ABSTRACT OBJECTIVE To show the implementation process of IPT-G in primary care, including facilitating and obstructing factors, implementation strategies, and training and supervision of primary care professionals. METHODS Quantitative (cross-sectional and longitudinal) analysis of pre and post-knowledge tests; qualitative analyses of the training courses; patient recruitment; conduction of IPT-G sessions; supervision of IPT-G therapists; application of a semi-structured questionnaire to assess, investigate, and develop strategies against the identified barriers. RESULTS About 120 clinicians answered the pre-test; 84 completed the post-test. Pre- and post-test scores of IPT-G knowledge were significantly different. Twenty initially trained clinicians completed additional supervision in IPT-G. Qualitative analysis identified twelve barriers and six facilitators to IPT-G implementation in individual, organizational, and systemic contexts. CONCLUSIONS Implementation of IPT-G in primary care is a complex process with several steps. In the first step, health professionals were successfully trained in IPT-G. However, subsequent steps were more complex. Therefore, careful planning of IPT-G implementation is essential to maximize the success of this innovation.

ABSTRACT OBJECTIVE To show the implementation process of IPT-G in primary care, including facilitating and obstructing factors, implementation strategies, and training and supervision of primary care professionals. METHODS Quantitative (cross-sectional and longitudinal) analysis of pre and post-knowledge tests; qualitative analyses of the training courses; patient recruitment; conduction of IPT-G sessions; supervision of IPT-G therapists; application of a semi-structured questionnaire to assess, investigate, and develop strategies against the identified barriers. RESULTS About 120 clinicians answered the pre-test; 84 completed the post-test. Pre- and post-test scores of IPT-G knowledge were significantly different. Twenty initially trained clinicians completed additional supervision in IPT-G. Qualitative analysis identified twelve barriers and six facilitators to IPT-G implementation in individual, organizational, and systemic contexts. CONCLUSIONS Implementation of IPT-G in primary care is a complex process with several steps. In the first step, health professionals were successfully trained in IPT-G. However, subsequent steps were more complex. Therefore, careful planning of IPT-G implementation is essential to maximize the success of this innovation.

Objective: The Sydney Melancholia Prototype Index (SMPI) is a scale that uses a non-conventional strategy to assess melancholia status based on prototypic symptoms and illness course variables. This study aimed to evaluate the performance of the first translation of this instrument in a non-English-speaking population. Methods: A sample comprising 106 Brazilian outpatients with depression was evaluated simultaneously with the Brazilian version of the self-rated SMPI (SMPI-SR) and clinician-rated SMPI (SMPI-CR). The kappa coefficient and t test were used to evaluate concurrent validity vs. DSM-IV, CORE system, Hamilton Depression Rating Scale-6 item (HAM-D6), and HAM-D17 assignments to a melancholic or non-melancholic class. The prevalence of melancholia as well as sensitivity and specificity were calculated across instruments. Results: The prevalence of melancholia was highest using DSM-IV criteria (56.6%). The kappa agreement between SMPI-CR and DSM-IV melancholia assignment was moderate (kappa 0.44, p ≤ 0.001). SMPI-CR-assigned melancholic patients had significantly higher CORE, HAM-D17, and HAM-D6 scores. The test-retest consistency values for the SMPI were modest at best, and somewhat superior for the CR version. Conclusion: The Brazilian SMPI-CR presented satisfactory psychometric properties (which were superior to those of the SMPI-SR), and therefore appears to be a useful option for identifying melancholia and studying its causes and optimal treatments.

Abstract Introduction Individuals with major depressive disorder (MDD) face more barriers to engagement in sports and exercise interventions. Evaluating clinical and demographic factors associated with adherence to sports and exercise among MDD outpatients could support development of new options and strategies to increase their participation. Methods In a cross-sectional study, 268 depressed outpatients were evaluated (83.51% females; mean age = 50.74 [standard deviation {SD} = 10.39]). Sports and exercise participation were assessed using a question about participation frequency during the previous month. Clinical and demographic factors were evaluated. Linear regression was used to identify predictors of participation in sports and exercise. Results MDD patients with mild symptoms of depression (odds ratio [OR] = 2.42; 95% confidence interval [95%CI] 1.00, 5.88; p = 0.04) and patients with mild to moderate symptoms (OR = 3.96; 95%CI 1.41, 11.15; p = 0.009) were more likely to engage regularly in sports and exercise than patients with more severe depression. Moreover, smoking (OR = 0.23; 95%CI 0.67, 0.80; p = 0.007) and being divorced (OR = 0.22; 95%CI 0.57, 0.86; p = 0.03) were associated with lower rates of engagement in sports and exercise. Conclusion Our findings indicate a significant association between clinical and demographic factors and participation in sports and exercise among MDD outpatients.

