Study setting and design
A multi-centered institutional based cross-sectional survey through patient interviews and medical record review was conducted from October to December 2021 at three public comprehensive specialized hospitals; University of Gondar Comprehensive Specialized Hospital (UOGCSH), Felege Hiwot Comprehensive Specialized Hospital (FHCSH) and Tibebe Ghion Comprehensive Specialized Hospital (TGCSH) ambulatory care. The University of Gondar Comprehensive Specialized Hospital is a public comprehensive referral health facility present in northern Ethiopia, which serves as a teaching hospital for the University of Gondar College of medicine and health science students. The hospital is located around 738 km far from the capital city of Ethiopia. Asthma follows up runs every on Monday and reviews at least 280–300 patients with asthma monthly as per the UOGCSH records. Felege Hiwot Comprehensive Specialized Hospital is located in Bahir Dar city, which is located in the northwest and 565 km away from the capital of Ethiopia. It is one of the three governmental Hospitals in the city. It has 200 beds and three medical OPD serve for medical patients of which one serves as a referral and follow-up clinics for patients with chronic diseases. The chest clinic of the hospital serves chronic asthma and patients with COPD. Asthma follow-up runs from on Monday to Friday on average reviews at least 190–200 patients monthly as FHRH medical records. Tibebe Ghion Comprehensive Specialized Hospital (TGCSH) ambulatory care is a teaching hospital under the college of medicine and health sciences of Bahir Dar University located in Bahir Dar, Ethiopia. This is one of the 43 governmental hospitals in the Amhara region. The hospital serves more than five million people in a catchment area. This teaching hospital has more than 500 beds and 2000 patients per day in both inpatient and outpatient services. From the OPD service asthma, follow-up runs every Wednesday and reviews on average 70–80 patients per month as FGSH medical records.
Study population and sampling
Patients with asthma aged 18 years and above who attended the selected hospital’s ambulatory care for follow-up were eligible for this study. Also, the study subjects should have received ICS therapy for the last 3 months to be included. Whereas, patients who were unable to communicate, critically ill, admitted to inpatient departments and uncompleted medical records were excluded. The sample size was determined using a single population proportion formula and 422 individuals included by expecting the proportion of patients with controlled asthma were used from a previous study in Ethiopia which was reported to be 46.7% . 5% absolute precision or margin of error, 5% significance, and 95% confidence level were employed; and 10% contingency was for non-response used. A systematic random sampling technique was used to recruit the study participants. Then, we proportional allocated the study participants proportionally in each selected hospital. Here 224, 142, and 56 patients participated in UOGCSH, FHCSH, and TGCSH, respectively. Respondents were allocated proportionally as per the number of patient flow into the respected hospitals, which were selected through a systematic random sampling method. Finally, the sample was collected within 3 months, this makes the sampling fraction (k-interval) 1695/422 = 4 approximately the initial study subject was selected by the lottery method, and then corresponding medical records were collected, study individuals were chosen by every four person and relevant data were taken. For medical records of the study subjects who met the inclusion criteria were considered and whenever one medical record on hand was ineligible, the next immediate one was selected, and the same approach was followed throughout the data collection procedure.
Data collection tools and procedures
After reviewing various related literature, the data collection tool was primarily prepared in English. It was then translated into the local language (Amharic) and then translated back to English to ensure consistency. The instrument consisted of five sections; (I) the first section included socio-demographic characteristics of the study participants, (II) the second section included the clinical characteristics, and measurement of asthma control, and (III) the third section contained the instrument to measure ICS treatment adherence (MARS-A), (IV) fourth section contained medication recorded and last (V) consisted of healthcare provider factors. Data collectors had received training on the aims of the study, data collection instruments and producers, and ethical issues. Relevant data were obtained by interviewing participants and reviewing the medical records volunteer study participants. However, if one of the available medical records was ineligible, the next one was considered, and the same approach was followed throughout the data collection. The Asthma Control Test (ACT) was employed in this study to measure the levels of asthma control. The tool is standardized and applicable across populations worldwide . For this study participants, the data collectors administered the questionnaires to participants in a questionnaire-guided interview, mitigating against such obstacles as language barriers and low literacy levels. The ACT tool is a simple test for patients with asthma aged 12 years and above and measures the level of asthma control. It contains 5 questions on a 5-point scale depicting the frequency of asthma symptoms and usage of rescue medication by participants in the last 4 weeks. The overall score was in the range of 5 (worse control) to 25 (total control) .
The Medication Adherence Rate Scale (MARS-A) was used to measure the adherence of the patient to their medication , and an old version of the Beliefs about Medicine Questionnaire (BMQ)  was used to measure the beliefs of the patient in their medication and other different studies [3, 14] were used to develop other related questions.
