Does an early, balanced resuscitation strategy reduce the incidence of hypofibrinogenemia in hemorrhagic shock?

Objectives: Some centers have recommended including concentrated fibrinogen replacement in massive transfusion protocols (MTPs). Given our center's policy of aggressive early balanced resuscitation (1:1:1), beginning prehospital, we hypothesized that our rates of hypofibrinogenemia may be lower than those previously reported. Methods: In this retrospective cohort study, patients presenting to our trauma center November 2017 to April 2021 were reviewed. Patients were defined as hypofibrinogenemic (HYPOFIB) if admission fibrinogen <150 or rapid thrombelastography angle <60. Univariate and multivariable analyses assessed risk factors for HYPOFIB. Inverse probability of treatment weighting analyses assessed the relationship between cryoprecipitate administration and outcomes. Results: Of 29 782 patients, 6618 level 1 activations, and 1948 patients receiving emergency release blood, <1%, 2%, and 7% were HYPOFIB. HYPOFIB patients were younger, had higher head Abbreviated Injury Scale value, and had worse coagulopathy and shock. HYPOFIB had lower survival (48% vs 82%, p<0.001), shorter time to death (median 28 (7, 50) vs 36 (14, 140) hours, p=0.012), and were more likely to die from head injury (72% vs 51%, p<0.001). Risk factors for HYPOFIB included increased age (OR (95% CI) 0.98 (0.96 to 0.99), p=0.03), head injury severity (OR 1.24 (1.06 to 1.46), p=0.009), lower arrival pH (OR 0.01 (0.001 to 0.20), p=0.002), and elevated prehospital red blood cell to platelet ratio (OR 1.20 (1.02 to 1.41), p=0.03). Among HYPOFIB patients, there was no difference in survival for those that received early cryoprecipitate (within 2 hours; 40 vs 47%; p=0.630). On inverse probability of treatment weighted analysis, early cryoprecipitate did not benefit the full cohort (OR 0.52 (0.43 to 0.65), p<0.001), nor the HYPOFIB subgroup (0.28 (0.20 to 0.39), p<0.001). Conclusions: Low rates of hypofibrinogenemia were found in our center which treats hemorrhage with early, balanced resuscitation. Previously reported higher rates may be partially due to unbalanced resuscitation and/or delay in resuscitation initiation. Routine empiric inclusion of concentrated fibrinogen replacement in MTPs is not supported by the currently available data. Level of evidence: Level III.

Impact of COVID status and blood group on complications in patients in hemorrhagic shock.

Objective: Among critically injured patients of various blood groups, we sought to compare survival and complication rates between COVID-19-positive and COVID-19-negative cohorts. Background: SARS-CoV-2 infections have been shown to cause endothelial injury and dysfunctional coagulation. We hypothesized that, among patients with trauma in hemorrhagic shock, COVID-19-positive status would be associated with increased mortality and inpatient complications. As a secondary hypothesis, we suspected group O patients with COVID-19 would experience fewer complications than non-group O patients with COVID-19. Methods: We evaluated all trauma patients admitted 4/2020-7/2020. Patients 16 years or older were included if they presented in hemorrhagic shock and received emergency release blood products. Patients were dichotomized by COVID-19 testing and then divided by blood groups. Results: 3281 patients with trauma were evaluated, and 417 met criteria for analysis. Seven percent (29) of patients were COVID-19 positive; 388 were COVID-19 negative. COVID-19-positive patients experienced higher complication rates than the COVID-19-negative cohort, including acute kidney injury, pneumonia, sepsis, venous thromboembolism, and systemic inflammatory response syndrome. Univariate analysis by blood groups demonstrated that survival for COVID-19-positive group O patients was similar to that of COVID-19-negative patients (79 vs 78%). However, COVID-19-positive non-group O patients had a significantly lower survival (38%). Controlling for age, sex and Injury Severity Score, COVID-19-positive patients had a greater than 70% decreased odds of survival (OR 0.28, 95% CI 0.09 to 0.81; p=0.019). Conclusions: COVID-19 status is associated with increased major complications and 70% decreased odds of survival in this group of patients with trauma. However, among patients with COVID-19, blood group O was associated with twofold increased survival over other blood groups. This survival rate was similar to that of patients without COVID-19.

