Diary of a randomised controlled trial 25 July 2008
This diary is partly for my own amusement, but also to record the enormously long drawn-out process of setting up and running a large scale randomised controlled trial.
We (which is the Warwick Medical School Clinical Trials Unit) were lucky enough to be awarded funding a few weeks ago by the NIHR Health Technology Assessment Programme for a randomised controlled trial of the LUCAS mechanical compression device for cardiac arrest. Briefly, this is a mechanical device for providing chest compressions for people who have had a cardiac arrest. Its suggested advantages over standard manual compression is that it doesn't tire so the quality of compressions remains constant, it can operate in situations where a paramedic wouldn't be able to do manual compressions (such as when a patient is being moved) and it frees up paramedics to do other important jobs, like saving other people. But there is no evidence that it actually does save peoples' lives and it's also possible that it kills them; for example, it might cause internal injuries that cause more people to die later on. Hence the need for the trial, which we are doing in collaboration with Coventry University, Leeds University and the West Midlands and Scottish Ambulance Services.
We were awarded this grant at the end of June 2008 but the project was already over a year old by then. The original idea to do this trial came up in meetings towards the end of 2006 and we submitted an outline proposal in May 2007. Just after we had done this there was a call for proposals in the field of Emergency and Prehospital care, and the funding body suggested to us that we should move our application into this funding stream, which we agreed to. However, it became clear that there was another application for a trial of the same device so we had some direct competition. As a result of the outlines we were invited to submit a full application, which went in in February 2008.
So we are now finally at the point of having the money and having to deliver this trial.