Cargando…
Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis
BACKGROUND: Recruitment of participants is crucial to the success of randomised control trials (RCTs) but can be challenging and expensive. Current research on trial efficiency is often focused at the patient-level with an emphasis on effective recruitment strategies. Less is known about selection o...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9985191/ https://www.ncbi.nlm.nih.gov/pubmed/36869362 http://dx.doi.org/10.1186/s13063-023-07177-4 |
_version_ | 1784900900270112768 |
---|---|
author | Tew, Michelle Catchpool, Max Furler, John De La Rue, Katie Clarke, Philip Manski-Nankervis, Jo-Anne Dalziel, Kim |
author_facet | Tew, Michelle Catchpool, Max Furler, John De La Rue, Katie Clarke, Philip Manski-Nankervis, Jo-Anne Dalziel, Kim |
author_sort | Tew, Michelle |
collection | PubMed |
description | BACKGROUND: Recruitment of participants is crucial to the success of randomised control trials (RCTs) but can be challenging and expensive. Current research on trial efficiency is often focused at the patient-level with an emphasis on effective recruitment strategies. Less is known about selection of study sites to optimise recruitment. We examine site-level factors that are associated with patient recruitment and cost efficiency using data from an RCT conducted across 25 general practices (GP) in Victoria, Australia. METHODS: Data on number of participants screened, excluded, eligible, recruited, and randomised from each study site were extracted from a clinical trial. Details regarding site characteristics, recruitment practices, and staff time commitment were collected using a three-part survey. The key outcomes assessed were recruitment efficiency (ratio of screened to randomised), average time, and cost for each participant recruited and randomised. To identify practice-level factors associated with efficient recruitment and lower cost, outcomes were dichotomised (25th percentile vs others) and each practice-level factor assessed against the outcomes to determine its association. RESULTS: Across 25 GP study sites, 1968 participants were screened of which 299 (15.2%) were recruited and randomised. The mean recruitment efficiency was 7.2, varying from 1.4 to 19.8 across sites. The strongest factor associated with efficiency was assigning clinical staff to identify potential participants (57.14% vs. 22.2%). The more efficient sites were smaller practices and were more likely to be rural locations and in areas of lower socioeconomic status. The average time used for recruitment was 3.7 h (SD2.4) per patient randomised. The mean cost per patient randomised was $277 (SD161), and this varied from $74 to $797 across sites. The sites identified with the 25% lowest recruitment cost (n = 7) were more experienced in research participation and had high levels of nurse and/or administrative support. CONCLUSION: Despite the small sample size, this study quantified the time and cost used to recruit patients and provides helpful indications of site-level characteristics that can help improve feasibility and efficiency of conducting RCT in GP settings. Characteristics indicative of high levels of support for research and rural practices, which often tends to be overlooked, were observed to be more efficient in recruiting. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07177-4. |
format | Online Article Text |
id | pubmed-9985191 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-99851912023-03-05 Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis Tew, Michelle Catchpool, Max Furler, John De La Rue, Katie Clarke, Philip Manski-Nankervis, Jo-Anne Dalziel, Kim Trials Research BACKGROUND: Recruitment of participants is crucial to the success of randomised control trials (RCTs) but can be challenging and expensive. Current research on trial efficiency is often focused at the patient-level with an emphasis on effective recruitment strategies. Less is known about selection of study sites to optimise recruitment. We examine site-level factors that are associated with patient recruitment and cost efficiency using data from an RCT conducted across 25 general practices (GP) in Victoria, Australia. METHODS: Data on number of participants screened, excluded, eligible, recruited, and randomised from each study site were extracted from a clinical trial. Details regarding site characteristics, recruitment practices, and staff time commitment were collected using a three-part survey. The key outcomes assessed were recruitment efficiency (ratio of screened to randomised), average time, and cost for each participant recruited and randomised. To identify practice-level factors associated with efficient recruitment and lower cost, outcomes were dichotomised (25th percentile vs others) and each practice-level factor assessed against the outcomes to determine its association. RESULTS: Across 25 GP study sites, 1968 participants were screened of which 299 (15.2%) were recruited and randomised. The mean recruitment efficiency was 7.2, varying from 1.4 to 19.8 across sites. The strongest factor associated with efficiency was assigning clinical staff to identify potential participants (57.14% vs. 22.2%). The more efficient sites were smaller practices and were more likely to be rural locations and in areas of lower socioeconomic status. The average time used for recruitment was 3.7 h (SD2.4) per patient randomised. The mean cost per patient randomised was $277 (SD161), and this varied from $74 to $797 across sites. The sites identified with the 25% lowest recruitment cost (n = 7) were more experienced in research participation and had high levels of nurse and/or administrative support. CONCLUSION: Despite the small sample size, this study quantified the time and cost used to recruit patients and provides helpful indications of site-level characteristics that can help improve feasibility and efficiency of conducting RCT in GP settings. Characteristics indicative of high levels of support for research and rural practices, which often tends to be overlooked, were observed to be more efficient in recruiting. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07177-4. BioMed Central 2023-03-04 /pmc/articles/PMC9985191/ /pubmed/36869362 http://dx.doi.org/10.1186/s13063-023-07177-4 Text en © The Author(s) 2023 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 Tew, Michelle Catchpool, Max Furler, John De La Rue, Katie Clarke, Philip Manski-Nankervis, Jo-Anne Dalziel, Kim Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis |
title | Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis |
title_full | Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis |
title_fullStr | Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis |
title_full_unstemmed | Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis |
title_short | Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis |
title_sort | site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9985191/ https://www.ncbi.nlm.nih.gov/pubmed/36869362 http://dx.doi.org/10.1186/s13063-023-07177-4 |
work_keys_str_mv | AT tewmichelle sitespecificfactorsassociatedwithclinicaltrialrecruitmentefficiencyingeneralpracticesettingsacomparativedescriptiveanalysis AT catchpoolmax sitespecificfactorsassociatedwithclinicaltrialrecruitmentefficiencyingeneralpracticesettingsacomparativedescriptiveanalysis AT furlerjohn sitespecificfactorsassociatedwithclinicaltrialrecruitmentefficiencyingeneralpracticesettingsacomparativedescriptiveanalysis AT delaruekatie sitespecificfactorsassociatedwithclinicaltrialrecruitmentefficiencyingeneralpracticesettingsacomparativedescriptiveanalysis AT clarkephilip sitespecificfactorsassociatedwithclinicaltrialrecruitmentefficiencyingeneralpracticesettingsacomparativedescriptiveanalysis AT manskinankervisjoanne sitespecificfactorsassociatedwithclinicaltrialrecruitmentefficiencyingeneralpracticesettingsacomparativedescriptiveanalysis AT dalzielkim sitespecificfactorsassociatedwithclinicaltrialrecruitmentefficiencyingeneralpracticesettingsacomparativedescriptiveanalysis |