Background incidence rates of hospitalisations and emergency department visits for thromboembolic and coagulation disorders in Ontario, Canada for COVID-19 vaccine safety assessment: a population-based retrospective observational study.

OBJECTIVE: The objective of this study was to estimate background rates of selected thromboembolic and coagulation disorders in Ontario, Canada. DESIGN: Population-based retrospective observational study using linked health administrative databases. Records of hospitalisations and emergency department visits were searched to identify cases using International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Canada diagnostic codes. PARTICIPANTS: All Ontario residents. PRIMARY OUTCOME MEASURES: Incidence rates of ischaemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage, deep vein thrombosis, pulmonary embolism, idiopathic thrombocytopaenia, disseminated intravascular coagulation and cerebral venous thrombosis during five prepandemic years (2015-2019) and 2020. RESULTS: The average annual population was 14 million with 51% female. The mean annual rates per 100 000 population during 2015-2019 were 127.1 (95% CI 126.2 to 127.9) for ischaemic stroke, 22.0 (95% CI 21.6 to 22.3) for intracerebral haemorrhage, 9.4 (95% CI 9.2 to 9.7) for subarachnoid haemorrhage, 86.8 (95% CI 86.1 to 87.5) for deep vein thrombosis, 63.7 (95% CI 63.1 to 64.3) for pulmonary embolism, 6.1 (95% CI 5.9 to 6.3) for idiopathic thrombocytopaenia, 1.6 (95% CI 1.5 to 1.7) for disseminated intravascular coagulation, and 1.5 (95% CI 1.4 to 1.6) for cerebral venous thrombosis. Rates were lower in 2020 than during the prepandemic years for ischaemic stroke, deep vein thrombosis and idiopathic thrombocytopaenia. Rates were generally consistent over time, except for pulmonary embolism, which increased from 57.1 to 68.5 per 100 000 between 2015 and 2019. Rates were higher for females than males for subarachnoid haemorrhage, pulmonary embolism and cerebral venous thrombosis, and vice versa for ischaemic stroke and intracerebral haemorrhage. Rates increased with age for most of these conditions, but idiopathic thrombocytopaenia demonstrated a bimodal distribution with incidence peaks at 0-19 years and ≥60 years. CONCLUSIONS: Our estimated background rates help contextualise observed events of these potential adverse events of special interest and to detect potential safety signals related to COVID-19 vaccines.

Direct Oral Anticoagulants in the Real World: Insights Into Appropriate Prescribing and Medication Use.

Background Direct oral anticoagulants are convenient because of their fixed dosing and without laboratory monitoring. There are instructions on avoidance of moisture, no crushing of capsules, and administration with food for some direct oral anticoagulants. Whether patients adhere to this and are prescribed appropriate doses are unknown. Aims To assess direct oral anticoagulant dosing and medication use. Methods Patients ≥18 years old, receiving a direct oral anticoagulant for any diagnosis, were prospectively included. Nurses at our perioperative anticoagulation clinic helped patients complete a 12-item questionnaire. Results Ninety-three consecutive patients were recruited. Forty-nine were on dabigatran, 18 on apixaban, and 26 were on rivaroxaban. Sixty-two patients (67%) received appropriate direct oral anticoagulant dosing and administered the medication correctly. Eighteen patients (19%) administered the direct oral anticoagulant properly but at an inappropriate dose. Thirteen patients (14%) received an appropriate dose but administered the direct oral anticoagulant inappropriately: 10 (11%) removed dabigatran from its packaging before administration (exposing it to moisture); 2 (2%) did not take rivaroxaban with food; and 1 (1%) crushed the dabigatran capsule. Conclusion Our study demonstrates a large variability in how direct oral anticoagulants are dosed, and how patients take them. Improved medication literacy around direct oral anticoagulants is needed. Our study highlights opportunities that nurses have to improve patients' medication literacy.

Putting People First: Critical Reforms for Canada's Health Care System.