Em março de 2020, a Organização Mundial da Saúde anunciou a nova pandemia denominada de COVID-19, representando um desafio para os profissionais e serviços de saúde. Ainda não foi identificado um tratamento eficaz contra essa doença e vários fármacos são utilizados sem evidências de sua eficácia, que em alguns casos pode causar eventos indesejados. Esse é um estudo transversal com o objetivo de avaliar as reações adversas a medicamentos (RAMs) nos pacientes com COVID-19, identificadas entre 1º de março e 15 agosto de 2020 no Brasil, e os fatores associados ao surgimento de reações graves. Para comparar as proporções das amostras relacionadas ao notificador, paciente, fármacos e eventos adversos utilizamos os testes não paramétricos qui-quadrado e exato de Fisher, e para comparar as médias dos dados com a distribuição normal foi usado o teste t e de Mann-Whitney. Também foi realizada a análise de regressão logística multivariável, estimando as odds ratio (OR) brutas e ajustadas pelo software Stata, versão 10.0. Foram identificadas 631 RAMs em 402 pacientes. Os medicamentos mais envolvidos foram hidroxicloroquina (59,5%), azitromicina (9,8%) e a cloroquina (5,2%). As reações se manifestaram prioritariamente no sistema cardíaco (38,8%), gastrointestinal (14,4%), tecido cutâneo (12,2%) e hepático (8,9%). A cloroquina (OR = 5,4; IC95%: 1,9-15,6) e a hidroxicloroquina (OR = 2,1; IC95%: 1,2-3,6) foram os únicos medicamentos associados a RAM grave. Nossos achados fornecem subsídios para melhores práticas em farmacovigilância, contribuindo para tomadas de decisões regulatórias efetivas e seguras pela Agência Nacional de Vigilância Sanitária, para os pacientes e toda a sociedade.

In March 2020, the World Health Organization announced the new COVID-19 pandemic, which represented a challenge for health services and professionals. An effective treatment against this disease has not yet been developed; as such, several drugs are used without evidence of efficacy, which in some cases may lead to unwanted events. This is a cross-sectional study with the objective of evaluating adverse drug reactions (ADRs) in patients with COVID-19, identified between March 1 and August 15, 2020, in Brazil, as well as assessing the factors associated with the emergence of severe reactions. To compare the proportions of samples related to the notifier, patient, drugs and adverse events, we used Fisher’s chi-square and exact nonparametric tests; and to compare the means of the data with normal distribution, we used the Student’s t-test and Mann-Whitney’s test. A multivariate logistic regression analysis was also performed, estimating the crude and adjusted odds ratio (OR) by the Stata software, version 10.0. A total of 631 ADRs were identified in 402 patients. The main drugs were hydroxychloroquine (59.5%), azithromycin (9.8%) and chloroquine (5.2%). The reactions manifested primarily in the cardiac system (38.8%), gastrointestinal system (14.4%), skin tissue (12.2%) and hepatic system (8.9%). Chloroquine (OR = 5.4; 95%CI: 1.9-15.6) and hydroxychloroquine (OR = 2.1; 95CI%: 1.2-3.6) were the only drugs associated with severe ADR. Our findings provide support for better practices in pharmacovigilance, contributing to effective and secure regulatory decision-making by the Brazilian Health Regulatory Agency, patients and society as a whole.

