Review of a Research Protocol Prepared by the University of Utah Letter Report (2002) / Chapter Skim
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It may also have less uncertainty in the dosimetry than Hanford because of the substantial number of external exposure measurements made in the study areas at the time of the Nevada Test Site nuclear detonations. The past performance of these investigators in locating and enlisting the participation of the study subjects in the previous cycle of this study was very good, which is important for minimizing selection bias.
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to test whether a healthy group of children, inadvertently exposed to radioactive iodine will have an increased number of thyroid neoplasms related to this exposure while controlling for other causes of thyroid cancer including medical x-rays ant! occupational radiation." Insufficient ant!
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close assignment model with information that has become available cluring the past 15 years, and to improve the treatment of uncertainty in the dose assignment moclel." Too little information is given in the protocol as to the close-assignment mocle] that has been or will be used, the information that has become available, and the methods proposed for treatment of uncertainty for the committee to determine attainability of this objective.
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Tracing such people who reside outside of the three-state area, especially women, after about 50 years will be clifficult. Furthermore, their participation in going to their local thyroid physicians in diverse locations might lead to greater attrition than that in the Utah-Nevacia-Arizona in-state screening program and may thereby be subject to greater self-selection bias, as well as to lack of uniformity in the thyroid screening procedures by the local physicians.
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. The investigators propose to augment the more highly exposed portion of the cohort from the targeted Utah and Nevada counties by searching state birth records to identify persons who were probably in the targeted} Utah and Nevacla counties cluring the peak fallout period but who emigrated from those states before the initial cohort definition in 1965.
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We recommend that the investigators lay out a protocol in detail that (lescribes how they will handle persons resicling outside the three-state area ant! that they explicitly consider the maintenance of consistency between those inside and those outside the three-state area, provide information on how the screening will be handiest for those residing outside the three-state area, and consider the financial aspects of this protocol.
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We also recommend that power calculations be performed for selected nonneoplastic thyroid diseases for which the background prevalence rates are much higher, e.g., autoimmune diseases. This would give a more realistic iciea of the likely statistical power of the stiffly.
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The main issue, then, to be addressed is the amount of new information that will be obtained in the update of the study. Formal power calculations should be done separately for the updated study, neglecting all the previously obtained data (so that follow-up of each subject only starting from the time of the previous examination up to the present exam, is consiclered)
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to be consistent with the study objectives and to reduce potential bias. · The infonnation provided on the number of people to be interviewed, the length of interview time, ant!
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, Professor Emeritus, Houston, TX BRUCE B BOECKER, Scientist Emeritus, Albuquerque, NM ANDRE BOUVILLE, National Cancer Institute, Bethesda, MD A
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D Assessment of Leukemia and Thyroid Disease in Relation to Fallout in Utah: Report of a Cohort Study of Thyroid Disease and Radioactive Fallout from the Nevada Test Site.
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