Wales Cancer Trials Unit will randomise patients centrally using the method of minimisation with a random element.
Patients are randomised centrally by the Wales Cancer Trials Unit using the method of minimisation which includes a random element.
Patients were assigned to study treatment using a computer generated random code according to the method of minimisation.
In total, 220 adult patients with PDR will be randomised 1 1 at the level of the individual using the method of minimisation incorporating a random element.
Large imbalances between study arms in the number of allocated villages, the number of villagers in households eligible for a box, and the previous history of pesticide self-harm in the village, are avoided by the method of minimisation.
The Taves method of minimisation 48 was used to ensure the groups were balanced for general practice, gender, age group (≤50/>50 years), BMI category (≤30/>30 kg/m), diagnosis of diabetes (yes/no) and taking antipsychotic medication or not.
Patients in Group C must be fit to undergo CRT and meet additional criteria as per Table 2.>> Patients in Groups B and C will be randomised to a trial arm using the method of minimisation with a random element.
When a patient is eligible to participate in the study, randomisation, using the method of minimisation, will be performed using a centralised Study Randomisation Centre at the NHMRC Clinical Trial Centre at the University of Sydney.
Patients were stratified by centre (CUH or WSH), treatment intent (cure, palliation or supportive care), patient performance status (PS 0, 1 or 2), gender and prior cancer drug treatment (yes or no), and randomisation was carried out independently of the trial co-ordination, using the method of minimisation including a random element.
Patients are randomised on a 1 1 1 basis to one of 3 arms: treatment delivered in the hospital out-patient and day unit environment (control arm A), treatment delivered at home (arm B) or treatment delivered in a GP surgery (arm C) using the method of minimisation with a random element to the assignment.
