Magrath 1976.
Methods | Randomised, parallel group, single‐centre trial (Uganda). ITT: unclear. Withdrawals: stated. | |
Participants | Baseline characteristics: screening population: 80; 48 participants randomised (40 evaluated: BCG: 21; control: 19; male:female: BCG 15:6; control: 14:5).
Mean age: BCG: 10 years; control: 6 years.
Tumour staging: WHO classification.
Diagnosis: histopathology. Entry criteria: untreated BL; remission two weeks after treatment with C. |
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Interventions | BCG versus no treatment. Participants randomised if in remission two weeks after the last dose of C. Follow‐up: median 1.75 years. |
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Outcomes | Relapse. Overall survival. Event‐free survival. Toxicity. | |
Notes | Participants recruited if in remission. Study type: remittance maintenance. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Said to be "randomised by stage". |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) All outcomes | High risk | Unlikely: therapy involved scarification. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were accounted for. |