Development of the PedsQL™ Epilepsy Module: Focus group and cognitive interviews.

UNLABELLED: Youth with epilepsy have impaired health-related quality of life (HRQOL). Existing epilepsy-specific HRQOL measures are limited by not having parallel self- and parent-proxy versions, having a restricted age range, not being inclusive of children with developmental disabilities, or being too lengthy for use in a clinical setting. Generic HRQOL measures do not adequately capture the idiosyncrasies of epilepsy. The purpose of the present study was to develop items and content validity for the PedsQL™ Epilepsy Module. METHODS: An iterative qualitative process of conducting focus group interviews with families of children with epilepsy, obtaining expert input, and conducting cognitive interviews and debriefing was utilized to develop empirically derived content for the instrument. Eleven health providers with expertise in pediatric epilepsy from across the country provided feedback on the conceptual model and content, including epileptologists, nurse practitioners, social workers, and psychologists. Ten pediatric patients (age 4-16years) with a diagnosis of epilepsy and 11 parents participated in focus groups. Thirteen pediatric patients (age 5-17years) and 17 parents participated in cognitive interviews. RESULTS: Focus groups, expert input, and cognitive debriefing resulted in 6 final domains including restrictions, seizure management, cognitive/executive functioning, social, sleep/fatigue, and mood/behavior. Patient self-report versions ranged from 30 to 33 items and parent proxy-report versions ranged from 26 to 33 items, with the toddler and young child versions having fewer items. CONCLUSIONS: Standardized qualitative methodology was employed to develop the items and content for the novel PedsQL™ Epilepsy Module. The PedsQL™ Epilepsy Module has the potential to enhance clinical decision-making in pediatric epilepsy by capturing and monitoring important patient-identified contributors to HRQOL.

Development and validation of the Pediatric Epilepsy Side Effects Questionnaire.

OBJECTIVE: To develop and validate a measure of antiepileptic drug (AED) side effects in children with a variety of seizure types, treatments, and therapy durations. METHODS: Content for an initial 44-item measure was developed using the previously published Hague Scale and expert opinion from recognized pediatric epileptologists (n = 12) and caregivers of children with epilepsy (n = 21). The measure was completed by caregivers during routine clinic visits. Demographic and medical data were collected through chart reviews. Factor analysis was conducted and internal consistency, test-retest reliability, and construct validity were assessed. RESULTS: Questionnaires were analyzed from 495 children with epilepsy (M(age) = 10.1 years; range 2-21 years; 42% female; 14% African American; 32% new onset vs 68% chronic epilepsy). The final questionnaire, the Pediatric Epilepsy Side Effects Questionnaire (PESQ), is a 19-item measure with 5 subscales (i.e., cognitive, motor, behavioral, general neurological, and weight) that accounts for 99% of the variance. Internal consistency coefficients and test-retest reliabilities ranged from 0.72 to 0.93 and 0.74 to 0.97, respectively. Construct validity was demonstrated by increasing side effects as the number of drugs increased. Participants on valproic acid had significantly higher scores on the Weight Scale compared to those on carbamazepine. CONCLUSIONS: The PESQ is a reliable and valid measure of AED side effects in children across the epilepsy spectrum that can be used in both clinical and research settings.

Development and reliability of a correction factor for parent-reported adherence to pediatric antiepileptic drug therapy.

