Lippincott Williams & Wilkins, Inc.
© 2005 The American Laryngological,
Rhinological and Otological Society, Inc.
John S. Rhee, MD, MPH; David M. Poetker, MD; Timothy L. Smith, MD, MPH; Andres Bustillo, MD;
Mary Burzynski, RN; Richard E. Davis, MD
Objectives/Hypothesis: Disease-specific quality-oflife (QOL) assessment of patients with nasal valve compromise and symptomatic nasal obstruction has not been studied previously.
The objectives of the study were to determine whether surgical treatment of thenasal valve improves disease-specific QOL and to identify clinical or demographic variables predictive of patients’baseline QOL or change in QOL.
Study Design: Prospective, multi-institutional outcomes study of 20 patients with nasal obstruction and a surgically treatable diagnosis of nasal valve compromise.
Methods:Disease-specific QOL assessment was performed using the Nasal Obstruction Symptom Evaluation (NOSE) scale preoperatively (n = 20) and at 3 (n = 14) and 6months (n =20) after surgery. Clinical and demographic data were collected, along with physicianreported assessments of degree of nasal obstruction.
Results: MeanNOSEscores significantly improved from baseline to 3 months after surgery (68.9 vs. 20.7 [P <.0001]), from baseline to 6 months after surgery (68.9 vs.15.8 [P < .0001]), and from 3 to 6 months after surgery (20.7 vs. 15.8 [P<.0077]). Physician assessment of degree of nasal obstruction using a visual analogue scale was significantly correlated with baseline NOSE scores (P.013) and change inNOSEscores at 6 months (P=.0015). No other clinical or demographic factors were found to be predictive. Conclusion: In patients with symptomatic nasal obstruction and nasal valve compromise, surgical repair of the nasal valve improves disease-specific QOL.Physician rating of degree of nasal obstruction was found to be significantly correlated with patientreported QOL. Key Words: Quality of life, nasal obstruction, nasal valve, septorhinoplasty,rhinoplasty. Laryngoscope, 115:437–440, 2005
Presented at the Middle Section Meeting of the Triological Society, Inc., Chicago, IL, January 21–23, 2005.From the Department of Otolaryngology and Communication Sciences (J.S.R., D.M.P., T.L.S., M.B.), Medical College of Wisconsin, Milwaukee, Wisconsin, and the Department of Otolaryngology (R.E.D., A.B.), University of Miami School of Medicine, Miami, Florida, U.S.A. Editor’s Note: This Manuscript was accepted for publication
August 4, 2004.
Nasal airway obstruction is a common complaint in the otolaryngology and facial plastic practice. The causes of nasal obstruction are numerous, including septal deviation,turbinate hypertrophy, nasal polyposis, and adenoidal hypertrophy. More recently, nasal valve compromise, often associated with an external nasal deformity, has become increasingly recognized as another major reason for nasal airway obstruction.1–3.
Despite the prevalence of this problem and the numerous methods of treatment, the severity of nasal airway obstruction and the outcomes of therapy have been difficult to assess objectively. Until recently, no diseasespecific quality-of-life (QOL) instrument designed for nasal obstruction existed. The Nasal Obstruction Symptom Evaluation (NOSE) scale was recently developed and validated by Stewart et al.4 A follow-up study using the NOSE scale demonstrated that nasal septoplasty resulted in significant improvement in disease-specific QOL in patients with septal deformity.5 Patients with nasal valve collapse or compromise were not included in the study. The objectives of the present study were to determine whether surgical treatment of the nasal valve improves disease-specific QOL after surgery as measured by the NOSE scale and to identify clinical or demographic variables predictive of patients’ baseline QOL or change in QOL.
PATIENTS AND METHODS
Study Design and Patient Population
We performed a multicenter, prospective observational study. The study period, consisting of enrollment, treatment, and follow-up, spanned 1.5 years (from September 2002 to March 2004). Eligible participants consisted of patients who presented to the Medical College of Wisconsin (J.S.R.) (Milwaukee, WI) or to the University of Miami (R.E.D.) (Miami, FL) facial plastic clinic
for evaluation of nasal airway obstruction between September 2002 and November 2003. These clinics represent tertiary care referral centers for facial plastic and reconstructive surgery. All eligible patients were required to have a diagnosis of surgically treatable nasal valve compromise, either internal (mid vault) or external (ala, tip, vestibule) or both. Patients with concomitant septal deviation or turbinate hypertrophy, or both, were included. All patients were required to speak and read English and be able to participate in the initial evaluation. A trained research assistant explained the research study to the participating patients and obtained an Institutional Review Board–approved informed consent.
