Vital status ascertainment in cancerlinq discovery (CLQD): Improvement in mortality capture with a supplemental data source.

7064 Background: Overall survival (OS) is the gold standard outcome in clinical cancer research but many clinical trials cannot assess long-term OS. Real-world data sources can be used to calculate long-term OS, but only if vital status is accurately captured. Methods: The primary goal was to assess concordance of death dates from CLQD and an external source, and the effect of incorporation of external death data on estimates of OS. CLQD obtains electronic medical record (EMR) data from participating US oncology sites. Under-reporting of vital status is a common problem with EMR data; we investigated the value of including death data from a commercially available database, obituarydata.com (OBD) into CLQD. OBD pulls death data from published obituaries across the US. A matching algorithm is used to match patients in CLQD and OBD. OBD death data from breast, lung, ovarian, and pancreatic cancer patients diagnosed between 2010–2018 supplemented the CLQD in this study. OS was calculated using Kaplan-Meier estimation; Pearson correlation was used for comparing time to death. Results: The addition of OBD modestly changes OS estimates (see Table). Among a subset of patients with death dates in both CQLD and OBD, dates were highly correlated for breast (r = 0.98), lung (r = 0.93), ovarian (r = 0.99), and pancreatic (r = 0.88) cancers. When date differences existed, they were ≤10 days for > 95% of the patients. These results suggest death dates are reliable in CLQD EMRs. OS curves were as expected, with OS decreasing by stage and age at diagnosis. Conclusions: Incorporating OBD modestly improves OS estimates and shows that when death data is present in CLQD, it is reliable. Future enhancements will focus on improving sensitivity of mortality ascertainment with external data linkages, without compromising specificity. [Table: see text]

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878-P: Real-World Data from U.S. Patients Using a Long-Term Implantable Continuous Glucose Monitoring (CGM) System: Age Effect on Glycemic Control

Diabetes ◽

10.2337/db20-878-p ◽

2020 ◽

Vol 69 (Supplement 1) ◽

pp. 878-P

Author(s):

KATHERINE TWEDEN ◽

SAMANWOY GHOSH-DASTIDAR ◽

ANDREW D. DEHENNIS ◽

FRANCINE KAUFMAN

Keyword(s):

Glycemic Control ◽

Continuous Glucose Monitoring ◽

Real World ◽

Glucose Monitoring ◽

Age Effect ◽

Real World Data ◽

World Data

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401-P: Mortality, Major Adverse Cardiovascular Events (MACDE), and Diabetic Complications in Men with Hypogonadism and Type 2 Diabetes (T2DM) Receiving Long-Term Treatment with Testosterone Undecanoate Injections (TU): 11-Year Real-World Data

Diabetes ◽

10.2337/db20-401-p ◽

2020 ◽

Vol 69 (Supplement 1) ◽

pp. 401-P

Author(s):

AHMAD HAIDER ◽

KARIM S. HAIDER ◽

FARID SAAD

Keyword(s):

Type 2 Diabetes ◽

Diabetic Complications ◽

Cardiovascular Events ◽

Term Treatment ◽

Major Adverse Cardiovascular Events ◽

Real World Data ◽

Testosterone Undecanoate ◽

Long Term Treatment

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Impact of established cardiovascular disease on 10-year death after coronary revascularization for complex coronary artery disease

Clinical Research in Cardiology ◽

10.1007/s00392-021-01922-y ◽

2021 ◽

Author(s):

Rutao Wang ◽

Scot Garg ◽

Chao Gao ◽

Hideyuki Kawashima ◽

Masafumi Ono ◽

...

Keyword(s):

Cardiovascular Disease ◽

Coronary Artery Disease ◽

Coronary Artery ◽

Coronary Revascularization ◽

Long Term Outcomes ◽

Vital Status ◽

Increased Risk ◽

Artery Disease ◽

The Impact

Abstract Aims To investigate the impact of established cardiovascular disease (CVD) on 10-year all-cause death following coronary revascularization in patients with complex coronary artery disease (CAD). Methods The SYNTAXES study assessed vital status out to 10 years of patients with complex CAD enrolled in the SYNTAX trial. The relative efficacy of PCI versus CABG in terms of 10-year all-cause death was assessed according to co-existing CVD. Results Established CVD status was recorded in 1771 (98.3%) patients, of whom 827 (46.7%) had established CVD. Compared to those without CVD, patients with CVD had a significantly higher risk of 10-year all-cause death (31.4% vs. 21.7%; adjusted HR: 1.40; 95% CI 1.08–1.80, p = 0.010). In patients with CVD, PCI had a non-significant numerically higher risk of 10-year all-cause death compared with CABG (35.9% vs. 27.2%; adjusted HR: 1.14; 95% CI 0.83–1.58, p = 0.412). The relative treatment effects of PCI versus CABG on 10-year all-cause death in patients with complex CAD were similar irrespective of the presence of CVD (p-interaction = 0.986). Only those patients with CVD in ≥ 2 territories had a higher risk of 10-year all-cause death (adjusted HR: 2.99, 95% CI 2.11–4.23, p < 0.001) compared to those without CVD. Conclusions The presence of CVD involving more than one territory was associated with a significantly increased risk of 10-year all-cause death, which was non-significantly higher in complex CAD patients treated with PCI compared with CABG. Acceptable long-term outcomes were observed, suggesting that patients with established CVD should not be precluded from undergoing invasive angiography or revascularization. Trial registration SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050. Graphic abstract

