Edward M. Weaver

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.)

A randomized trial of temperature-controlled radiofrequency, continuous positive airway pressure, and placebo for obstructive sleep apnea syndrome

OBJECTIVE The study goal was to determine the effectiveness of (1) multilevel temperature-controlled radiofrequency tissue ablation (TCRFTA) or (2) continuous positive airway pressure (CPAP) for the treatment of mild to moderate obstructive sleep apnea syndrome (OSAS). STUDY DESIGN AND METHODS We conducted a randomized, placebo-controlled, 2-site trial, comparing TCRFTA (n = 30) and CPAP (n = 30) with sham-placebo (n = 30) using intention-to-treat analysis. RESULTS Compared with pretreatment baseline, TCRFTA improved reaction time, OSAS-specific quality of life (QOL), and subjective sleepiness (all P < 0.05). Compared with sham-placebo, TCRFTA improved QOL, airway volume, apnea index, and respiratory arousal index (all P < 0.05). TCRFTA side effects and complications were mild, temporary, and similar to sham-placebo. CPAP improved QOL and sleepiness compared with baseline and QOL when compared with sham-placebo (all P < 0.05). Significant differences were not seen between TCRFTA and CPAP outcomes. CONCLUSION TCRFTA and CPAP each improve QOL for mild-moderate OSAS patients. TCRFTA improvements may result from changes in airway volume, apnea index, and respiratory arousal index.

Radiofrequency Treatment of Turbinate Hypertrophy in Subjects Using Continuous Positive Airway Pressure: A Randomized, Double‐Blind, Placebo‐Controlled Clinical Pilot Trial

Objectives To estimate the treatment effect of temperature‐controlled radiofrequency (TCRF) reduction of turbinate hypertrophy in patients with sleep‐disordered breathing (SDB) treated with nasal continuous positive airway pressure (CPAP), and to assess the impact of study design on this estimate.

Incidence of serious complications after Uvulopalatopharyngoplasty

Objectives Uvulopalatopharyngoplasty (UPPP) is the most common surgical treatment for obstructive sleep apnea (OSA). Anatomic and physiologic abnormalities associated with OSA can make perioperative management difficult. Only single‐site case series provide current estimates of the incidence of perioperative complications, with a pooled crude serious complication rate of 3.5% and a crude mortality rate of 0.4%. The primary objective of this study was to calculate the incidence of perioperative morbidity and mortality in a large, multisite cohort of UPPP patients.

An official american thoracic society statement: Continuous positive airway pressure adherence tracking systems the optimal monitoring strategies and outcome measures in adults

BACKGROUND Continuous positive airway pressure (CPAP) is considered the treatment of choice for obstructive sleep apnea (OSA), and studies have shown that there is a correlation between patient adherence and treatment outcomes. Newer CPAP machines can track adherence, hours of use, mask leak, and residual apnea-hypopnea index (AHI). Such data provide a strong platform to examine OSA outcomes in a chronic disease management model. However, there are no standards for capturing CPAP adherence data, scoring flow signals, or measuring mask leak, or for how clinicians should use these data. METHODS American Thoracic Society (ATS) committee members were invited, based on their expertise in OSA and CPAP monitoring. Their conclusions were based on both empirical evidence identified by a comprehensive literature review and clinical experience. RESULTS CPAP usage can be reliably determined from CPAP tracking systems, but the residual events (apnea/hypopnea) and leak data are not as easy to interpret as CPAP usage and the definitions of these parameters differ among CPAP manufacturers. Nonetheless, ends of the spectrum (very high or low values for residual events or mask leak) appear to be clinically meaningful. CONCLUSIONS Providers need to understand how to interpret CPAP adherence tracking data. CPAP tracking systems are able to reliably track CPAP adherence. Nomenclature on the CPAP adherence tracking reports needs to be standardized between manufacturers and AHIFlow should be used to describe residual events. Studies should be performed examining the usefulness of the CPAP tracking systems and how these systems affect OSA outcomes.