Data Collection and Outcome Measures
Data collected included demographic and clinical information. Demographic variables included age, gender, ethnicity, education level, and date of onset of nasal obstruction. Clinical variables included history of previous nasal surgery and type of surgery, other nasal diagnoses, and medical comorbid conditions.The NOSE score is scaled from 0 to 100 with higher scores correlating with more severe nasal airway obstruction.4 A trained research assistant administered the NOSE scale and accompanying questions. All patients received a complete head and neck physical examination performed by the surgeon (J.S.R. or R.E.D.) with emphasis on the anatomical and functional aspects of the nasal examination. Degree of septal deviation was assessed by the examiner and recorded, as were data on the presence or absence of nasal valve compromise and turbinate hypertrophy. The physician then completed a 10-cm visual analogue scale (VAS) to assess the overall severity of the patient’s nasal blockage. Physicians also completed a physician-rated severity scale, which was identical to that used in the study by Stewart et al.5 Physicians were asked to rate the septal deviation on the four-point severity scale as none, mild, moderate, or severe. Additional data were collected regarding medication use and overall satisfaction. Medication usage was recorded at all three time points. Patients were specifically asked which types of medications they were using to control nasal symptoms. In addition to the specific types of medication currently being used,relative amounts of medication compared with the use preoperatively were recorded at both 3- and 6-month postoperative surveys.Patient satisfaction with results of surgery was recorded at the 3- and 6-month intervals. Patients were asked to rate their happiness with the surgery based on a Leikert scale ranging from 1 (“not happy”) to 5 (“extremely happy”).
All patients underwent a functional septorhinoplasty to repair the nasal valve and associated deformities, if present. We use the term “functional septorhinoplasty” to refer to a group of surgeries designed to correct the underlying anatomical or functional problem associated with nasal valve compromise, either internal or external. These included but were not limited to procedures designed to correct the lower third of the nose (alar batten grafts, tip elevation and support, vestibular stenosis repair), middle third of the nose (spreader graft insertion, upper lateral cartilage suturing or suspension) or upper third of the nose (osteotomies). The septum and other internal abnormalities (hypertrophied turbinates, intranasal synechiae) were addressed during the nasal valve repair, if applicable.
A power analysis with the NOSE scale as the primary outcome measure was performed before the initiation of the study (two-tailed ß = 0.05, ß =0.10). Given the large effect size that was found in the study by Stewart et al.,5 only a small sample size (n = 7) was needed if the nasal valve compromised–patients were predicted to have a similar large benefit following surgery. However, because of the unknown clinical course for this patient cohort and to account for attrition, the sample size was arbitrarily set at 20 participants.
After reviewing the distribution of the scores, a paired t test was used to compare the preoperative and postoperative NOSE scores. The patients who did not complete the 3-month postoperative survey were excluded from the preoperative versus 3-month and the 3- versus 6-month analyses. To assess the patient and physician predictors of improvement, a univariate analysis was performed using stepwise regression. The Wilcoxon signed rank test was used to compare preoperative and postoperative medication usage. A P value of less than .05 was considered statistically significant.
Twenty-six patients agreed to participate in the study, and all of these individuals completed the initial evaluation and survey. The overall follow-up rate at 6 months was 77%. Twenty participants completed the 6-month survey, and of those 20, 14 completed the 3-month surveys as well. Six patients did not complete any of the subsequent surveys. Reasons included refusal to participate (n =2), lost to follow-up (n = 3), and incomplete survey completion (n = 1). The demographic information of the 20 patients completing the 6-month postoperative survey is presented in Table I. The most common preoperative diagnoses included nasal valve collapse,which was seen in all 20 patients; septal deviation, which was diagnosed in 14 patients, and turbinate hypertrophy, which was seen in 8 patients. Eleven of the 20 patients had undergone prior nasal surgeries (Table I).
Patient and Disease Characteristics
|Variable||No. (%)/Mean Value (range)|
|Septoplasty + other||3(15)|
|Septorhinoplasty + other||2(10)|
|No of comorbid medical conditions|
|Nasal valve compromise||20 (100)|
Surgeries performed included 19 patients undergoing rhinoplasty, which we define in the present study to include nasal tip work and osteotomies. Eighteen patients underwent septoplasty or septal cartilage harvesting, and 11 patients underwent the placement of spreader grafts with or without flaring sutures to address the mid vault. Eight patients had turbinate reductions, and two patients had alar batten grafting.
