Abstract
Background:
Greater patient satisfaction with his or her inhalation device is associated with better adherence to pharmacological therapy and better clinical outcomes, such as improved quality of life, greater asthma control, and fewer exacerbations. The objective of this study was to determine the satisfaction level of a group of patients diagnosed with bronchial asthma concerning their devices for inhalation of bronchodilators and glucocorticoids.
Methods:
This was a cross-sectional study of patients treated in the Colombian health system. Satisfaction with inhalation devices was evaluated with the Feeling of Satisfaction with Inhaler (FSI)-10 questionnaire. A score of ≥44 points indicated high satisfaction.
Results:
In total, 362 patients from 59 cities were identified, their median age was 55 years, and 74.6% were women. The FSI-10 average score was 44.6; 68.5% of patients showed high satisfaction, especially with pressurized metered-dose inhalers (pMDIs), and 63.4% did not use them with an inhalation chamber. Users of pMDIs (odds ratio [OR]: 1.80; 95% confidence interval [CI]: 1.05–3.10) and those who received training by medical specialists (OR: 2.29; 95% CI: 1.33–3.97) had high satisfaction, while patients who were older (40–64 vs. <40 years: OR: 0.38; 95% CI: 0.19–0.78 and ≥65 vs. <40 years: OR: 0.35; 95% CI: 0.15–0.81), resided in the Caribbean region (OR: 0.48; 95% CI: 0.29–0.81), and had a university education (OR: 0.54; 95% CI: 0.32–0.90) had lower satisfaction.
Conclusions:
The majority of patients with asthma used pMDIs without an inhalation chamber, and their overall satisfaction was higher than that of patients using other inhalation devices. Patients who received special training from medical specialists showed better satisfaction.
Introduction
Inhalation devices allow the administration of medications for the management of pulmonary diseases such as bronchial asthma and chronic obstructive pulmonary disease (COPD).1,2 By this route of administration, glucocorticoids and bronchodilators such as β-2 adrenergic agonists and muscarinic antagonists can be used, allowing the direct and rapid action of the active ingredient in the respiratory tract, with lower doses than those necessary through the systemic route and with fewer adverse drug-related reactions.1–3
In the market, there are three main types of inhalation devices: the pressurized metered-dose inhaler (pMDI), the dry powder inhaler (DPI) in single or multiple doses, and the soft mist inhaler (SMI), all of which allow the delivery of the active ingredient to the respiratory tract.4,5 However, to achieve an adequate response to therapy, the user must be able to perform the appropriate inhalation technique. 6 In fact, errors in inhaler technique and poor adherence lead to poor asthma control, with a higher risk of hospitalization, more visits to the emergency department, and an increase in the use of oral glucocorticoids.7–9 In contrast, greater patient satisfaction with the inhalation device is associated with better adherence to pharmacological therapy and better clinical outcomes in terms of quality of life, with fewer exacerbations and visits to the doctor or hospital.7,10
Satisfaction can be understood as the degree to which a patient considers that the service or health care product, or how the provider provides it, is useful, effective, or beneficial. 11 It can be quantified by means of the Feeling of Satisfaction with Inhaler (FSI)-10 questionnaire, an understandable, easy-to-use tool that is capable of identifying differences in patient satisfaction among different inhalers and that includes items related to comfort, difficulty, transportability, and utilization. 12 This questionnaire consists of 10 questions, each with five response options on a 5-point Likert scale (“very high satisfaction,” “high satisfaction,” “moderate satisfaction,” “low satisfaction,” and “very low satisfaction”) scored, respectively, from 5 to 1 (total score: 50), and this scale has been validated for application to asthmatic patients and in Spanish. 12
When selecting the type of inhaled therapy for patients diagnosed with asthma, the characteristics of the inhaler, the preferences and opinions of the patients, and the conditions that could improve adherence and control of the disease should be taken into account.13,14 Likewise, user satisfaction with the inhaler is related to more favorable clinical results,7,10 and difficulties in using the inhaler have been shown to contribute to poor treatment adherence 13 ; thus, the choice of inhaler is key to asthma control.13,14 The objective of this study was to determine the satisfaction of a group of patients with bronchial asthma from Colombia with the use of their devices for inhalation of bronchodilators and glucocorticoids in 2021.
