The diagnostic accuracy of endobronchial ultrasound and spiral chest computed tomography scan in the prediction of infiltrating and non-infiltrating lymph nodes in patients undergoing endobronchial ultrasound.

PURPOSE: Endobronchial ultrasound (EBUS) and spiral chest computed tomography (CT) scan are important methods in the prediction of infiltrating and non-infiltrating lymph nodes, and the determination of their diagnostic accuracy would result in a reduction of the burden of problems and an improvement in prognosis. The purpose in this study was to determine the diagnostic accuracy of endobronchial ultrasound and spiral chest CT scan in the prediction of infiltrating and non-infiltrating lymph nodes in patients undergoing endobronchial ultrasound. MATERIAL AND METHODS: In this observational prospective study, 40 consecutive patients with infiltrating and non-infiltrating lymph nodes in Masih-Daneshvari Hospital in 2017 and 2018 were enrolled, and the sensitivity, specificity, and accuracy of EBUS and CT-scan versus fine needle aspiration pathology results were determined in them. RESULTS: The results in this study demonstrated that the congruence between EBUS and CT scan was 80.5% (p = 0.0001). The sensitivity, specificity, and accuracy for CT scan were 100%, 22.6%, and 40%, respectively, and the sensitivity, specificity, and accuracy for EBUS were 100%, 16.1%, and 35%, respectively. CONCLUSION: According to the obtained results, it may be concluded that CT scan and EBUS results have good congruence and high sensitivity to differentiate infiltrating and non-infiltrating lymph nodes. Hence, these methods are useful for screening methods, but due to their low specificity and accuracy the use of them for a confirmative approach is not beneficial. However, regarding the accessibility and less invasive nature, use of chest CT scan is more rational and is recommended in these patients.

Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial.

BACKGROUND: Primary angle-closure glaucoma is a leading cause of irreversible blindness worldwide. In early-stage disease, intraocular pressure is raised without visual loss. Because the crystalline lens has a major mechanistic role, lens extraction might be a useful initial treatment. METHODS: From Jan 8, 2009, to Dec 28, 2011, we enrolled patients from 30 hospital eye services in five countries. Randomisation was done by a web-based application. Patients were assigned to undergo clear-lens extraction or receive standard care with laser peripheral iridotomy and topical medical treatment. Eligible patients were aged 50 years or older, did not have cataracts, and had newly diagnosed primary angle closure with intraocular pressure 30 mm Hg or greater or primary angle-closure glaucoma. The co-primary endpoints were patient-reported health status, intraocular pressure, and incremental cost-effectiveness ratio per quality-adjusted life-year gained 36 months after treatment. Analysis was by intention to treat. This study is registered, number ISRCTN44464607. FINDINGS: Of 419 participants enrolled, 155 had primary angle closure and 263 primary angle-closure glaucoma. 208 were assigned to clear-lens extraction and 211 to standard care, of whom 351 (84%) had complete data on health status and 366 (87%) on intraocular pressure. The mean health status score (0·87 [SD 0·12]), assessed with the European Quality of Life-5 Dimensions questionnaire, was 0·052 higher (95% CI 0·015-0·088, p=0·005) and mean intraocular pressure (16·6 [SD 3·5] mm Hg) 1·18 mm Hg lower (95% CI -1·99 to -0·38, p=0·004) after clear-lens extraction than after standard care. The incremental cost-effectiveness ratio was £14 284 for initial lens extraction versus standard care. Irreversible loss of vision occurred in one participant who underwent clear-lens extraction and three who received standard care. No patients had serious adverse events. INTERPRETATION: Clear-lens extraction showed greater efficacy and was more cost-effective than laser peripheral iridotomy, and should be considered as an option for first-line treatment. FUNDING: Medical Research Council.

Burden of musculoskeletal disorders in the Eastern Mediterranean Region, 1990-2013: findings from the Global Burden of Disease Study 2013.

