Magnitude of clinical inertia and its associated factors among adult patients with asthma on chronic follow-up at Jimma Medical Center, Ethiopia: prospective observational study
Magnitude of clinical inertia and its associated factors among adult patients with asthma on chronic follow-up at Jimma Medical Center, Ethiopia: prospective observational study
To assess the magnitude of clinical inertia and its associated factors among adult patients with asthma on chronic follow-up at Jimma Medical Center, Ethiopia, from December 2021 to May 2022.
A hospital-based prospective observational study was conducted in Jimma Medical Center from 1 December 2021 to 30 May 2022.
135 patients with asthma who fulfilled the inclusion criteria were enrolled in the study consecutively and followed for 3 months.
Of 148 patients, 135 patients’ data were analysed. The mean (SD) age of the patients was 52.03 (±15.75) years. More than half (54.1%) of the study participants were men. Most of the study participants (68.9%) at the first and (70.4%) at the second visit, which is 3 months after the first visit, had clinical inertia, respectively. Comorbidity (adjusted OR (AOR) 3.35, 95% CI (1.15, 9.81), p<0.027), asthma duration of 5–10 years (AOR 7.58, 95% CI (1.51, 38.05), p<0.014), moderate persistent asthma (AOR 6.91, 95% CI (2.46, 19.42), p<0.00) and severe persistent asthma (AOR 10.84, 95% CI (1.1, 107.0), p<0.041) were contributing factors for clinical inertia.
The burden of clinical inertia in this study was high at both visits. Comorbidity, duration of asthma of 5–10 years, moderate persistent and severe persistent asthma were identified as contributing factors to clinical inertia. Policymaker intervention to avoid clinical inertia is necessary to improve asthma treatment outcomes.
Data are available upon reasonable request. The datasets that were used to support the conclusions of this article are made available upon the request of the corresponding author.
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Asthma is a chronic inflammatory disorder of the airways within which several cells and cellular components play a task, especially mast cells, eosinophil, T-lymphocytes and neutrophils. Repeated episodes of wheezing, dyspnoea, chest tightness and cough, which significantly occur in the night and in the early morning, are caused by airway inflammation that is typically related to widespread, however, variable flow obstruction that is usually reversible either spontaneously or with treatment.1 A patient’s symptoms and medical record are typically used to diagnose asthma and establish its severity. Symptoms and drug needs are used to decide the severity of asthma. The initial doses of medicines and the frequencies are based on severity and are essential to guide the later medical reviews for patients with asthma. Chronic asthma is classed as intermittent or persistent asthma. Persistent asthma is once more classified into mild, moderate and severe persistent asthma.1 2
A global burden of disease study estimated that there were 262 million people worldwide who were affected by asthma in 2019.3 Australia (21.5%), Sweden (20.2%), the UK (18.2%), Netherlands (15.3%) and Brazil (13.0%) are among the countries with the highest prevalence of asthma.4 The estimate of asthma prevalence in Africa suggested that greater than 119.3 million (12.8%) of the total population have asthma in 2010. The prevalence is highest in South Africa (53%, 5–12 years), followed by Egypt (26.5%, 11–15 years) and Nigeria (18.4%, 15–35 years).5 In Ethiopia, the unavailability of appropriate and affordable medications, poor knowledge of patients and poor communication between physician and patient increased the burden of asthma.6 Nationwide data addressing asthma prevalence in the adult population are scarce in Ethiopia. A hospital-based study done in Debre Berhan and a community-based cross-sectional study done in Jimma reported 29.6% and 4.9% prevalence of asthma, respectively.7 8
Routine assessment and monitoring, patient education to create a partnership between clinician and patient, controlling environmental factors and comorbid conditions that contribute to asthma severity and pharmacological therapy are essential components for optimal management of patients with asthma.9 Pharmacological therapy is a key part of asthma management, and guidelines recommend a stepwise approach to the treatment of asthma. Treatment is started at the step most appropriate to the initial severity of asthma, with the aim of achieving early control of symptoms and optimising respiratory function. Continuous treatment cycle assessment and adjustment, as well as the review of response, are vital to identify asthma control status. Control is maintained by stepping up treatment as necessary and stepping down once control is good.1 10 11 Despite such advances, healthcare providers often fail to initiate or intensify therapy appropriately during visits of patients with asthma. Such behaviour is described as clinical inertia, recognition of the problem, but failure to act. Clinical inertia is commonly caused by three problems: overestimation of care provided; avoiding intensification of therapy; lack of education and training and practice organisation focused on achieving therapeutic goals.12 Provider factors and patient-related factors are the factors that contribute to clinical inertia in the management of asthma.13
The status of asthma control is the extent to which the symptoms of asthma can be observed in the patient, have been reduced or removed by treatment and asthma control is achieved when there is suppression of asthma symptoms resulting in a reduction in the frequency of rescue β2-agonist use.1 14 Asthma control is affected by different factors. Frequency of short-acting beta2-agonist (SABA) use, age, presence of comorbidity, use of SABA alone as anti-asthmatic medication, longer duration of asthma (>30 years) and asthma exacerbation in the last 12 months are factors that affect asthma control.15
The burden of bronchial asthma is high and its impact includes reduced quality of life, lost productivity, increased healthcare costs, the risk of hospitalisation and even death. Worldwide annually around 461 000 deaths were attributed to asthma and most of those deaths occur in low and low to middle-income countries where underdiagnoses and undertreatment are a challenge.3 The other impact of asthma is its economic burden. Estimated total medical costs of asthma were US $57.9 billion and US $21.65 billion per year in the USA and Europe, respectively, in 2013.16 In developing countries, the annual asthma cost was estimated at US $20 billion.17 These deaths and costs resulted from poor asthma control and management.
