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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

-