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1.
Front Nutr ; 10: 1271825, 2023.
Article in English | MEDLINE | ID: mdl-37743921

ABSTRACT

Symptomatic perianal disease is common in patients with Crohn's disease (CD), and perianal fistulas represent the primary form of anal involvement. This type of involvement is associated with a poor prognosis and a disabling course. The treatment is challenging and involves both surgical and medical approaches. Despite combined therapy, a significant portion of patients may still require proctectomy to control the symptoms. Consequently, investigating factors that may influence the outcome of perianal disease remains a priority area of research in CD. Nutritional deficiencies are well documented among CD patients with luminal forms of involvement and are closely related to poor clinical outcomes, therapy response, and postoperative complications. As a result, leading guidelines recommend regular nutritional assessment and correction of nutritional deficiencies in patients requiring a surgical approach. Despite these recommendations and the high rate of surgeries among CD patients with perianal disease, there is a shortage of studies addressing the real impact of nutritional status on the course and outcomes of perianal disease. This knowledge gap underscores the importance of further research to understand better and improve the management of perianal CD. This narrative review aims to provide an overview of nutritional status assessment and the influence of nutritional status on the outcomes of patients with perianal CD.

2.
Health Res Policy Syst ; 21(1): 72, 2023 Jul 12.
Article in English | MEDLINE | ID: mdl-37438823

ABSTRACT

BACKGROUND:  The aim of this work is to characterize the processes associated with patient and public involvement (PPI) in the form of public consultations (PC) during the first 10 years of operation of the National Committee for Health Technology Incorporation in the Unified Health System (Conitec) of Brazil, and to identify factors associated with changes in Conitec's recommendations following these PC. METHODS:  This cross-sectional study analysed all processes related to the adoption of technologies that took place in Brazil between 2012 and 2021 based on technical reports and self-reported information collected from PC participants. A multiple logistic regression model identified factors associated with changes in Conitec's recommendations following PC. RESULTS:  A total of 479 technical reports were published, of which 83% (n = 400) were submitted to PC. Demands were made mainly by applicants from the government (n = 262; 55%), regarding the adoption of medicines (n = 366; 76%), in which context neoplasms and infectious diseases were the most frequent indications (n = 66; 14% for each). A total of 264 (55%) processes resulted in a final recommendation in favour of introducing the technology. Over the period of 10 years, 196 483 contributions were received in response to PC. The largest volume of contributions was made by patients and their families or representatives (n = 99 082; 50%), females (122 895; 67%), white individuals (129 165; 71%) and individuals between the ages of 25 and 59 years (145 364; 80%). Alteration of the preliminary recommendation occurred in 13% (n = 53) of the PC, with a higher proportion of recommendations being altered from 2017 onwards. Increased participation by patients had a significant impact on the alteration of the preliminary recommendation (odds ratio 3.87, 95% CI 1.33-13.35, p = 0.02). CONCLUSIONS: Increased engagement of patients and their families and caregivers in PC was associated with changing the preliminary recommendation of Conitec about the adoption of technologies into the public health system in Brazil.


Subject(s)
Public Health , Referral and Consultation , Female , Humans , Adult , Middle Aged , Brazil , Cross-Sectional Studies , Retrospective Studies
3.
Article in English | MEDLINE | ID: mdl-37282638

ABSTRACT

BACKGROUND: Ruthenium complexes have shown promise in treating many cancers, including breast cancer. Previous studies of our group have demonstrated the potential of the trans-[Ru(PPh3)2(N,N-dimethylN'-thiophenylthioureato-k2O,S)(bipy)]PF6 complex, the Ru(ThySMet), in the treatment of breast tumor cancers, both in 2D and 3D culture systems. Additionally, this complex presented low toxicity when tested in vivo. AIMS: Improve the Ru(ThySMet) activity by incorporating the complex into a microemulsion (ME) and testing its in vitro effects. METHODS: The ME-incorporated Ru(ThySMet) complex, Ru(ThySMet)ME, was tested for its biological effects in two- (2D) and three-dimensional (3D) cultures using different types of breast cells, MDA-MB-231, MCF-10A, 4T1.13ch5T1 and Balb/C 3T3 fibroblasts. RESULTS: An increased selective cytotoxicity of the Ru(ThySMet)ME for tumor cells was found in 2D cell culture, compared with the original complex. This novel compound also changed the shape of tumor cells and inhibited cell migration with more specificity. Additional 3D cell culture tests using the non-neoplastic S1 and the triple-negative invasive T4-2 breast cells have shown that Ru(ThySMet)ME presented increased selective cytotoxicity for tumor cells compared with the 2D results. The morphology assay performed in 3D also revealed its ability to reduce the size of the 3D structures and increase the circularity in T4-2 cells. CONCLUSION: These results demonstrate that the Ru(ThySMet)ME is a promising strategy to increase its solubility, delivery, and bioaccumulation in target breast tumors.

