Tesis

Reaksi Simpang pada Penggunaan OAE Pasien Epilepsi Menggunakan Kuesioner Liverpool Adverse Events Profile Versi Bahasa Indonesia (Uji Validitas dan Reliabilitas) = Adverse Events of Antiepileptic Drugs in Patients with Epilepsy Using The Indonesian Version of Liverpool Adverse Events Profile (Validity and Reliability Study).

Latar belakang : Reaksi simpang yang terjadi akibat penggunaan OAE berpengaruh terhadap kualitas hidup pasien epilepsi. Angka kejadian reaksi simpang akibat penggunaan OAE dilaporkan mencapai 80%. Sampai saat ini belum didapatkan studi atau instrumen yang valid dalam menilai reaksi simpang pada penggunaan OAE di Indonesia. Tujuan dari studi ini adalah melakukan validasi terhadap kuesioner Liverpool Adverse Events Profile (LAEP) versi bahasa Indonesia dan mendapatkan prevalensi reaksi simpang serta faktor yang berpengaruh. Metode penelitian : Dilakukan studi observasional potong lintang pada pasien epilepsi dengan dosis OAE yang stabil di poliklinik epilepsi rumah sakit Cipto Mangunkusumo. Kuesioner diterjemahkan dari versi bahasa Inggris ke bahasa Indonesia dan dilakukan penerjemahan kembali ke bahasa aslinya untuk menilai ketepatan dari bahasa. Validitas dan reliabilitas diuji dengan menggunakan koefisien korelasi Spearman dan cronbach’s alpha. Faktor yang dianalisis adalah durasi epilepsi, onset epilepsi, frekuensi bangkitan, tipe epilepsi, etiologi epilepsi, sindrom epilepsi, jumlah OAE, durasi OAE dan komorbiditas. Hasil : Didapatkan 19 variabel pertanyaan yang valid dengan rentang koefisien korelasi 0,465 sampai 0,690. Cronbach’s alpha 0,846. Prevalensi reaksi simpang pada pasien epilepsi yaitu 91%. Reaksi simpang yang sering terjadi adalah kelelahan (67,8%), mengantuk (66,7%), gangguan daya ingat (62,2%) dan kesulitan berkonsentrasi (56,7%). Variabel klinis yang berpengaruh terhadap kejadian reaksi simpang yaitu politerapi (p=0.022). Kesimpulan : Kuesioner Liverpool Adverse Events Profile versi bahasa Indonesia merupakan instrumen yang valid dan reliabel dalam menilai reaksi simpang pada penggunaan OAE pada pasien epilepsi. Politerapi merupakan faktor yang berpengaruh terhadap kejadian reaksi simpang.
Kata kunci : Epilepsi; Obat antiepilepsi; Reaksi simpang; Validasi



Background : Adverse effects (AE) of antiepileptic drugs (AEDs) affect the quality of life of patients with epilepsy. The prevalence of AE of AEDs in patients with epilepsy is up to 80%. There are no studies nor validated instruments in measuring AE of AEDs in patients with epilepsy in Indonesia. This study aimed to validate the Indonesian version of The Liverpool Adverse Events Profile (LAEP) also to determine the prevalence of AE of AEDs in patients with epilepsy and related factors. Methods : An observational cross-sectional study was carried out on epilepsy outpatients clinic in Cipto Mangunkusumo Hospital. Patient treated with a stable dose of AED were enrolled. The questionnaire was translated from the English version into Indonesian version and then was back-translated to examine its accuracy. The validity and reliability was tested by Spearman correlation coefficient and cronbach’s alpha. The Indonesian version of LAEP was selfadministered by the patient. The analyzed factors consisted of epilepsy duration, onset of epilepsy, seizure frequency, type of epilepsy, etiology and epilepsy syndrome, number of AEDs, AEDs duration and comorbidity. Results : All of the 19 variable of questions were valid, with range of correlation coefficient from 0.465 to 0.690. The cronbach’s alpha was 0.846. Ninety patients were enrolled. The prevalence of AE of AEDs in patients with epilepsy was 91%. The most common AE were tiredness (67.8%), sleepiness (66.7%), memory problems (62.2%) and difficulty in concentrating (56.7%). Clinical variables that influenced the AE was polytherapy. Conclusion : The Indonesian version of the Liverpool Adverse Events Profile is a valid and reliable instrument in assessing AE of AEDs in patients with epilepsy. Almost all of the patients in this study experienced an AE. Polytherapy was the related factors of AE of AEDs.
Keyword(s) : Adverse events; Antiepileptic drug; Epilepsy; Validation