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The effect of personalised versus non-personalised study invitations on recruitment within the ENGAGE feasibility trial: an embedded randomised controlled recruitment trial
BACKGROUND: Recruitment into clinical trials is challenging and there is a lack of evidence on effective recruitment strategies. Personalisation of invitation letters is a potentially pragmatic and feasible way of increasing recruitment rates at a low-cost. However, there is a lack of evidence conce...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8898447/ https://www.ncbi.nlm.nih.gov/pubmed/35249543 http://dx.doi.org/10.1186/s12874-022-01553-5 |
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author | Thiblin, Ella Woodford, Joanne Öhman, Mattias von Essen, Louise |
author_facet | Thiblin, Ella Woodford, Joanne Öhman, Mattias von Essen, Louise |
author_sort | Thiblin, Ella |
collection | PubMed |
description | BACKGROUND: Recruitment into clinical trials is challenging and there is a lack of evidence on effective recruitment strategies. Personalisation of invitation letters is a potentially pragmatic and feasible way of increasing recruitment rates at a low-cost. However, there is a lack of evidence concerning the effect of personalising of study invitation letters on recruitment rates. METHODS: We undertook a Study Within A Trial (SWAT) to investigate the effect of personalised versus non-personalised study invitation letters on recruitment rates into the host feasibility trial ENGAGE, a feasibility study of an internet-administered, guided, Low Intensity Cognitive-Behavioural Therapy based self-help intervention for parents of children previously treated for cancer. An intervention group (n = 254) received a personalised study invitation letter and the control group (n = 255) received a non-personalised study invitation letter. The primary outcome was the proportion of participants in the intervention group and the control group enrolled into the ENGAGE host feasibility trial. Secondary outcomes relating to the recruitment and screening process, and retention were examined. Differences in proportions between groups for the primary and secondary outcomes were estimated using logistic regression. RESULTS: Of the 509 potential participants, 56 (11.0%) were enrolled into the ENGAGE host feasibility trial: personalised: 30/254 (11.8%) and non-personalised: 26/255 (10.2%). No statistically significant effect on personalisation of enrolment was found (OR 1.18, 95% CI 0.68–2.06). No statistically significant differences were found for any secondary outcome. CONCLUSIONS: Personalisation of study invitations had no effect on recruitment. However, given the small study sample size in the present SWAT, and lack of similar embedded recruitment RCTs to enable a meta-analysis, additional SWATs to examine the personalisation of study invitation letters are warranted. TRIAL REGISTRATION: ISRCTN57233429; ISRCTN18404129; SWAT 112, Northern Ireland Hub for Trials Methodology Research SWAT repository (2018 OCT 1 1231) (https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,939618,en.pdf). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-022-01553-5. |
format | Online Article Text |
id | pubmed-8898447 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-88984472022-03-17 The effect of personalised versus non-personalised study invitations on recruitment within the ENGAGE feasibility trial: an embedded randomised controlled recruitment trial Thiblin, Ella Woodford, Joanne Öhman, Mattias von Essen, Louise BMC Med Res Methodol Research BACKGROUND: Recruitment into clinical trials is challenging and there is a lack of evidence on effective recruitment strategies. Personalisation of invitation letters is a potentially pragmatic and feasible way of increasing recruitment rates at a low-cost. However, there is a lack of evidence concerning the effect of personalising of study invitation letters on recruitment rates. METHODS: We undertook a Study Within A Trial (SWAT) to investigate the effect of personalised versus non-personalised study invitation letters on recruitment rates into the host feasibility trial ENGAGE, a feasibility study of an internet-administered, guided, Low Intensity Cognitive-Behavioural Therapy based self-help intervention for parents of children previously treated for cancer. An intervention group (n = 254) received a personalised study invitation letter and the control group (n = 255) received a non-personalised study invitation letter. The primary outcome was the proportion of participants in the intervention group and the control group enrolled into the ENGAGE host feasibility trial. Secondary outcomes relating to the recruitment and screening process, and retention were examined. Differences in proportions between groups for the primary and secondary outcomes were estimated using logistic regression. RESULTS: Of the 509 potential participants, 56 (11.0%) were enrolled into the ENGAGE host feasibility trial: personalised: 30/254 (11.8%) and non-personalised: 26/255 (10.2%). No statistically significant effect on personalisation of enrolment was found (OR 1.18, 95% CI 0.68–2.06). No statistically significant differences were found for any secondary outcome. CONCLUSIONS: Personalisation of study invitations had no effect on recruitment. However, given the small study sample size in the present SWAT, and lack of similar embedded recruitment RCTs to enable a meta-analysis, additional SWATs to examine the personalisation of study invitation letters are warranted. TRIAL REGISTRATION: ISRCTN57233429; ISRCTN18404129; SWAT 112, Northern Ireland Hub for Trials Methodology Research SWAT repository (2018 OCT 1 1231) (https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,939618,en.pdf). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-022-01553-5. BioMed Central 2022-03-06 /pmc/articles/PMC8898447/ /pubmed/35249543 http://dx.doi.org/10.1186/s12874-022-01553-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Thiblin, Ella Woodford, Joanne Öhman, Mattias von Essen, Louise The effect of personalised versus non-personalised study invitations on recruitment within the ENGAGE feasibility trial: an embedded randomised controlled recruitment trial |
title | The effect of personalised versus non-personalised study invitations on recruitment within the ENGAGE feasibility trial: an embedded randomised controlled recruitment trial |
title_full | The effect of personalised versus non-personalised study invitations on recruitment within the ENGAGE feasibility trial: an embedded randomised controlled recruitment trial |
title_fullStr | The effect of personalised versus non-personalised study invitations on recruitment within the ENGAGE feasibility trial: an embedded randomised controlled recruitment trial |
title_full_unstemmed | The effect of personalised versus non-personalised study invitations on recruitment within the ENGAGE feasibility trial: an embedded randomised controlled recruitment trial |
title_short | The effect of personalised versus non-personalised study invitations on recruitment within the ENGAGE feasibility trial: an embedded randomised controlled recruitment trial |
title_sort | effect of personalised versus non-personalised study invitations on recruitment within the engage feasibility trial: an embedded randomised controlled recruitment trial |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8898447/ https://www.ncbi.nlm.nih.gov/pubmed/35249543 http://dx.doi.org/10.1186/s12874-022-01553-5 |
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