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1.
J Oncol Pharm Pract ; 29(4): 934-943, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-36916182

RESUMO

OBJECTIVE: Patients with non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations have a poor prognosis and few therapeutic alternatives. We conducted a review of scientific evidence about therapies in NSCLC with EGFR exon 20 insertion mutations. DATA SOURCES: A systematic review in PubMed® database was performed up to November 19, 2022. Clinical trials (CTs) about treatments of patients diagnosed with advanced or metastatic NSCLC harbouring EGFR exon 20 insertions who had previously received platinum-based chemotherapy were selected. CTs with a sample size of less than 10 patients were discarded. Efficacy results were used to determine the most interesting drugs. Subsequently, a more exhaustive analysis of the design of the CTs and safety of the most interesting schemes was conducted. Comparisons were attempted to develop. DATA SUMMARY: A total of 40 records were found in the systematic search. Twelve selected CTs included the following therapies: poziotinib, osimertinib, pertuzumab-trastuzumab-docetaxel scheme, mobocertinib, amivantamab, erlotinib-onalespib regimen, luminespib, ado-trastuzumab emtansine and dacomitinib. Mobocertinib, amivantamab and poziotinib were determined as the most interesting treatments according to efficacy data. Gastrointestinal and dermatological adverse reactions were relevant in these regimens. All CTs presented a non-randomised design. No reliable comparisons could be developed. CONCLUSIONS: The efficacy of mobocertinib, amivantamab and poziotinib in NSCLC with EGFR exon 20 insertion mutations is promising. However, therapies were assessed in single-arm CTs with low-quality evidence. Comparative studies with more extensive patient follow-up, larger sample size and better design are needed to reliably quantify the effect of these drugs.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/genética , Carcinoma Pulmonar de Células não Pequenas/patologia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/patologia , Mutagênese Insercional , Inibidores de Proteínas Quinases/uso terapêutico , Mutação , Receptores ErbB/genética , Éxons/genética
2.
J Oncol Pharm Pract ; 29(1): 155-161, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34846221

RESUMO

INTRODUCTION: There is subgroup analysis suggesting a lack of benefit of daratumumab use in multiple myeloma (MM) and hepatic disease (HD). The objectives of this study were to conduct a systematic review and interpretation of daratumumab-based regimen efficacy in transplant-ineligible patients with untreated MM and HD. METHODS: A systematic search in Pubmed® database about randomized clinical trials (RCTs) with subgroup analysis regarding hepatic function for overall survival (OS) or progression-free survival (PFS) were developed. Two methodologies were applied. One of them considered statistical interaction, prespecification, biological support and consistency of subgroup results. Second methodology was two-part validated tool: preliminary questions to reject subset analysis without minimal relevance, and a checklist relating a recommendation for applicability in clinical practice. RESULTS: It was included three records. About first methodology, statistical interaction among subgroups was found for PFS in one RCT. Subsets were prespecified in all RCTs. Biological support of efficacy differences could be reasonable. Inconsistent results were found. Second methology directly rejected applicability of subset analysis in two records. Checklist recommended "null" application of results in the remaining RCT. CONCLUSIONS: No consistent heterogeneity for daratumumab-based regimen efficacy was observed among subgroups regarding hepatic function in transplant-ineligible patients with untreated MM. Patients with normal hepatic function and HD could benefit from these treatments.


Assuntos
Mieloma Múltiplo , Humanos , Mieloma Múltiplo/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Intervalo Livre de Progressão
3.
Support Care Cancer ; 30(5): 3761-3772, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35028720

