10-Year Fracture Risk in Postmenopausal Women with Osteopenia and Osteoporosis in South Korea.

Background: In South Korea, women aged 66 years are eligible for complimentary bone mineral density (BMD) screening via the National Screening Program for Transitional Ages. We aimed to evaluate the 10-year fracture risk in women receiving BMD screening between January 2008 and December 2015.

Methods: BMD was classified as normal (T-score ≥-1.

Prospective, Noninterventional Study of Nivolumab in Real-world Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Chemotherapy (ENLARGE-Lung).

Nivolumab was the first immune checkpoint inhibitor approved for use in advanced non-small cell lung cancer (NSCLC). This noninterventional, prospective cohort study investigates real-world effectiveness of nivolumab in pretreated NSCLC patients in Germany (Enlarge-Lung/CA209-580). Patients with squamous (SQ) or nonsquamous (NSQ) NSCLC previously treated for locally advanced or metastatic (stage IIIB/IV) disease received nivolumab according to the current Summary of Product Characteristics.

Risk of infections and mortality in Danish patients with cancer diagnosed with bone metastases: a population-based cohort study.

Objectives: Risk of infections in patients with solid cancers and bone metastases (BM) and the subsequent impact on prognosis is unclear. We examined the risk of infections among patients with cancer diagnosed with BM and the subsequent impact of infections on mortality.

Design: Population-based cohort study.

Factors associated with time to initiation of a PCSK9 inhibitor after hospital discharge for acute myocardial infarction.

Background: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) lower atherosclerotic cardiovascular disease (ASCVD) event risk.

Objective: Analyze patient characteristics associated with time to PCSK9i initiation following an acute myocardial infarction (AMI).

Methods: We analyzed characteristics of patients ≥21 years of age in the Marketscan or Medicare databases who initiated a PCSK9i 0-89 days, 90-179 days, or 180-365 days after an AMI between July 2015 and December 2018 (n=1,705).

Economic evaluation of quality improvement interventions to prevent catheter-associated urinary tract infections in the hospital setting: a systematic review.

Background: Hospitals have implemented diverse quality improvement (QI) interventions to reduce rates of catheter-associated urinary tract infections (CAUTIs). The economic value of these QI interventions is uncertain.

Objective: To systematically review economic evaluations of QI interventions designed to prevent CAUTI in acute care hospitals.

Assessment of a Claims-Based ICD-9 and ICD-10 Medication-Related Osteonecrosis of the Jaw Algorithm in the United States.

Purpose: Medication-related osteonecrosis of jaw (MRONJ) is associated with certain drug therapies. Pharmacoepidemiologic studies often rely on electronic healthcare data to assess adverse events following drug exposure. Few studies have developed and validated claims-based MRONJ identification algorithms.

Real-world use of bevacizumab-awwb, a bevacizumab biosimilar, in US patients with metastatic colorectal cancer.

Evaluated real world use of bevacizumab-awwb (MVASI), a bevacizumab biosimilar, for treating metastatic colorectal cancer (mCRC). Adult mCRC patients who received bevacizumab-awwb during the first year after market availability were identified from the ConcertAI oncology dataset. Of 304 patients, 47% initiated bevacizumab-awwb as reference product (RP) naive patients and 53% received bevacizumab-awwb with prior exposure to RP.

Machine learning applications for therapeutic tasks with genomics data.

Thanks to the increasing availability of genomics and other biomedical data, many machine learning algorithms have been proposed for a wide range of therapeutic discovery and development tasks. In this survey, we review the literature on machine learning applications for genomics through the lens of therapeutic development. We investigate the interplay among genomics, compounds, proteins, electronic health records, cellular images, and clinical texts.

Atherosclerotic Cardiovascular Disease Events in Adults With CKD Taking a Moderate- or High-Intensity Statin: The Chronic Renal Insufficiency Cohort (CRIC) Study.

Rationale & Objective: The 2018 American Heart Association/American College of Cardiology (AHA/ACC) cholesterol guideline uses risk stratification to guide the decision to initiate nonstatin lipid-lowering medication among adults with atherosclerotic cardiovascular disease (CVD). We determined atherosclerotic CVD (ASCVD) event rates among adults with chronic kidney disease (CKD) taking statin therapy within 2018 AHA/ACC cholesterol guideline risk categories.

