Effectiveness of Heterologous Coronavirus Disease 2019 (COVID-19) Vaccine Booster Dosing in Brazilian Healthcare Workers, 2021.

BACKGROUND: Little is currently known about vaccine effectiveness (VE) for either 2 doses of Oxford-AstraZeneca (ChAdOx1) viral vector vaccine or CoronaVac (Instituto Butantan) inactivated viral vaccine followed by a third dose of mRNA vaccine (Pfizer/BioNTech) among healthcare workers (HCWs). METHODS: We conducted a retrospective cohort study among HCWs (aged ≥18 years) working in a private healthcare system in Brazil from January to December 2021. VE was defined as 1 - incidence rate ratio (IRR), with IRR determined using Poisson models with the occurrence of laboratory-confirmed coronavirus disease 2019 (COVID-19) infection as the outcome, adjusting for age, sex, and job type. We compared those receiving viral vector or inactivated viral primary series (2 doses) with those who received an mRNA booster. RESULTS: A total of 11 427 HCWs met the inclusion criteria. COVID-19 was confirmed in 31.5% of HCWs receiving 2 doses of CoronaVac vaccine versus 0.9% of HCWs receiving 2 doses of CoronaVac vaccine with mRNA booster (P < .001) and 9.8% of HCWs receiving 2 doses of ChAdOx1 vaccine versus 1% among HCWs receiving 2 doses of ChAdOx1 vaccine with mRNA booster (P < .001). In the adjusted analyses, the estimated VE was 92.0% for 2 CoronaVac vaccines plus mRNA booster and 60.2% for 2 ChAdOx1 vaccines plus mRNA booster, when compared with those with no mRNA booster. Of 246 samples screened for mutations, 191 (77.6%) were Delta variants. CONCLUSIONS: While 2 doses of ChAdOx1 or CoronaVac vaccines prevent COVID-19, the addition of a Pfizer/BioNTech booster provided significantly more protection.

Cost-effectiveness of a second opinion program on spine surgeries: an economic analysis.

BACKGROUND: In this study we proposed a new strategy to measure cost-effectiveness of second opinion program on spine surgery, using as measure of effectiveness the minimal important change (MIC) in the quality of life reported by patients, including the satisfaction questionnaire regarding the treatment and direct medical costs. METHODS: Retrospective analysis of patients with prior indication for spine surgery included in a second opinion program during May 2011 to May 2019. Treatment costs and outcomes were compared considering each patients' recommended treatment before and after the second opinion. Costs were measured under the perspective of the hospital, including hospital stay, surgical room, physician and staff fees and other costs related to hospitalization when surgery was performed and physiotherapy or injection costs when a conservative treatment was recommended. Reoperation costs were also included. For comparison analysis, we used data based on our clinical practice, using data from patients who underwent the same type of surgical procedure as recommended by the first referral. The measure of effectiveness was the percentage of patients who achieved the MIC in quality of life measured by the EQ-5D-3 L 2 years after starting treatment. An incremental cost-effectiveness ratio (ICER) was calculated. RESULTS: Based upon the assessment of 1,088 patients that completed the entire second opinion process, conservative management was recommended for 662 (60.8%) patients; 49 (4.5%) were recommended to injection and 377 (34.7%) to surgery. Complex spine surgery, as arthrodesis, was recommended by second opinion in only 3.7% of cases. The program resulted in financial savings of -$6,705 per patient associated with appropriate treatment indication, with an incremental effectiveness of 0.077 patients achieving MIC when compared to the first referral, resulting in an ICER of $-87,066 per additional patient achieving the MIC, ranging between $-273,016 and $-41,832. CONCLUSION: After 2 years of treatment, the second opinion program demonstrated the potential for cost-offsets associated with improved quality of life.

Impact of perioperative hemodynamic optimization therapies in surgical patients: economic study and meta-analysis.