RESUMO

Subgroup analysis evaluates a health intervention in subpopulations according to a characteristic or factor. It can be useful for generating new hypotheses or conducting new studies. However, subgroup analysis presents several limitations and it should be considered cautiously. The development of new onco-hematological drugs is accelerating in recent years and the impact of subgroup analysis on clinical decision-making is increasing. The interpretation of subgroup analyses can be controversial in some cases, negatively affecting patients and healthcare systems. This work is a review of the clinical and pharmacoeconomic impact of subgroup analysis in onco-hematological patients. The study describes some illustrative examples of inadequate interpretations about subset analysis: combination of pembrolizumab plus chemotherapy in lung cancer, inhibitors of cyclin-dependent kinases in breast cancer, daratumumab-based regimens in newly diagnosed multiple myeloma, combination of nivolumab with ipilimumab in melanoma and docetaxel in prostate cancer. Subgroup analysis can have a significant impact on the data selection for the development of studies; efficacy, safety, and convenience of treatments in onco-hematological patients; efficiency of therapies in health systems; and therapeutic positioning of antineoplastic drugs. There is a strong need to establish homogeneous criteria for the assessment of subgroup analysis and to develop new tools for its consideration.


Assuntos
Antineoplásicos , Melanoma , Antineoplásicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Farmacoeconomia , Humanos , Ipilimumab/uso terapêutico , Masculino , Melanoma/tratamento farmacológico , Nivolumabe/uso terapêutico
4.
J Oncol Pharm Pract ; 28(6): 1375-1380, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35306910

RESUMO

Objective: Refractory multiple myeloma (MM) presents poor responses to therapies. New drugs for highly pretreated MM are a hope for this clinical context with limited treatment options. We developed a comparative commentary on the evidence about the use of belantamab mafodotin in heavily pretreated relapsed or refractory MM with respect to other therapies. Data sources: Regimen data were extracted from pivotal clinical trials. Data summary: Response rates were the main efficacy outcomes reported in trials. Overall response was achieved by approximately 30% of patients trated with belantamab mafodotin. Response rates of different regimens must be supported by more relevant data, such as overall survival or progression-free survival. Subgroups of patients with extramedullary disease and revised International Staging System III should be thoroughly evaluated in phase III comparative clinical trials with larger sample sizes. Belantamab mafodotin presented specific adverse events (visual disturbances and kerathopathies). Grade 3-4 adverse events involved high percentages of patients treated with the different schemes. The budgetary impact of different treatments for heavily pretreated refractory MM would be very high. Literature suggested increased efficiency of belantamab mafodotin versus chimeric antigen receptor T-cell therapies. Conclusions: Belantamab mafodotin and other regimens are promising drugs for MM, especially for triple-class refractory patients. Comparative studies are necessary to perform a reliable therapeutic positioning.


Assuntos
Mieloma Múltiplo , Anticorpos Monoclonais Humanizados/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Humanos , Mieloma Múltiplo/tratamento farmacológico , Intervalo Livre de Progressão
5.
J Oncol Pharm Pract ; 27(7): 1743-1750, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34424094

RESUMO

BACKGROUND: Use of docetaxel in low- and high-burden metastatic hormone-sensitive prostate cancer presents considerable controversy. There is literature suggesting lack of benefit for low-volume of metastases. OBJECTIVE: The study aims to develop a systematic review and methodological assessment of subset analysis about use of docetaxel in metastatic hormone-sensitive prostate cancer regarding volume of metastatic disease. METHODS: A systematic review in the Pubmed® database was conducted up to 25 September 2020. A reference tracking was also developed. Randomised clinical trials with subgroup analysis according volume of metastatic disease for overall survival were selected. Two methodologies were used. One of them considered statistical interaction of subsets (p(i) < 0.1), pre-specification, biological plausibility and consistency among subset results of similar randomised clinical trials. The second methodology was a two-part validated tool: preliminary questions to discard subset analysis without minimal relevance and a checklist The checklist provides recommendations for applicability of subgroup analysis in clinical practice. RESULTS: A total of 31 results were found in systematic reviews in the Pubmed® database. One result was identified in the reference tracking. Of the total of 32 results, four randomised clinical trials were included in the study. About first methodology, statistical interaction among subgroups was obtained in one randomised clinical trial. Subgroup analysis was pre-specified in two randomised clinical trials. Biological plausibility was reasonable. No external consistency among results of subgroup analyses in randomised clinical trials was observed. Preliminary questions of second methodology rejected applicability of subgroup analysis in three randomised clinical trials. A 'null' recommendation for applicability of subset results was obtained in the remaining randomised clinical trial. CONCLUSIONS: Patients with low- and high-burden metastatic hormone-sensitive prostate cancer would benefit from docetaxel therapy. No consistent differences for overall survival were observed in subgroup analyses regarding volume of metastatic disease.


