Recommendations for Interchangeability in a Growing Biosimilar Market in Latin America.

BACKGROUND: Biosimilars offer significant advantages for improving access to biologic treatments in Latin America. However, their uptake has been slow due to misconceptions, regulatory uncertainties, and inadequate pharmacovigilance. OBJECTIVE: To address these issues, Americas Health Foundation convened a multidisciplinary panel of regional experts in biosimilar use and interchangeability from Latin America. The panel assessed the current landscape and recommended steps to enhance access. RESULTS: Key recommendations include strengthening biosimilar regulations, ensuring transparent enforcement, implementing robust pharmacovigilance, and promoting collaboration among stakeholders to educate about the safety, efficacy, and economic advantages of biosimilars and their interchangeability. CONCLUSIONS: By embracing biosimilars and interchangeability, Latin American countries can expand patient access, foster competition, diversify treatment sources, and enhance the sustainability of their healthcare systems. However, achieving these goals requires addressing knowledge gaps and biases among healthcare providers, patients, regulators, and government agencies. This can be accomplished through clear communication and the use of real-world evidence.

Biosimilars offer an opportunity to expand access to crucial biologic treatments in Latin America by providing lower-cost alternatives when patents expire. However, adopting biosimilars has been slow due to misconceptions and regulatory uncertainties. To address this, experts recommend considering approved biosimilars as interchangeable with reference products, allowing for switching without compromising safety or efficacy, with the limitation of switching only once per year. To improve access, well-defined regulations, enforcement, and transparency from regulatory agencies are necessary, along with education for healthcare providers, patients, and other stakeholders to address knowledge gaps and negative perceptions. Improved pharmacovigilance systems and collaboration between stakeholders can help communicate the benefits of biosimilars and interchangeability. By embracing biosimilars, Latin American countries can expand patient access, foster market competition, diversify treatment options, and improve the sustainability of healthcare systems.

Decisional tool development and application for techno-economic analysis of fungal laccase production.

Textile and medical effluents causing bioaccumulation and biomagnification have been successfully biodegraded by fungal laccases. Here, a decision-making tool was developed and applied to evaluate 45 different laccase production strategies which determined the best potential source from a techno-economical perspective. Laccase production cost was calculated with a fixed output of 109 enzymatic units per batch (USD$per109U) and a sensitivity analysis was performed. Results indicate that optimization of enzymatic kinetics for each organism is essential to avoid exceeding the fermentation time point at which production titer reaches its peak and, therefore, higher production costs. Overall, the most cost-effective laccase-producing strategy was obtained when using Pseudolagarobasidium acaciicola with base production cost of USD $42.46 per 109 U. This works serves as platform for decision-making to find the optimal laccase production strategy based on techno-economic parameters.

Electronic Decision-Making Tool for Smoking Cessation (Pare de Fumar Conosco) Versus Standard of Care: A Cost-Effectiveness Analysis.

OBJECTIVES: The study aimed to evaluate the cost-effectiveness of the Pare de Fumar Conosco software compared with the standard of care adopted in Brazil for the treatment of smoking cessation. METHODS: In the cohort of smokers with multiple chronic conditions, we developed an decision tree model for the benefit measures of smoking cessation. We adopted the perspectives of the Brazilian Unified Health System and the service provider. Resources and costs were measured by primary and secondary sources and effectiveness by a randomized clinical trial. The incremental cost-effectiveness ratio (ICER) was calculated, followed by deterministic and probabilistic sensitivity analyses and deterministic and probabilistic sensitivity analyses. No willingness to pay threshold was adopted. RESULTS: The software had a lower cost and greater effectiveness than its comparator. The ICER was dominant in all of the benefits examined (-R$2 585 178.29 to -R$325 001.20). The cost of the standard of care followed by that of the electronic tool affected the ICER of the benefit measures. In all probabilistic analyses, the software was superior to the standard of care (53.6%-82.5%). CONCLUSION: The Pare de Fumar Conosco software is a technology that results in cost savings in treating smoking cessation.

Challenges in adapting a stroke unit in a middle-income country: warning about costs and underfunding to achieve the Brazilian Ministry of Health's benchmark.

