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Effectiveness of individualized inhaler technique training on low adherence (LowAd) in ambulatory patients with COPD and asthma

Effectiveness of individualized inhaler technique training on low adherence (LowAd) in ambulatory... www.nature.com/npjpcrm ARTICLE OPEN Effectiveness of individualized inhaler technique training on low adherence (LowAd) in ambulatory patients with COPD and asthma 1,2,3 1,2,3 1 4 Juan Miguel Sánchez-Nieto , Roberto Bernabeu-Mora , Irene Fernández-Muñoz , Andrés Carrillo-Alcaraz , 1 1 1 1 Juan Alcántara-Fructuoso , Javier Fernández-Alvarez , Juan Carlos Vera-Olmos , María José Martínez-Ferre , 1 1 2,5,6 Mercedes Garci-Varela Olea , Maria José Córcoles Valenciano and Diego Salmerón Martínez To analyze whether there is improvement in adherence to inhaled treatment in patients with COPD and asthma after an educational intervention based on the teach-to-goal method. This is a prospective, non-randomized, single-group study, with intervention and before-after evaluation. The study population included 120 patients (67 females and 53 males) diagnosed with asthma (70.8%) and COPD (29.1%). The level of adherence (low and optimal) and the noncompliance behavior pattern (erratic, deliberate and unwitting) were determined by the Test of the adherence to Inhalers (TAI). This questionnaire allows you to determine the level of adherence and the types of noncompliance. Low Adherence (LowAd) was defined as a score less than 49 points. All patients received individualized educational inhaler technique intervention (IEITI). Before the IEITI, 67.5% of the patients had LowAd. Following IEITI, on week 24, LowAd was 55% (p = 0.024). Each patient can present one or more types of noncompliance. The most frequent type was forgetting to use the inhaler (erratic), 65.8%. The other types were deliberate: 43.3%, and unwitting: 57.5%. All of them had decreased on the final visit: 51.7% (p = 0.009), 25.8% (p = 0.002), 39.2% (p = 0.002). There were no significant differences in adherence between asthma and COPD patients at the start of the study. The only predicting factor of LowAd was the female gender. An individualized educational intervention, in ambulatory patients with COPD and asthma, in real-world clinical practice conditions, improves adherence to the inhaled treatment. npj Primary Care Respiratory Medicine (2022) 32:1 ; https://doi.org/10.1038/s41533-021-00262-8 INTRODUCTION complementary 12-item questionnaires with domains for patients and for professionals. It gathers information on the degree of Chronic obstructive pulmonary disease (COPD) and asthma are adherence and patterns of noncompliance. This test correlated conditions particularly prone to adherence issues due to their better with adhesion measures made with electronic devices than chronic nature and to their periods of symptom remission . the Morisky-Green test . Incorrect adherence and inhaler technique reduces the treatment The inappropriate use of an inhaler is one of the most commonly benefits and leads to concerns in the healthcare management and 2 associated barriers with LowAd. Even easy application devices health-related consequences . Adherence to oral or inhaler 3,4 require training . The ability to successfully administer medication medication ranges between 41 to 57% in COPD and, in asthma, 5 6 through an inhaler has a direct effect, not just on their deposition it is 50% in children and 30% in adults . Adherence is associated but also in the perception of benefits by the patient and in their with numerous factors such as the disease, the route of willingness to maintain adherence. The training of the inhaler administration, access to the treatment and specific characteristics technique is the main factor that health professionals can modify, of the patient . Some systematic reviews have evaluated the although the real benefits are controversial . The most effective effectiveness of interventions to improve medication adherence, training method to teach the inhaler technique is verbal instruction from self-management training to eHealth tools, with hetero- 18,19 combined with a physical demonstration .The objectiveof the 8,9 geneous results . Similarly, assessing medication adherence has present study is to evaluate adherence to inhaled treatment using been done using a variety of methods and has rendered TAI , in real clinical practice conditions, with a cohort of ambulatory heterogeneous results. There is no standard prospective metho- patients diagnosed with asthma and COPD; before and after an dology in COPD or asthma . The stated objectives include individualized educational inhaler technique intervention (IEITI). biochemical or electronic monitoring of medication administra- tion . An example of these is the audio recording devices which simultaneously report on inhaler technique and adherence . Self- METHODS reporting questionnaires overestimate adherence. Also, most of Study design and participants these instruments have been designed to monitor oral medica- 13,14 15 tion . Recently, the Test of adherence to inhalers (TAI) has The prospective, non-randomized, single-group study, with been validated for asthma and COPD. It comprises two intervention and before-after evaluation, carried out between 1 2 Division of Pneumology, Morales Meseguer General University Hospital, 30008 Murcia, Spain. Institute for Bio-health Research of Murcia (IMIB-Arrixaca), El Palmar, 30120 Murcia, 3 4 Spain. Department of Internal Medicine, University of Murcia, El Palmar, 30120 Murcia, Spain. Division of Intensive Care Unit, Morales Meseguer General University 5 6 Hospital, 30008 Murcia, Spain. Department of Health and Social Sciences, Murcia University, Murcia, Spain. CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain. email: rbernabeumora@hotmail.com Published in partnership with Primary Care Respiratory Society UK 1234567890():,; JM Sánchez-Nieto et al. Week 0 Recruitment Inclusion criteria Evaluaons IEITI Inial visit Adherence* Inhaler technique** Adherence* Week 24 Final visit Inhaler technique** * Evaluation of adherence by means of Inhaler Adherence Test (IAT) ** Evaluation of inhaler technique by means of Inhaler Technique Evaluation Cards (see Appendix) Abbreviations: IEITI, individualized educational inhaler technique intervention; IAT, Inhaler Adherence Test. Fig. 1 Study sequence. January 11, 2017 and December 21, 2018. Were included 160 Data collection ambulatory patients from a Pulmonology Department of a Public The degree of adherence to the inhaler treatment was evaluated General University Hospital. The patients included were adults >18 using the ten-item TAI (https://www.taitest.com/). Each item years of age, diagnosed of bronchial asthma or COPD, who were scored from 1 to 5 (where 1 was the worst possible score and 5 being treated with one of the following devices: Pressurized was the best possible score), resulting in a minimum score of 10 metered-dose inhaler (pMDI)/Soft mist inhaler (SMI), Dry powder points and a maximum of 50 points. Three levels of adherence inhaler multidose (DPIm), Dry powder inhaler single dose (DPIs), were established along this continuum: poor (≤45), intermediate and Pressurized metered-dose inhaler (pMDI) with spacer holding (46–49), and good (50). For this study, we have used a composite chamber (pMDI + spacer). The diagnosis of asthma was based on variable that we have named Low Adherence (LowAd), which GINA criteria . The diagnosis of COPD was done using GOLD includes all patients with “intermediate” and “poor” adherence, criteria of airflow limitation (FEV1/FVC post-bronchodilator according to the cut-off points established by the authors, with <0,70) . In all cases, more than 6 months have passed since the the purpose to facilitate the interpretation of the results. There- initial diagnosis of COPD or asthma. Patients over 70 years old fore, LowAd patients are those with a score ≤49. Consequently, and/or with psychiatric history were evaluated for cognitive patients with Optimal Adherence (OptAd) are those with a score function using the Pentagon Drawing Test . The patients who did of 50 points. The “complete TAI” includes two additional questions not pass this test were excluded from the study and the treatment 15 (12-item TAI ), performed asked by the professional in order to with nebulizers was recommended. Other criteria for exclusion explore nonadherence or noncompliance patterns. In item 11, 1 were refusal to participate and the presence of a language barrier. point is given if patients do not remember the dosage or The study protocol was approved by the institutional review board frequency, and 2 points are given if they remember it. In item 12, 1 of the hospital, called the “Ethical Committee of Clinical Research point indicates that the patient makes some critical error in inhaler of the General University Hospital” on 09/28/2016 (approval technique whereas 2 points indicate that the patient does not number: EST-30/16). All study participants provided written make any errors when using the inhaler. Three patterns of informed consent. noncompliance have been identified by dividing up the scores Following the recruitment phase, they were scheduled for an into three groups of questions: “erratic” <25 points (items 1–5), initial visit (IV) with a physical therapist who was not involved in “deliberate” <25 points (items 6–10), and “unwitting” <4 points the recruitment. Two Pulmonology investigators recruited patients (items 11–12). in the consultation. The Physical therapists were trained during several sessions until they master the competence in inhalation Individualized educational inhaler technique intervention technique training and using the TAI test. During this visit, IEITI (IEITI) was done and a final visit (FV) was performed on week 24. The IEITI The stages of IEITI are shown in Fig. 2. An IEITI was carried out in consisted of an educational intervention based on the teach-bak an individual session of 30–40 min, conducted by a physical model . The patient received verbal instruction on the inhaler therapist. The session included the demonstration and assessment technique and then was asked to show their ability to do it. When of the inhaler technique. Errors were corrected until the patient the patient does not show an acceptable skill technique, further reached an acceptable technique. Prior to the intervention, the instructions are given until he achieved that. The patient did not patient was asked to complete the TAI (10 items). At the show an acceptable level of skill if, after explanations followed by beginning of the session, the therapist asks the patient to show physiotherapy and two consecutive patient demonstrations, he how he uses the inhaler prescribed, before receiving any could not perform the loading of the system and/or the instructions for correct use. For that purpose, the patient received inspiratory maneuver. The sequence of study visits is shown in an identical device with a placebo. It was considered that the Fig. 1 and the systematic training, divided into four consecutive patient had a Deficient Inhaler Technique (DeIT) when the stages, is explained in Fig. 2. The IEITI also included informational inspiratory flow maneuver was insufficient and/or a critical error material on dosage, scheduling, and characteristics of the inhalers was made. The results of the evaluation were entered on an (Supplementary Fig. 1). inhaler technique evaluation card (ITEC) (Fig. 3). Next, the patient npj Primary Care Respiratory Medicine (2022) 1 Published in partnership with Primary Care Respiratory Society UK 1234567890():,; JM Sánchez-Nieto et al. Paents included Cognive test* Paents excluded Inhaler adherence test IAT: items 1–10 IEITI 1º Paent demonstrates inhaler technique using placebo inhaler 2º ITEC Physical therapist evaluates paent’s inhaler technique Correct yes no inhaler technique? Inhaler adherence test IAT: 11–12 End visit + hand out infographic materials 3º Physical therapist models correct inhaler technique using placebo inhaler 4º ITEC Re-evaluate inhaler technique Paent demonstrates learned technique Correct inhaler no yes technique? Inform prescribing Inhaler Adherence Test doctor IAT: 11–12 Change to nebulizer? End visit End visit + hand out infographic materials *Cognitive test or Pentagon Drawing Test (Patients > 70 years of age and/or psychiatric history). ITEC: Inhaler Technique Evaluation Card. Record of the inhaler technique steps taken by the patient Placebo inhaler device (canister or powder) Abbreviations: IIAT, Inhaler Adherence Test; EITI, individualized educational inhaler technique intervention; ITEC: Inhaler Technique Evaluation Card Fig. 2 Individualized educational inhaler technique intervention (IEITI): four stages. was asked about the dosage and frequency of the inhaler (item patient does not present an acceptable skill level, the physical 11). If they have not made any “critical error ” (item 12), a graphic therapist will proceed to the correct inhaler use model, correct material of the inhaled medication is given (Supplementary Fig. 1) errors, and ask the patient to show what he learned through this and the session is concluded. “Critical error” were considered if the process. When the patient continued displaying DeIT, the therapist patient showed an action or inaction that, in itself, which can lead contacted the prescribing doctor to report that the inhaler needed to a detrimental impact on drug administration in the lung . If the to be changed. Published in partnership with Primary Care Respiratory Society UK npj Primary Care Respiratory Medicine (2022) 1 JM Sánchez-Nieto et al. Fig. 3 Inhaler technique evaluation card (ITEC). Clinical variables and outcome measure a nurse previously trained in conducting the questionnaire TAI, blinded to the results of the initial questionnaire and who has not Data was gathered on sociodemographic, clinical, and spirometric participated in the initial training. information, type of inhaler evaluated, and the results of the inhaler technique skill level of the patient (optimal or poor inhaler technique). The primary and secondary variables were analysed at Statistical analysis the baseline and after the intervention (IEITI). The main variable The sample size was calculated in bilateral contrast factoring in a was the decrease in the percentage of patients with LowAd in the 5% alpha risk and 0.1 beta risk (90% statistical power). A sample of final visit. Secondary variables were: types of noncompliance: 130 participants is necessary assuming that the initial rate of LAd 25–27 erratic unwitting and deliberate, and percentage of patients with would be 45% and the final rate 25% . The rate of patient loss poor Inhaler Technique and critical errors. The differences to follow-up was estimated at 8%. Quantitative variables are between patients diagnosed with asthma and COPD were also shown as averages ± standard deviation (interquartile range: first analysed as part of the study variables. To minimize measurement and third quartile). Comparisons between groups were performed bias, the evaluation of the last visit, in week 24, was performed by with the Fisher exact test. Categorical variables were expressed as npj Primary Care Respiratory Medicine (2022) 1 Published in partnership with Primary Care Respiratory Society UK JM Sánchez-Nieto et al. absolute and relative frequencies, and comparisons between them were made using the Pearson Chi test or Fisher’s test. Quantitative variables were expressed as mean ± standard devia- tion and the comparisons were made between independent groups using the Student’s t-test or the Mann–Whitney test if the variable did not present a normal distribution. When the variables have been measured at different points, the McNemar test was used for their comparison and the paired samples t-test or Wilcoxon test depending on whether or not the distribution of the quantitative variables. A multivariate logistic regression analysis was performed to evaluate associated factors with LowAd, calculating the odds ratios (ORs) and 95% confidence intervals (CI). The independent variables considered were: age, sex, deficient inhaler technique (initial visit), smokers status, previous training, the severity level of disease (COPD/Asthma), type of disease (COPD/asthma), and types of inhalers evaluated (initial visit). First, a univariate analysis of each variable was performed, and then, the variables whose univariate test had a p value <0.3 were included in the multivariate logistic regression model. The goodness-of-fit of the multivariate model was evaluated with the Hosmer–Lemeshow test. Odds ratio (OR) values were calculated with 95% confidence intervals (CI 95% CI). All analyses were performed “two tails”, and a p value of less than 0.05 was considered significant. All analyses Fig. 4 Study inclusion and follow-up algorithm. were performed with the SPSS statistical software program (SPSS version 25.0; IBM®, Armonk, NY) and Stata [StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP]. Table 1. Baseline characteristics of patients in the initial visit (n = 120). A blinded researcher carried out the data analysis. Characteristic N = 120 % Reporting summary Female, n (%) 67 55,8 Further information on research design is available in the Nature Age, years, mean ± SD 60,8 ± 16.6 Research Reporting Summary linked to this article. Asthma diagnosis Mild-intermittent 54 63,8 Moderate-severe 31 36,5 RESULTS COPD Diagnosis Mild-moderate 20 57,1 Participants Severe-very severe 15 52,9 A group of 160 patients was recruited for the study. Of these, 31 Smokers status, n (%) 25 20,8 (19.1%) were excluded, a majority of which, 20 (64.5%), refused to Previous training*, n (%) 54 45 attend the visits. Nine patients (5.6%) were lost to follow-up. Two Number drugs /patient**, 2 (1,5) patients have prescribed a home nebulizer due to repeated critical mean ± SD errors in inhaler technique and120 finished the study. The Number inhalers/patient***, 2 (2,2) inclusion criteria and follow-up algorithm are shown in Fig. 4. mean ± SD Most of the patients were female (55.8%) with an average age No studies or primary, n (%) 83 69,2 of 60,8 (±16.6) years. Most of them had been diagnosed with asthma, 85 patients (70.8%) and the rest, 35 patients, were SD standard deviation, FEV1 forced expiratory volume in 1 second, COPD diagnosed with COPD. The average FEV was 72.6 ± 20.4 (of the chronic obstructive pulmonary disease. predicted value). 