Assuntos
Antagonistas de Androgênios , Neoplasias da Próstata , Humanos , Masculino , Docetaxel/uso terapêutico , Hormônios , Neoplasias da Próstata/tratamento farmacológico
7.
Eur J Haematol ; 105(1): 56-65, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32145104

RESUMO

OBJECTIVES: Multiple myeloma (MM) is a complex disease. Lack of direct comparisons among treatments and incorporation of new alternatives make it necessary to perform studies that allow for clinical decision-making. A network meta-analysis (NMA) was developed to evaluate the comparative efficacy among different therapeutic alternatives in newly diagnosed transplant-ineligible MM patients. METHODS: MEDLINE® and EMBASE® were systematically searched up for these drugs: lenalidomide, thalidomide, bortezomib, and daratumumab. Comparative phase II-III randomized clinical trials (RCTs) were included. Progression-free survival (PFS) was selected as efficacy outcome. The NMA was developed using Bayesian methods. Fixed- and random-effects models were assessed using deviance information criteria. RESULTS: The systematic search yielded 593 results. Ten RCTs were included. No differences were observed between fixed- and random-effects models. The combination of daratumumab, bortezomib, melphalan, and prednisone showed the best HR in PFS (reference treatment). Along with this scheme, the best PFS results were obtained by combination of daratumumab, lenalidomide, and dexamethasone (HR 1.2, 95% CrI 0.64-2.4) and bortezomib with lenalidomide and dexamethasone (HR 1.6, 95% CrI 0.81-3.0). CONCLUSIONS: Schemes with the best PFS results were daratumumab treatments and combination of bortezomib, lenalidomide, and dexamethasone, although the latter scheme has been analyzed in heterogeneous populations.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Cuidados Pré-Operatórios , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Ensaios Clínicos como Assunto , Transplante de Células-Tronco Hematopoéticas/métodos , Humanos , Quimioterapia de Indução , Mieloma Múltiplo/diagnóstico , Mieloma Múltiplo/mortalidade , Prognóstico , Resultado do Tratamento
8.
J Clin Pharm Ther ; 45(3): 530-538, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31854128

RESUMO

WHAT IS KNOWN AND OBJECTIVE: Subgroup analysis plays an important role in clinical decision-making. Correct management of subgroup analysis is necessary to optimize effectiveness, safety and efficiency of treatments. No homogeneous criteria have been developed for interpretation of subgroup analysis. In this study, the researcher develops a checklist to evaluate the reliability and applicability of the results of subset analyses. METHODS: With a review of previous literature, three main criteria were included in the checklist: statistical association, biological plausibility and consistency among studies. Statistical association considered interaction probability, prespecification of analysis, number of subgroups analysed, sample size and positive/negative result in global analysis. Each item was given an indicative score. Total score was related to a level of applicability for the results in clinical practice. Checklist validation included interinvestigator concordance and assessment about utility. Three drug examples were used to validate the tool. RESULTS AND DISCUSSION: Twenty-six evaluators showed adequate interinvestigator concordance (kappa 0.79, 1 and 0.83 for each drug example regarding applicability). Kappa values increased to 0.94, 1 and 1 after group discussion. Checklist utility score was greater than 4.7/5 in three drug examples. In pre-analysis, inter-researcher agreement on global applicability recommendation of subgroup results to practice was 92.3% (ramucirumab), 96% (nivolumab) and 100% (mepolizumab). In post-analysis, inter-researcher agreement on applicability recommendation of subgroup results was 100%, 94.45% and 100%, respectively. The checklist validation shows a high interindividual agreement of the results, both with respect to the evaluation of the applicability of subgroup analysis and concerning clinical decision-making. WHAT IS NEW AND CONCLUSION: We have developed the first validated tool for interpretation of subgroup analyses. The checklist contributes to the adoption of homogeneous criteria for subgroup analyses, thereby allowing discussion and evaluation of the effects of a health intervention.