4.
Clinics (Sao Paulo) ; 78: 100203, 2023.
Article in English | MEDLINE | ID: mdl-37099816

ABSTRACT

Colorectal Cancer (CRC) is the third most common type of cancer worldwide and ranks second in mortality. Screening programs for early detection and treatment have been implemented in several countries. Economic evaluations are an important tool to support decision-making about reimbursement and coverage decisions in health systems and, therefore, to support efficient resource allocation. The article aims to review the up-to-date evidence on economic evaluations of CRC screening strategies. MEDLINE, EMBASE, Web of Science, SCOPUS, SciELO, Lilacs, CRD databases, and lists of references were reviewed to identify relevant literature regarding full economic evaluations of CRC screening in asymptomatic average-risk individuals over 40 years old. Searches were conducted with no restriction to language, setting, or date. Qualitative syntheses described CRC screening strategies and comparators (baseline context), study designs, key parameter inputs and incremental cost-effectiveness ratios. Seventy-nine articles were included. Most of the studies were from high-income countries and a third-party payer perspective. Markov models were predominantly used, although microsimulation has been increasingly adopted in the last 15 years. The authors found 88 different screening strategies for CRC, which differed in the type of technique, the interval of screening, and the strategy, i.e., isolated or combined. The annual fecal immunochemical test was the most predominant screening strategy. All studies reported cost-effective results in their scenarios compared to no screening scenarios. One-quarter of the publications reported cost-saving results. It is still necessary to develop future economic evaluations in Low- and Middle-Income Countries (LMICs), which account for the high burden of disease.


Subject(s)
Colorectal Neoplasms , Early Detection of Cancer , Humans , Adult , Cost-Benefit Analysis , Colorectal Neoplasms/diagnosis
5.
Clinics ; 78: 100203, 2023. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1439913

ABSTRACT

Abstract Colorectal Cancer (CRC) is the third most common type of cancer worldwide and ranks second in mortality. Screening programs for early detection and treatment have been implemented in several countries. Economic evaluations are an important tool to support decision-making about reimbursement and coverage decisions in health systems and, therefore, to support efficient resource allocation. The article aims to review the up-to-date evidence on economic evaluations of CRC screening strategies. MEDLINE, EMBASE, Web of Science, SCOPUS, SciELO, Lilacs, CRD databases, and lists of references were reviewed to identify relevant literature regarding full economic evaluations of CRC screening in asymptomatic average-risk individuals over 40 years old. Searches were conducted with no restriction to language, setting, or date. Qualitative syntheses described CRC screening strategies and comparators (baseline context), study designs, key parameter inputs and incremental cost-effectiveness ratios. Seventy-nine articles were included. Most of the studies were from high-income countries and a third-party payer perspective. Markov models were predominantly used, although microsimulation has been increasingly adopted in the last 15 years. The authors found 88 different screening strategies for CRC, which differed in the type of technique, the interval of screening, and the strategy, i.e., isolated or combined. The annual fecal immunochemical test was the most predominant screening strategy. All studies reported cost-effective results in their scenarios compared to no screening scenarios. One-quarter of the publications reported cost-saving results. It is still necessary to develop future economic evaluations in Low- and Middle-Income Countries (LMICs), which account for the high burden of disease.

