Side effects
Subjective complaints are assessed using the SIDAED (Side effects of Anti-Epileptic Drug), a list of 46 items with possible anti-epileptic drug-related complaints. The items included in the SIDAED form 10 categories: general Central Nervous System (CNS), behavior (increased irritability), depressive symptoms, changes in cognitive function, motor problems and coordination, visual complaints, headache, cosmetic and dermatological complaints, gastrointestinal complaints, and sexuality and menses. For each item the parents rate the severity of the complaint on a four-point Likert scale (no problem, mild, moderate, or serious problem). In addition, the duration of the complaints is scored (for a few weeks, for months or for a half year or longer).
Neurocognitive assessment
Peabody Picture Vocabulary test
The Peabody Picture Vocabulary test (PPVT-III-NL: Dutch version) is an individually administered measure of receptive vocabulary [
27]. The test can be administered beginning at the age of 2 1/2 years. The child listens to the examiner's stimulus word and must choose the picture that best describes the word from a 4-picture multiple choice array. The score on this test can be interpreted as an achievement test of the child's vocabulary that does not require a verbal response and as a screening measure of verbal ability. There is supportive data for the validity of the PPVT-III as a measure for global cognitive intelligence.
Beery Developmental Visual-Motor Integration test
The Beery Developmental test of Visual-Motor Integration (Beery-VMI) is a widely used assessment of psychomotor development. It measures problems with visual perception, motor coordination, and visual motor integration. The 30-item test can be administered from the age of 2 years. The Beery VMI was standardized on a national US sample of 1,737 individuals age 2 to 18 years (2010) and 1,021 adults ages 19-100 (2006), and has proven reliability and validity [
28].
Fepsy computerized test
The Fepsy is a neurocognitive computerized test battery consisting of different subtests. For this study we use the simple auditory and visual reaction times, in which the stimulus exposure endures until a push-button (space-bar) response is given [
29]. Simple reaction tests give information on alertness functions and on the speed at which the information processing system is activated. We also use the binary choice reaction task in which a combination of accuracy and speed of responses are measured. This test measures the speed of central information processing. Finally, we use the finger tapping task in which motor activation and fluency is measured. In general, these tests can be administered from the age of 6.
Kaufman Assessment Battery
The Kaufman Assessment Battery for Children II (K-ABC II) is used to investigate the level of information processing capacities of children beginning at the age of 2 1/2 years [
30]. Two subtests will be administered: (1) Number recall, which is a measure of sequential processing and short term memory. The examiner says a series of numbers and the child repeats them. Digit span forward is considered a measure of efficiency of attention or "freedom from distractibility" and (2) conceptual thinking, which is a measure of nonverbal reasoning skills. The child looks at pictures and determines the one that does not belong.
Actigraphy
During the administration of the PPVT-III and the K-ABCII test, an actigraphic device (Actiwatch® model AW4: Cambridge Neurotechnology Ltd., United Kingdom) will be used to assess motor activity as a measure of alertness. As some of the children in the design are not testable with the described cognitive tests we decided to use an assessment of motor activity in a standardized situation. A wrist watch will be used that translates activity into movement of the watch hand. Registration takes place in a standardized way during the first 10 minutes of the Peabody Picture Vocabulary test and the first 5 minutes of the K-ABC-II test. When patients are not eligible to perform the neurocognitive assessment, the wrist watch will be used for 15 minutes during the visit at the nurse practitioner's office while watching a DVD with songs and pictures.
SEV Questionnaire
The SEV questionnaire (Sociaal Emotionele Vragenlijst: Social Emotional Questionnaire) is a DSM-IV oriented questionnaire which is used to assess four domains of behavioral and social emotional dysfunction. These domains are: Attention Deficit Hyperactivity Disorders, Oppositional Defiant behavior and Conduct Disorders, Anxiety and Depression, and Autism spectrum disorders. The questionnaire consists of 72 items describing problem behavior [
31].
SDQ Questionnaire
The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioral screening questionnaire that provides balanced coverage of children and young people's behaviors, emotions, and relationships [
32]. The SDQ is applicable to children beginning at the age of 4 and asks about 25 attributes that are divided into five relevant dimensions: namely conduct problems, emotional symptoms, hyperactivity, peer relationships, and pro-social behavior.
POMS Questionnaire
The Profile of Mood States (POMS) has been developed to identify and assess seven transient, fluctuating affective mood states: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigour-Activity, Fatigue-Inertia, Friendliness, and Confusion-Bewilderment [
33]. The questionnaire contains 65 items. All items describe an emotional state which can be rated on a 5-point scale ranging from "not at all" to "extremely".
The Personal Adjustment and Role Skills Scale (PARS)
The Personal Adjustment and Role Skills Scale, 3rd edition (PARS-III) was specifically developed to measure psychosocial adjustment in children with chronic physical illness [
34]. This instrument is a brief parent-completed index of youth psychosocial adjustment. The instrument yields six factor-derived psychosocial subscales: namely peer relations, dependency, hostility, productivity, anxiety/depression, and withdrawal. The PARS-III is a reliable and valid index of youth psychosocial adjustment and can be used for both clinical screening and research purposes [
35].
The Hague Restrictions in Childhood Epilepsy Scales (HARCES)
The HARCES is a questionnaire consisting of 11 items used to assess impairments in daily functioning that are related to epilepsy, e.g. how much influence does the epilepsy have on your child's freedom of functioning in the house? Items are answered on a 4-point scale ranging from "no impairment" to "very much impairment" [
36].
Generic quality of life
EuroQol
Living with uncontrolled seizures has a negative impact on the quality of life of the child and his/her parents. Therefore, we will measure generic quality of life of both the children and their parents. For this purpose we will use the EuroQol instrument for children of 12 years and older developed by the EuroQol group [
38]. For younger children, we will use a version of the EuroQol developed for children (EuroQol-Youth) or proxies (Wille, 2010). In accordance with the regular EuroQol, the EuroQol-Youth is comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems and severe problems, thus defining 243 (3
5) possible health states. 'Unconscious' and 'dead' have been added to these states, resulting in a total of 245 states. Furthermore, the EQ-5 D consists of a visual analogue scale (VAS) ranging from zero (worst imaginable health state) to 100 (best imaginable health state).
TAPQOL or TACQOL
QoL will also be assessed using the TAPQOL (TNO-AZL Preschool Children's Quality of Life) for children aged between 1-5 years [
39] and the TACQOL (TNO-AZL Children's Quality of life) for children aged between 6-16 years [
40]. There are 12 dimensions in the TAPQOL: lungs, stomach, skin, sleep, appetite, aggressive behavior, positive emotions, fear, vitality, social behavior, motor functioning and communication. All dimensions are scored on a scale from 0-100. The TACQOL is comprised of 7 dimensions: bodily complaints, independence, motor functioning, cognition, social functioning, positive and negative emotions. The scores of the first 5 dimensions vary from 0-32 and the scores of the last two dimensions from 0-16.