Impact of Intra-Operative Shock and Resuscitation on Surgical Site Infections After Trauma Laparotomy.

Background: Patients undergoing trauma laparotomy experience high rates of surgical site infection (SSI). Although intra-operative shock is a likely contributor to SSI risk, little is known about the relation between shock, intra-operative restoration of physiologic normalcy, and SSI development. Patients and Methods: A retrospective review of trauma patients who underwent emergent definitive laparotomy was performed. Using shock index and base excess at the beginning and end of laparotomy, patients were classified as normal, persistent shock, resuscitated, or new shock. Univariable and multivariable analyses were performed to identify predictors of organ/space SSI, superficial/deep SSI, and any SSI. Results: Of 1,191 included patients, 600 (50%) were categorized as no shock, 248 (21%) as resuscitated, 109 (9%) as new shock, and 236 (20%) as persistent shock, with incidence of any SSI as 51 (9%), 28 (11%), 26 (24%), and 32 (14%), respectively. These rates were similar in organ/space and superficial/deep SSIs. On multivariable analysis, resuscitated, new shock, and persistent shock were associated with increased odds of organ/space SSI (odds ratio [OR], 2.2; 95% confidence interval [CI], 1.3-3.5; p < 0.001) and any SSI (OR, 2.0; 95% CI, 1.4-3.2; p < 0.001), but no increased risk of superficial/deep SSI (OR, 1.4; 95% CI, 0.8-2.6; p = 0.331). Conclusions: Although the trajectory of physiologic status influenced SSI, the presence of shock at any time during trauma laparotomy, regardless of restoration of physiologic normalcy, was associated with increased odds of SSI. Further investigation is warranted to determine the relation between peri-operative shock and SSI in trauma patients.

Patient-Reported Outcomes Following Severe Abdominal Trauma: A Secondary Analysis of the Damage Control Laparotomy Trial.

INTRODUCTION: Little is known about patient-reported outcomes (PROs) following abdominal trauma. We hypothesized that patients undergoing definitive laparotomy (DEF) would have better PROs compared to those treated with damage control laparotomy (DCL). METHODS: The DCL Trial randomized DEF versus DCL in abdominal trauma. PROs were measured using the European Quality of Life-5 Dimensions-5 Levels (EQ-5D) questionnaire at discharge and six months postdischarge (1 = perfect health, 0 = death, and <0 = worse than death) and Posttraumatic Stress Disorder (PTSD) Checklist-Civilian. Unadjusted Bayesian analysis with a neutral prior was used to assess the posterior probability of achieving minimal clinically important difference. RESULTS: Of 39 randomized patients (21 DEF versus 18 DCL), 8 patients died (7 DEF versus 1 DCL). Of those who survived, 28 completed the EQ-5D at discharge (12 DEF versus 16 DCL) and 25 at 6 mo (12 DEF versus 13 DCL). Most patients were male (79%) with a median age of 30 (interquartile range (IQR) 21-42), suffered blunt injury (56%), and were severely injured (median injury severity score 33, IQR 21 - 42). Median EQ-5D value at discharge was 0.20 (IQR 0.06 - 0.52) DEF versus 0.31 (IQR -0.03 - 0.43) DCL, and at six months 0.51 (IQR 0.30 - 0.74) DEF versus 0.50 (IQR 0.28 - 0.84) DCL. The posterior probability of minimal clinically important difference DEF versus DCL at discharge and six months was 16% and 23%, respectively. CONCLUSIONS: Functional deficits for trauma patients persist beyond the acute setting regardless of laparotomy status. These deficits warrant longitudinal studies to better inform patients on recovery expectations.

Patients with both traumatic brain injury and hemorrhagic shock benefit from resuscitation with whole blood.

