A. Selection bias |
Representativeness |
Somewhat likely |
Not likely |
Not likely |
Not likely |
Not likely |
Not likely |
Not likely |
Not likely |
Percentage agreed |
Can't tell |
Can't tell |
<60% |
Can't tell |
Can't tell |
<60% |
80–100% |
Can't tell |
Rating |
Moderate |
Weak |
Weak |
Weak |
Weak |
Weak |
Weak |
Weak |
B. Study design |
Study design type |
Cohort |
Cohort |
Other |
Cohort |
Other |
Other |
RCT |
RCT |
Described as randomized? |
No |
No |
No |
No |
N.a. |
No |
Yes |
Yes |
Method of randomization described? |
N.a. |
N.a. |
N.a. |
N.a. |
N.a. |
N.a. |
Yes |
Yes |
Method appropriate? |
N.a. |
N.a. |
N.a. |
N.a. |
N.a. |
N.a. |
Yes |
Yes |
Rating |
Moderate |
Moderate |
Weak |
Moderate |
Weak |
Weak |
Strong |
Strong |
C. Confounders |
Pre-intervention differences? |
Yes |
N.a. |
N.a. |
N.a. |
N.a. |
Yes |
Yes |
Yes |
Percentage confounders controlled for |
<60% (few or none) |
N.a. |
N.a. |
N.a. |
N.a. |
<60% (few or none) |
80–100% |
<60% (few or none) |
Rating |
Weak |
N.a. |
N.a. |
N.a. |
N.a. |
Weak |
Strong |
Weak |
D. Blinding |
Outcome assessors were blinded? |
No |
No |
No |
No |
Can't tell |
No |
No |
Yes |
Participants were blinded? |
Can't tell |
Can't tell |
Can't tell |
Can't tell |
Can't tell |
Can't tell |
Can't tell |
Yes |
Rating |
Weak |
Weak |
Weak |
Weak |
Weak |
Weak |
Weak |
Strong |
E. Data collection methods |
Valid measures? |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Reliable measures? |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Rating |
Strong |
Strong |
Strong |
Strong |
Strong |
Strong |
Strong |
Strong |
F. Withdrawals and dropouts |
Numbers and reasons reported per group? |
No |
No |
N.a. |
No |
Yes |
N.a. |
Yes |
No |
Percentage completing study? |
80–100% |
<60% |
N.a. |
80–100% |
80–100% |
N.a. |
80–100% |
<60% |
Rating |
Weak |
Weak |
N.a. |
Weak |
Strong |
N.a. |
Strong |
Weak |
Total A-F: |
WEAK |
WEAK |
WEAK |
WEAK |
WEAK |
WEAK |
WEAK |
WEAK |
Number of “strong” ratings |
1/6 |
1/6 |
1/6 |
1/6 |
2/6 |
1/6 |
4/6 |
3/6 |
G. Intervention integrity |
Percentage participants received intervention? |
80–100% |
80–100% |
80–100% |
80–100% |
80–100% |
80–100% |
80–100% |
60–79% |
Intervention consistency measured? |
Can't tell |
Can't tell |
Can't tell |
Can't tell |
Yes |
Can' tell |
Can't tell |
Yes |
Confounding unintended intervention? |
Can't tell |
Can't tell |
Can't tell |
Can't tell |
Can't tell |
Can't tell |
Can't tell |
Can't tell |
H. Analyses |
Unit of allocation |
Individual |
Individual |
Individual |
Individual |
Individual |
Individual |
Individual |
Individual |
Unit of analysis |
Individual |
Individual |
Individual |
Individual |
Individual |
Individual |
Individual |
Individual |
Appropriate statistical methods? |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Analysis by intention-to-treat status |
No |
No |
No |
No |
No |
No |
No |
Can't tell |