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.).

Recommended Essential Equipment for Basic Life Support and Advanced Life Support Ground Ambulances 2020: A Joint Position Statement.

In continued support of establishing and maintaining a foundation for standards of care, our organizations remain committed to periodic review and revision of this position statement. This latest revision was created based on a structured review of the National Model EMS Clinical Guidelines Version 2.2 in order to identify the equipment items necessary to deliver the care defined by those guidelines. In addition, in order to ensure congruity with national definitions of provider scope of practice, the list is differentiated into BLS and ALS levels of service utilizing the National Scope of Practice-defined levels of Emergency Medical Responder (EMR) and Emergency Medical Technician (EMT) as BLS, and Advanced EMT (AEMT) and Paramedic as ALS. Equipment items listed within each category were cross-checked against recommended scopes of practice for each level in order to ensure they were appropriately dichotomized to BLS or ALS levels of care. Some items may be considered optional at the local level as determined by agency-defined scope of practice and applicable clinical guidelines. In addition to the items included in this position statement our organizations agree that all EMS service programs should carry equipment and supplies in quantities as determined by the medical director and appropriate to the agency's level of care and available certified EMS personnel and as established in the agency's approved protocols.

"Should We Phenobarb-it-All?" A Phenobarbital-Based Protocol for Non-Intensive Care Unit Trauma Patients at High Risk of or Experiencing Alcohol Withdrawal.

BACKGROUND: Alcohol use is frequent in trauma patients and alcohol withdrawal syndrome (AWS) is associated with significant morbidity. Benzodiazepines are commonly used for AWS, but may cause neurologic and respiratory adverse events (AEs). The objective was to evaluate the effectiveness and safety of a phenobarbital-based protocol for the treatment of AWS in non-intensive care unit (ICU) trauma patients. METHODS: Adult non-ICU trauma patients at high risk of or experiencing AWS PRE and POST implementation of a phenobarbital-based protocol were included. Outcomes were AWS-related complications (AWS-RC), benzodiazepine use, adjunctive medication use, hospital length of stay (HLOS), and medication-related AEs. Subgroup analyses were performed on patients with traumatic brain injury (TBI), rib fractures, and at high risk of severe AWS. RESULTS: Overall, 110 patients were included (51 PRE, 59 POST). AWS-RC developed in 17 PRE patients compared to 10 POST patients (33% vs 17%; P = .05). PRE patients were more likely to receive benzodiazepines (88% vs 42%, P < .0001) and higher total dose (11 vs 4 mg lorazepam equivalent; P = .001). No difference noted in HLOS (8 vs 8 days, P = .27), adjunctive medication use (49% vs 54%, P = .60), or AEs (57% vs 39%, P = .06). There was no difference in AWS-RC in the TBI subgroup (P = .19), less AEs in the rib fracture POST subgroup (P = .04), and less AWS-RC in the high risk of severe AWS POST subgroup (P = .03). DISCUSSION: A phenobarbital-based protocol in trauma patients is effective in preventing AWS-RC and decreasing benzodiazepine use without increasing AEs.

Outcomes of Protocol-Driven Venous Thromboembolic Chemo-Prophylaxis in Trauma Patients: A Trauma Quality Improvement Project Analysis.