BACKGROUND: Hemorrhagic shock in the setting of traumatic brain injury (TBI) reduces cerebral blood flow and doubles mortality. The optimal resuscitation strategy for hemorrhage in the setting of TBI is unknown. We hypothesized that, among patients presenting with concomitant hemorrhagic shock and TBI, resuscitation including whole blood (WB) is associated with decreased overall and TBI-related mortality when compared with patients receiving component (COMP) therapy alone. METHODS: An a priori subgroup of prospective, observational cohort study of injured patients receiving emergency-release blood products for hemorrhagic shock is reported. Adult trauma patients presenting November 2017 to September 2020 with TBI, defined as a Head Abbreviated Injury Scale of ≥3, were included. Whole blood group patients received any cold-store low-titer Group O WB units. The COMP group received fractionated blood components alone. Overall and TBI-related 30-day mortality, favorable discharge disposition (home or rehabilitation), and 24-hour blood product utilization were assessed. Univariate and inverse probabilities of treatment-weighted multivariable analyses were performed. RESULTS: Of 564 eligible patients, 341 received WB. Patients who received WB had a higher injury severity score (median, 34 vs. 29), lower scene blood pressure (104 vs. 118), and higher arrival lactate (4.3 vs. 3.6, all p < 0.05). Univariate analysis noted similar overall mortality between WB and COMP; however, weighted multivariable analyses found WB was associated with decreased overall mortality and TBI-related mortality. There were no differences in discharge disposition between the WB group and COMP group. CONCLUSION: In patients with concomitant hemorrhagic shock and TBI, WB transfusion was associated with decreased overall mortality and TBI-related mortality. Whole blood should be considered a first-line therapy for hemorrhage in the setting of TBI. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

Is Low-Titer Group O Whole Blood Truly a Universal Blood Product?

BACKGROUND: Whole blood was historically transfused as a type-specific product. Given recent advocacy for low-titer group O whole blood (LTOWB) as a universal blood product, we examined outcomes after LTOWB transfusion stratified by recipient blood groups. STUDY DESIGN: Adult trauma patients receiving prehospital or in-hospital transfusion of LTOWB (November 2017 to July 2020) at a single trauma center were prospectively evaluated. The patients were divided into blood type groups (O, A, B, and AB). Major complications and survival to 30 days were compared. Univariate analyses among blood groups were followed by purposeful regression modeling, reflecting 6 variables of significance: male sex, White race, injury severity, arrival lactate, arrival systolic blood pressure, and emergency department blood products. RESULTS: Of 1,075 patients receiving any LTOWB, 539 (50.1%) were Group O, 340 (31.6%) were Group A, 150 (14.0%) were Group B, and 46 (4.3%) were Group AB. There were no statistically significant differences in demographics, injury severity, hemolysis panels, prehospital vitals, or resuscitation parameters (all p > 0.05). However, arrival systolic pressure was lower (91 vs 102, p = 0.034) and lactate was worse (5.5 vs 4.1, p = 0.048) in Group B patients compared to other groups. While survival and most major complications did not differ across recipient groups, acute kidney injury (AKI) initially appeared higher for Group B. Stepwise regression did not show a difference in AKI rates. This analysis was repeated in patients receiving only component products. Group B again showed no significantly increased risk of AKI (13%) compared to other groups (O 7%, A 7%, AB 5%; p = 0.091). CONCLUSIONS: LTOWB appears to be a safe product for universal use across all blood groups. Group B recipients arrived with worse physiologic values associated with hemorrhagic shock whether receiving LTOWB or standard component products.

Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort.

