Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19:A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States

Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability. Patients and Methods: We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries. Patients were followed for 90 days after COVID-19 diagnosis. The primary outcomes were ATE and VTE over 90 days from diagnosis date. We measured country -level estimates of 90 -day absolute risk (with 95% confidence intervals) of ATE and VTE. Results: The seven cohorts included 1,061,565 patients initially diagnosed with COVID-19 in the ambulatory setting before COVID19 vaccines were available (through November 2020). The 90 -day absolute risk of ATE during this period ranged from 0.11% (0.09- 0.13%) in Canada to 1.01% (0.97-1.05%) in the US, and the 90 -day absolute risk of VTE ranged from 0.23% (0.21-0.26%) in Canada to 0.84% (0.80-0.89%) in England. The seven cohorts included 3,544,062 patients with COVID-19 during vaccine availability (beginning December 2020). The 90 -day absolute risk of ATE during this period ranged from 0.06% (0.06-0.07%) in England to 1.04% (1.01-1.06%) in the US, and the 90 -day absolute risk of VTE ranged from 0.25% (0.24-0.26%) in England to 1.02% (0.99- 1.04%) in the US. Conclusion: There was heterogeneity by country in 90 -day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability. Plain Language Summary: Cohort studies of patients diagnosed with COVID-19 in both the ambulatory and hospital settings have suggested that SARS-CoV-2 infection promotes hypercoagulability that could lead to arterial or venous thromboembolism. However, few studies have examined how the risk of thromboembolism with COVID-19 has evolved over time across different countries. A new collaboration was established among the regulatory authorities of Canada, Europe, and the US within the International Coalition of Medicines Regulatory Authorities to evaluate the 90 -day risk of both arterial and venous thromboembolism after initial diagnosis of COVID-19 in the ambulatory or hospital setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability. The study found that there was variability in the risk of both arterial and venous thromboembolism by month across the countries among patients initially diagnosed with COVID-19 in the ambulatory or hospital setting. Differences in the healthcare systems, prevalence of comorbidities in the study cohorts, and approaches to the case definitions of thromboembolism likely contributed to the variability in estimates of thromboembolism risk across the countries

Crusade for Cancer Data: How a Non-SEER Site Populated the Virtual Data Warehouse Tumor Table

Background: The virtual data warehouse (VDW) tumor table is a valuable data resource available to Cancer Research Network (CRN) researchers to examine the feasibility of potential projects or to conduct research. The Surveillance, Epidemiology and End-Results (SEER) registry provides timely and efficient data for VDW tumor tables. HealthPartners Institute (HPI) is a non-SEER site that has developed alternative approaches (claims-based algorithms, medical record review) to obtain tumor data and participate in cancer-related research. These approaches can identify false-positive cases, be time-consuming and be costly. Methods: Over the past 15 years, HPI has undertaken numerous activities to identify a viable electronic data source to populate the VDW tumor table and thereby more readily participate in multisite studies within the CRN. These activities included two internally-funded capacity-building projects. The first, conducted in 2009, examined the ability to connect with the population-based cancer registry Minnesota Cancer Surveillance System, maintained by the Minnesota Department of Health (MDH), to identify cancer cases with specific diagnostic and treatment criteria preparatory to research. In 2011, our second project explored linking with the electronic registry system (ERS) at an HPI-owned hospital, Regions. More recently, HPI increased its tumor registry case ascertainment with the inclusion of care centers in Eastern Minnesota and Western Wisconsin as well as the merging of another health system, Park Nicollet. Results: The 2009 feasibility project demonstrated that MDH was able to link 79% of cases identified by HPI claims data. Nonmatches occurred from misclassification by HPI-created algorithms, patients not living in Minnesota, or patients with cancers different from those identified by HP records. Concordance for determining eligibility (stage, date of diagnosis) was high, but not 100%. The 2011 feasibility project demonstrated that HPI programmers can access Regions cancer registry data directly via the ERS similar to other data sources (eg, Clarity, Epic) through procurement of a software license and training. The project programmer extracted registry cases from ERS, mapped data elements to variables outlined in the VDW tumor tables and performed quality assurance checks provided by the VDW tumor work group. Thus, ERS data is currently our electronic source for the VDW tumor table. Following the expansion of the HPI care network to include Lakeview Hospital and three Cancer Center of Western Wisconsin sites (Westfields Hospital and Clinic, Amery Hospital and Clinic, Hudson Hospital and Clinic) along with the 2014 merger of HPI and Park Nicollet organizations, HPI is currently extracting tumor data from the ERS at these sites and Park Nicollet Methodist Hospital. Ongoing efforts to enhance the HPI tumor file include obtaining any available tumor information from MDH for all HPI patients and members. Conclusion: After time and vigorous exploration, HPI’s tumor data is part of the CRN Cancer Counter. More recent activities have enriched this data. HPI is in a better position to not only conduct internal cancer research, but also to participate in multisite studies. A visual timeline of the activities undertaken to identify and connect with tumor data sources, as well as the challenges, successes and proposed future work, will be presented

PS2-19: Validation of Self-Reported Diabetes From the Women’s Health Initiative (WHI) Clinical Trials

Background: The Women’s Health Initiative (WHI) clinical trials offer a wealth of data on patient outcomes including cancer, coronary heart disease, and hip fracture, which were confirmed via medical record review. Diabetes was self-reported, but was not validated by independent review. The literature shows wide variations on the validity of self-reported diabetes in diverse populations