The mean preoperative NOSE score was 68.9 (range,20–90 [SD = 20.9]) (Table II). The mean 3-month postoperative NOSE score was 20.7 (range, 0–60 [SD = 19.5]). The mean 6-month postoperative NOSE score was 15.8(range, 0–65 [SD 8.2]). There was a statistically significant difference between the values obtained preoperatively and those obtained at both the 3-month and the 6-month postoperative surveys (P < .0001). In addition, there was a statistically significant difference between the 3-month and the 6-month postoperative NOSE scores (P=0077).
Of the 20 patients, 7 (35%) were using medications for symptomatic control of nasal congestion preoperatively.Those medications included antihistamines, decongestant tablets, decongestant sprays, steroid tablets, and steroid sprays. At the 3-month survey, 3 of the 15 respondents (20%) reported using medications for nasal congestion, and at the 6-month survey, 4 of 12 respondents (33%) reported the use of medications for symptomatic control.Medication use did not significantly change following surgery at 6 months compared with baseline (P = .25).
Eleven of the 15 respondents (73.3%) at the 3-month postoperative survey and 9 of the 12 (75%) at the 6-month postoperative survey reported that they were either “very happy” or “extremely happy” with the results of their surgery. None of the patients reported that they were “not happy” with the results of their surgery in either of the postoperative surveys.
The univariate analyses revealed no statistically significant difference in the preoperative versus postoperative NOSE scores regarding previous surgery or mucosal inflammatory process. There was a significant difference when considering patient gender, although the large discrepancy between female (n=17) and male participants (n= 3) weakened this statistical finding. On average, the female patients had higher preoperative NOSE scores, indicating worse QOL, and showed a more dramatic improvement postoperatively based on the NOSE scores at both the 3-month and the 6-month postoperative surveys (P= .036).
Nasal Obstruction Symptom Evaluation Scores at Baseline and at 3 and 6 Month After Surgery
|3 mo||6 months|
Data are given as mean (SD) with higher scores indicating worse quality of life or greater nasal obstruction. Baseline vs. 3 months, P <.0001; baseline vs. 6 months, P < .0001; 3 months vs. 6 months, P= 0.0077. NOSE = Nasal Obstruction Symptom Evaluation.
The physician-rated severity scale, assessing septal deviation, correlated poorly with baseline NOSE scores (correlation coefficient [r] = 0.194 [P = .426]) (Table III).It was also poorly correlated with improvement in NOSE scores following surgery (r=0.198 [P = .416]). However, the VAS, which takes into account all contributors to nasal airway obstruction, proved to be significantly correlated with both baseline NOSE scores (r = 0.546 [P 013]) and improvement in NOSE scores following surgery (r =-0.662 [P= .0015]) (Table III).
Nasal valve compromise as the cause for nasal airway obstruction has been well described in the literature. 1–3 Although several authors have sought to assess the degree of obstruction and the impact of medical and surgical interventions using objective measures of nasal airflow, resistance, and cross-sectional area, there have been no studies regarding the impact of this particular problem on patients’ QOL. Furthermore, until recently, investigators have had to rely on using general rhinological QOL measures or global QOL measures to study patients with symptoms of nasal obstruction.6,7 In response to the lack of a disease-specific QOL instrument for nasal obstruction, the NOSE scale was recently developed and validated.4 In a subsequent study, the NOSE scale was used by Stewart et al.5 to study outcomes after nasal septoplasty. The researchers showed that patients with nasal obstruction and septal deformity had significant improvements in their disease-specific QOL after undergoing septoplasty. We have demonstrated that patients with nasal obstruction and a diagnosis of nasal valve compromise have a significant improvement in their disease-specific QOL after undergoing nasal valve surgery. This improvement was seen at both 3 and 6 months postoperatively. We further have shown a significant improvement in nasal obstruction symptoms at 6 months when compared with 3 months postoperatively. This finding is not surprising because clinical experience of surgeons performing these types of procedures attest to surgical edema taking approximately 6 months to significantly resolve. The absolute NOSE scores and the magnitude of change in NOSE scores were similar to those obtained by Stewart et al.5 in their study with patients with septal deviation and symptomatic nasal obstruction. As predicted, despite the relatively small sample size, the effect
Comparison of Physician-Rated Severity of Nasal Obstruction With Baseline Nasal Obstruction Symptom Evaluation (NOSE)
Score and Change in NOSE Score After Surgery.