6.
Microbiol Spectr ; 10(4): e0065022, 2022 08 31.
Article in English | MEDLINE | ID: mdl-35862994

ABSTRACT

Dental caries is a multifactorial biofilm- and sugar-dependent disease. This study investigated the influence of different agents on the induction of surviving Streptococcus mutans cells after successive treatment cycles and characterized the biofilms formed by these cells recovered posttreatment. The agents (with their main targets listed in parentheses) were compound 1771 (lipoteichoic acids), 4' hydroxychalcone (exopolysaccharides), myricetin (exopolysaccharides), tt-farnesol (cytoplasmatic membrane), sodium fluoride (enolase-glycolysis), chlorhexidine (antimicrobial), and vehicle. Recovered cells from biofilms were generated from exposure to each agent during 10 cycles of consecutive treatments (modeled on a polystyrene plate bottom). The recovered cell counting was different for each agent. The recovered cells from each group were grown as biofilms on saliva-coated hydroxyapatite discs (culture medium with sucrose/starch). In S. mutans biofilms formed by cells recovered from biofilms previously exposed to compound 1771, 4' hydroxychalcone, or myricetin, cells presented higher expression of the 16S rRNA, gyrA (DNA replication and transcription), gtfB (insoluble exopolysaccharides), and eno (enolase-glycolysis) genes and lower quantities of insoluble dry weight and insoluble exopolysaccharides than those derived from other agents. These findings were confirmed by the smaller biovolume of bacteria and/or exopolysaccharides and the biofilm distribution (coverage area). Moreover, preexposure to chlorhexidine increased exopolysaccharide production. Therefore, agents with different targets induce cells with distinct biofilm formation capacities, which is critical for developing formulations for biofilm control. IMPORTANCE This article addresses the effect of distinct agents with distinct targets in the bacterial cell (cytoplasmatic membrane and glycolysis), the cell's extracellular synthesis of exopolysaccharides that are important for cariogenic extracellular matrix construction and biofilm buildup in the generation of cells that persisted after treatment, and how these cells form biofilms in vitro. For example, if preexposure to an agent augments the production of virulence determinants, such as exopolysaccharides, its clinical value may be inadequate. Modification of biofilm formation capacity after exposure to agents is critical for the development of formulations for biofilm control to prevent caries, a ubiquitous disease associated with biofilm and diet.


Subject(s)
Dental Caries , Streptococcus mutans , Biofilms , Chlorhexidine/metabolism , Chlorhexidine/pharmacology , Humans , Phosphopyruvate Hydratase/metabolism , Polysaccharides, Bacterial/metabolism , RNA, Ribosomal, 16S , Streptococcus mutans/metabolism
7.
Eur Arch Otorhinolaryngol ; 279(8): 4043-4051, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35441894

ABSTRACT

This study aimed to examine the association between voice disorder and depressive symptoms in schoolteachers. A cross-sectional survey was conducted with elementary and secondary schoolteachers. Voice disorders and depressive symptoms were assessed with the Voice Handicap Index-10 and the Beck Depression Inventory-II, respectively. Logistic and linear regressions models were adjusted for confounding variables. In the 389 schoolteachers studied, the prevalence of voice handicap and depressive symptoms was 18.8 and 38.8%, respectively. Voice handicap was associated with depressive symptoms on all models tested. The logistic regression showed an odds ratio of 2.21 (95% confidence interval: 1.19, 4.08; p value < 0.05), while in the linear regression each point increase on the voice disorder scale increased the Beck Depression Inventory-II score by 0.39 points (95% confidence interval: 0.26, 0.54; p value < 0.05). This study showed that teachers of public schools with voice handicap are twice as likely to report depressive symptoms.


Subject(s)
Voice Disorders , Voice , Cross-Sectional Studies , Depression/diagnosis , Depression/epidemiology , Humans , Prevalence , Surveys and Questionnaires , Voice Disorders/diagnosis , Voice Disorders/epidemiology , Voice Disorders/etiology
8.
J Fungi (Basel) ; 7(5)2021 Apr 28.
Article in English | MEDLINE | ID: mdl-33924814

ABSTRACT

Candida albicans and Streptococcus mutans interact synergistically in biofilms associated with a severe form of dental caries. Their synergism is driven by dietary sucrose. Thus, it is necessary to devise strategies to hinder the development of those biofilms and prevent cavities. Six compounds [tt-farnesol (sesquiterpene alcohol that decreases the bacterium acidogenicity and aciduricity and a quorum sensing fungal molecule), myricetin (flavonoid that interferes with S. mutans exopolysaccharides production), two 2'-hydroxychalcones and 4'-hydroxychalcone (intermediate metabolites for flavonoids), compound 1771 (inhibitor of lipoteichoic synthase in Gram-positive bacteria)] with targets in both fungus and bacterium and their products were investigated for their antimicrobial and antibiofilm activities against single-species cultures. The compounds and concentrations effective on single-species biofilms were tested alone and combined with or without fluoride to control initial and pre-formed dual-species biofilms. All the selected treatments eliminated both species on initial biofilms. In contrast, some combinations eliminated the bacterium and others the fungus in pre-formed biofilms. The combinations 4'-hydroxychalcone+tt-farnesol+myricetin, 4'-hydroxychalcone+tt-farnesol+fluoride, and all compounds together with fluoride were effective against both species in pre-formed biofilms. Therefore, combinations of compounds with distinct targets can prevent C. albicans and S. mutans dual-species biofilm build-up in vitro.

