|Year : 2020 | Volume
| Issue : 1 | Page : 1-8
Impact of adherence to antiepileptic medications on quality of life of epileptic patients in the Eastern Province of Saudi Arabia: A cross-sectional study
Faheem Hyder Pottoo1, Dhfer Mahdi Alshayban2, Royes Joseph2, Fatimah Al-Musa2, Ola Al-Jabran2, Danah Aljaafari3
1 Department of Pharmacology, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
2 Department of Pharmacy Practice, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
3 Department of Neurology, College of Medicine, King Fahad Hospital of the University, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
|Date of Submission||17-Jun-2019|
|Date of Acceptance||27-Sep-2019|
|Date of Web Publication||30-Dec-2019|
Dr. Faheem Hyder Pottoo
Departments of Pharmacology, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal University, P.O.BOX 1982, Dammam 31441
Source of Support: None, Conflict of Interest: None
Background: Epilepsy is one of the most common neurological diseases, characterized by recurrent epileptic seizures. Adherence to antiepileptic drugs (AEDs) is vital in establishing seizure control. The adherence, in turn, impacts the quality of life (QoL) in epileptic patients.
Methodology: This was a hospital-based cross-sectional study conducted at King Fahd Hospital of the University, Qatif Central Hospital, and Dammam Central Hospital in the Eastern region of Saudi Arabia during the period from January 2018 to April 2018. Epileptic patients from all age groups treated with at least single AED and who had follow-up in hospital for the past 6 months were included in the study. Patients with intellectual disabilities and those who received AEDs for other indications were excluded. The participants were interviewed in Arabic, and validated translated version of questionnaire was completed under the following sections: sociodemographic characteristics, adherence assessment using the General Medication Adherence Scale (GMAS), and QoL in epilepsy patients using EQ-5D-5L.
Results: We report 48% of participants with high adherence, 34% with moderate adherence, while 19% exhibited low adherence toward AEDs. Of 80 participants, 25 (31%) reported perfect health status (11,111) and 2 (3%) reported extremely worst health status (55,555). Further, the study revealed a significant (P = 0.045 and 0.035) improvement of QOL in patients with moderate and high adherence compared to patients with low adherence.
Conclusion: This study reports high health-related quality index (QoL) in participants with moderate–high adherence. The relationship between adherence and overall HRQoL was directly proportional.
Keywords: Adherence, antiepileptic drugs, epilepsy, EQ-5D-5L, General Medication Adherence Scale, quality of life
|How to cite this article:|
Pottoo FH, Alshayban DM, Joseph R, Al-Musa F, Al-Jabran O, Aljaafari D. Impact of adherence to antiepileptic medications on quality of life of epileptic patients in the Eastern Province of Saudi Arabia: A cross-sectional study. Imam J Appl Sci 2020;5:1-8
|How to cite this URL:|
Pottoo FH, Alshayban DM, Joseph R, Al-Musa F, Al-Jabran O, Aljaafari D. Impact of adherence to antiepileptic medications on quality of life of epileptic patients in the Eastern Province of Saudi Arabia: A cross-sectional study. Imam J Appl Sci [serial online] 2020 [cited 2021 Jan 18];5:1-8. Available from: https://www.e-ijas.org/text.asp?2020/5/1/1/274291
| Introduction|| |
Epilepsy is one of the most common neurological diseases, which affects people from all ages, characterized by recurrent epileptic seizures. Epileptic seizure is a transient occurrence of signs and/or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Epilepsy is mainly classified as partial seizures and generalized seizures. It affects more than 70 million people worldwide. Antiepileptic drugs (AEDs) derive only symptomatic relief, while the underlying pathology remains unabated, and 20%–30% of patients remain refractory to treatment., The prevalence of epilepsy is measured by the number of epileptic cases in a population at a given time, whereas the incidence is the rate of new cases over a period of time. In the Kingdom of Saudi Arabia (KSA), epilepsy occurs in 6.54 of every 1000 individuals. Data indicate that about 80% of the affected individuals reside in low- and middle-income countries and that the incidence and prevalence of epilepsy are higher in low- to middle-income countries, especially in rural areas., The primary determinants of the medication effectiveness are adherence. It is defined as the extent to which a patient's behavior, in terms of taking medications, is in agreement with their health-care provider's recommendations., Patient adherence is one of the most important factors for successful treatment and management of epilepsy (as treatment is symptomatic). Therefore, poor adherence to AEDs leads to poor seizure control. There are several factors that affect the adherence to AEDs including socioeconomic status, complexity of the drug regimen, better understanding of the illness, age, educational level, and employment status. The reason for higher number of people suffering from epilepsy in poor resource countries could possibly be linked to level of adherence toward AEDs in these countries and its subsequent impact on quality of life (QoL).
