scholarly journals COVID19 Real-World Data for the US and Lessons to Re-Open Business

2020 ◽  
Author(s):  
Pascal J. Goldschmidt-Clermont
Keyword(s):  
Enterprise Resource Planning ◽  
Real World ◽  
Resource Planning ◽  
The United States ◽  
Lessons Learned ◽  
Planning System ◽  
Real World Data ◽  
World Data ◽  
The Us ◽  
Contact Tracking

AbstractIn March of 2020, the COVID19 pandemic had expanded to the United States of America (US). Companies designated as “essential” for the US had to maintain productivity in spite of the growing threat created by the SARS-CoV-2 virus. With this report, we present the response of one such company, the Lennar Corporation, a major homebuilder in the US. Within days, Lennar had implemented a morning health check via its enterprise resource planning system, to identify associates (employees) who were sick, or not in their “usual state of health”. With this survey, Lennar was able to ensure that no one sick would show up to work, and instead, would self-quarantine at home. Furthermore, with thorough contact tracking, associates exposed to COVID19 patients (suspected or RT-PCR test-confirmed), were also asked to self-quarantine. This survey, in addition to other safety measures, such as an overhaul of the company with nearly 50% of the company working from home, prolific communication, and many more measures, Lennar was able to function safely for its associates and successfully as an enterprise. The data that we present here are “real world data” collected in the context of working throughout a dreadful pandemic, and the lessons learned could be helpful to other companies that are preparing to return to work.

Real-world utilization and costs with biosimilar and reference filgrastim in patients with breast cancer receiving myelosuppressive chemotherapy in a community oncology setting from 2015 to 2017.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 57-57
Author(s):  
Robert M. Rifkin ◽  
Lisa Herms ◽  
Chuck Wentworth ◽  
Anupama Vasudevan ◽  
Kimberley Campbell ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Initial Period ◽  
The United States ◽  
Time Frame ◽  
Real World Data ◽  
Electronic Health Record Data ◽  
Myelosuppressive Chemotherapy ◽  
Community Oncology ◽  
The Us

57 Background: Biosimilars have potential to reduce healthcare costs and increase access in the United States, but lack of uptake has contributed to lost savings. Filgrastim-sndz was the first FDA-approved biosimilar, and much can be learned by evaluating its uptake. In February 2016, the US Oncology Network converted to filgrastim-sndz as its short-acting granulocyte colony-stimulating factor (GCSF) of choice for prevention of febrile neutropenia (FN) following myelosuppressive chemotherapy (MCT). To understand utilization and cost patterns, this study analyzes real-world data of GCSFs within a community oncology network during the initial period of conversion to the first biosimilar available in the US. Methods: This descriptive retrospective observational study used electronic health record data for female breast cancer (BC) patients receiving GCSF and MCT at high risk of FN. Patient cohorts were defined by first receipt of either filgrastim or filgrastim-sndz during the 410 days before and after biosimilar conversion. Healthcare resource utilization (HCRU) and costs for GCSF and complete blood counts (CBC) were collected at GCSF initiation through the earliest of 30 days following end of MCT, loss to follow up, death, or data cutoff. Results: 146 patients were identified: 81 (55.5%) filgrastim and 65 (44.5%) filgrastim-sndz. No directional differences existed in baseline characteristics between the cohorts. Higher proportions of filgrastim-sndz patients received dose-dense MCT (33.8% vs 22.2%). Time trends show an initial spike in HCRU and cost for filgrastim-sndz patients after formulary conversion, which subsequently decreased and converged to that of the filgrastim cohort after 12 months. When aggregated, the overall median total administration counts, per patient per month (PPPM) and dosage, were marginally higher for filgrastim-sndz (5 vs 3; 2.9 vs 1.4; 1920 vs 1440 mcg, respectively). Median PPPM costs were higher for filgrastim-sndz ($803 vs $545). Median CBC utilization and costs were higher for filgrastim-sndz (2.8 vs 2.5; $28 vs $23, respectively). Conclusions: This study provides insight into real-world HCRU and cost patterns after formulary conversion to a biosimilar for BC patients receiving MCT and GCSF. As a descriptive study, causal inferences cannot be made and an underlying effect from index chemotherapy cannot be excluded. Convergence of HCRU and costs after 12 months suggests that overall results may be driven by behavior at initial formulary switch. Since filgrastim-sndz was the first US biosimilar approved, the uptake may be indicative of an experience with biosimilar acceptance in general. Future real-world studies of biosimilars must consider inconsistent utilization and practice trends during the time frame directly following formulary conversion.

