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July 29, 2019

Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices

Abstract Full Text
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JAMA. Published online July 29, 2019. doi:10.1001/jama.2019.10191

This Viewpoint reviews the FDA’s 510(k) premarket review pathway through which many medical devices are brought into the US market based on “substantial equivalence” to a currently available device and the FDA’s 2019 guidance for an alternative “Safety and Performance Based Pathway,” and proposes additional strategies and policies to reduce harms from 510(k) approval mechanism and improve the safety and effectiveness of medical devices.

CAR T-Cell Therapy: A Microcosm for the Challenges Ahead in Medicare

Abstract Full Text
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JAMA. Published online July 29, 2019. doi:10.1001/jama.2019.10194

This Viewpoint discusses existing mechanisms of Medicare reimbursement for chimeric antigen receptor (CAR) T-cell therapy, which at US $375 000 to $475 000 per treatment is prohibitively expensive, and proposes ways to mitigate the challenges of covering the therapy appropriately and equitably for those who need it while realistically managing cost constraints.

July 26, 2019

Prescriptions on Demand: The Growth of Direct-to-Consumer Telemedicine Companies

Abstract Full Text
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JAMA. Published online July 26, 2019. doi:10.1001/jama.2019.9889

This Viewpoint discusses advantages and theoretical harms of direct-to-consumer drug telemedicine, whereby patients obtain prescription drugs through online visits, and calls for monitoring of for-profit DTC direct-to-consumer telemedicine ventures (eg, Curology, Hims, Nurx, and The Pill Club) to ensure that quality and safety are not being sacrificed for convenience of care.

JAMA Diagnostic Test Interpretation

Interpretation of Vitamin B12 Status After a Roux-en-Y Gastric Bypass

Abstract Full Text
has active quiz
JAMA. Published online July 26, 2019. doi:10.1001/jama.2017.18945

A 37-year-old woman with a history of depression and Roux-en-Y gastric bypass 16 years earlier presented with chronic fatigue, weight loss, irregular periods lasting 7 to 10 days, a vitamin B12 level of 149 pg/mL, and an iron level of 13 µg/dL. She reported a daily total calorie intake of less than 500 kcal and less than 20 g of protein. How do you interpret these results?

July 25, 2019

Realizing Shared Decision-making in Practice

Abstract Full Text
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JAMA. Published online July 25, 2019. doi:10.1001/jama.2019.9797

This Viewpoint discusses the importance of and obstacles to shared decision-making in clinical practice and proposes potential suggestions for enhancing patients’ engagement in their care.

Harms From Uninformative Clinical Trials

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JAMA. Published online July 25, 2019. doi:10.1001/jama.2019.9892

This Viewpoint discusses key features of and incentives for randomized clinical trials (RCTs) that make many of them uninformative; reviews the challenges uninformative trials pose to ethics, science, and medical practice; and recommends what academic medical centers and funders can do to incentivize the conduct of RCTs that provide valid information that informs clinical practice.

July 22, 2019

Health Policy

The Commercial Differential for Hospital Prices: Responses From States and Employers

Abstract Full Text
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JAMA. Published online July 22, 2019. doi:10.1001/jama.2019.9275

This Viewpoint reviews the discrepancy in prices paid for hospital services by commercial insurers vs Medicare and Medicaid, and calls for greater hospital accountability, cost transparency, and data to guide pricing so that the cost of services are benchmarked to the value they offer patients and paying employers rather than the negotiating leverage of health care organizations.

JAMA Insights

Diagnosing the Onset of Menopause

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JAMA. Published online July 22, 2019. doi:10.1001/jama.2019.6250

This JAMA insights clinical update reviews menstruation-based criteria for defining menopause in women, the physiologic changes underlying menopausal transition, and how and when to use testing to counsel women about the timing and duration of the transition.

July 19, 2019

Evidence vs Consensus in Clinical Practice Guidelines

Abstract Full Text
JAMA. Published online July 19, 2019. doi:10.1001/jama.2019.9751

This Viewpoint argues that the language distinguishing evidence-based from consensus-based clinical guidelines is misleading because both require consensus, and argues that it is more accurate to distinguish evidence-based guidelines, which require recommendations consistent with underlying evidence, from non–evidence-based guidelines, which do not.

July 18, 2019
JAMA Clinical Guidelines Synopsis

Management of Patients With Acute Ischemic Stroke

Abstract Full Text
JAMA. Published online July 18, 2019. doi:10.1001/jama.2019.10436

This JAMA Clinical Guidelines Synopsis describes the 2018 American Heart Association/American Stroke Association guidelines for management of patients with acute ischemic stroke.

July 12, 2019

Redefining the Physician’s Role in Cost-Conscious Care: The Potential Role of the Electronic Health Record

Abstract Full Text
JAMA. Published online July 12, 2019. doi:10.1001/jama.2019.9114

This Viewpoint argues for integration of price information in electronic health records (EHRs) as a mechanism to increase price transparency and promote cost-conscious, patient-centered, shared decision making at the point of care.