OBJECTIVES: We used findings from the Global Burden of Disease Study 2013 to report the burden of musculoskeletal disorders in the Eastern Mediterranean Region (EMR). METHODS: The burden of musculoskeletal disorders was calculated for the EMR's 22 countries between 1990 and 2013. A systematic analysis was performed on mortality and morbidity data to estimate prevalence, death, years of live lost, years lived with disability and disability-adjusted life years (DALYs). RESULTS: For musculoskeletal disorders, the crude DALYs rate per 100 000 increased from 1297.1 (95% uncertainty interval (UI) 924.3-1703.4) in 1990 to 1606.0 (95% UI 1141.2-2130.4) in 2013. During 1990-2013, the total DALYs of musculoskeletal disorders increased by 105.2% in the EMR compared with a 58.0% increase in the rest of the world. The burden of musculoskeletal disorders as a proportion of total DALYs increased from 2.4% (95% UI 1.7-3.0) in 1990 to 4.7% (95% UI 3.6-5.8) in 2013. The range of point prevalence (per 1000) among the EMR countries was 28.2-136.0 for low back pain, 27.3-49.7 for neck pain, 9.7-37.3 for osteoarthritis (OA), 0.6-2.2 for rheumatoid arthritis and 0.1-0.8 for gout. Low back pain and neck pain had the highest burden in EMR countries. CONCLUSIONS: This study shows a high burden of musculoskeletal disorders, with a faster increase in EMR compared with the rest of the world. The reasons for this faster increase need to be explored. Our findings call for incorporating prevention and control programmes that should include improving health data, addressing risk factors, providing evidence-based care and community programmes to increase awareness.

Coronary bypass surgery versus percutaneous coronary intervention: cost-effectiveness in Iran: a study in patients with multivessel coronary artery disease.

OBJECTIVES: The aim of this study was to evaluate cost effectiveness of coronary artery bypass graft (CABG) versus percutaneous coronary intervention (PCI) with stenting from Iran society perspective. METHODS: A retrospective study was carried out to estimate the annual cost and health related quality of life (HRQoL) of 109 patients who underwent coronary revascularization (PCI [n = 75] and CABG [n = 34]). A Markov model has been developed to determine the cost effectiveness of CABG compared with PCI. We used the model to calculate lifetime costs, life-years (LYs), and quality-adjusted life-years (QALYs) of each strategy. We also used probabilistic sensitivity analysis to test model robustness. RESULTS: We found that discounted QALY lived per person in CABG versus PCI group in 5 years, 10 years, and lifetime time horizon were (3.8 ± 0.13 versus 3.88 ± 0.14), (6.4 ± 0.23 versus 6.33 ± 0.22), and (8.74 ± 0.29 versus 8.33 ± 0.27), respectively. The estimated medical cost of CABG and PCI per patient in 5 years, 10 years, and lifetime time horizon were (USD 6,819 ± 765 versus 9,011 ± 1,816), (USD 8,852 ± 1,348 versus 12,034 ± 2,375), and (USD 14,037± 4,201 versus 18,798 ± 5,821), respectively. The incremental cost-effectiveness ratio results showed CABG is a dominate alternative in 10 years and lifetime time horizon. CONCLUSIONS: This study demonstrated that despite higher initial cost and lower HRQoL, CABG is a cost-effective revascularization strategy compared with PCI for patients with multivessel coronary artery disease in long-term.

Cost-effectiveness analysis of Avance® allograft for the treatment of peripheral nerve injuries in the USA.

Aim: Peripheral nerve injury (PNI) is a debilitating condition with significant associated morbidity, and which places a substantial socioeconomic burden on healthcare systems worldwide. Recently, allograft has emerged as a viable surgical alternative to autograft for the treatment of PNI. This study evaluated the cost effectiveness of allograft (Avance® Nerve Graft) compared with autograft for the peripheral nerve repair, from a US payer perspective. Methods: A Markov cohort model was developed to consider the treatment pathways followed by a patient population undergoing a single transected nerve repair with either allograft, or autograft. The marginal difference in meaningful recovery (MR) (effectiveness), and costs, between the two groups were estimated over a lifetime horizon. Deterministic and probabilistic sensitivity analyses (PSA) were performed to consider the uncertainty surrounding the base-case input parameter values and their effect on the overall incremental cost-effectiveness ratio (ICER). Results: The base-case analysis indicates that there is a small difference in the average probability of MR between the two groups (75.15% vs 70.46%; +4.69% with allograft). Allograft also results in cost savings ($12,677 vs $14,023; -$-1346 with allograft) compared with autograft. Deterministic sensitivity analysis shows that the costs of the initial surgical procedures are the main drivers of incremental cost, but that the intervention is likely to be cost saving compared with autograft regardless of the parameter variations made. Conclusion: The use of allograft with the Avance Nerve Graft has the potential to be a cost-effective alternative to autograft for the surgical treatment of PNI in the USA.

Digital variance angiography in patients undergoing lower limb arterial recanalization: cost-effectiveness analysis within the English healthcare setting.

