Millar 1980.
Methods | RCT of intrapleural Corynebacterium parvum vs mustine in recurrent MPE (UK) | |
Participants | Recurrent effusion associated with histologically proved malignant disease (all cell types); at least two previous pleural aspirations; symptoms of dyspnoea, cough or local pain 21 participants randomised |
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Interventions | Effusion completely aspirated using an Abrams pleural biopsy needle Group A: intrapleural mustine 20 mg (max 2 doses) Group B: intrapleural C. parvum 7 mg (max 2 doses) |
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Outcomes | Response to pleurodesis (defined by fluid re‐accumulation on CXR and need for repeat aspiration ‐ success/partial success/failure) at four weeks Symptoms (nausea, vomiting, pain) |
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Notes | Trapped lung not accounted for Only 'success' counted as a pleurodesis success for analysis (not partial successes as these participants required a further aspiration of effusion) Included in network meta‐analysis for pleurodesis efficacy and mortality |
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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 | Unclear risk | No mention of blinding in the paper |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of blinding in the paper. If unblinded, symptom and side effect reporting could have been biased |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Three participants excluded from analysis as died before primary outcome measure |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Low risk | Unclear who provided C. parvum and their study involvement |