Materials and Methods
Study design
This was an observational cross-sectional study on the satisfaction of patients and the type of inhalation devices used by patients diagnosed with asthma who were managed with inhaled bronchodilators or glucocorticoids. The variables of interest were collected from a drug dispensing database and from telephone calls.
Population of study
The Colombian Health System offers universal coverage to the entire population through two affiliation regimes: the contributory one, which is paid by the workers and employers, and the subsidized one by the state, which is responsible for insuring all people without the ability to pay, and includes a benefit plan that involves a large number of medications. Patients were identified based on a drug dispensing database that collects the information of ∼8.5 million people affiliated with the Colombian health system from six health insurance companies, corresponding to ∼30.0% of the active affiliated population of the contributory or paid regime and 6.0% of the state-subsidized regime, comprising 17.3% of the Colombian population.
From this population, patients diagnosed with asthma were selected using the codes of the International Classification of Diseases (ICD-10), namely, J450, J451, J458, J459, and J46X, with ≥12 years, of any sex and city of residence, and undergoing pharmacological management with at least one bronchodilator or inhaled glucocorticoid between June 1 and June 30, 2021. Patients with a concomitant or previous diagnosis of COPD and those who were undergoing treatment only with oral pharmaceuticals were excluded.
During the study period, a total of 8101 people who met the previously established criteria were identified. For the characterization of the different inhalation devices, all identified patients were considered, and for the evaluation of satisfaction and other sociodemographic and pharmacological variables, only those aged 18 years or older (n = 6387) were included. From this group of patients, a stratified random sample of 362 cases was calculated using the Epi Info program, and stratification was performed according to the type of inhalation device (pMDI, DPI, and SMI), with an error of 5%, a confidence level of 95%, and an expected frequency of 50%. Telephone calls were made to the selected patients, and with prior verbal informed consent, satisfaction was evaluated using the FSI-10 questionnaire.
Data collection and variables
With the information obtained from the patient and the medications dispensed by the company Audifarma SA, a database that allowed the collection of the following groups of variables was designed:
1. Sociodemographic variables: sex, age, education, occupation, health system affiliation, and city of residence. The place of residence was categorized by the department according to the regions of Colombia and considering the classification of the National Administrative Department of Statistics (DANE) of Colombia, as follows: Caribbean region, Central region, Bogotá–Cundinamarca region, Pacific region, and Eastern–Orinoquía–Amazonia region.
2. Classification of devices:
pMDI: with or without inhalation chamber. DPI: single dose or multidose. SMI.
3. Training methods: demonstration, video, verbal instructions, booklet, others.
4. Training was administered by a general practitioner, specialist physician (pulmonologist, pediatrician, internist, or allergist), nurse, respiratory therapist, pharmacist, or any health professional.
5. Satisfaction/attributes of the device: the FSI-10 questionnaire was used. Supplementary Table S1 shows the questions contained in the instrument. An FSI-10 score of 44 or more points was considered high satisfaction. 15
6. Comorbidities were identified from the main and secondary diagnoses reported by the ICD-10 in the selected patients.
7. Bronchodilators and inhaled corticosteroids: salbutamol, formoterol—budesonide, beclomethasone, salmeterol—fluticasone, ipratropium bromide, vilanterol—fluticasone, tiotropium, others.
8. Comedications: they were grouped into the following categories: (a) antidiabetics (oral and subcutaneous), (b) antihypertensives and diuretics, (c) lipid-lowering drugs, (d) antiulcer drugs, (e) antidepressants, (f) anxiolytics and hypnotics, (g) thyroid hormone, (h) antipsychotics, (i) antiepileptics, (j) antihistamines, (k) analgesics and anti-inflammatories, (l) antileukotrienes, and (m) antithrombotics (antiplatelet agents and anticoagulants), among others.
Supplementary Table S2 shows the variables collected from the drug dispensing database and the variables collected from telephone calls.
Ethics considerations
The protocol was approved by the Bioethics Committee of the Technological University of Pereira in the category of research without risk (endorsement code: 39-070521). The ethical principles established by the Declaration of Helsinki were followed. Informed consent was applied orally before the interview by telephone for those selected patients.
Statistical analysis
The data were analyzed with the statistical package SPSS Statistics, version 26.0 for Windows (IBM, USA). A descriptive analysis was performed with frequencies and proportions for the qualitative variables and measures of central tendency and dispersion for the quantitative variables, depending on their parametric behavior established by the Kolmogorov–Smirnov test. Mann–Whitney U tests were used for comparisons of quantitative variables, and the χ 2 or Fisher's exact test was used for categorical variables. A multivariate binary logistic regression model was developed that included the associated variables in the bivariate analyses, as well as those with sufficient plausibility or reported association to identify those that could be associated with having high satisfaction (FSI-10: ≥44 points) (yes/no).
