Quality of life benefit after endoscopic frontal sinus surgery Mohamed R. ElBadawey, M.D., F.R.C.S. (ORL HNS),1,2 Ahmad Alwaa, F.R.C.S. (ORL HNS),1 Mostafa ElTaher, MBChB, M.Sc. Otolaryngology,3 and Sean Carrie, F.R.C.S. (ORL HNS)1 ABSTRACT
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Background: There is a lack of reports on the quality of life (QOL) assessment after frontal sinus surgery. This study aimed to assess the QOL of patients after one of three frontal sinus procedures, using the Glasgow Benefit Inventory (GBI) and the 22-item Sino-Nasal Outcome Test (SNOT-22). Methods: We designed an observational study with two arms. The first arm was a cross-sectional retrospective study recruiting all patients (with rhinosinusitis or mucocele) who had balloon sinuplasty, frontal recess clearance, or endoscopic modified Lothrop procedure in our tertiary referral unit at Newcastle upon Tyne Hospitals, between April 2010 and April 2012. The second arm was a prospective cohort study recruiting all patients having frontal sinus procedures between April 2012 and September 2012. The QOL was measured primarily by the GBI and SNOT-22 questionnaires. A total of 45 patients were recruited. Retrospectively, we identified 27 patients, of whom 19 (70%) returned the questionnaires. Eighteen patients were recruited in the prospective cohort and 14 (77.7%) of them completed the questionnaires 3 months postoperatively. Results: The total benefit of frontal sinus surgery was found to be ⫹31 for the retrospective group and ⫹25.59 for the prospective arm. The three domains of GBI showed a positive impact after surgery. The general domain scored ⫹37.5 in the retrospective study and ⫹29.76 for the prospective one. The social domain scored ⫹18.81 retrospectively and ⫹21.42 prospectively. The physical domain scores were ⫹17.71 retrospectively and ⫹13 prospectively. The SNOT-22 preoperative score was ⫹59.8 and this significantly improved to ⫹35.2 (p ⫽ 0.017). Conclusion: Our study is the first report of QOL benefit after all three frontal sinus procedures using the validated GBI, showing benefit in all aspects of health domains. The physical symptoms and QOL assessed by SNOT-22 significantly improved after all three procedures. (Am J Rhinol Allergy 28, 428 –432, 2014; doi: 10.2500/ajra.2014.28.4063)
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anagement of inflammatory disease within the frontal sinus is widely recognized as challenging. Many procedures, both endoscopic and external, have been described to address frontal sinus outflow obstruction. Draf1,2 described his microscopic approach to the frontal sinus. He divided them into three types (I, IIa, IIb, and III) according to the extent of surgery. Warmold described the frontal recess clearance (FRC) using the building blocks concept.3 More recently, balloon dilatation of the frontal recess introduced a noninvasive technique to improve frontal sinus drainage.4 The endoscopic modified Lothrop procedure (EMLP) has gained increasing popularity, particularly for extensive pathologies or revision cases.5 A number of studies have assessed the quality of life (QOL) for chronic rhinosinusitis (CRS) patients after endoscopic sinus surgery (ESS). Newton et al. used the Glasgow Benefit Inventory (GBI), which showed significant improvement of the patient’s general and physical health.6 Akarcay et al., used the Chronic Sinusitis Survey, and Outcomes Short Form-12, which showed significantly better scores postoperatively.7 Litvack et al. used the Rhinosinusitis Disability Index and the Chronic Sinusitis Survey, which showed improvement of QOL for primary and revision ESS procedures.8 A number of studies have used the 22-item Sino-Nasal Outcome Test (SNOT-22) and/or QOL questionnaires that showed better scores after ESS.9–12 In the literature, there is a lack of reports on QOL assessment after frontal sinus surgery procedures. In a recent systematic review, the authors found only one randomized control study evaluating balloon dilatation of the frontal recess. The outcome measure was the percentages of observed patent postoperative frontal recesses and a
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Department of Otolaryngology and Head and Neck Surgery, Freeman Hospital, University of Newcastle, Newcastle upon Tyne, United Kingdom, 2Department of Otolaryngology and Head and Neck Surgery, Tanta University, Tanta, Gharbia, Egypt, and 3Department of Otolaryngology and Head and Neck Surgery, Sohag University, Sohag, Egypt The authors have no conflicts of interest to declare pertaining to this article Address correspondence to Mohamed R. ElBadawey, M.D., Department of Otolaryngology and Head and Neck Surgery, Freeman Hospital, Newcastle upon Tyne, NE7 7DN, U.K. E-mail address: [email protected] Copyright © 2014, OceanSide Publications, Inc., U.S.A.
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simple visual analog scale score without any assessment of the QOL.4,13 This study aimed to assess the QOL after frontal sinus surgery procedures using the GBI and SNOT-22.
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MATERIALS AND METHODS
We designed an observational study with two arms. The first arm was a cross-sectional retrospective study recruiting all patients who had frontal sinus surgery for CRS between April 2010 and April 2012. The patients were identified from the patient record system for two surgeons who provided the frontal surgery service in our tertiary referral Ear, Nose, and Throat (ENT) unit at the Newcastle upon Tyne Hospitals National Health Service (NHS) Foundation Trust. The study was registered and approved by the audit and clinical governance office in the Newcastle upon Tyne Hospitals NHS Trust. The second arm of the study was a prospective cohort study recruiting all patients having frontal sinus procedures for CRS between April 2012 and September 2012. The eligibility criteria included patients ⬎16 years old who had pathology in the frontal sinus/recess confirmed by computed tomography CT scans associated with specific frontal sinus symptoms in the form of facial pain, discomfort, or pressure in the forehead. The preoperative planning and the procedures included an approach to the frontal sinus. Patients with no intervention to the frontal recess were excluded. We also excluded patients with neoplastic lesions in the recess. Patients’ data were collected from the notes including age, sex, symptoms and signs, CT scan findings including the Lund-Mackay staging, preoperative medical treatment, and the surgical procedure. The Lund-Mackay radiological staging gives a numeric score between 0 and 2 for each sinus, where 0 indicates a completely clear sinus, 1 for partly opaque, and 2 for completely opaque sinus.14 It is validated and widely accepted because of its simple numeric scores with a satisfactory interobserver reliability.15 The Task Force on Rhinosinusitis recommended it for future outcome research.16 For the prospective arm we planned a 3-month follow-up assessment.
