The need for reliable evidence for medical interventions has long been recognised and the history of attempts to produce this evidence is thoroughly documented in the James Lind library (http://www.jameslindlibrary .org/). The status of randomised controlled trials as the most reliable method for evaluating the effects of treatments is now well established. Although the basic principles of the ...

In today’s Lancet, results from two randomised trials show considerable benefit of male circumcision in reducing HIV incidence in men, confirming findings from an earlier trial in South Africa. The recent focus on antiretroviral treatment—although necessary and appropriate—has made primary prevention a secondary issue. Renewed interest in HIV prevention is welcome. The South African trial was d...

In today’s Lancet, results from two randomised trials show considerable benefit of male circumcision in reducing HIV incidence in men, confirming findings from an earlier trial in South Africa. The recent focus on antiretroviral treatment—although necessary and appropriate—has made primary prevention a secondary issue. Renewed interest in HIV prevention is welcome. The South African trial was d...

BACKGROUND Concerns have been expressed about the impact that screening for risk of suicide may have on a person's mental health. AIMS To examine whether screening for suicidal ideation among people who attend primary care services and have signs of depression increases the short-term incidence of feeling that life is not worth living. METHOD In a multicentre, single-blind, randomised contr...

BACKGROUND The preferred method to evaluate public health interventions delivered at the level of whole communities is the cluster randomised trial (CRT). The practical limitations of CRTs and the need for alternative methods continue to be debated. There is no consensus on how to classify study designs to evaluate interventions, and how different design features are related to the strength of ...

The randomised controlled trial reported by MacDonald et al documents an impressive increase in overall survival with postoperative chemoradiotherapy compared with surgical resection of gastric cancer alone (36 months v 27 months). Of equal importance is the finding of a significant reduction in the hazard ratio for relapse (1.52, 95% CI 1.23–1.86; p<0.001). Although not the first randomised co...

BACKGROUND Depersonalisation is the experience of being detached or disconnected from one's experience. Studies suggest that clinically significant levels of depersonalisation are common in individuals who have psychotic symptoms and are associated with increased impairment. However, to date, there have been no studies that have investigated an intervention designed to target clinically signifi...

BACKGROUND The multi-arm multi-stage (MAMS) trial is a new paradigm for conducting randomised controlled trials that allows the simultaneous assessment of a number of research treatments against a single control arm. MAMS trials provide earlier answers and are potentially more cost-effective than a series of traditionally designed trials. Prostate cancer is the most common tumour in men and the...

187 1. The FOOD Trial Collaboration. Routine oral nutritional supplementation for stroke patients in hospital (FOOD): a multicentre randomised controlled trial. Lancet 2005; 365: 755–63. 2. The FOOD Trial Collaboration. Effect of timing and method of enteral tube feeding for dysphagic stroke patients (FOOD): a multicentre randomised controlled trial. Lancet 2005; 365: 764–72. 3. Spiegelhalter D...

BACKGROUND Trials which test the effectiveness of interventions compared with the status quo frequently encounter challenges. The cohort multiple randomised controlled trial (cmRCT) design is an innovative approach to the design and conduct of pragmatic trials which seeks to address some of these challenges. MAIN TEXT In this article, we report our experiences with the first completed randomi...