Rintoul 2014.
| Methods | Open label, multicentre parallel group RCT of VATS pleurectomy and talc pleurodesis (either slurry or poudrage) in mesothelioma (UK) | |
| Participants | Inclusion: age > 18; confirmed or suspected MPM with pleural effusion; fit enough for VATS pleurectomy Exclusion: previous pleurodesis; previous primary treatment for MPM; history of previous malignancy and suspected MPM Those with suspected MPM who were found to have a different cause after randomisation were excluded from analysis 196 participants randomised |
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| Interventions | VATS pleurectomy group: thoracoscopic debulking pleurectomy‐decortication under GA, according to agreed protocol Pleurodesis group: 4 g talc pleurodesis (either slurry or poudrage) |
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| Outcomes | Primary outcome: survival at one year post randomisation Secondary outcomes: presence or absence of effusion on CXR, QOL (EQ5D and QLQ‐LC13, QLQ‐C30), lung function and exercise tolerance, complications, healthcare utilisation costs |
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| Notes | People with trapped lung included. No data available on whether participants in the pleurodesis arm who had poudrage may have had trapped lung released at the same time Pleurodesis success defined according to CXR (as assessed by reporting radiologist, unblinded to treatment allocation) 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 | Computerised random‐number generator in blocks of 10. 1:1. stratified by EORTC score (low or high) |
| Allocation concealment (selection bias) | Low risk | Telephone randomisation line operated by staff independent to the study |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind due to nature of the interventions |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants and investigators not blinded, leading to potential bias in reporting of quality of life, exercise tolerance and complications. CXRs not interpreted blindly (personal communication with authors) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Participants excluded after randomisation if MPM not confirmed, but this was stated a‐priori. Missing data well balanced between the treatment arms |
| Selective reporting (reporting bias) | Low risk | Very thorough reporting of all stated outcomes |
| Other bias | Low risk | No other biases identified |