Cost-Effectiveness Analysis of Pharmacological Treatment for Adult Kidney Transplant Recipients in Colombia.

OBJECTIVES: To evaluate cost-effective pharmacological treatment in adult kidney transplant recipients from the perspective of the Colombian health system. METHODS: A decision tree model for the induction phase and a Markov model for the maintenance phase were built. A review of the clinical literature was conducted to extract probabilities, and the life-years were used as the outcome. Costs were calculated using the administrative databases. The evaluating treatment schemes are organized by groups of evidence with direct comparisons. RESULTS: In the induction phase, anti-thymocyte immunoglobulin+ methylprednisolone is dominant, more effective, and less expensive, compared with basiliximab+methylprednisolone. In the maintenance phase, azathioprine (AZA) is dominant in contrast to mycophenolate mofetil (MFM) both with cyclosporine (CIC)+ corticosteroids (CE); CIC is dominant relative to sirolimus (SIR) and tacrolimus (TAC) (both with MFM+CE or AZA+CE), and TAC is dominant compared with SIR (in addition with MFM+CE or mycophenolate sodium [MFS]+CE); MFM is dominant in relation to MFS and everolimus, and SIR is more effective MFM but it does not exceed the threshold (in sum with TAC+CE); MFS and MFM are dominant relative to everolimus, and SIR is more effective than MFM, but it does not exceed the threshold (in addiction with CIC+CE); MFM is dominant in relation to TAC (in sum with SIR+CE), and CIC+AZA+CE is dominant in relation to TAC+MFM+CE. CONCLUSIONS: The base-case results for all evidence groups are consistent with the different sensitivity analyses.

Eficacia y seguridad de rituximab más corticoides sistémicos en pacientes adultos con pénfigo vulgar moderado a severo refractario o no tributario a tratamiento convencional con agentes inmunosupresores más corticoides sistémicos / Efficacy and safety of rituximab plus systemic corticosteroids in adult patients with moderate to severe pemphigus vulgaris refractory or not amenable to conventional treatment with immunosuppressive agents plus systemic corticosteroids

ANTECEDENTES: En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias, aprobada mediante Resolución N°111-IETSI-ESSALUD-2021 del Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), se ha elaborado el presente dictamen, el cual expone la evaluación de la eficacia y seguridad de rituximab en pacientes adultos con pénfigo vulgar refractario a tratamiento convencional, en adyuvancia a corticoides sistémicos. Así, los siguientes médicos especialistas de la institución : Cindy Rodríguez Arbi, Juan Cavero Guardamino, José Catacora Cama, y Edward Alca Villarroel (médicos dermatólogos del Servicio de Dermatología del Hospital Nacional Guillermo Almenara Irigoyen de la Red Prestacional Almenara); María Pajuelo Levano, Adeliza Manrique Vera, y Celia Moisés Alfaro (médicos dermatólogos del Servicio de Dermatología del Hospital Nacional Edgardo Rebagliati Martins de la Red Prestacional Rebagliati) enviaron al IETSI las solicitudes de aprobación de uso del producto farmacéutico rituximab no incluido en Petitorio Farmacológico de EsSalud siguiendo la Directiva N°003-IETSI-ESSALUD-2016. ASPECTOS GENERALES: El pénfigo vulgar (PV) es una enfermedad autoinmune poco común, caracterizada por la presencia de ampollas intraepidérmicas extensas en las membranas mucosas y la piel. A nivel mundial, se han informado tasas de incidencia anual de entre 0.1 y 0.5 por 100,000 personas (M. Hertl and Sitaru 2022). El PV se caracteriza por la presencia de autoanticuerpos IgG dirigidos contra cadherinas dependientes de calcio: la desmogleína 3 y la desmogleína 1. La acantólisis (pérdida de la adhesión intercelular con formación consiguiente de ampollas epidérmicas) es el resultado de la inhibición de la función de las desmogleínas por la unión a los autoanticuerpos IgG que causa un descenso de la adhesión intercelular (M. Hertl and Sitaru 2022). El diagnóstico del PV se realiza por biopsia cutánea con pruebas de inmunofluorescencia y enzimoinmunoensayo inmunoadsorbente (ELISA) (M. Hertl and Sitaru 2022). METODOLOGÍA: Se realizó una búsqueda sistemática utilizando las bases de datos PubMed, Cochrane Library y LILACS. Además, se realizó una búsqueda dentro de bases de datos pertenecientes a grupos que realizan evaluaciones de tecnologías sanitarias (ETS) y guías de práctica clínica (GPC), incluyendo el Scottish Medicines Consortium (SMC), el National Institute for Health and Care Excellence (NICE), la Canadian Agency for Drugs and Technologies in Health (CADTH), la Haute Autorité de Santé (HAS), el Institute for Quality and Efficiency in Health Care (IQWiG), el Instituto de Evaluación Tecnológica en Salud de Colombia (IETS), la Comissáo Nacional de Incorpornáo de Tecnologias no Sistema Único de Saúde (CONITEC), entre otros. Asimismo, se revisó la Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA) y páginas web de sociedades especializadas en dermatología, tales como: la American Academy of Dermatology (AAD), la British Association of Dermatologists (BAD), la European Academy of Dermatology and Venereology (EADV) y la International Pemphigus and Pemphigoid Foundation (IPPF). Adicionalmente, se hizo una búsqueda en las páginas web del registro de ensayos clínicos administrado por la Biblioteca Nacional de Medicina de los Estados Unidos (https://clinicaltrials.gov/) y de la International Clinical Trial Registry Platform (ICTRP) (https://apps.who.int/trialsearch/), para identificar ensayos clínicos en curso o cuyos resultados no hayan sido publicados. RESULTADOS: La búsqueda de literatura permitió identificar cuatro publicaciones: una GPC realizada por la BAD (Harman et al. 2017); una ETS elaborada por el Servicio Nacional de Salud (NHS, por sus siglas en inglés) de Inglaterra (NHS England 2016); y dos publicaciones del ECA Ritux 3 (Joly et al. 2017; Chen et al. 2020). CONCLUSIÓN: Por todo lo expuesto, el IETSI aprueba el uso de rituximab más corticoides sistémicos en pacientes adultos con pénfigo vulgar moderado a severo refractario o no tributario a tratamiento convencional con agentes inmunosupresores (azatioprina y micofenolato de mofetilo) más corticoides sistémicos, como producto farmacéutico no incluido en el Petitorio Farmacológico de EsSalud, sus condiciones de uso se encuentran establecidas en el Anexo N° 1. La vigencia del presente dictamen preliminar es de un año a partir de la fecha de publicación. Así, la continuación de dicha aprobación estará sujeta a la evaluación de los resultados obtenidos y de mayor evidencia que pueda surgir en el tempo.

