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Racial disparities among patients with multiple myeloma enrolled in clinical trials [Meeting Abstract]

Nishat, N; Bari, T; Islam, S; Braunstein, M J
Background: Tremendous therapeutic progress has been made over the past decade in the field of multiple myeloma (MM). Although the incidence of MM is twice as high for black compared to white individuals, mortality rates remain higher for black patients (Marinac, et al. Blood Ca J 2020). In addition, black Americans are significantly less likely to participate in clinical trials in general (Hong, et al. Am J Prev Med 2021), leading to disproportionate enrollment in studies of novel agents. Various factors may account for these disparities, including access to clinical trials, clinician bias, and hesitancy to enroll in clinical trials among different patient populations. Furthermore, underrepresentation of racial groups within clinical trials impacts the generalizability of important findings from these studies. Here we characterized the racial representation of MM clinical trials.
Method(s): Randomized clinical trials focused on MM interventions published between 2012-2022 were included. We screened 431 publications during this period and characterized racial demographics as available in the literature. A twosided Cochran-Armitage Trend Test was used to assess if there was a linear trend in the percentage of black participants in clinical trials over time.
Result(s): Among 431 studies published over the past 10 years, 76 collected over past 5 years that included racial demographic details were included. Among the 38,830 participants, 87.5% were white, 4.8% were black, and 7.7% were other (reported as either Asian, mixed, or other). There was a significant trend toward increased enrollment comparing over time between 2018 to 2021 (2.1 to 7.0%, p < 0.001 for trend), however black individual remained largely underrepresented in all these studies.
Conclusion(s): While the number of black participating in randomized controlled trials involving MM patients over the past five years is significantly increasing, these studies included a disproportionate number of white participants, despite the incidence of MM being higher for black patients. Efforts are underway in the field to enhance enrollment of underrepresented populations, including a recent randomized study that included 19% black MM patients (Richardson, et al. New Eng J Med 2022). Our study was limited due to many trials not reporting details about racial demographics until relatively recently. Further investigations required to examine the reasons underlying racial disparities in MM trial recruitment and enrollment
EMBASE:639386128
ISSN: 1527-7755
CID: 5366892

Improved Morbidity, Mortality, and Cost with Minimally Invasive Colon Resection Compared to Open Surgery

Hakmi, Hazim; Amodu, Leo; Petrone, Patrizio; Islam, Shahidul; Sohail, Amir H; Bourgoin, Michael; Sonoda, Toyooki; Brathwaite, Collin E M
Background and Objectives/UNASSIGNED:Despite the growth of minimally invasive surgery (MIS) in many specialties, open colon surgery is still routinely performed. The purpose of this study was to compare outcomes and costs between open colon and minimally invasive colon resections. Methods/UNASSIGNED:test was used for categorical variables. Multiple Logistic and Quintile regression were used for multivariable analyses. Results/UNASSIGNED:A total of 88,405 elective colon resections (open: 56,599; minimally invasive: 31,806) were reviewed. A significantly larger proportion of patients undergoing minimally invasive surgery were obese (body mass index > 30) compared to those undergoing open surgery (71.4% vs. 59.6%; p < 0.0001). As compared to minimally invasive colectomy, open colectomy patients had: a longer median length of stay [median (range): 7 (4-13) days vs. 4 (3 - 6) days, p < 0.0001], higher 30-day readmission rate [n = 8557 (15.1%) vs. 2815 (8.9%), p < 0.0001], higher mortality [n = 2590 (4.4%) vs. 107 (0.34%), p < 0.0001], and a higher total direct cost [median (range): $13,582 (9041-23,094) vs. $9013 (6748 - 12,649), p < 0.0001]. Multivariable models confirmed these findings. Conclusion/UNASSIGNED:Minimally invasive colon surgery has clear benefits in terms of length of stay, readmission rate, mortality and cost, and the routine use of open colon resection should be revaluated.
PMCID:9205462
PMID: 35815326
ISSN: 1938-3797
CID: 5268992

Assessment of Safety of Remdesivir in Covid -19 Patients with Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min per 1.73 m^2

