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. 2016 May 8;2016(5):CD010529. doi: 10.1002/14651858.CD010529.pub2

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
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
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
Notes Translated from German
People with trapped lung excluded from participation
Included in network meta‐analysis for pleurodesis efficacy, mortality, fever and pain
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