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