Peter M. Vila

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.

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.

Low-Cost Endomicroscopy in the Esophagus and Colon

To the Editor: Confocal endomicroscopy is emerging as a safe, minimally-invasive means of improving the accuracy of endoscopic screening and surveillance for Barrett’s esophagus (1) and colorectal cancer (2). When used alongside “red-flag” techniques such as autofluorescence imaging (AFI) or narrow-band imaging (NBI), endomicroscopy enables the gastroenterologist to evaluate the gastric or colonic mucosa with cellular level resolution in a real-time “optical biopsy” (3). Both endoscope-based and probe-based platforms have demonstrated improved diagnostic yield and very high preliminary accuracy compared to standard endoscopy in prospective, double-blind studies (4,5). However, the cost and learning curve associated with these systems limits their usage to a select number of academic centers (3). To enable widespread translation of this promising technology, we developed a high-resolution microendoscope (HRME) in prototype form for under

Asymmetric and Unilateral Hearing Loss in Children

5,000 (6,7). The instrument uses a 1-mm diameter probe which passes through the working channel of a standard gastroscope or colonoscope; images are displayed at 15 frames-per-second at 400× magnification. A light-emitting diode (LED) provides illumination at 445 nm which is delivered through the probe to the tissue surface. The spatial resolution of the probe is 4.4 µm and the field-of-view 720 µm in diameter. In this Letter, we present the first in vivo clinical applications of this technology in the upper and lower GI tracts. We present a case involving surveillance and guided therapy of Barrett’s esophagus, followed by three cases illustrating the characteristic features of normal, inflammatory, and adenomatous tissue in the colon. The study was approved by the Institutional Review Boards of Mount Sinai Hospital and Rice University. Similar to several confocal endomicroscopy studies (3), the HRME uses fluorescent contrast agents, typically either topical acriflavine or proflavine. In the esophagus, this enables the discrete, evenly spaced nuclei of normal squamous mucosa to be distinguished from the glandular appearance of columnar metaplasia (fig. 1a–d). Barrett’s metaplasia has previously been characterized on HRME by large glands with intact nuclear polarity, whereas high-grade dysplasia (HGD) exhibits crowded, irregular glands and loss of nuclear polarity (6,8). Figure 1 HRME imaging in the esophagus. (a) Normal squamous mucosa and (c) Barrett’s metaplasia with focal HGD (arrows) in a 47-year old male undergoing endoscopic evaluation. (b,d) Histopathology sections (H&E) corresponding to the locations imaged ... A 47-year-old male with longstanding reflux symptoms and Barrett’s esophagus was referred for endoscopic evaluation. The patient underwent high-definition white light endoscopy (fig. 1e) with narrow-band imaging (fig. 1f) which revealed a 6-cm segment of Barrett’s (Prague Classification C5M6) with several “NBI-abnormal” areas showing a distorted mucosal and vascular pattern. These areas were sprayed with 1–2 ml of 0.01% (w/v) proflavine and imaged with the HRME probe (see Supplementary Video 1 online). HRME imaging revealed non-neoplastic epithelium in the majority of NBI-abnormal areas. However, focal HGD was noted in two separate areas in the proximal portion of the segment, evidenced by a proliferation of small irregular glandular structures (arrows in Fig. 1c,d). The patient opted for and subsequently underwent endoscopic cryoablation of the Barrett’s segment (Fig. 1g,h). We have also used the HRME during screening colonoscopy, where the ability to rapidly stratify benign polyps and precancerous adenomas is essential. In normal colonic mucosa, small uniformly spaced circular crypts, absent of glandular distortion or atrophy are readily apparent under HRME imaging (fig. 2a), and also seen in the corresponding histopathology (fig. 2b). Small, basally oriented nuclei are also apparent under HRME imaging. With inflammatory polyps, a dense population of inflammatory cells is commonly observed on HRME (fig. 2c), with only a few irregularly shaped and variably sized glands visible. Tubular adenomas (fig. 2e) are easily distinguished; glands appear as irregular structures with heterogeneous orientation, involving elongated, crowded cells, and enlarged nuclei. Figure 2 HRME imaging in the colon. (a) HRME image of the normal colon in vivo, with corresponding histopathology from the same site (b). Note the appearance of small, uniformly spaced circular crypts, with small, basally oriented nuclei. (c) HRME image and (d) ... Endomicroscopy has the potential to become an important clinical tool (9), but its overall impact on patient care may ultimately be limited by cost. HRME imaging provides real-time “optical biopsies” with many of the same diagnostically relevant features established for confocal endomicroscopy, yet costs significantly less than probe and endoscope based confocal platforms. Low-cost endomicroscopy may prove to be a more widely accessible adjunct to standard endoscopy for managing conditions including Barrett’s metaplasia and screening colonoscopy, by assisting the endoscopist in selecting sites for biopsy and/or guiding treatment.

