Long-term outcomes and cost-effectiveness evaluation of robot-assisted stereotactic hematoma drainage for spontaneous intracerebral hemorrhage.

Background: To investigate the long-term follow-up and economic estimation outcomes of hematoma drainage for spontaneous intracerebral hemorrhage (SICH) with the assistance of neurosurgical navigation and positioning planning system (referred to as robot). Methods: Data were retrospectively obtained from consecutive patients with SICH who were admitted to our single-center between March 2019 and March 2022. Different minimally invasive surgery (MIS) procedures were performed according to the inclusion/exclusion criteria. The different groups were sampled and matched using the propensity score method, with age, sex, history of stroke, hypertension, bleeding volume and site of bleeding as matching variables, and matched with inverse probability weighting using R statistical analysis software. From the time of discharge up until 1 year after the surgery, records were gathered on clinical results and medical expenditures. An analysis was conducted to compare the costs and health outcomes of both robot-assisted stereotactic hematoma drainage and neuro-endoscopic surgery, considering both short-term and long-term effects. Health outputs were measured using modified Rankin scale (mRS) and quality adjusted life years (QALYs). Results: Of the 142 patients, there were 77 patients in the robotic surgery group and 65 patients in the neuro-endoscopic surgery group. Propensity score sampling was matched, resulting in a balanced and comparable group of 37 patients in each, with the robotic surgery group [mean age (57.29 ± 12.74) years, 27 males (72.97%), hematoma volume (44.54 ± 10.49 ml), 22 deep location (59.46%)] and the neuro-endoscopic surgery group [mean age (57.27 ± 11.12) years, 27 males (72.97%), hematoma volume (44.70 ± 10.86 ml), 23 deep location (62.16%)]. At both three-month and one-year postoperative follow-up, the proportion of mRS scores ≤3 was higher in the robotic surgery group (45.95%,70.27%) than in the neuro-endoscopic surgery group (35.14%, 62.16%), but there was no statistically significant difference (P = 0.344, 0.461). One year after surgery, the robotic group demonstrated cost savings of ¥36,862.14 per individual and a gain of 0.062 QALYs compared to the neuro-endoscopic group. Conclusion: Our calculations based on a model for SICH suggest that robotic-assisted stereotactic drainage offers health economic benefits due to its lower cost and higher effectiveness. However, to confirm these findings, more data from multicenter, prospective randomized controlled trials with larger sample sizes are needed.

The Cost-Effectiveness Analysis of Self-Efficacy-Focused Structured Education Program for Patients With Type 2 Diabetes Mellitus in Mainland China Setting.

Objective: To assess the long-term (50 years) cost-effectiveness of the self-efficacy-focused structured education program (SSEP) as opposed to routine education among patients with type 2 diabetes mellitus (T2DM) in mainland China from a healthcare service perspective. Methods: A cost-effectiveness analysis method was used. The IQVIA CORE Diabetes Model (version 9.0) was adopted to estimate the outcomes. The baseline cohort characteristics, variations of physiological parameters, costs of intervention and other treatments, and management-related diabetes were derived from a randomized controlled trial. Moreover, the complications costs and utilities were extracted from published sources. Furthermore, the univariate sensitivity analysis and the probabilistic sensitivity analysis were conducted. Results: As compared with the control group, the life expectancy and quality-adjusted life-year in the intervention group were increased. Besides, the intervention group achieved lower cumulative incidences of complications and saved more direct medical costs compared with the control group. The sensitivity analysis revealed that the SSEP had 100% probability to be cost-effective. Conclusion: The SSEP is recognized as a highly cost-effective option for managing patients with T2DM, which are projected to both improve clinical outcomes and reduce costs.

First line nucleos(t)ide analog monotherapy is more cost-effective than combination strategies in hepatitis B e antigen-positive chronic hepatitis B patients in China.

BACKGROUND: Nucleos(t)ide analog (NA) in combination with peginterferon (PegIFN) therapy in patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) shows better effectiveness than NA monotherapy in hepatitis B surface antigen loss, termed "functional cure," based on previous published studies. However, it is not known which strategy is more cost-effective on functional cure. The aim of this study was to analyze the cost-effectiveness of first-line monotherapies and combination strategies in HBeAg-positive CHB patients in China from a social perspective. METHODS: A Markov model was developed with functional cure and other five states including CHB, compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and death to assess the cost-effectiveness of seven representative treatment strategies. Entecavir (ETV) monotherapy and tenofovir disoproxil fumarate (TDF) monotherapy served as comparators, respectively. RESULTS: In the two base-case analysis, compared with ETV, ETV generated the highest costs with $44,210 and the highest quality-adjusted life-years (QALYs) with 16.78 years. Compared with TDF, treating CHB patients with ETV and NA - PegIFN strategies increased costs by $7639 and $6129, respectively, gaining incremental QALYs by 2.20 years and 1.66 years, respectively. The incremental cost-effectiveness ratios were $3472/QALY and $3692/QALY, respectively, which were less than one-time gross domestic product per capita. One-way sensitivity analysis and probabilistic sensitivity analyses showed the robustness of the results. CONCLUSION: Among seven treatment strategies, first-line NA monotherapy may be more cost-effective than combination strategies in HBeAg-positive CHB patients in China.