Background: Since the implementation of the stroke care line in Brazil, the relationship (adequacy) of costs spent during hospitalization with the Brazilian Ministry of Health indicators for a stroke unit have not yet been analyzed. Aims: This study aimed to assess the adequacy of a comprehensive stroke center for key performance indicators and analyze the costs involved in hospitalization. We verified the association between stroke severity at admission and care costs during hospitalization. Methods: A retrospective medical chart review of 451 patients was performed using semiautomatic electronic data from a single comprehensive stroke center in Brazil between July 2018 and January 2020. Clinical and resource utilization data were collected, and the mean acute treatment cost per person was calculated. The Kruskal-Wallis test with Dunn's post-test was used to compare the total costs between stroke types and reperfusion therapies. A robust linear regression test was used to verify the association between stroke severity at hospital admission and the total hospitalization costs. Good adequacy rates were observed for several indicators. Results: Data from 451 patients were analyzed. The stroke unit had good adaptation to key performance indicators, but some critical points needed revision and improvement to adapt to the requirements of the Ministry of Health. The average total cost of the patient's stay was the USD 2,637.3, with the daily hospitalization, procedure, operating room, and materials/medication costs equating to USD 2,011.1, USD 220.7, USD 234.1, and USD 98.8, respectively. There was a positive association between the total cost and length of hospital stay (p < 0.001). Conclusion: The stroke unit complied with most of the main performance indicators proposed by the Brazilian Ministry of Health. Underfunding of the costs involved in the hospitalization of patients was verified, and high costs were associated with the length of stay, stroke severity, and mechanical thrombectomy.

Caminhos possíveis da avaliação econômica para práticas integrativas e complementares nas condições crônicas / Possible paths of economic assessment for integrative and complementary practices in chronic conditions

Resumo Objetivos Analisar desenhos de avaliação econômica em Práticas Integrativas e Complementares em Saúde (PICS). Métodos O estudo é uma revisão integrativa de estudos disponíveis na Biblioteca Virtual em Saúde, de 2009 a 2021. Resultados Vinte e um estudos foram selecionados para análise final, apresentando importante conformidade com as recomendações dos especialistas. Em geral, a população foi composta por mulheres adultas com distúrbios osteomusculares, que receberam terapias manipulativas, acupuntura/acupressão e homeopatia. Para avaliar essas intervenções, foram utilizadas as perspectivas da sociedade ou do provedor, a partir de análises de custo-efetividade e de custo-consequência, concentrando-se em estimar os custos diretos de saúde, e por vezes, os custos indiretos. Quanto aos desfechos, a maioria dos estudos coletou mais de uma medida, principalmente relacionadas a manifestações sintomáticas, bem-estar global e/ou fatores psicossociais. Conclusões A avaliação econômica está evoluindo para considerar perspectivas mais amplas, com maior variedade de custos e resultados, adaptando-se a diversos cenários de intervenção, atendendo às especificidades das PICS. Conciliar o desenho metodológico ao contexto de inserção das PICS no Brasil é possível e necessário, dada a carência de avaliações nacionais, aos vieses gerados por comparações internacionais e às disputas pela sustentabilidade desse conjunto de práticas no Sistema Único de Saúde.

Abstract Objectives To analyze economic evaluation designs in Integrative and Complementary Health Practices (PICS). Methods This study is an integrative review of available studies in the Virtual Health Library, from 2009 to 2021. Results Twenty-one studies were selected for final analysis, showing significant compliance with the experts' recommendations. In general, the population consisted of adult women with musculoskeletal disorders, who received manipulative therapies, acupuncture/acupressure and homeopathy. To evaluate these interventions, society's or provider's perspectives were used, based on cost-effectiveness and cost-consequence analyses, focusing on estimating direct health costs, and sometimes indirect costs. As for outcomes, most studies collected more than one measure, mainly related to symptomatic manifestations, overall well-being and/or psychosocial factors. Conclusions The economic evaluation is evolving to consider broader perspectives, with a greater variety of costs and results, adapting to different intervention scenarios, meeting the specificities of PICS. Reconciling methodological design and PICS' context of insertion in Brazil is possible and necessary, given the lack of national assessments, the biases generated by international comparisons, and the disputes over the sustainability of this set of practices in the Brazilian Unified Healht System.

At-home bleaching versus whitening toothpastes for treatment of tooth discoloration: a cost-effectiveness analysis

Abstract Objectives This study aimed to analyze the cost-effectiveness of whitening toothpastes and at-home bleaching for the treatment of tooth discoloration. Methodology A cost-effectiveness economic analysis was conducted, and eight randomized clinical trials were selected based on the whitening agent product used: blue covarine dentifrices (BCD), hydrogen peroxide dentifrices (HPD), dentifrices without bleaching agents (CD, negative control), and 10% carbamide peroxide (CP10, positive control) for at-home bleaching. The consumer/patient perspective was adopted, macro-costing techniques were used and a decision tree model was performed considering the costs in the American and Brazilian markets. The color change evaluation (ΔE*ab) was used to calculate the effectiveness of tooth bleaching. A probabilistic analysis was performed using a Monte Carlo simulation and incremental cost-effectiveness ratios were obtained. Results CP10 resulted in the highest cost-effectiveness compared to the use of dentifrices in both markets. In Brazil, HPD was more cost-effective than BCD and CD. In the US, the increased costs of HPD and BCD did not generate any whitening benefit compared to CD. Conclusions CP10 was more cost-effective than BCD and HPD for tooth bleaching from the perspectives of the Brazilian and American markets. Decision-making should consider the use of CP10 for treating tooth discoloration.