QoL is a term used to describe patient satisfaction toward his physical, psychological, and social status. Epilepsy has a major impact on patients' QoL because of its social and psychological consequences., Several studies demonstrated that epilepsy worsens patients' QoL and the frequency of seizures seems to be the most relevant determinant of that. Furthermore, depression and anxiety contribute to poor QoL in patients with epilepsy compared with healthy people. The disparity in the QoL of epileptic patients among different countries is largely related to the cultural, ethnic, and economical differences.
Adherence to AEDs has a significant impact on patients' QoL. Several studies suggested that seizure control with appropriate AEDs will reduce seizure frequency and epilepsy-related complications and therefore improve overall patient QoL. Furthermore, some studies suggest that adherence to AEDs should be monitored to provide appropriate support in improving patients' QoL., The aim of our study was to measure the adherence and QoL of epileptic patients and their interrelation with each other in the Eastern Province of KSA.
| Methodology|| |
A cross-sectional study using a validated structured questionnaire was utilized to identify the demographic characteristics of patients, level of adherence to AEDs using the General Medication Adherence Scale ( GMAS), and QoL using EQ-5D-5L. The study was initiated after approval from the Institutional Ethical Committee, Imam Abdulrahman Bin Faisal University, KSA.
Setting and study subjects
Participants were conveniently recruited from the Outpatient Department of King Fahd Hospital of the University (Khobar), Qatif Central Hospital (Qatif), and Dammam Central Hospital (Dammam), from January 2018 to April 2018, with a total of eighty participants. Patients who met the following inclusion criteria were enrolled in this study: (1) epilepsy diagnosis (according to the International League Against Epilepsy criteria, 1989), (2) treatment with one or more AEDs, (3) no change in AED therapy regimen during the past 6 months, and (4) willing to participate and provide a written informed consent. Moreover, patients with intellectual disabilities, those who received AEDs for indications other than epilepsy, and pregnant women were excluded from the study.
An Arabic version of the EQ-5D questionnaire was used., The participants were interviewed in Arabic, and participants' sociodemographic and clinical characteristics were requested. The EQ-5D and GMAS questionnaires were filled by the participants.
The sociodemographic characteristics included gender, age, education level, income status, and social status. The comorbid conditions and antiepileptic medication (monotherapy or polytherapy) were also recorded.
Adherence assessment: The General Medication Adherence Scale
The adherence toward AEDs was measured using the GMAS, a three-item validated questionnaire with a total of 11 questions. The items were categorized as (1) nonadherence due to patient behavior (unintentional and intentional), (2) nonadherence due to additional disease and pill burden, and (3) nonadherence due to financial constraints. All questions in the GMAS were answered on a 4-point scale (0–3; from always to never). Each item was graded individually, with the overall medication adherence (cumulative) grading as:
- High adherence = 30–33
- Good adherence = 27–29
- Partial adherence = 17–26
- Low adherence = 11–16
- Poor adherence = 0–10.
Quality of life in epilepsy patients (EQ-5D-5L)
Health-related QOL (HRQoL) was assessed using the standardized EQ-5D-5L tool, where patients self-reported their health status in terms of five dimensions. The dimensions include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. An item from each dimension was asked to rate on a five-level scale (no problems, slight, moderate, severe, and extreme); the corresponding numerical score ranges from 1 to 5. Thus, HRQoL of each patient is represented by five-digit code where the digits indicate the severity in the five dimensions in order; there are 3125 possible sets of values, called health states, for EQ-5D-5L. The lowest possible combination 11,111 denotes the perfect health state, and the highest possible combination 55,555 denotes the worst health state. The health states can be converted into a single-weighted index score (EQ-5D index) using population preference scores. We used the values derived from the UK general population survey reported to derive the EQ-5D index. Thus, the EQ-5D index would range from −0.285 to 1, where “1” indicates a perfect health state and an index value lower than “0” indicates a health state to be worse than death.,
Sociodemographic and disease characteristics of the patients were summarized using descriptive statistics. Percentages and frequencies were used for the categorical variables, while median and interquartile range were calculated for the continuous variables. The association of sociodemographic and clinical factors and medication adherence on HRQoL was assessed using three approaches: (1) using Chi-square test, (2) using a multiple logistic regression where the outcome variable was a binary variable indicating “perfect health” (EQ-5D index = 1.000) or “imperfect health” (EQ-5D index <1.000), and (3) using a multiple linear regression where the dependent variable was the cubic function of EQ-5D index score (the cubic function ensured normally distributed residuals). P <0.05 was considered as statistically significant. All analyses were carried out using SPSS Statistics 24.0 (IBM SPSS statistics for windows, Armonk, NY, IBM Corp).