scholarly journals Transmission of SARS-CoV-2 Considering Shared Chairs in Outpatient Dialysis: A Real-World Case-Control Study

2021 ◽  
Author(s):  
Ravi Thadhani ◽  
Joanna Willetts ◽  
Catherine Wang ◽  
John Larkin ◽  
Hanjie Zhang ◽  
...  
Keyword(s):  
Real World ◽  
Case Control Study ◽  
The United States ◽  
Hemodialysis Patients ◽  
Case Control ◽  
Positive Patient ◽  
Sensitivity Analyses ◽  
Real World Data ◽  
World Data ◽  
Control Study

AbstractBackgroundSARS-CoV-2 is primarily transmitted through aerosolized droplets; however, the virus can remain transiently viable on surfaces.ObjectiveWe examined transmission within hemodialysis facilities, with a specific focus on the possibility of indirect patient-to-patient transmission through shared dialysis chairs.DesignWe used real-world data from hemodialysis patients treated between February 1st and June 8th, 2020 to perform a case-control study matching each SARS-CoV-2 positive patient (case) to a non-SARS-CoV-2 patient (control) in the same dialysis shift and traced back 14 days to capture possible exposure from chairs sat in by SARS-CoV-2 patients. Cases and controls were matched on age, sex, race, facility, shift date, and treatment count.Setting2,600 hemodialysis facilities in the United States.PatientsAdult (age ≥18 years) hemodialysis patients.MeasurementsConditional logistic regression models tested whether chair exposure after a positive patient conferred a higher risk of SARS-CoV-2 infection to the immediate subsequent patient.ResultsAmong 170,234 hemodialysis patients, 4,782 (2.8%) tested positive for SARS-CoV-2 (mean age 64 years, 44% female). Most facilities (68.5%) had 0 to 1 positive SARS-CoV-2 patient. We matched 2,379 SARS-CoV-2 positive cases to 2,379 non-SARS-CoV-2 controls; 1.30% (95%CI 0.90%, 1.87%) of cases and 1.39% (95%CI 0.97%, 1.97%) of controls were exposed to a chair previously sat in by a shedding SARS-CoV-2 patient. Transmission risk among cases was not significantly different from controls (OR=0.94; 95%CI 0.57 to 1.54; p=0.80). Results remained consistent in adjusted and sensitivity analyses.LimitationAnalysis used real-world data that could contain errors and only considered vertical transmission associated with shared use of dialysis chairs by symptomatic patients.ConclusionsThe risk of indirect patient-to-patient transmission of SARS-CoV-2 infection from dialysis chairs appears to be low.Primary Funding SourceFresenius Medical Care North America; National Institute of Diabetes and Digestive and Kidney Diseases (R01DK130067)

scholarly journals Estimating the Population Benefits and Costs of Rituximab Therapy in the United States from 1998 to 2013 Using Real-World Data

Medical Care ◽  
2016 ◽  
Vol 54 (4) ◽  
pp. 343-349 ◽  
Author(s):  
Mark D. Danese ◽  
Carolina M. Reyes ◽  
Michelle L. Gleeson ◽  
Marc Halperin ◽  
Sandra L. Skettino ◽  
...  
Keyword(s):  
United States ◽  
Real World ◽  
The United States ◽  
Real World Data ◽  
World Data ◽  
Benefits And Costs

