MICK (Mobile Integrated Cognitive Kit) app: Feasibility of an accessible tablet-based rapid picture and number naming task for concussion assessment in a division 1 college football cohort.

Although visual symptoms are common following concussion, quantitative measures of visual function are missing from concussion evaluation protocols on the athletic sideline. For the past half century, rapid automatized naming (RAN) tasks have demonstrated promise as quantitative neuro-visual assessment tools in the setting of head trauma and other disorders but have been previously limited in accessibility and scalability. The Mobile Interactive Cognitive Kit (MICK) App is a digital RAN test that can be downloaded on most mobile devices and can therefore provide a quantitative measure of visual function anywhere, including the athletic sideline. This investigation examined the feasibility of MICK App administration in a cohort of Division 1 college football players. Participants (n = 82) from a National Collegiate Athletic Association (NCAA) Division 1 football team underwent baseline testing on the MICK app. Total completion times of RAN tests on the MICK app were recorded; magnitudes of best time scores and between-trial learning effects were determined by paired t-test. Consistent with most timed performance measures, there were significant learning effects between the two baseline trials for both RAN tasks on the MICK app: Mobile Universal Lexicon Evaluation System (MULES) (p < 0.001, paired t-test, mean improvement 13.3 s) and the Staggered Uneven Number (SUN) (p < 0.001, mean improvement 3.3 s). This study demonstrated that the MICK App can be feasibly administered in the setting of pre-season baseline testing in a Division I environment. These data provide a foundation for post-injury sideline testing that will include comparison to baseline in the setting of concussion.

The MICK (Mobile integrated cognitive kit) app: Digital rapid automatized naming for visual assessment across the spectrum of neurological disorders.

OBJECTIVE: Rapid automatized naming (RAN) tasks have been utilized for decades to evaluate neurological conditions. Time scores for the Mobile Universal Lexicon Evaluation System (MULES, rapid picture naming) and Staggered Uneven Number (SUN, rapid number naming) are prolonged (worse) with concussion, mild cognitive impairment, multiple sclerosis and Parkinson's disease. The purpose of this investigation was to compare paper/pencil versions of MULES and SUN with a new digitized format, the MICK app. METHODS: Participants (healthy office-based volunteers, professional women's hockey players), completed two trials of the MULES and SUN tests on both platforms (tablet, paper/pencil). The order of presentation of the testing platforms was randomized. Between-platform variability was calculated using the two-way random-effects intraclass correlation coefficient (ICC). RESULTS: Among 59 participants (median age 32, range 22-83), no significant differences were observed for comparisons of mean best scores for the paper/pencil versus MICK app platforms, counterbalanced for order of administration (P = 0.45 for MULES, P = 0.50 for SUN, linear regression). ICCs for agreement between the MICK and paper/pencil tests were 0.92 (95% CI 0.86, 0.95) for MULES and 0.94 (95% CI 0.89, 0.96) for SUN, representing excellent levels of agreement. Inter-platform differences did not vary systematically across the range of average best time score for either test. CONCLUSION: The MICK app for digital administration of MULES and SUN demonstrates excellent agreement of time scores with paper/pencil testing. The computerized app allows for greater accessibility and scalability in neurological diseases, inclusive of remote monitoring. Sideline testing for sports-related concussion may also benefit from this technology.

A Low-Vision Navigation Platform for Economies in Transition Countries.

An ability to move freely, when wanted, is an essential activity for healthy living. Visually impaired and completely blinded persons encounter many disadvantages in their day-to-day activities, including performing work-related tasks. They are at risk of mobility losses, illness, debility, social isolation, and premature mortality. A novel wearable device and computing platform called VIS4ION is reducing the disadvantage gaps and raising living standards for the visually challenged. It provides personal mobility navigational services that serves as a customizable, human-in-the-loop, sensing-to-feedback platform to deliver functional assistance. The platform is configured as a wearable that provides on-board microcomputers, human-machine interfaces, and sensory augmentation. Mobile edge computing enhances functionality as more services are unleashed with the computational gains. The meta-level goal is to support spatial cognition, personal freedom, and activities, and to promoting health and wellbeing. VIS4ION can be conceptualized as the dovetailing of two thrusts: an on-person navigational and computing device and a multimodal functional aid providing microservices through the cloud. The device has on-board wireless capabilities connected through Wi-Fi or 4/5G. The cloud-based microservices reduce hardware and power requirements while allowing existing and new services to be enhanced and added such as loading new map and real-time communication via haptic or audio signals. This technology can be made available and affordable in the economies of transition countries.

