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. 2016 May 8;2016(5):CD010529. doi: 10.1002/14651858.CD010529.pub2

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
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
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)
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
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