Okur 2011.
Methods | Single centre RCT of intrapleural streptokinase in MPE undergoing chest drainage (Turkey) | |
Participants | Inclusion: definitive diagnosis of MPE with dyspnoea Exclusion: mesothelioma; endobronchial tumour causing obstruction; anticoagulant medication 48 participants randomised between Jan 2007 and Dec 2008 |
|
Interventions | All participants had 10 Fr pleural catheter inserted under local anaesthetic. Pleurodesis (5 g talc in 50 ml saline) given only in those patients with complete lung re‐expansion and < 250 ml drain output per day. Drain removed when output < 150 ml/day or after three days Those randomised to streptokinase received 3 doses of 250000 IU in 100 ml N saline at 12‐hourly intervals intrapleurally prior to pleurodesis |
|
Outcomes | Primary: lung expansion on chest X‐ray Secondary: success of pleurodesis at one month; Volume of 24‐hour pleural drainage before and after fibrinolytic |
|
Notes | Pleurodesis defined as "no accumulation of moderate to massive pleural fluid or any accumulation which causes dyspnoea" Didn't pleurodese those with trapped lung. Degree of loculation or septation on imaging at baseline was not recorded. Not included in network meta‐analysis |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Web‐based random‐number generator |
Allocation concealment (selection bias) | Low risk | Web‐based random‐number generator |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Nature of interventions precluded blinding (one group got 3 doses of drug and other group got nothing) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No mention of blinding and side effects and symptom reporting could be influenced by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | LTFU for pleurodesis success (1/17 in control group; 4/23 in streptokinase group ‐ 1 died; 1 in intensive care; 3 LTFU). Only those with full lung re‐expansion were given pleurodesis and this could have been affected by giving streptokinase, which might effect pleurodesis success rate, although this was not the study's primary outcome measure |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Low risk | No other biases identified |