CAR T-cell Therapy for Diffuse Large B-cell Lymphoma in Canada: A Cost-Utility Analysis.

BACKGROUND: Chimeric antigen receptor (CAR) T-cell therapy is a novel cell therapy for treating non-Hodgkin lymphoma. The development of CAR T-cell therapy has transformed oncology treatment by offering a potential cure. However, due to the high cost of these therapies, and the large number of eligible patients, decision makers are faced with difficult funding decisions. Our objective was to assess the cost-effectiveness of tisagenlecleucel for adults with relapsed/refractory diffuse large B-cell lymphoma in Canada using updated survival data from the recent JULIET trial. METHODS: We developed an individual-simulated discrete event simulation model to assess the costs and quality-adjusted life-years (QALY) of tisagenlecleucel compared with salvage chemotherapy. Survival estimates were obtained from a published clinical trial and retrospective analysis. If patients remained progression free for 5 y, they were assumed to be in long-term remission. Costing and utility data were obtained from reports and published sources. A Canadian health care payer perspective was used, and outcomes were modeled over a lifetime horizon. Costs and outcomes were discounted at 1.5% annually, with costs reported in 2021 Canadian dollars. A probabilistic analysis was used, and model parameters were varied in 1-way sensitivity analyses and scenario analyses. RESULTS: After we incorporated the latest clinical evidence, tisagenlecleucel led to an additional cost of $503,417 and additional effectiveness of 2.48 QALYs, with an incremental cost-effectiveness ratio of $202,991 compared with salvage chemotherapy. At a willingness-to-pay threshold of $100,000/QALY, tisagenlecleucel had a 0% likelihood of being cost-effective. CONCLUSIONS: At the current drug price, tisagenlecleucel was not found to be a cost-effective option. These results heavily depend on assumptions regarding long-term survival and the price of CAR T. Real-world evidence is needed to reduce uncertainty. HIGHLIGHTS: For patients with diffuse large B-cell lymphoma who failed 2 or more lines of systemic therapy, CAR T was not found to be a cost-effective treatment option at a willingness-to-pay threshold of $100,000.These results heavily depend on the expected long-term survival. The uncertainty in the model may be improved using real-world evidence reported in the future.

The change of healthcare service in Chinese patients with inflammatory bowel disease during the pandemic: a national multicenter cross-sectional study.

The pandemic of COVID-19 was a major public health events and had a deeply impact on the healthcare acquired by patients with inflammatory bowel disease (IBD). The purpose of this study was to evaluate the long-term impacts on healthcare service in Chinese IBD patients under the dynamic zero-COVID strategy. The study was performed in the Inflammatory Bowel Disease Quality of Care Centers in mainland China in 2021. The data about the healthcare was collected by a 44-item questionnaire. Totally 463 were from ulcerative colitis (UC) patients and 538 from Crohn's disease (CD) patients were included in the study. The pandemic impacted 37.5% patients on their treatment, and the biggest problem was unable to follow up timely (77.9%). There was a significant increase in healthcare costs in CD (P < 0.001) and no significant change in UC (P = 0.14) after the outbreak. Both UC and CD had an increase in the frequency of outpatient visits (UC 5.07 vs. 4.54, P = 0.001; CD 6.30 vs. 5.76, P = 0.002), and hospitalizations (UC 1.30 vs. 1.02, P < 0.001; CD 3.55 vs. 2.78, P < 0.001). The hospitalization rate in UC reduced slightly (40.2% vs. 42.8%, P = 0.423) after the outbreak, but it significantly increased in CD (75.8% vs. 67.8%, P = 0.004). The rate of biologics had significant increased (UC 11.2% vs. 17.7%, P = 0.005; CD 53.2% vs. 71.0%, P < 0.001). Besides, the proportion of people using telemedicine also increased from 41.6% to 55.1% (P < 0.001). However, 82.8% patients still preferred face-to-face visits. Recurrent outbreaks and the regular pandemic prevention and control policy had a long-term impact on medical care service for IBD patients. The preferred mode of healthcare was still face-to-face visit. It will be a long way to go in the construction of telemedicine in China.