Despite available guidelines for diagnosis and treatment of asthma, studies from different parts of the world showed poor physician adherence to this clinical practice guideline in the management of asthma.18 19 Daily controller medication was only prescribed by a few physicians even in adults and children with a recent acute care visit.20 Access to essential asthma drugs is also limited in the developing world where the majority of persons living with asthma are living and inadequately treated. This inadequate treatment and the high cost of medications lead to disability, absenteeism and poverty.17 Moreover, the cumulative duration of available prescriptions covers less than 50% of the follow-up period, even when prescribed.21
Inappropriate management of asthma was also reported, which was attributed to the omission of necessary medications and incorrect dosing of medications.22 These problems of management are a leading cause of uncontrolled asthma and therefore, disability, death and excess medical care costs from this disease.23 Underutilisation of corticosteroids, which is the key medication in managing asthma, is reported in different studies worldwide.24 25 A study that was done in different parts of Ethiopia also reported underutilisation of inhalational corticosteroids (ICS), which is identified as a significant predictor of uncontrolled asthma and asthmatic attacks.26 27 Given the high prevalence of uncontrolled asthma and the paucity of information on the burden of clinical inertia and its determinants, it is crucial to identify the burden of clinical inertia and its determinants in the management of chronic asthma. Therefore, this study aimed to assess the magnitude of clinical inertia and associated factors among adult patients with asthma on chronic follow-up at Jimma Medical Center (JMC). The findings of this study will help policymakers and health planners in designing strategies for promoting adequate management of asthma. Understanding clinical inertia and its burden will also help to manage premature death from poorly managed asthma in Ethiopia.
General objective
To assess the magnitude of clinical inertia and associated factors among adult patients with asthma on chronic follow-up at JMC from December 2021 to March 2022.
Specific objectives
The study was conducted at JMC. Geographically, JMC is located in Jimma Town, which is 352 km away from the capital Addis Ababa to southwest Ethiopia. It is among the largest teaching university hospitals in Ethiopia with a bed number of 800 and covers about 20 million people under its catchment area in the southwest part of Ethiopia. It provides services nearly for 15 000 inpatients, 160 000 outpatients and 11 000 emergency services. The study was conducted from Dec 2021 to May 2022.
A hospital-based prospective observational study was conducted. The treatment received over the last 3 months and current treatment were abstracted from the chart at the first visit. On the second visit, 3 months later, medical history and asthma control were reassessed and treatment optimisation was re-evaluated at the date of their appointment.
Source population
All patients attending the chronic care unit of JMC with confirmed asthma cases.
Study populations
The study populations were patients with asthma attending the chronic care unit of JMC during the study period and who fulfilled the inclusion criteria.
Inclusion criteria
Patients with asthma who attended follow-ups at JMC chronic care unit and aged>18 years and on follow-up for the last consecutive 6 months before data collection and provided oral informed consent.
Exclusion criteria
Patients with asthma who were diagnosed with interstitial lung diseases, chronic obstructive pulmonary diseases (COPD) and bronchiectasis and lung cancer were excluded from the study due to the similarity of symptoms. Pregnant patients with asthma were excluded due to the variable effects of pregnancy on asthma. Patients whose charts are incomplete were also excluded from the study.
