title: Sample size formula for proportional hazards modelling of competing risks.
abstract: To test the effect of a therapeutic or prognostic factor on the occurrence of a particular cause of failure in the presence of other causes, the interest has shifted in some studies from the modelling of the cause-specific hazard to that of the subdistribution hazard. We present approximate sample size formulas for the proportional hazards modelling of competing risk subdistribution, considering either independent or correlated covariates. The validity of these approximate formulas is investigated through numerical simulations. Two illustrations are provided, a randomized clinical trial, and a prospective prognostic study.
authors.affiliation: Département de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, Université Paris 7, Inserm Erm 321, Paris, France. aurelien.latouche@chu-stlouis.fr
authors.forename: Aurélien
authors.initials: A
authors.lastname: Latouche
authors.forename: Raphaël
authors.initials: R
authors.lastname: Porcher
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
mesh_terms: D000282:Administration, Intravaginal; D015331:Cohort Studies; D003198:Computer Simulation; D036861:Delivery, Obstetric; D015232:Dinoprostone / Q000008:administration & dosage / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006086:Graft vs Host Disease / Q000209:etiology; D006801:Humans; D007938:Leukemia / Q000628:therapy; D016595:Misoprostol / Q000008:administration & dosage / Q000627:therapeutic use; D010120:Oxytocics / Q000627:therapeutic use; D011247:Pregnancy; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012307:Risk Factors; D018401:Sample Size; D033581:Stem Cell Transplantation
chemical_list: D010120:Oxytocics; D016595:Misoprostol; D015232:Dinoprostone