Original Article Determinants and Differences in Satisfaction with the Inhaler Among Patients with Asthma or COPD Vicente Plaza, MD, PhDa,b, Jordi Giner, PhDa,b, Elena Curto, MDa,b, M. Belén Alonso-Ortiz, MDc, Miren Itxaso Orue, MDd, José María Vega, MD, PhDe, and Borja G. Cosío, MD, PhDf; the group of investigators of the RE-TAI study* Barcelona, Las Palmas, Bilbao, Málaga, and Mallorca, Spain What is already known about this topic? Satisfaction with the inhaler is an important determinant of treatment adherence in patients with asthma and chronic obstructive pulmonary disease. Few studies have compared these groups to identify differences in satisfaction and to determine the factors associated with high inhaler satisfaction in both diseases. What does this article add to our knowledge? This study identifies clinically relevant differences between these 2 patient populations in satisfaction with the inhaler, indicating that the specific diagnosis is less relevant to inhaler satis- faction than other variables (age, disease control, and training in inhalation technique). How does this study impact current management guidelines? These findings—particularly the role of training on satisfaction with the inhaler—provide a clear target to improve satisfaction and thereby clinical outcomes. BACKGROUND: Satisfaction with the inhaler is an important Adherence to Inhalers and either the Asthma Control Test (ACT) determinant of treatment adherence in patients with asthma and or the COPD Assessment Test (CAT). chronic obstructive pulmonary disease (COPD). However, few RESULTS: Overall, the asthma group was significantly more studies have compared these 2 groups to identify the factors satisfied with the inhaler (mean [standard deviation] FSI-10 associated with satisfaction with the inhaler. scores: 44.1 [6.5] vs 42.0 [7.7]; P < .001) and more satisfied on OBJECTIVE: To assess and compare satisfaction with the most (7 of 10; 70%) items. Patients with asthma were signifi- inhaler in patients with asthma or COPD and to determine the cantly more satisfied with the inhaler regardless of the adherence variables associated with high inhaler satisfaction. level or the type of nonadherence pattern. Younger age, good METHODS: A multicenter, cross-sectional study of 816 patients disease control (ACT ‡20 or CAT £10), previous inhaler (406 with asthma and 410 with COPD) was conducted. Satis- training, and absence of unwitting nonadherence were all inde- faction was assessed with the Feeling of Satisfaction with Inhaler pendently and significantly associated with high inhaler (FSI-10) questionnaire. All participants completed the Test of satisfaction. a Department of Respiratory Medicine, Hospital de la Santa Creu i Sant Pau, Bar- training by Chiesi, Menarini, Recordati, Faes Farma, Novartis, and Novo Nordisk. celona, Spain M. I. Orue has received funding to travel and attend to training activities from b Department of Medicine, Institut d’Investigació Biomédica Sant Pau (IIB Sant Pau), GSK, Ferrer, AstraZeneca, and Chiesi. J. M. Vega has received honoraria for Universitat Autònoma de Barcelona, Barcelona, Spain speaking at sponsored meetings and received financial support to travel from Leti, c Department of Respiratory Medicine, Hospital Universitario de Gran Canaria ALK, AstraZeneca, Chiesi, GSK, Teva, Mundipharma, and Novartis. B. G. Cosío Doctor Negrín Las Palmas de Gran Canaria, Las Palmas, Spain has received honoraria for speaking at sponsored meetings from AstraZeneca, d Centro de Salud Javier Sáenz de Buruaga, Bilbao, Spain Teva, Mundipharma, Boehringer Ingelheim, Chiesi, GSK, and Novartis; received e Department of Allergy, Hospital Regional Universitario de Málaga, Málaga, Spain financial support to travel to meetings organized by Chiesi, Menarini, and f Department of Respiratory Medicine, Hospital Universitario Espases-IdISBa and Novartis; acts as a consultant for ALK, AstraZeneca, Mundipharma, Chiesi, and CIBERES, Mallorca, Spain Sanofi; and has received funding/grant support for research projects from a variety The study was supported in part by an unrestricted grant from Chiesi (Spain). The of governmental agencies and not-for-profit foundations, as well as from Boeh- sponsor had no role in the design of this study or in the analyses, data interpre- ringer Ingelheim, AstraZeneca, Chiesi, and Menarini. tation, and decision to submit results. Received for publication July 10, 2019; revised September 3, 2019; accepted for Conflicts of interest: In the last 3 years, V. Plaza has received honoraria for speaking publication September 20, 2019. at sponsored meetings from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Available online October 3, 2019. and Novartis; received financial