INTRODUCTION: Low molecular weight heparin (LMWH) is the standard for venous thromboembolic (VTE) chemo-prophylaxis in trauma patients; however, inconsistencies in the use of LMWH exist. The objective of this study was to assess VTE outcomes in response to a chemo-prophylaxis protocol guided by patient physiology (eg, creatinine clearance) and comorbidities. METHODS: ACS TQIP Benchmark Reports at a level 1 trauma center using a patient physiology and comorbidity directed VTE chemo-prophylaxis protocol were analyzed for Spring 2019 to Fall 2021. Patient demographics, VTE rates and pharmacologic VTE prophylaxis type were collected for "All Patients" and "Elderly" (TQIP: age ≥ 55 years) cohorts. RESULTS: Data was analyzed for 1919183 "All Hospitals" (AH) and 5843 patients single institution (SI) using the physiologic and comorbidity guided VTE chemo-prophylaxis protocol. Elderly subgroup had 701965 (AH) and 2939 (SI) patients. Use of non-LMWH chemo-prophylaxis was significantly higher at SI: All patients = 62.6% SI vs 22.1% (P < .01); Elderly = 68.8% SI vs 28.1% AH (P < .01). VTE, DVT, and PE rates for All Patients and Elderly subgroup were significantly reduced at SI, except Elderly PE which was statistically equivalent. CONCLUSIONS: Protocol-driven VTE chemo-prophylaxis was associated with significantly lower LMWH use accompanied by significant reductions in All VTE, DVT, PE, and Elderly VTE and DVT with no difference in Elderly PE rates. These results may imply that adherence to a physiologic and comorbidity directed chemo-prophylaxis protocol, rather than LMWH, reduces VTE events in trauma patients. Further investigation to elucidate best practice is warranted.

Severity and patterns of injury in helmeted vs. non-helmeted motorcyclists in a rural state.

INTRODUCTION: Under current law in our rural state, there is no universal requirement for motorcyclists to wear helmets. Roughly 500 motorcycle crashes are reported by the state each year and only a fraction of those riders wear helmets. We sought to determine the difference in injury patterns and severity in helmeted versus non-helmeted riders. METHODS: Retrospective review (2014-2018) of a single level 1 trauma center's registry was done for subjects admitted after a motorcycle collision. Demographic, injury and patient outcome data were collected. Patients were stratified by helmet use (n = 81), no helmet use (n = 144), and unknown helmet use (n = 194). Statistical analysis used Student's t-test or Pearson's χ2p-value ≤0.05 as significant. State Department of Transportation data registry for state level mortality and collision incidence over the same time period was also obtained. RESULTS: Of the 2,022 state-reported motorcycle collisions, 419 individuals admitted to our trauma center were analyzed (21% capture). State-reported field fatality rate regardless of helmet use was 4%. Our inpatient mortality rate was 2% with no differences between helmet uses. Helmeted riders were found to have significantly fewer head and face injuries, higher GCS, lower face, neck, thorax and abdomen AIS, fewer required mechanical ventilation, shorter ICU length of stay, and had a greater number of upper extremity injuries and higher upper extremity AIS. CONCLUSIONS: Helmeted motorcyclists have fewer head, face, and cervical spine injuries, and lower injury severities: GCS and face, neck, thorax, abdomen AIS. Helmeted riders had significantly less mechanical ventilation requirement and shorter ICU stays. Non-helmeted riders sustained worse injuries. Practical Applications: Helmets provide safety and motorcycle riders have a 34-fold higher risk of death following a crash. Evaluating injury severities and patterns in motorcycle crash victims in a rural state with no helmet laws may provide insight into changing current legislation.

Protocoled thrombolytic therapy for frostbite improves phalangeal salvage rates.

BACKGROUND: Frostbite is a cold injury that has the potential to cause considerable morbidity and long-term disability. Despite the complexity of these patients, diagnostic and treatment practices lack standardization. Thrombolytic therapy has emerged as a promising treatment modality, demonstrating impressive digit salvage rates. We review our experience with thrombolytic therapy for severe upper extremity frostbite. METHODS: Retrospective data on all frostbite patients evaluated at our institution from December 2017 to March 2018 was collected. A subgroup of patients with severe frostbite treated with intra-arterial thrombolytic therapy (IATT) were analysed. RESULTS: Of the 17 frostbite patients treated at our institution, 14 (82%) were male and the median age was 31 (range: 19-73). Substance misuse was involved in a majority of the cases (58.8%). Five (29.4%) patients with severe frostbite met inclusion criteria for IATT and the remaining patients were treated conservatively. Angiography demonstrated a 74.5% improvement in perfusion after tissue plasminogen activator thrombolysis. When comparing phalanges at risk on initial angiography to phalanges undergoing amputation, the phalangeal salvage rate was 83.3% and the digit salvage rate was 80%. Complications associated with IATT included groin hematoma, pseudoaneurysm and retroperitoneal hematoma. CONCLUSIONS: Thrombolytic therapy has the potential to greatly improve limb salvage and functional recovery after severe frostbite when treated at an institution that can offer comprehensive, protocoled thrombolytic therapy. A multi-center prospective study is warranted to elucidate the optimal treatment strategy in severe frostbite.

