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The impact of associated to sinonasal disease on quality of life

J.M. Guilemanya,Ã, I. Alobida,b, J. Angrillc, F. Ballesterosa, M. Bernal-Sprekelsena, C. Picadoc, J. Mullola,d

aRhinology Unit, Department of , Hospital Clinic de Barcelona, ENT, Barcelona, Spain bDepartment of Otorhinolaryngology, Hospital Municipal de Badalona, Badalona, Spain cDepartment of Pneumology, Hospital Clı´nic, Department of Medicine, University of Barcelona, Spain dInstitut d’Investigacions Biome`diques August Pi i Sunyer (IDIBAPS), Barcelona, Spain

Received 20 September 2005; accepted 19 February 2006

KEYWORDS Summary Bronchiectasis; Background: Bronchiectasis (BQs) is an uncommon disease with the potential to Nasal polyposis; cause devastating complications. All patients with BQs have cough and chronic Quality of life; sputum production that may have a great impact on patient’s quality of life. Upper SF-36 questionnaire airway symptoms are also frequent in patients with BQs. Associations between upper and lower airways diseases have been demonstrated in allergic and , nasal polyposis and asthma, chronic and chronic rhinosinusitis. Objective: (1) To investigate the impact of bronchiectasis and nasal symptoms on quality of life. (2) To evaluate the added impact of nasal polyposis on quality of life in patients with BQs. Methods: Sixty patients with bronchiectasis and upper airway symptoms were included. Patients were evaluated for nasal symptoms, nasal size by , and quality of life using the SF-36 generic questionnaire. Results: In comparison with the Spanish general population, patients with BQs had worse scores in all SF-36 domains (Po0.05). Males reported significantly higher quality of life scores on physical functioning and social functioning than females did. Although the age, pulmonary function, presence of nasal polyps, upper airway symptoms, tobacco smoking history, and disease duration was similar between them. Males with BQs had worse quality of life than males from the Spanish general population on body pain, general health, and vitality (Po0.05). Females with BQs had worse quality of life than females from the Spanish general population on physical function, body pain, general health, vitality, social function, and emotional role (Po0.05). Nasal polyps were found in 25 (41.6%) of 60 patients with BQs.

ÃCorresponding author. Tel.: +34 932 279 872; fax: +34 932 275 454. E-mail address: [email protected] (J.M. Guilemany).

0954-6111/$ - see front matter & 2006 Elsevier Ltd. All rights reserved. doi:10.1016/j.rmed.2006.02.016 ARTICLE IN PRESS

1998 J.M. Guilemany et al.

No significant differences were observed on quality of life outcomes between patients with BQs with and without nasal polyposis. Conclusion: These results suggest that BQs has a considerable impact on quality of life while nasal polyposis has no additional impact on the quality of life of patients with BQs. & 2006 Elsevier Ltd. All rights reserved.

