OMB#: 0925-0216
Exp. 12/2007
Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0216). Do not return the completed form to this address.
OMB#: 0925-0216
Date
Mr. John Smith
XXXXXXXX
Framingham, MA 01702
Dear Mr. Smith:
Thank you for taking part in the CT scan examination at MGH West in Waltham, Ma.
This study would not be possible if it were not for your willingness to participate. Your involvement has taken us one step closer to finding answers regarding cardiovascular health.
Your coronary calcium score did not indicate any significant findings. This CT scan is designed for research purposes only, and as such, it may not detect clinically important abnormalities. Therefore, this scan should not be used instead of a clinical CT scan.
If you have any questions regarding this study, please do not hesitate to contact Barbara Inglese at (508) 935-3451.
Sincerely,
Christopher J. O’Donnell, M.D., MPH
Director, CT Study
Framingham Heart Study
Date
Mr. John Smith
XXXXXXXX
Framingham, MA 01702
Dear Mr. Smith:
Thank you for taking part in the CT scan examination at MGH West in Waltham, Ma.
We are sending the report of your CT scan to your physician. This CT scan is designed for research purposes only and is not as complete as a scan used for medical diagnosis. Therefore, this scan should not be used in place of a clinical CT scan. Because the Framingham Heart Study does not provide any clinical diagnosis or treatment, we recommend that you follow-up with your physician regarding the results of this report.
Again, thank-you for your participation. This study would not be possible if it were not for your willingness to participate. Your involvement has taken us one step closer to finding answers regarding cardiovascular health.
If you have any questions regarding this study, please do not hesitate to contact Barbara Inglese at (508) 935-3451.
Sincerely,
Christopher J. O’Donnell, M.D., MPH
Director, CT Study
Framingham Heart Study
Date
Mr. John Smith
XXXXXXXX
Framingham, MA 01702
Dear Mr. Smith:
Thank you for taking part in the CT scan examination at MGH West in Waltham, Ma.
A radiologist has reviewed your scan and has encountered a finding that may be important to you and your physician. We are sending the report of your CT scan to your physician. This CT scan is designed for research purposes only and is not as complete as a scan used for medical diagnosis. Therefore, this scan should not be used in place of a clinical CT scan. Because the Framingham Heart Study does not provide any clinical diagnosis or treatment, we recommend that you follow-up with your physician regarding the results of this report.
Again, thank-you for your participation. This study would not be possible if it were not for your willingness to participate. Your involvement has taken us one step closer to finding answers regarding cardiovascular health.
If you have any questions regarding this study, please do not hesitate to contact Barbara Inglese at (508) 935-3451.
Sincerely,
Christopher J. O’Donnell, M.D., MPH
Director, CT Study
Framingham Heart Study
February 27, 2003
John Doe, M.D.
73 Mt. Wayte Avenue
Framingham, MA 01701
Dear Dr. Doe:
Jane Doe, a patient of yours, is a participant at the Framingham Heart Study and recently underwent a test to screen for coronary calcium using a MultiDetector (spiral) Computed Tomography (CT) scanner at Massachusetts General Hospital West, Waltham, MA. This test was performed as part of a research study. Limited scans of the chest and abdomen were obtained. This letter is being sent to notify you of the coronary calcium score and of any clinically important incidental findings.
Your patient has an Agatston coronary calcium score of 51. Compared to available age and sex-adjusted distribution of coronary calcium, this score is considered:
[ ] High (greater than 90th percentile)
[ X] Not High (less than 90th percentile)
A high calcium score might be helpful in determining whether a patient is at an increased risk for coronary heart disease; conversely, a low calcium score might be helpful in determining whether a patient is a low risk for coronary heart disease. However, there is currently lack of consensus regarding the utility of the coronary calcium score, and it is not known whether the calcium score adds to the information provided by other measurements such as cholesterol and blood pressure in predicting future heart disease risk. More information regarding the most recent consensus guidelines for the use of this test can be found at: http://www.acc.org/clinical/consensus/electron/dirIndex.htm.
In the event that potentially important incidental findings were subsequently identified during a partial review of the CT scan, a report will be enclosed describing these findings.
Report Enclosed: [NO: ] [YES: X ] if yes, please review the enclosed report
The Framingham Heart Study is designed exclusively for epidemiologic research. However, we routinely send letters to a participant’s physician if he/she has a high calcium score or an important incidental finding, or if the participant requests that the results be sent. If you have any questions about this test, please direct inquiries to me via our CT Study Coordinator, Barbara Inglese at (508) 935-3451. We greatly appreciate your support of the Framingham Heart Study.
Sincerely,
Christopher J. O’Donnell, M.D., MPH
Director, CT Study
Framingham Heart Study
Cc: Thomas Brady, M.D.
Massachusetts General Hospital
Date of call ___/___/_____
Framingham Heart Study CT Scan Incidental Finding Follow-up Questionnaire_____
«scan_date» Date of CT Scan
«letter_date» Date of IF letter
«percent90»
|__|__|__| Interviewer ID.
