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jksagDKG [ABSTRACT FROM AUTHOR]

Background: Rising medical malpractice premiums have reached a crisis point in many areas of the United States. In 2003 the Texas legislature passed a comprehensive package of tort reform laws that included a cap at $250,000 on noneconomic damages in most medical malpractice cases. We hypothesized that tort reform laws significantly reduce the risk of malpractice lawsuit in an academic medical center. We compared malpractice prevalence, incidence, and liability costs before and after comprehensive state tort reform measures were implemented. Study Design: Two prospectively maintained institutional databases were used to calculate and characterize malpractice risk: a surgical operation database and a risk management and malpractice database. Risk groups were divided into pretort reform (1992 to 2004) and post-tort reform groups (2004 to the present). Operative procedures were included for elective, urgent, and emergency general surgery procedures. Results: During the study period, 98,513 general surgical procedures were performed. A total of 28 lawsuits (25 pre-reform, 3 postreform) were filed, naming general surgery faculty or residents. The prevalence of lawsuits filed/100,000 procedures performed is as follows: before reform, 40 lawsuits/100,000 procedures, and after reform, 8 lawsuits/100,000 procedures (p < 0.01, relative risk 0.21 [95% CI 0.063 to 0.62]). Virtually all of the liability and defense cost was in the pretort reform period: $595,000/year versus $515/year in the postreform group (p < 0.01). Conclusions: Implementation of comprehensive tort reform in Texas was associated with a significant decrease in the prevalence and cost of surgical malpractice lawsuits at one academic medical center. [ABSTRACT FROM AUTHOR]

Background: Delayed splenic hemorrhage after nonoperative management (NOM) of blunt splenic injury (BSI) is a feared complication, particularly in the outpatient setting. Significant resources, including angiography (ANGIO), are used in an effort to prevent delayed splenectomy (DS). No prospective, long-term data exist to determine the actual risk of splenectomy. The purposes of this trial were to ascertain the 180-day risk of splenectomy after 24 hours of NOM of BSI and to determine factors related to splenectomy., Methods: Eleven Level I trauma centers participated in this prospective observational study. Adult patients achieving 24 hours of NOM of their BSI were eligible. Patients were followed up for 180 days. Demographic, physiologic, radiographic, injury-related information, and spleen-related interventions were recorded. Bivariate and multivariable analyses were used to determine factors associated with DS., Results: A total of 383 patients were enrolled. Twelve patients (3.1%) underwent in-hospital splenectomy between 24 hours and 9 days after injury. Of 366 discharged with a spleen, 1 (0.27%) required readmission for DS on postinjury Day 12. No Grade I injuries experienced DS. The splenectomy rate after 24 hours of NOM was 1.5 per 1,000 patient-days. Only extravasation from the spleen at time of admission (ADMIT-BLUSH) was associated with splenectomy (odds ratio, 3.6; 95% confidence interval, 1.4-12.4). Of patients with ADMIT-BLUSH (n = 49), 17 (34.7%) did not have ANGIO with embolization (EMBO), and 2 of those (11.8%) underwent splenectomy; 32 (65.3%) underwent ANGIO with EMBO, and 2 of those (6.3%, p = 0.6020 compared with no ANGIO with EMBO) required splenectomy., Conclusion: Splenectomy after 24 hours of NOM is rare. After the initial 24 hours, no additional interventions are warranted for patients with Grade I injuries. For Grades II to V, close observation as an inpatient or outpatient is indicated for 10 days to 14 days. ADMIT-BLUSH is a strong predictor of DS and should lead to close observation or earlier surgical intervention., Level of Evidence: Prognostic/epidemiological study, level III; therapeutic study, level IV.

