Mager 2002.
| Methods | Single centre RCT evaluating the distribution of talc during a talc slurry pleurodesis ‐ comparing rotation with non‐rotation of participants after instillation of talc slurry (Netherlands) | |
| Participants | Inclusion: symptomatic MPE confirmed by cytology or histology (all cell types) Exclusion: haemorrhagic disease; trapped lung; previous pleurodesis on ipsilateral side; other disease which would interfere with the study; participants on systemic treatment or expected to be within four weeks of pleurodesis; expected survival < 1month 20 participants randomised |
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| Interventions | Chest drain inserted and pleurodesis performed when drainage < 150 ml/24 hours and lung fully re‐expanded. Talc suspension was radiolabeled. Dynamic scintigraphy performed during, immediately after and one hour after instillation Rotation arm: sequence of four positions changing every 10 mins after instillation of talc for one hour Non‐rotation arm: strict bed rest in supine position after instillation Tube removed when < 100 ml/24hour fluid drained |
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| Outcomes | Distribution of talc in the thoracic cavity, measured on scintigram immediately after instillation of talc and after one hour Success rate of pleurodesis (defined on CXR) at four weeks |
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| Notes | People with trapped lung excluded Not included in network meta‐analysis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Sealed envelopes (10 allocating participant to rotation and 10 to non‐rotation) |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind due to the nature of the interventions |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if CXR reporting was performed by a blinded individual |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Small numbers but no LTFU. Minimal data on baseline participant characteristics |
| Selective reporting (reporting bias) | Low risk | No serious side effects. Some discomfort in rotation group (not quantified). All study participants alive at one months' follow up. (Personal communication) |
| Other bias | Low risk | CXR only used to define pleurodesis. Small numbers in the study |