Terra 2015.
Methods | Single centre RCT evaluating three different doses of silver nitrate for pleurodesis in malignant pleural effusion (Brazil) | |
Participants | Inclusion criteria: recurrent and symptomatic MPE (with pleural histological or cytological confirmation); previous CXR showing full lung expansion (> 90%) after chest drainage; Karnofsky performance score > 40; written consent Exclusion criteria: trapped lung after pleural catheter insertion; haemorrhagic diathesis (PT < 50% or platelets < 80,000); active pleural or systemic infection; neoplastic infiltration of the skin at the site of pleural catheter insertion; inability to understand QoL questionnaires; contralateral pleurodesis < 30 days before study entry 60 participants randomised |
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Interventions | All participants were admitted for five days and had baseline assessment. All had a 14 Fr chest drain inserted under USS guidance prior to randomisation. The randomised interventions were given via the chest tube, which was then clamped for one hour. Drain removed on day 5. The silver nitrate was dissolved in 100 ml distilled water, which was passed through a 0.22 micrometer filter to ensure sterility within six hours of instillation Group 1: 30 ml of 0.3% silver nitrate (90 mg) given as a single dose intrapleurally Group 2: 30 ml of 0.5% silver nitrate (150 mg) given as a single dose intrapleurally Group 3: 60 ml of 0.3% silver nitrate (180 mg) given as a single dose intrapleurally |
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Outcomes | Primary outcome: occurrence of serious or severe adverse event during follow up Secondary outcomes: systemic inflammation (measured using CRP); chest pain (measured using VAS score); effusion recurrence (defined as need for additional pleural procedures during trial follow up); residual pleural cavity volume (calculated using difference between day 5 and day 30 on CT) |
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Notes | People with trapped lung excluded from study entry Pleurodesis failure defined as need for additional pleural procedure during follow up 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 | Block randomisation |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Pharmacy employees and clinicians who instilled the sclerosant were aware of treatment allocation, but these clinicians were not involved in patient follow up. Participants, investigators that followed participants up and rated their complications were blinded to group allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Pharmacy employees and clinicians who instilled the sclerosant were aware of treatment allocation, but these clinicians were not involved in patient follow up. Participants, investigators that followed participants up and rated their complications were blinded to group allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | LTFU well balanced and justified |
Selective reporting (reporting bias) | Low risk | No data provided for MRC dyspnoea score. Otherwise all predefined outcome measures reported |
Other bias | Low risk | No other biases identified |