The Hosmer–Lemeshow test was performed to describe the goodness of fit. The predictive capacity of the model was determined according to the area under the curve (AUC). A level of statistical significance was established at p < 0.05.
Results
In total, 8101 patients ≥12 years old who met the initial inclusion criteria were identified. Of these, the majority used pMDIs (n = 5911; 73.0%), followed by multidose DPIs (n = 2241; 28.0%), single-dose DPIs (n = 628; 7.8%), and SMIs (n = 330; 4.1%). The 362 patients who were selected in the stratified randomized sampling came from 59 different cities; 74.6% (n = 270) were women, and the median age was 55.0 years (interquartile range: 41.8–66.0 years; range: 18.0–91.0 years). A total of 21.5% (n = 78) were between 18 and 39 years old, 52.5% (n = 190) were between 40 and 64 years old, and 26.0% (n = 94) were aged 65 or older.
The majority of patients came from the Bogotá–Cundinamarca region (n = 133; 36.7%), followed by the Caribbean region (n = 110; 30.4%), the Central region (n = 77; 21.3%), Pacific region (n = 39; 10.8%), and Eastern–Orinoquía–Amazonia region (n = 3; 0.8%). The educational level of most patients was secondary (n = 129; 35.6%), followed by university (n = 114; 31.5%) and primary (n = 110; 30.4%), and the main occupation was household activities (n = 139; 38.4%). A total of 80.9% (n = 293) of the patients were affiliated with the contributory regime, and 19.1% (n = 69) were affiliated with the subsidized regime of the Colombian health system.
Inhalation devices
A total of 93.9% (n = 340) of the patients stated that they received training to learn to use the inhalation device, mainly through verbal instructions (n = 187; 51.7%) or demonstration (n = 180; 49.7%), by specialist physicians (n = 235; 64.9%) and general practitioners (n = 113; 31.2%) (Table 1). Of the 216 patients who used pMDIs, 63.4% (n = 137) did not use them with an inhalation chamber. The inhalation chamber is mainly used for short-acting bronchodilators compared with long-acting bronchodilators and inhaled glucocorticoids (67.5% vs. 48.1%; p = 0.784).
Comparison of the Type of Inhaler with Some Sociodemographic Variables, Type of Training Received and Professional Who Performed It, in Patients Diagnosed with Bronchial Asthma, Colombia
IQR, interquartile range.
According to the FSI-10 questionnaire, the average score was 44.6 ± 4.5 (range 18–50 points), and 68.5% (n = 248) indicated high satisfaction (≥44 points), mainly for pMDIs (n = 160/216; 74.1%). Table 2 shows the score obtained for each question of the FSI-10 questionnaire by type of inhalation device. A total of 18.5% (n = 67) of patients used two different inhalation devices for their treatment, and compared with those using a single inhalation device, patients with two or more had similar satisfaction (45.0 vs. 46.0 points; p = 0.066). Furthermore, satisfaction was similar among those using short-acting bronchodilators compared with users of long-acting bronchodilators and inhaled glucocorticoids (45.0 vs. 46.0 points; p = 0.789).
Description of the Type of Inhaler with the Score Obtained in Each Question of the Feeling of Satisfaction with Inhaler-10 Questionnaire in Patients with a Diagnosis of Bronchial Asthma, Colombia
FSI, Feeling of Satisfaction with Inhaler; SD, standard deviation.
Comorbidities
The main comorbidities that were identified were hypertension (n = 135; 37.3%), followed by allergic rhinitis (n = 44; 12.2%), diabetes mellitus (n = 41; 11.3%), hypothyroidism (n = 37; 10.2%), and dyslipidemia (n = 28; 7.7%). The vast majority also received medications other than inhalers (n = 340; 93.9%), mainly analgesics and anti-inflammatories (n = 212; 58.6%), antihistamines (n = 167; 46.1%), antiulcer agents (n = 164; 45.3%), antihypertensives and diuretics (n = 135; 37.3%), lipid-lowering drugs (n = 128; 35.4%), antileukotrienes (n = 106; 29.3%), antidepressants (n = 72; 19.9%), antithrombotics (n = 64; 17.7%), antidiabetic drugs (n = 51; 14.1%), and thyroid hormone (n = 50; 13.8%). Neuroleptics were prescribed to 25.4% (n = 92) of the patients.
