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Coulter I, Hardy M, Shekelle P, et al. Effect of the Supplemental Use of Antioxidants Vitamin C, Vitamin E, and Coenzyme Q10 for the Prevention and Treatment of Cancer. Rockville (MD): Agency for Healthcare Research and Quality (US); 2003 Aug. (Evidence Reports/Technology Assessments, No. 75.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Effect of the Supplemental Use of Antioxidants Vitamin C, Vitamin E, and Coenzyme Q10 for the Prevention and Treatment of Cancer

Effect of the Supplemental Use of Antioxidants Vitamin C, Vitamin E, and Coenzyme Q10 for the Prevention and Treatment of Cancer.

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Appendix D

RAND EPC, CAM Project

Quality Review Form, Topic = ANTIOXIDANT

Article ID:____ Reviewer:________________

First Author: _______________________________________

(Last Name Only)

Study Number: ___of____Description:___________________

(Enter ‘1of 1’ if only one) (if more than one study)

1. Design: (Circle one)
RCT1
CCT2
Other3 (STOP)
(If not RCT or CCT, change study design on cover sheet and STOP)
2 What topic(s) does the study report on? (check all that apply)
Vitamin C
Vitamin E
Co-Q10
None of the above(STOP)
2. What condition(s) does the study report on? (circle one)
Cardiovascular1
Cancer2
Both3
None4 (STOP)
3. Is the study described as randomized? (circle one)
Yes1
No2
4. If the study was randomized, was method of randomization appropriate? (circle one)
Yes1
No2
Method not described8
Not applicable9
5. Is the study described as: (circle one)
Double blind1
Single blind, patient2
Single blind, outcome assessment3
Open4
Blinding not described8
Not applicable9
6. If reported, was the method of double blinding appropriate? (circle one)
Yes1
No2
Double blinding method not described8
Not applicable9
7. If study was randomized, did the method of randomization provide for concealment of allocation? (circle one)
Yes1
No2
Concealment not described8
Not applicable9
8. Are withdrawals (W) and dropouts (D) described? (circle one)
Yes, reason described for all W and D1
Yes, reason described for some W and D2
Not described8
Not applicable9
9. Is this a cross-over study design? (circle one)
Yes1
No2
Not described8
10. Does the study population include a purposefully selected group of individuals chosen because they have any of the following characteristics? (check all that apply)
Race:
African-American□ (01)
Asian□ (02)
Hispanic□ (03)
Gender:
Male□(04)
Female□ (05)
Age:
Children (under 18)□ (06)
Elderly (over 65)□ (07)
Miscellaneous:
Smokers□ (08)
Other:
(Enter code: ____ ____, ____ ____, ____ ___, ____ ____, ____ ____ )
None of the above□ (97)
11. Does the study population include a purposefully selected group of individuals chosen because they have any of the following comorbidities? (enter code or circle)
Code: ____ ____, ____ ____, ____ ___, ____ ____, ____ ____
Not applicable99
12. Does the study population include a purposefully selected group of individuals chosen because they have any of the following predisposing factors? (enter code or circle)
Code: ____ ____, ____ ____, ____ ___, ____ ____, ____ ____
Not applicable99
13. If this study is from a larger trial, please note the name of original trial. (circle one or enter code)
ADMT□ (01)
ATBC□ (02)
CGPPP□ (03)
CHAOS□ (04)
GISSI/GIZZI□ (05)
HOPE□ (06)
MRC/BHF□ (07)
PHS II□ (08)
SPACE□ (09)
SUVIMAX□ (10)
WHI□ (11)
WHS□ (12)
Code: ____ ____
Not from a larger trial□ (99)
Patient Characteristics - CARDIOVASCULAR
14. What type of cardiovascular disease did the study report on? (check all that apply and/or add code)
CADπ (01)
CVA/TIAρ (02)
PVDρ (03)
CHFρ (04)
Anginaρ (05)
Code: ____ ____
____ ____
____ ____
____ ____
Not Applicableρ (99)
15. What was the severity of the disease?
Enter code: ____ ____ (enter 99 if not applicable)
Patient Characteristics - CANCER
16. What type of cancer did the study report on? (check all that apply and/or add code)
Breastρ (01)
Lungρ (02)
Prostateρ (03)
Oralρ (04)
Cervixρ (05)
Gastricρ (06)
Colonρ (07)
Code: ____ ____
____ ____
____ ____
____ ____
Not Applicable99
17. What was the severity of the disease? (check all that apply and/or add code)
Pre-cancerousρ (01)
Localizedρ (02)
Metastaticρ (03)
Other code: ____ ____
Not Applicable99
If the study has a control/usual care arm, enter that data in arm 1. Otherwise, enter data for the groups in order of first mention.

