Journal of the American College of Surgeons
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Comparative Study
Quality of reporting in randomized trials published in high-quality surgical journals.
Randomized controlled trials (RCTs) in surgery can provide valuable evidence of the efficacy of interventions if they are well-designed, appropriately executed, and adequately reported. Adequate reporting of methodology in surgical RCTs is known to be poor, and adverse-event reporting in surgical research is inconsistent. The Consolidated Standards of Reporting Trials (CONSORT) statement is a framework to help authors report their findings in a transparent manner. Extensions to the CONSORT statement have been published recently to address deficiencies in adverse-event reporting and in reporting of specific criteria related to nonpharmacologic treatments. The aim of this study was to assess the quality of reporting of trial methodology and adverse events in a sample of general surgical RCTs published in high-quality surgical journals using the criteria specified in the CONSORT statements. ⋯ Quality of reporting of generic methodologic, adverse-event-related, and specific nonpharmacologic criteria in surgical RCTs is poor. Increased attention to quality of reporting of surgical RCTs is required if studies are to meet published criteria.
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Clinical Trial
Fondaparinux for prevention of venous thromboembolism in high-risk trauma patients: a pilot study.
Venous thromboembolic events (VTE) remain a major cause of morbidity and mortality after trauma. Fondaparinux, a synthetic, nonheparin drug, has shown promise in reducing VTE in orthopaedic patients, but has not previously been studied in trauma patients. The goal of this study was to determine the safety and efficacy of fondaparinux when incorporated into our VTE prevention protocol. We hypothesized that the occult deep vein thrombosis (DVT) rate in high-risk patients receiving fondaparinux would be <5%. ⋯ Fondaparinux appears to offer protection against VTE in high-risk trauma patients. Its once-daily dosing regimen can improve compliance and reduce cost and eliminate risk of heparin-induced thrombocytopenia.
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Like most trauma registries, the National Trauma Data Bank (NTDB) is limited by the problem of missing physiologic data. Multiple imputation (MI) has been proposed to simulate missing Glasgow Coma Scale (GCS) scores, respiratory rate (RR), and systolic blood pressure (SBP). The aim of this study was to develop an MI model for missing physiologic data in the NTDB and to provide guidelines for its implementation. ⋯ This article proposes an MI model for imputing missing physiologic data in the NTDB and provides guidelines to facilitate its use. Implementation of the model should improve the quality of research involving the NTDB. The methodology can also be adapted to other trauma registries.
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Reoperation rate has gained increasing attention as a potential indicator of surgical quality. Objectives of this study were to examine the feasibility of assessing reoperation rates at 182 hospitals to identify institutions with outlying performance, to examine potentially modifiable factors that are associated with reoperations, and to determine if a more parsimonious logistic regression model effectively predicts reoperations. ⋯ There is considerable variability in reoperation rates at American College of Surgeon's National Surgical Quality Improvement Program hospitals. American College of Surgeon's National Surgical Quality Improvement Program data can be used to provide individual hospitals with risk-adjusted self-assessment data on reoperations to potentially identify quality-improvement opportunities.
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Comparative Study
Predicted risk of mortality models: surgeons need to understand limitations of the University HealthSystem Consortium models.
The University HealthSystem Consortium (UHC) mortality risk adjustment models are increasingly being used as benchmarks for quality assessment. But these administrative database models may include postoperative complications in their adjustments for preoperative risk. The purpose of this study was to compare the performance of the UHC with the Society of Thoracic Surgeons (STS) risk-adjusted mortality models for adult cardiac surgery and evaluate the contribution of postoperative complications on model performance. ⋯ Although the UHC model demonstrated better performance in the total study population, this difference in performance reflects adjustments for conditions that are postoperative complications. The current UHC models should not be used for quality benchmarks.