Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review.

OBJECTIVES: To map the available methodological guidelines and documents for conducting and reporting benefit-risk assessment (BRA) during health technologies' life cycle; and to identify methodological guidelines for BRA that could serve as the basis for the development of a BRA guideline for the context of health technology assessment (HTA) in Brazil. DESIGN: Scoping review. METHODS: Searches were conducted in three main sources up to March 2023: (1) electronic databases; (2) grey literature (48 HTA and regulatory organisations) and (3) manual search and contacting experts. We included methodological guidelines or publications presenting methods for conducting or reporting BRA of any type of health technologies in any context of the technology's life cycle. Selection process and data charting were conducted by independent reviewers. We provided a structured narrative synthesis of the findings. RESULTS: From the 83 eligible documents, six were produced in the HTA context, 30 in the regulatory and 35 involved guidance for BRA throughout the technology's life cycle. We identified 129 methodological approaches for BRA in the documents. The most commonly referred to descriptive frameworks were the Problem, Objectives, Alternatives, Consequences, Trade-offs, Uncertainty, Risk and Linked decisions and the Benefit-Risk Action Team. Multicriteria decision analysis was the most commonly cited quantitative framework. We also identified the most cited metric indices, estimation and utility survey techniques that could be used for BRA. CONCLUSIONS: Methods for BRA in HTA are less established. The findings of this review, however, will support and inform the elaboration of the Brazilian methodological guideline on BRA for HTA. TRIAL REGISTRATION NUMBER: https://doi.org/10.17605/OSF.IO/69T3V.

Clinical characteristics, diagnosis, treatment, and outcome of patients with liver abscess due to Aspergillus spp: a systematic review of published cases.

BACKGROUND: Aspergillus spp liver abscess is a relatively rare entity and thus far no systematic review has been performed examining patients' demographics, clinical manifestations, diagnosis, management, and outcome. METHODS: We performed a systematic review of the literature using MEDLINE and LILACS databases. We searched for articles published in the period from January 1990 to December 24, 2022, to identify patients who developed liver abscesses due to Aspergillus spp. RESULTS: Our search yielded 21 patients all of whom had invasive aspergillosis confirmed on liver biopsy. Of these patients 81% were adults, and 60% were males. The majority (86%) of patients were immunocompromised and 95% had symptomatic disease at the time of diagnosis. The most common symptoms were fever (79%), abdominal pain (47%), and constitutional symptoms (weight loss, chills, night sweats, fatigue) (38%). Liver enzymes were elevated in 50%, serum galactomannan was positive in 57%, and fungal blood cultures were positive in only 11%. Co-infection with other pathogens preceded development of apsergillosis in one-third of patients, and the majority of the abscesses (43%) were cryptogenic. In the remaining patients with known source, 28% of patients developed liver abscess through dissemination from the lungs, 19% through the portal vein system, and in 10% liver abscess developed through contiguous spread. The most common imaging modality was abdominal computerized tomography done in 86% of patients. Solitary abscess was present in 52% of patients while 48% had multiple abscesses. Inadequate initial empiric therapy was prescribed in 60% of patients and in 44% of patients definite treatment included combination therapy with two or more antifungal agents. Percutaneous drainage of the abscesses was done in 40% of patients, while 20% required liver resection for the treatment of the abscess. Overall mortality was very high at 38%. CONCLUSION: Further studies are urgently needed for a better understanding of pathophysiology of liver aspergillosis and for developement of newer blood markers in order to expedite diagnosis and decrease mortality.

Renal Manifestations of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Syndrome: A Systematic Review of 71 Cases.

Unlike other adverse drug reactions, visceral organ involvement is a prominent feature of drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome and correlates with mortality. The aim of this study was to systematically review cases published in PubMed-indexed, peer-reviewed journals in which patients had renal injury during the episode of DRESS syndrome (DS). We found 71 cases, of which 67 were adults and 56% were males. Female sex was associated with higher mortality. Chronic kidney disease (CKD) was present in 14% of patients who developed acute kidney injury (AKI) during DS. In 21% of cases, the kidneys were the only visceral organ involved, while 54% of patients had both liver and kidney involvement. Eosinophilia was absent in 24% of patients. The most common classes of medication associated with renal injury in DS were antibiotics in 34%, xanthine oxidase inhibitors in 15%, and anticonvulsants in 11%. Among antibiotics, vancomycin was the most common culprit in 68% of patients. AKI was the most common renal manifestation reported in 96% of cases, while isolated proteinuria or hematuria was present in only 4% of cases. In cases with AKI, 88% had isolated increase in creatinine and decrease in glomerular filtration (GFR), 27% had AKI concomitantly with proteinuria, 18% had oliguria, and 13% had concomitant AKI with hematuria. Anuria was the rarest manifestation, occurring in only 4% of patients with DS. Temporary renal replacement therapy was needed in 30% of cases, and all but one patient fully recovered renal function. Mortality of DS in this cohort was 13%, which is higher than previously reported. Medication class, latency period, or pre-existing CKD were not found to be associated with higher mortality. More research, particularly prospective studies, is needed to better recognize the risks associated with renal injury in patients with DS. The development of disease-specific biomarkers would also be useful so DS with renal involvement can be easier distinguished from other eosinophilic diseases that might affect the kidney.

