Cost-Effectiveness of Universal Screening for Blunt Cerebrovascular Injury: A Markov Analysis.

BACKGROUND: Blunt cerebrovascular injury (BCVI) is a significant cause of morbidity and mortality after blunt trauma. Numerous screening strategies exist, although which is used is institution- and physician-dependent. We sought to identify the most cost-effective screening strategy for BCVI, hypothesizing that universal screening would be optimal among the screening strategies studied. STUDY DESIGN: A Markov decision analysis model was used to compare the following screening strategies for identification of BCVI: (1) no screening; (2) Denver criteria; (3) extended Denver criteria; (4) Memphis criteria; and (5) universal screening. The base-case scenario modeled 50-year-old patients with blunt traumatic injury excluding isolated extremity injures. Patients with BCVI detected on imaging were assumed to be treated with antithrombotic therapy, subsequently decreasing risk of stroke and mortality. One-way sensitivity analyses were performed on key model inputs. A single-year horizon was used with an incremental cost-effectiveness ratio threshold of $100,000 per quality-adjusted life-year. RESULTS: The most cost-effective screening strategy for patients with blunt trauma among the strategies analyzed was universal screening. This method resulted in the lowest stroke rate, mortality, and cost, and highest quality-adjusted life-year. An estimated 3,506 strokes would be prevented annually as compared with extended Denver criteria (incremental cost-effectiveness ratio of $71,949 for universal screening vs incremental cost-effectiveness ratio of $12,736 for extended Denver criteria per quality-adjusted life-year gained) if universal screening were implemented in the US. In 1-way sensitivity analyses, universal screening was the optimal strategy when the incidence of BCVI was greater than 6%. CONCLUSIONS: This model suggests universal screening may be the cost-effective strategy for BCVI screening in blunt trauma for certain trauma centers. Trauma centers should develop institutional protocols that take into account individual BCVI rates.

Endoscopic Screening Program for Control of Esophageal Adenocarcinoma in Varied Populations: A Comparative Cost-Effectiveness Analysis.

BACKGROUND & AIMS: Guidelines suggest endoscopic screening for esophageal adenocarcinoma (EAC) among individuals with symptoms of gastroesophageal reflux disease (GERD) and additional risk factors. We aimed to determine at what age to perform screening and whether sex and race should influence the decision. METHODS: We conducted comparative cost-effectiveness analyses using 3 independent simulation models. For each combination of sex and race (White/Black, 100,000 individuals each), we considered 41 screening strategies, including one-time or repeated screening. The optimal strategy was that with the highest effectiveness and an incremental cost-effectiveness ratio <$100,000 per quality-adjusted life-year gained. RESULTS: Among White men, 536 EAC deaths were projected without screening, and screening individuals with GERD twice at ages 45 and 60 years was optimal. Screening the entire White male population once at age 55 years was optimal in 26% of probabilistic sensitivity analysis runs. Black men had fewer EAC deaths without screening (n = 84), and screening those with GERD once at age 55 years was optimal. Although White women had slightly more EAC deaths (n = 103) than Black men, the optimal strategy was no screening, although screening those with GERD once at age 55 years was optimal in 29% of probabilistic sensitivity analysis runs. Black women had a very low burden of EAC deaths (n = 29), and no screening was optimal, as benefits were very small and some strategies caused net harm. CONCLUSIONS: The optimal strategy for screening differs by race and sex. White men with GERD symptoms can potentially be screened more intensely than is recommended currently. Screening women is not cost-effective and may cause net harm for Black women.

The Optimal Age to Stop Endoscopic Surveillance of Patients With Barrett's Esophagus Based on Sex and Comorbidity: A Comparative Cost-Effectiveness Analysis.

