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

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

ORIGINAL ARTICLES Outcomes after nasal septoplasty: Results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study MICHAEL G. STEWART, MD, ...

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Houston, Texas, Milwaukee, Wisconsin, Seattle, Washington, Durham, North Carolina, Alexandria, Virginia, and Pittsburgh, Pennsylvania 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.)


asal obstruction is a common presenting symptom in otolaryngology practice. A common etiolFrom the Bobby R. Alford Department of Otorhinolaryngology and Communicative Sciences, Baylor College of Medicine, Houston (Dr Stewart), Department of Otolaryngology–Head and Neck Surgery, Medical College of Wisconsin, Milwaukee (Dr Smith), Health Services Research and Development Service, VA Puget Sound Healthcare System, and the Department of Otolaryngology–Head and Neck Surgery, University of Washington School of Medicine, Seattle (Drs Weaver and Yueh), Division of Otolaryngology–Head and Neck Surgery, Department of Surgery, Duke University School of Medicine, Durham (Dr

ogy is deviation of the nasal septum, although nasal obstruction can be caused by other conditions, such as turbinate hypertrophy, adenoid hypertrophy, and nasal polyposis. Surgical correction of a deviated septum—nasal septoplasty—is the definitive treatment for septal deviation. Although several studies have addressed outcomes after septoplasty,1-9 most were retrospective, and Witsell), American Academy of Otolaryngology–Head and Neck Surgery Foundation, Alexandria (Drs Hannley, Johnson, and Witsell), and Department of Otolaryngology– Head and Neck Surgery, University of Pittsburgh School of Medicine, Pittsburgh (Dr Johnson). *NOSE Study Investigators: C. Ron Cannon, MD, Joel Ernster, MD, Bruce Gordon, MD, Andrew Gould, MD, James Hadley, MD, Patty Huang, MD, Barton Knox, MD, Howard Levine, MD, Vincent Nalbone, MD, Mark Reinke, MD, John S. Rhee, MD, J. Lewis Romett, MD, Richard Scher, MD, and authors Timothy L. Smith, Michael G. Stewart, Edward L. Weaver, and David L. Witsell. This study was supported by the National Center for the Promotion of Research in Otolaryngology at the American Academy of Otolaryngology–Head and Neck Surgery Foundation, which was partially funded by a generous unrestricted grant from Schering-Plough Corporation. Dr Weaver is supported by Career Development Award HL068849 from the National Heart, Lung, and Blood Institute. Dr Yueh is supported by a Career Development Award CD-98318 from the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs. Reprint requests: Michael G. Stewart, MD, MPH, The Bobby R. Alford Department of Otorinolaryngology and Communicative Sciences, Baylor College of Medicine, One Baylor Plaza, NA-102, Houston, TX 77030; e-mail, mgstew@ bcm.tmc.edu. 0194-5998/$30.00 Copyright © 2004 by the American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. 10.1016/j.otohns.2003.12.004 283

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uation (NOSE) Scale (Fig 1). The validation data are reported in a prior publication,12 but in summary the NOSE scale is brief, valid, reliable, and responsive. In particular, responsiveness to change in clinical status was very robust in that study, with an effect size of 2.65 and a standardized response mean of 1.66. Therefore, using this newly developed diseasespecific outcomes instrument, we have performed a prospective outcomes study of patients undergoing nasal septoplasty, with or without partial turbinectomy.

Fig 1. Items on the NOSE (Nasal Obstruction Symptom Evaluation) scale.

none used an outcomes instrument validated for nasal obstruction. Despite multiple study methods, however, prior studies have found that septoplasty is generally beneficial in the treatment of nasal obstruction. Hypertrophy of the inferior turbinate(s) can also cause symptomatic nasal obstruction, by obstructing the area of the nasal valve. Turbinate hypertrophy can be treated surgically by a variety of methods, commonly with partial resection of the bulbous anteroinferior portion of the turbinate. Turbinate procedures may be performed alone for turbinate hypertrophy or with septoplasty for patients with a combination of obstructing septal deformity and turbinate hypertrophy. Prior studies have addressed outcomes after partial turbinectomy,10,11 but, again, validated outcomes instruments were not used. Septal surgery is also performed for other reasons besides nasal obstruction, such as access to nasal and sinus tumors, pituitary surgery, and as part of treatment for sleep apnea. In this study, those patients were excluded as we were considering only treatment of nasal obstruction. As a previous step for this prospective protocol, we developed and validated a disease-specific quality of life (QOL) instrument for use in nasal obstruction: the Nasal Obstruction Symptom Eval-

