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1.
J Surg Res ; 302: 420-427, 2024 Aug 16.
Artículo en Inglés | MEDLINE | ID: mdl-39153364

RESUMEN

INTRODUCTION: Surgical stabilization of rib fractures (SSRF) is associated with lower rates of mortality and fewer complications. This study evaluates whether the decision to undergo SSRF is associated with age, race, ethnicity, and insurance status and assesses associated clinical outcomes. METHODS: This retrospective analysis included patients ≥45 y old with rib fractures who underwent SSRF in the Trauma Quality Improvement Program from 2016 to 2020. Race, ethnicity, and insurance statuses were collected. Age in years was dichotomized into two groups: 45-64 and 65+. Outcomes included ventilator-associated pneumonia, unplanned endotracheal intubation, acute respiratory distress syndrome, in-hospital mortality, failure to rescue (FTR) after major complications, and FTR after respiratory complications. Logistic regression models were fit to evaluate outcomes, controlling for gender, body mass index, Injury Severity Score, flail chest, chronic obstructive pulmonary disease, congestive heart failure, and smoking. RESULTS: Two thousand eight hundred thirty-nine patients aged 45-64 and 1828 patients aged 65+ underwent SSRF. No significant difference in clinical outcomes was noted between these groups. Analysis showed that the association of SSRF with ventilator-associated pneumonia, unplanned intubation, acute respiratory distress syndrome, in-hospital mortality, FTR after a major complication, or FTR after a respiratory complication did not vary by age (P > 0.05). Black (odds ratio [OR] 0.67; 95% confidence interval [CI]: 0.59-0.77; P < 0.001), Hispanic (OR 0.80; 95% CI: 0.71-0.91; P < 0.001), and Medicaid (OR = 0.85; 95% CI = 0.76-0.95; P = 0.005) patients were less likely to receive SSRF. CONCLUSIONS: No differences in clinical outcomes were measured between adults aged 45-64 and ≥65 who underwent SSRF. Older age should not preclude patients from receiving SSRF. Further work is needed to improve underutilization in Black, Hispanic and Medicaid patients.

2.
Clin Infect Dis ; 79(2): 339-347, 2024 Aug 16.
Artículo en Inglés | MEDLINE | ID: mdl-39149937

RESUMEN

During pandemics, healthcare providers struggle with balancing obligations to self, family, and patients. While HIV/AIDS seemed to settle this issue, coronavirus disease 2019 (COVID-19) rekindled debates regarding treatment refusal. We searched MEDLINE, Embase, CINAHL Complete, and Web of Science using terms including obligation, refusal, HIV/AIDS, COVID-19, and pandemics. After duplicate removal and dual, independent screening, we analyzed 156 articles for quality, ethical position, reasons, and concepts. Diseases in our sample included HIV/AIDS (72.2%), severe acute respiratory syndrome (SARS) (10.2%), COVID-19 (10.2%), Ebola (7.0%), and influenza (7.0%). Most articles (81.9%, n = 128) indicated an obligation to treat. COVID-19 had the highest number of papers indicating ethical acceptability of refusal (60%, P < .001), while HIV had the least (13.3%, P = .026). Several reason domains were significantly different during COVID-19, including unreasonable risks to self/family (26.7%, P < .001) and labor rights/workers' protection (40%, P < .001). A surge in ethics literature during COVID-19 has advocated for permissibility of treatment refusal. Balancing healthcare provision with workforce protection is crucial in effectively responding to a global pandemic.