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Chances and challenges of a long-term data repository in multiple sclerosis: 20th birthday of the German MS registry

Scientific Reports ◽

10.1038/s41598-021-92722-x ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Lisa-Marie Ohle ◽

David Ellenberger ◽

Peter Flachenecker ◽

Tim Friede ◽

Judith Haas ◽

...

Keyword(s):

Multiple Sclerosis ◽

Sociodemographic Factors ◽

Healthcare Research ◽

Structure Design ◽

Data Repository ◽

Research Projects ◽

Real World Data ◽

Data Repositories ◽

Term Data

AbstractIn 2001, the German Multiple Sclerosis Society, facing lack of data, founded the German MS Registry (GMSR) as a long-term data repository for MS healthcare research. By the establishment of a network of participating neurological centres of different healthcare sectors across Germany, GMSR provides observational real-world data on long-term disease progression, sociodemographic factors, treatment and the healthcare status of people with MS. This paper aims to illustrate the framework of the GMSR. Structure, design and data quality processes as well as collaborations of the GMSR are presented. The registry’s dataset, status and results are discussed. As of 08 January 2021, 187 centres from different healthcare sectors participate in the GMSR. Following its infrastructure and dataset specification upgrades in 2014, more than 196,000 visits have been recorded relating to more than 33,000 persons with MS (PwMS). The GMSR enables monitoring of PwMS in Germany, supports scientific research projects, and collaborates with national and international MS data repositories and initiatives. With its recent pharmacovigilance extension, it aligns with EMA recommendations and helps to ensure early detection of therapy-related safety signals.

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Long-term persistence with denosumab: real-world data from the Austrian Osteoporosis Clinic (AOC). A retrospective data analysis

Osteoporosis International ◽

10.1007/s00198-021-06102-2 ◽

2021 ◽

Author(s):

Ewald Boschitsch ◽

Oliver Naegele ◽

Anita Klinger ◽

Harald Brix-Samoylenko

Keyword(s):

Data Analysis ◽

Real World ◽

Retrospective Data ◽

Real World Data ◽

World Data ◽

Retrospective Data Analysis ◽

Osteoporosis Clinic

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Long-term effectiveness in patients previously treated with cladribine tablets: a real-world analysis of the Italian multiple sclerosis registry (CLARINET-MS)

Therapeutic Advances in Neurological Disorders ◽

10.1177/1756286420922685 ◽

2020 ◽

Vol 13 ◽

pp. 175628642092268 ◽

Cited By ~ 1

Author(s):

Francesco Patti ◽

Andrea Visconti ◽

Antonio Capacchione ◽

Sanjeev Roy ◽

Maria Trojano ◽

...

Keyword(s):

Multiple Sclerosis ◽

Real World ◽

Event Analysis ◽

Treatment Change ◽

Real World Data ◽

Indirect Measure ◽

Disease Modifying Drugs ◽

Disease Modifying ◽

Using Data

Background: The CLARINET-MS study assessed the long-term effectiveness of cladribine tablets by following patients with multiple sclerosis (MS) in Italy, using data from the Italian MS Registry. Methods: Real-world data (RWD) from Italian MS patients who participated in cladribine tablets randomised clinical trials (RCTs; CLARITY, CLARITY Extension, ONWARD or ORACLE-MS) across 17 MS centres were obtained from the Italian MS Registry. RWD were collected during a set observation period, spanning from the last dose of cladribine tablets during the RCT (defined as baseline) to the last visit date in the registry, treatment switch to other disease-modifying drugs, date of last Expanded Disability Status Scale recording or date of the last relapse (whichever occurred last). Time-to-event analysis was completed using the Kaplan–Meier (KM) method. Median duration and associated 95% confidence intervals (CI) were estimated from the model. Results: Time span under observation in the Italian MS Registry was 1–137 (median 80.3) months. In the total Italian patient population ( n = 80), the KM estimates for the probability of being relapse-free at 12, 36 and 60 months after the last dose of cladribine tablets were 84.8%, 66.2% and 57.2%, respectively. The corresponding probability of being progression-free at 60 months after the last dose was 63.7%. The KM estimate for the probability of not initiating another disease-modifying treatment at 60 months after the last dose of cladribine tablets was 28.1%, and the median time-to-treatment change was 32.1 (95% CI 15.5–39.5) months. Conclusion: CLARINET-MS provides an indirect measure of the long-term effectiveness of cladribine tablets. Over half of MS patients analysed did not relapse or experience disability progression during 60 months of follow-up from the last dose, suggesting that cladribine tablets remain effective in years 3 and 4 after short courses at the beginning of years 1 and 2.

