JAMA internal medicine
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JAMA internal medicine · Dec 2013
Conflicts of interest in approvals of additives to food determined to be generally recognized as safe: out of balance.
Food and Drug Administration (FDA) guidance allows food manufacturers to determine whether additives to food are "generally recognized as safe" (GRAS). Manufacturers are not required to notify the FDA of a GRAS determination, although in some instances they notify the agency. The individuals that companies select to make these determinations may have financial conflicts of interest. ⋯ Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS. The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns.
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JAMA internal medicine · Nov 2013
Review Meta AnalysisDifferential effectiveness of placebo treatments: a systematic review of migraine prophylaxis.
When analyzing results of randomized clinical trials, the treatment with the greatest specific effect compared with its placebo control is considered to be the most effective one. Although systematic variations of improvements in placebo control groups would have important implications for the interpretation of placebo-controlled trials, the knowledge base on the subject is weak. ⋯ Sham acupuncture and sham surgery are associated with higher responder ratios than oral pharmacological placebos. Clinicians who treat patients with migraine should be aware that a relevant part of the overall effect they observe in practice might be due to nonspecific effects and that the size of such effects might differ between treatment modalities.
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JAMA internal medicine · Nov 2013
Hospitalized but not admitted: characteristics of patients with "observation status" at an academic medical center.
The Centers for Medicare & Medicaid Services (CMS) defines observation status for hospitalized patients as a "well-defined set of specific, clinically appropriate services," usually lasting less than 24 hours, and that in "only rare and exceptional cases" should last more than 48 hours. Although an increasing proportion of observation care occurs on hospital wards, studies of patients with observation status have focused on the efficiency of dedicated units. ⋯ In an academic medical center, observation status for hospitalized patients differed markedly from the CMS definition. Patients had a wide variety of diagnoses; lengths of stay were typically more than 24 hours and often more than 48 hours. The hospital lost money, primarily because reimbursement for general medicine patients was inadequate to cover the costs. It is uncertain what role, if any, observation status for hospitalized patients should have in the era of health care reform.
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JAMA internal medicine · Nov 2013
National burden of invasive methicillin-resistant Staphylococcus aureus infections, United States, 2011.
Estimating the US burden of methicillin-resistant Staphylococcus aureus (MRSA) infections is important for planning and tracking success of prevention strategies. ⋯ An estimated 30,800 fewer invasive MRSA infections occurred in the United States in 2011 compared with 2005; in 2011 fewer infections occurred among patients during hospitalization than among persons in the community without recent health care exposures. Effective strategies for preventing infections outside acute care settings will have the greatest impact on further reducing invasive MRSA infections nationally.