Incremental direct healthcare expenditures of valvular heart disease in the USA.

Aim: To quantify the healthcare expenditures for valvular heart disease (VHD) in the USA. Patients & methods: Direct annual incremental healthcare expenditures were estimated using multiple logistic and linear regression models. Results were stratified by age cohorts (18-64 years, ≥65 and ≥75 years) and disease status: symptomatic aortic valve disease (AVD), asymptomatic AVD, symptomatic mitral valve disease (MVD) and asymptomatic MVD. Results: A total of 1463 VHD patients were identified. The overall aggregated incremental direct expenditures were $56.62 billion ($26.48 billion for patients ≥75 years). Individuals ≥75 years with symptomatic AVD had the largest incremental effect on annual, per-patient healthcare expenditure of $30,949. The annualized incremental costs of VHD were greatest for individuals ≥75 years with AVD. Conclusion: Identification of VHD at an earlier stage may reduce the economic burden.

MULES on the sidelines: A vision-based assessment tool for sports-related concussion.

OBJECTIVE: The Mobile Universal Lexicon Evaluation System (MULES) is a test of rapid picture naming under investigation. Measures of rapid automatic naming (RAN) have been used for over 50 years to capture aspects of vision and cognition. MULES was designed as a series of 54 grouped color photographs (fruits, random objects, animals) that integrates saccades, color perception and contextual object identification. We examined MULES performance in youth, collegiate and professional athletes at pre-season baseline and at the sidelines following concussion. METHODS: Our study teams administered the MULES to youth, collegiate and professional athletes during pre-season baseline testing. Sideline post-concussion time scores were compared to pre-season baseline scores among athletes with concussion to determine degrees and directions of change. RESULTS: Among 681 athletes (age 17 ±â€¯4 years, range 6-37, 38% female), average test times at baseline were 41.2 ±â€¯11.2 s. The group included 280 youth, 357 collegiate and 44 professional athletes; the most common sports were ice hockey (23%), soccer (17%) and football (11%). Age was a predictor of MULES test times, with longer times noted for younger participants (P < .001, linear regression). Consistent with other timed performance measures, significant learning effects were noted for the MULES during baseline testing with trial 1 test times (mean 49.2 ±â€¯13.1 s) exceeding those for trial 2 (mean 41.3 ±â€¯11.2 s, P < .0001, paired t-test). Among 17 athletes with concussion during the sports seasons captured to date (age 18 ±â€¯3 years), all showed increases (worsening) of MULES time scores from pre-season baseline (median increase 11.2 s, range 0.6-164.2, P = .0003, Wilcoxon signed-rank test). The Symptom Severity Score from the SCAT5 Symptom Evaluation likewise worsened from pre-season baseline following injury among participants with concussion (P = .002). CONCLUSIONS: Concussed athletes demonstrate worsening performance on the MULES test compared to their baseline time scores. This test samples a wide network of brain pathways and complements other vision-based measures for sideline concussion assessment. The MULES test demonstrates capacity to identify athletes with sports-related concussion.

Hospital costs associated with intraoperative hypotension among non-cardiac surgical patients in the US: a simulation model.

