Assessment of Median and Mean Survival Time in Cancer Clinical Trials.

This cohort study assesses the relative stability of median and mean survival time estimates reported in cancer clinical trials.

Landscape assessment of the cities in the state of Maharashtra: first step towards air quality management (AQM) and strategic implementation of mitigation plans.

OBJECTIVE OF THE STUDY: This study aims to understand the need for landscape assessment of the 18 non-attainment cities in the state of Maharashtra, to understand and rank the cities according to the need and necessity for strategic implementation of air quality management. This air quality management is a National Clean Air Programme initiative to curb the air pollution level in all the highly polluted Indian cities by 20-30% till 2024. METHODOLOGY: The ranking and selection of the cities consisted of a two-phase approach including (a) desk research and (b) field interventions and stakeholders' consultations. The first phase included (ai) review of 18 non-attainment cities in Maharashtra, (aii) identification of suitable indicators to inform prioritisation during the ranking process, (aiii) data collection and analysis of the indicators and (aiv) the ranking of the 18 non-attainment cities in Maharashtra. The second phase, i.e. field interventions included (bi) Mapping of stakeholders and field visits, (bii) the consultations with the stakeholders, (biii) information and data collection and (biv) ranking and selection of cities. On analysing the score obtained from both the approaches a ranking of all the cities is done accordingly. RESULTS AND DISCUSSION: The screening of cities from the first phase gave a possible list of 8 cities-Aurangabad, Kolhapur, Mumbai, Nagpur, Nashik, Navi Mumbai, Pune, Solapur. Further, the second round of analysis involving field interventions and stakeholder consultations was done within the 8 cities to find out the most suitable list of two to 5 cities. The second research analysis gave Aurangabad, Kolhapur, Mumbai, Navi Mumbai and Pune. A more granular stakeholder consultation resulted in the selection of cities like Navi Mumbai and Pune as the cities where implementation of new strategies seemed feasible. INTERVENTION AND ACTIVITIES: New strategic interventions like (a) strengthen the clean air ecosystem/institutions, (b) air quality monitoring and health impact assessment, and (c) skill development to ensure the long-term sustainability of initiatives planned for the cities.

Impact of the COVID-19 pandemic on the workflow of an ambulatory endoscopy center: an assessment by discrete event simulation.

BACKGROUND AND AIMS: As community-based ambulatory endoscopy centers (AECs) across the nation are trying to reopen and safely resume outpatient endoscopic procedures after the unprecedented lockdown related to the coronavirus disease 2019 (COVID-19) pandemic, guidelines recommend pretesting and screening for COVID-19 along with other mitigation measures for the safety of patients and staff. The impact of such changes in the workflow of AECs on throughput and other performance indicators is largely unknown, although a significant reduction in revenue stream is expected. METHODS: A discrete event simulation-based model was developed in the setting of a small to medium community-based single-specialty AEC to quantify the impact of COVID-19-related workflow changes on performance indicators and cost per case compared with the pre-COVID-19 baseline. RESULTS: In the simulation model, post-COVID-19 recommended workflow changes significantly impacted the operational and productivity metrics and, in turn, adversely affected financial metrics. Overall, there was a significant decrease in staff utilization and consequent increase in total facility time, waiting time for patients, and cost per case because of a bottleneck at the time of preprocedure COVID-19 screening and testing while practicing social distancing. Strategies to minimize this adverse impact on productivity were assessed. CONCLUSIONS: Pretesting and screening for COVID-19 as recommended by current guidelines will significantly impact the productivity and revenue stream of AECs. Urgent measures by payors are needed to adjust the facility reimbursement of endoscopy centers to ensure successful reopening and ramping up outpatient endoscopy services in these facilities already hit hard by the pandemic.

Cost effectiveness of endoscopic gallbladder drainage to treat acute cholecystitis in poor surgical candidates.

