The utilization of live biological agents as vectors for gene delivery systems is becoming more prevalent in clinical research. Often, these agents are handled in patient care environments, such as hospitals and ambulatory sites. While expanding the use of these agents from nonclinical to clinical research, Northwell Health first established a robust process to standardize biological agent research and protect patients, employees, and visitors. A collaborative, multidisciplinary approach was employed to develop an organizational-wide approach to using live biological agents in clinical research. The needs of both investigators and patient subjects were addressed while outlining a process to safely conduct clinical research, which was rapidly established with project management support and methodologies. An organizational-wide Institutional Biosafety Committee (IBC) was established within 6 months. In addition, a comprehensive Biosafety Program standardized Northwell Health’s approach to biological agent research, including agent handling and containment, training and education of providers and subjects, and an audit process for compliance. During clinical research involving biological agents, potential risks must be assessed throughout the agent’s chain of custody. Northwell Health successfully implemented a robust process in a large organization that other health systems can replicate to safely conduct research in this rapidly expanding area.
Background: The Oswestry Disability Index (ODI) is a commonly used patient reported outcome measure for measuring disability and Quality of Life (QOL) impairment in adult patients in both clinical and research practice. Whilst excellent reliability has been demonstrated the effect of variables such as gender and age on ODI scores appear less well reported. Objective: This study explores the relationship between total ODI scores and factors such as age, gender and diagnosis in a group of low back pain patients. Methods: All patients attending a Spinal Assessment Clinic (SAC) completed the ODI questionnaire at their initial appointment. Data was also collected on age, gender and provisional diagnosis. Results: ODI summary scores were available for 573 patients, with non-specific pain (n=444, 77%), lumbar radiculopathy (n=87, 15%) and spinal claudication (n=42, 7%). Only gender was related to ODI score, with females reporting higher ODI scores across all diagnostic categories, although the average difference between male and female scores failed to reach the Minimally Clinically Important Difference in all categories. Conclusions: A patient’s self-reported levels of disability, as measured by the ODI are influenced by their gender more than by their diagnosis or age
Abstract An immunization proram with pneumococcal vaccine was carried out in 38 patients with systemic lupus erythematosus (SLE). Mean antibody levels at 1 month and 1 year were significantly lower than in normal controls. This decreased response did not correlate with drug therapy at the time of immunization. Other parameters such as anergy state, renal function, and serum immunoglobulin levels also did not correlate with antibody response. There were no adverse effects noted in the vaccinated group in comparison to matched non‐vaccinated SLE patients.
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A designer of metallic energy absorption structures using additively manufactured cellular materials must address the question of which of a multitude of cell shapes to select from, the majority of which are classified as either honeycomb, beam-lattice, or Triply Periodic Minimal Surface (TPMS) structures. Furthermore, there is more than one criterion that needs to be assessed to make this selection. In this work, six cellular structures (hexagonal honeycomb, auxetic and Voronoi lattice, and diamond, gyroid, and Schwarz-P TPMS) spanning all three types were studied under quasistatic compression and compared to each other in the context of the energy absorption metrics of most relevance to a designer. These shapes were also separately studied with tubes enclosing them. All of the structures were fabricated out of AlSi10Mg with the laser powder bed fusion (PBF-LB. or LPBF) process. Experimental results were assessed in the context of four criteria: the relationship between the specific energy absorption (SEA) and maximum transmitted stress, the undulation of the stress plateau, the densification efficiency, and the design tunability of the shapes tested—the latter two are proposed here for the first time. Failure mechanisms were studied in depth to relate them to the observed mechanical response. The results reveal that auxetic and Voronoi lattice structures have low SEA relative to maximum transmitted stresses, and low densification efficiencies, but are highly tunable. TPMS structures on the other hand, in particular the diamond and gyroid shapes, had the best overall performance, with the honeycomb structures between the two groups. Enclosing cellular structures in tubes increased peak stress while also increasing plateau stress undulations.
Northwell Health, an integrated health system in New York, has treated more than 15,000 inpatients with COVID-19 at the US epicenter of the SARS-CoV-2 pandemic.We describe the demographic characteristics of patients who died of COVID-19, observation of frequent rapid response team/cardiac arrest (RRT/CA) calls for non-intensive care unit (ICU) patients, and factors that contributed to RRT/CA calls.A team of registered nurses reviewed the medical records of inpatients who tested positive for SARS-CoV-2 via polymerase chain reaction before or on admission and who died between March 13 (first Northwell Health inpatient expiration) and April 30, 2020, at 15 Northwell Health hospitals. The findings for these patients were abstracted into a database and statistically analyzed.Of 2634 patients who died of COVID-19, 1478 (56.1%) had oxygen saturation levels ≥90% on presentation and required no respiratory support. At least one RRT/CA was called on 1112/2634 patients (42.2%) at a non-ICU level of care. Before the RRT/CA call, the most recent oxygen saturation levels for 852/1112 (76.6%) of these non-ICU patients were at least 90%. At the time the RRT/CA was called, 479/1112 patients (43.1%) had an oxygen saturation of <80%.This study represents one of the largest reviewed cohorts of mortality that also captures data in nonstructured fields. Approximately 50% of deaths occurred at a non-ICU level of care despite admission to the appropriate care setting with normal staffing. The data imply a sudden, unexpected deterioration in respiratory status requiring RRT/CA in a large number of non-ICU patients. Patients admitted at a non-ICU level of care suffered rapid clinical deterioration, often with a sudden decrease in oxygen saturation. These patients could benefit from additional monitoring (eg, continuous central oxygenation saturation), although this approach warrants further study.
