A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.

BACKGROUND: Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis. METHODS: We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith. RESULTS: In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50). CONCLUSIONS: For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.).

The Need for Accurate Risk Assessment in a High-Risk Patient Population: A NSQIP Study Evaluating Outcomes of Cholecystectomy in the Patient With Cancer.

BACKGROUND: Cholecystectomy is considered a low-risk procedure with proven safety in many high-risk patient populations. However, the risk of cholecystectomy in patients with active cancer has not been established. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database was queried to identify all patients with disseminated cancer who underwent cholecystectomy from 2005 to 2016. Postcholecystectomy outcomes were defined for patients with cancer and those without by comparing several outcomes measures. A multivariate model was used to estimate the odds of 30-d mortality. RESULTS: We compared outcomes in 3097 patients with disseminated cancer to a matched cohort of patients without cancer. Patients with cancer had more comorbidities at baseline: dyspnea (10.5% versus 7.0%, P < 0.0001), steroid use (10.1% versus 3.0%, P < 0.0001), and loss of >10% body weight in 6-mo prior (9.3% versus 1.6%, P < 0.0001). Patients with cancer sustained higher rates of wound (2.3% versus 5.6%, P < 0.0001), respiratory (1.4% versus 3.9%, P < 0.0001), and cardiovascular (2.0% versus 6.8%, P < 0.0001) complications. In addition, patients with disseminated cancer experienced a longer length of stay and higher 30-d mortality. Multivariate modeling showed that the odds of 30-d mortality was 3.3 times greater in patients with cancer. CONCLUSIONS: Compared to patients without cancer, those with disseminated cancer are at higher risk of complication and mortality following cholecystectomy. Traditional treatment algorithms should be used with caution and care decisions individualized based on the patient's disease status and treatment goals.

Importance of Radiologists in Optimizing Outcomes for Older Americans with Acute Abdomen.

BACKGROUND: Patients presenting with acute abdominal pain often undergo a computed tomography (CT) scan as part of their diagnostic workup. We investigated the relationship between availability, timeliness, and interpretation of CT imaging and outcomes for life-threatening intra-abdominal diseases or "acute abdomen," in older Americans. METHODS: Data from a 2015 national survey of 2811 hospitals regarding emergency general surgery structures and processes (60.1% overall response, n = 1690) were linked to 2015 Medicare inpatient claims data. We identified beneficiaries aged ≥65 admitted emergently with a confirmatory acute abdomen diagnosis code and operative intervention on the same calendar date. Multivariable regression models adjusted for significant covariates determined odds of complications and mortality based on CT resources. RESULTS: We identified 9125 patients with acute abdomen treated at 1253 hospitals, of which 78% had ≥64-slice CT scanners and 85% had 24/7 CT technicians. Overnight CT reads were provided by in-house radiologists at 14% of hospitals and by teleradiologists at 66%. Patients were predominantly 65-74 y old (43%), white (88%), females (60%), and with ≥3 comorbidities (67%) and 8.6% died. STAT radiology reads by a board-certified radiologist rarely/never available in 2 h was associated with increased odds of systemic complication and mortality (adjusted odds ratio 2.6 [1.3-5.4] and 2.3 [1.1-4.8], respectively). CONCLUSIONS: Delays obtaining results are associated with adverse outcomes in older patients with acute abdomen. This may be due to delays in surgical consultation and time to source control while waiting for imaging results. Processes to ensure timely interpretation of CT scans in patients with abdominal pain may improve outcomes in high-risk patients.

Identifying the fundamental structures and processes of care contributing to emergency general surgery quality using a mixed-methods Donabedian approach.

