Ozkul 2014.
Methods | Single centre, prospective RCT comparing rapid and standard drainage prior to talc slurry pleurodesis (Turkey) | |
Participants | Inclusion: potentially recurrent histologically &/or cytologically proven malignant pleural effusion (all cell types) Exclusion: participants whose lung did not expand; endobronchial lesion; suitable for curative therapy 79 participants randomised |
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Interventions | All participants underwent insertion of a 12 Fr chest drain in the posterior axillary lune with local anaesthetic (bupivacaine) and IM ketorolac Rapid group: 1 litre drained every eight hours until complete drainage. Then talc slurry administered once CXR showed complete fluid evacuation and no trapped lung Standard group: drainage of a maximum of 1.5 litre/day. Talc slurry administered once CXR showed complete fluid evaluation and no trapped lung and pleural fluid drainage < 300 ml/day |
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Outcomes | Primary outcome: efficacy of pleurodesis assessed at 1, 2, 3, and 6 months Secondary outcome: hospital length of stay |
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Notes | people with trapped lung excluded from study entry Pleurodesis efficacy defined using a combination of radiology and symptomatic effusion re‐accumulation 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 | Internet‐based random‐number generator |
Allocation concealment (selection bias) | Unclear risk | Not stated and no response from study authors |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind given nature of two treatment groups with such different drainage regimes |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The assessment of success was performed by an investigator blinded to allocation" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear if any LTFU‐ not stated in paper and no response from study authors |
Selective reporting (reporting bias) | High risk | Minimal data provided on side effect and mortality data. Not all time points reported as stated in methods |
Other bias | Low risk | No other sources of bias identified |