pharmacist interventions identified in the studies were described based on key domains in DEPICT v.2. Two independent reviewers performed study selection and data extraction and any disagreements were resolved by third and fourth authors. Results: A total of 751 records were identified, of which 8 studies fully met the eligibility criteria. Most of them were conducted in Brazil (n = 5), in an ambulatory setting (n = 8) and the most common study design was descriptive cross-sectional (n = 6). Different roles of pharmacists were identified, such as medication review, therapeutic drug monitoring, patient education, drug information, and dispensing. All studies described pharmacist interventions for patients through one-on-one contact and face-to-face. Pharmacists were responsible for patient counseling (n = 8), suggestions for change in therapy (n = 2), and monitoring results report (n = 2). The studies reported benefits associated with pharmacist interventions, despite the limited descriptions regarding these actions. Conclusions: Few studies that described the activities of pharmacists in the management of Hansen's Disease were found. As the studies did not offer a satisfactory level of description and quality, further research should be conducted to strengthen this field.

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Global healthcare systems, including the National Health System in Brazil - one of the largest public models in the world -, continue to evolve, as well as populations' health needs, currently shaped on individuals feeling a greater desire to manage their own health. Self-care practices are part of several public policies and clinical guidelines in Brazil including the National Policy on Complementary and Integrative Practices, the National AIDS Control Program, the National Policy for Women's Health, and the Guidelines for Care of People with Chronic Diseases. There are over 100,700 community pharmacies, in the country (89.2% privately owned) employing 234,300 pharmacists, representing an important delivery point for self-care, as they are the first point of access to care for most patients. Self-medication is a common practice in Brazil (prevalence rates of self-medication ranging from 16.1% to 35.0%), especially with non-prescription/over-the-counter medicinal products (65.0%). In fact, these products represent over 25% of volume marketed of medicines, summing revenues of USD 1.9 billion per year. Studies demonstrated a positive budget impact as important savings for the National Health System due to reductions of unnecessary medical appointments and loss of working days. In addition to minor ailments management, other self-care services provided by community pharmacies that are frequently sought by Brazilian citizens (20-25% of cases) are smoking cessation and weight management (costs per service ranging from around USD 5.00-12.00). However, pharmacy services are not yet as fully integrated in Brazil to the same extent as in other countries. Barriers such as standardization of processes (from services' design, implementation, and evaluation in practice), pharmacist remuneration for the provision of services and the amount to be charged for the service are still a matter of controversy. For more rapid and sustainable advances in these practices, communication among various stakeholders, professional practice and healthcare regulations, standardization of services and financing of self-care (both publicly and privately) are urgently needed. This paper provides an overview of some self-care services provided by community pharmacies in Brazil and call attention to the ongoing challenges to move the National Health system forward.

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OBJECTIVE: To identify and evaluate the quality of mobile apps available in Brazil focused on the care of patients with anxiety disorders. METHODS: A comprehensive search was conducted until October 2021 on Play Store (Android) and Apple Store (iOS) in Brazil, using the terms "anxiety," "phobia," "panic attack," and "social phobia." Two independent authors identified the apps and performed data extraction and quality assessment using the Mobile App Rating Scale (MARS). Pearson's correlation was used to analyze the relationship between user star rating and the quality defined by the MARS instrument. RESULTS: A total of 3,278 potential apps were identified, of which 71 fully met the eligibility criteria. Most apps were made available on the Play Store (91.74%), in English (69.01%), and updated in the last two years (90.14%). Approximately half of the apps (50.70%) did not inform the developer's country and most of them did not report the user star rating (70.42%). The target population was indicated as free by most apps (85.92%), with generalized anxiety disorder being the most addressed disorder (74.65%), followed by panic disorder (33.80%). The three main purposes of the apps were education (83.10%), self-assessment (38.03%), and meditation/breathing (32.39%). Only 31 apps (43.66%) had acceptable quality (above 3.0) and the average total MARS quality score of 2.93 (2.20 to 3.90), with the functionality section receiving the highest score (3.90) and the lowest scoring sections being engagement (2.16). The apps that were rated stars by users (29.58%) showed a negative Pearson correlation (ρ = -0.100), evidencing a difference in the user's evaluation and that performed using the MARS instrument. CONCLUSION: Gaps in the quality of apps focused on the care of patients with anxiety disorders were evidenced since most were classified as having low quality through the MARS instrument. Thus, users are recommended to use these apps with caution.

