Adverse Reproductive Outcomes in Families of Atomic Veterans The Feasibility of Epidemiologic Studies (1995) / Chapter Skim
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EXECUTIVE SUMMARY
EXECUTIVE SUMMARY
Pages 1-8
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The Radiation-Exposed Veterans Compensation Act of 1988 (Public Law 100-321) recognized this concern and identified 13 cancers (specifically, leukemia, multiple myeloma, lymphoma except Hodgkin's disease, and cancers of the thyroid, breast, pharynx, esophagus, stomach, small intestine, pancreas, bile ducts, gall bladder, and liver)
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1. Is it feasible to conduct an epidemiologic study to determine whether there is an increased risk of adverse reproductive outcomes in the spouses and of adverse health effects in the children and grandchildren of Atomic Veterans?
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ORGANIZATION AND FRAMEWORK OF THE REPORT no evaluate the feasibility of conducting an epidemiologic study of the families of Atomic Veterans, the committee felt it necessary to begin with a review of the fundamental principles of epidemiology, radiation biology, and genetics. This review is then followed by discussions of current information on the risk of genetic mutations due to environmental exposure, definitions and possible causes of adverse reproductive outcomes, the factors to be considered when determining the feasibility of a study, and finally, a review of possible alternative approaches for evaluating the health effects of exposure to low levels of ionizing radiation.
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The presence of so many causes of adverse reproductive outcomes makes it difficult to design an epidemiologically valid study and to know the cause of the health outcome in any particular person. The likelihood that genetic effects may be seen following exposure of the human male to ionizing radiation is an important factor in assessing the feasibility of studying adverse reproductive outcomes among Atomic Veterans and their families.
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Definition of the Study Sample Anecdotal information can be valuable in establishing the need for an epidemiologic study, but self-volunteered information is unlikely to provide a basis for reliable estimates of risk since experience shows that persons with a personal interest in an exposure to some hazard are more likely to respond Accordingly, a scientifically defensible and valid study of the effects of ionizing radiation on adverse reproductive outcomes depends on the availability of a representative sample of exposed veterans and their families, and the means to establish these outcomes without reference to whether they are normal or abnormal.
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In the first instance, to calculate the sample size required, the committee estimated what the maximum relative risk would be, given the data on the effects of ionizing radiation provided by animal and human studies. The maximum relative risk, for the purposes of determining sample size, was estimated to be 1.002 (0.2 percent increase in adverse health effects in the exposed population compared with the adverse health effects in an unexposed one)
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Roughly 90% of the Atomic Veterans have estimated doses below the extra background radiation received from living in Denver, CO, or in an area of similar altitude, compared to a more typical background area in the United States. Thus, without detailed residential histories the movement of these veterans in their post-service years could be an important confounder in the estimation of their cumulative doses.
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Each of these cohorts has strengths and limitations in sample size, population composition, adequate dose information, the presence of concurrent diseases, and the presence of confounding factors. The committee recognizes the real concerns of the Atomic Veterans as expressed by their representatives, but it must conclude that epidemiologic studies cannot adequately address these concerns.
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