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Path Analysis of RCT Recruitment: Secondary Analysis of Results from a Systematic Review
Nicole Jochym1, Lisa Y Lin2, Jon F Merz3
1363994Cooper Medical School of Rowan University, New Jersey, USA.
Summary
Recruitment screening and testing may slightly increase refusal rates in clinical trials, but obtaining consent after these steps significantly lowers refusal. Most trials secure consent post-eligibility determination.
Area of Science:
- Clinical research methodology
- Health services research
Background:
- Participant recruitment is crucial for clinical trial success.
- Understanding refusal points in recruitment is essential for improving trial efficiency.
Purpose of the Study:
- To analyze refusal rates at different stages of recruitment in pragmatic and comparative effectiveness trials.
- To identify factors influencing participant refusal to screen, test, and consent.
Main Methods:
- Systematic review of 71 pragmatic and comparative effectiveness trials.
- Path analysis to examine refusal rates at screening, testing, and consent stages.
- Statistical tests including Mann-Whitney and Wilcoxon rank-sum tests.
Main Results:
- Refusal rates for screening or testing were not significantly higher (p=0.11).
- Informed consent refusal rates were significantly lower when participants agreed to screening/testing (OR=0.40, p=0.008).
- Most trials obtained consent after eligibility determination, even with screening/testing.
Conclusions:
- While initial screening/testing may not significantly deter participation, obtaining consent post-eligibility is associated with lower refusal rates.
- Optimizing the consent process after eligibility assessment can enhance clinical trial recruitment.
- Further research into ethical implications and recruitment strategies is warranted.
Keywords:
comparative effectiveness trialinformed consentpath analysispragmatic trialrandomized controlled trialrecruitmentrefusal to participateMore Related Videos
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