Assuntos
Lista de Checagem , Sistemas de Apoio a Decisões Clínicas , Anticorpos Monoclonais Humanizados/uso terapêutico , Antineoplásicos/uso terapêutico , Humanos , Nivolumabe/uso terapêutico , Reprodutibilidade dos Testes , Ramucirumab
9.
Matern Child Health J ; 24(9): 1099-1103, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32671537

RESUMO

INTRODUCTION: Background cross-reactivity with other coronaviruses may reduce the specificity of COVID-19 rapid serologic tests. The vast majority of women attend prenatal care, which is a unique source of population-based blood samples appropriate for validation studies. We used stored 2018 serum samples from an existing pregnancy cohort study to evaluate the specificity of COVID-19 serologic rapid diagnostic tests. METHODS: We randomly selected 120 stored serum samples from pregnant women enrolled in a cohort in 2018 in Tegucigalpa, Honduras, at least 1 year before the COVID-19 pandemic. We used stored serum to evaluate four lateral flow rapid diagnostic tests, following manufacturers' instructions. Pictures were taken for all tests and read by two blinded trained evaluators. RESULTS: We evaluated 120, 80, 90, and 90 samples, respectively. Specificity for both IgM and IgG was 100% for the first two tests (95% confidence intervals [CI] 97.0-100 and 95.5-100, respectively). The third test had a specificity of 98.9% (95% CI 94.0-100) for IgM and 94.4% (95% CI 87.5-98.2) for IgG. The fourth test had a specificity of 88.9% (95% CI 80.5-94.5) for IgM and 100% (95% CI 96.0-100) for IgG. DISCUSSION: COVID-19 serologic rapid tests are of variable specificity. Blood specimens from sentinel prenatal clinics provide an opportunity to validate serologic tests with population-based samples.


Assuntos
Infecções por Coronavirus/diagnóstico , Pneumonia Viral/diagnóstico , Cuidado Pré-Natal/métodos , Adolescente , Adulto , Betacoronavirus , COVID-19 , Teste para COVID-19 , Técnicas de Laboratório Clínico , Estudos de Coortes , Infecções por Coronavirus/sangue , Infecções por Coronavirus/epidemiologia , Feminino , Humanos , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Valor Preditivo dos Testes , Gravidez , SARS-CoV-2 , Sensibilidade e Especificidade , Testes Sorológicos , Adulto Jovem
10.
Rev Panam Salud Publica ; 41: e104, 2017 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-28902264

RESUMO

OBJECTIVE: To describe the relationship between exposure to physical and/or sexual intimate partner violence (IPV) and indicators of antenatal care (ANC) service utilization among Honduran women of reproductive age. METHODS: Data from the 2011-2012 Honduras Demographic and Health Survey were analyzed to describe the relationship between self-reported exposure to IPV and two ANC outcomes: (1) sufficient ANC visits (defined by the Honduran Ministry of Health as five or more visits) and (2) early ANC initiation (within the first trimester). Multiple logistic regression was used to estimate effects of physical and sexual IPV on the outcomes, controlling for women's age, education, literacy, residence, household size, religion, parity, wealth, husband's age, and husband's education. RESULTS: Of women who were married, had at least one living child 5 years or younger, and completed the IPV module (N = 6 629), 13.5% of them reported any physical IPV, and 4.1% reported both physical and sexual IPV. There was no significant association between IPV and early ANC; however, a significant relationship between IPV and sufficient ANC was found. Women who experienced any physical IPV (adjusted odds ratios (aOR) = 1.25; 95% confidence interval (CI): 1.00-1.56) or sexual IPV (aOR = 1.53; 95% CI: 1.08-2.16) were, respectively, 25% and 53% more likely to receive insufficient ANC. CONCLUSIONS: Honduras has one of highest rates of interpersonal violence of any nation in the world. In Honduras, IPV is a contributor to this broader category of interpersonal violence as well as a risk factor for insufficient ANC. Our findings suggest that universal IPV screening during ANC as well as future initiatives aimed at reducing IPV might improve ANC utilization in the country.