BACKGROUND: Acute Care Surgery (ACS) was developed as a structured, team-based approach to providing round-the-clock emergency general surgery (EGS) care for adult patients needing treatment for diseases such as cholecystitis, gastrointestinal perforation, and necrotizing fasciitis. Lacking any prior evidence on optimizing outcomes for EGS patients, current implementation of ACS models has been idiosyncratic. We sought to use a Donabedian approach to elucidate potential EGS structures and processes that might be associated with improved outcomes as an initial step in designing the optimal model of ACS care for EGS patients. METHODS: We developed and implemented a national survey of hospital-level EGS structures and processes by surveying surgeons or chief medical officers regarding hospital-level structures and processes that directly or indirectly impacted EGS care delivery in 2015. These responses were then anonymously linked to 2015 data from the American Hospital Association (AHA) annual survey, Medicare Provider Analysis and Review claims (MedPAR), 17 State Inpatient Databases (SIDs) using AHA unique identifiers (AHAID). This allowed us to combine hospital-level data, as reported in our survey or to the AHA, to patient-level data in an effort to further examine the role of EGS structures and processes on EGS outcomes. We describe the multi-step, iterative process utilizing the Donabedian framework for quality measurement that serves as a foundation for later work in this project. RESULTS: Hospitals that responded to the survey were primarily non-governmental and located in urban settings. A plurality of respondent hospitals had fewer than 100 inpatient beds. A minority of the hospitals had medical school affiliations. DISCUSSION: Our results will enable us to develop a measure of preparedness for delivering EGS care in the US, provide guidance for regionalized care models for EGS care, tiering of ACS programs based on the robustness of their EGS structures and processes and the quality of their outcomes, and formulate triage guidelines based on patient risk factors and severity of EGS disease. CONCLUSIONS: Our work provides a template for team science applicable to research efforts combining primary data collection (i.e., that derived from our survey) with existing national data sources (i.e., SIDs and MedPAR).

Discharge destination and readmission rates in older trauma patients.

BACKGROUND: In older trauma patients, the impact of discharge destination on readmission rates is not known. The objective of this study was to evaluate the association between the discharge destination and the 30-day readmission rate in older trauma patients. MATERIALS AND METHODS: A previously validated database of all patients aged 45 years or older undergoing trauma evaluation at our level 1 trauma center between January 1, 2008 and December 31, 2008 was analyzed to retrospectively compare the incidences of 30-day readmission between patients discharged to home, to inpatient rehabilitation facilities, and to other extended care facilities (ECFs). Demographic information including age and gender and potentially confounding factors including injury severity, trauma activation level, comorbidities, medications, and preinjury functional status were included. Univariate analysis was undertaken using chi-square testing. Multiple logistic regression was performed with potential confounding variables to evaluate for independent contribution to readmission risk. RESULTS: A total of 960 patients were evaluated; 81 patients (8.4%) were excluded, leaving 879 patients included in the analysis. Seventy-six patients (8.6%) were readmitted within 30 d of discharge. Overall, 6% of those discharged to home, 13% of those discharged to ECF, and 16% of those discharged to rehabilitation were readmitted (P < 0.01 on univariate analysis). Overall, 866 (98.5%) patients had data recorded for all variables analyzed using multiple logistic regression; among these, only discharge destination was independently associated with the rate of readmission (P < 0.01). CONCLUSIONS: Discharge to ECFs and inpatient rehabilitation facilities appear to be an independent risk factor for hospital readmissions in this population despite controlling for injury severity and comorbidities. Recognition of this risk factor may aid in the disposition planning of these patients and suggests the need for further evaluation of this correlation at other US medical centers.

Benefit of balance? Odds of survival by unit transfused: Retrospective analysis of the ACS-TQIP database.

BACKGROUND: The critical blood shortage in January 2022 threatened the availability of blood. Utility of transfusion per unit was reported in a previous study, revealing patients receiving balanced transfusion are more likely to die after 16 units of packed red blood cells. We aimed to validate this study using a larger database. METHODS: Retrospective analysis utilizing the American College of Surgeons Trauma Quality Improvement Program was performed. Trauma patients aged ≥16 receiving transfusion within 4 hours of arrival were included and excluded if they died in the emergency department, received <2 units of packed red blood cells, did not receive fresh frozen plasma, or were missing data. Primary outcome was mortality. Subgroups were balanced transfusion if receiving ≤2:1 ratio of packed red blood cells:fresh frozen plasma, and unbalanced transfusion if >2:1 ratio. RESULTS: A total of 17,047 patients were evaluated with 28% mortality (4,822/17,408). Multivariable logistic regression identified advancing age (odds ratio 1.03 95% confidence interval 1.03-1.04), higher ISS (odds ratio 1.04, 95% confidence interval 1.03-1.04), and lower GCS (odds ratio 0.82, 95% confidence interval 0.82-0.83) as risk factors for mortality. Protective factors were balanced transfusion (odds ratio 0.81 95% confidence interval 0.71-0.93), male sex (odds ratio 0.90, 95% confidence interval 0.81-0.99), and blunt mechanism (odds ratio 0.74, 95% confidence interval 0.67-0.81). At 11 units of packed red blood cells, balanced transfusion patients were more likely to die (odds ratio 0.88, 95% confidence interval 0.80-0.98). Balanced transfusion patients survived at a higher rate for each unit of packed red blood cells, between 6 and 23 units of packed red blood cells. CONCLUSION: Mortality increases with each unit of packed red blood cell transfused. At 11 units of packed red blood cells, mortality is the more likely outcome. Balanced transfusion improves the chance of survival through 23 units of packed red blood cells.