A prognosis and cost-effectiveness systematic review of non-invasive treatments for root caries / Revisão sistemática de prognóstico e custo-efetividade de tratamentos não invasivos para cárie radicular

Aim: to evaluate the prognosis of root cariestreatment with non-invasive methods, as well as to compare non-invasive therapies as viable alternatives for clinicians, indicating their cost-effectiveness.Literaturereview: Data collected were number of active lesions at baseline(BL) and in the last clinical assessment after follow-up(FL), and the follow-up period in months(P). The outcome was the monthly progression rate of the lesions that was calculated by (FL­BL)/P. A negative progression rate means the arrestment of the lesions. A cost-effectiveness rate was calculated. Results: From 596 titles retrieved in the search, 8 studies were included in a qualitative synthesis after assessed for eligibility. The monthly progression rate of lesions of home-based treatments (toothpastes, mouth rinses, supplemented milk intake) was an average of -0.79 (-3.68 to 2.3), while the office-based treatments (varnish, topic solutions) was 0.07 (-0.01 to 0.51), suggesting a better prognosis of the home-based treatments. The lowest monthly progression rate was -3.97 (toothpaste 5000ppm/F) while the highest was 2.31 (conventional toothpaste). The cost-effectiveness rate was better for treatments with toothpastes with 5000ppm/F (BRL21.78) when compared to mouthwashes (BRL579.47). Discussion: A better prognosis was found for toothpastes with a high fluoride concentration (5000ppm/F) compared to other therapies, as well as a better cost-effectiveness when compared to mouthwashes. Conclusion: Home-based therapiesrepresented the highest rates of good prognosis for treating root caries lesions within the available scientific evidence. Although 5000ppm/F toothpastes have a very high cost for the Brazilian market, this treatment presented the highest cost-effectiveness when compared to mouthrinses(PROSPERO:CRD42019136035).

Objetivo: avaliar o prognóstico do tratamento da cárie radicular com métodosnão invasivos, bem como comparar as terapias não invasivas como alternativas viáveis para os clínicos, indicando seu custo-efetividade. Revisão deliteratura: os dados coletados foram o número de lesões ativas no início do estudo(BL) e na última avaliação clínica após o acompanhamento(FL), e o período de acompanhamento em meses(P). O desfecho foi a taxa de progressão mensal das lesões calculada por (FL­BL)/P. Uma taxa de progressão negativa significou a inativação das lesões. Uma taxa de custo-efetividade foi calculada.Resultados: Dos 596 títulos recuperados na busca, 8 estudos foram incluídos em uma síntese qualitativa após avaliação de elegibilidade. A taxa de progressão mensal das lesões dos tratamentos caseiros (dentifrícios, enxaguatórios bucais, ingestão de leite complementado) foi em média -0,79 (-3,68 a 2,3), enquanto os tratamentos de consultório (verniz, soluções tópicas) foi de 0,07 (-0,01 a 0,51), sugerindo um melhor prognóstico dos tratamentos domiciliares. A menor taxa de progressão mensal foi de -3,97 (dentifrício 5000ppm/F), enquanto a maior foi de 2,31 (dentifrício convencional). A taxa de custo-efetividade foi melhor para tratamentos com dentifrícios com 5000ppm/F(R$21,78) quando comparados aos bochechos (R$579,47). Discussão: Foi encontrado melhor prognóstico para dentifrícios com alta concentração de flúor(5000ppm/F) em comparação com outras terapias, bem como melhor custo-efetividade quando comparados aos bochechos. Conclusão: As terapias domiciliares representaram as maiores taxas de bom prognóstico para o tratamento de lesões de cárie radicular dentro das evidências científicas disponíveis. Embora dentifrícios de 5000ppm/F tenham um custo muito alto para o mercado brasileiro, este tratamento apresentou o maior custo-efetividade quando comparado aos enxaguatórios bucais(PROSPERO:CRD42019136035).

A three-sequence dynamic contrast enhanced abbreviated MRI protocol to evaluate response to breast cancer neoadjuvant chemotherapy.

