Identifying ventricular arrhythmia and sudden cardiac arrest in clinical notes of an electronic health record database.

Aim: Validating an operational algorithm for identifying ventricular arrhythmia and sudden cardiac arrest (VA/SCA) in electronic health record (EHR) data may be useful to minimize measurement bias in studies characterizing real-world VA/SCA risk; however, validation studies require an appropriate reference standard. We aimed to assess if adequate information is documented in unstructured clinical notes of a large EHR database to serve as a reference standard for future validation studies of VA/SCA.

Methods: Twenty potential VA/SCA events were randomly selected from unstructured clinical notes of a large EHR database, TriNetX Dataworks - USA.

Patterns of belatacept use and risk of post-transplant lymphoproliferative disorder in US kidney transplant recipients: An analysis of the Organ Procurement and Transplantation Network database.

Background: Belatacept is approved for the prophylaxis of organ rejection in Epstein-Barr virus (EBV)-seropositive kidney transplant recipients and is associated with a risk of post-transplant lymphoproliferative disorder (PTLD).

Methods: Data from the Organ Procurement and Transplantation Network were used to examine patterns of belatacept use, describe patient characteristics, and estimate risk of PTLD in EBV-seropositive, kidney-only transplant recipients receiving belatacept- or calcineurin inhibitor (CNI)-based immunosuppression as part of US Food and Drug Administration-mandated safety monitoring.

Results: During the study period (June 15, 2011-June 14, 2016), 94.

Contemporary Practice and Considerations for Real-World Data Source Identification and Feasibility Assessment.

Purpose: There has been rapid growth in the variety and number of real-world data (RWD) sources, as well as the number of regulatory documents that provide guidance for assessing the suitability of RWD sources for pharmacoepidemiology studies. This study aims to assess differences in RWD guidance and variability in current practice for identifying and assessing RWD for studies with regulatory purpose.

Methods: Key criteria for feasibility assessment were mapped against relevant regulatory guidance documents across US, EU, and Asia-Pacific regions.

Abatacept for acute graft-versus-host disease prophylaxis after unrelated donor hematopoietic cell transplantation.

Abatacept plus calcineurin inhibitors/methotrexate (CNI/MTX) is the first US Food and Drug Administration (FDA)-approved regimen for acute graft-versus-host disease (aGVHD) prophylaxis during unrelated-donor hematopoietic cell transplantation (URD-HCT). Using Center for International Blood and Marrow Transplant Research data, we investigated its impact in patients receiving 7/8 HLA-mismatched unrelated donor (MMUD) or 8/8 HLA-matched unrelated donor (MUD) URD-HCT between 2011 and 2018. Primary outcomes included day-180, 1-year, and 2-year overall survival (OS) and relapse-free survival (RFS) for abatacept + CNI/MTX vs CNI/MTX, CNI/MTX + antithymocyte globulin (ATG), and posttransplant cyclophosphamide-based prophylaxis (PT-Cy).

Preliminary Evidence for the Role of Fungi, Specifically Chaetomium, in Gulf War Illness.

Introduction: For veterans of the Persian Gulf War (1990-1991), dozens of possible causes for their illness have been proposed. We hypothesize that all may be correct. These may have weakened the immunity of the military personnel to fungal pathogens in the soil.

Long-term Safety in Epstein-Barr Virus-Seropositive Kidney-only Transplant Recipients Treated With Belatacept in Clinical Practice: Final Study Results From the ENLiST Registry.

Background: Belatacept, a selective T-cell costimulation blocker, was associated with improved survival and renal function but also with a risk of posttransplant lymphoproliferative disorder (PTLD) in adult kidney transplant recipients in phase 3 trials. This registry examined long-term safety in Epstein-Barr virus (EBV)-seropositive kidney transplant recipients treated with belatacept.

Methods: This US-based, prospective, voluntary, multicenter registry (Evaluating Nulojix Long-Term Safety in Transplant [ENLiST]) included adult EBV-seropositive kidney-only transplant recipients treated de novo (within 14 d of transplantation) with belatacept.

Use of quantitative bias analysis to evaluate single-arm trials with real-world data external controls.

Purpose: Use of real-world data (RWD) for external controls added to single-arm trials (SAT) is increasingly prevalent in regulatory submissions. Due to inherent differences in the data-generating mechanisms, biases can arise. This paper aims to illustrate how to use quantitative bias analysis (QBA).

Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries.

