1. Rose C, Svider PF, Sheyn A, et al. Protecting the most vulnerable: litigation from pediatric otolaryngologic procedures and conditions. Laryngoscope. 2014;124:2161-2166.
  2. Metcalfe CW, Muzaffar SJ, Coulson CJ. Litigation trends and costs in otorhinolaryngology. J Laryngol Otol. 2015;129:941-944.
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  8. Robertson PJ, Brereton JM, Roberson DW, Shah RK, Nielsen DR. Choosing wisely: our list. Otolaryngol Head Neck Surg. 2013;148:534-536.
  9. American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer, Cooper DS, Doherty GM, et al. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009;19:1167-1214.
  10. Gharib H, Papini E, Paschke R, et al; AACE/AME/ETA Task Force on Thyroid Nodules. American Association of Clinical Endocrinologists, Associazione Medici Endocrinologi, and European Thyroid Association medical guidelines for clinical practice for the diagnosis and management of thyroid nodules. Endocr Pract. 2010;16 Suppl 1:1-43.
  11. Moon WJ, Baek JH, Jung SL, et al; Korean Society of Thyroid Radiology (KSThR); Korean Society of Radiology. Ultrasonography and the ultrasound-based management of thyroid nodules: consensus statement and recommendations. Korean J Radiol. 2011;12:1-14.
  12. Levine RA. Current guidelines for the management of thyroid nodules. Endocr Pract. 2012;18:596-599.
  13. Schwartz SR, Cohen SM, Dailey SH, et al. Clinical practice guideline: hoarseness (dysphonia). Otolaryngol Head Neck Surg. 2009;141(3 Suppl 2):S1-S31.
  14. Pretorius PM, Milford CA. Investigating the hoarse voice. BMJ. 2008;337:a1726.
  15. Paquette CM, Manos DC, Psooy BJ. Unilateral vocal cord paralysis: a review of CT findings, mediastinal causes, and the course of the recurrent laryngeal nerves. Radiographics. 2012;32:721-740.
  16. Kang BC, Roh JL, Lee JH, et al. Usefulness of computed tomography in the etiologic evaluation of adult unilateral vocal fold paralysis. World J Surg. 2013;37:1236-1240.
  17. Paddle PM, Mansor MB, Song PC, Franco RA Jr. Diagnostic yield of computed tomography in the evaluation of idiopathic vocal fold paresis. Otolaryngol Head Neck Surg. 2015;153:414-419.
  18. Johns MM 3rd, Sataloff RT, Merati AL, Rosen CA. Shortfalls of the American Academy of Otolaryngology-Head and Neck Surgery's Clinical practice guideline: hoarseness (dysphonia). Otolaryngol Head Neck Surg. 2010;143:175-177.
  19. Hayes JT, Houston R. Flexible nasolaryngoscopy. A low-risk, high-yield procedure. Postgrad Med. 1999;106:107-110, 114.
  20. Hocutt JE Jr, Corey GA, Rodney WM. Nasolaryngoscopy for family physicians. Am Fam Physician. 1990;42:1257-1268.
  21. Wilkins T, Gillies RA, Getz A, Zimmerman D, Kang L. Nasolaryngoscopy in a family medicine clinic: indications, findings, and economics. Am Board Fam Med. 2010;23:591-597.
  22. Moser SE. Nasolaryngoscopy. Prim Care. 2014;41:109-113.
  23. Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013;108:308-328.
  24. Ko Y, Tang J, Sanagapalli S, Kim BS, Leong RW. Safety of proton pump inhibitors and risk of gastric cancers: review of literature and pathophysiological mechanisms. Expert Opin Drug Saf. 2016;15:53-63.