PURPOSE: To develop an ABP-MRI to evaluate response to NAC for invasive breast carcinoma. STUDY TYPE: A single-center, cross-sectional study. SUBJECTS: A consecutive series of 210 women with invasive breast carcinoma who underwent breast MRI after NAC between 2016 and 2020. FIELD STRENGTH/SEQUENCE: 1.5 T / Dynamic contrast-enhanced. ASSESSMENT: MRI scans were independently reevaluated, with access to dynamic contrast-enhanced without contrast and to the first, second, and third post-contrast time (ABP-MRI 1-3). STATISTICAL TESTS: The diagnostic performance of the ABP-MRIs and the Full protocol (FP-MRI) were analyzed. The Wilcoxon non-parametric test (p-value <0.050) was used to compare the capability in measuring the most extensive residual lesion. RESULTS: The median age was 47 (24-80) years. ABP-MRI 1 showed higher specificity (84.6%; 77/91) but a higher probability of false-negatives (16.8%) and lower sensitivity (83.2%; 99/119) than ABP-MRI 2,3 and the FP-MRI, which were identical in specificity (81.3%; 74/91), probability of false-negatives (8.4%), and sensitivity (91.6%; 109/119). ABP-MRI 2 showed a mean underestimation of only 0.03 cm in the measurement of the longest axis of the residual lesion (p = 0.008) with an average reduction in the acquisition time of 75%, compared with the FP-MRI. CONCLUSION: ABP-MRI 2 showed diagnostic performance equivalent to the FP-MRI with a 75% reduction in the acquisition time.

Contribution margin per hour of operating room to reallocate unutilized operating room time: a cost-effectiveness analysis

Abstract Background and objectives: Contribution margin per hour (CMH) has been proposed in healthcare systems to increase the profitability of operating suites. The aim of our study is to propose a simple and reproducible model to calculate CMH and to increase cost-effectiveness. Methods: For the ten most commonly performed surgical procedures at our Institution, we prospectively collected their diagnosis-related group (DRG) reimbursement, variable costs and mean procedural time. We quantified the portion of total staffed operating room time to be reallocated with a minimal risk of overrun. Moreover, we calculated the total CMH with a random reallocation on a first come-first served basis. Finally, prioritizing procedures with higher CMH, we ran a simulation by calculating the total CMH. Results: Over a two-months period, we identified 14.5 hours of unutilized operating room to reallocate. In the case of a random ''first come -first serve'' basis, the total earnings were 87,117 United States dollars (USD). Conversely, with a reallocation which prioritized procedures with a high CMH, it was possible to earn 140,444 USD (p < 0.001). Conclusion: Surgical activity may be one of the most profitable activities for hospitals, but a cost-effective management requires a comprehension of its cost profile. Reallocation of unused operating room time according to CMH may represent a simple, reproducible and reliable tool for elective cases on a waiting list. In our experience, it helped improving the operating suite cost-effectiveness.

Is primary health care worth it in the long run? Evidence from Brazil.

This paper assesses whether Brazilian primary health care is worth it in the long-run by estimating the accumulated costs and benefits of its flagship, the Family Health Strategy program (ESF). We employ an alternative strategy centered on years of exposure to the program to incorporate its dynamics. We also account for the program's heterogeneity with respect to the remuneration of ESF health teams and the intensity of coverage across Brazilian municipalities, measure by the number of people assisted by each ESF team, on average. To address heterogeneity in professional earnings, this paper employs, for the first time, a dataset containing the remuneration of professionals allocated to all ESF teams nationwide. The benefits are measured by the avoided deaths and hospitalizations due to causes sensitive to primary care. Results suggest that the net monetary benefit of the program is positive on average, with an optimum time of exposure of approximately 16 years. Significant heterogeneities in cost-benefit results were found since costs outweigh benefits in localities where the coverage is low intensive. On the other hand, the benefits outweigh the costs by 22.5% on average in municipalities with high intensive coverage.

Economic evaluations of colorectal cancer screening: A systematic review and quality assessment.

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.

Eficácia E Custo-Utilidade De Intervenções Para O Tratamento Da Enurese Em Crianças E Adolescentes Sob A Perspectiva Do Sistema Único De Saúde Brasileiro: Effectiveness and Cost-Utility of Interventions for Enuresis Treatment in Children and Adolescents From the Brazilian Single Health System Perspective.

OBJECTIVES: This study aimed to estimate the cost-utility of effective interventions for enuresis treatment in children and adolescents and to calculate the incremental cost-utility ratio from the perspective of the Brazilian Unified Health System in a 1-year time horizon. METHODS: The economic analysis is in 7 stages: (1) survey of evidence of treatments for enuresis, (2) performing the network meta-analysis, (3) estimation of the probability of cure, (4) cost-utility analysis, (5) model sensitivity analysis, (6) analysis of acceptability of interventions by acceptability curve, and (7) monitoring the technological horizon. RESULTS: The association between desmopressin and oxybutynin is the therapeutic strategy with the highest probability of success in the treatment of enuresis in children and adolescents compared with placebo (relative risk [RR] 2.88; 95% confidence interval [CI] 1.65-5.04), followed by the combination therapy between desmopressin and tolterodine (RR 2.13; 95% CI 1.13-4.02), alarm (RR 1.59; 95% CI 1.14-2.23), and neurostimulation (RR 1.43; 95% CI 1.04-1.96). Combination therapy between desmopressin and tolterodine was the only 1 considered not to be cost-effective. Neurostimulation, alarm therapy, and therapy had the respective incremental cost-utility ratio values: R$5931.68, R$7982.92, and R$29 050.56/quality-adjusted life-years. CONCLUSION: Among the therapies that are on the borderline of efficiency, the combined therapy between desmopressin and oxybutynin presents the greatest incremental benefit at an incremental cost that is still feasible, given that it does not exceed the reference value of the cost-effectiveness threshold established in Brazil.

