The association between proton-pump inhibitor use and recurrence of hepatocellular carcinoma after hepatectomy.

BACKGROUND AND AIM: The association between long-term proton-pump inhibitors (PPIs) use and malignancies had long been discussed, but it still lacks consensus. Our study investigated the association between PPI use and hepatocellular carcinoma (HCC) recurrence following curative surgery. METHODS: We retrospectively enrolled 6037 patients with HCC who underwent hepatectomy. Patients were divided into four groups according to their PPI usage. (non-users: < 28 cumulative defined daily dose [cDDD]; short-term users: 28-89 cDDD; mid-term users: 90-179 cDDD, and long-term users: ≥ 180 cDDD, respectively). Recurrence-free survival (RFS) and overall survival (OS) were analyzed using Kaplan-Meier method and Cox proportional hazard models. RESULTS: Among the 6037 HCC patients, 2043 (33.84%) were PPI users. PPI users demonstrated better median RFS (3.10 years, interquartile range [IQR] 1.49-5.01) compared with non-users (2.73 years, IQR 1.20-4.74; with an adjusted hazard ratio [aHR] of 0.57, 95% confidence interval [CI] 0.44-0.74, P < 0.001). When considering the cumulative dosage of PPI, only long-term PPI users had significant lower risk of HCC recurrence than non-PPI group (adj-HR: 0.50; 95% CI: 0.35-0.70; P < 0.001). Moreover, the impact of long-term PPIs use on improving RFS was significant in most of the subgroup analysis, except in patients with advanced tumor stages, with non-cirrhosis, or with a history of chronic kidney disease. However, there were no significant differences in median OS between PPI users and non-users (4.23 years, IQR 2.73-5.86 vs 4.04 years, IQR 2.51-5.82, P = 0.369). CONCLUSION: Long-term PPI use (≥ 180 cDDD) may be associated with a better RFS in HCC patients after hepatectomy.

Empagliflozin is associated with lower cardiovascular risk compared with dipeptidyl peptidase-4 inhibitors in adults with and without cardiovascular disease: EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study results from Europe and Asia.

BACKGROUND: Studies that have reported lower risk for cardiovascular outcomes in users of Sodium-Glucose Cotransporter-2 Inhibitors (SGLT-2i) are limited by residual cofounding and lack of information on prior cardiovascular disease (CVD). This study compared risk of cardiovascular events in patients within routine care settings in Europe and Asia with type 2 diabetes (T2D) initiating empagliflozin compared to dipeptidyl peptidase-4 inhibitors (DPP-4i) stratified by pre-existing CVD and history of heart failure (HF). METHODS AND RESULTS: Adults initiating empagliflozin and DPP-4i in 2014-2018/19 from 11 countries in Europe and Asia were compared using propensity score matching and Cox proportional hazards regression to assess differences in rates of primary outcomes: hospitalisation for heart failure (HHF), myocardial infarction (MI), stroke; and secondary outcomes: cardiovascular mortality (CVM), coronary revascularisation procedure, composite outcome including HHF or CVM, and 3-point major adverse cardiovascular events (MACE: MI, stroke and CVM). Country-specific results were meta-analysed and pooled hazard ratios (HR) with 95% confidence intervals (CI) from random-effects models are presented. In total, 85,244 empagliflozin/DPP4i PS-matched patient pairs were included with overall mean follow-up of 0.7 years. Among those with pre-existing CVD, lower risk was observed for HHF (HR 0.74; 95% CI 0.64-0.86), CVM (HR 0.55; 95% CI 0.38-0.80), HHF or CVM (HR 0.57; 95% CI 0.48-0.67) and stroke (HR 0.79; 95% CI 0.67-0.94) in patients initiating empagliflozin vs DPP-4i. Similar patterns were observed among patients without pre-existing CVD and those with and without pre-existing HF. CONCLUSION: These results from diverse patient populations in routine care settings across Europe and Asia demonstrate that initiation of empagliflozin compared to DPP-4i results in favourable cardioprotective effects regardless of pre-existing CVD or HF status.

Risk of placenta accreta spectrum following myomectomy: a nationwide cohort study.