  25. Lazarus B, Chen Y, Wilson FP, et al. Proton pump inhibitor use and the risk of chronic kidney disease. JAMA Intern Med. 2016;176:238-246.
  26. Xie Y, Bowe B, Li T, Xian H, Xian H, Balasubramanian S, Al-Aly Z. Proton pump inhibitors and risk of incident CKD and progression to ESRD. J Am Soc Nephrol. 2016 Apr 14. [Epub ahead of print]
  27. Tunkel DE, Bauer CA, Sun GH, et al. Clinical practice guideline: tinnitus. Otolaryngol Head Neck Surg. 2014;151(2 Suppl):S1-S40.
  28. Ryan M, Weissman JL, Kaylie D. Is gadolinium contrast enhancement necessary in screening MRI for asymmetric sensorineural hearing loss? Laryngoscope. 2015;125:783-784.
  29. Kontorinis G, Crowther JA. Asymmetric hearing loss and tinnitus. BMJ. 2014;348:g3601.
  30. Choi KJ, Sajisevi MB, Kahmke RR, Kaylie DM. Incidence of retrocochlear pathology found on MRI in patients with non-pulsatile tinnitus. Otol Neurotol. 2015;36:1730-1734.
  31. Stachler RJ, Chandrasekhar SS, Archer SM, et al; American Academy of Otolaryngology-Head and Neck Surgery. Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg. 2012;146(3 Suppl):S1-S35.
  32. Ramakers GG, Kraaijenga VJ, Cattani G, van Zanten GA, Grolman W. Effectiveness of earplugs in preventing recreational noise-induced hearing loss: a randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2016 Apr 7. [Epub ahead of print]
  33. Yassi A, Pollock N, Tran N, Cheang M. Risks to hearing from a rock concert. Can Fam Physician. 1993;39:1045-1050.
  34. Helleman HW, Dreschler WA. Short-term music-induced hearing loss after sound exposure to discotheque music: the effectiveness of a break in reducing temporary threshold shift. Int J Audiol. 2015;54 Suppl 1:S46-S52.
  35. Eggermont JJ, Roberts LE. The neuroscience of tinnitus. Trends Neurosci. 2004;27:676-682.
  36. Turner BG, Rhea JT, Thrall JH, Small AB, Novelline RA. Trends in the use of CT and radiography in the evaluation of facial trauma, 1992-2002: implications for current costs. AJR Am J Roentgenol. 2004;183:751-754.
  37. Tanrikulu R, Erol B. Comparison of computed tomography with conventional radiography for midfacial fractures. Dentomaxillofac Radiol. 2001;30:141-146.
  38. Sun JK, LeMay DR. Imaging of facial trauma. Neuroimaging Clin N Am. 2002;12:295-309.
  39. Roth FS, Kokoska MS, Awwad EE, et al. The identification of mandible fractures by helical computed tomography and panorex tomography. J Craniofac Surg. 2005;16:394-399.
  40. Mehta N, Butala P, Bernstein MP. The imaging of maxillofacial trauma and its pertinence to surgical intervention. Radiol Clin North Am. 2012;50:43-57.
  41. Shaye DA, Tollefson TT, Strong EB. Use of intraoperative computed tomography for maxillofacial reconstructive surgery. JAMA Facial Plast Surg. 2015;17:113-119.
  42. Nigam A, Goni A, Benjamin A, Dasgupta AR. The value of radiographs in the management of the fractured nose. Arch Emerg Med. 1993;10:293-297.
  43. Logan M, O'Driscoll K, Masterson J. The utility of nasal bone radiographs in nasal trauma. J Clin Radiol. 1994;49:192-194.
  44. Clayton MI, Lesser TH. The role of radiography in the management of nasal fractures. J Laryngol Otol. 1986;100:797-801.
  45. Illum P. Legal aspects in nasal fractures. Rhinology. 1991;29:263-236.

