A Path to Real-World Evidence in Critical Care Using Open-Source Data Harmonization Tools.

COVID-19 highlighted the need for use of real-world data (RWD) in critical care as a near real-time resource for clinical, research, and policy efforts. Analysis of RWD is gaining momentum and can generate important evidence for policy makers and regulators. Extracting high quality RWD from electronic health records (EHRs) requires sophisticated infrastructure and dedicated resources. We sought to customize freely available public tools, supporting all phases of data harmonization, from data quality assessments to de-identification procedures, and generation of robust, data science ready RWD from EHRs. These data are made available to clinicians and researchers through CURE ID, a free platform which facilitates access to case reports of challenging clinical cases and repurposed treatments hosted by the National Center for Advancing Translational Sciences/National Institutes of Health in partnership with the Food and Drug Administration. This commentary describes the partnership, rationale, process, use case, impact in critical care, and future directions for this collaborative effort.

Hospitalization costs and clinical outcomes in CABG patients treated with intensive insulin therapy.

BACKGROUND: The financial impact of intensive (blood glucose [BG] 100-140mg/dl [5.5-7.8mM] vs. conservative (141-180mg/dl (7.9-10.0mM) glucose control in the ICU in patients, with and without diabetes, undergoing coronary artery bypass graft (CABG) surgery is not known. METHODS: This post-hoc cost analysis determined differences in hospitalization costs, resource utilization and perioperative complications in 288 CABG patients with diabetes (n=143) and without diabetes (n=145), randomized to intensive (n=143) and conservative (n=145) glucose control. RESULTS: Intensive glucose control resulted in lower BG (131.4±14mg/dl-(7.2±0.8mM) vs. 151.6±17mg/dl (8.4±0.8mM, p<0.001), a nonsignificant reduction in the median length of stay (LOS, 7.9 vs. 8.5days, p=0.17) and in a composite of perioperative complications including wound infection, bacteremia, acute renal and respiratory failure, major cardiovascular events (42% vs 52%, p=0.10) compared to conservative control. Median hospitalization costs were lower in the intensive group ($39,366 vs. $42,141, p=0.040), with a total cost savings of $3654 (95% CI: $1780-$3723), than conservative control. Resource utilization for radiology (p=0.008), laboratory (p=0.014), consultation service (p=0.013), and ICU utilization (p=0.007) were also lower in the intensive group. Compared to patients without perioperative complications, those with complications had longer hospital length of stay (10.7days vs. 6.7days, p<0.001), higher total hospitalization cost ($48,299 vs. $32,675, p<0.001), and higher resource utilization units (2745 vs. 1710, p<0.001). CONCLUSION: Intensive glycemic control [BG 100-140mg/dl (5.5-7.8mM)] in patients undergoing CABG resulted in significant reductions in hospitalization costs and resource utilization compared to patients treated with conservative [BG 141-180mg/dl (7.9-10.0mM)] glucose control.

Impact of obesity on hospital complications and mortality in hospitalized patients with hyperglycemia and diabetes.

OBJECTIVE: Obesity is associated with increased risk of diabetes, hypertension and cardiovascular mortality. Several studies have reported increased length of hospital stay and complications; however, there are also reports of obesity having a protective effect on health, a phenomenon coined the 'obesity paradox'. We aimed to investigate the impact of overweight and obesity on complications and mortality in hospitalized patients with hyperglycemia and diabetes. RESEARCH DESIGN AND METHODS: This retrospective analysis was conducted on 29 623 patients admitted to two academic hospitals in Atlanta, Georgia, between January 2012 and December 2013. Patients were subdivided by body mass index into underweight (body mass index <18.5 kg/m(2)), normal weight (18.5-24.9 kg/m(2)), overweight (25-29.9 kg/m(2)) and obese (>30 kg/m(2)). Hyperglycemia was defined as a blood glucose >10 mmol/L during hospitalization. Hospital complications included a composite of pneumonia, acute myocardial infarction, respiratory failure, acute kidney injury, bacteremia and death. RESULTS: A total of 4.2% were underweight, 29.6% had normal weight, 30.2% were overweight, and 36% were obese. 27.2% of patients had diabetes and 72.8% did not have diabetes (of which 75% had hyperglycemia and 25% had normoglycemia during hospitalization). A J-shaped curve with higher rates of complications was observed in underweight patients in all glycemic groups; however, there was no significant difference in the rate of complications among normal weight, overweight, or obese patients, with and without diabetes or hyperglycemia. CONCLUSIONS: Underweight is an independent predictor for hospital complications. In contrast, increasing body mass index was not associated with higher morbidity or mortality, regardless of glycemic status. There was no evidence of an obesity paradox among inpatients with diabetes and hyperglycemia.

Report on Racial Disparities in Hospitalized Patients with Hyperglycemia and Diabetes.