support to travel to meetings organized by Chiesi Corresponding author: Vicente Plaza, MD, PhD, Servei de Pneumologia i Al$lèrgia, and Novartis; is a consultant for ALK, AstraZeneca, Boehringer, Mundipharma, Hospital de la Santa Creu i Sant Pau, C/Sant Antoni M. Claret 167, E-08025 and Sanofi; and received funding/grant support for research projects from a variety Barcelona, Spain. E-mail: vplaza@santpau.cat. of governmental agencies and not-for-profit foundations, as well as from Astra- * The list of investigators of the RE-TAI study is given under the Acknowledgments Zeneca, Chiesi, and Menarini. J. Giner has received funding to travel to and attend section. training activities from Menarini, Teva, AstraZeneca, Chiesi, GSK, Mundipharma, 2213-2198 and Boehringer. E. Curto has received funding to travel to and attend training Ó 2019 The Authors. Published by Elsevier Inc. on behalf of the American Academy activities from ALK, Menarini, Teva, AstraZeneca, Chiesi, Boehringer, and of Allergy, Asthma & Immunology. This is an open access article under the CC Novartis. M. B. Alonso-Ortiz has received honoraria for speaking at sponsored BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). meetings from AstraZeneca, Boehringer Ingelheim, Chiesi, Recordati, Bayer, and https://doi.org/10.1016/j.jaip.2019.09.020 Novo Nordisk; received financial support to travel to meetings and medical 645 646 PLAZA ET AL J ALLERGY CLIN IMMUNOL PRACT FEBRUARY 2020 Feeling of Satisfaction with Inhaler (FSI-10) questionnaire.23 Abbreviations used Treatment adherence was assessed with the Test of Adherence to ACT- Asthma Control Test Inhalers (TAI),24 a validated self-report instrument that also provides CAT- COPD Assessment Test data on the type of nonadherence (erratic, deliberate, or unwitting). COPD- Chronic obstructive pulmonary disease Inclusion criteria were as follows: (1) age 18 years; (2) FSI-10- Feeling of Satisfaction with Inhaler confirmed diagnosis of asthma or COPD according to the Global TAI- Test of Adherence to Inhalers Initiative for Asthma criteria9 or the Global Initiative for Chronic Obstructive Lung Disease,25 respectively; (3) treatment with inhalers CONCLUSIONS: Age, disease control, and training in (either pressurized metered dose inhaler or dry powder inhaler) for inhalation technique all play a more significant role than the the last 6 or more months; and (4) signed informed consent. specific diagnosis in explaining satisfaction with the device in The study was conducted in accordance with the Declaration of patients with asthma and COPD. These findings underscore the Helsinki and was approved by the Clinical Research Ethics Com- need to provide better training and more active monitoring of mittee of the Hospital de la Santa Creu i Sant Pau Barcelona (Spain) the inhalation technique to improve patient satisfaction, (CHI-ASM-2015-02[RETAI]). The study was registered with the treatment adherence, and clinical outcomes. Ó 2019 The Spanish Agency of Medicines and Medical Devices. Written Authors. Published by Elsevier Inc. on behalf of the American informed consent was obtained from all participants. All personal Academy of Allergy, Asthma & Immunology. This is an open data were maintained confidential and anonymized. access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/). (J Allergy Clin Study procedures Immunol Pract 2020;8:645-53) Clinicians from 26 hospitals or primary care centers in Spain Key words: Asthma; Pulmonary disease; Chronic obstructive; participated in this study. In accordance with real-world practice, the Self-reported success; Patient compliance; Patient satisfaction; 36 participating clinicians were recruited from several different Nebulizers; Vaporizers medical specialties, including pulmonology (11 centers; 42.3%), allergology (5 centers; 19.2%), internal medicine (5 centers; 19.2%), and primary care (5 centers; 19.2%). Each participating institution Suboptimal adherence to inhaler therapy is common among was expected to recruit 30 consecutive patients during the 7-month patients with asthma and chronic obstructive pulmonary disease study enrolment period (September 2016 to April 2017). (COPD),1-3 frequently resulting in poor disease control and increased morbidity and mortality. A wide range of sociodemo- graphic (eg, age, educational level) and clinical variables (eg, disease Study variables severity)4 may influence adherence to treatment. However, inhaler- All study variables were recorded in the study database by the related factors—ease of use, inhalation technique, and patient treating physician during a single visit conducted in the course of satisfaction with the inhaler—also play a key role in determining routine care. Informed consent