Contributor Information

Gordon H. Sun, MD, MS
Chief Medical Quality Officer; Chief, Division of Otolaryngology and Ophthalmology
Rancho Los Amigos National Rehabilitation Center
Downey, California;
Adjunct Clinical Associate Professor of Otolaryngology
University of Southern California
Los Angeles, California
Gordon Sun: Operation Healthcare

Disclosure: Gordon H. Sun, MD, MS, has disclosed the following relevant financial relationship:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Partnership for Health Analytic Research, LLC


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Diagnostic Error in Patients With Ear, Nose, or Throat Symptoms

Gordon H. Sun, MD, MS  |  June 3, 2016

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Slide 1

Diagnostic error occurs in every healthcare setting. Diagnosis in medicine will never be perfect, but misdiagnosis or failure to diagnose in a timely manner are major factors in litigation in the field of otorhinolaryngology.[1,2] In this slideshow, Dr Gordon Sun, Chief Medical Quality Officer at Rancho Los Amigos National Rehabilitation Center in Downey, California, describes diagnostic errors often encountered in patients with ear, nose, or throat symptoms, many of whom may present in primary care or emergency medicine settings. The following patient scenarios are not ranked in any order of importance, frequency, or potential harm.

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Slide 2

Ear-Popping and Fullness

A 36-year-old otherwise healthy man presented to an urgent care center with nasal congestion, sore throat, bilateral aural fullness, and "popping" sensations in his ears for 2 days. He reports that one of his work colleagues recently had the flu. He noted that he has had a slight amount of clear, watery nasal discharge but no other nasal or otologic symptoms, cough, or hoarseness. He denied environmental allergies or tobacco use.

The patient was afebrile on examination, and anterior rhinoscopy was notable only for pale, congested nasal mucosa and a scant amount of clear rhinorrhea. Otoscopy and pharyngeal exam were unremarkable. Noncontrast CT of the sinuses was ordered before initiating medical treatment.

Why is this a medical diagnostic error?

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Slide 3

Imaging in Acute Rhinosinusitis

The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) criteria for acute rhinosinusitis (ARS) include the following: up to 4 weeks of purulent rhinorrhea with nasal obstruction, facial pain/pressure/fullness, or both.[3] Bacterial infection should be suspected if the above symptoms or signs last for at least 10 days without improvement, or worsen within 10 days after initial improvement (a phenomenon known as "double worsening").

Clinical findings (eg, purulent rhinorrhea, localized nasal pain) may have a diagnostic accuracy similar to that of radiographic imaging of the sinuses.[4] A prospective clinical study of patients with viral upper respiratory infections found that the paranasal sinuses frequently demonstrated abnormalities on CT that would also be seen in patients with bacterial rhinosinusitis, including air/fluid levels and mucosal edema.[5] Furthermore, sinus CT exposes patients to radiation, which can lead to radiation-induced cataracts and other problems.[6,7] Thus, using imaging studies to distinguish between viral and bacterial causes of ARS in patients with otherwise uncomplicated presentations is ineffective. Avoidance of radiographic imaging for patients diagnosed with uncomplicated ARS is one of the Choosing Wisely® recommendations from the AAO-HNSF.[8]

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Slide 4

An Incidental Nodule

A 54-year-old woman underwent CT of the cervical spine for evaluation of spinal stenosis and was incidentally found to have a 3-mm nodule in the right lobe of her thyroid gland. She was referred back to her primary care provider to discuss the thyroid nodule. The patient, a nonsmoker and nondrinker, reported no constitutional or compressive symptoms, including neck fullness, dysphagia, odynophagia, choking, or dyspnea. She had no history of surgery or radiation to the neck and no history of thyroid disease in her immediate family.

Physical examination was unremarkable; no thyromegaly or neck masses were appreciated. After exam, the clinician ordered serum thyroid-stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), anti-thyroid peroxidase antibody (anti-TPO), anti-TSH receptor antibody, and thyroglobulin levels, and referred the patient to an otolaryngologist for fine-needle aspiration (FNA) of the nodule.

Why is this a medical diagnostic error?

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Slide 5

Thyroid Nodule Evaluation

The best-known guidelines for the management of solitary thyroid nodules are published by the American Thyroid Association (ATA)[9]; a consortium of the American Association of Clinical Endocrinologists (AACE), Associazione Medici Endocrinologi (AME), and European Thyroid Association (ETA)[10]; and the Korean Society of Thyroid Radiology and the Korean Society of Radiology.[11] The ATA and AACE/AME/ETA guidelines recommend checking a TSH level as part of the initial workup of thyroid nodules. Calcitonin is mentioned in the guidelines but remains a controversial choice for patients without a personal or family history of medullary thyroid cancer. The ATA guideline recommends against the routine measurement of thyroglobulin in the initial evaluation of thyroid nodules, owing to a lack of sensitivity and specificity for thyroid cancer. Thyroglobulin levels can be elevated in a wide variety of thyroid diseases. Other laboratory studies, such as T3, T4, and anti-TPO antibodies, should be obtained as necessary on the basis of TSH results (ie, if the TSH level is outside of the reference range).

