Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery
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Otolaryngol Head Neck Surg · Sep 2015
Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration.
The US Food and Drug Administration (FDA) grants initial marketing clearance for novel high-risk medical devices via the premarket approval (PMA) pathway, which requires clinical data demonstrating safety and effectiveness. Manufacturers may subsequently file supplemental PMA applications (supplements) to implement incremental device changes, usually without additional clinical data. Given the potentially significant clinical implications of using new device models, this study characterized the frequency and nature of changes to high-risk therapeutic otolaryngic devices cleared via the PMA pathway. ⋯ A substantial number of incremental changes have been made to high-risk therapeutic otolaryngic devices over time, including many major design changes without supporting clinical data.
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Otolaryngol Head Neck Surg · Sep 2015
The Changing Landscape of Vestibular Schwannoma Management in the United States--A Shift Toward Conservatism.
To characterize the evolving management of vestibular schwannoma (VS) in the United States. ⋯ While the incidence of VS has remained steady, tumor size at time of diagnosis has decreased over time. Within the United States there has been a clear, recent evolution in management toward observation.
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Otolaryngol Head Neck Surg · Aug 2015
Comparative StudyHospital and Surgeon Adherence to Pediatric Tonsillectomy Guidelines Regarding Perioperative Dexamethasone and Antibiotic Administration.
To (1) determine adherence to American Academy of Otolaryngology-Head and Neck Surgery Foundation guidelines for pediatric tonsillectomy recommending routine administration of perioperative dexamethasone and against routine antibiotic administration among surgeons and hospitals in a multihospital network and (2) evaluate the impact of adherence on the risk of complications. ⋯ Most hospitals and surgeons administered perioperative dexamethasone routinely. While the overall frequency of antibiotic administration decreased after the guidelines were published, a significant percentage of surgeons continued to give antibiotics routinely, suggesting the need for improved dissemination and implementation of guidelines to promote adherence.
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Otolaryngol Head Neck Surg · Aug 2015
Randomized Controlled TrialDoes Montelukast Have an Effect on Post-tonsillectomy Pain Control in Children? A Randomized Trial Study.
Tonsillectomy surgery is associated with severe postoperative pain that usually requires analgesics including opioids. Pain control is still a big problem after tonsillectomy surgery. We aimed to evaluate the efficacy of preemptive analgesia using montelukast for pediatric post-tonsillectomy pain management. This is the first-time use of montelukast in post-tonsillectomy pain. ⋯ Preemptive montelukast can be used safely to reduce the serious pain caused by tonsillectomy in children.
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Accountable care organizations represent a shift in health care delivery while providing a significant potential for improved quality and coordination of care across multiple settings. Otolaryngologists have an opportunity to become leaders in this expanding arena. ⋯ These resources will become increasingly important for surgical specialists to be active participants in population health. This article reviews the fundamental issues that otolaryngologists should consider when pursuing new roles in accountable care organizations.