Background: Prediction of outcome after injury is fraught with uncertainty and statistically beset by misspecified models. Single-time point regression only gives prediction and inference at one time, of dubious value for continuous prediction of ongoing bleeding. New statistical machine learning techniques such as SuperLearner (SL) exist to make superior prediction at iterative time points while evaluating the changing relative importance of each measured variable on an outcome. This then can provide continuously changing prediction of outcome and evaluation of which clinical variables likely drive a particular outcome., Methods: PROMMTT data were evaluated using both naive (standard stepwise logistic regression) and SL techniques to develop a time-dependent prediction of future mortality within discrete time intervals. We avoided both underfitting and overfitting using cross validation to select an optimal combination of predictors among candidate predictors/machine learning algorithms. SL was also used to produce interval-specific robust measures of variable importance measures (VIM resulting in an ordered list of variables, by time point) that have the strongest impact on future mortality., Results: Nine hundred eighty patients had complete clinical and outcome data and were included in the analysis. The prediction of ongoing transfusion with SL was superior to the naive approach for all time intervals (correlations of cross-validated predictions with the outcome were 0.819, 0.789, 0.792 for time intervals 30-90, 90-180, 180-360, >360 minutes). The estimated VIM of mortality also changed significantly at each time point., Conclusion: The SL technique for prediction of outcome from a complex dynamic multivariate data set is superior at each time interval to standard models. In addition, the SL VIM at each time point provides insight into the time-specific drivers of future outcome, patient trajectory, and targets for clinical intervention. Thus, this automated approach mimics clinical practice, changing form and content through time to optimize the accuracy of the prognosis based on the evolving trajectory of the patient.

Background: The classic definition of massive transfusion, 10 or more units of red blood cells (RBCs) in 24 hours, has never been demonstrated as a valid surrogate for severe hemorrhage and can introduce survival bias. In addition, the definition fails to capture other products that the clinician may have immediately available, and may use, during the initial resuscitation. Assuming that units of resuscitative fluids reflect patient illness, our objective was to identify a rate of resuscitation intensity (RI) that could serve as an early surrogate of sickness for patients with substantial bleeding after injury., Methods: Adult patients surviving at least 30 minutes after admission and receiving one or more RBCs within 6 hours of admission from 10 US Level 1 trauma centers were enrolled in the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study. Total fluid units were calculated as the sum of the number of crystalloid units (1 L = 1 U), colloids (0.5 L = 1 U), and blood products (1 RBC = 1 U, 1 plasma = 1 U, 6 pack platelets = 1 U). Univariable and multivariable logistic regressions were used to evaluate associations between RI and 6-hour mortality, adjusting for age, center, penetrating injury, weighted Revised Trauma Score (RTS), and Injury Severity Score (ISS)., Results: A total of 1,096 eligible patients received resuscitative fluids within 30 minutes, including 620 transfused with blood products. Despite varying products used, the total fluid RI was similar across all sites (3.2 ± 2.5 U). Patients who received four or more units of any resuscitative fluid had a 6-hour mortality rate of 14.4% versus 4.5% in patients who received less than 4 U. The adjusted odds ratio of 6-hour mortality for patients receiving 4 U or more within 30 minutes was 2.1 (95% confidence interval, 1.2-3.5)., Conclusion: Resuscitation with four or more units of any fluid was significantly associated with 6-hour mortality. This study suggests that early RI regardless of fluid type can be used as a surrogate for sickness and mortality in severely bleeding patients.

Background: The trauma transfusion literature has yet to resolve which is more important for hemorrhaging patients, transfusing plasma and platelets along with red blood cells (RBCs) early in resuscitation or gradually balancing blood product ratios. In a previous report of PROMMTT results, we found (1) plasma and platelet:RBC ratios increased gradually during the 6 hours following admission, and (2) patients achieving ratios more than 1:2 (relative to ratios <1:2) had significantly decreased 6-hour to 24-hour mortality adjusting for baseline and time-varying covariates. To differentiate the association of in-hospital mortality with early plasma or platelet transfusion from that with delayed but gradually balanced ratios, we developed a separate analytic approach., Methods: Using PROMMTT data and multilevel logistic regression to adjust for center effects, we related in-hospital mortality to the early receipt of plasma or platelets within the first three to six transfusion units (including RBCs) and 2.5 hours of admission. We adjusted for the same covariates as in our previous report: Injury Severity Score (ISS), age, time and total number of blood product transfusions upon entry to the analysis cohort, and bleeding from the head, chest, or limb., Results: Of 1,245 PROMMTT patients, 619 were eligible for this analysis. Early plasma was associated with decreased 24-hour and 30-day mortality (adjusted odds ratios of 0.47 [p = 0.009] and 0.44 [p = 0.002], respectively). Too few patients (24) received platelets early for meaningful assessment. In the subgroup of 222 patients receiving no early plasma but continuing transfusions beyond Hour 2.5, achieving gradually balanced plasma and platelet:RBC ratios of 1:2 or greater by Hour 4 was not associated with 30-day mortality (adjusted odds ratios of 0.9 and 1.1, respectively). There were no significant center effects., Conclusion: Plasma transfusion early in resuscitation had a protective association with mortality, whereas delayed but gradually balanced transfusion ratios did not. Further research will require considerably larger numbers of patients receiving platelets early.

