Appendix D

Ian Coulter; Mary Hardy; Paul Shekelle; Sally C Morton; Jay Udani; Myles Spar; Karen Oda; Lara K Jungvig; Wenli Tu; Roberta Shanman; Sydne Newberry; Louis R Ramirez; Di Valentine

This publication is provided for historical reference only and the information may be out of date.

Appendix D

Publication Details

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)

Table

Outcomes

21. Type of outcomes measured:

Table

Evaluation

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

Enter the number and letters in the appropriate box

Table

Use the following abbreviations for units:

Publication Details

Copyright

Publisher

Agency for Healthcare Research and Quality (US), Rockville (MD)

NLM Citation

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.) Appendix D.

1. Design: (Circle one)
RCT		1
CCT		2
Other		3 (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)
Cardiovascular		1
Cancer		2
Both		3
None		4 (STOP)
3. Is the study described as randomized? (circle one)
Yes		1
No		2
4. If the study was randomized, was method of randomization appropriate? (circle one)
Yes		1
No		2
Method not described		8
Not applicable		9
5. Is the study described as: (circle one)
Double blind		1
Single blind, patient		2
Single blind, outcome assessment		3
Open		4
Blinding not described		8
Not applicable		9
6. If reported, was the method of double blinding appropriate? (circle one)
Yes		1
No		2
Double blinding method not described		8
Not applicable		9
7. If study was randomized, did the method of randomization provide for concealment of allocation? (circle one)
Yes		1
No		2
Concealment not described		8
Not applicable		9
8. Are withdrawals (W) and dropouts (D) described? (circle one)
Yes, reason described for all W and D		1
Yes, reason described for some W and D		2
Not described		8
Not applicable		9
9. Is this a cross-over study design? (circle one)
Yes		1
No		2
Not described		8
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 applicable		99
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 applicable		99
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)
CAD		π (01)
CVA/TIA		ρ (02)
PVD		ρ (03)
CHF		ρ (04)
Angina		ρ (05)
Code: ____ ____
____ ____
____ ____
____ ____
Not Applicable		ρ (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)
Breast		ρ (01)
Lung		ρ (02)
Prostate		ρ (03)
Oral		ρ (04)
Cervix		ρ (05)
Gastric		ρ (06)
Colon		ρ (07)
Code: ____ ____
____ ____
____ ____
____ ____
Not Applicable		99
17. What was the severity of the disease? (check all that apply and/or add code)
Pre-cancerous		ρ (01)
Localized		ρ (02)
Metastatic		ρ (03)
Other code: ____ ____
Not Applicable		99
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)
Placebo	1
Usual care	2
Primary Antioxidant	3
Other active treatment	4
19. What was the sample size in this arm?
___ ___ ___ , ___ ___ ___	___ ___ ___ , ___ ___ ___
Entering	Completing
(Enter 999,999 if not reported.)

Intervention	Daily Dose	Units		Route of administration	Duration	Units
1 _______	_______	________	taken	_________	_________	________
2 _______	_______	________	taken	_________	_________	________
3 _______	_______	________	taken	_________	_________	________
4 _______	_______	________	taken	_________	_________	________
Enter code	Enter a number	1. μg		1. PO	Enter a number	1. Hour	8. Mean Year
		2. mg		2. IV		2. Day	9. Median Year
	998. ND	3. gm		8. ND	998. ND	3. Week	10. Maximum Month
	999. NA	4. IU		9. NA	999. NA	4. Month	11. Minimum Month
		8. ND				5. Year	12. Maximum Year
		9. NA				6. Mean Month	13. Minimum Year
						7. Median Month	98. ND
							99. NA

Arm 2 of Description

18. What type of arm is this? (circle one)
Placebo	1
Usual care	2
Primary Antioxidant	3
Other active treatment	4
19. What was the sample size in this arm?
___ ___ ___ , ___ ___ ___	___ ___ ___ , ___ ___ ___
Entering	Completing
(Enter 999,999 if not reported.)

Intervention	Daily Dose	Units		Route of administration	Duration	Units
1 _______	_______	________	taken	_________	_________	________
2 _______	_______	________	taken	_________	_________	________
3 _______	_______	________	taken	_________	_________	________
4 _______	_______	________	taken	_________	_________	________
Enter code	Enter a number	1. μg		1. PO	Enter a number	1. Hour	8. Mean Year
		2. mg		2. IV		2. Day	9. Median Year
	998. ND	3. gm		8. ND	998. ND	3. Week	10. Maximum Month
	999. NA	4. IU		9. NA	999. NA	4. Month	11. Minimum Month
		8. ND				5. Year	12. Maximum Year
		9. NA				6. Mean Month	13. Minimum Year
						7. Median Month	98. ND
							99. NA

Arm 3 of Description

18. What type of arm is this? (circle one)
Placebo	1
Usual care	2
Primary Antioxidant	3
Other active treatment	4
19. What was the sample size in this arm?
___ ___ ___ , ___ ___ ___	___ ___ ___ , ___ ___ ___
Entering	Completing
(Enter 999,999 if not reported.)

Intervention	Daily Dose	Units		Route of administration	Duration	Units
1 _______	_______	________	taken	_________	_________	________
2 _______	_______	________	taken	_________	_________	________
3 _______	_______	________	taken	_________	_________	________
4 _______	_______	________	taken	_________	_________	________
Enter code	Enter a number	1. μg		1. PO	Enter a number	1. Hour	8. Mean Year
		2. mg		2. IV		2. Day	9. Median Year
	998. ND	3. gm		8. ND	998. ND	3. Week	10. Maximum Month
	999. NA	4. IU		9. NA	999. NA	4. Month	11. Minimum Month
		8. ND				5. Year	12. Maximum Year
		9. NA				6. Mean Month	13. Minimum Year
						7. Median Month	98. ND
							99. NA

Arm 4 of Description

18. What type of arm is this? (circle one)
Placebo	1
Usual care	2
Primary Antioxidant	3
Other active treatment	4
19. What was the sample size in this arm?
___ ___ ___ , ___ ___ ___	___ ___ ___ , ___ ___ ___
Entering	Completing
(Enter 999,999 if not reported.)

Intervention	Daily Dose	Units		Route of administration	Duration	Units
1 _______	_______	________	taken	_________	_________	________
2 _______	_______	________	taken	_________	_________	________
3 _______	_______	________	taken	_________	_________	________
4 _______	_______	________	taken	_________	_________	________
Enter code	Enter a number	1. μg		1. PO	Enter a number	1. Hour	8. Mean Year
		2. mg		2. IV		2. Day	9. Median Year
	998. ND	3. gm		8. ND	998. ND	3. Week	10. Maximum Month
	999. NA	4. IU		9. NA	999. NA	4. Month	11. Minimum Month
		8. ND				5. Year	12. Maximum Year
		9. NA				6. Mean Month	13. Minimum Year
						7. Median Month	98. ND
							99. NA

Enter the code for each outcome measured.

____ ____

	Number	Unit
1^st follow-up

2^nd follow-up

3^rd follow-up

4^th follow-up

5^th follow-up

6^th follow-up

Additional follow-ups:

MI	minute
HR	hour
DY	day
WK	week
MO	month
YR	year
YRMN	mean for year
YRME	median for year
YRMX	maximum for year
YRMI	minimum for year
MOMN	mean for month
MOME	median for month
MOMX	maximum for month
MOMI	minimum for month
ND	not described
NA	not applicable

23. Is there a sub-group analysis? (circle one)
Yes	1
No	2
If yes, code	_____ _____ _____ _____
	_____ _____ _____ _____
	_____ _____ _____ ____