was obtained at this same visit. adherence.5-8 For this reason, clinical guidelines recommend indi- The following sociodemographic variables were registered: sex, vidualized inhaler selection to ensure a good match between patient age, educational level, and occupational status. Clinical variables needs and the attributes of the particular device.9,10 assessed at baseline were diagnosis, years since onset, pre- and Numerous studies have assessed satisfaction with the inhaler in postbronchodilation forced vital capacity and forced expiratory vol- patients with asthma and COPD,6-8,11-20 some of them with a ume in 1 second, smoking status (years smoking and pack-years), potential conflict of interest. Although several studies have included and Charlson comorbidity index. both patients with COPD and patients with asthma,11-13,18 most Inhaler-related variables included the following: number of studies have grouped these patients into a single category when inhalers used, inhaler training received (yes or no), and professional reporting results. As a result, it is not clear whether there are any assessment of inhalation technique (yes or no). At the study visit, the relevant differences between these 2 groups in terms of inhaler treating physician verbally determined whether the patient had satisfaction.20 Although these 2 patient populations share many previously received training and verification of the inhalation tech- similarities,21 the numerous clinical and sociodemographic differ- nique by a health care professional. ences could potentially influence their relative satisfaction with the All patients underwent spirometry testing, performed according inhaler.2 The limited evidence reported to date suggests that patients to the Spanish Society of Pneumology and Thoracic Surgery with asthma and COPD prioritize different inhaler guidelines26 using the predicted values for the Mediterranean pop- attributes.7,11,17,20,22 However, more data are needed to better ulation.27 Disease severity and control was assessed by the COPD characterize the differences between these 2 populations with regard Assessment Test (CAT)28 or the Asthma Control Test (ACT), as to satisfaction with the inhaler.2 appropriate.29 The aim of the present cross-sectional, multi-institutional study was to assess and compare satisfaction with the inhaler in patients Evaluation instruments diagnosed with asthma or COPD and to determine the factors FSI-10. This is a validated 10-item, self-completed questionnaire independently associated with increased inhaler satisfaction. that assesses patient satisfaction with the inhaler. Each question has 5 response options scored on a Likert scale ranging from 5 (very) to 1 METHODS (hardly at all). Total scores range from 10 to 50 points, with higher Study design and patients scores indicating greater satisfaction.23 For purposes of the present This was a cross-sectional, multicenter study designed to assess study, we calculated the median FSI-10 score for the sample and and compare satisfaction with the inhaler in patients with COPD or then used this score as the cutoff value to differentiate between high asthma. Satisfaction with the current inhaler was assessed with the and low satisfaction with the device. J ALLERGY CLIN IMMUNOL PRACT PLAZA ET AL 647 VOLUME 8, NUMBER 2 TABLE I. Sociodemographic and clinical characteristics of the patients Variable* All (n [ 816) Asthma (n [ 406) COPD (n [ 410) P value† Sociodemographic variables Age (y) 60.1 (17.2) 49.8 (16.7) 70.2 (10.2) <.001 Sex, male, n (%) 445 (54.5) 129 (31.8) 316 (77.1) <.001 Educational level: secondary or university level studies, n (%) 329 (40.3) 233 (57.4%) 96 (23.4) <.001 Work status: employed, n (%) 263 (32.2) 211 (52.0) 52 (12.7) <.001 Never smoker, n (%) 304 (37) 283 (70) 21 (5) <.001 Clinical characteristics Years since diagnosis 12.7 (11.0) 16.0 (13.0) 9.4 (7.3) <.001 Received training in inhaler use, n (%) 616 (75.5) 331 (81.5) 285 (69.5) <.001 Proper inhaler technique verified, n (%) 602 (73.8) 325 (80.0) 277 (67.6) <.001 Number of devices used (range, 1-4) 1.8 (0.7) 1.8 (0.7) 1.9 (0.7) .059 Charlson comorbidity index 3.76 (2.48) 2.35 (1.67) 5.16 (2.36) <.001 FEV1 (postBD)% 72.1 (25.2) 88.5 (18.3) 53.5 (17.9) <.001 FEV1/FVC (postBD)% 0.7 (0.3) 0.8 (0.3) 0.5 (0.1) <.001 Disease control Mean ACT or CAT score NA 19.3 (4.8) 17.1 (7.6) NA Uncontrolled disease (ACT <20 or CAT >10), n (%) NA 176 (43.8%) 319 (77.8%) <.001 Treatment adherence TAI-10 score 46.0 (6.0) 45.1 (6.6) 47.0 (5.2) <.001 Level of adherence, n (%)z Good 342 (41.9) 131 (32.3) 211 (51.5) <.001 Intermediate 234 (28.7) 134 (33.0) 100 (24.4) <.001 Poor 240 (29.4) 141 (34.7) 99 (24.1) <.001 Type of nonadherence, n (%)x Erratic 447 (45.6) 262 (51.2) 185 (39.5) <.001 Deliberate 295 (30.1) 166 (32.4) 129 (27.6) <.005 Unwitting 238 (24.3) 84 (16.4) 154 (32.9) <.001 ACT, Asthma Control Test; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; NA, not applicable; postBD, postbronchodilator testing; TAI, Test of Adherence to Inhalers. *All data given as means with standard deviation unless otherwise indicated. †P values: Student’s t test or c2 test, as appropriate. zLevel of adherence defined as good (TAI-10 ¼ 50 points), intermediate (46-49 points), or poor (45 points). xThe type of nonadherence was based on the 2 physician-rated items (11 and 12) on the TAI-12. TAI. The TAI is a validated self-report instrument designed to variables. The Statistical Package for the Social Sciences, v. 23 (SPSS- assess adherence to inhaler therapy. There are 2 versions of this IBM, Chicago, Ill) was used to perform the statistical analysis. Statistical instrument: the TAI-10 and the TAI-12. The TAI-10 includes 10 significance was set at P < .05. patient-rated items with a total score ranging from 10 to 50; patients who score <50 are classified as nonadherent. The TAI-12 contains the same 10 items plus 2 additional physician-rated items designed RESULTS to orient the type of nonadherent behavior, classified as erratic (due Sociodemographic and clinical characteristics to forgetfulness), deliberate (intentional), or unwitting (due to Table I shows the sociodemographic and clinical characteris- insufficient understanding of the dosing schedule and/or poor tics of the patient sample. A total of 824 patients were initially inhalation technique). recruited; of these, 8 did not meet the inclusion criteria. Statistical analysis Therefore, the final sample included a total of 816 patients (406 The study was sized to obtain a 5% precision in the 95% confidence with asthma and 410 with COPD). interval for estimation of a proportion of approximately 70%, in both As expected, significant between-group differences on several patients with asthma and patients with COPD, allowing for 25% of study variables were observed (Table I). Patients in the COPD invalid cases for the analysis. A descriptive analysis of the sociodemo- group were significantly older (mean age: 70.2 vs 49.8 years). A graphic and baseline clinical characteristics of the study population was significantly higher proportion of the patients with asthma had performed. Data are described as means (standard deviation) or n (%), as received inhaler training (81.5% vs 69.5%) and verification of the appropriate. A univariate analysis was performed to identify the study inhalation technique (80% vs 67.6%). A significantly greater pro- variables significantly associated with satisfaction with the inhaler portion of the COPD group had uncontrolled disease (77.8% vs (cutoff: FSI-10 44), and these were then entered into a multivariate 43.8%) despite being more treatment adherent (mean TAI-10 logistic regression model. For univariate comparisons, Student’s t test score: 47.0 vs 45.1). Patients with asthma were more likely to pre- was used for quantitative variables and the c2 test for categorical sent an erratic (51.2% vs 39.5%) or deliberate (32.4% vs 27.6%) 648 PLAZA ET AL J ALLERGY CLIN IMMUNOL PRACT FEBRUARY 2020 TABLE II. Satisfaction with the inhaler: results for the FSI-10 All (n [ 816) Asthma (n [ 406) COPD (n [ 410) P* Total score, mean (SD) NA 44.1 (6.5) 42.0 (7.7) <.001 n Percent n Percent n Percent 1. Has it been easy to learn how to use the inhaler? <.001 Very 361 44.2 222 54.7 139 33.9 Fairly 305 37.4 130 32.0 175 42.7 Somewhat 83 10.2 29 7.1 54 13.2 Not very 35 4.3 12 3.0 23 5.6 Hardly at all 32 3.9 13 3.2 19 4.6 2. Was it easy to prepare the inhaler for use? <.001 Very 387 47.4 234 57.6 153 37.3 Fairly 291 35.7 128 31.5 163 39.8 Somewhat 77 9.4 19 4.7 58 14.1 Not very 30 3.7 8 2.0 22 5.4 Hardly at all 31 3.8 17 4.2 14 3.4 3. Was it easy to use the inhaler? <.001 Very 421 51.6 252 62.1 169 41.2 Fairly 290 35.5 120 29.6 170 41.5 Somewhat 60 7.4 18 4.4 42 10.2 Not very 24 2.9 9 2.2 15 3.7 Hardly at all 21 2.6 7 1.7 14 3.4 4. Was it easy to keep the inhaler clean and in good working condition? .009 Very 456 55.9 248 61.1 208 50.7 Fairly 281 34.4 130 32.0 151 36.8 Somewhat 43 5.3 14 3.4 29 7.1 Not very 11 1.3 6 1.5 5 1.2 Hardly at all 25 3.1 8 2.0 17 4.1 5. Was it easy to continue normal activities with the use of the inhaler? .239 Very 434 53.2 231 56.9 203 49.5 Fairly 285 34.9 133 32.8 152 37.1 Somewhat 60 7.4 27 6.7 33 8.0 Not very 17 2.1 8 2.0 9 2.2 Hardly at all 20 2.5 7 1.7 13 3.2 6. Did the inhaler fit your lips comfortably? .001 Very 441 54.0 247 60.8 194 47.3 Fairly 283 34.7 131 32.3 152 37.1 Somewhat 53 6.5 13 3.2 40 9.8 Not very 17 2.1 4 1.0 13 3.2 Hardly at all 22 2.7 