9.
Ecotoxicol Environ Saf ; 208: 111636, 2021 Jan 15.
Article in English | MEDLINE | ID: mdl-33396156

ABSTRACT

BACKGROUND: Since the first report by Perry et al. (1955), most studies affirmed the hypertensive effects of cadmium (Cd) in humans. Nonetheless, conclusions between studies remain inconsistent. OBJECTIVE: The aim of this study was to reevaluate the evidence for a potential relationship between Cd exposure and altered blood pressure and/or hypertension, focusing on studies published between January 2010 and March 2020. METHODS: We reviewed all observational studies from database searches (PubMed and SCOPUS) on Cd exposure and blood pressure or hypertension. We extracted information from studies that provided sufficient data on population characteristics, smoking status, exposure, outcomes, and design. RESULTS: Thirty-eight studies met our inclusion criteria; of those, twenty-nine were cross sectional, three case control, five cohort and one interventional study. Blood or urinary Cd levels were the most commonly used biomarkers. CONCLUSIONS: A positive association between blood Cd levels and blood pressure and/or hypertension was identified in numerous studies at different settings. Limited number of representative population-based studies of never-smokers was observed, which may have confounded our conclusions. The association between urinary Cd and blood pressure and/or hypertension remains uncertain due to conflicting results, including inverse relationships with lack of strong mechanistic support. We point to the urgent need for additional longitudinal studies to confirm our findings.


Subject(s)
Blood Pressure , Cadmium/analysis , Environmental Exposure/analysis , Environmental Pollutants/analysis , Hypertension/epidemiology , Biomarkers/analysis , Humans , Hypertension/blood , Hypertension/urine
10.
Rev Saude Publica ; 54: 136, 2020.
Article in English, Portuguese | MEDLINE | ID: mdl-33331420

ABSTRACT

OBJECTIVE: The study aims to characterize and discuss the processes of patient and public involvement (PPI) in the Brazilian Health Regulatory Agency (Anvisa), the National Committee for Health Technology Incorporation (Conitec), and the National Agency for Supplementary Health (ANS) in Brazil. METHODS: This is an exploratory, descriptive, and comparative study, conducted by analyzing the public documents and regulation of the three institutions. RESULTS: The mechanisms for PPI included public consultations, public hearings, participation in advisory committees, and health technology evaluation requests. Anvisa conducted 187 public consultations between 1999 and 2018, gathering 10,699 contributions. In total, 76 (41%) public consultations did not present information about the contributions received. Conitec carried out 234 public consultations and received 53,174 contributions between 2011 and 2018. It was identified that 70 (23%) recommendations from Conitec did not go through public consultation, and 26 (8%) recommendations changed after public consultation. Recommendation changes seemed to have occurred especially in cases with a greater number of contributions in the public consultation process. ANS conducted eight public consultations regarding the list of health procedures and events covered by health insurances between 2000 and 2018, and it received 31,498 contributions. For three public consultations, there was no information about the number of contributions received. CONCLUSIONS: There are regulatory advances and institutional activity supporting PPI in highly technical decision-making processes in Brazil, although heterogeneously among the analyzed institutions. The power of PPI to influence health technology deliberative processes still requires in-depth studies, including the characterization of stakeholders and the legitimacy of decisions.


Subject(s)
Biomedical Technology , Community Participation , Decision Making , Patient Participation , Brazil , Humans
12.
Health Res Policy Syst ; 18(1): 95, 2020 Aug 26.
Article in English | MEDLINE | ID: mdl-32843051

