scholarly journals Looking in the medicine cabinet: methods for using real-world data to assess the impact of measles, mumps and rubella (MMR) and recombinant adjuvanted varicella-zoster vaccines on coronavirus disease 2019 (COVID-19) prevention and case fatality

2021 ◽  
Vol 5 ◽  
pp. 115
Author(s):  
Douglas McNair ◽  
Hao Hu ◽  
Casey Selwyn
Keyword(s):  
Real World ◽  
Case Fatality ◽  
Data Interpretation ◽  
The United States ◽  
Zoster Vaccine ◽  
Real World Data ◽  
World Data ◽  
Varicella Zoster ◽  
Viral Vaccines ◽  
The Impact

Background: Analysis of real-world data can be used to identify promising leads and dead ends among products being repurposed for clinical practice for coronavirus disease 2019 (COVID-19).  This paper uses real-world data from Cerner Labs collected from 90 source institutions in the United States to assess the potential impact of live viral vaccines on COVID-19 case fatality rates. Methods: We identified 373,032 polymerase chase reaction (PCR)-positive COVID-19 cases in the Cerner Labs database between 01-MAR-2020 and 31-DEC-2020 and identified patients that had received measles, mumps and rubella (MMR) or a recombinant adjuvanted varicella-zoster vaccine within the previous 5 years. We calculated heterogeneity scores to support interpretation of results across institutions, and used stepwise forward variable selection to construct covariable-based propensity scores. These scores were used to match cases and control for biasing and confounding issues inherent in observational data. Results: Neither the recombinant adjuvanted varicella-zoster vaccine nor MMR showed significant efficacy in prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We could not derive clinically significant results on the impact of MMR for case fatality rates due to persistently high rates of heterogeneity between institutions. However, we were able to achieve acceptable levels of heterogeneity for the analysis of the recombinant adjuvanted varicella-zoster vaccine, and found a clinically meaningful benefit of reduced case fatality rate, with an odds ratio of 0.43 (95% confidence interval [CI]: 0.38 – 0.48). Conclusions: Using propensity score matching and heterogeneity statistics can help guide our interpretation of real-world data, and rigorous statistical methods are needed to reduce bias or disparities in data interpretation. Applying these methods to the impact of live viral vaccines on COVID-19 case fatalities yields actionable findings for further analysis.

scholarly journals Role of efficient testing and contact tracing in mitigating the COVID-19 pandemic: a network modelling study

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e045886
Author(s):  
Yiying Hu ◽  
Jianying Guo ◽  
Guanqiao Li ◽  
Xi Lu ◽  
Xiang Li ◽  
...  
Keyword(s):  
Real World ◽  
Case Fatality ◽  
Contact Tracing ◽  
Secondary Outcome ◽  
Time Interval ◽  
Fatality Rate ◽  
Real World Data ◽  
Network Modelling ◽  
World Data ◽  
Quantitative Evidence

ObjectivesThis study quantified how the efficiency of testing and contact tracing impacts the spread of COVID-19. The average time interval between infection and quarantine, whether asymptomatic cases are tested or not, and initial delays to beginning a testing and tracing programme were investigated.SettingWe developed a novel individual-level network model, called CoTECT (Testing Efficiency and Contact Tracing model for COVID-19), using key parameters from recent studies to quantify the impacts of testing and tracing efficiency. The model distinguishes infection from confirmation by integrating a ‘T’ compartment, which represents infections confirmed by testing and quarantine. The compartments of presymptomatic (E), asymptomatic (I), symptomatic (Is), and death with (F) or without (f) test confirmation were also included in the model. Three scenarios were evaluated in a closed population of 3000 individuals to mimic community-level dynamics. Real-world data from four Nordic countries were also analysed.Primary and secondary outcome measuresSimulation result: total/peak daily infections and confirmed cases, total deaths (confirmed/unconfirmed by testing), fatalities and the case fatality rate. Real-world analysis: confirmed cases and deaths per million people.Results(1) Shortening the duration between Is and T from 12 to 4 days reduces infections by 85.2% and deaths by 88.8%. (2) Testing and tracing regardless of symptoms reduce infections by 35.7% and deaths by 46.2% compared with testing only symptomatic cases. (3) Reducing the delay to implementing a testing and tracing programme from 50 to 10 days reduces infections by 35.2% and deaths by 44.6%. These results were robust to sensitivity analysis. An analysis of real-world data showed that tests per case early in the pandemic are critical for reducing confirmed cases and the fatality rate.ConclusionsReducing testing delays will help to contain outbreaks. These results provide policymakers with quantitative evidence of efficiency as a critical value in developing testing and contact tracing strategies.