Introduction thereby making it possible to assess the burden of illness in different conditions. The Short Form-36 Bronchiectasis (BQs) consists of a permanent and Health Survey (SF-36) is the most widely used irreversible destruction and dilatation of bronchi generic instrument to measure health status. This and bronchioles due to retained secretions and questionnaire has been recently adapted for the recurrent infections that cause inflammation, ob- Spanish-speaking general population according to struction, and damage of the lower airway. BQs are the International Quality of Life Assessment (IQO- a consequence of a variety of different diseases LA) project showing a good reproducibility and 8–10 where infection and obstruction appears to be the validity. most important contributory factors. BQs are The aims of this study were: (1) to investigate frequently associated with cystic fibrosis, primary the impact of BQs and nasal symptoms on QoL ciliary dyskinesia, immunodeficiency, rheumatoid compared with the Spanish general population arthritis, and inflammatory bowel disease.1 using the SF-36 questionnaire; and (2) to evaluate Nasal polyposis (NP) is a chronic inflammatory the additional impact of mild-moderate nasal disease of the and sinus mucosa that, despite polyposis on QoL in patients with BQs. differing hypotheses of its cause, remains poorly understood.2,3 NP can lead to progressive nasal Material and methods obstruction, loss of smell, , and sneez- ing. NP is frequently associated with asthma and Study population: sixty patients with non-cystic other pulmonary disorders such as cystic fibrosis, fibrosis BQs in a stable phase of their illnes with primary ciliary dyskinesia, and sensitivity.4,5 upper airways symptoms were included in this BQs is a disease with the potential to cause prospective study from April 2002 to July 2004. devastating complications. The patients with BQs Design: the diagnosis of BQs was based on have cough and chronic sputum production that symptoms, physical findings, and thoracic high- have a great impact on patient’s quality of life resolution CT scan. Stability of the BQs condition (QoL). Most patients undergo slow and progressive was assessed with a complete clinical evaluation, a health deterioration over decades. It can have forced spirometry, and if is necessary a thorax detrimental effects on physical, psychological, and . Stable BQs condition was defined as the social aspects of the patient0s life, significantly absence of , no impairment of airflow limita- worsening the patient’s QoL. The lung function tion, no increase in sputum overproduction or does not reflect the impact of the disease in the change of the macroscopic characteristics (puru- patient0s health status and thus should be supple- lent), and no increase in chronic cough. In mented using QoL questionnaires.6 However, the summary, no increase in respiratory symptoms or impact of BQs to patients’ general health status has modifications in the treatment over the previous 6 not been reported for the Spanish patients. Gen- weeks. The day of the study, a complete clinical erally, there are two major types of QoL instru- evaluation and a forced spirometry (Collins Survey ments used in clinical trials: specific and generic. III, plus, USA) were performed. Exclusion criteria Specific questionnaires are usually focused on one were hospitalization in the previous 2 months, use particular area such as a disease state, a selected of in the last 4 weeks or presence of a population, or a certain function or problem. The serious concomitant illness. St. George Respiratory Questionnaire (SGRQ) has The diagnosis of nasal polyposis was based on the been used to assess the QoL in patients with visualization of bilateral polyps under nasal endo- asthma, COPD, a1-antitrypsin deficiency, intersti- scopic examination. Approval for the study was cial lung diseases and BQ.7 obtained from the Ethic’s Committee of our Generic QoL questionnaires are also available institution and a signed informed consent was and may be administrated to any individual, obtained from all patients. ARTICLE IN PRESS

