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3 Data and Methods for the SHAD II Study
Pages 59-72

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From page 59...
... attempting to refine the assessment of individuals' potential exposures to specific substances; and (3) obtaining information about health outcomes for members of the study population from records of health care services received between 1999 and 2011, as reflected in Medicare databases of the Centers for Medicare & Medicaid Services (CMS)
From page 60...
... and may be based on indirect markers of exposure such as time spent in a particular job assignment. Because the SHAD tests were generally designed to assess physical penetration of ship spaces by the test substances, or the effectiveness of protective gear, information on human exposure was not systematically collected.
From page 61...
... Zinc cadmium sulfide Tracer Chronic kidney disease Lung cancer a Because the individuals who served on the vessels involved in testing staphylococcal enterotoxin type B were not identified, the committee could not test the hypotheses generated for this agent. exposure groups were defined: Group A for simulants Bacillus globigii (BG)
From page 62...
... The SHAD I study sought to maximize the comparability of the comparison group by selecting military personnel from comparable ships or Marine Corps units that were serving at the same time as the units that participated in the SHAD tests. Use of this comparison population counters the concerns that might
From page 63...
... The IOM staff independently reviewed the quarterly unit rosters (BuPers Report 1080-14) as well as the daily personnel diaries for each ship in each test to compile lists of personnel present on the vessels involved in Project SHAD tests.
From page 64...
... ASSESSING EXPOSURE The SHAD tests involved at least 19 different vessels and 7 Marine Corps units in 21 tests that used at least 16 different test substances (alone or in combination) over a period of 7 years.
From page 65...
... Because the nature of the tests varied widely, the nature of SHAD veterans' potential exposures also vary. Information about the substances used in the SHAD tests -- active agents, simulants, tracers, and decontaminants -- was available to the committee from three sources.
From page 66...
... Because of its role, care was taken to keep the ship upwind from the tests specifically to avoid exposure to the test substances. The ship's regular crew was supplemented by identified members of the Project SHAD technical staff.
From page 67...
... For analyses that addressed specific forms of exposure, the Project SHAD technical staff was considered as potentially exposed and the members of the regular crew were excluded as unexposed. Accounting for Trials as Well as Tests Through a detailed review of the available documentation on each test, the study staff compiled information on the dates of the trials in each test, the test substances used for each trial, the equipment and patterns used to disperse test substances, and the ships or other units participating in the trial.
From page 68...
... A comparison of the SHAD study population with the VBA records and Lexis/Nexis led to ascertainment of 1,347 new deaths since the final ascertainment for the SHAD I study. 5 The declassified portions of the SHAD II reports are publicly available from the DoD Freedom of Information Act (FOIA)
From page 69...
... Each state has its own procedures and requirements for processing such requests. Because place of death is not reliably recorded in the records on the members of the study population from VA and DoD, the IOM staff supplemented information on residence and claims processing from VA and DoD records with searches of electronic death indexes maintained by some states and of other online genealogic resources.
From page 70...
... Second, the data do not include information about care provided by Medicare Managed Care enrollees. Medicare data contain information only about conditions for which diagnoses have been recorded as part of a health care claim.
From page 71...
... or R software. The principal analyses were Kaplan-Meier survival analyses and Cox proportional hazards regression analyses for mortality, and logistic regression, Fisher's exact tests, and Wilcoxon rank-sum tests for indicators of morbidity, including median hospital days.
From page 72...
... 2010. National survey of veterans, active duty service members, demobilized National Guard and reserve members, family members, and surviving spouses.


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