We used a random intercept and random slopes model.
Central randomisation through the trials unit used minimisation (with a random element) based on pre-protocol chemotherapy, primary tumour site, and centre.
Randomization will be achieved using minimization, incorporating a random element through a computer-generated program accessed via a 24-hour telephone service.
Randomisation will be performed using minimisation, incorporating a random element, via a central 24-hour automated telephone randomisation system based at the Leeds Clinical Trials Research Unit.
Following informed consent, patients will be randomly assigned in a 1 1 ratio using minimisation with a random element to undergo either chest drain insertion with talc slurry pleurodesis or thoracoscopy with talc poudrage.
Randomisation will be performed using minimisation incorporating a random element, to ensure treatment groups are well-balanced for: Centre; Age (≥65 or <65); Disease Duration (≥10years or <10years); Consent for minor labial gland biopsy; Consent for ultrasound scan.
Treatment group allocation will use minimisation incorporating a random element, via a computer-generated programme, to ensure treatment groups are well-balanced for: centre; disease duration (<5 years or ≥ 5 years); non-response (primary or secondary); rheumatoid factor status (RF seropositive or ACPA positive) or (RF seronegative and ACPA negative)).
Patients are randomly assigned, in a 1 1 ratio, to either an observation group or UFT adjuvant therapy group, using minimization by introducing a random element with a 0.8 assignment probability [ 14], balanced on the following stratification factors: depth of tumor invasion (T3 vs. T4), number of lymph-nodes examined (<12 vs. ≥12) and institution.
We used a random-effects model.
Wales Cancer Trials Unit will randomise patients centrally using the method of minimisation with a random element.
