Davies 2012.
| Methods | Unblinded, multi‐centre RCT comparing indwelling pleural catheter (IPC) with talc slurry pleurodesis (UK)‐ TIME‐2 Trial. | |
| Participants | Inclusion criteria: clinically confident diagnosis of MPE requiring pleurodesis Exclusion criteria: age < 18, expected survival of < 3 months, chylothorax, previous ipsilateral lobectomy or pneumonectomy, previous attempted pleurodesis, pleural infection, WCC < 1000/microlitre, hypercapnic ventilatory failure, pregnancy, lactating mothers, irreversible bleeding diathesis, irreversible visual impairment 106 participants randomised |
|
| Interventions | Group 1: IPC inserted with drainage three times a week (or as required to relieve dyspnoea) Group 2: 12 F Seldinger chest tube and 4 g talc slurry as an inpatient All patients had standard oncological management for the primary tumour |
|
| Outcomes | Primary outcome: mean daily dyspnoea visual analogue score (VAS) over the first 42 days Secondary outcomes: proportion achieving clinically significant decrease in mean VAS dyspnoea; mean VAS dyspnoea at 6 weeks, 3 months and 6 months; mean daily chest pain VAS over the first 42 days; mean VAS chest pain at 6 weeks, 3 months and 6 months; nights spent in hospital; self‐reported quality of life; frequency of adverse events |
|
| Notes | Participants with trapped lung in group 2 did not receive talc pleurodesis, but remained in trial follow‐up Pleurodesis in the IPC group was defined as removal of IPC following spontaneous cessation of drainage with no significant fluid recurrence on chest x‐ray (CXR) or ultrasound scan (USS) and no further ipsilateral pleural intervention. In the talc group, pleurodesis failure defined as the need for further ipsilateral pleural intervention If participants died during follow up, included as a pleurodesis success if no intervention prior to death 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 | Central telephone randomisation |
| Allocation concealment (selection bias) | Low risk | Central telephone randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind participants or personnel due to nature of interventions (IPC vs talc slurry) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | VAS scores, QOL and symptom recurrence (which informs assessment of pleurodesis efficacy) could be biased by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | LTFU clearly documented with reasons given |
| Selective reporting (reporting bias) | Low risk | All predefined endpoints reported |
| Other bias | Low risk | No other biases identified |