A prospective longitudinal study of clinical outcome and quality of life assessment in patients with chronic rhinosinusitis after functional endoscopic sinus surgery using sino nasal outcome test-22

Abstract

Chronic rhinosinusitis (CRS) significantly affect the quality of life (QoL) of patients. The study was conducted in CRS patients who were treated with functional endoscopic sinus surgery (FESS) after failure of medical treatment to analyze clinical outcome using prospectively collected data through a symptom-based rhinosinusitis outcome measure, the Sino-nasal Outcome Test-22 (SNOT-22). The aim of the study was to evaluate and compare the QoL in patients of chronic rhinosinusitis pre-operative and after FESS by SNOT-22. The prospective study was conducted on 40 patients of chronic rhinosinusitis with or without nasal polyposis. Demographic, clinical, diagnostic nasal endoscopy and radiological findings were recorded. Visual analogue scoring and SNOT-22 questionnaire scoring were done preoperatively and at 3rd and 6th months post-operatively. These scores were compared and a value of p < 0.01 was considered statistical significant. Nasal obstruction (80%) was the most commonly reported disabling condition followed by rhinorrhea (75%), facial pain-pressure (72.5%), headache and sneezing. The mean preoperative nasal endoscopy score was 8.08 ± 3.65. The mean preoperative Lund Mackay CT scan score was 11.725 ± 3.64. The mean preoperative SNOT-22 score was 46.25 ± 20.44. After FESS, nasal discharge was improved in 86% patients. Average VAS scores showed significant postoperative improvement at 6 months (p < 0.01). The mean postoperative diagnostic nasal endoscopy score improved to 2.80 ± 1.64 at 6 months (p < 0.01). The mean postoperative SNOT-22 scores decreased at postoperative follow up visits at 3 and 6 months to 14.58 ± 4.90 at 3 months and 22.38 ±7.93 at 6 months (p < 0.01). CRS patient refractory to medical treatment showed statistical significant improvement after FESS. The SNOT-22 scoring was easy to use scoring used for QoL assessment showed significant improvement after FESS.

Introduction

Chronic rhinosinusitis (CRS) is defined as a group of disorders characterized by inflammation of nasal and paranasal sinuses mucosa for at least 12 consecutive weeks duration, either accompanied by nasal polyps or without nasal polyps [1]. The presenting features consist of two or more symptoms one of which should be nasal blockage, nasal obstruction, nasal congestion or nasal discharge (anterior/posterior nasal drip) with or without facial pain/pressure with or without reduction or loss of smell for more than 12 weeks [2]. Rhinosinusitis is a significant health problem which seems to mirror the increasing frequency of allergic rhinitis and which results in a large financial burden on society.

CRS is essentially a medical disease, however in conditions not responding to medical treatment, surgical intervention may be required. Nasal polyposis and asthma were two of the most important factors that have been associated with the refractory nature of CRS. Functional endoscopic sinus surgery (FESS) is conducted to minimally remove the inflamed mucosa and restore the ciliary transport mechanism and mucous clearance pathway [3, 4].

CRS may lead to significant limitations in physical, emotional and social aspects of life of the affected patients [5, 6]. For CRS, objective measures fail to capture the full burden of disease experienced by the individual patient. The discordance between radiographic findings and patients’ symptoms in CRS highlights this dilemma. Numerous studies have shown that the degree of sino-nasal inflammation as measured by CT scan or nasal endoscopy fails to correlate with the extent of symptoms experienced by the individual patient as patients may have debilitating symptoms with only minimal mucosal thickening or vice versa [7].

Recently, the use of patient-reported outcome measures is rapidly growing in studies of clinical effectiveness, and CRS has been shown to have significant impact on quality of life (QoL). A number of rhinologic-specific instruments have been developed to measure QoL in patients with rhinologic conditions, including the Chronic Sinusitis Survey (CSS), Rhinosinusitis Disability Index (RSDI), Rhinitis Quality of Life Questionnaire, and most recently the 22-item Sinonasal Outcomes Test (SNOT-22). These instruments provide a validated means to objectively quantify a patient’s perception of their disease burden both before and after intervention [7].

SNOT-22 is a validated patient-reported measure of symptom severity and health related QoL in sino-nasal conditions [5]. The reliability, validity, responsiveness, and ease of use of SNOT-22 scores have been well tested and reported in previous studies. The measures of QoL have evolved, to know the impact of any disease on the general health and well being of patient [4]. The aim of the study is to evaluate clinical outcomes and QoL in patients with CRS after FESS.