BACKGROUND: Whether myomectomy increases the risk of placenta accreta spectrum in the following pregnancies remains controversial. OBJECTIVE: This study aimed to investigate the effect of myomectomy on the risk of placenta accreta spectrum in the following pregnancies. Moreover, different methods of myomectomy on the risk of placenta accreta spectrum were explored. STUDY DESIGN: A nationwide cohort study was conducted using data from the Taiwan National Health Insurance Research Database, including all pregnant patients in Taiwan who gave birth between January 2008 and December 2017. A 1:1 propensity score estimation matching was performed for the analysis of myomectomy on the risk of placenta accreta spectrum. Among pregnant patients who received myomectomy, different methods of myomectomy on the risk of placenta accreta spectrum were compared with the control group. RESULTS: Among the 1,371,458 pregnant patients in this study, 11,255 pregnant patients had a history of myomectomy. The risk of placenta accreta spectrum was higher in pregnant patients with a history of myomectomy than in pregnant patients without a history of myomectomy (incidence: 0.96% vs 0.20%; adjusted odds ratio, 2.28; 95% confidence interval, 1.85-2.81; P<.01). Among pregnant patients with a history of myomectomy, 5045 (46.87%) received laparotomic myomectomy, 3973 (36.93%) received laparoscopic myomectomy, and 1742 (16.20%) received hysteroscopic myomectomy. The incidence of placenta accreta spectrum was higher in the hysteroscopic group than in the laparotomic group or the laparoscopic group (1.89% [hysteroscopic group] vs 0.71% [laparotomic group] and 0.81% [laparoscopic group]; P<.05). Compared with patients without a history of myomectomy, the adjusted odds ratio for placenta accreta spectrum was 3.88 (95% confidence interval, 2.68-5.63; P<.05) in the hysteroscopic group. CONCLUSION: Myomectomy, especially hysteroscopic myomectomy, is associated with an increased risk of placenta accreta spectrum in the subsequent pregnancy.

Cost-Effectiveness of Endovascular Thrombectomy in M2 Occlusion Stroke: Real-World Experience Versus Clinical Trials.

OBJECTIVES: This study sought to establish the cost-effectiveness of endovascular thrombectomy (EVT) in M2 occlusions compared with patients who did not have EVT using both real-world and clinical trial evidence. METHODS: The effectiveness of EVT in M2 occlusions was informed by the International Stroke Perfusion Imaging Registry (INSPIRE, real-world data for a wide range of strokes) and HERMES collaboration, trial data. Patients who received EVT and non-EVT treatment from INSPIRE were matched according to baseline characteristics. A Markov model with 7 health states defined by the 3-month modified Rankin scale (mRS) was constructed. Endovascular thrombectomy and non-EVT-treated patients in real-world, and clinical trials were run through the Markov model separately to generate the results from a limited societal perspective. National statistics and published literature informed the long-term probability of recurrent stroke, mortality, costs of management post-stroke, non-medical care, and nursing home care. RESULTS: A total of 83 (42 EVT and 41 non-EVT) patients were matched of 278 (45 EVT and 233 non-EVT) patients in INSPIRE who had M2 occlusion stroke at presentation. The long-term simulation estimated that offering EVT to M2 occlusion stroke patients was associated with greater benefits (5.48 EVT vs 5.24 non-EVT quality-adjusted life year [QALY]) and higher costs (A$133 457 EVT vs A$126 127 non-EVT) compared with non-EVT treatment in real-world from a limited societal perspective. The incremental cost-effectiveness ratio (ICER) of EVT in real-world was A$29 981 (€19 488)/QALY. The analysis using the data from HERMES collaboration yielded consistent results for the EVT patients. Comparison with real-world cost-effectiveness analyses of EVT in internal carotid artery/middle cerebral artery-M1 (ICA/MCA-M1) occlusion suggested a potential reduced QALY gains and increased ICER in M2 occlusions. CONCLUSIONS: Our study suggested that the benefits gained from EVT in M2 occlusion stroke in the real-world were similar to that derived from the clinical trials. The clinical and cost benefits from EVT appeared to be reduced in M2 compared with that from the ICA/MCA-M1 occlusions. CLINICAL IMPACT: Our study has provided valuable insights into the clinical significance of endovascular therapy (EVT) in the context of M2 occlusion stroke within a real-world setting. It is noteworthy that our findings indicate that the benefits obtained from EVT in M2 occlusion stroke closely align with those observed in controlled clinical trials. However, it is essential to recognize that there is a reduction in the clinical and cost-related advantages when comparing M2 occlusions to more proximal ICA/MCA-M1 occlusions.