| Results|| |
Sociodemographic and clinical characteristics of participants
Among a total of eighty patients who complied with the inclusion criteria, more than half were female (59%), 55% were older than 30 years, 69% had high school level education or more, 40% were married, 70% were free of chronic diseases other than epilepsy, and 85% of them were controlled on one antiepileptic medication [Table 1].
Overall, 48% of participants had maintained high adherence, 34% had moderate adherence, while 19% had maintained low adherence to AEDs. Specifically, 18%, 23%, and 20% of participants had maintained a low adherence due to financial constraints, additional diseases or pill burden, and unintentional and intentional patient behavior, respectively [Figure 1] and [Table 2].
|Figure 1: Level of adherence to antiepileptic drugs (measured using the General Medication Adherence Scale)|
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|Table 2: Descriptive summary of General Medication Adherence Scale score|
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Association of sociodemographic factors on overall adherence to antiepileptic drugs
It was found that gender and comorbidity diseases were associated (P < 0.05) with overall adherence to AEDs. The percentage of high adherence was more among male than female gender (52% vs. 45%, P = 0.039). In addition, people who suffered from a disease other than epilepsy were more adherent than exclusively epileptic patients (58% vs. 43%, P = 0.002) [Table 3].
|Table 3: Association of sociodemographic factors on overall adherence to antiepileptic drugs|
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Health-related quality of life using EQ-5D-5L
The results reveal that the majority of our participants had no problem in overall HRQoL due to epilepsy disease [Figure 2]. Of 80, 25 (31%) reported perfect health status of 11,111 according to EQ-5D and 2 (3%) reported extremely worst health status of 55,555 [Figure 3].
Association of sociodemographic factors on health state of patients
There was no significant association of sociodemographic factors on health state of patients [Table 4].
|Table 4: Association of sociodemographic factors on health state of patients' variables|
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The impact of adherence on health-related quality of life
To compute the risk of imperfect health status due to lack of medication adherence, odds ratio was calculated. [Figure 4] shows that there was an increased, but not statistically significant, risk for imperfect health among patients with moderate adherence (odds ratio [OR] of 1.55 with 95% confidence interval [CI]: 0.54–4.43) and among patients with low adherence (OR of 4.24 with 95% CI: 0.84–21.52) compared to patients with high adherence [Figure 4], while the linear regression analysis performed to identify the relation between adherence and the EQ-5D index score revealed a significant (P = 0.045 and 0.035) improvement of QOL in patients with moderate and high adherence compared to patients with low adherence [Table 5].
|Figure 4: Odds ratio and 95% confidence interval for imperfect health status|
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|Table 5: Summary of linear regression model for cubic function of the European Quality of Life-5 Dimensions Index|
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| Discussion|| |
This study examined sociodemographic characteristics of epileptic patients, the level of adherence toward AEDs using GMAS, and QoL using EQ-5D-5L. Further, the impact of adherence on QoL in epilepsy patients was also accessed. We found among the sample population (n = 80); 59% females, 70% to be free of other chronic disorders and 85% on monotherapy with AEDs. The 48% of participants maintained high adherence, 34% moderate adherence and 19% low adherence toward AEDs. Interestingly, the percentage of high adherence was more among male than female gender (52% vs. 45%, P = 0.039). In addition, patients on drug therapy for comorbid conditions were more adherent compared to epilepsy patients without comorbid conditions (58% vs. 43%, P = 0.002). Of 80, 25 (31%) reported perfect health status of 11,111 and 2 (3%) reported extremely worst health status of 55,555. The QoL was better in patients with moderate–high adherence compared to low adherence epileptic patients. This study features direct relationship between adherence and overall HRQoL i.e improving adherence improves QoL.