Deep Learning-Assisted Gait Parameter Assessment for Neurodegenerative Diseases: Model Development and Validation.

BACKGROUND: Neurodegenerative diseases (NDDs) are prevalent among older adults worldwide. Early diagnosis of NDD is challenging yet crucial. Gait status has been identified as an indicator of early-stage NDD changes and can play a significant role in diagnosis, treatment, and rehabilitation. Historically, gait assessment has relied on intricate but imprecise scales by trained professionals or required patients to wear additional equipment, causing discomfort. Advancements in artificial intelligence may completely transform this and offer a novel approach to gait evaluation. OBJECTIVE: This study aimed to use cutting-edge machine learning techniques to offer patients a noninvasive, entirely contactless gait assessment and provide health care professionals with precise gait assessment results covering all common gait-related parameters to assist in diagnosis and rehabilitation planning. METHODS: Data collection involved motion data from 41 different participants aged 25 to 85 (mean 57.51, SD 12.93) years captured in motion sequences using the Azure Kinect (Microsoft Corp; a 3D camera with a 30-Hz sampling frequency). Support vector machine (SVM) and bidirectional long short-term memory (Bi-LSTM) classifiers trained using spatiotemporal features extracted from raw data were used to identify gait types in each walking frame. Gait semantics could then be obtained from the frame labels, and all the gait parameters could be calculated accordingly. For optimal generalization performance of the model, the classifiers were trained using a 10-fold cross-validation strategy. The proposed algorithm was also compared with the previous best heuristic method. Qualitative and quantitative feedback from medical staff and patients in actual medical scenarios was extensively collected for usability analysis. RESULTS: The evaluations comprised 3 aspects. Regarding the classification results from the 2 classifiers, Bi-LSTM achieved an average precision, recall, and F1-score of 90.54%, 90.41%, and 90.38%, respectively, whereas these metrics were 86.99%, 86.62%, and 86.67%, respectively, for SVM. Moreover, the Bi-LSTM-based method attained 93.2% accuracy in gait segmentation evaluation (tolerance set to 2), whereas that of the SVM-based method achieved only 77.5% accuracy. For the final gait parameter calculation result, the average error rate of the heuristic method, SVM, and Bi-LSTM was 20.91% (SD 24.69%), 5.85% (SD 5.45%), and 3.17% (SD 2.75%), respectively. CONCLUSIONS: This study demonstrated that the Bi-LSTM-based approach can effectively support accurate gait parameter assessment, assisting medical professionals in making early diagnoses and reasonable rehabilitation plans for patients with NDD.

An Efficient Multi-Dimensional Resource Allocation Mechanism for Beam-Hopping in LEO Satellite Network.

Low Earth Orbit (LEO) satellite communication networks have become an important means to provide internet access services for areas with limited infrastructure. Compared with the Geostationary Earth Orbit (GEO) satellites, the LEO satellites have limited on-board communication caching and calculating resources. Furthermore, the distribution of traffic requests is dynamically changing and uneven due to the relative movement between the LEO satellites and the ground. Therefore, how to schedule the multi-dimensional resources is an important issue for the LEO satellite communication networks. Beam-hopping is an efficient approach to improve the resource utilization by dynamically allocating time, power, and frequency according to the traffic requests. This paper proposes an efficient multi-dimensional resource allocation mechanism for beam-hopping in LEO satellite networks, which simultaneously satisfies the GEO interference avoidance. First, we construct the beam-hopping model of LEO satellites, and formulate the resource optimization problem. Second, we provide the weighted greedy strategy to determine the illumination pattern. In order to reduce the search space, the cells are clustered to non-interference clusters. Then, an improved genetic algorithm is provided to jointly allocate the communication resources. Finally, we construct various simulations to evaluate our proposed mechanism. Compared with the random-BH, polling-BH and traditional genetic algorithm, our algorithm achieves better performance in terms of both system throughput, access success rate, average delay and fairness between cells. The performance improvement is more significant in scenarios where traffic demand is unevenly distributed.

