Bruna Ascef - Academia.edu (original) (raw)

Papers by Bruna Ascef

JAMA Network Open

ImportanceBiosimilar drugs are potentially lower-cost versions of biologics that may improve acce... more ImportanceBiosimilar drugs are potentially lower-cost versions of biologics that may improve access to therapy. However, there is a lack of adequate systematic reviews demonstrating equivalence between these drugs for the treatment of rheumatoid arthritis (RA).ObjectivesTo assess the efficacy, safety, and immunogenicity associated with biosimilars of adalimumab, etanercept, and infliximab compared with their reference biologics in patients with RA.Data SourcesMEDLINE via PubMed, Embase, Cochrane Central Register of Controlled Trials, and LILACS databases were searched from inception to September 2021.Study SelectionHead-to-head randomized clinical trials (RCTs) of biosimilars of adalimumab, etanercept, and infliximab and their biologic reference drugs for RA were assessed.Data Extraction and SynthesisTwo authors independently abstracted all data. Meta-analysis was conducted with bayesian random effects using relative risks (RRs) for binary outcomes and standardized mean differences ...

Additional file 1. PRISMA for systematic review protocols (PRISMA-P) Checklist. Source: Moher et ... more Additional file 1. PRISMA for systematic review protocols (PRISMA-P) Checklist. Source: Moher et al. [21].

Additional file 1. Preferred Reporting Items for Systematic reviews and Meta-Analyses extension f... more Additional file 1. Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) Checklist [27].

Additional file 2. Classification of HTA reports according to the criteria of Merlin et al. [29].... more Additional file 2. Classification of HTA reports according to the criteria of Merlin et al. [29]. HTA Health Technology Assessment. * A synthesis that collates all empirical evidence fitting pre-specified eligibility criteria to answer a specific research question. Systematic reviews are conducted according to a pre-specified protocol. The methods used are selected to minimise bias, thus providing more reliable findings from which conclusions can be drawn and decisions made.

Primeiro Congresso da REBRATS, 2019

Background: Até julho de 2019, a European Medicine Agency havia aprovado 14 biossimilares do adal... more Background: Até julho de 2019, a European Medicine Agency havia aprovado 14 biossimilares do adalimumabe (ADAbios: 8), etarnecepte (ETNbios: 2) e infliximabe (IFXbios: 4); o Food and Drug Administration, 9 biossimilares (4 ADAbios /2 ETNbios/3 IFXbios); e a Agência Nacional de Vigilância Sanitária, 5 biossimilares (1 ADAbios/1 ETNbios/3 IFXbios). Objetivou-se revisar sistematicamente a evidência da equivalência (EQ) ou não inferioridade (NI), substituição ou intercambialidade de biossimilares do ADAbios, ETNbios e IFXbios comparado aos seus biológicos de referência para o tratamento de artrite reumatoide.

2 17 Β-Estradiol mineralization in human waste products and soil in the presence and 3 absence of... more 2 17 Β-Estradiol mineralization in human waste products and soil in the presence and 3 absence of antimicrobials 4 5 6 INOKA AMARAKOON, ANNEMIEKE FARENHORST*, KARIN ROSE, ANNE 7 CLAEYS and BRUNA ASCEF 8 9 10 Department of Soil Science, University of Manitoba, Winnipeg, Manitoba R3T 2N2, Canada 11 Department of Biologie, Institt Universitaire de Technologie de Perpignan, Perpignan, 12 Pyrénées Orientales, France 13 Department of Pharmacy, Universidade Federal dos Vales do Jequitinhonha e Mucuri, 14 Diamantina, Minas Gerais, Brazil 15

Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-li... more Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven to the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. These two systematic reviews aim to investigate the efficacy and safety profile of biosimilars compared to biologics (systematic review 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (systematic review 2).Methods Electronic searches will be performed through MEDLINE (via Pubmed), EMBASE, LILACS, and CENTRAL (from inception to September 2020). Risk of bias assessments will be carried out with the Cochrane risk of bias tool, supplemented with specific domains from equivalence t...