Assuntos
Violência por Parceiro Íntimo/estatística & dados numéricos , Cuidado Pré-Natal/estatística & dados numéricos , Adulto , Estudos Transversais , Feminino , Previsões , Honduras , Humanos , Gravidez
13.
Ultrastruct Pathol ; 38(3): 167-77, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24134634

RESUMO

The composition of atheromatous plaque determines its progression toward rupture or thrombosis. Although its histopathological structure has been widely studied, little attention has been paid to its structural and chemical composition and even less to its mineral component. Thirty-three atheromatous plaques were obtained by carotid thromboendarterectomy. Three types of materials were observed under polarized light microscopy: apatite crystals in the form of glomeruli (dark with plane polarized illumination and greensh with cross-polarized illumination); fibrous-like cholesterol (uncolored or grayish with plane-polarized illumination); and amorphous organic material as brownish deposits. SEM-EDX analysis showed an abundance of phosphorus and calcium in sufficient quantities to form calcium phosphates, and appreciably reduced levels of sodium. X-ray diffraction results differentiated samples into three groups: group I with predominance of hydroxyapatite-type crystals, group II with crystalline material containing an amorphous component, and group III with wholly amorphous material. The most abundant mineral in atheromatous plaque is hydroxyapatite, on which crystals of cholesterol and lipid nuclei are deposited, stratifying the plaque into layers that reflect the different stages of its formation. The difference in calcium and sodium concentrations between arteries with and without atheromata may indicate an important relationship in the pathophysiological development of calcium deposits.


Assuntos
Artérias Carótidas/química , Doenças das Artérias Carótidas/metabolismo , Placa Aterosclerótica , Calcificação Vascular/metabolismo , Idoso , Idoso de 80 Anos ou mais , Cálcio/análise , Artérias Carótidas/cirurgia , Artérias Carótidas/ultraestrutura , Doenças das Artérias Carótidas/patologia , Doenças das Artérias Carótidas/cirurgia , Colesterol/análise , Cristalização , Durapatita/análise , Endarterectomia das Carótidas , Feminino , Humanos , Masculino , Microscopia Eletrônica de Varredura , Microscopia de Polarização , Pessoa de Meia-Idade , Fósforo/análise , Sódio/análise , Espectrometria por Raios X , Trombectomia , Calcificação Vascular/patologia , Calcificação Vascular/cirurgia , Difração de Raios X
14.
World J Microbiol Biotechnol ; 29(10): 1773-81, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23558460

RESUMO

Andrimid, a known non-ribosomal pseudo-peptide antibiotic, was isolated from a psychrotolerant Serratia proteamaculans strain. The antibiotic peptide was produced at low temperature (8 °C) in a 7.5 l BIOFLO 101 bioreactor under batch culture mode. Andrimid activity from S. proteamaculans culture was only detected at 25 °C and below and potent antibacterial activity was revealed against both, pathogenic and non-pathogenic bacteria. Minimal inhibitory concentration values determined by microdilution experiments varied in the range between 0.01 and 0.78 µg/ml. Antimicrobial purification and structure elucidation were carried out by LC-MS/MS and ¹H/¹³C NMR approaches. The effects on the ultrastructure of sensitive Escherichia coli 35,218 cells were observed by transmission electron microscopy at different inhibition stages. This work demonstrated the significance of bioprospection from cold environments through the screening of microorganisms with ability to produce cold-active biomolecules of biotechnological interest. S. proteamaculans 136 was revealed as a novel microbial source for andrimid production at low temperatures, showing biotechnological potential to be applied in cryopreservation, food or cosmetic industries against pathogenic bacteria.