11 2.7 11 2.7 7. Was using the inhaler easy in terms of size and weight? .014 Very 449 55.0 247 60.8 202 49.3 Fairly 286 35.0 122 30.0 164 40.0 Somewhat 44 5.4 18 4.4 26 6.3 Not very 12 1.5 7 1.7 5 1.2 Hardly at all 25 3.1 12 3.0 13 3.2 8. Was it easy to carry the inhaler with you? .820 Very 426 52.2 213 52.5 213 52.0 Fairly 267 32.7 130 32.0 137 33.4 Somewhat 76 9.3 42 10.3 34 8.3 Not very 20 2.5 9 2.2 11 2.7 Hardly at all 27 3.3 12 3.0 15 3.7 9. After you have used the inhaler do you have the feeling that you used it correctly? .276 Very 381 46.7 199 49.0 182 44.4 Fairly 320 39.2 157 38.7 163 39.8 Somewhat 82 10.0 32 7.9 50 12.2 (continued) J ALLERGY CLIN IMMUNOL PRACT PLAZA ET AL 649 VOLUME 8, NUMBER 2 TABLE II. (Continued) All (n [ 816) Asthma (n [ 406) COPD (n [ 410) P* Not very 16 2.0 9 2.2 7 1.7 Hardly at all 17 2.1 9 2.2 8 2.0 10. Overall, considering your responses to the previous questions, were you satisfied with the inhaler? .011 Very 414 50.7 225 55.4 189 46.1 Fairly 342 41.9 162 39.9 180 43.9 Somewhat 46 05.6 13 3.2 33 8.0 Not very 4 0.5 2 0.5 2 0.5 Hardly at all 10 1.2 4 1.0 6 1.5 COPD, Chronic obstructive pulmonary disease; FSI-10, Feeling of Satisfaction with Inhaler; NA, not applicable; SD, standard deviation. *P values from the c2 test and Student’s t test (total score). FIGURE 1. Percentage of patients very or fairly satisfied on the FSI-10 survey. COPD, Chronic obstructive pulmonary disease; FSI-10, Feeling of Satisfaction with Inhaler. nonadherence pattern. The unwitting nonadherence pattern was Correlation analyses more common in patients with COPD (32.9% vs 24.3%). A Spearman’s correlation analysis for the whole sample showed a statistically significant (P ¼ .0001) but weak positive correlation (r ¼ 0.168) between treatment adherence (TAI-10) Satisfaction with the inhaler and satisfaction (FSI-10). Treatment adherence by group was Table II shows the FSI-10 scores by group and for the whole also weakly correlated with inhaler satisfaction (r ¼ 0.168 and cohort. The asthma group was more satisfied overall (mean r ¼ 0.158 for COPD and asthma, respectively; P ¼ .001). FSI-10 score: 44.1 vs 42.0; P < .001) and significantly more A high ACT score in the asthma group was positively corre- satisfied on 7 of the 10 FSI-10 items, with no significant lated with high inhaler satisfaction (r ¼ 0.174; P < .001), between-group differences on the remaining 3 FSI-10 items suggesting that good disease control was associated with high (questions 5, 8, and 9). inhaler satisfaction. A low CAT score in the COPD group was Although 90% of patients in both groups were “very” or negatively correlated with satisfaction (r ¼ 0.274; P < .001), “fairly” satisfied with the inhaler (item 10), the proportion of also suggesting that low disease impact in this group was asso- very or fairly satisfied patients was higher in the asthma group ciated with high inhaler satisfaction. (95.3% vs 90.0%). These differences are depicted graphically in Figure 1, which shows the percentage of patients in each group Univariate analysis who were very or fairly satisfied on each of the 10 items on the The median FSI-10 score in the whole cohort was 44 points. FSI-10 questionnaire. Based on a cutoff value of FSI-10 44, satisfaction was considered high in 450 patients (55.2%) and low in 366 patients Treatment satisfaction according to adherence level (44.8%). Table IV shows the variables significantly associated (P < .05) and patterns with inhaler satisfaction (FSI-10 44) on the univariate analysis. Table III shows the mean FSI-10 scores in both groups ac- Two variables—asthma diagnosis and previous training in cording to the level of adherence and the type of nonadherence. inhaler use—were significantly associated with high satisfaction, Patients in the asthma group were more satisfied with the inhaler, and 3 variables—older age, poor disease control, and unwitting regardless of the level of adherence or specific pattern of non- nonadherence—were significantly associated with low adherence (except for the unwitting pattern). satisfaction. 