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

Clementsen 1998.

Methods Single centre RCT of tetracycline pleurodesis using a small percutaneous catheter (CH10), compared to a large‐bore chest tube (CH24) inserted after thoracoscopy (Denmark)
Participants Symptomatic, recurrent MPE, proven on pleural fluid cytology. Expected survival of > 3 months (all tumour types included)
21 participants randomised
Interventions Group 1: small percutaneous catheter (CH10 65 cm) inserted under local anaesthesia
Group 2: medical thoracoscopy, followed by insertion of a large‐bore chest tube (CH24)
Both groups received pleurodesis with 500 mg tetracycline and 100 mg bupivicaine intrapleurally. The drain was clamped for six hours after instillation after which suction was applied. Drain removed when fluid output < 200 ml in 24 hours
Outcomes Treatment response at 3, 6 and 9 weeks defined by roentgenographic response ('Complete response' ‐ no recurrence of pleural fluid; 'Partial response' ‐ slight re‐accumulation with blunted costophrenic angle; 'No response' ‐ complete recurrence of pleural fluid) and clinical response (by the need for new thoracentesis)
Questionnaire evaluating discomfort in connection with the tube and the pleurodesis
Notes Trapped lung not accounted for in inclusion/exclusion criteria, but one patient excluded as they had hydropneumothorax at time of instillation
CR and PR included as pleurodesis successes for analysis
Not included in network meta‐analysis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Allocation by lot"
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not possible to blind, as different drain sizes used (although not stated explicitly in the paper)
Blinding of outcome assessment (detection bias) 
 All outcomes High risk "All data were evaluated by the same physician, who was without knowledge of the result of the randomisation". However, symptom‐based adverse events and symptomatic need for repeat pleural intervention may be biased by lack of patient blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All data reported and justified. Missing outcome data balanced between the two treatment arms (two excluded from group 1 (one died of cancer soon after drain insertion and one developed hydropneumothorax necessitating large‐bore drain), one excluded from group 2 (patient withdrew consent for study participation)
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias Low risk No other biases identified