Asunto(s)
COVID-19 , SARS-CoV-2 , Humanos , COVID-19/epidemiología , Personal de Salud/ética , Infecciones por VIH/tratamiento farmacológico , Pandemias , Negativa del Paciente al Tratamiento/ética , Obligaciones Morales
3.
Blood Adv ; 2024 Jul 18.
Artículo en Inglés | MEDLINE | ID: mdl-39024543

RESUMEN

Following systemically-administered adeno-associated virus (AAV) gene therapy, vector particles are widely distributed, which has raised concerns about horizontal or germline transmission of vector. Characterization of biodistribution and kinetics of vector DNA in body fluids can address these concerns and provide insights into vector behavior in accessible samples. We investigated the biodistribution and vector shedding profile of valoctocogene roxaparvovec in men with severe hemophilia A enrolled in the phase 3 GENEr8-1 trial. Participants (n=134) received a single 6E13 vg/kg infusion and were assessed over 3 years. Vector DNA was measured with 4 different assays. Total vector DNA was evaluated in blood, saliva, stool, semen, and urine by quantitative (q)PCR. Encapsidated vector DNA was measured in plasma and semen with immunocapture-based qPCR. Contiguity of vector genomes and assembly of inverted terminal repeat fusions were measured in whole blood and peripheral blood mononuclear cells (PBMCs) using multi-color digital PCR. Median peak vector DNA levels observed 1 to 8 days after dosing were highest in blood, followed by saliva, semen, stool, and urine. Concentrations then declined steadily. Encapsidated vector DNA cleared faster than total vector DNA, achieving clearance by <=12 weeks in plasma and semen. Predominant vector genome forms transitioned from non-contiguous to full-length over time in whole blood and PBMCs, indicating formulation of stable circularized episomes within nucleated cells. The replication-incompetent nature of valoctocogene roxaparvovec, coupled with the steady clearance of total and encapsidated vector DNA from shedding matrices, indicates risk of transmission is low. This trial is registered at www.clinicaltrials.gov as NCT03370913.

4.
J Am Coll Surg ; 2024 Jul 11.
Artículo en Inglés | MEDLINE | ID: mdl-38990176

RESUMEN

BACKGROUND: Firearms are the leading cause of death among U.S. children and adolescents. This study evaluates whether state gun laws are associated with firearm suicides and homicides in children. STUDY DESIGN: This is a cross-sectional database study comparing childhood firearm mortality with 36 state firearm laws using data from CDC WONDER and the RAND state firearm law database. Primary outcomes were firearm-related suicide and homicide mortalities per 100,000 persons. We examined suicide deaths by all firearms, including intentional self-harm by handguns only, intentional self-harm by rifles, shotguns, or large firearms only, and intentional self-harm by other or unspecified firearms, as well as homicide deaths for the same firearm types in each state. Welch's t-tests compared mean rates of suicide and homicide mortalities between states with and without these laws. States that either enacted or rescinded firearm legislation during this period were excluded. RESULTS: From 2009-2020, there were 6,735 suicides and 10,278 homicides by firearm totaling 17,013 child deaths (<18) by firearm. States with "child access prevention- negligent storage" laws demonstrated lower suicide mortality rates across all firearm types (handguns) N=13, M (mean per 100,000)=0.68, SD=0.27, p<0.001; (long guns) N=12, M=0.65, SD=0.25, p<0.001). There were no significant differences in mean suicide death rates across all firearm types when comparing states with or without firearm laws related to "minimum age youth possession", "minimum age youth purchase and sale", or "child access prevention - intentional." Comparing homicide mortality rates for all firearm types revealed no notable distinctions between states with and without the identified laws. CONCLUSIONS: Firearm legislation is associated with decreased suicide rates for individuals under 18, but its influence on homicides is less certain. Comprehensive research and thoughtful policy formulation are essential for addressing this pressing public health concern.