Emerging treatments for lupus nephritis: health equity considerations in clinical research and coverage.

DISCLOSURES: No funding was received for the writing of this commentary. The authors report no conflicts of interest.

Lessons Learned Treating Patients with Multiple Myeloma in Resource-Constrained Settings.

PURPOSE OF REVIEW: Based on personal experiences, recommendations for physicians treating patients with multiple myeloma (MM) in low- and middle-income countries (LMICs) are proposed. RECOMMENDATIONS: (1) Implement strategies to keep the patient in the best possible condition for the longest time, in addition to focusing on ways to avoid financial toxicity; (2) if lenalidomide is unavailable, start treatment with thalidomide and dexamethasone, include, if possible, bortezomib; (3) conduct an outpatient-based autologous stem cell transplantation (ASCT) in all eligible patients; (4) use thalidomide as post-ASCT maintenance treatment if lenalidomide is unavailable for the standard risk patients; (5) monitor monoclonal proteins with serum protein electrophoresis and free light chain measurements; (6) employ novel drugs in cases of relapsed or refractory disease; and (7) do not forget supportive therapy. The therapeutic recommendations to treat patients with MM are somewhat different for physicians working in LMICs, compared with those treating patients in high-income countries. These are relevant since more than 50% of the inhabitants of the world live in LMICs, thus indicating that the vast majority of patients with MM are being treated in resource-constrained settings. As time goes by, physicians may acquire the ability to analyze and express their feelings and experiences about topics in the practice of medicine in which they could have learned lessons (1). Since 1980, we have been treating patients with multiple myeloma (MM); to date, we have been personally involved in the study and treatment of more than 300 patients with this disease (2). Having gained experience dealing with MM patients in underprivileged circumstances, such as those prevailing in our country: México, having explored different ideas, treatments, and methods, and being aware of the financial implications which may impact our selection of therapeutic strategies and recommendations, we felt that it was appropriate to share in this article some of these ideas with practitioners around the world who are involved in the treatment of patients with MM in low- and middle-income countries (LMICs).

Nonadherence to Immunosuppressive Medications Following Pediatric Kidney Transplantation Within Full Cost Coverage Health System: Prevalence and Correlates.

OBJECTIVES: Pediatric patients are at higher risk of nonadherence to immunosuppressive medication after kidney transplant and the resulting adverse outcomes. Factors associated with nonadherence vary, which follow an epidemiological framework and according to health system patterns. The Brazilian public health system covers all costs of kidney transplant, including immunosuppressive medications. We aimed to assess the prevalence and correlates of nonadherence to immunosuppressive medications in a pediatric kidney transplant population who received free access to immunosuppressive medications within the health care system. MATERIALS AND METHODS: In this single-center crosssectional study, we studied a convenience sample of 156 outpatients (< 18 years old) who were a minimum of 4 weeks posttransplant. Implementation nonadherence to immunosuppressive medications was measured by the 4 questions of the Basel Assessment of Adherence to Immunosuppressive Medications Scale. Multilevel correlates to non - adherence (patient, micro, and macro levels) were assessed. RESULTS: In our patient population, 61% were males, mean age was 13.6 ± 3.1 years, 77% were adolescents, and 84% received organs from deceased donors. We found that 33% were nonadherent to immuno - suppressive medications, mainly in timing (25%) and taking (10.9%) dimensions. Being an adolescent (odds ratio: 2.66; CI, 1.02-6.96), religion other than Catholic or Protestant (odds ratio: 4.33; CI, 1.13-16.67), and family income higher than 4 reference wages (odds ratio: 3.50; CI, 1.14-10.75) were factors associated with nonadherence. CONCLUSIONS: In our patient population of mostly adolescents, one-third displayed nonadherence to immunosuppressants. Unexpectedly, a higher economic profile, potentially representing better previous access to health care, was independently associated with nonadherence. This result highlights the need for identifying specific correlates to non - adherence before designing interventions.