Aim: Digital variance angiography (DVA) is a recently developed image processing method capable of improving image quality compared with the traditionally used digital subtraction angiography (DSA), among patients undergoing lower limb x-ray angiography. This study aims to explore the potential cost-effectiveness of DVA from an English National Health Service perspective. Materials & methods: A two-part economic model, consisting of a decision tree and a Markov model, was developed to consider the costs and health outcomes associated with the use of DVA as part of current practice imaging, compared with x-ray angiography using standard DSA. The model explored the impact of DVA on the development of acute kidney injury (AKI), chronic kidney disease and radiation-induced cancer over a lifetime horizon. Both deterministic and probabilistic analyses were performed to assess the cost per quality-adjusted life-year (QALY). Results: Base-case results indicate that DVA results in cost savings of £309 per patient, with QALYs also improving (+0.025) over a lifetime. As shown in sensitivity analysis, a key driver of model results is the relative risk (RR) reduction of contrast-associated acute kidney injury associated with use of DVA. The intervention also decreases the risk of carcinoma over a lifetime. Scenario analyses show that cost savings range from £310 to £553, with QALY gains ranging from 0.048 to 0.109 per patient. Conclusion: The use of DVA could result in a decrease in costs and an increase in QALYs over a lifetime, compared with existing imaging practice. The potential for this technology to offer an economically viable alternative to existing image processing methods, through a reduction in contrast media volume and radiation exposure, has been demonstrated.

Cost-utility analysis of oral deferasirox versus infusional deferoxamine in transfusion-dependent ß-thalassemia patients.

BACKGROUND: Deferasirox (DFX) is a novel iron chelator that has been shown to have similar efficacy and safety compared with deferoxamine (DFO) in patients with ß-thalassemia. The aim of this study was to determine the cost utility of DFX versus DFO in ß-thalassemia major patients from Iran's society perspective. STUDY DESIGN AND METHODS: A Markov model has been developed to determine lifetime cost and quality-adjusted life-years (QALYs) of patients. To estimate the annual cost of each method, a cross-sectional study was conducted among two groups of patients who received DFO and DFX (n = 100 and n = 45, respectively). Also a time trade-off method was used to estimate the utility of two strategies. Finally a one-way and probabilistic sensitivity analysis was conducted to examine the strength of the results. RESULTS: Our base-case analysis showed that estimated total lifetime costs per patient for DFX and DFO were 47,029 international dollar ($Int) and $Int143,522, respectively, while the estimated total discounted QALYs per person were 12.28 and 7.76, respectively. Calculated incremental cost-effectiveness ratio showed that DSX is a dominant therapy and its estimated lifetime net monetary benefit was $Int273,528. CONCLUSION: We conclude that the use of DFX instead of DFO represents a cost-effective use of resources for treatment of iron overload in patients with ß-thalassemia from Iran's society perspective.

Cost-Utility Analysis of the Caresyntax Platform to Identify Patients at Risk of Surgical Site Infection Undergoing Colorectal Surgery.

BACKGROUND: Surgical site infections (SSIs) account for up to 18% of all healthcare-associated infections (HAIs). The Caresyntax data-driven surgery platform incorporates the most common risk factors for SSI, to identify high-risk surgical patients before they leave the operating theatre and treat them prophylactically with negative pressure wound therapy (NPWT). An economic analysis was performed to assess the costs and health outcomes associated with introduction of the technology in the English healthcare setting. METHODS: A hybrid decision tree/Markov model was developed to reflect the treatment pathways that patients undergoing colorectal surgery would typically follow, both over the short term (30-day hospital setting) and long term (lifetime). The analysis considered implementation of Caresyntax's platform-based SSI predictive algorithm in the hospital setting, compared with standard of care, from an English National Health Service (NHS) perspective. The base-case analysis presents results in terms of cost per quality-adjusted life-year (QALY) gained, as well as operational impact. RESULTS: The base-case analysis indicates that the intervention leads to a cost saving of £55.52m across the total NHS colorectal surgery patient population in 1 year. In addition, the intervention has a 98.36% probability of being cost effective over a lifetime horizon. The intervention results in the avoidance of 19,744 SSI events, as well 191,911 excess hospital bed days saved. CONCLUSION: Caresyntax's platform-based SSI predictive algorithm has the potential to result in cost savings and improved patient quality of life. Additionally, operational gains for the healthcare provider, including reduced infection rates and hospital bed days saved, have been shown through the economic modeling.

Early Cost-Effectiveness and Price Threshold Analyses of Resmetirom: An Investigational Treatment for Management of Nonalcoholic Steatohepatitis.