Material and method

The study was conducted on the patients of CRS with or without nasal polyposis admitted in the Department of Otorhinolaryngology, JLN Medical College & Hospital, Ajmer from January 2017 to April 2018. The ethical approval for the study was as granted by the ethical committee of JLN Medical College, Ajmer by permission letter number 268/Acad-III/MCA. All procedures performed in the study were in accordance with the ethical standards of the Ethical committee of the institute.

Inclusion criteria

• Chronic rhinosinusitis diagnosed according to European position paper on rhinosinusitis and nasal polyps (EPOS) 2012 [2].

• Characteristic changes in pre-operative computed tomography of paranasal sinuses assessed according to EPOS 2012 [2].

• Chronic rhinosinusitis patients with bilateral nasal polyps who had not improved after medical treatment.

• Chronic rhinosinusitis patients without nasal polyps who had not improved after medical treatment.

Patients under 18 years, pregnant females, immunodeficient patients, patients with secondary CRS and patients who underwent revision endoscopic sinus surgery during the study for other complications were excluded from the study.

Medical treatment is the first therapy for chronic rhinosinusitis introduced for at least for 3 months. This is based on oral steroid (tab. Prednisolone) for 7 days and topical nasal steroid (Fluticasone furoate 27.5 mcg) on each nostril every 12 h [2]. Voluntary, informed consent was obtained from all study participants at the initial enrollment meeting. Forty-seven patients fulfilled the inclusion criteria for study, but seven patients were not enrolled in the study since they fell in the exclusion criteria of the study. All the 40 patients included in the study completed 6 months follow-up.

The symptom intensity was presented using Visual Analogue Scale (VAS) score. Rigid sino-nasal endoscopy was performed and graded according to the Lund-Kennedy system (score range 0–20). Non contrast CT scan nose and PNS were conducted. Preoperative CT scans of the sinuses were classified using the Lund–Mackay scoring system [8]. FESS was then scheduled and performed in accordance with established functional principles. All study patients completed postoperative follow-up at two time points after surgery at three and 6 months. FESS was performed under general anaesthesia and the extent of surgery included at least a bilateral uncinectomy, middle meatal antrostomy with anterior ethmoidectomy. Eight patients underwent additional sphenoidotomy and four patients underwent additional frontal sinusotomy. Three patients underwent additional posterior ethmoidectomy and septoplasty. Fourteen patients underwent septoplasty along with FESS. Merocel nasal packing was done. The nasal packing was removed on 5th post-operative day. The intra-operative and post-operative period was uneventful and no major intra-operative and postoperative complications were seen. Minor complications, includes minor intra-operative bleeding, postoperative pain, and nasal discharge. All patients received amoxicillin and clavulanic acid (1 g/125 mg) twice a day for 10 days and topical nasal steroid on each nostril every 12 h, saline irrigation and endoscopic cleaning/dressing were performed for 6 weeks for crusting and mild scarring. Synechia formation was present in 13.33% of the patients which were released during the post operative follow up (6 months). However there were no permanent sequelae encountered. Patients were motivated at every visit for regular follow up and were also followed up telephonically. All 40 patients completed 6 months follow-up.

The objective findings presented on endoscopic examination and computerised tomography scores were calculated. QoL was assessed by SNOT-22 questionnaire. The intensity of each symptom, SNOT-22, and endoscopic scores were analyzed pre operatively, 3rd months and 6th months after surgery. The data was compiled in Microsoft Excel spreadsheet and analysed by Graph Pad and OpenEpi statistical software [9].

Observations

A total of 40 patients were enrolled for the study (Table 1) There were 24 (60%) males and 16 (40%) females. Maximum number of patients in the study was in the age group of 18–30 years having 14 (35%) patients. Mean age was 40.475 years. 80% patients presented with the complaint of nasal blockage, 75% rhinorrhea, followed by 72.5% with headache and/or facial pain, 70% with sneezing, and 37.5% with hyposmia. The duration of symptoms varied from 6 to 36 months.

Table 1.

