High-Risk Medications in Persons Living With Dementia: A Randomized Clinical Trial.

Importance: Individuals with Alzheimer disease (AD) and Alzheimer disease-related dementias (ADRD) may be at increased risk for adverse outcomes relating to inappropriate prescribing of certain high-risk medications, including antipsychotics, sedative-hypnotics, and strong anticholinergic agents.

Objective: To evaluate the effect of a patient/caregiver and prescriber-mailed educational intervention on potentially inappropriate prescribing to patients with AD or ADRD.

Design, Setting, And Participants: This prospective, open-label, pragmatic randomized clinical trial, embedded in 2 large national health plans, was conducted from April 2022 to June 2023.

Electronic Health Record Data for Lyme Disease Surveillance, Massachusetts, USA, 2017-2018.

Lyme disease surveillance based on provider and laboratory reports underestimates incidence. We developed an algorithm for automating surveillance using electronic health record data. We identified potential Lyme disease markers in electronic health record data (laboratory tests, diagnosis codes, prescriptions) from January 2017-December 2018 in 2 large practice groups in Massachusetts, USA.

Electronic Health Record-Based Algorithm for Monitoring Respiratory Virus-Like Illness.

Viral respiratory illness surveillance has traditionally focused on single pathogens (e.g., influenza) and required fever to identify influenza-like illness (ILI).

Validity of inpatient electronic health record-based measures of oxygen-related therapy in the United States: Lessons applicable for studying COVID-19 endpoints.

Introduction: During the COVID-19 pandemic, inpatient electronic health records (EHRs) have been used to conduct public health surveillance and assess treatments and outcomes. Invasive mechanical ventilation (MV) and supplemental oxygen (O) use are markers of severe illness in hospitalized COVID-19 patients. In a large US system (n = 142 hospitals), we assessed documentation of MV and O use during COVID-19 hospitalization in administrative data versus nursing documentation.

Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States.

Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability.

Patients And Methods: We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries.

Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in the Elderly with Alzheimer's Disease (D-PRESCRIBE-AD): Trial protocol and rationale of an open-label pragmatic, prospective randomized controlled trial.

Context: Potentially inappropriate prescribing of medications in older adults, particular those with dementia, can lead to adverse drug events including falls and fractures, worsening cognitive impairment, emergency department visits, and hospitalizations. Educational mailings from health plans to patients and their providers to encourage deprescribing conversations may represent an effective, low-cost, "light touch", approach to reducing the burden of potentially inappropriate prescription use in older adults with dementia.

Objectives: The objective of the Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease (D-PRESCRIBE-AD) trial is to evaluate the effect of a health plan based multi-faceted educational outreach intervention to community dwelling patients with dementia who are currently prescribed sedative/hypnotics, antipsychotics, or strong anticholinergics.

COVID-19 Severity in People With HIV Compared With Those Without HIV.

Background: People with HIV (PWH) may be at risk for more severe COVID-19 outcomes. We compared risk for severe COVID-19 in PWH with matched individuals without HIV.

Methods: We identified adults in Massachusetts with a positive SARS-CoV-2 test, March 2020-July 2022, using electronic medical record data from 3 large clinical practice groups.

Validation of Claims-Based Algorithm for Lyme Disease, Massachusetts, USA.

Compared with notifiable disease surveillance, claims-based algorithms estimate higher Lyme disease incidence, but their accuracy is unknown. We applied a previously developed Lyme disease algorithm (diagnosis code plus antimicrobial drug prescription dispensing within 30 days) to an administrative claims database in Massachusetts, USA, to identify a Lyme disease cohort during July 2000-June 2019. Clinicians reviewed and adjudicated medical charts from a cohort subset by using national surveillance case definitions.

Syndromic Surveillance for COVID-19, Massachusetts, February 2020-November 2022: The Impact of Fever and Severity on Algorithm Performance.

Objectives: Syndromic surveillance can help identify the onset, location, affected populations, and trends in infectious diseases quickly and efficiently. We developed an electronic medical record-based surveillance algorithm for COVID-19-like illness (CLI) and assessed its performance in 5 Massachusetts medical practice groups compared with statewide counts of confirmed cases.

Materials And Methods: Using data from February 2020 through November 2022, the CLI algorithm was implemented in sites that provide ambulatory and inpatient care for about 25% of the state.

Treatment and care received by children hospitalized with COVID-19 in a large hospital network in the United States, February 2020 to September 2021.

We described care received by hospitalized children with COVID-19 or multi-system inflammatory syndrome (MIS-C) prior to the 2021 COVID-19 Omicron variant surge in the US. We identified hospitalized children <18 years of age with a COVID-19 or MIS-C diagnosis (COVID-19 not required), separately, from February 2020-September 2021 (n = 126 hospitals). We described high-risk conditions, inpatient treatments, and complications among these groups.

Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren't so simple.

Background: There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensings, vaccine administrations, behavioral healthcare encounters, and some laboratory results. Such trials can be large and efficient, using these data to identify trial-eligible patients and to ascertain outcomes.

Methods: We use our experience primarily with the National Institutes of Health Pragmatic Trials Collaboratory Distributed Research Network, which comprises health plans that participate in the US Food & Drug Administration's Sentinel System, to describe lessons learned from the conduct and planning of embedded pragmatic trials.

Risk of admission to hospital with arterial or venous thromboembolism among patients diagnosed in the ambulatory setting with covid-19 compared with influenza: retrospective cohort study.

Objective: To measure the 90 day risk of arterial thromboembolism and venous thromboembolism among patients diagnosed with covid-19 in the ambulatory (ie, outpatient, emergency department, or institutional) setting during periods before and during covid-19 vaccine availability and compare results to patients with ambulatory diagnosed influenza.