45% of the patients report having some previous *some form of “unstructured” instruction, **excluded inhalers, ***were training in the use of the inhaler that was prescribed. The evaluated 430 inhalers. remaining baseline characteristics of the 120 patients that participated in the study are shown in Table 1. of noncompliance, in 69 patients (57.5%). Finally, nonadherence The average score in the ten-item TAI questionnaire was 43,1 (±8,8) points in the initial visit and 46.6 (±5.9) at the end of the that is deliberate and largely associated with patient motivation to study (p < 0.001). About 120 inhalers were evaluated in the initial use the inhaler, was identified in 52 patients (43.3%). and final visits. The most commonly used inhaler at study recruitment was multidose DPIm, in 52 patients (43.3%) followed Effects of the intervention on the study variables by pMDI with spacer chamber, in 31 patients (25.8%). The During the IV, 81 patients (67.5%) presented LowAd compared to numbers and types of inhalers evaluated in the visits are listed in 66 (55%) in the FV. In contrast, the number of patients that Table 2. presented OptAd at the start, 39 (32.5%), had increased to 54 Based on the definition established in this study to evaluate (45%) at the end of the study. The intervention (IEITI) produced a inhaler technique, during the IV it was determined that the significant change in the level of adherence (p = 0.024) and a technique was poor or deficient in 69 inhalers (72.8%) and a decrease in the rate of patients with LowAd on week 24 of the critical error was made in the manipulation of 21 inhalers (16.3%). study. There was a decrease in erratic, 79 patients (65.8%), in the IV Regarding the level of adherence, during the IV, 81 patients vs 62 (51.7%) after the IEITI (P = 0.009). The number of patients (67.5%) had LowAd. The most frequent form of noncompliance presenting noncompliance deliberate went from 52 (43.3%) to 31 was forgetting to use the inhaler in 65.8% of the patients (Noncompliance erratic). Lack of knowledge of the dosage and/or (25.8%) at the end (p = 0.002). Lastly, out of 69 patients (57.5%) inhaler technique (unwitting), was the second most common form with unwitting noncompliance, 47 (39.2%) remained in this Published in partnership with Primary Care Respiratory Society UK npj Primary Care Respiratory Medicine (2022) 1 JM Sánchez-Nieto et al. characteristics of the patients except in the case of being a female Table 2. Types of inhalers evaluated in the study visits. patient (OR = 2.384, IC: 1.039–5.5518; p = 0.040). (Table 6). Type inhaler Initial visit Final visit N = 120 (%) N = 120 (%) DISCUSSION The problem of low adherence to inhaled treatment of chronic pMDI 12 (10) 18 (15) respiratory disease includes numerous factors of different nature pMDI + chamber spacer 31 (25,8) 24 (20) and complexity. The perception of a therapeutic benefitby the Soft mist inhaler 12 (10) 19 (15,8) patient and the effective use of the inhaler are the key to achieve MDPI 52 (43,3) 48 (40) adherence to the treatment. Insufficient instructions on the use of UDPI 13 (10,8) 11 (9,1) the inhaler and poor inhaler technique are common and have negative repercussions on adherence in the case of asthma and pMDI metered-dose inhaler pressurized, MDPI inhaler dry powder multi- 8,9 COPD . Several studies have evaluated the implementation of dose, UDPI inhaler dry powder unidose. interventions to improve inhaled treatment adherence. Interven- tions vary from providing only information in different formats to complex self-management programs and have had uneven results . Nine authors used “teach-back” interventions similar to those used in the present study and evaluated their impact on the proportion of Table 3. Changes in adherence, type of noncompliance and critical patients with the correct use of the inhaler but did not look at the errors in initial an final visit. changes in the adherence . Other reviews have evaluated multi- Initial visit Final visit P component strategies to improve adherence but it is hard to Adherence (items 1–10 TAI) n (%) n (%) determine the contribution of each component to the outcomes. It is also difficult to compare the results due to the diversity of Low adherence (≤49 points) 81 (67,5) 66 (55) 0.024 8 methods employed to evaluate adherence . An observational study Optimal adherence (=50 points) 39 (32,5) 54 (45) with 88 patients with COPD that evaluated adherence by means of a four-question self-administered questionnaire found that the only Types noncompliance (items 1–12 TAI) factor significantly related to adherence was having received Erratic noncompliance (items 1–5) 79 (65,8) 62 (51,7%) 0.009 instructions of inhaler technique previously . Ignorant noncompliance 69 (57,5) 47 (39,2%) 0.002 We did not find any studies on the impact of adherence of an (items 11–12) inhaler technique education intervention, using the IAT, on a Deliberate noncompliance (items 52 (43,3) 31 (25,8%) 0.002 population with asthma and COPD. After the IEITI intervention, 6–10) patients with LowAd decreased significantly and at the same time, Critical errors (Item 12 TAI) 21 (16,3%) 3 (2,5%) 0.461 patients with optimal adherence increased. The types of Evaluations with poor inhalation 69 (57,5%) 22 (11,2%) 0.002 noncompliance, the percentage of patients with poor inhaler technique* technique, and the percentage of critical errors also improved. A recent metanalysis addressed the impact of these interventions on TAI test of the adherence to inhalers, DeIT deficient inhaler technique. asthma and COPD exacerbations . Only three studies evaluated *Deficient inhaler technique (DeIT). the impact on adherence to the inhaled medication although, according to the authors, the benefit could be explained, in part, category at the end (p = 0.002). The pattern and relative frequency through the so-called Hawthorne effect: the awareness of being observed or of having a behavior that is being evaluated, of noncompliance did not change by the end of the study, being generates beliefs about the researcher’s expectations and the erratic pattern the most common one. Regarding the considerations of social acceptance that lead to a change in secondary variables, a significant change was found in the behavior . percentage of inhalers that were used with poor inhaler Also, different measures of adherence were used and, finally, technique. Similarly, the percentage of critical errors found in these were not included in the quantitative analysis. the initial visit improved after the IEITI. Table 3 shows the The percentage of LowAd in the COPD and asthma population description of the level of adherence, noncompliance, technique, in the study is similar to those reported by other authors who used and critical errors in the initial and final visit. different measurement instruments . About 67.5% of the patients Figure 5 shows point averages ± standard deviation of the in our study presented a low level of adherence, with an average patients in the initial and final visit according to the cut-off points score of 43.1 ± 8.8 (10-item TAI). The TAI and other recent established for the classification of noncompliance and level of 31–33 observational studies report similar results . The first, which adherence was carried out among Asian patients with exacerbated COPD, No significant differences were identified between the group of reported low adherence in 70% of the cases (low + intermediate patients with COPD and asthma. Patients with asthma presented a adherence) . Another study which was carried in Spain with 122 higher rate of LowAd than patients with COPD, 71.8 vs 57.1% (p = COPD and asthma patients found low adherence in 71.3% of the 0.120). Deliberate noncompliance was also most frequent in 32 patients studied . However, a multinational study conducted in patients with asthma, 48 vs 31.4%. In contrast, asthma patients Latin America with 795 patients found surprisingly good displayed a better skill level in the use of the inhalers. 52.9% adherence results. The average score was 47.4 ± 4.9 and the asthma patients had DeIT vs 68.6% in COPD patients (p = 0.039). percentage of LowAd in this population was 45.9% . The differences between patients with COPD and asthma are When we analyze separately the levels of adherence in patients shown in Table 4. with asthma and COPD, we found a LowAd level in asthma patients The baseline characteristics of the patients, such as having (57.1%) compared with COPD patients (71.8%), although without received previous training or their level of studies, showed no any significant differences. A multicentric study that analysed these relationship with low adherence. Only gender was related to low differences using the same TAI instrument, found significant adherence (Table 5). Finally, age, gender, and asthma diagnosis differences in levels of adherence in both groups of patients, with were chosen for the multivariate adjustment. The analysis did not a higher rate of LowAd in asthma patients (72%) and lower in COPD show any relation between the level of adherence and baseline patients (51%) . The noncompliance patterns between COPD and npj Primary Care Respiratory Medicine (2022) 1 Published in partnership with Primary Care Respiratory Society UK JM Sánchez-Nieto et al. Score Non –compliance Errac Items 1–5 Non –compliance Deliberate Items 6–10 Score Non –compliance Level unwing adherence ítems 11 y 12 Inial Final Inial Final Visits Non –compliance score range (minimum and maximum): Unwing: 2–4. Delbierate: 5–25. Errac: 5–25 Adherence level score (minimum and maximum): 10–50 Fig. 5 Average scores (±SD) were obtained by the patients according to the established ranges to classify the type of noncompliance and the level of Adherence. showed an error rate for inhalers (pMDI and DPIm) higher than Table 4. Changes in adherence, type of noncompliance, and critical 90% . At this point, we must comment on our results. Unlike errors between COPD and asthma. other studies , our definition of poor inhalation technique was not based on a strict recording of an error checklist. Only the COPD ASTHMA presence of an insufficient or uncoordinated inspiratory step and/ n (%) n (%) P or the existence of a critical error led us to consider an inhalation technique as deficient. Following the opinion of some authors , Adherence (items 1–10 TAI) some steps such as exhaling before inhaling and/or the absence Low adherence (≤49 points) 20 (57,1) 61 (71,8) 0.120 of apnea were not considered sufficient to consider the inhalation Types noncompliance (items 1–12 TAI) technique as deficient. These considerations may represent a Erratic noncompliance (items 1–5) 20 (57,1) 59 (69,4) 0.198 lower percentage of DeIT than reported in other studies . Unwitting noncompliance (items 11–12) 20 (57,1) 49 (57,5) 0.095 Something