Ostrowski 1989.
| Methods | Multi‐centre RCT bleomycin vs Corynebacterium parvum in MPE (UK) | |
| Participants | Inclusion criteria: histocytologically proven malignancy with effusion (all cell types); life expectancy of > 30 days Exclusion criteria: previous intrapleural drug administration; change in cancer treatment in previous 30 days 58 participants randomised |
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| Interventions | Aspiration of effusion with a cannula. Study drug instilled through the cannula. After cannula removed, participantrepositioned every five minutes Bleomycin group: 60 mg bleomycin in 100 ml saline. Single dose intrapleurally C. parvum group: 7 mg in 20 ml saline. Single dose intrapleurally |
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| Outcomes | Efficacy of pleurodesis agent at 30 days (defined as 'complete response' (CR) (no re‐accumulation of fluid confirmed by CXR), 'partial response' (PR) (minimal fluid re‐accumulation not sufficient to produce symptoms &/or need for a further aspiration) or 'failure') Duration of treatment response Toxicity Efficacy of pleurodesis at 2, 3, 6, 9 and 12 months |
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| Notes | People with trapped lung included in the study For this review, CR and PR counted as pleurodesis success 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) | Low risk | Sequentially labelled sealed envelopes |
| Allocation concealment (selection bias) | Low risk | Sequentially labelled sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not stated explicitly, but agents given as different volumes |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Symptom recurrence and side effect reporting would be influenced by lack of blinding. Not stated if CXR assessment was blinded. Mortality data would not be biased by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 14/58 (24%) excluded from primary analysis due to death or not receiving drug. But, balanced numbers between the groups |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
| Other bias | Low risk | No other biases identified |