The sample size was determined based on the single population proportion formula.
From the previous study at JMC, the proportion (p) of uncontrolled asthma was 0.645,28 with a 95% CI and marginal error (d) of 5%.
The study populations were less than 10 000, so the sample size was adjusted by using the following formula to get the minimum sample size required for the study.
The total population of patients with asthma attending the chest clinic of JMC during the data recruitment period (3 months) last year at a similar period is about 216 (N). The adjusted sample size was 134 by substituting the values in the above formula. Taking 10% for non-response (14), the final sample size is 148.
Consecutive technique was used because the number of patients with chronic asthma is small in number. Eligible patients who declined to patients and did not give informed consent did not participate. The response rate was 100% in the current study. All patients with asthma attending the chronic care unit of JMC during the study period and fulfilling the inclusion criteria were included in the study consecutively until the calculated sample size was obtained and were followed for 3 months. The study participants who lost follow-up were not included in the study
Independent variables
Socio-demographic characteristics (age, gender, level of education, residence, marital status, occupation, family history of asthma), patient behavioural characteristics (chat chewing, smoking, asthma knowledge and attitude, alcohol consumption, follow-up schedule, exercise, avoidance of allergens, usual source of energy), disease-related factors (asthma severity, duration of asthma since diagnosed, comorbidity, exacerbation over last 12 months), medication-related factors (adherence to medication, medication type, medication dose, medication frequency).
Dependent variables
Clinical inertia.
A structured questionnaire was adopted from previous studies and appropriate modifications were made to fit the purpose of this study. The data that were collected by interviewing the study participants on the first visit include socio-demographic characteristics, patient behavioural information, self-care management of the patient and asthma control status. The treatment received over the last 3 months and current treatment were abstracted from the chart at the first visit. On the second visit, 3 months later, medical history and asthma control were reassessed and treatment optimisation was re-evaluated. All study participants’ card numbers who underwent the interview were documented, and to start the interview with the next study participant, the participant’s card number was cross-checked with the documented card number to avoid double counting of the cases.
Medication Adherence Report Scale, which is a five-item questionnaire rated on a 5-point Likert scale, was used to evaluate medication adherence. Patients with asthma who scored 23 or above were categorised as adherent to medication, while those who scored less than 23 were categorised as non-adherent.29
Asthma knowledge was evaluated using consumer questions for asthma knowledge. 12 ‘true/false’ questions of equal weight were included in the questionnaire. Those who scored 9 or above were categorised as having good knowledge of asthma and below 9 as having poor knowledge of asthma.30
Five questions rated on a 5-point Likert scale were used to assess attitude towards asthma. The score ranges from 5 to 25; patients’ attitudes were categorised into two groups: ‘positive attitude’ for a score≥15 and ‘negative attitude’ for a score<15.31 Clinical data and medication management data were collected by semi-structured questionnaires developed after a review of different literatures.13 32
Clinical inertia
Taking the identified patients’ asthma severity into account, clinical inertia was identified by comparing the patient’s treatment with GINA (Global Initiative for Asthma) 2021 guideline recommendations to the specific step of asthma management.
Failure to initiate
Asthma severity was identified first, and failure to initiate at both visits was considered when ICS was not initiated for mild, moderate and severe persistent asthma as recommended by the GINA 2021 guideline for these severity levels of asthma management.33
Lack of intensification
At the first visit, the dose of ICS used over the past 3 months was used as a baseline as the preventive medication for chronic asthma is ICS. Lack of intensification was considered if the dose of ICS was not titrated for the patients as recommended by GINA 2021 guidelines for the specific step of asthma management after severity was identified and despite patients’ asthma being uncontrolled.33
The training was provided for the data collectors on how best to extract information from the patients and the collected data was reviewed and checked every day for completeness, and the necessary feedback was provided to the data collectors. The questionnaire was translated into the local languages Afan Oromo and Amharic and then retranslated back to English to check for consistency of meaning. Finally, a pretest was conducted on 5% of patients with asthma whose data were not included in the final analysis before the actual data collection to check the consistency and understandability of the tools.
The collected data were cleaned and exported to SPSS V.25.0 for analysis. Independent predictors of outcome and strength of association between dependent and independent variables were identified by using binary and multivariable logistic regression analysis. Bivariate logistic regression analysis was done for all independent variables, and p value<0.25 was used as a cut point for multivariable regression to control possible confounders. In the multivariable logistic regression, the backward elimination method was employed and the strength of the associations between the dependent variable and its determinants was assessed by adjusted ORs with their corresponding CI at p value<0.05 cut point.