BACKGROUND: Nonalcoholic steatohepatitis (NASH) is characterized by inflammation and hepatocellular damage caused by accumulation of fat in the liver. Resmetirom (MGL-3196) is an orally administered, small-molecule, liver-targeted, selective thyroid hormone receptor-ß agonist. This early analysis explored the potential cost effectiveness of resmetirom for the treatment of NASH from a US commercial payer perspective. METHODS: An early economic model was developed to reflect the clinical pathways typically followed by patients with NASH and liver fibrosis. Use of resmetirom, compared with placebo, was assessed. The Markov model structure was informed by a previous modeling study and a randomized, double-blind, placebo-controlled, phase II trial of resmetirom. Costs and outcomes were assessed over a lifetime time horizon with results presented in terms of cost per quality-adjusted life-year (QALY) gained. RESULTS: Resmetirom treatment resulted in increased costs of US$66,764 per patient, while increasing QALYs by 1.24. The incremental cost-effectiveness ratio was US$53,929 per QALY gained, indicating resmetirom treatment would potentially be cost effective at a willingness-to-pay (WTP) threshold of US$100,000. Results indicated that resmetirom would reduce the lifetime number of cases of decompensated cirrhosis (- 87), hepatocellular carcinoma (- 59), and liver transplants (- 30) per 1,000 patients compared with placebo. Resmetirom treatment remained cost effective at a US$100,000 WTP threshold up to a daily price point of US$72.00. CONCLUSION: Resmetirom is a potentially cost-effective treatment option for patients with NASH and liver fibrosis based on an analysis performed from a US commercial payer perspective. Future economic analyses of the technology should, however, focus on overcoming the limitations of existing modeling methodology.

Continuous Monitoring of Respiratory Rate with Wearable Sensor in Patients Admitted to Hospital with Pneumonia Compared with Intermittent Nurse-Led Monitoring in the United Kingdom: A Cost-Utility Analysis.

BACKGROUND: Respiratory rate (RR) is one of the most important physiologic measures for predicting patients' deterioration of clinical condition and final prognosis. In several studies, RR has been the most important predictor of patients' prognoses. OBJECTIVES: The objective of this study was to conduct a cost-utility analysis to estimate the cost and effectiveness of automatic respiratory rate monitoring (ARRM) with a non-invasive sensor (RespiraSense™) plus intermittent nurse-led RR monitoring (ARRM strategy) compared with intermittent nurse-led RR monitoring (IM strategy) in patients admitted to hospital in the UK with pneumonia. METHODS: A decision analytic model was developed based on a hypothetical cohort of patients who were admitted to hospital with pneumonia. After admission, the patients could be monitored with either ARRM or IM strategies. The outcomes of interest included total costs and total effectiveness of each strategy, including length of stay (LoS) in hospital, LoS in intensive care unit, quality-adjusted life-years (QALYs), deaths, and incremental cost per QALY gained. An incremental cost of £20,000 or less per QALY gained was considered cost effective. A lifetime time horizon (38 years) was used to capture the long-term benefits. Probabilistic and deterministic sensitivity analyses were performed. RESULTS: Total costs of patient care in ARRM and IM strategies were £1986.9 million and £2079.4 million, respectively. Total incremental QALYs lived were 3548 higher in the intervention arm (ARRM), meaning that the ARRM strategy was dominant (i.e., less costly [£92.6 million less] and more effective). The results were stable in probabilistic and most of the deterministic sensitivity analyses. Results from threshold analysis indicated that a minimum of 7 and 10% improvement in percentage of early detection of respiratory compromise is required for ARRM to become cost effective and cost saving, respectively. CONCLUSIONS: Our results indicate that ARRM using RespiraSense, in addition to intermittent nurse-led monitoring of RR, in patients admitted to the hospital with pneumonia could be a cost-saving and cost-effective intervention if the minimum clinical thresholds are met.

Cost-Effectiveness Analysis of a Medial Meniscus Replacement Prosthesis for the Treatment of Patients with Medial Compartment Pain in the United Kingdom.