BACKGROUND: Several studies suggest that hemodynamic optimization therapies can reduce complications, the length of hospital stay and costs. However, Brazilian data are scarce. Therefore, the objective of this analysis was to evaluate whether the improvement demonstrated by hemodynamic optimization therapy in surgical patients could result in lower costs from the perspective of the Brazilian public unified health system. METHODS: A meta-analysis was performed comparing surgical patients who underwent hemodynamic optimization therapy (intervention) with patients who underwent standard therapy (control) in terms of complications and hospital costs. The cost-effectiveness analysis evaluated the clinical and financial benefits of hemodynamic optimization protocols for surgical patients. The analysis considered the clinical outcomes of randomized studies published in the last 20 years that involved surgeries and hemodynamic optimization therapy. Indirect costs (equipment depreciation, estate and management activities) were not included in the analysis. RESULTS: A total of 21 clinical trials with a total of 4872 surgical patients were selected. Comparison of the intervention and control groups showed lower rates of infectious (RR = 0.66; 95% CI = 0.58-0.74), renal (RR = 0.68; 95% CI = 0.54-0.87), and cardiovascular (RR = 0.87; 95% CI = 0.76-0.99) complications and a nonstatistically significant lower rate of respiratory complications (RR = 0.82; 95% CI = 0.67-1.02). There was no difference in mortality (RR = 1.02; 95% CI = 0.80-1.3) between groups. In the analysis of total costs, the intervention group showed a cost reduction of R$396,024.83-BRL ($90,161.38-USD) for every 1000 patients treated compared to the control group. The patients in the intervention group showed greater effectiveness, with 1.0 fewer days in the intensive care unit and hospital. In addition, there were 333 fewer patients with complications, with a consequent reduction of R$1,630,341.47-BRL ($371,173.27-USD) for every 1000 patients treated. CONCLUSIONS: Hemodynamic optimization therapy is cost-effective and would increase the efficiency of and decrease the burden of the Brazilian public health system.

Can hydrophilic coated catheters be beneficial for the public healthcare system in Brazil? - A cost-effectiveness analysis in patients with spinal cord injuries.

INTRODUCTION: Detrusor sphincter dyssynergia affects 70% to 80% of all spinal cord injury patients, resulting in increased risk of urinary tract infections (UTIs) and potential exposure to antimicrobial resistance. In Brazil, local guidelines recommend intermittent catheterization as the best method for bladder emptying, and two catheter types are available: the conventional uncoated PVC and the hydrophilic coated catheters. OBJECTIVE: To evaluate the cost-effectiveness of two types of catheters for intermittent catheterization from the perspective of the Brazilian public healthcare system. MATERIALS AND METHODS: A Markov model was used to evaluate cost-effectiveness in those with spinal cord injuries. A primary analysis was conducted on all possible adverse events, and a secondary analysis was performed with urinary tract infections as the only relevant parameter. The results were presented as cost per life years gained (LYG), per quality-adjusted life years (QALY) and per number of urinary tract infections (UTIs) avoided. RESULTS: The base scenario of all adverse events shows a cost-effective result of hydrophilic coated catheters compared to uncoated PVC catheters at 57,432 BRL (Brazilian Reais) per LYG and 122,330 BRL per QALY. The secondary scenario showed that the use of hydrophilic coated catheters reduces the total number of UTIs, indicating that an additional cost of hydrophilic coated catheters of 31,240 BRL over a lifetime will reduce lifetime UTIs by 6%. CONCLUSIONS: Despite the higher unit value, the use of hydrophilic coated catheters is a cost-effective treatment from the perspective of the Brazilian public healthcare system.

Timing or Dosing of Intravenous Proton Pump Inhibitors in Acute Upper Gastrointestinal Bleeding Has Low Impact on Costs.

OBJECTIVES: High-dose intravenous proton pump inhibitors (PPIs) post endoscopy are recommended in non-variceal upper gastrointestinal bleeding (UGIB), as they improve outcomes of patients with high-risk lesions. Determine the budget impact of using different PPI regimens in treating non-variceal UGIB, including pre- and post-endoscopic use, continuous infusion (high dose), and intermittent bolus (twice daily) dosing. METHODS: A budget impact analysis using a decision model informed with data from the literature adopting a US third party payer's perspective with a 30-day time horizon was used to determine the total cost per patient (US$2014) presenting with acute UGIB. The base-case employing high-dose pre- and post-endoscopic IV PPI was compared with using only post-endoscopic PPI. For each, continuous or intermittent dosing regimens were assessed with associated incremental costs. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: The overall cost per patient is $11,399 when high-dose IV PPIs are initiated before endoscopy. The incremental costs are all inferior in alternate-case scenarios: $106 less if only post-endoscopic high-dose IVs are used; with intermittent IV bolus dosing, the savings are $223 if used both pre and post endoscopy and $191 if only administered post endoscopy. Subgroup analysis suggests cost savings in patients with clean-base ulcers who are discharged early after endoscopy. Results are robust to sensitivity analysis. CONCLUSIONS: The incremental costs of using different IV PPI regimens are modest compared with total per patient costs.

