Annals of internal medicine
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Nearly all medical devices reviewed by the U. S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. ⋯ Advocates of the 510(k) clearance process tout its support for device innovation and rapid market access, and critics of the 510(k) clearance process express that it may inadequately protect patient safety. In September 2023, the FDA issued 3 guidance documents that, if finalized, would significantly change medical device regulation. This article provides clinical and regulatory context for the proposed guidance documents, which focus on predicate selection, clinical testing requirements, and implantable devices, and identifies opportunities for further reforms that promote transparency and patient safety.
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Pain is a debilitating symptom generally caused by injuries or various conditions. It can be acute, subacute, or chronic and can have a significant impact on a patient's quality of life. The goal of managing pain is to relieve or reduce suffering and improve patient functioning. ⋯ This paper aims to present a review of current performance measures for pain to inform physicians, payers, and policymakers in their selection and use of performance measures. The PMC reviewed 6 performance measures for pain relevant to internal medicine physicians, of which 3 were considered valid at their intended levels of attribution ("Use of Imaging for Low Back Pain," "Use of Opioids at High Dosage in Persons Without Cancer," and "Use of Opioids From Multiple Providers in Persons Without Cancer"). This paper also proposes a performance measure concept to address a quality-of-care gap based on the current clinical guideline from ACP and the American Academy of Family Physicians, "Nonpharmacologic and Pharmacologic Management of Acute Pain From Non-low Back, Musculoskeletal Injuries in Adults."
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Induced abortion is safe, is common, and reduces pregnancy-related maternal morbidity and mortality. Internal medicine physicians are uniquely positioned to counsel patients on their pregnancy options, assess medical risks of pregnancy in the context of comorbidities, refer for abortion care when the patient desires it, or provide abortion care themselves. Clinicians can also provide anticipatory guidance about what patients should expect if they seek abortion care.
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Postmenopausal women commonly experience vulvovaginal, urinary, and sexual symptoms associated with genitourinary syndrome of menopause (GSM). ⋯ Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42023400684).
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Postmenopausal women commonly experience vulvovaginal, urinary, and sexual symptoms associated with genitourinary syndrome of menopause (GSM). ⋯ Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42023400684).