similar happens with the disparity of assessments of inhaler technique critical errors . Deliberate noncompliance (items 6–10) 11 (31,4) 41 (48,2) 0.091 Our results suggest that educational interventions on inhaler Critical errors (item 12 TAI) 4 (11,4) 14 (16,5) 0.482 techniques improve patients’ ability and, at the same time, can Inhalation technique* 24 (68,6) 45 (52,9) 0.115 also improve the perception of therapeutic benefit and adherence Evaluations with por to inhaled medication. Although, these results should be inhalation technique* 24 (68,6) 45 (52,9) 0.115 interpreted with caution. First, the efficacy of a healthcare intervention is ideally demonstrated under the conditions of TAI test of the adherence to inhalers, COPD chronic obstructive pulmonary double-blind randomized controlled trials with highly selected disease, DeIT deficient inhaler technique. populations and operating under highly monitored and controlled *Deficient inhaler technique (DeIT). conditions . However, logistical limitations conditioned the design to a pre-post intervention study, thus incorporating possible biases to the results obtained. Occasionally, studies with asthma are also different in this study, being the most frequent minimal exclusion criteria may be more representative of the pattern in asthmatics the erratic (66.8%). These differences are more patients seen in daily clinical practice and provide complementary 34 39 likely to be related to sociodemographic characteristics . In our data to those obtained in traditional efficacy studies . study, the erratic pattern was also higher in patients with asthma Second, it is possible that the modifications in the patients’ with very similar values (69%). In this group of patients, at baseline, behavior could have influenced the results of the IAT in the final the frequency of the erratic pattern was 65% compared to 57.9% visit since the patients knew that they were being evaluated and 15 30 that was obtained in the validation work of the TAI .These not as an effect of the intervention itself (Hawthorne effect) . 15,34 studies did not include educational interventions nor a long- Having a wide age range in the study may have introduced a bias, itudinal evolution analysis of patient adherence. mainly due to endotypic and phenotypic differences. This could In relation to the evaluation of the inhalation technique, there is have led to different clinical and questionnaire responses to the high variability in the comparison of results due to the educational intervention . Another aspect that should be heterogeneity of the methods used. In general, the ability of considered when interpreting the results is the measure of patients in the inhalation technique seems not to have improved adherence to the inhaled medication by means of a self- in the last 40 years . The international study “International Helping administered questionnaire due to the biases inherent to this Asthma in Real-life Patients” (iHARP), the largest asthma study on type of qualitative instrument . Recent studies show evidence of patient inhaler technique with 5000 structured evaluations, an overstatement of adherence in patients evaluated using the TAI Published in partnership with Primary Care Respiratory Society UK npj Primary Care Respiratory Medicine (2022) 1 Half points quesonnaire (± SD) JM Sánchez-Nieto et al. Table 5. Relation of the low and optimal adherence and baseline characteristics of the patients with COPD and asthma. Characteristics Low adherence Optimal adherence P 45 (69.7) 22 (38.9) 0.001 Females 58.9 ± 16.7 80.7 ± 23.7 70.9 ± 20.1 0.073 Asthma diagnosis Mild-intermittent 31 (62) 23 (65.7) *0.726 Moderate-severe 19 (38) 12 (34.3) COPD diagnosis Mild-moderate 9 (56.3) 11(57.9) *0.922 Severe-very severe 7 (43.8) 8 (42.1) Smoker 16 (24.2) 9 (16.7) 0.429 Previous inhaler technique training ** 30 (45.5) 24 (44.4) 0.912 Medications /patient excluding inhalers 2 ± 1.5 2 (0.5) 0.746 Inhalers/patient 2 ± 2.2 2 (0.5) 0.456 No formal or basic education 44 (66.7) 39 (72.2) 0.512 The dates show n (%) or average ± standard deviation. COPD chronic obstructive pulmonary disease. *P result severity of asthma and COPD, ** some form of “unstructured” instruction. objective, it is necessary to better understand the conceptual Table 6. Logistic regression model. connection between adherence and technique (whether they are different aspects, or they must be combined into one integrated Variable OR IC-95% OR p value quality approach to the administration of inhaled medication). Age >70 0.591 0.252–1.394 0.231 Understanding behavioral patterns of adherence in a subpopula- tion of patients (e.g., children, adults) and at different stages of the Female 2.394 1.039–5.518 0.04 disease, will help to develop more specific and effective Asthma diagnosis 1.384 0.573–3.341 0.469 interventions. This study can contribute to the understanding of The variables identified as predictors of low adherence on univariate how adherence and inhaler technique interact by evaluating them analysis: age, gender and asthma or COPD diagnosis, were included. For longitudinally following a structured educational intervention in this model, the Hosmer–Lemeshow test showed a p value= 0.699. real-world clinical practice conditions. OR odds ratio, IC interval confidence, COPD chronic obstructive pulmonary We demonstrated that, among patients with COPD and asthma, disease. an individualized educational inhaler technique intervention, carried out in real-world clinical practice conditions, improves adherence to the inhaled treatment, as evaluated by means of TAI. 40,41 compared to medication administration records . The TAI However, the small sample size limits the external validity of these seems to be more reliable when assessing patients with low results and suggests the need for further studies. adherence. But, with higher scores, it should be modulated with more objective methods, particularly in the context of studies of intervention effectiveness . In our study, the TAI was evaluated DATA AVAILABILITY longitudinally in two visits. This bias could have been present in The data that support the findings of this study are available from the corresponding both measurements, but it did not condition the favorable author upon reasonable request. The original contributions presented in the study evolution of adherence in a significant way. Another limitation of are included in the article/supplementary material (Supplementary Fig. 1). Correspondence and requests for supplementary materials should be addressed to the study is the sample size, which was slightly lower than the the corresponding author. calculated sample size, and the possible impact of other unmeasured confounding or covariates not included in the Received: 17 February 2021; Accepted: 12 November 2021; variable selection in the logistic regression model, such as the educational or socioeconomic level of the patients. 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Test of an interactive voice response intervention to improve Supplementary information The online version contains supplementary material adherence to controller medications in adults with asthma. J. Am. Board Fam. available at https://doi.org/10.1038/s41533-021-00262-8. Med. 23, 159–165 (2010). 26. Petrie, K. J., Perry, K., Broadbent, E. & Weinman, J. A text message programme Correspondence and requests for materials should be addressed to Roberto designed to modify patients’ illness and treatment beliefs improves self-reported Bernabeu-Mora. adherence to asthma preventer medication. Br. J. Health Psychol. 17,74–84 (2012). 27. Jentzscha, N. S., Silvaa, G. C. G., Mendes, G. M. S., Brandb, P. L. P. & Camargos, P. Reprints and permission information is available at http://www.nature.com/ Treatment adherence and level of control in moderate persistent asthma in reprints children and adolescents treated with fluticasone and salmeterol. J. Pediatr. 95, 69–75 (2019). Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims 28. Takemura, M. et al. Relationships between repeated instruction on inhalation in published maps and institutional affiliations. therapy, medication adherence, and health status in chronic obstructive pul- monary disease. Int. J. Chron. Obstrcut. Pulmon. Dis. 6,97–104 (2011). 29. Maricoto, T., Monteiro, L., Gama, J. M. R., Correia-de-Sous, J. & Taborda-Barata, L. Inhaler technique education and exacerbation risk in older adults with asthma or Open Access This article is licensed under a Creative Commons chronic obstructive pulmonary disease: a meta-analysis. JAGS 67,57–66 (2019). Attribution 4.0 International License, which permits use, sharing, 30. McCambridgea, J., Wittonb, J. & Elbournec, D. R. Systematic review of the Haw- adaptation, distribution and reproduction in any medium or format, as long as you give thorne effect: new concepts are needed to study research participation effects. J. appropriate credit to the original author(s) and the source, provide a link to the Creative Clin. Epidemiol. 67, 267–77. (2014). Commons license, and indicate if changes were made. The images or other third party 31. Ngo, C. Q. et al. Inhaler technique and adherence to inhaled medications among material in this article are included in the article’s Creative Commons license, unless patients with acute exacerbation of chronic obstructive pulmonary disease in indicated otherwise in a credit line to the material. If material is not included in the Vietnam. Int. J. Environ. Res. Public Health. 16, 185 (2019). article’s Creative Commons license and your intended use is not permitted by statutory 32. Barja-Martínez, E., Casas-González, S., Simón-López, A. F., Mancheño-Ovejero, C. & regulation or exceeds the permitted use, you will need to obtain permission directly Padial-de la Cruz, M. L. G. Adherence to inhaled therapy in the outpatient setting. from the copyright holder. To view a copy of this license, visit http://creativecommons. Enferm. Clin. 29,34–38 (2019). org/licenses/by/4.0/. 33. Montes de Oca, M. et al. Adherence to inhaled therapies of COPD patients from seven Latin American countries: the LASSYC study. PLoS ONE 12, e0186777 (2017). © The Author(s) 2022 Published in partnership with Primary Care Respiratory Society UK npj Primary Care Respiratory Medicine (2022) 1 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png npj Primary Care Respiratory Medicine Springer Journals

