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BACKGROUND There is a paucity of data on the adequacy of the resources and tools used by the Centers for Medicaid and Medicare Services (CMS) in making national coverage determinations about services for beneficiaries. The objective of this study was to determine the extent to which clinical trials relied on by the CMS are applicable to Medicare(More)
CONTEXT Medical devices are common in clinical practice and have important effects on morbidity and mortality, yet there has not been a systematic examination of evidence used by the US Food and Drug Administration (FDA) for device approval. OBJECTIVES To study premarket approval (PMA)--the most stringent FDA review process--of cardiovascular devices and(More)
BACKGROUND Cardiovascular devices can have different safety and effectiveness profiles in men and women. The type and quality of sex-specific data reviewed by the Food and Drug Administration (FDA) before approval of these devices are unknown. METHODS AND RESULTS We performed a systematic review of the demographics, comments on gender bias, and analysis(More)
2699 their salary and would serve for 2 years with the corps. In addition, the fiscal year 2010 budget includes $169 million for the NHSC — an increase of $34 million from fiscal year 2009 — for recruitment and retention of primary care physicians, as well as dentists and other health care professionals. As a result, the NHSC’s “field strength” is projected(More)
Anesthetic agents are sometimes added to the wrong vaporizer on an anesthesia machine. As a result, the vaporizer may deliver a mixture of anesthetic agents at concentrations inappropriate for use on a patient. However, untoward clinical complications related to vaporizers can be prevented with a time-shared mass spectrometer. This device accurately and(More)
IN 1992, THE US FOOD AND DRUG ADMINISTRATION (FDA) introduced the accelerated approval process to allow earlier approval of drugs for serious or lifethreatening illnesses on the basis of surrogate end points. This approval requires the drug’s sponsor to agree to conduct postmarketing studies proving a benefit in clinical outcomes. Seventy-nine of the 90(More)
Importance Overuse of medical care is an increasingly recognized problem in clinical medicine. Objective To identify and highlight original research articles published in 2015 that are most likely to reduce overuse of medical care, organized into 3 categories: overuse of testing, overtreatment, and questionable use of services. The articles were reviewed(More)
BACKGROUND Training patients are the first individuals in whom a physician uses an investigational device. There is great variability in the use of data from training patients in the absence of guidelines. The prevalence and extent of data reporting from training patients in cardiovascular device studies submitted for US Food and Drug Administration (FDA)(More)