Propensity weighted analysis of chemical venous thromboembolism prophylaxis agents in isolated severe traumatic brain injury: An EAST sponsored multicenter study.

BACKGROUND: In patients with severe traumatic brain injury (TBI), clinicians must balance preventing venous thromboembolism (VTE) with the risk of intracranial hemorrhagic expansion (ICHE). We hypothesized that low molecular weight heparin (LMWH) would not increase risk of ICHE or VTE as compared to unfractionated heparin (UH) in patients with severe TBI. METHODS: Patients ≥ 18 years of age with isolated severe TBI (AIS ≥ 3), admitted to 24 level I and II trauma centers between January 1, 2014 to December 31, 2020 and who received subcutaneous UH and LMWH injections for chemical venous thromboembolism prophylaxis (VTEP) were included. Primary outcomes were VTE and ICHE after VTEP initiation. Secondary outcomes were mortality and neurosurgical interventions. Entropy balancing (EBAL) weighted competing risk or logistic regression models were estimated for all outcomes with chemical VTEP agent as the predictor of interest. RESULTS: 984 patients received chemical VTEP, 482 UH and 502 LMWH. Patients on LMWH more often had pre-existing conditions such as liver disease (UH vs LMWH 1.7 % vs. 4.4 %, p = 0.01), and coagulopathy (UH vs LMWH 0.4 % vs. 4.2 %, p < 0.001). There were no differences in VTE or ICHE after VTEP initiation. There were no differences in neurosurgical interventions performed. There were a total of 29 VTE events (3 %) in the cohort who received VTEP. A Cox proportional hazards model with a random effect for facility demonstrated no statistically significant differences in time to VTE across the two agents (p = 0.44). The LMWH group had a 43 % lower risk of overall ICHE compared to the UH group (HR = 0.57: 95 % CI = 0.32-1.03, p = 0.062), however was not statistically significant. CONCLUSION: In this multi-center analysis, patients who received LMWH had a decreased risk of ICHE, with no differences in VTE, ICHE after VTEP initiation and neurosurgical interventions compared to those who received UH. There were no safety concerns when using LMWH compared to UH. LEVEL OF EVIDENCE: Level III, Therapeutic Care Management.

Increased risk of pneumonia among ventilated patients with traumatic brain injury: every day counts!

BACKGROUND: Patients with traumatic brain injury (TBI) frequently require mechanical ventilation (MV). The objective of this study was to examine the association between time spent on MV and the development of pneumonia among patients with TBI. MATERIALS AND METHODS: Patients older than 18 y with head abbreviated injury scale (AIS) scores coded 1-6 requiring MV in the National Trauma Data Bank 2007-2010 data set were included. The study was limited to hospitals reporting pneumonia cases. AIS scores were calculated using ICDMAP-90 software. Patients with injuries in any other region with AIS score >3, significant burns, or a hospital length of stay >30 d were excluded. A generalized linear model was used to determine the approximate relative risk of developing all-cause pneumonia (aspiration pneumonia, ventilator-associated pneumonia [VAP], and infectious pneumonia identified by the International Classification of Disease, Ninth Revision, diagnosis code) for each day of MV, controlling for age, gender, Glasgow coma scale motor score, comorbidity (Charlson comorbidity index) score, insurance status, and injury type and severity. RESULTS: Among the 24,525 patients with TBI who required MV included in this study, 1593 (6.5%) developed all-cause pneumonia. After controlling for demographic and injury factors, each additional day on the ventilator was associated with a 7% increase in the risk of pneumonia (risk ratio 1.07, 95% confidence interval 1.07-1.08). CONCLUSIONS: Patients who have sustained TBIs and require MV are at higher risk for VAP than individuals extubated earlier; therefore, shortening MV exposure will likely reduce the risk of VAP. As patients with TBI frequently require MV because of neurologic impairment, it is key to develop aggressive strategies to expedite ventilator independence.