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Long-term outcome of minimally invasive mitral valve annuloplasty in disproportionate mitral regurgitation

European Heart Journal ◽

10.1093/ehjci/ehaa946.0894 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

M Albano ◽

S Nagumo ◽

M Vanderheyden ◽

J Bartunek ◽

C Collet ◽

...

Keyword(s):

Mitral Valve ◽

Mitral Regurgitation ◽

Minimally Invasive ◽

Real World ◽

Independent Predictor ◽

Real World Data ◽

Long Term Outcome ◽

World Data ◽

Mitral Valve Annuloplasty

Abstract Background Hypothetical concept of disproportionate secondary mitral regurgitation (SMR) has been recently introduced to facilitate patient's selection for mitral valve intervention. However, real world data validating this concept are unavailable. Purpose To investigate long-term effects of minimally invasive mitral valve annuloplasty (MVA) in patients with disproportionate (dSMR) versus proportionate SMR. Methods The study population consisted of 44 consecutive patients (age 67±9,5 years; 64% males) on guidelines-directed therapy with advanced heart failure (HF), reduced LV ejection fraction (EF) (32±9,7%) and SMR undergoing isolated mini-invasive MVA. Patients with organic mitral regurgitation or concomitant myocardial revascularization were excluded. To assess SMR disproportionality, the PISA-derived effective regurgitant orifice area (EROA) and regurgitant volume (RV) were compared to the estimated EROA and RV by using Gorlin formula and pooled real world data. Results According to EROA, a total of 20 (46%) and 24 (54%) patients, respectively, had dSMR and proportionate SMR (pSMR). According to RV, a total of 17 (39%) had dSMR and 27 (61%) had pSMR. Patients with dSMR showed significantly lower prevalence of male gender and higher prevalence of diabetes mellitus than patients with pSMR (p<0,001). Moreover, we observed smaller LV end-diastolic volume, larger EROA and RV (both p<0,01) and higher LV EF (p=0,02) in the dSMR versus the pSMR group. Other baseline characteristics were similar. During median follow up of 4.39 y (IQR 2,2–9,96y), a total of 25 (56%) patients died from any cause while 21 (47%) individuals were readmitted for worsening HF. Patients with dSMR versus pSMR according to both EROA and RV showed significantly lower rate of HF readmissions (both p<0.05) (Figure 1, 2). In Cox regression analysis combining clinical and imaging parameters, dSMR was the only independent predictor of HF readmissions (HR 0.20, 95% CI 0.07–0.60, p=0.004). In contrast, mortality was similar between dSMR and pSMR (NS) with age as the only independent predictor (HR 1,10; 95% CI 1,03–1,18, p=0,003). Conclusions Minimally invasive MVA is associated with significant reduction of HF readmissions in patients with dSMR versus pSMR while the mortality is similar. This suggests the importance of other parameters, i.e. age and degree of LV remodeling, to guide clinical management in SMR. Funding Acknowledgement Type of funding source: None

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Inferring Long-Term Demand of Newly Established Stations for Expansion Areas in Bike Sharing System

Applied Sciences ◽

10.3390/app11156748 ◽

2021 ◽

Vol 11 (15) ◽

pp. 6748

Author(s):

Hsun-Ping Hsieh ◽

Fandel Lin ◽

Jiawei Jiang ◽

Tzu-Ying Kuo ◽

Yu-En Chang

Keyword(s):

New York ◽

Feature Extraction ◽

Real World ◽

Extraction Methods ◽

Real World Data ◽

Urban Dynamics ◽

Bike Sharing ◽

The Government ◽

Short Time

Research on flourishing public bike-sharing systems has been widely discussed in recent years. In these studies, many existing works focus on accurately predicting individual stations in a short time. This work, therefore, aims to predict long-term bike rental/drop-off demands at given bike station locations in the expansion areas. The real-world bike stations are mainly built-in batches for expansion areas. To address the problem, we propose LDA (Long-Term Demand Advisor), a framework to estimate the long-term characteristics of newly established stations. In LDA, several engineering strategies are proposed to extract discriminative and representative features for long-term demands. Moreover, for original and newly established stations, we propose several feature extraction methods and an algorithm to model the correlations between urban dynamics and long-term demands. Our work is the first to address the long-term demand of new stations, providing the government with a tool to pre-evaluate the bike flow of new stations before deployment; this can avoid wasting resources such as personnel expense or budget. We evaluate real-world data from New York City’s bike-sharing system, and show that our LDA framework outperforms baseline approaches.

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