Summary of findings 5. Participant information leaflet (PIL) developed with feedback from users vs usual PIL.
| Participant information leaflet (PIL) developed with feedback from users vs usual PIL | |||||
| Patient or population: individuals eligible for a trial Settings: any Intervention: PIL developed with feedback from users Comparison: usual PIL | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | |
| Effect with usual PIL | Effect with PIL developed with feedback from users | ||||
| Number recruited | As measureda | RR 1.09 (0.96 to 1.25) | 16763 (2 studies) | ⊕⊕⊕⊝ Moderatec | |
| 5 per 100 |
5 per 100 (5 to 6) |
||||
| Lowb | |||||
| 10 per 100 | 11 per 100 (10 to 13) | ||||
| Moderateb | |||||
| 30 per 100 | 33 per 100 (29 to 38) | ||||
| Highb | |||||
| 50 per 100 | 55 per 100 (48 to 63) | ||||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The effect with a PIL developed with feedback from users (and its 95% confidence interval) is based on the assumed risk in the comparison group (usual PIL) and the relative effect of the intervention (and its 95% CI). CI: confidence interval; 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. cWe downgraded evidence by 1 level because of indirectness: Chen 2011 actually measures entry to pre‐randomisation phase, not recruitment.