Elsevier

Epilepsy & Behavior

Volume 62, September 2016, Pages 115-120
Epilepsy & Behavior

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

https://doi.org/10.1016/j.yebeh.2016.06.011Get rights and content

Highlights

  • PedsQL™ Epilepsy Module captures idiosyncratic HRQOL in youth with epilepsy.

  • Instrument has parallel self-report and parent-proxy versions.

  • Assesses HRQOL in children 2–18 years

  • Appropriate for use with patients of varying levels of functioning

  • Developed using the same standardized qualitative methods as other PedsQL™ modules

Abstract

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 4–16 years) with a diagnosis of epilepsy and 11 parents participated in focus groups. Thirteen pediatric patients (age 5–17 years) 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.

Introduction

Youth with epilepsy have impaired health-related quality of life (HRQOL) compared with both healthy peers and those with other chronic medical conditions [1], [2], [3]. HRQOL is a multidimensional construct that measures patient perceived impacts of health across a range of dimensions, including physical, emotional, academic, and social domains [4]. In an era of increased attention to patient-reported outcomes [5], HRQOL is considered an important clinical measure in pediatric medical care [6]. Accordingly, being able to accurately capture this information in a developmentally-sensitive, valid, and expeditious way is essential for both clinical and research applications.

To date, the field of pediatric epilepsy has used generic HRQOL measures such as the PedsQL™ 4.0 Generic Core Scales [4], which are relatively brief (23 items) and beneficial when making comparisons across a wide variety of pediatric populations [7]. Conversely, generic measures may not fully capture the idiosyncratic impacts of epilepsy on functioning or be sensitive to changes in disease status [6]. This limits their utility as a disease-specific clinical outcome measure. Epilepsy-specific HRQOL measures, including the Quality of Life in Epilepsy-Adolescent-48 [8] and the Quality of Life in Childhood Epilepsy [9], capture a broader range of domains than generic measures. These measures focus on disease and treatment issues that are salient in epilepsy. However, several notable weaknesses compromise their usefulness. For example, the Quality of Life in Epilepsy-Adolescent-48 is a self-report measure for adolescents (ages 11–17) only, which is a significant limitation given that the median age of onset of childhood epilepsy is between 5 and 6 years [10]. In addition, no parent proxy-report version was co-developed with the Quality of Life in Epilepsy-Adolescent-48. Obtaining information from both parents and patients is optimal as they can offer unique and valuable perspectives about their subjective experiences [11]. The Quality of Life in Childhood Epilepsy (USA Version) instrument covers a wider developmental spectrum (parent report of 4–18 year olds) than the Quality of Life in Epilepsy-Adolescent-48; however, there is no companion self-report measure, and the measure is 79 items long. Lastly, both the Quality of Life in Epilepsy-Adolescent-48 and the Quality of Life in Childhood Epilepsy were developed without the inclusion of individuals with learning or intellectual disabilities. Considering that 1/3 of patients with childhood-onset epilepsy have intellectual or learning disorders [12] and recognizing its impact on HRQOL [13], eliciting input during the item development stage from these patients and their caregivers could potentially reveal additional areas for the development of a new epilepsy-specific HRQOL measure.

The primary aim of the current study was to create an epilepsy-specific module of the PedsQL™ that will build on existing measures in several important ways. First, our measure will assess a broad age spectrum of 2–18 years in a developmentally appropriate fashion. Second, self-report and parent proxy-report versions will be developed in tandem for children age 5–18. Third, the increased relevancy of the measure will lie in its ability to assess QOL in all youth with epilepsy and its increased sensitivity to factors impacting QOL in youth with cognitive and learning comorbidities.

The methodology to develop a PedsQL™ disease-specific module has previously been reported [14], [15]. In line with these established procedures, development of the PedsQL™ Epilepsy Module has occurred in several phases: 1) content generation (Phase 1); 2) construction of the initial measure and item pool (Phase 2); 3) pretesting and instrument refinement (Phase 3), 4) national validation (Phase 4); and 5) dissemination and international translation (Phase 5). The purpose of the current paper is to describe the first three steps of the validation process, including how the items were generated, modified, and adapted based on a thorough literature review (Phase 1a), expert feedback (Phases 1a and 2b), focus groups (Phase 2a), and cognitive interviewing with children with epilepsy and their caregivers (Phase 3). Through this rigorous content validation process, a PedsQL™ Epilepsy Module will be created for national validation testing for children 2–18 years of age with epilepsy, with parallel pediatric patient self-report, and parent proxy-report versions.

Section snippets

Participants

Study participants were youth ages 5–18 years diagnosed with epilepsy and their primary caregiver, as well as primary caregivers of children age 2–4 years diagnosed with epilepsy. Families were recruited during routine medical visits through the Comprehensive Epilepsy Center at Cincinnati Children's Hospital Medical Center. Recruitment was targeted to ensure that our participants represented the spectrum of ages, developmental abilities, sex, and type of epilepsy (e.g., newly diagnosed,

Participants

Overall, 74 families were approached for participation and 16 declined participation, yielding a recruitment rate of 78%. Of the 58 families who consented, 28 families participated in either the focus group or cognitive interviews (48% participation). Eleven families participated in the focus group and 17 families participated in the cognitive interview. Reasons for non-participation included scheduling conflicts (e.g., could not attend scheduled focus group day), family emergencies on the day

Discussion

The purpose of this paper was to present the qualitative, iterative development of the new PedsQL™ Epilepsy Module, which is a disease-specific HRQOL measure designed for youth 2–18 years with epilepsy. The instrument was developed through a rigorous process of 1) conducting focus groups with pediatric patients and their parents to identify the most salient aspects of functioning and develop items, 2) obtain expert feedback, and 3) pretest the instrument using cognitive interviewing of families

Conflict of interest

The authors declare no conflicts of interest for this manuscript.

Acknowledgments and funding

Funding: This research was funded by the Fifth Third Bank/Charlotte R. Schmidlapp Women Scholars Program to the senior author.

We would like to extend our deepest appreciation to the youth with epilepsy and their families that participated in our focus groups and cognitive interviews. We would also like to thank the members of the Comprehensive Epilepsy Center at Cincinnati Children's Hospital who help to care for these patients on a daily basis. Finally, we would like to thank the volunteers

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