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A Novel Definition of Urinary Tract Infection across a National Primary Care Network [Geriatrics]

Annals of Family Medicine

Objective To develop and validate a novel electronic medical records (EMR)-based UTI case definition that can be applied to elucidate and understand UTI treatment and practice patterns in primary care. Study Design and Analysis Retrospective cross-sectional study.

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The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice

FDA Law Blog

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

FDA Law Blog

In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program. 11-12 of the guidance for a list of these resources). Ask clarifying questions.

Provider 111
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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice.

Medical 111
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You don’t need X-Rays in a child with bronchiolitis, croup, asthma, or first time wheezing

PEMBlog

ED providers and radiologists commonly face the scenario of interpreting a CXR in a child with respiratory complaints prompting the questions: Does that infiltrate represent bacterial pneumonia, inflammation, or simply atelectasis? Drivers of CXR overuse are myriad and can be thought of at the system, provider, and patient levels.

Asthma 52
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Screening for Dementia: A Podcast with Anna Chodos, Joseph Gaugler and Soo Borson

GeriPal

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective.

Screening 119
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Are your patients satisfied?

Physician's Practice

Welcome to Five Minute Practice Fix, featuring instructional videos by physician and business of medicine expert Neil Baum, M.D. Dr. Baum is Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana. He has also written The Complete Business Guide to a Successful Medical Practice, which was published in 2015.