The economic and health burden of stroke among younger adults in Australia from a societal perspective.

BACKGROUND: To estimate the short term (5 years) and long term (30 years) economic burden of stroke among younger adults (18-64 years), and to calculate the loss of health-related quality of life in these individuals, in Australia. METHODS: A Markov microsimulation model was built to simulate incidence of stroke among younger adults in Australia. Younger adults with stroke commenced in the model via health states defined by the modified Rankin Scale at 12 months from the AVERT study (A Very Early Rehabilitation Trial), and transitioned through these health states. Costs in Australian dollars (AUD) were measured from a societal perspective for a 2018 reference year and categorised into medical, non-medical and indirect costs. Probabilistic sensitivity analyses were performed to test the robustness around the cost of illness estimates. The loss of health-related quality of life due to stroke among younger adults was calculated by determining the difference in estimated quality-adjusted life years (QALYs) between the stroke population and the general population. This was determined by multiplying the predicted remaining life years for the modelled stroke cohort and the age-matched general population, by their corresponding age-dependent utilities. RESULTS: The economic burden of stroke among younger adults was estimated to be AUD2.0 billion over 5 years, corresponding to a mean of $149,180 per stroke patient. Over 30 years, the economic impact was AUD3.4 billion, equating to a mean of $249,780 per case. Probabilistic sensitivity analyses revealed a mean cost per patient of $153,410 in the short term, and a mean cost per patient of $273,496 in the long term. Compared to the age-matched general population, younger adults with stroke experienced a loss of 4.58 life years and 9.21 QALYs. CONCLUSIONS: The results of our study suggests high economic and health burden of stroke among younger adults and highlights the need for preventive interventions targeting this age group. TRIAL REGISTRATION: ACTRN12606000185561 , retrospectively registered.

Postoperative Sore Throat Helps Predict Swallowing Disturbance on Postoperative Day 30 of Anterior Cervical Spine Surgery: A Secondary Exploratory Analysis of a Randomized Clinical Trial of Tracheal Intubation Modes.

Nasotracheal intubation benefits dysphonia recovery after anterior cervical spine surgery (ACSS). The aim of the present study was to investigate the effect of tracheal intubation modes on post-ACSS swallowing function and identify factors associated with deglutition on postoperative day 30 (POD 30). Adult patients were randomized to receive either nasotracheal or orotracheal intubation during surgery. A numerical rating scale (NRS) was used to assess postoperative sore throat, and the Bazaz grading system was used to assess the severity of swallowing disturbance. The primary endpoints were the effect of tracheal intubation modes on postoperative sore throat and deglutition. Thereafter, we further elucidated the predictors of swallowing disturbance on POD 30. Postoperative sore throat and swallowing disturbance did not differ between the nasotracheal and orotracheal intubation groups. A secondary dataset analysis revealed that among 108 patients with complete follow-up until POD 30, 71 (65.7%) presented complete recovery without swallowing disturbance, whereas 37 (34.3%) presented varying degrees of swallowing disturbance. Receiver operating characteristic curve analysis indicated that the NRS score for sore throat predicted a swallowing disturbance-free status on POD 30. The optimal cutoff values were ≤ 4 and ≤ 2 on PODs 1 and 2, respectively. The adjusted odds ratio (OR) for independent predictors was a sore throat NRS score of ≤ 4 on POD 1 (OR 3.2; 95% CI 1.29-7.89; P = 0.012) and score of ≤ 2 on POD 2 (OR 6.67; 95% CI 2.41-18.47; P < 0.001). Therefore, tracheal intubation mode did not affect the incidence of post-ACSS swallowing disturbance, and the severity of sore throat on PODs 1 and 2 could predict a swallowing disturbance-free status on POD 30.The trial was registered at clinicaltrials.gov (Trial No. NCT03240042, date of registration 10/17/2017).

Practice and outcomes of airway management in patients with cervical orthoses.

