Table 2.
Controlled Trial |
Carissoli (2015) [16] |
David (2018) [17] |
Levin (2017) [18] |
Pham (2016) [19] |
Yang (2018) [20] |
Mohr (2017) [21] |
Ebert (2016) [22] |
Wylde (2017) [23] |
Bakker (2018) [24] |
Arean (2016) [25] |
Winslow (2016) [26] |
Lee (2018) [27] |
Flett (2019) [28] |
Hwang (2019) [29] |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1.1 The study addresses an appropriate and clearly focused question. | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | |
1.2 The assignment of subjects to treatment groups is randomized. | Y | NA | Y | Y | NA | Y | NA | Y | Y | Y | Y | Y | Y | |
1.3 An adequate concealment method is used. | CS | NA | Y | Y | NA | Y | NA | Y | Y | N | Y | Y | CS | |
1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation. | CS | NA | N | Y | NA | Y | NA | Y | Y | N | Y | Y | CS | |
1.5 The treatment and control groups are similar at the start of the trial | Y | * | Y | Y | NA | Y | Y | Y | Y | Y | Y | Y | Y | |
1.6 The only difference between groups is the treatment under investigation. | Y | NA | Y | Y | NA | Y | Y | Y | Y | Y | Y | Y | Y | |
1.7 All relevant outcomes are measured in a standard, valid, and reliable way. | N | Y | Y | Y | Y | Y | Y | Y | CS | Y | Y | Y | Y | |
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? | 0.0% | 7.1% | 0.0% | 6.8% | 5.7% | 0.4% | 0.0% | 35.8% | 55.4% (4 weeks) 64.3% (8 weeks) 69.7% (12 weeks) |
0.0% | 20.9% | 1.0% | 6.7% | |
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | |
1.10 Where the study is carried out at more than one site, results are comparable for all sites. | CS | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | |
Overall assessment of the study. | + | ++ | ++ | ++ | ++ | ++ | ++ | ++ | ++ | ++ | ++ |
Y = YES; N = No; CS = cannot say; NA = Not applied; * = intervention group.