Clinical inertia
as recommended by a GINA 2021 guideline for the specific step of asthma management based on severity and/or
as recommended by GINA guidelines for the specific step of asthma management based on severity despite uncontrolled asthma and/or
as recommended by a GINA 2021 guideline for the specific step of asthma management based on the severity.
The hospital visit of the study participant during which this study participant was interviewed for the first time for this study.
The hospital visit of the study participant during which this study participant was interviewed for the second time for the study.
Self-reported asthma symptoms in the last month but less than per week and flare-ups more than four times in the last year.
Self-reported symptoms more than once weekly but not daily and flare-ups more than monthly in the last year
Self-reported symptoms daily and more than weekly flare-ups in the last year.
None
Of 148 patients enrolled in the study at the first visit, 8 study participants lost the follow-up. Five study participants, three with incomplete data and two with COPD, were excluded. A total of 135 patients’ data was included in the final analysis. With 135 participants, the study potentially lacks statistical power to detect smaller but clinically significant associations, and the suggestion for this was given in the Discussion section. Only cases with complete data were included in the final analysis as they are representative of the remaining sample. The mean (SD) age of the study participants was 52.03 (±15.75) years. More than half, 73 (54.1%), of the study population were men, and more than three-fourths, 105 (77.8%), of the participants were married. More than 36% (36.3%) of the study participants were unable to read and write (table 1).
Table 1
Socio-demographic characteristics of the study participants (N=135)
Medication appropriateness based on recommendations by GINA 2021 was evaluated and most of the study participants 93 (68.9%) at the first and 95 (70.4%) at the second visits had one or more types of clinical inertia. The need for additional drugs (ICS) occurred in 29.6% at the first visit and 32% at the second visit of the study participants. Overall lack of ICS intensification occurred in about one-third (34.1% at the first visit and 32.6% at the second visit) of the study participants (figure 1).
The majority of the study participants 119 (88.1%) were living with their families. More than three-fourths, 105 (77.8%), of the study participants were non-smokers. About two-thirds of the study participants, 89 (65.9%), had a positive attitude toward asthma and more than half, (51.1%), of the study participants had poor knowledge about asthma (table 2).
Table 2
Behavioural and clinical characteristics of the study participants (N=135)
Of the total study participants diagnosed with mild persistent asthma at each visit, most of them 39 (69.6%) at the first visit and 44 (74.6%) at the second visit were prescribed salbutamol puff+low dose beclomethasone. Of study participants diagnosed with moderate persistent asthma, 31 (47.7%) of study participants at the first visit and 27 (43.5%) study participants at the second visit had used a combination of low dose beclomethasone puff with salbutamol puff (table 3).
Table 3
Medication use pattern for management of each severity of asthma among study participants (N=135)
Bivariate and multivariate analyses were done to identify associated factors for clinical inertia. The study participants who had allergic-related comorbidities were about three (adjusted OR (AOR) 3.35, 95% CI (1.15, 9.81), p<0.027) times more likely to have clinical inertia compared with patients without comorbidities. Asthma duration of 5–10 years increases the likelihood of having clinical inertia by about seven (AOR 7.58, 95% CI (1.51, 38.05), p<0.014) times as compared with less than 5 years of asthma duration. Patients with moderate persistent asthma were about seven (AOR 6.91, 95% CI (2.46, 19.42), p<0.000) times more likely to have clinical inertia, and patients with severe persistent asthma were about 10 (AOR 10.84, 95% CI (1.1, 107.0), p<0.014) times more likely to have clinical inertia as compared with mild persistent asthma (table 4).
Table 4
Bivariate and multivariate regression for factors affecting clinical inertia among the study participants
The proportion of the study participants that had clinical inertia was 68.9% at the first visit. This finding is higher than the reports from a study conducted in Italy that reported inadequate treatment in 48% of their study participants.34 The discrepancy may be attributed to participants’ socio-demographic differences and healthcare infrastructure differences. The mean age of the Italian study participants was 34 years compared with 52 years in this study population. Perhaps younger patients may have adhered to their medication more than we observed in the current study. Patients’ understanding of medication and adherence to asthma management is critically important. The finding was higher than the report from the domestic study in Gonder University Hospital in which 52% of study participants were inappropriately treated.22 This indicates a lot to be improved to ensure appropriate management of asthma according to GINA guidelines in the current study area.
