Maureen T. Hannley

Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale.

OBJECTIVE: The study goal was to validate a disease-specific health status instrument for use in patients with nasal obstruction. DESIGN, SETTINGS, AND PATIENTS: The study consisted of a prospective instrument validation conducted at 4 academic medical centers with 32 adults with nasal septal deformity. METHODS: Prospective instrument validation occurred in 2 stages. Stage 1 was the development of a preliminary (alpha-version) instrument of potential items. Stage 2 was a test of the alpha-version for item performance, internal consistency, and test-retest reliability; construct, discriminant, criterion validity, and responsiveness; and creation of the final instrument. RESULTS: Items with poor performance were eliminated from the alpha-version instrument. In testing the final instrument, test-retest reliability was adequate at 0.702; internal consistency reliability was also adequate at 0.785. Validity was confirmed using correlation and comparison analysis, and response sensitivity was excellent. CONCLUSIONS: The Nasal Obstruction Symptom Evaluation Scale is a valid, reliable, and responsive instrument that is brief and easy to complete and has potential use for outcomes studies in adults with nasal obstruction.

Outcomes after nasal septoplasty: Results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study ☆

OBJECTIVE: Our goal was to assess disease-specific quality of life outcomes after nasal septoplasty in adults with nasal obstruction. DESIGN, SETTINGS, AND PATIENTS: We conducted a prospective observational outcomes multicenter study with 14 sites and 16 investigators, including private practice and academic settings. Patients had had septal deviation and symptomatic nasal obstruction for at least 3 months, and medical management had failed. METHODS: Patients with septal deviation completed a validated outcomes instrument (the Nasal Obstruction Septoplasty Effectiveness (NOSE) scale) before and 3 and 6 months after septoplasty, with or without partial turbinectomy. RESULTS: Fifty-nine patients underwent surgery; there was a significant improvement in mean NOSE score at 3 months after septoplasty (67.5 versus 23.1, P < 0.0001), and this improvement was unchanged at 6 months. Patient satisfaction was very high, and patients used significantly fewer nasal medications. CONCLUSIONS: In patients with septal deformity, nasal septoplasty results in significant improvement in disease-specific quality of life, high patient satisfaction, and decreased medication use. (Otolaryngol Head Neck Surg 2004;130:283–90.)

Clinical Practice Guideline: Acute Otitis Externa

OBJECTIVE: This guideline provides evidence-based recommendations to manage diffuse acute otitis externa (AOE), defined as generalized inflammation of the external ear canal, which may also involve the pinna or tympanic membrane. The primary purpose is to promote appropriate use of oral and topical antimicrobials and to highlight the need for adequate pain relief. STUDY DESIGN: In creating this guideline, the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) selected a development group representing the fields of otolaryngology-head and neck surgery, pediatrics, family medicine, infectious disease, internal medicine, emergency medicine, and medical informatics. The guideline was created with the use of an explicit, a priori, evidence-based protocol. RESULTS: The group made a strong recommendation that management of AOE should include an assessment of pain, and the clinician should recommend analgesic treatment based on the severity of pain. The group made recommendations that clinicians should: 1) distinguish diffuse AOE from other causes of otalgia, otorrhea, and inflammation of the ear canal; 2) assess the patient with diffuse AOE for factors that modify management (nonintact tympanic membrane, tympanostomy tube, diabetes, immunocompromised state, prior radiotherapy); and 3) use topical preparations for initial therapy of diffuse, uncomplicated AOE; systemic antimicrobial therapy should not be used unless there is extension outside of the ear canal or the presence of specific host factors that would indicate a need for systemic therapy. The group made additional recommendations that: 4) the choice of topical antimicrobial therapy of diffuse AOE should be based on efficacy, low incidence of adverse events, likelihood of adherence to therapy, and cost; 5) clinicians should inform patients how to administer topical drops, and when the ear canal is obstructed, delivery of topical preparations should be enhanced by aural toilet, placing a wick, or both; 6) when the patient has a tympanostomy tube or known perforation of the tympanic membrane, the clinician should prescribe a nonototoxic topical preparation; and 7) if the patient fails to respond to the initial therapeutic option within 48 to 72 hours, the clinician should reassess the patient to confirm the diagnosis of diffuse AOE and to exclude other causes of illness. And finally, the panel compiled a list of research needs based on limitations of the evidence reviewed. CONCLUSION: This clinical practice guideline is not intended as a sole source of guidance in evaluating patients with AOE. Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. It is not intended to replace clinical judgment or establish a protocol for all individuals with this condition and may not provide the only appropriate approach to the diagnosis and management of this problem. SIGNIFICANCE: This is the first, explicit, evidence-based clinical practice guideline on acute otitis externa, and the first clinical practice guideline produced independently by the AAO-HNSF.

