Ziegler 1971.
Methods | Randomised, parallel group, chemotherapeutic trial, single‐site trial (Uganda). ITT: unclear. Withdrawals: not stated. | |
Participants | Baseline characteristics: sample size; 20 evaluated for study, main study apparently focused on an initial 15.
Age range: 3 to 14 years.
Tumour staging: Ziegler.
Diagnosis: unclear. Entry criteria: BL at stages I to III; no evidence of malignant pleocytosis on admission. Exclusion criteria: not stated. |
|
Interventions | Prophylactic IT versus no treatment. Treatment duration: 4 or 10 days. Follow‐up: participants followed to relapse. |
|
Outcomes | Relapse rate | |
Notes | Full publication. The study describes a sequential trial of different drug regimens following relapse in the same set of participants. Induction of remission was by a randomised schedule though outcomes were not described. Study type: remittance maintenance. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were said to be "randomly allocated". |
Allocation concealment (selection bias) | Unclear risk | Not described in the text. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Method of blinding but it was unlikely that blinding was done. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Relapse rates were described for outcomes and were reported for all participants who relapsed. |