Adequate treatment was provided for 7 (10.8%) of the study participants with moderate persistent asthma at the first visit and 8 (12.9%) of study participants with moderate persistent asthma at the second visit and 1 (7.1%) of the participants with severe persistent asthma at both visits. This finding is lower than reports from Australia which reported adequate treatment in 17.4% of the study participants with moderate persistent asthma, 25.9% of the participants with severe persistent asthma and 28.6% of the participants with mild persistent asthma.35 The lower adequate treatment report in the current study may be attributed to a better management approach and well-equipped healthcare facilities in Australia compared with Ethiopia.
In the current study, about 35.6% of the study participants had not used any ICS at each visit of the follow-up. This finding is comparable with the study done in Canada (37%).36 In this study, treatment with ICS was initiated for 87 (64.4%) of the study participants. This figure is similar to the figure reported in Italy and Spain (61.3%).37 However, this finding is higher than the report from previous study at JMC.27 The higher report rate in this study might be due to improvements in health services and accessibility of medication.
According to the current study, the level of therapy is intensified for 5.2% of the participants at each visit of the study. Contrary to this finding, a study conducted in Italy and Spain reported higher levels (75.8%) of medication intensification.37 The higher intensification level may be due to the availability and accessibility of guidelines and well-equipped healthcare institutions in Italy and Spain compared with our country where there is struggle with infrastructure and resources. Of 87 (64.4%) study participants who were prescribed ICS, lack of intensification (suboptimal use) was reported in 46 (52.8%) and (50.57%) of the study participants at the first and second visits, respectively, in the current study. This figure is higher than the reports from a study done in Adama (46.8%).26 The difference could be due to the use of combined ICS and LABA by 12.05% of participants, which most probably does not require intensification. However, this medication (LABA) is not available in the current study area and therefore increases the number of patients who require ICS dose intensification.
Bivariate and multivariate regression were conducted and allergic-related comorbidities, asthma severity and 5–10 years of asthma duration since diagnosis were identified as contributing factors for clinical inertia. Study participants who had allergic-related comorbidities were about two times more likely to have clinical inertia compared with patients without comorbidity. This may be because the comorbidities especially allergic-related comorbidities can complicate the diagnosis and management of asthma. Asthma-related comorbidities negatively affect asthma control status.
Asthma duration of 5–10 years increases the likelihood of clinical inertia by about seven (7.58) times as compared with less than 5 years of asthma duration. The possible reason for this may be due to patient preferences against the treatment while they were asymptomatic.38 Perhaps our study depicted that this group of the study population was 15% less likely to have uncontrolled asthma as compared with the study population who had asthma for 5 years. This implies that the healthcare policymakers and health planners should give concern for managing patients with asthma whose asthma is greater than 5 years to mitigate clinical inertia.
Patients with moderate persistent asthma were about seven times more likely to have clinical inertia and patients with severe persistent asthma were about eight times more likely to have clinical inertia as compared with mild persistent. This is likely to be causally taking improper therapy leading to more severe disease and worse outcomes. Evidence supports this suggestion regular use of adequate preventer medication for an adequate period results in shifting from more severe to less severe disease.39 40 The clinical implication of this finding is that timely evaluation, initiating or intensifying asthma medication is crucial for better management and prevention of clinical inertia.
Policymakers should focus on providing training for healthcare providers on the application of GINA guidelines, encourage teamwork in the chronic follow-up unit and improve the availability of equipment for effective severity measurement of asthma. Further study has to be conducted on the magnitude of clinical inertia and associated factors prospectively with prolonged follow-up duration, large sample size and multicentre study areas.
The study demonstrated a high burden of clinical inertia among patients with asthma on follow-up at each visit of the follow-up. Smoking, asthma duration and non-adherence were associated factors to uncontrolled asthma. Allergic-related comorbidities, asthma severity and 5–10 years of asthma duration since diagnosis were identified as contributing factors for clinical inertia.
Data are available upon reasonable request. The datasets that were used to support the conclusions of this article are made available upon the request of the corresponding author.
Consent obtained directly from patient(s).
This study involves human participants and was approved by Institutional Review Board (IRB) of Jimma University by the ref no: JUFRBOOP/21. Participants gave informed consent to participate in the study before taking part.
We would like to express our deepest gratitude to Jimma Medical Center for approving the conduct of the study. We would also like to thank the study participants for their cooperation and willing participation.