BACKGROUND/PURPOSE: Increasing evidence indicates an association of video laryngoscopy with the success rate of airway management in patients with neck immobilization. Nevertheless, clinical practice protocols for tracheal intubation in patients immobilized using various types of cervical orthoses and the outcomes remain unclear. METHODS: We retrospectively assessed the tracheal intubation techniques selected for patients immobilized using cervical orthoses from 2015 to 2018. The endpoints were the intubation outcomes of the different techniques and the factors associated with the selection of the technique. RESULTS: We included 218 patients, 118 of whom wore halo vest braces (halo vest group) and 100 wore cervical collars (collar group). GlideScope video laryngoscopy (GVL) and fiberoptic bronchoscopy (FOB) were the initial intubation methods in 98 and 120 patients, respectively. GVL had a higher first-attempt success rate than did FOB in the collar group (p = 0.002) but not in the halo vest group (p = 0.522). GVL was associated with a lower risk of episodes of SaO2< 90% (adjusted relative risk [aRR], 0.11; 95% CI, 0.02-0.67; p = 0.016) and shorter intubation time (aRR, -3.52; 95% CI, -4.79∼-2.25; p < 0.001) in the collar group. However, in the halo vest group, more frequent requirement of a rescue technique (p = 0.002) and necessity of patient awakening (p = 0.001) was noted when GVL was used. Use of the halo vest brace and noting of severe cord compression were independent predictors of the initial selection of FOB. CONCLUSION: Caution should be exercised when using GVL for tracheal intubation in patients immobilized using halo vest braces.

The incidence and characteristics of ventilator-associated pneumonia in a regional nontertiary Australian intensive care unit: A retrospective clinical audit study.

BACKGROUND: Ventilator-associated pneumonia (VAP) is a common complication of mechanical ventilation in the intensive care unit. The incidence, patient characteristics, and outcomes have not been described in a regional Australian setting. OBJECTIVES: Τhe primary objective was to establish the incidence of VAP in a regional intensive care unit using predetermined diagnostic criteria. The secondary objective was to compare the agreement between criteria-based and physician-based diagnostic processes. The tertiary objectives were to compare patient characteristics and clinical outcomes of cases with and without VAP. METHODS: A retrospective clinical audit was performed of adult patients admitted to Rockhampton Intensive Care Unit, Australia, between 2013 and 2016. We included all patients ventilated for ≥72 h and not diagnosed with a pneumonia before or during the first 72 h of ventilation. RESULTS: A total of 170 cases met the inclusion criteria. The incidence of VAP as per the criteria-based diagnosis was 27.3 cases per 1000 ventilator days (95% confidence interval [CI]: 18.4-36.2) and as per the physician-based diagnosis was 25.8 cases per 1000 ventilator days (95% CI: 17.1-34.4). There was a moderate chance-corrected agreement between the criteria- and physician-based diagnosis. Very obese cases (body mass index [BMI] ≥40) were nearly four times more likely to develop VAP than cases with normal BMI (BMI <30) (odds ratio: 3.664; 95% CI: 1.394-9.634; p = 0.008). After controlling for sex, BMI category, comorbidities, and Acute Physiology and Chronic Health Evaluation II scores, there was a trend (p = 0.283) for higher adjusted mortality rate for cases with VAP (10.1%, 95% CI: 4.8-21.5) than for those without VAP (6.1%, 95% CI: 3.0-12.4). Cases with VAP had a higher total hospital cost ($123,223 AUD vs $66,425 AUD, p < 0.001), than cases without VAP. CONCLUSIONS: This is the first study reporting incidence of VAP in an Australian regional intensive care unit setting. An increased length of stay and significantly higher hospital costs warrant research investigating reliable and valid clinical prediction rules to forecast those at risk of VAP.

Proton Pump Inhibitors and Risk of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B or C.

