We recommend that trialists emphasise risk in patient information in the context of an intervention evaluation.
How can I use this straight away?
See Resource bundle below for details of how to emphasise risk in patient information.
Practical Impact
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.
Cumulative Meta-Analysis*
*Random effects model done using Comprehensive Meta-Analysis v4 (www.meta-analysis.com). Differences >0% favour the intervention. The GRADE assessment is low because of the imprecision of a single study.
The ‘Does it work?’ statement is structured according to effect size and GRADE certainty as per GRADE Guidelines 26 (https://doi.org/10.1016/j.jclinepi.2019.10.014). The statement is for a trivial, small unimportant or no effect size and GRADE Low certainty.
The recommendation statement is the consensus view of the authors of this summary based on the GRADE certainty and features of the trials contributing to the evidence.