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Introduction: The COVID-19 pandemic has changed many care pathways. We have analysed the treatment of patients with ureteric colic during the pandemic compared to an equivalent period before it began. Methods: Patients with acute ureteric colic were identified from acute CTKUBs requested in the emergency department from 1 September to 31 December 2020 ('pandemic cohort') and compared to the same timeframe in 2019 ('pre-pandemic cohort'), supplemented by clinical notes review. Results: There were 92 patients in the pandemic cohort, and 107 in the pre-pandemic cohort. Full results are detailed in Table 4. The rates of conservative management (64% vs 76%), temporising stent insertion (11% vs 14%) and emergency nephrostomy insertion (1% vs 1%) was similar in both cohorts (p > 0.05). However, more primary treatment was provided during the pandemic (25% vs 10%) mainly as extracorporeal shockwave therapy (ESWL, 21% vs 7%;p < 0.05). The pandemic cohort also had a shorter time to intervention (17 vs 39 days), driven by more rapid ESWL (4 vs 12 days) and to confirmation of stone passage (44 vs 91 days) (p < 0.05 for all three parameters), whereas the time to salvage ureteroscopy for failed conservative management was equivalent (35 vs 45 days, p > 0.05). Fifteen percent of the pandemic and 30% of the prepandemic cohort were lost to follow-up (p < 0.05). Conclusion: During COVID, reduced elective activity, particularly ESWL for renal stones, created capacity for urgent intervention such that the proportion of patients who had acute ESWL tripled (21% vs 7%) and were treated in one-third of the time (4 vs 12 days). Accordingly, the time to confirmation of stone passage was more than halved during the pandemic (44 vs 91 days). In accordance with recommendations from NICE, TISU, and GIRFT, these data confirm the importance of ringfencing urgent ESWL slots as we emerge from the pandemic.
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Background: RRx-001 is a small molecule immunotherapeutic in Phase 3 for the treatment of SCLC that is associated with M2- M1 tumor associated macrophage (TAM) repolarization with CD47 downregulation, vascular normalization and reversal of chemoresistance. In a controlled, multicenter clinical trial called REPLATINUM that was prematurely halted due to COVID-19, data from 17 patients with third line or beyond SCLC was analyzed. Moving forward, REPLATINUM(restrated) has added SARS-CoV-2 exclusion criteria. Our aim was to explore the efficacy of RRx-001 in REPLATINUM and to assess the statistical assumptions of the REPLATINUM(restrated) trial in order to inform future clinical development in SCLC. Methods: Patients in REPLATINUM were randomized to receive 1 of 2 arms: 1) carboplatin AUC 5 IV on day 1 or cisplatin 60 mg/m2 IV on day 1 plus etoposide 100 mg/m2 IV on days 1 through 3 every 21 days for up to 4 cycles or 2) 4 mg of RRx-001 administered sequentially with 4 cycles of a platinum doublet (cisplatin or carboplatin plus etoposide as outlined above). Progression Free Survival (PFS) was the primary efficacy endpoint based on a blinded independent central review (BICR). Results: The trial was suspended prematurely after 17 patients had been enrolled due to widespread COVID-19 exposure with the plan to restart the trial. The decision to restart the trial has provided an opportunity to examine the data for preliminary evidence of treatment efficacy. At the time that the REPLATINUM trial was halted, there were 11 patients enrolled on the control arm and 6 on the investigational arm. The BICR assessed median PFS was approximately 7.1 months for RRx-001 + platinum doublet and 3.5 months for the platinum doublet alone based on the truncated database. The BICR assessed PFS hazard ratio was approximately 0.5. OS medians were approximately 8.2 and 6.3 months for RRx-001 +platinum doublet and platinum doublet alone, respectively. Additionally, patients on the RRx001 + platinum doublet-treated experimental arm experienced less toxicity than patients on the platinum doublet-treated control arm. Conclusions: Despite the small sample size, preliminary results from REPLATINUM suggest a trend toward a favorable primary outcome and improved safety in RRx-001-treated patients and support the validity of the statistical assumptions that underlie the REPLATINUM(restrated) trial. Pivotal evidence will emerge from REPLATINUM(restrated), which is imminently recommencing.