Design of Digital and Intelligent Financial Decision Support System Based on Artificial Intelligence.

The quality of financial decision-making is very important to the future development of an enterprise, but it is often affected by the completeness of useful information for decision-making and the subjective factors of decision makers, and is often unstable. With the development of computer technology, the financial decision support system came into being, which improved the quality of financial decision to some extent. However, although the existing financial decision support system has achieved dataization to a certain extent, it still faces problems such as artificial leadership, insufficient intelligence, and poor decision-making efficiency, and cannot fully meet the needs of decision-makers. The explosion of artificial intelligence technology in recent years has provided potential improvements to financial decision support systems. In this article, we conduct a detailed analysis of the deficiencies in the current financial decision support system, build the mechanism and implementation path of the financial decision support system under artificial intelligence, and design a digital and intelligent financial decision support system. At the same time, we apply the proposed financial decision support system to the financial practice of X enterprise. Through the questionnaire survey, it is found that through the comprehensive application of artificial intelligence technology, the new system has a higher degree of intelligence than the existing system, and its construction can effectively improve the timeliness and accuracy of financial decision-making, while reducing the cost of financial decision-making. It is conducive to promoting the integration of management accounting and financial accounting.

Radiopharmaceutical imaging based on 3D-CZT Compton camera with 3D-printed mouse phantom.

PURPOSE: The study proposes the use of three-dimensional CdZnTe Compton camera (3D-CZT CC) for radiopharmaceutical imaging and investigates the influence factors using a 3D-printed mouse phantom. METHODS: The event selection method and image reconstruction algorithm are optimized by Monte Carlo simulations and mouse phantom experiments. RESULTS: Simulation results show that the intrinsic energy resolution and spatial resolution of 3D-CZT cause a certain deviation in the calculated Compton scattering angle and Compton axis. Such deviation causes the imaging quality to deteriorate. By selecting events whose distance between Compton and photoelectronic interactions are larger than 10 mm, the mean deviation of the Compton axis could be reduced to less than 10%. Using the ordered origin ensemble algorithm with resolution recovery, the artifacts around organs where the radiopharmaceutical was placed are reduced, and the quality of the reconstruction results are improved compared to the results with simple back projection and origin ensembles algorithms. The phantom study shows that the 3D-CZT CC imaging device could visualize the radiopharmaceuticals distribution by 15 min detection. CONCLUSIONS: Through the analysis of this study, the feasibility of 3D-CZT CC for in-vivo distribution measurement of radiopharmaceuticals is demonstrated, and the quality of reconstruction result has been improved.

Cost-effectiveness analysis of hepatitis C virus (HCV) point-of-care assay for HCV screening.

BACKGROUND & AIMS: Hepatitis C virus (HCV) continues to pose significant public health concerns with approximately 44% of chronically infected Canadians undiagnosed. The current HCV screening in Canada is a two-step diagnosis pathway consisting of anti-HCV testing and HCV ribonucleic acid (RNA) testing. The introduction of HCV point-of-care assays, such as the Xpert HCV viral load finger-stick assay, can facilitate HCV RNA diagnosis during a single visit and provide quick linkage to care. We evaluated the cost-effectiveness of HCV point-of-care testing compared with current HCV screening strategies for injection drug users (IDUs) from a Canadian provincial Ministry of Health perspective. METHODS: A state-transition model based on published literature was developed to compare HCV point-of-care assay with the standard-of-care blood screening for a one-time HCV screening and treatment program. It adopted a lifetime time horizon and included health states related to treatment, fibrosis stages, and advanced liver disease clinical states. Outcomes were expressed in costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. Sensitivity analyses were conducted to assess the robustness of the model. RESULTS: HCV point-of-care assay generated an additional 0.035 QALYs/person at a cost reduction of $21.15 compared with the standard-of-care screening. The results were the most sensitive to the specificity of HCV point-of-care assay. CONCLUSIONS: The implementation of HCV point-of-care screening in Canada is likely to be cost-saving for IDUs. Early detection and treatment of undiagnosed individuals can prolong people's life span and save healthcare costs associated with HCV-related complications.

