1 |
Hypothesis/aim/objective described? |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
Main outcomes to be measured described?1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
3 |
Characteristcs of patients described? |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
4 |
Interventions of interests clearly described? |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
5 |
Distributions of confounders described? |
2 |
2 |
2 |
1 |
2 |
0 |
2 |
0 |
2 |
2 |
6 |
Main findings clearly described? |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
7 |
Estimates of random variability in data? |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
8 |
Important adverse events reported? |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
Described patients lost to follow-up? |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
Actual probability values reported except where P values <.001? |
0 |
0 |
1 |
1 |
0 |
1 |
1 |
0 |
1 |
1 |
11 |
Subjects asked to participate representative of entire population? |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
1 |
1 |
12 |
Subjects prepared to participate representative of population? |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
1 |
1 |
13 |
“Staff, places, facilities representative of treatment majority of patients receive?” |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
14 |
Attempt made to blind subjects? |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
15 |
Attempt made to blind those measuring the outcomes to intervention? |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
16 |
“Any of the results based on “”data dredging,”” was this made clear?” |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
17 |
“Analysis adjust for different lengths of follow-up of patients, or is this time period between the intervention and outcome the same for cases and controls?” |
1 |
0 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
18 |
Statistical tests appropriate |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
0 |
1 |
19 |
Compliance with treatments reliable? |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
20 |
Outcomes measures valid/reliable? |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
21 |
Patients in intervention groups or cases and controls recruited from the same population? |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
22 |
Subjects in different intervention groups or cases and controls recruited over same time period? |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
23 |
Subjects randomized to groups? |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
24 |
Randomized assignments concealed until recruitment was complete? |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
25 |
Adjustment for confounding in analyses? |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
26 |
Losses to follow-up accounted for? |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
27 |
Sufficient power to detect clinically important effect where P value for differences due to chance is <5% |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
5 |
0 |
|
Total Score out of 32 |
16/32 |
15/32 |
19/32 |
17/32 |
16/32 |
21/32 |
18/32 |
15/32 |
23/32 |
22/32 |