Comparison of anatomic, physiological, and subjective measures of the nasal airway

Background Studies comparing different categories of nasal measures have reported inconsistent results. We sought to compare validated measures of the nasal airway: anatomic (acoustic rhinometry), physiological (nasal peak inspiratory flow), and subjective experience (Nasal Obstruction Symptom Evaluation Scale and a visual analog scale [VAS]). Methods This prospective cross-sectional study of 290 nonrhinologic patients included upright and supine rhinometry (minimum cross sectional area [MCA] and volume) and flow (mean and maximum) measurements, as well as subjective measures. Associations between measures were evaluated with Spearman correlations and multivariate linear regression, adjusting for age, sex, race, body mass index, and smoking history. Results Correlations between objective (rhinometry and flow) and subjective categories of nasal measures ranged from –-0.16 to 0.03 (mean correlation, -0.07 ± 0.05), with 0 significant correlations of 16 tested. Correlations between anatomic (rhinometry) and physiological (flow) categories ranged from 0.04 to 0.15 (mean correlation, 0.10 ± 0.03), with 0 significant correlations of 16 tested. In contrast, within each category (rhinometry, flow, and subjective), all correlations were significant (13 correlations, all p < 0.001) and ranged from 0.62 to 0.99. Of 16 adjusted associations between objective and subjective measures, 14 were not significant (p > 0.05); only upright and supine MCAs were significantly associated with the VAS (both, p < 0.05). Conclusion Validated anatomic, physiological, and subjective nasal measures may assess different aspects of the nasal airway and provide complementary information. Future studies should be directed at developing a composite measure including components from all three categories of nasal measurement.

Polysomnography indexes are discordant with quality of life, symptoms, and reaction times in sleep apnea patients.

OBJECTIVE: We tested whether polysomnography (PSG) indexes were associated with sleepiness, quality of life, or reaction times at baseline and as outcome measures following surgical or sham treatment for patients with obstructive sleep apnea syndrome (OSAS). STUDY DESIGN AND METHODS: Mild-moderate OSAS subjects were measured before and 8 weeks after surgical or sham treatment in this prospective longitudinal study. Measures included standard PSG indexes, sleepiness, quality of life, and reaction times. Associations were examined with Spearman correlations and multivariate linear regression. RESULTS: Correlations between baseline PSG and non-PSG measures ranged from −0.22 to 0.25 (n, 87 subjects; mean correlation, 0.00 ± 0.11), with one positive association significant of 56 tested (arousal index and SF36 Mental Component Summary, r, 0.25; P = 0.03). Correlations between change in PSG and non-PSG measures ranged from −0.37 to 0.35 (n, 54 subjects; mean correlation, −0.05 ± 0.19), with no significant positive association of 56 tested. Regression analyses confirmed these results. CONCLUSIONS: PSG indexes are not consistently associated with sleepiness, quality of life, or reaction time, both at baseline and as outcome measures in patients with mild-moderate OSAS. PSG indexes may not quantify some important aspects of OSAS disease burden or treatment outcome. Clinically important outcomes should be measured directly. EBM rating: A.

Clinical consensus statement: Diagnosis and management of nasal valve compromise

Objective: To create a clinical consensus statement to address ambiguities and disparities in the diagnosis and management of nasal valve compromise (NVC). Subjects and Methods: An updated systematic review of the literature was conducted. In addition, a Modified Delphi Method was used to refine expert opinion and facilitate a consensus position. Results: After two rounds of surveys and conference calls, 36 items reached consensus, six items reached near consensus, and 10 items reached no consensus. The categories that had the greatest percentage of consensus or near consensus items were as follows: definition, history and physical examination, outcome measures, and management. Conversely, the categories with greater percentage of no consensus items were adjunctive tests and coding. Conclusion: The consensus panel agreed that NVC is a distinct clinical entity that is best evaluated with history and physical examination findings. Endoscopy and photography are useful but not routinely indicated, whereas radiographic studies are not useful in evaluating NVC. Other objective nasal outcome measures may not be useful or accepted for NVC. Nasal steroid medication is not useful for treatment of NVC in the absence of rhinitis, and mechanical treatments may be useful in selected patients. Surgical treatment is the primary mode of treatment of NVC, but bill coding remains ambiguous and confusing.

Association Between Gastroesophageal Reflux and Sinusitis, Otitis Media, and Laryngeal Malignancy: A Systematic Review of the Evidence

This study was conducted to review and evaluate the published evidence for an association between gastroesophageal reflux (GER) and 3 supraesophageal pathologies: sinusitis, otitis media, and laryngeal malignancy. Relevant articles were located using MEDLINE (search limits: 1966-2001, English language, human studies). Only new data or new analyses of previous data were included. Relevant articles were designated by their level of evidence, based on published standards, and grouped by pathology. An overall grade was assigned to each group for the strength of evidence for or against an association. The search produced 152 articles, 42 of which met inclusion criteria and were reviewed in detail. There is grade C evidence for a positive association between GER and sinusitis (57 articles screened, 14 articles included); for a negative association between GER and otitis media (28 articles screened, 10 articles included); and for a positive association between GER and laryngeal malignancy (67 articles screened, 18 articles included). The published literature weakly supports a positive association between GER and both sinusitis and laryngeal malignancy, and a negative association between GER and otitis media.