Keywords
nasal obstruction - quality of life - septoplasty
Introduction
Nasal congestion, also called stuffy nose, is a common complaint in otolaryngologist's
practice. This problem affects between 9.5 and 15% of the general population.[1] In the adult population, it is often a symptom of another health problem, as the
main causes for nasal blockage are chronic diseases, such as chronic rhinosinusitis
and allergic rhinitis. In Europe, chronic rhinosinusitis has a prevalence of 10.9%,[2] and allergic rhinitis has a prevalence of between 17 and 29%.[3] The aforementioned diseases cause mucosal congestion, which results in nasal obstruction
with decreased nasal airflow. The third main cause for nasal blockage is nasal septal
deviation, where abnormalities of the bony and cartilaginous structures of the nose
can lead to difficulties in breathing caused by reduced nasal airflow. Deviation of
the nasal septum has a prevalence of between 19 and 65% depending on the criterion
for defining a deviated septum.[4]
Not all patients with a deviated septum need surgery to relieve symptoms. In the ear
nose and throat (ENT) specialty, nasal septoplasty is the third most common surgery
performed.[5] Several studies have evaluated the outcome of septoplasty, but most of them are
retrospective,[6] conducted on a small group of patients,[6] include different surgical techniques,[5]
[7]
[8] or are associated with other surgical treatments,[9]
[10]
[11]
[12] which may interfere with their interpretation. There is a poor correlation between
objective measurements and subjective nasal potency symptoms:[13] several studies in which objective measures were used showed no correlation with
patient satisfaction after septoplasty.[14]
[15] Other studies did not use validated instruments to assess surgical outcomes.[5]
[16]
Over the last decades, disease-specific instruments that measure nasal obstruction
and health-related quality of life have been developed and validated to assess the
outcomes of nose surgery. These tools are reliable, reproducible, valid, and sensitive
to change.[9]
[17]
[18] We carried the translation and cultural adaptation in Polish of the NOSE questionnaire
and confirmed that the Polish version has the same psychometric properties as the
original tool.[19]
The primary goal of the present study is to compare the severity of symptoms and the
quality of life related to nasal obstruction before septoplasty, 3 months later and,
finally, 7 months after surgery. A secondary goal was the assessment of the effectiveness
of septoplasty in patients with nasal obstruction.
Method
Measures
The participants were asked to complete the Nasal Obstruction Symptom Evaluation (NOSE-POL),
the Visual Analogue Scale (VAS), and the Clinical Global Impression Scale (CGI-S).
The NOSE scale is a questionnaire specific to nasal obstruction. It was developed
by Stewart et al. in 2004,[17] and since then has been translated into many languages, adapted, and validated[12]
[13]
[14]
[15]
[16]
[17]. We chose this questionnaire because it is brief, easy for the patient to complete,
and specific to nasal obstruction. Furthermore, it can be also applied after septoplasty,[20] functional rhinoplasty,[9] or turbinoplasty.[10] Patients from our study group completed the NOSE 3 times: once prior to surgery
(2 weeks before) and then 3 months and 7 months postoperatively.
The visual analogue scale (VAS) was also used. The participants were asked to mark
on a horizontal line how difficult it was to breathe through the nose. There was a
line 100 mm long and 3 verbal descriptors (or word anchors): 'none' (on the left);
'medium' (in the center); and 'severe' (on the right). The mark made by the participants
was converted into a number from 0 to 10. The higher the number, the more troublesome
was breathing through the nose.
The Clinical Global Impression Scale (CGI-S) is a brief tool used to assess change
in a subject's condition.[21] In our study, the patients were asked to evaluate the change in their nasal obstruction
and the change in their quality of life 7 months after septoplasty in comparison with
the state before the surgery. The evaluation was done by means of a 7-point scale
with the following degrees: 1, very much worse; 2, much worse; 3, minimally worse;
4, no change; 5, minimally improved; 6, much improved; and 7, very much improved.
Separately, the patients assessed the change in their nasal obstruction and the change
in their quality of life, selecting one answer for each.
Subjects
This was a single institution prospective observational study. The study protocol,
informed consent form, and patient information brochure were approved by the Institutional
Ethics Committee and accorded with the World Medical Association Declaration of Helsinki.
Each patient gave informed written consent for participating in the study.
Initially, the study group consisted of 51 patients. The inclusion criteria were:
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 management (including topical nasal steroids, topical or
oral decongestants, or an oral antihistamine/decongestant combination). The exclusion
criteria were: sinonasal malignancy; radiation therapy to the head or neck; previous
surgery (septoplasty, sinus surgery, rhinoplasty, or turbinoplasty); history or clinical
evidence of chronic sinusitis (using the criteria from the European Position Paper
on Rhinosinusitis and Nasal Polyps 2012)[22]; adenoid hypertrophy; sleep apnea syndrome; septal perforation; craniofacial syndrome;
acute nasal trauma or fracture in the past 3 months; nasal valve collapse; sarcoidosis;
Wegener granulomatosis; uncontrolled asthma; pregnancy; or illiteracy.