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After a 4-week washout period of oral and Statistical analysis: was performed using SPSS for intranasal , all patients with BQs completed Windows (SPSS 11.0, Chicago, IL, USA). All analyses the SF-36 survey. Nasal symptoms and nasal were performed using two-tailed tests significance endoscopy were also scored. Most of experimental at the 0.05 level. The data are presented as studies and clinical trails investigating nasal poly- mean7SD (standard deviation). All data were posis consider adequate a washout period of 4 assesed for normal distribution and the Bonferroni weeks since patients with sinonasal often correction for multiple comparisons was used. Our follow treatments with oral , oral first objective was to investigate the impact of BQs and intranasal , oral antibiotics, and and nasal symptoms on QoL compared with the nasal lavages that may improve the clinical Spanish general population using the SF-36 ques- symptoms.11,12 tionnaire. A study population size of 29 patients per Quality of life: the Health Survey SF-36 consists group, achieves 95% power to detect a difference of 36 self-administered questions and was devel- of 20% between the null hypothesis mean of 82.7 oped to measure eight health domains: physical (PCS) and the alternative hypothesis mean of 66.4 functioning (PF), role physical (RP), bodily pain with an estimated standard deviation of 23.3 and (BP), general health (GH), vitality (VT), role with a significance level (alpha) of 0.05 using a two- emotional (RE), social functioning (SF), and mental sided one-sample t-test. health (MH). Two summary scales are also included: Unpaired Student’s t test was used to compare the physical component summary (PCS) and the nasal symptoms and SF-36 scores of patients with mental component summary (MCS). Spanish version BQs with those from the Spanish general popula- of the SF-36 Health Survey was used. This version is tion, and between patients with or without NP. SF- very similar to the original US questionnaire in 36 scores for healthy control subjects from the absolute values, age and gender. We needed a Spanish population used in comparative analyses generic questionnaire to assess QoL in pathology were derived from a sample of 9984 people of potentially involved both upper and lower airways: whom 51.8% were females. Males of the Spanish bronchiectasis and sinonasal pathology (with or general population have demonstrated significant without nasal polyposis). Scale scores in each higher scores than females in all SF-36 dimensions.7 domain and summaries range from 0 to 100, higher After analyzing matching for age, no significant scores indicating better QoL.13 difference on the mean age between patients of Nasal symptoms: obstruction, loss of the sense of our study and the Spanish general population. smell, rhinorrhea (anterior and posterior), facial Pearson correlation coefficients were used to pain, itching, and sneezing was scored. The severity examine the association between QoL scores and of nasal symptoms was assessed and scored, follow- gender, age, nasal symptoms, nasal polyps, and ing the system designed by Rasp et al.,14 and lung function. Multiple linear regression analysis published before11,12 byourgroup,asfollows:0,no with SF-36 scores were used, alternatively the PCS symptom; 1, mild but not troublesome symptom; 2, and MCS scores as the dependent variable and age, moderate symptom somewhat troublesome but not sex, nasal polyps size as independent variables. enough to interfere with daily activities or sleep; Internal consistency was calculated by Cronbach’s a and 3, severe and troublesome symptom that coefficient for each SF-36 scale. This coefficient interferes with daily activities or sleep. ranges from 0 to 1, and a minimum coefficient of Nasal endoscopy: polyp size was scored from 0 to 0.7 is recommended to ensure a good internal 3 for each following Lildholdt0s consistency.17 classification: 0, no polyps; 1, mild polyposis (small polyps not reaching the upper edge of the inferior Results turbinate); 2, moderate polyposis (polyps between the upper and lower edges of the inferior turbi- The mean age of patients with BQs was 52716 nate); 3, severe polyposis (large polyps reaching years (ranging from 18 to 78 years). Thirty-nine the lower edge of the inferior turbinate).15,16 All patients (65%) were female (Table 1). Patients with patients had upper airway symptoms and were BQs scored anterior and posterior rhinorrhea, loss examined by the same otorhinolaryngologist at the of the sense of smell, and nasal obstruction as the Department of Otolaryngology of our Hospital. major complaints, while itching, facial pain and Lung function: evaluated by forced spirometry sneezing were much less frequent and discomfort- according to standard methods. The best one- ing (Table 2). second forced expiratory volume (FEV1) was chosen Twenty-five patients (41.6%) with BQs had nasal for analysis and expressed as percent predicted polyps with a size score of 1.570.4 with a range 15 FEV1 (FEV1%). (1–2). The patients distribution by lildholdt is: ARTICLE IN PRESS

2000 J.M. Guilemany et al.

Table 1 Characteristics of patients with bronchiectasis (BQs).

N Age (yr) Gender Disease Smoking habit FEV1% FEV1 FVC (M/F) duration (yr)

All patients 60 52716 21/39 1570.7 15 8173.4 2.570.2 8974 BQs BQs without NP 35 55713 9/26 1670.7 6 (5 ex-smokers) 8276 2.870.6 9076.1 BQs with NP 25 48718 12/13 1370.7 9 (7 ex-smokers) 80.674.2 2.370.2 88.476

Table 2 Nasal symptoms in patients with bronchiectasis (BQs).

N Nasal Loss of sense of Anterior Posterior Sneezing obstruction smell rhinorrhea rhinorrhea

All patients 60 1.6570.9 0.971 1.970.9 1.870.9 1.271 with BQs BQs without NP 35 1.470.8 0.570.8 1.870.9 1.970.9 1.270.9 BQs with NP 25 2.0570.8y 1.471.0y 270.8 1.770.9 1.271

Nasal symptoms and polyp size were scored from 0 to 3. yPo0.05, compared to patients with bronchiectasis without nasal polyposis.

