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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. Context Misdiagnosis and over-diagnosis of urinary tract infection (UTI) are a leading cause of inappropriate antimicrobial use.

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Position Statement on Measurement Based Care

Integrated Care News by CFHA

MBC is presented not simply as data collection, but as a dynamic, evidence-based clinical process that enhances outcomes, promotes equity, and strengthens team-based care. MBC supports optimal clinical practice, demonstrates the value of integrated care teams, and improves outcomes. What is MBC? 3, 4) Why is MBC important?

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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. By Julie Kim & Deborah L. No word yet on whether FDA will issue guidance endorsing the final ICH E6(R3).

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

FDA Law Blog

BIMO inspections can consist of on-site inspections, data audits, and remote regulatory assessments of nonclinical laboratories, clinical investigators, sponsors, contract research organizations (CROs), bioequivalence facilities, institutional review boards (IRBs), and postmarketing surveillance. 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

As many as 40% of these children will receive a chest x-ray (CXR) during their ED visit despite clinical guidelines advising most of these tests are low value. Understanding root causes of CXR use in the ED clinical setting is key to mitigating overuse of this test. But it’s just a CXR right?

Asthma 52
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Are your patients satisfied?

Physician's Practice

These videos are 5 to 10 minutes in length and will provide practical ideas and suggestions that have been tested in his practice or used by other physicians that significantly improve the efficiency and productivity of their medical practices. About Neil Baum, M.D.