Study Design: Observational cohort study.

Patient characteristics, treatment patterns, and mortality in elderly patients newly diagnosed with acute myeloid leukemia meeting ineligibility criteria for high intensity chemotherapy.

To describe patient characteristics, treatment patterns, and survival among elderly patients (≥66 years) newly diagnosed with acute myeloid leukemia (AML) meeting ≥1 ineligibility criteria for high-intensity chemotherapy (HIC; i.e. age >75 years, cardiac disease/prior anthracycline therapy, or secondary AML), we analyzed 2007-2017 100% Medicare hematologic cancer data.

Clinical features and diagnosis of multiple myeloma: a population-based cohort study in primary care.

Objectives: Patients with multiple myeloma (MM) experience significant delays in diagnosis due to non-specific symptomatology. The aim of this study was to characterise the frequency and timing of clinical features in the primary care setting prior to MM diagnosis.

Design: Population-based cohort study.

The Projected Impact of Population-Wide Achievement of LDL Cholesterol <70 mg/dL on the Number of Recurrent Events Among US Adults with ASCVD.

Purpose: Adults with atherosclerotic cardiovascular disease (ASCVD) are recommended high-intensity statins, with those at very high risk for recurrent events recommended adding ezetimibe and/or a proprotein convertase subtilisin/kexin type 9 inhibitor if their low-density lipoprotein cholesterol (LDL-C) is ≥70 mg/dL. We estimated the number of recurrent ASCVD events potentially averted if all adults in the United States (US) ≥45 years of age with ASCVD achieved an LDL-C <70 mg/dL.

Methods: The number of US adults with ASCVD and LDL-C ≥70 mg/dL was estimated from the National Health and Nutrition Examination Survey 2009-2016 (n = 596).

Migraine Characteristics, Comorbidities, Healthcare Resource Utilization, and Associated Costs of Early Users of Erenumab in the USA: A Retrospective Cohort Study Using Administrative Claims Data.

Introduction: Erenumab is indicated for migraine preventive treatment in adults. The objective of this study was to provide descriptive information on real-world use of erenumab including patient profile and treatment patterns.

Methods: We completed a retrospective review of US data (through May 2019) from the IBM MarketScan Early View Databases, identifying adult patients newly treated with erenumab with a migraine claim in the year prior to first erenumab claim (index) and at least 1 year of continuous pre-index medical and pharmacy insurance coverage, to assess pre- and post-erenumab migraine characteristics, comorbidities, healthcare resource utilization, and associated costs.

Patterns of etanercept use in juvenile idiopathic arthritis in the Childhood Arthritis and Rheumatology Research Alliance Registry.

Background: We aimed to characterize etanercept (ETN) use in juvenile idiopathic arthritis (JIA) patients enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry.

Methods: The CARRA Registry is a convenience cohort of patients with paediatric onset rheumatic diseases, including JIA. JIA patients treated with ETN for whom the month and year of ETN initiation were available were included.

Lessons Learned Using Real-World Data to Emulate Randomized Trials: A Case Study of Treatment Effectiveness for Newly Diagnosed Immune Thrombocytopenia.

Regulatory agencies are increasingly considering real-world evidence (RWE) to support label expansions of approved medicines. We conducted a comparative effectiveness study to emulate a proposed randomized trial of romiplostim vs. standard-of-care (SOC) therapy among patients with recently diagnosed (≤12 months) immune thrombocytopenia (ITP), that could support expansion of the romiplostim label.

Cinacalcet and gastrointestinal bleeding risk in patients receiving hemodialysis.

Purpose: Secondary hyperparathyroidism (SHPT) is common among dialysis patients, and calcimimetics are a mainstay of treatment. This study assessed whether cinacalcet use is associated with gastrointestinal bleeding in a large hemodialysis cohort.

Methods: A linked database of clinical records and medical claims for patients receiving hemodialysis in a large dialysis organization, 2007-2010, was used.

Characteristics and outcomes of hospitalised adults with COVID-19 in a Global Health Research Network: a cohort study.

