Elsevier

Epilepsy & Behavior

Volume 46, May 2015, Pages 209-214
Epilepsy & Behavior

Validation of the Neuro-QoL measurement system in children with epilepsy

https://doi.org/10.1016/j.yebeh.2015.02.038Get rights and content

Highlights

  • Neuro-QoL is a valid and reliable assessment tool for children with epilepsy.

  • Neuro-QoL is a comprehensive measurement system measuring 10 domains.

  • Neuro-QoL was developed using item response theory models, and a computerized adaptive testing platform is available.

Abstract

Objective

Children with epilepsy often face complex psychosocial consequences that are not fully captured by existing patient-reported outcome (PRO) measures. The Neurology Quality of Life Measurement System “Neuro-QoL” was developed to provide a set of common PRO measures that address issues important to people with neurologic disorders. This paper reports Neuro-QoL (anxiety, depression, interaction with peers, fatigue, pain, cognitive function, stigma, and upper and lower extremity functions) validation in children with epilepsy.

Method

Patients (aged 10–18 years) diagnosed with epilepsy completed Neuro-QoL and legacy measures at time 1 (initial study visit) and 6-month follow-up. Internal consistency reliability was also evaluated. Concurrent validity was assessed by comparing Neuro-QoL measures with more established “legacy” measures of the same concepts. Clinical validity was evaluated by comparing mean Neuro-QoL scores of patients grouped by clinical anchors such as disease severity. Responsiveness of the Neuro-QoL from time 1 (initial study visit) to 6 months was evaluated using self-reported change as the primary anchor.

Results

Sixty-one patients (mean age = 13.4 years; 62.3% male, 75.9% white) participated. Most patients (64.2%) had been seizure-free in the 3 months prior to participation, and seizure frequency was otherwise described as follows: 17.8% daily, 13.3% weekly, 35.6% monthly, and 33.3% yearly. All patients were taking antiepileptic drugs. Patients reported better function/less symptoms compared to the reference groups. Internal consistency (alpha) coefficients ranged from 0.76 to 0.87. Patients with different seizure frequencies differed on anxiety (p < .01) and cognitive function (p < .05). Compared to patients on polytherapy, those on monotherapy had better upper extremity scores (p < .05). Compared to those with localized seizures, those experiencing generalized seizures reported worse stigma (p < .05). Depression, anxiety, lower extremity, fatigue, pain, interaction with peers, and stigma also significantly discriminated patients with different levels of quality of life (p  .05). All Neuro-QoL measures were significantly correlated with other measures assessing similar domains. Stigma was related to self-reported change in several areas of functioning but in sometimes unexpected directions.

Significance

The Neurology Quality of Life Measurement System is a valid and reliable assessment tool for children with epilepsy and can be used in research and clinical settings.

Introduction

The prevalence of epilepsy among patients seen in pediatric neurology practice may be as high as 70% [1], and these children often experience a variety of comorbid conditions such as attention problems and cognitive deficits [2]. Children with epilepsy often face complex psychosocial consequences that can derail the course of normal development, often extending to adulthood [3], [4]. They have approximately a threefold increased risk of subnormal mental ability or other learning and behavior problems [1], [5], [6], [7], twice the referral rate for mental health services, and a threefold increase in utilization of special education services [8], [9]. Adolescents with epilepsy are also noted to have a higher frequency of behavioral problems than peers who are healthy or have other chronic health problems [10]. Thus, it is important to monitor their health-related quality of life (HRQL) regularly.

Several factors complicate the assessment of HRQL in children and adolescents with epilepsy, including development-related change in basal functioning; difficulties associated with proxy assessment; limitations related to learning ability, behavioral disorders, and motor handicap; and the episodic nature of the disease [5]. Recently, pediatric and adolescent measures have been designed to address the above concerns. Carpay et al. [11] developed a seizure severity (SS) and side effects (SE) scale for children, designed for parent completion. The Quality of Life in Childhood Epilepsy (QOLCE) questionnaire by Sabaz et al. [12] is a parent report scale sampling five core functional domains across 16 subscales. Adolescent self-report measures include the Adolescent Psychosocial Seizure Inventory [13], which does not offer a complete HRQL assessment, and the more comprehensive Quality of Life in Epilepsy for Adolescents inventory (QOLIE-AD-48) [12], [14], [15].

From 2004 to 2009, the National Institute of Neurologic Disorders and Stroke (NINDS) sponsored a multisite project to develop a clinically relevant and psychometrically sound HRQL measurement tool for adults and children with neurological disorders [16], [17], [18], [19]. This effort, Neuro-QoL, enables clinical researchers to compare the HRQL impact of different interventions within and across various conditions. The pediatric Neuro-QoL consists of ten self-report measures: 8 item banks (anxiety, depression, anger, interaction with peers, fatigue, pain, cognitive function, and stigma) and 2 scales (upper and lower extremity functions). These measures are applicable for use with children ages 8 through 17 years and available in both English and Spanish. Different from other HRQL measures used with patients with epilepsy, all Neuro-QoL item banks were developed using rigorous qualitative and quantitative approaches and were calibrated using item response theory (IRT) models [20], [21], [22]. An item bank provides the foundation for the development of dynamic computer adaptive testing (CAT), as well as the creation of a variety of static, fixed-length short forms. The scores produced by any of the instruments created from an item bank are calibrated on the same latent trait and are comparable regardless of the specific questions asked of a given individual or group of respondents. Fixed-length short forms, in which a subset of bank items can be selected from across the trait spectrum to produce a static instrument, can be used when access to computers is limited. When computers are available, CAT, a dynamic process of test administration in which items are selected on the basis of patients' responses to previously administered items, can provide brief-yet-precise measures [23], [24], [25], [26]. The purpose of this paper is to report the validation of Neuro-QoL fixed-length forms in a sample of children with epilepsy.

