Automated recruitment and randomisation for an efficient randomised controlled trial in primary care

Area of Science:

• Health Informatics
• Clinical Trial Methodology
• Primary Care Research

Background:

• Electronic health records and IT are increasingly used to enhance clinical trial efficiency.
• This study compares automated versus manual recruitment and randomisation methods in primary care.

Purpose of the Study:

• To evaluate methodological issues and data quality of automated versus manual recruitment and randomisation.
• To assess the feasibility of using automated systems for clinical trials in primary care settings.

Main Methods:

• A three-arm randomised controlled trial was conducted in primary care.
• Manual recruitment/randomisation involved monthly general practice visits.
• Automated recruitment/randomisation used a bespoke algorithm within the health check management system.

Main Results:

• 8588 participants recruited manually vs. 4093 automatically.
• Manual method was faster to implement but labour-intensive and led to data loss.
• Automated method had no data loss, and effect estimates were consistent between methods.

Conclusions:

• Automated recruitment and randomisation are feasible for primary care clinical trials.
• Future research should explore these automated techniques in diverse clinical and healthcare settings.