Assuntos
Antibacterianos/metabolismo , Serratia/crescimento & desenvolvimento , Serratia/metabolismo , Antibacterianos/química , Antibacterianos/isolamento & purificação , Reatores Biológicos/microbiologia , Cromatografia Líquida , Temperatura Baixa , Escherichia coli/efeitos dos fármacos , Escherichia coli/ultraestrutura , Espectroscopia de Ressonância Magnética , Testes de Sensibilidade Microbiana , Microscopia Eletrônica , Polienos/química , Polienos/isolamento & purificação , Polienos/metabolismo , Pirróis/química , Pirróis/isolamento & purificação , Pirróis/metabolismo , Espectrometria de Massas em Tandem
15.
Eur J Hosp Pharm ; 30(4): e19, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34521726

RESUMO

A multicentre case series of patients with chronic migraine (CM) treated with monoclonal antibodies directed against calcitonin gene-related peptide (CGRP-mAbs) switching were developed. The effectiveness and safety of CGRP-mAbs switching as a preventive treatment for CM in clinical practice were recorded. Effectiveness was measured by ≥50% reduction of monthly migraine days in respect to baseline and reduction in pain intensity. Safety was analysed through adverse events (AEs) and treatment discontinuations. Seven patients were included. The reason for switching was non-response in all cases. Two patients presented a response to the first CGRP-mAb, but the effect was lost after 3 months. The remaining five patients were non-responders. Response to the second CGRP-mAb was observed in three patients, one of them for >3 months. Less than half of the patients previously treated with a CGRP-mAb responded to switching with a second CGRP-mAb. AEs were rare, with no treatment discontinuations.


Assuntos
Peptídeo Relacionado com Gene de Calcitonina , Transtornos de Enxaqueca , Humanos , Peptídeo Relacionado com Gene de Calcitonina/uso terapêutico , Anticorpos Monoclonais/efeitos adversos , Transtornos de Enxaqueca/tratamento farmacológico , Transtornos de Enxaqueca/prevenção & controle
16.
Ultrastruct Pathol ; 36(6): 367-76, 2012 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23216234

RESUMO

The authors review the mineralogical methods and techniques of analyzing calculi, stony concretions in the body. They discuss the main types of kidney stones (prostate, testicular, salivary, and bile) and the different diagnostic methods in mineralogy. By applying the techniques of optical microscopy and electron microscopy, they describe the different characteristics of human stones, based on extensive experience as evidenced by their numerous studies.


Assuntos
Cálculos/diagnóstico , Técnicas Citológicas , Geologia/métodos , Litíase/diagnóstico , Cálculos/química , Cálculos/ultraestrutura , Cálculos/urina , Cristalização , Cristalografia por Raios X , Cisteína/química , Feminino , Doenças dos Genitais Masculinos/diagnóstico , Humanos , Cálculos Renais/diagnóstico , Litíase/química , Litíase/ultraestrutura , Litíase/urina , Masculino , Microscopia Eletrônica , Ácido Oxálico/química , Fosfatos/química , Valor Preditivo dos Testes , Doenças Prostáticas/diagnóstico , Ácido Úrico/química
18.
J Ophthalmic Vis Res ; 17(2): 225-232, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35765633

RESUMO

Purpose: To describe the prevalence and causes of avoidable blindness in people aged 50 and over in the areas of influence of doctors in social service during the years 2018-2019. Methods: This observational, descriptive, cross-sectional study, with analysis of association of variables, was conducted on patients 50 years and older at the national level, selected under simple random sampling, where sociodemographic variables, background, and clinical characteristics were studied. An ophthalmological clinical examination was performed with prior informed consent, and the information was processed and analyzed using Epi Info 7.2 statistical package and SPSS version 25. Results: Overall, 7992 people were evaluated, with a mean age of 62 years; 60.8% (4861) were women and 39.2% (3131) were men. The prevalence of blindness for both eyes was 4.5% (356/7992, 95% CI: 4.1-5.1%, p < 0.001). The prevalence of severe and moderate visual impairment was 1.5% (118/127) and 12.9% (1029)/12.6% (1004) for the right and left eyes, respectively. The main causes of blindness were cataract, refractive error, and glaucoma. Conclusion: The prevalence of avoidable blindness found in the study was higher than expected and the respective causes were consistent with previous studies. Consequently, it is recommended to implement health policies aimed at the prevention and management of avoidable blindness.