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www.nature.com/npjpcrm ARTICLE OPEN Effectiveness of individualized inhaler technique training on low adherence (LowAd) in ambulatory patients with COPD and asthma 1,2,3 1,2,3 1 4 Juan Miguel Sánchez-Nieto , Roberto Bernabeu-Mora , Irene Fernández-Muñoz , Andrés Carrillo-Alcaraz , 1 1 1 1 Juan Alcántara-Fructuoso , Javier Fernández-Alvarez , Juan Carlos Vera-Olmos , María José Martínez-Ferre , 1 1 2,5,6 Mercedes Garci-Varela Olea , Maria José Córcoles Valenciano and Diego Salmerón Martínez To analyze whether there is improvement in adherence to inhaled treatment in patients with COPD and asthma after an educational intervention based on the teach-to-goal method. This is a prospective, non-randomized, single-group study, with intervention and before-after evaluation. The study population included 120 patients (67 females and 53 males) diagnosed with asthma (70.8%) and COPD (29.1%). The level of adherence (low and optimal) and the noncompliance behavior pattern (erratic, deliberate and unwitting) were determined by the Test of the adherence to Inhalers (TAI). This questionnaire allows you to determine the level of adherence and the types of noncompliance. Low Adherence (LowAd) was defined as a score less than 49 points. All patients received individualized educational inhaler technique intervention (IEITI). Before the IEITI, 67.5% of the patients had LowAd. Following IEITI, on week 24, LowAd was 55% (p = 0.024). Each patient can present one or more types of noncompliance. The most frequent type was forgetting to use the inhaler (erratic), 65.8%. The other types were deliberate: 43.3%, and unwitting: 57.5%. All of them had decreased on the final visit: 51.7% (p = 0.009), 25.8% (p = 0.002), 39.2% (p = 0.002). There were no significant differences in adherence between asthma and COPD patients at the start of the study. The only predicting factor of LowAd was the female gender. An individualized educational intervention, in ambulatory patients with COPD and asthma, in real-world clinical practice conditions, improves adherence to the inhaled treatment. npj Primary Care Respiratory Medicine (2022) 32:1 ; https://doi.org/10.1038/s41533-021-00262-8 INTRODUCTION complementary 12-item questionnaires with domains for patients and for professionals. It gathers information on the degree of Chronic obstructive pulmonary disease (COPD) and asthma are adherence and patterns of noncompliance. This test correlated conditions particularly prone to adherence issues due to their better with adhesion measures made with electronic devices than chronic nature and to their periods of symptom remission . the Morisky-Green test . Incorrect adherence and inhaler technique reduces the treatment The inappropriate use of an inhaler is one of the most commonly benefits and leads to concerns in the healthcare management and 2 associated barriers with LowAd. Even easy application devices health-related consequences . Adherence to oral or inhaler 3,4 require training . The ability to successfully administer medication medication ranges between 41 to 57% in COPD and, in asthma, 5 6 through an inhaler has a direct effect, not just on their deposition it is 50% in children and 30% in adults . Adherence is associated but also in the perception of benefits by the patient and in their with numerous factors such as the disease, the route of willingness to maintain adherence. The training of the inhaler administration, access to the treatment and specific characteristics technique is the main factor that health professionals can modify, of the patient . Some systematic reviews have evaluated the although the real benefits are controversial . The most effective effectiveness of interventions to improve medication adherence, training method to teach the inhaler technique is verbal instruction from self-management training to eHealth tools, with hetero- 18,19 combined with a physical demonstration .The objectiveof the 8,9 geneous results . Similarly, assessing medication adherence has present study is to evaluate adherence to inhaled treatment using been done using a variety of methods and has rendered TAI , in real clinical practice conditions, with a cohort of ambulatory heterogeneous results. There is no standard prospective metho- patients diagnosed with asthma and COPD; before and after an dology in COPD or asthma . The stated objectives include individualized educational inhaler technique intervention (IEITI). biochemical or electronic monitoring of medication administra- tion . An example of these is the audio recording devices which simultaneously report on inhaler technique and adherence . Self- METHODS reporting questionnaires overestimate adherence. Also, most of Study design and participants these instruments have been designed to monitor oral medica- 13,14 15 tion . Recently, the Test of adherence to inhalers (TAI) has The prospective, non-randomized, single-group study, with been validated for asthma and COPD. It comprises two intervention and before-after evaluation, carried out between 1 2 Division of Pneumology, Morales Meseguer General University Hospital, 30008 Murcia, Spain. Institute for Bio-health Research of Murcia (IMIB-Arrixaca), El Palmar, 30120 Murcia, 3 4 Spain. Department of Internal Medicine, University of Murcia, El Palmar, 30120 Murcia, Spain. Division of Intensive Care Unit, Morales Meseguer General University 5 6 Hospital, 30008 Murcia, Spain. Department of Health and Social Sciences, Murcia University, Murcia, Spain. CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain. email: rbernabeumora@hotmail.com Published in partnership with Primary Care Respiratory Society UK 1234567890():,; JM Sánchez-Nieto et al. Week 0 Recruitment Inclusion criteria Evaluaons IEITI Inial visit Adherence* Inhaler technique** Adherence* Week 24 Final visit Inhaler technique** * Evaluation of adherence by means of Inhaler Adherence Test (IAT) ** Evaluation of inhaler technique by means of Inhaler Technique Evaluation Cards (see Appendix) Abbreviations: IEITI, individualized educational inhaler technique intervention; IAT, Inhaler Adherence Test. Fig. 1 Study sequence. January 11, 2017 and December 21, 2018. Were included 160 Data collection ambulatory patients from a Pulmonology Department of a Public The degree of adherence to the inhaler treatment was evaluated General University Hospital. The patients included were adults >18 using the ten-item TAI (https://www.taitest.com/). Each item years of age, diagnosed of bronchial asthma or COPD, who were scored from 1 to 5 (where 1 was the worst possible score and 5 being treated with one of the following devices: Pressurized was the best possible score), resulting in a minimum score of 10 metered-dose inhaler (pMDI)/Soft mist inhaler (SMI), Dry powder points and a maximum of 50 points. Three levels of adherence inhaler multidose (DPIm), Dry powder inhaler single dose (DPIs), were established along this continuum: poor (≤45), intermediate and Pressurized metered-dose inhaler (pMDI) with spacer holding (46–49), and good (50). For this study, we have used a composite chamber (pMDI + spacer). The diagnosis of asthma was based on variable that we have named Low Adherence (LowAd), which GINA criteria . The diagnosis of COPD was done using GOLD includes all patients with “intermediate” and “poor” adherence, criteria of airflow limitation (FEV1/FVC post-bronchodilator according to the cut-off points established by the authors, with <0,70) . In all cases, more than 6 months have passed since the the purpose to facilitate the interpretation of the results. There- initial diagnosis of COPD or asthma. Patients over 70 years old fore, LowAd patients are those with a score ≤49. Consequently, and/or with psychiatric history were evaluated for cognitive patients with Optimal Adherence (OptAd) are those with a score function using the Pentagon Drawing Test . The patients who did of 50 points. The “complete TAI” includes two additional questions not pass this test were excluded from the study and the treatment 15 (12-item TAI ), performed asked by the professional in order to with nebulizers was recommended. Other criteria for exclusion explore nonadherence or noncompliance patterns. In item 11, 1 were refusal to participate and the presence of a language barrier. point is given if patients do not remember the dosage or The study protocol was approved by the institutional review board frequency, and 2 points are given if they remember it. In item 12, 1 of the hospital, called the “Ethical Committee of Clinical Research point indicates that the patient makes some critical error in inhaler of the General University Hospital” on 09/28/2016 (approval technique whereas 2 points indicate that the patient does not number: EST-30/16). All study participants provided written make any errors when using the inhaler. Three patterns of informed consent. noncompliance have been identified by dividing up the scores Following the recruitment phase, they were scheduled for an into three groups of questions: “erratic” <25 points (items 1–5), initial visit (IV) with a physical therapist who was not involved