Multi-System Inflammatory Syndrome Presenting as Non-Specific Colitis: A Medical Diagnosis with a Surgical Presentation.

A 20-year-old woman with previous COVID-19 diagnosis presented with abdominal pain and colitis on CT scan. She was admitted in septic shock, with etiology of colitis unclear. After resuscitation, antibiotics, and steroids, she clinically deteriorated. Worsening Clostridioides difficile infection was most likely and she was taken to the operating room. Intraoperatively, only a segment of transverse colon appeared abnormal on gross and endoscopic evaluation. Total colectomy was deferred in favor of segmental resection. Given her unusual disease pattern and recent COVID-19 infection, diagnosis of MIS-C was considered. Steroids were continued and treatment broadened to include heparin and IVIG. The patient returned to the operating room for planned reexploration, endoscopy, and end colostomy. On hospital day three, the patient had an acute mental status change. Computed tomography demonstrated acute cerebral edema with brainstem herniation. The family chose comfort-care measures. Final pathology from the transverse colon demonstrated COVID-19-associated vasculitis.

Are we waiting for the sky to fall? Predictors of withdrawal of life-sustaining support in older trauma patients: A retrospective analysis.

BACKGROUND: Limited data exist regarding the impact of advanced care planning for injured geriatric patients. We hypothesized that patients with advance directives limiting care (ADLC) compared with those without ADLC are more likely to undergo withdrawal of life-sustaining support (WLSS). METHODS: This is a propensity-matched analysis utilizing American College of Surgeons Trauma Quality Improvement Program patients 65 years or older who presented between 2017 and 2018. Patients with and without ADLC on admission were compared. The primary outcome was WLSS and days prior to WLSS. Additional factors examined included hospital length of stay (LOS), unplanned operations, unplanned intensive care unit admissions, and in-hospital cardiac arrests. Prior to matching, logistic regression model assessed factors associated with WLSS. Patients with and without ADLC were matched 1:1 via a propensity score using patient and injury factors as covariates, and matched pair analysis compared differences in WLSS between patients with and without ADLC. RESULTS: There were 597,840 patients included: 44,001 patients with an ADLC (7.36%) compared with 553,839 with no ADLC (92.64%). Patients with an ADLC underwent WLSS more often than those with no ADLC (7.68% vs. 2.48%, p < 0.001). In a 1:1 propensity-matched analysis, patients with ADLC were more likely to undergo WLSS (odds ratio [OR], 2.38' 95% confidence interval [CI], 2.22-2.55), although stronger predictors of WLSS included severity of injury (Injury Severity Score, 25+; OR, 23.84; 95% CI, 21.55-26.36), unplanned intensive care unit admissions (OR, 3.30; 95% CI, 2.89-3.75), and in-hospital cardiac arrests (OR, 4.97; 95% CI, 4.02-6.15). CONCLUSION: A small proportion of the geriatric trauma population had ADLC on admission. While ADLC was predictive of WLSS, adverse events were more strongly associated with WLSS. To ensure patient-centered care and reduce futile interventions, surgeons should delineate goals of care early regardless of ADLC. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

When is enough enough? Odds of survival by unit transfused.