OBJECTIVE: To compare secondary patient reported outcomes of perceptions of treatment success and function for patients treated for appendicitis with appendectomy vs. antibiotics at 30 days. SUMMARY BACKGROUND DATA: The Comparison of Outcomes of antibiotic Drugs and Appendectomy trial found antibiotics noninferior to appendectomy based on 30-day health status. To address questions about outcomes among participants with lower socioeconomic status, we explored the relationship of sociodemographic and clinical factors and outcomes. METHODS: We focused on 4 patient reported outcomes at 30 days: high decisional regret, dissatisfaction with treatment, problems performing usual activities, and missing >10 days of work. The randomized (RCT) and observational cohorts were pooled for exploration of baseline factors. The RCT cohort alone was used for comparison of treatments. Logistic regression was used to assess associations. RESULTS: The pooled cohort contained 2062 participants; 1552 from the RCT. Overall, regret and dissatisfaction were low whereas problems with usual activities and prolonged missed work occurred more frequently. In the RCT, those assigned to antibiotics had more regret (Odd ratios (OR) 2.97, 95% Confidence intervals (CI) 2.05-4.31) and dissatisfaction (OR 1.98, 95%CI 1.25-3.12), and reported less missed work (OR 0.39, 95%CI 0.27-0.56). Factors associated with function outcomes included sociodemographic and clinical variables for both treatment arms. Fewer factors were associated with dissatisfaction and regret. CONCLUSIONS: Overall, participants reported high satisfaction, low regret, and were frequently able to resume usual activities and return to work. When comparing treatments for appendicitis, no single measure defines success or failure for all people. The reported data may inform discussions regarding the most appropriate treatment for individuals. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02800785.

Impact of Incorporating Whole Blood into Hemorrhagic Shock Resuscitation: Analysis of 1,377 Consecutive Trauma Patients Receiving Emergency-Release Uncrossmatched Blood Products.

BACKGROUND: Use of whole blood (WB) for trauma resuscitation has seen a resurgence. The purpose of this study was to investigate survival benefit of WB across a diverse population of bleeding trauma patients. STUDY DESIGN: A prospective observational cohort study of injured patients receiving emergency-release blood products was performed. All adult trauma patients resuscitated between November 2017 and September 2020 were included. The WB group included patients receiving any group O WB units. The component (COMP) group received no WB units, instead relying on fractionated blood (red blood cells, plasma, and platelets). Univariate and multivariate analyses were performed. Given large observed differences in our regression model, post hoc adjustments with inverse probability of treatment were conducted and a propensity score created. Propensity scoring and Poisson regression supported these findings. RESULTS: Of 1,377 patients receiving emergency release blood products, 840 received WB and 537 remained in the COMP arm. WB patients had higher Injury Severity Score (ISS; 27 vs 20), lower field blood pressure (103 vs 114), and higher arrival lactate (4.2 vs 3.5; all p < 0.05). Postarrival transfusions and complications were similar between groups, except for sepsis, which was lower in the WB arm (25 vs 30%, p = 0.041). Although univariate analysis noted similar survival between WB and COMP (75 vs 76%), logistic regression found WB was independently associated with a 4-fold increased survival (odds ratio [OR] 4.10, p < 0.001). WB patients also had a 60% reduction in overall transfusions (OR 0.38, 95% CI 0.21-0.70). This impact on survival remained regardless of location of transfusion, ISS, or presence of head injury. CONCLUSION: In patients experiencing hemorrhagic shock, WB transfusion is associated with both improved survival and decreased overall blood utilization.

Validation of the Adapted Clavien-Dindo in Trauma (ACDiT) Classifications in Medical and Surgical Management of Acute Diverticulitis.