Single incision laparoscopic appendectomy with surgical-glove port is cost-effective and reliable in complicated acute appendicitis: A casecontrol multicenter study in Colombia.

Background: The single-port (SPL) and multi-port (MPL) laparoscopic approach are the gold standard of management of acute appendicitis, due to its multiple advantages over open surgery, mainly because of its direct effects on recovery, esthetics and costs of the procedure. However, in third-world countries, the laparoscopic approach is not yet fully reproducible due to the costs of the technique. The surgical-glove port single incision laparoscopic appendectomy (SGP-SILA) has been proposed as a viable option. However, it has never been studied in Colombia. Objective: To evaluate the cost-effectiveness and reliability of SGP-SILA in the management of complicated acute appendicitis, compared to traditional MPL approach. Materials and methods: A retrospective case control study was carried out comparing patients undergoing laparoscopic appendectomy by SGP-SILA vs. MPL, evaluating operating costs associated with intraoperative and postoperative variables in two tertiary centers in Bogota, Colombia. The data were analyzed and expressed according to their nature and distribution. Results: 116 patients were included (SGP-SILA: 62 and MPL: 54). The median surgical time for SGP-SILA was 60 min vs. 39 min for MPL. SGP-SILA was shown to cause lower frequency of surgical site infection (4 vs. 8 patients; p = 0.047). It was found a significant correlation between Grade III surgical site infection and surgery time (p = 0.047) in the MPL group; also, with hospital stay (p < 0.001). Also, a lower risk of surgical site infection was found with the SGP-SILA technique (22% vs. 31%). SGP-SILA generated a reduction in both direct and indirect operating costs of approximately 10% (616 USD vs. 683 USD). Conclusion: SGP-SILA and MPL are feasible and comparable procedures in the resolution of complicated acute appendicitis. SGP-SILA turns out to be more cost-effective compared to MPL, due to the use of more easily accessible instruments. This may be a reproducible technique in low- and middle-income countries.

A cost-effectiveness analysis of pneumococcal conjugate vaccines in infants and herd protection in older adults in Colombia.

BACKGROUND: Pneumococcal diseases have a clinical and economic impact on the population. Until this year, a 10-valent pneumococcal vaccine (PCV10) used to be applied in Colombia, which does not contain serotypes 19A, 3, and 6A, the most prevalent in the country. Therefore, we aimed to assess the cost-effectiveness of the shift to the 13-valent pneumococcal vaccine (PCV13). RESEARCH DESIGN AND METHODS: A decision model was used for newborns in Colombia between 2022-2025 and adults over 65 years. The time horizon was life expectancy. Outcomes are Invasive Pneumococcal Diseases (IPD), Community-Acquired Pneumonia (CAP), Acute Otitis Media (AOM), their sequelae, Life Gained Years (LYGs), and herd effect in older adults. RESULTS: PCV10 covers 4.27% of serotypes in the country, while PCV13 covers 64.4%. PCV13 would avoid in children 796 cases of IPD, 19,365 of CAP, 1,399 deaths, and generate 44,204 additional LYGs, as well as 9,101 cases of AOM, 13 cases of neuromotor disability and 428 cochlear implants versus PCV10. In older adults, PCV13 would avoid 993 cases of IPD and 17,245 of CAP, versus PCV10. PCV13 saves $51.4 million. The decision model shows robustness in the sensitivity analysis. CONCLUSION: PCV13 is a cost-saving strategy versus PCV10 to avoid pneumococcal diseases.

Análise de custo-efetividade do teste de oximetria de pulso na triagem de cardiopatias congênitas / Cost-effectiveness analysis of the pulse oximetry test in screening for congenital heart diseases