The patients completed the NOSE-POL 2 weeks before the septoplasty and 3 months later,
after surgery, when all patients returned to the outpatient clinic (reporting symptoms
at this follow-up should minimize reporting errors). Seven months after the surgery,
questionnaires were sent by post to all the patients. The follow-up rate was 53% –
only 27 subjects sent back completed questionnaires. There were 6 women and 21 men
aged from 20 to 62 years old (median [M] = 34.67; standard deviation [SD] = 11.95).
Statistical Analysis
Repeated measures analysis of variance (rANOVA) was conducted to compare baseline
and 3-month and 7-month follow-up NOSE-POL scores. Bonferrroni correction was applied
for multiple comparisons.
Additionally, pretreatment to post-treatment change in the NOSE-POL and VAS scores
was assessed in two other ways. First, with the mean difference between baseline and
postoperative results (i.e., the follow-up postoperative score was subtracted from
the preoperative score: a positive result indicated improvement (reduction of nasal
obstruction symptoms); a negative result indicated deterioration (enhancement of nasal
obstruction symptoms). Second, the pretreatment to post-treatment change in the NOSE-POL
and VAS scores was assessed as the standardized mean difference and taken as a measure
of Cohen effect size[23]: 0.2 was considered a small effect, 0.5, a moderate effect, and 0.8 a large effect.
Correlations between change in the NOSE-POL and change in the VAS and changes in nasal
obstruction and quality of life were calculated using rho-Spearman correlation. The
hypothesis was that the correlations would be positive and at least moderate. The
strength of correlation was evaluated according to criteria provided by the British
Medical Journal guidelines:[24] more than 0.8, a very strong correlation; 0.6–0.79, strong; 0.4–0.59, moderate;
0.2–0.39, weak; and below 0.2, very weak.
A p-value < 0.05 was considered statistically significant. Statistical analysis was conducted
using IBM SPSS Statistics for Windows, version 24 (IBM Corp., Armonk, NY).
Results
Pretreatment and Post-treatment Results
Baseline NOSE-POL scores (2 weeks before septoplasty) and the results obtained after
septoplasty (3 and 7 months postoperatively) are shown in [Table 1].
Table 1
Scores of the NOSE-POL 2 weeks before septoplasty and 3 months and 7 months after
septoplasty
|
Min
|
Max
|
Me
|
M
|
SD
|
|
Baseline
|
15
|
95
|
65
|
60.37
|
20.38
|
|
3 months postoperatively
|
0
|
60
|
35
|
32.96
|
16.77
|
|
7 months postoperatively
|
0
|
100
|
30
|
39.63
|
33.22
|
Abbreviations: M, mean; Max, maximum; Me, median; Min, minimum; SD, standard deviation.
The results of repeated measures ANOVA showed that the NOSE-POL scores were significantly
different: F = 12.62; p< 0.001; e
2 = 0.33. Post-hoc tests revealed that there was a significant improvement in nasal
obstruction 3 months (p < 0.001) and 7 months (p < 0.05) after septoplasty compared with baseline. A comparison between the 3-month
and 7-month scores was not statistically significant (p > 0.05), indicating stability of nasal obstruction symptoms. The mean change in the
NOSE-POL scores 3 months after septoplasty was 27.41; SD = 16.01 (95% confidence interval
[CI]: 21.1–33.7) and 7 months after septoplasty it was 20.74; SD = 37.56 (95%CI: 5.9–35.6).
The effect size 3 months after the surgery was 1.71 and after 7 months it was 0.55.
The VAS score before septoplasty was M = 6.33 (SD = 2.28). A statistically significant
improvement in nasal obstruction symptoms was revealed 3 months after septoplasty
(M = 2.39; SD = 1.31; p < 0.001), as well as 7 months after surgery (M = 3.84; SD = 3.38; p< 0.01).
The mean change in the VAS score 3 months after septoplasty was 3.94; SD = 2.12 (95%CI:
3.1–4.8) and 7 months after septoplasty it was 2.50; SD = 3.54 (95%CI: 5.9–35.6).
The effect size 3 months after surgery was 1.86, and 7 months after the surgery it
was 0.71.
Change in the NOSE-POL and Change in Other Measures
The data in [Table 2] show how the patients assessed the perceived change in their nasal obstruction and
the change in their quality of life 7 months after septoplasty.
Table 2
Subjectively perceived change in nasal obstruction and quality of life 7 months after
septoplasty
|
Subjective change in nasal obstruction
|
Subjective change in quality of life
|
|
Very much worse
|
0
|
1 (4%)
|
|
Much worse
|
3 (12%)
|
1 (4%)
|
|
Minimally worse
|
0
|
1 (4%)
|
|
No change
|
4 (16%)
|
5 (20%)
|
|
Minimally improved
|
3 (12%)
|
4 (16%)
|
|
Much improved
|
12 (48%)
|
10 (40%)
|
|
Very much improved
|
3 (12%)
|
3 (12%)
|
Twenty-five patients answered the questions concerning change in nasal obstruction
and quality of life, and 72% of them reported improvement in their nasal obstruction
7 months after septoplasty. No change in nasal obstruction was reported by 16% of
the patients and deterioration was reported by 12%.