OBJECTIVES: To validate the adapted Clavien-Dindo in trauma (ACDiT) tool as a novel outcome measure for patients with acute diverticulitis managed both operatively and nonoperatively. BACKGROUND: Complications following diverticulitis are difficult to classify because no traditional tools address patients managed both operatively and nonoperatively. The ACDiT grading system-graded from 0 to 5b-is applied in this manner but has not yet been validated for this patient group. METHODS: We performed a 5-year observational study of patients with acute diverticulitis at a safety-net hospital. Baseline demographics and hospitalization data were collected. ACDiT scores were assigned, and validation was undertaken by comparing scores with hospital-free days, and verifying that higher scores were associated with known risk factors for poor outcomes. Inverse probability weighted propensity scores were assigned for surgical management, and inverse probability weighted regression analysis was used to determine factors associated with ACDiT ≥ grade 2. RESULTS: Of 260 patients, 188 (72%) were managed nonoperatively. Eighty (31%) developed a complication; 73 (91%) were grades 1 to 3b. Higher grades correlated inversely with hospital-free days (rs = -0.67, P < 0.0001) for all patients and for nonoperative (rs = -0.63, P < 0.0001) and operative (rs = -0.62, P < 0.0001) patients. Hinchey 2 to 3 and initial operative management had higher odds of having a complication of ACDiT ≥ grade 2. CONCLUSION: The ACDiT tool was successfully applied to acute diverticulitis patients managed operatively and nonoperatively, is associated with known risk factors for adverse outcomes. ACDiT may be considered a meaningful outcome measure for comparing strategies for acute diverticulitis.

Impact of Early Cholecystectomy on the Cost of Treating Mild Gallstone Pancreatitis: Gallstone PANC Trial.

BACKGROUND: The Gallstone Pancreatitis: Admission vs Normal Cholecystectomy (Gallstone PANC) Trial demonstrated that cholecystectomy within 24 hours of admission (early) compared with after clinical resolution (control) for mild gallstone pancreatitis, significantly reduced 30-day length-of-stay (LOS) without increasing major postoperative complications. We assessed whether early cholecystectomy decreased 90-day healthcare use and costs. STUDY DESIGN: A secondary economic evaluation of the Gallstone PANC Trial was performed from the healthcare system perspective. Costs for index admissions and all gallstone pancreatitis-related care 90 days post-discharge were obtained from the hospital accounting system and inflated to 2020 USD. Negative binomial regression models and generalized linear models with log-link and gamma distribution, adjusting for randomization strata, were used. Bayesian analysis with neutral prior was used to estimate the probability of cost reduction with early cholecystectomy. RESULTS: Of 98 randomized patients, 97 were included in the analyses. Baseline characteristics were similar in early (n = 49) and control (n = 48) groups. Early cholecystectomy resulted in a mean absolute difference in LOS of -0.96 days (95% CI, -1.91 to 0.00, p = 0.05). Ninety-day mean total costs were $14,974 (early) vs $16,190 (control) (cost ratio [CR], 0.92; 95% CI, 0.73-1.15, p = 0.47), with a mean absolute difference of $1,216 less (95% CI, -$4,782 to $2,349, p = 0.50) per patient in the early group. On Bayesian analysis, there was an 81% posterior probability that early cholecystectomy reduced 90-day total costs. CONCLUSION: In this single-center trial, early cholecystectomy for mild gallstone pancreatitis reduced 90-day LOS and had an 81% probability of reducing 90-day healthcare system costs.

Timely Care is Patient-Centered Care for Patients with Acute Cholecystitis at a Safety-Net Hospital.

BACKGROUND: Multiple strategies exist to improve the timeliness and efficiency of surgical care at safety-net hospitals (SNH), such as acute care surgery models and nighttime surgery. However, the patient-centeredness of such approaches is unknown. METHODS: Adults ( ≥18 years) with acute cholecystitis were interviewed upon admission to a SNH. Interviews were semi-structured and designed to obtain both exploratory qualitative data and ratings of patient-centered outcomes, ranked by importance to the patient. Outcomes included for rating were general health, symptom status, quality of life, and return to prior functional status. Latent content analysis applying inductive coding methods were used to code and condense raw qualitative data from interview transcripts. RESULTS: Thematic saturation was reached with a sample size of 15 patients. Most participants were female (87%), Hispanic (87%), and had prior diagnosis of benign biliary disease (60%). Patients identified symptom resolution as the highest-ranked outcome in their treatment. Themes expressed by patients during the exploratory segments of the interview included: desire for pain alleviation, frustration with delays to both symptom resolution and surgical intervention, lack of perceived control over their health care, and reticence in discussing preferences with physicians. All patients preferred to have surgical treatment as soon as possible, even if that meant having nighttime surgery. CONCLUSIONS: Effective and timely resolution of symptoms is of utmost importance to patients with acute cholecystitis at a SNH. Efforts to improve timeliness of surgical care are also perceived as patient-centered.