Is it possible to estimate the number of patients with COVID-19 admitted to intensive care units and general wards using clinical and telemedicine data?

BACKGROUND: Gabaldi et al. utilized telemedicine data, web search trends, hospitalized patient characteristics, and resource usage data to estimate bed occupancy during the COVID-19 pandemic. The results showcase the potential of data-driven strategies to enhance resource allocation decisions for an effective pandemic response. OBJECTIVE: To develop and validate predictive models to estimate the number of COVID-19 patients hospitalized in the intensive care units and general wards of a private not-for-profit hospital in São Paulo, Brazil. METHODS: Two main models were developed. The first model calculated hospital occupation as the difference between predicted COVID-19 patient admissions, transfers between departments, and discharges, estimating admissions based on their weekly moving averages, segmented by general wards and intensive care units. Patient discharge predictions were based on a length of stay predictive model, assessing the clinical characteristics of patients hospitalized with COVID-19, including age group and usage of mechanical ventilation devices. The second model estimated hospital occupation based on the correlation with the number of telemedicine visits by patients diagnosed with COVID-19, utilizing correlational analysis to define the lag that maximized the correlation between the studied series. Both models were monitored for 365 days, from May 20th, 2021, to May 20th, 2022. RESULTS: The first model predicted the number of hospitalized patients by department within an interval of up to 14 days. The second model estimated the total number of hospitalized patients for the following 8 days, considering calls attended by Hospital Israelita Albert Einstein's telemedicine department. Considering the average daily predicted values for the intensive care unit and general ward across a forecast horizon of 8 days, as limited by the second model, the first and second models obtained R² values of 0.900 and 0.996, respectively and mean absolute errors of 8.885 and 2.524 beds, respectively. The performances of both models were monitored using the mean error, mean absolute error, and root mean squared error as a function of the forecast horizon in days. CONCLUSION: The model based on telemedicine use was the most accurate in the current analysis and was used to estimate COVID-19 hospital occupancy 8 days in advance, validating predictions of this nature in similar clinical contexts. The results encourage the expansion of this method to other pathologies, aiming to guarantee the standards of hospital care and conscious consumption of resources. BACKGROUND: Developed models to forecast bed occupancy for up to 14 days and monitored errors for 365 days. BACKGROUND: Telemedicine calls from COVID-19 patients correlated with the number of patients hospitalized in the next 8 days.

Microcosting analysis of haematopoietic stem cell transplantation and chemotherapy with intermediate doses of cytarabine in the treatment of acute myeloid leukaemia.

BACKGROUND: Acute myeloid leukaemia (AML) is considered a costly disease. Depending on the risk stratification, the patient may receive consolidation with cycles of intermediate doses of cytarabine, auto-HSCT or allo-HSCT according to availability in each service and the availability of a compatible donor. Literature data indicate that safety and effectiveness do not differ between consolidation therapy with intermediate-dose cytarabine or auto-HSCT, and so the cost can help physicians and health managers in their choice. METHOD: The cost of the second consolidation was compared in 18 to 60-year-old patients with de novo AML who were included in the International Consortium of Acute Myeloid Leukaemia (ICAML) protocol. Patients treated with auto-HSCT or intermediate doses of cytarabine (IDAC) were analysed during four years using the microcosting methodology. RESULTS: The mean costs for auto-HSCT and IDAC were BRL$ 34,900.95 (range: 23,611.36-41,229.59) and 15,231.64 (range: 6,546.36-23,253.53), respectively. The mean duration of in-hospital stay was 88.4 (93-133) and 94 (50-153) days, respectively. The mean cost of the four cycles of treatment was BRL$ 114.212,78 for auto-HSCT and BRL$ 121.980,93 for the chemotherapy group. Regardless of the type of treatment, the input that had the greatest economic impact was hospital admission, mainly due to infections. CONCLUSION: Auto-HSCT had a lower average cost per patient and hospitalization rate than chemotherapy.

Impact of a quality programme on overindication of surgeries for endometriosis and cholecystectomies.

