ABSTRACT
ABSTRACT Introduction For the reduction of PTH levels, two classes of drugs are available in the Brazilian market: non-selective and selective vitamin D receptor activators and calcimimetics. Among the mentioned drugs, the SUS provides oral calcitriol, paricalcitol and cinacalcet. Objectives: Develop cost-effectiveness (CE) and budgetary impact (BI) analysis of cinacalcet versus paricalcitol for patients on dialysis with SHPT, from the perspective of SUS. Methodology: A decision tree model was constructed for CE analysis, which considered the outcome of avoided parathyroidectomy and a time horizon of 1 year. As for the BI analysis, two scenarios were considered, one of which was measured demand and other epidemiological, based on data from the Brazilian Society of Nephrology (BSN). Results: The CE analysis showed that the use of cinacalcet results in one-off savings of R$1,394.64 per year and an incremental effectiveness of 0.08, in relation to avoided parathyroidectomy. The incremental CE ratio (ICER) was - R$ 17,653.67 per avoided parathyroidectomy for cinacalcet, as it was more effective and cheaper compared to paricalcitol. As for the BI analysis, it was estimated that the incremental BI with the expansion of the use of cinacalcet in the SUS will be between - R$ 1,640,864.62 and R$ 166,368.50 in the first year, considering the main and the epidemiological scenarios. At the end of 5 years after the expansion of use, an BI was estimated between - R$ 10,740,743.86 and - R$ 1,191,339.37; considering the same scenarios. Conclusion: Cinacalcet was dominant to avoid parathyroidectomies, being cost-effective.
RESUMO Introdução: Para a redução dos níveis do paratormônio (PTH) estão disponíveis no mercado brasileiro duas classes de medicamentos: ativadores do receptor da vitamina D (não seletivos e seletivos) e calcimiméticos. Dentre os medicamentos supracitados, o SUS disponibiliza calcitriol oral, paricalcitol e cinacalcete. Objetivos: Desenvolver análise de custo-efetividade (CE) e de impacto orçamentário (IO) do cinacalcete versus paricalcitol para pacientes em diálise com HPTS, na perspectiva do SUS. Metodologia: Foi construído um modelo de árvore de decisão para a análise de CE, que considerou o desfecho paratireoidectomia evitada e um horizonte temporal de 1 ano. Quanto à análise de IO, foram considerados dois cenários, um de demanda aferida e outro de abordagem epidemiológica, baseado nos dados da Sociedade Brasileira de Nefrologia (SBN). Resultados: A análise de CE mostrou que o uso de cinacalcete resulta em economia de R$ 1.394,64 ao ano e efetividade incremental de 0,08, em relação a paratireoidectomia evitada. A razão de CE incremental (RCEI) foi de - R$ 17.653,67 por paratireoidectomia evitada para o cinacalcete, já que se mostrou mais efetivo e mais barato comparado ao paricalcitol. Estimou-se que o IO incremental com a ampliação do uso do cinacalcete no SUS estará entre - R$ 1.640.864,62 e R$ 166.368,50 no primeiro ano, considerando os cenários principal e epidemiológico baseado nos dados da SBN. Já ao final de 5 anos após a ampliação do uso, estimou-se um impacto incremental entre - R$ 10.740.743,86 e - R$ 1.191.339,37; considerando os mesmos cenários. Conclusão: Cinacalcete foi dominante para evitar paratireoidectomias, sendo custo-efetivo.
ABSTRACT
OBJECTIVE:We refer to the effectiveness (known as pragmatic or real world) and efficacy (known as explanatory or desired or ideal world) of interventions. However, these terms seem to be randomly chosen by investigators who design clinical trials and do not always reflect the true purpose of the study. A pragmatic-explanatory continuum indicator summary tool was thus developed with the aim of identifying the characteristics of clinical trials that distinguish between effectiveness and efficacy issues. We verified whether clinical trials used the criteria proposed by the indicator summary tool, and we categorized these clinical trials according to a new classification.METHOD:A systematic survey of randomized clinical trials was performed. We added a score ranging from 0 (more efficacious) to 10 (more effective) to each domain of the indicator summary tool and proposed the following classifications: high efficacy (<25), moderate efficacy (25-50), moderate effectiveness (51-75), and high effectiveness (<75).RESULTS:A total of 844 randomized trials were analyzed. No analyzed trials used the criteria proposed by the indicator summary tool. Approximately 44% of the trials were classified as having moderate effectiveness, and 43.82% were classified as having moderate efficacy.CONCLUSIONS:Most clinical trials used the term “efficacy” to illustrate the application of results in clinical practice, but the majority of those were classified as having moderate effectiveness according to our proposed score. The classification based on the 0-100 score is still highly subjective and can be easily misunderstood in all domains based on each investigator’s own experiences and knowledge.
Subject(s)
Humans , Randomized Controlled Trials as Topic/statistics & numerical data , Treatment Outcome , Bibliometrics , Clinical Trials as Topic/classification , Research Design , Randomized Controlled Trials as Topic/classificationABSTRACT
Esta pesquisa teve como objetivo geral investigar a influência exercida pelo pai, oficial do exército, na decisão do filho para seguir a carreira militar e como este último percebe a referida carreira. Especificamente, procurou-se analisar as motivações que levaram à escolha pela carreira por parte dos filhos; os ganhos obtidos e as dificuldades para exercer a carreira; o papel da família e as expectativas acerca do futuro. A pesquisa foi realizada com 20 cadetes alunos da Academia Militar das Agulhas Negras, que responderam a uma entrevista analisada de acordo com a técnica da análise de conteúdo temática. Os resultados apontaram a forte influência do pai, o apoio da família, além da convivência diária com a rotina e as normas da instituição como as principais motivações para a escolha da carreira. O sentimento de orgulho e de honra perpassara todas as entrevistas, embora os participantes tenham reconhecido ser uma carreira caracterizada por perdas, sacrifícios e esforço constante. As expectativas de futuro remetem ao desejo de contínua dedicação para melhorar o desempenho e as colocações, bem como a construção de uma família.
The aim of this study was to investigate the influence exerted by a father and Army officer, in deciding if the child will follow a military career and how the child perceives this career. More specifically, it sought to analyze the motivations that led to this decision; the gains achieved and the difficulties in exercising this career; the role of the family and expectations for the future. The study was carried out on twenty student cadets in the Agulhas Negras Military Academy (named for one of the highest mountains in Brazil, literally Black Needles). They responded to an interview that was analyzed in accordance with the technique of Thematic Content Analysis. As the main motivations for this career choice, the results pointed to the strong influence of the father, family support, as well as daily contact with the routine and the rules of the institution. The feeling of pride and honor pervaded all the interviews, although they acknowledged that it is a career that involves loss, sacrifice and constant effort. Expectations of the future relate to the desire for continuous dedication to improving the performance and postings, as well as building a family.