Jennifer J. Shin

Clinical Practice Guideline Otitis Media with Effusion (Update)

Objective This update of a 2004 guideline codeveloped by the American Academy of Otolaryngology—Head and Neck Surgery Foundation, the American Academy of Pediatrics, and the American Academy of Family Physicians, provides evidence-based recommendations to manage otitis media with effusion (OME), defined as the presence of fluid in the middle ear without signs or symptoms of acute ear infection. Changes from the prior guideline include consumer advocates added to the update group, evidence from 4 new clinical practice guidelines, 20 new systematic reviews, and 49 randomized control trials, enhanced emphasis on patient education and shared decision making, a new algorithm to clarify action statement relationships, and new and expanded recommendations for the diagnosis and management of OME. Purpose The purpose of this multidisciplinary guideline is to identify quality improvement opportunities in managing OME and to create explicit and actionable recommendations to implement these opportunities in clinical practice. Specifically, the goals are to improve diagnostic accuracy, identify children who are most susceptible to developmental sequelae from OME, and educate clinicians and patients regarding the favorable natural history of most OME and the clinical benefits for medical therapy (eg, steroids, antihistamines, decongestants). Additional goals relate to OME surveillance, hearing and language evaluation, and management of OME detected by newborn screening. The target patient for the guideline is a child aged 2 months through 12 years with OME, with or without developmental disabilities or underlying conditions that predispose to OME and its sequelae. The guideline is intended for all clinicians who are likely to diagnose and manage children with OME, and it applies to any setting in which OME would be identified, monitored, or managed. This guideline, however, does not apply to patients <2 months or >12 years old. Action Statements The update group made strong recommendations that clinicians (1) should document the presence of middle ear effusion with pneumatic otoscopy when diagnosing OME in a child; (2) should perform pneumatic otoscopy to assess for OME in a child with otalgia, hearing loss, or both; (3) should obtain tympanometry in children with suspected OME for whom the diagnosis is uncertain after performing (or attempting) pneumatic otoscopy; (4) should manage the child with OME who is not at risk with watchful waiting for 3 months from the date of effusion onset (if known) or 3 months from the date of diagnosis (if onset is unknown); (5) should recommend against using intranasal or systemic steroids for treating OME; (6) should recommend against using systemic antibiotics for treating OME; and (7) should recommend against using antihistamines, decongestants, or both for treating OME. The update group made recommendations that clinicians (1) should document in the medical record counseling of parents of infants with OME who fail a newborn screening regarding the importance of follow-up to ensure that hearing is normal when OME resolves and to exclude an underlying sensorineural hearing loss; (2) should determine if a child with OME is at increased risk for speech, language, or learning problems from middle ear effusion because of baseline sensory, physical, cognitive, or behavioral factors; (3) should evaluate at-risk children for OME at the time of diagnosis of an at-risk condition and at 12 to 18 months of age (if diagnosed as being at risk prior to this time); (4) should not routinely screen children for OME who are not at risk and do not have symptoms that may be attributable to OME, such as hearing difficulties, balance (vestibular) problems, poor school performance, behavioral problems, or ear discomfort; (5) should educate children with OME and their families regarding the natural history of OME, need for follow-up, and the possible sequelae; (6) should obtain an age-appropriate hearing test if OME persists for 3 months or longer OR for OME of any duration in an at-risk child; (7) should counsel families of children with bilateral OME and documented hearing loss about the potential impact on speech and language development; (8) should reevaluate, at 3- to 6-month intervals, children with chronic OME until the effusion is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected; (9) should recommend tympanostomy tubes when surgery is performed for OME in a child <4 years old; adenoidectomy should not be performed unless a distinct indication exists (nasal obstruction, chronic adenoiditis); (10) should recommend tympanostomy tubes, adenoidectomy, or both when surgery is performed for OME in a child ≥4 years old; and (11) should document resolution of OME, improved hearing, or improved quality of life when managing a child with OME.