BACKGROUND: Endoscopic gallbladder drainage (GBD) is an alternative to percutaneous GBD (PGBD) to treat acute cholecystitis, yielding similar success rates and fewer adverse events. To our knowledge, no cost-effectiveness analysis has compared these procedures. We performed an economic analysis to identify clinical and cost determinants of three treatment options for acute cholecystitis in poor surgical candidates. METHODS: We compared three treatment strategies: PGBD, endoscopic retrograde cholangiographic transpapillary drainage (ERC-GBD), and endosonographic GBD (EUS-GBD). A decision tree was created over a 3-month period. Effectiveness was measured using hospital length of stay, including adverse events and readmissions. Costs of care were calculated from the National Inpatient Sample. Technical and clinical success estimates were obtained from the published literature. Cost effectiveness was measured as incremental cost effectiveness and compared to the national average cost of one hospital bed per diem. RESULTS: Analysis of a hypothetical cohort of poor candidates for cholecystectomy showed that, compared to PGBD, ERC-GBD was a cost-saving strategy and EUS-GBD was cost effective, requiring $1312 per hospitalization day averted. Additional costs of endoscopic interventions were less than the average cost of one hospital bed per diem. Compared to ERC-GBD, EUS-GBD required expending an additional $8950 to prevent one additional day of hospitalization. Our model was considerably affected by lumen-apposing metal stent cost and hospital length of stay for patients managed conservatively and those requiring delayed surgery. CONCLUSIONS: Endoscopic GBD is cost effective compared to PGBD, favoring ERC-GBD over EUS-GBD. Further efforts are needed to make endoscopic GBD available in more medical centers, reduce equipment costs, and shorten inpatient stay.

Cost-effectiveness of Pancreatic Cancer Surveillance in High-Risk Individuals: An Economic Analysis.

OBJECTIVE: The aim of the study was to perform an economic analysis to identify the clinical and cost determinants of pancreatic cancer (PC) surveillance in high-risk individuals (HRIs). METHODS: A Markov model was created to compare the following 3 strategies: no screening, endoscopic ultrasound (EUS), and magnetic resonance imaging (MRI) screening. Patients were considered HRIs according to the Cancer of the Pancreas Screening consortium recommendations. Risk for developing PC, survival, and costs data were obtained from the Surveillance, Epidemiology, and End Results and Medicare databases. Surveillance effectiveness was obtained from a recent meta-analysis. RESULTS: Analysis of a cohort with fivefold relative risk of PC higher than the US population showed that MRI is the most cost-effective strategy. For those with the highest risk (>×20 relative risk), EUS became the dominant strategy. Our model was impacted by cost and imaging performance, but still cost-effective within the range reported in literature. Threshold analysis showed that if MRI increases greater than US $1600, EUS becomes more cost-effective. Once patients reached the age of 76 years, "no screening" was favored. Both surveillance strategies were cost-effective over a wide range of willingness to pay. CONCLUSIONS: Abdominal imaging followed by pancreatectomy is cost-effective to prevent PC in HRIs, favoring MRI in moderate risk cases but EUS in those with highest risk.

A randomized controlled cross-over trial and cost analysis comparing endoscopic ultrasound fine needle aspiration and fine needle biopsy.

BACKGROUND AND STUDY AIMS: Techniques to optimize endoscopic ultrasound-guided tissue acquisition (EUS-TA) in a variety of lesion types have not yet been established. The primary aim of this study was to compare the diagnostic yield (DY) of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) to endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for pancreatic and non-pancreatic masses. PATIENTS AND METHODS: Consecutive patients referred for EUS-TA underwent randomization to EUS-FNA or EUS-FNB at four tertiary-care medical centers. A maximum of three passes were allowed for the initial method of EUS-TA and patients were crossed over to the other arm based on on-site specimen adequacy. RESULTS: A total of 140 patients were enrolled. The overall DY was significantly higher with specimens obtained by EUS-FNB compared to EUS-FNA (90.0 % vs. 67.1 %, P = 0.002). While there was no difference in the DY between the two groups for pancreatic masses (FNB: 91.7 % vs. FNA: 78.4 %, P = 0.19), the DY of EUS-FNB was higher than the EUS-FNA for non-pancreatic lesions (88.2 % vs. 54.5 %, P = 0.006). Specimen adequacy was higher for EUS-FNB compared to EUS-FNA for all lesions (P = 0.006). There was a significant rescue effect of crossover from failed FNA to FNB in 27 out of 28 cases (96.5 %, P = 0.0003). Decision analysis showed that the strategy of EUS-FNB was cost saving compared to EUS-FNA over a wide range of cost and outcome probabilities. CONCLUSIONS: RESULTS of this RCT and decision analysis demonstrate superior DY and specimen adequacy for solid mass lesions sampled by EUS-FNB.

Endoscopic ablation is a cost-effective cancer preventative therapy in patients with Barrett's esophagus who have elevated genomic instability.

