Brief participant information leaflet (PIL) vs full PIL (ID REC12)
Evidence Summary
What is it?
People are sent a brief participant information leaflet (PIL) instead of a full PIL when invited to take part in a trial.
Does it work?
A brief participant information leaflet (PIL) probably results in little to no difference in recruitment compared to a full PIL.
How big is the effect?
An increase of 0.2% (95% confidence interval = -1.5% to 1.8%).
How certain are we?
GRADE moderate certainty.
Recommendation
We recommend that trialists only consider brief PILs as part of a SWAT evaluation.
How can I use this straight away?
See More SWAT Resources below for details of how to build a SWAT evaluation of it into your trial.
Practical Impact
Imagine a trial that needs to recruit 30 participants and where 30% of approached people are recruited (see chart, 30/100 black dots).
Now imagine that people are sent a brief PIL instead of a full PIL. The chart below shows the impact of an absolute increase of 0.2% (95% CI = -1.5% to 1.8%). Recruitment is now 30.2%, which means our best estimate is that 99 people would now need to be approached to recruit 30 of them (see chart, 100 minus 1 pink dot).
Cumulative Meta-Analysis*
More SWAT resources
How to Cite
More Information
- This summary is from the Cochrane review of Strategies to improve recruitment to randomised trials.
- This summary was supported by the Irish Trial Methodology Research Network (HRB-TMRN) Phase III.
- 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 moderate certainty (downgraded one level for indirectness: Chen 2011 measures entry to a pre-randomisation run-in period, not final recruitment).
- 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.
- Claude Sonnet 5 (Anthropic) was used to draft narrative text, generate the SVG infographic and forest plot visualisations, and extract and independently calculate the cumulative meta-analysis figures from individual-study data obtained from the review’s supplementary RevMan data export. All outputs were reviewed, fact-checked against the source review, and approved by Treweek S and Bruhn H, who take full responsibility for the content. The generic prompts used to produce this summary are available upon request.
- If you have any questions contact info@trialforge.org