Wang, Shan; Huynh, Christy; Islam, Shahidul; Malone, Brian; Masani, Naveed; Joseph, D'Andrea
PURPOSE/OBJECTIVE:Safety of remdesivir in patients with renal impairment is unknown. Incidence of liver injury secondary to remdesivir is also unknown. The objective of this study is to assess the incidence of acute kidney injury (AKI) and to trend the liver enzymes during remdesivir treatment and change in eGFR from baseline to end of treatment as well as 48 h post completion of remdesivir therapy. METHODS:This is a retrospective chart review study including adult patients admitted with COVID-19 receiving remdesivir with a baseline eGFR < 30 ml/min per 1.73 m^2 from December 2020 to May 2021. The primary outcome was to assess the incidence of AKI and hepatic injury. The secondary outcome was to assess the efficacy of remdesivir defined by change in oxygen requirement. RESULTS:Seventy-one patients were included in the study. Patients experienced an improvement in eGFR from baseline (T0) to end of remdesivir treatment (T1), as well as 48 h after the end of the treatment (T2) ( + 30.3% and + 30.6% respectively, P < .0001). Creatinine reduced from baseline (T0) to T1 and T2 (-20.9% and -20.5% respectively, P < .0001). Creatinine clearance improved from baseline to T1 and T2 ( + 26.6% and + 26.2% respectively, p < .0001). Elevation of aminotransferase (AST) was observed at T1 ( + 2.5%, P  =  .727), however, AST reduction was seen at T2 (-15.8%, P  =  .021). Elevation in alanine transaminase (ALT) was observed at T1 and T2 ( + 25% and + 12%, P  =  .004 and P  =  .137 respectively). Both direct and total bilirubin remained stable and were not significantly changed from baseline. CONCLUSION/CONCLUSIONS:Our study showed that remdesivir use in renally-impaired patients with eGFR < 30 ml/min is safe. Remdesivir may be considered as a therapeutic option in this population with COVID-19 infection.
PMID: 34967255
ISSN: 1525-1489
CID: 5138362

Are Orthopaedic Trauma Surgeons Adequately Compensated for Longer Procedures? An Analysis of Relative Value Units and Operative Times from the ACS-NSQIP database

Simcox, Trevor; Becker, Jacob; Kreinces, Jason; Islam, Shahidul; Grossman, Mark; Gould, Jason
BACKGROUND:The physician work Relative Value Unit (wRVU) scale is the primary determinant of compensation. Operative time, technical skill, effort, and surgical complexity contribute to wRVU allocation. The aim of this study is to identify the relationship between these factors and reimbursement for trauma procedures. METHODS:The National Surgical Quality Improvement Program (NSQIP) database was queried for orthopedic trauma procedures from 2016-18. Physician wRVU data was obtained from the 2020 Centers for Medicare & Medicaid Services fee schedule. The primary outcome measured was mean wRVU per minute of operative time (wRVU/min). Wilcoxon rank-sum test and quantile regression were used to determine the association between wRVU, operative time, complication rate, upper or lower extremity procedure, and wRVU/min. RESULTS:63 CPT codes or 107,171 cases queried. Median wRVU/min was significantly lower for longest 50% of procedures (0.119vs0.160, p<0.001) and higher for the top 50% with regard to complication rate (0.161vs0.124, p<0.001). Upper extremity procedures were reimbursed less than lower extremity (0.110vs0.145, p<0.001). Quintile regression showed that adjusted for complication rate, median wRVU/min decreased by 0.0005 (95% CI: 0.0007-0.0003, R1=0.27, p<0.001) for every additional minute of operative time. CONCLUSIONS:The 2020 wRVU scale does not allocate sufficient wRVUs to orthopedic trauma procedures with longer mean operative time or to procedures performed on the upper extremity. There is a negative correlation between operative time and hourly reimbursement, equating to a decrease of $64.96/hour per hour of operation. LEVEL OF EVIDENCE/METHODS:Economic Level III. See Instructions for Authors for a complete description of levels of evidence.
PMID: 34369456
ISSN: 1531-2291
CID: 5034772

Correlation of hemoglobin A1c and outcomes in patients hospitalized with COVID-19

Patel, Amy J; Klek, Stanislaw P; Peragallo-Dittko, Virginia; Goldstein, Michael; Burdge, Eric; Nadile, Victoria; Ramadhar, Julia; Islam, Shahidul; Rothberger, Gary D
BACKGROUND:) level and poor outcomes in hospitalized patients with diabetes and COVID-19. METHODS:results for each patient were divided into quartiles; 5.1-6.7% (32-50 mmol/mol), 6.8-7.5% (51-58 mmol/mol), 7.6-8.9% (60-74 mmol/mol), and >9% (>75 mmol/mol). The primary outcome was in-hospital mortality. Secondary outcomes included admission to an intensive care unit, invasive mechanical ventilation, acute kidney injury, acute thrombosis, and length of hospital stay. RESULTS:Five hundred and six patients were included. The number of deaths within quartiles 1 through 4 were 30 (25%), 37 (27%), 34 (27%) and 24 (19%), respectively. There was no statistical difference in the primary or secondary outcomes between the quartiles except acute kidney injury was less frequent in quartile 4. CONCLUSIONS:should not be used for risk stratification in these patients.
PMCID:8286241
PMID: 34284145
ISSN: 1530-891x
CID: 4981152