BACKGROUND: The most common intra-articular knee injury is a meniscal tear, which commonly occurs secondary to trauma following twisting or hyperflexion. Treatment options for meniscal tears can either be surgical or non-surgical, and range from rest, exercise, bracing and physical therapy to surgical intervention, including meniscal repair and partial meniscectomy. In patients with persistent pain following loss of meniscus tissue, treatment can include partial replacement or meniscal allograft transplantation. The NUsurface® prosthesis has been developed as a treatment option for patients experiencing persistent knee pain post medial meniscus (MM) surgery. OBJECTIVE: The aim of this study was to assess the cost effectiveness of MM replacement using NUsurface for the treatment of patients with medial compartment pain following previous partial medial meniscectomy, from a UK health service perspective. METHODS: An economic decision-analytic model was developed to assess the cost per quality-adjusted life-year (QALY) gained associated with the introduction of MM replacement using NUsurface compared with non-surgical standard of care, over a lifetime time horizon. The model structure was primarily informed by a previous clinical trial (VENUS) and was developed based on the clinical pathways typically followed by patients with this condition, with treatment pathways and probabilities of clinical progression adjusted depending on whether patients were receiving the intervention or undergoing current practice. A hypothetical cohort of adult patients (mean age of 50 years) was modelled, with clinical data sourced from the VENUS study as well as relevant UK literature. Both deterministic and probabilistic sensitivity analyses were carried out to explore uncertainty in the model results. RESULTS: The base-case probabilistic results indicate that MM replacement using NUsurface is likely to be cost effective across a range of willingness-to-pay (WTP) thresholds (95% probability of being cost effective at the National Institute for Health and Care Excellence (NICE)-recommended £20,000 WTP threshold). Although per-patient costs increase, QALYs are also gained, with the incremental cost per QALY (probabilistic value = £5011) being below £20,000. Deterministic sensitivity analyses indicate that the parameters that have the greatest impact on results are the failure rate in the control group (current practice), utility scores, and the cost of undergoing MM replacement using NUsurface. CONCLUSIONS: Based on the analysis presented, MM replacement with the NUsurface prosthetic implant is likely to be a cost-effective use of UK health care service resources compared with current standard care.

Cost-Effectiveness Analysis of Intravascular Targeted Temperature Management after Cardiac Arrest in England.

BACKGROUND: Targeted temperature management (TTM) has been shown to improve neurological outcomes and survival in patients resuscitated from cardiac arrest; however, the cost effectiveness of multiple TTM methods is not well studied. OBJECTIVE: This study aimed to evaluate the cost effectiveness of intravascular temperature management (IVTM) using Thermogard XP compared with surface cooling methods after cardiac arrest in the England from the perspectives of the UK national health service and Personal Social Services. METHODS: We developed a multi-state Markov model that evaluated IVTM (Thermogard XP) compared with surface cooling using two different devices (Blanketrol III and Arctic Sun 5000) over a short-term and lifetime time horizon. Model input parameters were obtained from the literature and local databases. We assumed a hypothetical cohort of 1000 patients who required TTM after cardiac arrest per year in the England. The outcomes were costs (in £, year 2019 values) and quality-adjusted life-years (QALYs), discounted at 3.5% annually. Deterministic and probabilistic sensitivity analyses were undertaken to examine the effect of alternative assumptions and uncertainty in model parameters on the results. RESULTS: The cost-effectiveness analysis determined that Thermogard XP resulted in direct cost savings of £2339 and £2925 (per patient) compared with Blanketrol III and Arctic Sun 5000, respectively, and a gain of 0.98 QALYs over the patient lifetime. The probabilistic sensitivity analysis demonstrated that the probability of Thermogard XP being cost saving would be 69.2% and 65.3% versus the Arctic Sun 5000 and Blanketrol III, respectively. CONCLUSION: Implementation of IVTM using Thermogard XP can lead to cost savings and improved patient quality of life versus surface cooling methods.

Economic Analysis of the CADScor System for Ruling Out Coronary Artery Disease in England.

BACKGROUND: Coronary artery disease (CAD) is the most common type of heart and circulatory disease and is the leading cause of death worldwide. The current diagnostic pathway can lead to patient complications and is also extremely costly. A new medical device, the CADScor System (Acarix AB), was developed for the acoustic detection of CAD before patients undergo invasive diagnostic procedures. OBJECTIVES: Our objective was to assess the cost utility of the CADScor System for the diagnosis of CAD at an early stage in the diagnostic testing pathway in England. METHODS: A two-part economic model, consisting of a decision tree and Markov model, was developed to consider the cost utility (cost per quality-adjusted life-year [QALY] gained) of introducing the CADScor System for the diagnosis of CAD. The decision tree component explored the short-term costs and diagnostic outcomes associated with introduction of the test compared with the existing testing pathway. A Markov model was developed to explore the longer-term health and economic implications of the condition and original diagnosis, with costs and health effects estimated over different time horizons. Parameter uncertainty was explored in deterministic and probabilistic sensitivity analyses. RESULTS: Base-case results indicated that the CADScor System would result in cost savings (- £131 per patient) and a marginal increase in QALYs (0.00001) over a 1-year time horizon. Probabilistic results indicated that the intervention had a > 99% probability of being cost effective at a willingness-to-pay threshold of £20,000 per QALY gained and 100% probability of being cost saving. Results from the deterministic sensitivity analyses indicated that variations in parameters related to the accuracy and cost of the CADScor System, and the prevalence of CAD, had the greatest impact on the overall results. The overall cost saving was estimated to be over £12.3 million per 100,000 eligible patient population. CONCLUSIONS: The CADScor System is a potentially cost-saving test for the diagnosis of CAD. When initiated before the use of non-invasive cardiac imaging tests such as computed tomography coronary angiography, the test reduced costs to the healthcare service over various time horizons.

