Table 4

Scoring system

No	Items	Score		Total†
No	Items	Yes	No	Total†
*1 = partial information; †score range = 0, worst to 28, best.
1.	Are the hypothesis/aims/objectives described?	1	0
2.	Are outcomes describes in the introduction or methods?	1	0
3.	Are the patient inclusion/exclusion criteria outlined?	1	0
4.	Is the intervention described?	1	0
5.	Are the age/weight/sex/disease characteristics recorded?	2 (1)*	0
6.	Are the main findings in simple outcome data?	1	0
7.	Are there estimates of random variability?	1	0
8.	Is there measurement of adverse events?	1	0
9.	Are the characteristics of subjects lost to follow up described?	1	0
10.	Have actual probability values been reported?	1	0
11.	Is the source of the subject recruitment recorded?	1	0
12.	Is the proportion of subjects willing to participate recorded?	1	0
13.	Were the staff, places, and facilities representative?	1	0
14.	Are the study subjects “blinded”?	1	0
15.	Are those measuring the main outcome blinded?	1	0
16.	Are all the outcomes described in the results referenced in the introduction/methods?	1	0
17.	Are there adjustments for different lengths of follow up?	1	0
18.	Are the statistical tests appropriate?	1	0
19.	Is compliance with the intervention monitored?	1	0
20.	Were the outcome measures used clearly described?	1	0
21.	Are the patient characteristics similar between groups?	1	0
22.	Were the subjects recruited over the same time period?	1	0
23.	Were the study subjects randomised to intervention groups?	1	0
24.	Was the randomisation assignment concealed from subjects and staff?	1	0
25.	Was there an attempt to adjust for significant differences in subjects’ age/weight/sex/main disease characteristics between intervention groups?	1	0
26.	Were losses of subjects to follow up taken into account?	1	0
27.	Did the study calculate the number of subjects required to provide sufficient powers?	1	0