Form (6A) - Page 1 of 3 (07-21-06)
Benefits of Repeat Back Within a Computer-Based Informed Consent Program
Consent Comprehension Questionnaire -
CE
FORM(6A)
1. Check the answer that best describes the surgery you will be having.
1 The blocked artery will be completely removed The surgeon will repair the lining of the carotid artery
A balloon will be blown up in the artery to clear out the blockage The blocked artery will be heated to melt away the fatty deposits Not Sure or Don’t know
2. Check the answer that most closely matches why you will be having the surgery:
Hardening or blockage of the artery to the brain Degenerative arthritis of the hip
Hardening or blockage of an artery in the heart Blockage of a vein in the chest
Not Sure or Don’t know
3. Check the answer that is the name of the surgery you will be having:
Hip arthroplasty
Carotid endarterectomy Radical prostatectomy
Laparoscopic cholecystectomy Not Sure or Don’t know
The study subject will complete this form at Visit “1”, after surgical informed consent is obtained.
2 3 4 9
1 2 3 4 9
1 2 3 4 9
Date:
Subject ID #:
Year Day
Month
2 0
Visit #:
Subject's Initials:
Form #: Record #:
1-6 7 8-9 10-11
12-19 20-22
6 A 0 1
2 3
2 4
2 5
Appendix 1A
Form (6A) - Page 2 of 3 (07-21-06)
4. If this surgery isn’t done, which of the following are alternative treatments for your condition?
(Check “Yes” if the item is an alternative treatment for your condition, check “No” if it is not an alternative. If you don’t know or are not sure, check “Don’t Know”).
a. Medication:
b. Radiation therapy:
c. Observation (wait and see):
d. Other surgical procedures:
e. Radiographic procedures using stents:
f. Physical therapy:
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
5. What are the main benefits of the surgery? (Check “Yes” if the item is a potential benefit of the surgery, check “No” if it is not a potential benefit. If you don’t know or are not sure, check Don’t Know”).
a. Prevention of heart attack:
b. Prevention of symptoms caused by inadequate blood supply:
c. Prevention of stroke:
d. Prevention of transient ischemic attack (TIA or mini-stroke):
e. Relief of pain:
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
1
1 1 1 1 1
2
2 2 2 2 2
9
9 9 9 9 9
1
1 1
1 1
2
2 2
2 2
9
9 9
9
9
Date:
Subject ID #:
Year Day
Month
2 0
Visit #:
Subject's Initials:
Form #: Record #:
1-6 7 8-9 10-11
12-19 20-22
6 A 0 1
2 6
2 7
2 8
2 9
3 0
3 1
3 2
3 3
3 4
3 5
3 6
Form (6A) - Page 3 of 3 (07-21-06)
6. Which of the following are possible complications of your surgery?
(Check “Yes” if the item is a possible complication of the surgery, check “No” if it is not a possible complication. If you don’t know or are not sure, check “Don’t Know”).
a. Urinary leakage:
b. Inadequate blood supply to the brain causing stroke:
c. Neck hematoma (collection of blood that forms a mass):
d. Infection:
e. Development of a hernia:
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
f. Cranial (head) nerve injury: Yes No Don’t Know
g. Gallstones: Yes No Don’t Know
h. Numbness to skin on neck and earlobe: Yes No Don’t Know
i. Fracture: Yes No Don’t Know
j. Problems with swallowing or hoarseness: Yes No Don’t Know
7. Do you know the name of the supervising surgeon for your surgery?
Yes No Not Sure or Don’t Know
8. Will other practitioners such as surgical residents or trainees be involved in your surgery?
Yes No Not Sure or Don’t Know
We would appreciate any comments you might have about the consent or about your surgery:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
1
1 1 1 1 1 1 1
1 1
2
2 2 2 2
2 2
2 2 2
9
9 9 9 9
9 9
9 9 9
1 2 9
1 2 9
Date:
Subject ID #:
Year Day
Month
2 0
Visit #:
Subject's Initials:
Form #: Record #:
1-6 7 8-9 10-11
12-19 20-22
6 A 0 1
3 7
3 8
3 9
4 0
4 1
4 2
4 3
4 4
4 5
4 7
4 8
4 6
Form (6B) - Page 1 of 3 (07-21-06)
Benefits of Repeat Back Within a Computer-Based Informed Consent Program
Consent Comprehension Questionnaire -
CHLY
FORM(6B)
A thin tube will be put into my abdomen through a small incision and my gall bladder will be removed A medicine will be put in my gall bladder to dissolve the gallstones
A scope will be put in my throat and passed down to the stomach so that the gall bladder can be removed
The gall bladder will be removed through a large incision in my abdomen Not Sure or Do Not Know
Inflamed liver
Symptomatic gallstones or an infected gall bladder Kidney stones or inflamed kidneys
Inflamed pancreas
Not Sure or Do Not Know
Laparoscopic cholecystectomy Hysterectomy
Appendectomy Colectomy
Not Sure or Do Not Know
1. Check the answer that best describes the surgery you will be having.
2. Check the answer that most closely matches why you will be having the surgery:
3. Check the answer that is the name of the surgery you will be having:
The study subject will complete this form at Visit “1”, after surgical informed consent is obtained.
1 2
3 4 9
1 2 3 4 9
1 2 3 4 9
Date:
Subject ID #:
Year Day
Month
2 0
Visit #:
Subject's Initials:
Form #: Record #:
1-6 7 8-9 10-11
12-19 20-22
6 B 0 1
2 3
2 4
2 5
Appendix 1B
Form (6B) - Page 2 of 3 (07-21-06)
4. If this surgery isn’t done, which of the following are alternative treatments for your condition?
(Check “Yes” if the item is an alternative treatment for your condition, check “No” if it is not an alternative. If you don’t know or are not sure, check “Don’t Know”).
a. Medication:
b. Use of an “open” non-laparoscopic surgical approach:
c. Observation:
d. Radiation therapy:
e. Physical therapy:
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
5. What are the main benefits of the surgery? (Check “Yes” if the item is a potential benefit of the surgery, check “No” if it is not a potential benefit. If you don’t know or are not sure, check Don’t Know”).
a. Relief and prevention of infection:
b. Relief and prevention of inflammation:
c. Relief and prevention of cirrhosis:
d. Relief and prevention of blockages of gall bladder or bile ducts:
e. Relief and prevention of pain:
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
f. Relief and prevention of liver cancer: Yes No Don’t Know
1
1 1 1 1
2
2 2 2 2
9
9 9 9 9
1
1 1
1 1 1
2
2 2 2
2 2
9
9 9 9
9 9
Date:
Subject ID #:
Year Day
Month
2 0
Visit #:
Subject's Initials:
Form #: Record #:
1-6 7 8-9 10-11
12-19 20-22
6 B 0 1
2 6
2 7
2 8
2 9
3 0
3 1
3 2
3 3
3 4
3 5
3 6
Form (6B) - Page 3 of 3 (07-21-06)
7. Do you know the name of the supervising surgeon for your surgery?
Yes No Not Sure or Don’t Know
8. Will other practitioners such as surgical residents or trainees be involved in your surgery?
Yes No Not Sure or Don’t Know
We would appreciate any comments you might have about the consent or about your surgery:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
1 2 9
1 2 9
Date:
Subject ID #:
Year Day
Month
2 0
Visit #:
Subject's Initials:
Form #: Record #:
1-6 7 8-9 10-11
12-19 20-22
6 B 0 1
4 7
4 8
6. Which of the following are possible complications of your surgery you will be having?
(Check “Yes” if the item is a possible complication of the surgery, check “No” if it is not a possible complication. If you don’t know or are not sure, check “Don’t Know”).