Systematic Reviews, 2021

Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-li... more Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. This paper aims to outline the protocol of a systematic review that will investigate the efficacy and safety profile of biosimilars compared to biologics (objective 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (objective 2). Methods We will investigate the effects of any biosimilars of adalimumab, etanercept, and infliximab on RA patients. We will include randomized controlled trials (RCTs) or quasi-RCTs to assess efficacy and safety outcomes and RCTs with two- or multiple-par...

INTRODUCAO: A medida de qualidade de vida relacionada a saude (QVRS) refere-se ao modo como um in... more INTRODUCAO: A medida de qualidade de vida relacionada a saude (QVRS) refere-se ao modo como um individuo avalia seu proprio bem-estar geral e sua saude. OBJETIVOS: Objetivou-se nesse estudo avaliar a QVRS dos usuarios da Atencao Primaria em Saude (ABS) do Sistema Unico de Saude (SUS) no Brasil e os fatores a ela associados. . METODOS: Estudo transversal com dados oriundos da Pesquisa Nacional sobre Acesso, Utilizacao e Promocao do Uso Racional de Medicamentos (PNAUM), componente Servicos no Brasil. A coleta de dados foi realizada entre Julho a Dezembro de 2014 por meio de questionario que incluiu o instrumento de medida de QVRS, o Euroqol 5 Dimensions (EQ-5D). Regressao linear multipla foi utilizada para analisar a QVRS e fatores a ela associados. RESULTADOS: No total, 8.590 usuarios da APS reportaram sua QVRS. Dor/Mal-estar (50,7%) e Ansiedade/ Depressao (38,8%) foram as dimensoes em que os usuarios relataram com maior frequencia algum problema. Cerca de 10% dos usuarios reportaram...

Health Research Policy and Systems, 2020

Background Health technology assessment (HTA) should provide an assessment of a technology’s effe... more 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...

Value in Health, 2020

Annual increases in list and net prices were higher in 2007-2014, when they averaged 17-18%, but ... more Annual increases in list and net prices were higher in 2007-2014, when they averaged 17-18%, but slowed down after 2015, with annual increases of 10.9% and 6.9% in 2015-2017. After 2017, list prices increased by an annual average of 5.9%, while net prices leveled off. From 2007-2019, manufacturer discounts for self-administered MS DMTs increased, on average, by 40.4 percentage points for Medicaid, from 26.7% to 67.1%; and by 7.2% for payers other than Medicaid, from 8.5% to 15.7%. Conclusions: Prices of self-administered MS DMTs rose dramatically in 2007-2019, even after accounting for manufacturer discounts. Recent leveling off of net prices was particularly driven by increases in manufacturers discounts for payers other than Medicaid.

Revista Brasileira de Pesquisa em Saúde/Brazilian Journal of Health Research, 2016

Resumo| Introdução: Acesso a medicamentos é componente-chave na viabilização e mensuração do dese... more Resumo| Introdução: Acesso a medicamentos é componente-chave na viabilização e mensuração do desempenho dos sistemas de saúde. Objetivos: Este estudo objetivou verificar, por meio de revisão sistemática, o perfil de estudos e os resultados dos indicadores de acesso a medicamentos no Brasil. Métodos: Revisão sistemática de estudos observacionais disponíveis nas bases de dados, US National Library of Medicine (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Centre of Reviews and Dissemination (CRD) e Essential Medicines and Health Products Information Portal (WHO), incluindo busca manual nas referências dos estudos incluídos e literatura cinzenta (Banco de Teses-Capes, Biblioteca Digital de Teses e Dissertações da USP, ProQuest Dissertação e Teses, relatórios técnicos do WHO Medicines Strategy e relatórios de pesquisa: PNAD, Ministério da Saúde, IBGE). Resultados: Foram incluídos 29 estudos sobre Acesso a Medicamentos. Destes, 19 estudos avaliaram acesso no nível municipal, 9 no setor público, 12 sob a perspectiva exclusiva dos usuários, 22 estudos avaliaram medicamentos essenciais, 14 avaliaram mais de uma dimensão do acesso e 24 estudos apresentaram indicadores relacionados à disponibilidade. Entre todas as dimensões do AAM, foram encontrados 19 indicadores distintos. O indicador "disponibilidade física" foi utilizado em 12 estudos. Conclusão: Os estudos tiveram foco na disponibilidade e nenhum estudo avaliou todas as dimensões do acesso. O nível de acesso foi variável entre os estudos. Esta avaliação levanta a necessidade de desenvolver uma diretriz para avaliar AAM, que fomente comparações e avaliações de desempenho dos sistemas de saúde ao longo do tempo. Palavras-chave| Acesso aos Serviços de Saúde; Assistência Farmacêutica; Brasil.