Introductory script:
On __________ you underwent a CT scan examination for the Framingham Heart Study at MGH West in Waltham, MA. The Heart Study sent you and your physician a letter regarding a finding on the CT scan identified by a radiologist as part of the normal review of your scan. Most such findings were not dangerous however in some cases your doctor may have recommended additional testing. We are conducting a brief follow-up survey to determine the type of medical testing you may have undergone. We would also like to ask you a few questions about the letter you and your doctor received regarding the CT scan to better understand what difficulties you may have encountered as a result of participating in this study.
Is this a good time? if no, when would be a good time to call back?
Date: ___-___-____ Time: ___:___ am/pm
«C01»
«C02»
«C03»
«C04»
«C05»
«C06»
«C07»
«C08»
«C09»
«C10»
«C11»
«C12»
«C13»
«C14»
«C15»
«C16»
«C17»
«C18»
«C19»
«C20»
«C21»
«C22»
«C23»
«C24»
«C25»
1. Who is completing this form?
o Participant
o Spouse
o Other relative
o Other (write in relation to participant)
2. Do you remember receiving a letter after the scan?
o Yes
o No
o Unknown
If no or unknown, skip question 3.
3. When you received the letter regarding the CT scan findings, did you feel anxious or worried?
(read all responses)
o Not at all
o Mildly but it didn’t bother me much
o Moderately, it wasn’t pleasant
o Severely, it bothered me a lot
4. Did you and your doctor discuss the findings on the CT scan? (check all that apply)
oNo
oYes, phone contact
oYes, office visit
If yes, please specify the following:
Name of physician ______________________________________
Address of physician ______________________________________
Phone number of physician ______________________________________
5. Do you know the type of finding and its location (eg, “spot” or “abnormality” on the lung, liver, kidney)?
o No
o Yes, specify the type of finding and its location briefly:
_____________________________________________
If yes, did you know previously that the finding existed?
o No
o Yes
6. Were you referred to a specialist?
o No
o Yes
If yes, please specify for each specialist:
Type of specialist |
|
Name of specialist |
|
Address of specialist |
|
Phone number of specialist |
|
Type of specialist |
|
Name of specialist |
|
Address of specialist |
|
Phone number of specialist |
|
Type of specialist |
|
Name of specialist |
|
Address of specialist |
|
Phone number of specialist |
|
7. Please estimate the total number of office visits to any physician (primary care physician and specialists) to address the finding(s) on the CT Scan examination?
o No physician visits
o One visit
o More than one visit
8. Did you undergo any of the following tests for the finding on your CT scan? (read each test)
If yes obtain name and address of facility where testing was performed and date of test
YES |
NO |
PROCEDURE |
DATE |
FACILITY |
o |
o |
Ultrasound |
__-__-____ |
_____________________________________
|
o |
o |
CT scan |
__-__-____ |
_____________________________________
|
o |
o |
MRI scan |
__-__-____ |
_____________________________________
|
o |
o |
Endoscopy (look into GI tract) |
__-__-____ |
_____________________________________
|
o |
o |
Bronchoscopy (look into lungs) |
__-__-____ |
_____________________________________
|
o |
o |
Biopsy Specify site _____________________ |
__-__-____ |
_____________________________________
|
o |
o |
Angiogram (put “dye”/contrast in blood vessels) Specify site _____________________ |
__-__-____ |
_____________________________________
|
o |
o |
Other Write in name of test _____________________ |
__-__-____ |
_____________________________________
|
9. What special treatments did you undergo as a result of the finding on your CT scan?
YES |
NO |
o |
o |
if yes, Specify each specific surgery, surgery date, and hospital
SURGERY |
DATE |
HOSPITAL |
1. |
|
|
2. |
|
|
3. |
|
|
YES |
NO |
o |
o |
if yes list all medications
LIST OF MEDICATIONS |
1. |
2. |
3. |
4. |
10. If you discussed the CT scan findings further with your doctor and/or if your doctor recommended further testing, did you feel anxious or worried? (read all responses)
o Not at all
o Mildly but it didn’t bother me much
o Moderately, it wasn’t pleasant
o Severely, it bothered me a lot
11. Did the discovery of the CT scan finding and the evaluation by your physician require you to miss any of your full-time responsibilities (eg, work or care of your children)?
o No
o Yes, less than one day ( 0-8 hours) total
o Yes, 1-2 days
o Yes, > 2 days
12. Did you incur any financial costs related to the CT scan finding?
o No
o Yes
13. If you had further testing for the finding on the CT scan examination, please tell us the final medical diagnosis for the finding
write in _________________________________________
14. Do you have any comments about the CT examination you would like to share with the study investigators?
o No
o Yes
If yes write in _______________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
Thank you for completing this survey.
Version 10-14-2004 6 GM
| File Type | application/msword |
| File Title | Thank you Letter, No Abnormalities Noted |
| Author | Emily Manders |
| Last Modified By | Administrator |
| File Modified | 2007-12-11 |
| File Created | 2007-12-06 |