TY - JOUR
T1 - Comparing the effects of a patient-designed-and-informed participant information leaflet in comparison with a standard, researcher-designed information leaflet on recruitment, retention and understanding
T2 - A study-within-a-trial
AU - Dwyer, Christopher P.
AU - Joyce, Robert A.
AU - Rogers, Fionnuala
AU - Hynes, Sinéad M.
N1 - Publisher Copyright:
© 2022 The Authors
PY - 2022/8
Y1 - 2022/8
N2 - Background and aim: The process of trial recruitment is vital, given its impact on resources, statistical power and the validity of findings. A participant information leaflet (PIL) is often the initial and primary source of information engaged by potential participants during recruitment. Research suggests that a variety of manipulations to a PIL can be made during its development to enhance understanding, readability and accessibility. In light of this, PIL-design led by Public and Patient Involvement (PPI) may also yield positive effects in this respect, as well as consent and retention. This study-within-a-trial (SWAT) compared the effects of a PPI-developed PIL with a standard, researcher-developed PIL on rates of consent, retention, decision certainty, understanding, readability, accessibility, likeability and decision to consent. Method: This SWAT used a double-blind, two-armed randomised design. The SWAT was conducted within a host trial of cognitive rehabilitation in multiple sclerosis. Results: A total of 234 people expressed interest in the trial, of which 94 were retained at 6-month follow up. Results revealed no effects on levels of consent and retention between the two PIL groups. Conclusions: These null effects provide interesting points of discussion and important implications for not only future research on PILs, but also for future research that involves recruitment to health-related interventions.
AB - Background and aim: The process of trial recruitment is vital, given its impact on resources, statistical power and the validity of findings. A participant information leaflet (PIL) is often the initial and primary source of information engaged by potential participants during recruitment. Research suggests that a variety of manipulations to a PIL can be made during its development to enhance understanding, readability and accessibility. In light of this, PIL-design led by Public and Patient Involvement (PPI) may also yield positive effects in this respect, as well as consent and retention. This study-within-a-trial (SWAT) compared the effects of a PPI-developed PIL with a standard, researcher-developed PIL on rates of consent, retention, decision certainty, understanding, readability, accessibility, likeability and decision to consent. Method: This SWAT used a double-blind, two-armed randomised design. The SWAT was conducted within a host trial of cognitive rehabilitation in multiple sclerosis. Results: A total of 234 people expressed interest in the trial, of which 94 were retained at 6-month follow up. Results revealed no effects on levels of consent and retention between the two PIL groups. Conclusions: These null effects provide interesting points of discussion and important implications for not only future research on PILs, but also for future research that involves recruitment to health-related interventions.
KW - PPI
KW - Patient involvement
KW - Recruitment
KW - Retention
KW - SWAT
KW - Study-within-a-trial
UR - http://www.scopus.com/inward/record.url?scp=85131676743&partnerID=8YFLogxK
U2 - 10.1016/j.conctc.2022.100936
DO - 10.1016/j.conctc.2022.100936
M3 - Article
AN - SCOPUS:85131676743
SN - 2451-8654
VL - 28
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 100936
ER -