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PIL development #2: with user feedback (ID REC22)

Evidence Summary

What is it?

A more patient friendly patient information leaflet is developed using user feedback (rewritten for a lay audience, reorganised into subsections, had graphic design and undergone user feedback).

Does it work?

Optimising the PIL through using user feedback probably makes little or no difference in recruitment.

How big is the effect?

An increase of 0% (95% confidence interval = 0% to 1%).

How certain are we?

GRADE Moderate certainty.


We recommend that trialists develop patient information leaflets with user feedback in the context of an intervention evaluation

How can I use this straight away?

See Resource bundle below for details on how to develop patient information leaflets with user feedback.

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 using a participant information leaflet developed using feedback. The chart below shows the impact of an absolute increase of 0% (95% CI = -2% to 2%). Recruitment is still 30%, which means our best estimate is that 100 people would still need to be approached to recruit 30 of them.

Cumulative Meta-Analysis*

*Random effects model done using Comprehensive Meta-Analysis v4 ( Differences >0% favour the intervention. The GRADE assessment is moderate because of imprecision.

Resource Bundle

How to Cite

Citation: Treweek S, Bruhn H, Gardner H. Evidence pack­– Recruitment: PIL development #2: with user feedback (REC22), 2023,

More Information

  1. This summary is from the Cochrane review of strategies to improve recruitment in randomised trials (
  2. It was prepared with financial support from Evidence Synthesis Ireland.
  3. The ‘Does it work?’ statement is structured according to effect size and GRADE certainty as per GRADE Guidelines 26 ( The statement is for trivial, small unimportant effect or no effect and GRADE Moderate certainty.
  4. 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.
  5. If you have any questions contact
v2.0 - 10/07/2023
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