1383. Characterizing Real-world Patterns of Early Childhood Vaccination

Abstract Background Vaccine hesitancy is increasingly common, but more information is needed on patterns of childhood vaccination. We characterized patterns of vaccine delay among commercially-insured children in the U.S. Methods Using the IBM MarketScan Commercial Database, we identified infants who received a timely first dose of diphtheria-tetanus-acellular pertussis (DTaP) vaccine from October 2009 to June 2017. We used CPT codes to collect vaccine administration history on antigen, formulation, dose, and date. We ascertained injectable and oral vaccine antigens (DTaP, polio, pneumococcal conjugate, rotavirus, Haemophilus influenza type b (Hib), measles, mumps, rubella, varicella). Timely receipt was defined as concomitant administration of the CDC-recommended number of antigens during the following time windows: 2, 4, 6, and 12-15 months of age (grace period: -7, +21 days). We generated heat maps to illustrate age distributions at receipt of specific antigens and doses. We created Sankey diagrams to illustrate the number of antigens received concomitantly during each time window and depict transitions to different states over time (e.g., no vaccine delay to vaccine delay). For each antigen and dose, we estimated the cumulative incidence of receipt. Results Among 1,066,216 eligible infants, the majority (84%) concomitantly received all 5 CDC-recommended antigens at 2 months of age while others only received 1 (1%), 2 (2%), 3 (4%) or 4 (9%) antigens. Many vaccinations were delayed – 30% and 39% of children did not receive all recommended antigens concomitantly at 4 and 6 months, respectively. The heat map shows wide variation in age at vaccination. For several antigens including Hib, measles, mumps, rotavirus, rubella, and varicella, the cumulative incidence increased steeply at ≥2 time points, suggesting vaccine delay for some infants (e.g., the first dose of Hib was administered to 85% of infants by 2 months of age, with subsequent small but distinct increases at 4, 6, 12, and 15 months of age). Conclusion Using real-world data to study early childhood vaccination patterns, we observed evidence of substantial deviation from the CDC-recommended schedule. These results expand current knowledge on the magnitude and timing of antigen- and dose-specific vaccine delay on a population level. Disclosures Jason Newland, MD, MEd, FPIDS, Merck (Grant/Research Support)Pfizer (Other Financial or Material Support, Industry funded clinical trial) Leah McGrath, PhD, NoviSci, Inc. (Employee)

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Real-world effectiveness of Human Papillomavirus vaccination against vulvovaginal high-grade precancerous lesions and cancers

JNCI Journal of the National Cancer Institute ◽

10.1093/jnci/djaa209 ◽

2020 ◽

Author(s):

Christian Dehlendorff ◽

Louise Baandrup ◽

Susanne K Kjaer

Keyword(s):

Human Papillomavirus ◽

Real World ◽

Cumulative Incidence ◽

Precancerous Lesions ◽

Hpv Vaccination ◽

Hazard Rates ◽

High Grade ◽

Real World Data ◽

Human Papillomavirus Vaccination ◽

World Data

Abstract Background Vaccination against human papillomavirus (HPV) has proven to be effective against severe cervical lesions and genital warts, whereas no previous study has provided real-world data on the HPV vaccine effectiveness against high-grade vulvovaginal lesions. Methods A cohort of all women aged 17–26 years, living in Denmark during 2006–2019 was followed in nationwide registers for individual-level information about HPV vaccination and first diagnoses of vulvar and vaginal high-grade intraepithelial lesions or worse (HSIL+). The cumulative incidence of vulvar and vaginal HSIL+, respectively, was estimated with the Aalen-Johansen estimator and Cox proportional hazards regression was used to estimate hazard ratios (HRs) for vulvar and vaginal lesions separately comparing women vaccinated at age <16 years and at age 17–26 years with unvaccinated women. Results The cohort consisted of 514,537 women, of which 50.6% were vaccinated at baseline (<16 years), 31.8% were vaccinated during follow-up (17–26 years) and 17.6% remained unvaccinated. The cumulative incidence was less than 0.6‰ for vulvar HSIL+ and less than 0.2‰ for vaginal HSIL+. Adjusted analyses showed reduced hazard rates for both vulvar (HR = 0.22, 95% CI = 0.13 to 0.38) and vaginal HSIL + (HR = 0.16, 95% CI = 0.04 to 0.55) for women vaccinated at age ≤16 years compared to unvaccinated women. For women vaccinated at 17–26 years, the reductions in hazard rates were smaller for vaginal HSIL+ and close to zero for vulvar HSIL+. Conclusion HPV vaccination before 17 years of age reduces the risk of vulvar and vaginal HSIL+ based on real-world data.