Revista da Associação Médica Brasileira, 2019

SUMMARY OBJECTIVE: To assist clinicians to make adequate interpretation of scientific evidence fr... more SUMMARY OBJECTIVE: To assist clinicians to make adequate interpretation of scientific evidence from studies that evaluate diagnostic tests in order to allow their rational use in clinical practice. METHODS: This is a narrative review focused on the main concepts, study designs, the adequate interpretation of the diagnostic accuracy data, and making inferences about the impact of diagnostic testing in clinical practice. RESULTS: Most of the literature that evaluates the performance of diagnostic tests uses cross-sectional design. Randomized clinical trials, in which diagnostic strategies are compared, are scarce. Cross-sectional studies measure diagnostic accuracy outcomes that are considered indirect and insufficient to define the real benefit for patients. Among the accuracy outcomes, the positive and negative likelihood ratios are the most useful for clinical management. Variations in the study's cross-sectional design, which may add bias to the results, as well as other domai...

Revista de saude publica, Jan 13, 2017

To analyze the Health-Related Quality of Life (HRQoL) of patients of the primary health care of t... more To analyze the Health-Related Quality of Life (HRQoL) of patients of the primary health care of the Brazilian Unified Health System (SUS) and its associated factors. This is a cross-sectional study with data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Serviços, 2015 (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines - Services, 2015). Data were collected with a questionnaire that included the EuroQol 5 Dimensions (EQ-5D) instrument. Patients from the five regions of Brazil were interviewed. Multiple linear regression was used to analyze their Health-Related Quality of Life and its associated factors. Of the total of 8,590 patients, the most frequent dimensions were pain/discomfort (50.7%) and anxiety/depression (38.8%). About 10% of the patients reported extreme problems in these dimensions. The following factors were significantly associated with a worse quality of life: being female; having arthri...

Revista de saude publica, Jan 13, 2017

To evaluate the access to medicines in primary health care of the Brazilian Unified Health System... more To evaluate the access to medicines in primary health care of the Brazilian Unified Health System (SUS), from the patients' perspective. This is a cross-sectional study that used data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Services, 2015 (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines), conducted by interviews with 8,591 patients in cities of the five regions of Brazil. Evaluation of access to medicines used concepts proposed by Penshansky and Thomas (1981), according to the dimensions: availability, accessibility, accommodation, acceptability, and affordability. Each dimension was evaluated by its own indicators. For the "availability" dimension, 59.8% of patients reported having full access to medicines, without significant difference between regions. For "accessibility," 60% of patients declared that the basic health unit (UBS) was not far from their house, 83% sai...

Value in Health, 2016

PHC reported its HRQoL. Pain/Discomfort (50.7%) and Anxiety/Depression (38.8%) were dimensions in... more PHC reported its HRQoL. Pain/Discomfort (50.7%) and Anxiety/Depression (38.8%) were dimensions in which users reported more often some problem. About 10% of users reported extreme problems in these dimensions. A worse HRQoL was significantly associated with the following factors: women (β =-0,012); stroke (β =-0,106), arthritis, osteoarthritis or rheumatism (β =-0,086), depression (β =-0,079), heart diseases (β =-0,032); diet to lose weight (β =-0,014); diet to reduce fat intake (β =-0,017); health self-assessment as poor or very poor (β =-0,239); the use of alcoholic beverage once or more per month (β =-0,020). A greatest HRQoL was significantly associated with the following factors: users residing in the North and the Southeast (β = 0,049; β = 0,032), the practice of physical activity (β = 0,019), and better level of education. There was no association with HRQoL and factors related to health services. ConClusions: These findings show that the HRQoL of the users of PHC of SUS was influenced by demographic, socioeconomic, health-related conditions and lifestyle factors. Users with stroke had significantly lower HRQoL. Thus, the HRQoL can be an important measure for promoting health and comprehensive health care to users of SUS.