Proton range monitoring based on picosecond detection using a Cherenkov radiation detector: A Monte Carlo study.

In this study, we analyzed the performance of a PbF2 crystal-based detector at proton range monitoring with Monte Carlo simulations. The correlations between the depth-dose and Cherenkov profiles showed that the changes in the peak position in the Cherenkov profiles corresponded to the changes in the corresponding depth-dose profiles. Moreover, the deviations between the changes in the peak positions in the two curves were generally less than 2 mm. The results also showed that the actual proton range could be obtained using flight time information. When the proton energy was 160 MeV, the peak position detected in the Cherenkov profile detected was 14.83 cm with a flight time of 5.3-5.4 ns (starting from the time when protons were emitted), and the actual proton range in polymethyl-methacrylate was 15 cm. Therefore, the accuracy of the proton range measurements could be improved and the absolute range obtained by using the fast and time-sensitive characteristics of the proposed Cherenkov radiator.

Cost-effectiveness of Anbainuo plus methotrexate compared to conventional disease-modifying antirheumatic drugs for rheumatoid arthritis patients in China.

BACKGROUND: This study aimed to evaluate the cost-effectiveness of Anbainuo (ABN) plus methotrexate (MTX) vs. conventional disease-modifying antirheumatic drugs (cDMARDs) in Chinese rheumatoid arthritis (RA) patients. METHODS: A total of 90 RA patients who underwent ABN + MTX [assigned as ABN + MTX group (n=47)] or cDMARDs [assigned as control group (n=43)] treatment were analyzed. Disease activity was assessed at baseline (M0), 3rd month (M3), 6th month (M6), and 12th month (M12) after treatment. Drug, other medical, indirect, and total costs were calculated. Then, pharmacoeconomic analyses were performed with the threshold of cost-effectiveness set as 3 times of the mean gross domestic product (GDP) per capita in China during the study period. RESULTS: Treatment response rate was similar between the 2 groups, while disease remission and low disease activity (LDA) rates were increased in the ABN + MTX group compared to control group. Drug cost, other medical costs, and total cost were higher in the ABN + MTX group than control group, while indirect cost was similar between the 2 groups. Meanwhile, the quality-adjusted life-years (QALY) in ABN + MTX group and control group were 0.72 and 0.48 years, respectively. The incremental cost-effectiveness ratios (ICER) of ABN + MTX group compared to control group among the entire participant cohort, moderate-disease-activity participants, and severe-disease-activity participants were ¥135,486.7, ¥146,450.4, and ¥124,987.2/QALY, respectively, which were all below the cost-effectiveness threshold. Further sensitivity analyses revealed that the cost-effectiveness of ABN + MTX vs. cDMARDs was relatively robust, while among all the indexes, ABN price and Health Assessment Questionnaire Disability Index (HAQ-DI) score change for the ABN + MTX group affected ICER most. CONCLUSIONS: Treatment with ABN + MTX offers acceptable cost-effectiveness compared to cDMARDs treatment in Chinese RA patients.

Effect of spatial distribution of boron and oxygen concentration on DNA damage induced from boron neutron capture therapy using Monte Carlo simulations.

PURPOSE: This paper aims to investigate how the spatial distribution of boron in cells and oxygen concentration affect the DNA damage induced by charged particles in boron neutron capture therapy (BNCT) by Monte Carlo simulations, and further to evaluate the relative biological effectiveness (RBE) of DNA double-strand breaks (DSBs) induction. MATERIALS AND METHODS: The kinetic energy spectra of α, 7Li particles in BNCT arriving at the nucleus surface were obtained from GEANT4 (Geant4 10.05.p01). The DNA damage caused by BNCT was then evaluated using MCDS (MCDS 3.10A). RESULTS: When α or 7Li particles were distributed in the cytomembrane or cytoplasm, the difference in DNA damage of the same types was less than 0.5%. Taking the 137Cs photons as the reference radiation, when the oxygen concentration varied from 0% to 50%, the RBE of 0.54MeV protons and recoil protons varied from 5 to 2, whereas it decreased from 10 to 3 for α or 7Li particles. CONCLUSION: The RBE of DSB induction all charged particles in BNCT decreased with the increase of oxygen concentration. This work indicated that the RBE of different radiation particles of BNCT might be affected by many factors, which should be paid attention to in theoretical research or clinical application.

