Phlegmonous gastritis: Evolving from surgical to medical disease

We present a case of phlegmonous gastritis, which is a rare, life-threatening infection involving transmural inflammation of the stomach of multiple possible etiologies. Historically this disease has required surgical management, including gastrectomy, which is quite morbid. Evolving literature suggests that antimicrobial therapy alone may be adequate treatment for this infection. The diagnosis of phlegmonous gastritis was suggested by radiology but confirmed by endoscopic pathology. This particular case is unique given the patient’s age, lack of co-morbidities and being the first description of Helicobacter pylori with phlegmonous gastritis. We report on a specific successful antimicrobial regimen and duration of therapy, which has not been well documented elsewhere in the literature, which may be helpful to clinicians

Decarceration strategies: How 5 states achieved substantial prison population reductions

From 1980 until its peak in 2009, the total federal and state prison population of the United States climbed from about 330,000 to more than 1.6 million - a nearly 400% increase - while the total general population of the country grew by only 36%, and the crime rate fell by 42%. The catalyst of this prison expansion was policy changes that prioritized “getting tough” on crime. The national prison population began a gradual descent after 2009, lessening by nearly 113,000 (6%) from 2009 through 2016. Several factors contributed to this decline: ongoing decreases in crime rates leading to fewer felony convictions; scaling back “war on drugs” policies; increased interest in evidence-based approaches to sentencing and reentry; and growing concerns about the fiscal cost of corrections and its impact on other state priorities. The state of California alone was responsible for 36% of the overall population decline, a function of a 2011 U.S. Supreme Court ruling declaring its overcrowded prison system to be unconstitutional and subsequent legislative responses to reduce the use of state incarceration. Despite the decline, the overall pace of change is quite modest. A recent analysis documents that at the rate of change from 2009 to 2016 it will take 75 years to reduce the prison population by half. And while 42 states have experienced declines from their peak prison populations, 20 of these declines are less than 5%, while 8 states are still experiencing rising populations. To aid policymakers and criminal justice officials in achieving substantial prison population reductions, this report examines the experience of five states – Connecticut, Michigan, Mississippi, Rhode Island, and South Carolina – that have achieved prison population reductions of 14-25%. This produced a cumulative total of 23,646 fewer people in prison with no adverse effects on public safety. (While a handful of other states have also experienced significant population reductions –including California, New York, and New Jersey – these have been examined in other publications, and so are not addressed here. The five states highlighted in this report are geographically and politically diverse and have all enacted a range of shifts in policy and practice to produce these outcomes. All five were engaged in the Justice Reinvestment Initiative process, spearheaded by the Pew Charitable Trusts and the Council on State Governments, which was designed to work with stakeholders to respond to the driving forces of prison expansion in each state and to develop strategies for change in policy and practice. This report seeks to inform stakeholders in other states of the range of policy options available to them for significantly reducing their prison population. While we provide some assessment of the political environment which contributed to these changes, we do not go into great detail in this area since stakeholders will need to make their own determinations of strategy based on the particularities of their state. We note, though, that the leaders of reform varied among states, and emerged among governors, legislators, criminal justice officials, and advocacy organizations, often benefiting from media coverage and editorial support

Fair and equitable subject selection in concurrent COVID-19 clinical trials

Clinical trials emerged in rapid succession as the COVID-19 pandemic created an unprecedented need for life-saving therapies. Fair and equitable subject selection in clinical trials offering investigational therapies ought to be an urgent moral concern. Subject selection determines the distribution of risks and benefits, and impacts the applicability of the study results for the larger population. While Research Ethics Committees monitor fair subject selection within each trial, no standard oversight exists for subject selection across multiple trials for the same disease. Drawing on the experience of multiple clinical trials at a single academic medical centre in the USA, we posit that concurrent COVID-19 trials are liable to unfair and inequitable subject selection on account of scientific uncertainty, lack of transparency, scarcity and, lastly, structural barriers to equity compounded by implicit bias. To address the critical gap in the current literature and international regulation, we propose new ethical guidelines for research design and conduct that bolsters fair and equitable subject selection. Although the proposed guidelines are tailored to the research design and protocol of concurrent trials in the COVID-19 pandemic, they may have broader relevance to single COVID-19 trials

Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more

Background: Congenital toxoplasmosis is a treatable, preventable disease, but untreated causes death, prematurity, loss of sight, cognition and motor function, and substantial costs worldwide. Objectives: We asked whether high performance of an Immunochromatographic-test (ICT) could enable accurate, rapid diagnosis/treatment, establishing new, improved care-paradigms at point-of-care and clinical laboratory. Methods: Data were obtained in 12 studies/analyses addressing: 1-feasibility/efficacy; 2-false-positives; 3-acceptability; 4-pink/black-line/all studies; 5-time/cost; 6-Quick-Information/Limit-of-detection; 7, 8-acute;-chronic; 9-epidemiology; 10-ADBio; 11,12-Commentary/Cases/Chronology. Findings: ICT was compared with gold-standard or predicate-tests. Overall, ICT performance for 1093 blood/4967 sera was 99.2%/97.5% sensitive and 99.0%/99.7% specific. However, in clinical trial, FDA-cleared-predicate tests initially caused practical, costly problems due to false-positive-IgM results. For 58 persons, 3/43 seronegative and 2/15 chronically infected persons had false positive IgM predicate tests. This caused substantial anxiety, concerns, and required costly, delayed confirmation in reference centers. Absence of false positive ICT results contributes to solutions: Lyon and Paris France and USA Reference laboratories frequently receive sera with erroneously positive local laboratory IgM results impeding patient care. Therefore, thirty-two such sera referred to Lyon’s Reference laboratory were ICT-tested. We collated these with other earlier/ongoing results: 132 of 137 USA or French persons had false-positive local laboratory IgM results identified correctly as negative by ICT. Five false positive ICT results in Tunisia and Marseille, France, emphasize need to confirm positive ICT results with Sabin-Feldman-Dye-test or western blot. Separate studies demonstrated high performance in detecting acute infections, meeting FDA, CLIA, WHO REASSURED, CEMark criteria and patient and physician satisfaction with monthly-gestational-ICT-screening. Conclusions/significance: This novel paradigm using ICT identifies likely false positives or raises suspicion that a result is truly positive, rapidly needing prompt follow up and treatment. Thus, ICT enables well-accepted gestational screening programs that facilitate rapid treatment saving lives, sight, cognition and motor function. This reduces anxiety, delays, work, and cost at point-of-care and clinical laboratories. Trial registration: NCT04474132,&nbsp;https://clinicaltrials.gov/study/NCT04474132ClinicalTrials.gov</p

Passive Immunity Trial for Our Nation (PassITON): Study Protocol for a Randomized Placebo-Control Clinical Trial Evaluating COVID-19 Convalescent Plasma in Hospitalized Adults

Background: Convalescent plasma is being used widely as a treatment for coronavirus disease 2019 (COVID-19). However, the clinical efficacy of COVID-19 convalescent plasma is unclear. Methods: The Pass ive I mmunity T rial for O ur N ation (PassITON), is a multicenter, placebo-controlled, blinded, randomized clinical trial being conducted in the United States to provide high-quality evidence on the efficacy of COVID-19 convalescent plasma as a treatment for adults hospitalized with symptomatic disease. Adults hospitalized with COVID-19 with respiratory symptoms for less than 14 days are eligible. Enrolled patients are randomized in a 1:1 ratio to 1 unit (200-399 mL) of COVID-19 convalescent plasma that has demonstrated neutralizing function using a SARS-CoV-2 chimeric virus neutralization assay. Study treatments are administered in a blinded fashion and patients are followed for 28 days. The primary outcome is clinical status 14 days after study treatment as measured on a 7-category ordinal scale assessing mortality, respiratory support, and return to normal activities of daily living. Key secondary outcomes include mortality and oxygen-free days. The trial is projected to enroll 1000 patients and is designed to detect an odds ratio ≤ 0.73 for the primary outcome. Discussion: This trial will provide the most robust data available to date on the efficacy of COVID-19 convalescent plasma for the treatment of adults hospitalized with acute moderate to severe COVID-19. These data will be useful to guide the treatment of COVID-19 patients in the current pandemic and for informing decisions about whether developing a standardized infrastructure for collecting and disseminating convalescent plasma to prepare for future viral pandemics is indicated. Trial Registration: ClinicalTrials.gov: NCT04362176. Date of trial registration: April 24, 2020, https://clinicaltrials.gov/ct2/show/NCT04362176