Cockayne 2017.

Methods	Randomised controlled trial
Data	Setting: community NHS clinics, UK. 6900 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. Ineligible if report neuropathy, dementia or other neurological condition, unable to walk unaided, lower limb amputation, unwilling to attend local podiatry clinic. 3‐arm trial of a bespoke user‐tested PIL and a template‐developed PIL against the usual PIL
Comparisons	Investigated different version of the participant information leaflet (PIL) Intervention 1: bespoke, user‐tested PIL and letter, with graphic design input Intervention 2: template developed PIL and original study letter with public and patient involvement (PPI) feedback but no user‐testing or design input Comparator: PIL developed for REFORM trial using NRES (ethics) template with study invitation letter
Outcomes	Proportion recruited to trial
Notes
Risk of bias
Item	Authors' judgement	Description
Random Sequence generation ok?	Yes	Generated electronically, stratified by centre
Allocation concealment?	Yes	Independent data manager, IDs used, invitation packs sent centrally
Blinding of participants and personnel ok?	Yes	Participants and research staff blinded; not admin staff but unlikely to have affected the allocation
Blinding of outcome assessment ok?	Yes	Objective assessment
Incomplete outcome data handled ok?	Yes	No missing data
Free of selective reporting?	Yes	Recruitment outcome presented, which is all the review needs
Was the study free of other bias?	Yes	No other biases apparent. Sensitivity analysis showed negligible effect of newsletter in pack. May be underpowered
Overall bias?	No	Low risk of bias