Digital Commons Network^™

Adverse Event Reporting For Cellular Therapy Products: Current Status And Future Directions, Kathy Loper, Michele W. Sugrue, Jay S. Raval, Joseph Yossi Schwartz, Kevin Land, Mickey Koh, Thilo Mengling, Hildegard Greinix, Jörg P. Halter, Christina M Celluzzi, Maysum Chaudhri

Pathology Research and Scholarship

Adverse event (AE) and adverse reaction (AR) reporting are key components of patient safety and surveillance systems. Review and analysis of this data yields opportunities for process improvement, product information and interventions, and can lead to improved patient outcomes and donor safety overall. AE and AR reporting for cellular therapy products is fragmented and not well characterized in a central reference. This review article, authored by experts from various organizations, serves to summarize the current state of reporting and offers opportunities for streamlining and coordination, as well as key reference for professionals in this field.

Unrecognised Self-Injury Mortality (Sim) Trends Among Racial/Ethnic Minorities And Women In The Usa, Ian R H Rockett, Eric D. Caine, Hilary S. Connery, Kurt B. Nolte, Paul S. Nestadt, Lewis S. Nelson, Haomiao Jia

Pathology Research and Scholarship

AIM: To assess whether an enhanced category combining suicides with non-suicide drug self-intoxication fatalities more effectively captures the burden of self-injury mortality (SIM) in the USA among US non-Hispanic black and Hispanic populations and women irrespective of race/ethnicity.

METHODS: This observational study used deidentified national mortality data for 2008-2017 from the CDC's

RESULTS: While the suicide rate increased by 29% for blacks, 36% for Hispanics and 25% for non-Hispanic whites between 2008 and 2017, corresponding SIM rate increases were larger at 109%, 69% and 55% (p

CONCLUSION: Application of SIM exposed substantial excess burdens from substance poisoning relative to suicide …

Covid-19: Postmortem Diagnostic And Biosafety Considerations, J Matthew Lacy, Erin G. Brooks, Joshua Akers, Danielle Armstrong, Lauren Decker, Adam Gonzalez, William Humphrey, Romana Mayer, Matthew Miller, Catherine Perez, Jose Antonio Ruiz Arango, Lakshmanan Sathyavagiswaran, Wendy Stroh, Suzanne Utley

Pathology Research and Scholarship

As a result of the 2019 novel human coronavirus (COVID-19) global spread, medical examiner/coroner offices will inevitably encounter increased numbers of COVID-19-infected decedents at autopsy. While in some cases a history of fever and/or respiratory distress (eg, cough or shortness of breath) may suggest the diagnosis, epidemiologic studies indicate that the majority of individuals infected with COVID-19 develop mild to no symptoms. Those dying with-but not of-COVID-19 may still be infectious, however. While multiple guidelines have been issued regarding autopsy protocol in cases of suspected COVID-19 deaths, there is some variability in the recommendations. Additionally, limited recommendations to date have …

Age-Adjusted D-Dimer Cutoffs: A Warning From The Laboratory, Marian A. Rollins-Raval, Richard A. Marlar, Andrew J. Goodwin

Pathology Research and Scholarship

D-dimer assays have been Food and Drug Administration (FDA)–approved or cleared for results below a manufacturer-defined cutoff in conjunction with low or intermediate pretest clinical probability to rule out venous thromboembolism.¹ Given apparent overall increase of D-dimer level with age, clinical guidelines have recommended application of an age-adjusted D-dimer–level cutoff to exclude suspected pulmonary embolus specifically in patients with low or intermediate pretest clinical probability.^2,3 Despite additional studies and literature availble, these guidelines themselves rest solely on the Age-Adjusted D-Dimer Cutoff Levels to Rule Out Pulmonary Embolism: The ADJUST-PE Study,⁴ applying an age-adjusted D-dimer–level …

Preliminary Incidence And Trends Of Infections With Pathogens Transmitted Commonly Through Food - Foodborne Diseases Active Surveillance Network, 10 U.S. Sites, 2016-2019, Danielle M. Tack, Logan Ray, Patricia M. Griffin, Paul R. Cieslak, John Dunn, Tamara Rissman, Rachel Jervis, Sarah Lathrop, Alison Muse, Monique Duwell, Kirk Smith, Melissa Tobin-D'Angelo, Duc J. Vugia, Joanna Zablotsky Kufel, Beverly J. Wolpert, Robert Tauxe, Daniel C. Payne