Researchers have hypothesized that the long-term use of proton pump inhibitors (PPIs) can increase the risk of developing cancer. However, the association between PPI use and hepatocellular carcinoma (HCC) risk is unclear. Using data from the Taiwan National Health Insurance Research Database for the period between 2003 and 2013, we identified 35,356 patients with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infections. One-to-one propensity score matching by gender, age, cohort entry year, comorbidity, and medication resulted in the inclusion of 7,492 pairs of patients (PPI users and non-PPI users) for analyses. We performed multivariate and stratified analysis using the Kaplan-Meier method and Cox proportional hazards models in order to estimate the association between PPI use and the risk of developing HCC. In the HBV cohort, 237 patients developed HCC during a median follow-up of 53 months. However, PPI use was not associated with an increased risk of developing HCC (adjusted hazard ratio [aHR], 1.25; 95% confidence interval [CI], 0.90-1.73; P = 0.18). In the HCV cohort, 211 patients developed HCC; but again, PPI use was not associated with an increase in the risk of developing HCC (aHR, 1.19; 95% CI, 0.88-1.61; P = 0.25). We observed no relationship between a dose-dependent effect of PPI use and HCC risk. Subgroup analysis also confirmed that PPI use was not correlated to an increased HCC risk. Conclusion: Based on a retrospective population-based cohort study throughout Taiwan, where the prescription of PPI is tightly regulated, PPI use is not associated with the risk of developing HCC among patients with chronic HBV or HCV infections.

Second victim: Malpractice disputes and quality of life among primary care physicians.

PURPOSE: The health of physicians can have a strong impact on the quality and safety of the health care they provide. Studies have shown a link between work stress, burnout, and depression. The aim of this study was to examine the association between malpractice dispute experiences and the well-being of physicians. METHODS: We conducted a cross-sectional survey to collect information about the malpractice experiences of primary care physicians in 2004. Data on sociodemographic and clinical characteristics and SF-36 measures were also collected. We used propensity score matching to estimate the association of medical malpractice experience with the general health, mental health, and vitality of physicians. RESULTS: Among the 1206 primary care physicians who completed the survey (response rate of 13.4%), 25.2% reported having ever experienced a malpractice dispute. After adjustment for baseline variables, physicians who had experienced a malpractice dispute had significantly worse health-related quality of life with regard to general health [-4.85; 95% confidence interval (CI), -7.61 to -1.80; P = 0.0016], mental health (-2.68; 95% CI, -5.03 to -0.34; P = 0.0252), and vitality (-3.28; 95% CI, -6.10 to -0.47; P = 0.0224). The effects were particularly strong among physicians specializing in surgery or obstetrics and gynecology. CONCLUSION: The results reveal that a malpractice dispute can have a long-term negative effect on the health of physicians. Harm reduction programs for physicians involved in malpractice disputes should be implemented.

Real-world cost-effectiveness of laparoscopy versus open colectomy for colon cancer: a nationwide population-based study.

BACKGROUND: Laparoscopic colectomy is increasingly being adopted for the treatment of colon cancer; however, the long-term effectiveness of this approach in a real-world clinical setting has yet to be verified. This study aims to compare the effectiveness and costs associated with laparoscopic and open colectomy from the perspective of the National Health Insurance (NHI) system in Taiwan. METHODS: A nationwide population-based colon cancer cohort was observed by linking the Taiwan Cancer Registry, claims data from NHI system, and the National Death Registry. Adult patients with Stage I to Stage III colon cancer who underwent primary cancer resection using either laparoscopy or open colectomy between 2009 and 2011 were included. A propensity score-matched cohort (1745 pairs) was applied to examine three clinical endpoints: overall survival, recurrence-free survival, and disease-free survival within 2 years after the operation. To comply with the perspective as well as the analytic horizon of the study, we limited the research to NHI claims from the study population for the corresponding time period. The health outcomes and net monetary benefits were verified by multivariate mixed-effect models. RESULTS: This analysis revealed that laparoscopy resulted in longer overall survival (adjusted difference 16.8 days, 95 % CI 7.3-26.2), recurrence-free survival (16.8 days, 5.0-28.6) and disease-free survival (26.4 days, 7.4-45.4), compared to open colectomy at 2 years post-op. Laparoscopy also led to a significantly shorter length of stay (3.2 days, 2.4-3.9) and lower index hospitalization costs (US$ 455, 181-729) than open colectomy; however, no differences in costs were observed over the long term. Overall, laparoscopy was more cost-effective than open colectomy under various willingness-to-pay thresholds in the setting of the Taiwan NHI. CONCLUSIONS: The continued adoption of laparoscopy in primary curable colon cancer resection is expected to reduce health care costs over the short term while providing considerable health benefits over the long term.

Comparing the effectiveness of capecitabine versus 5-fluorouracil/leucovorin therapy for elderly Taiwanese stage III colorectal cancer patients based on quality-of-life measures (QLQ-C30 and QLQ-CR38) and a new cost assessment tool.

