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
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.
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Otolaryngol Head Neck Surg · Sep 2017
Practice GuidelineClinical Practice Guideline: Evaluation of the Neck Mass in Adults.
Objective Neck masses are common in adults, but often the underlying etiology is not easily identifiable. While infections cause most of the neck masses in children, most persistent neck masses in adults are neoplasms. Malignant neoplasms far exceed any other etiology of adult neck mass. ⋯ The development group made the following recommendations: (1) Clinicians should identify patients with a neck mass who are at increased risk for malignancy because the patient lacks a history of infectious etiology and the mass has been present for ≥2 weeks without significant fluctuation or the mass is of uncertain duration. (2) Clinicians should identify patients with a neck mass who are at increased risk for malignancy based on ≥1 of these physical examination characteristics: fixation to adjacent tissues, firm consistency, size >1.5 cm, or ulceration of overlying skin. (3) Clinicians should conduct an initial history and physical examination for patients with a neck mass to identify those with other suspicious findings that represent an increased risk for malignancy. (4) For patients with a neck mass who are not at increased risk for malignancy, clinicians or their designees should advise patients of criteria that would trigger the need for additional evaluation. Clinicians or their designees should also document a plan for follow-up to assess resolution or final diagnosis. (5) For patients with a neck mass who are deemed at increased risk for malignancy, clinicians or their designees should explain to the patient the significance of being at increased risk and explain any recommended diagnostic tests. (6) Clinicians should perform, or refer the patient to a clinician who can perform, a targeted physical examination (including visualizing the mucosa of the larynx, base of tongue, and pharynx) for patients with a neck mass deemed at increased risk for malignancy. (7) Clinicians should perform fine-needle aspiration (FNA) instead of open biopsy, or refer the patient to someone who can perform FNA, for patients with a neck mass deemed at increased risk for malignancy when the diagnosis of the neck mass remains uncertain. (8) For patients with a neck mass deemed at increased risk for malignancy, clinicians should continue evaluation of patients with a cystic neck mass, as determined by FNA or imaging studies, until a diagnosis is obtained and should not assume that the mass is benign. (9) Clinicians should obtain additional ancillary tests based on the patient's history and physical examination when a patient with a neck mass is deemed at increased risk for malignancy who does not have a diagnosis after FNA and imaging. (10) Clinicians should recommend evaluation of the upper aerodigestive tract under anesthesia, before open biopsy, for patients with a neck mass deemed at increased risk for malignancy and without a diagnosis or primary site identified with FNA, imaging, and/or ancillary tests. The development group recommended against clinicians routinely prescribing antibiotic therapy for patients with a neck mass unless there are signs and symptoms of bacterial infection.
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Otolaryngol Head Neck Surg · Jun 2017
Computer-Aided Design and 3-Dimensional Printing for Costal Cartilage Simulation of Airway Graft Carving.
Autologous cartilage grafting during open airway reconstruction is a complex skill instrumental to the success of the operation. Most trainees lack adequate opportunities to develop proficiency in this skill. We hypothesized that 3-dimensional (3D) printing and computer-aided design can be used to create a high-fidelity simulator for developing skills carving costal cartilage grafts for airway reconstruction. ⋯ In this blinded, prospective observational study, resident trainees completed a physical simulator exercise using a 3D-printed costal cartilage grafting tool. Participant assessment was performed using a Likert scale questionnaire, and airway grafts were assessed by a blinded expert surgeon. Most participants found this to be a very relevant training tool and highly rated the level of realism of the simulation tool.
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Otolaryngol Head Neck Surg · Jun 2017
The P Value Problem in Otolaryngology: Shifting to Effect Sizes and Confidence Intervals.
There is a lack of reporting effect sizes and confidence intervals in the current biomedical literature. The objective of this article is to present a discussion of the recent paradigm shift encouraging the use of reporting effect sizes and confidence intervals. Although P values help to inform us about whether an effect exists due to chance, effect sizes inform us about the magnitude of the effect (clinical significance), and confidence intervals inform us about the range of plausible estimates for the general population mean (precision). Reporting effect sizes and confidence intervals is a necessary addition to the biomedical literature, and these concepts are reviewed in this article.