6.
J Surg Res ; 301: 191-197, 2024 Jun 27.
Artículo en Inglés | MEDLINE | ID: mdl-38941715

RESUMEN

INTRODUCTION: Firearm-related suicides among children present a significant public health concern and a tragic loss of young lives. This study explores the relationship between firearm-related suicides, gun ownership, and state-specific gun laws. METHODS: This retrospective cohort study collected data from the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research on children under 18 who died by firearm-related suicides between 2009 and 2016 in all 50 states and D.C. It also utilized data from the RAND State-Level Estimates of Household Firearm Ownership. The study focused on the rate of child firearm suicide deaths per 100,000 individuals. The key variable of interest was the percentage of guns owned per household in each state. Univariable analysis was conducted to examine the association between individual gun laws and child firearm suicide mortalities, while multivariable regression, adjusting for household gun ownership and significant firearm legislation, was employed to assess connection to child firearm suicide mortality. RESULTS: From 2009 to 2016, 3903 children died from firearm-related suicides in the United States. In our analysis, 15 out of 44 firearm laws were found to be associated with reducing the rates of firearm suicides among children (P < 0.05). However, multivariable regression showed that higher state gun ownership rates were the primary predictor of increased child fatalities from firearms, with children in such states being 325% more likely to die when analyzing handgun laws and 337% more likely when analyzing long gun laws, as indicated by coefficients of 4.25 and 4.37, respectively. No state laws alone notably improved death rates. CONCLUSIONS: Gun ownership has a stronger association with child suicide rates than state-specific gun laws. Given the weight of gun ownership, future research should prioritize comprehensive public health initiatives to prevent child firearm-related suicides.

7.
Mol Ther ; 32(7): 2052-2063, 2024 Jul 03.
Artículo en Inglés | MEDLINE | ID: mdl-38796703

RESUMEN

Gene transfer therapies utilizing adeno-associated virus (AAV) vectors involve a complex drug design with multiple components that may impact immunogenicity. Valoctocogene roxaparvovec is an AAV serotype 5 (AAV5)-vectored gene therapy for the treatment of hemophilia A that encodes a B-domain-deleted human factor VIII (FVIII) protein controlled by a hepatocyte-selective promoter. Following previous results from the first-in-human phase 1/2 clinical trial, we assessed AAV5-capsid- and transgene-derived FVIII-specific immune responses with 2 years of follow-up data from GENEr8-1, a phase 3, single-arm, open-label study in 134 adult men with severe hemophilia A. No FVIII inhibitors were detected following administration of valoctocogene roxaparvovec. Immune responses were predominantly directed toward the AAV5 capsid, with all participants developing durable anti-AAV5 antibodies. Cellular immune responses specific for the AAV5 capsid were detected in most participants by interferon-γ enzyme-linked immunosorbent spot assay 2 weeks following dose administration and declined or reverted to negative over the first 52 weeks. These responses were weakly correlated with alanine aminotransferase elevations and showed no association with changes in FVIII activity. FVIII-specific cellular immune responses were less frequent and more sporadic compared with those specific for AAV5 and showed no association with safety or efficacy parameters.


Asunto(s)
Dependovirus , Factor VIII , Terapia Genética , Vectores Genéticos , Hemofilia A , Humanos , Hemofilia A/terapia , Hemofilia A/inmunología , Hemofilia A/genética , Dependovirus/genética , Dependovirus/inmunología , Terapia Genética/métodos , Vectores Genéticos/genética , Vectores Genéticos/administración & dosificación , Factor VIII/genética , Factor VIII/inmunología , Masculino , Adulto , Resultado del Tratamiento , Transgenes , Adulto Joven , Anticuerpos Antivirales/inmunología , Anticuerpos Antivirales/sangre , Persona de Mediana Edad
8.
Leuk Lymphoma ; : 1-11, 2024 May 07.
Artículo en Inglés | MEDLINE | ID: mdl-38712673

RESUMEN

AMG 330, a bispecific T-cell engager (BiTE®) that binds CD33 and CD3 on T cells facilitates T-cell-mediated cytotoxicity against CD33+ cells. This first-in-human, open-label, dose-escalation study evaluated the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AMG 330 in adults with relapsed/refractory acute myeloid leukemia (R/R AML). Amongst 77 patients treated with AMG 330 (0.5 µg/day-1.6 mg/day) on 14-day or 28-day cycles, maximum tolerated dose was not reached; median duration of treatment was 29 days. The most frequent treatment-related adverse events were cytokine release syndrome (CRS; 78%) and rash (30%); 10% of patients experienced grade 3/4 CRS. CRS was mitigated with stepwise dosing of AMG 330, prophylactic dexamethasone, and early treatment with tocilizumab. Among 60 evaluable patients, eight achieved complete remission or morphologic leukemia-free state; of the 52 non-responders, 37% had ≥50% reduction in AML bone marrow blasts. AMG 330 is a promising CD33-targeted therapeutic strategy for R/R AML.