Socio-demographic characteristics and clinical findings of study population

Gender	n (%)
Male	24 (60%)
Female	16 (40%)

Age group	n (%)
18–30 years	14 (35%)
31–40 years	8 (20%)
41-50 years	9 (22.5%)
> 50 years	9 (22.5%)

Clinical presentation	n = 40	Duration
		Mean (months)	Range (months)
Clinical findings
Nasal blockage	32	12	6–24
Rhinorrhea	30	15	7–24
Headache	29	15	6–18
Sneezing	28	28	6–36
Facial pain	29	10	6–12
Hyposmia	15	12	1–24

CRS characteristics
Nasal polyps	25 (62.5%)
Endoscopy score, mean ± SD	8.08 ± 3.65
SNOT-22 score, mean ± SD	46.25 ± 20.44
CT scan Lund Mackay score, mean ± SD	11.725 ± 3.64

Scores were given for each symptom of SNOT-22 questionnaire from 0 to 5 depending upon the severity. Mean preoperative total SNOT-22 score was 46.25 ± 20.44. Maximum SNOT-22 scores were given to nasal blockage (4.20 ± 1.40), runny nose (3.68 ± 1.79) and facial pain/pressure (3.43 ± 1.55). The mean total eosinophilic count was 431 ± 172.59 per cubic mm, and mean serum IgE was 149.33 ± 155.82.

Most of the patients (n = 33) reported their symptoms as annoying or uncomfortable on visual analogue scale, while remaining (n = 7) as dreadful. Out of 40 patients, 25 patients had nasal polyps. Most of the patients (n = 36) had discharge in their nasal cavities. Sixteen patients had deviated nasal septum. The pre-operative mean total score on diagnostic nasal endoscopy was 8.08 ± 3.65. On NCCT nose and paranasal sinus, five patients had inferior turbinate hypertrophy and six had concha bullosa. Out of 40 patients, osteomeatal complex of 34 patients was blocked. The mean CT scan Lund Mackay scoring was 11.725 ± 3.64. Average VAS scores for nasal obstruction, nasal discharge, sneezing and facial pain/pressure showed significant and sustainable postoperative improvement at 6 months after surgery (p < 0.001), as shown in Table 2.

Table 2.

Preoperative and postoperative mean total VAS score

Parameters	Baseline (mean ± SD)	At 6 months (mean ± SD)	p value
Nasal obstruction	6.80 ± 0.55	1.13 ± 0.41	< 0.001
Nasal discharge	3.87 ± 0.11	2.13 ± 0.43	< 0.001
Sneezing	3.17 ± 2.04	1.07 ± 0.37	< 0.001
Facial pain/pressure	4.20 ± 0.41	2.10 ± 0.31	< 0.001

Four patients showed nasal polyps at follow-up done at 6 months postoperatively. The post operative mean total score on diagnostic nasal endoscopy after 3 months was 2.88 ± 1.7 and after 6 months was 2.80 ± 1.64 (p < 0.0001) as shown in Table 3. The endoscopy scores are depicted in Fig. 1.

Table 3.

Pre-operative and post-operative mean diagnostic nasal endoscopy

Parameters	Pre-operative (mean ± SD)	At 6 months (mean ± SD)	p value
Polyp	3.35 ± 2.44	0.10 ± 0.30	< 0.0001
Discharge	3.33 ± 1.05	0.20 ± 0.41	< 0.0001
Scarring	0.85 ± 0.77	0.75 ± 0.93	< 0.0001
Crusting	0.55 ± 0.75	1.75 ± 0.54	< 0.0001

Fig. 1.

Bar diagram showing pre-operative and post-operative Diagnostic Nasal Endoscopy scores of patients of CRS pre-operatively and 3rd and 6th month post-operatively

Mean postoperative total SNOT-22 score after 3 months was 14.5 ± 4.90, and after 6 months was 22.38 ± 7.93 (p < 0.0001). The distribution of self-reported CRS symptom control is shown in Table 4 and Fig. 2. Pre and post-operative SNOT-22 score of each patients is drawn in a scattered diagram showed significant improvement in most of the patients (Fig. 3).

Table 4.

