scholarly journals Validation of a Mortality Composite Score in the Real-World Setting: Overcoming Source-Specific Disparities and Biases

2021 ◽  
pp. 401-413
Author(s):  
Michelle H. Lerman ◽  
Benjamin Holmes ◽  
Daniel St Hilaire ◽  
Mary Tran ◽  
Matthew Rioth ◽  
...  
Keyword(s):  
Real World ◽  
High Sensitivity ◽  
The United States ◽  
Composite Score ◽  
Data Sources ◽  
Mortality Data ◽  
National Death Index ◽  
Real World Data ◽  
The Real ◽  
Real World Setting

PURPOSE This study tested whether a composite mortality score could overcome gaps and potential biases in individual real-world mortality data sources. Complete and accurate mortality data are necessary to calculate important outcomes in oncology, including overall survival. However, in the United States, there is not a single complete and broadly applicable mortality data source. It is further likely that available data sources are biased in their coverage of sex, race, age, and socioeconomic status (SES). METHODS Six individual real-world data sources were combined to develop a high-quality composite mortality score. The composite score was benchmarked against the gold standard for mortality data, the National Death Index. Subgroup analyses were then conducted to evaluate the completeness and accuracy by sex, race, age, and SES. RESULTS The composite mortality score achieved a sensitivity of 94.9% and specificity of 92.8% compared with the National Death Index, with concordance within 1 day of 98.6%. Although some individual data sources show significant coverage gaps related to sex, race, age, and SES, the composite score maintains high sensitivity (84.6%-96.1%) and specificity (77.9%-99.2%) across subgroups. CONCLUSION A composite score leveraging multiple scalable sources for mortality in the real-world setting maintained strong sensitivity, specificity, and concordance, including across sex, race, age, and SES subgroups.

Real-world data on usage of scalp cooling for chemotherapy associated alopecia in the United States.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18739-e18739
Author(s):  
Nicole Olivia Williams ◽  
Richard Paxman ◽  
Emma Thornhill ◽  
Mahmoud Kassem ◽  
Michael Grimm ◽  
...  
Keyword(s):  
Hair Loss ◽  
Real World ◽  
The United States ◽  
Scalp Cooling ◽  
Real World Data ◽  
The Real ◽  
System A ◽  
The Usa ◽  
Number Of Cycles ◽  
Cancer Network

e18739 Background: Hair loss is a well-known side effect of chemotherapy. The Paxman Hair Loss Prevention System, a scalp cooling device, has been shown to be effective in reducing chemotherapy induced alopecia in patients receiving chemotherapy (Nangia, JAMA, 2017). The National Comprehensive Cancer Network and the European Society for Medical Oncology guidelines have recommended scalp cooling as category 2A and 2B options, respectively. Methods: The real world use of scalp cooling using the Paxman device, as documented by orders through the Paxman Hub during the years of 2017-2020 was summarized. Descriptive statistics were used to summarize demographics and utilization. Results: Data from 6649 patients who used scalp cooling were reviewed. Patients with breast cancer were the most common users of scalp cooling (78%, n=5197) followed by gynecology (12%, n=775), gastrointestinal (3%, n=201), lung (1%, n=81) and genitourinary (1%, n=52). The majority of patients were between the ages of 45-65 (55%), followed by 65-74 (18%), older than 75 (5%), and 25-44 (2%). Average number (#) of cycles of cooling completed was 6.53 (range of average # of cycles 4.50-12). Scalp cooling with this device was commonly used in 39 out of 50 states. Conclusions: This is the largest report of scalp cooling usage in the real world setting in the USA, including scalp cooling usage in older adults. Uptake of scalp cooling across various cancers has not been uniform and this deserves further study.

Real-world treatment and outcomes of frontline chemotherapy in patients with metastatic pancreatic cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16249-e16249
Author(s):  
Salwan Al Mutar ◽  
Muhammad Shaalan Beg ◽  
Eric Hansen ◽  
Andrew J. Belli ◽  
Maegan Vaz ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Real World ◽  
Univariate Analysis ◽  
The United States ◽  
Metastatic Pancreatic Cancer ◽  
Future Research ◽  
Real World Data ◽  
The Real ◽  
The Impact