ABSTRACT

BACKGROUND: Health technology assessment (HTA) should provide an assessment of a technology's effects on health and of the related social, economic, organisational and ethical issues. HTA reports on biosimilars can specifically assess their immunogenicity, their extrapolation to one or more conditions, and the risks of interchangeability and substitution. We aimed to complete a scoping review within the context of HTA organisations to synthesise HTA reports on biosimilars and to map the extension, scope and methodological practices. MAIN BODY: A scoping review methodology was applied. The sources for biosimilars HTA reports were database searches and grey literature from HTA organisation websites up to June 2019. HTA reports of biosimilars were classified as full HTA, mini-HTA or rapid reviews. Data were extracted and recorded on a calibrated predefined data form. We identified 70 HTA reports of biosimilars of 16 biologic products (65.71% in 2015-2018) produced by 13 HTA organisations from 10 countries; 2 full HTAs, 4 mini-HTAs and 64 rapid reviews met the inclusion criteria. Almost all the rapid reviews gave no information regarding any evidence synthesis method and approximately half of the rapid reviews did not appraise the risk of bias of primary studies or the overall quality of evidence. All full-HTAs and mini-HTAs addressed organisational, ethical, social and legal considerations, while these factors were assessed in less than half of the rapid reviews. The immunogenicity and extrapolation of one or more conditions were often considered. The majority of full-HTAs and mini-HTAs contained an assessment of switching and a discussion of an educational approach about biosimilars. No HTA report rejected the adoption/reimbursement of the biosimilar assessed. CONCLUSION: HTA of biosimilars are emerging in the context of HTA organisations and those that exist often duplicate reports of the same biosimilar. Most HTA reports of biosimilars do not conduct a systematic literature review or consider economic issues. No report has rejected the adoption/reimbursement of biosimilars. There is a need to standardise the minimum criteria for the development of HTA on biosimilars to ensure a better understanding and better decision-making.


Subject(s)
Biosimilar Pharmaceuticals , Technology Assessment, Biomedical , Humans , Research Design
13.
Cancers (Basel) ; 12(7)2020 Jul 17.
Article in English | MEDLINE | ID: mdl-32708835

ABSTRACT

Clinical criteria/Family history-based BRCA testing misses a large proportion of BRCA carriers who can benefit from screening/prevention. We estimate the cost-effectiveness of population-based BRCA testing in general population women across different countries/health systems. A Markov model comparing the lifetime costs and effects of BRCA1/BRCA2 testing all general population women ≥30 years compared with clinical criteria/FH-based testing. Separate analyses are undertaken for the UK/USA/Netherlands (high-income countries/HIC), China/Brazil (upper-middle income countries/UMIC) and India (low-middle income countries/LMIC) using both health system/payer and societal perspectives. BRCA carriers undergo appropriate screening/prevention interventions to reduce breast cancer (BC) and ovarian cancer (OC) risk. Outcomes include OC, BC, and additional heart disease deaths and incremental cost-effectiveness ratio (ICER)/quality-adjusted life year (QALY). Probabilistic/one-way sensitivity analyses evaluate model uncertainty. For the base case, from a societal perspective, we found that population-based BRCA testing is cost-saving in HIC (UK-ICER = $-5639/QALY; USA-ICER = $-4018/QALY; Netherlands-ICER = $-11,433/QALY), and it appears cost-effective in UMIC (China-ICER = $18,066/QALY; Brazil-ICER = $13,579/QALY), but it is not cost-effective in LMIC (India-ICER = $23,031/QALY). From a payer perspective, population-based BRCA testing is highly cost-effective in HIC (UK-ICER = $21,191/QALY, USA-ICER = $16,552/QALY, Netherlands-ICER = $25,215/QALY), and it is cost-effective in UMIC (China-ICER = $23,485/QALY, Brazil-ICER = $20,995/QALY), but it is not cost-effective in LMIC (India-ICER = $32,217/QALY). BRCA testing costs below $172/test (ICER = $19,685/QALY), which makes it cost-effective (from a societal perspective) for LMIC/India. Population-based BRCA testing can prevent an additional 2319 to 2666 BC and 327 to 449 OC cases per million women than the current clinical strategy. Findings suggest that population-based BRCA testing for countries evaluated is extremely cost-effective across HIC/UMIC health systems, is cost-saving for HIC health systems from a societal perspective, and can prevent tens of thousands more BC/OC cases.

