Building the Business Case for an Inclusive Approach to Digital Health Measurement With a Web App (Market Opportunity Calculator): Instrument Development Study.

Background: The use of digital health measurement tools has grown substantially in recent years. However, there are concerns that the promised benefits from these products will not be shared equitably. Underserved populations, such as those with lower education and income, racial and ethnic minorities, and those with disabilities, may find such tools poorly suited for their needs.

The Role of Perceived Neighborhood Cohesion in the Association between Depressive Symptoms and Cigarette Smoking.

Background: Greater depression has been linked to increased smoking rates. However, the mechanisms underlying this association are not fully understood. It is possible that high perceived neighborhood cohesion may serve as one such mechanism given its associations with decreased depression and smoking.

Time to publication of cost-effectiveness analyses for medical devices.

Objectives: Academic researchers and physicians have called for greater use of cost-effectiveness analyses in informing treatment and reimbursement decisions. This study examines the availability of cost-effectiveness analyses for medical devices, in terms of both the number of studies and when studies are published.

Study Design: Analysis of the number of years between FDA approval/clearance and publication for cost-effectiveness analyses of medical devices in the United States published between 2002 and 2020 (n = 86).

CAR NK-92 cell-mediated depletion of residual TCR+ cells for ultrapure allogeneic TCR-deleted CAR T-cell products.

Graft-versus-host disease (GVHD) is a major risk of the administration of allogeneic chimeric antigen receptor (CAR)-redirected T cells to patients who are HLA unmatched. Gene editing can be used to disrupt potentially alloreactive T-cell receptors (TCRs) in CAR T cells and reduce the risk of GVHD. Despite the high knockout rates achieved with the optimized methods, a subsequent purification step is necessary to obtain a safe allogeneic product.

Differences in health care provider advice on abstaining from tobacco use: Findings from the 2020 National Youth Tobacco Survey.

Background: Health care providers' (HCP) advice on tobacco prevention and cessation is critical in addressing the tobacco use epidemic among adolescents. However, examination of whether receiving advice from HCPs differs by adolescent sociodemographic characteristics and tobacco use is limited.

Methods: HCP advice to abstain from using tobacco was examined using the 2020 National Youth Tobacco Survey (N = 12,483).

Long-term impact of the COVID-19 pandemic on use behavior and risk perceptions of college student E-cigarette users.

Work examining the long-term impact of the COVID-19 pandemic on e-cigarette use among college students is limited. Therefore, the current study examined differences in college student e-cigarette users' changes in use behavior and risk perceptions as the pandemic continues. 129 undergraduate current e-cigarette users ( = 19.

Racial/Ethnic Discrimination and Cardiometabolic Diseases: A Systematic Review.

Introduction: Racial discrimination has been identified as a risk factor for cardiometabolic diseases, the leading cause of morbidity and mortality among racial/ethnic minority groups; however, there is no synthesis of current knowledge on the association between discrimination and cardiometabolic diseases. The objective of this systematic review was to summarize evidence linking racial/ethnic discrimination and cardiometabolic diseases.

Methods: The review was conducted based on studies identified via electronic searches of 5 databases (PubMed, Google Scholar, WorldWideScience.

The Effect of Repetition on the Perceived Truth of Tobacco-Related Health Misinformation Among U.S. Adults.

As concerns about the effects of health misinformation rise, understanding why misbeliefs are accepted is increasingly important. People believe repeated statements more than novel statements, an effect known as truth by repetition, however this has not been examined in the context of tobacco information. Misbeliefs about tobacco are rampant and novel facts about tobacco are viewed as less believable.

Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan.

A cancer diagnosis is devastating for both patients and their caregivers. With high morbidity and mortality, cancer is a serious disease area with unmet medical needs. Thus, innovative anticancer drugs are in high demand worldwide but are unequally available.

Validation of Predictive Analyses for Interim Decisions in Clinical Trials.

Purpose: Adaptive clinical trials use algorithms to predict, during the study, patient outcomes and final study results. These predictions trigger interim decisions, such as early discontinuation of the trial, and can change the course of the study. Poor selection of the Prediction Analyses and Interim Decisions (PAID) plan in an adaptive clinical trial can have negative consequences, including the risk of exposing patients to ineffective or toxic treatments.

Evidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials.

Digital Health Technologies (DHTs) such as connected sensors offer particular promise for improving data collection and patient empowerment in neurology research and care. This study analyzed the recent evolution of the use of DHTs in trials registered on ClinicalTrials.gov for four chronic neurological disorders: epilepsy, multiple sclerosis, Alzheimer's, and Parkinson's disease.

Long-term response to autologous anti-CD19 chimeric antigen receptor T cells in relapsed or refractory B cell acute lymphoblastic leukemia: a systematic review and meta-analysis.

Chimeric Antigen Receptor (CAR) T cell therapy is an effective treatment approach for patients with relapsed or refractory acute lymphoblastic leukemia (R/R B-ALL). However, identifying the factors that influence long-term response to this therapy is necessary to optimize patient selection and treatment allocation. We conducted a literature review and meta-analysis to investigate the use of autologous anti-CD19 CAR T cell therapy in both pediatric and adult patients with R/R B-ALL, using several databases including MEDLINE, Cochrane Central, ScienceDirect, Web of Science, Journals@Ovid, Embase, and clinicaltrial.

Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance.

Importance: Most regulated medical devices enter the US market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are "substantially equivalent" to 1 or more "predicate" devices (legally marketed medical devices with similar intended use). Most recalled medical devices are 510(k) devices.

Objective: To examine the association between characteristics of predicate medical devices and recall probability for 510(k) devices.

Harm perceptions of secondhand e-cigarette aerosol among youth in the United States.

E-cigarette use among youth remains a public health concern. Although extant literature has examined the perceived harms of cigarette use and secondhand smoke, perceptions of harms associated with secondhand e-cigarette aerosol (SHA) are not well understood. Therefore, we used data from the 2020 U.

Regulatory considerations to keep pace with innovation in digital health products.

Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a useful structure, but the evolution of digital devices requires concomitant innovation in regulatory approaches to maximize the potential benefits of these emerging technologies. A number of specific adaptations could strengthen current regulatory oversight while promoting ongoing innovation.

US Food and Drug Administration Approval of High-risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021.

This study uses data from US Food and Drug Administration (FDA) databases to quantify approval of high-risk cardiovascular devices for use in pediatric populations and assess the clinical evidence supporting the approvals.

Trends in Remote Patient Monitoring Use in Traditional Medicare.

This cross-sectional study uses traditional Medicare claims data to assess trends in general remote patient monitoring from January 2018 through September 2021.

Differences in young adults' perceptions of e-cigarettes by history of use.

The current study examined group differences in college students' views on e-cigarettes in terms of safety, popularity, health risks, social acceptability, efficacy as a cessation aid, and promoting combustible cigarette use. : 337 undergraduates ( = 20.84,  = 3.

Readability of online e-cigarette cessation information.

Introduction: Given the growing awareness of the health risks associated with e-cigarettes, many users will access information about how to effectively quit using e-cigarettes, and the internet likely will be a popular source of information. However, little is known about the readability of online e-cigarette cessation information. Therefore, the goal of the current study was to assess the readability of webpage information about e-cigarette cessation.

Learning in Medicine: The Importance of Statistical Thinking.

In many fields, including medicine and biology, there has been in the last years an increasing diffusion and availability of complex data from different sources. Examples include biological experiments or data from health care providers. These data encompass information that can potentially enhance therapeutic advancement and constitute the core of modern system medicine.