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1.
BMJ ; 375: n2400, 2021 10 14.
Article in English | MEDLINE | ID: covidwho-1978540

ABSTRACT

OBJECTIVE: To evaluate the effects of therapeutic heparin compared with prophylactic heparin among moderately ill patients with covid-19 admitted to hospital wards. DESIGN: Randomised controlled, adaptive, open label clinical trial. SETTING: 28 hospitals in Brazil, Canada, Ireland, Saudi Arabia, United Arab Emirates, and US. PARTICIPANTS: 465 adults admitted to hospital wards with covid-19 and increased D-dimer levels were recruited between 29 May 2020 and 12 April 2021 and were randomly assigned to therapeutic dose heparin (n=228) or prophylactic dose heparin (n=237). INTERVENTIONS: Therapeutic dose or prophylactic dose heparin (low molecular weight or unfractionated heparin), to be continued until hospital discharge, day 28, or death. MAIN OUTCOME MEASURES: The primary outcome was a composite of death, invasive mechanical ventilation, non-invasive mechanical ventilation, or admission to an intensive care unit, assessed up to 28 days. The secondary outcomes included all cause death, the composite of all cause death or any mechanical ventilation, and venous thromboembolism. Safety outcomes included major bleeding. Outcomes were blindly adjudicated. RESULTS: The mean age of participants was 60 years; 264 (56.8%) were men and the mean body mass index was 30.3 kg/m2. At 28 days, the primary composite outcome had occurred in 37/228 patients (16.2%) assigned to therapeutic heparin and 52/237 (21.9%) assigned to prophylactic heparin (odds ratio 0.69, 95% confidence interval 0.43 to 1.10; P=0.12). Deaths occurred in four patients (1.8%) assigned to therapeutic heparin and 18 patients (7.6%) assigned to prophylactic heparin (0.22, 0.07 to 0.65; P=0.006). The composite of all cause death or any mechanical ventilation occurred in 23 patients (10.1%) assigned to therapeutic heparin and 38 (16.0%) assigned to prophylactic heparin (0.59, 0.34 to 1.02; P=0.06). Venous thromboembolism occurred in two patients (0.9%) assigned to therapeutic heparin and six (2.5%) assigned to prophylactic heparin (0.34, 0.07 to 1.71; P=0.19). Major bleeding occurred in two patients (0.9%) assigned to therapeutic heparin and four (1.7%) assigned to prophylactic heparin (0.52, 0.09 to 2.85; P=0.69). CONCLUSIONS: In moderately ill patients with covid-19 and increased D-dimer levels admitted to hospital wards, therapeutic heparin was not significantly associated with a reduction in the primary outcome but the odds of death at 28 days was decreased. The risk of major bleeding appeared low in this trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT04362085.


Subject(s)
Anticoagulants/therapeutic use , COVID-19/mortality , COVID-19/therapy , Heparin/therapeutic use , Hospitalization/statistics & numerical data , Respiration, Artificial , Biomarkers/blood , Female , Humans , Intensive Care Units/statistics & numerical data , Male , Middle Aged , SARS-CoV-2 , Severity of Illness Index
2.
Risk Manag Healthc Policy ; 14: 4243-4252, 2021.
Article in English | MEDLINE | ID: covidwho-1477676

ABSTRACT

BACKGROUND: While past experiences show that a health system financing mechanism can support resilience to shocks, the impact on the sustainability of the financing system is exceptionally important considering the magnitude of the COVID-19 pandemic. The role of Social Health Insurance (SHI) in responding to the pandemic brings about an influence on insurance system sustainability. This study investigates the impact of China's COVID-19 treatment policy on the sustainability of its SHI system, explores influences of the policy on Wuhan's system, and discusses the effects of an assumed equivalent emergency on SHI funds for five other provincial capital cities in China. METHODS: The study was conducted using pay-as-you-go actuarial models of Urban Employee Basic Medical Insurance (UEBMI) and Urban and Rural Residents Basic Medical Insurance (URRBMI) funds, which constitute China's basic health insurance system. Current and accumulated balances of the funds in 2020 are predicted and utilized to measure the sustainability of health insurance funds during emergencies. RESULTS: The findings suggest a disparity in the capacities of insurance schemes and localities. If the surplus before 2018 is not considered, it is likely that the URRBMI fund of Wuhan would suffer a deficit, whereas the UEBMI would retain a considerable surplus. To maintain the current actuarial balance of the URRBMI fund, coverage for ordinary inpatient and outpatient expenses would have to be significantly reduced in Wuhan, potentially affecting enrollees' wellbeing. A similar situation may occur in three other cities, some with underdeveloped economies and lower per capita income are likely to be encountered with worse situation than Wuhan. CONCLUSION: Concerning fragmentation of China's SHI system, to strengthen longer-term preparedness to manage future emergencies, this study suggests the integration of insurance schemes and provincial pooling, fund balance adjusting and an emergency safety net are also advised. All options call for more public health investments.