The belief about Medicine Questionnaire is a 10-item questionnaire that assesses the patient’s beliefs about their prescribed medication. It is composed of two-five item scales that are the specific necessity and specific-concern scales. The specific-necessity scale assesses patients’ beliefs about the prescribed medication to maintain their health now and in the future. However, the scale of the specific concern assesses patients’ perceptions about the adverse consequences of taking medicines related to long-term effects and dependence . The patients’ level of beliefs about medicine (s) before and clinical appointments toward their asthma management care were computed using a 5-point Likert-type scale ranging from strongly disagree = 1 to strongly agree = 5 .
Adherence to ICS was measured using the MARS-A, a self-reported adherence tool that demonstrated good test-retest reliability (r = 0.65, p-value < 0.001), internal consistency reliability of 0.85, and the sensitivity of 0.82, and specificity of 0.69. The responses were measured using a 5-point Likert scale (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Always). Self-reported adherence is reported as the average score of the 10 items (1–5), where higher scores indicate higher levels of reported adherence. High self-reported adherence was defined as a MARS-A score of 4.5 or higher .
The modified patient enablement index (mPEI) was used to evaluate the enablement of the patient and a score of more than 6 indicated clinically meaningful enablement. It contains six items: assess the patient’s ability to deal with life, understand the illness, cope with it, keep healthy, remain confident about health, and help oneself . The comorbidity index was done using the Charlson comorbidity index to determine the burden of comorbidity on asthma control and health-related quality of life (HRQOL) .
All the above tools were translated into Amharic using translators who were speakers of English and Amharic. The translation was verified for compatibility with the original version by a process of forward and backward translation, performed by persons who were native speakers of Amharic and fluent in English. Face validity of the survey was assessed among three clinical pharmacy teachers for clarity of the questions. Then, the survey was pretested for content, design, readability, and comprehension on 42 people, and modifications were made as necessary so that the survey was simple to understand and answer, yet provided accurate data.
Data quality management
The data collection instruments were prepared after reviewing similar literature and amendment was performed by considering local clinical settings. The face validity of the questionnaire was checked by three language experts for clarity of questions. Subsequently, the survey was pretested for content, design, readability, and comprehensibility in 10% of study participants who were excluded from the final analysis. Socio-cultural adaptation was performed using recommendations from WHO, and changes were made based on responses. Thus, the survey was easy to understand and respond to while still providing accurate data. The Cronbach alpha was used for tools and medication belief (α = 0.726), MARS-A (α = 0.90), mini-AQLQ (α = 0.898), ACT (0.83), and the role of patient enablement (0.92).
Asthma control: implies the extent to which the various manifestations of asthma are reduced or removed by treatment.
Well-controlled: It represents asthma control in which a respondent’s score of 20–25 for ACT-like daytime symptoms, night time symptoms, limitations in activities, and rescue medications used to be none in the previous 4 weeks .
Partially controlled This stands for the respondent’s score is 15–19 out of 25 according to the ACT tool .
Uncontrolled: This stands for the respondent’s score being less than 15 of 25 ACT scores .
Highly Adherent to medication: A patient who scored ≥4.5 for the MARS-A was adherent to the controller medication .
Low adherent to medication: A patient who scored < 4.5 for the MARS-A was non-adherent to the controller medication .
The role of patient enablement means the measure of patient’s ability to understand and cope with life and illness after a consultation with a general practitioner .
Patient enablement: There was a minimum score of 0 and a maximum score of 12. A PEI score of ≥6 has been reported as indicating clinically meaningful “enablement” .
Optimal: The most favorable interventions and their amounts for achieving asthma control.
Adherence/compliance: are synonymously used. Adherence to guidelines is the degree to which HCP behavior corresponds with the collaborative agreed recommendations from GINA, 2018 guideline. Compliance refers to the extent to which a patient’s behavior matches guideline advice.
The data was checked for its completeness, and cleanness, then coded and entered into the Epi Information Version 7 database and exported to SPSS Version 26 for analysis. Descriptive statistics, means, median, proportions, tables, and figures, were used to describe the characteristics of the study patients and displayed the study results. First, all the assumptions of the ordinal model were checked (outliers, multicollinearity, and proportional odds) the statistical methods for all variables were tested and those fulfilling the assumptions were entered into further analysis. Additionally, a histogram or normal probability plot of the residuals was used to examine the data distribution and the test indicated that the residuals were approximately normally distributed. Finally, variables with a p-value ≤0.2 in bi-variable were entered into a multivariable ordinal logistic regression to determine the independent predictor variables of asthma control. To identify factors associated with asthma control, multivariable ordinal regression was tested and an adjusted odds ratio (AOR) and 95% confidence interval  were used to assess the strength and direction of associations between the dependent and independent variables. The statistical significance was declared using a p-value less than 0.05. The adequacy of the models was checked by the like hood Chi square-test of the goodness of fit.
Ethical considerations and confidentiality
The study protocol was approved by a research review committee of the clinical pharmacy department, the University of Gondar with the reference number 132/2021. An official letter of cooperation was written to the chronic ambulatory department of each hospital. The names and addresses of the patients were not documented during the data collection to ensure confidentiality. The information will not be disclosed to anyone in any way and will only be used for the study purpose.