Mapping epilepsy-specific patient-reported outcome measures for children to a proposed core outcome set for childhood epilepsy

Objective: To (1) map questions in epilepsy-specific patient-reported outcome measures (PROMs) of children’s health-related quality of life (HRQoL) to a proposed core outcome set (COS) for childhood epilepsy research; (2) gain insight into the acceptability of two leading candidate PROMs.

Method: We identified 11 epilepsy-specific PROMs of children’s HRQoL (17 questionnaire versions) in a previous systematic review. Each item from the PROMs was mapped to 38 discrete outcomes across 10 domains of the COS: seizures, sleep, social functioning, mental health, cognition, physical functioning, behaviour, adverse events, family life and global quality of life. We consulted with three children with epilepsy and six parents of children with epilepsy in Patient Public Involvement and Engagement (PPIE) work to gain an understanding of the acceptability of the two leading PROMs from our review of measurement properties: Quality of Life in Childhood Epilepsy (QOLCE-55) and Health-Related Quality of Life Measure for Children with Epilepsy (CHEQOL).

Results: Social Functioning is covered by all PROMs except DISABKIDS and G-QOLCE and Mental Health is covered by all PROMs except G-QOLCE and HARCES. Only two PROMs (ELDQOL and GEOS-YP) have items that cover the Seizure domain. QOLCE-55 includes items that cover the domains of Physical Functioning, Social Functioning, Behaviour, Mental Health and Cognition. CHEQOL parent and child versions cover the same domains as QOLCE-55 except for Physical Functioning and Behaviour, and the child version has one item that covers the discrete outcome of Overall Quality of Life and one item that covers the discrete outcome of Relationship with parents and siblings. QOLCE-55 parent version was acceptable to the parents we consulted with, and CHEQOL parent and child versions were described as acceptable to our child and parent advisory panel members.

Significance: Mapping items from existing epilepsy-specific PROMs for children is an important step in operationalizing our COS for childhood epilepsy research, alongside evaluation of their measurement properties. Two leading PROMS, QOLCE-55 and CHEQOL cover a wide range of domains from our COS and would likely be used in conjunction with assessment tools selected for specific study objectives. PPIE work provided practical insights into the administration and acceptability of candidate PROMs in appropriate context. We promote our COS as a framework for selecting outcomes and PROMs for future childhood epilepsy evaluative research.

Key words: Epilepsy, children, core outcome set, pediatric, patient-reported outcome measure, patient public involvement and engagement