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Background: Latinos are the fastest growing ethnic group in the US: cancer is the leading cause of death. Cancer screening is designed to decrease cancer-specific mortality among age- and gender-appropriate populations, but is implemented less frequently among Latino populations. Barriers to screening among Latinos are less well understood. Methods: A crosssectional, online survey was used to assess perspective on cancer information-seeking behavior, demographic, economic, healthcare access and COVID-related factors among Latino adults (>18) living in Indiana able to read and write in Spanish or English. Respondents were recruited using Facebook targeted advertisement and data were collected through Qualtrics. USPSTF recommendations for breast (BC), cervical (CC) and colorectal cancer (CRC) screening were used to evaluate screening adherence. The influence of explanatory variables on cancer-related outcomes was analyzed using univariate chi-squared tests for categorical variables and t-test for scale variables. Following this, significantly influential factors (p < 0.05) were included in multivariate logistic regression models for each response variable. Model selection was performed using stepwise regression. Results: A total of 1624 respondents participated, with 832 (51.2%) completing the survey in Spanish. Median age was 52 years old (range 18-71) for English and 54 (18-77) for Spanish respondents. 80% of respondents were located in urban areas. Cancer screening adherence rates were 45.2% for BC, 61.8% for CC and 68.0% for CRC. The main factor associated with screening adherence across all malignancies (Table) was white self-identification, other factors included having children (OR: 1.79) and having received a COVID test (OR: 1.91) for CRC, having Spanish as chosen language for the survey for CC and BC respectively. Having higher income was associated with less adherence in CRC (OR: 0.50 when expressed as subjective income adequacy, compared with people finding difficult on present income) and CC (OR: 0.18 when expressed as > 75,000 USD annual income, compared with 0- 35,000 USD annual income). Conclusions: In this interim analysis of the largest Latino survey in Indiana, our findings were counter-intuitive regarding the association of income and language with cancer screening adherence. For income, these findings may have been due to lower out-ofpocket costs among vulnerable populations covered by Medicaid or Medicare insurance. For Spanish differences may be explained by increased language specific outreach for certain screening tests but not for others. Overall, these results highlight the necessity for targeted awareness campaigns for the Latino population in Indiana. Multivariate model, odds ratio noting association with cancer screening adherence.
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Rationale: Deficiencies exist in the communication of prognosis for patients requiring prolonged mechanical ventilation (PMV) from COVID-19 pneumonia, in part because of clinician uncertainty about the natural history of disease and observational cohort studies with variable outcomes. In order to address this gap for PMV patients, we developed a modified clinical prediction model based on the ProVent-14 model to predict in-hospital mortality for patients receiving at least 14 days of mechanical ventilation for acute respiratory distress syndrome (ARDS) from COVID-19. Methods: We evaluated 107 patients with COVID-19 requiring PMV (at least 14 days of mechanical ventilation (MV)) at 2 tertiary care medical centers in the US in a retrospective observational cohort study. On day 14 of MV, we collected data for the original ProVent-14 variables (age, platelet count, requirement for vasopressors, non-trauma admission, and dialysis requirement). We also collected data for 2 other potential predictor variables (extra-corporeal membrane oxygenation (ECMO) on day 14 and neutrophil to lymphocyte ratio). Model Development: Logistic regression models were used to evaluate the performance of the ProVent-14 variables with the outcome inhospital mortality. We then assessed successive models adding variable combinations including requirement of ECMO and neutrophil to lymphocyte ratio on day 14 to predict inhospital mortality. We assessed discrimination of the models by measuring the area under the receiver operating characteristic curve (AUC). We assessed calibration by the Hosmer-Lemeshow goodness of fit statistic. Results: The AUC for the model using original Provent-14 variables was 0.78 (trauma omitted for N=1). The most parsimonious model using the additional variables includes risk factors age 50-64 and ≥65;platelet count <100, and requirement for vasopressors, renal replacement or ECMO on day 14 of MV. The area under the curve for this model is 0.83. Calibration for the modified parsimonious model is provided in the table below (Goodness-of-fit statistic p=0.80). Dichotomized neutrophil to lymphocyte ratio on day 14 (N:L>15) improves the model slightly AUC=0.83, Goodness-of-fit p=0.61, though this variable was available for only 60% of the cohort. Conclusion: A modified clinical prediction model based on the previously validated ProVent-14 model is a simple method to accurately identify patients with ARDS from COVID-19 requiring PMV who are at high risk of in-hospital mortality. Further validation of model performance in a larger population and including long-term survival is warranted.
