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. 2020 Jan 8;2020(1):CD011935. doi: 10.1002/14651858.CD011935.pub2

Michielsen 2013.

Methods Study design: prospective, randomised controlled clinical trial
Number of study centres: 1 probably
Study dates: not reported
Participants randomly assigned: unclear
Participants Inclusion criteria:
  • people with intermediate risk of non‐muscle invasive urothelial carcinoma of the bladder


Exclusion criteria:
  • not reported

Interventions Group A: MMC 40 mg in 50 mL 0.9% saline
Group B: BCG full dose
Procedure:
  • treatments weekly for 6 weeks, each group had a specific maintenance programme.

Outcomes Disease‐specific quality of life, measured with EORTC QLQ BLS24
Funding sources No information reported.
Declarations of interest No information reported.
Notes Congress abstract available only.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: no information reported to allow a judgement.
Allocation concealment (selection bias) Unclear risk Comment: no information reported to allow a judgement.
Blinding of participants and personnel (performance bias) 
 all outcomes Unclear risk Comment: no information reported to allow a judgement.
Blinding of outcome assessment (detection bias) 
 overall survival Unclear risk Comment: no information reported to allow a judgement.
Blinding of outcome assessment (detection bias) 
 recurrence and progression free survival Unclear risk Comment: no information reported to allow a judgement.
Blinding of outcome assessment (detection bias) 
 serious and non‐serious adverse effects Unclear risk Comment: no information reported to allow a judgement.
Blinding of outcome assessment (detection bias) 
 quality of life Unclear risk Comment: no information reported to allow a judgement.
Incomplete outcome data (attrition bias) 
 Survival outcomes Unclear risk Comment: no information reported to allow a judgement.
Incomplete outcome data (attrition bias) 
 Adverse effect outcomes Unclear risk Comment: no information reported to allow a judgement.
Incomplete outcome data (attrition bias) 
 Quality of life outcomes Unclear risk Comment: no information reported to allow a judgement.
Selective reporting (reporting bias) Unclear risk Comment: no study protocol available.
Other bias Unclear risk Comment: no information reported to allow a judgement.