Devices and Diagnostics

Development, regulation, pricing, and reimbursement of medical devices and diagnostic products.

Increasing HIV Testing and Viral Suppression via Stigma Reduction in a Social Networking Mobile Health Intervention Among Black and Latinx Young Men and Transgender Women Who Have Sex With Men (HealthMpowerment): Protocol for a Randomized Controlled Trial

Dec. 16, 2020

Kathryn Elizabeth Muessig, Jesse M. Golinkoff, Lisa B. Hightow-Weidman, Aimee E. Rochelle, Marta I. Mulawa, Sabina Hirshfield, A. Lina Rosengren, Subhash Aryal, Nickie Buckner, M. Skye Wilson, Dovie L. Watson, Steven Houang, José Arturo Bauermeister

Abstract [from journal]

Background: Stigma and discrimination related to sexuality, race, ethnicity, and HIV status negatively impact HIV testing, engagement in care, and consistent viral suppression (VS) among young Black and Latinx men who have sex with men and transgender women who have sex with men (YBLMT). Few interventions address the effects of intersectional stigma among youth living with HIV and those at risk for HIV within the same virtual space.

Objective: Building on the success of the HealthMpowerment (


A Rapid Pre-Implementation Evaluation To Inform a Family Engagement Navigator Program During COVID-19

Rinad Beidas, PhD, U of Penn
Dec. 9, 2020

Stephanie Parks Taylor, Robert T. Short, Anthony M. Asher, Brice Taylor, Rinad S. Beidas

Abstract [from journal]

Background: Innovative models of family engagement and support are needed in the intensive care unit (ICU) during times of restricted visitation such as the COVID-19 pandemic. Limited understanding of the factors affecting the uptake and outcomes of different family support models hinders the implementation of best practices. We aimed to conduct a rapid pre-implementation evaluation of stakeholder-perceived facilitators and barriers to design implementation strategies to support a novel program using medical students


Group-Randomized Trial of Tailored Brief Shared Decision-Making to Improve Asthma Control in Urban Black Adults

Karen Glanz
Nov. 29, 2020

Maureen George, Jean-Marie Bruzzese, Marilyn Lynn S. Sommers, Michael V. Pantalon, Haomiao Jia, Joseph Rhodes, Allison A. Norful, Annie Chung, Jesse Chittams, Danielle Coleman, Karen Glanz

Abstract [from journal]

Aims: To assess the intervention effects of BREATHE (BRief intervention to Evaluate Asthma THErapy), a novel brief shared decision-making intervention and evaluate feasibility and acceptability of intervention procedures.

Design: Group-randomized longitudinal pilot study.

Methods: In total, 80 adults with uncontrolled persistent asthma participated in a trial comparing BREATHE (N = 40) to a dose-matched attention control intervention (N = 40). BREATHE is a one-time


Vaccipack, A Mobile App to Promote Human Papillomavirus Vaccine Uptake Among Adolescents Aged 11 to 14 Years: Development and Usability Study

Kristen Feemster, MD, MPH, MSHP
Oct. 29, 2020

Anne M. TeitelmanEmily F. Gregory, Joshua Jayasinghe, Zara Wermers, Ja H. Koo, Jennifer F. Morone, Damien C. Leri, Annet Davis, Kristen A. Feemster

Abstract [from journal]

Background: More than 90% of human papillomavirus (HPV)-related cancers could be prevented by widespread uptake of the HPV vaccine, yet vaccine use in the United States falls short of public health goals.

Objective: The purpose of this study was to describe the development, acceptability, and intention to use the mobile app Vaccipack, which was designed to promote uptake and completion of the adolescent HPV vaccine series.

Methods: Development of the mobile health (mHealth) content was based...

Direct-to-Consumer COVID-19 Testing

Oct. 14, 2020

In the midst of the pandemic, many companies have started marketing diagnostic and serological (antibody) COVID-19 tests directly to consumers. Such direct-to-consumer (DTC) tests can be initiated by consumers, typically through the company’s website. The sample can be collected at home or in a laboratory, with no or little direct involvement from a health care provider. About a dozen companies have received emergency use authorization (EUA) for diagnostic DTC COVID-19 tests and at least two for serological testing.

Measuring Parent Satisfaction With Care In Neonatal Intensive Care Units: The EMPATHIC-NICU-USA Questionnaire

Eileen Lake, PhD, RN
Oct. 6, 2020

Eileen T. Lake, Jessica G. Smith, Douglas O. Staiger, Kathryn M. Schoenauer, Jeannette A. Rogowski 

Abstract [from journal]

Background: Neonatal intensive care unit (NICU) patient satisfaction is measured as parent satisfaction. Parents are critical to the family-centered care model and can evaluate care. Several EMpowerment of PArents in THe Intensive Care (EMPATHIC) instruments were developed in the Netherlands to measure parent satisfaction with neonatal and pediatric intensive care. EMPATHIC instruments comprise five domains and a total score: information, care and treatment, organization, parental participation, and professional


Early Noninvasive Cardiac Testing After Emergency Department Evaluation For Suspected Acute Coronary Syndrome

Benjamin Sun, MD
Oct. 5, 2020

Aniket A. Kawatkar, Adam L. Sharp, Aileen S. Baecker, Shaw Natsui, Rita F. Redberg, Ming-Sum Lee, Maros Ferencik, Yi-Lin Wu, Ernest Shen, Chengyi Zheng, Visanee V. Musigdilok, Michael K. Gould, Steve Goodacre, Praveen Thokala , Benjamin C. Sun

Abstract [from journal]

Importance: Professional guidelines recommend noninvasive cardiac testing (NIT) within 72 hours of an emergency department (ED) evaluation for suspected acute coronary syndrome. However, there is inexact evidence that this strategy reduces the risk of future death or acute myocardial infarction (MI).

