Within the last week, the BMJ has published an official extension of the CONSORT 2010 Statement for reporting N-of-1 trials. This guidance from the EQUATOR Network (www.equator-network.org) provides a set of essential items (a checklist) to include when preparing reports of prospectively planned, multiple crossover single patient trials, which may or may not be randomised.
The authors conclude: “N-of-1 trials offer a pragmatic approach to evidence based clinical practice. Rather than forcing patients into an all or none fit with a rigid parallel group-based trial protocol, N-of-1 trials can be flexible and adapt around the individual to help assess treatment effectiveness under real world circumstances. They facilitate shared decision making between patients and practitioners, thereby bringing evidence based medicine into real clinical practice. While N-of-1 trials can be flexible enough for clinical use, they can also be standardised for the purpose of research, which may allow outcomes to be combined for population estimates. By improving the clarity of N-of-1 trial reporting, the CENT 2015 guidelines offer an opportunity to improve the interpretation and usefulness of N-of-1 trials.”.