Table 13 Navari et al., 2007
Domain | Description | Review author’s judgement |
|---|---|---|
Sequence generation | The randomization method is not described. | “Unclear” |
Allocation concealment | The exact method is not described. | “Unclear” |
Blinding of participants, personnel, and outcome | Double blind trial. The issue is not addressed by the authors. | “Unclear” |
Incomplete outcome data | The main outcome was the scores on FACT-G and BZSDS. 193 patients enrolled in the study, 183 were available at the first follow-up and 180 at the second. The reasons for dropouts are not reported. The authors used a completers’ analysis, which was not pre-specified in the description of the study. | “No” |
Selective outcome reporting | The scores of the FACT-G and BZSDS are not reported. The results are presented as numbers of patients with significant improvement, which is not pre-specified in the description of the study. The AEs are also not reported. | “No” |
Other sources of bias | The study seems to be free from other sources of bias. | “Yes” |