Journal of Environmental Science and Health, Part B, 2016

Natural steroidal estrogens such as 17 β-estradiol (E2), as well as antimicrobials such as doxycy... more Natural steroidal estrogens such as 17 β-estradiol (E2), as well as antimicrobials such as doxycycline and norfloxacin, are excreted by humans and hence detected in sewage sludge and biosolid. The disposal of human waste products on agricultural land results in estrogens and antibiotics being detected as mixtures in soils. The objective of this study was to examine microbial respiration and E2 mineralization in sewage sludge, biosolid and soil in the presence and absence of doxycycline and norfloxacin. The antimicrobials were applied to the media either alone or in combination at total rates of 4 and 40 mg kg-1 , with the 4 mg kg-1 rate being an environmentally relevant concentration. The calculated time that half of the applied E2 was mineralized ranged from 294 to 418 d in sewage sludge, from 721 to 869 d in soil and from 2,258 to 14,146 d in biosolid. E2 mineralization followed first-order and the presence of antimicrobials had no significant effect on mineralization half-lives, except for some antimicrobial applications to the human waste products. At 189 d, total E2 mineralization was significantly greater in sewage sludge (38 ±0.7%) > soil (23 ±0.7%) > biosolid (3 ±0.7%), while total respiration was significantly greater in biosolid (1,258 mg CO 2) > sewage sludge (253 mg CO 2) ≥ soil (131 mg CO 2). Strong sorption of E2 to the organic fraction in biosolid may have resulted in reduced E2 mineralization despite the high microbial activity in this media. Total E2 mineralization at 189 d was not significantly influenced by the presence of doxycycline and/or norfloxacin in the media. Antimicrobial additions also did not significantly influence total respiration in media, except that total CO 2 respiration at 189 d was significantly greater for biosolid with 40 mg kg-1 doxycycline added, relative to biosolid without antimicrobials. We conclude that it is unlikely for doxycycline and norfloxacin, or their mixtures, to have a significant effect on E2 mineralization in human waste products and soil. However, the potential for E2 to be persistent in biosolids, with and without the presence of antimicrobials, is posing a challenge for biosolid disposal to agricultural lands.

JAMA Network Open

ImportanceBiosimilar drugs are potentially lower-cost versions of biologics that may improve acce... more ImportanceBiosimilar drugs are potentially lower-cost versions of biologics that may improve access to therapy. However, there is a lack of adequate systematic reviews demonstrating equivalence between these drugs for the treatment of rheumatoid arthritis (RA).ObjectivesTo assess the efficacy, safety, and immunogenicity associated with biosimilars of adalimumab, etanercept, and infliximab compared with their reference biologics in patients with RA.Data SourcesMEDLINE via PubMed, Embase, Cochrane Central Register of Controlled Trials, and LILACS databases were searched from inception to September 2021.Study SelectionHead-to-head randomized clinical trials (RCTs) of biosimilars of adalimumab, etanercept, and infliximab and their biologic reference drugs for RA were assessed.Data Extraction and SynthesisTwo authors independently abstracted all data. Meta-analysis was conducted with bayesian random effects using relative risks (RRs) for binary outcomes and standardized mean differences ...

Additional file 1. PRISMA for systematic review protocols (PRISMA-P) Checklist. Source: Moher et ... more Additional file 1. PRISMA for systematic review protocols (PRISMA-P) Checklist. Source: Moher et al. [21].

Additional file 1. Preferred Reporting Items for Systematic reviews and Meta-Analyses extension f... more Additional file 1. Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) Checklist [27].

Additional file 2. Classification of HTA reports according to the criteria of Merlin et al. [29].... more Additional file 2. Classification of HTA reports according to the criteria of Merlin et al. [29]. HTA Health Technology Assessment. * A synthesis that collates all empirical evidence fitting pre-specified eligibility criteria to answer a specific research question. Systematic reviews are conducted according to a pre-specified protocol. The methods used are selected to minimise bias, thus providing more reliable findings from which conclusions can be drawn and decisions made.