BACKGROUND: Balanced transfusion is lifesaving for hemorrhagic shock. The American Red Cross critical blood shortage in 2022 threatened the immediate availability of blood. To eliminate waste, we reviewed the utility of transfusions per unit to define expected mortality at various levels of balanced transfusion. METHODS: A retrospective study of 296 patients receiving massive transfusion on presentation at a level 1 trauma center was performed from January 2018 to December 2021. Units of packed red blood cells (PRBCs), fresh frozen plasma (FFP), and platelets received in the first 4 hours were recorded. Patients were excluded if they died in the emergency department, died on arrival, received <2 U PRBCs or FFP, or received PRBC/FFP >2:1. Primary outcomes were mortality and odds of survival to discharge. Subgroups were defined as transfused if receiving 2 to 9 U PRBCs, massive transfusion for 10 to 19 U PRBCs, and ultramassive transfusion for ≥20 U PRBCs. RESULTS: A total of 207 patients were included (median age, 32 years; median Injury Severity Score, 25; 67% with penetrating mechanism). Mortality was 29% (61 of 207 patients). Odds of survival is equal to odds of mortality at 11 U PRBCs (odds ratio [OR], 0.95; 95% confidence interval [CI], 0.50-1.79). Beyond 16 U PRBCs, odds of mortality exceed survival (OR, 0.36; 95% CI, 0.16-0.82). Survival approaches zero >36 U PRBCs (OR, 0.09; 95% CI, 0.00-0.56). Subgroup mortality rates increased with unit transfused (16% transfused vs. 36% massive transfusion, p = 0.003; 36% massive transfusion vs. 67% ultramassive transfusion, p = 0.006). CONCLUSION: Mortality increases with each unit balanced transfusion. Surgeons should view efforts heroic beyond 16 U PRBCs/4 hours and near futile beyond 36 U PRBCs/4 hours. While extreme outliers can survive, consider cessation of resuscitation beyond 36 U PRBCs. This is especially true if hemostasis has not been achieved or blood supplies are limited. LEVEL OF EVIDENCE: Prognostic and Epidemiologic; Level IV.

Intrathecal delivery of nanoparticle PARP inhibitor to the cerebrospinal fluid for the treatment of metastatic medulloblastoma.

The morbidity associated with pediatric medulloblastoma, in particular in patients who develop leptomeningeal metastases, remains high in the absence of effective therapies. Administration of substances directly into the cerebrospinal fluid (CSF) is one approach to circumvent the blood-brain barrier and focus delivery of drugs to the site of tumor. However, high rates of CSF turnover prevent adequate drug accumulation and lead to rapid systemic clearance and toxicity. Here, we show that PLA-HPG nanoparticles, made with a single-emulsion, solvent evaporation process, can encapsulate talazoparib, a PARP inhibitor (BMN-673). These degradable polymer nanoparticles improve the therapeutic index when delivered intrathecally and lead to sustained drug retention in the tumor as measured with PET imaging and fluorescence microscopy. We demonstrate that administration of these particles into the CSF, alone or in combination with systemically administered temozolomide, is a highly effective therapy for tumor regression and prevention of leptomeningeal spread in xenograft mouse models of medulloblastoma. These results provide a rationale for harnessing nanoparticles for the delivery of drugs limited by brain penetration and therapeutic index and demonstrate important advantages in tolerability and efficacy for encapsulated drugs delivered locoregionally.

Early VTE prophylaxis in severe traumatic brain injury: A propensity score weighted EAST multicenter study.

BACKGROUND: Patients with traumatic brain injury (TBI) are at high risk of venous thromboembolism events (VTE). We hypothesized that early chemical VTE prophylaxis initiation (≤24 hours of a stable head CT) in severe TBI would reduce VTE without increasing risk of intracranial hemorrhage expansion (ICHE). METHODS: A retrospective review of adult patients 18 years or older with isolated severe TBI (Abbreviated Injury Scale score, ≥ 3) who were admitted to 24 Level I and Level II trauma centers from January 1, 2014 to December 31 2020 was conducted. Patients were divided into those who did not receive any VTE prophylaxis (NO VTEP), who received VTE prophylaxis ≤24 hours after stable head CT (VTEP ≤24) and who received VTE prophylaxis >24 hours after stable head CT (VTEP>24). Primary outcomes were VTE and ICHE. Covariate balancing propensity score weighting was utilized to balance demographic and clinical characteristics across three groups. Weighted univariate logistic regression models were estimated for VTE and ICHE with patient group as predictor of interest. RESULTS: Of 3,936 patients, 1,784 met inclusion criteria. Incidences of VTE was significantly higher in the VTEP>24 group, with higher incidences of DVT in the group. Higher incidences of ICHE were observed in the VTEP≤24 and VTEP>24 groups. After propensity score weighting, there was a higher risk of VTE in patients in VTEP >24 compared with those in VTEP≤24 (odds ratio, 1.51; 95% confidence interval, 0.69-3.30; p = 0.307), however was not significant. Although, the No VTEP group had decreased odds of having ICHE compared with VTEP≤24 (odds ratio, 0.75; 95% confidence interval, 0.55-1.02, p = 0.070), the result was not statistically significant. CONCLUSION: In this large multi-center analysis, there were no significant differences in VTE based on timing of initiation of VTE prophylaxis. Patients who never received VTE prophylaxis had decreased odds of ICHE. Further evaluation of VTE prophylaxis in larger randomized studies will be necessary for definitive conclusions. LEVEL OF EVIDENCE: Therapeutic Care Management; Level III.

