We report a prospective multi-centre study of the clinical course and hospital management of thoracic empyema in 119 patients (mean age 54.8). The commonest presenting symptom was malaise (75%), 55% were febrile; 31% were previously well with no predisposing condition. Initial treatments were antibiotics alone (5), needle aspirations (46), intercostal tube drainage (61), rib resection (3) and decortication (4). Overall, intercostal drainage was used in 77 patients (16 failed aspirations), surgical rib resection in 24 (1 failed aspirations, 20 failed drainage), and surgical decortication in 28 (6 failed aspirations, 17 failed drainage). Only 4 patients received intrapleural fibrinolytic agents. Aspiration and drainage were likely to fail if the empyema was > 40% of the hemithorax. Median time from treatment start to discharge was: aspirations, 26 days; drainage, 23 days; resection 11 days; decortication, 12 days. Overall 21 patients died (12 with empyema as the major cause); two had been surgically treated. Mortality correlated with age, diabetes, heart failure, and low serum albumin at admission. Infecting organisms, identified in 109 patients (92%) included anaerobes (37), Str. melleri (36), and Str. pneumoniae (28). Six months after discharge, all but six survivors had regained their previous health.
We describe a large series of 41 cases of SAF showing that it is a distinct entity with typical clinical, histological and immunohistochemical features. Follow-up was available only in 12 patients, precluding a firm comment on recurrence. However, complete excision and follow-up review is recommended.
Summary
The most commonly used methods for testing the significance of differences between treatments in a cross‐over clinical trial with a binary response utilize only those patients responding differently to the two treatments. A method of analysis is proposed in which the data from all patients are utilized. Simulations suggest that in the usual experimental setting the proposed test is more powerful than those currently in use.
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