19.
Farm Hosp ; 46(6): 367-371, 2022 10 04.
Artigo em Inglês | MEDLINE | ID: mdl-36520577

RESUMO

Patient empowerment is one of the main pillars of humanisation. Therefore, consideration of patients' preferences and expectations should be  taken into account during the practice of any healthcare professional.  Improving overall survival and quality of life are the main wishes of patients.  Indeed, the recent emergence of Patient Reported Outcomes has become an important focus for healthcare providers. The hospital pharmacist  specialised in drug evaluation is a professional who evaluates the efficacy,  safety, appropriateness and efficiency of treatments prescribed by physicians, and decision-making must be based on both technical factors and  the four principles of bioethics. The correct application of evidence-based  clinical practice allows to provide patients with increases in survival and/or quality of life, adapting the convenience and costs to the current  situation. With this in mind, it could be said that the evaluation of medicines  involves a strong commitment to humanisation. On the other hand,  rganisations that promote the rigorous evaluation and selection of medicines  stand as allies of patients, as they have a direct impact on them and an  indirect impact on society. Regulatory agencies in charge of approving and  financing medicines in healthcare systems play a key role in the process of humanising clinical decision-making and empowering patients. If  these agencies approve the use of new medicines based on data that do not measure quality of life or survival of patients when there are already other therapeutic alternatives for these pathologies, they are indirectly failing  to meet patients' expectations and are infringing bioethical principles. This can  have a considerable influence on the benefit-risk ratio of drugs, and  patients  may be treated with regimens that do not provide benefit, or may even harm  them. Therefore, where should the process of humanisation be oriented? It  seems reasonable that the benefit of the patient should be the fundamental  objective of the process of humanisation of healthcare, evidently.


El empoderamiento del paciente supone uno de los principales pilares de la  humanización. Por ello, la consideración de las preferencias y expectativas de  los pacientes debería ser tenida en cuenta durante el ejercicio de cualquiera de  los profesionales de la salud. Mejorar la supervivencia global y la calidad de  vida son los deseos principales de los pacientes. De hecho, la reciente  aparición de los llamados Patient Reported Outcomes ha supuesto un  importante foco para los agentes involucrados en la asistencia sanitaria. El  farmacéutico hospitalario especializado en la evaluación de medicamentos es  un profesional que evalúa la eficacia, seguridad, adecuación y eficiencia de los  tratamientos prescritos por facultativos, y debe basar la toma de decisiones  tanto en factores técnicos como en los cuatro principios bioéticos. La correcta  aplicación de la práctica clínica basada en la evidencia permite proveer a los  pacientes de incrementos de supervivencia y/o calidad de vida, adecuando la  conveniencia y costes a la situación actual. Teniendo en cuenta esto, podría  decirse que la evaluación de medicamentos supone un fuerte compromiso con  la humanización. Por otra parte, las organizaciones que promueven la  evaluación y selección de medicamentos rigurosamente se erigen como aliados  de los pacientes, ya que repercuten de forma directa en éstos y de  forma indirecta en la sociedad. Las agencias reguladoras encargadas de la  aprobación y financiación de medicamentos en los sistemas sanitarios  protagonizan un papel fundamental en el proceso de humanización de la toma  de decisiones clínicas y empoderamiento de pacientes, ya que si aprueban el  uso de nuevos medicamentos según datos que no miden la calidad de vida o  supervivencia de los pacientes cuando ya existen otras alternativas  terapéuticas para estas patologías, indirectamente no estarán dando respuesta a las expectativas de los pacientes y conculcarán los principios bioéticos. Esto puede tener una considerable influencia en la relación beneficio-riesgo de los  fármacos, pudiendo tratar a pacientes con esquemas que no aportan beneficio,  o incluso podrían perjudicarles. Por tanto, ¿hacia dónde debiera ir  orientado el proceso de humanización? Parece razonable que el beneficio del  paciente sea el objetivo fundamental del proceso de humanización de la  asistencia sanitaria, evidentemente.