BACKGROUND: The surveillance of patients with nondysplastic Barrett's esophagus (NDBE) has a high cost and is of limited effectiveness in preventing esophageal adenocarcinoma (EAC). Ablation for NDBE remains expensive and controversial. Biomarkers of genomic instability have shown promise in identifying patients with NDBE at high risk for progression to EAC. Here, we evaluate the cost-effectiveness of using such biomarkers to stratify patients with NDBE by risk for EAC and, subsequently, the cost-effectiveness of ablative therapy. METHODS: A Markov decision tree was used to evaluate four strategies in a hypothetical cohort of 50-year old patients with NDBE over their lifetime: strategy I, natural history without surveillance; strategy II, surveillance per current guidelines; strategy III, ablation for all patients; strategy IV, risk stratification with use of a biomarker panel to assess genomic instability (i. e., mutational load [ML]). Patients with no ML underwent minimal surveillance, patients with low ML underwent standard surveillance, and patients with high ML underwent ablation. The incremental cost-effectiveness ratio (ICER) and incremental net health benefit (INHB) were assessed. RESULTS: Strategy IV provided the best values for quality-adjusted life years (QALYs), ICER, and INHB in comparison with strategies II and III. RESULTS were robust in sensitivity analysis. In a Monte Carlo analysis, the relative risk for the development of cancer in the patients managed with strategy IV was decreased. Critical determinants of strategy IV cost-effectiveness were the complete response rate, cost of ablation, and surveillance interval in patients with no ML. CONCLUSION: The use of ML to stratify patients with NDBE by risk was the most cost-effective strategy for preventive EAC treatment. Targeting ablation toward patients with high ML presents an opportunity for a paradigm shift in the management of NDBE.

Endoscopic resection is cost-effective compared with laparoscopic resection in the management of complex colon polyps: an economic analysis.

BACKGROUND AND AIMS: Endoscopic resection (ER) is an efficacious treatment for complex colon polyps (CCPs). Many patients are referred for surgical resection because of concerns over procedural safety, incomplete polyp resection, and adenoma recurrence after ER. Efficacy data for both resection strategies are widely available, but a paucity of data exist on the cost-effectiveness of each modality. The aim of this study was to perform an economic analysis comparing ER and laparoscopic resection (LR) strategies in patients with CCP. METHODS: A decision analysis tree was constructed using decision analysis software. The 2 strategies (ER vs LR) were evaluated in a hypothetical cohort of patients with CCPs. A hybrid Markov model with a 10-year time horizon was used. Patients entered the model after colonoscopic diagnosis at age 50. Under Strategy I, patients underwent ER followed by surveillance colonoscopy at 3 to 6 months and 12 months. Patients with failed ER and residual adenoma at 12 months were referred for LR. Under Strategy II, patients underwent LR as primary treatment. Patients with invasive cancer were excluded. Estimates regarding ER performance characteristics were obtained from a systematic review of published literature. The Centers for Medicare & Medicaid Services (2012-2013) and the 2012 Healthcare Cost and Utilization Project databases were used to determine the costs and loss of utility. We assumed that all procedures were performed with anesthesia support, and patients with adverse events in both strategies required inpatient hospitalization. Baseline estimates and costs were varied by using a sensitivity analysis through the ranges. RESULTS: LR was found to be more costly and yielded fewer quality-adjusted life-years (QALYs) compared with ER. The cost of ER of a CCP was $5570 per patient and yielded 9.640 QALYs. LR of a CCP cost $18,717 per patient and yielded fewer QALYs (9.577). For LR to be more cost-effective, the thresholds of 1-way sensitivity analyses were (1) technical success of ER for complete resection in <75.8% of cases, (2) adverse event rates for ER > 12%, and (3) LR cost of <$14,000. CONCLUSIONS: Our data suggest that ER is a cost-effective strategy for removal of CCPs. The effectiveness is driven by high technical success and low adverse event rates associated with ER, in addition to the increased cost of LR.

Managing incidental pancreatic cystic neoplasms with integrated molecular pathology is a cost-effective strategy.

