Background The CONSORT statement is intended to improve reporting of randomised controlled trials and focuses on minimising the risk of bias (internal validity). The applicability of a trial’s results (generalisability or external validity) is also important, particularly for pragmatic trials. A pragmatic trial (a term first used in 1967 by Schwartz and Lellouch) can be broadly defined as a randomised controlled trial whose purpose is to inform decisions about practice. This extension of the CONSORT statement is intended to improve the reporting of such trials and focuses on applicability. Methods At two, two-day meetings held in Toronto in 2005 and 2008, we reviewed the CONSORT statement and its extensions, the literature on pragmatic trials and applicability, and our experiences in conducting pragmatic trials. Recommendations We recommend extending eight CONSORT checklist items for reporting of pragmatic trials: the background, participants, interventions, outcomes, sample size, blinding, participant flow, and generalisability of the findings. These extensions are presented, along with illustrative examples of reporting, and an explanation of each extension. Adherence to these reporting criteria will make it easier for decision makers to judge how applicable the results of randomised controlled trials are to their own conditions. Empirical studies are needed to ascertain the usefulness and comprehensiveness of these CONSORT checklist item extensions. In the meantime we recommend that those who support, conduct, and report pragmatic trials should use this extension of the CONSORT statement to facilitate the use of trial results in decisions about health care.

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When, in the summer of 1994, a pilot project on prevention of drug use and transmission of HIV was launched in Hindelbank, a Swiss prison for women, not many outsiders paid attention to it. Yet only a few months later, the prison director received repeated calls from television stations, newspapers, and drug experts asking how the project was developing. We describe how this high level of public interest in a small prison (around 85 inmates, 100 entries and releases per year) came about. Provision of syringes-the cutting edge?The installation of six automatic dispensers for exchange of syringes attracted special attention. The dispensers are freely accessible but hidden from general view in different wings of the prison (fig 1). Clean injection equipment is dispensed only in exchange for another (used) syringe. The first exchange is by means of a dummy syringe that is given to all inmates when they enter the prison.To distribute equipment for illegal drug use in the framework of a penitentiary-and to provide inmates, many of whom have been sentenced for drug related crimes, with syringes-seemed paradoxical to many people. Fears abounded that inmates could misuse contaminated syringes as weapons against the prison's staff or that improper disposal of injection equipment would provoke injuries and thus cause infections with bloodborne viruses. There was-and still isspeculation that issuing syringes to drug addicts in prison might encourage drug use.

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