Gallstone Pancreatitis: Admission Versus Normal Cholecystectomy-a Randomized Trial (Gallstone PANC Trial).

INTRODUCTION: Early cholecystectomy shortly after admission for mild gallstone pancreatitis has been proposed based on observational data. We hypothesized that cholecystectomy within 24 hours of admission versus after clinical resolution of gallstone pancreatitis that is predicted to be mild results in decreased length-of-stay (LOS) without an increase in complications. METHODS: Adults with predicted mild gallstone pancreatitis were randomized to cholecystectomy with cholangiogram within 24 hours of presentation (early group) versus after clinical resolution (control) based on abdominal exam and normalized laboratory values. Primary outcome was 30-day LOS including readmissions. Secondary outcomes were time to surgery, endoscopic retrograde cholangiopancreatography (ERCP) rates, and postoperative complications. Frequentist and Bayesian intention-to-treat analyses were performed. RESULTS: Baseline characteristics were similar in the early (n = 49) and control (n = 48) groups. Early group had fewer ERCPs (15% vs 29%, P = 0.038), faster time to surgery (16 h vs 43 h, P < 0.005), and shorter 30-day LOS (50 h vs 77 h, RR 0.68 95% CI 0.65 - 0.71, P < 0.005). Complication rates were 6% in early group versus 2% in controls (P = 0.613), which included recurrence/progression of pancreatitis (2 early, 1 control) and a cystic duct stump leak (early). On Bayesian analysis, early cholecystectomy has a 99% probability of reducing 30-day LOS, 93% probability of decreasing ERCP use, and 72% probability of increasing complications. CONCLUSION: In patients with predicted mild gallstone pancreatitis, cholecystectomy within 24 hours of admission reduced rate of ERCPs, time to surgery, and 30-day length-of-stay. Minor complications may be increased with early cholecystectomy. Identification of patients with predicted mild gallstone pancreatitis in whom early cholecystectomy is safe warrants further investigation.

The Effect of Financial Conflict of Interest, Disclosure Status, and Relevance on Medical Research from the United States.

BACKGROUND: Financial interactions between industry and healthcare providers are reportable. Substantial discrepancies have been detected between industry and self-report of these conflicts of interest (COIs). OBJECTIVE: Our aim was to determine if authors who fail to disclose reportable COI are more likely to publish findings that are favorable to industry than authors with no COI. DESIGN: In this blinded, observational study of medical and surgical primary research articles in PubMed, 590 articles were reviewed. MAIN MEASURES: Reportable financial relationships between authors and industry were evaluated. COIs were considered to have relevance if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, defined as an impression favorable to the product(s) discussed by an article and determined by 3 independent, blinded clinicians for each article. Primary analysis compared Incomplete Self-Disclosure to No COI. Two-level multivariable mixed-effects ordered logistic regression was used to assess factors associated with favorability. KEY RESULTS: A 69% discordance rate existed between industry and self-report in COI disclosure. When authors failed to disclose COI, their conclusions were more likely to favor industry partners than authors without COI (favorable ratings 73% versus 62%, RR 1.18, p = < 0.001). On univariate (any COI 74% versus no COI 62%, RR 1.11, p = < 0.001) and multivariable analyses, any COI was associated with favorability. CONCLUSIONS: All financial COIs (disclosed or undisclosed, relevant or not relevant, research or non-research) influence whether studies report findings favorable to industry sponsors.

Protocol for a randomized trial of the effect of timing of cholecystectomy during initial admission for predicted mild gallstone pancreatitis at a safety-net hospital.