3.
JAMA Netw Open ; 4(8): e2121867, 2021 08 02.
Article in English | MEDLINE | ID: covidwho-1375583

ABSTRACT

Importance: Postoperative atrial fibrillation (POAF) occurring after cardiac surgery is associated with adverse outcomes. Whether POAF persists beyond discharge is not well defined. Objective: To determine whether continuous cardiac rhythm monitoring enhances detection of POAF among cardiac surgical patients during the first 30 days after hospital discharge compared with usual care. Design, Setting, and Participants: This study is an investigator-initiated, open-label, multicenter, randomized clinical trial conducted at 10 Canadian centers. Enrollment spanned from March 2017 to March 2020, with follow-up through September 11, 2020. As a result of the COVID-19 pandemic, enrollment stopped on July 17, 2020, at which point 85% of the proposed sample size was enrolled. Cardiac surgical patients with CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes, prior stroke or transient ischemic attack, vascular disease, age 65-74 years, female sex) score greater than or equal to 4 or greater than or equal to 2 with risk factors for POAF, no history of preoperative AF, and POAF lasting less than 24 hours during hospitalization were enrolled. Interventions: The intervention group underwent continuous cardiac rhythm monitoring with wearable, patch-based monitors for 30 days after randomization. Monitoring was not mandated in the usual care group within 30 days after randomization. Main Outcomes and Measures: The primary outcome was cumulative AF and/or atrial flutter lasting 6 minutes or longer detected by continuous cardiac rhythm monitoring or by a 12-lead electrocardiogram within 30 days of randomization. Prespecified secondary outcomes included cumulative AF lasting 6 hours or longer and 24 hours or longer within 30 days of randomization, death, myocardial infarction, ischemic stroke, non-central nervous system thromboembolism, major bleeding, and oral anticoagulation prescription. Results: Of the 336 patients randomized (163 patients in the intervention group and 173 patients in the usual care group; mean [SD] age, 67.4 [8.1] years; 73 women [21.7%]; median [interquartile range] CHA2DS2-VASc score, 4.0 [3.0-4.0] points), 307 (91.4%) completed the trial. In the intent-to-treat analysis, the primary end point occurred in 32 patients (19.6%) in the intervention group vs 3 patients (1.7%) in the usual care group (absolute difference, 17.9%; 95% CI, 11.5%-24.3%; P < .001). AF lasting 6 hours or longer was detected in 14 patients (8.6%) in the intervention group vs 0 patients in the usual care group (absolute difference, 8.6%; 95% CI, 4.3%-12.9%; P < .001). Conclusions and Relevance: In post-cardiac surgical patients at high risk of stroke, no preoperative AF history, and AF lasting less than 24 hours during hospitalization, continuous monitoring revealed a significant increase in the rate of POAF after discharge that would otherwise not be detected by usual care. Studies are needed to examine whether these patients will benefit from oral anticoagulation therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT02793895.


Subject(s)
Atrial Fibrillation/diagnosis , Atrial Flutter/diagnosis , Cardiac Surgical Procedures/adverse effects , Electrocardiography, Ambulatory/methods , Mass Screening/methods , Patient Discharge , Postoperative Complications/diagnosis , Aged , Atrial Fibrillation/etiology , Atrial Flutter/etiology , COVID-19 , Canada , Cardiovascular Diseases/complications , Cardiovascular Diseases/surgery , Electrocardiography , Female , Hemorrhage , Hospitalization , Humans , Intention to Treat Analysis , Ischemic Attack, Transient , Male , Pandemics , Risk Factors , Stroke , Thromboembolism
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