Cost-Effectiveness of Natalizumab Compared With Fingolimod for Relapsing-Remitting Multiple Sclerosis Treatment in Colombia.

OBJECTIVES: Multiple sclerosis (MS) is a degenerative neurological disorder. Treatment aims to avoid relapses and disability progression. The purpose of this study was to evaluate the cost-effectiveness of natalizumab compared with fingolimod for treating highly active relapsing-remitting MS (RRMS) patients from the Colombian third-party payer perspective. METHODS: We used a Markov economic model from the perspective of the Colombian healthcare system to estimate the cost-effectiveness of natalizumab compared with fingolimod for RRMS with high disease activity or failure of interferons as first-line therapy. This model was centered on disability progression and relapses. We considered a 5-year time horizon with a 5% discount rate. We included only direct medical costs. Local experts were consulted to obtain resource utilization estimates, and local standardized costing methodologies and sources were used. Outcome was considered in terms of quality-adjusted life-years (QALYs). Utilities were extracted or calculated from the literature. Transition probabilities were calculated from available efficacy and safety information (1 USD = 3050.98 COP). RESULTS: Natalizumab showed lower total costs (USD 80 024 vs USD 98 137) and higher QALY yield (3.01 vs 2.94) than fingolimod, dominating it (incremental cost-effectiveness ratio = -$1861). Univariate sensitivity analysis showcased the relevance of the measures of effect on disability progression for natalizumab on model results. Probabilistic sensitivity analysis replicated base-case results in most simulations. CONCLUSIONS: This study showed that natalizumab dominated fingolimod with lower costs and higher QALYs in patients with high-activity RRMS. These results are consistent with previous published international literature.

Immunosuppressants in Brazil: underlying drivers of spending trends, 2010-2015.

BACKGROUND: Immunosuppressants are recommended for treatment of autoimmune diseases, and in transplant therapy. The high cost of these drugs has been causing an important impact on global pharmaceutical spending. OBJECTIVE: Analyzing immunosuppressant expenditure in Brazil, using data from the Federal Procurement System database (SIASG), between 2010 and 2015. METHODS: The pharmaceutical products were classified in accordance with the Anatomical, Therapeutic and Chemical (ATC) classification system recommended by World Health Organization (WHO) and aggregated by volume and by expenditure. The expenditure variation was decomposed into three broad categories: price effects, quantity effects, and drug mix effects. RESULTS: During the period, annual expenditure increased by 49%, ranging from USD 494.5 million in 2010 to USD 738.7 million in 2015, while purchased quantities increased by 294%, ranging from 49.8 million in 2010 to 196.5 million in 2015. Two factors drove expenditures: the quantity effect and the drug-mix effect. CONCLUSION: These findings may contribute to understand immunosuppressant spending trends and the factors that influence them in order to formulate effective cost containment strategies and design optimum drug policy. Rigorous evaluations are recommended to reduce the drug-mix effect, including systems to monitor price, effectiveness, safety, therapeutic value and budget impact of pharmaceutical innovations.

Health Care Cost for Multiple Sclerosis: The Case of a Health Insurer in Colombia.

BACKGROUND: There have been many studies on the cost of multiple sclerosis in countries with high prevalence, whereas in Latin America such analyses are few. Taking into consideration the burden of this disease and the high financial impact of treatment on the health care system, it is necessary to know the behavior of cost of illness. OBJECTIVES: To describe the direct costs associated with health care in patients with multiple sclerosis affiliated with a health insurer in Colombia. METHODS: An analysis of direct costs of disease was performed from the perspective of the third-party payer. A direct measurement from the technical costing "top-down" approach was used. Data were adjusted for inflation and expressed in 2014 US dollars. RESULTS: The average annual cost per patient for the country was $29,339 (2010), $20,956 (2011), $23,892 (2012), $24,148 (2013), and $22,688 (2014). Drug therapy represented 86.1% of the total cost. Between 2010 and 2013, interferons accounted for the largest proportion of the costs of drug treatment (98.5% to 53%), whereas fingolimod showed an increase and accounted for 47% in 2014. CONCLUSIONS: Medications account for the largest proportion of disease costs, with few variations in the last 5 years; nevertheless, the increase in the use of new pharmaceuticals poses a challenge to maintain the financial balance of health insurance.

Impact of Cost-Sharing Increases on Continuity of Specialty Drug Use: A Quasi-Experimental Study.

