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An item response theory based integrated model of headache, nausea, photophobia, and phonophobia in migraine patients

 Dongwoo Chae  ;  Kyungsoo Park 
 Journal of Pharmacokinetics and Pharmacodynamics, Vol.45(5) : 721-731, 2018 
Journal Title
 Journal of Pharmacokinetics and Pharmacodynamics 
Issue Date
Disease progression model ; Item response theory ; Migraine ; Proportional odds model
This study developed an integrated model of severity scores of migraine headache and the incidence of nausea, photophobia, and phonophobia to predict the natural time course of migraine symptoms, which are likely to occur by a common disease progression mechanism. Data were acquired from two phase 3 clinical trials conducted during the development of eletriptan. Only the placebo arm was used for analysis. A conventional proportional odds model was compared with an item response theory (IRT) based approach. Results suggested that the IRT based approach led to a better model fit, successfully revealing the difference in relief rates among different symptoms, which was the fastest in phonophobia and the slowest in headache. Simulation with the developed model suggested that using headache scores at 4 h post-dose attained greatest statistical power, yielding sample size of 100 per arm given drug effect of 40%, as compared to that of 200 per arm when 2 h post-dose scores were used as in the original eletriptan protocol. This work demonstrated the usefulness of an IRT based model as applied to analyzing multidimensional migraine symptoms and designing clinical trials. Our model can be similarly applied to analyzing other multiple endpoints sharing a common underlying mechanism.
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1. College of Medicine (의과대학) > Dept. of Pharmacology (약리학교실) > 1. Journal Papers
Yonsei Authors
박경수(Park, Kyungsoo) ORCID logo https://orcid.org/0000-0002-6972-1143
채동우(Chae, Dong Woo) ORCID logo https://orcid.org/0000-0002-7675-3821
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