Primeiro Congresso da REBRATS, 2019

Background: Até julho de 2019, a European Medicine Agency havia aprovado 14 biossimilares do adal... more Background: Até julho de 2019, a European Medicine Agency havia aprovado 14 biossimilares do adalimumabe (ADAbios: 8), etarnecepte (ETNbios: 2) e infliximabe (IFXbios: 4); o Food and Drug Administration, 9 biossimilares (4 ADAbios /2 ETNbios/3 IFXbios); e a Agência Nacional de Vigilância Sanitária, 5 biossimilares (1 ADAbios/1 ETNbios/3 IFXbios). Objetivou-se revisar sistematicamente a evidência da equivalência (EQ) ou não inferioridade (NI), substituição ou intercambialidade de biossimilares do ADAbios, ETNbios e IFXbios comparado aos seus biológicos de referência para o tratamento de artrite reumatoide.

2 17 Β-Estradiol mineralization in human waste products and soil in the presence and 3 absence of... more 2 17 Β-Estradiol mineralization in human waste products and soil in the presence and 3 absence of antimicrobials 4 5 6 INOKA AMARAKOON, ANNEMIEKE FARENHORST*, KARIN ROSE, ANNE 7 CLAEYS and BRUNA ASCEF 8 9 10 Department of Soil Science, University of Manitoba, Winnipeg, Manitoba R3T 2N2, Canada 11 Department of Biologie, Institt Universitaire de Technologie de Perpignan, Perpignan, 12 Pyrénées Orientales, France 13 Department of Pharmacy, Universidade Federal dos Vales do Jequitinhonha e Mucuri, 14 Diamantina, Minas Gerais, Brazil 15

Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-li... more Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven to the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. These two systematic reviews aim to investigate the efficacy and safety profile of biosimilars compared to biologics (systematic review 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (systematic review 2).Methods Electronic searches will be performed through MEDLINE (via Pubmed), EMBASE, LILACS, and CENTRAL (from inception to September 2020). Risk of bias assessments will be carried out with the Cochrane risk of bias tool, supplemented with specific domains from equivalence t...

Systematic Reviews, 2021

Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-li... more Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. This paper aims to outline the protocol of a systematic review that will investigate the efficacy and safety profile of biosimilars compared to biologics (objective 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (objective 2). Methods We will investigate the effects of any biosimilars of adalimumab, etanercept, and infliximab on RA patients. We will include randomized controlled trials (RCTs) or quasi-RCTs to assess efficacy and safety outcomes and RCTs with two- or multiple-par...

INTRODUCAO: A medida de qualidade de vida relacionada a saude (QVRS) refere-se ao modo como um in... more INTRODUCAO: A medida de qualidade de vida relacionada a saude (QVRS) refere-se ao modo como um individuo avalia seu proprio bem-estar geral e sua saude. OBJETIVOS: Objetivou-se nesse estudo avaliar a QVRS dos usuarios da Atencao Primaria em Saude (ABS) do Sistema Unico de Saude (SUS) no Brasil e os fatores a ela associados. . METODOS: Estudo transversal com dados oriundos da Pesquisa Nacional sobre Acesso, Utilizacao e Promocao do Uso Racional de Medicamentos (PNAUM), componente Servicos no Brasil. A coleta de dados foi realizada entre Julho a Dezembro de 2014 por meio de questionario que incluiu o instrumento de medida de QVRS, o Euroqol 5 Dimensions (EQ-5D). Regressao linear multipla foi utilizada para analisar a QVRS e fatores a ela associados. RESULTADOS: No total, 8.590 usuarios da APS reportaram sua QVRS. Dor/Mal-estar (50,7%) e Ansiedade/ Depressao (38,8%) foram as dimensoes em que os usuarios relataram com maior frequencia algum problema. Cerca de 10% dos usuarios reportaram...

Health Research Policy and Systems, 2020

Background Health technology assessment (HTA) should provide an assessment of a technology’s effe... more 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...

Value in Health, 2020

Annual increases in list and net prices were higher in 2007-2014, when they averaged 17-18%, but ... more Annual increases in list and net prices were higher in 2007-2014, when they averaged 17-18%, but slowed down after 2015, with annual increases of 10.9% and 6.9% in 2015-2017. After 2017, list prices increased by an annual average of 5.9%, while net prices leveled off. From 2007-2019, manufacturer discounts for self-administered MS DMTs increased, on average, by 40.4 percentage points for Medicaid, from 26.7% to 67.1%; and by 7.2% for payers other than Medicaid, from 8.5% to 15.7%. Conclusions: Prices of self-administered MS DMTs rose dramatically in 2007-2019, even after accounting for manufacturer discounts. Recent leveling off of net prices was particularly driven by increases in manufacturers discounts for payers other than Medicaid.