Understanding Quality Measures in Otolaryngology-Head and Neck Surgery.

Asymmetric and unilateral hearing losses in children have traditionally been underappreciated, but health care practitioners are now beginning to understand their effect on development and the underlying pathophysiologic mechanisms. The common wisdom among medical and educational professionals has been that at least one normal-hearing or near-normal-hearing ear was sufficient for typical speech and language development in children. The objective of this review is to illustrate, to the non-otolaryngologist, the consequences of asymmetric and unilateral hearing loss in children on developmental and educational outcomes. Etiology, detection, and management are also discussed. Lastly, implications for further research are considered.

High resolution microendoscopy for classification of colorectal polyps.

As health care reimbursements based on pay-for-performance models become more common, there is an unprecedented demand for ways to measure health care quality and demonstrate value. Performance measures, a type of quality measure, are unique tools in a health care delivery system that allow objective monitoring of adherence to specific goals and tracking of outcomes. We sought to provide information on the development of quality measures in otolaryngology-head and neck surgery, as well as the goals of performance measurement at a national level and for our specialty. The historical development, various types, and approach to creating effective performance measures are discussed. The primary methods of developing performance measures (using clinical practice guidelines, clinical registries, and alternative methods) are also discussed. Performance measures are an important tool that can aid otolaryngologists in achieving effective, efficient, equitable, timely, safe, and patient-centered care as outlined by the Institute of Medicine.

Accuracy and interrater reliability for the diagnosis of Barrett's neoplasia among users of a novel, portable high-resolution microendoscope.

BACKGROUND AND STUDY AIMS It can be difficult to distinguish adenomas from benign polyps during routine colonoscopy. High resolution microendoscopy (HRME) is a novel method for imaging colorectal mucosa with subcellular detail. HRME criteria for the classification of colorectal neoplasia have not been previously described. Study goals were to develop criteria to characterize HRME images of colorectal mucosa (normal, hyperplastic polyps, adenomas, cancer) and to determine the accuracy and interobserver variability for the discrimination of neoplastic from non-neoplastic polyps when these criteria were applied by novice and expert microendoscopists. METHODS Two expert pathologists created consensus HRME image criteria using images from 68 patients with polyps who had undergone colonoscopy plus HRME. Using these criteria, HRME expert and novice microendoscopists were shown a set of training images and then tested to determine accuracy and interobserver variability. RESULTS Expert microendoscopists identified neoplasia with sensitivity, specificity, and accuracy of 67 % (95 % confidence interval [CI] 58 % - 75 %), 97 % (94 % - 100 %), and 87 %, respectively. Nonexperts achieved sensitivity, specificity, and accuracy of 73 % (66 % - 80 %), 91 % (80 % - 100 %), and 85 %, respectively. Overall, neoplasia were identified with sensitivity 70 % (65 % - 76 %), specificity 94 % (87 % - 100 %), and accuracy 85 %. Kappa values were: experts 0.86; nonexperts 0.72; and overall 0.78. CONCLUSIONS Using the new criteria, observers achieved high specificity and substantial interobserver agreement for distinguishing benign polyps from neoplasia. Increased expertise in HRME imaging improves accuracy. This low-cost microendoscopic platform may be an alternative to confocal microendoscopy in lower-resource or community-based settings.