Settings This project was performed at the tertiary referral ENT unit at the Newcastle upon Tyne Hospitals NHS Foundation Trust.
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Main Outcome Measure
Table 1 The demographics of patients included in the two prospective and the retrospective arms of the study showing no significant difference between the two groups indicating that both groups were matched
The QOL impact was measured primarily by the GBI questionnaire, which was introduced and validated by Robinson et al.17 It has been used successful in evaluating the QOL impact of a number of ENT conditions.18–20 It contains 18 items and its analysis provides a measure of the positive or negative impact in the total score and in three domains of health status (general, social, and physical). The score ranges from ⫹100 to ⫺100 in each domain, indicating whether the QOL becomes better or worse after the intervention. We also used The SNOT-22 questionnaire, which has been validated for the assessment of physical symptoms and QOL of rhinosinusitis patients.21 It provides a score range from 0 to 110. For the retrospective group we posted an information sheet about the study, the GBI, and the SNOT-22 questionnaires with a stamped self-addressed envelope to all patients identified. For the prospective group, the patients were invited to the study preoperatively using the information sheet, and then they completed the SNOT-22 questionnaire. In the 3-month postoperative visit, they completed both the GBI and the SNOT-22 questionnaires.
Parameter Sex Male (n) Female (n) Age (y) Range Mean SD Previous surgery Yes No Follow-up Mean
Statistical Analysis
RESULTS Demographics
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Procedure
A total of 45 patients were recruited to the study; however, only 33 patients completed the postoperative questionnaires. In the retrospective group we identified 27 patients who had frontal sinus surgery in the 2-year period. Nineteen patients (70%) returned the questionnaires. The mean age was 56 years. There were 10 male and 9 female patients. The mean follow-up period was 12 months, with a range of 6 months to 2 years. Eighteen patients were recruited in the prospective study, 14 (77.7%) of them completed the questionnaires 3 months postoperatively. The remaining 4 patients did not attend their postoperative visit. Their mean age was 49.7 years, with an equal female/male ratio (Table 1).
Radiological Scoring The average preoperative Lund-Mackay score for the 33 patients who completed the questionnaires was 12.46 (confidence interval [CI], 8.8–16). The mean right frontal sinus score was 1.06 (SD ⫽ 0.8), and the left sinus score was 1.43 (SD ⫽ 0.8) out of a maximum of 2.
Preoperative Medication In both groups patients were offered the surgery after failure of medical treatment (nasal steroids) to control their symptoms. The medical treatment included steroid nasal drops for 2 months followed
p Value
7 7
⬎0.05 ⬎0.05
18:71 49.7 12
24:74 56 14
⬎0.05
11 (58%) 8 (42%)
3 (21%) 11 (79%)
3 mo
12 mo
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10 9
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Pathology CRS without NPs CRS with NPs Mucocele
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The study was registered and approved by the audit and clinical governance office in the Newcastle upon Tyne Hospitals NHS Foundation Trust. The study was classified as an audit; therefore, ethical approval was not required.
Prospective Group
Table 2 The primary pathology and surgical interventions for patients in the retrospective group
Descriptive statistics were used on patient characteristics. Data from the GBI were collected using Windows Excel software (Microsoft Corp., Redmond, WA) and scored in the four domains according to the recommended equations.17 Statistical analysis was performed using SPSS (SPSS, Inc., Chicago, IL). We used Mann-Whitney test to compare the data between different procedures as they were unpaired nonparametric data. The SNOT-22 preoperative and postoperative scores were analyzed by the Wilcoxon signed-ranked test because they were paired nonparametric data.
Ethical Consideration
Retrospective Group
BS
BS ⴙ ESS
5
FRC
EMLP
Total n/%
4
1
3
2
10/53% 4/21% 5/26%
4
BS ⫽ balloon sinuplasty; ESS ⫽ endoscopic sinus surgery; FRC ⫽ frontal recess clearance; EMLP ⫽ endoscopic modified Lothrop procedure; CRS ⫽ chronic rhinosinusitis; NPs ⫽ nasal polyps.
by steroid nasal spray for 6 months, in addition to alkaline nasal douches.
Interventions In the retrospective group, the main frontal sinus procedure performed was balloon sinuplasty (BS) in nine patients (47%). This group was further divided into BS alone in five patients (26%) and BS ⫹ ESS in four patients (21%). The second procedure was FRC performed in seven patients (37%). All patients who had FRC had ESS to other sinuses. The least performed procedure was EMLP in three patients (16%) (Table 2). The majority of patients (58%) had previous ESSs. In the prospective group, BS was performed in eight patients (57%). This group was further divided into BS alone in two patients (14%) and BS ⫹ ESS in six patients (21%). The second procedure was FRC, performed in six patients (43%). Only three patients (21%) had previous ESS (Table 3). For both groups, all patients were prescribed corticosteroids nasal drops for 6 weeks, followed by long-term corticosteroids nasal spray.
