Developing CONSORT guidelines for lay summaries on clinical trials, and evaluating their impact.

Clinical trials are commonly used to find out which intervention works best in medicine. Lay summaries are short accounts of research projects, aimed at a general audience. Lay summaries can help support public engagement with research, and recruitment into studies. Public engagement is a priority for funders, and it is important that lay summaries meet the needs of wider society.

A lay summary should be written in plain English, avoid jargon, explain any technical terms, and include salient information about the project. However, researchers without specific training write many lay summaries or insight, leading to summaries that focus upon their concerns, are variable in quality, and often may mislead by oversimplification. They may also be incomplete, and miss out salient information.

Various current guidelines for lay summaries created for the public make general suggestions on using clear english, on using a review process, on engaging the public, and on selecting personnel to write the summaries, but do not set out checklists for content, or suggest phrasing for the recurring features of all clinical trials.

We plan to develop a guide and a toolkit for producing very high quality lay summaries on the methods and results of clinical trials. We will assemble a large panel of experts and patients, and develop this toolkit as a "CONSORT/EQUATOR guideline". These are highly respected - and widely used - guidelines on best practice in reporting the results of scientific research to other scientists. They are developed and kept up to date using robust methods. Using this platform will help ensure our toolkit is both rigorous and highly used. Having created this toolkit, we will then conduct a small research project to assess whether lay summaries made using it are more readable, and more complete, than existing lay summaries.

Amount awarded: £48,959