Kefford 1980.
| Methods | Single centre RCT of intrapleural Adriamycin, nitrogen mustard and rolitetracycline (Australia) | |
| Participants | Histocytologically confirmed malignant effusions (pleural or pericardial or peritoneal); no previous intracavitary chemotherapy; no concurrent radiotherapy or systemic treatment 38 participants reported as being randomised in total (26 of whom had malignant pleural effusion). However in the discussion it refers to 90 participants being randomised originally |
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| Interventions | All participants had a needle thoracentesis to dryness. The drug was diluted in 20 ml saline and injected through needle as a bolus Adriamycin group: 30 mg intrapleurally Nitrogen mustard group: 20 mg intrapleurally Rolitetracycline group: 500 mg intrapleurally |
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| Outcomes | Pleurodesis success at eight weeks (defined as complete response (CR) (absence of significant effusion on CXR), partial response (reduction in frequency of aspiration with improvement in exercise tolerance and CXR) or no response) Complications |
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| Notes | People with trapped lung eligible for the trial For the purposes of this review, only data on participants with pleural effusions included in our analysis and only CR counted as a pleurodesis success Included in network meta‐analysis for pleurodesis efficacy. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of whether anyone was blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if CXR interpretation was done blind to treatment allocation |
| Incomplete outcome data (attrition bias) All outcomes | High risk | "More than half of the original 90 patients randomised were ineligible for assessment because of subsequent systemic therapy... or... early death". Although in the results, it states 38 participants were randomised |
| Selective reporting (reporting bias) | Low risk | Only a brief report and side effects data for the pleural and peritoneal effusions combined. However, generally all predefined outcomes reported |
| Other bias | Unclear risk | Six participants received more than one of the treatments, but not clear whether re‐randomised separately each time |