Study design
Facility based cross-sectional study was employed to determine the HRQoL and its determinant among adult living with asthma who visited the health facilities in Northwest Ethiopia.
Study settings and population
From five comprehensive specialized hospitals found in northwestern Ethiopia, three of them selected randomly. The study was conducted from August, 01/2021 to October, 30/2021 at University of Gondar comprehensive specialized hospital (UOGCSH), Felege Hiwot Comprehensive Specialized Hospital (FHCSH) and Tibebe Ghion Comprehensive Specialized Hospital (TGCSH) ambulatory care. 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 sciences students. The hospital is located around 738 km far from the capital city of Ethiopia. The asthma follows up run every Monday and reviews at least 280-300 asthmatic patients monthly as per the UOGCSH records [26].
Felege Hiwot Comprehensive Specialized hospital which is found in Bahir Dar city, which is located on in the northwest and 565 km away from the capital of Ethiopia. This is one of the three governmental Hospitals in the city. It has 200 beds and three medical outpatient department (OPD) serves for medical patients of which one serve as referral and follow up clinic for patients with chronic diseases. The chest clinic of the hospital serves for chronic asthma and chronic obstructive pulmonary diseases (COPD) patients. The asthma follow up run from Monday to Friday on average reviews at least 190-200 patients monthly as FHCSH medical records.
Tibebe Ghion Comprehensive Specialized Hospital a teaching hospital under college of medicine and health sciences of Bahir Dar University located in Bahir Dar, Ethiopia. This is one of the 43 governmental hospitals in Amhara region. The hospital serves more than five million people in the 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 run every Wednesday and reviews on average 70-80 patients per month as FGSH medical records.
The sample size was determined by using single population proportion formula. Thus, considering as W= marginal error of 5% (w=0.05), Z α/2= the degree of accuracy required (95% level of significance = 1.96), since there was no studies conducted on HRQoL of asthmatic patient in the study area P was taken 50%. In view of the said points a single proportion formula is calculated as follows:
n = Z α/22 p (1-p)
W2 Where n= sample size required,
n= (1.96)2 (0.5) (0.5) = 384
(0.05)2
Finally, considering a 10% contingency for possible non-response rate, and missed data. The calculated sample size was to be 422. A total of 1695 asthmatic patients 900,570 and 225 were from Gondar, Felegehiwot and Tibebegion hospitals, respectively were taken as study population. Proportional allocation was done to get the representative sample by taking the total number of asthmatic patient in each study area (UOGCSH 900/1695×422=224, FHCSH 570/1695×422=142 and TGCSH 225/1695×422=56) patients were included.
Sampling technique
Patients who fulfill the inclusion criteria were included in the study using systematic random sampling technique. As to University of Gondar asthma ambulatory care records, on average 300 asthma patients have been visited the ambulatory care per month , as to Felege Hiwot Comprehensive hospital chest clinic records on average 190 patients have been visited per month and according to Tibebe Ghion Specialized Hospital ambulatory care records on average 75 patients have been visited per month (minding that all the asthma patients will be attended from one to three month in all hospitals),Since asthma patients are recommended to visit the ambulatory for a minimum of one month and a maximum of three month .So that adding all average three month number of the patient yield about 900 at Gondar,570 at Felegehiwot and 225 at Tibebe Ghion hospitals were visited and the overall number of patient per three months in all hospitals had 1695. Taking into consideration, the sample was collected within three months, this makes the sampling fraction (k-interval) 1695/422=4 approximately the initial study subject was selected by lottery method and then study participants was chosen by every four person and there corresponding medical records were collected, and relevant data was taken. Side by side the selected respondent was interviewed. For this medical record of study subjects that met the inclusion criteria was considered and whenever one medical record on hand was not eligible, the next immediate one be selected, and the same approach was followed throughout the entire data collection procedure
The study populations were Adult asthmatic patients who visited UOGCSH, FHCSH and TGCSH ambulatory care follow up from August to October, 2021. During the study period, Adult asthmatic patients whose age 18 years and above, had a diagnosis for asthma and on treatment for minimum of three months, attended at UOGCSH, FHRH and TGRH ambulatory ward for their asthma routine management and follow-up, provided their verbal informed consent to participate in the study were included in the study. Participants, who were unable to communicate, had incomplete medical records and patients requiring admission were excluded.
Data collection tools and procedures
The ACT and the Mini-AQLQ tools were employed in this study to measure the levels of asthma control and the HRQoL, respectively. These tools are standardized and are applicable across populations worldwide [27, 28]. For this population, the data collectors were interviewed the participants and mitigating against such obstacles as language barrier and low literacy levels Amharic version of the tool were used. The Asthma Control Test (ACT) tool is a simple test for asthmatic patients 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 previous four weeks. The overall score is in the ranges of 5 (worse control) to 25 (total control) [27].
The mini- AQLQ is a disease specific tool for measuring the HRQoL due to asthma. It contains 15 questions in sections in four domains: Symptoms, Activity Limitation, Emotional Function and Environmental Stimuli. Participants were asked about how their conditions had been in the previous two weeks prior to enrollment into the study. Investigators were recorded participant responses to each of the 15 questions on the 7-point scale onto the questionnaire. The overall mini AQLQ score was the mean of all the 15 responses while each domain score were the mean of responses to items in that particular domain [28].