BACKGROUND AND AIMS: Current guidelines recommend surveillance for patients with nondysplastic Barrett's esophagus (NDBE) but do not include a recommended age for discontinuing surveillance. This study aimed to determine the optimal age for last surveillance of NDBE patients stratified by sex and level of comorbidity. METHODS: We used 3 independently developed models to simulate patients diagnosed with NDBE, varying in age, sex, and comorbidity level (no, mild, moderate, and severe). All patients had received regular surveillance until their current age. We calculated incremental costs and quality-adjusted life-years (QALYs) gained from 1 additional endoscopic surveillance at the current age versus not performing surveillance at that age. We determined the optimal age to end surveillance as the age at which incremental cost-effectiveness ratio of 1 more surveillance was just less than the willingness-to-pay threshold of $100,000/QALY. RESULTS: The benefit of having 1 more surveillance endoscopy strongly depended on age, sex, and comorbidity. For men with NDBE and severe comorbidity, 1 additional surveillance at age 80 years provided 4 more QALYs per 1000 patients with BE at an additional cost of $1.2 million, whereas for women with severe comorbidity the benefit at that age was 7 QALYs at a cost of $1.3 million. For men with no, mild, moderate, and severe comorbidity, the optimal ages of last surveillance were 81, 80, 77, and 73 years, respectively. For women, these ages were younger: 75, 73, 73, and 69 years, respectively. CONCLUSIONS: Our comparative modeling analysis illustrates the importance of considering comorbidity status and sex when deciding on the age to discontinue surveillance in patients with NDBE.

The Association of Payer Status and Injury Patterns in Pediatric Bicycle Injuries.

BACKGROUND: Bicycle injuries continue to cause significant morbidity in the United States. How insurance status affects outcomes in children with bicycle injuries has not been defined. We hypothesized that payer status would not impact injury patterns or outcomes in pediatric bicycle-related accidents. METHODS: The National Trauma Data Bank was used to identify pediatric (≤18 y) patients involved in bicycle-related crashes admitted in year 2016. Patients with private insurance were compared with all others (uninsured, Medicaid, and Medicare). RESULTS: There were 5619 patients that met study criteria. Of these, 2500 (44%) had private insurance. Privately insured were older (12 y versus 11, P < 0.001), more likely to be white (77% versus 56%, P < 0.001), and more likely to wear a helmet (26% versus 9%, P < 0.001). On multivariate analysis, factors associated with traumatic brain injury included age (odds ratio [OR], 1.07; 95% confidence interval [CI], 1.06-1.08; P < 0.001) and helmet use (OR, 0.64; 95% CI, 0.55-0.74; P < 0.001). Patients without private insurance were significantly less likely to wear a helmet (OR, 0.52; 95% CI, 0.44-0.63; P < 0.001). Uninsured patients had significantly higher odds of a fatal injury (OR, 4.43; 95% CI, 1.52-12.92; P = 0.006). CONCLUSIONS: Uninsured children that present to a trauma center after a bicycle accident are more likely to die. Although helmet use reduced the odds of traumatic brain injury, minorities and children without private insurance were less likely to be helmeted. Public health interventions should increase helmet access to children without private insurance, especially uninsured children.

Cost effectiveness of a novel device for improving resuscitation of apneic newborns.

BACKGROUND: Intrapartum-related hypoxic events are a major cause of morbidity and mortality in low resource countries. Neonates who receive proper resuscitation may go on to live otherwise healthy lives. However, even when a birth attendant is present, these babies frequently receive suboptimal ventilation with poor outcomes. The Augmented Infant Resuscitator (AIR) is a low-cost, reusable device designed to provide birth attendants real-time objective feedback on measures of ventilation quality during resuscitations and is intended for use in training and at the point of care. The goal of our study was to determine the impact and cost-effectiveness of AIR deployment in conjunction with existing resuscitation training programs in low resource settings. METHODS: We developed a simulation model of the natural history of intrapartum-related neonatal hypoxia and resuscitation deriving parameters from published literature and model calibration. Simulations estimated the number of disability-adjusted life years (DALYs) averted with use of the AIR by birth attendants if deployed at the point of care. Potential decreases in neonatal mortality and long-term subsequent morbidity from disability were modeled over a lifetime horizon. The primary outcome for the analysis was the cost per DALY averted. Model parameters were specific to the Mbeya region of Tanzania. RESULTS: Implementation of the AIR strategy resulted in an additional cost of $24.44 (4.80, 73.62) per DALY averted on top of the cost of existing, validated resuscitation programs. Per hospital, this adds an extra $656 to initial training costs and averts approximately 26.84 years of disability in the cohort of children born in the first year, when projected over a lifetime. The findings were robust to sensitivity analyses. Total roll-out costs for AIR are estimated at $422,688 for the Mbeya region, averting approximately 9018 DALYs on top of existing resuscitation programs, which are estimated to cost $202,240 without AIR. CONCLUSION: Our modeling analysis finds that use of the AIR device may be both an effective and cost-effective tool when used as a supplement to existing resuscitation training programs. Implementation of this strategy in multiple settings will provide data to improve our model parameters and potentially confirm our findings.