Postoperative Endoscopic Evaluation In the prospective group, the endoscopic examination of the frontal recess, postoperatively, revealed patent healthy ostia in 11 cases (79%) and polypoid edematous frontal recess mucosa in 3 cases (21%; Fig. 1).
QOL Assessment In the retrospective group, the GBI total benefit for frontal sinus surgery was ⫹31 (CI, 20–45). The three domains showed a positive impact with a score of ⫹37.5 (CI, 24–51) in the general domain, ⫹18.81 (CI, 6–30) in the social domain, and a score of ⫹17.71 (CI, 5–29) in the physical domain (Fig. 2).
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Table 3 The primary pathology and surgical interventions for patients in the prospective group Procedure
BS
BS ⴙ ESS
FRC
Pathology CRS without NPs CRS with NPs
2
2 4
4 2
Total n/% 8/57% 6/43%
BS ⫽ balloon sinuplasty; ESS ⫽ endoscopic sinus surgery; FRC ⫽ frontal recess clearance; EMLP ⫽ endoscopic modified Lothrop procedure; CRS ⫽ chronic rhinosinusitis; NPs ⫽ nasal polyps.
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Figure 3. The benefits in the quality of life (QOL) assessed by the Glasgow Benefit Inventory (GBI) after the two techniques of frontal sinus surgery used in the prospective cohort.
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Figure 1. The postoperative findings on endoscopic examination of the frontal recess in the two procedures used in the prospective cohort.
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Figure 2. The benefits in the quality of life (QOL) assessed by the Glasgow Benefit Inventory(GBI) in the whole group and in each subgroup after frontal sinus surgery.
In the prospective group, the GBI total benefit showed a positive impact of frontal sinus surgery scoring ⫹25.59 (CI, 19–42). The three domains scored ⫹37.5 (CI, 24–51) in the general domain, ⫹18.81 (CI, 6–30) in the social domain and ⫹17.71(CI, 5–29) in the physical domain (Fig. 2). Comparing the prospective and retrospective scores did not show any significant difference between the two groups. There was no statistically significant difference between BS and FRC in the prospective group using Mann-Whitney U test (Fig. 3). In the retrospective group, although the EMLP produced higher scores, there was no significant difference between the procedures except for general domain, where the EMLP scored significantly higher than BS (p ⫽ 0.045) (Fig. 4).
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Figure 4. The benefits in the quality of life (QOL) assessed by the Glasgow Benefit Inventory (GBI) after the three techniques of frontal sinus surgery used in the retrospective study.
For the prospective group the SNOT-22 scores were compared using the Wilcoxon signed-ranked test showing significant reduction of the scores for the group (p ⫽ 0.017), and for both surgical techniques indicating substantial improvement in nasal symptoms postoperatively (Table 4). In the retrospective group, the SNOT-22 postoperative average score was 25.5. There were no adverse side effects reported in any patients.
DISCUSSION Our study shows that frontal sinus surgery alone or in addition to other sinus surgeries improves the QOL of CRS patients who have frontal sinus symptoms. The analysis of the total score of the GBI showed a positive improvement of the QOL in all patients after frontal sinus surgery in both the prospective and the retrospective groups. The triple domain analysis of the GBI has shown a positive improvement throughout. General benefit was maximum, followed by social and physical ben-
September–October 2014, Vol. 28, No. 5
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Table 4 The data from SNOT-22 for the prospective cohort of patients who had frontal sinus surgery Preoperative
All cases FRC BS
Postoperative
p Value
Mean (SD)
Median (IQR)
Mean (SD)
Median (IQR)
59.86 (19.1) 64.17 (17.6) 56.63 (20.7)
60.50 (25.5) 64 (21.75) 56.5 (26.5)
35.42 (28.3) 36.17 (29.9) 34.88 (29.1)
30.5 (33.25) 27 (39.75) 30.5 (53)
0.017 0.046 0.014
FRC ⫽ frontal recess clearance; BS ⫽ balloon sinuplasty; ESS ⫽ endoscopic sinus surgery; SNOT-22 ⫽ 22-item Sino-Nasal Outcome Test; IQR ⫽ interquartile range.
