PURPOSE: To help guide future outcomes research regarding the use of magnetic resonance (MR) imaging in patients with acute knee trauma in an emergency department setting, with use of prospective data from a randomized clinical trial and value of information analysis. MATERIALS AND METHODS: A total of 189 patients (123 male, 66 female; mean age, 33.4 years) were randomly assigned to undergo radiography alone (n = 93) or radiography and MR imaging (n = 96). Institutional review board approval and informed consent (parental consent for minors) were obtained. During 6 months of follow-up, data on quality of life and 39 cost parameters were collected. Value-of-information analysis was used to estimate the expected benefit of future research to eliminate the decision uncertainty that remained after trial completion. In addition, the parameters that were responsible for most of the decision uncertainty were identified, the expected benefits of various study designs were evaluated, and the optimal sample size was estimated. RESULTS: Only three parameters were responsible for most of the decision uncertainty: number of quality-adjusted life-years, cost of an overnight hospital stay, and friction costs. A study in which data on these three parameters are gathered would have an optimal sample size of 3500 patients per arm and would be expected to result in a societal benefit of euro 5.6 million or 70 quality-adjusted life-years. CONCLUSION: The optimal study design for use of MR imaging to evaluate acute knee trauma involves a trial in which there are 3500 patients per trial arm, and data on the number ofquality-adjusted life-years, cost of an overnight hospital stay, and friction costs are collected. (c) RSNA, 2008.
RCT Entities:
PURPOSE: To help guide future outcomes research regarding the use of magnetic resonance (MR) imaging in patients with acute knee trauma in an emergency department setting, with use of prospective data from a randomized clinical trial and value of information analysis. MATERIALS AND METHODS: A total of 189 patients (123 male, 66 female; mean age, 33.4 years) were randomly assigned to undergo radiography alone (n = 93) or radiography and MR imaging (n = 96). Institutional review board approval and informed consent (parental consent for minors) were obtained. During 6 months of follow-up, data on quality of life and 39 cost parameters were collected. Value-of-information analysis was used to estimate the expected benefit of future research to eliminate the decision uncertainty that remained after trial completion. In addition, the parameters that were responsible for most of the decision uncertainty were identified, the expected benefits of various study designs were evaluated, and the optimal sample size was estimated. RESULTS: Only three parameters were responsible for most of the decision uncertainty: number of quality-adjusted life-years, cost of an overnight hospital stay, and friction costs. A study in which data on these three parameters are gathered would have an optimal sample size of 3500 patients per arm and would be expected to result in a societal benefit of euro 5.6 million or 70 quality-adjusted life-years. CONCLUSION: The optimal study design for use of MR imaging to evaluate acute knee trauma involves a trial in which there are 3500 patients per trial arm, and data on the number of quality-adjusted life-years, cost of an overnight hospital stay, and friction costs are collected. (c) RSNA, 2008.
Authors: Andrew Micieli; Maria C Bennell; Ba' Pham; Murray Krahn; Sheldon M Singh; Harindra C Wijeysundera Journal: J Am Heart Assoc Date: 2014-09-16 Impact factor: 5.501