Platelet reactivity and nonresponse to dual antiplatelet therapy: A review

The high-resolution microendoscope (HRME) is a novel imaging modality that may be useful in the surveillance of Barretts esophagus in low-resource or community-based settings. In order to assess accuracy and interrater reliability of microendoscopists in identifying Barretts-associated neoplasia using HRME images, we recruited 20 gastroenterologists with no microendoscopic experience and three expert microendoscopists in a large academic hospital in New York City to interpret HRME images. They prospectively reviewed 40 HRME images from 28 consecutive patients undergoing surveillance for metaplasia and low-grade dysplasia and/or evaluation for high-grade dysplasia or cancer. Images were reviewed in a blinded fashion, after a 4-minute training with 11 representative images. All imaged sites were biopsied and interpreted by an expert pathologist. Sensitivity of all endoscopists for identification of high-grade dysplasia or cancer was 0.90 (95% confidence interval [CI]: 0.88-0.92) and specificity was 0.82 (95% CI: 0.79-0.85). Positive and negative predictive values were 0.72 (95% CI: 0.68-0.77) and 0.94 (95% CI: 0.92-0.96), respectively. No significant differences in accuracy were observed between experts and novices (0.90 vs. 0.84). The kappa statistic for all raters was 0.56 (95% CI: 0.54-0.58), and the difference between groups was not significant (0.64 vs. 0.55). These data suggest that gastroenterologists can diagnose Barretts-related neoplasia on HRME images with high sensitivity and specificity, without the aid of prior microendoscopy experience.

The Burden and Epidemiology of Eustachian Tube Dysfunction in Adults

Clopidogrel is a second-generation thienopyridine that irreversibly inhibits the P2Y12 adenosine diphosphate (ADP) receptor on platelets, preventing platelet aggregation. As early as 2003, researchers have observed inter-patient variability in response to clopidogrel, leading to a multitude of studies investigating the phenomenon of “clopidogrel resistance,” due to the possible link between clopidogrel resistance and in-stent thrombosis. However, due to differences in study methodology and the lack of a clear definition, there is confusion about what it means and its clinical implications. Literature searches were performed using the Web of Science Database. Keywords used to search for relevant literature included clopidogrel resistance. While several studies have shown associations between high platelet reactivity and a high incidence of adverse outcomes, the optimal level of platelet inhibition is unknown. Regardless of the term used to describe high platelet reactivity after treatment, evidence shows that this leads to adverse clinical outcomes. Future goals for research should be aimed at developing a standard method of measuring platelet function and investigating determinants of high platelet reactivity. Alternative treatment options for patients with high platelet reactivity in the face of dual antiplatelet therapy are currently being investigated.

Quantitative analysis of high-resolution microendoscopic images for diagnosis of neoplasia in patients with Barrett’s esophagus

Objectives Pediatric eustachian tube dysfunction (ETD), otitis media with effusion (OME), and tympanic membrane retraction (TMR) have been well studied, but no large analyses have described the associated burden beyond childhood. The potential impact and feasibility of prospective trials designed to optimize management of affected adults are thus unclear. Our objectives were therefore (1) to determine the national visit burden associated with ETD/OME/TMR beyond childhood and (2) to examine risk factors specific to adults, highlighting differences in comparison with children. Study Design Cross-sectional analysis of a national database. Setting Ambulatory visits in the United States. Methods Epidemiologic analysis of the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey (2005-2012) included data from 761,291 observations representing 9,369,388,092 visits. Chi-square test with Bonferroni adjustment for multiple comparisons was utilized for hypothesis testing. Results Visits related to ETD/OME/TMR exceeded 2 million per annum in patients 0 to 20 years of age (mean 2,625,965; range 2,239,288-3,329,858). Among those >20 years old, visits also exceeded 2 million (mean, 2,025,050; range, 1,550,669-2,353,799). Characteristics differed according to age: whereas ETD/OME/TMR affected more males <20 years, females were more frequently diagnosed in the older age group (P < .0001). Patients >20 to 40 years of age were the most likely to visit the emergency department (P = .0022). There were no statistically significant differences per season or region. The related diagnoses of cholesteatoma and chronic otitis media prompted additional visits. Conclusions ETD/OME/TMR is associated with a visit burden for adults that extends beyond childhood. Among adults, there may also be age-related differences in patient characteristics.