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