En marzo de 2020 la Organización Mundial de la Salud anunció la nueva pandemia denominada COVID-19, representando un desafío para los profesionales y servicios de salud. Todavía no se identificó un tratamiento eficaz contra esta enfermedad y varios fármacos se utilizan sin evidencias de su eficacia, que, en algunos casos, pueden causar eventos indeseados. Este es un estudio transversal, con el objetivo de evaluar las reacciones adversas a medicamentos (RAMs) en pacientes con COVID-19, identificadas desde el 1º de marzo al 15 agosto de 2020 en Brasil, y los factores asociados al surgimiento de reacciones graves. Para comparar las proporciones de las muestras relacionadas con el notificador, paciente, fármacos y eventos adversos, utilizamos los tests no paramétricos chi-cuadrado y exacto de Fisher, y para comparar las medias de los datos con la distribución normal, se utilizó el test t y de Mann-Whitney. También se realizó un análisis de regresión logística multivariable, estimando las odds ratio (OR) brutas y ajustadas, mediante el software Stata, versión 10.0. Se identificaron 631 RAMs en 402 pacientes. Los medicamentos más implicados fueron: hidroxicloroquina (59,5%), azitromicina (9,8%) y la cloroquina (5,2%). Las reacciones se manifestaron prioritariamente en el sistema cardíaco (38,8%), gastrointestinal (14,4%), tejido cutáneo (12,2%) y hepático (8,9%). La cloroquina (OR = 5,4; IC95%: 1,9-15,6) e hidroxicloroquina (OR = 2,1; IC95%: 1,2-3,6) fueron los únicos medicamentos asociados a RAM grave. Nuestros resultados proporcionan apoyo para mejores prácticas en farmacovigilancia, contribuyendo a las tomas de decisiones regulatorias efectivas y seguras, por parte de la Agencia Nacional de Vigilancia Sanitaria, para los pacientes y toda la sociedad.

Em março de 2020, a Organização Mundial da Saúde anunciou a nova pandemia denominada de COVID-19, representando um desafio para os profissionais e serviços de saúde. Ainda não foi identificado um tratamento eficaz contra essa doença e vários fármacos são utilizados sem evidências de sua eficácia, que em alguns casos pode causar eventos indesejados. Esse é um estudo transversal com o objetivo de avaliar as reações adversas a medicamentos (RAMs) nos pacientes com COVID-19, identificadas entre 1º de março e 15 agosto de 2020 no Brasil, e os fatores associados ao surgimento de reações graves. Para comparar as proporções das amostras relacionadas ao notificador, paciente, fármacos e eventos adversos utilizamos os testes não paramétricos qui-quadrado e exato de Fisher, e para comparar as médias dos dados com a distribuição normal foi usado o teste t e de Mann-Whitney. Também foi realizada a análise de regressão logística multivariável, estimando as odds ratio (OR) brutas e ajustadas pelo software Stata, versão 10.0. Foram identificadas 631 RAMs em 402 pacientes. Os medicamentos mais envolvidos foram hidroxicloroquina (59,5%), azitromicina (9,8%) e a cloroquina (5,2%). As reações se manifestaram prioritariamente no sistema cardíaco (38,8%), gastrointestinal (14,4%), tecido cutâneo (12,2%) e hepático (8,9%). A cloroquina (OR = 5,4; IC95%: 1,9-15,6) e a hidroxicloroquina (OR = 2,1; IC95%: 1,2-3,6) foram os únicos medicamentos associados a RAM grave. Nossos achados fornecem subsídios para melhores práticas em farmacovigilância, contribuindo para tomadas de decisões regulatórias efetivas e seguras pela Agência Nacional de Vigilância Sanitária, para os pacientes e toda a sociedade.

In March 2020, the World Health Organization announced the new COVID-19 pandemic, which represented a challenge for health services and professionals. An effective treatment against this disease has not yet been developed; as such, several drugs are used without evidence of efficacy, which in some cases may lead to unwanted events. This is a cross-sectional study with the objective of evaluating adverse drug reactions (ADRs) in patients with COVID-19, identified between March 1 and August 15, 2020, in Brazil, as well as assessing the factors associated with the emergence of severe reactions. To compare the proportions of samples related to the notifier, patient, drugs and adverse events, we used Fisher’s chi-square and exact nonparametric tests; and to compare the means of the data with normal distribution, we used the Student’s t-test and Mann-Whitney’s test. A multivariate logistic regression analysis was also performed, estimating the crude and adjusted odds ratio (OR) by the Stata software, version 10.0. A total of 631 ADRs were identified in 402 patients. The main drugs were hydroxychloroquine (59.5%), azithromycin (9.8%) and chloroquine (5.2%). The reactions manifested primarily in the cardiac system (38.8%), gastrointestinal system (14.4%), skin tissue (12.2%) and hepatic system (8.9%). Chloroquine (OR = 5.4; 95%CI: 1.9-15.6) and hydroxychloroquine (OR = 2.1; 95CI%: 1.2-3.6) were the only drugs associated with severe ADR. Our findings provide support for better practices in pharmacovigilance, contributing to effective and secure regulatory decision-making by the Brazilian Health Regulatory Agency, patients and society as a whole.

