Participant information leaflet (PIL) development #2: with user feedback
Optimising the PIL through using user feedback probably makes little or no difference to recruitment.
The absolute increase is 0% (95% CI = 0% to 1%)1
MODERATE CERTAINTY in the evidence (but see 'What we don't know' below)
1 Treweek S, Pitkethly M, Cook J, Fraser C, Mitchell E, Sullivan F, Jackson C, Taskila TK, Gardner H. Strategies to improve recruitment to randomised trials. Cochrane Database of Systematic Reviews 2018, Issue 2.
The practical impact of user feedback on PILs
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 below).
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%)1. Recruitment is still 30%, which means our best estimate is that 100 people would still need to be approached to recruit 30 of them.
Where have brief participant information leaflets (PIL) been tested?
Study 1: Cockayne 2017
Patients eligible for the REFORM study (over 64 years, routine podiatry appointment in past 6 months) and offered an appointment at NHS podiatry clinics across 5 centres.
Community NHS clinics, UK.
3.0% of those receiving the PIL with user feedback were recruited; 2.7% of those receiving the standard PIL were recruited.
Study 2: Chen 2011
Participants were eligible for 3 host trials, but unclear what the trials were.
Unclear but probably secondary, UK.
6.1% of those receiving the PIL with user-feedback were recruited to a pre-randomisation phase; 5.6% of those receiving the standard PIL were recruited to the pre-randommisation phase.
What we still don’t know about PILs with user feedback
- The information we have is based on a two trials, one of which (Chen 2011) us actually recruitment to a pre-randomisation phase so has pulled down the GRADE rating to moderate because of indirectness. Ideally we need to test this intervention in more trials.
- Both trials were done in the UK; evaluations outside the UK would be welcome.
- Please get in touch (email email@example.com) if you would like to do an evaluation because we can help with text for ethics etc.