Death ORACL: An Algorithm to Predict Death Using Insurance Claims Data.

The inability to identify dates of death in insurance claims data is the United States is a major limitation to retrospective claims-based research. While deaths result in disenrollment, disenrollment can also occur due to changes in insurance providers. We created an algorithm to differentiate between disenrollment from health plans due to death and disenrollment for other reasons.

The University of North Carolina Cancer Survivorship Cohort: A Resource for Collaborative Survivorship Research.

Background: Rapid growth in the number of US cancer survivors drives the need for ongoing research efforts to improve outcomes and experiences after cancer. In this study, we describe the University of North Carolina (UNC) Cancer Survivorship Cohort, a medical center-based cohort of adults with cancer that integrates medical record-abstracted cancer information, patient-reported outcomes, and biological specimens.

Methods: Participants ages 18+ were recruited from UNC oncology clinics between April 2010 and August 2016.

Greater Adherence and Persistence with Injectable Dulaglutide Compared with Injectable Semaglutide at 1-Year Follow-up: Data from US Clinical Practice.

Purpose: Greater medication adherence and persistence have been associated with improved glycemic control in patients with type 2 diabetes mellitus. This study compared adherence, persistence, and treatment patterns among patients naïve to glucagon-like peptide 1 receptor agonists initiating once-weekly injectable treatment with dulaglutide versus semaglutide over 6-month (6M) and 12-month (12M) follow-up periods.

Methods: This retrospective, observational cohort study used administrative claims data from three IBM MarketScan research databases.

EXOGEN Mitigates Risk of Fifth Metatarsal Fracture Nonunion: Results of a Novel Real-World Clinical Study.

Category:: Midfoot/Forefoot

Introduction/purpose:: Fifth metatarsal fractures are the most commonly fractured metatarsal in adults and are associated with high rates of nonunion. This study compared the 9-month incidence of nonunion in fifth metatarsal fracture patients using EXOGEN (Bioventus LLC), low-intensity pulsed ultrasound, versus a control cohort of patients receiving standard of care.

Methods:: Adults (21-80 years) prescribed EXOGEN for any acute or delayed fifth metatarsal fracture and initiated treatment within 91 days of the fracture were enrolled via prescription record abstraction and direct-to-patient outreach.

Methodologies for Validation of Diagnoses in Real-World Data: BONES-A Case Study.

The accuracy of any claim-based study is dependent on the quality of real-world coding of the condition of interest. This retrospective, administrative claims analysis presents a method for using a real-world data source to evaluate the accuracy of coding for nonunion of a fifth metatarsal fracture. Patients 21-80 years old with a diagnosis of a fifth metatarsal fracture between January 1, 2016, and October 31, 2016, and a nonunion of the fifth metatarsal fracture within the next 9 months were identified in the MarketScan Databases.

Breaking Barriers: Studying Fracture Healing in the BONES Program.

The Bioventus Observational Noninterventional EXOGEN Studies (BONES) Program includes 3 concurrent studies designed to estimate the incidence of fracture nonunions in patients treated with the EXOGEN Ultrasound Bone Healing System compared with those receiving standard fracture care. This article outlines the design and methodology within the fifth metatarsal fracture study; similar approaches are taken in the second and third BONES Program studies, which examine nonunions of the tibia and scaphoid. The BONES Program is an external comparator design and incorporates several unique, fit-for-purpose components to strengthen the approach and allow it to be submitted to the US Food and Drug Administration (FDA) to be considered for a label expansion.

Randomized Clinical Trial or Real-World Evidence: How Historical Events, Public Demand, and the Resulting Laws and Regulations Shaped the Body of Medical Evidence.

The signing of the 21st Centuries Cures Act in 2016 was a confirmational step in a long journey toward an understood use and need for real-world evidence (RWE), even though the Food and Drug Administration (FDA) had the legislative authority to accept RWE since 1962 to demonstrate efficacy. The 21st Century Cures Act, as well as the subsequent FDA guidance published in 2017 and other supporting guidance, documents that since are opening the doors for the clinical and research community. They specifically allow for labeling changes and indication expansion based on RWE.

