Budget impact analyses for treatment of heart failure. A systematic review.

Heart failure (HF) is increasing globally and turning out to be a serious worldwide public health problem with significant morbidity and mortality. This study aims to systemically review the budget impact analysis of heart failure treatments on health care expenditure worldwide. Scientific databases such as PubMed, Web of Science, Scopus, and Google Scholar were searched for budget impact analysis and heart failure treatments, over January 2001 to August 2023. The quality assessment of the selected studies was evaluated through ISPOR practice guideline. Nineteen studies were included in this systematic review. Based on ISPOR recommendations, most studies were performed on a 1-year time horizon and used a government (public health) or health system perspective. Data for selected studies was mainly collected from randomized clinical trials, published literature, pharmaceutical companies, and registry data. Only direct costs were reported in the studies. Sensitivity analyses were stated in almost all studies. However, studies conducted in high-income countries reported sensitivity analyses more elaborately than those performed in low- and middle-income countries. In many published articles related to the budget impact analyses of heart failure treatment, addition of new treatments to the health system's formularies can lead to a reduction in cardiovascular hospitalization rates, re-hospitalization rates, cardiac-associated mortality rates, and an improvement in heart failure class, which can decrease the costs of hospitalizations, specified care visits, primary care visits, and other related treatments.

An economic evaluation on sub-optimal breastfeeding in Hong Kong: Infant health outcomes and costs.

AIM: This study estimated the healthcare cost savings for the government due to the prevention of gastroenteritis (GE) infections and lower respiratory tract infections (LRTI) in the first year of life, attributed to an increase in the exclusive breastfeeding rate at 4 months in Hong Kong. METHODS: The model used the best available data inputs, with uncertainty considered using probabilistic sensitivity analysis. We additionally assessed the impact of neonatal jaundice (NNJ) on the economic benefits of increasing exclusive breastfeeding rates. RESULTS: During 2010-2019, five admissions for GE and three admissions for LRTI per 1000 births would have been prevented in the first year of life if the exclusive breastfeeding rate at 4 months increased from the actual levels (~15-30%) to 50%, resulting in annual healthcare cost savings of USD1.05 (95% CI 1.03-1.07) million/year. The cost saving would reach USD1.89 (95% CI 1.86-1.92) million/year if the exclusive breastfeeding rate at 4 months increase to 70%. However, if higher NNJ admissions during 7-90 days related to more exclusive breastfeeding are considered, the cost saving would reduce by 60%. CONCLUSION: Our findings can guide policymakers in allocating budget and resources for breastfeeding promotion in Hong Kong. The prevention of unnecessary NNJ admissions would maximise the economic benefits of exclusive breastfeeding at 4 months.

Investigating the sterile surgical supply waste in laparotomy surgery.

BACKGROUND: Operating rooms contribute to over 40% of hospital expenses, with a portion attributed to waste from single-use, sterile surgical supplies (SUSSS). This research aimed to determine the amount of cost wastage due to not using SUSSS during laparotomy procedures. METHODS: A descriptive-analytical investigation was conducted in two prominent teaching hospitals in Mashhad, Iran 2018. Seventy-seven laparotomy surgeries were scrutinized, documenting both used and unused disposable devices, with their respective costs being assessed. Data analysis was performed using SPSS version 16 software. RESULTS: The study revealed that during surgery in the operating rooms, waste of SUSSS averaged 5.9%. Betadine solution and sterile Gauze types were the top two contributors to resource wastage. Sterile Gauze types incurred the highest cost loss. The study found a significant correlation between cost wastage and surgeon experience (r = 0.296, P < 0.001) as well as surgery duration (r = 0.439, P < 0.001). CONCLUSION: Inadequate management of available and commonly used disposable supplies leads to increased hospital expenses. Enhancing the surgical team's knowledge of sterile surgical supplies usage and making thoughtful selections can play a vital role in curbing health costs by minimizing waste of SUSSS in the operating rooms.

Cost savings from medication reviews in community pharmacies for nursing home residents in Estonia: a case study.