Safety, efficiency, and cost-effectiveness of a multidisciplinary percutaneous tracheostomy program.

OBJECTIVE: The frequency of bedside percutaneous tracheostomies is increasing in intensive care medicine, and both safety and efficiency of care are critical elements in continuing success of this procedure. Prioritizing patient safety, a tracheostomy team was created at our institution to provide bedside expertise in surgery, anesthesiology, respiratory, and technical support. This study was performed to evaluate the metrics of patient outcome, efficiency of care, and cost-benefit analysis of the multidisciplinary Johns Hopkins Percutaneous Tracheostomy Program. DESIGN: A review was performed for patients who received tracheostomies in 2004, the year before the Johns Hopkins Percutaneous Tracheostomy Program was established, and those who received tracheostomies in 2008, the year following the program's establishment. Comparative outcomes were evaluated, including the efficiency of procedure and intensive care unit length of stay, complication rate including bleeding, hypoxia, loss of airway, and a financial cost-benefit analysis. SETTING: Single-center, major university hospital. PATIENTS: The sample consisted of 363 patients who received a tracheostomy in the years 2004 and 2008. MEASUREMENTS AND MAIN RESULTS: The number of percutaneous procedures increased from 59 of 126 tracheostomy patients in 2004, to 183 of 237 in 2008. There were significant decreases in the prevalence of procedural complications, particularly in the realm of airway injuries and physiologic disturbances. Regarding efficiency, the structured program reduced the time to tracheostomy and overall procedural time. The intensive care unit length of stay in nonpulmonary patients and improvement in intensive care unit and operating room back-fill efficiency contributed to an overall institutional financial benefit. CONCLUSIONS: An institutionally subsidized, multi-disciplinary percutaneous tracheostomy program can improve the quality of care in a cost-effective manner by decreasing the incidence of tracheostomy complications and improving both the time to tracheostomy, duration of procedure, and postprocedural intensive care unit stay.

Analysis of Outcomes Associated With Outpatient Management of Nonoperatively Treated Patients With Appendicitis.

Importance: In the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial, which found antibiotics to be noninferior, approximately half of participants randomized to receive antibiotics had outpatient management with hospital discharge within 24 hours. If outpatient management is safe, it could increase convenience and decrease health care use and costs. Objective: To assess the use and safety of outpatient management of acute appendicitis. Design, Setting, and Participants: This cohort study, which is a secondary analysis of the CODA trial, included 776 adults with imaging-confirmed appendicitis who received antibiotics at 25 US hospitals from May 1, 2016, to February 28, 2020. Exposures: Participants randomized to antibiotics (intravenous then oral) could be discharged from the emergency department based on clinician judgment and prespecified criteria (hemodynamically stable, afebrile, oral intake tolerated, pain controlled, and follow-up confirmed). Outpatient management and hospitalization were defined as discharge within or after 24 hours, respectively. Main Outcomes and Measures: Outcomes compared among patients receiving outpatient vs inpatient care included serious adverse events (SAEs), appendectomies, health care encounters, satisfaction, missed workdays at 7 days, and EuroQol 5-dimension (EQ-5D) score at 30 days. In addition, appendectomy incidence among outpatients and inpatients, unadjusted and adjusted for illness severity, was compared. Results: Among 776 antibiotic-randomized participants, 42 (5.4%) underwent appendectomy within 24 hours and 8 (1.0%) did not receive their first antibiotic dose within 24 hours, leaving 726 (93.6%) comprising the study population (median age, 36 years; range, 18-86 years; 462 [63.6%] male; 437 [60.2%] White). Of these participants, 335 (46.1%; site range, 0-89.2%) were discharged within 24 hours, and 391 (53.9%) were discharged after 24 hours. Over 7 days, SAEs occurred in 0.9 (95% CI, 0.2-2.6) per 100 outpatients and 1.3 (95% CI, 0.4-2.9) per 100 inpatients; in the appendicolith subgroup, SAEs occurred in 2.3 (95% CI, 0.3-8.2) per 100 outpatients vs 2.8 (95% CI, 0.6-7.9) per 100 inpatients. During this period, appendectomy occurred in 9.9% (95% CI, 6.9%-13.7%) of outpatients and 14.1% (95% CI, 10.8%-18.0%) of inpatients; adjusted analysis demonstrated a similar difference in incidence (-4.0 percentage points; 95% CI, -8.7 to 0.6). At 30 days, appendectomies occurred in 12.6% (95% CI, 9.1%-16.7%) of outpatients and 19.0% (95% CI, 15.1%-23.4%) of inpatients. Outpatients missed fewer workdays (2.6 days; 95% CI, 2.3-2.9 days) than did inpatients (3.8 days; 95% CI, 3.4-4.3 days) and had similar frequency of return health care visits and high satisfaction and EQ-5D scores. Conclusions and Relevance: These findings support that outpatient antibiotic management is safe for selected adults with acute appendicitis, with no greater risk of complications or appendectomy than hospital care, and should be included in shared decision-making discussions of patient preferences for outcomes associated with nonoperative and operative care. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Increase in gunshot wounds at a level 1 trauma center following the COVID19 pandemic.

