How do we build a comprehensive Vein-to-Vein (V2V) database for conduct of observational studies in transfusion medicine? Demonstrated with the Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric V2V database protocol.

BACKGROUND: The Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) is the fourth iteration of the National Heart, Lung, and Blood Institute's REDS program and includes a focus on pediatric populations. The REDS-IV-P Vein-to-Vein (V2V) database encompasses linked information from blood donors, blood components, and patients to facilitate studies in transfusion medicine. STUDY DESIGN AND METHODS: The V2V database is an Observational Medical Outcomes Partnership Common Data Model database. The study period is April 1, 2019 through December 31, 2023. Data from all donors and donations at participating blood centers, all blood components derived from the donations, and all inpatient visits and selected outpatient visits at participating hospitals are included. The database captures all information within patient data domains not restricting data to a preselected subset of medical records. RESULTS: The V2V database contains data from 7 blood centers and 22 hospitals. We project the database will have over 2 billion pieces of information from 1.3 million patients with 20.6 million healthcare encounters. The database will include data on approximately 1 million transfused units and 2.3 million donors with approximately 6.8 million donation visits. CONCLUSION: The REDS-IV-P V2V database is a comprehensive database with data from millions of blood donors, blood components, and patients. A diverse set of data from the encounters are included in the database such that emerging questions can likely be addressed. The Observational Medical Outcomes Partnership Common Data Model is an efficient, flexible, and increasingly used common data model. The final de-identified database will be publicly available.

Use and Impact of Type 2 Diabetes Prevention Interventions.

INTRODUCTION: RCTs have found that type 2 diabetes can be prevented among high-risk individuals by metformin medication and evidence-based lifestyle change programs. The purpose of this study is to estimate the use of interventions to prevent type 2 diabetes in real-world clinical practice settings and determine the impact on diabetes-related clinical outcomes. METHODS: The analysis performed in 2020 used 2010‒2018 electronic health record data from 69,434 patients aged ≥18 years at high risk for type 2 diabetes in 2 health systems. The use and impact of prescribed metformin, lifestyle change program, bariatric surgery, and combinations of the 3 were examined. A subanalysis was performed to examine uptake and retention among patients referred to the National Diabetes Prevention Program. RESULTS: Mean HbA1c values declined from before to after intervention for patients who were prescribed metformin (-0.067%; p<0.001) or had bariatric surgery (-0.318%; p<0.001). Among patients referred to the National Diabetes Prevention Program lifestyle change program, the type 2 diabetes postintervention incidence proportion was 14.0% for nonattendees, 12.8% for some attendance, and 7.5% for those who attended ≥4 sessions (p<0.001). Among referred patients to the National Diabetes Prevention Program lifestyle change program, uptake was low (13% for 1‒3 sessions, 15% for ≥4 sessions), especially among males and Hispanic patients. CONCLUSIONS: Findings suggest that metformin and bariatric surgery may improve HbA1c levels and that participation in the National Diabetes Prevention Program may reduce type 2 diabetes incidence. Efforts to increase the use of these interventions may have positive impacts on diabetes-related health outcomes.

The Longitudinal Epidemiologic Assessment of Diabetes Risk (LEADR): Unique 1.4 M patient Electronic Health Record cohort.

BACKGROUND: The Longitudinal Epidemiologic Assessment of Diabetes Risk (LEADR) study uses a novel Electronic Health Record (EHR) data approach as a tool to assess the epidemiology of known and new risk factors for type 2 diabetes mellitus (T2DM) and study how prevention interventions affect progression to and onset of T2DM. We created an electronic cohort of 1.4 million patients having had at least 4 encounters with a healthcare organization for at least 24-months; were aged ≥18 years in 2010; and had no diabetes (i.e., T1DM or T2DM) at cohort entry or in the 12 months following entry. EHR data came from patients at nine healthcare organizations across the U.S. between January 1, 2010-December 31, 2016. RESULTS: Approximately 5.9% of the LEADR cohort (82,922 patients) developed T2DM, providing opportunities to explore longitudinal clinical care, medication use, risk factor trajectories, and diagnoses for these patients, compared with patients similarly matched prior to disease onset. CONCLUSIONS: LEADR represents one of the largest EHR databases to have repurposed EHR data to examine patients' T2DM risk. This paper is first in a series demonstrating this novel approach to studying T2DM. IMPLICATIONS: Chronic conditions that often take years to develop can be studied efficiently using EHR data in a retrospective design. LEVEL OF EVIDENCE: While much is already known about T2DM risk, this EHR's cohort's 160 M data points for 1.4 M people over six years, provides opportunities to investigate new unique risk factors and evaluate research hypotheses where results could modify public health practice for preventing T2DM.

Trends in blood mercury concentrations and fish consumption among U.S. women of reproductive age, NHANES, 1999-2010.

BACKGROUND: Consumption of finfish and shellfish is the primary exposure pathway of methylmercury (MeHg) in the US. MeHg exposure in utero is associated with neurodevelopmental and motor function deficits. Regulations and fish advisories may contribute to decreased exposure to mercury over time. OBJECTIVES: Combine fish tissue mercury (FTHg) concentrations and 1999-2010 NHANES blood mercury concentrations and fish consumption data to investigate trends in blood mercury concentrations, fish consumption, and mercury intake in women of reproductive age. METHODS: Blood MeHg was calculated from the blood total and inorganic concentrations. Dietary datasets were combined to estimate 30-day fish consumption, then combined with FTHg concentrations to estimate mercury intake and mercury concentration in the fish consumed. Non-linear and logistic regression analyses were used to evaluate trends over time. RESULTS: Regression analysis found NHANES 1999-2000 to have higher blood MeHg concentrations than the mean of the later releases (p<0.0001) and a positive quadratic trend since 2000 (p=0.004). No trend was observed in fish consumption amount or mercury intake. A decreasing trend was found in the ratio of mercury intake to fish consumed (p=0.04). CONCLUSIONS: The analyses found blood MeHg concentrations in NHANES 1999-2000 to be significantly higher than the mean of the later releases. There was no trend in fish consumption amount across the study period. The analysis found a decreasing trend in the ratio of mercury intake to fish consumed, consistent with women shifting their consumption to fish with lower mercury concentrations.