title: Inference on the rate ratio of recurrent events for the matched pairs design.
abstract: As statistical methods for testing the null hypothesis of no difference between two groups for the matched pairs design, the paired-t test, Wilcoxon signed rank sum test and McNemar test are well known. However, there is no simple test for the comparison of incidence rate of recurrent events. This paper proposes a simple statistical method and a sample size formula for the comparison of counts of recurrent events over a specified period of observation under the matched pairs design, where the subject-specific incidence of recurrent events is assumed to follow a time-homogeneous Poisson process. As a special case, the proposed method is found to be virtually equivalent in form to Mantel-Haenszel method for a common rate ratio among the set of stratified tables based on person-time data. The proposed methods are illustrated with the within-arm comparison of data from a clinical trial of 59 epileptics with baseline count data.
authors.affiliation: Data Management Clinical Development Division, Actelion Pharmaceuticals Japan Ltd., 1-1-39 Hiroo Shibuya-ku, Tokyo 150-0012, Japan. Mariko.Sumi@actelion.com
authors.forename: Mariko
authors.initials: M
authors.lastname: Sumi
authors.forename: Toshiro
authors.initials: T
authors.lastname: Tango
mesh_terms: D000927:Anticonvulsants / Q000627:therapeutic use; D003627:Data Interpretation, Statistical; D004827:Epilepsy / Q000188:drug therapy; D006801:Humans; D015994:Incidence; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012008:Recurrence; D018401:Sample Size; D012640:Seizures / Q000517:prevention & control; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives / Q000627:therapeutic use
chemical_list: D000927:Anticonvulsants; C017985:progabide; D005680:gamma-Aminobutyric Acid