Power Estimation and Follow-Up Period Evaluation in Korea Radiation Effect and Epidemiology Cohort Study / 예방의학회지

ABSTRACT

OBJECTIVES: The objective of this study was to calculate sample size and power in an ongoing cohort, Korea radiation effect and epidemiology cohort (KREEC). METHOD: Sample size calculation was performed using PASS 2002 based on Cox regression and Poisson regression models. Person-year was calculated by using data from '1993-1997 Total cancer incidence by sex and age, Seoul' and Korean statistical informative service. RESULTS: With the assumption of relative risk=1.3, exposure:non-exposure=1:2 and power=0.8, sample size calculation was 405 events based on a Cox regression model. When the relative risk was assumed to be 1.5 then number of events was 170. Based on a Poisson regression model, relative risk=1.3, exposure:non-exposure=1:2 and power=0.8 rendered 385 events. Relative risk of 1.5 resulted in a total of 157 events. We calculated person-years (PY) with event numbers and cancer incidence rate in the non-exposure group. Based on a Cox regression model, with relative risk=1.3, exposure:non-exposure=1:2 and power=0.8, 136 245PY was needed to secure the power. In a Poisson regression model, with relative risk=1.3, exposure:non-exposure=1:2 and power=0.8, person-year needed was 129517PY. A total of 1939 cases were identified in KREEC until December 2007. CONCLUSIONS: A retrospective power calculation in an ongoing study might be biased by the data. Prospective power calculation should be carried out based on various assumptions prior to the study.