Lildholdt 1: 8 patients; Lildholdt 1.5: 10 patients Spanish population without NP (a NP punctuation of 2 in a fossa and 1 in the other); All BQs with NP Lildholdt 2: 7 patients. Patients with BQ and NP 100 had higher scores (Po0.05) of nasal obstruction and loss of sense of smell than patients with BQ 80 * * * * without NP. * * In comparison with the Spanish general popula- 60 tion,8 patients with BQs had significantly (Po0.05) * * worse QoL scores in all SF-36 domains (Fig. 1)as Score 40 * * well as in MCS and PCS (Table 3). No significant differences on QoL of patients with BQs and NP or 20 without NP were observed. Females showed lower physical functioning (dif- 0 PF RP BP GH VT SF RE MH PCS MCS ference: 13.1, Po0.05 and 95%CI: 1.7–24.5), and SF-36 domains lower social functioning (difference: 15.7, Po0.05 and 95%CI: 0.4–31) than males. Females with Figure 1 Quality of life in patients with bronchiectasis BQs had lower scores of QoL (Po0.05) than and sinonasal disease compared to the Spanish general females from the Spanish general population on population. Physical functioning (PF), role physical functioning (RP), bodily pain (BP), general health (GH), physical functioning, body pain, general health, vitality (VT), social functioning (SF), role emotional vitality, social functioning, and role emotional. functioning (RE), mental health (MH), mental component Males with BQs also showed lower scores of QoL summary (MCS), and physical component summary (PCS). (Po0.05) than males from the Spanish general All patients (with and without polyps) had significantly population on body pain, general health, and worse scores in all SF-36 domains. Unpaired student’s t vitality. No significant differences were observed test was used, *Po0.05. between males and females on age, pulmonary function, presence of nasal polyps, upper airway symptoms, tobacco smoking history, and disease Patients showed a degree of pulmonary function duration. Analysis of internal consistencies for all impairment on the FEV1% (8173.4). There were no SF-36 domains showed a Cronbach’s a value higher significant correlation between the two QoL sum- than 0.7 (0.75–0.91). Age, nasal symptoms, and maries and the degree of pulmonary function are: polyp size score were not statistically correlated to SCF (r: 0.21; P ¼ 0:242) and SCM (r: 0.095; SF-36 scores. P ¼ 0:599). Multiple linear regression analysis with ARTICLE IN PRESS

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Table 3 Quality of life domains and summary data of patients with bronchiectasis and sinonasal disease.

Spanish general population7 All patients with BQs

Physical functioning (PF) 90.3717.1 76722Ã Role physical (RP) 87.6730.4 71742Ã Body pain (BP) 81.9726 62.3724.9Ã General health (GH) 70.9719.6 35.5718Ã Vitality (VT) 71.6721 48.7717.3Ã Role emotional (RE) 94.6721.8 71.3742.5Ã Social functioning (SF) 94.1715.6 75.2728.3Ã Mental health (MH) 77.7718.7 65.4721.4Ã Physical component summary (PCS) 82.7723.3 46.5726.7Ã Mental component summary (MCS) 84.5719.3 39.7727.3Ã Ã Po0.05 bronchiectasis with nasal pathology compared to the Spanish general population.

