Adherence to Antiepileptic Regime: A Cross-sectional Survey
Keywords: Adherence, anti epileptic regime, epilepsy, non-adherence
Epilepsy is one among the common neurological disorders which are featured by recurrent paroxysmal episodes of abnormal movements or behavioral changes with or without loss of consciousness due to transient cerebral dysfunction. There are two major types of epilepsies; generalized or partial., All over the world, misconceptions, fright, and negative public attitudes toward this most prevalent neurological disorder result in discrimination, isolation, and widespread social abnegation of epileptic patients. This common disease can be prevented and treated at a bearable cost effectively. Adherence to medication is a central pillar to effectiveness of antiepileptic therapy. Antiepileptic therapy is an essential intervention aimed at improving and prolonging the quality of life of patients who suffer from a disease which is known for its stigmatization with many cultural misconceptions. Poor adherence to long-term therapies such as epilepsy deeply derange the efficiency of treatment making this a crucial issue in public health from all the perspectives of life.,
Cross-sectional survey design was adopted to assess the adherence pattern to antiepileptic regimen among patients with epilepsy. This study was conducted among 100 epilepsy patients in epilepsy clinic of a tertiary care hospital, South India during August 2014–February 2015. Sample size was estimated with an expected percentage of patients with adherence as 50% (which gives the maximum sample size) at 5% level of significance and 20% relative precision. The inclusion criterion was patients diagnosed with epilepsy, taking antiepileptic medications for at least one year. Patients who were below 18 years and newly diagnosed with epilepsy were excluded from the study.
A consecutive sampling technique was used. Structured interview was done using a pretested questionnaire and medical records review was done for all recruits to collect the data. Eight-item Morisky Medication Adherence Scale (MMAS) was used to assess the adherence pattern to antiepileptic regimen. The MMAS is a standardized 8-item questionnaire with seven Yes/No questions and one question answered on a 5-point Likert scale. According to the scoring system for the MMAS, 0 = high adherence, 1–2 = medium adherence, and >2 = low adherence. Patients who had a score of 0–2 were considered adherent and >2, nonadherent in many studies. The present study adopted the same scoring system.
Validity and reliability
Morisky et al. reported Cronbach's α of 0.83 for the MMAS-8. For test–retest reliability, the MMAS-8 showed an excellent interclass correlation coefficient of 0.79. The study was approved by Institute Scientific Advisory Committee and Ethics Committee. Informed written consent was obtained from all subjects under study. Confidentiality of the data, the right to withdraw from the study at any period of time, and anonymity of the subjects were explained prior.
Both descriptive and inferential statistics were used for analysis of data. Descriptive statistics (mean, standard deviation, frequency, and percentages) were used to describe the clinical and demographic variables of study participants. The determinants of medication adherence were analyzed using Chi-square test and independent Student's t-test.
Fifty-two percent of the patients were females and 69% were below the poverty line. Regarding the education status, majority (65%) had education up to primary or secondary. Only 63% of the patients were employed. Majority (68%) of the patients were married and 90% were from rural background [Table 1].
Fifty-two percent of patients had partial type of epilepsy with 17.13 years as the mean age of onset and 6.16 years as the mean duration of epilepsy. Majority (94%) had at least one seizure episode last year and the mean frequency of seizure per year was 7.25. Majority (91%) had no comorbidities like hypertension or diabetes mellitus. Neurological comorbidities were noted in 4% of the subjects. Regarding the complexity of treatment, 51% were on polytherapy and the remaining were on monotherapy. Majority (67%) were taking medications thrice a day. Side effects were reported by 59% of the study participants. Among the 100 patients, 26 had the family history of epilepsy [Table 2].
This study identified that majority (71%) of patients were not adherent to antiepileptic treatment which was indicated by Morisky value higher than 2 and further those who were poorly adherent had increased frequency of seizure per year as 8.79 ± 5.17 compared to subjects who were highly adherent to antiepileptic regime as 3.48 ± 3.13 seizure episodes per year which was significant at P = 0.0001.
Among the clinical factors, severity of seizure (indicated by the presence of seizure last year; P = 0.007), medication frequency (P = 0.001), and complexity of treatment (P = 0.003) were found to have significant association with the Anti-Epileptic Drugs (AED) adherence status. The nonadherent group (mean 8.79 ± 5.17 SD) had more number of seizures last year comparing to the adherent group (mean 3.48 ± 3.53 SD). Those who were on monotherapy were more adherent than those who were on polytherapy which shows that as the number of drugs increases, adherence decreases. Majority of the non-adherent group were taking medications thrice a day compared to the adherent group, most of whom were taking drugs twice a day. Interestingly, other factors such as type of epilepsy, duration of epilepsy, side effects, family history, and comorbidity were not associated with the status of adherence in the study [Table 3].