efits. In the prospective cohort, SNOT-22 scores were significantly reduced from 59.9 to 35.4 (p ⫽ 0.017). These values are comparable with other otolaryngological procedures. The scores are better than those obtained after rhinoplasty, tonsillectomy, laser palatoplasty, middle ear surgery for activity, and total ESS but slightly less than middle ear surgery for hearing, bone anchored hearing aids, and cochlear implants.17–20 The pattern of maximum improvement in general domain, followed by social and physical ones, was also observed in other ENT conditions.17 In the retrospective arm the total score and the three domains showed a positive improvement of QOL after BS, FRC, and EMLP. They followed the pattern of maximum benefit in the general domain followed by social and physical domains. The only statistically significant finding was the benefit of EMLP in the general domain when compared with BS (p ⫽ 0.045). Other comparisons did not show any significant difference between the procedures. This might be related to the small number of patients in the study. This small number reflects the nature and incidence of frontal sinus symptoms in patients with CRS with or without polyps. In the retrospective period, the authors performed ESS on 158 patients with only 27 (17%) patients requiring frontal sinus approaches because of the specific frontal symptoms with positive findings on CT scans. In the prospective cohort, comparing the two procedures (BS and FRC), the total GBI score was higher in the BS group (⫹27) than in the FRC group (⫹23.6). The general domain was the same (⫹29). The social domain was higher with BS (⫹29) when compared with the FRC (⫹11). The physical domain scored ⫹14.5 in BS, which is slightly higher than the FRC of ⫹11. No significant difference was found between the two groups. The Lund-Mackay average score for the frontal sinuses was 1.06 for the right sinus and 1.43 for the left side. This reflects marked opacification in the frontal sinuses, indicating significant pathology in the frontal sinus/recess areas, requiring surgical intervention. This correlates well with the nature of the surgery offered. Previous studies confirmed that the Lund-Mackay scores correlate well with the disease severity, the degree of surgical interventions, and their outcome; however, it does not correlate with subjective assessments of patients.22,23 BS is a relatively new technique and its use adds approximately $995 to the cost of ESS. It is important to assess the QOL after BS to record its effectiveness as a part of outcome research needed to measure functional capacity, psychological well-being, and symptomatic relief.24 It is reassuring that BS alone or as a part of ESS has a positive impact on the QOL of patients. Our study provides evidence that BS as a noninvasive technique is associated with a positive impact on the QOL of patients with frontal sinus disease. More research is required to provide evidence for this novel surgical tool to be used routinely. A recent systematic review found only one randomized control trial, which studied 34 patients comparing BS ⫹ ESS and FRC ⫹ ESS. Their outcome measures were the percentage of observed patent frontal recesses at 12 months and the degree of radiological resolution of the frontal sinuses. They did not find any significant difference between the groups. The main shortcoming in the study was the lack of subjective assessment of QOL.4,13 In our
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study the main outcome measure was the impact of the surgery on the QOL of patients. Interestingly, the SNOT-22 scores in our groups were higher than the average postoperative score in the recent report from the England and Wales national prospective audit, which reported a postoperative score of 18.3 in CRS with nasal polyps and 14.1 in CRS without nasal polyps, 3 months postoperatively.25 This might be related to the longer follow-up in the retrospective part of the study and the peculiar subgroup that we studied involving mainly symptomatic frontal sinus pathology. Our study showed significant reduction of the SNOT-22 scores in the prospective cohort.
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Strength of the Study
To our knowledge, this is the first study to assess the QOL of patients after frontal sinus surgery using the GBI. Our study shows the long-term positive benefit after surgery in patients who had pathology in the frontal sinus/recess.
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Study Limitations
The limitation of the study includes the small number of patients in each category of the study. The response rate of returning the questionnaires was 71%, which potentially introduced a bias that nonresponders might have a less or more favorable outcome. However, most studies using and developing QOL questionnaires reported the same rate of response (72%)12 and it represented the population studied. Given the frequency of these procedures, we recommend repeating the study as a multicenter prospective cohort to recruit more patients. Finally, the lack of a “control nonfrontal sinus surgery” group was recognized. All patients in the study had maximum medical treatment before surgery. The authors considered it unethical not to offer surgery to those patients who had both clinical and radiological evidence of frontal sinus disease.
Clinical Implications Frontal sinus surgery requires particular skills in association with specialist instrumentation carrying a potential for increased cost in times of financial austerity. Our study shows a positive benefit in QOL after these procedures. We have shown in this study that the different procedures described to address disease in the frontal sinus achieved a positive benefit in the total and the three domains of health status assessed by the GBI.
CONCLUSION Our study is the first report of QOL benefit after frontal sinus surgery using the validated GBI. Frontal sinus surgery, as an isolated procedure or a part of ESS, has shown benefit in all aspects of health domains assessed by the GBI. The physical symptoms and the QOL assessed by SNOT-22 significantly improved after frontal sinus ESS.
REFERENCES 1.
Draf W. Endonasal micro-endoscopic frontal sinus surgery, the Fulda concept. Oper Tech Otolaryngol Head Neck Surg 2:234–240, 1991.
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Delivered by Ingenta to: Economics Dept IP: 91.236.120.119 On: Wed, 29 Jun 2016 03:16:51 Copyright (c) Oceanside Publications, Inc. All rights reserved. For permission to copy go to https://www.oceansidepubl.com/permission.htm
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Draf W, and Weber R. Endonasal micro-endoscopic pansinusoperation in chronic sinusitis. I. Indications and operation technique. Am J Otolaryngol 14:394–398, 1993. Wormald PJ. Surgery of the frontal recess and frontal sinus. Rhinology 43:82–85, 2005. Plaza G, Eisenberg G, Montojo J, et al. Balloon dilation of the frontal recess: A randomised clinical trial. Ann Otol Rhinol Laryngol 120: 511–518, 2011. Wormald PJ. Salvage frontal sinus surgery: The endoscopic modified Lothrop procedure. Laryngoscope 113:276–283, 2003. Newton JR, Shakeel M, and Ram B. Evaluation of endoscopic sinus surgery by Glasgow benefit inventory. J Laryngol Otol. 122:357–360, 2008. Akarcay M, Kizilay A, Miman MC, et al. The effect of endoscopic sinus surgery on quality of life [in Turkish]. Kulak Burun Bogaz Ihtis Derg11:65–71, 2003. Litvack JR, Griest S, James KE, and Smith TL. Endoscopic and quality-of-life outcomes after revision endoscopic sinus surgery. Laryngoscope 117:2233–2238, 2007. Jiang XJ, Guo XY, Yuan W, et al. Long-term improvements in quality of life after functional endoscopic sinus surgery for adolescents with chronic rhinosinusitis. Acta Otolaryngol 132:798–802, 2012. Masterson L, Tanweer F, Bueser T, and Leong P. Extensive endoscopic sinus surgery: Does this reduce the revision rate for nasal polyposis? Eur Arch Otorhinolaryngol 267:1557–1561, 2010. Browne JP, Hopkins C, Slack R, et al. Health-related quality of life after polypectomy with and without additional surgery. Laryngoscope 116:297–302, 2006. Naraghi M, Amirzargar B, and Meysamie A. Quality of life comparison in common rhinologic surgeries. Allergy Rhinol (Providence) 3:e1–e7, 2012. Ahmed J, Pal S, Hopkins C, and Jayaraj S. Functional endoscopic balloon dilation of sinus ostia for chronic rhinosinusitis. Cochrane Database Syst Rev 7:CD008515, 2011.