Approximately 45% of patients receive medical services with minimal or no benefit (low-value care). In addition to the increasing costs to the health system, performing invasive procedures without an indication poses a potentially preventable risk to patient safety. This study aimed to determine whether a managed quality improvement programme could prevent cholecystectomy and surgery for endometriosis treatment with minimal or no benefit to patients.This before-and-after study was conducted at a private hospital in São Paulo, Brazil, which has a main medical remuneration model of fee for service. All patients who underwent cholecystectomy or surgery for endometriosis between 1 August 2020 and 31 May 2021 were evaluated.The intervention consisted of allowing the performance of procedures that met previously defined criteria or for which the indications were validated by a board of experts.A total of 430 patients were included in this analysis. The programme prevented the unnecessary performance of 13% of cholecystectomies (p=0.0001) and 22.2% (p=0.0006) of surgeries for the treatment of endometriosis. This resulted in an estimated annual cost reduction to the health system of US$466 094.93.In a hospital with a private practice and fee-for-service medical remuneration, the definition of clear criteria for indicating surgery and the analysis of cases that did not meet these criteria by a board of reputable experts at the institution resulted in a statistically significant reduction in low-value cholecystectomies and endometriosis surgeries.

Prevalence, predictors, and patient-reported outcomes of long COVID in hospitalized and non-hospitalized patients from the city of São Paulo, Brazil.

Background: Robust data comparing long COVID in hospitalized and non-hospitalized patients in middle-income countries are limited. Methods: A retrospective cohort study was conducted in Brazil, including hospitalized and non-hospitalized patients. Long COVID was diagnosed at 90-day follow-up using WHO criteria. Demographic and clinical information, including the depression screening scale (PHQ-2) at day 30, was compared between the groups. If the PHQ-2 score is 3 or greater, major depressive disorder is likely. Logistic regression analysis identified predictors and protective factors for long COVID. Results: A total of 291 hospitalized and 1,118 non-hospitalized patients with COVID-19 were included. The prevalence of long COVID was 47.1% and 49.5%, respectively. Multivariable logistic regression showed female sex (odds ratio [OR] = 4.50, 95% confidence interval (CI) 2.51-8.37), hypertension (OR = 2.90, 95% CI 1.52-5.69), PHQ-2 > 3 (OR = 6.50, 95% CI 1.68-33.4) and corticosteroid use during hospital stay (OR = 2.43, 95% CI 1.20-5.04) as predictors of long COVID in hospitalized patients, while female sex (OR = 2.52, 95% CI 1.95-3.27) and PHQ-2 > 3 (OR = 3.88, 95% CI 2.52-6.16) were predictors in non-hospitalized patients. Conclusion: Long COVID was prevalent in both groups. Positive depression screening at day 30 post-infection can predict long COVID. Early screening of depression helps health staff to identify patients at a higher risk of long COVID, allowing an early diagnosis of the condition.

Effectiveness of two coronavirus disease 2019 (COVID-19) vaccines (viral vector and inactivated viral vaccine) against severe acute respiratory coronavirus virus 2 (SARS-CoV-2) infection in a cohort of healthcare workers.

OBJECTIVE: We investigated real-world vaccine effectiveness for Oxford-AstraZeneca (ChAdOx1) and CoronaVac against laboratory-confirmed severe acute respiratory coronavirus virus 2 (SARS-CoV-2) infection among healthcare workers (HCWs). METHODS: We conducted a retrospective cohort study among HCWs (aged ≥18 years) working in a private healthcare system in Brazil between January 1, 2021 and August 3, 2021, to assess vaccine effectiveness. We calculated vaccine effectiveness as 1 - rate ratio (RR), with RR determined by adjusting Poisson models with the occurrence of SARS-CoV-2 infection as the outcome and the vaccination status as the main variable. We used the logarithmic link function and simple models adjusting for sex, age, and job types. RESULTS: In total, 13,813 HCWs met the inclusion criteria for this analysis. Among them, 6,385 (46.2%) received the CoronaVac vaccine, 5,916 (42.8%) received the ChAdOx1 vaccine, and 1,512 (11.0%) were not vaccinated. Overall, COVID-19 occurred in 6% of unvaccinated HCWs, 3% of HCWs who received 2 doses of CoronaVac vaccine, and 0.7% of HCWs who received 2 doses of ChAdOx1 vaccine (P < .001). In the adjusted analyses, the estimated vaccine effectiveness rates were 51.3% for CoronaVac, and 88.1% for ChAdOx1 vaccine. Both vaccines reduced the number of hospitalizations, the length of hospital stay, and the need for mechanical ventilation. In addition, 19 SARS-CoV-2 samples from 19 HCWs were screened for mutations of interest. Of 19 samples, 18 were the γ (gamma) variant. CONCLUSIONS: Although both COVID-19 vaccines (viral vector and inactivated virus) can significantly prevent COVID-19 among HCWs, CoronaVac was much less effective. The COVID-19 vaccines were also effective against the dominant γ variant.

