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.

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.

An Open-Source Framework for Mass Calculation of Antibody-Based Therapeutic Molecules.

Biotherapeutic masses are a means of verifying identity and structural integrity. Mass spectrometry (MS) of intact proteins or protein subunits provides an easy analytical tool for different stages of biopharmaceutical development. The protein's identity is confirmed when the experimental mass from MS is within a pre-defined mass error range of the theoretical mass.

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.

Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial.

Importance: Only about half of patients with atrial fibrillation (AF) who are at increased risk for stroke are treated with an oral anticoagulant (OAC), despite guideline recommendations for their use. Educating patients with AF about prevention of stroke with OACs may enable them as agents of change to initiate OAC treatment.

Objective: To determine whether an educational intervention directed to patients and their clinicians stimulates the use of OACs in patients with AF who are not receiving OACs.

Identifying prescribing cascades in Alzheimer's disease and related dementias: The calcium channel blocker-diuretic prescribing cascade.

Purpose: Prescribing cascades occur when a physician prescribes a new drug to address the side-effect of another drug. Persons with Alzheimer's disease and related dementias (ADRD) are at increased risk for prescribing cascades. Our objective was to develop an approach to estimating the proportion of calcium channel blocker-diuretic (CCB-diuretic) prescribing cascades among persons with ADRD in two U.

Antidopaminergic-Antiparkinsonian Medication Prescribing Cascade in Persons with Alzheimer's Disease.

Objectives: Persons living with Alzheimer's disease (AD) may be at increased risk for prescribing cascades due to greater multimorbidity, polypharmacy, and the need for more complex care. Our objective was to assess the proportion of the antidopaminergic-antiparkinsonian medication prescribing cascades among persons living with Alzheimer's disease.

Setting: Two large administrative claims databases in the United States.

Underuse of oral anticoagulants in privately insured patients with atrial fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib).

Background: Many studies showing underuse of oral anticoagulants (OACs) in patients with atrial fibrillation (AF) predated the advent of the non-vitamin K antagonist OACs. We retrospectively examined use of OACs in a large commercially insured population.

Methods: Administrative claims data from 4 research partners participating in FDA-Catalyst, a program of the Sentinel Initiative, were queried in September 2017.

FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial.

Background: The US Food and Drug Administration's Sentinel Initiative is well positioned to support pragmatic clinical trials. FDA-Catalyst combines direct contact with health plan members and/or providers with data in the Sentinel infrastructure. Here, we describe the rationale, feasibility analyses, and lessons learned from the planning phase of the first large pragmatic trial conducted using the Sentinel Initiative's delivery system capabilities-IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (the IMPACT-AFib trial).

Impact of certified CME in atrial fibrillation on administrative claims.

Objective: To determine whether changes in physician behavior associated with a continuing medical education (CME) activity on atrial fibrillation (AF) can be measured using an administrative claims database.

Study Design: A retrospective, analytical review of physician practice changes and AF patient- related healthcare utilization and costs derived from an administrative claims database was performed on a cohort of Humana health system physicians.

Methods: The Humana physicians participated in a specified CME activity on the management of patients with AF.

A systematic review of validated methods for identifying venous thromboembolism using administrative and claims data.

Background: Venous thromboembolism (VTE) is a serious complication. Large claims databases can potentially identify the effects that medications have on VTE. The purpose of this study is to evaluate the evidence supporting the validity of VTE codes.

A systematic review of validated methods for identifying ventricular arrhythmias using administrative and claims data.

Background: Drug-induced pro-arrhythmia is a serious and unexpected event. Large administrative and claims databases can potentially identify drugs or interactions leading to cardiac arrhythmias. The purpose of this study is to evaluate the evidence supporting the validity of algorithms or codes to identify ventricular arrhythmias using administrative and claims data.

Social integration and health behavioral change in San Luis, Honduras.

This study explores the effects of social integration on behavioral change in the course of an intensive, community-based public health intervention. The intervention trained volunteers and mobilized local organizations to promote 16 key family health practices in rural San Luis, Honduras, during 2004 to 2006. A mixed methods approach is used.

The health benefits of social mobilization: experiences with community-based Integrated Management of Childhood Illness in Chao, Peru and San Luis, Honduras.

This article reviews the implementation of the community component of the Integrated Management of Childhood Illness (IMCI) strategy in Chao, Peru (2001 to 2004) and San Luis, Honduras (2003 to 2005). An evaluation was conducted in 2005 and included a project documentation review, key-informant interviews, and a household level baseline and follow-up survey of the WHO/UNICEF key family practices in each intervention site. The promotion of the key family practices in Chao and San Luís demonstrated measurable success.