Schmidt 1997.
Methods | Multi‐centre RCT comparing pleurodesis using bleomycin with mitoxantrone (Germany). Paper in German | |
Participants | Inclusion: symptomatic, cytologically proven MPE; life expectancy > 3 months; WHO performance score 0‐2 Exclusion: prior chemotherapy or pleurodesis in previous four weeks; contraindication to bleomycin or mitoxantrone; persistent pneumothorax; leucopenia; thrombocytopaenia; incomplete pleural fluid drainage 102 participants randomised |
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Interventions | All participants had a 24 Fr chest drain inserted and left in situ for 48 hours Bleomycin group: single dose of 60 mg bleomycin in 100 ml saline intrapleurally Mitoxantrone group: single dose of 30 mg mitoxantrone in 100 ml saline intrapleurally Drains clamped for six hours after instillation and left in place for 24 ‐ 48 hours with or without suction |
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Outcomes | Pleurodesis success rate at four weeks (defined by recurrence of effusion requiring repeat pleural procedure) Toxicity/adverse events Length of hospital stay Time to repeat pleural intervention |
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Notes | Translated from German People with trapped lung excluded from participation Included in network meta‐analysis for pleurodesis efficacy, mortality, fever and pain |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Low risk | Telephone randomisation |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated if anyone was blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if anyone was blinded. If unblinded, symptom recurrence, adverse event reporting and length of stay could have been biased |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Six participants excluded from analysis, but reasons given and balanced numbers in the two treatment arms |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No other biases identified |