Evidence supporting endoscopic sinus surgery in the management of adult chronic rhinosinusitis : A systematic review

Background Evidence-based medicine calls for a critical evaluation of the scientific evidence for treatments of disease. This report synthesizes the available evidence on the use of endoscopic sinus surgery (ESS) in the management of adult chronic rhinosinusitis (CRS) examining the clinical question: “In adults with CRS who have failed medical management, does ESS improve symptoms and/or quality of life (QOL)?” Methods The American Rhinologic Society and the American Academy of Otolaryngology–Head and Neck Surgery convened a steering committee composed of the authors. Primary research articles evaluated for this report were identified using appropriate search terms and a Medline search. Two authors independently reviewed each article. Articles were assigned an evidence level based on accepted guidelines (level 1 = randomized trials; level 2 = prospective cohort studies with comparison group; level 3 = case-control studies; level 4 = retrospective case series; level 5 = expert opinion). Results We identified 886 abstracts to review, retrieved 75 articles for full review, and included 45 articles in our report. The vast majority of articles represented level 4 evidence (n = 42) and two articles represented level 5 evidence. One article was identified that qualified for level 2 evidence. All of these articles generally supported the finding that ESS improves symptoms and/or QOL in adult patients with CRS. Conclusion There is substantial level 4 evidence with supporting level 2 evidence that ESS is effective in improving symptoms and/or QOL in adult patients with CRS. Future research efforts should focus on prospective studies that include appropriate comparison groups in their design.

Techniques of intranasal steroid use.

OBJECTIVE: The effectiveness of topical intranasal steroids (INS) sprays for the treatment of allergic and nonallergic rhinitis may be limited by lack of instruction in the optimal spray technique. To determine whether the technique used affects the efficacy and safety of the product, this review of evidence had the goal of identifying and establishing a preferred method of applying INS sprays. STUDY DESIGN: A MEDLINE search of pertinent literature on 7 INS and 1 intranasal antihistamine spray preparations conducted with the use of appropriate search terms, yielded an initial 121 articles, 29 of which were identified as appropriate for review and grading for quality of evidence. RESULTS: The analysis provided no definitive evidence regarding how best to instruct patients to use INS or antihistamine spray devices. CONCLUSIONS: On the basis of a lack of clear evidence regarding instructions to maximize efficacy and safety of these drugs, the panel recommended a 7-step standard technique. (Otolaryngol Head Neck Surg 2004;130:5–24.)

Use of ototopical antibiotics in treating 3 common ear diseases

Prompted by rising rates of antibiotic resistance, lack of standardized treatment regimens, and new treatment alternatives, the American Academy of Otolaryngology-Head and Neck Surgery convened an expert consensus panel to consider recommendations for the responsible use of antibiotics in chronic suppurative otitis media, tympanostomy tube otorrhea, and otitis externa. The Panel concluded that in the absence of systemic infection or serious underlying disease, topical antibiotics alone constitute first-line treatment for most patients with these conditions, finding no evidence that systemic antibiotics alone or in combination with topical preparations improve treatment outcomes compared with topical antibiotics alone. Topical preparations should be selected on the basis of expected bacteriology and informed knowledge of the risk-benefit of each available preparation. The use of nonototoxic preparations in treating acute otitis externa (when the tympanic membrane is perforated or its status is unknown), chronic suppurative otitis media, and tympanostomy tube otorrhea should be considered.

