Human preparedness: Relational infrastructures and medical countermeasures in Sierra Leone.

This paper examines health worker experiences in two areas of post-epidemic preparedness in Sierra Leone - vaccine trials and laboratory strengthening - to reflect on the place of people in current models of epidemic response. Drawing on ethnographic research and interviews with health workers in the aftermath of Ebola, it explores the hopes and expectations that interventions foster for frontline workers in under-resourced health systems, and describes the unseen work involved in sustaining robust response infrastructures. Our analysis focuses on what it means for the people who sustain health systems in an emergency to be 'prepared' for an epidemic. Human preparedness entails more than the presence of a labour force; it involves building and maintaining 'relational infrastructures', often fragile social and moral relationships between health workers, publics, governments, and international organisations. The COVID-19 pandemic has underscored the value of rethinking human resources from an anthropological perspective, and investing in the safety and support of people at the forefront of response. In describing the labour, personal losses, and social risks undertaken by frontline workers for protocols and practicality to meet in an emergency context, we describe the social process of preparedness; that is, the contextual engineering and investment that make response systems work.

The Montreal Cognitive Assessment (MoCA) in neuro-oncology: A pilot study of feasibility and utility in telehealth and in-person clinical assessments

Background Cognitive impairments are a common burden for patients with primary CNS tumors. Neuropsychological assessment batteries can be too lengthy, which limits their use as an objective measure of cognition during routine care. The purpose of this study was to evaluate the feasibility and utility of the brief Montreal Cognitive Assessment (MoCA) in routine in-person and telehealth visits (as a result of the global COVID-19 pandemic) with neuro-oncology patients. Methods Seventy-one adults with primary CNS tumors completed MoCA testing in person (n = 47) and via telehealth (n = 24). Correlation analysis and patient-reported outcomes (PROs), including symptom burden and interference, perceived cognition, general health status, and anxiety and depression, were included in this study. Feasibility was assessed through a provider satisfaction questionnaire. Results Patients were primarily White (83%), college-educated (71%) males (54%) with high-grade tumors (66%). The average total score on the MoCA administered in person was 25 (range: 6-30), with 34% classified as abnormal, and the average total score via telehealth was 26 (range: 12-30), with 29% classified as abnormal. Providers reported satisfaction in using the MoCA during routine clinical care, both in person and via telehealth. Lower MoCA scores correlated with worse symptom severity, KPS, age, education, and previous treatment. Conclusions The MoCA was feasible in clinical and telehealth settings, and its relationship to clinical characteristics and PROs highlights the need for both objective and patient-reported measures of cognition to understand the overall cognitive profile of a patient with a CNS tumor.

The Montreal Cognitive Assessment (MoCA) in neuro-oncology: A pilot study of feasibility and utility in telehealth and in-person clinical assessments.

Background: Cognitive impairments are a common burden for patients with primary CNS tumors. Neuropsychological assessment batteries can be too lengthy, which limits their use as an objective measure of cognition during routine care. The purpose of this study was to evaluate the feasibility and utility of the brief Montreal Cognitive Assessment (MoCA) in routine in-person and telehealth visits (as a result of the global COVID-19 pandemic) with neuro-oncology patients. Methods: Seventy-one adults with primary CNS tumors completed MoCA testing in person (n = 47) and via telehealth (n = 24). Correlation analysis and patient-reported outcomes (PROs), including symptom burden and interference, perceived cognition, general health status, and anxiety and depression, were included in this study. Feasibility was assessed through a provider satisfaction questionnaire. Results: Patients were primarily White (83%), college-educated (71%) males (54%) with high-grade tumors (66%). The average total score on the MoCA administered in person was 25 (range: 6-30), with 34% classified as abnormal, and the average total score via telehealth was 26 (range: 12-30), with 29% classified as abnormal. Providers reported satisfaction in using the MoCA during routine clinical care, both in person and via telehealth. Lower MoCA scores correlated with worse symptom severity, KPS, age, education, and previous treatment. Conclusions: The MoCA was feasible in clinical and telehealth settings, and its relationship to clinical characteristics and PROs highlights the need for both objective and patient-reported measures of cognition to understand the overall cognitive profile of a patient with a CNS tumor.

Risk Factors Associated With SARS-CoV-2 Breakthrough Infections in Fully mRNA-Vaccinated Individuals: Retrospective Analysis.

BACKGROUND: COVID-19 messenger RNA (mRNA) vaccines have demonstrated efficacy and effectiveness in preventing symptomatic COVID-19, while being relatively safe in trial studies. However, vaccine breakthrough infections have been reported. OBJECTIVE: This study aims to identify risk factors associated with COVID-19 breakthrough infections among fully mRNA-vaccinated individuals. METHODS: We conducted a series of observational retrospective analyses using the electronic health records (EHRs) of the Columbia University Irving Medical Center/New York Presbyterian (CUIMC/NYP) up to September 21, 2021. New York City (NYC) adult residences with at least 1 polymerase chain reaction (PCR) record were included in this analysis. Poisson regression was performed to assess the association between the breakthrough infection rate in vaccinated individuals and multiple risk factors-including vaccine brand, demographics, and underlying conditions-while adjusting for calendar month, prior number of visits, and observational days in the EHR. RESULTS: The overall estimated breakthrough infection rate was 0.16 (95% CI 0.14-0.18). Individuals who were vaccinated with Pfizer/BNT162b2 (incidence rate ratio [IRR] against Moderna/mRNA-1273=1.66, 95% CI 1.17-2.35) were male (IRR against female=1.47, 95% CI 1.11-1.94) and had compromised immune systems (IRR=1.48, 95% CI 1.09-2.00) were at the highest risk for breakthrough infections. Among all underlying conditions, those with primary immunodeficiency, a history of organ transplant, an active tumor, use of immunosuppressant medications, or Alzheimer disease were at the highest risk. CONCLUSIONS: Although we found both mRNA vaccines were effective, Moderna/mRNA-1273 had a lower incidence rate of breakthrough infections. Immunocompromised and male individuals were among the highest risk groups experiencing breakthrough infections. Given the rapidly changing nature of the SARS-CoV-2 pandemic, continued monitoring and a generalizable analysis pipeline are warranted to inform quick updates on vaccine effectiveness in real time.