BACKGROUND: The aim of this study is to assess the cost savings from medication reviews conducted for individuals living in nursing homes in Estonia. Medication reviews performed as part of the automated dose dispensing (ADD) service by community pharmacies might help identify suboptimal medicine regimens. METHODS: We use a case study approach to identify suboptimal use of medication in treatment plans and estimate the potential cost saving from medication reviews. To achieve this, we assess 101 treatment plans submitted for medication review by nursing homes in Estonia between 2021 and 2023. Additionally, we run OLS regressions to identify the most important determinants of medication cost savings. RESULTS: We estimate an average direct cost saving of €43.62 per patient per year, which corresponds to 8.27% of the average annual medication costs. If medication reviews were conducted for all elderly individuals over 75 years old who use six or more prescription medicines, nearly 2% of Estonia's pharmaceutical budget could be saved. Regression analysis indicates that the most significant contributors to these cost savings are suboptimal use of generics, incorrect dosages (too high), and the elimination of incorrect medications. CONCLUSIONS: Our study suggests that annual medication reviews conducted as part of the ADD service might help reduce medication expenditure when offered to a wider public.

The economic and clinical impact of fast- versus slow-setting cement in primary total knee arthroplasty.

INTRODUCTION: New bone cement products have been developed attempting to shorten their setting time and thus cut down time in the operating room. This study determines whether faster-setting bone cement shortens time in the operating room, and whether the quantity used compromises postoperative TKA outcomes. Additionally, this study looks at cost analyses of the quantity of bone cement used in TKA procedures. MATERIALS AND METHODS: One-hundred and sixty patients at a single institution with primary TKA surgeries between January 2019 and December 2021, and a clinic follow-up of at least one year, were identified. Five cement products used in this time period were identified and categorized by fast- or slow-setting products if their set times were marketed below or above six minutes, respectively. RESULTS: Estimated blood loss was higher in patients receiving fast-setting cements (160.0 vs 126.4 mL; p = 0.0009); however, operative time showed no difference between the cohorts (88.2 vs 89.2 min; p = 0.99). Fewer bags of cement were used for the fast cohort (1.3 vs 1.8 bags; p < 0.0001). The fast group was significantly cheaper on average per patient only when comparing between antibiotic bone cements (p = 0.007). No differences were found in postoperative outcomes between the two groups. CONCLUSIONS: No differences were found in operative times between the fast and slow cemented groups. Fewer bags of faster-setting cement only proved cost saving relative to other antibiotic bone cements studied. Nonetheless, decreased usage of fast cement did not result in any different postoperative outcomes compared to slow cements. LEVEL OF EVIDENCE: III.

Group testing regression analysis with covariates and specimens subject to missingness.

We develop parametric estimators of a conditional prevalence in the group testing context. Group testing is applied when a binary outcome variable, often a disease indicator, is assessed by testing a specimen for the presence of the disease. Instead of testing all individual specimens separately, these are pooled in groups and the grouped specimens are tested for the disease, which permits to significantly reduce the number of tests to be performed. Various techniques have been developed in the literature for estimating a conditional prevalence from group testing data, but most of them are not valid when the data are subject to missingness. We consider this problem in the case where the specimen and the covariates are subject to nonmonotone missingness. We propose parametric estimators of the conditional prevalence, establish identifiability conditions for a logistic missing not at random model, and introduce an ignorable missing at random model. In theory, our estimators could be applied with multiple covariates missing, but in practice, they face numerical challenges when more than one covariate is missing for given individuals. We illustrate the method on simulated data and on a dataset from the Demographics and Health Survey.

Cost-savings of short stay sleeve gastrectomy and walk-in hydration clinic versus conventional inpatient care.

OBJECTIVE: We aim to evaluate the cost-saving of the short stay ward (SSW) versus conventional inpatient care following sleeve gastrectomy (LSG). We also compared the readmission rates pre- and post-inception of the intravenous hydration clinic and analyzed the cost-savings. METHODS: Patients who underwent LSG between December 2021 to March 2022 with SSW care were compared with standard inpatient care. Total costs were analyzed using univariate analysis. With a separate cohort of patients, 30-day readmission rates in the 12-months preceding and following implementation of the IV hydration clinic and associated cost-savings were evaluated. RESULTS: After matching on the propensity score to within ± 0.1, 20-subjects pairs were retained. The total cost per SSW-subject was significantly lower at $13,647.81 compared to $15,565.27 for conventional inpatient care (p = 0.0302). Lower average ward charges ($667.76 vs $1371.34, p < 0.0001), lower average daily treatment fee per case ($235.68 vs $836.54, p < 0.0001), and lower average laboratory investigation fee ($612.31 vs $797.21, p < 0.0001) accounted for the difference in costs between the groups. Thirty-day readmission rate reduced from 8.9 to 1.8% after implementation of the hydration clinic (p < 0.01) with decreased 30-day readmission cost (S$96,955.57 vs. S$5910.27, p < 0.01). CONCLUSION: SSW for LSG is cost-effective and should be preferred to inpatient management. Walk-in hydration clinics significantly reduced readmission rates and result in tremendous cost-savings.

