Demmy 2012.
| Methods | Multi‐centre RCT comparing bedside talc pleurodesis and daily tunnelled catheter drainage for management of malignant pleural effusion (USA) | |
| Participants | Inclusion: symptomatic patients with histo/cytologically proven malignancy and a previously untreated, unilateral pleural effusion requiring management; ECOG performance score 0‐2 Exclusion: active pleural infection; talc allergy; contraindications to talc use; trapped lung; survival < 60 days; severe comorbid medical conditions 68 participants randomised |
|
| Interventions | Talc pleurodesis group: 4 g to 5 g sterile talc slurry in 100 ml saline infused into pleural space via > 24 Fr chest drain. Tube clamped for two hours. Drain removed when < 150 ml drainage/24hours Indwelling pleural catheter (IPC) group: PleurX catheter inserted and drained daily (output volumes recorded). Removed when < 30 ml output on three consecutive days |
|
| Outcomes | Primary: compare the proportion of maintained successful treatments 30 days after the intervention (success defined as being (1) alive (2) no effusion recurrence (3) > 90% lung re‐expansion after complete drainage (4) completion of the intervention by two weeks ie drain removed or IPC functioning normally) Secondary: Quality of life (QOL); dyspnoea; patient satisfaction and acceptability; lung expansion; pleurodesis success; fluid drainage volume; days device in place; removal of device before death; survival |
|
| Notes | Pleurodesis success measured at 30 days according to chest x‐ray (CXR) and need for repeat pleural intervention People with known trapped lung excluded from trial entry Included in network meta‐analysis for pleurodesis efficacy and mortality. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Permuted block randomisation via a web‐based randomisation service |
| Allocation concealment (selection bias) | Low risk | Permuted block randomisation via a web‐based randomisation service |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to nature of interventions, not possible to blind participants or personnel (IPC vs talc slurry) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | "Pleurodesis success was classified by an unblinded local investigator" (personal communication). QOL, symptom recurrence and patient satisfaction questionnaires may be biased by lack of patient blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Five excluded from analysis in each arm, but justifications given |
| Selective reporting (reporting bias) | Low risk | All reported |
| Other bias | Low risk | Target recruitment numbers not reached |