Citations

Purpose Major cardiovascular complications associated with noncardiac surgery represent a substantial population health problem for which there are no established efficacious and safe prophylactic interventions. Acetyl-salicylic acid (ASA) represents a promising intervention. The objective of this study was to determine surgeons' perioperative usage of ASA, and if they would enrol their patients in a perioperative ASA randomized controlled trial (RCT). Methods Cross-sectional survey of all practicing Canadian general, orthopedic, and vascular surgeons. Our mailed, self-administered survey asked surgeons to consider only their patients who were at risk of a major perioperative cardiovascular complication. Results The response rate was 906/1854 (49%). For patients taking ASA chronically, there was marked variability regarding ASA continuation prior to surgery amongst the general and orthopedic surgeons, whereas 76% of vascular surgeons continued ASA in 81-100% of their patients. For patients not taking ASA chronically, approaches to starting ASA prior to surgery were variable amongst the vascular surgeons, whereas 70% of general and 82% of orthopaedic surgeons did not start ASA. For patients taking ASA chronically, 73% of general surgeons, 70% of orthopaedic surgeons, and 36% of vascular surgeons would allow at least 40% of their patients to participate in a perioperative RCT comparing stopping versus continuing ASA. For patients not taking ASA chronically, most general (76%), orthopaedic (67%), and vascular (51%) surgeons would allow at least 40% of their patients to participate in a perioperative RCT comparing starting ASA versus placebo. Conclusion This national survey demonstrates that perioperative ASA usage as reported by surgeons is variable, identifying the need for, and community interest in, a large perioperative ASA trial.

Abstract: Randomized controlled trials in orthopaedics are often underpowered to detect important differences in outcomes. Composite end points (CEPs) hold promise as a strategy to address this issue by combining multiple end points into one summary measure, thus increasing the observed event rate. The use of CEPs by trialists, however, can be problematic when they include components that vary greatly in importance to patients and when differences in apparent effect between components are large. We present an overview of CEPs with a focus on appropriate design and interpretation of results.

ABSTRACTPurposeTo identify studies that have validated administrative and claims database algorithms for identifying patients with orthopedic device revision or removal.MethodsAs a part of the Food and Drug Administration's Mini‐Sentinel pilot program, we performed a systematic review to identify algorithms for orthopedic implant removal/revision in administrative and claims databases in the USA or Canada.ResultsFive studies examined the validity of database algorithms against a gold standard of documentation in medical records (n = 3) or codes/documentation in another database (n = 2). The positive predictive values (PPV) of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) and/or the Current Procedural Terminology codes for revision total hip arthroplasty (THA) in the US Medicare population compared with medical record review were 92%and 91%, respectively. In another study of the US Medicare population, multiple ICD‐9 codes for revision total knee arthroplasty were compared with newly available single ICD‐9‐CM codes for revision knee arthroplasty; sensitivity was 87% and specificity was 99% (PPV not provided). The fourth study validated the ICD‐9‐CM codes for revision total knee arthroplasty against Ontario health insurance physician fee service claims as the gold standard and found a PPV of 32%. In the last study in Medicare population, the accuracy of the attribution of revision THA to the same side as the earlier index primary THA was examined; PPV for same laterality of revision THA was 71% (using ICD‐9‐CM codes).ConclusionsValidation data, with regard to the ICD‐9‐CM or the Current Procedural Terminology code algorithms for revision THA in the Medicare population, exist. More validation studies are needed to confirm these findings and examine other large databases. Copyright © 2012 John Wiley & Sons, Ltd.