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We at the W. Montague Cobb/NMA Health Institute share growing concern regarding prisons and immigrant detention as structural determinants of Coronavirus disparities for our most vulnerable and underserved populations. Black or African American adults represent 12% of the U.S. adult population but 33% of the sentenced prison population, with nearly six times the imprisonment rate for whites. Interestingly, but not surprisingly, immigrants who are also Black may be at higher risk for being detained compared to their non-Black immigrant counterparts because of racial profiling. Whereas Black immigrants account for 20 percent of immigrants facing deportation on criminal grounds and three out the last thirteen deaths in detention due to COVID-19, they comprise only 7 percent of the immigrant population. Wallace et al.’s recent Morbidity and Mortality Weekly (MMWR) Report noted 4,893 cases and 88 deaths among incarcerated or detained residents, 2,778 cases and 15 deaths among staff members, and at least one confirmed case among 420 facilities and representing 86% of the 37 of 54 jurisdictions reporting. Although the epidemiologic data on Coronavirus within these settings remains incomplete, we do know that crowded conditions and other factors that propagate pathogen transmission are common. Furthermore, these transient settings likely posit risk for local social networks, and the general population. In light of the burgeoning pandemic, guided decarceration and accompanying social support programs should be public health priorities as well as the adoption of national clinical management standards with additional focus on suicide prevention and mental health. Coordinated CDC-led tracking of relevant epidemiologic data including race-ethnicity and demographics of residents and staff may also be warranted. Along with protecting incarcerated or detained persons and their basic human rights, staff, and the communities to which they return, urging control measures should be the elimination of racial and ethnic disparities in health and healthcare.
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[Formula presented] Despite the challenging nature of the pandemic that made all events virtual, the 15th Annual W. Montague Cobb Symposium and Scientific Lectureship held as part of the 125th National Medical Association (NMA) Convention continued as a treasured event. Titled “The Role of HBCU Medical Schools in Driving Research Excellence in the Wake of COVID-19,” with the Cobb Lecturer as noted pediatrician Dr. Deborah Prothrow-Stith who defined youth violence as a health problem, this year’s Symposium featured the Consortium of all four medical institutions of historically black colleges and universities (HBCUs) including Charles R. Drew University of Medicine and Science, Howard University College of Medicine, Meharry Medical College, and Morehouse School of Medicine. Cobb Lecturer Prothrow-Stith touched on the context of the pandemic and traumatic murder of George Floyd for the enhanced attention to longstanding issues, and framed their Consortium efforts as “powerful together.” Beyond navigating community testing and intervention as well as vaccine strategies toward tackling Coronavirus-related disparities, their implemented measures around the undergirding social determinants of health are highly innovative. With Morehouse’s National COVID-19 Resiliency Network (NCRN) currently funded at $40 million under a three-year cooperative agreement with the U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) likely to prove transformational, renowned immunologist and physician Dr. James Hildreth urged keeping our institutions at the forefront of vaccine development and public health ambassadorship. Even with limited funding for efforts undertaken at a national level, and intervening where majority institutions often struggle, this Consortium holding a long legacy of trusted commitment to the underserved continues undeterred. We hope that their collaborative value is felt and that expanded, sustained funding to HBCU institutions from HHS and its Agencies and Offices for health-related research and development not only transcends this pandemic but is accelerated.