Zimmer 1997.
Methods | Prospective RCT of talc vs bleomycin pleurodesis for symptomatic MPE (USA) | |
Participants | Inclusion: MPE (all cell types); life expectancy > 1 month Exclusions: significant loculated effusions; trapped lung 40 procedures randomised in 35 participants |
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Interventions | All participants underwent tube thoracostomy (either at the end of a limited thoracotomy (two participants) or inserted at bedside (33 participants)). Tube remained on suction. After sclerosant injected intrapleurally, tube clamped for two hours and participant rotated Talc group: 5 g talc in 50 ml saline, with 20 ml 1% lignocaine. 1 dose Bleomycin group: 60 U bleomycin in 50 ml saline, with 20 ml 1% lignocaine. 1 dose |
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Outcomes | Effusion control on CXR (at a minimum of two weeks) Dyspnoea (according to functional class 1 ‐ 4) Pain (according to scale 0 ‐ 10) Cost Length of hospital stay |
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Notes | People with trapped lung excluded Participants only included in primary analysis if out of hospital and able to attend follow up at two weeks Study authors emailed for more information, but no response Included in network meta‐analysis for pleurodesis efficacy |
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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) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not explicitly stated but drugs had different appearances |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Symptom recurrence, pain, breathlessness, duration of stay and adverse events could all be biased by lack of blinding. Not stated radiology reported blindly |
Incomplete outcome data (attrition bias) All outcomes | High risk | No clear time point when follow up performed. Only those available for follow up included in the analysis. Unclear how many randomised to each arm (only data on numbers analysed by treatment arm) |
Selective reporting (reporting bias) | Low risk | All outcomes reported on |
Other bias | Low risk | No other biases identified |
ECOG: electrocochleography
IV: intravenous
LTFU: loss to follow up
QOL: quality of life
RCT: randomised controlled trial