BACKGROUND: There is evidence-based consensus for laparoscopic cholecystectomy during index admission for predicted mild gallstone pancreatitis, defined by the absence of organ failure and of local or systemic complications. However, the optimal timing for surgery within that admission is controversial. Early cholecystectomy may shorten hospital length of stay (LOS) and increase patient satisfaction. Alternatively, it may increase operative difficulty and complications resulting in readmissions. METHODS: This trial is a single-center randomized trial of patients with predicted mild gallstone pancreatitis comparing laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) at index admission within 24 hours of presentation versus after clinical resolution on clinical and patient-reported outcomes (PROs). The primary endpoint is 30-day LOS (hours) after initial presentation, which includes the index admission and readmissions. Secondary outcomes are conversion to open, complications, time from admission to cholecystectomy, initial hospital LOS, number of procedures within 30 days, 30-day readmissions, and PROs (change in Gastrointestinal Quality-of-Life Index). DISCUSSION: The primary goal of this research is to obtain the least biased estimate of effect of timing of cholecystectomy for mild gallstone pancreatitis on clinical and PROs; the results of this trial will be used to inform patient care locally as well as to design future multicenter effectiveness and implementation trials. This trial will provide data regarding PROs including health-related quality of life that can be used in cost-utility and cost-effectiveness analyses. TRIAL REGISTRATION NUMBER: NCT02806297, ClinicalTrials.gov.

The Impact of Financial Conflict of Interest on Surgical Research: An Observational Study of Published Manuscripts.

BACKGROUND: Substantial discrepancies exist between industry-reported and self-reported conflicts of interest (COI). Although authors with relevant, self-reported financial COI are more likely to write studies favorable to industry sponsors, it is unknown whether undisclosed COI have the same effect. We hypothesized that surgeons who fail to disclose COI are more likely to publish findings that are favorable to industry than surgeons with no COI. METHODS: PubMed was searched for articles in multiple surgical specialties. Financial COI reported by surgeons and industry were compared. COI were considered to be relevant if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, which was defined as an impression favorable to the product(s) discussed by an article and was determined by 3 independent, blinded clinicians for each article. Primary analysis compared incomplete self-disclosure to no COI. Ordered logistic multivariable regression modeling was used to assess factors associated with favorability. RESULTS: Overall, 337 articles were reviewed. There was a high rate of discordance in the reporting of COI (70.3%). When surgeons failed to disclose COI, their conclusions were significantly more likely to favor industry than surgeons without COI (RR 1.2, 95% CI 1.1-1.4, p < 0.001). On multivariable analysis, any COI (regardless of relevance, disclosure, or monetary amount) were significantly associated with favorability. CONCLUSIONS: Any financial COI (disclosed or undisclosed, relevant or not relevant) significantly influence whether studies report findings favorable to industry. More attention must be paid to improving research design, maximizing transparency in medical research, and insisting that surgeons disclose all COI, regardless of perceived relevance.

Multitargeted Feeding Strategies Improve Nutrition Outcome and Are Associated With Reduced Pneumonia in a Level 1 Trauma Intensive Care Unit.

BACKGROUND: Factors impeding delivery of adequate enteral nutrition (EN) to trauma patients include delayed EN initiation, frequent surgeries and procedures, and postoperative ileus. We employed 3 feeding strategies to optimize EN delivery: (1) early EN initiation, (2) preoperative no nil per os feeding protocol, and (3) a catch-up feeding protocol. This study compared nutrition adequacy and clinical outcomes before and after implementation of these feeding strategies. METHODS: All trauma patients aged ≥18 years requiring mechanical ventilation for ≥7 days and receiving EN were included. Patients who sustained nonsurvivable injuries, received parenteral nutrition, or were readmitted to the intensive care unit (ICU) were excluded. EN data were collected until patients received an oral diet or were discharged from the ICU. The improvement was quantified by comparing nutrition adequacy and outcomes between April 2014-May 2015 (intervention) and May 2012-June 2013 (baseline). RESULTS: The intervention group (n = 118) received significantly more calories (94% vs 75%, P < .001) and protein (104% vs 74%, P < .001) than the baseline group (n = 121). The percentage of patients receiving EN within 24 and 48 hours of ICU admission increased from 41% to 70% and from 79% to 96% respectively after intervention (P < .001). Although there were fewer 28-ay ventilator-free days in the intervention group than in the baseline group (12 vs 16 days, P = .03), receipt of the intervention was associated with a significant reduction in pneumonia (odds ratio, 0.53; 95% confidence interval, 0.31-0.89; P = .017) after adjusting sex and Injury Severity Score. CONCLUSIONS: Implementation of multitargeted feeding strategies resulted in a significant increase in nutrition adequacy and a significant reduction in pneumonia.