Objective: To evaluate the effectiveness of early NIT in reducing the risk of death or acute MI within 30 days.

Design, setting, and participants: This retrospective,


Improving Identification Of Patients At Low Risk For Major Cardiac Events After Noncardiac Surgery Using Intraoperative Data

Amole Navathe19-head
Oct. 1, 2020

Amol S. NavatheVictor J. LeiLee A. Fleisher, ThaiBinh Luong, Xinwei Chen, Edward Kennedy, Kevin G. VolppDaniel E. PolskyPeter W. Groeneveld, Mark Weiner, John H. Holmes...

Abstract [from journal]

Background/objective: Risk-stratification tools for cardiac complications after noncardiac surgery based on preoperative risk factors are used to inform postoperative management. However, there is limited evidence on whether risk stratification can be improved by incorporating data collected intraoperatively, particularly for low-risk patients.

Methods: We conducted a retrospective cohort study of adults who underwent noncardiac surgery between 2014 and 2018 at four


Validation Of A Machine Learning Algorithm To Predict 180-Day Mortality For Outpatients With Cancer

Sep. 24, 2020

Christopher R. Manz, Jinbo Chen, Manqing Liu, Corey Chivers, Susan Harkness Regli, Jennifer Braun, Michael Draugelis, C. William Hanson, Lawrence N. Shulman, Lynn M. Schuchter, Nina O'Connor, Justin E. BekelmanMitesh S. PatelRavi B....

Abstract [from journal]

Importance: Machine learning (ML) algorithms can identify patients with cancer at risk of short-term mortality to inform treatment and advance care planning. However, no ML mortality risk prediction algorithm has been prospectively validated in oncology or compared with routinely used prognostic indices.

Objective: To validate an electronic health record-embedded ML algorithm that generated real-time predictions of 180-day mortality risk in a general oncology cohort.



The Promise Of Direct-To-Consumer COVID-19 Testing: Ethical And Regulatory Issues

Louiza Kalokairinou
Sep. 23, 2020

Louiza Kalokairinou, Patricia J Zettler, Ashwini Nagappan, Moira A KywelukAnna Wexler

Abstract [from journal]

Widespread diagnostic and serological (antibody) testing is one key to mitigating the COVID-19 pandemic. While at first, the majority of COVID-19 diagnostic testing in the USA took place in healthcare settings, quickly a direct-to-consumer (DTC) testing market also emerged. In these DTC provision models, the test is initiated by a consumer and the sample collection occurs at home or in a commercial laboratory. Although the provision of DTC tests has potential benefits—such as...

The Effects Of Market Competition On Cardiologists' Adoption Of Transcatheter Aortic Valve Replacement

Sep. 17, 2020

Peter W. Groeneveld, Lin Yang, Andrea G. Segal, Pinar Karaca-Mandic, Genevieve P. Kanter

Abstract [from jorunal]

Background: For decades, the prevailing assumption regarding the diffusion of high-cost medical technologies has been that competitive markets favor more aggressive adoption of new treatments by health care providers (ie, the "Medical Arms Race"). However, novel regulations governing the adoption of transcatheter aortic valve replacement (TAVR) may have disrupted this paradigm when TAVR was introduced.

Objective: The objective of this study was to assess the relationship between the market


Medicaid Expansion And Ventricular Assist Device Implantation

Sep. 14, 2020

Sameed Ahmed M. Khatana, E. Wilson Grandin, J. Eduardo Rame, Changyu Shen, Robert W. Yeh and Peter W. Groeneveld

Abstract [from journal]

Durable ventricular assist device (VAD) therapy improves survival in patients with refractory heart failure with reduced ejection fraction, but is inaccessible to uninsured patients due to high cost. Medicaid expansion under the Affordable Care Act increased health insurance coverage for low-income

Wearable Devices To Monitor And Reduce The Risk Of Cardiovascular Disease: Evidence And Opportunities

Sep. 4, 2020

Atsushi Mizuno, Sujatha Changolkar, Mitesh S. Patel

Abstract [from journal]

There is a growing interest in using wearable devices to improve cardiovascular risk factors and care. This review evaluates how wearable devices are used for cardiovascular disease monitoring and risk reduction. Wearables have been evaluated for detecting arrhythmias (e.g., atrial fibrillation) as well as monitoring physical activity, sleep, and blood pressure. Thus far, most interventions for risk reduction have focused on increasing physical activity. Interventions have been more successful if the use of wearable devices is


Pooled Sampling of COVID-19 Tests Holds Promise

Aug. 25, 2020

Testing, as a mainstay of an effective response to COVID-19, requires sufficient supply to meet the demand. However, since the pandemic hit the US, this has not been the case. While governments have focused on procuring and producing additional tests, researchers have focused on finding ways to make the tests we do have more efficient.

Trends In Use Of Advanced Imaging In Pediatric Emergency Departments, 2009-2018

Margaret Samuels-Kalow, MD, MPhil
Aug. 3, 2020

Jennifer R. Marin,  Jonathan Rodean, Matt Hall, Elizabeth R. Alpern, Paul L. Aronson, Pradip P. Chaudhari, Eyal Cohen, Stephen B. Freedman, Rustin B. Morse, Alon Peltz, Margaret Samuels-Kalow, Samir S. Shah, Harold K. Simon, Mark I. Neuman

Abstract [from journal]

Importance: There is increased awareness of radiation risks from computed tomography (CT) in pediatric patients. In emergency departments (EDs), evidence-based guidelines, improvements in imaging technology, and availability of nonradiating modalities have potentially reduced CT use.

Objective: To evaluate changes over time and hospital variation in advanced imaging use.

Design, setting, and participants: This cross-sectional study assessed 26 082 062 ED visits by