SAIC will
prepare a summary report that provides a compilation of key findings from the
conduct of the AFHS and analysis of data collected for the AFHS. SAIC envisions that the report will have a
structure similar to the outline presented below:
Introduction
·
Background
·
History
·
Participation
statistics
·
Overview
of types and amount of data gathered and stored
·
Description
of the writing strategy
Historical Measures of Exposure
·
Group
·
Exposure
index
·
Dioxin
o
Extrapolated
to tour
o
Categorized
o
Measured
level
Results (to be arranged in order of
importance or amount of findings seen)
·
General
Health
·
Neoplasia
·
Neurology
·
Psychology
·
Gastrointestinal
·
Dermatology
·
Cardiovascular
·
Hematology
·
Renal
·
Endocrine
·
Immunology
·
Pulmonary
·
Reproductive
Outcomes.
Each of
the subsections under the Results section will include, where applicable,
findings from the baseline and follow-up reports, findings from journal
articles prepared by the U.S. Air Force, and findings from mortality studies
conducted by the U.S. Air Force.
The
results of the AFHS will also be compared to the Department of Veterans
Affairs’ Agent Orange Registry’s compensable conditions. For example, SAIC will provide information
on the number of AFHS veterans with non-Hodgkin’s lymphoma, a compensable condition
on the Agent Orange registry, under the description of results from the
Neoplasia clinical area.
Rather
than organizing the results by examination period, they will be organized
according to health endpoint within each of the clinical areas, with discussion
of trends, if present, across AFHS examinations. This organization will simplify the presentation of the findings.
SAIC will
gather the materials necessary to compose the summary report, which is
estimated to be approximately 50 pages long.
SAIC will work with U.S. Air Force technical staff to identify and
request necessary electronic documents or hard-copy reports. SAIC plans to submit a working outline of
the report to Air Force technical staff during the report writing process to
determine if all topics are being addressed in an appropriate manner.
The report shall be written in simple language in a
narrative format. No p-values or graphs
shall be used in this report. Only
statistically significant (p<.05) results from adjusted analyses shall be
discussed. The term “statistical
significance” or any variation thereof shall not be used. Negative results across an entire clinical
area shall be summarized in sweeping generalities, and isolated significant
results having no apparent interpretation shall not be mentioned or be
mentioned only briefly without emphasis.
Statistically significant increases or decreases shall be stated as
“increases” or “decreases.” Summary
statistics shall be used infrequently and, when used, shall include a 95% confidence
interval.
The
report will contain a list of references to indicate to the reader the
materials that have been used in the compilation of the report. To improve readability, SAIC suggests that
individual sentences not reference a citation, but rather that a list of all
citations to be provided as a stand-alone section.
SAIC is
assuming that the U.S. Air Force will provide a maximum of two sets of unified
comments for the report (unified across all Air Force reviewers). The draft report will be in Microsoft Word
and Portable Document File (PDF) formats.
SAIC will provide an initial draft, which will be followed by a first
set of comments by the U.S. Air Force.
SAIC will then prepare a revised draft, to be followed with a second set
of U.S. Air Force comments. After
resolution of the second set of comments, SAIC will submit a final report in
Microsoft Word and PDF formats once all comments are resolved.
SUGGESTED INSERTS TO THE 2002 AFHS STATEMENT OF WORK FOR THE
TASKS OUTLINED IN THE STATEMENT OF OBJECTIVES
3.8.1 Longitudinal Summary. The contractor shall prepare a summary report that describes
key aspects of the history of the AFHS.
The report shall include summaries of results from each of the six
physical examinations and journal articles co-authored by AFHS
investigators. The report shall be
written in simple language and in a narrative format.
3.8.1.1 The report shall include an
introduction section that describes the background of the AFHS. A description of historical measures of
exposure, including exposure group status, the exposure index that was used in
1982, 1985, and 1987, and the serum dioxin measures used in 1987, 1992, 1997,
and 2002, shall also be included.
3.8.1.2 The primary focus of the report
shall be twofold: (1) the results from
the analysis of data collected at the six physical examinations, and (2)
comparing the AFHS results with the Department of Veterans Affairs’ Agent
Orange Registry’s compensable conditions.
The analysis section shall include results from analysis reports and
journal articles written by the U.S. Air Force on the following topics or
areas: General Health, Neoplasia,
Neurology, Psychology, Gastrointestinal, Dermatology, Cardiovascular,
Hematology, Renal, Endocrine, Immunology, Pulmonary, and Reproductive
Outcomes. The report shall also contain
a list of references to indicate to the reader the materials that have been
used in the compilation of the report.
3.8.1.3 The report shall be written in
simple language in a narrative format.
No p-values or graphs shall be used in this report. Only statistically significant (p<.05)
results from adjusted analyses shall be discussed. The term “statistical significance” or any variation thereof
shall not be used. Negative results
across an entire clinical area shall be summarized in sweeping generalities,
and isolated significant results having no apparent interpretation shall not be
mentioned or be mentioned only briefly without emphasis. Statistically significant increases or
decreases shall be stated as “increases” or “decreases.” Summary statistics shall be used
infrequently and, when used, shall include a 95% confidence interval.
3.8.1.4 The U.S. Air Force shall furnish
papers, abstracts, reports, and other electronic documents as needed to
complete the overview report.
3.8.1.5 The contractor shall provide a
draft report to the U.S. Air Force in Microsoft Word and Portable Document File
(PDF) formats. The U.S. Air Force shall
make one unified set of written comments on the document, to which the
contractor will respond using a comment resolution sheet. The contractor shall submit a final report
in Microsoft Word and PDF formats once all comments are resolved. [INSERT CDRL
REFERENCE, INCLUDING TWO DRAFTS AND ONE FINAL]