Citations

135 Background: Black patients have a disproportionately high incidence and mortality from lung cancer. Despite the importance of clinical trials, there continue to be significant racial disparities in recruitment for pivotal registration studies. In 2016, the FDA recommended reporting racial enrollment with a minimum of 5 categories (White, Black, Asian, American Indian or Alaskan Native [AIAN] and Native Hawaiian or Pacific Islander [NHPI]). The International Committee of Medical Journal Editors also recommend reporting race and ethnicity. We evaluated race reporting and representation in registration trials for thoracic cancers. Methods: We reviewed the FDA website and identified all new drug licensing indications in thoracic malignancies (small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC) and mesothelioma) from 2006 to 2020. NSCLC was further classified as EGFR+, ALK+, other mutation and NOS (no driver mutation). Clinical trials cited on the licensing label for market authorization were recorded and the corresponding registration trial publication was identified. If race was unreported or underreported (defined as ≤3 groups) in the licensing study, then additional information was obtained from clinicaltrials.gov. We calculated the proportion of registration trials meeting FDA criteria and the proportion of each racial group in trials. Results: From 2006-2020, we identified 55 new licensing indications, involving 26 unique drugs; 5 approvals in SCLC, 49 approvals in NSCLC and 1 in mesothelioma. Prior to the FDA race reporting guidelines, 33% (6/18) of registration studies did not meet FDA requirements. This improved to 27% (10/37) after the guideline introduction. Overall 29,545 patients participated in thoracic registration trials; 66% White, 22% Asian, 2% Black, <1% AIAN, <1% NHPI, 1% other or multiple races and 9% unknown. Table shows race distribution by cancer subtype. Conclusions: Although improving, a substantial number of registrational clinical trials in thoracic oncology still do not report race per FDA guidance. In addition, Black individuals are disproportionately under-represented in registration trials. Greater efforts are needed for the inclusion of Black patients and other minorities in clinical trials.[Table: see text]

Abstract Background: The current pandemic of COVID-19 impacted the psychological wellbeing of populations globally. Objectives: We aimed to examine the extent and identify associated factors of psychological distress, fear of COVID-19, and coping.Methods: We conducted a cross-sectional study across 17 countries during Jun-2020 to Jan-2021. Levels of psychological distress (Kessler Psychological Distress Scale), fear of COVID-19 (Fear of COVID-19 Scale), and coping (Brief Resilient Coping Scale) were assessed. Results: A total of 8,559 people participated; mean age (±SD) was 33(±13) years, 64% were females and 40% self-identified as frontline workers. More than two-thirds (69%) experienced moderate-to-very high levels of psychological distress, which was 46% in Thailand and 91% in Egypt. A quarter (24%) had high levels of fear of COVID-19, which was as low as 9% in Libya and as high as 38% in Bangladesh. More than half (57%) exhibited medium to high resilient coping; the lowest prevalence (3%) was reported in Australia and the highest (72%) in Syria. Being female (AOR 1.31 [95% CIs 1.09-1.57]), perceived distress due to change of employment status (1.56 [1.29-1.90]), comorbidity with mental health conditions (3.02 [1.20-7.60]) were associated with higher levels of psychological distress and fear. Doctors had higher psychological distress (1.43 [1.04-1.97]), but low levels of fear of COVID-19 (0.55 [0.41-0.76]); nurses had medium to high resilient coping (1.30 [1.03-1.65]). Conclusions: The extent of psychological distress, fear of COVID and coping varied by country; however, some groups were more vulnerable than others. There is an urgent need to prioritise health and well-being of these people through well-designed intervention that may need to be tailored to meet country specific requirements.

Introduction: Baseline thrombocytopenia (TP) is a common condition in patients with acute coronary syndrome (ACS) and acute ischemic stroke and has been shown to increase mortality. The effect of baseline TP on cerebrovascular events following initial ACS event is not well studied. Methods: We retrospectively reviewed all patients identified from the institutional NCDR Chest Pain registry database at Mayo Clinic Arizona from Oct 2015 to Sep 2018. Patients were classified into TP (platelet <150) and control (platelet > 150) groups for clinical outcome (stroke/TIA and bleeding events) analysis. P-value < 0.05 is considered significant. Results: Five hundred and thirty-six patients were included for final analysis. Patient demographics and clinical outcomes are shown in Table 1. The rates of dual antiplatelet therapy (DAPT) prescription at discharge (TP vs. control: 68.1% and 75.4%, P=0.197), stroke/TIA (1.3% vs. 2.4%, P=1.000) and recurrent myocardial infarction (11.1% vs. 11.2%, P=1.000) were similar between the two groups. The TP group has more bleeding events compared to control (Figure 1). Conclusions: In patients with ACS, baseline TP does not affect stroke/TIA events but is associated with higher bleeding rate. The results could not be explained by the DAPT or anticoagulation use alone. Further studies are needed to investigate the pathophysiologic correlation of thrombocytopenia, DAPT, and stroke in ACS patients.

