Mangiarotti 2008.
Methods |
Study design: prospective, randomised clinical trial Number of study centres: 1 Study dates: recruitment period not reported, follow‐up 12–108 months Participants randomly assigned: 92 |
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Participants |
Inclusion criteria:
Exclusion criteria:
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Interventions |
Group A: MMC 40 mg in 50 mL saline Group B: BCG Tice Procedure:
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Outcomes | Recurrence rate, recurrence‐free survival, adverse effects | |
Funding sources | Not reported. | |
Declarations of interest | No information on interests reported. | |
Notes | Sample size estimation required 97 participants to allow a 5% dropout and 92 remaining participants (46 in each group). The article reported on the 92 participants and on the 46 per group. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: no information |
Allocation concealment (selection bias) | Unclear risk | Comment: no information |
Blinding of participants and personnel (performance bias) all outcomes | Unclear risk | Comment: no information |
Blinding of outcome assessment (detection bias) overall survival | Unclear risk | Outcome not reported. |
Blinding of outcome assessment (detection bias) recurrence and progression free survival | High risk | Comment: no information on blinding. We assumed that there was no blinding. We assumed that the absence of blinding might have had an effect on the detection and measurement of subjective outcomes. |
Blinding of outcome assessment (detection bias) serious and non‐serious adverse effects | High risk | Comment: no information on blinding. We assumed that there was no blinding. We assumed that the absence of blinding might have had an effect on the detection and measurement of subjective outcomes. |
Blinding of outcome assessment (detection bias) quality of life | Unclear risk | Outcome not reported. |
Incomplete outcome data (attrition bias) Survival outcomes | Low risk | Comment: all participants entered the analysis (46/46 in each group). |
Incomplete outcome data (attrition bias) Adverse effect outcomes | Low risk | Comment: all participants entered the analysis (46/46 in each group). |
Incomplete outcome data (attrition bias) Quality of life outcomes | Unclear risk | Outcome not reported. |
Selective reporting (reporting bias) | Unclear risk | Comment: no study protocol available. |
Other bias | Low risk | Comment: we assumed that there was no risk for other bias. |