14.
Environ Res ; 187: 109618, 2020 08.
Article in English | MEDLINE | ID: mdl-32447086

ABSTRACT

BACKGROUND: Cadmium (Cd) is a toxic metal that is widely present in the environment due to geologic and anthropogenic sources. Exposures to high Cd levels may cause nephrotoxicity, carcinogenicity, pulmonary and cardiovascular disease, among others. The goal of this study was to investigate in an adult urban population whether an association exists between sources and levels of Cd exposure and blood Cd concentrations. METHODS: Using a census-based design, a total of 959 adults, aged 40 years or older, were randomly selected. Information on socio-demographics, dietary, and lifestyle background was obtained by household interviews. Blood Cd levels were measured by inductively coupled-plasma mass spectrometry. Geometric means (GM) (95% CI) and the 50th percentile were determined, stratified by sex, age, race, education, income class, smoking status, consumption of vegetables, red meat and milk, occupation and blood pressure. To assess the association between Cd exposure and the aforementioned variables, we estimated the geometric mean ratio (GMR) (95%CI) of blood Cd concentrations. RESULTS AND CONCLUSION: The geometric mean (95%CI) of blood Cd levels in the total population was 0.25 (0.22, 0.27) ug/dL. In a univariate analysis, significantly higher blood Cd levels were found in men (p < 0.001), current and former smokers (p < 0.001), alcohol drinkers (p < 0.001), those who never or almost never consumed milk (p < 0.001), and in subjects with higher diastolic blood pressure (p = 0.03). Significant correlations were found between the number of cigarettes consumed daily and blood Cd levels. Multivariate analysis confirmed higher blood Cd concentrations were associated with alcohol consumption (GMR 95%CI = 1.28, 1.04-1.59) and in former and current smokers (GMR 95% IC = 1.33, 1.06-1.67 and 4.23, 3.24-5.52, respectively). Our results shed novel information on variables associated with blood Cd levels in an urban Brazilian population, and should encourage additional research to prevent environmental Cd exposure, both in Brazil and globally.


Subject(s)
Cadmium , Environmental Exposure , Adult , Brazil , Environmental Exposure/analysis , Geology , Humans , Male , Urban Population
15.
Respir Physiol Neurobiol ; 274: 103358, 2020 03.
Article in English | MEDLINE | ID: mdl-31811939

ABSTRACT

Mammals airways are extensively innervated by the vagus nerve, which controls the airway diameter and bronchial tone. However, very few studies described the respiratory function and lung morphology after vagal section. In the present study, we evaluated the respiratory mechanics after aerosolization of vehicle (to obtain control values), a muscarinic agonist (methacholine), a ß2-adrenergic agonist (salbutamol) or a muscarinic antagonist (ipratropium bromide) in intact (Vi) and bilaterally vagotomized (Vx) Swiss male mice. Different group was established for morphometric analyze. The total lung resistance, airway resistance, elastance, compliance, lung tissue damping, lung tissue elastance, and morphological parameters (collagen and elastic fibers) were significantly different in the Vx group compared to the Vi group. Bronchoconstrictor and bronchodilators change the respiratory function of the Vx group. In conclusion, the vagus nerve modulates the lung function in response to bronchoconstriction and bronchodilation, as well as lung architecture of mice.


Subject(s)
Adrenergic beta-2 Receptor Agonists/pharmacology , Bronchoconstrictor Agents/pharmacology , Bronchodilator Agents/pharmacology , Lung/drug effects , Lung/physiology , Muscarinic Antagonists/pharmacology , Respiratory Mechanics/drug effects , Respiratory Mechanics/physiology , Vagotomy , Vagus Nerve/physiology , Albuterol/pharmacology , Animals , Collagen , Elastic Tissue , Ipratropium/pharmacology , Lung/ultrastructure , Male , Methacholine Chloride/pharmacology , Mice , Muscarinic Agonists/pharmacology
16.
Rev. saúde pública (Online) ; 54: 136, 2020. tab, graf
Article in English | LILACS, BBO - Dentistry , Sec. Est. Saúde SP | ID: biblio-1145059

ABSTRACT

ABSTRACT OBJECTIVE The study aims to characterize and discuss the processes of patient and public involvement (PPI) in the Brazilian Health Regulatory Agency (Anvisa), the National Committee for Health Technology Incorporation (Conitec), and the National Agency for Supplementary Health (ANS) in Brazil. METHODS This is an exploratory, descriptive, and comparative study, conducted by analyzing the public documents and regulation of the three institutions. RESULTS The mechanisms for PPI included public consultations, public hearings, participation in advisory committees, and health technology evaluation requests. Anvisa conducted 187 public consultations between 1999 and 2018, gathering 10,699 contributions. In total, 76 (41%) public consultations did not present information about the contributions received. Conitec carried out 234 public consultations and received 53,174 contributions between 2011 and 2018. It was identified that 70 (23%) recommendations from Conitec did not go through public consultation, and 26 (8%) recommendations changed after public consultation. Recommendation changes seemed to have occurred especially in cases with a greater number of contributions in the public consultation process. ANS conducted eight public consultations regarding the list of health procedures and events covered by health insurances between 2000 and 2018, and it received 31,498 contributions. For three public consultations, there was no information about the number of contributions received. CONCLUSIONS There are regulatory advances and institutional activity supporting PPI in highly technical decision-making processes in Brazil, although heterogeneously among the analyzed institutions. The power of PPI to influence health technology deliberative processes still requires in-depth studies, including the characterization of stakeholders and the legitimacy of decisions.