INTRODUCTION: Gastroenterologists at all levels of practice benefit from formal mentoring. Much of the current literature on mentoring in gastroenterology is based on expert opinion rather than data. In this study, we aimed to identify gender-related barriers to successful mentoring relationships from the mentor and mentee perspectives. METHODS: A voluntary, web-based survey was distributed to physicians at 20 academic institutions across the United States. Overall, 796 gastroenterology fellows and faculty received the survey link, with 334 physicians responding to the survey (42% response rate), of whom 299 (90%; 129 women and 170 men) completed mentorship questions and were included in analysis. RESULTS: Responses of women and men were compared. Compared with men, more women preferred a mentor of the same gender (38.6% women vs 4.2% men, P < 0.0001) but less often had one (45.5% vs 70.2%, P < 0.0001). Women also reported having more difficulty finding a mentor (44.4% vs 16.0%, P < 0.0001) and more often cited inability to identify a mentor of the same gender as a contributing factor (12.8% vs 0.9%, P = 0.0004). More women mentors felt comfortable advising women mentees about work-life balance (88.3% vs 63.8%, P = 0.0005). Nonetheless, fewer women considered themselves effective mentors (33.3% vs 52.6%, P = 0.03). More women reported feeling pressured to mentor because of their gender (39.5% vs 0.9% of men, P < 0.0001). Despite no gender differences, one-third of respondents reported negative impact of the COVID-19 pandemic on their ability to mentor and be mentored. DISCUSSION: Inequities exist in the experiences of women mentees and mentors in gastroenterology, which may affect career advancement and job satisfaction.

Purpose To compare the dosimetric performances of small‐spot three‐dimensional (3D) and four‐dimensional (4D) robustly optimized intensity‐modulated proton (IMPT) plans in the presence of uncertainties and interplay effect simultaneously for distal esophageal carcinoma. Method and Materials Thirteen (13) patients were selected and re‐planned with small‐spot ( ~ 2–6 mm) 3D and 4D robust optimization in IMPT, respectively. The internal clinical target volumes (CTV high3d , CTV low3d ) were used in 3D robust optimization. Different CTVs (CTV high4d , CTV low4d ) were generated by subtracting an inner margin of the motion amplitudes in three cardinal directions from the internal CTVs and used in 4D robust optimization. All patients were prescribed the same dose to CTVs (50 Gy[RBE] for CTV high3d /CTV high4d and 45 Gy[RBE] for CTV low3d /CTV low4d ). Dose–volume histogram (DVH) indices were calculated to assess plan quality. Comprehensive plan robustness evaluations that consisted of 300 perturbed scenarios (10 different motion patterns to consider irregular motion (sampled from a Gaussian distribution) and 30 different uncertainties scenarios (sampled from a 4D uniform distribution) combined), were performed to quantify robustness to uncertainties and interplay effect simultaneously. Wilcoxon signed‐rank test was used for statistical analysis. Results Compared to 3D robustly optimized plans, 4D robustly optimized plans had statistically improved target coverage and better sparing of lungs and heart (heart D mean , P = 0.001; heart V 30Gy[RBE] , P = 0.001) in the nominal scenario. 4D robustly optimized plans had better robustness in target dose coverage (CTV high4d V 100% , P = 0.002) and the protection of lungs and heart (heart D mean , P = 0.001; heart V 30Gy[RBE] , P = 0.001) when uncertainties and interplay effect were considered simultaneously. Conclusions Even with small spots in IMPT, 4D robust optimization outperformed 3D robust optimization in terms of normal tissue protection and robustness to uncertainties and interplay effect simultaneously. Our findings support the use of 4D robust optimization to treat distal esophageal carcinoma with small spots in IMPT.