Economic Evaluation of Safflower Yellow Injection for the Treatment of Patients with Stable Angina Pectoris in China: A Cost-Effectiveness Analysis.

OBJECTIVE: The purpose of this study was to evaluate the cost-effectiveness of Safflower Yellow Injection (SYI) plus conventional treatment (SYI group) versus conventional treatment only (conventional group) for the treatment of stable angina pectoris (SAP) patients in China. METHODS: A decision-tree model was constructed and the treatment impact was estimated for up to 1 year. The data, including treatment effectiveness, episodes of angina pectoris (AP)-associated hospitalization and its in-hospital mortality, mortality rate of heart diseases, and cost of hospitalization, were obtained from literature. The costs of medications were calculated based on their average bidding prices in China. The authors also conducted a doctor survey to obtain cost associated with death of cardiovascular events. Sensitivity analysis was performed to evaluate the robustness of the results. RESULTS: SAP patients in the SYI group (n = 1000) gained incremental 66.01 quality-adjusted life years (QALYs) at a cost of $250,294 compared with patients receiving conventional treatment, yielding an incremental cost-effectiveness ratio of $3,791/QALY, which was less than Chinese GDP per capita and is considered to be highly cost effective per WHO-recommended economic evaluation guidelines. Sensitivity analysis indicated that the results were robust with variations for all major parameters of the model. CONCLUSION: SYI combined with conventional treatment is a highly cost-effective therapy option compared with the conventional treatment for treatment of SAP in China.

A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes: the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION-Europe) study.

BACKGROUND: Intensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain. OBJECTIVE: To quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes. DESIGN: Pragmatic, multicentre, cluster-randomised, parallel-group trial. SETTING: Three hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK. PARTICIPANTS: Individuals aged 40-69 years with screen-detected diabetes. INTERVENTIONS: Screening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol. MAIN OUTCOME MEASURES: The primary end point was a composite of first cardiovascular event (cardiovascular mortality/morbidity, revascularisation and non-traumatic amputation) during a mean [standard deviation (SD)] follow-up of 5.3 (1.6) years. Secondary end points were (1) all-cause mortality; (2) microvascular outcomes (kidney function, retinopathy and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective Diabetes Study outcomes model [version 1.3; (©) Isis Innovation Ltd 2010; see www.dtu.ox.ac.uk/outcomesmodel (accessed 27 January 2016)]. RESULTS: We included 3055 (RC, n = 1377; IT, n = 1678) of the 3057 recruited patients [mean (SD) age 60.3 (6.9) years] in intention-to-treat analyses. Prescription of glucose-lowering, antihypertensive and lipid-lowering medication increased in both groups, more so in the IT group than in the RC group. There were clinically important improvements in cardiovascular risk factors in both study groups. Modest but statistically significant differences between groups in reduction in glycated haemoglobin (HbA1c) levels, blood pressure and cholesterol favoured the IT group. The incidence of first cardiovascular event [IT 7.2%, 13.5 per 1000 person-years; RC 8.5%, 15.9 per 1000 person-years; hazard ratio 0.83, 95% confidence interval (CI) 0.65 to 1.05] and all-cause mortality (IT 6.2%, 11.6 per 1000 person-years; RC 6.7%, 12.5 per 1000 person-years; hazard ratio 0.91, 95% CI 0.69 to 1.21) did not differ between groups. At 5 years, albuminuria was present in 22.7% and 24.4% of participants in the IT and RC groups, respectively [odds ratio (OR) 0.87, 95% CI 0.72 to 1.07), retinopathy in 10.2% and 12.1%, respectively (OR 0.84, 95% CI 0.64 to 1.10), and neuropathy in 4.9% and 5.9% (OR 0.95, 95% CI 0.68 to 1.34), respectively. The estimated glomerular filtration rate increased between baseline and follow-up in both groups (IT 4.31 ml/minute; RC 6.44 ml/minute). Health status, well-being, diabetes-specific quality of life and treatment satisfaction did not differ between the groups. The intervention cost £981 per patient and was not cost-effective at costs ≥ £631 per patient. CONCLUSIONS: Compared with RC, IT was associated with modest increases in prescribed treatment, reduced levels of risk factors and non-significant reductions in cardiovascular events, microvascular complications and death over 5 years. IT did not adversely affect patient-reported outcomes. IT was not cost-effective but might be if delivered at a reduced cost. The lower than expected event rate, heterogeneity of intervention delivery between centres and improvements in general practice diabetes care limited the achievable differences in treatment between groups. Further follow-up to assess the legacy effects of early IT is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT00237549. FUNDING DETAILS: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 64. See the NIHR Journals Library website for further project information.

