Hillerdal 1986.
Methods | Multi‐centre RCT of pleurodesis using Corynbacterium parvum vs bleomycin (Sweden) | |
Participants | Inclusion criteria: pleural effusion due to metastases from cytologically‐ or histologically‐proven bronchogenic carcinoma or adenocarcinoma; at least two previous aspirations of effusion 40 participants randomised |
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Interventions |
Corynebacterium parvum 7 mg in 10 ‐ 20 ml saline IP or bleomycin 60 mg in 100 ml saline intrapleurally A second dose of the allocated agent was given if the first was ineffective No details given about method of drainage prior to instillation of pleurodesis agent or how long the drain remained in place |
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Outcomes | Pleurodesis success ("Success" = no recurrence of fluid within six weeks; "Partial success" = 2 instillations required within six weeks, with no recurring effusion within six weeks of the second instillation) | |
Notes | People with trapped lung eligible for trial entry For the purposes of this review, if participants required more than one treatment due to effusion recurrence within six weeks, they were counted as a failure Included in network meta‐analysis for pleurodesis efficacy, 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) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No specific mention of blinding but drugs reconstituted in different volumes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Definition of pleurodesis efficacy quite vague and not stated if blinded. Side effect reporting may be influenced by lack of blinding of participants and personnel |
Incomplete outcome data (attrition bias) All outcomes | High risk | No data on mortality. Numbers don't add up for side effects data |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Low risk | No other biases identified |