Mechanical Compression Versus Subcutaneous Heparin Therapy in Postoperative and Posttrauma Patients: A Systematic Review and Meta-Analysis

BackgroundThe risk of postoperative venous thromboembolic disease is as high as 30%, with an associated fatality risk of 1%. Therefore, prophylaxis is essential, but the optimal regimen remains controversial. This study was designed to systematically review and quantitatively summarize the impact of mechanical compression versus subcutaneous heparin on venous thromboembolic disease and posttreatment bleeding in postsurgical and posttrauma patients.MethodsComputerized searches of the MEDLINE and EMBASE databases through November 2008 were performed and supplemented with manual searches. We included studies that had: (1) a patient population undergoing surgery or admitted immediately posttrauma, (2) a randomized comparison of prophylaxis with mechanical compression versus subcutaneous heparin, (3) outcome measured in terms of deep vein thrombosis (DVT), pulmonary embolism (PE), or bleeding.ResultsTwo reviewers independently extracted data from the original articles, which represented 16 studies, including a total of 3,887 subjects. Meta-analysis was performed using a random effects model. The pooled relative risk for mechanical compression compared with subcutaneous heparin was 1.07 (95% confidence interval [CI] 0.72, 1.61) for DVT and 1.03 (95% CI 0.48, 2.22) for PE. Mechanical compression was associated with a significantly reduced risk of postoperative bleeding compared with subcutaneous heparin (risk ratio 0.47; 95% CI 0.31, 0.70). Subgroup analyses by heparin type suggested that low molecular weight heparin may reduce risk of DVT compared with compression (relative risk 1.80; 95% CI 1.16, 2.79) but remains similarly associated with an increased risk of bleeding.ConclusionsThese results suggest that the overall bleeding risk profile favors the use of compression over heparin, with the benefits in term of venous thromboembolic disease prophylaxis being similar between groups. Subgroup analyses suggest that low molecular weight heparin may have a differential effect; this observation should be further evaluated in future studies.

Clinical Consensus Statement: Pediatric Chronic Rhinosinusitis

Objective To develop a clinical consensus statement on the optimal diagnosis and management of pediatric chronic rhinosinusitis (PCRS). Methods A representative 9-member panel of otolaryngologists with no relevant conflicts of interest was assembled to consider opportunities to optimize the diagnosis and management of PCRS. A working definition of PCRS and the scope of pertinent otolaryngologic practice were first established. Patients of ages 6 months to 18 years without craniofacial syndromes or immunodeficiency were defined as the targeted population of interest. A modified Delphi method was then used to distill expert opinion into clinical statements that met a standardized definition of consensus. Results After 2 iterative Delphi method surveys, 22 statements met the standardized definition of consensus while 12 statements did not. Four statements were omitted due to redundancy. The clinical statements were grouped into 4 categories for presentation and discussion: (1) definition and diagnosis of PCRS, (2) medical treatment of PCRS, (3) adenoiditis/adenoidectomy, and (4) endoscopic sinus surgery (ESS)/turbinoplasty. Conclusion Expert panel consensus may provide helpful information for the otolaryngologist in the diagnosis and management of PCRS in uncomplicated pediatric patients.

Risk of Malignancy Associated with Head and Neck CT in Children: A Systematic Review

Objective To perform a systematic review to evaluate the risk of malignancy associated with computed tomography (CT) of the head and/or neck in infants, children, and adolescents. Data Sources Pubmed, EMBASE, and the Cochrane Library were assessed from the date of their inception to January 2014. Additionally, manual searches of bibliographies were performed and topic experts were contacted. Review Methods Data were obtained from studies measuring or estimating the risks of malignancy associated with radiation from head and/or neck CT in pediatric populations according to an a priori protocol. Two independent evaluators corroborated the extracted data. Results There were 16 criterion-meeting studies that included data from n = 858,815 patients. The radiation-related risk of malignancy was estimated using primary patient data for both the exposure and outcome in a minority of studies, with most analyses utilizing mathematical modeling techniques. The data regarding otolaryngology-specific studies were limited and suggested a borderline significant increase in the risk of all combined cancers after facial CT (incidence rate ratio [IRR] = 1.14; 95% CI, 1.01-1.28) and neck/spine CT (IRR = 1.13; 95% CI, 1.00-1.28). Cohort data suggest that 1 excess brain malignancy occurred after 4000 brain CTs (40 mSv per scan) and that the estimated risk in the 10 years following CT exposure was 1 brain tumor per 10,000 patients exposed to a 10 mGy scan at less than 10 years of age. Conclusion Detailed understanding of any potential malignancy risk associated with pediatric imaging of the head and neck furthers our ability to engage in rational, shared, informed decision making with families considering CT scan.

