Random sequence generation (selection bias) |
Low risk |
Quote: “Randomization was one to one with a block of size 6. The list of randomization was obtained using the SAS procedure plan at the data statistical analysis centre” |
Allocation concealment (selection bias) |
Unclear risk |
The randomisation list was created at the statistical data centre, but further description of allocation is not included |
Blinding of participants and researchers (performance bias) |
High risk |
Open label |
Blinding of outcome assessment (detection bias) |
High risk |
Open label |
Incomplete outcome data (attrition bias) |
Low risk |
Losses to follow-up were disclosed and the analyses were conducted using, firstly, a modified intention to treat analysis in which missing=failures and, secondly, on an observed basis. Although the authors describe an intention to treat analysis, the 139 participants initially randomised were not all included; five were excluded (four withdrew and one had lung cancer diagnosed). This is a reasonable attrition and not expected to affect results. Adequate sample size of 60 per group was achieved |
Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes were reported |
Other bias |
Unclear risk |
No description of the uptake of the therapeutic drug monitoring recommendations by physicians, which could result in performance bias |