Some 68% of the patients declared that their quality of life had improved 7 months
after the septoplasty, 20% reported no change, and 12% declared that their quality
of life had decreased in comparison with the pretreatment period.
For each of the aforementioned mentioned category of patients, the mean change in
the NOSE-POLE scores was calculated and is presented in [Fig. 1].
Fig. 1 Mean change in the NOSE-POL score due to change in nasal obstruction and due to change
in quality of life 7 months after septoplasty.
It can be seen that the mean change in NOSE-POL scores exhibit an orderly progression
from very much or much worse through no change to much or very much improved. The
highest change in the NOSE-POL (average 75 points) was in those patients who were
the most satisfied with their nasal obstruction according to the CGI-S. Similarly,
the patients who reported very much improvement in their quality of life demonstrated
a considerable reduction of complaints in the NOSE-POL. Also, the patients who answered
in the CGI-S that their nasal obstruction had worsened had a negative change in the
NOSE-POL, indicating deterioration of nasal obstruction symptoms. Thus, the change
in the NOSE-POL is consistent with the changes assessed subjectively by other measures,
and this is confirmed by the following correlations.
The correlations between change in the NOSE-POL scores and changes assessed with other
measures were statistically significant. They were: rho = 0.86; p< 0.001 (change in VAS scores), rho = 0.77; p < 0.001 (change in nasal obstruction, rho = 0.61; p < 0.05 (change in quality of life). All correlations were positive, meaning that the
higher the change in NOSE-POL score, the higher the change in the scores of other
measures.
Discussion
Patient-reported outcome measures are widely used among surgical specialties to estimate
the impact of interventions on patients' health-related quality of life. There is
a wide variety of elective operative procedures in otolaryngology, all of which aim
to improve quality of life. As septal deviation has a prevalence of up to 65%, we
as doctors should use questionnaires to choose those patients with the greatest likelihood
of improvement after septoplasty.
The present research showed a statistically and clinically significant enhancement
in quality of life and nasal obstruction scores after septal surgery. The NOSE baseline
scores for our patient population (67.5 ± 19.5) was similar to the study by Stewart
et al.[9] (60.37 ± 20.38). The NOSE scores after surgery[9] were also similar (26.6 ± 23.8 versus 39.63 ± 33.22). We have demonstrated that
NOSE scores are dependable on the results from other measures, therefore this self-report
questionnaire can be used to assess the effectiveness of septoplasty..
There are controversies in the literature regarding potentially positive results of
septoplasty with turbinoplasty versus septoplasty alone. Both Stewart[9] and Uppal[11] found no statistically significant difference between either group. Nielsen et al.[25] compared three groups of patients: septoplasty, radiofrequency therapy of the inferior
turbinate (RFIT), and both procedures. They concluded that patients who underwent
RFIT with septoplasty complained less about postoperative nasal congestion than patients
who went through RFIT only. We have not performed RFIT on our patients, just septoplasty.
In a systematic review of patient-reported nasal obstruction scores of the PubMed
database,[20] normal and anomalous values of NOSE and VAS scores were settled for clinical use.
This approach could be helpful in categorizing the severity of nasal obstruction,
guiding treatment, educating patients, and measuring surgical outcomes.
Bugten et al.[26] revealed that nasal blockage may augment symptoms such as snoring, oral breathing,
and nasal discharge, which may therefore weaken the general health of the patient.
Surgery leads to a highly significant symptom improvement.
Furthermore, nasal septoplasty is often performed in some patients who have coexisting
diseases such as chronic rhinosinusitis, obstructive sleep apnea, asthma, or allergy.
These are all conditions that may be affected by nasal blockage. Patients who suffer
with allergy might not achieve as good postoperative outcomes as nonallergic patients
after surgery. This group should benefit from additional preoperative diagnostic procedures,
such as computed tomography (CT) of the nose and sinuses, to improve preoperative
planning. Nevertheless, it is strongly recommended that allergic patients also receive
medical treatment postoperatively to optimize the results after surgery.[26]
It was shown in the study by Thorstensen[27] that asthmatic patients have more symptoms of nasal blockage than nonasthmatic patients,
and that they need an open nose to optimize airflow to the lower airways. A blocked
nose, with consequent lack of humid, warm, and clean inspired air, may harm the lungs
and lead to worsening of asthma, so treatment of nasal blockage in asthmatics is particularly
important.[28]
Many patients with chronic rhinosinusitis do have a deviated nasal septum, but we
excluded this group of patients from our study. The reason was so we could focus solely
on nasal obstruction and its impact on quality of life.
The present study has limitations. We have not randomized the patients to other treatment
options for comparison. The major strength of the present study is that it is prospective
and from one otolaryngology hospital with > 100 beds. All patients selected for surgery
were asked to participate. From the findings of the present study, we encourage other
specialists to use the NOSE questionnaire: it can successfully guide treatment and
can act as a clinically meaningful measure of surgical outcome.
Conclusions
Nasal septal surgery leads to a highly significant improvement in disease-specific
quality of life. Our patients reported a positive change in nasal obstruction and
quality of life after septoplasty.