Utility of thyroid function testing in the inpatient setting [Meeting Abstract]

Goldstein, M; Piccione, J; Migasiuk, L; Islam, S; Rothberger, G
Thyroid function tests (TFTs) are routinely checked in hospitalized patients with or without pre-existing thyroid disease, sometimes even without suspicion of thyroid derangement. Although alternative diagnoses may explain presentations, cultural norms often encourage routine assessment. The objective of this study was to evaluate whether routine measurement of TFTs is beneficial, unnecessary, or even harmful in cost-effective care for hospitalized patients. This is a retrospective observational study of 2278 patients admitted to an academic hospital over a 5.5-month period who had their TFTs checked. Chart notes were reviewed to evaluate for preadmission diagnosis of thyroid disease and clinical indications for ordering TFTs. Results of thyroid function testing were reviewed. Medical records of those with abnormal TFTs were reviewed to assess whether thyroid medication was initiated or adjusted. Of the thyroid function tests ordered, 20.1% were ordered due to suspicion of thyroid dysfunction, 20.8% due to history of thyroid disease, and 59.0% for reasons not directly related to thyroid dysfunction. 27.3% of those tested had abnormal results. The percentage of abnormal TFTs that led to medication initiation or adjustment was 15.1%, 12.1%, and 5.7%, for those tested on the basis of history of thyroid disease, suspicion of thyroid dysfunction, and reasons not directly related to thyroid dysfunction, respectively. Overall, 65 patients were started on thyroid medication or had the dosage of their thyroid medication adjusted, which represents 10.4% of those with abnormal TFTs and only 2.9% of those tested. Abnormal thyroid function test results are common, but a disproportionate amount of tests are needed to find a small percentage of clinically significant thyroid dysfunction, of which only a low percentage lead to changes in management. TFTs checked for reasons not directly related to thyroid dysfunction had the lowest percentage of results that led to medication initiation or adjustment, while those checked on the basis of history of thyroid disease had the highest. Education on this topic should be provided to inpatient providers to limit thyroid function testing to instances in which they are clinically indicated and abnormal results would lead to changes in management
EMBASE:636273775
ISSN: 1557-9077
CID: 5179412

Low-Dose Tocilizumab With High-Dose Corticosteroids in Patients Hospitalized for COVID-19 Hypoxic Respiratory Failure Improves Mortality Without Increased Infection Risk

Brosnahan, Shari B; Chen, Xian Jie Cindy; Chung, Juri; Altshuler, Diana; Islam, Shahidul; Thomas, Sarun V; Winner, Megan D; Greco, Allison A; Divers, Jasmin; Spiegler, Peter; Sterman, Daniel H; Parnia, Sam
BACKGROUND:Severe hypoxic respiratory failure from COVID-19 pneumonia carries a high mortality risk. There is uncertainty surrounding which patients benefit from corticosteroids in combination with tocilizumab and the dosage and timing of these agents. The balance of controlling inflammation without increasing the risk of secondary infection is difficult. At present, dexamethasone 6 mg is the standard of care in COVID-19 hypoxia; whether this is the ideal choice of steroid or dosage remains to be proven. OBJECTIVES/OBJECTIVE:The primary objective was to assess the impact on mortality of tocilizumab only, corticosteroids only, and combination therapy in patients with COVID-19 respiratory failure. METHODS:A multihospital, retrospective study of adult patients with severe respiratory failure from COVID-19 who received supportive therapy, corticosteroids, tocilizumab, or combination therapy were assessed for 28-day mortality, biomarker improvement, and relative risk of infection. Propensity-matched analysis was performed between corticosteroid alone and combination therapies to further assess mortality benefit. RESULTS:= 0.005] without increasing the risk of infection. CONCLUSION AND RELEVANCE/UNASSIGNED:Combination of tocilizumab and corticosteroids was associated with improved 28-day survival when compared with corticosteroids alone. Modification of steroid dosing strategy as well as steroid type may further optimize therapeutic effect of the COVID-19 treatment.
PMID: 34180274
ISSN: 1542-6270
CID: 4926192

Seasonal variation of respiratory viral infections: a comparative study between children with cancer undergoing chemotherapy and children without cancer

