Using Big Data for Cardiovascular Health Surveillance: Insights From 10.3 Million Individuals in the CANHEART Cohort

BackgroundThe increasing availability of large electronic population-based databases offers unique opportunities to conduct cardiovascular health surveillance traditionally done using surveys. We aimed to examine cardiovascular risk-factor burden, preventive care, and disease incidence among adults in Ontario, Canada—using routinely collected data—and compare estimates with health survey data.MethodsIn the Cardiovascular Health in Ambulatory Care Research Team (CANHEART) initiative, multiple health administrative databases were linked to create a population-based cohort of 10.3 million adults without histories of cardiovascular disease. We examined cardiovascular risk-factor burden and screening and outcomes between 2016 and 2020. Risk- factor burden was also compared with cycles 3 to 5 (2012 to 2017) of the Canadian Health Measures Survey (CMHS), which included 9473 participants across Canada.ResultsMean age of our study cohort was 47.9 ± 17.0 years, and 52.0% were women. Lipid and diabetes assessment rates among individuals 40 to 79 years were 76.6% and 78.2%, respectively, and lowest among men 40 to 49 years of age. Total cholesterol levels and diabetes and hypertension rates among men and women 20 to 79 years were similar to Canadian Health Measures Survey (CHMS) findings (total cholesterol: 4.80/4.98 vs 4.94/5.25 mmol/L; diabetes: 8.2%/7.1% vs 8.1%/6.0%; hypertension: 21.4%/21.6% vs 23.9%/23.1%, respectively); however, patients in the CANHEART study had slightly higher mean glucose (men: 5.79 vs 5.44; women: 5.39 vs 5.09 mmol/L) and systolic blood pressures (men: 126.2 vs 118.3; women: 120.6 vs 115.7 mm Hg).ConclusionsCardiovascular health surveillance is possible through linkage of routinely collected electronic population-based datasets. However, further investigation is needed to understand differences between health administrative and survey measures cross-sectionally and over time.     

Prognosis Comparison Between Chronic Hepatitis B Patients Receiving a Finite Course of Tenofovir and Entecavir Treatment: A Nationwide Cohort Study in Taiwan

PurposeEntecavir (ETV) and tenofovir disoproxil fumarate (TDF) are both recommended as first-line treatments for patients with chronic hepatitis B virus (CHB) infection according to international HBV treatment guidelines. However, recent studies reported conflicting results regarding the preferred antiviral in the prevention of hepatocellular carcinoma (HCC). This cohort study aimed to investigate this issue by using Taiwan's National Health Insurance Research Database, wherein a “finite” but not life-long treatment policy was applied.MethodsFrom January 2008 to December 2013, a total of 12,388 consecutive adult patients with CHB who received a finite course of TDF treatment (n = 1250) or ETV treatment (n = 11,138) were analyzed through screening for study eligibility followed by the 1:4 propensity score matching method.FindingsIn the entire cohort, the annual incidence and survival between the ETV and TDF groups were not significantly different regarding HCC occurrence (2.05 vs 2.74 per 100 patient-years [PY]; P = 0.055; hazard ratio [HR], 0.975; log-rank, P = 0.966), cirrhosis-related complications (1.9 vs 2.4 per 100 PY; P = 0.149; HR, 0.869; log-rank, P = 0.388), or all-cause mortality (2.16 vs 1.6 per 100 PY; P = 0.119; HR, 0.831; log-rank, P = 0.342), respectively. Propensity score matching analyses yielded similar results regarding HCC occurrence, cirrhosis-related complications, and all-cause mortality. In addition, these findings were consistently reproduced in the subgroups of patients with chronic hepatitis and cirrhosis that developed before antiviral treatment.ImplicationsETV and TDF did not significantly differ in prevention of HCC occurrence or reduction of cirrhosis-related complications and all-cause mortality in patients with CHB receiving a finite period of treatment.     

An Artificial Gut/Absorption Simulator: Simultaneous Evaluation of Desupersaturation and Absorption from Ketoconazole Supersaturated Solutions

For supersaturating formulations of BCS-II compounds, which by definition have high intestinal permeability, a closed USP apparatus does not provide the necessary absorptive conditions during dissolution. To address this, an artificial gut simulator (AGS) has been constructed consisting of a 2.5 mL donor compartment in which a hollow fiber-based absorption module is suspended. Drug from donor diffuses across the hollow fiber membrane to be absorbed by the continuously flowing intraluminal receiver fluid. The membrane surface area and intraluminal fluid flow rate are tuned to obtain the physiologically observed absorption rate constant for a weakly basic, poorly water-soluble model compound, ketoconazole (KTZ). Supersaturated solutions of KTZ were generated in the donor in pH 6.5 phosphate buffer by the pH-shift method in the absence (closed system, control) and presence (open system, biorelevant) of an optimally or suboptimally tuned absorption module. Drug concentrations in the donor and intraluminal fluids were determined by in-line UV spectroscopy. The presence of an absorptive sink reduced the supersaturated solution's crystallization propensity, more so in the case of the optimally tuned AGS. This study demonstrates the significance of simulating absorption of drug at a physiological rate during dissolution studies, especially to predict the performance of formulations of BCS-II drugs.     

Hyperamylasemia grade versus drain fluid amylase: which better predicts pancreatectomy outcomes?

BackgroundThe clinical importance of postoperative hyperamylasemia (POHA) grade is unknown. Our objectives were to evaluate the association of POHA grade with clinically relevant postoperative pancreatic fistula (CR-POPF) and compare its prognostic utility against postoperative day 1 drain fluid amylase (DFA-1).MethodsPatients who underwent pancreatectomy from January 2019 through March 2020 were identified in the ACS NSQIP pancreatectomy-targeted dataset. POHA grade was assigned using post-operative serum amylase and clinical sequelae. The primary outcome was CR-POPF within 30 days. The association of POHA grade with CR-POPF was assessed using multivariable logistic regression, and c-statistics were used to compare POHA grade versus DFA-1.ResultsPOHA occurred in 520 patients at 98 hospitals, including 261 (50.2%) with grade A, 234 (45.0%) with grade B, and 25 (4.8%) with grade C POHA. CR-POPFs were increased among patients with grade B (66.2%, OR 9.28 [5.84–14.73]) and C (68.0%, OR 10.50 [3.77–29.26]) versus grade A POHA (19.2%). POHA-inclusive models better predicted CR-POPF than those with DFA-1 alone (p < 0.002) and models with both predictors outperformed POHA alone (p = 0.039).ConclusionPOHA grade represents a measure of post-pancreatectomy outcomes that predicts CR-POPF and outperforms DFA-1 but must be aligned with new international definitions.