Objective: Recent studies indicate intraoperative hypotension, common in non-cardiac surgical patients, is associated with myocardial injury, acute kidney injury, and mortality. This study extends on these findings by quantifying the association between intraoperative hypotension and hospital expenditures in the US. Methods: Monte Carlo simulations (10,000 trial per simulation) based on current epidemiological and cost outcomes literature were developed for both acute kidney injury (AKI) and myocardial injury in non-cardiac surgery (MINS). For AKI, three models with different epidemiological assumptions (two models based on observational studies and one model based on a randomized control trial [RCT]) estimate the marginal probability of AKI conditional on intraoperative hypotension status. Similar models are also developed for MINS (except for the RCT case). Marginal probabilities of AKI and MINS sequelae (myocardial infarction, congestive heart failure, stroke, cardiac catheterization, and percutaneous coronary intervention) are multiplied by marginal cost estimates for each outcome to evaluate costs associated with intraoperative hypotension. Results: The unadjusted (adjusted) model found hypotension control lowers the absolute probability of AKI by 2.2% (0.7%). Multiplying these probabilities by the marginal cost of AKI, the unadjusted (adjusted) AKI model estimated a cost reduction of $272 [95% CI = $223-$321] ($86 [95% CI = $47-$127]) per patient. The AKI model based on relative risks from the RCT had a mean cost reduction estimate of $281 (95% CI = -$346-$750). The unadjusted (adjusted) MINS model yielded a cost reduction of $186 [95% CI = $73-$393] ($33 [95% CI = $10-$77]) per patient. Conclusions: The model results suggest improved intraoperative hypotension control in a hospital with an annual volume of 10,000 non-cardiac surgical patients is associated with mean cost reductions ranging from $1.2-$4.6 million per year. Since the magnitude of the RCT mean estimate is similar to the unadjusted observational model, the institutional costs are likely at the upper end of this range.

Ultrafiltration versus diuretics for the treatment of fluid overload in patients with heart failure: a hospital cost analysis.

Background: Heart failure (HF) is a common, serious disease in the US and Europe. Patients with HF often require treatment for fluid overload, resulting in costly inpatient visits; however, limited evidence exists on the costs of alternative treatments. This study performed a cost-analysis of ultrafiltration (UF) vs diuretic therapy (DIUR-T) for patients with HF from the hospital perspective. Methods: The model used clinical data from the literature and hospital data from the Healthcare Cost and Utilization Project to follow a decision-analytic framework reflecting treatment decisions, probabilistic outcomes, and associated costs for treating patients with HF and hypervolemia with veno-venous UF or intravenous DIUR-T. A 90-day timeframe was considered to account for hospital readmissions beyond 30 days. Sensitivity and scenario analyses were performed to gauge the robustness of the results. Results: Although initial hospitalization costs were higher, fluid removal by UF reduced hospital readmission days, leading to cost savings of $3,975 (14.4%) at the 90-day follow-up (UF costs, $23,633; DIUR-T costs, $27,608). Conclusions: UF is a viable alternative to DIUR-T when treating fluid overload in HF patients because it reduces hospital readmission rates and durations, which substantially lowers costs over a 90-day period compared to DIUR-T.

A Monte Carlo simulation estimating US hospital cost reductions associated with hypotension control in septic ICU patients.

OBJECTIVE: This economic analysis extends upon a recent epidemiological study to estimate the association between hypotension control and hospital costs for septic patients in US intensive care units (ICUs). METHODS: A Monte Carlo simulation decision analytic model was developed that accounted for the probability of complications-acute kidney injury and mortality-in septic ICU patients and the cost of each health outcome from the hospital perspective. Probabilities of complications were calculated based on observational data from 110 US hospitals for septic ICU patients (n = 8,782) with various levels of hypotension exposure as measured by mean arterial pressure (MAP, units: mmHg). Costs for acute kidney injury (AKI) and mortality were derived from published literature. Each simulation calculated mean hospital cost reduction and 95% confidence intervals based on 10,000 trials. RESULTS: In the base-case analysis hospital costs for a hypothetical "control" cohort (MAP of 65 mmHg) were $699 less per hospitalization (95% CI: $342-$1,116) relative to a "case" cohort (MAP of 60 mmHg). In the most extreme case considered (45 mmHg vs 65 mmHg), the associated cost reduction was $4,450 (95% CI: $2,020-$7,581). More than 99% of the simulated trials resulted in cost reductions. A conservative institution-level analysis for a hypothetical hospital (which assumes no benefit for increasing MAP above 65 mmHg) estimated a cost decline of $417 for a 5 mmHg increase in MAP per ICU septic patient. These results are applicable to the US only. CONCLUSIONS: Hypotension control (via MAP increases) for patients with sepsis in the ICU is associated with lower hospitalization cost.