Arm 1 of Description

18. What type of arm is this? (circle one)
Placebo1
Usual care2
Primary Antioxidant3
Other active treatment4
19. What was the sample size in this arm?
___ ___ ___ , ___ ___ ______ ___ ___ , ___ ___ ___
EnteringCompleting
(Enter 999,999 if not reported.)

20. Intervention

InterventionDaily DoseUnitsRoute of administrationDurationUnits
1 ______________________taken__________________________
2 ______________________taken__________________________
3 ______________________taken__________________________
4 ______________________taken__________________________
Enter codeEnter a number1. μg1. POEnter a number1. Hour8. Mean Year
2. mg2. IV2. Day9. Median Year
998. ND3. gm8. ND998. ND3. Week10. Maximum Month
999. NA4. IU9. NA999. NA4. Month11. Minimum Month
8. ND5. Year12. Maximum Year
9. NA6. Mean Month13. Minimum Year
7. Median Month98. ND
99. NA

Arm 2 of Description

18. What type of arm is this? (circle one)
Placebo1
Usual care2
Primary Antioxidant3
Other active treatment4
19. What was the sample size in this arm?
___ ___ ___ , ___ ___ ______ ___ ___ , ___ ___ ___
EnteringCompleting
(Enter 999,999 if not reported.)

20. Intervention

InterventionDaily DoseUnitsRoute of administrationDurationUnits
1 ______________________taken__________________________
2 ______________________taken__________________________
3 ______________________taken__________________________
4 ______________________taken__________________________
Enter codeEnter a number1. μg1. POEnter a number1. Hour8. Mean Year
2. mg2. IV2. Day9. Median Year
998. ND3. gm8. ND998. ND3. Week10. Maximum Month
999. NA4. IU9. NA999. NA4. Month11. Minimum Month
8. ND5. Year12. Maximum Year
9. NA6. Mean Month13. Minimum Year
7. Median Month98. ND
99. NA

Arm 3 of Description

18. What type of arm is this? (circle one)
Placebo1
Usual care2
Primary Antioxidant3
Other active treatment4
19. What was the sample size in this arm?
___ ___ ___ , ___ ___ ______ ___ ___ , ___ ___ ___
EnteringCompleting
(Enter 999,999 if not reported.)

20. Intervention

InterventionDaily DoseUnitsRoute of administrationDurationUnits
1 ______________________taken__________________________
2 ______________________taken__________________________
3 ______________________taken__________________________
4 ______________________taken__________________________
Enter codeEnter a number1. μg1. POEnter a number1. Hour8. Mean Year
2. mg2. IV2. Day9. Median Year
998. ND3. gm8. ND998. ND3. Week10. Maximum Month
999. NA4. IU9. NA999. NA4. Month11. Minimum Month
8. ND5. Year12. Maximum Year
9. NA6. Mean Month13. Minimum Year
7. Median Month98. ND
99. NA

Arm 4 of Description

18. What type of arm is this? (circle one)
Placebo1
Usual care2
Primary Antioxidant3
Other active treatment4
19. What was the sample size in this arm?
___ ___ ___ , ___ ___ ______ ___ ___ , ___ ___ ___
EnteringCompleting
(Enter 999,999 if not reported.)

20. Intervention

InterventionDaily DoseUnitsRoute of administrationDurationUnits
1 ______________________taken__________________________
2 ______________________taken__________________________
3 ______________________taken__________________________
4 ______________________taken__________________________
Enter codeEnter a number1. μg1. POEnter a number1. Hour8. Mean Year
2. mg2. IV2. Day9. Median Year
998. ND3. gm8. ND998. ND3. Week10. Maximum Month
999. NA4. IU9. NA999. NA4. Month11. Minimum Month
8. ND5. Year12. Maximum Year
9. NA6. Mean Month13. Minimum Year
7. Median Month98. ND
99. NA

Outcomes

21. Type of outcomes measured:

Enter the code for each outcome measured.
____ ____
____ ____
____ ____
____ ____
____ ____
____ ____
____ ____
____ ____
____ ____
____ ____
____ ____
____ ____

Evaluation

22. When, relative to the start of the intervention, were outcomes reported?

Enter the number and letters in the appropriate box

NumberUnit
1st follow-up
2nd follow-up
3rd follow-up
4th follow-up
5th follow-up
6th follow-up
Additional follow-ups:

Use the following abbreviations for units:

MIminute
HRhour
DYday
WKweek
MOmonth
YRyear
YRMNmean for year
YRMEmedian for year
YRMXmaximum for year
YRMIminimum for year
MOMNmean for month
MOMEmedian for month
MOMXmaximum for month
MOMIminimum for month
NDnot described
NAnot applicable
23. Is there a sub-group analysis? (circle one)
Yes1
No2
If yes, code_____ _____ _____ _____
_____ _____ _____ _____
_____ _____ _____ ____

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