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.