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How to develop highly informative serology assays to evaluate the quality of immune protection against coronavirus disease‐19 (COVID‐19) has been a global pursuit over the past years. Here, a microfluidic high‐plex immuno‐serolomic assay is developed to simultaneously measure50 plasma or serum samples for50 soluble markers including 35proteins, 11 anti‐spike/receptor binding domian (RBD) IgG antibodies spanningmajor variants, and controls. This assay demonstrates the quintuplicate test in a single run with high throughput, low sample volume, high reproducibilityand accuracy. It is applied to the measurement of 1012 blood samples including in‐depth analysis of sera from 127 patients and 21 healthy donors over multiple time points, either with acute COVID infection or vaccination. The protein analysis reveals distinct immune mediator modules that exhibit a reduced degree of diversity in protein‐protein cooperation in patients with hematologic malignancies or receiving B cell depletion therapy. Serological analysis identifies that COVID‐infected patients with hematologic malignancies display impaired anti‐RBD antibody response despite high level of anti‐spike IgG, which can be associated with limited clonotype diversity and functional deficiency in B cells. These findings underscore the importance to individualize immunization strategies for these high‐risk patients and provide an informative tool to monitor their responses at the systems level. [ABSTRACT FROM AUTHOR]

Real‐world data (RWD) and real‐world evidence (RWE) are becoming essential tools for informing regulatory decision making in health care and offer an opportunity for all stakeholders in the healthcare ecosystem to evaluate medical products throughout their lifecycle. Although considerable interest has been given to regulatory decisions supported by RWE for treatment authorization, especially in rare diseases, less attention has been given to RWD/RWE related to in vitro diagnostic (IVD) products and clinical decision support systems (CDSS). This review examines current regulatory practices in relation to IVD product development and discusses the use of CDSS in assisting clinicians to retrieve, filter, and analyze patient data in support of complex decisions regarding diagnosis and treatment. The review then explores how utilizing RWD could augment regulatory body understanding of test performance, clinical outcomes, and benefit‐risk profiles, and how RWD could be leveraged to augment CDSS and improve safety, quality, and efficiency of healthcare practices. Whereas we present examples of RWD assisting in the regulation of IVDs and CDSS, we also highlight key challenges within the current healthcare system which are impeding the potential of RWE to be fully realized. These challenges include issues such as data availability, reliability, accessibility, harmonization, and interoperability, often for reasons specific to diagnostics. Finally, we review ways that these challenges are actively being addressed and discuss how private‐public collaborations and the implementation of standardized language and protocols are working toward producing more robust RWD and RWE to support regulatory decision making. [ABSTRACT FROM AUTHOR]

The article focuses on myopericarditis in young adults presenting to the emergency department after receiving a second COVID-19 mRNA vaccine. Topics include the media reports from Israel, France, and the U.S. military have raised the possibility of a link between COVID-19 mRNA vaccines in young adults, the adults seen in emergency departments of a U.S. health care system who developed myopericarditis, and the local institutional health care system database for all diagnoses of myopericarditis.

Summary: Pathogen‐reduced (PR) platelets are routinely used in many countries. Some studies reported changes in platelet and red blood cell (RBC) transfusion requirements in patients who received PR platelets when compared to conventional (CONV) platelets. Over a 28‐month period we retrospectively analysed platelet utilisation, RBC transfusion trends, and transfusion reaction rates data from all transfused adult patients transfused at the Yale‐New Haven Hospital, New Haven, CT, USA. We determined the number of RBC and platelet components administered between 2 and 24, 48, 72 or 96 h. A total of 3767 patients received 21 907 platelet components (CONV = 8912; PR = 12 995); 1,087 patients received only CONV platelets (1578 components) and 1,466 patients received only PR platelets (2604 components). The number of subsequently transfused platelet components was slightly higher following PR platelet components (P < 0·05); however, fewer RBCs were transfused following PR platelet administration (P < 0·05). The mean time‐to‐next platelet component transfusion was slightly shorter following PR platelet transfusion (P = 0·002). The rate of non‐septic transfusion reactions did not differ (all P > 0·05). Septic transfusion reactions (N = 5) were seen only after CONV platelet transfusions (P = 0·011). These results provide evidence for comparable clinical efficacy of PR and CONV platelets. PR platelets eliminated septic transfusion reactions without increased risk of other types of transfusions with only slight increase in platelet utilisation. [ABSTRACT FROM AUTHOR]

