OBJECTIVES To investigate if repeated verbal instructions about physical activity to patients with ischaemic stroke could increase long term physical activity. DESIGN Multicentre, multinational, randomised clinical trial with masked outcome assessment. SETTING Stroke units in Denmark, China, Poland, and Estonia. PARTICIPANTS 314 patients with ischaemic stroke aged >or=40 years who were ab...

OBJECTIVE To assess the effectiveness of an integrated community based environmental management strategy to control Aedes aegypti, the vector of dengue, compared with a routine strategy. Design Cluster randomised trial. Setting Guantanamo, Cuba. Participants 32 circumscriptions (around 2000 inhabitants each). Interventions The circumscriptions were randomly allocated to control clusters (n=16) ...

BACKGROUND Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical eq...

The modern concept of testing new treatments in randomised control trials began in 1948 when the Medical Research Council in the UK reported the results of a trial of streptomycin for pulmonary tuberculosis which had been organised by Drs D’Arcy and Daniels. However, even before this trial started in 1946, another randomised trial had begun to assess the effect of immunisation for whooping coug...

Treatment guidelines recommend evidence-based guided self-help (GSH) as the first stage of treatment for bulimia nervosa and binge eating disorder. The current randomised control trial evaluated a cognitive behavioural therapy-based GSH pack, 'Working to Overcome Eating Difficulties,' delivered by trained mental health professionals in 6 sessions over 3 months. It was congruent with the transdi...

BACKGROUND A considerable number of people with a mental illness are parents caring for dependent children. For those with a mental illness, parenting can provide a sense of competence, belonging, identity and hope and hence is well aligned to the concept of personal recovery. However, little research has focused on the recovery journey of those who are parents and have a mental illness. This r...

BACKGROUND/AIMS The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency ga...