Propranolol vs prednisolone for symptomatic proliferating infantile hemangiomas: A randomized clinical trial

IMPORTANCE While propranolol is touted as superior to prednisolone for treating infantile hemangiomas (IH), a randomized clinical trial (RCT) comparing the outcome and tolerability of these medications for symptomatic, proliferating IH has not been reported. OBJECTIVES To determine if oral propranolol is more efficacious and better tolerated than prednisolone in treating symptomatic, proliferating IH and to determine the feasibility of conducting a multi-institutional, RCT comparing efficacy and tolerability of both medications. DESIGN, SETTING, AND PARTICIPANTS Phase 2, investigator-blinded, multi-institutional RCT conducted in 3 academic vascular anomalies clinics on 19 of 44 eligible infants aged between 2 weeks and 6 months. All participating patients had symptomatic proliferating IH treated between September 1, 2010, and August 1, 2012. INTERVENTIONS Treatment with oral propranolol vs prednisolone (2.0 mg/kg/d) until halted owing to toxic effects or clinical response. MAIN OUTCOMES AND MEASURES Primary outcome was change in IH size after 4 months of therapy. Secondary outcomes were response rate and frequency and severity of adverse events (AEs). RESULTS The primary outcome showed no difference in lesion size or affected skin area after 4 months of therapy: 41% and 1.32 mm2 for prednisolone vs 64% and 0.55 mm2 for propranolol (P = .12 for lesion size, and P = .56 for affected skin area). Longitudinal analyses showed a faster response in total lesion outer dimension with prednisolone (P = .03), but this advantage over time was not noted when central clearing and outer dimension were included in the analysis (P = .91). The overall frequency of AEs was similar (44 for prednisolone vs 32 for propranolol) (P = .84), but prednisolone-treated participants had more grade 3 severe AEs (11 vs 1) (P = .01), particularly growth retardation resulting in size and weight below the fifth percentile. Early study withdrawal owing to AEs occurred in 6 (75%) of 8 patients in the prednisolone group but 0 of 11 propranolol-treated participants. The mean duration of therapy was shorter for prednisolone (141 vs 265 days), reflecting the higher rate of early withdrawals. CONCLUSIONS AND RELEVANCE Both medications show similar efficacy for reducing the area of symptomatic, proliferating IH. Although prednisolone showed a faster response rate, propranolol was better tolerated with significantly fewer severe AEs. Propranolol should be the first line of therapy for symptomatic IH unless contraindicated or unless future studies demonstrate severe AEs from propranolol. Recruiting participants for a phase 3 RCT would be difficult owing to safety profiles measured here and emerging trends favoring propranolol. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00967226.

Clinical Practice Guideline Otitis Media with Effusion Executive Summary (Update)

The American Academy of Otolaryngology—Head and Neck Surgery Foundation has published a supplement to this issue of Otolaryngology—Head and Neck Surgery featuring the updated “Clinical Practice Guideline: Otitis Media with Effusion.” To assist in implementing the guideline recommendations, this article summarizes the rationale, purpose, and key action statements. The 18 recommendations developed emphasize diagnostic accuracy, identification of children who are most susceptible to developmental sequelae from otitis media with effusion, and education of clinicians and patients regarding the favorable natural history of most otitis media with effusion and the lack of efficacy for medical therapy (eg, steroids, antihistamines, decongestants). An updated guideline is needed due to new clinical trials, new systematic reviews, and the lack of consumer participation in the initial guideline development group.