None of the guidelines recommends FNA of a thyroid nodule without first obtaining an ultrasound. FNA is not indicated in a patient with a nodule < 5 mm, no cervical lymphadenopathy or suspicious features on ultrasound (eg, microcalcifications), and no high-risk history (eg, personal or first-degree family history of cancer, childhood exposure to radiation, or 18F-fluorodeoxyglucose avidity on PET).[12] Such nodules can be reevaluated clinically and sonographically at 6-18 month intervals, then at longer intervals if the nodule appearance is stable.

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Slide 6

Vocal Symptoms

A 46-year-old local newscaster presented with a 3-year history of intermittent hoarseness, which he described as "my voice is cracking." He stated that his hoarseness initially occurred only once every few months, but over the past 6 months, the frequency has increased to weekly. On occasion, he has also noticed a sensation of something irritating his throat, which usually would resolve after clearing his throat several times. The patient denied dyspnea, difficulty or pain with swallowing, hemoptysis, postnasal drip, heartburn, or regurgitation. The patient had no surgical history. He has never smoked tobacco or used illicit drugs. He used to have a glass of wine nightly with dinner, but stopped about a year ago because he thought it might have an adverse impact on his voice. The patient has used throat lozenges and warm tea with honey to soothe his throat, but he felt that this was becoming less effective with time. He expressed concern that continued hoarseness might cost him a promotion or even his job.

The patient appeared in good overall health on examination. He had a slightly coarse-sounding voice, which he stated was not his usual pitch. The patient also had mild cobblestoning of the posterior pharynx and moderately enlarged tonsils. Because the clinician did not have any equipment to visualize the patient's vocal cords, he ordered CT of the neck and chest with contrast, and started the patient on empirical proton pump inhibitor (PPI) therapy.

Why is this a medical diagnostic error?

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Slide 7

Visualizing the Larynx

The larynx should be directly visualized before obtaining radiographic studies. First, most vocal cord pathology can be identified with laryngoscopy or is self-limited, obviating the need for imaging.[13] Second, the value of imaging studies before laryngoscopy has not been studied, but the various risks associated with imaging studies (radiation exposure, allergic reaction to contrast dye, and safety risks pertaining to pacemakers and other metallic objects) are well documented.[13] Imaging plays an important supplemental diagnostic role in patients who are found to have laryngeal pathology on laryngoscopy with no obvious cause, such as vocal fold paralysis or a mass suggesting cancer or airway obstruction.[14-17]

Although there is controversy among the otolaryngology community with respect to the strength of the AAO-HNSF policy statement on laryngoscopy in the workup of dysphonia,[18] the value of direct visualization of the larynx is undeniable, hence its inclusion as a Choosing Wisely® recommendation from the AAO-HNSF.[8] Flexible laryngoscopy can be easily learned and incorporated into primary care practices in a safe manner.[19-22] However, the prevalence of laryngoscopic technology in primary care settings is low, probably owing to limited training or exposure. Only 6% of US family physicians routinely perform in-office laryngoscopy.[21] Providers who are unfamiliar with laryngoscopy should strongly consider referring patients with dysphonia to an otolaryngologist.

