Participants are presented with a version of the study protocol that explicitly describes all possible risks of injury.
Emphasising risk in information may make little or no difference to recruitment.
An increase of 0% (95% confidence interval = -1% to 1%).
GRADE Low certainty.
We recommend that trialists emphasise risk in patient information in the context of an intervention evaluation.
See Resource bundle below for details of how to emphasise risk in patient information.
Imagine a trial that needs to recruit 30 participants and initial recruitment is 30% of those approached. This means you’d need to approach 100 people to recruit 30 of them (see chart).
Now imagine emphasising risk in patient information. The chart below shows the impact of an absolute increase of 0% (95% CI = -1% to 1%). Recruitment is still 30%, which means our best estimate is still that 100 people would now need to be approached to recruit 30 of them.