Disposition of the Air Force Health Study Interim Letter Report (2006) / Chapter Skim
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Letter Report
Letter Report
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PURPOSE OF THE INTERIM LETTER REPORT The purpose of this interim letter report is to address a component of the charge that bears on the conduct of the Air Force Health Study in the time leading up to its scheduled termination date of September 30, 2006. Specifically, the committee applies the information it learned in a May 2005 site visit to the AFHS research facility to the question of "whether or not any obstacles exist to retaining and maintaining the medical records, other study data, and laboratory specimens" collected in the course of the study.
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These include paper originals of cycle physical exam reports and completed questionnaires; medical records from the subjects' physicians, dentists, and other health providers; X-rays and other diagnostic imagery; lists of medications taken; military administrative records such as duty station orders, flight records, performance reports, awards and decorations, and discharge documents; vital status records such as birth and death certificates; limited information on the subjects' spouse(s) and children; research reference materials; and the study's reports and papers.
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The AFHS investigators maintain what will be referred to in this report as master data files for each of the cycles that are used as the starting point for all analyses.2 Within a cycle, there are separate master files for various components of the cycle's data gathering effort: responses to questionnaires, results of particular physical exams, and the like. Data in these files are stored by case number.3 Working files are created from these masters and used for specific tasks.
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The AFHS investigators recently completed a physical inventory of all boxes in the repository and were able to locate all boxes listed in the database. To locate a particular box, one must refer to the hard copy list generated in the physical inventory to determine the current freezer and shelf location of a particular specimen.
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The committee concludes that the present state of the documentation and organization of the AFHS medical records, other study data, and laboratory specimens is an obstacle to retaining and maintaining these materials after the currently scheduled termination date of the study.
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is an example of such a document.7 · Create a comprehensive inventory of the variables contained in the master data files, organized by examination cycle and by questionnaire, physical examination report, or other data intake instrument. The Data Dictionary for Physical and Psychological Examination and Laboratory Data, Air Force Health Study, Cycle 6 (SAIC, 2003)
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Specific Recommendations Regarding Laboratory Specimens The committee recommends that the following actions regarding the documentation and reorganization of laboratory specimens take place before the currently scheduled termination date of the Air Force Health Study: · Reinventory all laboratory specimens held by the AFHS, verifying their location and ascertaining the number and volume of aliquots and type of sample. Carry out a visual inspection of specimen condition while performing this activity, and identify any problematic samples.
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· Document the status of all laboratory specimens sent to outside investigators. Ensure that extant specimens are either disposed of using current best practices or reintegrated into the inventory, clearly marked with their history.
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A total of $1,612,000 is assigned to these and other data analysis and support tasks.11 Whether or not existing funds are sufficient to accomplish the recommended actions, the committee believes that it is incumbent on the Air Force, as the custodian of the AFHS research materials, to insure their proper documentation and organization for both historic reasons and for possible future use. Therefore, should the available AFHS program funds not be sufficient to accomplish the actions elucidated above, the committee recommends that supplemental funding be provided to carry out such work in a complete and timely manner.
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2003. Data Dictionary for Physical and Psychological Examination and Laboratory Data Air Force Health Study, Cycle 6.
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