This cross-sectional study included 100 adult epilepsy patients with a mean age of 35.17 years ± SD 9.72. The gender distribution was almost equal (52% females and 48% males) and the mean duration of epilepsy was 6.16 years ± 6.03. Only 9% had comorbidities like diabetes and hypertension and majority (94%) had at least one seizure episode last year. Somewhat comparable demographic and clinical variables were observed, including male preponderance, early adults with age group between 32 and 38 years, with mean duration of epilepsy as 5–8 years.,
Approximately two-third of patients (65%) in this study had education up to primary or secondary. This is very much similar to an African study done by Ogundele and Dawodu where 65.8% of the respondents completed at least secondary education. A similar study done by Hovinga et al. observed very high level of education that most of the respondents (88%) completed at least primary or secondary education. Most of the studies on adherence reveal higher education profile.
In the present study, majority (68%) of the patients were married, the mean age of onset was found to be 17.13 years, and 48% were having generalized type of epilepsy. In a similar study by Hovinga et al., among 408 patients, more than half (52%) were married, the mean age of onset was 20 years, and about 57% were reported with generalized epilepsy. There was huge discordance in the presence of side effects reported in both studies. The present study reported that 59% were having side effects while this American study reported side effects of about 9%.
Approximately half of patients (51%) in this study were on polytherapy. Similar proportions were found in other studies also.,,,
Adherence pattern of antiepileptic regimen
In this study, patients were evaluated for their adherence status to the antiepileptic medications and they were classified into two groups: good adherence and poor adherence. Those who scored ≤2 out of 8 in the Morisky scoring constituted the highly adherent group and those who scored ≥3 were in the poorly adherent group. In the present study, among the 100 patients, majority (71%) of patients were not adherent to their antiepileptic drugs. Studies, which adopted the MMAS to assess adherence in epilepsy patients, revealed that more than 50% of the people were adherent to treatment regimen.,,, Similarly, a study carried out in the United States reported that 29% of the patients were nonadherent which is exactly contrary to the present study since it reported only 29% adherence. These results suggest that patients in this study had higher rates of nonadherence compared with patients in other studies carried out using the same methodology for assessment of adherence.
In another study conducted by Ogundele and Dawodu in 2013, good adherence was recorded in 70% of participants and the high adherence rate among patients in the study was explained by the fact that 65.8% of the respondents completed at least secondary education. But in contrast to that, the present study shows 71% nonadherence despite the high literacy (65% completed at least secondary education) among the participants
In a similar study conducted by Sweileh et al. to assess the medication adherence to epilepsy, out of the 75 participants, majority (64%) were nonadherent based on MMAS. Increasing age and longer duration of illness were observed as the reason for good adherence in the study. The findings of the present study also revealed a high rate of nonadherence (71%), but age or duration of illness were not found significant as determining factors in contrast to the above study. Some studies revealed high rate of nonadherence similar to the present study. A study conducted by Nakhutina et al. reported 63% of nonadherence. Similarly, a study conducted by Ahmad et al. observed a 79.8% of nonadherence.
Though all the subjects recruited in the study were educated about the importance of drug adherence at the end of data collection, a formal health education in all epilepsy clinics with trained health care professional is prime importance as many of the Indian studies have shown improved behavioral and clinical outcome following formal health education or counselling.
In this study, the complexity of the treatment, that is, the patients on multiple drugs and increased drug frequency, had low adherence compared to patients on monotherapy, which is well noted in other studies also., As increasing trend in polytherapy prescription in India, the health education services will certainly enhance drug adherence in people with epilepsy.
As the major proportion of the patients with epilepsy are nonadherent to treatment regime, necessary supportive education to patients with epilepsy regarding the disease condition and importance of being adherent to therapy as well as regular follow-up is important. Systematic and orderly planning and dissemination of health information will be very much beneficial for patients with epilepsy. This will encourage patients to follow a proper treatment regimen and also help to prevent recurrence of seizure attacks.
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Conflicts of interest
There are no conflicts of interest.
[Table 1], [Table 2], [Table 3]