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BACKGROUND: Recent studies on editorial team members of healthcare journals have been showing disparities in this distribution. However, there are limited data with respect to pharmacy journals. Thus, the aim of this study was to investigate the distribution of women among editorial board members of social, clinical, and educational pharmacy research journals around the globe. METHODS: A cross-sectional study was conducted between September and October 2022. Data were extracted from Scimago Journal & Country Rank and Clarivate Analytics Web of Science Journal Citation Reports The top 10 journals in each region of the world (continents) were analyzed. Editorial board members were categorized into four groups and determined based on information available on the journal's website. The sex was classified in binary form through name and photography, the personal and institutional web pages, or the Genderize program. RESULTS: A total of 45 journals were identified in the databases, of which 42 of them were analyzed. We identified 1482 editorial board members with only 527 (35.6%) being female. Analyzing the subgroups, there were 47 total editors-in-chief, 44 total co-editors, 272 associate editors, and 1119 editorial advisors. Of these, 10 (21.27%), 21 (47.72%), 115 (42.27%), and 381 (34.04%) were female, respectively. Only 9 journals (21.42%) presented more females among their editorial board members. CONCLUSION: A notable sex disparity among social, clinical, and educational pharmacy journals' editorial board members was identified. Efforts should be made to involve more female sex in their editorial teams.

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BACKGROUND: The clinical pharmacist is an essential member of the healthcare team and plays an important role in health care in the primary care and the hospital setting. Knowledge regarding the instruments that evaluate the different activities of the clinical pharmacist, as well as the evaluation of the psychometric properties of these instruments, is necessary. METHODS: A literature search was performed in the PubMed and Scopus electronic databases without time and language restrictions. For the search strategy, the "pharmaceutical services," "validity studies," and "professional performance" domains were used. To assess the quality of the instruments, the five sources of validity evidence of contemporary psychometry were used, and the Joanna Briggs Institute's standardized instrument was used to assess the methodological quality of the studies. After screening 4096 articles, 32 studies were selected. RESULTS: A total of 32 studies were included, and 32 instruments were identified to be used by pharmacists acting in various pharmaceutical practice scenarios. It was found that the available instruments were developed or adapted from others, with variation in the methods, constructs, dimensions, and domains, as well as the psychometric properties. Most of the instruments addressed community pharmacies, and evidence of content validity and internal structure was found most frequently. A standardized and validated instrument that comprehensively assessed the performance of the clinical pharmacist, addressing clinical activities, was not identified for all practice environments. CONCLUSIONS: Without standardized and validated instruments specifics to assess the performance of the clinical pharmacist, it is hard to establish the main clinical activities performed by pharmacists in their pharmaceutical practice environments and to propose training actions to improve professional practice. Despite the large number of instruments available and considered validated by the authors, it is questioned to what extent the validity indicators presented in the different studies really show the validation status. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD 42018099912.

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Cannabis is used in the treatment of several human conditions; however, its use is still less explored in veterinary medicine. This systematic review aims to summarize the evidence of efficacy and safety of the use of cannabis for the treatment of animal disease. A literature search was performed for studies published until 16 March 2021 in five databases. Randomized clinical trials (RCTs) that reported the efficacy or safety of cannabis in the treatment of animal disease were included. The RoB 2 Tool was used to assess the risk of bias. A total of 2427 records were identified, of which six studies fully met the eligibility criteria. RCTs were conducted in dogs with osteoarthritis (n = 4), with epilepsy (n = 1), and with behavioral disorders (n = 1). All studies used cannabidiol (CBD) oil in monotherapy or in combination with other drugs. Studies used CBD at 2 or 2.5 mg kg-1 twice daily (n = 4), orally (n = 5), during 4 or 6 weeks (n = 3), and compared CBD with placebo (n = 5). CBD significantly reduced pain and increased activity in dogs with osteoarthritis (n = 3). Moreover, CBD significantly reduced the frequency of seizures in dogs with epilepsy (n = 1) and the aggressive behavior of dogs (n = 1). Although promising results were identified, studies were heterogeneous and presented risks of bias that required caution in the interpretation of findings. Therefore, there was some evidence to support the use of CBD in dogs with osteoarthritis to reduce pain and increased activity, but limited evidence against epilepsy and behavioral problems. In addition, CBD was well tolerated with mild adverse effects. More RCTs with high quality of evidence are needed, including greater numbers of animal subjects, additional species, and clear readout measures to confirm these findings.