Clinical features related to hospital expenses for non-cystic fibrosis bronchiectasis in China.

OBJECTIVE: Bronchiectasis is a common chronic airway disease. We investigated the economic burden and associated factors of bronchiectasis in China. METHODS: In this multicenter retrospective cohort study, we reviewed medical records of patients admitted to 18 tertiary hospitals during 2010 to 2014 with a bronchiectasis-related diagnosis. RESULTS: A total 5469 patients with bronchiectasis were admitted, accounting for 3.13% ± 1.80% of all discharged patients with any diagnosis during the same period; 13 patients died upon discharge. The median hospitalization cost was RMB 8421.52 (RMB 5849.88-12,294.47). Risk factors associated with hospitalization costs included age at admission (>70 vs. <40 years, odds ratio (OR) = 1.221, 95% confidence interval (CI) = 1.082-1.379; >80 vs. <40 years, OR = 1.251, 95% CI = 1.089-1.438), smoking (≤15 packs/year vs. non-smokers, OR = 1.125, 95% CI = 1.006-1.271; >15 packs/year vs. non-smokers, OR = 1.127, 95% CI = 1.062-1.228), length of hospitalization (OR = 1.05, 95% CI = 1.046-1.054), combination antibiotic treatment (OR = 1.089, 95% CI = 1.033-1.148), cough (OR = 0.851, 95% CI = 0.751-0.965), dyspnea (OR = 0.93, 95% CI = 0.878-0.984), chronic obstructive pulmonary disease (OR = 0.935, 95% CI = 0.878-0.996), respiratory failure (OR = 0.923, 95% CI = 0.862-0.989), cor pulmonale (OR = 0.919, 95% CI = 0.859-0.982), and death (OR = 1.816, 95% CI = 1.113-2.838). CONCLUSIONS: Age, smoking status, symptoms, and respiratory comorbidities were associated with hospitalization costs of bronchiectasis.

Static resource allocation of advanced reservation requests in elastic optical networks.

Considering the flexibility characteristic of advanced reservation (AR) requests, the problem of static routing, modulation, spectrum, and time assignment (RMSTA) of AR requests in elastic optical networks is studied in this paper, in order to deploy the spectrum resource economically and enable more requests to be served. The multi-objective integer linear program (ILP) model, which can minimize the maximum utilized frequency and time slot indices as well as find a trade-off between them, is used to formulate the RMSTA problem. Then the proportion optimal RMSTA (PO-RMSTA) heuristic algorithm with three sorting strategies is proposed to get the sub-optimal solutions. The PO-RMSTA algorithm and sorting strategies, ascending order of elastic time (AET), descending order of data volume (DDV), and ascending order of alternative schemes (AAS), are simulated in our work and proved to obtain the approximate optimal solutions. The sorting policy AET achieved the best performance when minimizing the maximum utilized frequency slot index, whereas the sorting policy DDV worked best when minimizing the maximum utilized time slot index. As for the compromise between two indices, both AET and AAS provided satisfying results.

Cost-Effectiveness of Tenofovir Alafenamide for Treatment of Chronic Hepatitis B in Canada.