OBJECTIVES: To compare the number of patients with gunshot wounds presenting to our level 1 trauma center before and during the COVID-19 pandemic with a focus on volume trends after the lifting of stay-at-home directives through August 2020. DESIGN: Retrospective. SETTING: Level 1 trauma center. PATIENTS/PARTICIPANTS: Seven hundred six gunshot wound patients between 2016 and 2020 (months March to September only). INTERVENTION: COVID-19 pandemic and resultant stay at home directives. MAIN OUTCOME MEASUREMENTS: Number of patients presenting with gunshot wounds per time period. RESULTS: The number of patients with gunshot wounds presenting to our institution increased by 11.7% in March-April 2020 and by 67% in May-August 2020 when compared to previous years. Length of stay significantly decreased in 2020 compared to 2018 and 2019. In 2020, significantly fewer patients had orthopaedic procedures than in 2018. CONCLUSIONS: Patients presenting with gunshot wounds increased during the initial "stay-at-home" portion of the pandemic in March to April and increased significantly more after the restrictions were relaxed during May to August.Level of Evidence: Therapeutic Level III.

Re-examining "Never Letting the Sun Rise or Set on a Bowel Obstruction" in the Era of Acute Care Surgery.

BACKGROUND: Small bowel obstruction (SBO) no longer mandates urgent surgical evaluation raising the question of the role of operating room (OR) access on SBO outcomes. METHODS: Data from our 2015 survey on emergency general surgery (EGS) practices, including queries on OR availability and surgical staffing, were anonymously linked to adult SBO patient data from 17 Statewide Inpatient Databases (SIDs). Univariate and multivariable associations between OR access and timing of operation, complications, length of stay (LOS), and in-hospital mortality were measured. RESULTS: Of 32,422 SBO patients, 83% were treated non-operatively. Operative patients were older (median 66 vs 65 years), had more comorbidities (53% vs 46% with ≥ 3), and experienced more systemic complications (36% vs 23%), higher mortality (2.8% vs 1.4%), and longer LOS (median 10 vs 4 days). Patients had lower odds of operation if treated at hospitals lacking processes to tier urgent cases (aOR 0.90, 95% CI [0.83-0.99]) and defer elective cases (aOR 0.87 [0.80-0.94]). Patients had higher odds of operation if treated at hospitals with surgeons sometimes (aOR 1.14 [1.04-1.26]) or rarely/never (aOR 1.16 [1.06-1.26]) covering EGS at more than one location compared to always. Odds of systemic complication (OR 2.0 [1.6-2.4]), operative complication (OR 1.5 [1.2-1.8]), and mortality were increased for very late versus early operation (OR 2.6 [1.7-4.0]). CONCLUSIONS: Although few patients with SBO require emergency surgery, we identified EGS structures and processes that are important for providing timely and appropriate intervention for patients whose SBO remains unresolved and requires surgery.