En marzo de 2020 la Organización Mundial de la Salud anunció la nueva pandemia denominada COVID-19, representando un desafío para los profesionales y servicios de salud. Todavía no se identificó un tratamiento eficaz contra esta enfermedad y varios fármacos se utilizan sin evidencias de su eficacia, que, en algunos casos, pueden causar eventos indeseados. Este es un estudio transversal, con el objetivo de evaluar las reacciones adversas a medicamentos (RAMs) en pacientes con COVID-19, identificadas desde el 1º de marzo al 15 agosto de 2020 en Brasil, y los factores asociados al surgimiento de reacciones graves. Para comparar las proporciones de las muestras relacionadas con el notificador, paciente, fármacos y eventos adversos, utilizamos los tests no paramétricos chi-cuadrado y exacto de Fisher, y para comparar las medias de los datos con la distribución normal, se utilizó el test t y de Mann-Whitney. También se realizó un análisis de regresión logística multivariable, estimando las odds ratio (OR) brutas y ajustadas, mediante el software Stata, versión 10.0. Se identificaron 631 RAMs en 402 pacientes. Los medicamentos más implicados fueron: hidroxicloroquina (59,5%), azitromicina (9,8%) y la cloroquina (5,2%). Las reacciones se manifestaron prioritariamente en el sistema cardíaco (38,8%), gastrointestinal (14,4%), tejido cutáneo (12,2%) y hepático (8,9%). La cloroquina (OR = 5,4; IC95%: 1,9-15,6) e hidroxicloroquina (OR = 2,1; IC95%: 1,2-3,6) fueron los únicos medicamentos asociados a RAM grave. Nuestros resultados proporcionan apoyo para mejores prácticas en farmacovigilancia, contribuyendo a las tomas de decisiones regulatorias efectivas y seguras, por parte de la Agencia Nacional de Vigilancia Sanitaria, para los pacientes y toda la sociedad.

Abstract Introduction Depression is possibly not a single syndrome but rather comprises several subtypes. DSM-5 proposes a melancholia specifier with phenotypic characteristics that could be associated with clinical progression, biological markers or therapeutic response. The Sydney Melancholia Prototype Index (SMPI) is a prototypic scale aimed to improve the diagnosis of melancholia. So far, there is only an English version of the instrument available. The aim of this study is to describe the translation and adaptation of the English version of the SMPI into Brazilian Portuguese. Methods Translation and cross-cultural adaptation of the self-report (SMPI-SR) and clinician-rated (SMPI-CR) versions into Brazilian Portuguese were done following recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). This guideline includes the following steps: preparation, forward translation, reconciliation, back translation, back translation review, harmonization, cognitive debriefing, debriefing results review, proofreading and final report. Results The Brazilian Portuguese versions of the SMPI were well-accepted by respondents. Changes in about two-thirds of the items were considered necessary to obtain the final Brazilian Portuguese version of the SMPI. Conclusions Both versions of the SMPI are now available in Brazilian Portuguese. The instrument could become an important option to enhance studies on melancholia in Portuguese-speaking samples.

