Services

Psychometric Validation of COA Instruments

The Psychometrics Team can support your psychometric validation needs by conducting a non-interventional validation study (NIVS) or direct validation in Phase 2 or Phase 3 trial data.

We specialize in both modern structural validity and classical methods:

We have expertise in and experience engaging regulatory reviewers in all relevant facets

Areas of specific expertise include:

Modern Psychometric Methods

Item Response Theory (IRT) / Item Exploratory Factor Analysis (EFA)

Unidimensional & Multidimensional Models

Rasch (restricted parameter IRT models)

Evaluation of item redundancy via local dependence (LD) statistics

Evaluation of item and score bias via differential item functioning (DIF) and differential test functioning (DTF), respectively

Essential Dimensionality

Explanatory Models

Classical Methods

Reliability

Validity

Responsiveness

Effect Characterization

Meaningful Change Thresholds (MCT)