BACKGROUND AND STUDY AIMS: Current guidelines recommend using endoscopic ultrasound (EUS), carcinoembryonic antigen (CEA) testing and cytology to manage incidental pancreatic cystic neoplasms (PCN); however, studies suggest a strategy including integrated molecular pathology (IMP) of cyst fluid may further aid in predicting risk of malignancy. Here, we evaluate several strategies for diagnosing and managing asymptomatic PCN using healthcare economic modeling. PATIENTS AND METHODS: A third-party-payer perspective Markov decision model examined four management strategies in a hypothetical cohort of 1000 asymptomatic patients incidentally found to have a 3 cm solitary pancreatic cystic lesion. Strategy I used cross-sectional imaging, recommended surgery only if symptoms or risk factors emerged. Strategy II considered patients for resection without initial EUS. Strategy III (EUS + CEA + Cytology) referred only those with mucinous cysts (CEA > 192 ng/mL) for resection. Strategy IV implemented IMP; a commercially available panel provided a "Benign," "Mucinous," or "Aggressive" classification based on the level of mutational change in cyst fluid. "Benign" and "Mucinous" patients were followed with surveillance; "Aggressive" patients were referred for resection. Quality-adjusted life-years (QALY), relative risk with 95 %CI, Number Needed to Treat (NNT), and incremental cost-effectiveness ratios were calculated. RESULTS: Strategy IV provided the greatest increase in QALY at nearly identical cost to the cheapest approach, Strategy I. Relative risk of malignancy compared to the current standard of care and nearest competing strategy, Strategy III, was 0.18 (95 %CI 0.06 - 0.53) with an NNT of 56 (95 %CI 34 - 120). CONCLUSIONS: Use of IMP was the most cost-effective strategy, supporting its routine clinical use.

Endoscopic ultrasonography in esophageal cancer leads to improved survival rates: results from a population-based study.

BACKGROUND: The advantages of endoscopic ultrasound (EUS) and computed tomography (CT)-positron emission tomography (PET) with respect to survival for esophageal cancer patients are unclear. This study aimed to assess the effects of EUS, CT-PET, and their combination on overall survival with respect to cases not receiving these procedures. METHODS: Patients who were ≥66 years old when diagnosed with esophageal cancer were identified in the Surveillance, Epidemiology, and End Results-Medicare linked database. Cases were split into 4 analytic groups: EUS only (n = 318), CT-PET only (n = 853), EUS+CT-PET (n = 189), and no EUS or CT-PET (n = 2439). Survival times were estimated with the Kaplan-Meier method and were compared with the log-rank test for each group versus the no EUS or CT-PET group. Multivariate Cox proportional hazards models were used to compare 1-, 3-, and 5-year survival rates. RESULTS: Kaplan-Meier analyses showed that EUS, CT-PET, and EUS+CT-PET patients had improved survival for all stages (with the exception of stage 0 disease) in comparison with patients undergoing no EUS or CT-PET. Receipt of EUS increased the likelihood of receiving endoscopic therapies, esophagectomy, and chemoradiation. Multivariate Cox proportional hazards models showed that receipt of EUS was a significant predictor of improved 1- (hazard ratio [HR], 0.49; 95% confidence interval [CI], 0.39-0.59; P < .0001), 3- (HR, 0.57; 95% CI, 0.48-0.66; P < .0001), and 5-year survival (HR, 0.59; 95% CI, 0.50-0.68). Similar results were noted when the results were stratified on the basis of histology and for the CT-PET and EUS+CT-PET groups. CONCLUSIONS: Receipt of either EUS or CT-PET alone in esophageal cancer patients was associated with improved 1-, 3-, and 5-year survival. Future studies should identify barriers to the dissemination of these staging modalities.

Asymptomatic pancreatic cystic neoplasm: a cost-effectiveness analysis of different strategies of management.

BACKGROUND: Optimal management of asymptomatic pancreatic cystic neoplasm is not known. OBJECTIVE: In a decision analysis, the cost-effectiveness of different strategies for managing solitary, asymptomatic pancreatic cystic neoplasm were compared. INTERVENTION: Three strategies were examined in a Markov model with a third-party-payer perspective. In strategy I, the natural history of the lesion was followed without any specific intervention. In strategy II, an aggressive surgical approach was considered in that all patients were considered for resection. In strategy III, an initial EUS-guided FNA with cyst fluid analysis was performed for risk stratification, and patients with mucinous cysts were considered for resection. Transitional probabilities, discounted cost, and utility values to estimate quality-adjusted life years were obtained from published information. An operability risk score based on patient age, comorbidity, and size and location of the cyst was developed to estimate the probability of surgical resection. RESULTS: In the baseline analysis, strategy III yielded the highest quality-adjusted life years with an acceptable incremental cost-effectiveness ratio. In a Monte Carlo analysis, the relative risk of patients developing unresectable pancreatic cancer was decreased in strategy III compared to the other strategies. Although threshold analyses identified few important parameters influencing the conclusion of the analysis, operability risk score was the critical determinant of the optimal management strategy. LIMITATIONS: Indirect costs were not considered in this analysis. CONCLUSION: For asymptomatic patients with incidental solitary pancreatic cystic neoplasm, a blanket policy of surgical resection for all patients cannot be justified. A strategy based on risk stratification of malignant potential by EUS-guided FNA and cyst fluid analysis is the most cost-effective strategy.

