A recommended epidemiological study design for examining the adverse health effects among emergency workers who experienced the TEPCO fukushima daiichi NPP accident in 2011.

Results from medical examinations conducted in 2012 of workers who were engaged in radiation work in 2012 as a result of the 2011 Fukushima Daiichi Nuclear Power Plant (NPP) accident showed that the prevalence of abnormal findings was 4.21%, 3.23 points higher than the 0.98% that was found prior to the accident in the jurisdiction area of the labor inspection office which holds jurisdiction over the NPP. The Ministry of Health, Labour and Welfare (MHLW) concluded that the 2010 and 2012 data cannot be easily compared because 70% of the enterprises within the jurisdiction of the office that reported the 2012 results were different from those that did so in 2010. In addition, although the radiation workers' estimated average dose weighted by number of workers was 3.66 times higher than decontamination workers' dose, the prevalence among radiation workers was only 1.14 times higher than that among decontamination workers. Based on the results of the medical examinations, however, the MHLW decided to implement an epidemiological study on the health effects of radiation exposure on all emergency workers. This article explains key issues of the basic design of the study recommended by the expert meeting established in the MHLW and also identifies challenges that could not be resolved and thus required further consideration by the study researchers. The major issues included: (a) study methods and target group; (b) evaluation of cumulative doses; (c) health effects (end points); (d) control of confounding factors; and (e) study implementation framework. Identified key challenges that required further deliberation were: (a) preventing arbitrary partisan analysis; (b) ensuring a high participation rate; (c) inquiry about the medical radiation doses; and (d) the preparedness of new analytical technology. The study team formulated and implemented the pilot study in 2014 and started the full-scale study in April 2015 with funding from a research grant from the MHLW.