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Lund VJ, and Mackay IS. Staging in rhinosinusitis. Rhinology 31:183– 184, 1993. Oluwole M, Russell N, Tan L, et al. A comparison of computerized tomographic staging systems in chronic sinusitis. Clin Otolaryngol Allied Sci 21:91–95, 1996. Lund VJ, and Kennedy DW. Staging for rhinosinusitis. Otolaryngol Head Neck Surg 117:S35–S40, 1997. Robinson KGS, Browning GG. Measuring patient benefit from otorhinolaryngological surgery and therapy. Ann Otol Rhinol Laryngol Suppl. 105:415–422, 1996. Mehanna H, Mills J, Kelly B, and McGarry GW. Benefit from endoscopic sinus surgery. Clin Otolarygol Allied Sci 27:464–471, 2002. Banerjee A, and Dempster JH. Laser palatoplasty: Evaluation of patient benefit using the Glasgow benefit inventory. J Laryngology Otol 114:601–604, 2000. Arunachalam PS, Kilby D, Meikle D, et al. Bone-anchored hearing aid quality of life assessed by Glasgow Benefit Inventory. Laryngoscope 111:1260–1263, 2001. Hopkins C, Browne JP, Slack R, et al. Psychometric validity of the 22 item Sinonasal outcome Test. Clin Otolaryngol 34:447–454, 2009. Hopkins C, Browne JP, Slack R, et al. The Lund-Mackay staging system for chronic rhinosinusitis: How is it used and what does it predict? Otolaryngol Head Neck Surg 137:555–561, 2007. Basu S, Georgalas C, Kumar B, and Desai S. Correlation between symptoms and radiological findings in patients with chronic rhinosinusitis: An evaluation study using the Sinonasal Assessment Questionnaire and Lund-Mackay grading system. Eur Arch Otorhinolaryngol Head Neck 262:751–754, 2005. Piccirillo JF. Outcomes research and otolaryngology. Otolaryngol Head Neck Surg 111:764–769, 1994. Abdalla S, Alreefy H, and Hopkins C. Prevalence of sinonasal outcome test (SNOT-22) symptoms in patients undergoing surgery for chronic rhinosinusitis in the England and Wales national audit. Clin Otolaryngol 37:276–282, 2012. e
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September–October 2014, Vol. 28, No. 5
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Background: There is a lack of reports on the quality of life (QOL) assessment after frontal sinus surgery. This study aimed to assess the QOL of patients after one of three frontal sinus procedures, using the Glasgow Benefit Inventory (GBI) and the 22-item Sino-Nasal Outcome Test (SNOT-22). Methods: We designed an observational study with two arms. The first arm was a cross-sectional retrospective study recruiting all patients (with rhinosinusitis or mucocele) who had balloon sinuplasty, frontal recess clearance, or endoscopic modified Lothrop procedure in our tertiary referral unit at Newcastle upon Tyne Hospitals, between April 2010 and April 2012. The second arm was a prospective cohort study recruiting all patients having frontal sinus procedures between April 2012 and September 2012. The QOL was measured primarily by the GBI and SNOT-22 questionnaires. A total of 45 patients were recruited. Retrospectively, we identified 27 patients, of whom 19 (70%) returned the questionnaires. Eighteen patients were recruited in the prospective cohort and 14 (77.7%) of them completed the questionnaires 3 months postoperatively. Results: The total benefit of frontal sinus surgery was found to be ⫹31 for the retrospective group and ⫹25.59 for the prospective arm. The three domains of GBI showed a positive impact after surgery. The general domain scored ⫹37.5 in the retrospective study and ⫹29.76 for the prospective one. The social domain scored ⫹18.81 retrospectively and ⫹21.42 prospectively. The physical domain scores were ⫹17.71 retrospectively and ⫹13 prospectively. The SNOT-22 preoperative score was ⫹59.8 and this significantly improved to ⫹35.2 (p ⫽ 0.017). Conclusion: Our study is the first report of QOL benefit after all three frontal sinus procedures using the validated GBI, showing benefit in all aspects of health domains. The physical symptoms and QOL assessed by SNOT-22 significantly improved after all three procedures. (Am J Rhinol Allergy 28, 428 –432, 2014; doi: 10.2500/ajra.2014.28.4063)
M
anagement of inflammatory disease within the frontal sinus is widely recognized as challenging. Many procedures, both endoscopic and external, have been described to address frontal sinus outflow obstruction. Draf1,2 described his microscopic approach to the frontal sinus. He divided them into three types (I, IIa, IIb, and III) according to the extent of surgery. Warmold described the frontal recess clearance (FRC) using the building blocks concept.3 More recently, balloon dilatation of the frontal recess introduced a noninvasive technique to improve frontal sinus drainage.4 The endoscopic modified Lothrop procedure (EMLP) has gained increasing popularity, particularly for extensive pathologies or revision cases.5 A number of studies have assessed the quality of life (QOL) for chronic rhinosinusitis (CRS) patients after endoscopic sinus surgery (ESS). Newton et al. used the Glasgow Benefit Inventory (GBI), which showed significant improvement of the patient’s general and physical health.6 Akarcay et al., used the Chronic Sinusitis Survey, and Outcomes Short Form-12, which showed significantly better scores postoperatively.7 Litvack et al. used the Rhinosinusitis Disability Index and the Chronic Sinusitis Survey, which showed improvement of QOL for primary and revision ESS procedures.8 A number of studies have used the 22-item Sino-Nasal Outcome Test (SNOT-22) and/or QOL questionnaires that showed better scores after ESS.9–12 In the literature, there is a lack of reports on QOL assessment after frontal sinus surgery procedures. In a recent systematic review, the authors found only one randomized control study evaluating balloon dilatation of the frontal recess. The outcome measure was the percentages of observed patent postoperative frontal recesses and a
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Department of Otolaryngology and Head and Neck Surgery, Freeman Hospital, University of Newcastle, Newcastle upon Tyne, United Kingdom, 2Department of Otolaryngology and Head and Neck Surgery, Tanta University, Tanta, Gharbia, Egypt, and 3Department of Otolaryngology and Head and Neck Surgery, Sohag University, Sohag, Egypt The authors have no conflicts of interest to declare pertaining to this article Address correspondence to Mohamed R. ElBadawey, M.D., Department of Otolaryngology and Head and Neck Surgery, Freeman Hospital, Newcastle upon Tyne, NE7 7DN, U.K. E-mail address: [email protected] Copyright © 2014, OceanSide Publications, Inc., U.S.A.