in “deliberate” <25 points (items 6–10), and “unwitting” <4 points the recruitment. Two Pulmonology investigators recruited patients (items 11–12). in the consultation. The Physical therapists were trained during several sessions until they master the competence in inhalation Individualized educational inhaler technique intervention technique training and using the TAI test. During this visit, IEITI (IEITI) was done and a final visit (FV) was performed on week 24. The IEITI The stages of IEITI are shown in Fig. 2. An IEITI was carried out in consisted of an educational intervention based on the teach-bak an individual session of 30–40 min, conducted by a physical model . The patient received verbal instruction on the inhaler therapist. The session included the demonstration and assessment technique and then was asked to show their ability to do it. When of the inhaler technique. Errors were corrected until the patient the patient does not show an acceptable skill technique, further reached an acceptable technique. Prior to the intervention, the instructions are given until he achieved that. The patient did not patient was asked to complete the TAI (10 items). At the show an acceptable level of skill if, after explanations followed by beginning of the session, the therapist asks the patient to show physiotherapy and two consecutive patient demonstrations, he how he uses the inhaler prescribed, before receiving any could not perform the loading of the system and/or the instructions for correct use. For that purpose, the patient received inspiratory maneuver. The sequence of study visits is shown in an identical device with a placebo. It was considered that the Fig. 1 and the systematic training, divided into four consecutive patient had a Deficient Inhaler Technique (DeIT) when the stages, is explained in Fig. 2. The IEITI also included informational inspiratory flow maneuver was insufficient and/or a critical error material on dosage, scheduling, and characteristics of the inhalers was made. The results of the evaluation were entered on an (Supplementary Fig. 1). inhaler technique evaluation card (ITEC) (Fig. 3). Next, the patient npj Primary Care Respiratory Medicine (2022) 1 Published in partnership with Primary Care Respiratory Society UK 1234567890():,; JM Sánchez-Nieto et al. Paents included Cognive test* Paents excluded Inhaler adherence test IAT: items 1–10 IEITI 1º Paent demonstrates inhaler technique using placebo inhaler 2º ITEC Physical therapist evaluates paent’s inhaler technique Correct yes no inhaler technique? Inhaler adherence test IAT: 11–12 End visit + hand out infographic materials 3º Physical therapist models correct inhaler technique using placebo inhaler 4º ITEC Re-evaluate inhaler technique Paent demonstrates learned technique Correct inhaler no yes technique? Inform prescribing Inhaler Adherence Test doctor IAT: 11–12 Change to nebulizer? End visit End visit + hand out infographic materials *Cognitive test or Pentagon Drawing Test (Patients > 70 years of age and/or psychiatric history). ITEC: Inhaler Technique Evaluation Card. Record of the inhaler technique steps taken by the patient Placebo inhaler device (canister or powder) Abbreviations: IIAT, Inhaler Adherence Test; EITI, individualized educational inhaler technique intervention; ITEC: Inhaler Technique Evaluation Card Fig. 2 Individualized educational inhaler technique intervention (IEITI): four stages. was asked about the dosage and frequency of the inhaler (item patient does not present an acceptable skill level, the physical 11). If they have not made any “critical error ” (item 12), a graphic therapist will proceed to the correct inhaler use model, correct material of the inhaled medication is given (Supplementary Fig. 1) errors, and ask the patient to show what he learned through this and the session is concluded. “Critical error” were considered if the process. When the patient continued displaying DeIT, the therapist patient showed an action or inaction that, in itself, which can lead contacted the prescribing doctor to report that the inhaler needed to a detrimental impact on drug administration in the lung . If the to be changed. Published in partnership with Primary Care Respiratory Society UK npj Primary Care Respiratory Medicine (2022) 1 JM Sánchez-Nieto et al. Fig. 3 Inhaler technique evaluation card (ITEC). Clinical variables and outcome measure a nurse previously trained in conducting the questionnaire TAI, blinded to the results of the initial questionnaire and who has not Data was gathered on sociodemographic, clinical, and spirometric participated in the initial training. information, type of inhaler evaluated, and the results of the inhaler technique skill level of the patient (optimal or poor inhaler technique). The primary and secondary variables were analysed at Statistical analysis the baseline and after the intervention (IEITI). The main variable The sample size was calculated in bilateral contrast factoring in a was the decrease in the percentage of patients with LowAd in the 5% alpha risk and 0.1 beta risk (90% statistical power). A sample of final visit. Secondary variables were: types of noncompliance: 130 participants is necessary assuming that the initial rate of LAd 25–27 erratic unwitting and deliberate, and percentage of patients with would be 45% and the final rate 25% . The rate of patient loss poor Inhaler Technique and critical errors. The differences to follow-up was estimated at 8%. Quantitative variables are between patients diagnosed with asthma and COPD were also shown as averages ± standard deviation (interquartile range: first analysed as part of the study variables. To minimize measurement and third quartile). Comparisons between groups were performed bias, the evaluation of the last visit, in week 24, was performed by with the Fisher exact test. Categorical variables were expressed as npj Primary Care Respiratory Medicine (2022) 1 Published in partnership with Primary Care Respiratory Society UK JM Sánchez-Nieto et al. absolute and relative frequencies, and comparisons between them were made using the Pearson Chi test or Fisher’s test. Quantitative variables were expressed as mean ± standard devia- tion and the comparisons were made between independent groups using the Student’s t-test or the Mann–Whitney test if the variable did not present a normal distribution. When the variables have been measured at different points, the McNemar test was used for their comparison and the paired samples t-test or Wilcoxon test depending on whether or not the distribution of the quantitative variables. A multivariate logistic regression analysis was performed to evaluate associated factors with LowAd, calculating the odds ratios (ORs) and 95% confidence intervals (CI). The independent variables considered were: age, sex, deficient inhaler technique (initial visit), smokers status, previous training, the severity level of disease (COPD/Asthma), type of disease (COPD/asthma), and types of inhalers evaluated (initial visit). First, a univariate analysis of each variable was performed, and then, the variables whose univariate test had a p value <0.3 were included in the multivariate logistic regression model. The goodness-of-fit of the multivariate model was evaluated with the Hosmer–Lemeshow test. Odds ratio (OR) values were calculated with 95% confidence intervals (CI 95% CI). All analyses were performed “two tails”, and a p value of less than 0.05 was considered significant. All analyses Fig. 4 Study inclusion and follow-up algorithm. were performed with the SPSS statistical software program (SPSS version 25.0; IBM®, Armonk, NY) and Stata [StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP]. Table 1. Baseline characteristics of patients in the initial visit (n = 120). A blinded researcher carried out the data analysis. Characteristic N = 120 % Reporting summary Female, n (%) 67 55,8 Further information on research design is available in the Nature Age, years, mean ± SD 60,8 ± 16.6 Research Reporting Summary linked to this article. Asthma diagnosis Mild-intermittent 54 63,8 Moderate-severe 31 36,5 RESULTS COPD Diagnosis Mild-moderate 20 57,1 Participants Severe-very severe 15 52,9 A group of 160 patients was recruited for the study. Of these, 31 Smokers status, n (%) 25 20,8 (19.1%) were excluded, a majority of which, 20 (64.5%), refused to Previous training*, n (%) 54 45 attend the visits. Nine patients (5.6%) were lost to follow-up. Two Number drugs /patient**, 2 (1,5) patients have prescribed a home nebulizer due to repeated critical mean ± SD errors in inhaler technique and120 finished the study. The Number inhalers/patient***, 2 (2,2) inclusion criteria and follow-up algorithm are shown in Fig. 4. mean ± SD Most of the patients were female (55.8%) with an average age No studies or primary, n (%) 83 69,2 of 60,8 (±16.6) years. Most of them had been diagnosed with asthma, 85 patients (70.8%) and the rest, 35 patients, were SD standard deviation, FEV1 forced expiratory volume in 1 second, COPD diagnosed with COPD. The average FEV was 72.6 ± 20.4 (of the chronic obstructive pulmonary disease. predicted value). 