Abstract Objective We sought to investigate the patient experience of telemedicine for headache care during the coronavirus disease 2019 (COVID‐19) pandemic. Background The use of telemedicine has rapidly expanded and evolved since the beginning of the COVID‐19 pandemic. Telemedicine eliminates the physical and geographic barriers to health care, preserves personal protective equipment, and prevents the spread of COVID‐19 by allowing encounters to happen in a socially distanced way. However, few studies have assessed the patient perspective of telemedicine for headache care. Methods The American Migraine Foundation (AMF) designed a standardized electronic questionnaire to assess the patient experience of telemedicine for headache care between March and September 2020 to help inform future quality improvement as part of its patient advocacy initiative. The date parameters were identified as the emergence of severe acute respiratory syndrome coronavirus 2 disease and the declaration of a national emergency in the United States. The questionnaire was distributed electronically to more than 100,000 members of the AMF community through social media platforms and the AMF email database. Results A total of 1172 patients responded to our electronic questionnaire, with 1098 complete responses. The majority, 1081/1153 (93.8%) patients, had a previous headache diagnosis prior to the telemedicine encounter. A total of 648/1127 (57.5%) patients reported that they had used telemedicine for headache care during the study period. Among those who participated in telehealth visits, 553/647 (85.5%) patients used it for follow‐up visits; 94/647 (14.5%) patients used it for new patient visits. During the telemedicine encounters, 282/645 (43.7%) patients were evaluated by headache specialists, 222/645 (34.4%) patients by general neurologists, 198/645 (30.7%) patients by primary care providers, 73/645 (11.3%) patients by headache nurse practitioners, and 21/645 (3.2%) patients by headache nurses. Only 47/633 (7.4%) patients received a new headache diagnosis from telemedicine evaluation, whereas the other 586/633 (92.6%) patients did not have a change in their diagnoses. During these visits, a new treatment was prescribed for 358/636 (52.3%) patients, whereas 278/636 (43.7%) patients did not have changes made to their treatment plan. The number (%) of patients who rated the telemedicine headache care experience as “very good,” “good,” “fair,” “poor,” and “other” were 396/638 (62.1%), 132/638 (20.7%), 67/638 (10.5%), 23/638 (3.6%), and 20/638 (3.1%), respectively. Detailed reasons for “other” are listed in the manuscript. Most patients, 573/638 (89.8%), indicated that they would prefer to continue to use telemedicine for their headache care, 45/638 (7.1%) patients would not, and 20/638 (3.1%) patients were unsure. Conclusions Our study evaluating the patient perspective demonstrated that telemedicine facilitated headache care for many patients during the COVID‐19 pandemic, resulting in high patient satisfaction rates, and a desire to continue to use telemedicine for future headache care among those who completed the online survey.

Introduction: Serum creatinine (sCr) is routinely used to calculate estimated glomerular filtration rate (eGFR) in heart failure (HF) pts. However, changes in muscle mass may limit the accuracy of sCr as marker of renal function in this population. Cystatin C (CysC) is independent of muscle mass and provides an alternative measure of eGFR. In prior studies, higher sCr/CysC ratio has been associated with higher muscle mass. Herein, we compared CysC- and sCr-based eGFR at serial time points among pts admitted with HF. We hypothesized that muscle mass would decline during HF admission and this would result in a decrease of sCr/CysC ratio. Methods: We pooled pts from 3 trials performed in pts admitted with HF (DOSE, ROSE and CARRESS-HF). eGFR was calculated using CKD-EPI-CysC equation (eGFRCysC) and sCr-based MDRD equation (eGFRsCr). The relative difference between eGFRCysC and eGFRsCr (ΔeGFR) was calculated as follows: (eGFRCysC-eGFRsCr)/ eGFRsCr. To control for confounders, we analyzed changes in sCr/CysC ratio and in ΔeGFR among pts with samples available at both admission and a subsequent time point. Results: A total of 2849 samples were available in 841 pts (age 68 ± 13, 26% female, left ventricular ejection fraction 36 ± 17%). Compared with eGFRsCr, eGFRCysC reclassified 50% of the samples to different GFR categories, mainly to more advanced renal dysfunction (Fig. A). eGFRCysC was significantly lower than eGFRsCr at all time points (Fig. B). From time of admission to all subsequent time points, sCr/CysC ratio declined while ΔeGFR widened (all p-values<0.001). At time of enrollment in CARRESS-HF, each additional day of HF admission was associated with a decline in sCr/CysC ratio of 1.5% (p=0.04). Conclusions: The use of CysC reclassifies a large proportion of pts admitted with HF to more advanced renal dysfunction when compared to sCr-based assessment. The discrepancy between CysC- and sCr-based eGFR appears to widen during HF admission, likely due to muscle mass wasting.