The effect of trauma center verification level on traumatic brain injury outcome after implementation of the Orange Book

Plurad, David; Geesman, Glenn; Mahmoud, Ahmed; Sheets, Nicholas; Chawla‐Kondal, Bhani; Ayutyanont, Napatkamon; Ghostine, Samer

doi:10.1016/j.amjsurg.2020.06.021

Cited by 6 publications

(21 citation statements)

References 11 publications

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“…A total of 22 studies (65%) [21][22][23]25,[27][28][29][33][34][35][37][38][39]41,42,44,46,47,49,52,53 reported no difference in in-hospital mortality across different levels of trauma care (Table 1). Of these 22 studies, 17 studies (77%) 22,23,25,27,29,34,35,38,39,41,[44][45][46][47]49,52,55 compared Level I with Level II trauma centers. One study found Level I trauma centers to be associated with higher in-hospital mortality rates compared with Level II.…”

Section: In-hospital Mortality -Systematic Reviewmentioning

confidence: 99%

See 1 more Smart Citation

Evaluating associations between level of trauma care and outcomes of patients with specific severe injuries: A systematic review and meta-analysis

Ditshuizen

Rojer

Lieshout

et al. 2023

J Trauma Acute Care Surg

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Section: In-hospital Mortality -Systematic Reviewmentioning

confidence: 99%

“…Of 34 studies reporting in-hospital mortality, 22 studies (65%) [22][23][24][25][26][27][29][30][31][34][35][36][38][39][40][44][45][46][47]49,51,52 were included in the unadjusted meta-analysis on in-hospital mortality, comparing Level I and Level II trauma centers, comprising a total of 405,684 trauma patients (Fig. 2).…”

Section: Meta-analysis-unadjustedmentioning

confidence: 99%

Evaluating associations between level of trauma care and outcomes of patients with specific severe injuries: A systematic review and meta-analysis

Ditshuizen

Rojer

Lieshout

et al. 2023

J Trauma Acute Care Surg

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“…The identified 17 patents/patent applications of 14 patent families claimed different inventions of FEX (Figure 6). The compound patent of FEX [21] has expired long ago and is also not listed in the orange book of the USFDA [52,53]. Since this patent has expired, it is not eligible for any patent term extension [54,55].…”

Section: Expert Opinionmentioning

confidence: 99%

Discovery, Development, Inventions and Patent Review of Fexinidazole: The First All-Oral Therapy for Human African Trypanosomiasis

Imran

Khan²,

Alshammari

et al. 2022

Pharmaceuticals

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Human African trypanosomiasis (HAT or ‘sleeping sickness’) is a neglected tropical disease. If untreated, it is always fatal and leads to death. A few treatments are available for HAT, but most of them require a skilled professional, which increases the financial burden on the patient. Recently, fexinidazole (FEX) has been approved by the European Medicine Agency (EMA) and the United States Food and Drug Administration (USFDA) as the first all-oral therapy for the treatment of stage-1 (hemolymphatic) as well as stage-2 (meningoencephalitic) of HAT. Before the FEX approval, there were separate treatments for stage-1 and stage-2 of HAT. This study reviews the discovery, development timeline, inventions, and patent literature of FEX. It was first approved by EMA and USFDA in 2018 and 2021, respectively. FEX was also added to the World Health Organization’s list of essential drugs in 2019. The patent literature search revealed many types of patents/patent applications (compound, salt, process, method of treatment, drug combinations, and compositions) related to FEX, which have been summarized in this article. The authors foresee a great scope to develop more inventions based on FEX (novel salts, polymorphs, drug conjugates, cyclodextrin complex, etc.) for the treatment of many protozoal diseases (Leishmaniasis and Chagas disease), inflammatory diseases, and other microbial infections. New combinations of FEX with other treatments of HAT may also provide fruitful results. This review might be useful to the scientists working on the HAT and other neglected diseases to develop novel inventions and innovations of therapeutic relevance.

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“…We considered this group a distinct population due to variations in prehospital management and increased time from injury to treatment. 15 Therefore, our objective of this current study was to demonstrate that mortality outcome for TBI patients undergoing interfacility transfer to a Level I or a Level II center have similarly improved despite previous data to the contrary. 16 Under the auspices of the American College of Surgeons-Committee on Trauma (ACS-COT) quality programs, the National Trauma Databank (NTDB) is the largest repository of U.S. trauma registry data assembled to date.…”

mentioning

confidence: 90%

“…Our group has recently shown improvement in mortality for directly admitted isolated TBI at Level II relative to Level I centers though with patients who underwent interfacility transfer being excluded. We considered this group a distinct population due to variations in prehospital management and increased time from injury to treatment 15 . Therefore, our objective of this current study was to demonstrate that mortality outcome for TBI patients undergoing interfacility transfer to a Level I or a Level II center have similarly improved despite previous data to the contrary 16 …”

mentioning

confidence: 95%

The Effect of Trauma Center Verification Level on Outcomes in Traumatic Brain Injury Patients Undergoing Interfacility Transfer

Plurad

Geesman

Mahmoud

et al. 2020

Academic Emergency Medicine

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Background: Previous literature demonstrates increased mortality for traumatic brain injury (TBI) with transfer to a Level II versus Level I trauma center. Our objective was to determine the effect of the most recent American College of Surgeons-Committee on Trauma (ACS-COT) "Resources for the Optimal Care of the Injured Patient" resources manual ("The Orange Book") on outcomes after severe TBI after interfacility transfer to Level I versus Level II center. Methods: Utilizing the Trauma Quality Program Participant Use File of the American College of Surgeons admission year 2017, we identified patients with isolated TBI undergoing interfacility transfer to either Level I or Level II trauma center. Logistic regression was performed to determine independent associations with mortality. Results: There were 10,268 (71.6%) transferred to a Level I center and 4,025 (28.4%) were transferred to a Level II center. They were mostly male (61.4%) with a mean AE SD age of 61 AE 20.8 years. Mean Injury Severity Score was 16.3 AE 6.3 and most were injured in a single-level fall (51.5%). Patients transferred to a Level I center were less likely to be White (82.3% vs. 84.7%, 0.002) and more likely to have sustained penetrating trauma (2.7% vs. 1.6%, <0.001). The incidence of severe TBI (Glasgow Coma Scale [GCS] = 3-8) was similar (9.3% vs. 8.3%, 0.068). On logistic regression, severity of TBI predicted death; however, there was no difference in adjusted mortality outcome with admission to a Level II versus a Level I center (0.998 [0.836-1.192], 0.985). Conclusions: There is no mortality discrepancy in patients with isolated TBI transferred to a Level II versus Level I center despite previous contrary evidence and thus no reason to bypass a Level II in favor of a Level I. This relative improvement potentially relates to the new requirements as defined in the latest version of the ACS-COT's resources manual.

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The effect of trauma center verification level on traumatic brain injury outcome after implementation of the Orange Book

Cited by 6 publications

References 11 publications

Evaluating associations between level of trauma care and outcomes of patients with specific severe injuries: A systematic review and meta-analysis

Evaluating associations between level of trauma care and outcomes of patients with specific severe injuries: A systematic review and meta-analysis

Discovery, Development, Inventions and Patent Review of Fexinidazole: The First All-Oral Therapy for Human African Trypanosomiasis

The Effect of Trauma Center Verification Level on Outcomes in Traumatic Brain Injury Patients Undergoing Interfacility Transfer

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