The stepped-wedge cluster randomised trial (SW-CRT) is a novel research study design that is increasingly being used in the evaluation of service delivery type interventions. The SW-CRT is a type of randomised trial in which clusters are randomised to a date at which they initiate the intervention under evaluation. The design involves random and sequential crossover of clusters from control to ...

In the presence of non-compliance, conventional analysis by intention-to-treat provides an unbiased comparison of treatment policies but typically under-estimates treatment efficacy. With all-or-nothing compliance, efficacy may be specified as the complier-average causal effect (CACE), where compliers are those who receive intervention if and only if randomised to it. We extend the CACE approac...

OBJECTIVE To examine the psychosocial consequences of being allocated to the control group as compared with the screen group in a randomised lung cancer screening trial. METHOD The Danish Lung Cancer Screening Trial, a randomised controlled trial, ran from 2004 to 2010 with the purpose of investigating the benefits and harms of lung cancer screening. The participants in Danish Lung Cancer Scr...

‘Blinding’ involves concealing knowledge of which trial participants received the interventions from themselves and other personnel throughout trial. Blinding reduces bias arising beliefs expectations these groups. It is agreed that where possible, blinding should be attempted, for example by ensuring experimental control treatments look same. However, there a debate about if we measure whether...

OBJECTIVE To evaluate the effect of a clinical trial question prompt list in patients considering enrolment in cancer treatment trials. SETTING Tertiary cancer referral hospitals in three state capital cities in Australia. PARTICIPANTS 88 patients with cancer attending three cancer centres in Australia, who were considering enrolment in phase 3 treatment trials, were invited to enrol in an ...

OBJECTIVE To determine the feasibility of conducting a randomised controlled trial of a specialist physiotherapy intervention for functional motor symptoms (FMS). METHODS A randomised feasibility study was conducted recruiting patients with a clinically established diagnosis of FMS from a tertiary neurology clinic in London, UK. Participants were randomised to the intervention or a treatment ...