METHODS Study Design We performed a multicenter, prospective observational study. The study was designed and supervised by a steering committee.12 The study coordination center was the Duke Clinical Research Institute (DCRI), under contract with The Academy Foundation. Study coordination included data entry and maintenance, patient follow-up and data collection, and statistical analysis. Sites were enrolled voluntarily through an announcement on The Academy’s website. If the participating site was an academic center, they received institutional review board (IRB) approval from their own institution. IRB approval for community physicians was provided by Duke University through an Unaffiliated Investigator Agreement. All enrolled patients gave signed informed consent. The primary study hypothesis was the following: Surgical treatment of adult patients with nasal obstruction by performing a septoplasty with or without inferior turbinate reduction improves the disease-specific QOL measured at 3 months after the surgical procedure. The secondary hypotheses were that patients undergoing nasal septoplasty with or without turbinate reduction have sustained disease-specific QOL at 6 months after the procedure, show a high degree of satisfaction with the procedure, and use less nasal medication. Patient Sample Inclusion criteria were as follows: at least 18 years old, septal deviation consistent with presenting symptom of chronic nasal obstruction, symptoms lasting at least 3 months, and persistent symptoms after a 4-week trial of medical manage-

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ment, including either topical nasal steroids, topical or oral decongestants, or an oral antihistamine/decongestant combination. Exclusion criteria were the following: sinonasal malignancy; radiation therapy to the head and neck; septoplasty performed with concurrent sinus surgery, rhinoplasty, or sleep apnea surgery; septoplasty performed as access to other sites; prior septoplasty, rhinoplasty, or turbinoplasty; history or clinical evidence of chronic sinusitis (using the Academy Academy of Otolaryngology–Head and Neck Surgery Rhinosinusitis Task Force definition); septal perforation; craniofacial syndrome; acute nasal trauma or fracture in the past 3 months; nasal valve collapse; adenoid hypertrophy; sarcoidosis; Wegener’s granulomatosis; uncontrolled asthma; pregnancy; and illiteracy. The enrollment period was July 1, 2002, through January 31, 2003. Treatment Septoplasty was defined as an open surgical procedure on the nasal septum intended to straighten it, addressing all areas of deviation (ie, not merely removing a single spur for access), with reshaping, including scoring, morsellizing, crushing, etc, and/or removal of the deviated portion. Internal splints and packing were not mandatory. Turbinectomy was defined as a surgical procedure on the inferior nasal turbinate intended to decrease its size, including direct excision, elevation of mucosal flaps with removal of bone only, full-thickness cauterization, submucosal cauterization, radiofrequency or ultrasound treatment, etc. Patients underwent septoplasty with or without partial inferior turbinectomy according to the physician’s recommendation and the patient’s wishes; no treatment allocation, randomization, or other attempt to modify treatment was made. Physicians were blinded to the patient’s NOSE scores, both before and after treatment, and physicians did not collect follow-up data from their patients. Outcome Measures The primary outcome measure was disease-specific QOL at 3 months after surgery, as measured on the validated NOSE scale. Secondary outcomes included disease-specific QOL at 6 months postprocedure, medication use for nasal obstruction at

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3 and 6 months, and patient satisfaction. On follow-up questionnaires, patients also rated the change in the overall breathing through their nose on an 11-point Likert scale. Data Collection and Management If a patient met eligibility criteria and agreed to participate, they signed the consent form and completed a brief questionnaire with demographic and basic medical information. They also completed the NOSE scale. The treating physician completed a datasheet covering medical history as well as the physician’s assessment of the severity of septal deformity and the degree of turbinate hypertrophy. Questionnaires were mailed to the DCRI for data entry, and patients were contacted by the DCRI to complete the NOSE scale and a limited datasheet at 3 and 6 months after surgery. Patients were contacted by mail at least 3 times and called up to 5 times for follow-up. Data on clinical diagnosis were collected from patients who did not meet eligibility criteria. Analysis Nonparametric analysis (Wilcoxon signed rank test) was used to compare baseline and follow-up NOSE scores. Treatment groups (septoplasty alone versus septoplasty with turbinate procedure) were compared using the nonparametric Wilcoxon rank sum test. To assess predictors of improvement, linear regression was performed using forward entry of variables after confirming a normal distribution of the dependent variable. Univariate associations between variables were assessed using the nonparametric Spearman correlation coefficient. A P value less than 0.05 was considered statistically significant. RESULTS Overall, 14 practice locations representing a wide geographic spectrum across the United States participated in the study: Austin, TX; Cleveland, OH; Colorado Springs, CO; Durham, NC; Flowood, MS; Green Bay, WI; Houston, TX; Hyannis, MA; Las Vegas, NV; Louisville, KY; Memphis, TN; Milwaukee, WI; Rochester, NY; and Seattle, WA. Four sites were academic medical centers, and 10 represented private practices. One hundred fifty-eight patients were screened for