Pathology Research and Scholarship

To evaluate progress toward prevention of enteric illnesses, the Foodborne Diseases Active Surveillance Network (FoodNet) of CDC's Emerging Infections Program monitors the incidence of laboratory-diagnosed infections caused by eight pathogens transmitted commonly through food at 10 U.S. sites.* This report summarizes preliminary 2019 data and describes changes in incidence compared with that during 2016-2018. The incidence of enteric infections caused by these eight pathogens reported by FoodNet sites in 2019 continued to increase or remained unchanged, indicating progress in controlling major foodborne pathogens in the United States has stalled. Campylobacter and Salmonella caused the largest proportion of illnesses; trends in …

Total Plasma Volume Determinations For Patients With Potentially Challenging Conditions Requiring Therapeutic Plasma Exchange: Dealer's Choice, Lizabeth Rosenbaum, Mindi Johnson, Marissa Li, Jay S. Raval

Pathology Research and Scholarship

LETTER TO THE EDITORTotal plasma volume determinations for patients withpotentially challenging conditions requiring therapeuticplasma exchange: Dealer's choiceTo the Editor:Determination of total blood volume (TBV) and totalplasma volume (TPV) are essential steps in the process ofinitiating therapeutic plasma exchange (TPE).1Regardlessof the specific disease for which a procedure is to be per-formed, apheresis instruments typically require height,weight, sex, and hematocrit data to calculate TPV. For rou-tine patients, these calculations are generally straightfor-ward to perform and are accurate. However, certainconditions raise the concern of possibly inaccurate TPVdeterminations. These potentially challenging conditionsinclude obesity, pregnancy, and limb amputation. Despitenumerous modifications available to typical TBV and …

Evaluating Screening Participation, Follow-Up, And Outcomes For Breast, Cervical, And Colorectal Cancer In The Prospr Consortium, William E. Barlow, Elisabeth F. Beaber, Berta M. Geller, Aruna Kamineni, Yingye Zheng, Jennifer S. Haas, Chun R. Chao, Carolyn M. Rutter, Ann G. Zauber, Brian L. Sprague, Ethan A. Halm, Donald L. Weaver, Jessica Chubak, V Paul Doria-Rose, Sarah Kobrin, Tracy Onega, Virginia P. Quinn, Marilyn M. Schapira, Anna N A Tosteson, Douglas A. Corley, Celette Sugg Skinner, Mitchell D. Schnall, Katrina Armstrong, Cosette M. Wheeler, Michael J. Silverberg, Bijal A. Balasubramanian, Chyke A. Doubeni, Dale Mclerran, Jasmin A. Tiro

Pathology Research and Scholarship

BACKGROUND: Cancer screening is a complex process encompassing risk assessment, the initial screening examination, diagnostic evaluation, and treatment of cancer precursors or early cancers. Metrics that enable comparisons across different screening targets are needed. We present population-based screening metrics for breast, cervical, and colorectal cancers for nine sites participating in the Population-based Research Optimizing Screening through Personalized Regimens consortium.

METHODS: We describe how selected metrics map to a trans-organ conceptual model of the screening process. For each cancer type, we calculated calendar year 2013 metrics for the screen-eligible target population (breast: ages 40-74 years; cervical: ages 21-64 years; colorectal: ages …

Sclerosing Epithelioid Mesenchymal Neoplasm Of The Pancreas - A Proposed New Entity, Olca Basturk, Britta Weigelt, Volkan Adsay, Jamal K Benhamida, Gokce Askan, Lu Wang, Maria E. Arcila, Giuseppe Zamboni, Noriyoshi Fukushima, Rodrigo Gularte-Mérida, Arnaud Da Cruz Paula, Pier Selenica, Rahul Kumar, Fresia Pareja, Christopher A. Maher, John Scholes, Yoshinao Oda, Donatella Santini, Leona A. Doyle, Iver Petersen, Uta Flucke, Christian Koelsche, Samuel J. Reynolds, Aslihan Yavas, Andreas Von Deimling, Jorge S. Reis-Filho, David S. Klimstra