CONTEXT: A higher prevalence of diabetes-related complications is reported in minority populations; however, it is not known if there are racial disparities in diabetes care and outcomes in hospitalized patients. OBJECTIVE: Our objective was to determine the association between hyperglycemia, in patients with and without diabetes mellitus (non-DM), and complications among different racial groups. DESIGN: This observational study compared the frequency of hyperglycemia (blood glucose ≥ 180 mg/dL; 10 mmol/L) and DM and hospital complications between Black and White patients hospitalized patients between January 2012 and December 2013. SETTING AND PARTICIPANTS: Adults admitted to medical and surgery services in two academic hospitals were included in this study. RESULTS: Among 35 866 patients, there were 14 387 Black (40.1%) and 21 479 White patients (59.9%). Blacks had a higher prevalence of hyperglycemia (42.3% vs 36.7%, P < .0001) and DM (34.5% vs 22.8%, P < .0001) and a higher admission rate and mean daily blood glucose (P < .001). Blacks also had higher rates of complications (22.2% vs 19.2%, P < .0001), both in patients with DM (24.7 vs 22.9%, P = .0413) and non-DM with hyperglycemia (41.2% vs 37.2%, P = .0019). Using sequential modelling adjusted for age, gender, body mass index, comorbidities, and insurance coverage, non-DM Blacks with normoglycemia (odds ratio, 1.22; 95% confidence interval, 1.10-1.35) and non-DM Blacks with hyperglycemia (odds ratio, 1.18; 95% confidence interval, 1.04-1.33) had higher number of complications compared to Whites. CONCLUSIONS: Black patients have higher rates of hyperglycemia and diabetes, worse inpatient glycemic control, and greater frequency of hospital complications compared to Whites. Non-DM Blacks with hyperglycemia are a particularly vulnerable group. Further investigation is needed to better understand factors contributing the racial disparities in the hospital.

The impact of hyperglycemia and obesity on hospitalization costs and clinical outcome in general surgery patients.

BACKGROUND: The impact of obesity on clinical outcomes and hospitalization costs in general surgery patients with and without diabetes (DM) is unknown. MATERIALS AND METHODS: We reviewed medical records of 2451 patients who underwent gastrointestinal surgery at two university hospitals. Hyperglycemia was defined as BG ≥140 mg/dl. Overweight was defined by body mass index (BMI) between 25-29.9 kg/m(2) and obesity as a BMI ≥30 kg/m(2). Hospital cost was calculated using cost-charge ratios from Centers for Medicare and Medicaid Services. Hospital complications included a composite of major cardiovascular events, pneumonia, bacteremia, acute kidney injury (AKI), respiratory failure, and death. RESULTS: Hyperglycemia was present in 1575 patients (74.8%). Compared to patients with normoglycemia, those with DM and non-DM with hyperglycemia had higher number of complications (8.9% vs. 35.8% vs. 30.0%, p<0.0001), longer hospital stay (5 days vs. 9 days vs. 9 days, p<0.0001), more readmissions within 30 days (9.3% vs. 18.8% vs. 17.2%, p<0.0001), and higher hospitalization costs ($20,273 vs. $79,545 vs. $72,675, p<0.0001). In contrast, compared to normal-weight subjects, overweight and obesity were not associated with increased hospitalization costs ($58,313 vs. $58,173 vs. $66,633, p=0.74) or risk of complications, except for AKI (11.9% vs. 14.8% vs. 20.5%, p<0.0001). Multivariate analysis revealed that DM (OR=4.4, 95% CI=2.8,7.0) or perioperative hyperglycemia (OR=4.1, 95% CI=2.7-6.2) were independently associated with increased risk of complications. CONCLUSION: Hyperglycemia but not increasing BMI, in patients with and without diabetes undergoing gastrointestinal surgery was associated with a higher number of complications and hospitalization costs.

Three-dimensional visualization and thickness estimation of aortic valve cusps using high-frequency ultrasound.

High-frequency ultrasound techniques are introduced for three-dimensional imaging and thickness estimation of fresh heart valve cusps. Images of porcine aortic valve specimens were acquired within a 12 x 8 x 8 mm3 volume using a VisualSonics VS40 micro-imaging system operating at a 40 MHz centre frequency. Two image volumes were obtained from each of six left coronary cusps. One volume was acquired with the specimen submerged in distilled water and the second volume was acquired through either Hanks physiologic solution or coronary perfusion solution (CPS). The fibrosa, spongiosa and ventricularis were most readily distinguished when the specimen was imaged in distilled water. Colour thickness maps were computed from B-mode image data, and the mean and standard deviations of the thickness were determined for each cusp. In 11 of 12 trials, the image analysis algorithm yielded valid thickness estimates over greater than 98% of the region examined. Mean thickness estimates obtained with specimens submerged in Hanks solution or CPS ranged from 0.66 to 1.03 mm, and submersion in distilled water increased the mean thickness by 20-40%. This observation suggests that the cusps osmotically absorbed water. Information provided by high-frequency ultrasound is expected be valuable for characterizing the morphological properties of heart valves.