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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: A study-within-a-trial

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...

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Autores principales: Dwyer, Christopher P., Joyce, Robert A., Rogers, Fionnuala, Hynes, Sinéad M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9192790/
https://www.ncbi.nlm.nih.gov/pubmed/35711678
http://dx.doi.org/10.1016/j.conctc.2022.100936
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author Dwyer, Christopher P.
Joyce, Robert A.
Rogers, Fionnuala
Hynes, Sinéad M.
author_facet Dwyer, Christopher P.
Joyce, Robert A.
Rogers, Fionnuala
Hynes, Sinéad M.
author_sort Dwyer, Christopher P.
collection PubMed
description 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.
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spelling pubmed-91927902022-06-15 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: A study-within-a-trial Dwyer, Christopher P. Joyce, Robert A. Rogers, Fionnuala Hynes, Sinéad M. Contemp Clin Trials Commun Article 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. Elsevier 2022-06-02 /pmc/articles/PMC9192790/ /pubmed/35711678 http://dx.doi.org/10.1016/j.conctc.2022.100936 Text en © 2022 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Dwyer, Christopher P.
Joyce, Robert A.
Rogers, Fionnuala
Hynes, Sinéad M.
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: A study-within-a-trial
title 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: A study-within-a-trial
title_full 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: A study-within-a-trial
title_fullStr 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: A study-within-a-trial
title_full_unstemmed 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: A study-within-a-trial
title_short 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: A study-within-a-trial
title_sort 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: a study-within-a-trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9192790/
https://www.ncbi.nlm.nih.gov/pubmed/35711678
http://dx.doi.org/10.1016/j.conctc.2022.100936
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