Post-operative mean SNOT-22 symptoms score of patients with CRS

S. no.	SNOT-22 parameters	Pre-operative (mean ± S.D.)	At 3 months (mean ± S.D.)	p value	At 6 months (mean ± S.D.)	p value
1	Need to blow nose	3.08 ± 1.82	0.00 ± 0.00	< 0.0001	0.00 ± 0.00	< 0.0001
2	Nasal Blockage	4.20 ± 1.40	2.65 ± 0.86	< 0.0001	2.93 ± 0.80	< 0.0001
3	Sneezing	2.38 ± 1.46	1.38 ± 0.84	0.0003	1.83 ± 0.75	0.0372
4	Runny nose	3.68 ± 1.79	0.15 ± 0.66	< 0.0001	0.00 ± 0.00	< 0.0001
5	Cough	1.30 ± 1.34	1.23 ± 1.03	0.7802	1.30 ± 1.07	1.0000
6	Post nasal discharge	2.38 ± 2.17	1.23 ± 1.10	0.0037	1.75 ± 1.46	0.1317
7	Thick nasal discharge	2.15 ± 1.85	0.00 ± 0.00	< 0.0001	0.00 ± 0.00	< 0.0001
8	Ear fullness	1.05 ± 1.15	0.00 ± 0.00	< 0.0001	0.00 ± 0.00	< 0.0001
9	Dizziness	1.68 ± 1.62	0.80 ± 0.88	0.0037	1.10 ± 1.03	0.0625
10	Ear pain	0.63 ± 1.08	0.00 ± 0.00	0.0005	0.00 ± 0.00	0.0004
11	Facial pain/pressure	3.43 ± 1.55	2.58 ± 1.48	0.0141	2.93 ± 1.35	0.1280
12	Decreased sense of Smell/Taste	1.78 ± 1.73	1.28 ± 1.41	0.1625	1.80 ± 1.51	0.9444
13	Difficulty falling asleep	2.78 ± 1.79	0.48 ± 0.75	< 0.0001	1.45 ± 0.93	< 0.0001
14	Wake up at night	2.88 ± 1.73	0.45 ± 0.85	< 0.0001	1.43 ± 0.84	< 0.0001
15	Lack of a good night sleep	2.63 ± 1.97	1.00 ± 0.82	< 0.0001	1.45 ± 0.90	0.0010
16	Wake up tired	1.90 ± 1.79	0.40 ± 0.55	< 0.0001	1.23 ± 0.95	0.0399
17	Fatigue	3.25 ± 6.86	0.65 ± 0.58	0.0193	1.40 ± 1.06	0.0950
18	Reduced productivity	1.50 ± 1.62	0.10 ± 0.30	< 0.0001	0.68 ± 0.66	0.0040
19	Reduced concentration	1.55 ± 1.57	0.18 ± 0.45	< 0.0001	0.73 ± 0.68	0.0033
20	Frustrated/restless/irritable	1.25 ± 1.53	0.05 ± 0.22	< 0.0001	0.40 ± 0.59	0.0016
21	Sad	0.60 ± 1.17	0.00 ± 0.00	0.0018	0.00 ± 0.00	0.0018
22	Embarrassed	0.23 ± 0.80	0.00 ± 0.00	0.0790	0.00 ± 0.00	0.079

Fig. 2.

Bar diagram showing Preoperative and Postoperative SNOT-22 symptom scoring of patients of CRS

Fig. 3.

Scatter plot pre-operative and post-operative SNOT-22 scoring of each study patient

Discussion

In the presented study on refractory CRS patients treated with FESS for QoL assessment after surgery using SNOT-22 maximum number of patients were in the age group of 18–30 years (35%). Mean age was 40.475 years. Male: Female ratio was of 3:2 in the study. In similar study Mace et al. [10] reported average age of 49.4 (range 18–80) with a male–female ratio of 1.1:1. We noticed that out of 40 patients, 26 (65%) patients had history of allergy. The study of Gray et al. [11] had 46% allergic patients.

Nasal obstruction was the most commonly reported disabling condition, reported in 32 (80%) patients, followed by rhinorrhea (75%), headache (72.5%), facial pain (72.5%), sneezing (70%), hyposmia (37.5%). The study by Shivakumar et al. [12] reported that the commonest symptom was nasal blockade (86.66%), followed by anosmia (77.14%), facial pressure (73.33%), postnasal drip (70.47%), headache (62.85%), nasal discharge (58.09%), fatigue (30.47%), halitosis (26.66%), dry cough (11.42%), dental pain (10.4%) and earache/fullness (6.66%). Fatigue, halitosis, dental pain and earache/fullness were not commonly reported by the patients included in the study.

The mean preoperative nasal endoscopy Lund Kennedy score was 8.08 ± 3.65. In the study conducted by Smith et al. [13], all patients with CRS had a mean preoperative endoscopy score of 8.1 ± 4.6. Patients with nasal polyps had worse endoscopy scores, preoperatively, which was consistent with the study of Smith et al. [13]. Patients with allergy had similar endoscopy scores in preoperative period as compared to patients without allergy.

The mean preoperative CT Lund-Mackay score in this study was 11.725 ± 3.64. In the study conducted by Smith et al, all patients with CRS had a mean preoperative CT score of 12.1 ± 7.1. Patients with polyps had worse preoperative CT scores than patients without polyps which was consistent with the study of Smith et al. [13]. Patients with allergy also had similar preoperative CT scores, as that of patients without allergy.

