Factors predictive of good outcome in patients with chronic sinusitis

OtolaryngologyHead and Neck Surgery Volume 121 Number 2

steroid could be effectively treated with Astelin| nasal spray monotherapy. Methods: Following a 1- to 2-week washout, patients were randomized to 1 week of double-blind treatment with either Astelin| nasal spray monotherapy (2 sprays/nostril bid) or combination therapy with Claritin| (10 mg) plus Beconase AQ| (2 sprays/nostril bid). Efficacy was determined by (1) a physician assessment of symptom control as measured by the need for additional anti-rhinitis medication at the end of the study, and (2) a patient global evaluation of therapeutic effectiveness. Results: There was no statistically significant difference between the percentage of patients whose symptoms were controlled with Astelin| nasal spray (32%) versus combination therapy with Claritin| and Beconase AQ| (39%). This study confirms the results of 2 previously reported studies that also showed no statistically significant differences between the percentage of patients treated with Astelin| nasal spray (36% and 45%, respectively) who did not require additional antirhinitis therapy versus the percentage of patients treated with Claritin| plus Beconase AQ| (46% in both studies). The patient global evaluation indicated that 84% of the patients treated with Astelin| nasal spray and 85% of the patients treated with Claritin| and Beconase AQ| had symptomatic improvement. Conclusion: Based on percentages of patients not requiring additional antirhinitis medication, Astelin| nasal spray monotherapy was as effective as the combination of Claritin| plus Beconase AQ| Therefore many patients with SAR who are candidates for combination therapy with an oral antihistamine plus a nasal steroid can be controlled with Astelin| nasal spray alone. (Supported by Wallace Laboratories, Cranbury, NJ.) 8:40 AM

Cellular Responses in Nasal Challenges with Occupational Agents MARTIN Y DESROSIERSMD (presenter); GIAID ADEL PHD DMV; JEAN-LUC MALO MD FRCPC, Montreal C a n a d a

Purpose: While occupationally-induced nasal symptoms are frequently reported, occupational rhinitis is a little studied disease entity. We have attempted to determine the mechanisms of these responses by evaluating cellular responses and patterns of cytokine generation in nasal biopsies following nasal provocation with agents capable of inducing OA in a population with documented OA. Methods: Eight patients with OA with documented sensitivity to high-molecular-weight sensitizers (flour, n = 7; guar gum, n = 1) underwent nasal provocation. One nostril was occluded for the duration of the challenge and served as the control. Eight hours after challenge, simultaneous bilateral biopsies of the inferior turbinates were taken. Biopsies were evaluated for the inflammatory cells markers CD-3, CD-4,

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CD-8, and MBP by immunohistochemistry, and for synthesis of cytokines IL-4, IL-5, and IFN-7 by in situ hybridization. Conclusion: Nasal challenge with real-life exposure levels of agents capable of producing OA leads to inflammatory responses characterized by a 10-fold increase of CD-4+ (Thelper) cells. High levels of cytokines on the control side may reflect inflammatory phenomena persisting despite removal from exposure. (Supported by the 1996 Combined AAO-HNS Foundation/ AAOA Research grant.) 8:50 AM

Factors Predictive of Good Outcome in Patients with Chronic Sinusitis MICHAEL G STEWART MD MPH (presenter); DONALD T DONOVAN MD FACS; ROBERT B PARKE JR MD MBA; Houston TX

Problem: Currently, there is no ideal prognostic staging system for chronic sinusitis (CS). Although many authors have studied the impact of clinical and comorbid conditions on outcomes after treatment of CS, most have studied surgical outcomes only and used either retrospective techniques or physician-based outcomes. In this study, we used the prospective assessment of patient-based health status and quality of life as treatment outcomes, and we have attempted to identify clinical and comorbid factors that predict better outcome after treatment of CS. Methods: Analysis of data from an ongoing prospective clinical outcomes study at a tertiary academic medical center (n = 130, mean age 46.8 years). Disease-specific health status and symptom severity were measured using a validated health status instrument (the Chronic Sinusitis Survey). Statistical analysis was performed using univariate nonparametric analysis, followed by linear and logistic multiple regression analysis with stepwise entry of predictor variables. Results: Overall, patients treated with medical therapy showed only a moderate trend toward improvement in symptoms, while patients treated with endoscopic sinus surgery showed significant improvement in symptom scores at 3 months after treatment (P < 0.001); initial symptom severity did not differ between treatment groups. Patients with worse symptoms did not show proportionally larger improvements in symptom score, although they had larger improvements in absolute symptom score. We analyzed outcome by final symptom level after treatment and by dichotomizing patients into 2 groups: symptoms worse or better after treatment. The only clinical factor that predicted overall improvement in clinical outcome was the pretreatment CT scan severity (~ = 0.78, P = 0.03). Clinical factors that predicted a larger degree of improvement in symptom severity were CT severity (~ = -0.58, P = 0.001) and allergic rhinitis (~ = 0.34, P = 0.03), and pretreatment symptom severity showed a trend toward significance. Conclusions: Although patients with more severe symptoms prior to treatment showed larger absolute improvements