Longer-term effectiveness of a heterologous coronavirus disease 2019 (COVID-19) vaccine booster in healthcare workers in Brazil.

Objective: To compare the long-term vaccine effectiveness between those receiving viral vector [Oxford-AstraZeneca (ChAdOx1)] or inactivated viral (CoronaVac) primary series (2 doses) and those who received an mRNA booster (Pfizer/BioNTech) (the third dose) among healthcare workers (HCWs). Methods: We conducted a retrospective cohort study among HCWs (aged ≥18 years) in Brazil from January 2021 to July 2022. To assess the variation in the effectiveness of booster dose over time, we estimated the effectiveness rate by taking the log risk ratio as a function of time. Results: Of 14,532 HCWs, coronavirus disease 2019 (COVID-19) was confirmed in 56.3% of HCWs receiving 2 doses of CoronaVac vaccine versus 23.2% of HCWs receiving 2 doses of CoronaVac vaccine with mRNA booster (P < .001), and 37.1% of HCWs receiving 2 doses of ChAdOx1 vaccine versus 22.7% among HCWs receiving 2 doses of ChAdOx1 vaccine with mRNA booster (P < .001). The highest vaccine effectiveness with mRNA booster was observed 30 days after vaccination: 91% for the CoronaVac vaccine group and 97% for the ChAdOx1 vaccine group. Vacine effectiveness declined to 55% and 67%, respectively, at 180 days. Of 430 samples screened for mutations, 49.5% were SARS-CoV-2 delta variants and 34.2% were SARS-CoV-2 omicron variants. Conclusions: Heterologous COVID-19 vaccines were effective for up to 180 days in preventing COVID-19 in the SARS-CoV-2 delta and omicron variant eras, which suggests the need for a second booster.

Clinical characteristics and outcomes of patients with COVID-19 admitted to the intensive care unit during the first and second waves of the pandemic in Brazil: a single-center retrospective cohort study.

OBJECTIVE: To describe and compare the clinical characteristics and outcomes of patients admitted to intensive care units during the first and second waves of the COVID-19 pandemic. METHODS: In this retrospective single-center cohort study, data were retrieved from the Epimed Monitor System; all adult patients admitted to the intensive care unit between March 4, 2020, and October 1, 2021, were included in the study. We compared the clinical characteristics and outcomes of patients admitted to the intensive care unit of a quaternary private hospital in São Paulo, Brazil, during the first (May 1, 2020, to August 31, 2020) and second (March 1, 2021, to June 30, 2021) waves of the COVID-19 pandemic. RESULTS: In total, 1,427 patients with COVID-19 were admitted to the intensive care unit during the first (421 patients) and second (1,006 patients) waves. Compared with the first wave group [median (IQR)], the second wave group was younger [57 (46-70) versus 67 (52-80) years; p<0.001], had a lower SAPS 3 Score [45 (42-52) versus 49 (43-57); p<0.001], lower SOFA Score on intensive care unit admission [3 (1-6) versus 4 (2-6); p=0.018], lower Charlson Comorbidity Index [0 (0-1) versus 1 (0-2); p<0.001], and were less frequently frail (10.4% versus 18.1%; p<0.001). The second wave group used more noninvasive ventilation (81.3% versus 53.4%; p<0.001) and high-flow nasal cannula (63.2% versus 23.0%; p<0.001) during their intensive care unit stay. The intensive care unit (11.3% versus 10.5%; p=0.696) and in-hospital mortality (12.3% versus 12.1%; p=0.998) rates did not differ between both waves. CONCLUSION: In the first and second waves, patients with severe COVID-19 exhibited similar mortality rates and need for invasive organ support, despite the second wave group being younger and less severely ill at the time of intensive care unit admission.

Risk factors for long coronavirus disease 2019 (long COVID) among healthcare personnel, Brazil, 2020-2022.