OBJECTIVE: To examine the impact of cost-sharing increases on continuity of specialty drug use in Medicare beneficiaries with multiple sclerosis (MS) or rheumatoid arthritis (RA). DATA SOURCES/STUDY SETTING: Five percent Medicare claims data (2007-2010). STUDY DESIGN: Quasi-experimental study examining changes in specialty drug use among a group of Medicare Part D beneficiaries without low-income subsidies (non-LIS) as they transitioned from a 5 percent cost-sharing preperiod to a ≥25 percent cost-sharing postperiod, as compared to changes among a disease-matched contemporaneous control group of patients eligible for full low-income subsidies (LIS), who faced minor cost sharing (≤$6.30 copayment) in both the pre- and postperiods. DATA COLLECTION/EXTRACTION METHODS: Key variables were extracted from Medicare data. PRINCIPAL FINDINGS: Relative to the LIS group, the non-LIS group had a greater increase in incidence of 30-day continuous gaps in any Part D treatment from the lower cost-sharing period to the higher cost-sharing period (MS, absolute increase = 10.1 percent, OR = 1.61, 95% CI 1.19-2.17; RA, absolute increase = 21.9 percent, OR = 2.75, 95% CI 2.15-3.51). The increase in Part D treatment gaps was not offset by increased Part B specialty drug use. CONCLUSIONS: Cost-sharing increases due to specialty tier-level cost sharing were associated with interruptions in MS and RA specialty drug treatments.

Patterns of care and burden of chronic idiopathic thrombocytopenic purpura in Brazil.

AIMS: Although several therapeutic options are available for chronic immune thrombocytopenic purpura (cITP), little is known about the treatment of cITP in Brazil. MATERIALS AND METHODS: A multi-center, retrospective chart review, observational study was designed to describe the treatment patterns, clinical burden, resources use, and associated costs for adult patients diagnosed with cITP and treated in public and private institutions in Brazil. Patient charts were screened in reverse chronological order based on their last visit post January 1, 2012. (All costs were calculated using 1.00 USD = 3.9571 BRL, from February 2016.) Results: Of 340 patient charts screened, 50 patients were eligible for inclusion in the study. Single-drug therapy (prednisone, dexamethasone, or dapsone) was the most commonly used treatment, followed by combination therapies (azathioprine + prednisone, azathioprine + prednisone + danazol, and prednisone + dapsone). Splenectomy was performed in 22% of patients after at least first-line treatment. Platelet count and number of bleeding episodes at diagnosis were 31,561.1/mm3 (SD = ±26,396.1) and 40 episodes, respectively; in first-line, 92,631.1/mm3 (SD = ±79,955.3) and 19 episodes, respectively; in second-line, 96,950.0/mm3 (SD = ±76,476.4) and 17 episodes, respectively. Private system patients had a higher median cost compared to public system patients (USD 17.49/month, range = 0-2,020.77 vs USD 9.51/month, range = 0-192.64, respectively). LIMITATIONS: This study does not allow conclusions for causal explanations due to the cohort study design, and treatment patterns represent only the practices of physicians who have agreed to participate in the study. CONCLUSIONS: The data indicate that available therapeutic strategies for second- and third-line therapies appear to be limited.

Preemptive Renal Transplantation-The Best Treatment Option for Terminal Chronic Renal Failure.

Renal transplantation is the best therapeutic option for end-stage chronic renal disease. Assuming that it is more advisable if performed early, we aimed to show the clinical, social, and economic advantages in 70% of our patients who were dialyzed only for a short period. For this purpose, we retrospectively collected data over 28 years in 142 kidney transplants performed in patients with <6 weeks on dialysis. 66% of our patients were 30-60 years old; 98% of the patients had living donors. At transplantation, 64% of our patients had no public support; however, 64% of them returned to work and got health insurance 2 months later. Full rehabilitation was achieved in all cases, including integration to the family, return to full-time work, school and university, sports, and reproduction. Immunosuppression consisted of 3 drugs, including steroids, cyclosporine, and azathioprine or mycophenolate. The cost in the 1st year, including patient and donor evaluation, surgery, immunosuppression, and follow-up, was $13,300 USD versus $22,320 for hemodialysis. We conclude that preemptive renal transplantation with <6 weeks on dialysis is the best therapeutic option for end-stage renal failure, especially in developing countries such as Bolivia, where until last year, full public support for renal replacement therapy was unavailable.

Contemporary Context of Drug-Eluting Stents in Brazil: A Cost Utility Study.

BACKGROUND: Although drug-eluting stents (DES) have been widely incorporated into clinical practice in developed countries, several countries restrict their use mainly because of their high cost and unfavorable incremental cost-effectiveness ratios (ICER). OBJECTIVE: To evaluate the cost-effectiveness of DES in comparison with bare-metal stents (BMS) for treatment of coronary artery disease (CAD). DESIGN: Markov model. DATA SOURCES: Published literature, government database, and CAD patient cohort. TARGET POPULATION: Single-vessel CAD patients. TIME HORIZON: One year and lifetime. PERSPECTIVE: Brazilian Public Health System (SUS). INTERVENTION: Six strategies composed of percutaneous intervention with a BMS or 1 of 5 DES (paclitaxel, sirolimus, everolimus, zotarolimus, and zotarolimus resolute). OUTCOME MEASURES: Cost for target vessel revascularization avoided and cost for quality-adjusted life year gained. BASE CASE ANALYSIS: In the short-term analysis, sirolimus was the most effective and least costly among DES (ICER of I$20,642 per target vessel revascularization avoided), with all others DES dominated by sirolimus. Lifetime cumulative costs ranged from I$18,765 to I$21,400. In the base case analysis, zotarolimus resolute had the most favorable ICER among the DES (ICER I$62,761), with sirolimus, paclitaxel, and zotarolimus being absolute dominated and everolimus extended dominated by zotarolimus resolute, although all the results were above the willingness-to-pay threshold of 3 times the gross domestic product per capita (I$35,307). SENSITIVITY ANALYSIS: In deterministic sensitivity analysis, results were sensitive to cost of DES, number of stents used per patient, baseline probability, and duration of stent thrombosis risk. The probabilistic sensitivity analysis demonstrated a probability of 81% for BMS being the strategy of choice, with 9% for everolimus and 9% zotarolimus resolute, at the willingness-to-pay threshold. CONCLUSION: DES is not a good value for money in SUS perspective, despite its benefit in reducing target vessel revascularization. Since the cost-effectiveness of DES is mainly driven by the stents' cost difference, they should cost less than twice the BMS price to become a cost-effective alternative.