Bariatric Surgery Coverage: a Comprehensive Budget Impact Analysis from a Payer Perspective.

OBJECTIVE: The objective of this study was to estimate a payer's budget impact of bariatric surgery coverage under (1) unrestricted, (2) budget-restricted ($500,000/year), and (3) quantity-restricted (100/year) medical benefit plan scenarios versus non-coverage in general and type 2 diabetes mellitus (T2DM) populations over a 10-year period. METHODS: Using recently published literature and health technology assessment reports, the model evaluated a hypothetical payer population of 100,000 members under current real-world trends: BMI-defined obesity groups (31.3% normal/underweight, 33% overweight, 20.4% obese, 9% severely obese and 6.3% morbidly obese), T2DM prevalence (6.7-27.5%; 100% for the T2DM model), surgery type (LAGB, BPD/DS, VSG, and RYGB), and differential outcomes (T2DM resolution, costs, and reoperation and complications rates). Assuming a surgery election rate of 1.42% among eligible candidates with a 3% discount rate and 10% annual surgery turnover rate, the model calculated the incremental cost per-member-per-month (PMPM) by estimating the difference in total non-T2DM and T2DM-related expected costs and savings. One-way (± 25%) sensitivity analysis was performed. RESULTS: The impact of covering bariatric surgery under multiple scenarios for a general (or T2DM) population ranged from an additional $0.3 to $3.6 (T2DM: $0.3 to $10.5) PMPM in year 1. Incremental costs diminished over time, breaking even between years 5 and 9 (T2DM: 5-6), and by year 10, cost savings were estimated to be between $1.5 and $4.8 (T2DM: $1.2 and $31.8). CONCLUSION: Providing bariatric surgery coverage may have a modest short-term budget impact increase but would lead to long-term net cost savings in a general population model. The cost savings were much more pronounced in the T2DM model.

Hospital cost impact of orbital atherectomy with angioplasty for critical limb ischemia treatment: a modeling approach.

AIM: The incremental cost of peripheral orbital atherectomy system (OAS) plus balloon angioplasty (BA) versus BA-only for critical limb ischemia was estimated. MATERIALS & METHODS: A deterministic simulation model used clinical and healthcare utilization data from the CALCIUM 360° trial and current cost data. Incremental cost of OAS + BA versus BA-only included differential utilization during the procedure and adverse-event costs at 3, 6 and 12-months. RESULTS: For every 100 procedures, incremental annual costs to the hospital were US$350,930 lower with OAS + BA compared with BA-only. Despite higher upfront costs, savings were realized due to reduced need for revascularization, amputation and end-of-life care over 6-12-month postoperative period. CONCLUSION: Atherectomy with OAS prior to BA was associated with cost savings to the hospital.

Does Migration Limit the Effect of Health Insurance on Hypertension Management in China?

Background: In China, rapid urbanization has caused migration from rural to urban areas, and raised the prevalence of hypertension. However, public health insurance is not portable from one place to another, and migration may limit the effectiveness of this non-portable health insurance on healthcare. Our study aims to investigate whether migration limits the effectiveness of health insurance on hypertension management in China. Methods: Data were obtained from the national baseline survey of the China Health and Retirement Longitudinal Study in 2011, including 4926 hypertensive respondents with public health insurance. Outcome measures included use of primary care, hypertension awareness, medication use, blood pressure monitoring, physician advice, and blood pressure control. Multivariate logistic regressions were estimated to examine whether the effects of rural health insurance on hypertension management differed between those who migrated to urban areas and those who did not migrate and lived in rural areas. Results: Among hypertensive respondents, 60.7% were aware of their hypertensive status. Compared to rural residents, the non-portable feature of rural health insurance significantly reduced rural-to-urban migrants' probabilities of using primary care by 7.8 percentage points, hypertension awareness by 8.8 percentage points, and receiving physician advice by 18.3 percentage points. Conclusions: In China, migration to urban areas limited the effectiveness of rural health insurance on hypertension management due to its non-portable nature. It is critical to improve the portability of rural health insurance, and to extend urban health insurance and primary care coverage to rural-to-urban migrants to achieve better chronic disease management.

