Table 4

 Scoring system

*1  =  partial information; †score range = 0, worst to 28, best.
1.Are the hypothesis/aims/objectives described?10
2.Are outcomes describes in the introduction or methods?10
3.Are the patient inclusion/exclusion criteria outlined?10
4.Is the intervention described?10
5.Are the age/weight/sex/disease characteristics recorded?2 (1)*0
6.Are the main findings in simple outcome data?10
7.Are there estimates of random variability?10
8.Is there measurement of adverse events?10
9.Are the characteristics of subjects lost to follow up described?10
10.Have actual probability values been reported?10
11.Is the source of the subject recruitment recorded?10
12.Is the proportion of subjects willing to participate recorded?10
13.Were the staff, places, and facilities representative?10
14.Are the study subjects “blinded”?10
15.Are those measuring the main outcome blinded?10
16.Are all the outcomes described in the results referenced in the introduction/methods?10
17.Are there adjustments for different lengths of follow up?10
18.Are the statistical tests appropriate?10
19.Is compliance with the intervention monitored?10
20.Were the outcome measures used clearly described?10
21.Are the patient characteristics similar between groups?10
22.Were the subjects recruited over the same time period?10
23.Were the study subjects randomised to intervention groups?10
24.Was the randomisation assignment concealed from subjects and staff?10
25.Was there an attempt to adjust for significant differences in subjects’ age/weight/sex/main disease characteristics between intervention groups?10
26.Were losses of subjects to follow up taken into account?10
27.Did the study calculate the number of subjects required to provide sufficient powers?10