Background: There are few clinical data to guide the use of cryoprecipitate in severely injured trauma patients. Cryoprecipitate is a rich source of fibrinogen and has been associated with improved survival in animal as well as limited human studies. Our objectives were to identify patterns and predictors of cryoprecipitate use and determine whether transfusing cryoprecipitate was associated with improved survival., Methods: This secondary analysis of 1,238 of 1,245 PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study patients who had timed transfusion data included 359 (29%) who received cryoprecipitate. For this analysis, one dose of cryoprecipitate was defined as 10 U. Unadjusted predictors of cryoprecipitate use were identified using logistic regression. Multivariable time-dependent Cox models were performed to examine the association of cryoprecipitate on time to in-hospital death., Results: Cryoprecipitate use varied significantly by center, ranging from 7% to 82%. Among patients who received cryoprecipitate, the median number of units infused by 24 hours was 10 (interquartile range, 10-20). The median time from admission to first cryoprecipitate unit was 2.7 hours (interquartile range, 1.7-4.4 hours). Of those who died of a hemorrhagic death within 6 hours of admission, 72% received no cryoprecipitate. Other unadjusted predictors of cryoprecipitate use included Injury Severity Score (ISS), initial fibrinogen levels, base deficit, international normalized ratio, prothrombin time/partial thromboplastin time, hemoglobin, damage-control surgery, and surgical intervention of the chest and abdomen. Cryoprecipitate use was not associated with in-hospital mortality after adjusting for initial pH, initial hemoglobin, emergency department systolic blood pressure, emergency department Glasgow Coma Scale (GCS) score, blood product use, ISS, and center., Conclusion: Ten US Level 1 trauma centers vary greatly in their timing and use of cryoprecipitate in severely injured trauma patients. We could not identify any association of cryoprecipitate use with in-hospital mortality, although most patients did not receive this product. Randomized controlled studies are needed to determine if cryoprecipitate (or fibrinogen concentrates) have a beneficial effect.

Background: Several predictive models have been developed to identify trauma patients who have had severe hemorrhage (SH) and may need a massive transfusion (MT) protocol. However, almost all these models define SH as the transfusion of 10 or more units of red blood cells (RBCs) within 24 hours of emergency department admission (also known as MT). This definition excludes some patients with SH, especially those who die before a 10th unit of RBCs could be transfused, which calls the validity of these prediction models into question. We show how a latent class model could improve the accuracy of identifying the SH patients., Methods: Modeling SH classification as a latent variable, we estimate the posterior probability of a patient in SH based on emergency department admission variables (systolic blood pressure, heart rate, pH, hemoglobin), the 24-hour blood product use (plasma/RBC and platelet/RBC ratios), and 24-hour survival status. We define the SH subgroup as those having a posterior probability of 0.5 or greater. We compare our new classification of SH with that of the traditional MT using data from PROMMTT study., Results: Of the 1,245 patients, 913 had complete data, which were used in the latent class model. About 25.3% of patients were classified as SH. The overall agreement between the MT and SH classifications was 83.8%. However, among 49 patients who died before receiving the 10th unit of RBCs, 41 (84%) were classified as SH. Seven (87.5%) of the remaining eight patients who were not classified as SH had head injury., Conclusion: Our definition of SH based on the aforementioned latent class model has an advantage of improving on the traditional MT definition by identifying SH patients who die before receiving the 10th unit of RBCs. We recommend further improvements to more accurately classify SH patients, which could replace the traditional definition of MT for use in developing prediction algorithms.