e16249 Background: The difference between the FOLFIRINOX and gemcitabine/nab-paclitaxel (GnP) regimens’ clinical trial designs limit the ability to generate cross-study comparisons. Therefore, there is a significant need to understand the impact of various demographic and clinical characteristics on the effectiveness of these systemic therapies in the real-world treatment setting. This study seeks to compare the real-world outcomes of patients with metastatic pancreatic cancer treated with frontline FOLFIRINOX or GnP. Methods: Patients with primary metastatic pancreatic cancer who received first-line (1L) FOLFIRINOX or GnP were identified in the COTA real-world database. The COTA database is a de-identified database of real-world data (RWD) derived from the electronic health records of healthcare providers in the United States. Real-world overall response rate (rwORR) was calculated as the proportion of patients achieving complete response (CR) or partial response (PR). Overall survival (OS) was calculated using the Kaplan-Meier method and multivariate analyses utilized Cox proportional hazards. Results: The overall qualified cohort (n=236) was stratified by 1L FOLFIRINOX (n=109) or GnP (n=127). Select patient characteristics are shown in table. Patients treated with 1L FOLFIRINOX showed greater rwORR as compared to those treated with GnP (68.8% vs. 55.9%, p=0.04). Additionally, patients treated with 1L FOLFIRINOX had longer median OS (14.4 vs 11.4 mos, respectively). In univariate analysis, patients treated with GnP had a greater chance of mortality (HR: 1.3, 95% CI: 1.0, 1.8, p=0.05). This relationship strengthened in multivariate analysis (GnP treated HR: 1.6, 95% CI: 1.1, 2.1, p=0.01). Conclusions: Due to lack of enrollment of representative patients in clinical trials and in the absence of a comparative clinical trial, real-world experience with chemotherapy regimens provide critical insights on the outcome of treatments. In our cohort, patients treated with frontline GnP had a significantly greater chance of mortality as compared to patients treated with frontline FOLFIRINOX. The FOLFIRINOX cohort also showed greater rwORR. Future research will continue to expand on treatment patterns in subsequent lines of therapy, as well as emerging therapy types, in order to better understand the optimal treatment sequence in metastatic pancreatic cancer.[Table: see text]

Abstract 229: Real-world hsCRP Testing, With a Potential to Evaluate Residual Inflammatory Cardiovascular Risk, Among Patients With History of Myocardial Infarction in the United States: A Retrospective Database Analysis

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Celine Deschaseaux ◽  
Puza Sharma ◽  
Anders Gabrielsen ◽  
Athanasio Siadimas ◽  
Melissa Bauer ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Real World ◽  
Vascular Inflammation ◽  
High Sensitivity ◽  
Patient Characteristics ◽  
The United States ◽  
Low Grade ◽  
Systematic Effect ◽  
The Real ◽  
History Of

Background: C-reactive protein can be measured by a high-sensitivity assay (hsCRP) to detect persistent low grade vascular inflammation predictive of cardiovascular (CV) risk in patients with history of myocardial infarction (MI). However, the real-world use of hsCRP testing among patient with history of MI, and hence the contemporary usage to address residual inflammatory risk, is unknown Methods: Patients with ≥1 claim with an inpatient, primary diagnosis for MI (ICD-9-CM code: 410.xx) between 01 October 2011 to 30 September 2014 (the most recent set as an index) in MarketScan and 1 year continuous enrolment pre- and post-hospital admission were included Results: A total of 71,071 patients (mean age 63.6 years, 67.6% males) were included. The hsCRP measurement was performed in 3.3% patients (CCAE: 4.7%; Medicare: 1.3%) with a mean time of 4.3 months after the index MI; 81.7% of patients were tested ≥30 days after the index MI. Patient characteristics and resource uses were similar among hsCRP tested and non-tested patients (Table 1) Conclusion: hsCRP testing with a potential to evaluate residual inflammatory CV risk is not used widely in routine clinical practice in US patients with history of MI. No systematic effect of hsCRP testing was observed with respect to patient characteristics and resource use. Further research is warranted to understand and describe the real-world usage of hsCRP testing to evaluate residual inflammatory risk and the associated patient characteristics, outcomes and burden of disease

scholarly journals Characteristics and Absolute Survival of Metastatic Colorectal Cancer Patients Treated With Biologics: A Real-World Data Analysis From Three European Countries

2021 ◽  
Vol 11 ◽  
Author(s):  
Katja A. Oppelt ◽  
Josephina G. Kuiper ◽  
Ylenia Ingrasciotta ◽  
Valentina Ientile ◽  
Ron M. C. Herings ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Real World ◽  
European Countries ◽  
Real World Data ◽  
Exclusion Criteria ◽  
The Real ◽  
Randomized Controlled ◽  
Real World Setting ◽  
The Mean ◽  
Colorectal Cancer Patients

Introduction: Biologics were approved for the treatment of advanced colorectal cancer (CRC) based on favorable benefit-risk-assessments from randomized controlled trials (RCTs), but evidence on their use in the real-world setting is scarce. Based on descriptive analyses we therefore aimed to assess characteristics and survival of CRC patients treated with biologics using large healthcare databases from three European countries (Netherlands, Italy, Germany).Methods: We included CRC patients treated with a biologic in 2010 or 2014 and characterized them regarding age, sex, comorbidities, and absolute survival.Results: Among 4,758 patients, the mean age ranged from 64.8 to 66.8 years, the majority was male, and comorbidities used as exclusion criteria in RCTs were coded in up to 30% of these patients. The proportion of bevacizumab users decreased between 2010 (72–93%) and 2014 (63–85%). In 2014, the absolute 12-month survival in new users was 64% (95% CI 51–77%), 56% (30–80%), and 61% (58–63%) in the Dutch, Italian, and German database, respectively, varying by age and comorbidity.Conclusions: Our study suggests that in the real-world setting, CRC patients treated with biologics are older and less selected regarding comorbidities compared to patients in RCTs, potentially explaining the relatively low 12-month survival we found. Treatment decisions in the real-world setting may require careful evaluation given that the risk-benefit ratio may vary depending on age and co-existing conditions.