Is Less More? A Microsimulation Model Comparing Cost-effectiveness of the Revised American Thyroid Association's 2015 to 2009 Guidelines for the Management of Patients With Thyroid Nodules and Differentiated Thyroid Cancer.

OBJECTIVE: To assess relative clinical and economic performance of the revised American Thyroid Association (ATA) thyroid cancer guidelines compared to current standard of care. BACKGROUND: Diagnosis of thyroid cancer in the United States has tripled whereas mortality has only marginally increased. Most patients present with small papillary carcinomas and have historically received at least a total thyroidectomy as a treatment. In 2015, the ATA released the revised guidelines recommending an option for active surveillance (AS) of small papillary thyroid carcinoma and thyroid lobectomy for larger unifocal tumors. METHODS: We created a Markov microsimulation model to evaluate the performance of the ATA's 2015 guidelines compared to the ATA's 2009 guidelines. We modeled a cohort of simulated patients with demographic and thyroid nodule characteristics representative of those presenting clinically in the United States. Outcome measures include life expectancy, quality-adjusted life years, costs, and frequency of surgical adverse events. RESULTS: In our base case analysis, the ATA 2015 strategy dominates the ATA 2009 strategy. The ATA 2015 strategy delivers greater discounted average quality-adjusted life years (13.09 vs 12.43) at a lower discounted average cost ($14,752 vs $20,126). Deaths due to thyroid cancer under the 2015 strategy are higher than the 2009 strategy but this is offset by a reduction in surgical deaths, leading to greater average life expectancy under the ATA 2015 strategy. The optimal strategy is sensitive to patients who experience a greater decrement in quality of life while undergoing AS. CONCLUSIONS: The ATA 2015 Guidelines represent a cost-effective strategy regarding AS and extent of surgery.

Optimizing Management of Patients With Barrett's Esophagus and Low-Grade or No Dysplasia Based on Comparative Modeling.

BACKGROUND & AIMS: Endoscopic treatment is recommended for patients with Barrett's esophagus (BE) with high-grade dysplasia, yet clinical management recommendations are inconsistent for patients with BE without dysplasia (NDBE) or with low-grade dysplasia (LGD). We used a comparative modeling analysis to identify optimal management strategies for these patients. METHODS: We used 3 independent population-based models to simulate cohorts of 60-year-old individuals with BE in the United States. We followed up each cohort until death without surveillance and treatment (natural disease progression), compared with 78 different strategies of management for patients with NDBE or LGD. We determined the optimal strategy using cost-effectiveness analyses, at a willingness-to-pay threshold of $100,000 per quality-adjusted life-year (QALY). RESULTS: In the 3 models, the average cumulative incidence of esophageal adenocarcinoma was 111 cases, with costs totaling $5.7 million per 1000 men with BE. Surveillance and treatment of men with BE prevented 23% to 75% of cases of esophageal adenocarcinoma, but increased costs to $6.2 to $17.3 million per 1000 men with BE. The optimal strategy was surveillance every 3 years for men with NDBE and treatment of LGD after confirmation by repeat endoscopy (incremental cost-effectiveness ratio, $53,044/QALY). The average results for women were consistent with the results for men for LGD management, but the optimal surveillance interval for women with NDBE was 5 years (incremental cost-effectiveness ratio, $36,045/QALY). CONCLUSIONS: Based on analyses from 3 population-based models, the optimal management strategy for patient with BE and LGD is endoscopic eradication, but only after LGD is confirmed by a repeat endoscopy. The optimal strategy for patients with NDBE is endoscopic surveillance, using a 3-year interval for men and a 5-year interval for women.

Neoadjuvant FOLFIRINOX for Patients with Borderline Resectable or Locally Advanced Pancreatic Cancer: Results of a Decision Analysis.