650 PLAZA ET AL J ALLERGY CLIN IMMUNOL PRACT FEBRUARY 2020 TABLE III. Treatment satisfaction (FSI-10 score) by level and type TABLE V. Results of the multivariate logistic regression: variables of adherence for each group significantly associated with high satisfaction with the inhaler FSI-10 score, mean (SD) (FSI-10 score 44) Variable Asthma COPD P* Variable OR (95% CI) P* † Age 0.99 (0.98-1.00) .049 Level of adherence Good 44.6 (6.3) 42.7 (7.9) .012 Disease control (ACT 20 or CAT 10) 1.74 (1.28-2.36) <.001 Intermediate 45.0 (5.4) 42.3 (7.2) .002 Training in inhalation technique 1.85 (1.32-2.50) <.001 Poor 42.6 (7.3) 40.5 (7.4) .027 Absence of unwitting nonadherence pattern 1.82 (1.31- 2.52) <.001 Pattern of nonadherence ACT, Asthma Control Test; CAT, Chronic Obstructive Pulmonary Disease Assess- Erratic 43.8 (6.6) 41.3 (7.5) <.001 ment Test; CI, confidence interval; FSI-10, Feeling of Satisfaction with Inhaler; OR, odds ratio. Deliberate 43.0 (6.7) 40.7 (7.3) .006 *P value from Wald tests. Unwitting 41.8 (7.9) 40.2 (7.5) .111 COPD, Chronic obstructive pulmonary disease; FSI-10, Feeling of Satisfaction with Inhaler; SD, standard deviation; TAI, Test of Adherence to Inhalers. pattern. Notably, the diagnosis (asthma or COPD) was not *Student’s t test. significantly associated with satisfaction on the multivariate †Level of adherence is defined as good (TAI-10 ¼ 50 points), intermediate (46-49 analysis. These findings indicate that variables other than diag- points), or poor (45 points). The pattern of adherence was based on items 11 and 12 on the TAI-12. nosis appear to explain the differences in satisfaction with the inhaler among patients with asthma and COPD. TABLE IV. Univariate analysis: association between study vari- Between-group differences according to the results ables and satisfaction with the inhaler of the FSI-10 FSI-10 <44 FSI-10 ‡44 Patients with asthma were significantly more satisfied with the Variable (n [ 366), n (%) (n [ 450), n (%) P value* inhaler overall (Table II), regardless of the level of adherence Age, mean (SD) 63.3 (17.1) 58.5 (17.0) <.001 (Table III) or the pattern of nonadherence, except for the Sex (male) 211 (5.7%) 234 (52.0%) .107 unwitting pattern, for which no between-group differences were Asthma diagnosis 154 (42.1%) 252 (56.0%) <.001 observed. Poor disease 256 (69.9%) 239 (53.1%) <.001 If we group the patient responses on the 5-point scale (see control (ACT Figure 1) into positive (“very” or “fairly satisfied”) and negative <20 or CAT responses (“not very” or “hardly at all” satisfied), the highest >10) rated item in both groups was item 10 (overall satisfaction), Previous training 248 (67.8%) 368 (81.8%) <.001 which was rated positively by 95.3% and 90.0% of patients with in inhaler use asthma and COPD, respectively. The second highest rated item Unwitting 142 (38.8%) 96 (21.3%) <.001 among patients with asthma (93.1%) was item 4 (“ease of nonadherence keeping the inhaler clean and in good working condition”), Level of 144 (39.3%) 198 (44.0%) .180 whereas the second highest rated item among patients with adherence, TAI- COPD (89.3%) was item 7 (“size and weight”). By contrast, the 10 (<50) 2 lowest rated items were the same in both groups: item 1 (“easy ACT, Asthma Control Test; CAT, Chronic Obstructive Pulmonary Disease Assess- to learn”: 6.2% and 10.2% of patients with asthma and COPD, ment Test; FSI-10, Feeling of Satisfaction with Inhaler; SD, standard deviation; TAI, respectively) and item 2 (“easy to prepare the inhaler for use”: Test of Adherence to Inhalers. 6.2% and 8.8%, respectively). *P values calculated with Student’s t test or the c2 test. There was a wide discrepancy between the groups with regard to the perceived ease of inhaler use (item 3), with 91.7% of patients with asthma finding the inhaler very or fairly easy to use On the multivariate analysis (Table V), 4 variables were versus “only” 82.7% of the patients with COPD. The most significantly associated with high satisfaction (FSI-10 44): (1) likely explanation for this difference is the greater proportion of younger age; (2) good disease control; (3) previous inhaler patients in the asthma group (>80% vs 70%) who had received training; and (4) absence of unwitting nonadherence pattern. training and verification of the inhaler technique. However, the substantial age differences between the groups (patients in the COPD were, on average, 20 years older) probably also influenced DISCUSSION the scores on this item because of the presence of more physical Patients with asthma were significantly more satisfied with the limitations and comorbidities.11 inhaler and significantly more satisfied on most (70%) of the 10 Despite the clear differences in satisfaction between these inhaler-related variables assessed on the FSI-10. These differences groups, the results of the logistic regression analysis indicate that were maintained regardless of the specific adherence level (good, the diagnosis does not play a significant role in determining intermediate, or poor) and for 2 (erratic, deliberate) of the 3 satisfaction with the inhaler. Rather, as the multivariate analysis nonadherence patterns (Table III). After adjusting for con- shows, variables other than diagnosis were associated with high founding variables (multivariate analysis), 4 variables were asso- satisfaction with the inhaler: younger age, previous inhaler ciated with