Cost-effectiveness analysis of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with gastric cancer and peritoneal metastasis.

OBJECTIVE: The aim of this study was to assess the cost-effectiveness of pressurized intraperitoneal aerosol chemotherapy with low-dose cisplatin and doxorubicin (PIPAC C/D) for the treatment of advanced gastric cancer. METHODS: A Partitioned Survival Model followed by state transition Markov model was developed to estimate the costs and effectiveness of the use of PIPAC C/D versus palliative chemotherapy in the UK. The intervention was assessed at two different levels of care, including upfront therapy (PIPAC C/D plus Oxaliplatin in combination with Capecitabine (XELOX) chemotherapy versus first-line chemotherapy alone) and second-line therapy (PIPAC C/D alone versus second-line chemotherapy (ramucirumab monotherapy)). Data from multiple sources, including published literature and UK-based databases, were used to inform the economic model. RESULTS: For the upfront therapy analysis, the estimated total costs in the intervention and comparator arms were £32,606 (SD: £3877) and £17,844 (SD: £920), respectively. PIPAC C/D plus XELOX led to an increase of 0.46 in quality-adjusted life-years (QALYs) gained. The incremental cost per QALY gained was £31,868. For the second-line therapy analysis, the use of PIPAC C/D led to an increase of 0.19 in QALYs and a £21,474 reduction in costs, meaning the intervention was a dominant strategy. CONCLUSIONS: The cost-effectiveness results for the upfront therapy analysis indicate that PIPAC C/D plus chemotherapy is a cost-effective strategy. Additionally, PIPAC C/D alone as a second-line therapy has the potential to reduce costs and improve clinical outcomes for patients with advanced gastric cancer with peritoneal metastasis.

Cost-effectiveness of an enhanced Paramedic Acute Stroke Treatment Assessment (PASTA) during emergency stroke care: Economic results from a pragmatic cluster randomized trial.

BACKGROUND: The Paramedic Acute Stroke Treatment Assessment (PASTA) trial evaluated an enhanced emergency care pathway which aimed to facilitate thrombolysis in hospital. A pre-planned health economic evaluation was included. The main results showed no statistical evidence of a difference in either thrombolysis volume (primary outcome) or 90-day dependency. However, counter-intuitive findings were observed with the intervention group showing fewer thrombolysis treatments but less dependency. AIMS: Cost-effectiveness of the PASTA intervention was examined relative to standard care. METHODS: A within trial cost-utility analysis estimated mean costs and quality-adjusted life years over 90 days' time horizon. Costs were derived from resource utilization data for individual trial participants. Quality-adjusted life years were calculated by mapping modified Rankin scale scores to EQ-5D-3L utility tariffs. A post-hoc subgroup analysis examined cost-effectiveness when trial hospitals were divided into compliant and non-compliant with recommendations for a stroke specialist thrombolysis rota. RESULTS: The trial enrolled 1214 patients: 500 PASTA and 714 standard care. There was no evidence of a quality-adjusted life year difference between groups [0·007 (95% CI: -0·003 to 0·018)] but costs were lower in the PASTA group [-£1473 (95% CI: -£2736 to -£219)]. There was over 97.5% chance that the PASTA pathway would be considered cost-effective. There was no evidence of a difference in costs at seven thrombolysis rota compliant hospitals but costs at eight non-complaint hospitals costs were lower in PASTA with more dominant cost-effectiveness. CONCLUSIONS: Analyses indicate that the PASTA pathway may be considered cost-effective, particularly if deployed in areas where stroke specialist availability is limited.Trial Registration: ISRCTN12418919 www.isrctn.com/ISRCTN12418919.

DyeVert Contrast Reduction System Use in Patients Undergoing Coronary and/or Peripheral Angiography: A Systematic Literature Review and Meta-Analysis.