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enrollment; 62 met eligibility criteria, and 59 had surgery. The mean age was 44.7 years; 64.5% were male and 35.5% were female. Racial distribution was as follows: Caucasian, 86.9%; African American, 6.6%; Asian, 3.3%, with 1.6% each Native American and Asian. About 40% of patients came initially to an otolaryngologist for their problem, whereas 34.5% were referred from a family physician. A small number of referrals came from pulmonary physicians (7%), internal medicine physicians (7%), nurse practitioners (7%), and allergists (5%). Ninety-nine patients were excluded from the study; the most common reasons for exclusion from the study were concurrent sinus surgery (37), concurrent rhinoplasty (22), nasal valve collapse (9), and concurrent sleep apnea surgery (7). Follow-up rates were 81% at 3 months and 65% at 6 months. The NOSE scale was used to assess diseasespecific QOL and is scaled from 0 to 100, with higher scores meaning more severe nasal obstruction. Baseline NOSE scores, and those at 3 and 6 months after surgery, are shown in Table 1. There was a very significant improvement in NOSE score at 3 months after septoplasty. The comparison between 3-month and 6-month scores was not statistically significant, indicating stability of mean scores. At 3 and 6 months, although the patients undergoing septoplasty with turbinectomy appear to have a larger degree of improvement than patients undergoing septoplasty alone, the difference between groups was not statistically significant (Wilcoxon rank-sum, P ⫽ 0.27 at 3 months and P ⫽ 0.062 at 6 months). However, the number of patients undergoing septoplasty alone was small, and the possibility of a type II error exists for this comparison. We also assessed secondary outcomes. Patients reported very high levels of satisfaction with the results of surgery after 3 months. Only 6% of patients reported they were “not pleased” after surgery, and 63% rated their satisfaction as the 2 highest possible points on the 5-point scale (“very pleased” or “extremely pleased”). Patients also reported significant decreases in medication use at 3 months after surgery for oral decongestants (P ⫽ 0.02) and nasal steroids (P ⫽ 0.01); there was no significant change in use of

Table 1. Scores on the disease-specific quality-oflife instrument (NOSE scale) at baseline and at 3 months and 6 months after the date of surgery

Baseline 3 mo 6 mo

Septoplasty with turbinate reduction (n ⴝ 43)

Septoplasty alone (n ⴝ 16)

All subjects (n ⴝ 59)

66.6 (20.0) 20.3 (15.4)* 21.5 (21.3)*

69.7 (18.7) 31.2 (27.2)* 38.6 (25.9)*

67.5 (19.5) 23.1 (19.5)* 26.6 (23.8)*

*P ⬍ 0.0001 compared with baseline. Values are mean (SD); higher scores indicate worse nasal obstruction.

oral antihistamines or decongestant spray after surgery. There was no change in the frequency of epistaxis after surgery, although at baseline the prevalence of frequent epistaxis was low (7% of patients), and 83% of patients reported no epistaxis. We evaluated whether any clinical or demographic variables predicted a larger reduction in NOSE score (ie, greater reduction in symptoms). Multivariate analysis indicated that the only independent predictive variable for larger improvement was the pretreatment NOSE score (P ⬍ 0.001). Other potential predictive factors, including clinical variables (smoking, nasal allergy), demographic variables (age, gender, education level, etc), and treatment-related variables (turbinectomy), were not statistically significant. There was a positive regression coefficient for the baseline NOSE score, meaning that a higher baseline score (ie, worse nasal obstruction) indicated a higher predicted improvement in NOSE score. The distribution of physician-rated severity of the patient’s septal deformity at baseline was as follows: none (0%), mild (10%), moderate (68%), and severe (22%). Physician-rated severity of inferior turbinate hypertrophy was none (17%), moderate (60%), and severe (23%). Physicians apparently used their clinical assessment of turbinate hypertrophy to assist in the decision about performing partial turbinectomy; those data are summarized in Table 1. We also explored whether the physician-rated severity of septal deformity and turbinate hypertrophy was associated with either baseline disease-specific QOL or improve-