BACKGROUND: The effectiveness and cost-effectiveness of using neoadjuvant FOLFIRINOX (nFOLFIRINOX) for patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (BR/LA PDAC) are unknown. Our objective was to determine whether nFOLFIRINOX is more effective or cost-effective for patients with BR/LA PDAC compared with upfront resection surgery and adjuvant gemcitabine plus capecitabine (GEM/CAPE) or gemcitabine monotherapy (GEM). MATERIALS AND METHODS: We performed a decision-analysis to assess the value of nFOLFIRINOX versus GEM/CAPE or GEM using a mathematical simulation model. Model transition probabilities were estimated using published and institutional clinical data. Model outcomes included overall and disease-free survival, quality-adjusted life-years (QALYs), cost in U.S. dollars, and cost-effectiveness expressed as an incremental cost-effectiveness ratio. Deterministic and probabilistic sensitivity analyses explored the uncertainty of model assumptions. RESULTS: Model results found median overall survival (34.5/28.0/22.0 months) and disease-free survival (15.0/14.0/13.0 months) were better for nFOLFIRINOX compared with GEM/CAPE and GEM. nFOLFIRINOX was the optimal strategy on an efficiency frontier, resulting in an additional 0.35 life-years, or 0.30 QALYs, at a cost of $46,200/QALY gained compared with GEM/CAPE. Sensitivity analysis found that cancer recurrence and complete resection rates most affected model results, but were otherwise robust. Probabilistic sensitivity analyses found that nFOLFIRINOX was cost-effective 92.4% of the time at a willingness-to-pay threshold of $100,000/QALY. CONCLUSION: Our modeling analysis suggests that nFOLFIRINOX is preferable to upfront surgery for patients with BR/LA PDAC from both an effectiveness and cost-effectiveness standpoint. Additional clinical data that further define the long-term effectiveness of nFOLFIRINOX are needed to confirm our results. IMPLICATIONS FOR PRACTICE: Increasingly, neoadjuvant FOLFIRINOX has been used for borderline resectable and locally advanced pancreatic cancer with the goal of rendering them resectable and decreasing risk of recurrence. Despite many efforts to show the benefits of neoadjuvant over adjuvant therapies, clinical evidence to guide this decision is largely lacking. Decision-analytic modeling can provide a methodologic platform that integrates the best available data to quantitatively explore clinical decisions by simulating a hypothetical clinical trial. This modeling analysis suggests that neoadjuvant FOLFIRINOX is preferable to upfront surgery and adjuvant therapies by various outcome metrics including quality-adjusted life years, overall survival, and incremental cost-effectiveness ratio.

Systemic Thrombolysis, Catheter-Directed Thrombolysis, and Anticoagulation for Intermediate-risk Pulmonary Embolism: A Simulation Modeling Analysis.

OBJECTIVES: Decision making around the use of thrombolysis for patients with intermediate-risk (submassive) pulmonary embolism (PE) remains challenging. Studies indicate favorable clinical outcomes with systemic thrombolytics (intravenous tissue plasminogen activator [IV tPA]), but the risk of major bleeding and hemorrhagic stroke is a deterrent. Catheter-directed thrombolysis (CDT) may be a preferable strategy, as it has been shown to have a lower risk of bleeding than systemic thrombolysis. However, a three-arm randomized control study comparing IV tPA, CDT, and anticoagulation alone, with long-term follow up, would be costly and is unlikely to be performed. The aim of this study was to use decision modeling to quantitatively estimate the differences between the three strategies. METHODS: We created an individual-level state-transition model to simulate long-term outcomes of a hypothetical patient cohort treated with IV tPA, CDT, or anticoagulation alone. Our model incorporated clinical randomized controlled trial and longitudinal study data to inform patient characteristics and outcomes specific to each study arm. The base case was a 65-year-old patient. Additionally, we utilized preliminary data published by the Pulmonary Embolism Response Team at the Massachusetts General Hospital. Variance in model inputs was addressed with deterministic and probabilistic sensitivity analyses. Our primary endpoint was quality-adjusted life-years (QALYs). Secondary endpoints included total cost and incremental cost-effectiveness ratios (ICERs). RESULTS: Catheter-directed thrombolysis (mean, 95% confidence interval [CI] = 7.388 [7.381-7.396] QALYs) resulted in the most long-term utility for eligible patients compared to anticoagulation alone (7.352 [7.345-7.360] QALYs) or IV tPA (7.343 [7.336-7.351] QALYs). Patients receiving CDT had an elevated risk of hemorrhagic stroke in comparison to anticoagulation alone; however, patients treated with anticoagulation alone were more likely to experience recurrent PE associated adverse outcomes. Results were stable with sensitivity analyses varying age and sex. Our probabilistic sensitivity analysis assessing joint variance predicts CDT to be the most effective strategy, when measured by mean QALYs, in 98.4% of runs, while systemic thrombolysis was favored over anticoagulation alone 34.4% of the time. The ICER of CDT compared to anticoagulation was $317,042 per QALY gained. CONCLUSION: In our model, for those eligible, CDT results in the largest number of QALYs for patients with intermediate-risk PE, although it is relatively expensive and the absolute difference in QALYs between anticoagulation alone and CDT is small. Future studies that provide data on longitudinal quality-of-life outcomes of patients treated for PE and characteristics of CDT would be beneficial to augment model inputs, inform assumptions, and validate results.