Background: Contrast-associated acute kidney injury (CA-AKI) is an important adverse effect associated with injecting iodinated intra-arterial contrast media (CM) during coronary angiography. The DyeVert™ Contrast Reduction System is a medical device intended to reduce the intra-arterial CM volume (CMV) administered. The aim of this study was to assess DyeVert System clinical effectiveness and safety by implementing a systematic review and meta-analysis of existing evidence. Methods: Systematic electronic literature searches were conducted in MEDLINE, Embase, the Cochrane Database of Systematic Reviews, ClinicalTrials.gov, and the International Clinical Trials Registry Platform database. Relevant data were extracted from included studies and meta-analyses were performed to synthesize evidence across studies. Results: The review included 17 eligible studies involving 1,731 DyeVert System cases and 1,387 control cases (without the use of DyeVert). Meta-analyses demonstrated use of the DyeVert System reduced CMV delivered to the patient by 39.27% (95% CI, 36.10-42.48%, P < 0.001), reduced CMV/baseline renal function ratios (Hedges's g, -0.56; 95% CI, -0.70 to -0.42, P < 0.001) and percentage of cases exceeding the maximum CMV threshold (risk difference -0.31, 95% CI, -0.48 to -0.13, P < 0.001) while maintaining adequate image quality in 98% of cases. DyeVert System cases demonstrated lower CA-AKI incidence vs. controls (absolute risk reduction 5.00% (95% CI, 0.40-9.80%; P = 0.03), relative risk 0.60 (95% CI, 0.40-0.90; P = 0.01) with a pooled estimate of the number needed to treat with the DyeVert System to avoid 1 CA-AKI event of 20. Conclusion: DyeVert System use significantly reduces CMV delivered to the patient, CMV/baseline renal function ratios, and CA-AKI incidence while maintaining image quality. Accordingly, the device may serve as an adjunctive, procedure-based strategy to prevent CA-AKI. Future multi-center studies are needed to further assess effects of minimizing CMV on endpoints such as CA-AKI prevention, incidence of adverse cardiac and renal events, and health care costs.

Optimal Surveillance Strategies for Early-Stage Cutaneous Melanoma Post Primary Tumor Excision: An Economic Evaluation.

Background. Consensus on standardized active surveillance or follow-up care by clinicians is lacking leading to considerable variation in practice across countries. An important structural modelling consideration is that self-examination by patients and their partners can detect melanoma recurrence outside of active surveillance regimes. Objectives. To identify candidate melanoma surveillance strategies for American Joint Committee on Cancer (AJCC) stage I disease and compare them with the current recommended practice in a cost-utility analysis framework. Methods. In consultation with UK clinical experts, a microsimulation model was built in TreeAge Pro 2019 R1.0 (Williamstown, MA, USA) to evaluate surveillance strategies for AJCC stage IA and IB melanoma patients separately. The model incorporated patient behaviors such as self-detection and emergency visits to examine suspicious lesions. A National Health Service (NHS) perspective was taken. Model input parameters were taken from the literature and where data were not available, local expert opinion was sought. Probabilistic sensitivity analysis, one-way sensitivity analysis on pertinent parameters and value of information was performed. Results. In the base-case probabilistic sensitivity analysis, less intensive surveillance strategies for AJCC stage IA and IB had lower total lifetime costs than the current National Institute for Health and Care Excellence (NICE) recommended strategy with similar effectiveness in terms of quality-adjusted life years and thereby likely to be cost-effective. Many strategies had similar effectiveness due to the relatively low chance of recurrence and the high rate of self-detection. Sensitivity and scenario analyses did not change these findings. Conclusions. Our model findings suggest that less resource intensive surveillance may be cost-effective compared with the current NICE surveillance guidelines. However, to advocate convincingly for changes, better evidence is required.

Budget Impact of the Vest™ High Frequency Chest Wall Oscillation System for Managing Airway Clearance in Patients with Complex Neurological Disorders: A US Healthcare Payers' Perspective Analysis.

OBJECTIVE: As a recognized therapy to improve airway clearance, high-frequency chest wall oscillation (HFCWO) is used to manage reduced vital capacity in patients with complex neuromuscular disorders (cNMD). This study aimed to investigate the budget impact of HFCWO versus chest wall physical therapy (CWPT) from a US-commercial payer perspective. METHODS: In combination with a previously developed cost-effectiveness model, a budget impact model was developed to evaluate the incremental budgetary impact associated with introducing a HFCWO device over a 5-year time horizon. The model compared the cost implications associated with the commonly used CWPT procedure, as the current scenario, with a new scenario consisting of 80% of market share for HFCWO. The resource use and costs included in the analyses were costs associated with the HFCWO device (Vest™ System) and its consumables, patient training, and medical services such as hospitalization, medications, emergency room, and outpatient visits. The primary outcome measures included total and incremental budgetary impact per member per year (PMPY). RESULTS: In a hypothetical plan of 1,000,000 members (men: 49.2%), 2099 patients with cNMD were estimated to be eligible to receive airway clearance services over 5 years. The new scenario (HFCWO and CWPT [US$24 PMPY]) was cost-saving compared with the current scenario (CWPT only [$34 PMPY]) with a cost reduction of US$9.46 PMPY. The model estimated a net cost-saving of US$1,594,131 and US$9,591,343 over 1 and 5 years, respectively. CONCLUSION: This study suggests the HFCWO technique to manage the reduction in vital capacity in patients with cNMD would lead to favorable budget impact results.