OBJECTIVE: To determine risk factors for the development of long coronavirus disease 2019 (COVID-19) in healthcare personnel (HCP). METHODS: We conducted a case-control study among HCP who had confirmed symptomatic COVID-19 working in a Brazilian healthcare system between March 1, 2020, and July 15, 2022. Cases were defined as those having long COVID according to the Centers for Disease Control and Prevention definition. Controls were defined as HCP who had documented COVID-19 but did not develop long COVID. Multiple logistic regression was used to assess the association between exposure variables and long COVID during 180 days of follow-up. RESULTS: Of 7,051 HCP diagnosed with COVID-19, 1,933 (27.4%) who developed long COVID were compared to 5,118 (72.6%) who did not. The majority of those with long COVID (51.8%) had 3 or more symptoms. Factors associated with the development of long COVID were female sex (OR, 1.21; 95% CI, 1.05-1.39), age (OR, 1.01; 95% CI, 1.00-1.02), and 2 or more SARS-CoV-2 infections (OR, 1.27; 95% CI, 1.07-1.50). Those infected with the SARS-CoV-2 δ (delta) variant (OR, 0.30; 95% CI, 0.17-0.50) or the SARS-CoV-2 o (omicron) variant (OR, 0.49; 95% CI, 0.30-0.78), and those receiving 4 COVID-19 vaccine doses prior to infection (OR, 0.05; 95% CI, 0.01-0.19) were significantly less likely to develop long COVID. CONCLUSIONS: Long COVID can be prevalent among HCP. Acquiring >1 SARS-CoV-2 infection was a major risk factor for long COVID, while maintenance of immunity via vaccination was highly protective.

Stage-Related Cost of Treatment of Bladder Cancer in Brazil.

PURPOSE: Bladder cancer is the ninth most frequent cancer worldwide with the twelfth highest incidence. However, its treatment has financial impacts that directly affect health burden. There is a scarcity of data about the costs related to healthcare in Brazil, especially in the public setting. As previously demonstrated, despite not being one of the most frequent cancers, bladder cancer appears to be one of the most expensive. The present study aimed to assess the costs related to the treatment of bladder cancer in the public setting in Brazil. PATIENTS AND METHODS: Retrospective data of patients treated for urothelial bladder carcinoma from 2019 to 2020 were retrieved at a single center. All charts were reviewed, with the assessment of clinical data, exams, surgical data, and post-procedure outcomes. The hospital finance department calculated the costs for outpatient evaluation, inpatient procedures, complementary exams, materials, drugs, and professionals' fees throughout all operations. RESULTS: A total of 107 patients with bladder cancer were analyzed, representing a total expenditure of BRL 5,671,042.70 and a mean cost of BRL 53,000.04 per patient (US$1.00 = BRL 5.60). Median costs were progressively higher for patients with stages I, II, III, and IV. Patients who underwent radical cystectomy (n = 14) had a median treatment cost of BRL 136,606.25 ± 96,059.08, during a mean follow-up of 9.2 months. Hospitalization costs represented 25% (range 20-43% according to the stage) of all expenditure. Medications and medical supplies represented 18% (16-23% according to the stage) of expenditure. Medical fees represented 31% of costs for stage I disease, but only 4% in stage II, III, and IV. Costs associated with emergency room visits were only observed in stage III and IV disease, representing 1% of all expenditure. CONCLUSIONS: The management of bladder cancer resulted in a significant economic burden on our public health system. The costs associated with stage I bladder cancer were 4-12 times higher than those related to the treatment of other common malignancies at initial stages. Treatment was also expensive during the first months with more advanced stages.

Ideal vial size for bortezomib: real-world data on waste and cost reduction in treatment of multiple myeloma in Brazil.

OBJECTIVES: Single-size vials of drugs may be a source of waste and increase in treatment costs. Bortezomib, indicated for multiple myeloma (MM) treatment, is available in 3.5-mg vials, a quantity higher than the average dose commonly prescribed. This analysis aimed to demonstrate, through real-world data, which would be the optimal vial presentation for bortezomib in Brazil and quantify the reduction in medication waste related to this option. METHODS: From November 2007 to October 2009 all patients with MM treated with bortezomib were identified via the Evidências database. Analysis of prescribed, dispensed, and wasted doses, their costs and projections of the ideal vial size were performed. RESULTS: Thirty-five patients (mean body surface area of 1.73 m(2)) received 509 infusions in 131 cycles of treatment (average of 3.77 cycles per patient). The average dose prescribed was 2.1 mg per infusion (95% confidence interval [CI] 1.97-2.26) with average waste of 39.5% of the vial content (95% CI 35.35-43.76). The mean waste per patient per day was 1.38 mg (95% CI 1.24-1.52). If a 3-mg vial were available, the average drug waste per patient per day would be 0.88 mg (95% CI 0.74-1.03) or 36.2% less. With a 2.5-mg vial the waste would be 1.05 mg (95% CI 0.81-1.29) or 23.9% less. If two presentations were available (2.5 mg and 0.5 mg), the waste would be 0.52 mg (95% CI 0.4-0.63) or 62.5% less. Considering the price of the different vials to be proportional to the original 3.5-mg vial, the cost would be also reduced by the same rates described above. CONCLUSIONS: A simple adjustment in vial size may reduce the waste of bortezomib by 36% to 62% and can also reduce the cost of treatment.