O diagnóstico tardio na perspectiva do itinerário terapêutico: grau 2 de incapacidade física na hanseníase / El diagnóstico tardío desde la perspectiva del itinerario terapéutico: grado 2 de discapacidad física en la enfermedad de Hansen / Late diagnosis under the perspective of therapeutic itineraries: level 2 physical disabilities in Hansen's disease

Destacam-se casos novos de hanseníase com grau de incapacidade física 2 (GIF 2) que demonstram a ineficiente detecção oportuna. O artigo é um relato de casos e propõe analisar o diagnóstico tardio sob a perspectiva do itinerário terapêutico (IT), com base em um estudo qualitativo. O cenário foram dois municípios da Região Metropolitana da Baixada Santista: Praia Grande e São Vicente. Realizou-se análise documental e entrevista em profundidade com quatro participantes. O material foi submetido à análise de conteúdo e definiram-se as categorias temáticas: cuidado em saúde; corpo na hanseníase; incapacidades na hanseníase; e diagnóstico tardio. Revelaram-se intrincados itinerários terapêuticos, marcados pela fragilidade do cuidado com erro e atraso no diagnóstico, que potencializaram os riscos individuais e coletivos e impactaram negativamente o cotidiano dos sujeitos. (AU)

Se subrayan casos nuevos de enfermedad de Hansen (lepra) con grado de discapacidad física 2 (GIF 2), que demuestran la ineficiente detección oportuna. El artículo es un relato de casos y propone analizar el diagnóstico tardío bajo la perspectiva del itinerario terapéutico (IT), con base en un estudio cualitativo. El escenario fueron dos municipios de la Región Metropolitana de la Baixada Santista: Praia Grande y São Vicente. Se realizó el análisis documental y entrevista en profundidad con cuatro participantes. El material se sometió a análisis de contenido y se definieron las categorías temáticas: cuidado de salud, cuerpo en la enfermedad de Hansen; discapacidades en la enfermedad de Hansen y diagnóstico tardío. Se revelaron intricados itinerarios terapéuticos, señalados por la fragilidad del cuidado, con error y atraso en el diagnóstico, que potencializaron los riesgos individuales y colectivos e impactaron negativamente el cotidiano de los sujetos. (AU)

There are remarkable numbers of new leprosy cases with 2 (GIF 2) degree of physical disability, demonstrating the inefficient timely detection. This article presents case reports, based on a qualitative study, regarding four patients with Hansen's disease and a GIF 2 level at the time of diagnosis, analyzing the late diagnosis from the perspective of therapeutic itineraries (TI). The cases came from two municipalities in the Metropolitan Region of Baixada Santista: Praia Grande and São Vicente. Three men and one woman participated, between 45 and 61 years old. The researcher performed documentary analysis and in-depth interviews. Resulting data was submitted to content analysis and four thematic categories were identified: health care; body in leprosy; disabilities in leprosy; late diagnosis. The results reveal intricate therapeutic itineraries with obstacles for reaching a diagnosis. Lack of information about Hansen's disease and professional inability to diagnose increased both individual and collective risks, in addition to the negative impact on the subjects' daily lives. Thus, a late diagnosis due to the frailty of care strongly concurs to keep Hansen's disease as a stigmatizing and disabling disease. (AU)

O potencial da avaliação formativa nos processos de mudança da formação dos profissionais da saúde / The potential of formative evaluation on the change processes of professional healthcare education / El potencial de la evaluación formativa en los procesos de cambio de la formación de profesionales de salud

Apresenta-se um modelo avaliativo voltado para a indução de mudanças da formação dos profissionais da saúde em consonância com os princípios do Sistema Único de Saúde (SUS). Discutem-se potências e fragilidades dos programas Pró-PET-Saúde a partir das percepções dos atores locais, expressas em relatórios que nortearam a visita de avaliação realizada por assessores do Ministério da Saúde, conduzida na perspectiva formativa. Os dados confirmam repercussões positivas: na relação escolas e serviços de saúde, com avanços diferenciados na dinâmica curricular dos cursos; e no envolvimento de instituições e estudantes nas redes de atenção à saúde, com ampliação do compromisso com o SUS. Fragilidades são apontadas na sustentabilidade dos programas que requerem, das instituições, garantia de condições para o envolvimento, em larga escala, de todos os estudantes nas atividades desenvolvidas pelos programas, e ampliação das parcerias com os municípios e as regiões de saúde para firmação desta agenda.

