Devices and Diagnostics

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

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...

Clinician-Targeted Mobile Apps in Palliative Care: A Systematic Review

Jun. 21, 2017

Salimah H. Meghani, Meredith A. MacKenzie, Brianna Morgan, Youjeong Kang, Anum Wasim, and Saleem Sayani

 

In Journal of Palliative Medicine, Salimah Meghani and colleagues identify and review available palliative care-related smartphone applications for clinicians. The authors assess growth in development of these apps, and review them for purpose, target audience, and number of downloads. They found that the number of palliative care apps targeting clinicians has increased eight-fold over the past five years. Of the 46 applications identified, nine were designed to assist clinicians with goals of advance care planning, seven provide training materials for palliative care, 17 present...

The “value” of value in gynecologic oncology practice in the United States: Society of Gynecologic Oncology evidence-based review and recommendations

Jun. 20, 2017

David E. Cohn, Emily Ko, Larissa A. Meyer, Jason D. Wright, Sarah M. Temkin, Jonathan Foote, Nathaniel L. Jones, Laura J. Havrilesky

In Gynecologic Oncology, David Cohn and colleagues, including Emily Ko, examine trends in gynecologic oncology health care expenditures, and assess how costs may be affected by new models of health care delivery and payment. The authors conduct a review on behalf of the Society of Gynecologic Oncology, and discuss the financial burden of increasing co-payments for cancer patients. They emphasize the need for gynecologic oncology practitioners to prepare for new models of cancer care delivery, such as Oncology Patient-Centered Medical Homes (OCPHM), as well as newer pay for...

43 Ways to Leave Your Technology

Feb. 14, 2017

We recently convened an expert roundtable to tackle how health systems, payers, and providers can spur the ‘de-adoption’ of medical practices and technologies no longer considered valuable. This got us thinking - while the process by which ineffective practices or technologies are abandoned is neither simple nor automatic, even the language used to describe it is not clear. And language matters. It often reflects an unstated focus on one mechanism or one level of decision-making. Here we review, and potentially clarify, the terminology.

The Emerging Market of Smartphone-Integrated Infant Physiologic Monitors

Jan. 27, 2017

Christopher P. Bonafide,  David T. Jamison,  Elizabeth E. Foglia, 

In a JAMA Viewpoint, Christopher Bonafide and colleagues discuss the efficacy and safety of smartphone apps integrated with sensors that monitor infants’ vital signs. While the performance characteristics of these sensors are unknown to the public and the regulations around them are scarce, their sales have skyrocketed, reaching 40,000 units for a single brand of “smart sock” monitors. These companies use direct-to-parent advertising to portray their products as necessary to alert parents when something is wrong with their infants’ cardiorespiratory health, even though there are...

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