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simple visual analog scale score without any assessment of the QOL.4,13 This study aimed to assess the QOL after frontal sinus surgery procedures using the GBI and SNOT-22.
T
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MATERIALS AND METHODS
We designed an observational study with two arms. The first arm was a cross-sectional retrospective study recruiting all patients who had frontal sinus surgery for CRS between April 2010 and April 2012. The patients were identified from the patient record system for two surgeons who provided the frontal surgery service in our tertiary referral Ear, Nose, and Throat (ENT) unit at the Newcastle upon Tyne Hospitals National Health Service (NHS) Foundation Trust. The study was registered and approved by the audit and clinical governance office in the Newcastle upon Tyne Hospitals NHS Trust. The second arm of the study was a prospective cohort study recruiting all patients having frontal sinus procedures for CRS between April 2012 and September 2012. The eligibility criteria included patients ⬎16 years old who had pathology in the frontal sinus/recess confirmed by computed tomography CT scans associated with specific frontal sinus symptoms in the form of facial pain, discomfort, or pressure in the forehead. The preoperative planning and the procedures included an approach to the frontal sinus. Patients with no intervention to the frontal recess were excluded. We also excluded patients with neoplastic lesions in the recess. Patients’ data were collected from the notes including age, sex, symptoms and signs, CT scan findings including the Lund-Mackay staging, preoperative medical treatment, and the surgical procedure. The Lund-Mackay radiological staging gives a numeric score between 0 and 2 for each sinus, where 0 indicates a completely clear sinus, 1 for partly opaque, and 2 for completely opaque sinus.14 It is validated and widely accepted because of its simple numeric scores with a satisfactory interobserver reliability.15 The Task Force on Rhinosinusitis recommended it for future outcome research.16 For the prospective arm we planned a 3-month follow-up assessment.
Settings This project was performed at the tertiary referral ENT unit at the Newcastle upon Tyne Hospitals NHS Foundation Trust.
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Main Outcome Measure
Table 1 The demographics of patients included in the two prospective and the retrospective arms of the study showing no significant difference between the two groups indicating that both groups were matched
The QOL impact was measured primarily by the GBI questionnaire, which was introduced and validated by Robinson et al.17 It has been used successful in evaluating the QOL impact of a number of ENT conditions.18–20 It contains 18 items and its analysis provides a measure of the positive or negative impact in the total score and in three domains of health status (general, social, and physical). The score ranges from ⫹100 to ⫺100 in each domain, indicating whether the QOL becomes better or worse after the intervention. We also used The SNOT-22 questionnaire, which has been validated for the assessment of physical symptoms and QOL of rhinosinusitis patients.21 It provides a score range from 0 to 110. For the retrospective group we posted an information sheet about the study, the GBI, and the SNOT-22 questionnaires with a stamped self-addressed envelope to all patients identified. For the prospective group, the patients were invited to the study preoperatively using the information sheet, and then they completed the SNOT-22 questionnaire. In the 3-month postoperative visit, they completed both the GBI and the SNOT-22 questionnaires.
Parameter Sex Male (n) Female (n) Age (y) Range Mean SD Previous surgery Yes No Follow-up Mean
Statistical Analysis
RESULTS Demographics
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Procedure
A total of 45 patients were recruited to the study; however, only 33 patients completed the postoperative questionnaires. In the retrospective group we identified 27 patients who had frontal sinus surgery in the 2-year period. Nineteen patients (70%) returned the questionnaires. The mean age was 56 years. There were 10 male and 9 female patients. The mean follow-up period was 12 months, with a range of 6 months to 2 years. Eighteen patients were recruited in the prospective study, 14 (77.7%) of them completed the questionnaires 3 months postoperatively. The remaining 4 patients did not attend their postoperative visit. Their mean age was 49.7 years, with an equal female/male ratio (Table 1).
Radiological Scoring The average preoperative Lund-Mackay score for the 33 patients who completed the questionnaires was 12.46 (confidence interval [CI], 8.8–16). The mean right frontal sinus score was 1.06 (SD ⫽ 0.8), and the left sinus score was 1.43 (SD ⫽ 0.8) out of a maximum of 2.
