Treatment trends of systemic lupus erythematosus from 2007 to 2023 in the USA.

Objective: To characterise the changing trends in the pharmacological management of SLE in the USA between 2007 and 2023 as new treatment options emerged.

Methods: In a retrospective cohort study using data from OptumLabs Data Warehouse, we characterised the annual prevalent (ie, all) and incident (ie, new) use of antimalarials, glucocorticoids and immunosuppressive medications among patients with SLE from 2007 to 2023 and assessed for changing trends over time.

Results: We identified 19 122 adults with SLE; they were 51.

Innovative Research Methods: Using Simulation to Evaluate Health Care Policy.

Health care policies have the potential to improve patient outcomes, access to care, and reduce health disparities. However, new policy is often tested in the field, where unintended consequences are paid for by patients. In this perspective, we argue that health care simulations, which can elucidate the potential for policy to hinder clinicians' ability to provide high-quality care, are a complement to large-scale policy evaluations in the field.

Longitudinal Patterns in Testosterone Prescribing After US FDA Safety Communication in 2014.

Background: The objective of this study was to describe changes in testosterone prescribing following a 2014 US Food and Drug Administration (FDA) safety communication and how changes varied by physician characteristics.

Methods: Data were extracted from a 20% random sample of Medicare fee-for-service administrative claims data from 2011 through 2019. The sample included 1,544,604 unique male beneficiaries who received evaluation and management (E&M) services from 58,819 unique physicians that prescribed testosterone between 2011 and 2013.

Identifying treatment heterogeneity in atrial fibrillation using a novel causal machine learning method.

Background: Lifelong oral anticoagulation is recommended in patients with atrial fibrillation (AF) to prevent stroke. Over the last decade, multiple new oral anticoagulants (OACs) have expanded the number of treatment options for these patients. While population-level effectiveness of OACs has been compared, it is unclear if there is variability in benefit and risk across patient subgroups.

A prediction model for asthma exacerbations after stopping asthma biologics.

Background: Little is known regarding the prediction of the risks of asthma exacerbation after stopping asthma biologics.

Objective: To develop and validate a predictive model for the risk of asthma exacerbations after stopping asthma biologics using machine learning models.

Methods: We identified 3057 people with asthma who stopped asthma biologics in the OptumLabs Database Warehouse and considered a wide range of demographic and clinical risk factors to predict subsequent outcomes.

A Simple and Interpretable Mortality-Based Value Metric for Condition- or Procedure-Specific Hospital Performance Reporting.

Objective: To develop a simple, interpretable value metric (VM) to assess the value of care of hospitals for specific procedures or conditions by operationalizing the value equation: Value = Quality/Cost.

Patients And Methods: The present study was conducted on a retrospective cohort from 2015 to 2018 drawn from the 100% US sample of Medicare inpatient claims. The final cohort comprised 637,341 consecutive inpatient encounters with a cancer-related Medicare Severity-Diagnosis Related Grouping and 13,307 consecutive inpatient encounters with the or procedure code for partial or total gastrectomy.

Emulating the GRADE trial using real world data: retrospective comparative effectiveness study.

Objective: To emulate the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) trial using real world data before its publication. GRADE directly compared second line glucose lowering drugs for their ability to lower glycated hemoglobin A (HbA).

Design: Observational study.

Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021.

Importance: New formulations of prescription drugs can improve convenience and tolerability for patients, but they also constitute manufacturer strategies to extend brand-name drug market exclusivity periods.

Objective: To examine whether new formulations of brand-name novel drugs were associated with novel drugs' sales and/or therapeutic value, as well as characterize first new formulations' approval timing relative to the novel drug's generic approval.

Design Setting And Participants: This cross-sectional study used the Drugs@FDA database to identify all novel tablet and capsule drugs approved by the US Food and Drug Administration (FDA) between 1995 and 2010 and followed through December 31, 2021.

Precription Digita Thraputic for atients with nsomnia ( a protocol for a pragmatic randomised controlled trial.

Introduction: Cognitive behavioural therapy for insomnia (CBT-I) is effective at treating chronic insomnia, yet in-person CBT-I can often be challenging to access. Prior studies have used technology to bridge barriers but have been unable to extensively assess the impact of the digital therapeutic on real-world patient experience and multidimensional outcomes. Among patients with insomnia, our aim is to determine the impact of a prescription digital therapeutic (PDT) (PEAR-003b, FDA-authorised as Somryst; herein called PDT) that provides mobile-delivered CBT-I on patient-reported outcomes (PROs) and healthcare utilisation.

Shared Decision-Making for Patients Hospitalized with Acute Myocardial Infarction: A Randomized Trial.

Objective: Adherence to guideline-recommended medications after acute myocardial infarction (AMI) is suboptimal. Patient fidelity to treatment regimens may be related to their knowledge of the risk of death following AMI, the pros and cons of medications, and to their involvement in treatment decisions. Shared decision-making may improve both patients' knowledge and involvement in treatment decisions.