The surgical management of goiter: Part II. Surgical treatment and results†‡

Surgery for goiter embodies a unique challenge. Our objective is to provide a comprehensive analysis of cervical and substernal goiter data in two paired articles. This second article focuses on surgical management. The following null hypotheses regarding goiter excision have been tested: 1) there are no goiter‐associated risk factors for difficult intubation; 2) there are no predictive risk factors for recurrent laryngeal nerve injury (RLN) or postoperative hypocalcemia; 3) there is no difference in RLN injury with neural monitoring versus without.

Evidence-based medicine in otolaryngology, part 1: The multiple faces of evidence-based medicine

Evidence-based medicine, with its capacity to improve patient outcomes, has grown prominent throughout the medical field. Otolaryngology is at a crucial stage in the expansion of evidence-based medicine, with its impact seen in many arenas. As the evidence continues to shape our field, we hope to serve our otolaryngology community through this invited series, which is dedicated to the exposition of evidence-based medicine and its applications. This first installment examines evidence-based medicine itself and its multiple interpretations, including a purist view, a population-based view, and a view centered on the individual. Strengths and weaknesses of each are discussed, as well the potential for unification and evolution of these concepts. We also place evidence-based medicine in the context of the mindset of traditional medicine and anticipate future developments.

Hypopharyngeal Surgery in Obstructive Sleep Apnea Practice Patterns, Perceptions, and Attitudes

Objective To characterize factors that surgeons perceive as affecting selection of procedures designed to treat hypopharyngeal obstruction in adults with obstructive sleep apnea (OSA) and to compare those factors among 2 groups of American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) member surgeons. Study Design Cross-sectional online survey. Subjects and Methods AAO-HNS members with a self-identified subspecialty interest either in sleep medicine or general otolaryngology were asked to complete an online survey, each respondent rated (5-point Likert scale) the perceived quality of their education and training and the role of specific factors in selection, both for procedure categories (eg, all hypopharyngeal) and individual procedures. Responses were examined for the entire group and for subgroups. Results Response rate was 27% (163/610). Sixty-five percent of respondents rated their surgical OSA education and training during postgraduate continuing medical education (CME) courses as of high quality, compared with 39% for residency/fellowship and 4% for medical school (P < 0.01). For individual hypopharyngeal procedures, over 40% of respondents reported limited training (except for tongue radiofrequency), and over 30% raised concerns about scientific evidence and reimbursement. Surgeon personal experience suggested treatment benefits without clearly favoring individual procedures. Respondents noted that patients were reluctant to undergo procedures, despite treatment recommendations, particularly maxillomandibular advancement. The sleep medicine subgroup reported higher ratings for education and training quality, research evidence, and personal experience with hypopharyngeal procedures. Concerns about adequate education and training, the quality of research evidence, and reimbursement issues were major factors in procedure selection. Conclusion Multiple factors affect procedure selection. Surgeons identify concerns regarding education and training and research evidence.

Standardized Outcome and Reporting Measures in Pediatric Head and Neck Lymphatic Malformations

Objective To develop general and site-specific treatment effect and outcome measures to standardize the reporting of head and neck lymphatic malformation (HNLM) treatments. Study Design Consensus statement/expert opinion. Setting Multiple tertiary academic institutions. Subjects and Methods The modified Delphi method is an iterative process of collecting expert opinions, refining opinions through discussion and feedback, statistically aggregating opinions, and using these aggregates to generate consensus opinion in the absence of other data. The modified Delphi method was used by a multi-institutional group of otolaryngology and interventional radiology experts in the field of vascular anomalies to formulate a list of recommended reporting outcomes for the study and treatment of head and neck lymphatic malformations. Results Through 3 rounds of iteration, 10 expert panelists refined 98 proposed outcome measures and 9 outcome categories to a final consensus set of 50 recommended outcome measures in 3 global categories (general, demographics, and treatment complications) and 5 site-specific categories (orbit, oral cavity, pharynx, larynx, and neck). Conclusions We propose the first consensus set of standardized reporting measures for clinical and treatment outcomes in studies of HNLMs. Consistent outcome measures across future studies will facilitate comparison of treatment options and allow systematic review. We hope that these guidelines facilitate the design and reporting of subsequent HNLM studies.