Related Experiment Videos
Recruiting patients to randomized trials in primary care: principles and case study
1Centre for Health Economics, University of York, York YO1 5DD and Institute of Rehabilitation, University of Hull, Hull, UK.
Background:
There are many factors affecting recruitment to trials in primary care, and trials are often jeopardized due to the inability to enter sufficient patient numbers. It is generally agreed that the interest in and commitment of GPs to the project are important, and their forgetfulness and time pressures are major factors which mitigate against maximal recruitment.
Objectives:
The aim of this study is to focus on maximizing recruitment of patients to a randomized controlled trial of exercise classes for back pain patients.
Methods:
Two distinct methods of recruitment were used. One practice provided a computerized list of names and asked patients' permission, by letter, to be contacted by the researchers. The other 18 practices manually recorded referrals after the consultation by the GP.
Results:
Referral rates were slower than expected. Many patients either did not fit the inclusion criteria or excluded themselves due to domestic commitments or work. During 24 months, 1588 patients were referred. A total of 187 patients (12%) met the criteria and could be included in the study. The practice which referred patients through a computerized listing contributed 44% of the patients successfully included in the study.
Conclusions:
Recruitment rates depended on the method and rate of GP referrals, the proportion of referrals meeting the entry criteria and the proportion of patients available to attend the exercise classes.
Insights
Maximizing patient recruitment for exercise trials is crucial. Computerized patient lists significantly improved enrollment compared to manual GP referrals, highlighting effective strategies for clinical trial success.
Area of Science:
- Clinical Trial Recruitment
- Primary Care Research
- Health Services Research
Background:
- Recruitment challenges in primary care trials can jeopardize study completion.
- General practitioner (GP) interest and time constraints significantly impact patient enrollment.
- Effective strategies are needed to overcome barriers to maximal recruitment in clinical studies.
Purpose of the Study:
- To optimize patient recruitment for a randomized controlled trial focused on exercise interventions for back pain.
- To identify and evaluate methods for maximizing patient enrollment in primary care settings.
Main Methods:
- Comparison of two recruitment strategies: computerized patient listing with prior consent versus manual GP referral recording.
- Data collection over 24 months involving 19 primary care practices.
- Analysis of referral rates, patient eligibility, and successful inclusion in the study.
Main Results:
- Overall referral rates were lower than anticipated, with many patients ineligible or self-excluding.
- Out of 1588 referred patients over 24 months, only 187 (12%) met inclusion criteria.
- Practices utilizing computerized patient lists achieved 44% of all successfully included participants.
Conclusions:
- Patient recruitment success is influenced by the GP referral method and rate.
- The proportion of referred patients meeting eligibility criteria is a key factor.
- Patient availability and commitment to attending exercise classes impact overall trial recruitment.