The Need for New Care Strategies to Prevent A1c Relapse

Background/Aims: The principle treatment strategy for glycemic management in most care settings is reactive; monitor A1c levels and then react with treatment intensification when the A1c exceeds the recommended optimal care goal. Our goal was to assess the potential to improve diabetes performance measures through preventive strategies directed at patients who are at A1c goal but at high risk for disease progression and A1c relapse. Methods: Patients not meeting optimal care goals were partitioned into one of three different A1c trajectories: (a) FLAT –– those who are consistently above optimal A1c goal, (b) Negative slope –– those patients who are on an improvement trajectory, and (c) Positive slope –– those who have previously been meeting A1c goals but who have relapsed (often due to medical issues, comorbidities, psychosocial stress, behavioral or medication adherence, or disease progression). We quantified the proportion of patients with diabetes who contribute to the relapse vector by identifying patients with diabetes and A1c tests in the last two years (9/1/2012–8/31/2014) and quantifying the proportion of patients who relapsed in year 2, stratified by A1c range and pharmacologic treatment in year 1. Results: We identified 29,321 patients with at least two diabetes diagnoses in years 1 and 2, with median A1c of 7.4%. Of these, 8,889 (30%) had an A1c \u3e 8% in year 2. Of 6,321 patients with A1c of 7–7.9% in year 1, 2,332 (36.9%) relapsed to \u3e 8% in year 2. Relapse was higher (43.2%) for patients medicated with sulfonylurea or insulin. Only 689/10,202 (6.7%) patients with A1c \u3c 7% in year 1 relapsed to A1c \u3e 8% in year 2. Discussion: We estimate that the phenomenon of A1c relapse accounts for one-third of all adults identified as having uncontrolled glucose on quality measures. Proactive care strategies in high-risk patients close to goal (A1c 7–7.9%) to help them sustain control could reduce the proportion of patients not meeting optimal A1c goals. More systematic use of patient-reported self-monitored blood glucose data could further help to identify patients who are relapsing or progressing. Further research is needed to test these hypotheses

Pharmaceutical care and health care utilization in an HMO. Eff Clin Pract

CONTEXT. The belief that expanding the role of pharmacists in patient care could improve the safety and efficacy of drug therapy is growing. Specifically, pharmaceutical care programs through which pharmacists provide direct and ongoing counseling to patients have been introduced. Whether such programs reduce medicationrelated problems or health care utilization is unknown. OBJECTIVE. To assess whether a pharmaceutical care program decreases health care utilization, medication use, or charges. STUDY POPULATION. Adult HMO enrollees (n = 921) with heart or lung disease who used one of the selected pharmacies. INTERVENTION. Patients at intervention pharmacies were invited to participate in the pharmaceutical care program. The protocol-based program consisted of scheduled meetings between trained pharmacists and patients to assess drug therapy, plan goals, and intervene through counseling and/or consultation with other health professionals. OUTCOME MEASURES. Change in number of outpatient clinic visits, unique medications dispensed, and total charges over 1 year of follow-up. RESULTS. In an intention-to-treat analysis (after adjustment for gender, age, Charlson Comorbidity Index, disease category, and the baseline value of the utilization measure), the number of unique medications for patients in the pharmaceutical care group increased more than in the usual care group (1.0 vs. 0.4 unique medications; P = 0.03). There was no difference between the two groups in the change in total number of clinic visits or total costs. In secondary adherence analyses, participants were more likely than the usual care group to increase the number of clinic visits (1.2 vs. -0.9; P = < 0.01) and number of unique medications (1.0 vs. 0.2; P = 0.02). CONCLUSION. Pharmaceutical care for patients with chronic health conditions appears to be associated with a modest increase rather than a decrease in health care utilization. P harmaceutical care programs, in which pharmacists work directly with patients to assess, monitor, and modify their pharmaceutical regimens, are an increas

Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19:A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States

Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability. Patients and Methods: We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries. Patients were followed for 90 days after COVID-19 diagnosis. The primary outcomes were ATE and VTE over 90 days from diagnosis date. We measured country -level estimates of 90 -day absolute risk (with 95% confidence intervals) of ATE and VTE. Results: The seven cohorts included 1,061,565 patients initially diagnosed with COVID-19 in the ambulatory setting before COVID19 vaccines were available (through November 2020). The 90 -day absolute risk of ATE during this period ranged from 0.11% (0.09- 0.13%) in Canada to 1.01% (0.97-1.05%) in the US, and the 90 -day absolute risk of VTE ranged from 0.23% (0.21-0.26%) in Canada to 0.84% (0.80-0.89%) in England. The seven cohorts included 3,544,062 patients with COVID-19 during vaccine availability (beginning December 2020). The 90 -day absolute risk of ATE during this period ranged from 0.06% (0.06-0.07%) in England to 1.04% (1.01-1.06%) in the US, and the 90 -day absolute risk of VTE ranged from 0.25% (0.24-0.26%) in England to 1.02% (0.99- 1.04%) in the US. Conclusion: There was heterogeneity by country in 90 -day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability. Plain Language Summary: Cohort studies of patients diagnosed with COVID-19 in both the ambulatory and hospital settings have suggested that SARS-CoV-2 infection promotes hypercoagulability that could lead to arterial or venous thromboembolism. However, few studies have examined how the risk of thromboembolism with COVID-19 has evolved over time across different countries. A new collaboration was established among the regulatory authorities of Canada, Europe, and the US within the International Coalition of Medicines Regulatory Authorities to evaluate the 90 -day risk of both arterial and venous thromboembolism after initial diagnosis of COVID-19 in the ambulatory or hospital setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability. The study found that there was variability in the risk of both arterial and venous thromboembolism by month across the countries among patients initially diagnosed with COVID-19 in the ambulatory or hospital setting. Differences in the healthcare systems, prevalence of comorbidities in the study cohorts, and approaches to the case definitions of thromboembolism likely contributed to the variability in estimates of thromboembolism risk across the countries