COVID-19 Telehealth Service Can Increase Access to the Health Care System and Become a Cost-Saving Strategy.

Introduction: Data addressing the economic aspects of telehealth initiatives are incipient. This study aimed to evaluate the labor costs for running a COVID-19 telehealth system and its potential incremental access to health care service. Methods: From July 2020 to July 2021, data from a Brazilian teleconsultation service were analyzed. Labor costs were estimated by time-driven activity-based costing. A Generalized Reduced Gradient solving method was coded to maximize the mean incremental access rate and two scenarios were considered to compare the teleconsultation with the in-person consultation: (1) only the length of time that patients spent with a clinician in an in-person consultation was accounted and (2) in addition to the medical consultation, nursing screening was accounted. The mean incremental access rate of the teleconsultation service was defined as a maximization objective in the model. Results: Mean labor costs per medical and nursing teleconsultations are Int$ 24 and Int$ 10, based on data analyses from 25,258 patients. Telemonitoring a patient with a daily call for 7 days costs, on average, Int$ 14. COVID-19 teleconsultation service represents, on average, an incremental access to medical consultation rate of 35% to 52% (min 23% max 63%) for the scenarios (1) and (2), respectively, and considering the current consumed budget for this service. Discussion: A COVID-19 telehealth service contributes to increasing access to the health care system without increasing costs. These services can be included in the bundle of care strategies offered in a national public health care system that looks for more sustainable strategies to provide care.

Impact of three-dimensional printed planning in Paprosky III acetabular defects: a case-control and cost-comparison analysis.

PURPOSE: The main challenges in revision total hip arthroplasty (rTHA) are the treatment of the bone loss and the pre-operative planning. 3D-printed models may enhance pre-operative planning. The aim of the study is to compare the intra- and peri-operative results and costs for Paprosky type 3 rTHAs planned with 3D-printed models to ones accomplished with the conventional imaging techniques (X-rays and CT scan). METHODS: Seventy-two patients with Paprosky type 3 defect underwent rTHA between 2014 and 2021. Fifty-two patients were treated with standard planning and 20 were planned on 3D-printed models. Surgical time, intra-operative blood loss, number of transfused blood units, number of post-operative days of hospitalization, and use of acetabular rings were compared between the two groups. A costs comparison was also performed. RESULTS: The 3D-printed group showed reduced operative time (101.8 min (SD 27.7) vs. 146.1 min (SD 49.5), p < 0.001) and total days of hospitalization (9.3 days (SD 3.01) vs. 12.3 days (SD 6.01), p = 0.009). The cost of the procedures was significantly lower than the control group, with an adjusted difference of 4183 euros (p = 0.004). No significant differences were found for the number of total transfused blood units and blood loss and the number of acetabular rings. CONCLUSION: The use of 3D-printed models led to a meaningful cost saving. The 3D-printed pre-operative planning for complex rTHAs seems to be effective in reducing operating time, hospital stay and overall costs.

Combined partial denitrification-anammox with urea hydrolysis (U-PD-Anammox) process: A novel economical low-carbon method for nitrate-containing wastewater treatment.