Multilevel Correlates of Non-Adherence in Kidney Transplant Patients Benefitting from Full Cost Coverage for Immunosuppressives: A Cross-Sectional Study.

BACKGROUND: Adherence is the result of the interaction of the macro, meso, micro, and patient level factors. The macro level includes full coverage of immunosuppressive medications as is the case in Brazil. We studied the correlates of immunosuppressive non-adherence in post kidney transplant patients in the Brazilian health care system. METHODS: Using a cross-sectional design, adherence to immunosuppressives was assessed in a sample of 100 kidney transplant patients using a composite non-adherence score consisting of three methods (self-report [i.e., The Basel Adherence Scale for Assessment of Immunossupressives-BAASIS], collateral report, and immunosuppressive blood levels). Multilevel correlations of non-adherence were assessed (macro, meso, micro and patient level). Univariate and multivariate logistic regression was applied to assess the correlates of non-adherence. RESULTS: Our sample consisted primarily of male (65%), Caucasians (72%) with a mean age of 45.0 ± 13.5 years old, who received grafts from a living donor (89%), with a mean time after transplantation of 72.3 ± 44.4 months. Prevalence of non-adherence was 51%. Family income higher than five reference wages (21.6 vs. 4%; OR 6.46 [1.35-30.89], p = 0.009; patient level), and having access to private health insurance (35.3% vs. 18.4%; OR 2.42 [0.96-6.10], p = 0.04; meso level) were associated with non-adherence in univariate analysis. Only the higher family income variable was retained in the multiple logistic regression model (OR 5.0; IC: 1.01-25.14; p = 0.04). CONCLUSIONS: Higher family income was the only factor that was associated with immunosuppressive non-adherence. In Brazil, lower income recipients benefit from better access to care and coverage of health care costs after transplantation. This is supposed to result in a better immunosuppressive adherence compared to high-income patients who have experienced these benefits continuously.

Cyclosporine versus tacrolimus: cost-effectiveness analysis for renal transplantation in Brazil.

OBJECTIVE To analyze the cost-effectiveness of treatment regimens with cyclosporine or tacrolimus, five years after renal transplantation. METHODS This cost-effectiveness analysis was based on historical cohort data obtained between 2000 and 2004 and involved 2,022 patients treated with cyclosporine or tacrolimus, matched 1:1 for gender, age, and type and year of transplantation. Graft survival and the direct costs of medical care obtained from the National Health System (SUS) databases were used as outcome results. RESULTS Most of the patients were women, with a mean age of 36.6 years. The most frequent diagnosis of chronic renal failure was glomerulonephritis/nephritis (27.7%). In five years, the tacrolimus group had an average life expectancy gain of 3.96 years at an annual cost of R$78,360.57 compared with the cyclosporine group with a gain of 4.05 years and an annual cost of R$61,350.44. CONCLUSIONS After matching, the study indicated better survival of patients treated with regimens using tacrolimus. Moreover, regimens containing cyclosporine were more cost-effective [corrected].

Avaliação da carga de trabalho no pós-operatório de cirurgia cardíaca segundo o Nursing Activities Score / Evaluación de la carga de trabajo en el postoperatorio de cirugía cardíaca según la Nursing Activities Score / Assessment of workload in the postoperative period of cardiac surgery according to the Nursing Activities Score

RESUMO Objetivo Identificar os fatores associados à carga de trabalho de enfermagem no cuidado a pacientes no pós-operatório de cirurgia cardíaca. Método Estudo de coorte prospectivo, conduzido com 187 pacientes da Unidade de Terapia Intensiva Cirúrgica (UTI) do Instituto do Coração. Os dados foram coletados nas primeiras 24 e 72 horas do paciente na UTI. A variável dependente foi a carga de trabalho calculada por meio do Nursing Activities Score (NAS) e as independentes foram de natureza demográfico-clínicas e escores de morbimortalidade. Para análise dos dados utilizou-se os testes de Wilcoxon-Mann-Whitney e de correlação de Spearman, e a regressão linear com modelo de efeitos mistos. Resultados A maioria dos pacientes era do sexo masculino (59,4%), com média de idade de 61 anos (±12,7) e 43,9% desenvolveram algum tipo de complicação no pós-operatório. Nas 24 horas, a carga de trabalho foi de 82,4% (±3,4) e foi de 58,1% (±3,4) nas 72 horas. Os fatores associados ao aumento do NAS foram: tempo de internação do paciente na UTI (p=0,036) e a presença de complicações (p<0,001). Conclusão A gravidade do paciente nas 24 horas, em oposição a inúmeros estudos, não influenciou no aumento da carga de trabalho, a qual se mostrou associada ao tempo de internação e às complicações.

