Michielsen 2013.
Methods |
Study design: prospective, randomised controlled clinical trial Number of study centres: 1 probably Study dates: not reported Participants randomly assigned: unclear |
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Participants |
Inclusion criteria:
Exclusion criteria:
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Interventions |
Group A: MMC 40 mg in 50 mL 0.9% saline Group B: BCG full dose Procedure:
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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. |