We read with interest the subanalysis of the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS)[1] and accompanying editorial.[2] In contrast to preliminary data generated in animal models showing a decreased risk of alloimmunization to antigens expressed on white blood cells (WBCs), the subanalysis data raise the possibility that pathogen-reduced platelets (PR-PLTs) may I increase i the risk of class I HLA alloimmunization in humans. While the increase in testing may be explained in part by the decreased posttransfusion recovery/survival of PR-PLTs, the increase in the percentage of I positive i PLT alloimmunization screens is concerning to us, particularly given the PREPAReS data. [Extracted from the article]

Background The digital transformation of medical data provides opportunities to perform digital population health surveillance and identify people inadequately managed in usual care. We leveraged the electronic health records of a large health system to identify patients with markedly elevated blood pressure and characterize their follow-up care pattern. Methods and Results We included 373 861 patients aged 18 to 85 years, who had at least 1 outpatient encounter in the Yale New Haven Health System between January 2013 and December 2017. We described the prevalence and follow-up pattern of patients with at least 1 systolic blood pressure (SBP) ≥160 mm Hg or diastolic blood pressure (DBP) ≥100 mm Hg and patients with at least 1 SBP ≥180 mm Hg or DBP ≥120 mm Hg. Of 373 861 patients included, 56 909 (15.2%) had at least 1 SBP ≥160 mm Hg or DBP ≥100 mm Hg, and 10 476 (2.8%) had at least 1 SBP ≥180 mm Hg or DBP ≥120 mm Hg. Among patients with SBP ≥160 mm Hg or DBP ≥100 mm Hg, only 28.3% had a follow visit within 1 month (time window of follow-up recommended by the guideline) and 19.9% subsequently achieved control targets (SBP <130 mm Hg and DBP <80 mm Hg) within 6 months. Follow-up rate at 1 month and control rate at 6 months for patients with SBP ≥180 mm Hg or DBP ≥120 mm Hg was 31.9% and 17.2%. Conclusions Digital population health surveillance with an electronic health record identified a large number of patients with markedly elevated blood pressure and inadequate follow-up. Many of these patients subsequently failed to achieve control targets.

Background Traditional Chinese medicine (TCM) is used in the treatment of many conditions, including heart failure (HF), although it is not well characterized. Methods and Results We conducted a retrospective analysis of TCM use in a random sample of hospitalizations for HF within a random sample of Western medicine hospitals in China in 2015 using data from the China PEACE 5r-HF (China Patient-Centered Evaluative Assessment of Cardiac Events 5 Retrospective Heart Failure Study). We describe the frequency of TCM use and its association with patient characteristics, in-hospital use of evidence-based therapies, and hospital characteristics using hierarchical logistic regression models. Finally, we assessed risk-adjusted in-hospital bleeding and mortality. Among 10 004 patients hospitalized with HF (median age, 73 years; 48.9% women) from 189 hospitals, 74.7% received TCM (83.3% administered intravenously). The most commonly used agent was Salvia miltiorrhiza (51.2%). Patients with coronary artery disease (odds ratio [OR], 1.73; 95% CI, 1.53-1.95) or stroke (OR, 1.32; 95% CI, 1.15-1.51) were more likely to receive TCM; there was no correlation with evidence-based therapy use. Nearly all hospitals (99.4%) used TCM, with substantial variation across hospitals (median OR, 3.29; 95% CI, 2.82-3.76). In-patient bleeding (OR, 1.39; 95% CI, 1.03-1.88) and mortality (OR, 1.36; 95% CI, 1.04-1.79) were higher with Salvia miltiorrhiza, although not with other TCMs. Conclusions In a nationally representative sample of patients hospitalized with acute HF in China, three fourths received TCM. Nearly all hospitals used TCM, although use varied substantially by hospital. Although TCM was not used in lieu of evidence-based therapies for HF, we found a signal for harm with the most commonly used TCM. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT02877914.