Background: Rheumatoid arthritis (RA) patients have a lowered immune response to infection, potentially due to the use of corticosteroids and immunosuppressive drugs. Predictors of severe COVID-19 outcomes within the RA population have not yet been explored in a real-world setting.
Objectives: To identify the most influential predictors of severe COVID-19 within the RA population.
Background: Oxymorphone's metabolism does not involve the hepatic cytochrome P450 (CYP) system. The effect of this pharmacokinetic feature of oxymorphone on opioid prescribing is unknown.
Objective: To assess the relative frequency with which oxymorphone and oxycodone (a CYP3A-metabolized opioid analgesic) were each prescribed to patients concomitantly receiving CYP3A-modifying drugs (i.
Purpose: We validated an algorithm to detect frequency errors in computerized healthcare data and estimated the incidence of these errors in an integrated healthcare system.
Methods: We applied Sentinel System analytic tools on the electronic health records of Kaiser Permanente, Northern California, January 1, 2010, through May 30, 2015,to identify rheumatoid arthritis (RA) patients with new use of methotrexate (365-day baseline period). We identified potential methotrexate frequency errors using ICD-9 code 995.
Pharmacoepidemiol Drug Saf
December 2018
Purpose: Mortality data within the Sentinel Death Tables remain generally uncharacterized. Assessment of mortality data within Sentinel will help inform its utility for medical product safety studies.
Methods: To determine if Sentinel contains sufficient all-cause and cause-specific mortality events to power postmarketing safety studies.
Purpose/background: Stimulant abuse is associated with cardiomyopathy, but cardiomyopathy rates with therapeutic use of stimulants for attention-deficit/hyperactivity disorder (ADHD) are poorly characterized. Labels for methylphenidate, amphetamine, and atomoxetine caution against use in patients with cardiovascular disease. We sought to assess the incidence of new-onset heart failure or cardiomyopathy among initiators of these medications.
View Article and Find Full Text PDFPurpose: To replicate the well-established association between angiotensin-converting enzyme inhibitors versus beta blockers and angioedema in the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) era.
Methods: We conducted a retrospective, inception cohort study in a large insurance database formatted to the Sentinel Common Data Model. We defined study periods spanning the ICD-9-CM era only, ICD-10-CM era only, and ICD-9-CM and ICD-10-CM era and conducted simple-forward mapping (SFM), simple-backward mapping (SBM), and forward-backward mapping (FBM) referencing the General Equivalence Mappings to translate the outcome (angioedema) and covariates from ICD-9-CM to ICD-10-CM.
Purpose: To describe the consistency in the frequency of 5 health outcomes across the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and Tenth Revision, Clinical Modification (ICD-10-CM) eras in the US.
Methods: We examined the incidence of 3 acute conditions (acute myocardial infarction [AMI], angioedema, ischemic stroke) and the prevalence of 2 chronic conditions (diabetes, hypertension) during the final 5 years of the ICD-9-CM era (January 2010-September 2015) and the first 15 months of the ICD-10-CM era (October 2015-December 2016) in 13 electronic health care databases in the Sentinel System. For each health outcome reviewed during the ICD-10-CM era, we evaluated 4 definitions, including published algorithms derived from other countries, as well as simple-forward, simple-backward, and forward-backward mapping using the General Equivalence Mappings.
Sentinel is a program sponsored by the US Food and Drug Administration to monitor the safety of medical products. We conducted a cohort assessment to evaluate the ability of the Sentinel Propensity Score Matching Tool to reproduce in an expedited fashion the known association between glyburide (vs. glipizide) and serious hypoglycemia.
View Article and Find Full Text PDFPharmacoepidemiol Drug Saf
June 2014
Purpose: Developing electronic clinical data into a common data model posed substantial challenges unique from those encountered with administrative data. We present here the design, implementation, and use of the Mini-Sentinel Distributed Database laboratory results table (LRT).
Methods: We developed the LRT and guided Mini-Sentinel data partners (DPs) in populating it from their source data.
J Health Care Poor Underserved
May 2013
Nursing prides itself on the ability to advocate for patients. However, questions are raised in the National Health Care Disparities Reports from the Agency for Healthcare Research and Quality about how well nurses communicate with African Americans, Hispanics, and people who speak languages other than English. Our secondary analysis of patient data collected at an urban safety-net hospital oncology unit examined the relationships among race, language, patient-centered nursing care, and patient outcomes.
View Article and Find Full Text PDFPurpose: We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveillance system for monitoring the safety of medical products (drugs, biologics, and devices) in the USA.
Methods: A common data model was designed to address the priorities of the Mini-Sentinel Pilot and to leverage the experience and data of participating organizations and data partners.