Outcomes in Hispanics With COVID-19 Are Similar to Those of Caucasian Patients in Suburban New York.

BACKGROUND: Despite reported higher rates and worse outcomes due to COVID-19 in certain racial and ethnic groups, much remains unknown. We explored the association between Hispanic ethnicity and outcomes in COVID-19 patients in Long Island, New York. METHODS: We conducted a retrospective cohort study of 2,039 Hispanic and non-Hispanic Caucasian patients testing positive for SARS-CoV-2 between March 7 and May 23, 2020, at a large suburban academic tertiary care hospital near New York City. We explored the association of ethnicity with need for intensive care unit (ICU), invasive mechanical ventilation (IMV), and mortality. RESULTS: Of all patients, 1,079 (53%) were non-Hispanic Caucasians and 960 (47%) were Hispanic. Hispanic patients presented in higher numbers than expected for our catchment area. Compared with Caucasians, Hispanics were younger (45 years vs. 59 years), had fewer comorbidities (66% with no comorbidities vs. 40%), were less likely to have commercial insurance (35% vs. 59%), or were less likely to come from a nursing home (2% vs. 10%). In univariate comparisons, Hispanics were less likely to be admitted (37% vs. 59%) or to die (3% vs. 10%). Age, shortness of breath, congestive heart failure (CHF), coronary artery disease (CAD), hypoxemia, and presentation from nursing homes were associated with admission. Male sex and hypoxemia were associated with ICU admission. Male sex, chronic obstructive pulmonary disease, and hypoxemia were associated with IMV. Male sex, CHF, CAD, and hypoxemia were associated with mortality. After other factors were adjusted for, Hispanics were less likely to be admitted (odds ratio = 0.62, 95% confidence interval = 0.52 to 0.92) but Hispanic ethnicity was not associated with ICU admission, IMV, or mortality. CONCLUSIONS: Hispanics presented at higher rates than average for our population but outcomes among Hispanic patients with COVID-19 were similar to those of Caucasian patients.

The Biospecimen Preanalytical Variables Program: A Multiassay Comparison of Effects of Delay to Fixation and Fixation Duration on Nucleic Acid Quality.

CONTEXT.­: Despite widespread use of formalin-fixed, paraffin-embedded (FFPE) tissue in clinical and research settings, potential effects of variable tissue processing remain largely unknown. OBJECTIVE.­: To elucidate molecular effects associated with clinically relevant preanalytical variability, the National Cancer Institute initiated the Biospecimen Preanalytical Variables (BPV) program. DESIGN.­: The BPV program, a well-controlled series of systematic, blind and randomized studies, investigated whether a delay to fixation (DTF) or time in fixative (TIF) affects the quantity and quality of DNA and RNA isolated from FFPE colon, kidney, and ovarian tumors in comparison to case-matched snap-frozen controls. RESULTS.­: DNA and RNA yields were comparable among FFPE biospecimens subjected to different DTF and TIF time points. DNA and RNA quality metrics revealed assay- and time point-specific effects of DTF and TIF. A quantitative reverse transcription-polymerase chain reaction (qRT-PCR) assay was superior when assessing RNA quality, consistently detecting differences between FFPE and snap-frozen biospecimens and among DTF and TIF time points. RNA Integrity Number and DV200 (representing the percentage of RNA fragments longer than 200 nucleotides) displayed more limited sensitivity. Differences in DNA quality (Q-ratio) between FFPE and snap-frozen biospecimens and among DTF and TIF time points were detected with a qPCR-based assay. CONCLUSIONS.­: DNA and RNA quality may be adversely affected in some tumor types by a 12-hour DTF or a TIF of 72 hours. Results presented here as well as those of additional BPV molecular analyses underway will aid in the identification of acceptable delays and optimal fixation times, and quality assays that are suitable predictors of an FFPE biospecimen's fit-for-purpose.

Fundamental Considerations for Biobank Legacy Planning.

Biobanking in its various forms is an activity involving the collection of biospecimens and associated data and their storage for differing lengths of time before use. In some cases, biospecimens are immediately used, but in others, they are stored typically for the term of a specified project or in perpetuity until the materials are used up or declared to be of little scientific value. Legacy planning involves preparing for the phase that follows either biobank closure or a significant change at an operational level. In the case of a classical finite collection, this may be brought about by the completion of the initial scientific goals of a project, a loss of funding, or loss of or change in leadership. Ultimately, this may require making a decision about when and where to transfer materials or whether to destroy them. Because biobanking in its entirety is a complex endeavour, legacy planning touches on biobank operations as well as ethical, legal, financial, and governance parameters. Given the expense and time that goes into setting up and maintaining biobanks, coupled with the ethical imperative to appropriately utilize precious resources donated to research, legacy planning is an activity that every biobanking entity should think about. This article describes some of the fundamental considerations for preparing and executing a legacy plan, and we envisage that this article will facilitate dialogue to help inform best practices and policy development in the future.

The Biobank Economic Modeling Tool (BEMT): Online Financial Planning to Facilitate Biobank Sustainability.

BACKGROUND: Biospecimens are essential resources for advancing basic and translational research. However, there are little data available regarding the costs associated with operating a biobank, and few resources to enable their long-term sustainability. To support the research community in this effort, the National Institutes of Health, National Cancer Institute's Biorepositories and Biospecimen Research Branch has developed the Biobank Economic Modeling Tool (BEMT). The tool is accessible at http://biospecimens.cancer.gov/resources/bemt.asp. METHODS: To obtain market-based cost information and to inform the development of the tool, a survey was designed and sent to 423 biobank managers and directors across the world. The survey contained questions regarding infrastructure investments, salary costs, funding options, types of biospecimen resources and services offered, as well as biospecimen pricing and service-related costs. RESULTS: A total of 106 responses were received. The data were anonymized, aggregated, and used to create a comprehensive database of cost and pricing information that was integrated into the web-based tool, the BEMT. The BEMT was built to allow the user to input cost and pricing data through a seven-step process to build a cost profile for their biobank, define direct and indirect costs, determine cost recovery fees, perform financial forecasting, and query the anonymized survey data from comparable biobanks. CONCLUSION: A survey was conducted to obtain a greater understanding of the costs involved in operating a biobank. The anonymized survey data was then used to develop the BEMT, a cost modeling tool for biobanks. Users of the tool will be able to create a cost profile for their biobanks' specimens, products and services, establish pricing, and allocate costs for biospecimens based on percent cost recovered, and perform project-specific cost analyses and financial forecasting.