Factors associated with HRQoL were collected based on structured questionnaire that included socio demographic factor, modifiable and non-modifiable factor, triggers, patient compliance and clinical factors that influence asthma control and consequently, HRQoL. Medication Adherence Rate Scale (MARS-A) [29] was used to measure adherence of the patient to their medication, old version of Beliefs about Medicine Questionnaire (BMQ) [30] was used to measure the belief of the patient on their medication and other different literatures [2, 31] were used to develop other related questions.
A belief about Medicine Questionnaire is a 10-item questionnaire that assesses the patient beliefs to their prescribed medication. It is composed of two-five item scales that are specific necessity and specific-concerns scale. The specific-necessity scale that assesses patients’ beliefs about prescribed medication to maintain their health now and in the future. However, specific concerns scale assesses patients’ perception about adverse consequences of taking medicines related to long term effect and dependence [32]. The patients' level of beliefs about medicine (s) before and during clinical appointments towards their asthma management care were computed using a 5-point Likert-type scale ranging from strongly disagree=1 to strongly agree=5 [33].
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, 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) [34].
The modified patient enablement index (mPEI) was used to evaluate enablement of the patient and a score of >6 indicate 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[35]. Comorbidity index was done by using charlsone comorbid index and classified as mild, moderate and severe whose comorbidity index score 1 and 2,3 and 4, greater than 4 respectively, to determine the burden of comorbidity on asthma control and HRQOL [36].
All the above tools were translated into Amharic by English and Amharic versed persons. Translation was verified for compatibility with the original version in a process of forward and backward translation. 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 socio-cultural adoption were made by using WHO recommendations and modifications were made based on the response. So that the survey was simple to understand and answer, yet provided accurate data.
Training of research assistants
The principal investigator (PI) identified six data collectors (two data collectors for each study area) and trained for two days before commencement of the research. The data collectors were nurses working in the ambulatory care of UOGCSH, FHCSH chest clinic and TGCSH ambulatory care. The training entailed an explanation of the nature of the study, its objectives and importance. Demonstration and practical training of use of the data collection tools was done. Ethical considerations and overall expectation from scientific research were explained. The competence of the data collectors was assured by the PI during pre-testing before the study commence through. This was done by assessing how correctly the collector extracted data and filled up the questionnaires. Where further training was required, it was provided and reinforced until competence was ascertained. Finally, after the data was checked for its completeness, it was cleaned and analyzed. Pre-test on the 5% (42) patients of the sample size was done by administered 42 copies of the questionnaires to target population at the ambulatory ward. Based on the results obtained, modification of the questionnaire was done. The Cronbach alpha was done for tools and medication belief (α=0.73), MARS-A (α=0.90), mini-AQLQ (α=0.90), ACT (0.83) and role of patient enablement (0.92).
Data analysis and management
The data was checked for its completeness, cleanness, then coded and entered to Epi Info Version 7 database and export 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, the test assumptions (normality test, correlation coefficients tests, linearity tests, outliers, multicollinearity and homoscedasticity) of all the statistical methods for all variables were tested and those fulfilled the assumptions were entered in further analysis. Variables such as hospitalization, triggering factor and exercise were excluded from the analysis because they did not met linearity. Linearity was checked by generating separate scatter plots with the dependent variable on the y-axis and the independent variables on the x-axis. The relationship between mean score of HRQoL and another continuous variable was checked by the P-P plot. Similarly, the categorical variables linear relationship was checked by drawing a line between the mid-points of the observations at each level. The variables which had no linear relationship with the outcome were excluded from analysis. The variation around the regression line was tested by examining a plot of the standardised residuals versus standardised predicted values of the dependent variable and it was constant for all values of xi for each X variable. Additionally, histogram ,normal probability plot of the residuals and Shapiro wilk test were done to examine the data distribution and the test indicated that the residuals had approximate to be normally distributed. Results of the regression analysis were expressed in un-standardized coefficient β. Beta coefficients are measured in units of standard deviation and refer to the average change in the dependent variable for a unit increase in the predictor variable. Finally, assumptions of multiple linear regressions met (normality test, correlation coefficients tests, linearity tests, outliers, multicollinearity and homoscedasticity). Then, variables with a p-value ≤0.2 in bi-variable analysis were entered to multivariable linear regression to identify the independent predictor variables of HRQoL. The statistical significance was declared using a p-value less than 0.05. The adequacies of the models were checked by the F-test of goodness of fit for linear regression.
Ethical considerations and Confidentiality
Ethical clearance was obtained from the Institutional Review Board of University of Gondar. Letter of permission was obtained from each hospital clinical directorate. Study medical records numbers was used in place of patient names during the data collection and analysis process in order to conceal and safeguard participant’s identity. All the data collection materials were safely kept in a cabinet under lock and key. The databases were password protected by the PI for limited access during the entire study period. The collected data was used only for the purpose of the study. Verbal consent was taken after the purpose and objective of the study was explained to the selected participants. Moreover, all participants were informed that participation was on voluntary basis and they can withdraw from the study at any time if they are not comfortable about the questionnaire. Any identifiers of the study participants were not recorded.