Cost Effectiveness of Screening Patients With Gastroesophageal Reflux Disease for Barrett's Esophagus With a Minimally Invasive Cell Sampling Device.

BACKGROUND & AIMS: It is important to identify patients with Barrett's esophagus (BE), the precursor to esophageal adenocarcinoma (EAC). Patients with BE usually are identified by endoscopy, which is expensive. The Cytosponge, which collects tissue from the esophagus noninvasively, could be a cost-effective tool for screening individuals with gastroesophageal reflux disease (GERD) who are at increased risk for BE. We developed a model to analyze the cost effectiveness of using the Cytosponge in first-line screening of patients with GERD for BE with endoscopic confirmation, compared with endoscopy screening only. METHODS: We incorporated data from a large clinical trial of Cytosponge performance into 2 validated microsimulation models of EAC progression (the esophageal adenocarcinoma model from Massachusetts General Hospital and the microsimulation screening analysis model from Erasmus University Medical Center). The models were calibrated for US Surveillance, Epidemiology and End Results data on EAC incidence and mortality. In each model, we simulated the effect of a 1-time screen for BE in male patients with GERD, 60 years of age, using endoscopy alone or Cytosponge collection of tissue, and analysis for the level of trefoil factor 3 with endoscopic confirmation of positive results. For each strategy we recorded the number of cases of EAC that developed, the number of EAC cases detected with screening by Cytosponge only or by subsequent targeted surveillance, and the number of endoscopies needed. In addition, we recorded the cumulative costs (including indirect costs) incurred and quality-adjusted years of life lived within each strategy, discounted at a rate of 3% per year, and computed incremental cost-effectiveness ratios (ICERs) among the 3 strategies. RESULTS: According to the models, screening patients with GERD by Cytosponge with follow-up confirmation of positive results by endoscopy would reduce the cost of screening by 27% to 29% compared with screening by endoscopy, but led to 1.8 to 5.5 (per 1000 patients) fewer quality-adjusted life years. The ICERs for Cytosponge screening compared with no screening ranged from $26,358 to $33,307. For screening patients by endoscopy compared with Cytosponge the ICERs ranged from $107,583 to $330,361. These results were sensitive to Cytosponge cost within a plausible range of values. CONCLUSIONS: In a comparative modeling analysis of screening strategies for BE in patients with GERD, we found Cytosponge screening with endoscopic confirmation to be a cost-effective strategy. The greatest benefit was achieved by endoscopic screening, but with an unfavorable cost margin.

Tibial corticotomy and periosteal elevation induce angiogenesis in chronic critical limb ischaemia.

Corticotomy and periosteal elevation as a surgical procedure for management of chronic critical limb ischaemia is a relatively new technique. The current study aimed at assessing its safety, efficiency and cost/benefit ratio. The procedure was performed in 36patients. Preoperative documentation for age, sex, co-morbidities, ankle systolic pressure, and magnetic resonance contrast angiography was obtained. Early results included evaluation of skin perfusion. Late results involved assessment of wound healing, which was documented with photographs and was graded (healed, healing, resistant, recurrent), pain (intermittent claudication and pain at rest), Kelkar score, procedure morbidity, patient satisfaction and quality of life. Mean age was 68.03 +/- 5.5 years; 23 patients were males (63.9%) and 13 females (36.1%). Twenty (55.6%) patients had ankle systolic pressure < 50 mmHg and 29 (80.5%) had infra-inguinal vascular disease. Skin perfusion improved in 33/36 patients (91.7%). At final follow-up, 34 patients (94.1%) achieved complete wound healing. Relief from ischaemic rest pain and intermittent claudication was achieved in 86.1% and 55.6% respectively, with 20 (55.6%) patients having an excellent Kelkar score. Only one patient required a major amputation. Morbidity was noted in 17.7% of cases. Patient satisfaction scores at 12 months and at final follow-up were 7.1 +/- 1.3, and 8.7 +/- 1.7 respectively, on a scale from 0 to 10. Quality of life was markedly improved as compared to the preoperative status (overall score: p = 0.05, mental health scale: p <0.05 and pain/anxiety domain: p < 0.001). The procedure appears to represent an interesting tool, which should be evaluated in randomised studies. Our findings support the postulated angiogenic effect of the fracture haematoma.