Devices and Diagnostics

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

The Volume-Outcome Relationship in Robotic Proctectectomy: Does Center Volume Matter? Results of a National Cohort Study

E. Carter Paulson, MD, MSCE
Oct. 21, 2019

Seth J. Concors, Douglas R. Murken, Paul T. Hernandez, Najjia N. Mahmoud, E. Carter Paulson

Abstract [from journal]

Background: Utilization of robotic proctectomy (RP) for rectal cancer has steadily increased since the inception of robotic surgery in 2002. Randomized control trials evaluating the safety of RP are in process to better understand the role of robotic assistance in proctectomy. This study aimed to characterize the trends in the use of RP for rectal cancer, and to compare oncologic outcomes with center-level RP volume.

Materials and Methods: 8107 patients with rectal adenocarcinoma who underwent RP were

...

Performance of a Clinical Decision Support Tool to Identify PICU Patients at High Risk for Clinical Deterioration

Heather Wolfe, MD
Oct. 2, 2019

Maya Dewan, Naveen Muthu, Eric Shelov, Christopher Bonafide, Patrick Brady, Daniela Davis, Eric Kirkendall, Dana Niles, Robert Sutton, Danielle Traynor, Ken Tegtmeyer, Vinay Nadkarni, Heather Wolfe

Abstract [from journal]

Objectives: To evaluate the translation of a paper high-risk checklist for PICU patients at risk of clinical deterioration to an automated clinical decision support tool.

Design: Retrospective, observational cohort study of an automated clinical decision support tool, the PICU Warning Tool, adapted from a paper checklist to predict clinical deterioration events in PICU patients within 24 hours.

Setting: Two quaternary care medical-surgical PICUs—The Children’s Hospital of Philadelphia and...

Effect of Prices, Distribution Strategies, and Marketing on Demand for HIV Self-testing in Zimbabwe: A Randomized Clinical Trial

Aug. 28, 2019

Wei Chang, Primrose Matambanadzo, Albert Takaruza, Karin Hatzold, Frances M. Cowan, Euphemia Sibanda, Harsha Thirumurthy

Abstract [from journal]

Importance: HIV self-testing is a promising approach for increasing awareness of HIV status in sub-Saharan Africa, particularly in Zimbabwe, where HIV prevalence is 13%. Evidence is lacking, however, on the optimal pricing policies and delivery strategies for maximizing the effect of HIV self-testing.

Objective: To assess demand for HIV self-testing among adults and priority-population subgroups under alternative pricing and distribution strategies.

Design, Setting, and Participants:...

Impact of Public Reporting of Cardiovascular Outcomes on a Non-Reported Procedure

Apr. 26, 2019

Public reporting of cardiovascular outcomes remains controversial, 20 years after New York became the first state to mandate reporting of mortality data for percutaneous coronary intervention (PCI). It has been associated with a lower likelihood of performing potentially lifesaving procedures, perhaps reflecting an avoidance of intervening in high-risk cases.

Advances in Alzheimer's Imaging are Changing the Experience of Alzheimer's Disease

Jun. 20, 2018

Shana D. Stites, Richard Milne, and Jason Karlawish

ABSTRACT [FROM JOURNAL]

Neuroimaging is advancing a new definition of Alzheimer's disease (AD). Using imaging biomarkers, clinicians may begin to diagnose the disease by identifying pathology and neurodegeneration in either cognitively impaired or unimpaired adults. This “biomarker-based” diagnosis may allow clinicians novel opportunities to use interventions that either delay the onset or slow the progression of cognitive decline, but it will also bring novel challenges. How will changing the definition of AD from a clinical to a biomarker construct change the experience of...

Conflict of Interest Among Public Speakers at FDA Advisory Committees

Apr. 23, 2018

Engaging patients, families, and independent experts in policymaking is a laudable goal, but the process of doing so isn’t necessarily straightforward. If efforts to introduce patient and public perspectives also introduce bias, they may do more harm than good. A recent study raises concerns about bias in public engagement, finding that public engagement efforts by the Food and Drug Administration (FDA) may attract speakers with significant conflicts of interest (COI), which are frequently undisclosed.

Conflict of Interest for Patient-Advocacy Organizations

Jun. 29, 2017

Matthew S. McCoy, Micahel Carniol, Katherine Chockley, John W. Urwin, Ezekiel J. Emanuel, and Harald Schmidt

In the New England Journal of Medicine, Matthew McCoy and colleagues, including Ezekiel Emanuel, examine conflicts of interest arising from the presence of industry executives on the boards of patient-advocacy organizations. Previous research has raised concern that the presence of industry leaders on the boards of these non-profit organizations may lead to advocacy for questionable reforms that do not always benefit the organizations’ constituents. The authors analyzed tax records, annual reports, and websites of 104 of the largest U.S patient-advocacy organizations to understand...

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