Real-World Evidence: A Review of Real-World Data Sources Used in Orthopaedic Research.

Real-world data (RWD) play an increasingly important role in orthopaedics as demonstrated by the rapidly growing number of publications using registry, administrative, and other databases. Each type of RWD source has its strengths and weaknesses, as does each specific database. Linkages between real-world data sets provide even greater utility and value for research than single data sources.

Real-World Evidence: A Primer.

The insights that real-world data (RWD) can provide, beyond what can be learned within the traditional clinical trial setting, have gained enormous traction in recent years. RWD, which are increasingly available and accessible, can further our understanding of disease, disease progression, and safety and effectiveness of treatments with the speed and accuracy required by the health care environment and patients today. Over the decades since RWD were first recognized, innovation has evolved to take real-world research beyond finding ways to identify, store, and analyze large volumes of data.

Real-world healthcare resource utilization and costs in patients with chronic lymphocytic leukemia: differences between patients treated with first-line ibrutinib or bendamustine + rituximab.

Background: This study evaluated the real-world healthcare resource utilization and costs in chronic lymphocytic lymphoma (CLL) patients treated with first-line ibrutinib monotherapy (IbM) therapy or bendamustine plus rituximab (BR) combination therapy.

Methods: Treatment-naïve CLL patients in the IBM MarketScan Research Databases were identified based on the first prescription of either IbM or BR therapy between 1 February 2014 and 30 August 2017.

Results: A total of 1866 patients with 12 months of continuous enrollment (IbM  = 1157; BR= = 729) were identified.

Prevalence, characteristics, and costs of diagnosed homocystinuria, elevated homocysteine, and phenylketonuria in the United States: a retrospective claims-based comparison.

Background: Classical homocystinuria (HCU), an inborn error of homocysteine metabolism, has previously been estimated to affect approximately 1 in 100,000-200,000 people in the United States (US). HCU is poorly detected by newborn screening, resulting in underestimates of its prevalence. This study compared characteristics, healthcare use and costs, and projected prevalence between patients with diagnosed HCU, elevated total homocysteine (tHcy), and diagnosed phenylketonuria (PKU).

Estimated prevalence of moderate to severely elevated total homocysteine levels in the United States: A missed opportunity for diagnosis of homocystinuria?

Classical homocystinuria (HCU) is a genetic disorder caused by mutations in the cystathionine beta synthase gene, which results in impaired metabolism of the sulfur-bearing amino acid homocysteine and its accumulation in blood and tissues. Classical HCU can be detected via newborn screening in the United States, but the test is widely acknowledged to miss many patients. While severely elevated homocysteine levels (>100 μmol /L) frequently lead to a classical HCU diagnosis, intermediate levels (>30 to 100 μmol /L), though linked to many of the known complications of HCU, are not always recognized as associated with HCU.

Real-world healthcare resource utilization in patients with indolent non-Hodgkin lymphoma: differences between patients treated with first-line ibrutinib or bendamustine + rituximab.

This study evaluated the real-world healthcare resource utilization (HCRU) and costs in patients diagnosed with an indolent non-Hodgkin lymphoma (iNHL) and treated with either first-line ibrutinib monotherapy (IbM) therapy or bendamustine plus rituximab combination therapy (BR). Treatment-naïve iNHL patients in the IBM MarketScan Research Databases were identified based on the first prescription of either IbM or BR therapy between 02/01/2014 and 08/30/2017. A greater proportion of IbM patients ( = 207) had at least one inpatient admission (IP) or emergency room visit (ER), both all-cause and iNHL-related, than BR ( = 1337) patients.

Responsiveness of PROMIS® to change in chronic obstructive pulmonary disease.

Background: Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease characterized by airflow obstruction that leads to shortness of breath and substantial negative impacts on health-related quality of life (HRQL). The course of COPD includes periodic acute exacerbations that require changes in treatment and/or hospitalizations. This study was designed to examine the responsiveness of Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures to changes associated with COPD exacerbation recovery.

Meningococcal-group B (MenB) vaccine series completion and adherence to dosing schedule in the United States: A retrospective analysis by vaccine and payer type.