45% of the patients report having some previous *some form of “unstructured” instruction, **excluded inhalers, ***were training in the use of the inhaler that was prescribed. The evaluated 430 inhalers. remaining baseline characteristics of the 120 patients that participated in the study are shown in Table 1. of noncompliance, in 69 patients (57.5%). Finally, nonadherence The average score in the ten-item TAI questionnaire was 43,1 (±8,8) points in the initial visit and 46.6 (±5.9) at the end of the that is deliberate and largely associated with patient motivation to study (p < 0.001). About 120 inhalers were evaluated in the initial use the inhaler, was identified in 52 patients (43.3%). and final visits. The most commonly used inhaler at study recruitment was multidose DPIm, in 52 patients (43.3%) followed Effects of the intervention on the study variables by pMDI with spacer chamber, in 31 patients (25.8%). The During the IV, 81 patients (67.5%) presented LowAd compared to numbers and types of inhalers evaluated in the visits are listed in 66 (55%) in the FV. In contrast, the number of patients that Table 2. presented OptAd at the start, 39 (32.5%), had increased to 54 Based on the definition established in this study to evaluate (45%) at the end of the study. The intervention (IEITI) produced a inhaler technique, during the IV it was determined that the significant change in the level of adherence (p = 0.024) and a technique was poor or deficient in 69 inhalers (72.8%) and a decrease in the rate of patients with LowAd on week 24 of the critical error was made in the manipulation of 21 inhalers (16.3%). study. There was a decrease in erratic, 79 patients (65.8%), in the IV Regarding the level of adherence, during the IV, 81 patients vs 62 (51.7%) after the IEITI (P = 0.009). The number of patients (67.5%) had LowAd. The most frequent form of noncompliance presenting noncompliance deliberate went from 52 (43.3%) to 31 was forgetting to use the inhaler in 65.8% of the patients (Noncompliance erratic). Lack of knowledge of the dosage and/or (25.8%) at the end (p = 0.002). Lastly, out of 69 patients (57.5%) inhaler technique (unwitting), was the second most common form with unwitting noncompliance, 47 (39.2%) remained in this Published in partnership with Primary Care Respiratory Society UK npj Primary Care Respiratory Medicine (2022) 1 JM Sánchez-Nieto et al. characteristics of the patients except in the case of being a female Table 2. Types of inhalers evaluated in the study visits. patient (OR = 2.384, IC: 1.039–5.5518; p = 0.040). (Table 6). Type inhaler Initial visit Final visit N = 120 (%) N = 120 (%) DISCUSSION The problem of low adherence to inhaled treatment of chronic pMDI 12 (10) 18 (15) respiratory disease includes numerous factors of different nature pMDI + chamber spacer 31 (25,8) 24 (20) and complexity. The perception of a therapeutic benefitby the Soft mist inhaler 12 (10) 19 (15,8) patient and the effective use of the inhaler are the key to achieve MDPI 52 (43,3) 48 (40) adherence to the treatment. Insufficient instructions on the use of UDPI 13 (10,8) 11 (9,1) the inhaler and poor inhaler technique are common and have negative repercussions on adherence in the case of asthma and pMDI metered-dose inhaler pressurized, MDPI inhaler dry powder multi- 8,9 COPD . Several studies have evaluated the implementation of dose, UDPI inhaler dry powder unidose. interventions to improve inhaled treatment adherence. Interven- tions vary from providing only information in different formats to complex self-management programs and have had uneven results . Nine authors used “teach-back” interventions similar to those used in the present study and evaluated their impact on the proportion of Table 3. Changes in adherence, type of noncompliance and critical patients with the correct use of the inhaler but did not look at the errors in initial an final visit. changes in the adherence . Other reviews have evaluated multi- Initial visit Final visit P component strategies to improve adherence but it is hard to Adherence (items 1–10 TAI) n (%) n (%) determine the contribution of each component to the outcomes. It is also difficult to compare the results due to the diversity of Low adherence (≤49 points) 81 (67,5) 66 (55) 0.024 8 methods employed to evaluate adherence . An observational study Optimal adherence (=50 points) 39 (32,5) 54 (45) with 88 patients with COPD that evaluated adherence by means of a four-question self-administered questionnaire found that the only Types noncompliance (items 1–12 TAI) factor significantly related to adherence was having received Erratic noncompliance (items 1–5) 79 (65,8) 62 (51,7%) 0.009 instructions of inhaler technique previously . Ignorant noncompliance 69 (57,5) 47 (39,2%) 0.002 We did not find any studies on the impact of adherence of an (items 11–12) inhaler technique education intervention, using the IAT, on a Deliberate noncompliance (items 52 (43,3) 31 (25,8%) 0.002 population with asthma and COPD. After the IEITI intervention, 6–10) patients with LowAd decreased significantly and at the same time, Critical errors (Item 12 TAI) 21 (16,3%) 3 (2,5%) 0.461 patients with optimal adherence increased. The types of Evaluations with poor inhalation 69 (57,5%) 22 (11,2%) 0.002 noncompliance, the percentage of patients with poor inhaler technique* technique, and the percentage of critical errors also improved. A recent metanalysis addressed the impact of these interventions on TAI test of the adherence to inhalers, DeIT deficient inhaler technique. asthma and COPD exacerbations . Only three studies evaluated *Deficient inhaler technique (DeIT). the impact on adherence to the inhaled medication although, according to the authors, the benefit could be explained, in part, category at the end (p = 0.002). The pattern and relative frequency through the so-called Hawthorne effect: the awareness of being observed or of having a behavior that is being evaluated, of noncompliance did not change by the end of the study, being generates beliefs about the researcher’s expectations and the erratic pattern the most common one. Regarding the considerations of social acceptance that lead to a change in secondary variables, a significant change was found in the behavior . percentage of inhalers that were used with poor inhaler Also, different measures of adherence were used and, finally, technique. Similarly, the percentage of critical errors found in these were not included in the quantitative analysis. the initial visit improved after the IEITI. Table 3 shows the The percentage of LowAd in the COPD and asthma population description of the level of adherence, noncompliance, technique, in the study is similar to those reported by other authors who used and critical errors in the initial and final visit. different measurement instruments . About 67.5% of the patients Figure 5 shows point averages ± standard deviation of the in our study presented a low level of adherence, with an average patients in the initial and final visit according to the cut-off points score of 43.1 ± 8.8 (10-item TAI). The TAI and other recent established for the classification of noncompliance and level of 31–33 observational studies report similar results . The first, which adherence was carried out among Asian patients with exacerbated COPD, No significant differences were identified between the group of reported low adherence in 70% of the cases (low + intermediate patients with COPD and asthma. Patients with asthma presented a adherence) . Another study which was carried in Spain with 122 higher rate of LowAd than patients with COPD, 71.8 vs 57.1% (p = COPD and asthma patients found low adherence in 71.3% of the 0.120). Deliberate noncompliance was also most frequent in 32 patients studied . However, a multinational study conducted in patients with asthma, 48 vs 31.4%. In contrast, asthma patients Latin America with 795 patients found surprisingly good displayed a better skill level in the use of the inhalers. 52.9% adherence results. The average score was 47.4 ± 4.9 and the asthma patients had DeIT vs 68.6% in COPD patients (p = 0.039). percentage of LowAd in this population was 45.9% . The differences between patients with COPD and asthma are When we analyze separately the levels of adherence in patients shown in Table 4. with asthma and COPD, we found a LowAd level in asthma patients The baseline characteristics of the patients, such as having (57.1%) compared with COPD patients (71.8%), although without received previous training or their level of studies, showed no any significant differences. A multicentric study that analysed these relationship with low adherence. Only gender was related to low differences using the same TAI instrument, found significant adherence (Table 5). Finally, age, gender, and asthma diagnosis differences in levels of adherence in both groups of patients, with were chosen for the multivariate adjustment. The analysis did not a higher rate of LowAd in asthma patients (72%) and lower in COPD show any relation between the level of adherence and baseline patients (51%) . The noncompliance patterns between COPD and npj Primary Care Respiratory Medicine (2022) 1 Published in partnership with Primary Care Respiratory Society UK JM Sánchez-Nieto et al. Score Non –compliance Errac Items 1–5 Non –compliance Deliberate Items 6–10 Score Non –compliance Level unwing adherence ítems 11 y 12 Inial Final Inial Final Visits Non –compliance score range (minimum and maximum): Unwing: 2–4. Delbierate: 5–25. Errac: 5–25 Adherence level score (minimum and maximum): 10–50 Fig. 5 Average scores (±SD) were obtained by the patients according to the established ranges to classify the type of noncompliance and the level of Adherence. showed an error rate for inhalers (pMDI and DPIm) higher than Table 4. Changes in adherence, type of noncompliance, and critical 90% . At this point, we must comment on our results. Unlike errors between COPD and asthma. other studies , our definition of poor inhalation technique was not based on a strict recording of an error checklist. Only the COPD ASTHMA presence of an insufficient or uncoordinated inspiratory step and/ n (%) n (%) P or the existence of a critical error led us to consider an inhalation technique as deficient. Following the opinion of some authors , Adherence (items 1–10 TAI) some steps such as exhaling before inhaling and/or the absence Low