For the sake of exploring a new economical and low-carbon alternative for real nitrate-containing wastewater treatment, a new combined partial denitrification-anammox with urea hydrolysis (U-PD-Anammox) process was developed. The nitrogen removal performance of this process was investigated through long-term operation in a sequencing batch reactor (SBR) and two submerged anaerobic biological filters (SABF). Results showed that the average NO3--N to NO2-N transformation ratio improved to 82.6% with organic carbon source to NO3-N ratio of 1.8, and urea hydrolysis provided sufficient NH4+-N and inorganic carbon to anammox process for nitrogen removal. The influent NH4+-N/NO2--N ratio for subsequent anammox reactor could be adjacent to the optimal ratio of 1.32 during the whole operation. The combined process showed efficient nitrogen removal performance with 85% NO3--N removal, 93.8% total nitrogen removal and total nitrogen loading rate as 1.1 ± 0.5 kg N/(m3·d). High-throughput sequencing analysis results revealed that Genera Thauera, Hyphomicrobium and Candidatus Brocadia were the dominant species responsible for partial denitrification, urea hydrolysis and anammox, respectively. The proposed process was more economically and environmental-friendly than the traditional denitrification process with 51.7% operational cost reduction, 99.7% N2O and 60% CO2 emission decrement, facilitating the sustainable development of the nitrate-containing wastewater treatment industry in the future.

Extended Stability of Vasopressin Injection in Polyvinyl Chloride Bags and Polypropylene Syringes and Its Impact on Critically Ill Patient Care and Medication Waste.

Background. Vasopressin is frequently utilized for a variety of shock states in critically ill patients. Short stability (≤24 hours) after intravenous admixture with current manufacturer labeling requires just in time preparation and may lead to delays in therapy and increased medication waste. We aimed to evaluate vasopressin stability in 0.9% sodium chloride stored in polyvinyl chloride bags and polypropylene syringes for up to 90 days. Additionally, we evaluated the impact of extended stability on the time to administration and cost savings from reduced medical waste at an academic medical center. Methods. Dilutions of vasopressin to concentrations of 0.4 and 1.0 unit/mL were performed under aseptic conditions. The bags and syringes were stored at room temperature (23°C-25°C) or under refrigeration (3°C-5°C). Three samples of each preparation and storage environment were analyzed on days 0, 2, 14, 30, 45, 60, and 90. Physical stability was performed by visual examination. The pH was assessed at each point and upon final degradation evaluation. Sterility of the samples was not assessed. Chemical stability of vasopressin was evaluated using liquid chromatography with tandem mass spectrometry. Samples were considered stable if there was <10% degradation of the initial concentration. Results. Vasopressin diluted to 0.4 and 1.0 unit/mL with 0.9% sodium chloride injection was physically stable throughout the study. No precipitation was observed. At days 2, 14, 30, 45, 60, and 90 all bags and syringes diluted to 0.4 units/mL had <10% degradation. Vasopressin diluted to 1 unit/mL and stored under refrigeration had <10% degradation at all measured days, but when stored under room temperature was found to have >10% degradation at day 30. Implementation of a batching process resulted in reduced waste ($185 300) and improved time to administration (26 vs 4 minutes). Conclusion. Vasopressin diluted to a concentration of 0.4 units/mL with 0.9% sodium chloride injection is stable for 90 days at room temperature and under refrigeration. When diluted to 1.0 unit/mL with 0.9% sodium chloride injection it is stable for 90 days under refrigeration. Use of extended stability and sterility testing to batch prepare infusions may lead to improved time to administration and cost savings from reduced medication waste.

Cost-Effectiveness of 1-Time Universal Screening for Chronic Hepatitis B Infection in Adults in the United States.

BACKGROUND: An estimated 862 000 to 2.4 million people have chronic hepatitis B infection (CHB). Hepatitis B screening is recommended for pregnant women and populations with increased CHB risk. However, diagnosis rates remain low, with only 33% of people with CHB aware of their infection. This study aimed to assess the cost-effectiveness of universal adult screening for CHB. METHODS: We used a Markov model to calculate the costs, population health impact, and cost-effectiveness of 1-time universal screening and CHB monitoring and treatment compared with current practice. Sensitivity analysis was performed on model parameters to identify thresholds for cost-saving or cost-effectiveness based on a willingness to pay of $50 000/quality-adjusted life-year. The analysis assumed testing would be performed during routine healthcare visits and that generic tenofovir or entecavir would be dispensed for treatment. Testing costs were based on Medicare reimbursement rates. RESULTS: At an estimated 0.24% prevalence of undiagnosed CHB, universal hepatitis B surface antigen (HBsAg) screening in adults aged 18-69 years is cost-saving compared with current practice if antiviral treatment drug costs remain below $894/year. Compared with current practice, universal screening would avert an additional 7.4 cases of compensated cirrhosis, 3.3 cases of decompensated cirrhosis, 5.5 cases of hepatocellular carcinoma, 1.9 liver transplants, and 10.3 hepatitis B virus-related deaths at a saving of $263 000/100 000 adults screened. CONCLUSIONS: Universal HBsAg screening of adults in the US general population for CHB is cost-effective and likely cost-saving compared with current CHB screening recommendations.