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Scientific Sessions--Tuesday

in symptom score, they still had higher symptom levels after treatment than patients with less severe disease. Pretreatment CT scan severity was a significant predictor of both absolute and relative improvement after treatment. Pretreatment symptom severity showed a trend toward significance as a predictor of improvement after treatment, and concomitant allergic rhinitis was a significant predictor of outcome. 9:00 AM

Accuracy of Terminology and Methodology in Economic Analyses ERICJ KEZIRIANMD (presenter); BEVANYUEHMD; Seattle WA

Problem: Economic studies, such as cost-effectiveness, cost-benefit, and cost-utility analyses, have increasing impact on disease management in otolaryngology. Because rigorous adherence to proper research techniques is critical to ensure accuracy, we sought to evaluate how well recent articles in the otolaryngology literature met established criteria for economic analyses. Methods: Articles with economic analyses from 1990 to 1998 in 6 otolaryngology journals (American Journal of Otology; Annals of Otology, Rhinology, and Laryngology; Archives of Otolaryngology-Head and Neck Surgery; Head and Neck; The Laryngoscope; and Otolaryngology-Head and Neck Surgery) were considered; 45 met our inclusion criteria. Articles were then reviewed for adherence to terminology and methodology criteria as defined by the Panel on CostEffectiveness in Health and Medicine. Results: Twenty of 45 (44%) articles misused the terms "cost-effective," "cost-benefit," or "cost-utility." Of papers that derived cost estimates, 19 of 26 (73%) confused "charge" and "cost" data. Less than half of the authors reported a costeffectiveness, cost-benefit, or cost-utility ratio. Less than 20% of papers performed sensitivity analyses. No papers explicitly stated the perspective of their analysis. Conclusion: There is significant deviation from correct terminology and research methods in published otolaryngology economic analyses. Authors and editors need to be aware of these deficits to improve the quality and applicability of economic analyses. Clinical Significance: In an era of limited financial resources, economic analyses increasingly guide clinical decisions in both the public and private sectors. Greater attention to both terminology and methodology can enhance the quality of economic analyses and ultimately improve the clinical decisions that utilize this research. 9:10 AM

Discussion 9:15 to 9:35 AM

Poster Session (See pages P76~P109)

Session B: Larynx and Trachea (Room 245) JONATHAN E AVIV MD; ROY R CASIANO MD (moderators); N e w York NY; Miami FL 7:45 AM

Development of Homograft Tracheal Transplant in the Pig Model JEFFREYA FAULKNERMD (presenter); ERICA MAIR MD; Laurel MD; RockvilleMD

Problem Addressed: Homograft tracheal transplant has been reported as a successful technique for repair of congenital long-segment tracheal stenosis. The technique is simple in concept, but postoperative management of these patients can be difficult. This study addresses the stenting, the mercury content, and the condition of the transplant in the early postoperative period. Methods: Swine trachea were preserved in formalin, thimerosal, and acetone, and then 6-cm segments were transplanted into 20 piglets. Three groups were studied: group A, no stent; group B, rigid Teflon stents (Albouker); and group C, flexible Silastic stents with posts (Hood). The piglets were monitored with telescopic bronchoscopy and endoscopic photography for airway obstruction and healing, Histology was compared to evaluate the mucosal lining of the segments. Mercury levels were measured in samples treated for 90 days with thimerosal using induced coupling mass spectrometry. Results: Group A piglets survived 2 days. Group B survived up to 1 month, with a strong tendency to develop exuberant, firm granulation tissue at both ends of the stent. In spite of retention sutures, each Albouker stent migrated as the airway grew, resulting in obstruction. The grafts stented with Albouker stents were infected, and the mucosal coverage was incomplete. Group C survived up to 4.5 months. Many stents migrated at 2 months resulting in airway obstruction. Grafts that survived 2 months had a complete mucosal lining, but the transplant segments were small and extremely malacic. Control mercury levels were 10.48 pg/mg compared with 31.25 pg/mg in trachea treated for 90 days with tbimerosal. Conclusions: When performing homograft tracheal transplantation, stenting of the transplanted segment is required. Of the 2 stents that we tested, the Hood stents created less granulation tissue, were retained longer, and had a lower rate of infection than the Albouker stents. Mercury levels increased in tracheas treated with thimerosal, but not above acceptable levels. Clinical Significance: When performing homograft tracheal transplant, stenting of the grafted segment will be more successful if a self-retaining flexible stent is used. Mucosal coverage of the grafted segments occurs at approximately 2 months, and therefore the stent should not be changed prior to that time if possible. The mercury content of tracheas treated