Attachment 12 FEASIBILITY OF AN EPIDEMIOLOGIC STUDY OF A COHORT OF SUBMARINERS WHO RECEIVED RADIUM IRRADIATION TREATMENTS In a retrospective cohort study also called a historical cohort study, a cohort of individuals is identified based on characteristics of exposure in the past and their subsequent disease experience is evaluated to a defined point in time. A cohort is identified solely based on the exposure status independent of disease status. The cohort selected for this study must be one in which a large number of individuals have been irradiated with radium. Also, reasonably reliable data on exposure of individual cohort members should be available. The roster of 15,000 submariners who allegedly received the radium treatment is a roster of a self-selected group, most of whom have health problems (personal communication with Mr. James Garrity, Submarine Survivors Association). This group of veterans may not be appropriate for a cohort study for several reasons. First, they may or may not represent the entire group of veterans who received the radium treatments in the 40's and 50's. Second, they are self-selected into the group because of their health problems. Therefore, a study of this group of veterans will likely to be biased toward an overestimate of specific health risks. Third, because people with more serious health problems would have died already, a study of the survivors could underestimate the true risk. As alternative approach to study veterans who were treated with radium is discussed below. I. Identification of Study Subjects As a way of evaluating the feasibility of identifying a large number of Navy veterans who have received irradiation treatment with radium in the military during the 1940's and 50's and a group of controls, the following procedures are proposed: 1. Selection of a study group 1) obtain a dozen names and social security numbers (or service numbers) of Navy veterans who contacted the Submarine Survivors Group, Inc., 2) request their military personnel records and medical records from the National Personnel Records Center, 3) review their records for evidence of radium irradiation treatments 4) for those veterans with documented evidence of treatment, search for their class roster at the New London US Naval Submarine Base, 1 5) if the class roster is not available, look for the name of the submarine to which he was assigned subsequent to his training, 6) obtain microfilmed ship log of selected submarines from the Bureau of Naval Personnel, 7) list all submariners by their names, service numbers, and rank, 8) search their records at NPRC for evidence of radium treatment, 9) calculate the proportion of submariners with documented exposure history (to be used in the sample site estimate), 10) repeat the above steps until the desired number of individuals is accumulated. 2. Selection of a comparison group Because of a "health veteran effect," the general US male population is not an ideal comparison group. Veterans, on the average, are healthier than the general population for several reasons including pre-induction physical screening, requirements to maintain certain physical standards, lifestyle changes that are conducive to better health, and better access to medical care. Therefore, a veteran group that was susceptible to the same selective factors as the study group would be an appropriate comparison group. Another group of submariners who were on active duty during the same period but did not receive the radium treatment will be an ideal comparison group. However, it is possible that some submariners received the treatment without the event being recorded in his military records. Because of this possibility of misclassification of individuals, other submariners are not suitable as controls. The next group of choice would be a group of sailors who served on surface ships during the 1940's and 1950's. Navy ships that were active during this period can be identified and ship logs of these vessels can be obtained from the Bureau of Naval Personnel. Names, service numbers and ranks of an appropriate number of sailors could be abstracted. As an additional means of guarding against misclassification false negative) on exposure, their records can be searched at the NPRC for evidence of receiving the radium treatment and their names can be matched against the roster maintained by the Submarine Survivors Group. 2 II. Study Design Consideration These two groups (exposed and control) (can be studied for morbidity and mortality outcomes. A mortality follow-up study may be the most appropriate study design for several reasons. The suspected health outcomes of concern are cancers resulting from the irradiation of nasopharyngeal areas with radium, and most of the cancers of the head and neck areas are eventually fatal. Also, at least three decades have elapsed since the treatment, a period which is considered sufficient for the manifestation of radiogenic cancer. Finally, a mortality study can be completed quicker and is generally less costly than a morbidity study. If the mortality study results suggest any health effects related to the radium treatments, a morbidity study can be designed to further evaluate the adverse health outcomes. Prepared by Environmental Epidemiology Service (116E) Veterans Health Administration (202) 606-5420 ________________________ _________ Han K. Kang, Dr. P.H. Date