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Position Statement on Measurement Based Care

Integrated Care News by CFHA

Introduction The Collaborative Family Healthcare Association (CFHA) recognizes the utility and potential for Measurement Based Care (MBC) as a core feature of high-quality integrated healthcare. Position Statement on Utilization of Measurement Based Care. MBC is much more than simply administering behavioral health measures.

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog

Based on a review of premarket submissions made in 2012 through 2019, FDA identified 90 examples of 510(k)s, De Novos, HDEs, and PMAs approved/cleared which utilized RWE in support of regulatory decision-making. But by their very nature, RWD/RWE will have some gaps compared to randomized controlled trials. percent of examples.

Medical 111
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Goodbye NSURE, Hello ACNU! FDA Issues Long-Awaited Proposed Rule to Bring OTC Drugs with a Little Something Extra to Market

FDA Law Blog

In March 2012 , FDA convened a public meeting to discuss a new paradigm under consideration, “Using Innovative Technologies and Other Conditions of Safe Use to Expand Which Products Can Be Considered Nonprescription”. To date, no OTC drug has been approved under this guidance. This concept of operationalizing (operationalization?)

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Frailty Triples Odds of More Severe RSV Illness

Physician's Weekly

Data came from the three influenza seasons from 2012 to 2015. Frail patients often have compromised immune responses, which increases their vulnerability to infections and reduces their ability to recover from acute respiratory illnesses (ARIs), including influenza and respiratory syncytial virus (RSV), the researchers continued.

Illness 52
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FDA’s Accelerated Approval of Biogen’s Aduhelm for Alzheimer’s: A Sign of Applying the Emergency Use Standard Beyond COVID?

FDA Law Blog

As an aside, we have found this inconsistency between which accelerated approval therapies are saddled with this sentence to be a paradoxical FDA policy as there is but a single standard for surrogate endpoints to be utilized for purposes of every Accelerated Approval (i.e., This has been a decision we’ve been closely following.

Clinic 98
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Human papillomavirus vaccination in community-based clinics among adolescents by ethnicity, country of birth, and sex [Screening, prevention, and health promotion]

Annals of Family Medicine

Clinics should understand community strengths that might lead to robust vaccination utilization and possibly leverage these for improvement in other groups. Context Human papillomavirus (HPV) is a common sexually transmitted infection that can lead to multiple types of cancer. Dataset OCHIN electronic health record data from 27 US states.

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Under Pressure: Hypertensive Emergencies in the Pediatric Emergency Department

PEMBlog

While elucidating the underlying cause of the hypertensive emergency is important for a patients ongoing care, your role in the pediatric ED is to: 1) stabilize airway, breathing, circulation; 2) minimize worsening end-organ dysfunction by acutely lowering blood pressure; and, 3) start work up to evaluate cause (Patel 2012).