Open trial design (ID RET13)
Evidence Summary
What is it?
As opposed to a blinded placebo-controlled design, participants receive information based on the open trial design.
Does it work?
Randomising participants at recruitment to an open rather than a blinded trial may result in a large increase in retention.
How big is the effect?
An increase of 13% (95% confidence interval = 4% to 22%).
How certain are we?
GRADE Low certainty.
Recommendation
We recommend that trialists consider using an open trial design where possible.
How can I use this straight away?
See Resource bundle below for details on how to use an open trial design.
Practical Impact
Imagine initial retention is 65% of those approached. You have a trial with 100 participants that needs responses from 80 to meet its statistical power calculations. Retention of 65% means that you will be 15 responses short (see chart below).
Now imagine using open trial design. The chart below shows the impact of an absolute increase of 13% (95% CI = 4% to 22%). Retention is now 78%, which means our best estimate is that you would now only be 2 responses short.
Cumulative Meta-Analysis*
Resource Bundle
How to Cite
More Information
- This summary is from the Cochrane review of strategies to improve retention in randomised trials (https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.MR000032.pub3/full).
- The ‘Does it work?’ statement is structured according to effect size and GRADE certainty as per GRADE Guidelines 26 (https://doi.org/10.1016/j.jclinepi.2019.10.014). The statement is for large effect size and Low GRADE certainty.
- The recommendation statement is the consensus view of the authors of this summary based on the GRADE certainty and features of the trials contributing to the evidence.
- If you have any questions contact info@trialforge.org.