a. Infection of incision:
b. Blood clots:
c. Injury to the common bile duct, pancreas or bowel:
d. Hernia formation at the incision:
e. Inadequate blood supply to the brain causing stroke:
f. Fracture:
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
g. Leakage of bile from bile ducts or liver: Yes No Don’t Know
h. Cranial (head) nerve injury: Yes No Don’t Know
i. Urinary leakage: Yes No Don’t Know
j. Need for “open” non-laparoscopic surgery: Yes No Don’t Know
1
1 1 1 1
1 1 1
1 1
2 2 2 2 2 2
2 2 2 2
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9 9 9 9 3 7
3 8
3 9
4 0
4 1
4 2
4 3
4 4
4 5
4 6
Form (6D) - Page 1 of 3 (07-21-06)
Benefits of Repeat Back Within a Computer-Based Informed Consent Program
Consent Comprehension Questionnaire -
TP
FORM(6D)
The prostate will be shrunk down by using microwave
The prostate will be removed using a tube placed into the opening in the penis The prostate will be removed using a tube placed into my rectum
The prostate will be removed through an incision Not Sure or Do Not Know
Penile cancer Prostate cancer
Obstruction of the bladder
Hardening or blockage of an artery in the chest Not Sure or Do Not Know
Radical mastectomy Total hysterectomy
Total hip arthroplasty Not Sure or Do Not Know Radical prostatectomy
1. Check the answer that best describes the surgery you will be having.
2. Check the answer that most closely matches why you will be having the surgery:
3. Check the answer that is the name of the surgery you will be having:
The study subject will complete this form at Visit “1”, after surgical informed consent is obtained.
1 2 3 4 9
1 2 3 4 9
1 2 3 4 9
20-22
Date:
Subject ID #:
Year Day
Month
2 0
Visit #:
Subject's Initials:
Form #: Record #:
1-6 7 8-9 10-11
12-19
6 D 0 1
2 3
2 4
2 5
Appendix 1C
Form (6D) - Page 2 of 3 (07-21-06)
4. If this surgery isn’t done, which of the following are alternative treatments for your condition?
(Check “Yes” if the item is an alternative treatment for your condition, check “No” if it is not an alternative. If you don’t know or are not sure, check “Don’t Know”).
a. Radiation therapy:
d. Suppression or removal of male hormones:
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
5. What are the main benefits of the surgery? (Check “Yes” if the item is a potential benefit of the surgery, check “No” if it is not a potential benefit. If you don’t know or are not sure, check Don’t Know”).
a. Remove the tumor:
b. Delay progression of the cancer:
c. Cure the cancer:
d. Prevent cancer:
e. Cure biliary problems:
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
e. Other surgical approaches:
b. Radioactive implants:
c. Vasectomy:
f. Observation (wait and see): Yes No Don’t Know
Yes No Don’t Know
g. Physical therapy:
h. Chemotherapy: Yes No Don’t Know
1
1 1 1 1 1 1 1
2
2 2 2 2 2 2 2
9
9 9 9 9 9 9 9
1 1 1 1 1
2 2 2 2 2
9 9 9 9 9 20-22
Date:
Subject ID #:
Year Day
Month
2 0
Visit #:
Subject's Initials:
Form #: Record #:
1-6 7 8-9 10-11
12-19
6 D 0 1
2 6
2 7
2 8
2 9
3 0
3 1
3 2
3 3
3 4
3 5
3 6
3 7
3 8
Form (6D) - Page 3 of 3 (07-21-06)
7. Do you know the name of the supervising surgeon for your surgery?
Yes No Not Sure or Don’t Know
8. Will other practitioners such as surgical residents or trainees be involved in your surgery?
Yes No Not Sure or Don’t Know
We would appreciate any comments you might have about the consent or about your surgery:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
6. Which of the following are possible complications of your surgery? (Check “Yes” if the item is a possible complication of the surgery, check “No” if it is not a possible complication. If you don’t know or are not sure, check “Don’t Know”).
