Epilepsy is a chronic neurological disorder that results in recurring
seizures and can have a significant adverse effect on health related quality of
life (HRQL). Neuro-QoL is an NINDS-funded system of patient reported outcome
measures for neurology clinical research, which was designed to provide a
precise and standardized way to measure HRQL in epilepsy and other neurological
disorders. Using mixed-methods and item response theory-based approaches, we
developed generic item banks and targeted scales for adults and children with
major neurological disorders. This paper provides empirical results from a
clinical validation study with a sample of adults diagnosed with epilepsy. One
hundred twenty one people diagnosed with epilepsy participated, of which the
majority were male (62%), Caucasian (95%), with a mean age of
47.3 (SD=16.9). Baseline assessments included Neuro-QoL short forms and
general and external validity measures. Neuro-QoL short forms that are not
typically found in other epilepsy-specific HRQL instruments include Stigma,
Sleep Disturbance, Emotional and Behavioral Dyscontrol and Positive Affect &
Well-being. Neuro-QoL short forms demonstrated adequate reliability (internal
consistency range = .86–.96; test-retest range =
.57–.89). Pearson correlations (p<.01) between
Neuro-QoL forms of emotional distress (Anxiety, Depression, Stigma) and the
QOLIE-31 Emotional Well-being Subscale were in the moderate to strong range
(r’s = .66, .71 & .53, respectively), as were relations with
the PROMIS Global Mental Health subscale (r’s = .59, .74 &
.52, respectively). Moderate correlations were observed between Neuro-QoL Social
Role Performance and Satisfaction and the QOLIE-31 Social Function (r’s
= .58 & .52, respectively). In measuring aspects of physical
function, the Neuro-QoL Mobility and Upper Extremity forms demonstrated moderate
associations with the PROMIS Global Physical Function Subscale (r’s
= .60 & .61, respectively). Neuro-QoL measures of perceived
cognitive function (executive function and general concerns) produced moderate
to strong correlations with the QOLIE-31 Cognition subscale (r’s
= .65 & .75, respectively) and moderate relations with the Liverpool
Adverse Events scale (r’s = .51 & .69, respectively).
Finally, the Neuro-QoL Fatigue measure demonstrated moderate associations with
the QOLIE-31 Energy/Fatigue subscale (r=−.65), Liverpool Adverse
Events Scale (r=.69) and the Liverpool Seizure Severity Scale
(r=.50). Five Neuro-QoL short forms demonstrated statistically
significant responsiveness to change at 5–7 months, including Fatigue,
Sleep Disturbance, Depression, Positive Affect & Well-being, and Emotional
and Behavioral Dyscontrol. Overall, Neuro-QoL instruments showed good evidence
for internal consistency, test-retest reliability, convergent validity and
responsiveness to change over several months. These results support the validity
of Neuro-QoL to measure HRQL in adults with epilepsy.