RESUMEN Objetivo Identificar los factores asociados con la carga de trabajo de enfermería en el cuidado de los pacientes después de la cirugía cardíaca. Método Estudio prospectivo de cohorte, realizado con 187 pacientes de la Unidad Quirúrgica de Cuidados Intensivos (UCI) del Instituto do Coração. Los datos fueron recogidos en las primeras 24 y 72 horas el paciente en la UCI. La variable dependiente fue la carga de trabajo calculada por el Nursing Activities Score (NAS) y eran independientes de la naturaleza y de mortalidad puntajes demográficas y clínicas. Para el análisis de los datos se utilizó la prueba de Wilcoxon-Mann-Whitney y Spearman correlación y de regresión lineal con el modelo de efectos mixtos. Resultados La mayoría de los pacientes eran varones (59,4%) con una edad media de 61 años (±12,7) y 43,9% desarrollaron algún tipo de complicación en el postoperatorio. Dentro de 24 horas, la carga de trabajo fue 82,4% (±3,4) y 58,1% (±3,4) en 72 horas. Los factores asociados con el aumento de NAS fueron: longitud del paciente de la estancia en la UCI (p=0,036) y la presencia de complicaciones (p<0,001). Conclusión La gravedad de la paciente dentro de 24 horas, a diferencia de numerosos estudios, no afectó a la mayor carga de trabajo, que se asoció a la duración de la estancia y complicaciones.

ABSTRACT Objective Identify factors associated with the workload of nursing care for patients in the postoperative period of cardiac surgery. Method Prospective cohort study conducted with 187 patients in the surgical intensive care unit (ICU) of the Instituto do Coração(Heart Institute) in São Paulo-Brazil. Data were collected at 24 and 72 hours of the patients’ admittance in the ICU. The dependent variable was workload as calculated by the Nursing Activities Score (NAS). The independent variables were demographic and clinical, as well as mortality scores. For data analysis, the Wilcoxon-Mann-Whitney test and Spearman correlation were used, and linear regression with mixed effects model. Results The majority of patients were male (59.4%), with a mean age of 61 years (±12.7), and 43.9% developed some kind of complication in the postoperative period. In the first 24 hours, the workload was 82.4% (±3.4), and 58.1% (±3.4) in 72 hours. Factors associated with increased NAS were: patient’s length of stay in the ICU (p=0.036) and the presence of complications (p<0.001). Conclusion In contrast to numerous other studies, the severity of the patient’s condition in the first 24 hours of the postoperative period did not increase workload, the increase was associated with length of stay in the ICU and complications.

Carga de trabalho de enfermagem em transplante de células-tronco hematopoiéticas: estudo de coorte / Carga del trabajo de enfermería en trasplante de células madre hematopoyéticas: estudio de cohorte / Nursing workload in hematopoietic stem cell transplantation: a cohort study

RESUMO Objetivo Mensurar a carga de trabalho de enfermagem requerida por pacientes submetidos ao transplante de células-tronco hematopoiéticas (TCTH), autólogo e alogênico e analisar as atividades do Nursing Activities Score (NAS) executadas pela equipe de enfermagem durante a internação para o TCTH. Método Coorte prospectiva realizada de janeiro/2013 a abril/2014 com 62 pacientes internados na unidade de TCTH de um hospital universitário de Campinas/SP, Brasil. Mediu-se a carga de trabalho por meio do NAS e analisaram-se os dados utilizando os testes Qui-quadrado ou Exato de Fisher, Mann-Whitney e o coeficiente de correlação de Spearman; considerou-se nível de significância de 5%. Resultados A média da carga de trabalho de enfermagem foi de 67,3% (DP 8,2) em pacientes de TCTH autólogo e de 72,4% (DP 13,0) no TCTH alogênico (p=0,1380). O item Monitorização e controles apontou, em mais de 50% das observações, que os pacientes demandaram intensificação deste cuidado, exigindo duas horas ou mais em algum turno de trabalho por motivos de segurança, gravidade ou terapia. Conclusão A carga de trabalho de enfermagem e os itens do NAS mais pontuados refletem a magnitude, complexidade e especificidade dos cuidados demandados pelos pacientes submetidos ao TCTH.

RESUMEN Objetivo Medir la carga de trabajo de enfermería requerida por los pacientes sometidos al trasplante de células madre hematopoyéticas (TCTH), autólogo y alogénico, analizando actividades del Nursing Activities Score (NAS) emprendidas por equipo de enfermería en la internación para el TCTH. Método Cohorte prospectiva realizada entre enero/2013 y abril/2014 con 62 pacientes internados en la unidad de TCTH de hospital universitario en la ciudad de Campinas/SP (BR). En el análisis se utilizaron las pruebas Chi-cuadrado o test Exacto de Fisher, las no paramétricas Mann-Whitney o Kruskal-Wallis y el coeficiente de correlación de Spearman, conforme apropiado. Fijos los niveles de significación en 5%. Resultados La media de la carga de trabajo fue de 67,3% (DP 8,2) para los pacientes de TCTH autólogo y de 72,4% (DP 13,0) para los de TCTH alogénico (p=0,1380). El ítem Monitorización y controles apuntó que los pacientes, en más 50% de las observaciones, demandaban intensificación del cuidado por dos horas o más en algunos turnos de trabajo por cuestiones de seguridad, gravedad o terapia. Conclusión La carga de trabajo en enfermería y los ítems del NAS puntuados reflejan la magnitud, complejidad y especificidad de los cuidados demandados por los pacientes sometidos al TCTH.

