Does the Institution of a Statewide Trauma System Reduce Preventable Mortality and Yield a Positive Return on Investment for Taxpayers?

BACKGROUND: In July 2009, Arkansas began to annually fund $20 million for a statewide trauma system (TS). We studied injury deaths both pre-TS (2009) and post-TS (2013 to 2014), with attention to causes of preventive mortality, societal cost of those preventable mortality deaths, and benefit to tax payers of the lives saved. STUDY DESIGN: A multi-specialty trauma-expert panel met and reviewed records of 672 decedents (290 pre-TS and 382 post-TS) who met standardized inclusion criteria, were judged potentially salvageable, and were selected by a proportional sampling of the roughly 2,500 annual trauma deaths. Deaths were adjudicated into sub-categories of nonpreventable and preventable causes. The value of lives lost was calculated for those lives potentially saved in the post-TS period. RESULTS: Total preventable mortality was reduced from 30% of cases pre-TS to 16% of cases studied post-TS, a reduction of 14%. Extrapolating a 14% reduction of preventable mortality to the post-TS study period, using the same inclusion criteria of the post-TS, we calculate that 79 lives were saved in 2013 to 2014 due to the institution of a TS. Using a minimal standard estimate of $100,000 value for a life-year, a lifetime value of $2,365,000 per person was saved. This equates to an economic impact of the lives saved of almost $186 million annually, representing a 9-fold return on investment from the $20 million of annual state funding invested in the TS. CONCLUSIONS: The implementation of a TS in Arkansas during a 5-year period resulted in a reduction of the preventable death rate to 16% post-TS, and a 9-fold return on investment by the tax payer. Additional life-saving gains can be expected with ongoing financial support and additional system performance-improvement efforts.

Use of a Novel Accounting and Grouping Method for Major Trunk Injury-Analysis of Data from a Statewide Trauma Financial Survey.

Major trunk trauma is common and costly, but comparisons of costs between trauma centers (TCs) are rare. Understanding cost is essential to improve quality, manage trauma service lines, and to facilitate institutional commitment for trauma. We have used results of a statewide trauma financial survey of Levels I to IV TC to develop a useful grouping method for costs and clinical characteristics of major trunk trauma. The trauma financial survey collected billing and clinical data on 75 per cent of the state trauma registry patients for fiscal year 2012. Cost was calculated by separately accounting for embedded costs of trauma response and verification, and then adjusting reasonable costs from the Medicare cost report for each TC. The cost-to-charge ratios were then recalculated and used to determine uniform cost estimates for each patient. From the 13,215 patients submitted for the survey, we selected 1,094 patients with major trunk trauma: lengths of stay ≥ 48 hours and a maximum injury of AIS ≥3 for either thorax or abdominal trauma. These patients were then divided into three Injury Severity Score (ISS) groups of 9 to 15, 16 to 24, or 25+ to stratify patients into similar injury groups for analysis of cost and cost drivers. For abdominal injury, average total cost for patients with ISS 9 to 15 was $17,429. Total cost and cost per day increased with severity of injury, with $51,585 being the total cost for those with ISS 25. Similar trends existed for thoracic injury. Use of the Medicare cost report and cost-to-charge ratios to compute uniform costs with an innovative grouping method applied to data collected across a statewide trauma system provides unique information regarding cost and outcomes, which affects quality improvement, trauma service line management, and decisions on TC participation.

Financial conflicts of interest and their association with outcome and quality of fibromyalgia drug therapy randomized controlled trials.