Resumo: Introdução: Trata-se de uma tese desenvolvida na Pós-graduação em Enfermagem, na Linha de Pesquisa de Políticas e Práticas de Saúde, Educação e Enfermagem, de maneira a agregar valor à atividade de monitoramento de recém-nascidos, abrangendo a esfera mundial. Seu caráter inovador e sua relevância são fortes, considerando haver cenários de não realização da Triagem de Oximetria de Pulso (TOP) ou de desenvolvimento de técnica incorreta, de maneira que poderá favorecer a ampliação de sua aplicabilidade. Aponta-se que as Cardiopatias Congênitas (CC) são as anomalias de maior incidência nos recém-nascidos, com impacto na Mortalidade Infantil. Seu diagnóstico precoce está relacionado aos melhores desfechos e à sustentabilidade do sistema de saúde. O TOP comprova a importância do impacto social do diagnóstico para a real prevenção dos desfechos mórbidos, das mortes, e dos custos em saúde. Objetivos: Determinar a acurácia do TOP para triagem de CC nas primeiras 48 horas de vida, conforme especificidade e sensibilidade; e, desenvolver análise de custo-efetividade do TOP para triagem de CC. Método: Realizada revisão sistemática de acurácia de teste diagnóstico conforme as recomendações do Jonna Briggs Institute. O protocolo está registrado na plataforma PROSPERO - CRD42021256286 - e, publicado em periódico. Foram selecionados estudos com recém-nascidos sem o diagnóstico prévio de CC, independentemente da idade gestacional ao nascimento, que realizaram o TOP entre as primeiras 48h após o nascimento, em comparação ao exame físico realizado por profissional da saúde, ou estudos que não apresentaram comparadores e sim o diagnóstico de interesse, as CC. Para a seleção dos estudos utilizaram-se bases de dados e a literatura cinzenta. A Análise de Custo-Efetividade foi realizada conforme diretriz do Ministério da Saúde e, sob a perspectiva do SUS - Sistema Único de Saúde. Os dados de custo aplicados foram os disponibilizados em bases de dados nacionais. O modelo foi de Árvore de Decisão, com horizonte temporal de um ano, considerando quatro intervenções: 1) sem o TOP; 2) TOP sem reteste; 3) TOP com 1 reteste e 4) TOP com 2 reteste. Resultados: Na Revisão Sistemática foram incluídos 29 estudos, obtendo-se população total de 388.491 recém-nascidos. O TOP demonstrou sensibilidade de 47% (IC 95%: 43% a 50%) e, especificidade de 98% (IC 95%: 98% a 98%). Em estudos que apresentavam retestes e que incluíram recém-nascidos prematuros foram realizadas análises dos subgrupos, conforme o tempo de nascimento para realização do teste entre 24-48h. Na análise de custo-efetividade evidenciou-se que não realizar o TOP culminou com a estratégia de custo mais elevado, de R$ 85,41 por paciente. Os recém-nascidos triados com TOP + dois retestes possuem uma redução de custo entre R$ 0,21 a R$ 38,78 por paciente, conforme o protocolo aplicado. Conclusão: Para o diagnóstico precoce de CC, o TOP se configura como um teste de moderada sensibilidade, alta especificidade e custo-efetivo. Apresenta relação com o diagnóstico precoce, e contribui com a referência oportuna para atenção em serviço de saúde especializado e de qualidade, desde que na esfera de gestão estejam estabelecidos os acessos. Esta pesquisa é replicável considerando o rigor metodológico, assim como seu desenvolvimento e apresentação.

Abstract: Introduction: This is a thesis developed in the Graduate Program in Nursing, in the Research Line of Health, Education and Nursing Policies and Practices, in order to add value to the activity of monitoring newborns, covering the sphere worldwide. Its innovative character is high, as well as its relevance, considering that there are scenarios of non-performance of Pulse Oximetry Screening (POS), or of development of an incorrect technique, thus favoring the expansion of its applicability. It is pointed out that Congenital Heart Defects (CHD) are the anomalies with the highest incidence in newborns, with an impact on Infant Mortality. Its early diagnosis is related to better outcomes and sustainability of the health system. The POS proves the importance of the social impact of the diagnosis, for the real prevention of morbid outcomes, deaths, and health costs. Objectives: To determine the accuracy of the POS for CHD screening in the first 48 hours of life, according to specificity and sensitivity; and, develop a costeffectiveness analysis of the POS for CHD screening. Method: A systematic review of diagnostic test accuracy was carried out according to the Jonna Briggs Institute recommendations. The protocol is registered on the PROSPERO platform - CRD42021256286 - and published in a journal. Selected studies with newborns without a previous diagnosis of CHD, regardless of gestational age at birth, that performed the POS within the first 48 hours after birth, compared to the physical examination performed by a health professional or studies that did not present comparators, and the diagnosis of interest was CHD. For the selection of studies, databases and gray literature were used. The Cost-Effectiveness Analysis was carried out according to the guidelines of the Ministry of Health and from the perspective of the UHS - Unified Health System. The cost data applied were those available in national databases. The model was a Decision Tree, with a time horizon of one year, considering four interventions: 1) without the POS; 2) POS without retest; 3) POS with 1 retest and 4) POS with 2 retests. Results: The Systematic Review included 29 studies, resulting in a total population of 388,491 newborns. The POS showed a sensitivity of 47% (CI 95%: 43% to 50%) and specificity of 98% (CI 95%: 98% to 98%). In studies that presented retests and that included premature newborns, subgroup analyzes were performed, according to the time of birth for the test to be performed between 24-48 hours. In the cost-effectiveness analysis, it was shown that not performing the POS resulted in the highest cost strategy, R$ 85.41 per patient. Newborns screened with TOP + two retests have a cost reduction of between R$ 0.21 and R$ 38.78 per patient, depending on the protocol applied. Conclusion: For the early diagnosis of CHD, the POS is configured as a test of moderate sensitivity, high specificity and cost-effective. It is related to early diagnosis, and contributes to the timely referral for care in specialized and quality health services, as long as the accesses are established in the management sphere. This research is replicable considering the clarity of its development and presentation.