Performance of the UKPDS outcomes model for prediction of myocardial infarction and stroke in the ADDITION-Europe trial cohort.

OBJECTIVES: We assessed the performance of the UK Prospective Diabetes Study (UKPDS) outcomes model in predicting the risk of myocardial infarction (MI) and stroke in the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care (ADDITION-Europe) a trial cohort of patients with screen-detected type 2 diabetes from the United Kingdom, Denmark, and The Netherlands. METHODS: We estimated the 5-year accumulated risk of MI and stroke for 2899 screen-detected people with type 2 diabetes by using the UKPDS outcomes model (version 1.3). We compared the predicted and actual risks by country and by intervention group (routine care; intensive multifactorial treatment). We assessed discrimination and goodness of fit by using area under receiver operating characteristic curves and the Hosmer-Lemeshow chi-square test. Multiple imputations were used to overcome missing data. RESULTS: The UKPDS outcomes model overestimated the risk of MI and stroke. Mean predicted/actual ratios of 5-year accumulated risk were 2.31 for MI in the routine care group and 3.97 in the intensive multifactorial treatment group and 1.59 and 1.48 for stroke, respectively. The differences in absolute risk between the intervention groups were underestimated for MI (observed vs. predicted: 0.0127 vs. 0.0009) and slightly overestimated for stroke (-0.0013 vs. -0.0004). The area under the receiver operating characteristic curve was 0.72 (95% confidence interval 0.66-0.79) for MI and 0.70 (95% confidence interval 0.64-0.77) for stroke. The Hosmer-Lemeshow test statistic was nonsignificant in all groups. The model performed better in absolute risk prediction in Denmark and the United Kingdom than in The Netherlands. CONCLUSIONS: The UKPDS outcomes model has moderate discriminatory ability in the ADDITION-Europe trial cohort but overestimated absolute risk. The model may need updating for cardiovascular disease risk prediction in contemporary diabetes populations where patients may be diagnosed earlier in the disease trajectory and in whom cardiovascular risk is therefore lower.

[An economic evaluation of low dose recombinant human tissue-type plasminogen activator for the treatment of acute pulmonary thromboembolism].

OBJECTIVE: To compare and evaluate the cost and effectiveness between recombinant human tissue-type plasminogen activator (rt-PA) 50 mg and 100 mg regimen for the treatment acute pulmonary thromboembolism (PTE). METHODS: Based on a randomized clinical trial data, 118 cases were enrolled, 65 cases in group 50 mg and 53 cases in group 100 mg, which showed the similar efficacy and safety of rt-PA 50 mg and 100 mg. Progressive improvement in pulmonary artery obstructions was found to be similarly significant in both treatment groups, but there was no significant differences between the two groups (89.1% vs 89.6%, chi(2) = 0.007, P = 0.936). The rates of adverse events in two groups were same as well (17% vs 32%, chi(2) = 3.704, P = 0.054). We compared the cost directly and the cost-effective rate of the two groups. Based the cost saving of individual patient, prevalence rate of acute PTE, and co-pay rate of reimbursement, we calculated the cost saving of societal and payer's perspective. RESULTS: The cost of group 50 mg is 6352 RMB/person, and the cost of group 100 mg is 12,704 RMB/person. The cost-effect rates of the two groups were 7129 and 14,179 separately. With the same effect, each patient in 50 mg group can save 7050 RMB. If the PTE patients in China were treated with rt-PA 50 mg instead of 100 mg, the society cost saving would be 443,604,624 RMB. CONCLUSION: rt-PA 50 mg/2 h regimen, compared with 100 mg/2 h, can not only provide similar efficacy and safety, but also show a good health economic saving.

Cost-effectiveness of long-acting risperidone injection versus alternative atypical antipsychotic agents in patients with schizophrenia in China.

OBJECTIVES: To determine the most cost-effective strategy involving first-line treatment with long-acting risperidone, olanzapine, and quetiapine from the perspective of the Chinese health-care system. METHODS: A decision analytical model was applied. The model used a time horizon of 2 years. The probabilities of treatment response of different agents and the relapse and hospitalization rates were estimated by a Delphi panel of 17 senior psychiatrists in China. The unit cost for each medical service was calculated from the price system database built by China National Development and Reform Commission and the medical resource utilization was estimated by the Delphi panel. The principal efficacy measure was the proportion of patients successfully treated. Various sensitivity analyses were carried out to test the robustness of the model. RESULTS: The proportion of patients successfully treated over the 2-year period was 46.71% for long-acting risperidone, 39.93% for olanzapine, and 31.28% for quetiapine. The mean cost-effectiveness ratios were RMB189,427, RMB202,432, and RMB233,015 per successfully treated patient for long-acting risperidone, quetiapine and olanzapine, respectively. Results of the sensitivity analyses confirmed that the results were robust. CONCLUSIONS: The results showed that long-acting risperidone is more cost-effective than olanzapine and quetiapine for patients with schizophrenia in long-term maintenance treatment.