A clearly stated aim
|
1 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
Inclusion of consecutive patients
|
2 |
2 |
2 |
0 |
0 |
2 |
2 |
2 |
2 |
2 |
2 |
Prospective collection of data
|
1 |
1 |
0 |
0 |
2 |
2 |
0 |
1 |
1 |
0 |
1 |
Endpoints appropriate to the aim of the study
|
2 |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
2 |
2 |
2 |
Unbiased assessment of study endpoint
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Follow-up period appropriate to the aim of the study
|
0 |
0 |
2 |
2 |
2 |
0 |
2 |
2 |
1 |
0 |
2 |
Loss to follow-up less than 5%
|
0 |
0 |
1 |
2 |
1 |
0 |
2 |
2 |
0 |
0 |
0 |
Prospective calculation of the study size
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Additional items in the case of comparative study
|
|
|
|
|
|
|
|
An adequate control group
|
2 |
2 |
|
|
2 |
2 |
|
2 |
|
2 |
Contemporary groups
|
2 |
2 |
|
|
2 |
2 |
|
1 |
|
2 |
Baseline equivalence of groups
|
1 |
1 |
|
|
1 |
1 |
|
1 |
|
1 |
Adequate statistical analyses
|
1 |
2 |
|
|
1 |
1 |
|
2 |
|
2 |