Port Workers' Use of Medical Services in a Maritime Container Terminal in Costa Rica.

Supervised by three or four medical doctors and one nurse in rotating shifts, the medical clinic in Costa Rica's Moín Container Terminal is open 24/7 for visits from port workers. In our study, we aimed to identify the sociodemographic and clinical characteristics of a consecutive series of patients who attended the medical clinic for outpatient services during an 8-month period. Our descriptive study involved collecting patient records from the medical clinic during the first 8 months of 2021 (i.e., 1 January-31 August 2021), during which 3050 visits from 1301 port workers were registered. Terminal tractor drivers, crane operators, and stevedores were the most frequent job categories among the patients. Doping (i.e., ICD-10 Z03.6) was observed in 64% of the visits. The top ICD-10 codes among all other patients not observed to have engaged in doping (n = 469) were diseases of the musculoskeletal system (7.2%) and abnormal clinical and laboratory symptoms (6.2%). Problems with the musculoskeletal system were primarily back pain (36.0%), muscle contracture (30.1%), and secondary headache (25.2%). Two-thirds of the visits were due to screening for alcohol and drugs or doping; however, inconsistency in the coding system complicates the analysis of data, and a dropdown menu in the registration is therefore needed to prevent errors. Relative risk calculations are impossible due to a lack of data about the at-risk population but should be pursued under different circumstances in future studies. In the support chain of goods, the medical clinic in the port plays a key role in saving time in shipping, which means that the injured or sick employees in most cases can continue working. For the shipping industry, quick un- and offloading is very important to stay competitive in the market for transport.

Contribution margin per hour of operating room to reallocate unutilized operating room time: a cost-effectiveness analysis.

BACKGROUND AND OBJECTIVES: Contribution margin per hour (CMH) has been proposed in healthcare systems to increase the profitability of operating suites. The aim of our study is to propose a simple and reproducible model to calculate CMH and to increase cost-effectiveness. METHODS: For the ten most commonly performed surgical procedures at our Institution, we prospectively collected their diagnosis-related group (DRG) reimbursement, variable costs and mean procedural time. We quantified the portion of total staffed operating room time to be reallocated with a minimal risk of overrun. Moreover, we calculated the total CMH with a random reallocation on a first come-first served basis. Finally, prioritizing procedures with higher CMH, we ran a simulation by calculating the total CMH. RESULTS: Over a two-months period, we identified 14.5 hours of unutilized operating room to reallocate. In the case of a random "first come-first serve" basis, the total earnings were 87,117 United States dollars (USD). Conversely, with a reallocation which prioritized procedures with a high CMH, it was possible to earn 140,444 USD (p < 0.001). CONCLUSION: Surgical activity may be one of the most profitable activities for hospitals, but a cost-effective management requires a comprehension of its cost profile. Reallocation of unused operating room time according to CMH may represent a simple, reproducible and reliable tool for elective cases on a waiting list. In our experience, it helped improving the operating suite cost-effectiveness.

A simple and low-cost technic for immobilization of mandible during head and heck radiotherapy: a technical note.

Immobilization protocols for head and neck radiotherapy (HNR) are needed to reduce radiation dispersion in non-tumoral tissues and to reduce damage to noble structures; however, involuntary mandibular movements require additional adaptations of thermoplastic masks. PURPOSE: Our objective was to describe an easy and low-cost disposition to help thermoplastic masks immobilize the mandible during HNR. MATERIALS AND METHODS: We created Styrofoam models to stabilize the mandible which was used to make adaptation to the thermoplastic masks. The Styrofoam model was inserted into alginate to construct a mold and a self-curing acrylic resin was added into the mold. After the acrylic resin hardened, the dispositive mandibular immobilizer was removed from the alginate mold and adjusted with Maxicut and Minicut or other drills and sandpaper. The alginate mold can be used on the same day to create backup devices. RESULTS AND CONCLUSIONS: Our device was made in a simple way, has a low cost, and helps the thermoplastic masks to immobilize the mandible, leading to a more precise individualization of head and neck immobilization that can reduce unanticipated radiation scatter and improve radiation distribution.

Effectiveness and Cost-effectiveness of Minimal Ovarian Stimulation in-vitro Fertilization versus Conventional Ovarian Stimulation in Poor Responders: Economic Evaluation Alongside a Propensity Score Adjusted Prospective Observational Study.

