Table 3.

Phase 2 Gap Analysis Summary of Selected Measures

Key Concept	PRO	Content Validitya	Construct Validityb	Internal-Consistency Reliability	Test-Retest Reliabilityc	Ability to Detect Changed	Definition of CMC
Seizure severity	LSSS 2.0	✓	✓	✓ α = 0.66 to 0.87 pending scoring	X Not assessed for v2.0	✓	X
	NHS3	✓	✓	✓ α = 0.77 for total	✓ ICC = 0.90 for total	X	Suggestede
	SSQ	✓	✓	X	✓ ICC = 0.69 to 0.89 for raters	✓	✓
Impact of epilepsy	QOLIE-10	✓	✓	X α = 0.48 to 0.51 for domains	✓ r = 0.55 to 0.77 for domains	X	X
	QOLIE-31	✓	✓	✓ α = 0.93 for total	✓ r > 0.70 ICC = 0.93 for total score	✓	✓
	QOLIE-89	✓	✓	✓ α > 0.70 for all domains	✓ r = 0.58 to 0.86 ICC = 0.97 for total score	✓	✓
	WPAI	X	X	X	X	X	X
	PIES	✓	X	✓ α = 0.87 for total	✓ ICC = 0.56 to 0.99	X	X
Epilepsy treatment or side effects	SEALS	✓	✓	✓ α = 0.63 to 0.95 for domains (total not provided)	✓ Spearman Brown correlation = 0.79 for total score	X	X
Social support or coping strategies	Family APGAR	X	X	X	X	X	X
	AESMMI-65	✓	✓	✓ α = 0.94 for total score	X	X	X
	EASE	✓	✓	✓ α = 0.92 for total score	X	X	X

Notes: A checkmark (✓) indicates the information is validated in published literature detailing the use of the measure in patients with epilepsy. ^aContent validity was confirmed if literature review or interviews/focus groups were conducted with patients with epilepsy or input was obtained from experts at the time of development. ^bConstruct validity refers to the degree to which two measures of constructs that should be related are related. Known-groups validity was also assessed as a form of construct validity, defined as the ability of a measure to distinguish between known groups. ^cAlso included inter-rater reliability. ^dAbility to detect change (responsiveness/sensitivity) was assessed as the ability of scores to change when change was assessed using a separate anchor (eg, PGIC). ^eThis study hypothesized that a 2–3 point change in NHS3 scores might correspond to a clinically meaningful change for patients.

Abbreviations: AESMMI-65, adult epilepsy self-management instrument-65; CMC, clinically meaningful change; EASE, self-efficacy, assertiveness, social support, self-awareness, and helpful thinking in people with seizures; ICC, intraclass correlation; LSSS 2.0, Liverpool seizure severity scale 2.0; NHS3, national hospital seizure severity scale; PGIC, patient global impression of change; PIES, personal impact of epilepsy scale; PRO, patient-reported outcome; QOLIE, quality of life in epilepsy; SEALS, side effects and life satisfaction; SSQ, seizure severity questionnaire; WPAI, work productivity and activity impairment.