The mean preoperative SNOT-22 score was 46.25 ± 20.44. The score was 34.6 ± 24.0 in the study of Gray et al. [11] and Hopkins et al. [14] reported mean preoperative SNOT 22 scores as 41.7 ± 19.8.

Individual item analysis of the SNOT-22 data in the study by Hopkins et al. revealed that two symptoms were given higher scores than all other items. In their study mean score for nasal blockage was 3.7 and altered smell or taste was 4.3, while mean score for all other symptoms ranged from 0.8 to 2.8. In present study, we noted that the mean score for nasal blockage was 4.20, runny nose 3.68, facial pain and pressure 3.43, fatigue 3.25 and need to blow nose 3.08. Mean score for all other symptoms were less than three.

On VAS preoperatively, 80% of patients rated nasal congestion as their most disabling symptom, followed by rhinorrhea (75%), headache (72.5%) and facial pain-pressure fullness (72.5%). While in the study by Soler et al. [15] 29% of patients headache was the most disabling symptom, followed by facial pain-pressure fullness (20%) and nasal congestion (19%).

We noted that all the symptoms were significantly improvement after FESS (p < 0.001). Nasal discharge responded the best among the symptoms. Nasal discharge responded the best among the symptoms. The study by Shivakumar et al. showed that postoperatively, 87.01% of the nasal obstruction showed improvement. 87.87% of headache, 87.01% of facial pain/pressure, 85.24% of purulent nasal discharge showed improvement after surgery at the end of 6 month follow up. Headache and nasal obstruction responded the best among the symptoms [12].

We noted that VAS scores for 4 symptoms (nasal obstruction, nasal discharge, sneezing, facial pain/pressure) showed significant postoperative improvement sustainable at 6 months after surgery (p < 0.001). Similar results have been reported by Soler et al. [15]. The mean diagnostic nasal endoscopy Lund Kennedy score postoperatively was 2.80 with a standard deviation of 1.64 at 6 months. In the study conducted by Smith et al., postoperative mean of Lund Kennedy score was 4.5 ± 3.7 with a significant mean change of 3.5 ± 4.5 (p < 0001). In the analysis of subgroups by patient factor, all patients irrespective of subgroup showed significant improvement on endoscopy.

Patients with nasal polyps had worse endoscopy scores, postoperatively also, which was consistent with the study of Smith et al. [13]. Patients with nasal polyps also demonstrated a greater degree of improvement on endoscopy after surgery than patients without polyps. Allergies had no effect on objective measures, and all patients had similar endoscopy scores in postoperative periods as compared to patients without allergy.

The mean postoperative SNOT-22 score was 14.58 ± 4.90 at 3 months and 22.38 ± 7.93 at 6 months. There was a statistically significant (p < 0.0001, t = 6.89) decrease in patient reported SNOT-22 scores at 6 months. Hopkins et al. [14] reported mean postoperative SNOT-22 score as 25.5 ± 20.8 at 6 months. These scores decreased to 2.93 ± 0.80 of nasal blockage and 2.93 ± 1.35 of facial pain or pressure. Mean score for all other symptoms were less than two. Statistically significant reductions in major and minor symptom scores were achieved for all symptoms. Large effect sizes were noted for reductions in facial pressure, nasal obstruction, congestion and rhinorrhea. Similar large effect sizes were noted for reductions in headache and fatigue. These results were consistent with the results of the study conducted by Bhattacharya et al. [16]. Comparison of all data showed QoL improvement after FESS at 3 and 6 months.

Key messages

• Nasal obstruction/blockage, rhinorrhea, facial congestion, and facial pain/pressure were the most prevalent and severe symptoms in the study population of refractory CRS.

• The mean preoperative and postoperative SNOT-22 symptom scoring showed that the major CRS symptoms, rhinorrhea, headache and fatigue improved significantly after FESS. Similarly endoscopic scores showed significant improvement.

• SNOT-22 is a valid and easy to use rhinologic-specific instrument to measure QoL in patients with CRS and to measure the outcome of surgical intervention.

Funding

No financial funding received. Patients were treated free of cost under ‘MNDY (Mukhyamantri Nishulk Dava Yojana) scheme’ and Bhamashah Swasthya Beema Yojana sponsored by the Government of Rajasthan.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in the presented study involving human participants were in accordance with the ethical standards of the institutional research committee of JLN Medical College Ajmer (Ref. No. 268/Acad-III/MCA) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.