Empirical PPI therapy is not indicated in this case. The American College of Gastroenterology guideline on gastroesophageal reflux disease (GERD) recommends empirical PPI treatment in the setting of typical GERD symptoms, such as heartburn and regurgitation[23]—none of which were present in this case. Pharyngeal cobblestoning alone is an insufficient marker of GERD because cobblestoning is a feature of many conditions, including allergic rhinitis and pharyngitis, which are managed much differently. The AAO-HNSF guideline on dysphonia also recommends against prescribing an antireflux agent in the absence of signs or symptoms of GERD, citing sequelae of long-term PPI treatment, such as increased bacterial gastroenteritis and pneumonia risks, as well as impaired cognition and increased risk for hip fracture in older adults.[13] Other recently documented risks associated with prolonged PPI use include chronic kidney disease and in a subset of patients with Barrett esophagus, PPI-induced gastric neuroendocrine tumors, and adenocarcinomas.[24-26]

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Slide 8

Ringing in the Ears

A 22-year-old student presented to a nurse practitioner in the university health clinic with decreased hearing and constant "ringing" and "buzzing" tinnitus bilaterally ever since attending an outdoor music festival 1 week previously. She reported regularly attending concerts, and for the past 3 years she has played the drums in a college rock band without earplugs. The patient denied a history of hearing loss, ear infections, head trauma, or surgery. Otoscopic examination and Weber and Rinne testing with a 512-Hz tuning fork were unremarkable. A formal audiogram performed by the clinic audiologist demonstrated normal hearing thresholds at all frequencies except 4000 Hz, where a mild 20-dB decline was noted symmetrically. Tympanometry was normal binaurally. After noting the hearing loss on the audiogram, the clinician referred the patient for CT of the head with and without contrast.

Why is this a medical diagnostic error?

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Slide 9

Imaging Studies for Hearing Loss and Tinnitus

A formal audiogram and tympanogram are safe, noninvasive diagnostic tools for objectively characterizing hearing loss. The AAO-HNSF supports the use of audiologic testing in the evaluation of tinnitus, regardless of laterality, duration, or presence of concomitant hearing loss.[27] Carefully selected radiographic studies can be important in ruling out rare but important causes of unilateral or asymmetric hearing loss or tinnitus, such as vestibular schwannoma, paraganglioma, or even stroke.[27-30] However, in patients with symmetrical hearing loss or tinnitus with no complicating factors, such as focal neurologic deficits or known chronic middle ear disease, little new information is gained from CT that would significantly change clinical management.[8,27,31]

In this case, the clinician's focus should be on prevention and education rather than imaging. Because the patient reports a history of regular exposure to loud music without hearing protection, she should be informed of the risk for permanent hearing loss and strategies for mitigating this risk, including use of earplugs.[32] Short-term exposure to recreational noise leads to a transient decline in hearing known as a temporary threshold shift. Prolonged exposure can cause the temporary threshold shift to become permanent.[33,34] Tinnitus from short-term exposure to loud sound often resolves after a few minutes to a few days, but permanent hearing loss may be associated with concurrent, chronic tinnitus.[35]

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Slide 10

Facial Trauma

A 39-year-old man was being evaluated in an urgent care center after being confronted by a stranger at a bar and getting hit in the face with a beer bottle. The review of systems revealed no acute concerns. The physical examination revealed ecchymosis, crepitus, and a palpable step-off of the left cheek, as well as a visibly flattened nasal dorsum. He denied blurred vision or diplopia, and visual field testing was normal. Cranial nerve function was grossly intact. The physician ordered plain radiographs of the skull and face to check for facial fractures.

Why is this a medical diagnostic error?

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Slide 11

Radiographic Assessment of Facial Trauma

Historically, plain radiographs of the skull were considered a critical screening tool in the patient with facial injuries. However, over the past three decades, CT has supplanted plain films for this purpose.[36] CT provides higher-resolution images of both bony and soft-tissue trauma in a rapid, safe, and relatively inexpensive manner. CT is now considered superior to plain radiography in the assessment of midface and mandibular fractures.[37-39] More recent innovations, such as 3D reconstruction and intraoperative CT, have enhanced the ability of surgeons to develop preoperative management strategies and monitor progress during surgery, permitting immediate correction and reducing the need for revision procedures.[40,41]

A careful history and physical examination are often sufficient for diagnosing nasal fractures, and obtaining plain radiographs for this purpose is controversial. Management is often based not on radiographic results but on easily seen physical findings, such as external nasal deformity.[42,43] Plain films of the skull can yield a high rate of false-positive and false-negative interpretations, wasting time and resources and resulting in no significant medical or even legal value.[44,45]

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