OBJECTIVE: Information on the pregnancy rate after successive in-vitro fertilization (IVF) cycles and their associated costs is relevant for couples undergoing assisted reproduction treatments (ARTs). This study, therefore, sought to investigate the effectiveness and the cost-effectiveness of two ARTs, the minimal ovarian stimulation IVF (MS-IVF) compared to the conventional ovarian stimulation IVF (C-IVF) from the payer's perspective. METHODS: A 10-months follow-up prospective observational study was conducted in a sample of couples who sought ARTs in a private clinic in Southern Brazil. Women had to satisfy the Bologna Criteria and be older than 35 years. The effect outcome was pregnancy rate per initiated cycle. Medication costs were based on medical records. Costs and effect differences were estimated using seemingly unrelated regressions adjusted for the propensity score estimated based on women's characteristics. RESULTS: All 84 eligible women who agreed to participate received a total of 92 IVF cycles (MS-IVF, n=27[35 cycles]; C-IVF n=57[57 cycles]. The effect difference between MS-IVF and C-IVF was -5.1% (95%CI, -13.2 to 5.2). Medication costs of MS-IVF were significantly lower than C-IVF by €-1260 (95%CI, -1401 to -1118). The probabilities of MS-IVF being cost-effective compared to C-IVF ranged from 1 to 0.76 for willingness-to-pay of €0 to €15,000 per established pregnancy, respectively. CONCLUSIONS: Even though there were no positive effect differences between groups, MS-IVF might be cost-effective compared to C-IVF from the payer's perspective due to its relatively large cost savings compared to C-IVF. However, further investigation is needed to confirm these findings in a larger sample.

Dengue control in the State of Goiás-Brazil using "wMel Wolbachia": a cost-effectiveness study

Dengue and other arboviruses have a considerable economic impact in Brazil. There are vector control strategies for dengue: traditional control with pesticides, Incompatible Insect Technique (IIT) with "wMel Wolbachia", and Sterile Insect Technique (SIT). Objective: To analyze the cost-effectiveness ratio of the IIT/SIT strategy, compared to traditional vector control with pesticides, for dengue prevention from the perspective of the Brazilian Public Health System (BPHS) as the payer and from the societal perspective in the state of Goiás, Brazil. Methods: The two strategies were compared using a decision tree model developed in Amua® software. All estimated parameters were derived from published articles or SUS information systems. The willingness-to-pay threshold (WTP), quality-adjusted life years (QALYs), years of life gained, costs, incremental cost-effectiveness ratios (ICERs), and incremental cost-utility ratios (ICURs) were adopted as study outcomes and parameters. We conducted deterministic and probabilistic sensitivity analyses. Results: Form the BPHS perspective, the IIT-SIT strategy is cost-effective, with an ICUR of R$ 72,200 per QALY gained, which is lower than the WTP of R$ 122,064.30/QALY gained. From the societal perspective, the IIT-SIT strategy is dominant (cheaper and more effective than traditional vector control). Sensitivity analyses showed that these results are reliable. Conclusion: In the state of Goiás, Brazil, the IIT/SIT strategy is cost-effective from the perspective of BPHS and dominant from the societal perspective, when compared to traditional vector control

A dengue e demais arboviroses têm impacto econômico considerável no Brasil. Há estratégias para controle vetorial da dengue: controle vetorial tradicional com pesticidas; Técnica do Inseto Incompatível (TII) com "wMel Wolbachia" e Técnica do Inseto Estéril (TIE). Objetivo: Analisar a razão de custo-efetividade da estratégia de TII/TIE, comparada ao controle vetorial tradicional com pesticidas, para prevenção da dengue, na perspectiva do Sistema Único de Saúde (SUS) como pagador e na perspectiva societal no Estado de Goiás, Brasil. Métodos: As duas estratégias foram comparadas usando um modelo de árvore de decisão desenvolvido no software Amua®. Todos os parâmetros estimados foram derivados de artigos publicados ou dos sistemas de informação do SUS. Limite de disposição para pagar (LDAP), Anos de vida ajustados pela qualidade (QALYs), anos de vida ganho, custos e razões de custo-efetividade incremental (RCEI) e custo-utilidade incremental (RCUI) foram adotados como desfechos e parâmetros do estudo. Análises de sensibilidade determinísticas e probabilísticas foram conduzidas. Resultados: Na perspectiva do SUS como pagador, a estratégia de TII-TIE é custo-efetiva, com RCUI de R$ 72,2 mil reais por QALY ganho, que é inferior ao LDAP de R$ 122.064,30/QALY ganho. Na perspectiva societal, a estratégia de TII-TIE é dominante (mais barata e mais efetiva que o controle vetorial tradicional). As análises de sensibilidade mostraram que esses resultados são confiáveis. Conclusão: No Estado de Goiás, Brasil, a estratégia de TII/TIE parece ser custo-efetiva na perspectiva do SUS e dominante na perspectiva societal, quando comparada ao controle vetorial tradicional