Liquid Biopsy at Home: Delivering Precision Medicine for Patients with Cancer During the COVID-19 Pandemic.

CoronaVirus disease-2019 has changed the delivery of health care worldwide and the pandemic has challenged oncologists to reorganize cancer care. Recently, progress has been made in the field of precision medicine to provide to patients with cancer the best therapeutic choice for their individual needs. In this context, the Foundation Medicine (FMI)-Liquid@Home project has emerged as a key weapon to deal with the new pandemic situation. FoundationOne Liquid Assay (F1L) is a next-generation sequences-based liquid biopsy service, able to detect 324 molecular alterations and genomic signatures, from May 2020 available at patients' home (FMI-Liquid@Home). We analyzed time and costs saving for patients with cancer, their caregivers and National Healthcare System (NHS) with FMI-Liquid@Home versus F1L performed at our Department. Different variables have been evaluated. Between May 2020 and August 2021, 218 FMI-Liquid@Home were performed for patients with cancer in Italy. Among these, our Department performed 153 FMI-Liquid@Home with the success rate of 98% (vs. 95% for F1L in the hospital). Time saving for patients and their caregivers was 494.86 and 427.36 hours, respectively, and costs saving was 13 548.70€. Moreover, for working people these savings were 1084.71 hours and 31 239.65€, respectively. In addition, the total gain for the hospital was 163.5 hours and 6785€, whereas for NHS was 1084.71 hours and 51 573.60€, respectively. FMI-Liquid@Home service appears to be useful and convenient allowing time and costs saving for patients, caregivers, and NHS. Born during the COVID-19 pandemic, it could be integrated in oncological daily routine in the future. Therefore, additional studies are needed to better understand the overall gain and how to integrate this service in different countries.

Anticancer drug waste minimization and cost-saving study by using a closed-system transfer device for chemotherapy compounding.

INTRODUCTION: There is a need for an economic evaluation of the use of closed system (CSTD) in chemotherapy compounding, especially in resource-constrained settings. OBJECTIVE: The objective of this study was to assess the cost saving of the management of cancer drug leftovers before and after introduction of CSTD associated with an extension of the beyond-use date (BUD) of cancer vials. A secondary objective was to estimate the level of minimization of drug wastage. MATERIALS AND METHODS: This was a prospective, single-center study with two periods of two months each. The cost of drugs saved by using conventional systems (syringe and needle) without a closed system in the first period was compared to the cost of drugs saved by using the CSTD Chemoclave® system in the second period. The drug waste minimization rate compared actual drug waste to potential waste in Period 2. RESULTS: In Period 1, the amount of drug saved accounted for an average of 10.3% of the amount used in milligrams and the amount of drug wasted accounted for an average of 18.7%. In period 2, these proportions were 15.2% and 6.4% respectively. The CSTD generated an extra cost of 11,962.5 USD compared to the conventional system. The drug saved cost related only to the CSTD and the acquisition cost of the CSTD was a deficit of -7,444.95 USD and the cost saved from the compounding (CSTD and syringes) was a gain of 1,722.01 USD. The waste minimization represented an average of 72.5% ± 24.4% of potential waste. CONCLUSION: The use of CSTD to extend the BUD allowed to reduce waste due to microbiological instability without adding an economic profit.

The effect of the clinical pharmacist in minimizing drug-related problems and related costs in the intensive care unit in Turkey: A non-randomized controlled study.