In-house intensivist presence does not affect mortality in select emergency general surgery patients.

BACKGROUND: This study aimed to assess the relationship between availability of round-the-clock (RTC) in-house intensivists and patient outcomes in people who underwent surgery for a life-threatening emergency general surgery (LT-EGS) disease such as necrotizing soft-tissue infection, ischemic enteritis, perforated viscus, and toxic colitis. METHODS: Data on hospital-level critical care structures and processes from a 2015 survey of 2,811 US hospitals were linked to patient-level data from 17 State Inpatient Databases. Patients who were admitted with a primary diagnosis code for an LT-EGS disease of interest and underwent surgery on date of admission were included in analyses. RESULTS: We identified 3,620 unique LT-EGS admissions at 368 hospitals. At 66% (n = 243) of hospitals, 83.5% (n = 3,021) of patients were treated at hospitals with RTC intensivist-led care. These facilities were more likely to have in-house respiratory therapists and protocols to ensure availability of blood products or adherence to Surviving Sepsis Guidelines. When accounting for other key factors including overnight surgeon availability, perioperative staffing, and annual emergency general surgery case volume, not having a protocol to ensure adherence to Surviving Sepsis Guidelines (adjusted odds ratio, 2.10; 95% confidence interval, 1.12-3.94) was associated with increased odds of mortality. CONCLUSION: Our results suggest that focused treatment of sepsis along with surgical source control, rather than RTC intensivist presence, is key feature of optimizing EGS patient outcomes. LEVEL OF EVIDENCE: Therapeutic, level III.

Role of interprofessional teams in emergency general surgery patient outcomes.

BACKGROUND: In response to duty hour restrictions, hospitals expanded residency programs and added advanced practice providers. We sought to determine if type of clinical support was associated with emergency general surgery outcomes. METHODS: As part of our 2015 survey of acute care hospitals, we asked hospitals whether residents and advanced practice providers participate in emergency general surgery care. Data from responding hospitals were linked to patient data (≥18 years old admitted with an emergency general surgery diagnosis) from 17 State Inpatient Databases using American Hospital Association identifiers. Analyses compared emergency general surgery patient and hospital characteristics based on type of providers assisting emergency general surgery surgeons (none, only advanced practice providers, only residents, or both). Multivariable analysis determined if presence of advanced practice providers and/or residents was associated with type of management, mortality, or complications. RESULTS: Eighty-three hospitals and 49,271 unique emergency general surgery admissions were included. Hospitals without residents and advanced practice providers were most likely to manage patients operatively. However, hospitals with residents (alone or with advanced practice providers) had reduced odds of systemic complication compared with hospitals without clinical support (adjusted odds ratio 0.77 [95% confidence interval 0.60-0.98] and adjusted odds ratio 0.77 [95% confidence interval 0.62-0.95], respectively), while hospitals with only residents had the lowest odds of operative complication. CONCLUSION: Our findings highlight the positive effect residents (alone or partnering with advanced practice providers) can have on emergency general surgery patient outcomes.

Phenome-based approach identifies RIC1-linked Mendelian syndrome through zebrafish models, biobank associations and clinical studies.

Discovery of genotype-phenotype relationships remains a major challenge in clinical medicine. Here, we combined three sources of phenotypic data to uncover a new mechanism for rare and common diseases resulting from collagen secretion deficits. Using a zebrafish genetic screen, we identified the ric1 gene as being essential for skeletal biology. Using a gene-based phenome-wide association study (PheWAS) in the EHR-linked BioVU biobank, we show that reduced genetically determined expression of RIC1 is associated with musculoskeletal and dental conditions. Whole-exome sequencing identified individuals homozygous-by-descent for a rare variant in RIC1 and, through a guided clinical re-evaluation, it was discovered that they share signs with the BioVU-associated phenome. We named this new Mendelian syndrome CATIFA (cleft lip, cataract, tooth abnormality, intellectual disability, facial dysmorphism, attention-deficit hyperactivity disorder) and revealed further disease mechanisms. This gene-based, PheWAS-guided approach can accelerate the discovery of clinically relevant disease phenome and associated biological mechanisms.