BACKGROUND/AIM: Tenofovir alafenamide (TAF) has been approved for treating chronic hepatitis B (CHB) due to a proposed better safety profile in comparison with current therapies. We evaluated the cost effectiveness of TAF and other available treatment options for hepatitis B envelope antigen (HBeAg)-positive and HBeAg-negative CHB patients from a Canadian provincial Ministry of Health perspective. METHODS: A state-transition model based on the published literature was developed to compare treatment strategies involving entecavir (ETV), tenofovir disoproxil fumarate (TDF), and TAF. It adopted a lifetime time horizon. Outcomes measured were predicted number of liver-related deaths, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS: For HBeAg-positive patients, TAF followed by ETV generated an additional 0.16 QALYs/person at an additional cost of Can$14,836.18 with an ICER of Can$94,142.71/QALY compared with TDF followed by ETV. Of the iterations, 28.7% showed that it is the optimal strategy with a Can$50,000 willingness-to-pay threshold. For HBeAg-negative patients, ETV followed by TAF would prevent an additional 13 liver-related deaths per 1000 CHB patients compared with TDF, followed by ETV. It generated an additional 0.13 QALYs/person at an additional cost of Can$59,776.53 with an ICER of Can$461,162.21/QALY compared with TDF, followed by ETV. TAF-containing strategies are unlikely to be a rational choice in either case. The results were sensitive to the HBeAg seroconversion rates and viral suppression rates of the treatments. CONCLUSIONS: Our analysis suggests that TAF is not cost effective at its current cost. A 33.4% reduction in price would be required to make it cost effective for HBeAg-positive patients with a Can$50,000 willingness-to-pay threshold.

A novel etanercept biosimilar Anbainuo plus methotrexate exhibits increased cost-effectiveness compared to conventional disease-modifying anti-rheumatic drugs in treating rheumatoid arthritis patients.

The aim of this study was to evaluate the cost-effectiveness of Anbainuo (ABN) plus methotrexate (MTX) (ABN + MTX) versus conventional disease-modifying anti-rheumatic drugs (cDMARDs) in rheumatoid arthritis (RA) patients.Forty-eight moderate to severe RA patients underwent ABN + MTX or cDMARDs treatment were consecutively enrolled and assigned to ABN + MTX group (n = 26) and control group (n = 22). Patients were followed up and their disease activity and quality of life (QoL) were evaluated at 3rd month, 6th month and 12th month after initiation of treatment. Treatment costs of 2 groups were calculated, then pharmacoeconomic analysis was performed.ABN + MTX increased drug cost and total cost while decreased indirect cost compared with cDMARDs after 12-month treatment. ABN + MTX group gained additional 0.22 quality-adjusted life years (QALY) and yielded an incremental cost-effectiveness ratio (ICER) of ¥104,293.6 per QALY after treatment. Sensitivity analysis reveals that rising ABN price by 20% produced an ICER of ¥130,403.6 per QALY, which was still lower than 3 times of the mean gross domestic product (GDP) per capita during the same period in China (¥165,960). Besides, ABN + MTX was more cost-effective in severe RA patients compared to moderate RA patients.ABN + MTX is cost-effective in treating moderate to severe RA patients compared with cDMARDs, although the total cost of ABN + MTX is relatively higher.

Diagnostic accuracy of intracoronary optical coherence tomography-derived fractional flow reserve for assessment of coronary stenosis severity.

AIMS: A novel method for computation of fractional flow reserve (FFR) from optical coherence tomography (OCT) was developed recently. This study aimed to evaluate the diagnostic accuracy of a new OCT-based FFR (OFR) computational approach, using wire-based FFR as the reference standard. METHODS AND RESULTS: Patients who underwent both OCT and FFR prior to intervention were analysed. The lumen of the interrogated vessel and the ostia of the side branches were automatically delineated and used to compute OFR. Bifurcation fractal laws were applied to correct the change in reference lumen size due to the step-down phenomenon. OFR was compared with FFR, both using a cut-off value of 0.80 to define ischaemia. Computational analysis was performed in 125 vessels from 118 patients. Average FFR was 0.80±0.09. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value for OFR to identify FFR ≤0.80 was 90% (95% CI: 84-95), 87% (95% CI: 77-94), 92% (95% CI: 82-97), 92% (95% CI: 82-97), and 88% (95% CI: 77-95), respectively. The AUC was higher for OFR than minimal lumen area (0.93 [95% CI: 0.87-0.97] versus 0.80 [95% CI: 0.72-0.86], p=0.002). Average OFR analysis time was 55±23 seconds for each OCT pullback. Intra- and inter-observer variability in OFR analysis was 0.00±0.02 and 0.00±0.03, respectively. CONCLUSIONS: OFR is a novel and fast method allowing assessment of flow-limiting coronary stenosis without pressure wire and induced hyperaemia. The good diagnostic accuracy and low observer variability bear the potential of improved integration of intracoronary imaging and physiological assessment.

Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis.

BACKGROUND: Quantitative flow ratio (QFR) is a novel angiography-based method for deriving fractional flow reserve (FFR) without pressure wire or induction of hyperemia. The accuracy of QFR when assessed online in the catheterization laboratory has not been adequately examined to date. OBJECTIVES: The goal of this study was to assess the diagnostic performance of QFR for the diagnosis of hemodynamically significant coronary stenosis defined by FFR ≤0.80. METHODS: This prospective, multicenter trial enrolled patients who had at least 1 lesion with a diameter stenosis of 30% to 90% and a reference diameter ≥2 mm according to visual estimation. QFR, quantitative coronary angiography (QCA), and wire-based FFR were assessed online in blinded fashion during coronary angiography and re-analyzed offline at an independent core laboratory. The primary endpoint was that QFR would improve the diagnostic accuracy of coronary angiography such that the lower boundary of the 2-sided 95% confidence interval (CI) of this estimate exceeded 75%. RESULTS: Between June and July 2017, a total of 308 patients were consecutively enrolled at 5 centers. Online QFR and FFR results were both obtained in 328 of 332 interrogated vessels. Patient- and vessel-level diagnostic accuracy of QFR was 92.4% (95% CI: 88.9% to 95.1%) and 92.7% (95% CI: 89.3% to 95.3%), respectively, both of which were significantly higher than the pre-specified target value (p < 0.001). Sensitivity and specificity in identifying hemodynamically significant stenosis were significantly higher for QFR than for QCA (sensitivity: 94.6% vs. 62.5%; difference: 32.0% [p < 0.001]; specificity: 91.7% vs. 58.1%; difference: 36.1% [p < 0.001]). Positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio for QFR were 85.5%, 97.1%, 11.4, and 0.06. Offline analysis also revealed that vessel-level QFR had a high diagnostic accuracy of 93.3% (95% CI: 90.0% to 95.7%). CONCLUSIONS: The study met its prespecified primary performance goal for the level of diagnostic accuracy of QFR in identifying hemodynamically significant coronary stenosis. (The FAVOR [Functional Diagnostic Accuracy of Quantitative Flow Ratio in Online Assessment of Coronary Stenosis] II China study]; NCT03191708).

Prevalence of Developmental Dysplasia of the Hip in Chinese Adults: A Cross-sectional Survey.

BACKGROUND: The prevalence of developmental dysplasia of the hip (DDH) is unknown in China. We aimed to determine the prevalence of DDH in Chinese adults. METHODS: In this study, we performed a cross-sectional survey of a nationally representative sample of Chinese adults. All participants underwent questionnaire investigation, physical examination, and X-ray examination. Factors associated with DDH were analyzed with logistic regression. RESULTS: We invited 29,180 individuals aged 18 years and over to participate, randomly selected from 18 primary sampling units (street districts in urban areas and townships in rural areas). The survey and examination were completed in 25,767 people (10,296 men and 15,471 women). DDH was diagnosed in 391 people, yielding an overall DDH prevalence of 1.52%. Based on this information, we estimate the number of individuals with DDH in China to be approximately 16.05 million. DDH prevalence increased with age (odds ratio = 1.53 [1.03-2.27], P = 0.036), was significantly higher among women than men (2.07% vs. 0.75%, P< 0.001), and was higher among rural residents than urban residents (1.75% vs. 1.29%, P< 0.001). Economic development was independently associated with the presence of DDH. There was no evidence of an association between body mass index alone, education, or current smoking or drinking and risk of DDH (P > 0.05). CONCLUSIONS: DDH has become an important public health problem. Special attention should be paid to residents with DDH. Screening for DDH should be performed in China.

Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial.