Section snippets

Pediatric Neuro-QoL measurement system

Details of pediatric Neuro-QoL development have been previously described in Lai et al. [17]. In brief, items were generated by gathering concerns from parents, patients, and clinicians. Because generic item sets (pools) could be answered by a person without a medical condition, generic domains were field-tested on samples from the US pediatric general population. Targeted item pools, typically symptoms or side effects of a disease process (i.e., fatigue, cognitive function, stigma, and pain in

Subjects

Participants (N = 61) were primarily male (62.3%), white (75.9%), and non-Hispanic (79.3%) with average age = 13.4 years (SD = 2.6; range = 10 to 18 years). At time 1, 91.8% were a full-time student (1.6% part-time student and 6.6% did not attend school). Average time since diagnosis was 5 years (SD = 4.1, range = 0.2 to 14.8 years). Medical records revealed that most patients (64.2%) had not experienced a seizure in the past 3 months; 17.8% reported having a seizure daily, 13.3% weekly, 35.6% monthly, and

Discussion

Childhood epilepsy may impact several key aspects of patients' well-being such as cognition and physical, emotional, and social functioning. A valid and reliable measure can facilitate understanding of the impact of childhood epilepsy upon QOL and also enable prompt interventions. The Neuro-QoL measurement system is clinically relevant and psychometrically sound, providing a core set of questions sampling domains that are relevant to patients with many chronic neurological diseases. This paper

Conclusion

In conclusion, pediatric Neuro-QoL is a valid and reliable measure of quality of life for children with epilepsy. The validity of the pediatric Neuro-QoL needs to be evaluated further by recruiting a more diverse sample across the severity spectrum. Since the adult version of the Neuro-QoL was validated on patients with epilepsy [19], the same measurement system can be used to monitor these children throughout the lifespan in a consistent manner.

The pediatric Neuro-QoL can be used in research

Acknowledgments

This manuscript was supported the National Institute of Neurological Disorders and Stroke (HHSN271201200036C; PI: David Cella) and National Cancer Institute (R01CA125671; PI: Jin-Shei Lai).

Conflict of interest

All authors report no conflict of interest to be disclosed.

References (36)

  • F. Drislane et al.

    Seizures and epilepsy

  • J. Cramer

    Quality of life assessment for people with epilepsy

  • P.S. Fastenau et al.

    Neuropsychological status at seizure onset in children: risk factors for early cognitive deficits

    Neurology

    (2009)
  • A.T. Berg et al.

    Special education needs of children with newly diagnosed epilepsy

    Dev Med Child Neurol

    (2005)
  • M.R. Trimble et al.

    Quality of life measurements in children with epilepsy

  • L.W. Batzel et al.

    An objective method for the assessment of psychosocial problems in adolescents with epilepsy

    Epilepsia

    (1991)
  • J.A. Cramer et al.

    Development of the Quality of Life in Epilepsy Inventory for Adolescents: the QOLIE-AD-48

    Epilepsia

    (1999)
  • M. Sabaz et al.

    Validation of a new quality of life measure for children with epilepsy

    Epilepsia

    (2000)
  • Cited by (20)

    • Behavioral health screening in pediatric epilepsy: Which measures commonly used in the United States are ‘good enough’?

      2022, Epilepsy and Behavior
      Citation Excerpt :

      Three studies contributed to the evaluation of the Pediatric NeuroQoL-Depression, a free, 8-item self-report measure of depressive symptoms, which is part of a larger assessment of emotional, physical, and social health developed for youth with neurological conditions, including epilepsy. The Pediatric NeuroQoL-Depression was evaluated as “Adequate” on most criteria [35,38,39]. An exception is content validity for which the Pediatric NeuroQoL-Depression was rated “Excellent” because it was developed with a literature review, expert review, field testing, cognitive interviewing, and item response theory [35,39].

    • Analysis of factors related to low health-related quality of life in children with epilepsy using a self-assessed Japanese version of the KIDSCREEN-52

      2021, Brain and Development
      Citation Excerpt :

      To the best of our knowledge, the present study is the first to report that epileptic patients with a history of status epilepticus were significantly associated with low HRQOL with regards to Mood and Emotions. Children with more frequent seizures often express a lower HRQOL [25]. Indeed, strong convulsions lasting more than 30 min negatively impact mental state even if the number of seizures is low.

    • Proceedings from the Consensus Conference on Trauma Patient-Reported Outcome Measures

      2020, Journal of the American College of Surgeons
      Citation Excerpt :

      The Neuro-QoL51 is a measurement system that examines the physical, mental, and social effects of neurologic conditions in children and adults. It has been validated in patients with stroke, Parkinson disease, traumatic brain injury, epilepsy, spinal cord injury, and other neurologic diseases.52-56 Its advantages include flexible administration, availability in multiple languages, fast completion time, and the absence of user fees or licensure agreements.51

    • Quality of Life in Children With Sturge-Weber Syndrome

      2019, Pediatric Neurology
      Citation Excerpt :

      The primary aim of the Neuro-QoL was to standardize how studies assess the physical, mental, and social well-being of children with neurological conditions.3 The pediatric Neuro-QoL has been used in research studying the effects of epilepsy, muscular dystrophy, and traumatic brain injury on children.4-6 By providing a standardized assessment of quality of life of patients with SWS, providers can better address patients' needs and clinical trials can target outcomes important to patients and their families.7

    View all citing articles on Scopus
    View full text