A general theoretical framework for interpreting patient-reported outcomes estimated from ordinally scaled item responses.

A simple theoretical framework explains patient responses to items in rating scale questionnaires. Fixed latent variables position each patient and each item on the same linear scale. Item responses are governed by a set of fixed category thresholds, one for each ordinal response category. A patient's item responses are magnitude estimates of the difference between the patient variable and the patient's estimate of the item variable, relative to his/her personally defined response category thresholds. Differences between patients in their personal estimates of the item variable and in their personal choices of category thresholds are represented by random variables added to the corresponding fixed variables. Effects of intervention correspond to changes in the patient variable, the patient's response bias, and/or latent item variables for a subset of items. Intervention effects on patients' item responses were simulated by assuming the random variables are normally distributed with a constant scalar covariance matrix. Rasch analysis was used to estimate latent variables from the simulated responses. The simulations demonstrate that changes in the patient variable and changes in response bias produce indistinguishable effects on item responses and manifest as changes only in the estimated patient variable. Changes in a subset of item variables manifest as intervention-specific differential item functioning and as changes in the estimated person variable that equals the average of changes in the item variables. Simulations demonstrate that intervention-specific differential item functioning produces inefficiencies and inaccuracies in computer adaptive testing.