Real-world outcomes of patients with BRAF-mutated mCRC treated in the United States.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4030-4030
Author(s):  
Matthew Braithwaite ◽  
Christopher Duane Nevala-Plagemann ◽  
Kelsey Baron ◽  
Benjamin Haaland ◽  
Lisa M. Pappas ◽  
...  
Keyword(s):  
United States ◽  
Real World ◽  
Braf Mutation ◽  
The United States ◽  
Survival Outcomes ◽  
Prognostic Impact ◽  
Braf Mutations ◽  
Real World Data ◽  
World Data ◽  
Significant Difference

4030 Background: BRAF mutations portend a poor prognosis in metastatic colorectal cancer (mCRC). Recent trials have hypothesized that using more aggressive triplet-based chemotherapy regimens such as FOLFOXIRI in the frontline setting may improve outcomes in this patient population. In this study, we utilized real-world data to assess whether FOLFOXIRI is being used in the United States (US) and compared survival outcomes in BRAF mutated (BRAFmt) mCRC stratified by first line (1L) therapy. Methods: The nationwide Flatiron Health EHR-derived de-identified database was reviewed for patients diagnosed with mCRC between 2013 and 2018. Patients who had documented BRAF mutation testing and received a standard 1L therapy were included for analysis. Patients who did not have a visit or medication order within 90 days of metastatic diagnosis were excluded to ensure patients were engaged with care at the data-providing institution. Kaplan-Meier and Cox proportional hazard modeling were used to compare survival outcomes stratified by BRAF mutation status and 1L therapy received. Results: A total of 4,454 patients with documented BRAF mutational status were included, of which 3,988 (89.5%) were BRAF wild type (BRAFwt) and 466 (10.5%) were BRAFmt. Median OS was 15.4 months (mo) in the BRAFmt group compared to 28.1 mo in the BRAFwt group (HR 0.48, 95% CI 0.41- 0.56, p < 0.001). Only 3% (n = 16) of BRAFmt patients received 1L FOLFOXIRI +/- bevacizumab with a median OS of 13.8 mo compared to 15.5 mo in patients receiving a chemotherapy doublet (FOLFOX, CAPEOX, or FOLFIRI) +/- bevacizumab (95% CI 4.9 – not reached vs 14.3 – 19.0, p = 0.38). In BRAFmt patients, multivariate analysis (MVA) did not detect a significant improvement in OS with the use of FOLFIRI plus bevacizumab (HR 0.88, 95% CI 0.50-1.56, p = 0.67) or FOLFOX/CAPEOX plus bevacizumab (HR 0.89, 95% CI 0.59 – 1.34, p = 0.58) when compared to chemotherapy doublet alone. A MVA comparing 1L therapies in the BRAFwt group did not detect a significant improvement in OS with bevacizumab plus chemotherapy doublet compared to chemotherapy doublet alone. When stratified by 1L treatment regimen, similar proportions of BRAFmt patients received second line therapy. Conclusions: This analysis of real-world data confirms the negative prognostic impact of BRAF mutations in mCRC and suggests that FOLFOXIRI has not been widely adopted in the management of these patients in the US. We were unable to demonstrate any significant difference in OS of patients with BRAFmt mCRC based on type of 1L therapy received.

scholarly journals Challenges in Phase 4 post-licensure safety studies using real world data in the United States: hepatitis B vaccine example

Vaccine X ◽  
2021 ◽  
pp. 100101
Author(s):  
Katia Bruxvoort ◽  
Lina S. Sy ◽  
Bradley K. Ackerson ◽  
Jeff Slezak ◽  
Lei Qian ◽  
...  
Keyword(s):  
United States ◽  
Hepatitis B ◽  
Real World ◽  
The United States ◽  
Hepatitis B Vaccine ◽  
Real World Data ◽  
World Data ◽  
Safety Studies
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