Design: Retrospective cohort study.

Setting: Four integrated health systems and two national health insurers in the US Food and Drug Administration's Sentinel System.

Leveraging Electronic Health Record Data for Timely Chronic Disease Surveillance: The Multi-State EHR-Based Network for Disease Surveillance.

Context: Electronic health record (EHR) data can potentially make chronic disease surveillance more timely, actionable, and sustainable. Although use of EHR data can address numerous limitations of traditional surveillance methods, timely surveillance data with broad population coverage require scalable systems. This report describes implementation, challenges, and lessons learned from the Multi-State EHR-Based Network for Disease Surveillance (MENDS) to help inform how others work with EHR data to develop distributed networks for surveillance.

The US Food and Drug Administration Sentinel System: a national resource for a learning health system.

The US Food and Drug Administration (FDA) created the Sentinel System in response to a requirement in the FDA Amendments Act of 2007 that the agency establish a system for monitoring risks associated with drug and biologic products using data from disparate sources. The Sentinel System has completed hundreds of analyses, including many that have directly informed regulatory decisions. The Sentinel System also was designed to support a national infrastructure for a learning health system.

Association of COVID-19 vs Influenza With Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients.

Importance: The incidence of arterial thromboembolism and venous thromboembolism in persons with COVID-19 remains unclear.

Objective: To measure the 90-day risk of arterial thromboembolism and venous thromboembolism in patients hospitalized with COVID-19 before or during COVID-19 vaccine availability vs patients hospitalized with influenza.

Design, Setting, And Participants: Retrospective cohort study of 41 443 patients hospitalized with COVID-19 before vaccine availability (April-November 2020), 44 194 patients hospitalized with COVID-19 during vaccine availability (December 2020-May 2021), and 8269 patients hospitalized with influenza (October 2018-April 2019) in the US Food and Drug Administration Sentinel System (data from 2 national health insurers and 4 regional integrated health systems).

Precision Public Health for Non-communicable Diseases: An Emerging Strategic Roadmap and Multinational Use Cases.

Non-communicable diseases (NCDs) remain the largest global public health threat. The emerging field of precision public health (PPH) offers a transformative opportunity to capitalize on digital health data to create an agile, responsive and data-driven public health system to actively prevent NCDs. Using learnings from digital health, our aim is to propose a vision toward PPH for NCDs across three horizons of digital health transformation: Horizon 1-digital public health workflows; Horizon 2-population health data and analytics; Horizon 3-precision public health.

Evaluating Confounding Control in Estimations of Influenza Antiviral Effectiveness in Electronic Health Plan Data.

Observational studies of oseltamivir use and influenza complications could suffer from residual confounding. Using negative control risk periods and a negative control outcome, we examined confounding control in a health-insurance-claims-based study of oseltamivir and influenza complications (pneumonia, all-cause hospitalization, and dispensing of an antibiotic). Within the Food and Drug Administration's Sentinel System, we identified individuals aged ≥18 years who initiated oseltamivir use on the influenza diagnosis date versus those who did not, during 3 influenza seasons (2014-2017).

Assessment of Antibiotic Prescriptions for Lyme Disease After Modification of Reporting Language for Positive Screening Test Results.

This quality improvement study assesses whether revision of positive Lyme disease test result text was associated with decreases in the frequency of antibiotic prescriptions for patients without confirmatory results.

Impact of an Electronic Medical Record Best Practice Alert on Expedited Partner Therapy for Chlamydia Infection and Reinfection.

Background: Atrius Health implemented a best practice alert (BPA) to encourage clinicians to provide expedited partner therapy (EPT) in October 2014. We assessed (1) the impact of the BPA on EPT provision and chlamydial reinfection and (2) the impact of EPT on testing for chlamydia reinfection and reinfection rates.

Methods: We included patients ≥15 years with ≥1 positive chlamydia test between January 2013 and March 2019.

Validation of diagnosis codes to identify hospitalized COVID-19 patients in health care claims data.

Purpose: Health plan claims may provide complete longitudinal data for timely, real-world population-level COVID-19 assessment. However, these data often lack laboratory results, the standard for COVID-19 diagnosis.

Methods: We assessed the validity of ICD-10-CM diagnosis codes for identifying patients hospitalized with COVID-19 in U.

Association of Changes in Obesity Prevalence With the COVID-19 Pandemic in Youth in Massachusetts.

This cohort study assessed obesity prevalence before and during the COVID-19 pandemic (2018-2020) in children and adolescents in Massachusetts.

Using inpatient electronic medical records to study influenza for pandemic preparedness.

Background: We assessed the ability to identify key data relevant to influenza and other respiratory virus surveillance in a large-scale US-based hospital electronic medical record (EMR) dataset using seasonal influenza as a use case. We describe characteristics and outcomes of hospitalized influenza cases across three seasons.

Methods: We identified patients with an influenza diagnosis between March 2017 and March 2020 in 140 US hospitals as part of the US FDA's Sentinel System.

Long-term Risk of Parkinson Disease Following Influenza and Other Infections.

Importance: Influenza has been associated with the risk of developing Parkinson disease, but the association is controversial.

Objective: To examine whether prior influenza and other infections are associated with Parkinson disease more than 10 years after infection.

Design, Setting, And Participants: This case-control study used data from 1977 to 2016 from the Danish National Patient Registry.

Who gets treated for influenza: A surveillance study from the US Food and Drug Administration's Sentinel System.

Objective: We describe the baseline characteristics and complications of individuals with influenza in the US FDA's Sentinel System by antiviral treatment timing.

Design: Retrospective cohort design.

Patients: Individuals aged ≥6 months with outpatient diagnoses of influenza in June 2014-July 2017, 3 influenza seasons.