PD-0776 A Bayesian approach to evaluate the impact of change in IGRT protocol using real world data

2021 ◽  
Vol 161 ◽  
pp. S608
Author(s):  
I. Fornacon-Wood ◽  
H. Mistry ◽  
C. Johnson-Hart ◽  
J.P.B. O’Connor ◽  
C. Faivre-Finn ◽  
...  
Keyword(s):  
Bayesian Approach ◽  
Real World ◽  
Real World Data ◽  
World Data ◽  
The Impact

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)

VP08 Real-World Data Use In Health Technology Assessments: A Comparison Of Five Health Technology Assessment Agencies

2017 ◽  
Vol 33 (S1) ◽  
pp. 149-150
Author(s):  
Amr Makady ◽  
Ard van Veelen ◽  
Anthonius de Boer ◽  
Hans Hillege ◽  
Olaf Klunger ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Relative Effectiveness ◽  
Internal Validity ◽  
Health Technology ◽  
Real World Data ◽  
World Data ◽  
The Impact

INTRODUCTION:Reimbursement decisions are usually based on evidence from randomized controlled trials (RCT) with high internal validity but lower external validity. Real-World Data (RWD) may provide complimentary evidence for relative effectiveness assessments (REA's) and cost-effectiveness assessments (CEA's) of treatments. This study explores to which extent RWD is incorporated in REA's and CEA's of drugs used to treat metastatic melanoma (MM) by five Health Technology Assessment (HTA) agencies.METHODS:Dossiers for MM drugs published between 1 January 2011 and 31 December 2016 were retrieved for HTA agencies in five countries: the United Kingdom (NICE), Scotland (SMC), France (HAS), Germany (IQWiG) and the Netherlands (ZIN). A standardized data-extraction form was used to extract data on RWD mentioned in the assessment and its impact on appraisal (for example, positive, negative, neutral or unknown) for both REA and CEA.RESULTS:In total, fourty-nine dossiers were retrieved: NICE = 10, SMC = 13, IQWiG = 16, HAS = 8 and ZIN = 2. Nine dossiers (18.4 percent) included RWD in REA's for several parameters: to describe effectiveness (n = 5) and/or the safety (n = 2) of the drug, and/or the prevalence of MM (n = 4). CEA's were included in 25/49 dossiers (IQWiG and HAS did not perform CEA's). Of the twenty-five CEA's, twenty (80 percent) included RWD to extrapolate long-term effectiveness (n = 19), and/or identify costs associated with treatments (n = 7). When RWD was included in REA's (n = 9), its impact on the appraisal was negative (n = 4), neutral (n = 2), unknown (n = 1) or was not discussed in the appraisal (n = 2). When RWD was included in CEA's (n = 11), its impact on the appraisal varied between positive (n = 2), negative (n = 5) and unknown (n = 4).CONCLUSIONS:Generally, RWD is more often included in CEA's than REA's (80 percent versus 18.4 percent, respectively). When included, RWD was mostly used to describe the effectiveness of the drug (REA) or to predict long-term effectiveness (CEA). The impact of RWD on the appraisal varied greatly within both REA's and CEA's.

550 Real World Treatment Trends for Patients TBSA ≤ 20%: Evaluating Important Shifts in Care and Budget Impact of ASCS Adoption

2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S115-S115
Author(s):  
James H Holmes ◽  
Stacey Kowal ◽  
Cheryl P Ferrufino
Keyword(s):  
Survey Data ◽  
Resource Use ◽  
Real World ◽  
Budget Impact ◽  
Patient Characteristics ◽  
Real World Data ◽  
Treatment Pathways ◽  
World Data ◽  
Burn Care ◽  
The Impact

Abstract Introduction Treatment pathways in burn care are typically determined based on burn center (BC) and patient characteristics, although decisions may be influenced by anecdotal experience, personal preference, and hospital policies/purchasing decisions. Health economic (HE) evaluations can support improved decision-making, identifying the most cost-effective interventions for tailored care. A novel burn care model (BEACON) was developed with burn surgeons over several years and validated through numerous publications, including an assessment of the HE impacts of autologous skin cell suspension (ASCS) use for definitive burn closure. To ensure that BEACON accurately represents the current state of care, it is vital to update data that underpins model projections. This study collected real world data on practice patterns and patient outcomes for the most commonly seen burns (TBSA ≤ 20%) to update the current understanding of standard of care (SOC) costs and outcomes and to refine estimates on the impact of ASCS use in TBSA ≤ 20% patients. Methods Data was collected from a 10% sample of BCs, including: BC and patient characteristics, resource use, inpatient costs, and length of stay (LOS). NBR based inputs in BEACON were updated to reflect survey data for patients with TBSA ≤ 20%, with the ability to view data as a national aggregate sample and across BC characteristics. BEACON estimates patient and BC costs and outcomes across a spectrum of patient profiles (age, gender, inhalation injury, comorbidity status, burn depth, TBSA) and combines information on each patient profile to understand annual budget impact. Key outcomes were compared across the survey sample and published NBR trends. Using the updated BEACON, the BC budget impact of ASCS in burns TBSA ≤ 20% was assessed. Results The survey was collected from 16+ BCs, focusing on inpatient encounters in 2018. LOS was lower than NBR estimates, with some centers reporting LOS per %TBSA far below 1 d/%TBSA. Using the detailed bottom-up estimation of cost from BEACON with survey data, trends suggest total hospital costs for SOC are lower than published NBR charges given shorter LOS and updated cost and resource use assumption. Conclusions Compared to NBR 8.0, contemporary data suggests that fewer small TBSA burns are being treated in the inpatient setting; those treated have a LOS below NBR estimates. When using real world data, the impact of ASCS use in burns TBSA ≤ 20% was still calculated to be cost saving to a BC overall, given reductions in LOS and number of definitive closure procedures. Incorporating ASCS into appropriate TBSA ≤ 20% procedures can still result in a positive financial impact for BCs. Applicability of Research to Practice

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
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