Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis
Abstract 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 sel...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07177-4 |
| _version_ | 1797863606647259136 |
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| author | Michelle Tew Max Catchpool John Furler Katie De La Rue Philip Clarke Jo-Anne Manski-Nankervis Kim Dalziel |
| author_facet | Michelle Tew Max Catchpool John Furler Katie De La Rue Philip Clarke Jo-Anne Manski-Nankervis Kim Dalziel |
| author_sort | Michelle Tew |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-04-09T22:39:18Z |
| format | Article |
| id | doaj.art-5ecfd12ef3a44b02b40adbc1fbe6f09d |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T22:39:18Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-5ecfd12ef3a44b02b40adbc1fbe6f09d2023-03-22T12:17:29ZengBMCTrials1745-62152023-03-012411810.1186/s13063-023-07177-4Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysisMichelle Tew0Max Catchpool1John Furler2Katie De La Rue3Philip Clarke4Jo-Anne Manski-Nankervis5Kim Dalziel6Centre for Health Policy, Melbourne School of Population and Global Health, The University of MelbourneCentre for Health Policy, Melbourne School of Population and Global Health, The University of MelbourneDepartment of General Practice, University of MelbourneDepartment of General Practice, University of MelbourneCentre for Health Policy, Melbourne School of Population and Global Health, The University of MelbourneDepartment of General Practice, University of MelbourneCentre for Health Policy, Melbourne School of Population and Global Health, The University of MelbourneAbstract 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.https://doi.org/10.1186/s13063-023-07177-4Recruitment efficiencyCostClinical trialDiabetesGeneral practice |
| spellingShingle | Michelle Tew Max Catchpool John Furler Katie De La Rue Philip Clarke Jo-Anne Manski-Nankervis Kim Dalziel Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis Trials Recruitment efficiency Cost Clinical trial Diabetes General practice |
| 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 | Recruitment efficiency Cost Clinical trial Diabetes General practice |
| url | https://doi.org/10.1186/s13063-023-07177-4 |
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