3. Gemcitabine compared to saline (sensitivity analysis based on risk of bias).
| Patient or population: participants with non‐muscle invasive bladder cancer (344 men, 62 women) Country: US Setting: multicenter (23 centers), likely inpatients Intervention: gemcitabine Comparison: saline | |||||
| Outcomes | № of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
| Risk with salinea | Risk difference with gemcitabine | ||||
|
Time to recurrence Follow‐up: 4 years MCID: 5% absolute difference |
406 (1 RCT) | ⊕⊕⊕⊝ Moderateb | HR 0.66 (0.48 to 0.90) | Study population | |
| 470 per 1000 | 128 fewer per 1000 (207 fewer to 35 fewer) | ||||
|
Time to progression Follow‐up: 4 years MCID: 5% absolute difference |
406 (1 RCT) | ⊕⊕⊕⊕ High | HR 0.51 (0.17 to 1.50) | Study population | |
| 48 per 1000 | 23 fewer per 1000 (40 fewer to 23 more) | ||||
|
Grade III–V adverse events
assessed with: CTCAE version 3.0 and version 4.0 Follow‐up: 1 month MCID: 5% absolute difference |
340 (1 RCT) | ⊕⊕⊕⊝ Moderateb | RR 0.71 (0.20 to 2.46) | Study population | |
| 34 per 1000 | 10 fewer per 1000 (27 fewer to 50 more) | ||||
| Time to death from bladder cancer | Not reported | — | — | — | |
|
Time to death from any cause Follow‐up: 4 years MCID: 3% absolute difference |
406 (1 RCT) | ⊕⊕⊝⊝ Lowc | HR 0.68 (0.36 to 1.27) | Study population | |
| 121 per 1000 | 37 fewer per 1000 (76 fewer to 30 more) | ||||
|
Grade I or II adverse events
assessed with: CTCAE version 3.0 and version 4.0 Follow‐up: 1 month MCID: 5% absolute difference |
340 (1 RCT) | ⊕⊕⊕⊝ Moderateb | RR 1.20 (0.86 to 1.66) | Study population | |
| 269 per 1000 | 54 more per 1000 (38 fewer to 177 more) | ||||
| 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). CI: confidence interval; CTCAE: Common Terminology Criteria for Adverse Events; HR: hazard ratio; MCID: minimal clinically important difference; n: number of participants; RCT: randomized controlled trial; RR: risk ratio. | |||||
| 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. | |||||
aBaseline risk came from Messing 2018. bDowngraded one level for imprecision: confidence intervals crossed the assumed threshold of a clinically important difference. cDowngraded two levels for imprecision: confidence intervals crossed the line of no difference and the assumed threshold of a clinically important difference: wide confidence intervals.