Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants.Aims
Methods
Clinical, haematological or economic benefits of post-operative blood salvage with autologous blood re-transfusion have yet to be clearly demonstrated for primary total hip replacement. We performed a prospective randomised study to analyse differences in postoperative haemoglobin levels and homologous blood requirements in two groups of patients undergoing primary total hip replacement. A series of 158 patients was studied. In one group two vacuum drains were used and in the other the ABTrans autologous retransfusion system. A total of 58 patients (76%) in the re-transfusion group received autologous blood. There was no significant difference in the mean post-operative haemoglobin levels in the two groups. There were, however, significantly fewer patients with post-operative haemoglobin values less than 9.0 g/dl and significantly fewer patients who required transfusion of homologous blood in the re-transfusion group. There was also a small overall cost saving in this group.