Adherence to AED is a challenge in the management of epilepsy. The poor adherence is considered to be one of the causes of nonresponsiveness toward AED therapy. We found 48% participants with a high level of adherence, while 34% and 19% exhibited moderate and low adherence toward AEDs, respectively. The similar results were reported from a cross-sectional study conducted in India (Kolar, Karnataka) which reported 70% of epileptic patients as moderate–high adherent. A Ugandan other study as Verma et al., 2018 reported 49.6% and 7.4% participants with moderate-low adherence level towards AEDs. The retrospective study conducted in Germany in 2017 found that two-thirds of children and adolescents suffering from epilepsy in Germany were adherent to AED. Ferrari et al., 2013, also reported moderate-to-low adherence level in Brazilian population. We found high level of adherence in patients being treated for other comorbid conditions, which is contradictory to Guo et al., 2015, who reported low adherence (using the Morisky Medication Adherence Scale) toward AEDs in Chinese epileptic patients suffering from comorbid conditions such as depression and anxiety. Interestingly, high degree of adherence was found among male population which contradicts Gurumurthy et al., 2017, who reported no significant difference between adherence and age, gender, marital status, epilepsy duration, number and type of AEDs, and occurrence of adverse drug reactions. Further, it is worth mentioning here that Zafar et al., 2019, reported in their results from prospective study carried at the King Fahd Hospital of the University, KSA, that 48.7% of epileptic patients are nonadherent toward their AED therapy, while in the said study the adherence was not divided into high, moderate, and low levels. The reason for high-moderate level of adherence in our study signals toward importance of monotherapy (85% in this study) in the management of epileptic seizures, which avoids unnecessary adverse effects, and that pharmacist-led educational intervention had a positive impact on medication adherence in epilepsy patients, as is recited in existing literature as well.
HRQOL is a broad, multidimensional concept that typically incorporates subjective evaluations of both positive and negative aspects of life. The questionnaire-based study conducted in Russia revealed that the total score of quality of life in epilepsy-QOLIE-31 was low compared to data from the USA. It also stated that seizure frequency was the most important factor influencing QoL in epileptic patients. The cross-sectional prospective study conducted in India reported that epileptic patients are prone to have impaired QoL compared to healthy people and increased impairment was shown in women, the elderly, and those with partial seizure or recent seizure; it also suggested that controlling seizure will improve patients' QoL. Another Indian cross-sectional questionnaire-based study concluded that there are many factors that influence QoL of patients and the most important is the type of drug therapy use to control seizures and that patients on monotherapy had better QoL as they experience lower side effects. The cross-sectional study reported from Iran revealed that epileptic patients have lower QoL compared with healthy persons. Very few studies have been carried out on the QoL in epilepsy (EQ-5D-5L) in Saudi Arabia. Thus, we aimed to determine the level of health-related (EQ-5D-5L) in patients with epilepsy. We report good QoL in 31% of patients, while only 3% reported extremely worst health status. The best QOL scores are found in patients who are free from seizures. The reason for good QoL in patient population is attributed to moderate-high adherence towards antiepileptic medications. A prospective interventional study conducted in Riyadh, KSA, reported failure of keeping the clinic appointment, an indicator of poor compliance with AEDs. Furthermore, a telephone call was recommended to reduce the role of clinic noncompliance. Overall, the studies have insisted on counseling of the patients for improving their understanding of disease and therefore QoL.,
The relationship between adherence to AEDs and the QoL of epileptic patients and how they influence each other is widely reported in literature. A cross-sectional study conducted in the United Kingdom reported that the routine assessment of adherence should be conducted in patients with poor seizure control because they are more likely to be anxious and have discouraging treatment and illness beliefs, which is poor QoL. A questionnaire-based study conducted in Brazil confirmed that adverse effects of AEDs had impact on adherence and QoL of the patients. Furthermore, a prospective cross-sectional study conducted in Malaysia revealed that adherence intention has a significant impact on patients' QoL. Therefore, it should be monitored to provide appropriate support in improving epileptic patients' QoL. In line with the above studies, we found that there was an increased (statistically not significant) risk for imperfect health among patients with moderate adherence (OR of 1.55 with 95% CI: 0.54–4.43) and low adherence (OR of 4.24 with 95% CI: 0.84–21.52) compared to patients with high adherence, while the linear regression analysis performed to identify the relation between adherence and the EQ-5D index score clearly revealed a significant (P = 0.045 and 0.035) improvement of QOL in patients with moderate and high adherence compared to patients with low adherence. A systematic review conducted to identify the barriers to AED adherence among adults with epilepsy and the impact of AED nonadherence on QoL in its findings recommended that comprehensive adherence assessments should routinely be performed.
Limitations of the study
In our study the patients with intellectual disabilities were excluded.
| Conclusion|| |
This study reports high health-related quality index (QoL) in participants with moderate–high adherence. The relationship between adherence and overall HRQoL was directly proportional. Further, the study insists on educational interventional programs and counseling for the patients to improve their understanding of disease and therefore improve QoL.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]
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