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Online summarization of dynamic graphs using subjective interestingness for sequential data

Data Mining and Knowledge Discovery ◽

10.1007/s10618-020-00714-8 ◽

2020 ◽

Author(s):

Sarang Kapoor ◽

Dhish Kumar Saxena ◽

Matthijs van Leeuwen

Keyword(s):

Real World ◽

Information Gain ◽

Current Knowledge ◽

Maximum Entropy Principle ◽

Sequential Data ◽

Dynamic Graphs ◽

Dynamic Graph ◽

Real World Data ◽

Mdl Principle ◽

Subjective Interestingness

Abstract Many real-world phenomena can be represented as dynamic graphs, i.e., networks that change over time. The problem of dynamic graph summarization, i.e., to succinctly describe the evolution of a dynamic graph, has been widely studied. Existing methods typically use objective measures to find fixed structures such as cliques, stars, and cores. Most of the methods, however, do not consider the problem of online summarization, where the summary is incrementally conveyed to the analyst as the graph evolves, and (thus) do not take into account the knowledge of the analyst at a specific moment in time. We address this gap in the literature through a novel, generic framework for subjective interestingness for sequential data. Specifically, we iteratively identify atomic changes, called ‘actions’, that provide most information relative to the current knowledge of the analyst. For this, we introduce a novel information gain measure, which is motivated by the minimum description length (MDL) principle. With this measure, our approach discovers compact summaries without having to decide on the number of patterns. As such, we are the first to combine approaches for data mining based on subjective interestingness (using the maximum entropy principle) with pattern-based summarization (using the MDL principle). We instantiate this framework for dynamic graphs and dense subgraph patterns, and present DSSG, a heuristic algorithm for the online summarization of dynamic graphs by means of informative actions, each of which represents an interpretable change to the connectivity structure of the graph. The experiments on real-world data demonstrate that our approach effectively discovers informative summaries. We conclude with a case study on data from an airline network to show its potential for real-world applications.

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Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice

Thrombosis and Haemostasis ◽

10.1160/th16-06-0485 ◽

2016 ◽

Vol 116 (S 02) ◽

pp. S13-S23 ◽

Cited By ~ 26

Author(s):

A. Camm ◽

Craig Coleman ◽

CAPT Tamayo ◽

Jan Beyer-Westendorf

Keyword(s):

Clinical Practice ◽

Real World ◽

Clinical Decision Making ◽

Current Knowledge ◽

Oral Anticoagulants ◽

Clinical Decision ◽

Routine Clinical Practice ◽

Real World Data ◽

Real World Evidence ◽

Randomised Controlled

SummaryRandomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

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Long-Term Efficacy and Safety of Everolimus-Eluting Stent Implantation in Japanese Patients with Acute Coronary Syndrome: Five-Year Real-World Data from the Tokyo-MD PCI Study

Journal of Interventional Cardiology ◽

10.1155/2019/3146848 ◽

2019 ◽

Vol 2019 ◽

pp. 1-13

Author(s):

Shunji Yoshikawa ◽

Takashi Ashikaga ◽

Toru Miyazaki ◽

Ken Kurihara ◽

Kenzo Hirao

Keyword(s):

