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. 2018 Feb 22;2018(2):MR000013. doi: 10.1002/14651858.MR000013.pub6

Summary of findings for the main comparison. Open trial versus blinded trial.

Open RCT versus blinded RCT
Patient or population: individuals eligible for a trial
 Settings: any
 Intervention: open trial
 Comparison: blinded, placebo trial
Outcomes Illustrative effects* (95% CI) Relative effect
 (95% CI) No of participants
 (studies) Quality of the evidence
 (GRADE)
Effect with blinded trial Effect with open trial
Number recruited As measureda RR 1.25 
 (1.18 to 1.34) 4833
 (2 studies) ⊕⊕⊕⊕
 High
41 per 100 50 per 100 (51 to 55)
Lowb  
10 per 100 13 per 100
 (12 to 13)
Moderateb
30 per 100 38 per 100
 (35 to 40)
Highb
50 per 100 63 per 100
 (59 to 67)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The effect for the open trial (and its 95% confidence interval) is based on the assumed risk in the the comparison group (blinded trial) and the relative effect of the intervention (and its 95% CI).
 CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence
 High quality: further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low quality: we are very uncertain about the estimate.

aThis is the baseline recruitment measured in the studies presented in the 'Summary of findings' table.
 bWe selected the low, moderate and high illustrative recruitment levels of 10%, 30% and 50% based on our prior experience with trial recruitment.