Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery
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Otolaryngol Head Neck Surg · Oct 2017
Multicenter StudyDesmoplastic Melanoma of the Head and Neck: Incidence and Survival, 1992-2013.
Objective To describe the epidemiological characteristics and survival of desmoplastic melanoma of the head and neck (DMHN) and discuss the factors influencing survival variation among DMHN, DM of other sites (DMnHN), and conventional melanoma of the head and neck (CMHN). Study Design Retrospective cohort study. Setting Surveillance, Epidemiology, and End Results (SEER) database (years 1992-2013). ⋯ Kaplan-Meier survival analysis demonstrated disease-specific survival (DSS) at 5 and 10 years for DMHN to be 80.5% and 74.7%, respectively, compared with 89.1% and 86%, respectively, for DMnHN and 88.1% and 83%, respectively, for CMHN (log-rank test; P < .001). On multivariate Cox regression analysis, age at diagnosis ( P < .001), Breslow depth >4.00 mm ( P = .006), lymph node status ( P < .001), and presence of ulceration ( P < .001) were found to be independent predictors of DSS for DMHN. Conclusion The increasing incidence and poor survivability of DMHN compared to DMnHN and CMHN are parsimoniously explained by the later stage of disease and depth of invasion at diagnosis, highlighting the importance of improved diagnosis and awareness of DMHN.
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Otolaryngol Head Neck Surg · Oct 2017
ReviewReflections on Patient-Centered Care: From the Perspective of a Young Otolaryngologist.
It is now well recognized that patient engagement in health care is a key factor in improving satisfaction; however, it is also critical if we are to improve the health outcomes of our patients, as well as the economic and quality outcomes of our health system. Medicine, though, has traditionally resisted a culture of patient-centered or patient-controlled care. What follow are the reflections of one otolaryngologist on the importance and challenges of making the transition to patient-centered care.
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Otolaryngol Head Neck Surg · Oct 2017
US Food and Drug Administration Clearance of Moderate-Risk Otolaryngologic Devices via the 510(k) Process, 1997-2016.
Objective The US Food and Drug Administration (FDA) clears moderate-risk devices via the 510(k) process based on substantial equivalence to previously cleared devices; evidence of safety and effectiveness is not required. We characterized the premarket evidence supporting FDA clearance of otolaryngologic devices. Study Design Retrospective cross-sectional analysis. ⋯ Nonclinical and clinical performance data were rarely available (nonclinical: n = 49/247 [19.8%]; clinical: n = 32/247 [13.0%]) within public summaries. Conclusion The FDA cleared most moderate-risk otolaryngologic devices for marketing via the 510(k) process without clinical evidence of safety and effectiveness. Otolaryngologists should be aware of limitations in premarket evidence when considering the adoption of new devices into clinical practice.