Evans 1993.
| Methods | Single centre RCT of medical vs surgical pleurodesis with tetracycline (UK) | |
| Participants | Inclusion criteria: cytology‐proven MPE and histological or cytological evidence of metastatic breast cancer Exclusion criteria: unsuitable for general anaesthetic (GA); > 75 years old; severe non‐metastatic lung disease; evidence of life‐threatening metastatic disease at other sites 34 participants randomised |
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| Interventions | Medical group: intercostal cannula inserted into mid‐axillary line 7th/8th intercostal space and fluid aspirated. When drainage complete, 500 mg tetracycline in 100 ml N saline inserted IP. Drain removed after 24 hours Surgical group: under GA, bronchoscopy then thoracoscopy performed. 500 ml tetracycline in 100 ml saline inserted after fluid removed. Drain removed at 24 hours |
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| Outcomes | Fluid re‐accumulation on chest x‐ray (CXR) Need for repeat pleural aspirations Mortality |
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| Notes | Pleurodesis failure defined as need for repeat aspiration. Trapped lung not accounted for Not included in network meta‐analysis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details given regarding randomisation |
| Allocation concealment (selection bias) | Unclear risk | No details given regarding randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind due to nature of the interventions (surgery vs chest tube) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Need for repeat aspirations and other treatments given for cancer after pleurodesis may have been biased by lack of blinding of personnel and participants. Not stated if CXRs were reported by a blinded person |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons given for withdrawals (5/34 excluded (15%) ‐ 3 never received the treatment; 1 was randomised in error; 1 participant's records were lost) |
| Selective reporting (reporting bias) | High risk | No data on safety or side effects |
| Other bias | Low risk | No other biases identified |