9.
Haemophilia ; 30(4): 905-913, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38684460

RESUMEN

INTRODUCTION: Valoctocogene roxaparvovec, a gene therapy evaluated in the phase 3 GENEr8-1 trial, supports endogenous factor VIII (FVIII) production to prevent bleeding in people with severe haemophilia A. Individuals receiving emicizumab, an antibody mimicking the function of activated FVIII, were excluded from GENEr8-1 enrolment since emicizumab was an investigational therapy at the time of trial initiation. AIM: Utilize pharmacokinetic simulations to provide guidance on best practices for maintaining haemostatic control while transitioning from emicizumab prophylaxis to valoctocogene roxaparvovec. METHODS: To estimate bleeding risk at weekly intervals following valoctocogene roxaparvovec infusion, a published emicizumab pharmacokinetic model was used to simulate emicizumab concentrations and merged with FVIII activity time-course data for participants in GENEr8-1. The analysis investigated three approved emicizumab dosing regimens for two transition scenarios that varied whether the last dose of emicizumab was administered on the same day or 4 weeks after valoctocogene roxaparvovec infusion. RESULTS: Simulations demonstrated administering the last emicizumab dose the day of valoctocogene roxaparvovec infusion and 4 weeks after offered similar levels of haemostatic control, and bleeding risk was similar for all emicizumab dosing regimens. An algorithm was developed to provide guidance for discontinuation of emicizumab. Theoretical cases based on GENEr8-1 participants are presented to illustrate how decisions may vary among individuals. CONCLUSION: Pharmacokinetic simulations demonstrated no clinically meaningful difference in bleeding risk caused by decaying emicizumab levels and rising gene therapy-derived endogenous FVIII for all examined emicizumab doses and dosing regimens. Therefore, multiple approaches can safely transition individuals from emicizumab prophylaxis to valoctocogene roxaparvovec.


Asunto(s)
Anticuerpos Biespecíficos , Anticuerpos Monoclonales Humanizados , Factor VIII , Terapia Genética , Hemofilia A , Hemofilia A/tratamiento farmacológico , Humanos , Anticuerpos Biespecíficos/uso terapéutico , Anticuerpos Biespecíficos/farmacología , Anticuerpos Biespecíficos/farmacocinética , Anticuerpos Monoclonales Humanizados/uso terapéutico , Factor VIII/uso terapéutico , Terapia Genética/métodos , Hemorragia/prevención & control , Simulación por Computador , Masculino
10.
Am J Emerg Med ; 79: 144-151, 2024 05.
Artículo en Inglés | MEDLINE | ID: mdl-38432154

RESUMEN

INTRODUCTION: Time-To-OR is a critical process measure for trauma performance. However, this measure has not consistently demonstrated improvement in outcome. STUDY DESIGN: Using TQIP, we identified facilities by 75th percentile time-to-OR to categorize slow, average, and fast hospitals. Using a GEE model, we calculated odds of mortality for all penetrating abdominal trauma patients, firearm injuries only, and patients with major complication by facility speed. We additionally estimated odds of mortality at the patient level. RESULTS: Odds of mortality for patients at slow facilities was 1.095; 95% CI: 0.746, 1.608; p = 0.64 compared to average. Fast facility OR = 0.941; 95% CI: 0.780, 1.133; p = 0.52. At the patient-level each additional minute of time-to-OR was associated with 1.5% decreased odds of in-hospital mortality (OR 0.985; 95% CI:0.981, 0.989; p < 0.001). For firearm-only patients, facility speed was not associated with odds of in-hospital mortality (p-value = 0.61). Person-level time-to-OR was associated with 1.8% decreased odds of in-hospital mortality (OR 0.982; 95% CI: 0.977, 0.987; p < 0.001) with each additional minute of time-to-OR. Similarly, failure-to-rescue analysis showed no difference in in-hospital mortality at the patient level (p = 0.62) and 0.4% decreased odds of in-hospital mortality with each additional minute of time-to-OR at the patient level (OR 0.996; 95% CI: 0.993, 0.999; p = 0.004). CONCLUSION: Despite the use of time-to-OR as a metric of trauma performance, there is little evidence for improvement in mortality or complication rate with improved time-to-OR at the facility or patient level. Performance metrics for trauma should be developed that more appropriately approximate patient outcome.


