Table 1.
Quality assessment of the included trials
| Quality items | L02 | BLISS-52 | BLISS-76 |
|---|---|---|---|
| Does reporting suggest that randomisation was carried out appropriately? | Yes | Yes | Yes |
| Does reporting suggest that the concealment of treatment allocation adequate? | Unclear | Unclear | Unclear |
| Were the groups reported as similar at the outset of the study in terms of prognostic factors? | Yes | Yes | Yes |
| Were the care providers, participants and outcome assessors reported as blind to treatment allocation? | Yes | Yes | Yes |
| Were any unexpected imbalances in drop-outs reported between groups? | No | No | No |
| Is there any evidence to suggest that the authors measured more outcomes than they reported? | No | No | No |
| Did the analysis include an intention-to-treat analysis? If so, was this appropriate and were appropriate methods used to account for missing data? | Yes | Yes | Yes |
Quality assessment used information presented in the study journal articles and the manufacturer's submission to the US FDA and was based on CRD guidance (2008)19 for undertaking systematic reviews in healthcare.
(CRD, Centre for Reviews and Dissemination; York: Centre for Reviews and Dissemination).