ABSTRACT
Pain intensity is principally assessed using rating scales such as the 11-point Likert scale. In general, frequent pain assessments are serially correlated and underdispersed. The aim of this investigation was to develop population models adapted to fit the 11-point pain scale. Daily Likert scores were recorded over 18 weeks by 231 patients with neuropathic pain from a clinical trial placebo group. An integer model consisting of a truncated generalized Poisson (GP) distribution with Markovian transition probability inflation was implemented in NONMEM 7.1.0. It was compared to a logit-transformed autoregressive continuous model with correlated residual errors. In both models, the score baseline was estimated to be 6.2 and the placebo effect to be 19%. Developed models similarly retrieved consistent underlying features of the data and therefore correspond to platform models for drug effect detection. The integer model was complex but flexible, whereas the continuous model can more easily be developed, although requires longer runtimes.
