The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset (NCT04348656). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm—relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94–1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02–1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57–0.95 and OR = 0.66, 95% CI 0.50–0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14–2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.
BackgroundPatients are particularly susceptible to medical error during transitions from inpatient to outpatient care. We evaluated discharge summaries produced by incoming postgraduate year 1 (PGY-1) internal medicine residents for their completeness, accuracy, and relevance to family physicians.MethodsConsecutive discharge summaries prepared by PGY-1 residents for patients discharged from internal medicine wards were retrospectively evaluated by two independent reviewers for presence and accuracy of essential domains described by the Joint Commission for Hospital Accreditation. Family physicians rated the relevance of a separate sample of discharge summaries on domains that family physicians deemed important in previous studies.ResultsNinety discharge summaries were assessed for completeness and accuracy. Most items were completely reported with a given item missing in 5% of summaries or fewer, with the exception of the reason for medication changes, which was missing in 15.9% of summaries. Discharge medication lists, medication changes, and the reason for medication changes—when present—were inaccurate in 35.7%, 29.5%, and 37.7% of summaries, respectively. Twenty-one family physicians reviewed 68 discharge summaries. Communication of follow-up plans for further investigations was the most frequently identified area for improvement with 27.7% of summaries rated as insufficient.ConclusionsThis study found that medication details were frequently omitted or inaccurate, and that family physicians identified lack of clarity about follow-up plans regarding further investigations and visits to other consultants as the areas requiring the most improvement. Our findings will aid in the development of educational interventions for residents.
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