Table 3.
Methodological quality score | ||||
---|---|---|---|---|
Domaina | Items | IMLB | DLd | MALd |
2 | Were the eligibility criteria specified? | 20/6/0 | 8/17/1 | |
4 | Was the study described as randomized b | 25/1 | ||
4 | Was a method of randomization performed? | 25/1/0 | 10/2/14 | |
4 | Was the method of randomization described and appropriate? c | 8/17/1 | ||
4 | Was the treatment allocation concealed? | 4/5/17 | 4/5/17 | |
5 | Were outcome measures relevant? | 25/1/0 | ||
5 | Was the timing of the outcome assessment in both groups comparable? | 24/1/1 | ||
7 | Were the experimental and control interventions explicitly described? | 25/1/0 | ||
8 | Were the groups similar at baseline regarding the most important prognostic indicators? | 17/3/6 | 5/4/17 | |
8 | Were point estimates and measures of variability presented for the primary outcome measures? | 20/6/0 | 20/6/0 | |
8 | Was the sample size of each group described? | 20/5/1 | ||
9 | Was there a description of withdrawals and/ dropouts?b | 16/10 | ||
9 | Was the withdrawal / drop-out rate described and acceptable? | 16/9/1 | ||
9 | Was a short-term follow-up measurement performed? | 22/4/0 | ||
9 | Was a long-term follow-up measurement performed? | 15/11/0 | ||
10 | Was the care provider blinded to the intervention? | 7/18/1 | 7/18/1 | |
10 | Was the patient blinded to the intervention? | 8/18/0 | 8/18/0 | |
10 | Was the outcome assessor blinded to the intervention? | 16/2/8 | 16/2/8 | |
10 | Was the study described as double blind?b | 8/18 | ||
10 | Was the method of blinding described and appropriate?c | 6/19/1 | ||
11 | Were co-interventions avoided or comparable? | 15/8/3 | ||
12 | Were adverse effects described? | 8/18/0 | ||
13 | Was the compliance acceptable in all groups? | 10/0/16 | ||
15 | Did the analysis include an intention-to-treat analysis? | 13/7/6 | 13/8/5 |
a Domains described in Table 2
b Number of Yes (1)/No (0) answers
c Number of Appropriate (1)/Nothing (0)/Inappropriate (−1) answers
d Number of Yes (1)/No (0)/Don’t know (0) answers