The patient information sheet is rewritten for a lay audience, organised into subsections, has graphic design input and user testing. Sheet templates used for previous trials can be used as well.
Does it work?
The addition of optimised information, either as bespoke or template formats, may increase retention.
How big is the effect?
An increase of 6% (95% confidence interval = -7% to 20%).
We recommend that trialists consider using optimised information sheets.
How can I use this straight away?
See Resource bundle below for details on how to optimise patient information sheets.
Practical Impact
Imagine initial retention is 65% of those approached. You have a trial with 100 participants that needs responses from 80 to meet its statistical power calculations. Retention of 65% means that you will be 15 responses short (see chart below).
Now imagine using optimised information. The chart below shows the impact of an absolute increase of 6% (95% CI = -7% to 22%). Retention is now 71%, which means our best estimate is that you would now only be 9 responses short.
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 and a wide CI crossing RD=0.
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 moderate effect size and Low GRADE 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.