Randomisation and Bias Control

Cross-source consensus on Randomisation and Bias Control from 1 sources and 4 claims.

1 sources · 4 claims

Risks & contraindications

Randomisation uses a centralised computer-generated allocation sequence made in advance by an independent statistician using R software. — Megestrol acetate versus dexamethasone to prevent nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer treated with oxaliplatin-based chemotherapy: study protocol of a multicentre, randomised, non-inferiority trial
Allocation concealment uses sequentially numbered, opaque, sealed envelopes handled by a designated custodian. — Megestrol acetate versus dexamethasone to prevent nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer treated with oxaliplatin-based chemotherapy: study protocol of a multicentre, randomised, non-inferiority trial
The trial is open-label, so subjective outcomes may be affected by assessment bias. — Megestrol acetate versus dexamethasone to prevent nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer treated with oxaliplatin-based chemotherapy: study protocol of a multicentre, randomised, non-inferiority trial
The study prospectively tracks potential confounders including non-protocol antiemetic use and delays or deviations in oral chemotherapy administration. — Megestrol acetate versus dexamethasone to prevent nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer treated with oxaliplatin-based chemotherapy: study protocol of a multicentre, randomised, non-inferiority trial