Association of stay-at-home orders and COVID-19 incidence and mortality in rural and urban United States: a population-based study.

Objective: We examined the association between stay-at-home order implementation and the incidence of COVID-19 infections and deaths in rural versus urban counties of the United States.

Design: We used an interrupted time-series analysis using a mixed effects zero-inflated Poisson model with random intercept by county and standardised by population to examine the associations between stay-at-home orders and county-level counts of daily new COVID-19 cases and deaths in rural versus urban counties between 22 January 2020 and 10 June 2020. We secondarily examined the association between stay-at-home orders and mobility in rural versus urban counties using Google Community Mobility Reports.

Many Medicare Beneficiaries Do Not Fill High-Price Specialty Drug Prescriptions.

For high-price drugs, Medicare Part D beneficiaries who do not receive a low-income subsidy must pay a percentage of the drug's price for each medication fill. Without that subsidy, which lowers out-of-pocket spending, beneficiaries typically pay hundreds or thousands of dollars for a single fill. We estimated the proportion of Part D beneficiaries in fee-for-service Medicare, with and without a subsidy, who do not initiate treatment (that is, do not fill a new prescription) with high-price Part D drugs newly prescribed for four conditions.

Physical activity, patient-reported symptoms, and clinical events: Insights into postprocedural recovery from personal digital devices.

Background: Personal digital devices may offer insights into patient recovery and an approach for remote monitoring after procedures.

Objective: To examine associations between activity measured using personal digital devices, patient-reported outcome measures (PROMs), and clinical events among patients after catheter ablation for atrial fibrillation (AF) or bariatric surgery.

Methods: We aggregated personal digital device, PROM, and electronic health record data in a study conducted at 2 health systems.

Midwest rural-urban disparities in use of patient online services for COVID-19.

Purpose: Rural populations are disproportionately affected by the COVID-19 pandemic. We characterized urban-rural disparities in patient portal messaging utilization for COVID-19, and, of those who used the portal during its early stage in the Midwest.

Methods: We collected over 1 million portal messages generated by midwestern Mayo Clinic patients from February to August 2020.

A multicenter evaluation of computable phenotyping approaches for SARS-CoV-2 infection and COVID-19 hospitalizations.

Diagnosis codes are used to study SARS-CoV2 infections and COVID-19 hospitalizations in administrative and electronic health record (EHR) data. Using EHR data (April 2020-March 2021) at the Yale-New Haven Health System and the three hospital systems of the Mayo Clinic, computable phenotype definitions based on ICD-10 diagnosis of COVID-19 (U07.1) were evaluated against positive SARS-CoV-2 PCR or antigen tests.

Management and Outcomes of Acute Myocardial Infarction-Cardiogenic Shock in Uninsured Compared With Privately Insured Individuals.

Background: There are limited data on uninsured patients presenting with acute myocardial infarction-cardiogenic shock (AMI-CS). This study sought to compare the management and outcomes of AMI-CS between uninsured and privately insured individuals.

Methods: Using the National Inpatient Sample (2000-2016), a retrospective cohort of adult (≥18 years) uninsured admissions (primary payer-self-pay or no charge) were compared with privately insured individuals.

Heart Watch Study: protocol for a pragmatic randomised controlled trial.

Introduction: Personal digital devices that provide health information, such as the Apple Watch, have developed an increasing array of cardiopulmonary tracking features which have received regulatory clearance and are directly marketed to consumers. Despite their widespread and increasing use, data about the impact of personal digital device use on patient-reported outcomes and healthcare utilisation are sparse. Among a population of patients with atrial fibrillation and/or atrial flutter undergoing cardioversion, our primary aim is to determine the impact of the heart rate measurement, irregular rhythm notification, and ECG features of the Apple Watch on quality of life and healthcare utilisation.

Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults.

Importance: Switching among generic levothyroxine sodium products made by different manufacturers typically occurs at the pharmacy and may affect serum thyrotropin (TSH) levels.

Objective: To compare TSH levels between patients who continued taking the same sourced generic levothyroxine product and those who switched.

Design, Setting, And Participants: This comparative effectiveness research study with 1:1 propensity matching used data from OptumLabs Data Warehouse, a national administrative claims database linked to laboratory test results.

Association Between Payments by Pharmaceutical Manufacturers and Prescribing Behavior in Rheumatology.

Objective: To evaluate the association between pharmaceutical industry payments to rheumatologists and their prescribing behaviors.

Methods: A cross-sectional analysis was conducted of Medicare Part B Public Use File, Medicare Part D Public Use File, and Open Payments data for 2013 to 2015. Prescription drugs responsible for 80% of the total Medicare pharmaceutical expenditures in rheumatology were analyzed.