high satisfaction with the inhaler: (1) younger age; (2) training, absence of the unwitting nonadherence pattern, and good disease control (ACT 20 or CAT 10); (3) previous good disease control. These findings are consistent with the re- inhaler training; and (4) absence of the unwitting nonadherence sults of a study conducted previously by our group to determine J ALLERGY CLIN IMMUNOL PRACT PLAZA ET AL 651 VOLUME 8, NUMBER 2 the impact of patient satisfaction with the inhaler on adherence type and incidence of errors have remained largely unchanged in and disease control in a large sample (n ¼ 778) of patients with the last 40 years,31 highlighting the need for better training and asthma.8 In that study, younger age, disease control, and treat- more intuitive, easier to use inhalers. The findings of the present ment adherence were significantly associated with higher satis- study—in which ease of use was the lowest rated item on the FSI- faction with the inhaler (FSI-10). These findings are also in line 10 in both groups—would seem to support that conclusion. with the results of another study by our group that compared Comparative data on differences between patients with asthma differences in treatment adherence and in nonadherence patterns and COPD with regard to satisfaction with the inhaler are in patients with asthma and COPD,2 finding several significant limited. Although a few studies11,20,22 have investigated differ- differences between the 2 groups on those outcome measures; ences in patient preferences between these 2 groups, none of however, when the analysis was adjusted for confounders, only 2 those studies used a validated instrument such as the FSI-10. variables—younger age and active employment status (but not Moreover, none of those studies adjusted for confounding vari- diagnosis)—were significantly associated with nonadherence. ables, thus making it difficult to identify the true determinants of Although published reports on the association between disease satisfaction. The largest of these comparative studies was per- control and satisfaction with the inhaler are limited, our finding formed by Ding et al,11 who conducted an international, cross- that disease control is correlated with inhaler satisfaction in the sectional study involving more than 7300 patients diagnosed patients with asthma is consistent with other reports,7,14 with asthma, COPD, or asthma-COPD overlap syndrome in the including our previous study.8 In line with our findings in the context of routine care. Those authors administered an ad hoc asthma group, we observed a significant association between low survey that asked patients to rate their satisfaction with 12 disease impact and high inhaler satisfaction among the patients different inhaler attributes. In the asthma group, the most highly with COPD. rated feature was convenience (portability and minimal dose The multivariate analysis also revealed a significant association preparation). By contrast, robustness, reliability, and dose between the absence of the unwitting nonadherence pattern and reproducibility were the most important characteristics for the high satisfaction with the inhaler. In other words, patients who patients with COPD. Despite the valuable data provided by that presented an unwitting nonadherence (a failure to adhere to study, it is important to note that the influence of sociodemo- treatment due to forgetfulness, an inability to fully understand graphic and clinical variables on these preferences was not the dosing regimen, or poor inhalation technique) were less assessed. Two other studies have also described differences satisfied with the inhaler. Previous research6 has demonstrated among patients with asthma and COPD in terms of the inhaler that patients with this pattern of nonadherence tend to be older attributes.17,22 Hawken et al22 surveyed 294 patients with with some degree of cognitive and/or physical impairment, all of asthma (n ¼ 201) or COPD (n ¼ 93), finding that the most which are more characteristic of patients with COPD than pa- important feature for patients with asthma was the number of tients with asthma. Not surprisingly, nearly 1 of every 3 patients steps required for dose preparation; by contrast, patients with with COPD in our study presented an unwitting nonadherence COPD most valued an inhaler that could be used during epi- pattern versus only one sixth of the patients with asthma, an sodes of breathing difficulties. Finally, in a real-world study important difference that may partially explain the lower satis- designed to evaluate satisfaction with a specific inhaler (Easy- faction scores on the FSI-10 in the COPD group.6 haler), Gálffy et al17 found that a higher percentage of