WHAT IS KNOWN AND OBJECTIVE: Drug-related problems (DRPs) are common in hospitalized patients in intensive care unit (ICU). The aim of the study is to reduce DRPs and associated costs with clinical pharmacist's (CP) recommendations. METHODS: The study is a prospective, non-randomized controlled study conducted in the ICU for a total of 6 months (1 January 2021-30 June 2021) in 2-month control, 2-month study, and 2-month control periods. Patients who were hospitalized for more than 24 h and used more than one medication were included in the study. The PCNE V9.1 Classification system was used in the classification of DRPs. During the intervention period, CP recommendations for DRPs were proposed to the healthcare team. RESULTS AND DISCUSSION: A total of 146 patients were included in the study. A total of 1061 DRPs from all periods were detected. The most common causes of DRPs were potential drug-drug interactions (31.76%), high dose (12.44%), and dose timing instruction errors (9.24%). For 347 DRPs identified during the study period, 259 interventions (74.63%) were recommended, and 238 (91.89%) were accepted by physicians. Interventions were mostly made as interrupting/discontinuing the drug (28.02%), changing the dose (25.27%), changing the instructions for use (20.32%), and starting a new drug (15.93%). Cost savings were achieved with CP recommendations applied. WHAT IS NEW AND CONCLUSION: The CP's recommendations were highly accepted by the healthcare team. With the CP's participation in routine patient rounds in the healthcare team of the ICU, drug-related costs would also decrease.

Cost-savings and potential cost-savings through the distribution of generic antiretroviral drugs within the statutory health insurance market of Germany between January 2017 and June 2019.

BACKGROUND: Recent patent losses for antiretroviral drugs (ARV) have led to the debate of cost-saving through the replacement of patented drugs with generic drugs. The split of recommended single-tablet regimens (STR) into their single substance partners is one of the considerations mentioned in said debate. Particularly, generic tenofovir disoproxil/emtricitabine (TDF/FTC) is expected to hold untapped cost-saving potential, which may curb increasing overall expenditures for combined antiretroviral therapy (cART) within the statutory health insurance (SHI) of Germany. METHODS: Data of ARV reimbursed by the SHI were used to describe the trends of defined daily doses (DDD) as well as the revenue within the German ARV market. They were also used to determine the cost-savings of moving to generic drugs. The time period observed was between January 2017 and June 2019. The potential cost-savings were determined with following assumption in mind: the maximum possible use of generic ARV, including 1) the split of STR and replacing all substance partners with generic ones, and 2) replacing patented tenofovir alafenamide/emtricitabine (TAF/FTC) with generic TDF/FTC. RESULTS: Throughout the observation period, the DDD of generic ARV increased nearly five-fold while their revenue increased more than four-fold. Total cost-saving showed a sharp increase over the same period, with generic TDF/FTC accounting for a share of around 70%. The largest potential cost-saving could have been achieved through replacing patented TAF/FTC with generic TDF/FTC, peaking at nearly 10% of total revenue, but showing decreasing trends in general. CONCLUSION: The progressive distribution of generic ARV ensured increasing cost-savings, but consequently curbed the potential cost-savings. Unique price reductions of generic TDF/FTC have played a pivotal role for these effects. In any case, substituting with generic ARV should not fail to adhere to the treatment guidelines and continue to consider the medical requirements for the treatment.

Show Me The Money Saved! Cost Savings From Acute Asthma Care in the School-Based Health Center.

Chronic school absenteeism directly affects educational outcomes while reducing school funding and reimbursement. Asthma is a prevalent disease associated with chronic absenteeism. This quality improvement project demonstrated classroom seat time preserved through use of school-based health centers (SBHC). The project also highlights the educational benefits, reduced emergency department utilization, potential cost savings to hospitals, and lower overall health care costs. Visit summary data were collected and analyzed to show quality asthma care and cost savings. Of 44 acute asthma visits that returned to class, an average classroom time of 3:42 hours were saved per student during the 2017-2018 academic year, resulting in a combined total of 166:07 hours saved. A minimum potential cost savings was estimated to be $67,770 for all 44 visits. Data analysis of structural, process, and outcome measures through quality improvement tools can demonstrate cost savings of SBHC care, which advocates funding for this pediatric care model.

Prosigna test in breast cancer: real-life experience.

