4. Gemcitabine compared to BCG.
| Patient or population: participants with non‐muscle invasive bladder cancer1 (54 men, 10 women) Country: Italy Setting: single center, likely inpatients Intervention: gemcitabine Comparison: BCG | |||||
| Outcomes | № of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
| Risk with BCG | Risk difference with Gemcitabine | ||||
|
Time to recurrence Follow‐up: mean 44 months MCID: 5% absolute difference |
64 (1 RCT) | ⊕⊕⊝⊝ Lowa,b | HR 10.07 (4.48 to 22.63) | Study population | |
| 478 per 1000 | 521 more per 1000 (468 more to 522 more) | ||||
|
Time to progression Follow‐up: mean 44 months MCID: 5% absolute difference |
64 (1 RCT) | ⊕⊝⊝⊝ Verylowa,c | Not estimable | No events | No events |
| Grade III–V adverse events | Not reported | — | — | — | — |
| Time to death from bladder cancer | Not reported | — | — | — | — |
| Time to death from any cause | Not reported | — | — | — | — |
| Grade I or II adverse events | Not reported | — | — | — | — |
| Disease‐specific quality of life | Not reported | — | — | — | — |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BCG: Bacillus Calmette‐Guérin; CI: confidence interval; MCID: minimal clinically important difference; HR: hazard ratio; RCT: randomized controlled trial. | |||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | |||||
1The analysis was only based on participants with primary high‐risk non‐muscle invasive bladder cancer; the only included study did not include participants with recurrent disease.
aDowngraded one level for study limitations: unclear or high risk of bias on one or more domains.
bDowngraded one level for imprecision: outcome based on only a single study of a small number of participants.
cDowngraded two levels for imprecision: no events in either arm.