Background: Patients with rheumatoid arthritis (RA) have an increased risk of infection and malignancy compared with the general population. Infection risk is increased further with the use of disease-modifying antirheumatic drugs (DMARDs), whereas evidence on whether the use of biologic DMARDs increases cancer risk remains equivocal. This single-arm, post-marketing study estimated the incidence of prespecified infection and malignancy outcomes in patients with RA treated with intravenous or subcutaneous abatacept.

Receipt of Serial Endoscopy Procedures Prior to Esophageal Adenocarcinoma Diagnosis Is Associated with Better Survival.

Background: The poor prognosis of esophageal adenocarcinoma (EAC) has focused efforts on early detection by serial endoscopic surveillance of Barrett's esophagus (BE). Previously, we reported that receipt of endoscopy before EAC diagnosis was associated with improved survival.

Aim: We aimed to refine our previous analysis, assessing surveillance as measured by performance of serial endoscopy before EAC diagnosis and evaluating its association with stage and survival.

Realizing the Potential of the Patient Perspective.

Assessing a patient's perspective on their treatment is part of an increasingly integrated approach to pharmacovigilance and treatment optimization. New tools and methods developed in partnership with patients can capture and quantify cognitive and behavioral aspects of the treatment experience. These treatment insights have the potential to shape the drug development process, as well as supplement patient-reported outcome data in a way that is meaningful to the patient.

Abatacept: A Review of the Treatment of Polyarticular-Course Juvenile Idiopathic Arthritis.

Juvenile idiopathic arthritis (JIA) encompasses several forms of chronic inflammatory arthritis of unknown etiology presenting in children < 16 years of age, with a minimum symptom duration of 6 weeks. Approximately half of affected children have polyarticular-course JIA (pJIA), a functional concept related to several clinically and genetically heterogeneous JIA categories (systemic, extended oligoarthritis, polyarticular rheumatoid factor-positive or rheumatoid factor-negative, enthesitis-related arthritis, and psoriatic arthritis), which has as its defining feature the involvement of five or more joints during the disease course. Chronic inflammation and joint damage lead to the manifestations of JIA such as pain, limitation of motion, and loss of physical function, all of which negatively impact patients' quality of life.

Comparing record linkage software programs and algorithms using real-world data.

Linkage of medical databases, including insurer claims and electronic health records (EHRs), is increasingly common. However, few studies have investigated the behavior and output of linkage software. To determine how linkage quality is affected by different algorithms, blocking variables, methods for string matching and weight determination, and decision rules, we compared the performance of 4 nonproprietary linkage software packages linking patient identifiers from noninteroperable inpatient and outpatient EHRs.

Surgical approach and the impact of epidural analgesia on survival after esophagectomy for cancer: A population-based retrospective cohort study.

Background: Esophagectomy for esophageal cancer carries high morbidity and mortality, particularly in older patients. Transthoracic esophagectomy allows formal lymphadenectomy, but leads to greater perioperative morbidity and pain than transhiatal esophagectomy. Epidural analgesia may attenuate the stress response and be less immunosuppressive than opioids, potentially affecting long-term outcomes.

Risk of Cancer Following Lumbar Fusion Surgery With Recombinant Human Bone Morphogenic Protein-2 (rhBMP-2): An Analysis Using a Commercially Insured Patient Population.

Background: Recombinant human bone morphogenetic protein-2 (rhBMP-2) is frequently used to promote new bone growth after lumbar fusion surgery. However, because BMP receptors are found on cancer cells, there is concern about potential cancer following treatment with rhBMP-2. Data from clinical trials have reported divergent results and have been limited by small sample sizes and relatively short follow-up.

Cancer preventive services, socioeconomic status, and the Affordable Care Act.

Background: Out-of-pocket expenditures are thought to be an important barrier to the receipt of cancer preventive services, especially for those of a lower socioeconomic status (SES). The Affordable Care Act (ACA) eliminated out-of-pocket expenditures for recommended services, including mammography and colonoscopy. The objective of this study was to determine changes in the uptake of mammography and colonoscopy among fee-for-service Medicare beneficiaries before and after ACA implementation.

Outcomes after endoscopic versus surgical therapy for early esophageal cancers in an older population.

Background And Aims: Endoscopic treatment of early esophageal cancer provides an alternative to esophagectomy, which older patients may not tolerate. Population-based data regarding short-term outcomes and recurrence after endoscopic treatment for esophageal cancer are limited. We compared short-term outcomes, treated recurrence, and survival after endoscopic versus surgical therapy for early esophageal cancers in an older population.

