Kuzdzal 2003.
| Methods | Single centre, prospective RCT of talc vs doxycyline in the control of MPE (Poland) | |
| Participants | Inclusion criteria: pleural effusion with clinical suspicion of malignant origin Exclusion criteria: failure to confirm malignancy by pleural biopsy; mesothelioma; failure to achieve full re‐expansion of the lung 33 participants randomised |
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| Interventions | All participants all VATS under general anaesthetic and pleural biopsy. First dose of sclerosant given at end of procedure. Tube removed when full re‐expansion, no air leak and < 150 ml/day drainage. Rotation after procedure Talc: single 10 g dose intrapleurally by insufflation Doxycycline: 500 mg in 25 ml solution given intrapleurally. Up to 3 doses (if daily drainage > 150 ml/day) |
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| Outcomes | 'Long term' and 'short term' pleurodesis outcome (defined by need for repeat thoracentesis as 'Excellent' (no fluid re‐accumulation), 'Good' (limited residual fluid, not increasing, no indications for thoracentesis) or 'Poor' (fluid re‐accumulation requiring thoracentesis) Complications |
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| Notes | For purposes of this review, 'Excellent' and 'Good' pleurodesis outcomes included as pleurodesis successes for analysis Study authors emailed for further information, but no response Included in network meta‐analysis for pleurodesis efficacy |
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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 | Unable to blind due to the nature of the interventions, although not stated explicitly |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Pleurodesis efficacy defined by symptom recurrence and hence could be biased by lack of blinding. Not stated whether assessment of fluid re‐accumulation was performed by a blinded individual |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number of participants randomised not clear from paper |
| Selective reporting (reporting bias) | High risk | Treatment complications and survival not reported |
| Other bias | High risk | Number of doses for the two arms, therefore potential for confounding |