Background: In the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, waiver of consent was used because previous literature reported low response rates and subsequent bias. The goal of this article was to examine the rationale and tradeoffs of using waiver of consent in PROMMTT., Methods: PROMMTT enrolled trauma patients receiving at least 1 U of red blood cells within 6 hours after admission at 10 US Level 1 trauma centers. Local institutional review boards (IRBs) from all sites approved the study. Site 8 was required by their IRB to attempt consent but was allowed to retain data on patients unable to be consented., Results: Of 121 subjects enrolled at Site 8, 55 consents were obtained (46%), and no patient or legally authorized representative refused to give consent. Of the patients, 36 (30%) died, and 6 (5%) were discharged before consent could be attempted. Consent was attempted but not possible among 24 patients (20%). Of the 10 clinical sites, 6 of the local IRBs approved collection of residual blood samples, 1 had previous approval to collect timed blood samples under a separate protocol, and 3 reported that their local IRBs would not approve collection of residual blood under a waiver of consent., Conclusion: Waiver of consent was used in PROMMTT because of the potential adverse impact of consent refusals; however, there were no refusals. If the IRB for Site 8 had required withdrawal of patients unable to consent and destruction of their data, a serious bias would likely have been introduced. Other tradeoffs included a reduction in sites participating in residual blood collection and a smaller than expected amount of residual blood collected among sites operating under a waiver of consent. Noninterventional emergency research studies should consider these potential tradeoffs carefully before deciding whether waiver of consent would best achieve the goals of a study.

Background: Missing data are inherent in clinical research and may be especially problematic for trauma studies. This study describes a sensitivity analysis to evaluate the impact of missing data on clinical risk prediction algorithms. Three blood transfusion prediction models were evaluated using an observational trauma data set with valid missing data., Methods: The PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study included patients requiring one or more unit of red blood cells at 10 participating US Level I trauma centers from July 2009 to October 2010. Physiologic, laboratory, and treatment data were collected prospectively up to 24 hours after hospital admission. Subjects who received 10 or more units of red blood cells within 24 hours of admission were classified as massive transfusion (MT) patients. Correct classification percentages for three MT prediction models were evaluated using complete case analysis and multiple imputation. A sensitivity analysis for missing data was conducted to determine the upper and lower bounds for correct classification percentages., Results: PROMMTT study enrolled 1,245 subjects. MT was received by 297 patients (24%). Missing percentage ranged from 2.2% (heart rate) to 45% (respiratory rate). Proportions of complete cases used in the MT prediction models ranged from 41% to 88%. All models demonstrated similar correct classification percentages using complete case analysis and multiple imputation. In the sensitivity analysis, correct classification upper-lower bound ranges per model were 4%, 10%, and 12%. Predictive accuracy for all models using PROMMTT data was lower than reported in the original data sets., Conclusion: Evaluating the accuracy clinical prediction models with missing data can be misleading, especially with many predictor variables and moderate levels of missingness per variable. The proposed sensitivity analysis describes the influence of missing data on risk prediction algorithms. Reporting upper-lower bounds for percent correct classification may be more informative than multiple imputation, which provided similar results to complete case analysis in this study.