Management of common bile duct stones in cirrhotic patients with coagulopathy: a comparison of supra-papillary puncture and standard cannulation technique.

BACKGROUND AND STUDY AIMS: Bleeding is not uncommon following endoscopic sphincterotomy. Supra-papillary puncture (SPP) might be safer than standard cannulation (SC) techniques in patients with coagulopathy. The aim of the study was to compare the safety and effectiveness of SPP and SC. PATIENT AND METHODS: This was a prospective case control intervention study. Decompensated cirrhotic patients with coagulopathy and choledocolithiasis underwent SC and SPP methods for biliary access. RESULTS: One hundred five patients (56 [53.3%] men, mean [SD] age 56 [15.8]) underwent ERCP. SC and SPP were performed in 63 and 42 patients, respectively. Biliary access was achieved in 56/63 (89%) and 40/42 (95%) of patients undergoing SC and SPP, respectively (P = 0.13; 95% CI [-0.16; 0.03]). Complications occurred in 10/63 (15.8%) patients undergoing SC and 5/42 (11.9%) SPP (P = 0.28; 95% CI [-0.17, 0.16]). Five (7.9%) and two (3.2%) episodes of post-sphincterotomy bleeding was seen in the SC and SPP groups, respectively (P = 0.36; 95% CI [-0.16, 0.05]). In contrast, three (4.8%) episodes of pancreatitis were seen in the SC and none in the SPP group (P = 0.05; 95% CI [0.001; 0.004]). A cost-effectiveness analysis demonstrated that SPP is an acceptable alternative at an ICER of US$ 5,974.92 per additional successful procedure. CONCLUSION: SPP is a safe and effective technique for the management of common bile duct stones in decompensated cirrhotic patients. Conditional to the willingness-to-pay and to the local ERCP-related costs, SPP is also a cost-effective alternative to the SC methods. SPP is associated with a lower rate of complications but larger studies to validate these findings are necessary.

Percutaneous Cryoablation versus Robot-Assisted Partial Nephrectomy of Renal T1A Tumors: a Single-Center Retrospective Cost-Effectiveness Analysis.

PURPOSE: To evaluate the cost-effectiveness of percutaneous cryoablation (PCA) versus robot-assisted partial nephrectomy (RPN) in patients with small renal tumors (T1a stage), considering perioperative complications. MATERIALS AND METHODS: Retrospective study from November 2008 to April 2017 of 122 patients with a T1a renal mass who after being analyzed by a multidisciplinary board underwent to PCA (59 patients) or RPN (63 patients). Hospital costs in US dollars, and clinical and tumor data were compared. Non-complicated intervention was considered as an effective outcome. A hypothetical model of possible complications based on Clavien-Dindo classification (CDC) was built, grouping them into mild (CDC I and II) and severe (CDC III and IV). A decision tree model was structured from complications of published data. RESULTS: Patients who underwent PCA were older (62.5 vs. 52.8 years old, p < 0.001), presented with more coronary disease and previous renal cancer (25.4% vs. 10.1%, p = 0.023 and 38% vs. 7.2%, p < 0.001, respectively). Patients treated with PCA had a higher preoperative risk (American Society of Anesthesiologists-ASA ≥ 3) than those in the RPN group (25.4% vs. 0%, p < 0.001). Average operative time was significantly lower with PCA than RPN (99.92 ± 29.05 min vs. 129.28 ± 54.85 min, p < 0.001). Average hospitalization time for PCA was 2.2 ± 2.95 days, significantly lower than RPN (mean 3.03 ± 1.49 days, p = 0.04). The average total cost of PCA was significantly lower than RPN (US$12,435 ± 6,176 vs. US$19,399 ± 6,047, p < 0.001). The incremental effectiveness was 5% higher comparing PCA with RPN, resulting a cost-saving result in favor of PCA. CONCLUSION: PCA was the dominant strategy (less costly and more effective) compared to RPN, considering occurrence of perioperative complications.

Impact of the COVID-19 pandemic on emergency department visits: experience of a Brazilian reference center.

