Doug Altman, Sally Hopewell and Sallie Lamb report back from Consensus meeting for the development of a CONSORT extension for reporting pilot trials.

Details: 

An international multidisciplinary group spent an intense couple of days in Oxford exploring the definitions of and differences between pilot studies and feasibility studies, and also touched on proof of concept efficacy studies. Focusing on pilot randomised controlled trials, which set out to determine whether the trial logistics are feasible (as opposed to whether an intervention is sufficiently efficacious to progress), we were able to reach consensus on a range of items that should be included in reports of these trials. The diversity of types of study that might be included taxed the panel, but our sense is that the guidance which will emerge will be extremely helpful in giving a clearer identity and legitimacy to pilot randomised trials, and helping investigators report them to a higher standard.