Maskell 2004.
Methods | Single centre RCT comparing pleurodesis using mixed particle Talc (>50% of particles are <20μm) vs graded Talc (<50% of particles are <20μm) (UK) | |
Participants | Inclusion: Symptomatic pleural effusion, proven to be malignant by cytology or pleural biopsy (all cell types). Exclusion: Expected survival <6 weeks; bleeding diathesis contraindicating intercostal drain insertion; extensive trapped lung; previous ipsilateral pleurodesis; Age <18; Inability to give informed consent. 48 patients randomised. |
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Interventions | 12Fr intercostal drain inserted. Drainage until <150ml/day output. Agent instilled and left in for 2 hours, before suction being applied. Drain removed after 48 hours. Mixed particle talc group: >50% of talc particles are <20μm. Single 4g intrapleural dose. Graded talc group: <50% of talc particles are <20μm. Single 4g intrapleural dose. |
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Outcomes | Change in Aa gradient 48hours post pleurodesis breathing air Change in PaO2 at 48hours post pleurodesis Clinical efficacy of pleurodesis at 3 months Presence/absence of fever at 48hours Change in CRP Change in IL8 |
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Notes | Patients with trapped lung excluded. Pleurodesis success defined as no re‐accumulation of pleural fluid sufficient to require drainage. Paper presented 2 trials and only trial 2 was relevant to this review (trial 1 was RCT of mixed talc vs tetracycline, but pleurodesis success data was not collected) Not included in network meta‐analysis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | pre‐sealed numbered, opaque, sealed envelopes with stratification |
Allocation concealment (selection bias) | Low risk | pre‐sealed numbered, opaque, sealed envelopes with stratification |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | 'investigators and patients blind to treatment allocation' (personal communication with authors) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | 'investigators and patients blind to treatment allocation' (personal communication with authors) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data justified and balanced between the 2 groups (3 patients LTFU) |
Selective reporting (reporting bias) | Unclear risk | The study comprised of two sections and pleurodesis success only reported for the particle size section. The RCT of talc/tetracycline did not report pleurodesis success but this was not one of the pre‐defined outcome measures. |
Other bias | Low risk | No other biases identified |