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Background: Mobile applications (app) provide many benefits for healthcare professionals, making them a useful support clinical decision system. Objectives: To describe the development of a mobile app, CalcVAN, to calculate vancomycin dosage regimens for adult and pediatric patients. Methods: This study is a technological production research to develop a mobile app through the rapid prototyping type for the Android system in the Brazilian context. The mobile app structure was developed in four steps: 1) conception, including the needs assessment, the target audience, the literature search, and the definition of contents; 2) prototype planning, including the definition of topics and writing of modules, the selection of media, and the layout; 3) production of the mobile app, including the selection of multimedia tools, the navigation structure, and planning of environment configuration; and 4) make the mobile app available. Results: The CalcVAN has six screens, containing the vancomycin dosing calculator for adult and pediatric patients based on weight and estimated creatinine clearance parameters. Moreover, the mobile app is free and can be used without internet connection. Conclusions: A free mobile app was developed to calculate vancomycin dosage regimens for inpatients. This tool assists to optimize the vancomycin dosing, contributing to the antimicrobial stewardship.

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The evaluation of the National School Food Program (PNAE) is a strategic action to ensure the quality of management. This study aims to develop and validate an instrument of performance indicators to assess the management of the PNAE in the national context. A psychometric study was carried out for the development and validation of performance indicators. Twelve indicators were subsequently established and evaluated by an expert panel concerning seven attributes. The Delphi technique was used for the consensus of the expert panel, and the content validity of the indicators was analyzed with the Content Validity Ratio. Nutritionists working on the implementation of the PNAE assessed the relevance of the indicators by answering an online questionnaire to construct validity and reliability. Thirteen (43.3%, 13/30) experts participated in the Delphi round 1 and nine (69.2%, 9/13) completed the Delphi round 2. A new indicator was developed after the experts' suggestions. Furthermore, 281 nutritionists participated in this study assessing the relevance of the indicators. Overall, content and construct validity were achieved for 13 indicators. All were considered relevant and had the potential to promote the assessment of PNAE operational management.

A avaliação do Programa Nacional de Alimentação Escolar (PNAE) é ação estratégica para garantir a qualidade da gestão. O objetivo deste estudo é desenvolver e validar um instrumento de indicadores de desempenho para avaliação da gestão do PNAE no contexto nacional. Trata-se de um estudo psicométrico de construção e validação de indicadores de desempenho. Foram estabelecidos 12 indicadores, posteriormente, avaliados em painel de especialistas em relação a sete atributos. Para obter consenso foi utilizada a técnica Delphi e a validade de conteúdo foi analisada com a Razão de Validade de Conteúdo. Para a validade de constructo e confiabilidade, nutricionistas que trabalham na execução do PNAE avaliaram a relevância dos indicadores respondendo um questionário online. A taxa de resposta dos especialistas na primeira rodada da técnica Delphi foi de 43,3% (13/30) e de 69,2% (9/13) na segunda rodada. Um novo indicador foi desenvolvido após a avaliação do painel de especialistas. Um total de 281 nutricionistas participaram do estudo da relevância dos indicadores. No geral, a validade de conteúdo e constructo foi alcançada para 13 indicadores. Todos os 13 indicadores se apresentaram relevantes, com potencial para promover a avaliação da gestão operacional do PNAE.

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OBJECTIVE: We conducted this scoping review to map and summarize scientific evidence on the role of clinical pharmacists in the palliative care of adults and elderly patients with cancer. DATA SOURCES: A literature search was performed in MEDLINE, PubMed Central, Embase, Web of Science, Scopus, and BVS/BIREME for studies published until November 22nd, 2020. Studies that reported work experiences adopted by clinical pharmacists in the palliative care of adults and elderly patients with cancer were included. Two independent authors performed study selection and data extraction. Any disagreements were resolved by discussion with the third and fourth authors. The pharmacist interventions identified in the included studies were described based on key domains in the DEPICT v.2. DATA SUMMARY: A total of 586 records were identified, of which 14 studies fully met the eligibility criteria. Most of them were conducted in the United States of America (n = 5) and Canada (n = 5) and described the workplace of the pharmacist in clinic/ambulatory (n = 10). Clinical pharmacists performed several activities and provided services, highlighting medication review (n = 12), patient and caregivers education (n = 12), medication histories and-or medication reconciliation (n = 6). The pharmacist interventions were mostly conducted for patients/caregivers (n = 13), by one-on-one contact (n = 14), and by face-to-face (n = 13). Pharmacists were responsible mainly for change or suggestion for change in therapy (n = 12) and patient counselling (n = 12). Pharmacist interventions were well accepted by the clinical team. Overall, studies showed that pharmacists, within an interdisciplinary team, had significant impacts on measured outcomes. CONCLUSIONS: In recent years, there have been advances in the role of the pharmacist in palliative care of patients with cancer and there are great opportunities in this field. They play an important role in managing cancer pain and other symptoms, as well as resolving drug related problems. We encourage more research to be carried out to strengthen this field and to benefit patients with advanced cancer with higher quality of life.