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Table 2. Physician-rated degree of inferior turbinate hypertrophy, compared with performance of partial turbinectomy Degree of inferior turbinate hypertrophy Procedure




Septoplasty with turbinectomy Septoplasty alone







ment in disease-specific QOL after septoplasty. Those correlations are shown in Table 2; there was no association between physician-rated severity and baseline score or change in score. We attempted to calculate the minimal clinically important difference in NOSE score; in other words, the score change associated with the smallest detectable clinical change to a patient. This level of minimal clinical importance is distinguished from statistical significance. For example, a statistically significant change in score can still be too small to be clinically important.13,14 There are 2 ways to calculate the minimal clinically important difference: based on an “anchor” or external benchmark of patient perception or based on a statistical distribution of scores. We collected data for an anchor-based calculation. However, very few patients reported a minimal change in breathing status (most reported a moderate to high level of improvement), leaving a very small sample for calculation. Nevertheless, the weighted mean of change scores representing a minimal detectable change was 19.4 points (based on a total score of 100). Using a distribution-based approach, the minimal clinically important change is usually defined as 0.2 to 0.3 times the standard deviation of the baseline distribution.13 For this study, that would be 3.9 to 5.9 points. Regardless of which approach is used, the differences observed in this study were clearly clinically important. Further study is probably needed to define the minimal important difference. DISCUSSION Studies on outcome after septoplasty are not new. Many authors have reported on this topic, and the results have been consistent: patients have

good outcomes after nasal septoplasty. However, many studies were retrospective.1,3,4,8 Some of those were chart reviews retrieving physicianrated outcomes, so patient-based outcomes were not assessed. Other used a telephone survey of patient satisfaction4 or a nonvalidated questionnaire.1 One retrospective study3 used the Glasgow Benefit Inventory, which is a validated patientbased instrument designed to assess the benefit of any otolaryngologic intervention, but it is not specific for nasal obstruction. Of the prospective studies on septoplasty,2,5-7,9,15,16 many used questionnaires not validated for nasal obstruction, physical examination findings, and/or objective measures such as rhinometry. Much about rhinometry is still experimental, and it deserves further investigation before it can used as an outcomes assessment. Physical examination findings are subjective and vulnerable to examination bias.17 Objective measures often do not correlate well with each other or with patient symptoms. Previously, there were no prospective studies on septoplasty using validated patient-based outcomes specific for nasal obstruction as the patients’ main problem. Prospective studies on patient satisfaction have reported high satisfaction levels after septoplasty.6,9,15,16 Prospective studies of patient-based outcomes using unvalidated instruments also identified improvements after septoplasty.5,7 One study of note used a validated sinusitis instrument, and found improved scores after septoplasty.2 That study also used a global QOL instrument but found no changes after septoplasty. Although there are several useful validated instruments for use in rhinosinusitis,14,18-21 all were validated for patients with rhinitis and/or sinusitis. Their content is focused on rhinorrhea, pressure, cough, and so on. Although nasal obstruction can be a symptom of rhinosinusitis and there is some content on each instrument that addresses obstruction, none are ideal for the study of nasal obstruction. A recent study indicated that 2 instruments trended toward a significant correlation with nasal obstruction but concluded that an instrument specific for nasal obstruction was needed.22 Now that a validated instrument is available to assess nasal obstruction, we have performed this prospective observational study.

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We found that patients with nasal obstruction and septal deformity who undergo nasal septoplasty have very significant improvement in nasal obstruction at 3 months, regardless of whether partial turbinectomy was indicated and performed. Furthermore, this result is sustained at 6 months after surgery. Overall, despite the relatively small sample size, the effect of septoplasty in improving nasal obstruction is very powerful. Based on a distribution-based assessment of clinical change after an intervention, a change of 0.8 times the standard deviation of the mean preintervention score is considered to be a large clinically important effect. The standard deviation of the baseline group was 19.5, and mean change scores at 3 and 6 months were 44.0 and 39.5, respectively; therefore the improvement was at least 2.0 times the standard deviation, which indicates a very large effect of treatment. We also identified a possible trend toward greater improvement in the subgroup of patients who had septoplasty and turbinectomy. However, this study was not designed to test that hypothesis definitively and thus had insufficient sample size and statistical power to detect a difference. These results provide pilot data for future study on this point. Assessment of secondary outcomes indicates that patient satisfaction was very high after surgery. In addition, patients used significantly fewer medications after septoplasty as well. Although no increase or decrease in epistaxis was noted in this study, the frequency of epistaxis was very low at presentation. Evaluation of predictive factors for success yielded a predictable result: patients with worse symptoms tended to have greater improvement after surgery. This is likely because they had more significant QOL impact from their disease, and therefore more “room” for improvement after treatment. This finding of more severely affected patients having greater improvement has been seen in other QOL studies. Interestingly, no demographic or clinical variables, such as the presence of nasal allergy, were predictive of outcome. Of course, the surgery would not correct many of those other factors—for example, a patient would still have nasal allergy after septoplasty— but it was conceivable that other factors might still have