Shared decision-making during surgical consultation for gallstones at a safety-net hospital.

BACKGROUND: Understanding patient perspectives regarding shared decision-making is crucial to providing informed, patient-centered care. Little is known about perceptions of vulnerable patients regarding shared decision-making during surgical consultation. The purpose of this study was to evaluate whether a validated tool reflects perceptions of shared decision-making accurately among patients seeking surgical consultation for gallstones at a safety-net hospital. METHODS: A mixed methods study was conducted in a sample of adult patients with gallstones evaluated at a safety-net surgery clinic between May to July 2016. Semi-structured interviews were conducted after their initial surgical consultation and analyzed for emerging themes. Patients were administered the Shared Decision-Making Questionnaire and Autonomy Preference Scale. Univariate analyses were performed to identify factors associated with shared decision-making and to compare the results of the surveys to those of the interviews. RESULTS: The majority of patients (N = 30) were female (90%), Hispanic (80%), Spanish-speaking (70%), and middle-aged (45.7 ± 16 years). The proportion of patients who perceived shared decision-making was greater in the Shared Decision-Making Questionnaire versus the interviews (83% vs 27%, P < .01). Age, sex, race/ethnicity, primary language, diagnosis, Autonomy Preference Scale score, and decision for operation was not associated with shared decision-making. Contributory factors to this discordance include patient unfamiliarity with shared decision-making, deference to surgeon authority, lack of discussion about different treatments, and confusion between aligned versus shared decisions. CONCLUSION: Available questionnaires may overestimate shared decision-making in vulnerable patients suggesting the need for alternative or modifications to existing methods. Furthermore, such metrics should be assessed for correlation with patient-reported outcomes, such as satisfaction with decisions and health status.

Does compliance with antibiotic prophylaxis in pediatric simple appendicitis matter?

BACKGROUND: Institutional protocols for preincisional antibiotic prophylaxis can standardize care and improve outcomes. However, challenges remain in compliance with such protocols for urgent or emergent operations. We hypothesized that compliance with an institutional protocol for antibiotic prophylaxis for appendectomy for appendicitis in pediatric patients results in reduced surgical site infections (SSIs) after simple appendectomy. METHODS: This retrospective study assessed all pediatric patients (≤18 y) who underwent appendectomy for confirmed simple appendicitis at a tertiary children's hospital between 2012 and 2015. Demographic, admission, and outcome data were recorded. Compliance with the protocol was assessed. Univariate analyses were performed to identify factors associated with any SSI and protocol noncompliance. RESULTS: Overall compliance with antibiotic prophylaxis occurred in 590 of 697 patients (85%). Compliance was high with timing (91%), spectrum (95%), and protocol-recommended drug (87%). Admission antibiotics alone were administered in 65 patients (9%), preincisional antibiotics alone in 254 patients (36%), and both in 378 patients (55%). Patients included in the analysis received a median of 2 (range 1-6) doses of antibiotics preoperatively. Ten patients (1.4%) developed an SSI. Only receipt of any antibiotics within an hour of incision was associated with decreased odds of SSI (odds ratio 0.22, 95% confidence interval 0.06-0.87). No factors were associated with noncompliance. CONCLUSIONS: An institutional appendicitis protocol yields high compliance with prophylactic antibiotic administration and associated low SSI rates, but at a cost of antibiotic over-administration. Further efforts are necessary to sustain compliance while also practicing appropriate antibiotic stewardship.