Fentiman 1983.
| Methods | Single centre RCT of talc poudrage and mustine (via chest tube) in patients with breast cancer. All patients underwent VATS procedure under general anaesthetic. (UK) | |
| Participants | Inclusion criteria: histologically confirmed breast cancer and radiologically verified pleural effusion Exclusion criteria: no previous local treatment; non‐malignant cause for the effusion 46 participants randomised |
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| Interventions | Talc group: talc poudrage performed during VATS (dose of talc not stated), two chest drains in place for five days (with or without suction) Mustine group: after VATS and once lung fully re‐expanded on CXR, 15 mg mustine solution instilled via intercostal drain. Clamped for two hours. Drain removed when drainage stopped |
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| Outcomes | Success of pleurodesis (defined by lack of re‐accumulation of effusion on CXR) at one month; complications | |
| Notes | If died prior to one‐month follow up, excluded from analysis of pleurodesis success Participants with trapped lung eligible for enrolment Included in network meta‐analysis for pleurodesis efficacy and mortality. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Stratified for metastatic disease requiring treatment. "balanced randomisation" |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind patients or personnel due to the nature of the procedures |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated whether radiographic interpretation of CXRs were performed by a blinded person. Reporting of complications could be biased by lack of participant and personnel blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 3/23 non‐evaluable in talc group; 6/23 non‐evaluable in mustine group. All non‐evaluable patients died prior to one‐month follow up |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
| Other bias | High risk | Different number of intercostal drains in the two groups. Different duration of drainage for two groups |