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Resumo A avaliação do Programa Nacional de Alimentação Escolar (PNAE) é ação estratégica para garantir a qualidade da gestão. O objetivo deste estudo é desenvolver e validar um instrumento de indicadores de desempenho para avaliação da gestão do PNAE no contexto nacional. Trata-se de um estudo psicométrico de construção e validação de indicadores de desempenho. Foram estabelecidos 12 indicadores, posteriormente, avaliados em painel de especialistas em relação a sete atributos. Para obter consenso foi utilizada a técnica Delphi e a validade de conteúdo foi analisada com a Razão de Validade de Conteúdo. Para a validade de constructo e confiabilidade, nutricionistas que trabalham na execução do PNAE avaliaram a relevância dos indicadores respondendo um questionário online. A taxa de resposta dos especialistas na primeira rodada da técnica Delphi foi de 43,3% (13/30) e de 69,2% (9/13) na segunda rodada. Um novo indicador foi desenvolvido após a avaliação do painel de especialistas. Um total de 281 nutricionistas participaram do estudo da relevância dos indicadores. No geral, a validade de conteúdo e constructo foi alcançada para 13 indicadores. Todos os 13 indicadores se apresentaram relevantes, com potencial para promover a avaliação da gestão operacional do PNAE.

Abstract The evaluation of the National School Food Program (PNAE) is a strategic action to ensure the quality of management. This study aims to develop and validate an instrument of performance indicators to assess the management of the PNAE in the national context. A psychometric study was carried out for the development and validation of performance indicators. Twelve indicators were subsequently established and evaluated by an expert panel concerning seven attributes. The Delphi technique was used for the consensus of the expert panel, and the content validity of the indicators was analyzed with the Content Validity Ratio. Nutritionists working on the implementation of the PNAE assessed the relevance of the indicators by answering an online questionnaire to construct validity and reliability. Thirteen (43.3%, 13/30) experts participated in the Delphi round 1 and nine (69.2%, 9/13) completed the Delphi round 2. A new indicator was developed after the experts' suggestions. Furthermore, 281 nutritionists participated in this study assessing the relevance of the indicators. Overall, content and construct validity were achieved for 13 indicators. All were considered relevant and had the potential to promote the assessment of PNAE operational management.

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PURPOSE: To summarize the evidence of efficacy and safety of the use of ketamine and esketamine for depression. METHODS: A literature search was performed in Medline, the Cochrane Library, LILACS, and CRD until November 2020. We included systematic reviews with meta-analyses of randomized controlled trials on the use of ketamine and esketamine in adult patients with depression. Two authors independently performed the study selection and data extraction. The AMSTAR-2 tool was used to appraise the quality of included reviews. RESULTS: A total of 118 records were identified, and 11 studies fully met the eligibility criteria. Compared to control, ketamine improved the clinical response at 40 min to 1 week and clinical remission at 80 min to 72 h, and esketamine improved both outcomes at 2 h to 4 weeks. Ketamine and esketamine also had a beneficial effect on the depression scales score and suicidality. For adverse events, oral ketamine did not show significant change compared to control, while intranasal esketamine showed difference for any events, such as dissociation, dizziness, hypoesthesia, and vertigo. Most reviews were classified as "critically low quality," and none of them declared the source of funding of the primary studies and assessed the potential impact of risk of bias in primary studies. CONCLUSION: Ketamine and esketamine showed a significant antidepressant action within a few hours or days after administration; however, the long-term efficacy and safety are lacking. In addition, the methodological quality of the reviews was usually critically low, which may indicate the need for higher quality evidence in relation to the theme.