Organ donation after trauma: A 30-year review.

BACKGROUND: Over the past 30 years, the demographics, clinical characteristics, and management of trauma patients have changed dramatically. During this same period, the organ donor population has also changed. The interactions between these two demographic shifts have not been examined in a systematic way. We hypothesize that trauma victims continue to be an important source of organs. We set out to systematically examine traumatic donors in an attempt to identify opportunities to increase organ recovery and quality. METHODS: In this retrospective analysis, we compared trauma donors (TDs) and non-TDs (NTDs) in the Scientific Registry of Transplant Recipients standard analysis files, a clinical data set collected by the Organ Procurement Transplant Network on all solid organ transplant candidates, donors, and recipients in the United States since 1987. RESULTS: Scientific Registry of Transplant Recipients contained data on 191,802 deceased donors. The percentage of TDs decreased from 55.3% in 1987 to 35.8% in 2016 (p < 0.001) primarily due to a steady increase in NTDs. Trauma donors are younger and have fewer comorbidities while the percentage of donors who were public health service high risk or who underwent donation after cardiac death were clinically similar. The TDs produce more organs/donor (3.5 vs. 2.4, p < 0.001), are more likely to yield an extrarenal organ, and exhibit lower (better) Kidney Donor Risk Index scores, a predictor of graft longevity. These better outcomes are maintained after stratifying by age. CONCLUSION: Over the past 30 years, the number of NTDs has increased much more than the number of TDs. However, TDs remain a critically important organ donor source, yielding more organs per donor, better quality kidneys, and a higher likelihood of extrarenal organs. Potential causes, such as improved resuscitation protocols, should be examined in the future. LEVEL OF EVIDENCE: Retrospective review, level III.

Variations in institutional review board processes and consent requirements for trauma research: an EAST multicenter survey.

Oversight of human subject research has evolved considerably since its inception. However, previous studies identified a lack of consistency of institutional review board (IRB) determination for the type of review required and whether informed consent is necessary, especially for prospective observational studies, which pose minimal risk of harm. We hypothesized that there is significant inter-institution variation in IRB requirements for the type of review and necessity of informed consent, especially for prospective observational trials without blood/tissue utilization. We also sought to describe investigators' and IRB members' attitudes toward the type of review and need for consent. Eastern Association for the Surgery of Trauma (EAST) and IRB members were sent an electronic survey on IRB review and informed consent requirement. We performed descriptive analyses as well as Fisher's exact test to determine differences between EAST and IRB members' responses. The response rate for EAST members from 113 institutions was 13.5%, whereas a convenience sample of IRB members from 14 institutions had a response rate of 64.4%. Requirement for full IRB review for retrospective studies using patient identifiers was reported by zero IRB member compared with 13.1% of EAST members (p=0.05). Regarding prospective observational trials without blood/tissue collection, 48.1% of EAST members reported their institutions required a full IRB review compared with 9.5% of IRB members (p=0.01). For prospective observational trials with blood/tissue collection, 80% of EAST members indicated requirement to submit a full IRB review compared with only 13.6% of IRB members (p<0.001). Most EAST members (78.6%) stated that informed consent is not ethically necessary in prospective observational trials without blood/tissue collection, whereas most IRB members thought that informed consent was ethically necessary (63.6%, p<0.001). There is significant variation in perception and practice regarding the level of review for prospective observational studies and whether informed consent is necessary. We recommend future interdisciplinary efforts between researchers and IRBs should occur to better standardize local IRB efforts. LEVEL OF EVIDENCE: IV.