Table 2.
Clarity and quality of the included studies
| Study | Cheskes et al. [ 16 ] | Dib et al. [ 27 ] | Ducros et al. [ 30 ] | Frontin et al. [ 28 ] | Gardtman et al. [ 22 ] | Garuti et al. [ 25 ] | Hubble et al. [ 24 ] | Thompson et al. [ 23 ] | Craven et al. [ 29 ] | Roessler et al. [ 20 ] | Schmiedbauer et al. [ 21 ] | Weitz et al. [ 26 ] |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1.1 The study addresses an appropriate and clearly focused question | •••• | •• | •••• | •••• | ••• | •••• | •••• | •••• | •••• | •••• | •• | ••• |
| 1.2 The assignment of subjects to treatment groups randomised | NA | NA | ••• | •••• | NA | NA | NA | ••• | NA | •••• | •••• | ••• |
| 1.3 An adequate concealment method is used | NA | NA | • | •••• | NA | NA | NA | •••• | NA | •••• | •••• | • |
| 1.4 Subjects and investigators are kept ‘blind’ to treatment allocation | NA | NA | •• | ••• | NA | NA | NA | ••• | NA | • | • | • |
| 1.5 The treatment and control groups were similar at the start of the trial | ••• | •• | •••• | •••• | ••• | •• | •• | ••• | •• | •••• | ••• | •• |
| 1.6 The only difference between the groups is the treatment under investigation | ••• | •• | •••• | •••• | •• | •• | •• | ••• | ••• | •• | •••• | •• |
| 1.7 All relevant outcomes measured in a standard, valid and reliable way | •••• | ••• | ••• | ••• | •• | ••• | ••• | •••• | •••• | ••• | ••• | ••• |
| 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? | 00 | 4/14911/238 | 11/10713/100 | 0/622/62 | 00 | NRNR | 10/12024/95 | 1/351/36 | 9/71 in total | 2/51 in total | 1/18 0/18 | 0/13 0/10 |
| 1.9 All the subjects are analysed in the groups to which they were (randomly) allocated | ••• | NA | •••• | •••• | •••• | NA | •••• | •••• | •• | ••• | • | ••• |
| 1.10 Where the study is carried out at more than one site, results are comparable for all sites | NA | •• | ••• | NA | NA | NA | •• | NA | NA | NA | NA | NA |
| 2.1 How well was the study done to minimise bias? | + | - | ++ | ++ | - | - | - | + | - | + | + | - |
| 2.2 Taking into account clinical considerations, your evaluation of the methodolgy used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? | + | - | + | + | - | - | - | + | - | - | - | - |
| 2.3 Are the results of this study directly applicable to the patient group targeted by this review? | + | - | + | + | - | - | - | + | - | - | - | - |
Well covered ••••
Adequately addressed •••
Poorly addressed ••
Not addressed •
Not applicable NA
Not reported NR
Few/no criteria fulfilled -
Some criteria fulfilled +
All/most criteria fulfilled ++