ABSTRACT Objective Measure nursing workload required by patients submitted to autologous and allogeneic hematopoietic stem cell transplantation (HSCT) and analyze the Nursing Activities Score (NAS) of the nursing team during the hospitalization period for HSCT. Method A prospective cohort study conducted from January 2013 to April 2014 with 62 patients hospitalized in the HSCT unit of a university hospital in Campinas, São Paulo, Brazil. The workload was measured through NAS and data analysis was through chi-square test or Fisher’s exact test, Mann-Whitney test and Spearman’s correlation coefficient; with 5% significance level. Results Mean nursing workload was 67.3% (SD of 8.2) in autologous HSCT patients and 72.4% (SD of 13.0) in allogeneic HSCT patients (p=0.1380).Monitoring and titration showed, in more than 50% of the time, patients demanded intensified care, requiring two hours or more in a nursing shift for reasons of safety, severity or therapy. Conclusion The nursing workload and the NAS items with the highest scores reflect the magnitude, complexity and specificity of care required by patients submitted to HSCT.

O impacto do último enxágue na citotoxicidade de produtos críticos passíveis de processamento / Impacto del último enjuague en la citotoxicidad de productos críticos pasibles de procesamiento / The impact of the final rinse on the cytoxicity of critical products submitted for processing

RESUMO Objetivo Avaliar a citotoxicidade de produtos submetidos à contaminação desafio, limpeza baseada em procedimento operacional padrão (POP) validado e enxágue final em diferentes tipos de água: de torneira, deionizada, destilada, tratada por osmose reversa e ultrapurificada. Método Estudo experimental e laboratorial. Foram utilizadas como amostras 130 cânulas de hidrodissecção, 26 por grupo experimental, caracterizados, de acordo com a água utilizada no último enxágue. As amostras foram submetidas à contaminação desafio interna e externamente por uma solução contendo 20% sangue de carneiro desfibrinado e 80% de Cloreto de Sódio a 0,9%. Em seguida, tiveram o lúmen preenchido por solução viscoelástica, permanecendo em contato com o contaminante por 50 minutos, sendo então, processadas, de acordo com um POP validado. A citotoxicidade foi avaliada pela captura do corante vital vermelho neutro. Resultados Ausência de citotoxicidade nos extratos das amostras. Conclusão As amostras não demonstraram citotoxicidade, independentemente da qualidade de água utilizada no último enxágue. Os resultados apresentados puderam ser alcançados unicamente por meio do uso de um procedimento operacional padrão de limpeza validado, baseado em literatura científica, em recomendações oficiais e na legislação relacionada.

RESUMEN Objetivo Evaluar la citotoxicidad de productos sometidos a contaminación desafío, limpieza siguiendo procedimiento validado y enjuague en diferentes tipos de agua: de caño, desionizada, destilada, tratada por ósmosis inversa y ultrapurificada. Método fueron utilizados 130 canulas de hidrosección, 26 por grupo experimental, caracterizadas por el tipo agua utilizada en el último enjuague. La muestras fueron contaminadas interna y externamente por una solución con 20% sangre de carnero desfibrinado y 80% de Cloruro de Sodio a 0,9%. Luego el lumen fue cubierto por la solución viscoelastica, permaneciendo en contacto con el contaminante 50 minutos y posteriormente procesados, siguiendo orientaciones del procedimiento padrón validado. El ensayo de citotoxicidad se realizó mediante la incorporación del colorante vital rojo neutro. Resultados ausencia de toxicidad en extractos de las muestras. Conclusión no hubo toxicidad en las muestras, independiente del agua utilizada en el último enjuague. Los resultados fueron alcanzados gracias al uso del procedimiento operacional padrón de limpieza validado, embasado en literatura científica, recomendaciones oficiales y en legislación relacionada.

ABSTRACT Objective To assess the cytotoxicity of products subsequent to a cleaning process based on a validated standard operating procedure (SOP), and a final rinse with different types of water: tap, deionized, distilled, treated by reverse osmosis and ultra-purified. Method This was an experimental and laboratory study. The sample consisted of 130 hydrodissection cannulas, 26 per experimental group, characterized according to type of water used in the final rinse. The samples were submitted to internal and external contamination challenge with a solution containing 20% defibrinated sheep blood and 80% of sodium chloride 0.9%. Next, the lumens were filled with a ophthalmic viscosurgical device, remaining exposed for 50 minutes, and then were processed according to the validated SOP. Cytotoxicity was assessed using neutral red uptake assay. Results No cytoxicity was detected in the sample extracts. Conclusion The samples did not display signs of cytotoxicity, regardless of final rinse quality. The results obtained were reached by using only a validated cleaning operating procedure, based on the scientific literature, and on official recommendations and related regulation.