BACKGROUND: Colorectal cancer (CRC) is a leading cause of cancer-related deaths in developed countries and its incidence increases with age. Intravenous administration of bolus 5-fluorouracil (5-FU) and leucovorin (LV) has been a standard treatment regime for stage III CRC. However, patients generally prefer oral therapy such as Capecitabine. Studies showed that combination of oxaliplatin and capecitabine demonstrated efficacy and safety on par with treatment involving various 5-FU/LV-based regimens in elderly patients as they are in younger ones. However, little is known regarding the cost of adjuvant therapy or the effect of therapy on HRQoL. Thus the aims of this study were to evaluate the influence of different adjuvant care for stage III CRC on the HRQoL of elderly patients and to compare the economic costs associated with capecitabine-based and 5-FU/LV-based adjuvant treatments from a societal perspective in Taiwan. METHODS: A prospective, open-label, observational, multicenter study involving 123 patients aged 70 and over from 11 different centers was conducted between July 2008 and July 2011 in Taiwan. The adjusted monthly costs per patient and HRQoL were evaluated from individual-level data. The HRQoL of patients was assessed before and after adjuvant treatment. Direct and indirect costs of adjuvant treatment were estimated from a number of sources, and QoL scores were compared between groups. RESULTS: After correcting for baseline characteristics of patients, no significant differences were observed in the global HRQoL scores between treatment groups during the study period. According to QLQ-CR38 results, capecitabine-based therapy appeared to alleviate problems related to defecation (4.54 vs. 8.5; P = 0.011); however, micturition problems increased (9.27 vs. 7.51; P = 0.04), compared with 5-FU/LV-based treatment. The adjusted monthly treatment cost per patient was NT$27,300 for capecitabine-based treatment and NT$53,671 for 5-FU/LV-based treatment. The total cost of 5-FU/LV-based treatment was 59 % greater than that of capecitabine-based treatment. CONCLUSIONS: Analyzing from the societal perspective in Taiwan, capecitabine-based therapy incurred lower treatment costs than 5-FU/LV-based therapy and did not jeopardize HRQoL. Therefore, capecitabine, with or without oxaliplatin, could be considered as an alternative treatment option for elderly patients with stage III CRC.

Health-related quality of life and cost comparison of adjuvant capecitabine versus 5-fluorouracil/leucovorin in stage III colorectal cancer patients.

PURPOSE: The purpose of this study was to compare health-related quality of life (HRQoL) and costs associated with 2 adjuvant chemotherapy regimens [capecitabine-based therapy versus 5-fluorouracil/leucovorin (5-FU/LV)-based therapy] in stage III colorectal cancer patients. METHODS: We conducted a prospective, open-label, observational, multicenter study from July 2008 to July 2011. The European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-CR38 questionnaires was used to assess HRQoL before, during, and after treatment. The direct and indirect costs of adjuvant treatment were estimated from a specially prepared questionnaire, the National Health Insurance Research Database, and other published sources. We used propensity scoring to match samples between groups and performed multivariate analyses to adjust for differences in patient demographics and clinical characteristics. RESULTS: A total of 497 patients were enrolled, and 356 completed the surveys. Following propensity score matching, 239 patients were included in the analysis (122 in the capecitabine-based group, 117 in the 5-FU/LV-based group). Global HRQoL scores did not differ significantly between the two groups. However, compared to patients in the 5-FU/LV-based group, patients in the capecitabine-based group had less nausea and vomiting (mid-term, P = 0.024; final, P = 0.013), appetite loss (mid-term, P < 0.0001; final, P = 0.001), and fewer side effects from chemotherapy (mid-term, P = 0.017). In addition, the monthly cost of capecitabine-based therapy was lower than those of 5-FU/LV-based therapy [NT$31,895.46 (US$1063.18) vs. NT$79,159.24 (US$2638.64) per patient]. CONCLUSIONS: Capecitabine is a reasonable alternative and cost-effective treatment option under current conditions for patients with stage III colorectal cancer.

Is a diabetes pay-for-performance program cost-effective under the National Health Insurance in Taiwan?

