Discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitment
Background: A randomised controlled trial (RCT) in general practice, recruiting incident patients with (sub)acute sciatica, was discontinued because of insufficient recruitment. Aim: To describe factors that influenced the recruitment process and ultimately led to discontinuation of this trial, and...
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| Format: | Article |
| Language: | English |
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Royal College of General Practitioners
2017-10-01
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| Series: | BJGP Open |
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| Online Access: | https://bjgpopen.org/content/1/3/bjgpopen17X101085 |
| _version_ | 1811242008249892864 |
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| author | Wendelien H van der Gaag Roxanne van den Berg Bart W Koes Arthur M Bohnen Lonny MG Hazen Wilco C Peul Leen Voogt Arianne P Verhagen Sita MA Bierma-Zeinstra Pim AJ Luijsterburg |
| author_facet | Wendelien H van der Gaag Roxanne van den Berg Bart W Koes Arthur M Bohnen Lonny MG Hazen Wilco C Peul Leen Voogt Arianne P Verhagen Sita MA Bierma-Zeinstra Pim AJ Luijsterburg |
| author_sort | Wendelien H van der Gaag |
| collection | DOAJ |
| description | Background: A randomised controlled trial (RCT) in general practice, recruiting incident patients with (sub)acute sciatica, was discontinued because of insufficient recruitment. Aim: To describe factors that influenced the recruitment process and ultimately led to discontinuation of this trial, and to enable others to learn from this experience. Design & setting: A pragmatic RCT was designed to compare two pain medication prescription strategies for treatment of (sub)acute sciatica in general practice. After 1 year of patient recruitment, the trial was prematurely terminated. Method: To analyse the underperforming recruitment, patient information systems of 20 general practices were screened twice a month to search for eligible patients and identify reasons for non-eligibility. Secondly, after study termination, an open question was distributed to the participating GPs for their views on the recruitment process. Results: A total of 116 GPs from 37 general practices collaborated in the trial. Only eight of 234 patients were included after 12 months. The 22 GPs who offered their opinion on the main reasons for unsuccessful recruitment considered that these were the low incidence rate and strict eligibility criteria, a strong patient and/or GP preference, and time constraints. Conclusion: For this RCT, multiple factors were related to recruitment problems but it remains unknown which determinants prevailed. As the research question is unanswered but remains relevant, it is recommended that GPs’ daily practice is taken into account when designing an RCT, a pilot study should be performed for feasibility of recruitment, and GP assistants should be involved at an early stage. |
| first_indexed | 2024-04-12T13:45:29Z |
| format | Article |
| id | doaj.art-18c33d0c64704d0da95b87481acfacb1 |
| institution | Directory Open Access Journal |
| issn | 2398-3795 |
| language | English |
| last_indexed | 2024-04-12T13:45:29Z |
| publishDate | 2017-10-01 |
| publisher | Royal College of General Practitioners |
| record_format | Article |
| series | BJGP Open |
| spelling | doaj.art-18c33d0c64704d0da95b87481acfacb12022-12-22T03:30:42ZengRoyal College of General PractitionersBJGP Open2398-37952017-10-011310.3399/bjgpopen17X101085Discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitmentWendelien H van der Gaag0Roxanne van den Berg1Bart W Koes2Arthur M Bohnen3Lonny MG Hazen4Wilco C Peul5Leen Voogt6Arianne P Verhagen7Sita MA Bierma-Zeinstra8Pim AJ Luijsterburg9Department of General Practice, Erasmus MC, University Medical Center, Rotterdam, The NetherlandsDepartment of General Practice, Erasmus MC, University Medical Center, Rotterdam, The NetherlandsDepartment of General Practice, Erasmus MC, University Medical Center, Rotterdam, The NetherlandsDepartment of General Practice, Erasmus MC, University Medical Center, Rotterdam, The NetherlandsDepartment of General Practice, Erasmus MC, University Medical Center, Rotterdam, The NetherlandsDepartment of Neurosurgery, Leiden University Medical Center, Leiden, The NetherlandsDutch Association for Back Pain Patients, Lichtenvoorde, The NetherlandsDepartment of General Practice, Erasmus MC, University Medical Center, Rotterdam, The NetherlandsDepartments of General Practice and Orthopedics, Erasmus MC, University Medical Center, Rotterdam, The NetherlandsDepartment of General Practice, Erasmus MC, University Medical Center, Rotterdam, The NetherlandsBackground: A randomised controlled trial (RCT) in general practice, recruiting incident patients with (sub)acute sciatica, was discontinued because of insufficient recruitment. Aim: To describe factors that influenced the recruitment process and ultimately led to discontinuation of this trial, and to enable others to learn from this experience. Design & setting: A pragmatic RCT was designed to compare two pain medication prescription strategies for treatment of (sub)acute sciatica in general practice. After 1 year of patient recruitment, the trial was prematurely terminated. Method: To analyse the underperforming recruitment, patient information systems of 20 general practices were screened twice a month to search for eligible patients and identify reasons for non-eligibility. Secondly, after study termination, an open question was distributed to the participating GPs for their views on the recruitment process. Results: A total of 116 GPs from 37 general practices collaborated in the trial. Only eight of 234 patients were included after 12 months. The 22 GPs who offered their opinion on the main reasons for unsuccessful recruitment considered that these were the low incidence rate and strict eligibility criteria, a strong patient and/or GP preference, and time constraints. Conclusion: For this RCT, multiple factors were related to recruitment problems but it remains unknown which determinants prevailed. As the research question is unanswered but remains relevant, it is recommended that GPs’ daily practice is taken into account when designing an RCT, a pilot study should be performed for feasibility of recruitment, and GP assistants should be involved at an early stage.https://bjgpopen.org/content/1/3/bjgpopen17X101085primary health caregeneral practicerandomized controlled trialpatient recruitmentearly termination of clinical trialsstudy design |
| spellingShingle | Wendelien H van der Gaag Roxanne van den Berg Bart W Koes Arthur M Bohnen Lonny MG Hazen Wilco C Peul Leen Voogt Arianne P Verhagen Sita MA Bierma-Zeinstra Pim AJ Luijsterburg Discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitment BJGP Open primary health care general practice randomized controlled trial patient recruitment early termination of clinical trials study design |
| title | Discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitment |
| title_full | Discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitment |
| title_fullStr | Discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitment |
| title_full_unstemmed | Discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitment |
| title_short | Discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitment |
| title_sort | discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitment |
| topic | primary health care general practice randomized controlled trial patient recruitment early termination of clinical trials study design |
| url | https://bjgpopen.org/content/1/3/bjgpopen17X101085 |
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