Cyclosporine versus tacrolimus: cost-effectiveness analysis for renal transplantation in Brazil / Análise de custo-efetividade: ciclosporina versus tacrolimo para transplante renal no Brasil

OBJECTIVE To analyze the cost-effectiveness of treatment regimens with cyclosporine or tacrolimus, five years after renal transplantation. METHODS This cost-effectiveness analysis was based on historical cohort data obtained between 2000 and 2004 and involved 2,022 patients treated with cyclosporine or tacrolimus, matched 1:1 for gender, age, and type and year of transplantation. Graft survival and the direct costs of medical care obtained from the National Health System (SUS) databases were used as outcome results. RESULTS Most of the patients were women, with a mean age of 36.6 years. The most frequent diagnosis of chronic renal failure was glomerulonephritis/nephritis (27.7%). In five years, the tacrolimus group had an average life expectancy gain of 3.96 years at an annual cost of R$78,360.57 compared with the cyclosporine group with a gain of 4.05 years and an annual cost of R$61,350.44. CONCLUSIONS After matching, the study indicated better survival of patients treated with regimens using tacrolimus. However, regimens containing cyclosporine were more cost-effective. .

OBJETIVO Analisar custo-efetividade de regimes terapêuticos com ciclosporina ou tacrolimo cinco anos após transplante renal. MÉTODOS Análise de custo-efetividade com base em dados de coorte histórica 2000-2004, com 2.022 pacientes tratados com ciclosporina ou tacrolimo e pareados 1:1 segundo sexo, idade, tipo e ano de transplante. A sobrevida do enxerto e os custos diretos de cuidados médicos a partir das bases de dados do Sistema Único de Saúde foram utilizados como medida de resultado. RESULTADOS A maioria dos pacientes era do sexo feminino e média de idade de 36,6 anos. O diagnóstico mais frequente de insuficiência renal crônica foi a glomerulonefrite/nefrite (27,7%). Em cinco anos, o grupo tacrolimo obteve uma expectativa de vida média de 3,96 anos de vida ganhos ao custo anual de R$78.360,57 ante 4,05 anos de vida ganhos e de R$61.350,44 para ciclosporina. CONCLUSÕES Após o pareamento, o estudo não mostrou melhor sobrevida dos pacientes com regimes que usam tacrolimo. Além disso, regimes contendo ciclosporina foram mais custo-efetivos. .

Comparison of cost-effectiveness of oral rapamycin plus bare-metal stents versus first generation of drug-eluting stents (from the Randomized Oral Rapamycin in Argentina [ORAR] 3 trial).

The aim of this study was to compare 5-year cost-effectiveness and clinical outcomes of patients with oral rapamycin (OR) plus bare-metal stent versus the drug-eluting stent (DES) strategy. During 2006 to 2007, a total of 200 patients were randomized to OR (n = 100) and DES (n = 100). Primary end point was to compare costs of initial procedure and cost-effectiveness of both revascularization strategies. Safety was evaluated by the composite of death, myocardial infarction, and cerebrovascular accident. Efficacy was assessed by target vessel and target lesion revascularizations. The 2 groups had similar baseline demographic, clinical, and angiographic characteristics. In the DES group, paclitaxel-, zotarolimus-, and sirolimus-eluting stents were used. Five-year clinical follow-up was accomplished in 99% patients. The DES group had significantly higher procedural (p <0.001), discharge to first-year (p = 0.02), and 1- to 5-year costs (p <0.001) compared with the OR group. At 5 years, the composite end point of death, myocardial infarction, and cerebrovascular accident (12% in the OR group vs 25% in the DES group, p = 0.01) was significantly less in the OR group. Target vessel revascularization (14.5% in the OR group vs 21% in the DES group, p = 0.16) and target lesion revascularization (10% in the OR group vs 17.6% in the DES group, p = 0.05) were not significantly different. In conclusion, a strategy of OR plus bare-metal stent was cost saving than a first-generation DES.

Cost-effectiveness of the introduction of specialized oral care with laser therapy in hematopoietic stem cell transplantation.

Oral mucositis (OM) is one of the side effects of hematopoietic stem cell transplantation (HSCT), resulting in major morbidity. The aim of this study was to determine the cost-effectiveness of the introduction of a specialized oral care program including laser therapy in the care of patients receiving HSCT with regard to morbidity associated with OM. Clinical information was gathered on 167 patients undergoing HSCT and divided according to the presence (n = 91) or absence (n = 76) of laser therapy and oral care. Cost analysis included daily hospital fees, parenteral nutrition (PN) and prescription of opioids. It was observed that the group without laser therapy (group II) showed a higher frequency of severe degrees of OM (relative risk = 16.8, 95% confidence interval -5.8 to 48.9, p < 0.001), with a significant association between this severity and the use of PN (p = 0.001), prescription of opioids (p < 0.001), pain in the oral cavity (p = 0.003) and fever > 37.8°C (p = 0.005). Hospitalization costs in this group were up to 30% higher. The introduction of oral care by a multidisciplinary staff including laser therapy helps reduce morbidity resulting from OM and, consequently, helps minimize hospitalization costs associated with HSCT, even considering therapy costs.