SF-36 scores were used, alternatively the PCS and due to chronic infection of the lung resulting in MCS scores as the dependent variable and age, sex, fibrosis and bronchiectasis followed by respiratory nasal polyps size as independent variables without insufficiency. Some differences emerged between significant results. males and females, with females generally report- ing poorer QoL scores. Evidence indicated that males and females perceived their health status Discussion differently, with females having a more accurate perception of objective clinical health status.21 No studies have reported the impact of BQ and The St. George Respiratory Questionnaire (SGRQ) upper airway disease on QoL using the SF-36 is a self-administrated health-related QoL measure questionnaire. The main findings of our study were: containing 50 items and 76 weighted responses (1) patients with BQ have an impaired QoL when divided into three components: symptoms, activity, compared to the Spanish general population; (2) and impacts. The SGRQ has been used to assess the nasal polyposis has no additional impact on QoL in QoL in patients with asthma, COPD, a1-antitrypsin patients with BQs. deficiency,22–25 and more recently BQ.26 Anxiety This study demonstrates that QoL in patients with and depression are quite common in patients with BQ is impaired compared to the general populations BQ.27 QoL measured by the SGRQ in patients with in all SF-36 domains. No associations between QoL BQ assessing the pulmonary function and the and age, nasal symptoms, and polyp size were presence of colonization (with pseudomonas or observed. Furthermore, our findings supported the other microorganisms) shows that patients with BQ developer’s claim of internal consistency for the SF- colonized with pseudomonas have worse pulmonary 36 questionnaire since all the coefficients were at function and QoL than uncolonized patients. More- values above those recommended. over, patients having microorganisms other than This study also demonstrates that women with pseudomonas have a worse QoL than those without BQ report poorer QoL scores on physical functioning microorganisms.28 Pseudomonas aeruginosa is the and social functioning than males. Using the SF-36 most relevant pathogen producing chronic lung questionnaire, Bousquet et al. have observed that infections in patients with chronic underlying males with asthma report higher QoL scores than diseases such as cystic fibrosis (CF), bronchiectasis, females with asthma.18 Gender-related differences and chronic obstructive pulmonary disease (COPD). in response to a chronic disease such as asthma is Hypermutation of pseudomona is found to be a key important in tailoring an education and manage- factor for the development of multiple-antimicro- ment plan to each individual patient.19 Allergic bial resistance, and therefore these findings are rhinitis and asthma usually coexist. Patients with expected to have important consequences for the both diseases experience more physical limitations treatment of chronic infections.29,30 than patients with alone, but no Chronic rhinosinusitis (CRS) is an inflammatory differences were found between these two groups disease of the mucosa of the nasal cavity and for concepts related to social/mental health.20 with symptoms lasting longer Cystic fibrosis is the most common autosomal than 12 weeks. Currently, it is unclear, whether recessive disease with fatal outcome in Caucasians CRS with NP and CRS without NP represent different ARTICLE IN PRESS

2002 J.M. Guilemany et al. disease entities or just different stages of one for Llorenc- Quinto´ of the Statistic Department in single disease. Recent evidence suggests that, our Hospital, for their comments that greatly despite clinical similarities, CRS with and without improved the presentation of the paper. NP have different inflammatory pathways and profiles. Although the similar clinical References symptoms found in these patients, the great clinical differences probably remains in the inten- 1. Barker AL. Bronchiectasis. N Engl J Med 2002;346:1383–93. sity on nasal obstruction and smell disorders.31 2. Larsen PL, Tos M. Origin and structure of nasal polyps. In: Mygind N, Lildholdt T, editors. Nasal polyposis: an inflam- Nasalpolypsareoftenanindicativeofairway matory disease and its treatment. Copenhagen: Munks- disease involving both the upper and lower respira- gaard; 1997. p. 17–30. 32 33 tory tracts. Radenne et al. has investigated the 3. Fokkens W, Lund V, Bachert C, Clement P, Helllings P, impact of NP in QoL demonstrating that nasal polyps Holmstrom M, et al. EAACI. EAACI position paper on impaired QoL in all SF-36 domains. More recently our rhinosinusitis and nasal polyps executive summary. 2005;60(5):583–601. group demonstrated that asthma but not aspirin 4. Settipane GA. Epidemiology of nasal polyps. Allergy Asthma sensitivity has an additional negative impact on the Proc 1996;17:231–6. 11 QoL of patients with NP. QoL improved after NP 5. Widal MF, Abrani P, Lermoyez J. Anaphylaxie et idiosyncra- treatment, the improvement being related to nasal sie. Presse Med 1922;30:189–92. symptoms. Both medical and surgical treatment led 6. Jones PW, Quirk FH, Baveystock CM. Why quality of life measures should be used in the treatment of patients with to similar effects in improving QoL.12,34 Gliklich and 35 respiratory illness. Monaldi Arch Chest Dis 1994;49:79–82. Metson assessed the burden of chronic rhinosinusitis 7. 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