Pancreatic-stent placement for prevention of post-ERCP pancreatitis: a cost-effectiveness analysis.

BACKGROUND: Controlled trials support pancreatic-stent placement as an effective intervention for the prevention of post-ERCP acute pancreatitis in high-risk patients. OBJECTIVE: To perform a decision analysis to evaluate the most cost-effective strategy for preventing post-ERCP pancreatitis. DESIGN: Cost-effectiveness analysis. SETTING: Patients undergoing ERCP. INTERVENTIONS: Three competing strategies were evaluated in a decision analysis model from a third-party-payer perspective in hypothetical patients undergoing ERCP. In strategy I, none of the patients had pancreatic-stent placement. Strategy II had only those patients identified to be at high risk for post-ERCP, and, in strategy III, all patients underwent prophylactic stent placement. Probabilities of developing post-ERCP pancreatitis and the risk reduction by placement of a pancreatic stent were obtained from published information. Cost estimates were obtained from Medicare reimbursement rates. MAIN OUTCOME MEASUREMENTS: Incremental cost-effectiveness ratio (ICER) of different strategies. RESULTS: Strategy I was the least-expensive strategy but yielded the least number of life years. Strategy II yielded the highest number of years of life, with an ICER of $11,766 per year of life saved, and strategy III was dominated by strategy II. LIMITATIONS: Indirect costs and pharmacologic prophylaxis were not considered in this analysis. CONCLUSIONS: Pancreatic-stent placement for the prevention of post-ERCP pancreatitis in high-risk patients is a cost-effective strategy.

Cytomegalovirus infection in solid organ transplantation: economic implications.

Cytomegalovirus (CMV) is a pathogen, commonly encountered in the recipients of solid organ transplantation and is an important cause of morbidity and mortality in these patients. CMV infection and disease have been shown to increase the cost of care in transplant recipients and several different strategies of prevention have been shown to be effective in clinical trials. A systematic review of published information on the economic impact of CMV in solid organ transplantation was performed; both clinical- and decision-analysis-based studies were reviewed. Clinical studies have shown that CMV infection and disease is associated with increased length of hospital stay and overall costs. Decision-analysis-based studies suggest that in general, antiviral chemoprophylaxis against CMV in transplant recipients is a cost-effective intervention compared with other established healthcare interventions such as strategies for colorectal cancer screening. Prophylaxis with oral or parenteral ganciclovir is probably the most cost-effective strategy; however, restricting prophylaxis to high-risk groups (such as donor seropositive/recipient seronegative status and the use of an antilymphocyte antibody) or chemoprophylaxis for an extended period does not improve cost effectiveness. Pre-emptive therapy is an evolving strategy for prevention of CMV disease in transplant recipients and is rapidly gaining in popularity. Well-designed trials incorporating prospective cost data and comparing pre-emptive therapy versus conventional antiviral prophylaxis are needed to establish the superiority of one strategy over the other.

Management strategies for duodenal ulcer in India in the helicobacter pylori era: an economic analysis.

BACKGROUND: Duodenal ulcer (DU) is widely prevalent in India. Eradication of Helicobacter pylori (H. pylori) is considered to be the most cost-effective first-line therapy for DU in patients without a historyof use of non-steroidal anti-inflammatory drugs. Western investigators recommend initial empirical anti-H. pylori therapy for such patients. However, in India similar recommendations are lacking due to the absence of appropriate clinical studies. METHODS: An economic analysis for the management of DU with particular attention to H. pylori infection was performed using a decision analysis model. Three treatment strategies for DU diagnosed at index endoscopy were evaluated: in strategy I, anti-secretory therapy alone was administered for 8 weeks; in strategy II, a urease test and histological examination for H. pylori was performed at the time of initial endoscopy and subsequent management was based on the result of these tests; and in strategy III, empirical triple therapy for possible H. pylori infection was considered. Costs per patient treated were the outcome variables compared among the three strategies. RESULTS: In the baseline analysis, the cost per patient managed with initial anti-secretory therapy alone was Rs 544, cost of performing the urease test and histological examination at the time of initial endoscopy and subsequent treatment was Rs 692, and strategy III of empirical triple therapy for H. pylori yielded a cost per patient of Rs 523. Sensitivity analysis with a wide range of clinical probabilities and cost estimates and a second-order Monte Carlo simulation supported the conclusions of the baseline analysis. CONCLUSION: Initial empirical triple therapy followed by anti-secretory therapy is the most cost-minimizing approach for the treatment of endoscopically documented DU in India.