Eigentler 2008.
Study characteristics | ||
Methods | Phase III parallel‐group RCT. Open label study. Multicentre trial. |
|
Participants | Particpants with metastasised melanoma after complete metastasectomy. Randomised participants: 139. |
|
Interventions | Two‐arm trial:
|
|
Outcomes | Progression‐free survival. Overall survival. |
|
Notes | Cross‐over: not reported. Quality of life: evaluation of the quality of life was insufficient because of the low feedback rate of the questionnaires. Participants with brain metastasis: not reported. Median follow‐up: 46 months. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "...permuted block (size 12) randomization list" Comment: Randomisation method was adequate. |
Allocation concealment (selection bias) | Low risk | Risk was likely low because this was a multicentre trial with centralised randomisation. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | As an open label study, no blinding of participants or personnel was possible. However, we believe that in this setting (metastatic melanoma), with the treatments tested and outcomes assessed, the knowledge of which intervention was received or administered (rather than the intervention itself), could not affect the outcomes under investigation. Therefore, we judged the risk of performance bias as low. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | There was insufficient information to permit judgement. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data were balanced across intervention groups, with similar reasons for missing data across groups. |
Selective reporting (reporting bias) | Low risk | No differences between protocol and published report. |
Other bias | Low risk | The study appeared to be free of other sources of bias. |