Correction: Does NGAL reduce costs? A cost analysis of urine NGAL (uNGAL) & serum creatinine (sCr) for acute kidney injury (AKI) diagnosis.

[This corrects the article DOI: 10.1371/journal.pone.0178091.].

Does NGAL reduce costs? A cost analysis of urine NGAL (uNGAL) & serum creatinine (sCr) for acute kidney injury (AKI) diagnosis.

INTRODUCTION: Urine neutrophil gelatinase-associated lipocalin (uNGAL) is a sensitive and specific diagnostic test for acute kidney injury (AKI) in the Emergency Department (ED), but its economic impact has not been investigated. We hypothesized that uNGAL used in combination with serum creatinine (sCr) would reduce costs in the management of AKI in patients presenting to the ED in comparison to using sCr alone. MATERIALS AND METHODS: A cost simulation model was developed for clinical algorithms to diagnose AKI based on sCr alone vs. uNGAL plus sCr (uNGAL+sCr). A cost minimization analysis was performed to determine total expected costs for patients with AKI. uNGAL test characteristics were validated with eight-hundred forty-nine patients with sCr ≥1.5 from a completed study of 1635 patients recruited from EDs at two U.S. hospitals from 2007-8. Biomarker test, AKI work-up, and diagnostic imaging costs were incorporated. RESULTS: For a hypothetical cohort of 10,000 patients, the model predicted that the expected costs were $900 per patient (pp) in the sCr arm and $950 in the uNGAL+sCr arm. uNGAL+sCr resulted in 1,578 fewer patients with delayed diagnosis and treatment than sCr alone (2,013 vs. 436 pts) at center 1 and 1,973 fewer patients with delayed diagnosis and treatment than sCr alone at center 2 (2,227 vs. 254 patients). Although initial evaluation costs at each center were $50 pp higher in with uNGAL+sCr, total costs declined by $408 pp at Center 1 and by $522 pp at Center 2 due to expected reduced delays in diagnosis and treatment. Sensitivity analyses confirmed savings with uNGAL + sCr for a range of cost inputs. DISCUSSION: Using uNGAL with sCr as a clinical diagnostic test for AKI may improve patient management and reduce expected costs. Any cost savings would likely result from avoiding delays in diagnosis and treatment and from avoidance of unnecessary testing in patients given a false positive AKI diagnosis by use of sCr alone.

The economic value of rapid deployment aortic valve replacement via full sternotomy.

AIM: To compare the economic value of EDWARDS INTUITY Elite™ (EIE) valve system for rapid-deployment aortic valve replacement (RDAVR) in a full sternotomy (FS) approach (EIE-FS-RDAVR) versus FS-AVR using conventional stented bioprosthesis. DATA & METHODS: A simulation model to compare each treatment's 30-day inpatient utilization and complication rates utilized: clinical end points obtained from the TRANSFORM trial patient subset (EIE-FS-RDAVR) and a best evidence review of the published literature (FS-AVR); and costs from the Premier database and published literature. RESULTS: EIE-FS-RDAVR costs $800 less than FS-AVR per surgery episode attributable to lowered complication rates and utilization. Combined with the lower mortality, EIE-FS-RDAVR was a superior (dominant) technology versus FS-AVR. CONCLUSION: This preliminary investigation of EIE-FS-RDAVR versus conventional FS-AVR found the EIE valve offered superior economic value over a 30-day period. Real-world analyses with additional long-term follow-up are needed to evaluate if this result can be replicated over a longer timeframe.

Cost-effectiveness of In-Home Cognitive Behavioral Therapy for low-income depressed mothers participating in early childhood prevention programs.