Acute Coronary Syndrome ◽

Real World ◽

Cumulative Incidence ◽

Japanese Patients ◽

Efficacy And Safety ◽

Real World Data ◽

World Data ◽

Coronary Syndrome ◽

Term Efficacy

Background. The long-term safety of first-generation drug-eluting stent (DES) in acute coronary syndrome (ACS) was controversial. Purpose. The purpose of this study was to establish 5-year real-world data regarding the long-term efficacy and safety of second-generation DES in Japanese patients with ACS. Methods. The Tokyo-MD PCI study is a multicenter, observational cohort study enrolling consecutive patients who underwent everolimus-eluting stent (EES) implantation. The 5-year clinical events were compared between the ACS group (n = 644) and the stable coronary artery disease (SCAD) group (n = 1255). The primary efficacy endpoint was ischemia-driven target lesion revascularization (TLR), and the primary safety endpoint was the composite of all-cause death or myocardial infarction (MI). Results. The median follow-up duration was 5.4 years. The cumulative incidence of ischemia-driven TLR was similar between ACS and SCAD (1 year: 3.0% versus 2.7%; P=0.682, 1–5 years: 2.7% versus 2.9%; P=0.864). The cumulative incidence of all-cause death or MI within 1 year was significantly higher in ACS than in SCAD (7.4% versus 3.8%; P<0.001); however, ACS did not increase the risk of all-cause death or MI after adjusting confounders (adjusted hazard ratio, 1.260; 95% confidence interval, 0.774–2.053; P=0.352). From 1 to 5 years, the cumulative incidence of all-cause death or MI was not significantly different between ACS and SCAD (11.6% versus 11.4%; P=0.706). The cumulative incidence of very late stent thrombosis was low and similar between ACS and SCAD (0.2% versus 0.2%; P=0.942). Conclusion. This real-world registry suggested that EES has comparable long-term efficacy and safety in patients with ACS and SCAD.

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Socioeconomic disadvantage and sleep in early childhood: Real-world data from a mobile health application

Sleep Health ◽

10.1016/j.sleh.2021.01.002 ◽

2021 ◽

Vol 7 (2) ◽

pp. 143-152

Author(s):

Ariel A. Williamson ◽

Russell Gould ◽

Erin S. Leichman ◽

Russel M. Walters ◽

Jodi A. Mindell

Keyword(s):

Early Childhood ◽

Mobile Health ◽

Real World ◽

Socioeconomic Disadvantage ◽

Real World Data ◽

World Data ◽

Mobile Health Application ◽

Health Application

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Abstract #946: Assessment of Acromegaly Patients with and Without Diabetes Treated with Lanreotide Depot: 2-Year Real World Data

Endocrine Practice ◽

10.1016/s1530-891x(20)45236-x ◽

2016 ◽

Vol 22 ◽

pp. 219

Author(s):

Roberto Salvatori ◽

Olga Gambetti ◽

Whitney Woodmansee ◽

David Cox ◽

Beloo Mirakhur ◽

...

Keyword(s):

Real World ◽

Real World Data ◽

World Data

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Safety and efficacy of direct acting oral anticoagulants and vitamin K antagonists in nonvalvular atrial fibrillation – a network meta-analysis of real-world data

VASA ◽

10.1024/0301-1526/a000746 ◽

2019 ◽

Vol 48 (2) ◽

pp. 134-147 ◽

Cited By ~ 8

Author(s):

Mirko Hirschl ◽

Michael Kundi

Keyword(s):

Real World ◽

Meta Analysis ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Efficacy And Safety ◽

Nonvalvular Atrial Fibrillation ◽

Real World Data ◽

Hazard Ratios ◽

Direct Acting ◽

Event Rates

Abstract. Background: In randomized controlled trials (RCTs) direct acting oral anticoagulants (DOACs) showed a superior risk-benefit profile in comparison to vitamin K antagonists (VKAs) for patients with nonvalvular atrial fibrillation. Patients enrolled in such studies do not necessarily reflect the whole target population treated in real-world practice. Materials and methods: By a systematic literature search, 88 studies including 3,351,628 patients providing over 2.9 million patient-years of follow-up were identified. Hazard ratios and event-rates for the main efficacy and safety outcomes were extracted and the results for DOACs and VKAs combined by network meta-analysis. In addition, meta-regression was performed to identify factors responsible for heterogeneity across studies. Results: For stroke and systemic embolism as well as for major bleeding and intracranial bleeding real-world studies gave virtually the same result as RCTs with higher efficacy and lower major bleeding risk (for dabigatran and apixaban) and lower risk of intracranial bleeding (all DOACs) compared to VKAs. Results for gastrointestinal bleeding were consistently better for DOACs and hazard ratios of myocardial infarction were significantly lower in real-world for dabigatran and apixaban compared to RCTs. By a ranking analysis we found that apixaban is the safest anticoagulant drug, while rivaroxaban closely followed by dabigatran are the most efficacious. Risk of bias and heterogeneity was assessed and had little impact on the overall results. Analysis of effect modification could guide the clinical decision as no single DOAC was superior/inferior to the others under all conditions. Conclusions: DOACs were at least as efficacious as VKAs. In terms of safety endpoints, DOACs performed better under real-world conditions than in RCTs. The current real-world data showed that differences in efficacy and safety, despite generally low event rates, exist between DOACs. Knowledge about these differences in performance can contribute to a more personalized medicine.

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