Gorbonova 2000.
Study characteristics | ||
Methods | Phase II parallel‐group RCT. Open label study. |
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Participants | Untreated metastatic melanoma. Randomised participants: 30. |
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Interventions | Two‐arm study:
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Outcomes | Tumour response | |
Notes | Cross‐over: not allowed. Quality of life: not reported. Participants with brain metastasis: excluded. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | There was insufficient information to permit judgement. |
Allocation concealment (selection bias) | Unclear risk | There was insufficient information to permit judgement. |
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 | Unclear risk | There was insufficient information to permit judgement. |
Selective reporting (reporting bias) | Unclear risk | There was insufficient information to permit judgement. |
Other bias | Unclear risk | There was insufficient information to permit judgement. |