Alavi 2011.
| Methods | Single centre RCT of povidone‐iodine and bleomycin pleurodesis for malignant pleural effusion (Iran) | |
| Participants | Inclusion: biopsy or cytologically proven malignant pleural effusion (all tumour types); recurrent and symptomatic effusion; chest radiograph confirming lung expansion of 90% after thoracentesis; Karnofsky Performance Score > 70 Exclusion: co‐morbidities that preclude general anaesthesia; bleeding disorders; massive thoracic skin infiltration; active infectious disease 39 participants randomised |
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| Interventions | All participants underwent a 28 Fr intercostal drain under local anaesthetic (+/‐ IV opiates if required). Study agent administered intrapleurally the next day with 5 ml 2% lidocaine Bleomycin group: 1 mg/kg bleomycin in 60 ml saline. 1 dose Povidone‐iodine group: 5% (volume unclear). 1 dose After administration of the study agent, the drain was clamped for one hour and removed when < 200ml fluid output/day. If the fluid output remained high after 10 days, they were discharged home with a Heimlich valve in place |
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| Outcomes | Effusion recurrence on chest x‐ray at 30 days Pain (measured by numeric scale) at discharge and day 30 Dysponea (measured by numeric scale) at discharge and day 30 |
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| Notes | Minimal raw data in results section ‐ tables quoted in text but not available on line. Attempted to contact study authors by e mails ‐ no response People with trapped lung excluded from trial entry Pleurodesis success measured only using chest x‐ray criteria 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) | Low risk | Block randomisation |
| Allocation concealment (selection bias) | Low risk | Block randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Differing appearances of bleomycin and iodine make blinding not possible (although not stated explicitly in paper) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Pain and dyspnoea may be biased by lack of blinding. Not stated whether CXRs were evaluated by a blinded clinician. No response from study authors regarding this |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unable to see the tables. Response rates only given as % (no actual numbers), so unclear whether there was LTFU |
| Selective reporting (reporting bias) | Unclear risk | Raw data not provided for many of the outcomes. Tables missing |
| Other bias | Low risk | No other biases identified |