Asunto(s)
Traumatismos Abdominales , Armas de Fuego , Heridas por Arma de Fuego , Heridas Penetrantes , Humanos , Estudios Retrospectivos , Hospitales , Mortalidad Hospitalaria , Heridas Penetrantes/terapia , Puntaje de Gravedad del Traumatismo
11.
J Surg Res ; 297: 47-55, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38430862

RESUMEN

INTRODUCTION: As the older adult population increases, hospitals treat more older adults with injuries. After leaving, these patients suffer from decreased mobility and independence, relying on care from others. Family members often assume this responsibility, mostly informally and unpaid. Caregivers of other older adult populations have increased stress and decreased caregiver-related quality of life (CRQoL). Validated CRQoL measures are essential to capture their unique experiences. Our objective was to review existing CRQoL measures and their validity in caregivers of older adult trauma patients. METHODS: A professional librarian searched published literature from the inception of databases through August 12, 2022 in MEDLINE (via PubMed), Embase (via Elsevier), and CINAHL Complete (via EBSCO). We identified 1063 unique studies of CRQoL in caregivers for adults with injury and performed a systematic review following COnsensus-based Standards for the selection of health Measurement Instruments guidelines for CRQoL measures. RESULTS: From the 66 studies included, we identified 54 health-related quality-of-life measures and 60 domains capturing caregiver-centered concerns. The majority (83%) of measures included six or fewer CRQoL content domains. Six measures were used in caregivers of older adults with single-system injuries. There were no validated CRQoL measures among caregivers of older adult trauma patients with multisystem injuries. CONCLUSIONS: While many measures exist to assess healthcare-related quality of life, few, if any, adequately assess concerns among caregivers of older adult trauma patients. We found that CRQoL domains, including mental health, emotional health, social functioning, and relationships, are most commonly assessed among caregivers. Future measures should focus on reliability and validity in this specific population to guide interventions.


Asunto(s)
Cuidadores , Calidad de Vida , Heridas y Lesiones , Humanos , Cuidadores/psicología , Heridas y Lesiones/psicología , Heridas y Lesiones/terapia , Anciano
12.
Clin Nutr ESPEN ; 60: 135-138, 2024 04.
Artículo en Inglés | MEDLINE | ID: mdl-38479901

RESUMEN

BACKGROUND AND AIMS: Currently, 40 million Americans are food insecure. They are forced to skip meals and buy non-nutritious food, leading to health disparities for those of low socioeconomic status. This study aims to investigate relationships between malnutrition deaths and sociodemographic groups. METHODS: This cross-sectional study from 2009 to 2018 used aggregate data from the CDC Wide-ranging Online Data for Epidemiologic Research (CDC Wonder). Patients with known race, gender, and Hispanic origin age ≥18 who died from malnutrition (E40-E46) were included. Place of death was grouped into home, inpatient medical facility, hospice facility, nursing facility/long-term care, other (including outpatient, ED, and DOA), and unknown. Crude rates of malnutrition deaths per 100,000 persons for race, gender, and Hispanic origin were calculated using US census estimates. Gross proportions of total deaths were calculated for each place of death. RESULTS: Between 2009 and 2018, there were 46,517 malnutrition deaths in the US. Death rates for Black (1.8) and White Americans (2) were twice as high compared to Native Americans (1.1) and Asians or Pacific Islanders (0.7). Death rates among females (2.3) were higher than males (1.5). Death rates among non-Hispanics (2.1) were twice as high compared to Hispanics (0.7). Most people who died of malnutrition died in hospitals (37 %). CONCLUSION: Malnutrition deaths occur at greater rates among White, Black, non-Hispanic Americans, and females. Despite reported disparities in food access, Black and White Americans have similar malnutrition mortality rates, raising concerns that malnutrition is under-diagnosed among Black patients. Given the existing nutrition literature, this finding requires further investigation.