Objective: To examine age, gender, and temporal differences in baseline characteristics and clinical outcomes of adult patients hospitalised with COVID-19.

Design: A cohort study using deidentified electronic medical records from a Global Research Network.

Setting/participants: 67 456 adult patients hospitalised with COVID-19 from the USA; 7306 from Europe, Latin America and Asia-Pacific between February 2020 and January 2021.

Pediatric BMI changes during COVID-19 pandemic: An electronic health record-based retrospective cohort study.

Background: Beginning March 2020, the COVID-19 pandemic has disrupted different aspects of life. The impact on children's rate of weight gain has not been analysed.

Methods: In this retrospective cohort study, we used United States (US) Electronic Health Record (EHR) data from Optum® to calculate the age- and sex- adjusted change in BMI (∆BMI) in individual 6-to-17-year-old children between two well child checks (WCCs).

Death, long-term nursing home placement, and impoverishment after recurrent myocardial infarction.

Study Objective: To determine whether recurrent myocardial infarction (MI) is associated with increased risk of mortality, long-term nursing home placement, and impoverishment.

Design: Retrospective cohort study.

Setting: United States Medicare program.

Global epidemiology of hip fractures: a study protocol using a common analytical platform among multiple countries.

Introduction: Hip fractures are associated with a high burden of morbidity and mortality. Globally, there is wide variation in the incidence of hip fracture in people aged 50 years and older. Longitudinal and cross-geographical comparisons of health data can provide insights on aetiology, risk factors, and healthcare practices.

Osteonecrosis of the jaw among patients with cancer treated with denosumab or zoledronic acid: Results of a regulator-mandated cohort postauthorization safety study in Denmark, Norway, and Sweden.

Background: Osteonecrosis of the jaw (ONJ) is an adverse effect of antiresorptive treatment. This study estimated incidence proportions and incidence rates of ONJ in cancer patients with bone metastases from solid tumors treated for the prevention of skeletal-related events in routine clinical practice.

Methods: This cohort study in Denmark, Norway, and Sweden in 2011-2018 included 3 treatment cohorts: a denosumab inception cohort (DEIC), a zoledronic acid inception cohort (ZAIC), and a denosumab-switch cohort (DESC).

A retrospective observational study of the natural history of advanced non-small-cell lung cancer in patients with KRAS p.G12C mutated or wild-type disease.

Introduction: The KRAS p.G12C mutation, prevalent in non-small-cell lung cancer (NSCLC), has only recently become a viable target. Here we present results of the largest retrospective observational study analyzing KRAS p.

Lipoprotein(a) Testing Patterns in a Large Health System.

Lipoprotein (a) [Lp(a)] is associated with increased risk of atherosclerotic cardiovascular disease (ASCVD). As directed therapy for Lp(a) emerges, it is important to understand patterns of Lp(a) testing in routine clinical practice. We set out to characterize Lp(a) testing across a large academic health system.

Patient-reported pain severity and health-related quality of life in patients with multiple myeloma in real world clinical practice.

Background: The association between patient self-reported pain severity and health-related quality-of-life (HRQoL) is poorly understood.

Aims: This real-world study of symptomatic multiple myeloma (MM) patients sought to determine how pain severity from a single question asked during routine clinical consultation was associated with HRQoL.

Methods And Results: Point-in-time data on HRQoL of 330 patients with MM (median age 70 years) receiving anti-myeloma therapy in Germany and Italy from November 2017 through February 2018 were analyzed.

Prophylactic pegfilgrastim to prevent febrile neutropenia among patients receiving biweekly (Q2W) chemotherapy regimens: a systematic review of efficacy, effectiveness and safety.

Background: Pegfilgrastim, a long-acting granulocyte colony-stimulating factor (G-CSF), is commonly used to prevent febrile neutropenia (FN), a potentially life-threatening complication, following myelosuppressive chemotherapy. The FDA label for pegfilgrastim specifies that it should not be administered 14 days before or within 24 h of administration of myelosuppressive chemotherapy, precluding the use of pegfilgrastim in biweekly (Q2W) regimens. The National Comprehensive Cancer Network and the European Organisation for Research and Treatment of Cancer guidelines support the use of prophylactic pegfilgrastim in patients receiving Q2W regimens.