a. Impotence (inability to achieve adequate erections):
i. Infection of surgical incision:
c. Loss of urinary control (incontinence):
d. Narrowing of the bladder or urethra requiring a catheter:
f. Gallstones:
g. No guarantee of cancer cure:
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
e. Blood clots:
Yes No Don’t Know
h. Cranial (head) nerve injury: Yes No Don’t Know
b. Problem with swallowing and hoarseness:
Yes No Don’t Know
j. Fractures: Yes No Don’t Know
1 2 9
1 2 9
1 1
1 1 1 1
1 1 1
1 2
2 2
2 2 2 2
2 2 2
9 9 9
9 9
9 9
9 9 9 20-22
Date:
Subject ID #:
Year Day
Month
2 0
Visit #:
Subject's Initials:
Form #: Record #:
1-6 7 8-9 10-11
12-19
6 D 0 1
3 9
4 0
4 1
4 2
4 3
4 4
4 5
4 6
4 7
4 8
4 9
5 0
Form (6C) - Page 1 of 3 (07-21-06)
Benefits of Repeat Back Within a Computer-Based Informed Consent Program
Consent Comprehension Questionnaire -
THA
FORM(6C)
Surgical replacement of the ball and socket of the hip with metal and plastic components The hip joint will be rebuilt using my own bone
The entire upper leg bone will be replaced with plastic
The bone in my hip joint will be smoothed off and new cartilage will be put in Not Sure or Do Not Know
Osteoporosis
Hardening of the artery in the leg Degenerative joint disease Degenerative biliary disease Not Sure or Do Not Know
Laparoscopic cholecystectomy Total hip arthroplasty
Carotid endarterectomy Not Sure or Do Not Know Total knee arthroplasty
3. Check the answer that is the name of the surgery you will be having:
2. Check the answer that most closely matches why you will be having the surgery:
1. Check the answer that best describes the surgery you will be having.
The study subject will complete this form at Visit “1”, after surgical informed consent is obtained.
1 2 3 4 9
1 2 3 4 9
1 2 3 4 9
20-22
Date:
Subject ID #:
Year Day
Month
2 0
Visit #:
Subject's Initials:
Form #: Record #:
1-6 7 8-9 10-11
12-19
6 C 0 1
2 3
2 4
2 5
Appendix 1D
Form (6C) - Page 2 of 3 (07-21-06)
4. If this surgery isn’t done, which of the following are alternative treatments for your condition?
(Check “Yes” if the item is an alternative treatment for your condition, check “No” if it is not an alternative. If you don’t know or are not sure, check “Don’t Know”).
a. Chemotherapy:
b. Observation (wait and see):
d. Radiation therapy:
c. Other surgical procedures:
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
5. What are the main benefits of the surgery? (Check “Yes” if the item is a potential benefit of the surgery, check “No” if it is not a potential benefit. If you don’t know or are not sure, check Don’t Know”).
a. Relieve or decrease pain:
b. Prevention of arthritis:
c. Relief of biliary problems:
d. Prevention of heart attack:
e. Better able to walk:
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
e. Medication:
1
1 1 1 1
1 1
1 1 1
2
2 2 2 2
2 2 2
2 2
9
9 9 9 9 9
9 9 9 9
Date:
Subject ID #:
Year Day
Month
2 0
Visit #:
Subject's Initials:
Form #: Record #:
1-6 7 8-9 10-11
12-19
6 C 0 1
20-22
2 6
2 7
2 8
2 9
3 0
3 1
3 2
3 3
3 4
3 5
Form (6C) - Page 3 of 3 (07-21-06)
7. Do you know the name of the supervising surgeon for your surgery?
Yes No Not Sure or Don’t Know
8. Will other practitioners such as surgical residents or trainees be involved in your surgery?
Yes No Not Sure or Don’t Know
We would appreciate any comments you might have about the consent or about your surgery:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
1 2 9
1 2 9
6. Which of the following are possible complications of this surgery? (Check “Yes” if the item is a possible complication of the surgery, check “No” if it is not a possible complication. If you don’t know or are not sure, check “Don’t Know”).
a. Infection:
i. May not recover normal functions:
c. Nerve or blood vessel injury with possible excessive bleeding:
d. Temporary or permanent numbness or weakness of the leg:
e. Gallstones:
f. Development of hernia:
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
Yes No Don’t Know
g. Blood clots: Yes No Don’t Know
j. Cranial (head) nerve injury:
Yes No Don’t Know
b. Urinary leakage:
Yes No Don’t Know
h. May still have pain:
Yes No Don’t Know
1
1
1 1 1 1
1 1 1
1 2
2
2
2 2 2 2 2 2 2
9 9
9
9 9
9 9
9 9 9
Date:
Subject ID #:
Year Day
Month
2 0
Visit #:
Subject's Initials:
Form #: Record #:
1-6 7 8-9 10-11
12-19
6 C 0 1
20-22
3 6
3 7
3 8
3 9
4 0
4 1
4 2
4 3
4 4
4 5
4 6
4 7