Background: Two MenB vaccines with different dosing schedules are approved in the US: MenB-4C (2 doses) and MenB-FHbp (2-3 doses). Both vaccines were licensed on the basis of immunogenicity demonstrated after vaccine series completion. We evaluated vaccination completion and adherence to dosing schedules.

Maternal Immunization in the U.S.: A Nationwide Retrospective Cohort Study.

Introduction: At present, pregnant women in the U.S. are recommended to receive tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) and influenza vaccines.

Benchmarking HIV Quality Measures Across US Payer Types.

Despite advances in antiretroviral therapy (ART), human immunodeficiency virus (HIV) remains a significant issue in the United States. Early diagnosis, continuous treatment access/adherence, and long-term care engagement help patients benefit fully from ART; however, a shortfall in care engagement remains, potentially leading to poorer health outcomes. This analysis benchmarks rates of health care quality and process measures to identify areas for improvement.

Health Care Resource Utilization and Costs for Patients with Tardive Dyskinesia.

Background: Tardive dyskinesia (TD) is an often-irreversible movement disorder affecting any part of the body. Patients experience debilitating symptoms that lower quality of life and increase mortality. Prolonged exposure to dopamine antagonists, which are frequently prescribed for psychiatric disorders as neuroleptic (antipsychotic) drugs, is a common cause of TD.

Meningococcal Vaccination Among Adolescents in the United States: A Tale of Two Age Platforms.

Purpose: Despite recommended routine vaccination with meningococcal conjugate vaccine (MenACWY) at ages 11-12 years with a booster at age 16 years, national estimates indicate MenACWY uptake is lower in older adolescents than younger adolescents. This study aimed to identify factors associated with MenACWY uptake among adolescents.

Methods: Commercial Claims and Encounters (CCAE) and Medicaid MarketScan Databases from 2011 to 2016 were retrospectively analyzed (2017) to determine receipt of ≥1 dose of MenACWY during early (10.

Analysis of Vascular Event Risk After Herpes Zoster From 2007 to 2014 US Insurance Claims Data.

Objective: To estimate the risk of transient ischemic attack (TIA), stroke, and myocardial infarction in periods covering 4 weeks before to 52 weeks after herpes zoster (HZ) diagnosis in US adults.

Patients And Methods: This retrospective study (GSK study identifier: HO-15-15771) with matched cohorts used the Truven Health MarketScan Commercial and Medicare claims data set linked with obesity and smoking status information. Patients 18 years and older at the date of HZ diagnosis and 1-year pre- and post-HZ diagnosis continuous insurance enrollment (from January 1, 2007, through December 31, 2014) were propensity score matched to controls in terms of demographic characteristics, risk factors for vascular events, other comorbid disorders, general health, obesity, and smoking status.

Real-world characteristics and disease burden of patients with asthma prior to treatment initiation with mepolizumab or omalizumab: a retrospective cohort database study.

Purpose: Patients with severe asthma are eligible for asthma-specific biologics as add-on therapies, such as mepolizumab and omalizumab, when optimized controller therapies are unable to control their symptoms. However, few real-world data are available to describe the characteristics and associated economic burden of patients considered to be candidates for mepolizumab or omalizumab therapy.

Methods: This retrospective cohort study investigated patients with asthma (≥12 years of age) identified at the time of first mepolizumab or omalizumab administration (index date) in the MarketScan Commercial Database.

Gastrointestinal complications in patients treated with ipilimumab and nivolumab combination therapy or monotherapy.

Aim & methods: A retrospective study using the IBM Explorys Universe Database assessed the risk of gastrointestinal events (enterocolitis or diarrhea) among melanoma and lung cancer patients treated with ipilimumab and nivolumab combination or monotherapy. Results & conclusion: There were 904 melanoma patients (607 ipilimumab, 140 nivolumab and 157 combo) and 1641 lung cancer patients (68 ipilimumab, 1542 nivolumab and 31 combo). Approximately, 37% of lung patients and 46% of melanoma patients experienced at least one adverse event.