Objective: To test the reliability and the discriminant and convergent validity of the abbreviated Brazilian Portuguese World Health Organization’s Quality of Life Instrument – Spirituality, Religion, and Personal Beliefs module (WHOQOL-SRPB BREF). Methods: In a sample of 404 individuals, we applied a general questionnaire, the WHOQOL-BREF, the long-form SRPB, the Brief Religious-Spiritual Coping Scale (RCOPE), and the Beck Depression Inventory (BDI). Priority was given to the 9-item SRPB assessment: its unidimensionality was tested through confirmatory factor analysis and Rasch analysis. Results: Confirmatory factor analysis of the 9-item SRPB assessment indicated an adjusted model with acceptable fit to data. In the Rasch analysis, general fit measures showed adequate performance. The 9-item SRPB assessment showed good internal consistency (alpha = 0.85), and could differentiate (discriminant validity) between religious and atheist/agnostic respondents (mean = 74.7±14.1 and 56.8±15.5, respectively; t = 6.37; degrees of freedom [df] = 402; p < 0.01) and between non-depressed and depressed respondents (mean = 76.5±12.9 and 67.1±16.5; t = 5.57; df = 190.5; p < 0.01). Correlations (convergent validity) were significant with the positive-RCOPE subscale (r = 0.58, p < 0.01) and the WHOQOL-BREF domains (Pearson coefficient ranging between 0.24 and 0.49; p < 0.01), but were in the negative direction with the negative-RCOPE subscale (r = -0.10, p < 0.05). Correlation with the long-form SRPB domain (r = 0.934) was almost perfect. Conclusion: The Brazilian Portuguese 9-item SRPB has good psychometric properties and confirmed the findings of the long-form Brazilian Portuguese version and the abbreviated English version.

Abstract Background: malnutrition is a common problem in hospitalized patients, being associated with increased morbidity, mortality and costs. Multiple factors contribute to a deficient nutritional status, making malnutrition the cause or consequence of severe diseases. Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure indicated for long-term administration of enteral nutrition in patients with limited ability for oral intake who have an intact, functional gastrointestinal tract. The aim of this study was to determine the profile of patients undergoing PEG in a tertiary hospital in southern Brazil. Methods: single-center retrospective study of all patients who underwent PEG from January 1st to December 31st, 2016, in a private tertiary hospital located in southern Brazil. Data were collected retrospectively from the patients' medical records, including nutritional status, indications, complications and outcomes. Results: one hundred and thirty-three patients underwent PEG at our institution and were eligible for inclusion in the study. Median patient age was 82 years, and 57.9% were females. The main indication for PEG was dementia syndrome, followed by stroke. As much as 68.4% were diagnosed as severely malnourished and 23.0% had procedure-related complications. Conclusions: PEG tubes are being increasingly used for enteral nutrition in patients with dysphagia or inability to maintain adequate nutritional intake. The findings of the present study highlight the importance of regular nutritional risk screening by a multidisciplinary team, paying special attention to the patient's nutritional status and conditions that may place the patient at risk of developing dysphagia, with the implementation of measures to minimize malnutrition in hospitalized patients.

Resumen Introducción: la desnutrición es común en pacientes hospitalizados y se está convirtiendo en causa o consecuencia de enfermedades graves, asociándose a morbilidad, mortalidad y costos aumentados. Múltiples factores contribuyen a un estado nutricional deficiente. La gastrostomía endoscópica percutánea (PEG) es un procedimiento mínimamente invasivo para la administración de nutrición enteral en pacientes con capacidad limitada de ingesta oral que tengan el tracto gastrointestinal intacto y funcional. El objetivo de este estudio fue determinar el perfil de pacientes sometidos a PEG en un hospital terciario del sur de Brasil. Métodos: estudio retrospectivo unicéntrico de todos los pacientes sometidos a PEG del 1 de enero al 31 de diciembre de 2016 en un hospital terciario privado del sur de Brasil. Se recolectaron los datos retrospectivamente en los registros médicos, incluyendo estado nutricional, indicaciones, complicaciones y evolución. Resultados: ciento treinta y tres pacientes se sometieron a PEG en nuestra institución y fueron elegibles para el estudio. La edad mediana fue de 82 años y el 57,9% eran mujeres. Las principales indicaciones para PEG fueron demencia y accidente cerebrovascular. El 68,4% fueron diagnosticados con desnutrición grave y el 23,0% presentaron complicaciones relacionadas al procedimiento. Conclusiones: se utilizan cada vez más tubos de PEG para nutrición enteral en pacientes disfágicos o incapaces de mantener una ingesta nutricional adecuada. Nuestros hallazgos señalan la importancia del cribado para riesgo nutricional por un equipo multidisciplinario, con atención especial al estado nutricional del paciente y a condiciones que pueden ponerlo en riesgo para disfagia y la implementación de medidas para minimizar la desnutrición.