Assuntos
Motivação , Qualidade de Vida , Humanos , Objetivos , Pacientes , Pessoal de Saúde
20.
Farm Hosp ; 46(3): 157-165, 2022 03 29.
Artigo em Inglês | MEDLINE | ID: mdl-36183209

RESUMO

OBJECTIVE: The European Medicines Agency's marketing authorisation criteria  for drugs are reflected in the European Public Assessment Reports. The  objective is to describe the expectations and preferences of our  oncohematological outpatients with respect to their oral treatments, and to  evaluate the concordance with the results of European Public Assessment Reports. METHOD: A survey of onco-hematological patients' expectations and preferences about overall survival and quality of life was developed, with three items: expectations on treatment, preferences of benefit and  willingness to receive novel treatments with non-definitive results. European  Public Assessment Reports of the indicated drugs were reviewed. Kappa index  (κ) was used to assess the agreement between patients' expectations  and preferences respect to the benefit in overall survival and quality of life  described in the corresponding European Public Assessment Report.  Concordance between willingness of patients to receive novel treatments and European Public Assessment Reports results was evaluated by absolute  agreement (Ao). RESULTS: There were 29 participants, and 19 different European Public Assessment Reports were consulted. Patients' expectations about their  treatment: 82.1% expected improvement in overall survival and quality of life; the κ value between expectations and results of European Public Assessment Reports was 0.091 (confidence interval 95%: -0.025 to 0.207). Patients' preferences about benefit of their treatment: 92.6%  preferred quality of life; the κ value was 0.016 (confidence interval 95%: - 0.127 to 0.160). Willingness to receive novel treatments: 82.1% participants demanded benefit in overall survival or quality of life; exigences were met in Ao = 53.6% of patients. CONCLUSIONS: Little agreement was observed between expectations and  preferences of our onco-hematological patients and European Public Assessment Reports, according to overall survival and quality of life.  Most patients preferred an improvement in quality of life, but also expected  an  increase in overall survival with their treatment. Almost half of  patients would not meet their requirements to receive their drug when it was  authorized.


OBJETIVO: Los criterios de autorización de comercialización de medicamentos de la Agencia Europea del Medicamento se reflejan en los European Public Assessment Reports. El objetivo es describir las  expectativas y preferencias de nuestros pacientes externos oncohematológicos con respecto a sus tratamientos orales, y evaluar la  concordancia con los resultados de los European Public Assessment Reports. Método: Se elaboró una encuesta sobre las expectativas y preferencias de los  pacientes oncohematológicos respecto a la supervivencia global y calidad de  vida, con tres ítems: expectativas sobre el tratamiento, preferencias de  beneficio y disposición a recibir tratamientos novedosos con resultados  inmaduros. Se revisaron los European Public Assessment Reports de los  fármacos indicados. Se utilizó el índice kappa (κ) para evaluar la concordancia  entre las expectativas y preferencias de los pacientes respecto al beneficio en  supervivencia global y calidad de vida descrito en el European Public  Assessment Report correspondiente. La concordancia entre la disposición de  los pacientes a recibir nuevos tratamientos y los resultados de los European  Public Assessment Reports se evaluó mediante la concordancia absoluta (Ao). RESULTADOS: Se incluyeron 29 participantes y se consultaron 19 European Public Assessment Reports diferentes. Expectativas de los pacientes sobre su tratamiento: el 82,1% esperaba una mejora de la  supervivencia global y calidad de vida; el valor κ entre las expectativas y los  resultados de los European Public Assessment Reports fue de 0,091 (intervalo  de confianza 95%: ­0,025 a 0,207). Preferencias de los pacientes sobre el beneficio de su tratamiento: el 92,6% prefirió la calidad de vida; el valor κ fue de 0,016 (intervalo de confianza 95%: ­0,127 a 0,160). Disposición a  recibir tratamientos novedosos: el 82,1% de los participantes exigió un beneficio en la supervivencia global o en la calidad de vida; las exigencias se cumplieron en Ao = 53,6% de los pacientes. CONCLUSIONES: Se observó poca concordancia entre las expectativas y  preferencias de nuestros pacientes oncohematológicos y los European Public  Assessment Reports, según la supervivencia global y la calidad de vida. La  mayoría de los pacientes preferían una mejora de la calidad de vida, pero  también esperaban un aumento de la supervivencia global con su tratamiento.  Casi la mitad de los pacientes no cumpliría con sus requisitos para recibir su  medicación cuando ésta fuera autorizada.


Assuntos
Motivação , Qualidade de Vida , Humanos
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