Preoperative Medication In both groups patients were offered the surgery after failure of medical treatment (nasal steroids) to control their symptoms. The medical treatment included steroid nasal drops for 2 months followed
p Value
7 7
⬎0.05 ⬎0.05
18:71 49.7 12
24:74 56 14
⬎0.05
11 (58%) 8 (42%)
3 (21%) 11 (79%)
3 mo
12 mo
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10 9
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Pathology CRS without NPs CRS with NPs Mucocele
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The study was registered and approved by the audit and clinical governance office in the Newcastle upon Tyne Hospitals NHS Foundation Trust. The study was classified as an audit; therefore, ethical approval was not required.
Prospective Group
Table 2 The primary pathology and surgical interventions for patients in the retrospective group
Descriptive statistics were used on patient characteristics. Data from the GBI were collected using Windows Excel software (Microsoft Corp., Redmond, WA) and scored in the four domains according to the recommended equations.17 Statistical analysis was performed using SPSS (SPSS, Inc., Chicago, IL). We used Mann-Whitney test to compare the data between different procedures as they were unpaired nonparametric data. The SNOT-22 preoperative and postoperative scores were analyzed by the Wilcoxon signed-ranked test because they were paired nonparametric data.
Ethical Consideration
Retrospective Group
BS
BS ⴙ ESS
5
FRC
EMLP
Total n/%
4
1
3
2
10/53% 4/21% 5/26%
4
BS ⫽ balloon sinuplasty; ESS ⫽ endoscopic sinus surgery; FRC ⫽ frontal recess clearance; EMLP ⫽ endoscopic modified Lothrop procedure; CRS ⫽ chronic rhinosinusitis; NPs ⫽ nasal polyps.
by steroid nasal spray for 6 months, in addition to alkaline nasal douches.
Interventions In the retrospective group, the main frontal sinus procedure performed was balloon sinuplasty (BS) in nine patients (47%). This group was further divided into BS alone in five patients (26%) and BS ⫹ ESS in four patients (21%). The second procedure was FRC performed in seven patients (37%). All patients who had FRC had ESS to other sinuses. The least performed procedure was EMLP in three patients (16%) (Table 2). The majority of patients (58%) had previous ESSs. In the prospective group, BS was performed in eight patients (57%). This group was further divided into BS alone in two patients (14%) and BS ⫹ ESS in six patients (21%). The second procedure was FRC, performed in six patients (43%). Only three patients (21%) had previous ESS (Table 3). For both groups, all patients were prescribed corticosteroids nasal drops for 6 weeks, followed by long-term corticosteroids nasal spray.
Postoperative Endoscopic Evaluation In the prospective group, the endoscopic examination of the frontal recess, postoperatively, revealed patent healthy ostia in 11 cases (79%) and polypoid edematous frontal recess mucosa in 3 cases (21%; Fig. 1).
QOL Assessment In the retrospective group, the GBI total benefit for frontal sinus surgery was ⫹31 (CI, 20–45). The three domains showed a positive impact with a score of ⫹37.5 (CI, 24–51) in the general domain, ⫹18.81 (CI, 6–30) in the social domain, and a score of ⫹17.71 (CI, 5–29) in the physical domain (Fig. 2).
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Table 3 The primary pathology and surgical interventions for patients in the prospective group Procedure
BS
BS ⴙ ESS
FRC
Pathology CRS without NPs CRS with NPs
2
2 4
4 2
Total n/% 8/57% 6/43%
BS ⫽ balloon sinuplasty; ESS ⫽ endoscopic sinus surgery; FRC ⫽ frontal recess clearance; EMLP ⫽ endoscopic modified Lothrop procedure; CRS ⫽ chronic rhinosinusitis; NPs ⫽ nasal polyps.
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Figure 3. The benefits in the quality of life (QOL) assessed by the Glasgow Benefit Inventory (GBI) after the two techniques of frontal sinus surgery used in the prospective cohort.
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Figure 1. The postoperative findings on endoscopic examination of the frontal recess in the two procedures used in the prospective cohort.
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Figure 2. The benefits in the quality of life (QOL) assessed by the Glasgow Benefit Inventory(GBI) in the whole group and in each subgroup after frontal sinus surgery.
In the prospective group, the GBI total benefit showed a positive impact of frontal sinus surgery scoring ⫹25.59 (CI, 19–42). The three domains scored ⫹37.5 (CI, 24–51) in the general domain, ⫹18.81 (CI, 6–30) in the social domain and ⫹17.71(CI, 5–29) in the physical domain (Fig. 2). Comparing the prospective and retrospective scores did not show any significant difference between the two groups. There was no statistically significant difference between BS and FRC in the prospective group using Mann-Whitney U test (Fig. 3). In the retrospective group, although the EMLP produced higher scores, there was no significant difference between the procedures except for general domain, where the EMLP scored significantly higher than BS (p ⫽ 0.045) (Fig. 4).
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Figure 4. The benefits in the quality of life (QOL) assessed by the Glasgow Benefit Inventory (GBI) after the three techniques of frontal sinus surgery used in the retrospective study.
For the prospective group the SNOT-22 scores were compared using the Wilcoxon signed-ranked test showing significant reduction of the scores for the group (p ⫽ 0.017), and for both surgical techniques indicating substantial improvement in nasal symptoms postoperatively (Table 4). In the retrospective group, the SNOT-22 postoperative average score was 25.5. There were no adverse side effects reported in any patients.