Evidence supporting functional rhinoplasty or nasal valve repair : A 25-year systematic review

Objective To systematically review the existing literature supporting the efficacy of modern-day rhinoplasty techniques for treatment of nasal obstruction due to nasal valve compromise. Data Sources PubMed search of the English-language literature from January 1982 to August 2007 combined with manual review of citations within article bibliographies. Review Methods A systematic review of the literature for the targeted objective was conducted. Citations acquired from the targeted search were filtered and primary articles were reviewed to abstract information including interventions and outcome measures. Articles were then assigned level-of-evidence grades as defined by the Oxford Centre for Evidence-Based Medicine. Results A total of 861 citations were generated and 291 abstracts were identified as potentially relevant articles. Of these abstracts, 82 articles merited full-text review. A total of 44 articles met inclusion criteria. The majority of the studies were classified as level 4 evidence, and only two studies met level 2b criteria. There was considerable variation in the quality of the studies within the level 4 category. All articles generally supported the effectiveness of functional rhinoplasty techniques for treatment of nasal obstruction. Conclusions There is substantial level 4 evidence to support the efficacy of modern-day rhinoplasty techniques for treatment of nasal obstruction due to nasal valve collapse. More recent studies have incorporated validated patient-reported outcome measures, with more rigorous statistical analysis. Future study design improvements include the use of comparison cohorts and incorporating standardized objective outcome measures.

Treatment of tinnitus with gabapentin: a pilot study.

Objective: To evaluate the effectiveness of gabapentin (Neurontin®) improve the disease-specific quality of life in patients with moderate tinnitus. Study Design: Randomized, double blind, placebo-controlled clinical trial. Setting: Single-center academic outpatient otolaryngology practice. Intervention: Gabapentin 1800 mg daily versus placebo. Main Outcome Measures: The study design is a randomized, double blind placebo controlled single site trial conducted in an academic medical center. Inclusion criteria included patients between ages 18 and 70 with a complaint of nonpulsatile, subjective tinnitus, bilateral or unilateral, greater than 3 months in duration. The primary outcome measure is the Tinnitus Handicap Inventory; secondary measures include the Profile of Mood States (POMS) rating scale, subjective tinnitus severity. The null hypothesis addressed in this study is that the drug would not result in significant alleviation of the symptom of tinnitus. Results: Seventy-six patients completed the trial; of these 52 received the drug. No significant differences were found between the two groups after 5 weeks of treatment with gabapentin. Conclusion: There is insufficient evidence to support the effectiveness of gabapentin in the treatment of tinnitus.

Consensus panel on role of potentially ototoxic antibiotics for topical middle ear use: Introduction, methodology, and recommendations.

Abstract A special consensus panel of the American Academy of Otolaryngology-Head and Neck Surgery was appointed by Academy President Dr Jonas Johnson (2003) to determine the appropriate role of potentially ototoxic topical antibiotics in the treatment of ear disease. The consensus panel wished to determine, using current best evidence, if there were differences in efficacy between the potentially ototoxic and the nonototoxic topical antibiotics. This evidence-based review is designed to answer the specific question, ”Are there differences in clinical treatment efficacy between the aminoglycoside based ototopical antibiotic drops and the fluoroquinolone based antibiotic drops?“ A MEDLINE literature review was performed in September 2002. MeSH search terms included ”ototopical antibiotics“ and ”efficacy,“ with limits for human subjects and titles with abstracts. Fifty publications were identified. Four publications were eliminated from the review process because they were not in English (1 each in Japanese, French, Polish, and Hebrew) and 6 others were eliminated because they did not address the question of efficacy. A total of 40 relevant publications were reviewed and graded according to the standards established by the Centre for Evidence-based Medicine. Each article was reviewed and graded independently by 2 reviewers.

Quality of life after tonsillectomy in children with recurrent tonsillitis

OBJECTIVE To describe changes in disease-specific and global quality of life (QOL) for children with recurrent or chronic tonsillitis at 6 months and 1 year after tonsillectomy using two validated instruments, the Tonsil and Adenoid Health Status Instrument (TAHSI) and the Child Health Questionaire-PF28 (CHQ-PF28). STUDY DESIGN AND SETTING A multicenter, prospective observational outcomes study. RESULTS Ninety-two children, mean age (SD) 10.6 (3.4) years, enrolled with follow-up available for 58 children at 6 months and 38 children at 1 year. The children showed significant improvements in all subscales of the TAHSI including airway and breathing, infection, health care utilization, cost of care, eating and swallowing (all P < 0.001), and behavior (P = 0.01). Significant improvements were also found on several subscales of the CHQ-PF28, such as general health perceptions, physical functioning, parental impact, and family activities (all P < 0.001). CONCLUSION/SIGNIFICANCE This uncontrolled study provides prospective evidence of improved disease-specific and global QOL in children after tonsillectomy.