RESUMO OBJETIVO Caracterizar e discutir os processos formais de participação social previstos e implementados pelas instituições Agência Nacional de Vigilância Sanitária (Anvisa), Comissão Nacional de Incorporação de Tecnologias no SUS (Conitec) e Agência Nacional de Saúde Suplementar (ANS). MÉTODOS Estudo exploratório, descritivo, comparativo, conduzido por meio de análise de documentos publicados até 2018 no sítio eletrônico e da legislação específica de cada instituição. RESULTADOS Os espaços de participação social identificados incluem a representação em colegiados e participação direta por meio de uma demanda inicial ou em consultas públicas, audiências públicas e ouvidorias. A Anvisa conduziu 187 consultas públicas entre 1999 e 2018, e contabilizou 10.699 contribuições. Em 76 (41%) consultas públicas não há informações sobre as contribuições recebidas. A Conitec conduziu 234 consultas públicas, e recebeu 53.174 contribuições entre 2011 e 2018. Identificou-se que 70 (23%) recomendações da Conitec foram emitidas sem consulta pública, e 26 (8%) recomendações preliminares foram alteradas após consulta pública. As alterações de recomendação aconteceram especialmente em casos com grande volume de contribuições. A ANS conduziu 8 consultas públicas sobre o rol de procedimentos e eventos em saúde entre 2000 e 2018, e recebeu pelo menos 31.498 contribuições. Em três consultas públicas não há informações sobre o número de contribuições recebidas. CONCLUSÕES Observa-se recente avanço normativo e de desempenho institucional em favor da participação social em espaços decisórios notadamente técnicos, embora de forma bastante heterogênea entre as instituições analisadas. O poder deliberativo da participação social de influenciar as decisões em saúde ainda necessita de estudo aprofundado, incluindo a caracterização dos participantes e a legitimidade das decisões subsequentes.


Subject(s)
Humans , Patient Participation , Community Participation , Biomedical Technology , Decision Making , Brazil
18.
Mol Genet Metab ; 126(1): 6-13, 2019 01.
Article in English | MEDLINE | ID: mdl-30594472

ABSTRACT

Menkes disease is a rare X-linked neurodegenerative disorder caused by defect in copper metabolism. Parenteral copper supplementation has been used as a potential disease-modifying treatment of Menkes disease for decades. However, recent evidence suggests its efficacy only when treatment is started within days after birth, which also has important implications related to the techniques that enable early diagnosis. We aim at proposing a guideline for prenatal and neonatal diagnosis and for disease-modifying treatment of Menkes disease, guided by a systematic review of the literature, and built in conjunction with medical experts, methodologists and patient representatives. Thirteen articles were used for our recommendations that were based on GRADE system. Reviewed evidence suggests that prenatal genetic diagnosis in families with previous diagnosis of Menkes disease is feasible; analysis of plasma catecholamine levels is accurate for neonatal diagnosis of Menkes disease; treatment with copper-histidine is effective to increase survival and reduce neurologic burden of the disease if initiated in the neonatal period; and, treatment indication should not be guided by patient's genotype. In conclusion, our guideline can contribute to standardize some aspects of the clinical care of patients with Menkes disease, especially reducing disease burden and mortality and providers' and families' anxiety.


Subject(s)
Copper/metabolism , Menkes Kinky Hair Syndrome/diagnosis , Menkes Kinky Hair Syndrome/drug therapy , Practice Guidelines as Topic , Prenatal Diagnosis , Catecholamines/blood , Clinical Trials as Topic , Copper/therapeutic use , Early Diagnosis , Female , Humans , Male , Menkes Kinky Hair Syndrome/genetics , Mutation , Pregnancy
19.
Porto Alegre; s.n; 2019. 16 p.
Thesis in Portuguese | LILACS, Coleciona SUS | ID: biblio-1047995