BACKGROUND: To determine the cost-effectiveness of In-Home Cognitive Behavioral Therapy (IH-CBT) for low-income mothers enrolled in a home visiting program. METHODS: A cost-utility analysis was conducted using results from a clinical trial of IH-CBT and standard of care for depression derived from the literature. A probabilistic, patient-level Markov model was developed to determine Quality Adjusted Life Years (QALYs). Costs were determined using the Medical Expenditure Panel Survey. A three-year time horizon and payer perspective were used. Sensitivity analyses were employed to determine robustness of the model. RESULTS: IH-CBT was cost-effective relative to standard of care. IH-CBT was expected to be cost-effective at a three-year time horizon 99.5%, 99.7%, and 99.9% of the time for willingness-to-pay thresholds of US$25,000, US$50,000, and US$100,000, respectively. Patterns were upheld at one-year and five-year time horizons. Over the three-year time horizon, mothers receiving IH-CBT were expected to have 345.6 fewer days of depression relative to those receiving standard home visiting and treatment in the community. CONCLUSIONS: IH-CBT is a more cost-effective treatment for low-income, depressed mothers than current standards of practice. These findings add to the growing literature demonstrating the cost-effectiveness of CBT for depression, and expand it to cover new mothers. From a payer perspective, IH-CBT is a sound option for treatment of depressed, low-income mothers. Limitations include a restricted time horizon and estimating of standard of care costs.

Quality of pharmacoeconomic research in China: A systematic review.

BACKGROUND: The number of pharmacoeconomic publications in the literature from China has risen rapidly, but the quality of pharmacoeconomic publications from China has not been analyzed. OBJECTIVES: This study aims to identify all recent pharmacoeconomic publications from China, to critically appraise the reporting quality, and to summarize the results. METHODS: Four databases (PubMed, Web of Science, Medline, and EmBase) were searched for original articles published up to December 31, 2014. The Consolidated Health Economic Evaluation Reporting Standards statement including 24 items was used to assess the quality of reporting of these articles. RESULTS: Of 1046 articles identified, 32 studies fulfilled the inclusion criteria. They were published in 23 different journals. Quality of reporting varied between studies, with an average score of 18.7 (SD = 4.33) out of 24 (range 9-23.5). There was an increasing trend of pharmacoeconomic publications and reporting quality over years from 2003 to 2014. According to the Consolidated Health Economic Evaluation Reporting Standards, the reporting quality for the items including "title," "comparators of method," and "measurement of effectiveness" are quite low, with less than 50% of studies fully satisfying these reporting standards. In contrast, reporting was good for the items including "introduction," "study perspective," "choice of health outcomes," "study parameters," "characterizing heterogeneity," and "discussion," with more than 75% of the articles satisfying these reporting criteria. The remaining items fell in between these 2 extremes, with 50% to 75% of studies satisfying these criteria. CONCLUSION: Our study suggests the need for improvement in a number of reporting criteria. But the criteria for which reporting quality was low seem to be limitations that would be straightforward to correct in future studies.

The economic value of INTUITY in aortic valve replacement.

OBJECTIVE: The recent development of the EDWARDS INTUITY Elite™ (EIE) valve system enables the rapid deployment of a prosthetic surgical heart valve in an aortic valve replacement (AVR) procedure via both the minimally invasive (MISAVR) and conventional (CAVR) approaches. In order to understand its economic value, this study performed a cost evaluation of the EIE valve system used in a MIS rapid-deployment approach (MIS-RDAVR) vs MISAVR and CAVR, respectively, compared to standard prosthetic aortic valves. METHODS: A simulation model was developed using TreeAge (and validated with MS Excel) to compare the inpatient utilization and complication costs for each treatment arm. Thirty-day clinical end-points for the MIS-RDAVR (mortality and complications) were taken from the TRANSFORM trial; and a best evidence review of the published literature was used for the MISAVR and CAVR approaches. Studies were pooled and parameter estimates were weighted by sample size in order to compare the TRANSFORM patients. Cost data (2016 USD) were taken from the Premier database. Incremental cost and cost-effectiveness was assessed and one-way/probabilistic sensitivity analyses performed to gauge the robustness of the results. RESULTS: MIS-RDAVR costs $2,621 less than CAVR and had lower mortality rates, making it a superior (dominant) technology relative to CAVR. MIS-RDAVR costs $4,560 more than MISAVR, but was associated with an additional 0.20 life years-per-patient. This implies a cost-effectiveness ratio of $22,903 per-life-year-gained. Thus, MIS-RDAVR is cost-effective compared to MISAVR. CONCLUSIONS: The EIE valve system deployed in a MIS approach appears to be a cost-effective technology compared to MISAVR and CAVR. When compared to CAVR it may achieve cost savings as well. These results suggest that MIS-RDAVR confers superior economic value compared to both standard MISAVR and CAVR via lowered key complication rates (re-operation, renal complications, wound infection, TIA, endocarditis) and utilization (cross-clamp time, hospital ward days).