Revista Brasileira de Pesquisa em Saúde/Brazilian Journal of Health Research, 2016

Resumo| Introdução: Acesso a medicamentos é componente-chave na viabilização e mensuração do dese... more Resumo| Introdução: Acesso a medicamentos é componente-chave na viabilização e mensuração do desempenho dos sistemas de saúde. Objetivos: Este estudo objetivou verificar, por meio de revisão sistemática, o perfil de estudos e os resultados dos indicadores de acesso a medicamentos no Brasil. Métodos: Revisão sistemática de estudos observacionais disponíveis nas bases de dados, US National Library of Medicine (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Centre of Reviews and Dissemination (CRD) e Essential Medicines and Health Products Information Portal (WHO), incluindo busca manual nas referências dos estudos incluídos e literatura cinzenta (Banco de Teses-Capes, Biblioteca Digital de Teses e Dissertações da USP, ProQuest Dissertação e Teses, relatórios técnicos do WHO Medicines Strategy e relatórios de pesquisa: PNAD, Ministério da Saúde, IBGE). Resultados: Foram incluídos 29 estudos sobre Acesso a Medicamentos. Destes, 19 estudos avaliaram acesso no nível municipal, 9 no setor público, 12 sob a perspectiva exclusiva dos usuários, 22 estudos avaliaram medicamentos essenciais, 14 avaliaram mais de uma dimensão do acesso e 24 estudos apresentaram indicadores relacionados à disponibilidade. Entre todas as dimensões do AAM, foram encontrados 19 indicadores distintos. O indicador "disponibilidade física" foi utilizado em 12 estudos. Conclusão: Os estudos tiveram foco na disponibilidade e nenhum estudo avaliou todas as dimensões do acesso. O nível de acesso foi variável entre os estudos. Esta avaliação levanta a necessidade de desenvolver uma diretriz para avaliar AAM, que fomente comparações e avaliações de desempenho dos sistemas de saúde ao longo do tempo. Palavras-chave| Acesso aos Serviços de Saúde; Assistência Farmacêutica; Brasil.

Revista da Associação Médica Brasileira, 2019

SUMMARY OBJECTIVE: To assist clinicians to make adequate interpretation of scientific evidence fr... more SUMMARY OBJECTIVE: To assist clinicians to make adequate interpretation of scientific evidence from studies that evaluate diagnostic tests in order to allow their rational use in clinical practice. METHODS: This is a narrative review focused on the main concepts, study designs, the adequate interpretation of the diagnostic accuracy data, and making inferences about the impact of diagnostic testing in clinical practice. RESULTS: Most of the literature that evaluates the performance of diagnostic tests uses cross-sectional design. Randomized clinical trials, in which diagnostic strategies are compared, are scarce. Cross-sectional studies measure diagnostic accuracy outcomes that are considered indirect and insufficient to define the real benefit for patients. Among the accuracy outcomes, the positive and negative likelihood ratios are the most useful for clinical management. Variations in the study's cross-sectional design, which may add bias to the results, as well as other domai...

Revista de saude publica, Jan 13, 2017

To analyze the Health-Related Quality of Life (HRQoL) of patients of the primary health care of t... more To analyze the Health-Related Quality of Life (HRQoL) of patients of the primary health care of the Brazilian Unified Health System (SUS) and its associated factors. This is a cross-sectional study with data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Serviços, 2015 (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines - Services, 2015). Data were collected with a questionnaire that included the EuroQol 5 Dimensions (EQ-5D) instrument. Patients from the five regions of Brazil were interviewed. Multiple linear regression was used to analyze their Health-Related Quality of Life and its associated factors. Of the total of 8,590 patients, the most frequent dimensions were pain/discomfort (50.7%) and anxiety/depression (38.8%). About 10% of the patients reported extreme problems in these dimensions. The following factors were significantly associated with a worse quality of life: being female; having arthri...