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INTRODUCTION: Capecitabine is an oral anticancer drug which can cause some adverse reactions and the great challenge for its use is to ensure the medication adherence. The aim of this study was to analyze adverse reactions and adherence to capecitabine in patients with gastrointestinal cancer. METHODS: A prospective study was performed in a tertiary teaching hospital in Brazil. Outpatients undergoing capecitabine treatment for colorectal or gastric cancer were followed for three cycles of treatment. Patient demographic and clinical characteristics data were collected. Adverse reactions were analyzed using Common Terminology Criteria for Adverse Events (CTCAE) v.4. Adherence to capecitabine were evaluated using Morisky-Green and MedTake tests. Statistical analysis was conducted using Chi-square, Fisher's exact and McNemer tests. RESULTS: One hundred and four patients were enrolled in this study, with a mean age was 58.5 ± 10.9 years; 51.0% were men and 51.0% Caucasian. Nausea and diarrhea were the most frequently reported adverse reactions (82.7% and 62.5%, respectively), followed by vomiting (54.8%), fatigue (54.8%), and hand-foot syndrome (53.9%). Nausea and diarrhea were also the most severe adverse reactions. Most patients were adherent to capecitabine in all cycles of treatment using the Morisky-Green test. Adherence increased significantly between cycle 1 and cycle 2 by MedTake test (p < 0.001). Some demographic and clinical characteristics were associated with adverse reactions (e.g., age and nausea, gender and nausea and vomiting) and capecitabine adherence (e.g., marital status and educational level) as well as some adverse reactions were associated with capecitabine adherence (hand-foot syndrome and nausea). CONCLUSIONS: Clinical oncology pharmacists must provide patient information on the correct use of capecitabine, manage adverse reactions, and monitor adherence to treatment. Strategies to prevent non-adherence to capecitabine must be adopted to ensure the success of pharmacotherapy.

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This study aims to describe the profile for the requested incorporation of rare disease drugs submitted to CONITEC and its recommendations, comparing the incorporation criteria employed by other HTA agencies globally. To this end, requests for the treatment of rare diseases submitted to CONITEC from July 2012 to June 2019 and its recommendations to the Brazilian Unified Health System (SUS) were included in this study. Subsequently, we compared the criteria used by CONITEC and other HTA agencies to incorporate these drugs. Sixty medicine incorporation requests to treat thirty rare diseases were submitted to CONITEC. Pharmaceutical companies made the most requests (66%). Budget impact analyses were presented in 85% of the requests and HT economic analyses in 68%. A total of 52% of the requests were incorporated into the SUS. CONITEC's justifications for the non-incorporation were the lack of quality clinical evidence, non-cost-effective technologies, and modest clinical benefits that do not justify the high prices. International HTA agencies (CAN, UK, FR, AUS) use different criteria for rare diseases assessments. The data indicate that most of the evaluated drugs were incorporated into the SUS, and adopting different criteria to assess the incorporation of rare diseases medicines will possibly strengthen decision-making.

Descrever o perfil de solicitações de incorporação de medicamentos para doenças raras (DR) enviadas à Comissão Nacional de Incorporação de Tecnologias no SUS (CONITEC) e suas recomendações, comparando critérios usados para incorporação com outras agências de avaliações de tecnologias em saúde (ATS) no mundo. Para tanto, foram avaliadas as solicitações submetidas à CONITEC e suas recomendações ao SUS, de julho de 2012 a junho de 2019, para tratamento de DR. A seguir, foi feita comparação dos critérios utilizados pela CONITEC e por outras agências de ATS para incorporação destes medicamentos. Houve 60 solicitações de incorporação para 30 DR à CONITEC. A maioria das solicitações (66%) foi feita por indústrias farmacêuticas. Análises de impacto orçamentário foram apresentadas em 85% das solicitações e análises econômicas de tecnologias em saúde em 68% delas. Trinta e duas (52%) do total de avaliações foram incorporadas ao SUS. As justificativas da CONITEC para a não incorporação foram ausência de evidência clínica, tecnologias não custo-efetivas e modestos benefícios clínicos que não justificam o preço. Agências de ATS internacionais (UK, FR, CAN, AUS) usam critérios diferenciados para avaliações de DR. Os dados apontam que a maioria dos medicamentos avaliados foi incorporada ao SUS e que a adoção de critérios diferenciados para avaliação da incorporação de medicamentos para DR possivelmente trará robustez à tomada de decisão.