ABSTRACT

Introdução: a Atenção Primária à Saúde funciona como porta de entrada do sistema de saúde, ofertando serviços próximos aos domicílios, pautados na formação de vínculo e atenção centrada no indivíduo. A questão central da universalidade do acesso se dá no equilíbrio entre as demandas de saúde e a oferta de serviços. As barreiras de acesso aos serviços de saúde são geradas/agravadas pelo modelo de atenção praticado nas organizações de saúde. Fragmentado, com pouca articulação entre os serviços e redes de atenção, acaba por desorganizar o acesso, muitas vezes respondendo aos interesses próprios e não às necessidades dos usuários. Isso acarreta em uma circulação dos usuários em diversos serviços em busca da satisfação de sua demanda, o que aumenta a ineficiência da assistência e não impacta favoravelmente os níveis de saúde da população. Objetivo: identificar como os usuários da USJI entendem suas demandas, a forma de acesso e a oferta de serviços pela unidade. Justificativa: avaliar o acesso da população aos serviços e recursos de saúde, a fim de aprimorar a porta de entrada, os processos e os fluxos de trabalho, facilitando o acesso e qualificando a atenção à saúde. Metodologia: trata-se de uma pesquisa descritiva, de caráter exploratório com abordagem qualitativa. Foi realizado um grupo focal com usuários de uma Unidade de Saúde, vinculada ao Serviço de Saúde Comunitária do Grupo Hospitalar Conceição. Resultados e discussão: percebe-se um equilíbrio entre demanda e oferta de serviços de saúde, a partir da satisfação dos usuários. No que se refere às necessidades de saúde, percebe-se uma superação das expectativas, como na oferta das PICS e no vínculo com os profissionais de saúde. (AU)


Subject(s)
Unified Health System , Brazil , Public Health
20.
Rev. pesqui. cuid. fundam. (Online) ; 10(3): 619-625, jul.-set. 2018.
Article in English, Portuguese | LILACS, BDENF - Nursing | ID: biblio-906172

ABSTRACT

Objetivo: O estudo tem o objetivo de analisar as contribuições da disciplina optativa "Terapias complementares com ênfase em plantas medicinais" na prática dos enfermeiros egressos da Faculdade de Enfermagem da Universidade Federal de Pelotas. Método: Trata-se de uma pesquisa descritiva, de caráter exploratório com abordagem qualitativa. Os dados foram coletados em setembro e outubro de 2015, totalizando 12 enfermeiros. Resultados: Mostram a importância da disciplina na prática profissional e no contexto familiar dos participantes. Os enfermeiros destacaram o suporte teórico e prático da disciplina para a aplicabilidade das terapias complementares e plantas medicinais no cotidiano laboral. Contudo, relataram diversas dificuldades para sua aplicação, dentre os quais a falta de protocolos, a descontinuidade do cuidado nessa linha por colegas e a carência de conhecimento aprofundado da temática. Conclusão: Mudanças na educação das universidades são necessárias a fim de formar profissionais capacitados e qualificados para atuarem nessa área, aplicando o cuidado integral e fortalecendo o sistema de saúde


Objetivo: Analizar las contribuiciones de la asignatura optativa "Terapias complementarias, con énfasis en plantas medicinales" en la práctica de los enfermeros egresados de la facutad de enfermería de la Universidad Federal de Pelotas. Método: Investigación cualitativa realizada con 12 enfermeros en el año 2015. Resultados: Se evidenció la importancia de la asignatura en la práctica profesional y en el contexto familiar de los participantes. Las enfermeras destacaron el soporte de la asignatura para la aplicabilidad de las terapias complementarias y plantas medicinales en su trabajo. Sin embargo, reportaron dificultades en su aplicación, tales como la carencia de protocolos, la discontinuidad del cuidado y la falta de profundidad del conocimiento en esta temática. Conclusión: Se requieren cambios en los planes de estudio de las universidades para formar profesionales expertos, capaces de actuar en este ámbito. Esto se traduce en calificación de la atención y fortalecimiento del Sistema Único de Salud


Objective: The study's aim has been to analyze the contributions of the elective discipline "Complementary therapies with emphasis on medicinal plants" in the nurses' practice that have graduated from the Nursing School at Universidade Federal de Pelotas. Methods: It is a descriptive-exploratory research with a qualitative approach. Data were collected from September to October 2015, totaling 12 participating nurses. Results: The results show the importance of the discipline in professional practice and in the participants' family context. The nurses highlighted the theoretical and practical support of the discipline for the applicability of complementary therapies and medicinal plants in daily work practice. Nonetheless, they reported several difficulties for its application, among them the lack of protocols, the discontinuity of care by colleagues and the lack of in-depth knowledge of the theme. Conclusion: It is essential implementing changes in the education of universities in order to provide qualified training and qualified professionals willing to work in this area, and then applying comprehensive care and strengthening the health system


Subject(s)
Humans , Male , Female , Complementary Therapies/education , Education, Nursing, Continuing/methods , Education, Nursing, Continuing/trends , Phytotherapy/nursing
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