OBJECTIVE: To analyze the impact of COVID-19 on emergency department metrics at a large tertiary reference hospital in Brazil. METHODS: A retrospective analysis of consecutive emergency department visits, from January 1, 2020, to November 21, 2020, was performed and compared to the corresponding time frame in 2018 and 2019. The volume of visits and patients' demographic and clinic characteristics were compared. All medical conditions were included, except confirmed cases of COVID-19. RESULTS: A total of 138,138 emergency department visits occurred during the study period, with a statistically significant (p<0.01) reduction by 52% compared to both 2018 and 2019. This decrease was more pronounced for pediatric visits - a drop by 71% in comparison to previous years. Regarding clinical presentation, there was a decrease of severe cases by 34.7% and 37.6%, whereas mild cases decreased by 55.2% and 56.2% when comparing 2020 to 2018 and 2019, respectively. A 30% fall in the total volume of hospital admission from emergency department patients was observed during the study period, but accompanied by a proportional increase in monthly admission rates since April 2020. CONCLUSION: The COVID-19 pandemic led to a 52% fall in attendance at our emergency department for other conditions, along with a proportional increase in hospital admission rates of COVID-19 patients. Healthcare providers should raise patient awareness not to delay seeking medical treatment of severe conditions that require care at the emergency department.

Clinical characteristics and outcomes of COVID-19 patients admitted to the intensive care unit during the first year of the pandemic in Brazil: a single center retrospective cohort study.

OBJECTIVE: To describe clinical characteristics, resource use, outcomes, and to identify predictors of in-hospital mortality of patients with COVID-19 admitted to the intensive care unit. METHODS: Retrospective single-center cohort study conducted at a private hospital in São Paulo (SP), Brazil. All consecutive adult (≥18 years) patients admitted to the intensive care unit, between March 4, 2020 and February 28, 2021 were included in this study. Patients were categorized between survivors and non-survivors according to hospital discharge. RESULTS: During the study period, 1,296 patients [median (interquartile range) age: 66 (53-77) years] with COVID-19 were admitted to the intensive care unit. Out of those, 170 (13.6%) died at hospital (non-survivors) and 1,078 (86.4%) were discharged (survivors). Compared to survivors, non-survivors were older [80 (70-88) versus 63 (50-74) years; p<0.001], had a higher Simplified Acute Physiology Score 3 [59 (54-66) versus 47 (42-53) points; p<0.001], and presented comorbidities more frequently. During the intensive care unit stay, 56.6% of patients received noninvasive ventilation, 32.9% received mechanical ventilation, 31.3% used high flow nasal cannula, 11.7% received renal replacement therapy, and 1.5% used extracorporeal membrane oxygenation. Independent predictors of in-hospital mortality included age, Sequential Organ Failure Assessment score, Charlson Comorbidity Index, need for mechanical ventilation, high flow nasal cannula, renal replacement therapy, and extracorporeal membrane oxygenation support. CONCLUSION: Patients with severe COVID-19 admitted to the intensive care unit exhibited a considerable morbidity and mortality, demanding substantial organ support, and prolonged intensive care unit and hospital stay.

Impact of COVID-19 pandemic on care of oncological patients: experience of a cancer center in a Latin American pandemic epicenter.

OBJECTIVE: Since the rising of coronavirus disease 2019 (COVID-19) pandemic, there is uncertainty regarding the impact of transmission to cancer patients. Evidence on increased severity for patients undergoing antineoplastic treatment is posed against deferring oncologic treatment. We aimed to evaluate the impact of COVID-19 pandemic on patient volumes in a cancer center in an epicenter of the pandemic. METHODS: Outpatient and inpatient volumes were extracted from electronic health record database. Two intervals were compared: pre-COVID-19 (March to May 2019) and COVID-19 pandemic (March to May 2020) periods. RESULTS: The total number of medical appointments declined by 45% in the COVID-19 period, including a 56.2% decrease in new visits. There was a 27.5% reduction in the number of patients undergoing intravenous systemic treatment and a 57.4% decline in initiation of new treatments. Conversely, there was an increase by 309% in new patients undergoing oral chemotherapy regimens and a 5.9% rise in new patients submitted to radiation therapy in the COVID-19 period. There was a 51.2% decline in length of stay and a 60% reduction in the volume of surgical cases during COVID-19. In the stem cell transplant unit, we observed a reduction by 36.5% in length of stay and a 62.5% drop in stem cell transplants. CONCLUSION: A significant decrease in the number of patients undergoing cancer treatment was observed after COVID-19 pandemic. Although this may be partially overcome by alternative therapeutic options, avoiding timely health care due to fear of getting COVID-19 infection might impact on clinical outcomes. Our findings may help support immediate actions to mitigate this hypothesis.