Saúde bucal e cuidado odontológico: representações sociais de mães usuárias de um serviço público de saúde / Oral health and dental care: the social representations of mothers who attend a public health service

OBJETIVO: identificar as representações sociais de mães de crianças da faixa etária de zero a cinco anos de idade do Núcleo de Saúde da Família IV, em Ribeirão Preto - SP, procurando saber o que pensam sobre saúde bucal e tratamento odontológico. MÉTODO: trata-se de pesquisa qualitativa, sendo utilizada a entrevista semi-estruturada para a coleta dos dados e a análise de conteúdo. RESULTADOS: constatou-se grande dificuldade das mães em se expressar a respeito do que é, para elas, saúde. Para essas mães a saúde bucal está relacionada com normas de higiene e dietéticas e também com a ida ao dentista, restringindo-se na preocupação com a estética e pouco com a função. Já em relação ao tratamento odontológico, a grande maioria demonstrou apresentar medo, causado pela sua experiência anterior com o tratamento. A assistência particular está associada à pontualidade e ao atendimento da maneira desejada enquanto o tratamento oferecido pelo setor público à demora e à falta de equipamentos e materiais. A humanização no atendimento e competência do profissional emergiram como dois aspectos importantes, e podem estar determinando a decisão de ir ou não ao dentista. CONCLUSÕES: A expressão "saúde bucal" foi associada à assistência odontológica. O atendimento pelo setor privado foi referido como o que mais se aproxima do tipo ideal de assistência odontológica.(AU)

OBJECTIVE: To investigate the social representations of mothers with children aged 0 to 5 years from the Family Health Nucleus IV, at the city of Ribeirão Preto, state of São Paulo, in order to know what they think about oral health and dental care. METHODS: This is a qualitative study. Semi-structured interviews were employed to collect the data, which were submitted to content analysis. RESULTS: The interviewed mothers showed an enormous difficulty to express what they think health is. For them, oral health is related to dietary and hygiene norms, and to going to the dentist. In addition, it is restricted to a concern for aesthetics, not for the function. Regarding dental treatment, it was verified that the great majority of the mothers are afraid of it, due to their previous experience with the treatment. Private dental treatment is associated with punctuality and with assistance provided in the desired way, and the treatment offered by the public sector, with delays and lack of equipment/materials. Two questions are important for them and they can be influencing the decision of going or not to the dentist: humanization and the professional's competence. CONCLUSIONS: The expression "oral health" was associated with dental assistance. The assistance provided by the private sector was characterized as the closest one to the ideal type of dental assistance.(AU)

Saúde bucal e cuidado odontológico: representações sociais de mães usuárias de um serviço público de saúde / Oral health and dental care: the social representations of mothers who attend a public health service

OBJETIVO: identificar as representações sociais de mães de crianças da faixa etária de zero a cinco anos de idade do Núcleo de Saúde da Família IV, em Ribeirão Preto - SP, procurando saber o que pensam sobre saúde bucal e tratamento odontológico. MÉTODO: trata-se de pesquisa qualitativa, sendo utilizada a entrevista semi-estruturada para a coleta dos dados e a análise de conteúdo. RESULTADOS: constatou-se grande dificuldade das mães em se expressar a respeito do que é, para elas, saúde. Para essas mães a saúde bucal está relacionada com normas de higiene e dietéticas e também com a ida ao dentista, restringindo-se na preocupação com a estética e pouco com a função. Já em relação ao tratamento odontológico, a grande maioria demonstrou apresentar medo, causado pela sua experiência anterior com o tratamento. A assistência particular está associada à pontualidade e ao atendimento da maneira desejada enquanto o tratamento oferecido pelo setor público à demora e à falta de equipamentos e materiais. A humanização no atendimento e competência do profissional emergiram como dois aspectos importantes, e podem estar determinando a decisão de ir ou não ao dentista. CONCLUSÕES: A expressão "saúde bucal" foi associada à assistência odontológica. O atendimento pelo setor privado foi referido como o que mais se aproxima do tipo ideal de assistência odontológica.