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

FDA Law Blog

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

Medical 111
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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. Outcome Measures Outcomes included receipt of HPV vaccination, measured in two ways: 1) initiation (≥1 dose) and 2) ≥ 2 HPV vaccine doses.

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Under Pressure: Hypertensive Emergencies in the Pediatric Emergency Department

PEMBlog

Secondary hypertension is the more common cause of the two and is related to renal, cardiac, pulmonary, oncologic, endocrine, or autoimmune pathologies, in addition to medication side effects. 3 mg/kg/hr; onset of action is less than 5 minutes, and the duration of medication lasts between 2-6 hours. Labetalol dosing: 0.2-1

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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., be “reasonably likely to predict” ultimate clinical benefit).

Clinic 98
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Agitation Podcast Series Episode 2: Non-pharmacologic management of agitated children

PEMBlog

This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints. 2012 Jan;109(3):27-32. 2012 Feb;13(1):35-40. Patient that are agitated should always be treated with dignity and respect. Deaths due to physical restraint. Dtsch Arztebl Int. PMC3272587.

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End-of-Life Doulas: A Podcast with Jane Euler, Beth Klint, and John Loughnane

GeriPal

An end-of-life doula is a non-medical support person that provides a longitudinal relationship with aspects of medical, I mean, aspects of companionship, presence, holding space, some logistics, some practical help, decision making perhaps. There’s an organization that I took my training from, which began, I want to say, in 2012.

Provider 117
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RCT of Default Inpatient PC Consults: Kate Courtright & Scott Halpern

GeriPal

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Eric: Yeah.