GuLFOMBattachment14normal

National Institute of Environmental Health Sciences (NIEHS)

Appendix P:

– Normal Values (Mailed Follow-up)

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GuLF Study - Post IRB
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National Institute of Environmental Health Sciences (NIEHS)

GuLF Study - Post IRB
11/3/2010

SAMPLE LETTER – NORMAL RESULTS
(Version 0.5)

«TITLE» «PARTICIPANT FIRST» «PARTICIPANT LAST»
«STREET ADDRESS 1»
«STREET ADDRESS 2»
«CITY», «STATE» «ZIP CODE»
«DATE»
Dear «TITLE» «PARTICIPANT LAST»:
On behalf of the entire GuLF Study team, I want to thank you for your dedication in
completing your telephone interview and home visit. We know that it took a considerable
amount of your time to do all of this and it is greatly appreciated.
As part of your participation in the GuLF Study, you met with «HVA name» on «date»
and completed a questionnaire and a number of clinical evaluations. Our records
indicate that all of your evaluation findings were normal. The enclosed report
summarizes your evaluation results and includes the results of your lung function test
«[IF IN BIOMEDICAL SUBCOHORT] and complete blood count», which were not
provided to you during your visit. These results were also normal.
If you have any questions about your results or need assistance with a referral for health
care, please call the study center toll-free at 1-855-NIH-GULF (1-855-644-4853).
As you know, the GuLF Study is a long-term study and we plan to keep in touch with you
for at least the next ten years.


We will send you newsletters each year with the latest updates on the study.
Keeping you posted on GuLF Study events and findings is important to us.



Every two years, we will ask you to complete a short telephone interview and
answer questions about your health and environment.



In the years between calls, we will contact you by mail to request updated
contact information.



ADDITIONAL TEXT FOR BIOMEDICAL SUB-COHORT: << You may also be
invited to participate in additional studies with our research partners. >>

Please keep in touch and visit our website at www.nihgulfstudy.org for news about the
GuLF Study. If you have any questions, please call us toll-free at 1-855-NIH-GULF (1-

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National Institute of Environmental Health Sciences (NIEHS)

GuLF Study - Post IRB
11/3/2010

855-644-4853). Our hours are Monday through Saturday (9am – 9pm) and Sunday
(12pm – 6pm) Eastern Time [TIME ADJUSTED TO LOCAL TIME ZONE].
Sincerely,

Dale Sander
Principal Investigator, GuLF Study
National Institute of Environmental Health Sciences
National Institutes of Health

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National Institute of Environmental Health Sciences (NIEHS)

GuLF Study - Post IRB
11/3/2010

SAMPLE REPORT OF FINDINGS

Date of Study Visit:
Name:
Age:
Gender:

«Date»
«Participant Name»
«Age»
«Gender»

Body Measurements
Height:

«feet, inches»

Weight:

«pounds»

Body Mass Index:

«BMI»

Advice:

Your BMI indicates that your weight is in the normal range for
adults of your height. Maintaining a healthy weight may reduce
the risk of chronic diseases associated with overweight and
obesity.
If height and/or weight were not measured, omit the standard
text and the results table. Display the following message:
Your BMI could not be calculated because we did not have
complete height and weight measurements from your home visit.

Blood Pressure
Measurement 1

Measurement 2

Measurement 3

Average

Systolic BP

«SBP»

«SBP»

«SBP»

«SBP»

Diastolic BP

«DBP»

«DBP»

«DBP»

«DBP»

Advice:
Your blood pressure
readings are (mm Hg)
Systolic BP <120 AND
Diastolic BP <80

This is
considered
Normal

You are advised to
Your Blood Pressure is within
normal limits. Talk to a health care
provider about healthy lifestyle
choices that you can take to
prevent high blood pressure.

If blood pressure was not measured, omit the standard text and the results table. Display
the following message:

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National Institute of Environmental Health Sciences (NIEHS)

GuLF Study - Post IRB
11/3/2010

Blood pressure measurements were not taken during your visit. Therefore, we cannot
provide you with meaningful results.
Urine glucose (sugar)
Results:
Recent symptoms of diabetes:

«No»

Previously diagnosed with diabetes:

«Yes/No»

Urine Glucose Result:

«Negative»

Advice: Your results are negative. No follow-up action is required.
Lung Function Test
Your Best Values

Predicted Values

% of Predicted

FVC (L)

«value»

«value»

«value»

FEV 1 (L)

«value»

«value»

«value»

FEV 1 / FVC (%)

«value»

«value»

«value»

The purpose of the pulmonary function test, also known as spirometry or lung function test,
is to determine how your lung function compares to normal lung function for someone of
your age, gender, race, and height. The table above provides your results for three
measurements.


The forced vital capacity (FVC) is the maximal or total amount of air you can
forcefully breathe out after taking a deep breath.



The 1-second forced expiratory volume (FEV 1 ) is the amount of air that you can
breathe out in the first second of exhaling.



The FEV 1 / FVC (%) is the calculation of the ratio of FEV 1 to FVC.

The table also compares your results to predicted values for a healthy, non-smoking person
of the same age, height, sex, and race.
Your results have been reviewed by an expert in lung function testing. Please note that
any abnormal test result is not a diagnosis of disease; that determination can only be
made a health care provider following a complete medical examination.
Interpretation: Your lung function test results were within normal limits.
If results could not be interpreted due to low quality:
Interpretation: Your lung function test results were not interpretable.

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National Institute of Environmental Health Sciences (NIEHS)

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11/3/2010

If lung function testing was expected, but not done, was expected, but not done, omit the
standard text and the results table. Display the following message:
A lung function test was not completed during your home visit.
If the test was not performed by the participant, omit the entire section.

Complete Blood Count

Result

Units

Flag

Normal Range

Hemoglobin

«value»

(g/dl)

«value» «value»

-

«value»

Hematocrit

«value»

(%)

«value» «value»

-

«value»

Platelet Count

«value»

(x109/L)

«value» «value»

-

«value»

Advice: Your results are normal. You are encouraged to share your results with your
health care provider at your next appointment.
If blood collection was expected, but not done, omit the standard text and the results
table. Display the following message:
A blood sample for the complete blood count was not collected during your visit.
If the participant is not in the biomedical sub-cohort, omit entire section.

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