A Cluster Randomized Noninferiority Field Trial of Gestational Diabetes Mellitus Screening.

CONTEXT: Although it is well-acknowledged that gestational diabetes mellitus (GDM) is associated with the increased risks of adverse pregnancy outcomes, the optimal strategy for screening and diagnosis of GDM is still a matter of debate. OBJECTIVE: This study was conducted to demonstrate the noninferiority of less strict GDM screening criteria compared with the strict International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria with respect to maternal and neonatal outcomes. METHODS: A cluster randomized noninferiority field trial was conducted on 35 528 pregnant women; they were scheduled to have 2 phases of GDM screening based on 5 different prespecified protocols including fasting plasma glucose in the first trimester with threshold of 5.1 mmol/L (92 mg/dL) (protocols A, D) or 5.6 mmol/L (100 mg/dL) (protocols B, C, E) and either a 1-step (GDM is defined if one of the plasma glucose values is exceeded [protocol A and C] or 2 or more exceeded values are needed [protocol B]) or 2-step approach (protocols D, E) in the second trimester. Guidelines for treatment of GDM were consistent with all protocols. Primary outcomes of the study were the prevalence of macrosomia and primary cesarean section (CS). The null hypothesis that less strict protocols are inferior to protocol A (IADPSG) was tested with a noninferiority margin effect (odds ratio) of 1.7. RESULTS: The percentages of pregnant women diagnosed with GDM and assigned to protocols A, B, C, D, and E were 21.9%, 10.5%, 12.1%, 19.4%, and 8.1%, respectively. Intention-to-treat analyses satisfying the noninferiority of the less strict protocols of B, C, D, and E compared with protocol A. However, noninferiority was not shown for primary CS comparing protocol E with A. The odds ratios (95% CI) for macrosomia and CS were: B (1.01 [0.95-1.08]; 0.85 [0.56-1.28], C (1.03 [0.73-1.47]; 1.16 [0.88-1.51]), D (0.89 [0.68-1.17]; 0.94 [0.61-1.44]), and E (1.05 [0.65-1.69]; 1.33 [0.82-2.00]) vs A. There were no statistically significant differences in the adjusted odds of adverse pregnancy outcomes in the 2-step compared with the 1-step screening approaches, considering multiplicity adjustment. CONCLUSIONS: The IADPSG GDM definition significantly increased the prevalence of GDM diagnosis. However, the less strict approaches were not inferior to other criteria in terms of adverse maternal and neonatal outcomes.

Cost-Effectiveness of Tisagenlecleucel in Paediatric Acute Lymphoblastic Leukaemia (pALL) and Adult Diffuse Large B-Cell Lymphoma (DLBCL) in Switzerland.

INTRODUCTION: The purpose of the present analysis was to explore the cost-effectiveness of tisagenlecleucel in relapsed or refractory (r/r) paediatric acute lymphoblastic leukaemia (pALL) and r/r adult diffuse large B-cell lymphoma (DLBCL) in Switzerland against a range of historical standard-of-care treatments. METHODS: Two cost-utility models were constructed for the two licensed indications using similar methodologies but indication-specific data. Clinical efficacy data were based on pooled analyses of clinical trials for tisagenlecleucel (pALL: ELIANA, ENSIGN, B2101J; DLBCL: JULIET, NCT02030834) and published data for comparator treatments. Treatment effects were compared based on matching-adjusted indirect comparison (MAIC) analyses. Four clinical lymphoma and leukaemia experts provided Switzerland-specific input regarding comparators, diagnostic and therapeutic procedures, clinical evidence and costs, which were used to inform the models. The base case analysis reflected the perspective of the Swiss mandatory health insurance system. Deterministic, probabilistic and scenario analyses were carried out to explore the robustness of results. RESULTS: The base case analysis resulted in incremental costs of CHF 31,961-CHF 36,419 per quality-adjusted life year (QALY) gained for pALL across the different comparators and CHF 113,179 for DLBCL (1 CHF = 1.09 USD). Incremental costs per life-year gained ranged between CHF 33,906-CHF 97,399 across the two indications. Including productivity gains, tisagenlecleucel was shown to be dominant (more effective and less costly) over all the comparators for pALL and to result in incremental costs per life-year gained of CHF 57,324 for DLBCL. CONCLUSION: Using hypothetical willingness-to-pay thresholds of CHF 100,000-150,000 per QALY gained, the present analysis has shown tisagenlecleucel to be a cost-effective treatment option in pALL and DLBCL.