Objective: To relate in-hospital mortality to early transfusion of plasma and/or platelets and to time-varying plasma:red blood cell (RBC) and platelet:RBC ratios., Design: Prospective cohort study documenting the timing of transfusions during active resuscitation and patient outcomes. Data were analyzed using time-dependent proportional hazards models., Setting: Ten US level I trauma centers., Patients: Adult trauma patients surviving for 30 minutes after admission who received a transfusion of at least 1 unit of RBCs within 6 hours of admission (n = 1245, the original study group) and at least 3 total units (of RBCs, plasma, or platelets) within 24 hours (n = 905, the analysis group)., Main Outcome Measure: In-hospital mortality., Results: Plasma:RBC and platelet:RBC ratios were not constant during the first 24 hours (P < .001 for both). In a multivariable time-dependent Cox model, increased ratios of plasma:RBCs (adjusted hazard ratio = 0.31; 95% CI, 0.16-0.58) and platelets:RBCs (adjusted hazard ratio = 0.55; 95% CI, 0.31-0.98) were independently associated with decreased 6-hour mortality, when hemorrhagic death predominated. In the first 6 hours, patients with ratios less than 1:2 were 3 to 4 times more likely to die than patients with ratios of 1:1 or higher. After 24 hours, plasma and platelet ratios were unassociated with mortality, when competing risks from nonhemorrhagic causes prevailed., Conclusions: Higher plasma and platelet ratios early in resuscitation were associated with decreased mortality in patients who received transfusions of at least 3 units of blood products during the first 24 hours after admission. Among survivors at 24 hours, the subsequent risk of death by day 30 was not associated with plasma or platelet ratios.

Background: Few graduating residents seek surgical critical care (SCC) fellowships; fewer than half of positions fill. We hypothesized substantial differences exist in practice patterns and attitudes between SCC surgeons in academic practice (ACs) and in private practice (PVTs)., Study Design: A survey instrument was sent to 1,544 board-certified SCC intensivists in North America., Results: Of those invited, 489 responded (32% response rate). Respondents were mostly men (88%) and Caucasian (86%), with a mean age of 48 years; 60% were ACs, 28% were PVTs, and 12% reported "other;" 94% currently practiced SCC. PVTs (50%) were more likely than ACs (18%) to provide SCC for only their own patients, less likely (24% versus 74%) to function as an "ICU attending," and less likely to work with residents (36% versus 91%) and fellows (4% versus 60%; all p < 0.001). PVTs (48%) spent more time performing elective operations than ACs (27%; p < 0.001). They were more likely than ACs to relinquish management of SCC patients to medical consultants: infectious disease (34% versus 12%), cardiology (31% versus 12%), and pulmonary (23% versus 3%; all p < 0.001). Conflicts with medical specialists were a bigger problem for PVTs (43%) than for ACs (17%; p < 0.001)., Conclusions: Private practice surgical intensivists are more likely than academic intensivists to provide critical care for only their own patients and to use consultants to avoid conflicts.

Objective: We set out to determine if there is an increased medical malpractice lawsuit rate when trauma patient cases are presented at an open, multidisciplinary morbidity and mortality conference (M&M)., Introduction: Patient safety proponents emphasize the importance of transparency with respect to medical errors. In contrast, the tort system focuses on blame and punishment, which encourages secrecy. Our question: Can the goals of the patient safety movement be met without placing care providers and healthcare institutions at unacceptably high malpractice risk?, Methods: The trauma registry, a risk management database, along with the written minutes of the trauma morbidity and mortality conference (M&M) were used to determine the number and incidence of malpractice suits filed following full discussion at an open M&M conference at an academic level I trauma center., Results: A total of 20,749 trauma patients were admitted. A total of 412 patients were discussed at M&M conference and a total of seven lawsuits were filed. Six of the patients were not discussed at M&M prior to the lawsuit being filed. One patient was discussed at M&M prior to the lawsuit being filed. The incidence of lawsuit was calculated in three groups: all trauma patients, all trauma patients with complications, and all patients presented at trauma M&M conference. The ratio of lawsuits filed to patients admitted and incidence in the three groups is as follows: All Patients, 7 lawsuits/20,479 patients (4.25 lawsuits/100,000 patients/year); M&M Presentation, 1 lawsuit/421 patients (29.6 lawsuits/100,000 patients/year); All Trauma Complications, 7 lawsuits/6,225 patients (14 lawsuits/100,000 patients/year). Patients with a complication were more likely to sue (P < 0.01); otherwise, there were no statistical differences between groups., Conclusions: A transparent discussion of errors, complications, and deaths does not appear to lead to an increased risk of lawsuit.