patients The significant association between previous training in inha- with asthma were very satisfied with the device (52.6%) than lation technique and patient satisfaction was not unexpected, as those with COPD (33.4%), a finding that is consistent with our patients who understand how to use the inhaler properly are less data (55.4% and 46.1%, respectively). However, in contrast to likely to be frustrated or confused—thus eliminating a potential our findings, those authors did not find any age-related differ- cause of dissatisfaction—and therefore more satisfied. In this re- ences in satisfaction with the inhaler. gard, patient responses on several FSI-10 items—particularly item Although the findings from the aforementioned studies sug- 1 (ease of learning to use the inhaler)—underscore the importance gest that there may be small differences between patients with of providing device-specific training. Item 1 was the lowest-rated asthma and COPD in terms of device preferences and satisfac- item in both groups, with a substantial proportion of patients in tion, more research is needed to ascertain whether these differ- the asthma and COPD groups (6.2% and 10.2%, respectively) ences are due to factors other than the diagnosis. Although there reporting difficulty in learning to use the device. It also seems may well be differences between patients with asthma and probably that the significant between-group differences on several COPD in terms of preferences for certain device attributes, as other FSI-10 items (eg, items 2, 3, and 7; Table II) may be partially Ding et al concluded, these preferences could be attributable to due to differences in inhaler training and verification. The signif- variables other than the specific respiratory condition. icant association between previous training and satisfaction with the inhaler underscores the need to ensure that all patients— Study strengths and limitations particularly those with COPD (who received less training and were The present study has several limitations. First, our results could less satisfied)—receive quality instruction and ongoing monitoring have been influenced by the specific mix of devices used by patients of their inhalation technique, as recommended in several previous in this study. That said, the real-world study design reflects the reports30-32 and clinical guidelines.9,25 Numerous studies have heterogeneity of routine clinical practice. Second, limitations shown that errors in the inhalation technique are widespread in inherent to the FSI-10 scale may also have influenced our results, as patients with COPD and asthma, regardless of their level of no minimum score has been established to determine clinically satisfaction with the inhaler.11,33 Some studies have even found relevant differences and the cutoff level to distinguish between high that more than 90% of patients make at least 1 critical error.32 and low satisfaction was arbitrary. Nonetheless, the median score on Moreover, a systematic review published in 2016 found that the the FSI-10 in the current study was virtually the same as the median 652 PLAZA ET AL J ALLERGY CLIN IMMUNOL PRACT FEBRUARY 2020 value obtained in a previous study (44 and 43 points, respectively).8 Molina Osora; Anna Sala Cunill: Hospital Vall d’Hebron; Fer- Third, although the TAI has been validated against electronic nando J. Sánchez Lora: Hospital Universitario Virgen de la monitoring devices, it is worth noting that the validation study24 Victoria; Juan Miguel Sánchez Nieto: Hospital General Uni- found that electronic data showed higher adherence scores and versitario Morales Meseguer; Joan Serra Batlles: Hospital Uni- lower nonadherence scores versus the TAI. Fourth, most of the versitari de Vic; José Joaquín Torres Relucio: Hospital General participating physicians in this study were specialists (only 22.2% Universitario de Castellón; Agustín Valido Morales: Hospital were general practitioners), which could have biased sample selec- Universitario Virgen Macarena; Rubén Luciano Vázquez Alar- tion. Finally, the cross-sectional study design provides only a cón: Centro de Salud VERA; José Luis Velasco Garrido: Hospital “snapshot” of patient satisfaction, which is likely to vary over time Universitario Virgen de la Victoria. due to the chronic nature of these pathologies. By contrast, an important strength of this study is that it is the first to directly REFERENCES compare inhaler satisfaction in a large cohort of patients with COPD 1. Toy EL, Beaulieu NU, McHale JM, Welland TR, Plauschinat CA, Swensen A, and asthma. et al. Treatment of COPD: relationships between daily dosing frequency, adherence, resource use, and costs. 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