Multivariate analysis
The binary logistic regression found that the users of pMDIs and those who received training by medical specialists had high satisfaction with the inhalation device, while at an older age, residing in the Caribbean region and those with a university-level education had lower satisfaction (Hosmer–Lemeshow test p = 0.813 and AUC = 0.698) (Table 3).
Binary Logistic Regression on the Variables Associated with High Satisfaction in Patients with a Diagnosis of Bronchial Asthma, Colombia
CI, confidence interval; OR, odds ratio.
Discussion
This analysis allowed us to characterize the most used types of inhalation devices, the level of satisfaction, and the factors related to high satisfaction in a group of patients diagnosed with bronchial asthma treated in different geographical regions of Colombia. These findings can be useful for health care, academic, and scientific personnel in making decisions regarding the opinions, preferences, and satisfaction that patients have with the inhalation device, thereby contributing to improving their adherence to pharmacological management and clinical control of this pathology.7,10,13 In general, the median age was similar to that found in some studies (48.2–53.4 years)16–18 and higher than that reported by other authors (37.0–42.3 years),12,19 with a predominance of women in various studies (54.0%–82.0%).12,16,17,19–22 The most frequent comorbidities found in this group of patients were arterial hypertension, allergic rhinitis, and diabetes mellitus, which is consistent with what has been found in the literature.14,17,21
The most commonly used group of devices was pMDIs, which is in line with what has been described in other reports that have involved asthmatic patients,19,20,23,24 but is in contrast with a multicenter study that included patients from the United States, Europe, and Asia in which DPIs predominated. 14 The reason for the widespread use of pMDIs in this report is due to the high prescription of short-acting β-2 adrenergic agonists such as salbutamol and inhaled glucocorticoids such as beclomethasone.
This is consistent with what was reported in a pharmacoepidemiological study on the pattern of use of bronchodilators and inhaled corticosteroids in Colombia. 21 Also, these are the inhaled medications that are included in the country's health benefit plans and are mostly available as pMDIs. 25 This type of inhalation device has advantages and disadvantages, and so, health care professionals must adapt the device according to the needs, availability, costs, preferences, and capacity of patients.3,26,27 In this way, pMDIs are preferred for people who have spontaneous breathing, good coordination, and poor inspiratory flow, such as patients with severe airway obstruction. 26 The problem with pMDIs is that patients frequently make mistakes when using them. 8
The clinical guidelines recommend the use of an inhalation chamber when using pMDIs1,28 for facilitating the coordination between inhalation and activation, reducing the proportion of the active ingredient that impacts the oropharynx, decreasing the unpleasant taste and other side effects, and increasing the proportion of the medication that arrives at the respiratory tract.26,27 In addition, the use of inhaled chambers makes it possible to reduce the frequency of adverse drug reactions associated with inhaled corticosteroids.29,30
However, almost two-thirds of the patients in this study use their pMDIs without an inhalation chamber, something that has been also reported in studies from different countries.31,32 For example, in the United States, 54.3% of patients diagnosed with asthma or COPD did not use the inhalation chamber, 31 and in New Zealand, 47.0% of patients did not use it. 32
Most of the patients had received training for the use of their inhalation devices, which contrasts markedly with other studies, in which it was evidenced that a large proportion of the patients did not receive education on the proper way to use medications and inhalation devices (40.7%–44.3%).19,23,33 However, the findings of this report are consistent with those of a multicenter study that involved patients from seven European countries; it was documented that 78.0% of them received education on the correct use of the inhaler. 34 The teaching strategy most frequently found in this study was giving verbal instructions, which is in agreement with the European studies. 34 but it contrasts with what was found in Turkey where practical teaching prevailed (demonstration). 24
According to a systematic review and meta-analysis of clinical trials, all educational interventions (verbal instructions, demonstrations, or printed resources) optimized the performance of the inhaler and improved clinical outcomes such as hospitalization, exacerbations, and control of the pathology. Teaching through demonstrations with devices containing a placebo seems to be the most effective. 9