PURPOSE: Genomic tests can guide the decision to administer adjuvant chemotherapy in women with hormone receptor (HR)-positive, Human Epidermal growth Factor 2 (HER2)-negative breast cancer (BC) at intermediate risk of recurrence. We assessed the decision-making and economic impact of the Prosigna test in a real-life setting. METHODS: Retrospective cohort study of HR + , HER2- BC patients managed from 2016 to 2020, potential candidates for adjuvant chemotherapy, at intermediate risk of recurrence, in whom a Prosigna test was performed according to contemporary guidelines. The additional cost of chemotherapy over one year in terms of direct medical and non-medical costs was estimated in this study to be €9,737 (derived from a previous study, NCT02813317). The cost of the Prosigna test, as defined by the reimbursement system, was €1,849. RESULTS: Among the 809 patients included in this study, 2.3 Prosigna tests had to be performed to avoid adjuvant chemotherapy for one patient. The number of tests that had to be performed to avoid chemotherapy for one patient was higher for patients with grade 3 tumors and pN1mic axillary node involvement and lower for grade 1 tumors or in the absence of axillary node involvement (pN0), but did not vary according to the 10-year overall survival gain predicted by the Predict online test. The cost saving related to withholding of adjuvant chemotherapy for one patient on the basis of the Prosigna test results was €5,485. CONCLUSION: We present one of the largest cohorts of HR + , HER2- BC patients at intermediate risk of recurrence, in whom a Prosigna test was used to guide the adjuvant therapy decision in a real-life setting, resulting in a 44% decrease in the indication for chemotherapy.

Optimal uses of pooled testing for COVID-19 incorporating imperfect test performance and pool dilution effect: An application to congregate settings in Los Angeles County.

INTRODUCTION: Pooled testing is a potentially efficient alternative strategy for COVID-19 testing in congregate settings. We evaluated the utility and cost-savings of pooled testing based on imperfect test performance and potential dilution effect due to pooling and created a practical calculator for online use. METHODS: We developed a 2-stage pooled testing model accounting for dilution. The model was applied to hypothetical scenarios of 100 specimens collected during a one-week time-horizon cycle for varying levels of COVID-19 prevalence and test sensitivity and specificity, and to 338 skilled nursing facilities (SNFs) in Los Angeles County (Los Angeles) (data collected and analyzed in 2020). RESULTS: Optimal pool sizes ranged from 1 to 12 in instances where there is a least one case in the batch of specimens. 40% of Los Angeles SNFs had more than one case triggering a response-testing strategy. The median number (minimum; maximum) of tests performed per facility were 56 (14; 356) for a pool size of 4, 64 (13; 429) for a pool size of 10, and 52 (11; 352) for an optimal pool size strategy among response-testing facilities. The median costs of tests in response-testing facilities were $8250 ($1100; $46,100), $6000 ($1340; $37,700), $6820 ($1260; $43,540), and $5960 ($1100; $37,380) when adopting individual testing, a pooled testing strategy using pool sizes of 4, 10, and optimal pool size, respectively. CONCLUSIONS: Pooled testing is an efficient strategy for congregate settings with a low prevalence of COVID-19. Dilution as a result of pooling can lead to erroneous false-negative results.

Head-to-head comparison of amplified plasmonic exosome Aß42 platform and single-molecule array immunoassay in a memory clinic cohort.

BACKGROUND AND PURPOSE: Various blood biomarkers reflecting brain amyloid-ß (Aß) load have recently been proposed with promising results. However, to date, no comparative study amongst blood biomarkers has been reported. Our objective was to examine the diagnostic performance and cost effectiveness of three blood biomarkers on the same cohort. METHODS: Using the same cohort (n = 68), the performances of the single-molecule array (Simoa) Aß40, Aß42, Aß42/Aß40 and the amplified plasmonic exosome (APEX) Aß42 blood biomarkers were compared using amyloid positron emission tomography (PET) as the reference standard. The extent to which these blood tests can reduce the recruitment cost of clinical trials was also determined by identifying amyloid positive (Aß+) participants. RESULTS: Compared to Simoa biomarkers, APEX-Aß42 showed significantly higher correlations with amyloid PET retention values and excellent diagnostic performance (sensitivity 100%, specificity 93.3%, area under the curve 0.995). When utilized for clinical trial recruitment, our simulation showed that pre-screening with blood biomarkers followed by a confirmatory amyloid PET imaging would roughly half the cost (56.8% reduction for APEX-Aß42 and 48.6% for Simoa-Aß42/Aß40) compared to the situation where only PET imaging is used. Moreover, with 100% sensitivity, APEX-Aß42 pre-screening does not increase the required number of initial participants. CONCLUSIONS: With its high diagnostic performance, APEX is an ideal candidate for Aß+ subject identification, monitoring and primary care screening, and could efficiently enrich clinical trials with Aß+ participants whilst halving recruitment costs.