The dynamic change of SARS-CoV-2 variants in Sierra Leone.

Since the beginning of the SARS-CoV-2 pandemic, the emergence of multiple new variants posed an increased risk to global public health. The aim of this study is to investigate SARS-CoV-2 variants and possible transmission of variants of concern (VOCs) in Sierra Leone. A total of 65 nasal swab samples were collected from COVID-19 cases in Sierra Leone, among which 24 samples were collected during the second wave and 41 samples were collected during the third wave. Nanopore sequencing generated 54 SARS-CoV-2 whole genomes. The second COVID-19 wave was mainly caused by R.1 lineage while the third COVID-19 wave was dominated by B.1.617.2 lineage (Delta variant). The phylogenetic analysis suggested multiple introductions of SARS-CoV-2 Delta variant into Sierra Leone and subsequent local transmission in this country. Our findings highlight the importance of genomic surveillance of SARS-CoV-2 variants and the urgent need for implementation of strengthened public health and social measures (PHSM) to control the spread of virus variants.

A Framework for Systematic Assessment of Clinical Trial Population Representativeness Using Electronic Health Records Data.

BACKGROUND: Clinical trials are the gold standard for generating robust medical evidence, but clinical trial results often raise generalizability concerns, which can be attributed to the lack of population representativeness. The electronic health records (EHRs) data are useful for estimating the population representativeness of clinical trial study population. OBJECTIVES: This research aims to estimate the population representativeness of clinical trials systematically using EHR data during the early design stage. METHODS: We present an end-to-end analytical framework for transforming free-text clinical trial eligibility criteria into executable database queries conformant with the Observational Medical Outcomes Partnership Common Data Model and for systematically quantifying the population representativeness for each clinical trial. RESULTS: We calculated the population representativeness of 782 novel coronavirus disease 2019 (COVID-19) trials and 3,827 type 2 diabetes mellitus (T2DM) trials in the United States respectively using this framework. With the use of overly restrictive eligibility criteria, 85.7% of the COVID-19 trials and 30.1% of T2DM trials had poor population representativeness. CONCLUSION: This research demonstrates the potential of using the EHR data to assess the clinical trials population representativeness, providing data-driven metrics to inform the selection and optimization of eligibility criteria.

Towards clinical data-driven eligibility criteria optimization for interventional COVID-19 clinical trials.

OBJECTIVE: This research aims to evaluate the impact of eligibility criteria on recruitment and observable clinical outcomes of COVID-19 clinical trials using electronic health record (EHR) data. MATERIALS AND METHODS: On June 18, 2020, we identified frequently used eligibility criteria from all the interventional COVID-19 trials in ClinicalTrials.gov (n = 288), including age, pregnancy, oxygen saturation, alanine/aspartate aminotransferase, platelets, and estimated glomerular filtration rate. We applied the frequently used criteria to the EHR data of COVID-19 patients in Columbia University Irving Medical Center (CUIMC) (March 2020-June 2020) and evaluated their impact on patient accrual and the occurrence of a composite endpoint of mechanical ventilation, tracheostomy, and in-hospital death. RESULTS: There were 3251 patients diagnosed with COVID-19 from the CUIMC EHR included in the analysis. The median follow-up period was 10 days (interquartile range 4-28 days). The composite events occurred in 18.1% (n = 587) of the COVID-19 cohort during the follow-up. In a hypothetical trial with common eligibility criteria, 33.6% (690/2051) were eligible among patients with evaluable data and 22.2% (153/690) had the composite event. DISCUSSION: By adjusting the thresholds of common eligibility criteria based on the characteristics of COVID-19 patients, we could observe more composite events from fewer patients. CONCLUSIONS: This research demonstrated the potential of using the EHR data of COVID-19 patients to inform the selection of eligibility criteria and their thresholds, supporting data-driven optimization of participant selection towards improved statistical power of COVID-19 trials.

Breaking the China Supply Chain: How the 'Five Eyes' Can Decouple from Strategic Dependency

From the Executive Summary: [1] Since the end of the Cold War, the United Kingdom (UK), United States (US), Australia, Canada and New Zealand - the five powers commonly known in intelligence circles as the 'Five Eyes' - have been among the leading advocates of 'hyper-globalisation', the idea that markets should prevail over almost all other considerations. China has benefited disproportionally from this form of globalisation, leading to a fundamental transformation in its economic and industrial fortunes over the past two decades. [2] Although already well-established in the US, the idea of 'decoupling', particularly from China's economy, has gained currency with the COVID-19 [coronavirus disease 2019] crisis. The inability to produce and source Personal Protective Equipment via globalised supply chains has reminded democratic governments and peoples that it is necessary to be able to produce strategic commodities, just as China's actions and behaviour have reminded them of the authoritarian nature of the Chinese Communist Party (CCP). [3] Under Xi Jinping's leadership, the CCP has already used China's economic power as a geostrategic weapon to revise the rules-based international system. Now vulnerable to rising domestic and international criticism over its handling of the COVID-19 outbreak, the CCP has adopted a policy of aggressive defence, to the extent that it is exploiting accumulated economic dependencies for political gain.Supply and demand;China;COVID-19 (Disease);International economic relations