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RESUMO

Resumo Descrever o perfil de solicitações de incorporação de medicamentos para doenças raras (DR) enviadas à Comissão Nacional de Incorporação de Tecnologias no SUS (CONITEC) e suas recomendações, comparando critérios usados para incorporação com outras agências de avaliações de tecnologias em saúde (ATS) no mundo. Para tanto, foram avaliadas as solicitações submetidas à CONITEC e suas recomendações ao SUS, de julho de 2012 a junho de 2019, para tratamento de DR. A seguir, foi feita comparação dos critérios utilizados pela CONITEC e por outras agências de ATS para incorporação destes medicamentos. Houve 60 solicitações de incorporação para 30 DR à CONITEC. A maioria das solicitações (66%) foi feita por indústrias farmacêuticas. Análises de impacto orçamentário foram apresentadas em 85% das solicitações e análises econômicas de tecnologias em saúde em 68% delas. Trinta e duas (52%) do total de avaliações foram incorporadas ao SUS. As justificativas da CONITEC para a não incorporação foram ausência de evidência clínica, tecnologias não custo-efetivas e modestos benefícios clínicos que não justificam o preço. Agências de ATS internacionais (UK, FR, CAN, AUS) usam critérios diferenciados para avaliações de DR. Os dados apontam que a maioria dos medicamentos avaliados foi incorporada ao SUS e que a adoção de critérios diferenciados para avaliação da incorporação de medicamentos para DR possivelmente trará robustez à tomada de decisão.

Abstract This study aims to describe the profile for the requested incorporation of rare disease drugs submitted to CONITEC and its recommendations, comparing the incorporation criteria employed by other HTA agencies globally. To this end, requests for the treatment of rare diseases submitted to CONITEC from July 2012 to June 2019 and its recommendations to the Brazilian Unified Health System (SUS) were included in this study. Subsequently, we compared the criteria used by CONITEC and other HTA agencies to incorporate these drugs. Sixty medicine incorporation requests to treat thirty rare diseases were submitted to CONITEC. Pharmaceutical companies made the most requests (66%). Budget impact analyses were presented in 85% of the requests and HT economic analyses in 68%. A total of 52% of the requests were incorporated into the SUS. CONITEC's justifications for the non-incorporation were the lack of quality clinical evidence, non-cost-effective technologies, and modest clinical benefits that do not justify the high prices. International HTA agencies (CAN, UK, FR, AUS) use different criteria for rare diseases assessments. The data indicate that most of the evaluated drugs were incorporated into the SUS, and adopting different criteria to assess the incorporation of rare diseases medicines will possibly strengthen decision-making.

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RESUMO

BACKGROUND: Culinary skills are important objects of study in the field of Public Health. Studies that propose to develop instruments for assessing such construct show lack of methodological uniformity to report validity and reliability of their instruments. OBJECTIVE: To identify studies that have developed instruments to measure culinary skills in adult population, and critically assess their psychometric properties. DESIGN: We conducted a systematic review according to the PRISMA statement. We searched literature PubMed/Medline, Scopus, LILACS, and Web of Science databases until January 2021, and consulted Google Scholar for relevant grey literature. Two reviewers independently selected the studies, conducted data extraction, and assessed the psychometric quality of the instruments. A third reviewer resolved any doubts or disagreements in all steps of the systematic review. RESULTS: The search identified 1148 potentially relevant studies, out of which 9 met the inclusion criteria. In addition, we included 3 studies by searching the related articles and the reference lists of these studies, totaling 12 included studies in this review. Ten studies reported the development of tools measuring culinary skills in adults and 2 studies performed cross-cultural adaptations of original instruments. We considered adequate quality of internal consistency reliability in four studies. One study received adequate rating for test-retest reliability. No studies presented adequate rating for content validity and four studies showed satisfactory results for at least one type of construct validity. One study reported criterion validity and the quality of this psychometric property was inadequate. CONCLUSIONS: We identified many studies that surveyed culinary skills. Although the isolated measures appraised in this review show good promise in terms of quality of psychometric properties, no studies presented adequate measures for each aspect of reliability and validity. A more consistent and consensual definition of culinary skills is recommended. The flaws observed in these studies show that there is a need for ongoing research in the area of the psychometric properties of instruments assessing culinary skills.

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