DISCUSSION Our study shows that frontal sinus surgery alone or in addition to other sinus surgeries improves the QOL of CRS patients who have frontal sinus symptoms. The analysis of the total score of the GBI showed a positive improvement of the QOL in all patients after frontal sinus surgery in both the prospective and the retrospective groups. The triple domain analysis of the GBI has shown a positive improvement throughout. General benefit was maximum, followed by social and physical ben-
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Table 4 The data from SNOT-22 for the prospective cohort of patients who had frontal sinus surgery Preoperative
All cases FRC BS
Postoperative
p Value
Mean (SD)
Median (IQR)
Mean (SD)
Median (IQR)
59.86 (19.1) 64.17 (17.6) 56.63 (20.7)
60.50 (25.5) 64 (21.75) 56.5 (26.5)
35.42 (28.3) 36.17 (29.9) 34.88 (29.1)
30.5 (33.25) 27 (39.75) 30.5 (53)
0.017 0.046 0.014
FRC ⫽ frontal recess clearance; BS ⫽ balloon sinuplasty; ESS ⫽ endoscopic sinus surgery; SNOT-22 ⫽ 22-item Sino-Nasal Outcome Test; IQR ⫽ interquartile range.
efits. In the prospective cohort, SNOT-22 scores were significantly reduced from 59.9 to 35.4 (p ⫽ 0.017). These values are comparable with other otolaryngological procedures. The scores are better than those obtained after rhinoplasty, tonsillectomy, laser palatoplasty, middle ear surgery for activity, and total ESS but slightly less than middle ear surgery for hearing, bone anchored hearing aids, and cochlear implants.17–20 The pattern of maximum improvement in general domain, followed by social and physical ones, was also observed in other ENT conditions.17 In the retrospective arm the total score and the three domains showed a positive improvement of QOL after BS, FRC, and EMLP. They followed the pattern of maximum benefit in the general domain followed by social and physical domains. The only statistically significant finding was the benefit of EMLP in the general domain when compared with BS (p ⫽ 0.045). Other comparisons did not show any significant difference between the procedures. This might be related to the small number of patients in the study. This small number reflects the nature and incidence of frontal sinus symptoms in patients with CRS with or without polyps. In the retrospective period, the authors performed ESS on 158 patients with only 27 (17%) patients requiring frontal sinus approaches because of the specific frontal symptoms with positive findings on CT scans. In the prospective cohort, comparing the two procedures (BS and FRC), the total GBI score was higher in the BS group (⫹27) than in the FRC group (⫹23.6). The general domain was the same (⫹29). The social domain was higher with BS (⫹29) when compared with the FRC (⫹11). The physical domain scored ⫹14.5 in BS, which is slightly higher than the FRC of ⫹11. No significant difference was found between the two groups. The Lund-Mackay average score for the frontal sinuses was 1.06 for the right sinus and 1.43 for the left side. This reflects marked opacification in the frontal sinuses, indicating significant pathology in the frontal sinus/recess areas, requiring surgical intervention. This correlates well with the nature of the surgery offered. Previous studies confirmed that the Lund-Mackay scores correlate well with the disease severity, the degree of surgical interventions, and their outcome; however, it does not correlate with subjective assessments of patients.22,23 BS is a relatively new technique and its use adds approximately $995 to the cost of ESS. It is important to assess the QOL after BS to record its effectiveness as a part of outcome research needed to measure functional capacity, psychological well-being, and symptomatic relief.24 It is reassuring that BS alone or as a part of ESS has a positive impact on the QOL of patients. Our study provides evidence that BS as a noninvasive technique is associated with a positive impact on the QOL of patients with frontal sinus disease. More research is required to provide evidence for this novel surgical tool to be used routinely. A recent systematic review found only one randomized control trial, which studied 34 patients comparing BS ⫹ ESS and FRC ⫹ ESS. Their outcome measures were the percentage of observed patent frontal recesses at 12 months and the degree of radiological resolution of the frontal sinuses. They did not find any significant difference between the groups. The main shortcoming in the study was the lack of subjective assessment of QOL.4,13 In our
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study the main outcome measure was the impact of the surgery on the QOL of patients. Interestingly, the SNOT-22 scores in our groups were higher than the average postoperative score in the recent report from the England and Wales national prospective audit, which reported a postoperative score of 18.3 in CRS with nasal polyps and 14.1 in CRS without nasal polyps, 3 months postoperatively.25 This might be related to the longer follow-up in the retrospective part of the study and the peculiar subgroup that we studied involving mainly symptomatic frontal sinus pathology. Our study showed significant reduction of the SNOT-22 scores in the prospective cohort.
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Strength of the Study
To our knowledge, this is the first study to assess the QOL of patients after frontal sinus surgery using the GBI. Our study shows the long-term positive benefit after surgery in patients who had pathology in the frontal sinus/recess.
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Study Limitations
The limitation of the study includes the small number of patients in each category of the study. The response rate of returning the questionnaires was 71%, which potentially introduced a bias that nonresponders might have a less or more favorable outcome. However, most studies using and developing QOL questionnaires reported the same rate of response (72%)12 and it represented the population studied. Given the frequency of these procedures, we recommend repeating the study as a multicenter prospective cohort to recruit more patients. Finally, the lack of a “control nonfrontal sinus surgery” group was recognized. All patients in the study had maximum medical treatment before surgery. The authors considered it unethical not to offer surgery to those patients who had both clinical and radiological evidence of frontal sinus disease.
Clinical Implications Frontal sinus surgery requires particular skills in association with specialist instrumentation carrying a potential for increased cost in times of financial austerity. Our study shows a positive benefit in QOL after these procedures. We have shown in this study that the different procedures described to address disease in the frontal sinus achieved a positive benefit in the total and the three domains of health status assessed by the GBI.
CONCLUSION Our study is the first report of QOL benefit after frontal sinus surgery using the validated GBI. Frontal sinus surgery, as an isolated procedure or a part of ESS, has shown benefit in all aspects of health domains assessed by the GBI. The physical symptoms and the QOL assessed by SNOT-22 significantly improved after frontal sinus ESS.
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