AIMS: To evaluate the association of financial conflicts of interest (FCOI) with the characteristics, outcome and reported methodological quality of fibromyalgia drug therapy randomized controlled trials (FM-RCTs). METHODS: A cross-sectional study of original, parallel-group, drug therapy FM-RCTs published between 1997 and 2011 from Medline and Cochrane Central Register of Controlled Trials was conducted. Two reviewers independently assessed each RCT for funding source, authors' FCOI(s), study characteristics, reporting of methodological measures important for internal validity and outcome (positive [statistically significant result favoring experimental drug for the primary outcome] or non-positive). RESULTS: Forty-seven RCTs were eligible with funding source as: 26 (55.3%) industry; eight (17%) non-profit source(s); five (10.6%) mixed; and eight (17%) unspecified. Industry-funded RCTs were more likely to be multicenter and enroll greater number of patients. Reporting of key methodological measures was suboptimal; however, industry and non-profit funded RCTs did not differ in their reporting. Thirty (63.8%) RCTs had ≥ one author who disclosed an FCOI (receipt of research grant [21, 44.7%], industry sponsor employee [20, 42.6%], receipt of consultancy fee/honorarium [16, 34%] and stock ownership [11, 23.4%]). Although industry funding and certain authors' FCOIs (employment and receipt of consultancy fee/honorarium) were univariately associated with positive outcome, such association was not observed after adjusting for study sample size. CONCLUSIONS: The majority of FM-RCTs were industry-sponsored, and had at least one author with an FCOI. Reporting of key methodological measures was suboptimal. After adjusting for study sample size, no association of industry funding or author's FCOI with study outcome was seen.

Determining the hospital trauma financial impact in a statewide trauma system.

BACKGROUND: There have been no comprehensive studies across an organized statewide trauma system using a standardized method to determine cost. STUDY DESIGN: Trauma financial impact includes the following costs: verification, response, and patient care cost (PCC). We conducted a survey of participating trauma centers (TCs) for federal fiscal year 2012, including separate accounting for verification and response costs. Patient care cost was merged with their trauma registry data. Seventy-five percent of the 2012 state trauma registry had data submitted. Each TC's reasonable cost from the Medicare Cost Report was adjusted to remove embedded costs for response and verification. Cost-to-charge ratios were used to give uniform PCC across the state. RESULTS: Median (mean ± SD) costs per patient for TC response and verification for Level I and II centers were $1,689 ($1,492 ± $647) and $450 ($636 ± $431) for Level III and IV centers. Patient care cost-median (mean ± SD) costs for patients with a length of stay >2 days rose with increasing Injury Severity Score (ISS): ISS <9: $6,787 ($8,827 ± $8,165), ISS 9 to 15: $10,390 ($14,340 ± $18,395); ISS 16 to 25: $15,698 ($23,615 ± $21,883); and ISS 25+: $29,792 ($41,407 ± $41,621), and with higher level of TC: Level I: $13,712 ($23,241 ± $29,164); Level II: $8,555 ($13,515 ± $15,296); and Levels III and IV: $8,115 ($10,719 ± $11,827). CONCLUSIONS: Patient care cost rose with increasing ISS, length of stay, ICU days, and ventilator days for patients with length of stay >2 days and ISS 9+. Level I centers had the highest mean ISS, length of stay, ICU days, and ventilator days, along with the highest PCC. Lesser trauma accounted for lower charges, payments, and PCC for Level II, III, and IV TCs, and the margin was variable. Verification and response costs per patient were highest for Level I and II TCs.

Estimating misclassification error: a closer look at cross-validation based methods.

BACKGROUND: To estimate a classifier's error in predicting future observations, bootstrap methods have been proposed as reduced-variation alternatives to traditional cross-validation (CV) methods based on sampling without replacement. Monte Carlo (MC) simulation studies aimed at estimating the true misclassification error conditional on the training set are commonly used to compare CV methods. We conducted an MC simulation study to compare a new method of bootstrap CV (BCV) to k-fold CV for estimating clasification error. FINDINGS: For the low-dimensional conditions simulated, the modest positive bias of k-fold CV contrasted sharply with the substantial negative bias of the new BCV method. This behavior was corroborated using a real-world dataset of prognostic gene-expression profiles in breast cancer patients. Our simulation results demonstrate some extreme characteristics of variance and bias that can occur due to a fault in the design of CV exercises aimed at estimating the true conditional error of a classifier, and that appear not to have been fully appreciated in previous studies. Although CV is a sound practice for estimating a classifier's generalization error, using CV to estimate the fixed misclassification error of a trained classifier conditional on the training set is problematic. While MC simulation of this estimation exercise can correctly represent the average bias of a classifier, it will overstate the between-run variance of the bias. CONCLUSIONS: We recommend k-fold CV over the new BCV method for estimating a classifier's generalization error. The extreme negative bias of BCV is too high a price to pay for its reduced variance.