scholarly journals Management of Patients with Metastatic Castration-Sensitive Prostate Cancer in the Real-World Setting in the United States

2021 ◽  
Author(s):  
Charles J. Ryan ◽  
Xuehua Ke ◽  
Marie-Hélène Lafeuille ◽  
Hela Romdhani ◽  
Frederic Kinkead ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Real World ◽  
The United States ◽  
The Real ◽  
Real World Setting

Trends in Insulin Therapy—A1C and Age at the Time of Insulin Initiation in the Real-World Setting

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 2328-PUB
Author(s):  
RAJIV KOVIL ◽  
MANOJ S. CHAWLA ◽  
PURVI M. CHAWLA ◽  
MIKHIL C. KOTHARI ◽  
AMBARI F. SHAIKH
Keyword(s):  
Insulin Therapy ◽  
Real World ◽  
Insulin Initiation ◽  
The Real ◽  
Real World Setting

scholarly journals Parameter Optimization for Real-World ENSO Forecast in an Intermediate Coupled Model

2019 ◽  
Vol 147 (5) ◽  
pp. 1429-1445 ◽  
Author(s):  
Yuchu Zhao ◽  
Zhengyu Liu ◽  
Fei Zheng ◽  
Yishuai Jin
Keyword(s):  
Data Assimilation ◽  
Parameter Optimization ◽  
Real World ◽  
Climate Models ◽  
Coupled Model ◽  
Prediction Skill ◽  
Model Parameters ◽  
Real World Data ◽  
The Real ◽  
Advection Term

Abstract We performed parameter estimation in the Zebiak–Cane model for the real-world scenario using the approach of ensemble Kalman filter (EnKF) data assimilation and the observational data of sea surface temperature and wind stress analyses. With real-world data assimilation in the coupled model, our study shows that model parameters converge toward stable values. Furthermore, the new parameters improve the real-world ENSO prediction skill, with the skill improved most by the parameter of the highest climate sensitivity (gam2), which controls the strength of anomalous upwelling advection term in the SST equation. The improved prediction skill is found to be contributed mainly by the improvement in the model dynamics, and second by the improvement in the initial field. Finally, geographic-dependent parameter optimization further improves the prediction skill across all the regions. Our study suggests that parameter optimization using ensemble data assimilation may provide an effective strategy to improve climate models and their real-world climate predictions in the future.

The Cost-Effectiveness of Pre-school Peanut Oral Immunotherapy in the Real World Setting

2021 ◽  
Author(s):  
Marcus Shaker ◽  
Edmond S. Chan ◽  
Jennifer LP. Protudjer ◽  
Lianne Soller ◽  
Elissa M. Abrams ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Real World ◽  
Oral Immunotherapy ◽  
The Real ◽  
Real World Setting ◽  
The Cost

scholarly journals Trastuzumab-based palliative chemotherapy for HER2-positive gastric cancer: a single-center real-world data

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tae-Hwan Kim ◽  
Hun Do Cho ◽  
Yong Won Choi ◽  
Hyun Woo Lee ◽  
Seok Yun Kang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Real World ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Conversion Surgery ◽  
Single Center ◽  
Her2 Positive ◽  
Real World Data ◽  
World Data ◽  
The Real

Abstract Background Since the results of the ToGA trial were published, trastuzumab-based chemotherapy has been used as the standard first-line treatment for HER2-positive recurrent or primary metastatic gastric cancer (RPMGC). However, the real-world data has been rarely reported. Therefore, we investigated the outcomes of trastuzumab-based chemotherapy in a single center. Methods This study analyzed the real-world data of 47 patients with HER2-positive RPMGC treated with trastuzumab-based chemotherapy in a single institution. Results With the median follow-up duration of 18.8 months in survivors, the median overall survival (OS) and progression-free survival were 12.8 and 6.9 months, respectively, and the overall response rate was 64%. Eastern Cooperative Oncology Group performance status 2 and massive amount of ascites were independent poor prognostic factors for OS, while surgical resection before or after chemotherapy was associated with favorable OS, in multivariate analysis. In addition, 5 patients who underwent conversion surgery after chemotherapy demonstrated an encouraging median OS of 30.8 months, all with R0 resection. Conclusions Trastuzumab-based chemotherapy in patients with HER2-positive RPMGC in the real world demonstrated outcomes almost comparable to those of the ToGA trial. Moreover, conversion surgery can be actively considered in fit patients with a favorable response after trastuzumab-based chemotherapy.

scholarly journals Performance Characteristics of Breezhaler® and Aerolizer® in the Real-World Setting

2021 ◽  
Author(s):  
Mathieu Molimard ◽  
Ioannis Kottakis ◽  
Juergen Jauernig ◽  
Sonja Lederhilger ◽  
Ivan Nikolaev
Keyword(s):  
Real World ◽  
Performance Characteristics ◽  
The Real ◽  
Real World Setting
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