PURPOSE: Study aims were (1) to document and examine associations between parent-report and electronic monitoring (EM) of pediatric antiepileptic drug (AED) adherence, (2) to determine the sensitivity and specificity of parent-reported adherence, and (3) to develop a correction factor for parent-reported adherence. METHODS: Participants included 111 consecutive children with new-onset epilepsy (M(age) = 7.2 ± 2.0; 61.3% male; 75.8% Caucasian) and their primary caregivers. AED adherence was electronically monitored for 3 months prior to the 4-month clinic follow-up visit. Parent-reported adherence captured adherence 1-week prior to the clinic visit. For specificity/sensitivity analyses of parent-reported adherence, cut points of 50%, 80%, and 90% were used with electronically monitored adherence calculated 1-week prior to the clinic visit as the reference criterion. KEY FINDINGS: Electronically monitored adherence (80.3%) was significantly lower than parent-reported adherence (96.5%; p < 0.0001) 1-week prior to the clinic visit, but both were significantly correlated (rho = 0.46, p < 0.001). The 90% parent-reported adherence cut point demonstrated the most sensitivity and specificity to electronically monitored adherence; however, specificity was still only 28%. A correction factor of 0.83 was identified as a reliable adjustment for parent-reported adherence when compared to electronically monitored adherence. SIGNIFICANCE: Although EM is the gold standard of adherence measurement for pediatric epilepsy, it is often not clinically feasible to integrate it into routine clinical care. Therefore, use of a correction factor for interpreting parent-reported adherence holds promise as a reliable clinical tool. With reliable adherence measurement, clinicians can provide adherence interventions with the hope of optimizing health outcomes for children with epilepsy.

Even a single seizure negatively impacts pediatric health-related quality of life.

PURPOSE: Both a single seizure and chronic recurrent seizures (epilepsy) occur commonly in childhood. Although several studies have documented the impact of pediatric epilepsy on psychosocial functioning, such as health-related quality of life (HRQOL), no studies have examined the impact of a single seizure on HRQOL. The primary objectives of this study were: (1) to compare parent-proxy HRQOL in children with a single seizure and newly diagnosed untreated epilepsy to normative data and (2) to examine differences in parent-proxy HRQOL between children with single seizure and newly diagnosed untreated epilepsy. METHODS: A retrospective medical chart review was conducted on a consecutive cohort of children being evaluated for seizures at a New-Onset Seizure Disorder Clinic. Information from the medical chart review included demographic data, seizure information, and the parent-proxy Pediatric Quality of Life Inventory (PedsQL), a well-validated measure of HRQOL in pediatric chronic illnesses. RESULTS: Participants included 109 children (n = 53 single seizure; n = 56 newly diagnosed untreated epilepsy). Results indicated that both children with a single seizure and children with newly diagnosed untreated epilepsy had significant impairments in HRQOL compared to normative data. However, no significant HRQOL differences were found between the single seizure and the untreated epilepsy groups. DISCUSSION: Children diagnosed with a single seizure or epilepsy have similar clinically significant impairments in HRQOL. Evaluation of HRQOL, even after a first seizure, is important and will identify children at risk at the earliest opportunity, allowing for timely psychosocial intervention.

One-month adherence in children with new-onset epilepsy: white-coat compliance does not occur.

OBJECTIVES: Adherence to antiepileptic drug therapy plays an important role in the effectiveness of pharmacologic treatment of epilepsy. The purpose of this study was to use an objective measure of adherence to (1) document patterns of adherence for the first month of therapy for children with new-onset epilepsy, (2) examine differences in adherence by demographic and epilepsy variables, and (3) determine whether treatment adherence improves for a short time before a clinic visit (eg, "white-coat compliance"). METHODS: Participants included 35 children with new-onset epilepsy (mean age: 7.2 years; 34% female; 66% white) and their caregivers. Children had a diagnosis of partial (60%), generalized (29%), or unclassified (11%) epilepsy. Adherence to treatment was electronically monitored with Medication Event Monitoring System TrackCap, starting with the first antiepileptic drug dose. Adherence was calculated across a 1-month period and for the 1, 3, and 5 days before and 3 days after the clinic appointment. RESULTS: Adherence for the first month of treatment in children with new-onset epilepsy was 79.4%. One-month adherence was higher in children of married parents and those with higher socioeconomic status but did not correlate with child's gender, age, epilepsy type, prescribed medication, seizure frequency, or length of time since seizure onset. Adherence across the entire 1-month period was not different from adherence for the 1, 3, or 5 days before or 3 days after the clinic visit. CONCLUSIONS: Poor adherence seen for children with new-onset epilepsy during the first month of antiepileptic drug therapy is a cause for concern. Several demographic variables influence adherence to treatment, whereas the proximity to a clinic visit does not. Additional studies are needed to document whether this trend continues longitudinally and determine the clinical impact of poor adherence.