Cost comparison of radiofrequency catheter ablation versus cryoablation for atrial fibrillation in hospitals using both technologies.

OBJECTIVE: The objective of this study was to compare the cost of radiofrequency (RF) ablation vs cryoablation (Cryo) for atrial fibrillation (AF). METHODS: This retrospective cohort study used 2013-2014 records from the Premier Healthcare Database for adults with AF catheter ablation. Exclusions included non-AF ablation, surgical ablation, valve replacement or repair, or cardiac implant. Hospitals were required to perform ≥20 procedures using each technology, with the technology identifiable in at least 90% of cases. The primary endpoint was total variable visit cost, modeled separately for inpatient and outpatient visits, and adjusted for patient and hospital characteristics. Technology was categorized as RF or Cryo, with dual-technology procedures classified as Cryo. The Cryo cohort was further divided into Cryo only and Cryo with RF for sensitivity analyses. A composite adverse event endpoint was also compared. RESULTS: A total of 1261 RF procedures and 1276 Cryo procedures, of which 500 also used RF, met study criteria. RF patients were slightly older and sicker, and had more cardiovascular disease and additional arrhythmias. Adjusted inpatient costs were $2803 (30.0%) higher for Cryo, and adjusted outpatient costs were $2215 (19.5%) higher. Sensitivity models showed higher costs in both Cryo sub-groups compared with RF. Procedural complication rates were not significantly different between cohorts (p-values: 0.4888 inpatient, 0.5072 outpatient). CONCLUSION: AF ablation using RF results in significantly lower costs compared with Cryo, despite an RF population with more cardiovascular disease. This saving cannot be attributed to a difference in complication rates.

Budget impact analysis of bioabsorbable drug-eluting sinus implants following endoscopic sinus surgery.

OBJECTIVE: Propel is a bioabsorbable drug-eluting sinus implant inserted following an endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). The objective of this study was to estimate the budget impact of incorporating Propel post-ESS for CRS patients from a self-insured employer or third-party payer perspective. METHODS: An Excel-based budget impact model was developed. Estimates of the prevalence of CRS, rates of ESS, and effectiveness outcomes, along with direct and indirect costs from CRS were obtained from published literature. A total population of 1.5 million members was hypothesized for the analysis. All cost data were adjusted to October 2015 US dollars using the Medical Care Component of the Consumer Price Index. The cost and clinical/economic characteristics of Propel were compared to other treatments commonly used to minimize post-operative complications. The primary outcome was the incremental budget impact reported using per-member-per-month (PMPM) costs. Scenario-based, probabilistic, and one-way sensitivity analyses were performed to gauge the robustness of the results and identify the parameters with the most influence on the results. RESULTS: For a US self-insured employer or a commercial health plan of 1.5 million members, the incremental PMPM impact of incorporating Propel was estimated to range from -$0.003 to $0.036, respectively, for all members in the health plan. Sensitivity analyses identified the cost of Propel, probability of polyposis recurrence requiring medical intervention, probability of adhesion formation requiring surgical intervention, and the treatment costs for polyposis as the primary parameters influencing the results. CONCLUSION: This study has demonstrated the use of Propel following ESS procedures has a negligible impact on the budget of a US self-insured employer or payer. The upfront cost of Propel was offset by savings associated with reduced probability for polyp recurrence, adhesion formation, and their subsequent treatment.