title: Using the proportional odds model to assess the relationship between a multi-item and a global item efficacy scale in a psychiatric clinical trial.
abstract: The proportional odds model is illustrated in the analysis of two efficacy scales used in a phase II clinical trial involving 81 schizophrenic patients. The proportional odds model preserves the discrete, ordinal nature of one of the scales. The analysis of this data suggested that the relationship between the two scales is not captured by a linear proportional odds model. A linear model and a piecewise linear model for the explanatory variable were therefore compared using likelihood-based analyses. Residuals from both models were compared. Predicted probabilities for the ordinal categories were constructed from the estimated model. Extensions and limitations of the model for interpretation of other trials and for the planning of future trials are discussed.
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA.
authors.forename: R N
authors.initials: RN
authors.lastname: Tamura
authors.forename: Y
authors.initials: Y
authors.lastname: Tanaka
authors.forename: K
authors.initials: K
authors.lastname: Satoh
authors.forename: M
authors.initials: M
authors.lastname: Takahashi
mesh_terms: D014150:Antipsychotic Agents / Q000627:therapeutic use; D001569:Benzodiazepines; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D006801:Humans; D016014:Linear Models; D015337:Multicenter Studies as Topic; D000077152:Olanzapine; D010890:Pirenzepine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016016:Proportional Hazards Models; D011570:Psychiatry / Q000379:methods*; D012559:Schizophrenia / Q000188:drug therapy
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D010890:Pirenzepine; D000077152:Olanzapine