Revista de saude publica, Jan 13, 2017

To evaluate the access to medicines in primary health care of the Brazilian Unified Health System... more To evaluate the access to medicines in primary health care of the Brazilian Unified Health System (SUS), from the patients' perspective. This is a cross-sectional study that used data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Services, 2015 (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines), conducted by interviews with 8,591 patients in cities of the five regions of Brazil. Evaluation of access to medicines used concepts proposed by Penshansky and Thomas (1981), according to the dimensions: availability, accessibility, accommodation, acceptability, and affordability. Each dimension was evaluated by its own indicators. For the "availability" dimension, 59.8% of patients reported having full access to medicines, without significant difference between regions. For "accessibility," 60% of patients declared that the basic health unit (UBS) was not far from their house, 83% sai...

Value in Health, 2016

PHC reported its HRQoL. Pain/Discomfort (50.7%) and Anxiety/Depression (38.8%) were dimensions in... more PHC reported its HRQoL. Pain/Discomfort (50.7%) and Anxiety/Depression (38.8%) were dimensions in which users reported more often some problem. About 10% of users reported extreme problems in these dimensions. A worse HRQoL was significantly associated with the following factors: women (β =-0,012); stroke (β =-0,106), arthritis, osteoarthritis or rheumatism (β =-0,086), depression (β =-0,079), heart diseases (β =-0,032); diet to lose weight (β =-0,014); diet to reduce fat intake (β =-0,017); health self-assessment as poor or very poor (β =-0,239); the use of alcoholic beverage once or more per month (β =-0,020). A greatest HRQoL was significantly associated with the following factors: users residing in the North and the Southeast (β = 0,049; β = 0,032), the practice of physical activity (β = 0,019), and better level of education. There was no association with HRQoL and factors related to health services. ConClusions: These findings show that the HRQoL of the users of PHC of SUS was influenced by demographic, socioeconomic, health-related conditions and lifestyle factors. Users with stroke had significantly lower HRQoL. Thus, the HRQoL can be an important measure for promoting health and comprehensive health care to users of SUS.

Journal of Environmental Science and Health, Part B, 2016

Natural steroidal estrogens such as 17 β-estradiol (E2), as well as antimicrobials such as doxycy... more Natural steroidal estrogens such as 17 β-estradiol (E2), as well as antimicrobials such as doxycycline and norfloxacin, are excreted by humans and hence detected in sewage sludge and biosolid. The disposal of human waste products on agricultural land results in estrogens and antibiotics being detected as mixtures in soils. The objective of this study was to examine microbial respiration and E2 mineralization in sewage sludge, biosolid and soil in the presence and absence of doxycycline and norfloxacin. The antimicrobials were applied to the media either alone or in combination at total rates of 4 and 40 mg kg-1 , with the 4 mg kg-1 rate being an environmentally relevant concentration. The calculated time that half of the applied E2 was mineralized ranged from 294 to 418 d in sewage sludge, from 721 to 869 d in soil and from 2,258 to 14,146 d in biosolid. E2 mineralization followed first-order and the presence of antimicrobials had no significant effect on mineralization half-lives, except for some antimicrobial applications to the human waste products. At 189 d, total E2 mineralization was significantly greater in sewage sludge (38 ±0.7%) > soil (23 ±0.7%) > biosolid (3 ±0.7%), while total respiration was significantly greater in biosolid (1,258 mg CO 2) > sewage sludge (253 mg CO 2) ≥ soil (131 mg CO 2). Strong sorption of E2 to the organic fraction in biosolid may have resulted in reduced E2 mineralization despite the high microbial activity in this media. Total E2 mineralization at 189 d was not significantly influenced by the presence of doxycycline and/or norfloxacin in the media. Antimicrobial additions also did not significantly influence total respiration in media, except that total CO 2 respiration at 189 d was significantly greater for biosolid with 40 mg kg-1 doxycycline added, relative to biosolid without antimicrobials. We conclude that it is unlikely for doxycycline and norfloxacin, or their mixtures, to have a significant effect on E2 mineralization in human waste products and soil. However, the potential for E2 to be persistent in biosolids, with and without the presence of antimicrobials, is posing a challenge for biosolid disposal to agricultural lands.