Association of industry funding with the outcome and quality of randomized controlled trials of drug therapy for rheumatoid arthritis.

OBJECTIVE: To assess the association of industry funding with the characteristics, outcome, and reported quality of randomized controlled trials (RCTs) of drug therapy for rheumatoid arthritis (RA). METHODS: The Medline and Cochrane Central Register of Controlled Trials databases were searched to identify original RA drug therapy RCTs published in 2002-2003 and 2006-2007. Two reviewers independently assessed each RCT for the funding source, characteristics, outcome (positive [statistically significant result favoring experimental drug for the primary outcome] or not positive), and reporting of methodologic measures whose inadequate performance may have biased the assessment of treatment effect. RCTs that were registered at ClinicalTrials.gov and completed during the study years were assessed for publication bias. RESULTS: Of the 103 eligible RCTs identified, 58 (56.3%) were funded by industry, 19 (18.4%) were funded by nonprofit sources, 6 (5.8%) had mixed funding, and funding for 20 (19.4%) was not specified. Industry-funded RCTs had significantly more study centers and subjects, while nonprofit agency-funded RCTs had longer duration and were more likely to study different treatment strategies. Outcome could be assessed for 86 (83.5%) of the 103 RCTs studied. The funding source was not associated with a higher likelihood of positive outcomes favoring the sponsored experimental drug (75.5% of industry-funded RCTs had a positive outcome, compared with 68.8% of non-industry-funded RCTs, 40% of RCTs with mixed funding, and 81.2% of RCTs for which funding was not specified). Industry-funded RCTs showed a trend toward a higher likelihood of nonpublication (P=0.093). Industry-funded RCTs were more frequently associated with double-blinding, an adequate description of participant flow, and performance of an intent-to-treat analysis. CONCLUSION: Industry funding was not associated with a higher likelihood of positive outcomes of published RCTs of drug therapy for RA, and industry-funded RCTs performed significantly better than non-industry-funded RCTs in terms of reporting the use of some key methodologic quality measures.

Characteristics of inpatient thyroid surgery at US academic and affiliated medical centers.

OBJECTIVE: Describe data from patients undergoing thyroid surgeries for benign and malignant disease at US academic medical centers. STUDY DESIGN: Retrospective, database search. SETTING: The University Health System (UHC) Consortium (Oak Brook, Illinois) data compiled from discharge summaries. SUBJECTS AND METHODS: Discharge data were collected from the first quarter of 2002 through the fourth quarter of 2009. Searching strategy was based on diagnosis of thyroid disease and patients undergoing thyroid surgery across all UHC facilities. Demographic information was collected as well as length of stay (LOS) and costs. Complications were evaluated in this analysis. RESULTS: During the study period, 68,014 thyroidectomies were performed, with 27,200 for thyroid cancer. During the same period 6365 neck dissections were performed, with 1539 as stand-alone procedures. Total thyroidectomy was the procedure of choice for malignant disease. More total thyroidectomies and fewer hemithyroidectomies were being performed for benign thyroid disease in the inpatient setting. Almost all postoperative complications were more frequent after surgery for cancer except myocardial infarction and aspiration pneumonia. On average, LOS was longer for benign disease, but costs were higher for malignant disease. CONCLUSION: This is the largest series reporting inpatient LOS and mortality for thyroid surgery. The limitation of this study is that it reports patients whose stays were more than 23 hours, leaving out a significant number of thyroid surgeries that are performed as outpatients. Although the results contribute greatly to characterizing inpatient surgery, the results may not reflect current US trends for thyroid surgery.