Pathology Research and Scholarship

We have encountered pancreatic tumors with unique histologic features, which do not conform to any of the known tumors of the pancreas or other anatomical sites. We aimed to define their clinicopathologic features and whether they are characterized by recurrent molecular signatures. Eight cases were identified; studied histologically and by immunohistochemistry. Selected cases were also subjected to whole-exome sequencing (WES; n = 4), RNA-sequencing (n = 6), Archer FusionPlex assay (n = 5), methylation profiling using the Illumina MethylationEPIC (850k) array platform (n = 6), and TERT promoter sequencing (n = 5). Six neoplasms occurred in females. The mean age …

Protocols, Practices, And Needs For Investigating Sudden Unexpected Infant Deaths, Carri Cottengim, Sharyn Parks, Dale Rhoda, Tom Andrew, Kurt B. Nolte, John Fudenberg, Mary Ann Sens, Jennifer Brustrom, Betsy Payn, Carrie K. Shapiro-Mendoza

Pathology Research and Scholarship

Understanding case identification practices, protocols, and training needs of medical examiners and coroners (MEC) may inform efforts to improve cause-of-death certification. We surveyed a U.S.-representative sample of MECs and described investigation practices and protocols used in certifying sudden unexpected infant deaths (SUID). We also identified MEC training and resource needs. Of the 377 respondents, use of the SUID Investigation Reporting Form or an equivalent was 89% for large, 87% for medium, and 52% for small jurisdictions. Routine completion of infant medical history, witness interviews, autopsy, photos or videos, and family social history for infant death investigations was ≥80%, but routine …

A Multicenter Study Of The Revogene C. Difficile System For Detection Of The Toxin B Gene From Unformed Stool Specimens, Michael J. Mashock, Matthew L. Faron, Karen C. Carroll, Christina Dang, Shawna Lewis, Hossein Salimnia, Paul Lephart, Vivian G. Loo, Bryan H. Schmitt, Stephen Young, Blake W. Buchan, Nathan A. Ledeboer

Pathology Research and Scholarship

Clostridioides difficile is the leading cause of diarrhea in hospitalized U.S. patients and results in over 400,000 cases of C. difficile infection per year. C. difficile infections have mortality rates of 6 to 30% and significantly increase health care costs, because of increased length of stay and increased frequency of readmissions due to recurrences. Efforts to reduce the spread of C. difficile in hospitals have led to the development of rapid sensitive diagnostic methods. A multicenter study was performed to establish the performance characteristics of the Revogene C. difficile test (Meridian Bioscience, Cincinnati, OH, USA) for use in detection of …

Therapeutic Plasma Exchange For Neuromyelitis Optica Spectrum Disorder: A Multicenter Retrospective Study By The Asfa Neurologic Diseases Subcommittee, Tina S. Ipe, Jay S. Raval, Leonor P. Fernando, Amit Gokhale, Cyril Jacquot, Andrew D. Johnson, Haewon C. Kim, Grace F. Monis, Yunchun D. Mo, Shanna M. Morgan, Monica B. Pagano, Huy P. Pham, Kimberly Sanford, Amy E. Schmidt, Joseph Schwartz, Jennifer Webb, Jeffrey L. Winters, Yanyun Wu, Chisa Yamada, Edward C C Wong, Amy Waldman

Pathology Research and Scholarship

IMPORTANCE: Neuromyelitis optica/neuromyelitis optica spectrum disorder patients' response to therapeutic plasma exchange (TPE) is currently incompletely characterized.

OBJECTIVE: Our study aims to understand the clinical status improvement of neuromyelitis optica/neuromyelitis optica spectrum disorder patients treated with TPE.

DESIGN, SETTING, AND PARTICIPANTS: This is a multicenter retrospective study conducted between 1 January 2003 and 31 July 2017 at 13 US hospitals performing apheresis procedures. Subjects studied were diagnosed with neuromyelitis optica/neuromyelitis optica spectrum disorder who received TPE during presentation with acute disease.

MAIN OUTCOMES AND MEASURES: The primary outcome was clinical status improvement in patients treated with TPE. Secondary measures were …