According to the FSI-10 questionnaire, this group of asthmatic patients had an average satisfaction score of 44.6 points, which is consistent with other published studies.15,18,35 However, in Greece and Spain, the score was lower (42.8 and 42.5–42.6 points, respectively), but only DPIs were included in these studies.12,13,16 In the current analysis, differences were found in the degree of satisfaction according to the type of inhalation device used, which contrasts with the data reported by Aggarwal et al in India, who used the Treatment Satisfaction Questionnaire for Medication tool and did not find differences in the general satisfaction of asthmatic patients who used pMDIs or DPIs. 20
However, in Spain, using the FSI-10 questionnaire, differences in favor of DPIs were evident,18,22 and in other studies conducted in the European countries, significant differences were found but within the group of DPI devices.12,13,16,36 It is important to know the opinions and perceptions of patients because this contributes to improving adherence to pharmacological treatment and thus to better control of the pathology and fewer exacerbations.7,10,13,22,36
Several factors were found to influence patient satisfaction with the inhalation device, but few studies have compared the results.13,15,18 It was found that at an older age, satisfaction was lower, which is consistent with that reported in Spain by Plaza et al, where at a younger age, satisfaction was higher (odds ratio [OR]: 0.99; 95% confidence interval [CI]: 0.98–1.00, p = 0.049). 15 Similarly, they documented that prior training (OR: 1.85; 95% CI: 1.32–2.50, p < 0.001) and good control of the pathology (OR: 1.74; 95% CI: 1.28–2.36, p < 0.001) were associated with better satisfaction. 15 However, in this report, the degree of asthma control was not evaluated, but it was found that the education and training provided by a medical specialist improved patient satisfaction with the inhalation device.
On the contrary, it was found that patients who used pMDIs had better satisfaction than those who used the other devices. These differences in satisfaction were also evidenced in another study, in which DPIs were compared: users of Easyhaler® had a higher score on the FSI-10 questionnaire (OR: 1.70; 95% CI: 1.05–2.75). 13 Finally, it was found in this analysis that users with a higher level of education had lower satisfaction, contrasting with what was found by Donaire et al. In Spain, satisfaction improved with the increase in schooling. 18
Some limitations should be considered when interpreting the results. Access to the medical records was not obtained to verify the accuracy of the diagnoses assigned by the doctor, but they were validated with the patients during the telephone call. In addition, the severity and degree of asthma control and the inhalation technique, among other clinical and paraclinical variables, were not verified. Similarly, the medications used outside the health system or not delivered by the dispensing company that the patients may have received are unknown. However, the study included a significant number of patients distributed in most geographic regions of the national territory that are representative of the two institutions of affiliation with the health system of the country.
Conclusions
With the above results, we can conclude that the majority of patients with asthma used pMDIs without an inhalation chamber and that their overall satisfaction was higher than that with other inhalation devices. Similarly, patients who received training, especially medical specialists, had higher satisfaction; but increasing age and higher educational level were associated with lower satisfaction. Satisfaction was similar among those using short-acting and long-acting bronchodilators and inhaled glucocorticoids. These findings can be used by those responsible for the care of these patients to improve educational activities that improve adherence and the effectiveness of therapy. In addition, the use of inhaled chambers should be encouraged, especially in users of inhaled corticosteroids, to reduce the frequency of adverse drug reactions.
Footnotes
Acknowledgments
The authors thank Soffy Claritza López for her work in obtaining the database and also thank William Francisco Muñoz Ordoñez for his contribution to the preparation of the preliminary research project.
Authors' Contributions
J.E.M.A. participated in the conceptualization, data curation, formal analysis, investigation, validation, writing of the original draft, and writing—review and editing. L.F.V.R. participated in the conceptualization, data curation, formal analysis, investigation, validation, and writing of the original draft. J.C.S.N. participated in the formal analysis, investigation, validation, and writing of the original draft. C.A.M.C., V.M.D., J.A.G.O., L.M.C.M., A.G.M., and M.E.M.D. participated in the formal analysis, investigation, validation, and writing of the original drafts.
Ethics Approval
The protocol was approved by the Bioethics Committee of the Technological University of Pereira in the category of risk-free research (endorsement code: 02-091120). The ethical principles established by the Declaration of Helsinki were respected.
Data Sharing Statement
protocols.io
Author Disclosure Statement
The authors declare they have no conflicting financial interests.
Funding Information
This study did not receive funding.
Reviewed by:
Maria Santos-Martinez
Sabine Haussermann
References
Supplementary Material
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