|Baseline NOSE Score||Change in NOSE Score|
|Severity scale (septal
|0.194 (P=.426)||-0.198 (P =.416)|
|Visual analogue scale
of nasal valve surgery was powerful. Although one needs to be careful in comparing findings across studies, it appears that correction of surgically treatable causes for nasal airway obstruction, whether it is septoplasty or nasal valve repair, can result in significant QOL improvement. The physician-rated severity scale, assessing only nasal septal deviation, was a poor predictor of both baseline NOSE scores and improvement in NOSE score following surgery, a finding consistent with the study by Stewart et al.5 however, what is unique is that the VAS, which asked the physician to subjectively assess all factors of nasal airway obstruction, was a good predictor of baseline NOSE scores and an even better predictor of improvement in NOSE scores after surgery. To our knowledge, this is the first physician-derived scale that adequately predicts whether or not a patient with nasal airway obstruction will benefit from surgery. This finding suggests that a physical examination finding consistent with nasal valve collapse, as noted by a knowledgeable specialist, is anexcellent measure of disease burden and predictor of surgical success. It remains to be seen whether or not other”objective” measures such as acoustic rhinometry or rhinomanometry will correlate with patients’ QOL. However, we were unable to demonstrate any other statistically significant predictive clinical or demographic factors for either severity of symptoms at baseline or degree of improvement in symptoms after surgery. This is probably attributable to the homogeneity of the patients enrolled in the study. We did demonstrate that the female patients in our cohort had significantly higher preoperative scores, indicating a worse QOL. However, the strength of this finding and its clinical relevance is weak because of the small number of men in our study. High patient satisfaction level after septoplasty has been reported previously in the literature.5,8 Similarly, we did demonstrate an overall high satisfaction rate with nasal valve surgery. More than 70% of the patients responding reported that they were either “very happy” or “extremely happy” with the results of the surgery. We had no patients report that they were “not happy” with the results. Medication use did not change significantly following surgery. Although the average number of medications used per patient decreased, too few patients responded to this question on the postoperative survey to detect any statistical differences. Arguably, surgery should not be predicted to change the underlying conditions that affect the mucosal lining of the nose (e.g., allergies, infection, nonallergic rhinitis). Therefore, medication usage, which is targeted for mucosal disease, may not be predicted to change with nasal valve surgery.
The strengths of the present study include the prospective and multi-institutional design, as well as the use of a validated, disease-specific QOL scale. The primary weakness of the present study is the lack of an internal control or comparison group. Although a weakness, it is one that is difficult to overcome in a disease process that does not have an acceptable nonsurgical alternative. The other potential weakness of the present study is the duration of follow-up. Although 6 months is, arguably, an adequate duration of postoperative follow-up, past studies have shown that shrinkage and redraping of the skin around cartilage is a long-term occurrence in the healing process and that some nasal tip complications or bossae only become apparent 2 years or more after surgery.9 However, the effects of this long-term wound healing and contracture on the nasal valve after corrective surgery are unknown and have not been previously reported in the literature. Further investigations are needed to investigate the long-term (>2y) effects of nasal valve surgery on patients’ QOL.
We have demonstrated that corrective nasal valve surgery results in significant improvement in diseasespecific QOL and high satisfaction level. A physicianrated VAS, taking into consideration all factors that influence nasal obstruction, correlates significantly with patient-reported QOL.
The authors thank Yinghua Zhang and Raymond Hoffmann, PhD, of the Division of Biostatistics, Medical
College of Wisconsin, for their assistance with the statistical analyses.
- Constantian MB, Clardy RB. The relative importance of septal and nasal valvular surgery in correcting airway obstruction in primary and secondary rhinoplasty. Plast Reconstr Surg 1996;98:38–54; discussion, 55–38.
- Constantian MB. The incompetent external nasal valve: pathophysiology and treatment in primary and secondary rhinoplasty. Plast Reconstr Surg 1994;93:919–931; discussion, 932–913.
- Sheen JH. Spreader graft: a method of reconstructing the roof of the middle nasal vault following rhinoplasty. Plast Reconstr Surg 1984;73:230–239.
- Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the nasal obstruction symptom evaluation (nose) scale. Otolaryngol Head Neck Surg 2004;130:157–163.
- Stewart MG, Smith TL, Weaver EM, et al. Outcomes after nasal septoplasty: results from the nasal obstruction septoplasty effectiveness (nose) study. Otolaryngol Head NeckSurg 2004;130:283–290.
- Siegel NS, Gliklich RE, Taghizadeh F, Chang Y. Outcomes of septoplasty. Otolaryngol Head Neck Surg 2000;122: 228–232.
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- Gillman GS, Simons RL, Lee DJ. Nasal tip bossae in rhinoplasty: etiology, predisposing factors, and management techniques. Arch Facial Plast Surg 1999;1:83–89.