For over 70 years, since the Dominion Provincial Conferences at the end of the Second World War, Canadians have viewed health care as a right of citizenship. The Canada Health Act (CHA, 1984) formally entrenched the five principles that guide our current publicly operated, single payer, provincially managed system: public administration, comprehensiveness, universality, portability and accessibility. The health care system that has sprung up around the CHA has become increasingly complex, costly and strained. Our gradual descent through the rankings of major health care suggests that we are reaching the limits of what the current health care system can provide. Unfortunately, constructive political debate around this issue is often choked by intense ideological positioning. System reform is urgently needed to address the rapidly changing biological and demographic drivers of health. We do not feel that diverting ever larger flows of money into the status quo is a sustainable solution. Our nation's health and the means to advance it must be seen as assets rather than costs. We believe it is possible to meet increasing demands by expanding the supply and acknowledging the wealth of resources (scientific, human, managerial and educational) that we currently possess. In this paper we propose a cultural shift from an institution-centered system bent on cost control, to a patient-centered system that fosters a true health economy. We identify a series of interventions (some bold and others less so) to achieve a clear and evaluable goal: maximizing the well-being and debility-free life expectancy of each individual. To achieve a patient-centred system-we discuss strategies to address costs and utilization, the setting of real performance standards, the elimination of conflicts of interest and the provision of truly accessible care for all Canadians. To create a health economy, we discuss the importance of innovation, the need for a reinvigorated public health system and steps to overhaul the health care human resources environment. The goal of health care reform in Canada should be a system that is dynamic, evidence based, wealth creating and a global leader. We believe that, with leadership and vision, this goal is eminently achievable.

Diagnostic usefulness of a lumi-aggregometer adenosine triphosphate release assay for the assessment of platelet function disorders.

Platelet dense granule release assays are recommended for diagnosing platelet function disorders and are commonly performed by Lumi-Aggregometer (Chrono-Log, Havertown, PA) assays of adenosine triphosphate (ATP) release. We conducted a prospective cohort study of people tested for ATP release defects to assess bleeding symptoms. Reduced release, with 1 or more agonists, was more common among patients with bleeding disorders than among healthy control subjects (P < .001). The respective likelihood (odds ratio [95% confidence interval]) of a bleeding disorder or an inherited platelet function disorder were high when release was reduced with 1 or more agonists (17 [6-46]; 128 [30-545]), even if aggregation was normal (12 [4-34]; 105 [20-565]). ATP release had high specificity and moderate sensitivity for inherited platelet function disorders, with most abnormalities detected by the combination of 6 µmol/L epinephrine, 5.0 µg/mL collagen, and 1 µmol/L U46619. Platelet ATP release assays are useful for evaluating common bleeding disorders, regardless of aggregation findings.

Diagnostic assessment of platelet disorders: what are the challenges to standardization?

The platelet disorders are a group of heterogeneous, congenital and acquired bleeding disorders associated with impaired platelet function. There is a growing interest in standardizing the assessment of these disorders, but this is challenged by their heterogeneity, the absence of widely accepted diagnostic criteria, and inconsistency in laboratory testing practices for platelet disorders. Symptoms commonly associated with platelet disorders include rapid-onset bleeding with hemostatic challenges, peripartum bleeding, menorrhagia, epistaxis, gingival bleeding, and increased bruising. Attempts have been made to standardize the assessment of these symptoms, using clinical tools and bleeding scores. However, there are currently no standardized tools available with proven utility for the assessment of platelet disorders, apart from a tool specifically designed to assess Quebec platelet disorder. There have been several efforts to improve and standardize the laboratory assessment of platelet disorders. These efforts include guidelines from the International Society on Thrombosis and Haemostasis and the Clinical and Laboratory Standards Institute. Recent research indicates that the application of standardized laboratory tests for the assessment of platelet disorders in individuals referred for bleeding problems has valuable diagnostic utility. This has provided further incentive to standardize clinical and laboratory approaches to improve the diagnostic evaluation of platelet disorders worldwide.