Dror, Tal; Akerman, Meredith; Noor, Asif; Weinblatt, Mark E; Islam, Shahidul; Glasser, Chana L
Respiratory viral infections (RVIs) affect children year-round, with seasonal-specific patterns. Pediatric oncology patients are uniquely vulnerable to infection, but whether this predisposes them to different patterns of RVIs than healthy children is unknown. There is also limited data on the impact of RVIs on cancer patients. We conducted a retrospective study of children ages 1-21 with cancer presenting to the clinic and emergency department (ED) and a randomly selected subset of patients without cancer presenting to the ED who had positive nasopharyngeal viral polymerase chain reactions at our institution from 2014 to 2019. Sixty-seven cancer patients (206 RVI episodes) and 225 pediatric non-cancer patients (237 RVI episodes) were included. Human rhino/enterovirus (HRE) was the most common infection in both groups in the spring, summer, and fall. In the winter, the most common RVI was influenza in cancer patients verses respiratory syncytial virus in non-cancer patients. On age-adjusted analysis, the likelihood of detecting coronavirus in the winter, HRE in the spring and fall, and parainfluenza in the summer was significantly greater in cancer patients (OR = 2.60, 2.52, 5.73, 3.59 respectively). Among cancer RVI episodes, 50% received parenteral antibiotics, 22% were severely neutropenic, 22% had chemotherapy delays for a median of six days, 16% were hospitalized, and 6% received intravenous immunoglobulin. We conclude that there are differences in the seasonal patterns of RVIs between children with and without cancer. RVIs also cause significant morbidity in children with cancer.
PMID: 33792490
ISSN: 1521-0669
CID: 4830992

COVID-19 Antibodies and Outcomes among Outpatient Maintenance Hemodialysis Patients

Khatri, Minesh; Islam, Shahidul; Dutka, Paula; Carson, John; Drakakis, James; Imbriano, Louis; Jawaid, Imran; Mehta, Tapan; Miyawaki, Nobuyuki; Wu, Elain; Yang, Stephen; Ali, Nicole; Divers, Jasmin; Grant, Candace; Masani, Naveed
Background/UNASSIGNED:Patients on maintenance hemodialysis are particularly vulnerable to infection and hospitalization from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Due to immunocompromised patients and the clustering that occurs in outpatient dialysis units, the seroprevalence of COVID-19 antibodies in this population is unknown and has significant implications for public health. Also, little is known about their risk factors for hospitalization. Methods/UNASSIGNED:nasopharyngeal, real-time, reverse-transcriptase PCR (RT-PCR); SARS-CoV-2 IgG seropositivity; hospitalization; and mortality. Results/UNASSIGNED:<0.001) compared with those who tested negative. Higher positivity rates were also observed among those who took taxis and ambulettes to and from dialysis, compared with those who used personal transportation. Antibodies were detected in all of the patients with a positive PCR result who underwent serologic testing. Of those that were seropositive, 32% were asymptomatic. The hospitalization rate on the basis of either antibody or PCR positivity was 35%, with a hospital mortality rate of 33%. Aside from COPD, no other variables were more prevalent in patients who were hospitalized. Conclusions/UNASSIGNED:We observed significant differences in rates of COVID-19 infection within three outpatient dialysis units, with universal seroconversion. Among patients with ESKD, rates of asymptomatic infection appear to be high, as do hospitalization and mortality rates.
PMCID:8740990
PMID: 35373027
ISSN: 2641-7650
CID: 5219442

Continuous Subcutaneous Insulin Infusions vs. Multiple Daily Injections of Insulin in Hospitalized Patients: Glycemic Trends in the First 24 Hours of Admission

Halstrom, Amanda; Moledina, Iram; Peragallo-Dittko, Virginia; Ancona, Karena; Islam, Shahidul; Klek, Stanislaw; Rothberger, Gary
BACKGROUND/UNASSIGNED:Continuous subcutaneous insulin infusion (CSII) is a common diabetes treatment modality. Glycemic outcomes of patients using CSII in the first 24 hours of hospitalization have not been well studied. This timeframe is of particular importance because insulin pump settings are programmed to achieve tight outpatient glycemic targets which could result in hypoglycemia when patients are hospitalized. METHODS/UNASSIGNED:This retrospective cohort study evaluated 216 hospitalized adult patients using CSII and 216 age-matched controls treated with multiple daily injections (MDI) of insulin. Patients using CSII did not make changes to pump settings in the first 24 hours of admission. Blood glucose (BG) values within the first 24 hours of admission were collected. The primary outcome was frequency of hypoglycemia (BG < 70 mg/dL). Secondary outcomes were frequency of severe hypoglycemia (BG < 40 mg/dL) and hyperglycemia (BG ≥ 180 mg/dL). RESULTS/UNASSIGNED: = 0.06). CONCLUSIONS/UNASSIGNED:Patients using CSII experienced fewer events of both hypoglycemia and hyperglycemia in the first 24 hours of hospital admission than those treated with MDI. Our study demonstrates that CSII use is safe and effective for the treatment of diabetes within the first 24 hours of hospital admission.
PMID: 33563036
ISSN: 1932-2968
CID: 4931892