Was the assigned treatment adequately concealed prior to allocation? |
2 |
1 |
2 |
2 |
A clearly stated aim |
Were the outcomes of participants who withdrew described and included in the analysis? |
0 |
2 |
1 |
1 |
Inclusion of consecutive patients |
Were the outcome assessors blinded to treatment status? |
2 |
0 |
0 |
0 |
Prospective data collection |
Were the treatment and control group comparable at entry? |
2 |
2 |
1 |
2 |
Endpoints appropriate to the aim of the study |
Were the participants blind to assignment status after allocation? |
0 |
0 |
1 |
2 |
Unbiased assessment of the study endpoint |
Were the treatment providers blind to assignment status? |
0 |
0 |
2 |
2 |
A follow-up period appropriate to the aims of the study |
Were care programmes, other than the trial options, identical? |
2 |
2 |
2 |
2 |
Less than 5 % loss to follow-up |
Were the inclusion and exclusion criteria clearly defined? |
2 |
2 |
0 |
0 |
Prospective calculation of the sample size |
Were the interventions clearly defined? |
2 |
2 |
2 |
2 |
Prospective calculation of the sample size |
Were the outcome measures used clearly defined? |
2 |
2 |
1 |
2 |
An adequate control group |
Were diagnostic tests used in outcome assessment clinically useful? |
2 |
2 |
2 |
1 |
Baseline equivalence of groups |
Was the surveillance active, and of clinically appropriate duration? |
2 |
2 |
2 |
2 |
Adequate statistical analyses |