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affected disease-specific QOL after surgery. This analysis also confirmed our finding that performing a partial turbinectomy did not predict a larger change in NOSE score. Physician-rated severity of septal deviation or turbinate hypertrophy did not correlate with the patient’s disease-specific QOL at presentation or with improvement after treatment. Although this finding may seem surprising, multiple outcomesbased studies have demonstrated poor correlation between QOL and physical or anatomic findings. This strongly supports the notion that self-reported outcomes such as QOL are a distinct construct from observer-rated assessments. Of course, as an entry criterion, all patients did have nasal septal deviation. So, although it is clear that clinicians are very accurate in assessing the anatomic factors present in the patient’s nose, there are other factors that contribute to the patient’s disease-specific QOL besides the visible anatomy. An important potential implication is that patients with significant symptomatic nasal obstruction but only mild or moderate anatomic deformity may actually benefit more from surgery than patients with severe deformities but mild symptoms. This may be a reason that findings from rhinometric evaluations have been difficult to interpret: perhaps they accurately predict anatomic findings but those are not well correlated with symptoms of obstruction. An increasingly important concept is the distinction between clinical and statistical significance. For example, in a trial comparing 2 blood pressure medications, a 2 mm Hg difference may be statistically significant with a sufficiently large sample of patients, but the clinical significance of such a difference is less clear. In other words, for an intervention to be valuable, it should have not only statistical but also clinical significance. This is especially the case with QOL studies, when the scale used to report the results is often unfamiliar to readers: What is a clinically impressive change in a QOL scale? In this study, we used both anchor-based and distribution-based methods to gain insight into the change in score that would define a minimal clinically important difference. We found that minimal important difference on the NOSE scale was very small relative to the observed changes after septoplasty. This confirms that the impact of septoplasty has a large clinical

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Table 3. Comparison of physician-rated severity of septal deformity and inferior turbinate hypertrophy at baseline with patient’s score on the NOSE scale at baseline and with the change in score on the NOSE scale after surgery Physician rating of

Septal deformity Turbinate hypertrophy

Baseline NOSE Change in score NOSE score

0.020 ⫺0.099

0.005 ⫺0.144

Values are Spearman correlation coefficients; none are statistically significant.

significance in addition to its statistical significance. Strengths of this study are its prospective design, use of a validated instrument, patient-based outcome assessment, use of physicians at multiple sites, and follow-up data being retrieved from a remote location. Because the physician was not personally retrieving the follow-up outcome data from the patient and the data were not being returned to the physician’s office, the possibility of bias introduction at that level was minimized. The study also had a good follow-up rate. A particularly powerful aspect of this study is its enrollment from multiple centers, in terms of both geography and practice type. Any potential selection biases from certain physicians having a tertiary-type practice and seeing only severely affected patients, or any regional differences in referral patterns, prevalence of local allergens, etc, are likely not a factor in this multicenter study. Similarly, despite different surgical skills and probably somewhat different surgical techniques, the overall improvement in nasal obstruction after septoplasty was great. A weakness of the study is the lack of a control group. However, there is no alternative treatment for a deviated nasal septum other than surgical correction, so clinical equipoise does not allow for randomization away from septoplasty to sham or placebo surgery or nonsurgical treatment. Even without randomization, a nonsurgical control group could still be considered. However, most patients desire to have their anatomic deviation corrected, and we were concerned about being unable to recruit patients into a nonsurgical comparison group. Of course, enrollment criteria re-

quired that medical therapy had failed for each patient; therefore all patients in the study had a trial of nonsurgical treatment before septoplasty. CONCLUSIONS In patients with septal deformity, nasal septoplasty results in significant improvement in disease-specific QOL, high patient satisfaction, and decreased medication use. Patients with higher degree of symptomatic nasal obstruction had larger improvements after surgery. We acknowledge the substantial contributions of Tanya Darrow and Jack Shostak at the Duke Clinical Research Institute. REFERENCES

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