adherence (≤49 points) 20 (57,1) 61 (71,8) 0.120 of apnea were not considered sufficient to consider the inhalation Types noncompliance (items 1–12 TAI) technique as deficient. These considerations may represent a Erratic noncompliance (items 1–5) 20 (57,1) 59 (69,4) 0.198 lower percentage of DeIT than reported in other studies . Unwitting noncompliance (items 11–12) 20 (57,1) 49 (57,5) 0.095 Something similar happens with the disparity of assessments of inhaler technique critical errors . Deliberate noncompliance (items 6–10) 11 (31,4) 41 (48,2) 0.091 Our results suggest that educational interventions on inhaler Critical errors (item 12 TAI) 4 (11,4) 14 (16,5) 0.482 techniques improve patients’ ability and, at the same time, can Inhalation technique* 24 (68,6) 45 (52,9) 0.115 also improve the perception of therapeutic benefit and adherence Evaluations with por to inhaled medication. Although, these results should be inhalation technique* 24 (68,6) 45 (52,9) 0.115 interpreted with caution. First, the efficacy of a healthcare intervention is ideally demonstrated under the conditions of TAI test of the adherence to inhalers, COPD chronic obstructive pulmonary double-blind randomized controlled trials with highly selected disease, DeIT deficient inhaler technique. populations and operating under highly monitored and controlled *Deficient inhaler technique (DeIT). conditions . However, logistical limitations conditioned the design to a pre-post intervention study, thus incorporating possible biases to the results obtained. Occasionally, studies with asthma are also different in this study, being the most frequent minimal exclusion criteria may be more representative of the pattern in asthmatics the erratic (66.8%). These differences are more patients seen in daily clinical practice and provide complementary 34 39 likely to be related to sociodemographic characteristics . In our data to those obtained in traditional efficacy studies . study, the erratic pattern was also higher in patients with asthma Second, it is possible that the modifications in the patients’ with very similar values (69%). In this group of patients, at baseline, behavior could have influenced the results of the IAT in the final the frequency of the erratic pattern was 65% compared to 57.9% visit since the patients knew that they were being evaluated and 15 30 that was obtained in the validation work of the TAI .These not as an effect of the intervention itself (Hawthorne effect) . 15,34 studies did not include educational interventions nor a long- Having a wide age range in the study may have introduced a bias, itudinal evolution analysis of patient adherence. mainly due to endotypic and phenotypic differences. This could In relation to the evaluation of the inhalation technique, there is have led to different clinical and questionnaire responses to the high variability in the comparison of results due to the educational intervention . Another aspect that should be heterogeneity of the methods used. In general, the ability of considered when interpreting the results is the measure of patients in the inhalation technique seems not to have improved adherence to the inhaled medication by means of a self- in the last 40 years . The international study “International Helping administered questionnaire due to the biases inherent to this Asthma in Real-life Patients” (iHARP), the largest asthma study on type of qualitative instrument . Recent studies show evidence of patient inhaler technique with 5000 structured evaluations, an overstatement of adherence in patients evaluated using the TAI Published in partnership with Primary Care Respiratory Society UK npj Primary Care Respiratory Medicine (2022) 1 Half points quesonnaire (± SD) JM Sánchez-Nieto et al. Table 5. Relation of the low and optimal adherence and baseline characteristics of the patients with COPD and asthma. Characteristics Low adherence Optimal adherence P 45 (69.7) 22 (38.9) 0.001 Females 58.9 ± 16.7 80.7 ± 23.7 70.9 ± 20.1 0.073 Asthma diagnosis Mild-intermittent 31 (62) 23 (65.7) *0.726 Moderate-severe 19 (38) 12 (34.3) COPD diagnosis Mild-moderate 9 (56.3) 11(57.9) *0.922 Severe-very severe 7 (43.8) 8 (42.1) Smoker 16 (24.2) 9 (16.7) 0.429 Previous inhaler technique training ** 30 (45.5) 24 (44.4) 0.912 Medications /patient excluding inhalers 2 ± 1.5 2 (0.5) 0.746 Inhalers/patient 2 ± 2.2 2 (0.5) 0.456 No formal or basic education 44 (66.7) 39 (72.2) 0.512 The dates show n (%) or average ± standard deviation. COPD chronic obstructive pulmonary disease. *P result severity of asthma and COPD, ** some form of “unstructured” instruction. objective, it is necessary to better understand the conceptual Table 6. Logistic regression model. connection between adherence and technique (whether they are different aspects, or they must be combined into one integrated Variable OR IC-95% OR p value quality approach to the administration of inhaled medication). Age >70 0.591 0.252–1.394 0.231 Understanding behavioral patterns of adherence in a subpopula- tion of patients (e.g., children, adults) and at different stages of the Female 2.394 1.039–5.518 0.04 disease, will help to develop more specific and effective Asthma diagnosis 1.384 0.573–3.341 0.469 interventions. This study can contribute to the understanding of The variables identified as predictors of low adherence on univariate how adherence and inhaler technique interact by evaluating them analysis: age, gender and asthma or COPD diagnosis, were included. For longitudinally following a structured educational intervention in this model, the Hosmer–Lemeshow test showed a p value= 0.699. real-world clinical practice conditions. OR odds ratio, IC interval confidence, COPD chronic obstructive pulmonary We demonstrated that, among patients with COPD and asthma, disease. an individualized educational inhaler technique intervention, carried out in real-world clinical practice conditions, improves adherence to the inhaled treatment, as evaluated by means of TAI. 40,41 compared to medication administration records . The TAI However, the small sample size limits the external validity of these seems to be more reliable when assessing patients with low results and suggests the need for further studies. adherence. But, with higher scores, it should be modulated with more objective methods, particularly in the context of studies of intervention effectiveness . In our study, the TAI was evaluated DATA AVAILABILITY longitudinally in two visits. This bias could have been present in The data that support the findings of this study are available from the corresponding both measurements, but it did not condition the favorable author upon reasonable request. The original contributions presented in the study evolution of adherence in a significant way. Another limitation of are included in the article/supplementary material (Supplementary Fig. 1). Correspondence and requests for supplementary materials should be addressed to the study is the sample size, which was slightly lower than the the corresponding author. calculated sample size, and the possible impact of other unmeasured confounding or covariates not included in the Received: 17 February 2021; Accepted: 12 November 2021; variable selection in the logistic regression model, such as the educational or socioeconomic level of the patients. 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Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims 28. Takemura, M. et al. Relationships between repeated instruction on inhalation in published maps and institutional affiliations. therapy, medication adherence, and health status in chronic obstructive pul- monary disease. Int. J. Chron. Obstrcut. Pulmon. Dis. 6,97–104 (2011). 29. Maricoto, T., Monteiro, L., Gama, J. M. R., Correia-de-Sous, J. & Taborda-Barata, L. Inhaler technique education and exacerbation risk in older adults with asthma or Open Access This article is licensed under a Creative Commons chronic obstructive pulmonary disease: a meta-analysis. JAGS 67,57–66 (2019). Attribution 4.0 International License, which permits use, sharing, 30. McCambridgea, J., Wittonb, J. & Elbournec, D. R. Systematic review of the Haw- adaptation, distribution and reproduction in any medium or format, as long as you give thorne effect: new concepts are needed to study research participation effects. J. appropriate credit to the original author(s) and the source, provide a link to the Creative Clin. Epidemiol. 67, 267–77. (2014). Commons license, and indicate if changes were made. The images or other third party 31. Ngo, C. Q. et al. Inhaler technique and adherence to inhaled medications among material in this article are included in the article’s Creative Commons license, unless patients with acute exacerbation of chronic obstructive pulmonary disease in indicated otherwise in a credit line to the material. If material is not included in the Vietnam. Int. J. Environ. Res. Public Health. 16, 185 (2019). article’s Creative Commons license and your intended use is not permitted by statutory 32. Barja-Martínez, E., Casas-González, S., Simón-López, A. F., Mancheño-Ovejero, C. & regulation or exceeds the permitted use, you will need to obtain permission directly Padial-de la Cruz, M. L. G. Adherence to inhaled therapy in the outpatient setting. from the copyright holder. To view a copy of this license, visit http://creativecommons. Enferm. Clin. 29,34–38 (2019). org/licenses/by/4.0/. 33. Montes de Oca, M. et al. Adherence to inhaled therapies of COPD patients from seven Latin American countries: the LASSYC study. PLoS ONE 12, e0186777 (2017). © The Author(s) 2022 Published in partnership with Primary Care Respiratory Society UK npj Primary Care Respiratory Medicine (2022) 1

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