BACKGROUND: The drug-eluting balloon (DEB) is a promising tool to prevent restenosis after coronary angioplasty. However, data on the outcomes of DEB in de novo lesions are scarce. Vessel recoil and constrictive remodeling are the dominant causes of restenosis after angioplasty. The use of cutting balloons (CB) may effectively reduce elastic recoil after balloon dilation. In this study, we evaluate the efficacy and safety of DEB in treating de novo coronary artery lesions, using a predilation strategy with cutting balloon (CB) dilation before DEB angioplasty. METHODS/DESIGN: We present the design of a prospective, single-center, open-label, randomized, 2-arm clinical trial aiming to assess whether or not the strategy of CB dilation before DEB angioplasty reduces the primary end point of late lumen loss (LLL) compared with drug-eluting stent (DES) implantation alone for de novo coronary artery lesions. A total of 120 patients will be randomly enrolled into the DEB or DES group (1:1 ratio). The primary end point is insegment LLL at 12 months as measured by optical coherence tomography (OCT). Secondary end points include procedural success, such as angiographic success and device success, and clinical outcomes including all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. DISCUSSION: The study will evaluate the clinical efficacy, angiographic outcomes, and safety of DEB after CB dilation compared with DES for the treatment of de novo coronary artery lesions guided by OCT.

Real-world cost-effectiveness of infliximab for moderate-to-severe rheumatoid arthritis in a medium-sized city of China.

AIM: To assess the cost-effectiveness of infliximab-containing therapy (ICT) for moderate-to-severe rheumatoid arthritis (RA) in a medium-sized Chinese city. METHODS: A Chinese prospective cohort study comparing ICT (25 patients) versus conventional disease-modified antirheumatic drugs (24 patients) for RA was used to assess the cost-effectiveness of ICT. RESULTS: The cohort study observed significantly reduced disease activity score of 28 joints (coefficient -2.718, p < 0.001), improved EQ-5D (coefficient 0.453, p < 0.001) and increased medical costs (coefficient 1.289, p < 0.001) associated with ICT. The incremental cost-effectiveness ratio per gained quality-adjusted life year for ICT versus disease-modified antirheumatic drugs was 1.897-times of the local gross domestic product per capita. CONCLUSION: Infliximab was a favorable cost-effective alternative option for moderate-to-severe RA in a medium-sized city of China.

Assessment of characteristics of neointimal hyperplasia after drug-eluting stent implantation in patients with diabetes mellitus: an optical coherence tomography analysis.

OBJECTIVE: This study aims to assess the characteristics of neointimal hyperplasia after drug-eluting stent (DES) implantation in patients with diabetes mellitus (DM) by optical coherence tomography (OCT). METHODS: OCT was performed in 109 patients (45 with DM and 64 without DM) 1 year after DES implantation. Neointimal coverage and thickness on the luminal side were measured. The characteristics of neointimal hyperplasia were classified into three patterns, namely, high signal pattern, low signal pattern and layered signal pattern, according to the neointimal signal intensity. The development of in-stent neoatherosclerosis was also examined. In the DM group, glycated hemoglobin (HbA1c) levels were analyzed in order to assess their contribution to neointimal characteristics. RESULTS: OCT results indicated that neointimal thickness was thicker in the DM group than in the non-DM group (177.19 ± 165.36 vs. 166.76 ± 132.38 µm, p < 0.001). Lower incidence of high signal pattern (58.33 vs. 75.34%, p = 0.037) and higher incidence of in-stent neoatherosclerosis (18.33 vs. 5.48%, p = 0.027) were observed in the DM group. In the DM subgroup with HbA1c >7%, significantly higher incidence of low signal pattern (37.50 vs. 21.43%, p = 0.001) and layered signal pattern (18.75 vs. 3.57%, p = 0.001) and lower incidence of high signal pattern were observed (43.75 vs. 75.0%, p < 0.001). In-stent neoatherosclerosis was also frequently detected in the high HbA1c group compared with the low HbA1c group (28.13 vs. 7.14%, p = 0.048). CONCLUSION: Neointimal characteristics differed between DM and non-DM patients. HbA1c levels in DM patients contributed to the development of neointimal hyperplasia and in-stent neoatherosclerosis.