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Table 3 Instrument review against regulatory requirements

From: Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements

Instrument abbreviated name Conceptual framework Validity: content Validity: construct Reliability: test-retest Reliability: internal consistency Ability to detect change Interpretation of change
Patient input Literature & clinician input
ABNAS Partial Partial Partial Partial - -
Attack Symptom Measure Partial - Partial - -
BPSE Partial - Partial - -
EFA Partial Partial - -
EPSES Partial Partial Partial - - -
EPI-QOL Partial Partial Partial - -
ESES Partial Partial Partial Partial - -
ESI-55 Partial - Partial -
ICI Partial - - -
IES Partial - - -
LAEP Partial Partial -
LSSS Partial Partial Partial Partial -
NDDI-E - -
NEWQOL Partial Partial Partial Partial - -
Perceived Limitations Scale - - - -
Perceived Stigma Scale - - - -
PESOS Partial Partial Partial -
PNS Partial - - -
QOLIE-10 Partial Partial Partial Partial -
QOLIE-31 Partial Partial Partial Partial Partial
QOLIE-89 Partial Partial Partial Partial Partial
SEALS Partial Partial Partial - -
SHE Partial - -
SIDAED - - - - -
SSQ Partial Partial Partial - - -
WPSI Partial Partial Partial Partial -