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Published on: August 1, 2019
Discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitment
Wendelien H van der Gaag1, Roxanne van den Berg1, Bart W Koes2
1GP trainee and PhD student, Department of General Practice, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
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.
Insights
Recruitment challenges, including low incidence and strict criteria, led to the discontinuation of a randomized controlled trial (RCT) for subacute sciatica. Future RCTs should consider general practitioner daily practice and pilot studies for feasibility.
Area of Science:
- General Practice Research
- Clinical Trial Design
- Pain Management
Background:
- A randomized controlled trial (RCT) investigating pain medication strategies for subacute sciatica in general practice was halted due to insufficient patient recruitment.
- The trial aimed to compare two prescription strategies for incident cases of (sub)acute sciatica.
Purpose of the Study:
- To identify and describe factors contributing to recruitment difficulties and the eventual discontinuation of the sciatica RCT.
- To share lessons learned from this recruitment experience to inform future clinical trial design.
Main Methods:
- A pragmatic RCT design was employed to compare pain medication strategies in general practice.
- Patient information systems in 20 practices were screened to assess eligibility and identify non-recruitment reasons.
- Participating general practitioners (GPs) provided feedback on recruitment challenges post-termination.
Main Results:
- Only 8 out of 234 eligible patients were recruited over 12 months across 37 general practices involving 116 GPs.
- GPs cited low incidence rates, strict eligibility criteria, patient/GP preferences, and time constraints as primary recruitment barriers.
- The trial was prematurely terminated due to these recruitment issues.
Conclusions:
- Multiple factors complicated recruitment for this sciatica RCT, with the predominant determinants remaining unclear.
- Recommendations for future RCTs include: incorporating GP daily practice realities, conducting pilot studies for recruitment feasibility, and early engagement of GP assistants.
- The study highlights the importance of practical considerations in designing effective clinical trials for common conditions.
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