GuLFOMBattachment15abnormal

National Institute of Environmental Health Sciences (NIEHS)

Appendix Q:
Follow-up)

GuLF Study - Post IRB
11/3/2010

Report to Participant – Abnormal Values (Mailed

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National Institute of Environmental Health Sciences (NIEHS)

GuLF Study - Post IRB
11/3/2010

SAMPLE LETTER – ABNORMAL RESULTS
(Version 0.8)

«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 at least one of your evaluation findings was abnormal. The enclosed report
summarizes the evaluation findings and provides advice for following up on any
abnormal results. The summary report also 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. We encourage you to follow all the advice in the report,
if you have not done so already.
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). IF
REQUESTED THAT RESULTS BE SENT TO HEALTH CARE PROVIDER: <>
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
about your health and environment.

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National Institute of Environmental Health Sciences (NIEHS)

GuLF Study - Post IRB
11/3/2010



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(1855-644-4853). 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:

[CUSTOMIZED TO THE RESULTS OF THE PARTICIPANT]
If BMI is > 30:
Your BMI indicates that your weight is in the obese range for adults of
your height. People who are obese are at higher risk for chronic
conditions such as high blood pressure, diabetes, and high
cholesterol. You should talk to your health care provider about this
finding and any need for additional evaluation or consultation.

If BMI is between 25 and 29.9:
Your BMI indicates that your weight is in the overweight range for
adults of your height. People who are overweight may be at higher risk
for chronic conditions such as high blood pressure, diabetes, and high
cholesterol. You should talk to your health care provider about this
finding and any need for additional evaluation or consultation.

If BMI is between 18.5 and 24.9:
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 BMI is <18.5
Your BMI indicates that your weight is in the underweight category for
adults of your height. Talk with your health care provider to discuss
this finding and any need for additional evaluation or consultation.

If height and/or weight were not measured, omit the standard
text and the results table. Display the following message:
You BMI could not be calculated because we did not have complete
height and weight measurements from your home visit.

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National Institute of Environmental Health Sciences (NIEHS)

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 ≥ 180 OR
Diastolic BP ≥ 110

This is
considered
Emergency

Systolic BP 160 to 179 OR
Diastolic BP 100 to 109

Very High

Systolic BP 140 to 159 OR
Diastolic BP 90 to 99

Mildly to
Moderately
High

Systolic BP 120 to 139 OR
Diastolic BP 80 to 89

Slightly High

Systolic BP <120 AND
Diastolic BP <80

Normal

You are advised to
Call 911 or go to the emergency
department immediately.
Emergency Care Needed.
See a health care provider within
the next month to have your
blood pressure rechecked and
managed.
See a health care provider within
the next two months to have
your blood pressure rechecked
and managed.
Find out from a health care
provider if any additional
evaluations or lifestyle changes
are indicated.
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 measure, omit the standard text and the results table. Display
the following message:
Blood pressure measurements were not taken during your visit. Therefore, we cannot
provide you with meaningful results.

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National Institute of Environmental Health Sciences (NIEHS)

Urine glucose (sugar)
Results:
Recent symptoms of diabetes:

«Yes/No»

Previously diagnosed with diabetes:

«Yes/No»

Urine Glucose Result:

«0 to ≥ 2%»

Advice:
<>
This is
considered
Urgent

Of potential
concern

Normal

You are advised to
See a health care provider within
the next week to have your glucose
levels checked again
See a health care provider within
the next month to have your
glucose levels checked again or
sooner if symptoms should appear or
worsen
No follow-up action is required

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National Institute of Environmental Health Sciences (NIEHS)

Lung Function Test

Your Best Values

Predicted Values

Lower Limit of
Normal

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.
If FVC, FEV 1 , and FEV 1 / FVC are all above the lower limit of normal
Interpretation: Your lung function test results were within normal limits.
If either the FVC, FEV 1 , or FEV 1 / FVC are below the lower limit of normal and FEV 1 %
predicted is <50%:
Interpretation: Your lung function test results were interpreted as being abnormally low.
You are advised to see a health care provider as soon as possible, if you have not
done so already.
If either the FVC, FEV 1 , or FEV 1 / FVC are below the lower limit of normal and FEV 1 %
predicted is ≥ 50%:
Interpretation: Your lung function test results were interpreted as being abnormally low.
You are advised to see a health care within a month.

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11/3/2010

National Institute of Environmental Health Sciences (NIEHS)

If results could not be interpreted due to low quality:
Interpretation: Your lung function test results were not interpretable.
If lung function testing 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:
<>

ANALYTE

RESULTS

ADVICE

Hemoglobin

ALERT LEVEL

Your results should be
reviewed by a health care
provider as soon as possible.
You are advised to see you
health care provider within
one week of receiving your
results.

Males: <12; >20
Females: <10; >17

Results between alert level and
normal reference range

Your results are slightly out of
range. You are advised to see
you health care provider
within two months of
receiving your results.

Within lab normal reference range

Your results are normal. You
are encouraged to share your
results with your health care
provider at your net
appointment.

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GuLF Study - Post IRB
11/3/2010

National Institute of Environmental Health Sciences (NIEHS)

Hematocrit

ALERT LEVEL

Your results should be
reviewed by a health care
provider as soon as possible.
You are advised to see you
health care provider within
one week of receiving your
results.

Males <35; >53
Females <30; >50

Platelets

Results between alert level and
normal reference range

Your results are slightly out of
range. You are advised to see
you health care provider
within two months of
receiving your results.

Within lab normal reference range

Your results are normal. You
are encouraged to share your
results with your health care
provider at your net
appointment.

ALERT LEVEL

Your results should be
reviewed by a health care
provider as soon as possible.
You are advised to see you
health care provider within
one week of receiving your
results.

3

<50 x 10 ; >500 x 10

3

Results between alert level and
normal reference range

Your results are slightly out of
range. You are advised to see
you health care provider
within two months of
receiving your results.

Within lab normal reference range

Your results are normal. You
are encouraged to share your
results with your health care
provider at your net
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 home visit.
If the participant is not in the biomedical sub-cohort, omit entire section.

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