PURPOSE: In October 2001, a pay-for-performance (P4P) program for diabetes was implemented by the National Health Insurance (NHI), a single-payer program, in Taiwan. However, only limited information is available regarding the influence of this program on the patient's health-related quality of life. The aim of this study was to estimate the costs and consequences of enrolling patients in the P4P program from a single-payer perspective. METHODS: A retrospective observational study of 529 diabetic patients was conducted between 2004 and 2005. The data used in the study were obtained from the National Health Interview Survey (NHIS) in Taiwan. Direct cost data were obtained from NHI claims data, which were linked to respondents in the NHIS using scrambled individual identification. The generic SF36 health instrument was employed to measure the quality-of-life-related health status and transformed into a utility index. Patients enrolled in the P4P program for at least 3 months were categorized as the P4P group. Following propensity score matching, 260 patients were included in the study. Outcomes included life-years, quality-adjusted life-years (QALYs), diabetes-related medical costs, overall medical costs, and incremental cost-effectiveness ratios (ICERs). A single-payer perspective was assumed, and costs were expressed in US dollars. Nonparametric bootstrapping was conducted to estimate confidence intervals for cost-effectiveness ratios. RESULTS: Following matching, no significant difference was noted between two groups with regard to the patients' age, gender, education, family income, smoking status, BMI, or whether insulin was used. The P4P group had an increase of 0.08 (95 % CI 0.077-0.080) in QALYs, and the additional diabetes-related medical cost was US$422.74 (95 % CI US$413.58-US$435.05), yielding an ICER of US$5413.93 (95 % CI US$5226.83-US$5562.97) per QALY gained. CONCLUSIONS: Our results provides decision makers with valuable information regarding the impact of the P4P program of diabetes care through a direct comparison of equivalent groups of patients receiving regular care. Under the single-payer NHI system, the use of financial incentives under the DM-P4P program may be an effective means to ensure the quality of follow-up treatment.

Discrepancies Among Hospitals and Regions in the Provision of Low-Value Care.

BACKGROUND: Low-value care is a critical issue in terms of patient safety and fiscal policy; however, little has been known in Asia. For the purpose of better understanding the extent of low-value care on a national level, the utilization, costs and associated characteristics of selected international recommendations were assessed in this study. METHODS: This retrospective cohort study used the National Health Insurance claims data during 2013-2017 to evaluate the low-value care utilization. Adult beneficiaries who enrolled in the National Health Insurance program and received at least one of the low-value services in hospitals were included. We measured seven procedures derived from the international recommendations at the hospital level, and a composite measure was created by summing the total utilization of selected services to determine the overall prevalence and corresponding cost. The generalized estimating equation model was adopted to estimate the association. RESULTS: A total of 1,970,496 episodes of low-value care was identified among 1,218,146 beneficiary-year observations and 2,054 hospital-year observations. Overall, the utilization rate of the composite measure increased from 150.70 to 186.23 episodes per 10,000 beneficiaries with the growth in cost from US$5.40 to US$6.90 million. Low-value care utilization was proportional to the volume of outpatient visits and length of stay. Also, hospitals with a large volume of outpatient visits (aOR [95% CI], 2.10 [1.26 to 3.49] for Q2- Q3, 2.88 [1.45 to 5.75] for ≥Q3) and a higher proportion of older patients (aOR [95% CI], 1.06 [1.02 to 1.11]) were more likely to have high costs. CONCLUSION: The utilization and corresponding cost of low-value care appeared to increase annually despite the relatively lower prevalence compared to other countries. Multicomponent interventions such as recommendations, de-implementation policies and payment reforms are considered effective ways to reduce low-value care. Repeated measurements would be needed to evaluate the effectiveness of interventions.

Conventional and machine learning-based risk scores for patients with early-stage hepatocellular carcinoma.

