1. Was there clear concealment of allocation? |
3 |
1 |
3 |
1 |
1 |
1 |
0 |
3 |
3 |
0 |
1 |
3 |
1 |
2. Were the inclusion and exclusion criteria clearly defined? |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
3. Were the outcomes of trial participants who withdrew or excluded after allocation described and included in an intention-to-treat analysis? |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
4. Were the treatment and control groups adequately described at entry, and if so were the groups well matched or appropriate covariate adjustment made? |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
5.Were the healthcare workers/ surgeons experienced in both interventions prior to the start of the trials? |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
1 |
0 |
1 |
0 |
6. Were the care programs other than trial options identical? |
1 |
1 |
0 |
1 |
1 |
0 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
7.Were the outcome measures clearly defined in the text with a definition of any ambiguous terms encountered? |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
8. Were the outcome assessors blind to assignment status? |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
9. Was the timing of outcome measures appropriate? |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
10.Was followup active with the trial participants being called back or approached for assessment at set times or passive? |
0 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
0 |
1 |
0 |
1 |
1 |
11.Was loss to followup reported, and if so were less than 5% of trial participants lost to followup? |
0 |
0 |
0 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
12.Were the authors able to provide supplementary details of the trial in addition to published data? |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Total |
11 |
9 |
8 |
10 |
7 |
7 |
11 |
12 |
11 |
7 |
5 |
10 |
10 |