Changes in Receipt of Cancer Screening in Medicare Beneficiaries Following the Affordable Care Act.

Background: The Affordable Care Act (ACA) removed copayments for screening mammography and colonoscopy in Medicare beneficiaries, but its clinical impact is unknown.

Methods: Using a 5% random sample of Medicare claims from 2009 through 2012 in individuals age 70 years or older who were due for screening, we examined claims for screening mammography and screening or surveillance colonoscopy for two years prior to ACA (2009-2010) and two years post-ACA (2011-2012). Receipt of the procedures at the patient level was compared across years using generalized estimating equations.

Assessing the impact of propensity score estimation and implementation on covariate balance and confounding control within and across important subgroups in comparative effectiveness research.

Purpose: Researchers are often interested in estimating treatment effects in subgroups controlling for confounding based on a propensity score (PS) estimated in the overall study population.

Objective: To evaluate covariate balance and confounding control in sulfonylurea versus metformin initiators within subgroups defined by cardiovascular disease (CVD) history comparing an overall PS with subgroup-specific PSs implemented by 1:1 matching and stratification.

Methods: We analyzed younger patients from a US insurance claims database and older patients from 2 Medicare (Humana Medicare Advantage, fee-for-service Medicare Parts A, B, and D) datasets.

Risk of cancer after lumbar fusion surgery with recombinant human bone morphogenic protein-2 (rh-BMP-2).

Study Design: Retrospective cohort study among Medicare beneficiaries with lumbar spinal fusion surgery.

Objective: To determine the risk of subsequent cancer among patients who received recombinant human bone morphogenic protein (rhBMP) at surgery compared with those who did not.

Summary Of Background Data: rhBMP is commonly used to promote bone union after spinal surgery.

Complications following colonoscopy with anesthesia assistance: a population-based analysis.

Importance: Deep sedation for endoscopic procedures has become an increasingly used option but, because of impairment in patient response, this technique also has the potential for a greater likelihood of adverse events. The incidence of these complications has not been well studied at a population level.

Design: Population-based study.

Use of colonoscopy for polyp surveillance in Medicare beneficiaries.

Background: Professional society guidelines recommend follow-up colonoscopy for patients with resected colonic adenomas. However, adherence to guideline recommendations in routine clinical practice has not been well characterized.

Methods: The authors used a population-based sample of Medicare beneficiaries to identify all patients aged ≥70 years who had a claim for colonoscopy with polypectomy or hot biopsy during the period from 2001 to 2004.

Glycemic response and attainment of A1C goals following newly initiated insulin therapy for type 2 diabetes.

Objective: To identify the characteristics associated with glycemic response to newly initiated insulin therapy.

Research Design And Methods: We identified 1,139 type 2 diabetic patients who initiated insulin therapy between 1 January 2009 and 30 June 2010. Outcomes of interest were the proportion of patients achieving A1C <7% and mean change in A1C within 3-9 months.

Recombinant human bone morphogenetic protein-2 and pancreatic cancer: a retrospective cohort study.

Purpose: To assess whether use of recombinant human bone morphogenetic protein-2 (rhBMP-2) during lumbar spinal fusion surgery affects subsequent risk of pancreatic cancer.

Methods: Using US Medicare claims data, we performed a retrospective cohort study of patients who underwent lumbar spinal fusion surgery between October 2003 and December 2005. The study population, all >66 years, was identified from procedure codes for lumbar fusion.

Risk of upper gastrointestinal tract events in risedronate users switched to alendronate.

Upper gastrointestinal (GI) side effects are a known complication of therapy with oral aminobisphosphonates, but it is currently unclear if bisphosphonate type or formulation influences the risk of developing side effects. Here, we performed a retrospective cohort study to determine if patients who switched from weekly risedronate to weekly alendronate had an increased risk of upper GI side events. The study utilized The Health Improvement Network (THIN) database, which contained anonymous medical records from 390 general practices in the United Kingdom.

Receipt of guideline-recommended follow-up in older colorectal cancer survivors : a population-based analysis.

Background: After curative resection for colorectal cancer, routine follow-up with office visits, carcinoembryonic antigen (CEA), and colonoscopy is recommended. The actual adherence to these guidelines as well as the potential overuse of testing in routine practice has not been well studied.

Methods: The authors identified 9426 eligible patients aged > or = 66 years in a linked tumor registry-claims database who were diagnosed with adenocarcinoma of the colon or rectum from 2000 to 2001.