BACKGROUND/AIMS: The performance of machine learning (ML) in predicting the outcomes of patients with hepatocellular carcinoma (HCC) remains uncertain. We aimed to develop risk scores using conventional methods and ML to categorize early-stage HCC patients into distinct prognostic groups. METHODS: The study retrospectively enrolled 1,411 consecutive treatment-naïve patients with the Barcelona Clinic Liver Cancer (BCLC) stage 0 to A HCC from 2012 to 2021. The patients were randomly divided into a training cohort (n=988) and validation cohort (n=423). Two risk scores (CATS-IF and CATS-INF) were developed to predict overall survival (OS) in the training cohort using the conventional methods (Cox proportional hazards model) and ML-based methods (LASSO Cox regression), respectively. They were then validated and compared in the validation cohort. RESULTS: In the training cohort, factors for the CATS-IF score were selected by the conventional method, including age, curative treatment, single large HCC, serum creatinine and alpha-fetoprotein levels, fibrosis-4 score, lymphocyte-tomonocyte ratio, and albumin-bilirubin grade. The CATS-INF score, determined by ML-based methods, included the above factors and two additional ones (aspartate aminotransferase and prognostic nutritional index). In the validation cohort, both CATS-IF score and CATS-INF score outperformed other modern prognostic scores in predicting OS, with the CATSINF score having the lowest Akaike information criterion value. A calibration plot exhibited good correlation between predicted and observed outcomes for both scores. CONCLUSION: Both the conventional Cox-based CATS-IF score and ML-based CATS-INF score effectively stratified patients with early-stage HCC into distinct prognostic groups, with the CATS-INF score showing slightly superior performance.

Prognostic Nutritional Index as a Prognostic Factor for Very Early-Stage Hepatocellular Carcinoma.

INTRODUCTION: Field factors play more important roles in predicting the outcomes of patients compared with tumor factors in early-stage hepatocellular carcinoma (HCC). However, the prognostic ability of noninvasive serum marker scores for hepatic fibrosis and liver functional reserve on very early-stage HCC is still not yet determined. We aimed to investigate the performance of these serum marker scores in predicting the prognoses of patients with very early-stage HCC. METHODS: A total of 446 patients with very early-stage HCC from 2012 to 2022 were retrospectively enrolled. Serum biomarkers and prognostic scores determining overall survival (OS) were analyzed by Cox proportional hazards model. We compared the Akaike information criterion among the prognostic nutritional index (PNI), aspartate aminotransferase-to-platelet ratio index, albumin-bilirubin (ALBI) score, EZ (easy)-ALBI score, modified ALBI score, fibrosis-4 score, and lymphocyte-to-monocyte ratio to determine the predictability on the OS. RESULTS: After a median follow-up of 41.0 months (interquartile range 36.9-45.1 months), 81 patients died, with a 5-year OS rate of 71.0%. Among the noninvasive serum marker scores, PNI had the best performance in predicting the OS with the lowest Akaike information criterion (846.407) compared with other scores. Moreover, we stratified the patients into high-risk (PNI <45) and low-risk (PNI ≥45) groups. It showed that the 5-year OS rates were 83.4% and 60.8% in the low-risk and high-risk PNI groups, respectively ( P < 0.001). DISCUSSION: PNI had the best performance in predicting the OS for patients with very early-stage HCC.

Entecavir versus tenofovir on prognosis of hepatitis B virus-related hepatocellular carcinoma after curative hepatectomy.

BACKGROUND: There is still controversy about whether tenofovir disoproxil fumarate (TDF) and entecavir (ETV) have different effects on the outcomes of patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). AIMS: The aim of this study was to compare the prognoses between ETV and TDF treatment among patients with HBV-related HCC after hepatectomy. METHODS: An analysis was done on data from the Taiwan Cancer Registry, which was linked to Taiwan National Health Insurance Research Database, for the years 2011-2016. We identified 7107 patients with HBV-related HCC after curative hepatectomy, and 25.3% of them used ETV or TDF after surgery. After propensity score overlap weighting, 1797 patients treated with ETV (n = 1365) or TDF (n = 432) were included for analyses. Cox proportional hazards models were used to compare the efficacy of ETV and TDF for recurrence and overall survival (OS). RESULTS: After hepatectomy, the recurrence rate per 100 person-years was 14.87 for the ETV group and 9.25 for the TDF group. The risk of recurrence was similar in the TDF group and the ETV group (HR [95% CI]: 0.91 [0.69-1.19; p = 0.479]), as was the risk of all-cause mortality (HR [95% CI]: 0.67 [0.42-1.07]; p = 0.091). When considering early recurrence (<2 years) and late recurrence (≧2 years), the TDF and ETV groups showed no significant differences. Subgroup analyses and sensitivity analyses demonstrated consistent results. CONCLUSION: Both TDF and ETV showed similar health benefits in terms of recurrence and OS in patients with HBV-related HCC patients after hepatectomy.