Asunto(s)
Hispánicos o Latinos , Desnutrición , Femenino , Humanos , Masculino , Estudios Transversales , Demografía , Desnutrición/epidemiología , Estados Unidos/epidemiología , Blanco , Negro o Afroamericano , Asiático , Pueblos Isleños del Pacífico , Indio Americano o Nativo de Alaska
13.
Haemophilia ; 30(2): 320-330, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38317480

RESUMEN

INTRODUCTION: Valoctocogene roxaparvovec uses an adeno-associated virus serotype 5 (AAV5) vector to transfer a factor VIII (FVIII) coding sequence to individuals with severe haemophilia A, providing bleeding protection. AIM: To assess safety and efficacy of valoctocogene roxaparvovec 5-6 years post-treatment. METHODS: In a phase 1/2 trial, adult male participants with severe haemophilia A (FVIII ≤1 IU/dL) without FVIII inhibitors or anti-AAV5 antibodies received valoctocogene roxaparvovec and were followed for 6 (6 × 1013 vg/kg; n = 7) and 5 (4 × 1013 vg/kg; n = 6) years. Safety, including investigation of potential associations between a malignancy and gene therapy, and efficacy are reported. RESULTS: No new treatment-related safety signals emerged. During year 6, a participant in the 6 × 1013  vg/kg cohort was diagnosed with grade 2 parotid gland acinar cell carcinoma; definitive treatment was uncomplicated parotidectomy with lymph node dissection. Target enrichment sequencing of tumour and adjacent healthy tissue revealed low vector integration (8.25 × 10-5 per diploid cell). Integrations were not elevated in tumour samples, no insertions appeared to drive tumorigenesis, and no clonal expansion of integration-containing cells occurred. During all follow-ups, >90% decreases from baseline in annualised treated bleeds and FVIII infusion rates were maintained. At the end of years 6 and 5, mean FVIII activity (chromogenic assay) was 9.8 IU/dL (median, 5.6 IU/dL) and 7.6 IU/dL (median, 7.1 IU/dL) for the 6 × 1013 and 4 × 1013 vg/kg cohorts, respectively, representing proportionally smaller year-over-year declines than earlier timepoints. CONCLUSIONS: Valoctocogene roxaparvovec safety and efficacy profiles remain largely unchanged; genomic investigations showed no association with a parotid tumour.


Asunto(s)
Dependovirus , Hemofilia A , Hemostáticos , Neoplasias , Proteínas Recombinantes de Fusión , Adulto , Humanos , Masculino , Hemofilia A/complicaciones , Factor VIII/genética , Hemorragia/prevención & control , Neoplasias/complicaciones
14.
Trauma Surg Acute Care Open ; 9(1): e001294, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38352958

RESUMEN

Background/objectives: Surgical populations and particularly injury survivors often present with complex trauma that elevates their risk for prolonged opioid use and misuse. Changes in opioid prescribing guidelines during the past several years have yielded mixed results for pain management after trauma, with a limiting factor being the heterogeneity of clinical populations and treatment needs in individuals receiving opioids. The present analysis illuminates this gap between clinical guidelines and clinical practice through qualitative feedback from hospital trauma providers and unit staff members regarding current opioid prescribing guidelines and practices in the setting of traumatic injury. Methods: The parent study aimed to implement a pilot screening tool for opioid misuse in four level I and II trauma hospitals throughout Wisconsin. As part of the parent study, focus groups were conducted at each study site to explore the facilitators and barriers of implementing a novel screening tool, as well as to examine the current opioid prescribing guidelines, trainings, and resources available for trauma and acute care providers. Focus group transcripts were independently coded and analyzed using a modified grounded theory approach to identify themes related to the facilitators and barriers of opioid prescribing guidelines in trauma and acute care. Results: Three major themes were identified as impactful to opioid-related prescribing and care provided in the setting of traumatic injury; these include (1) acute treatment strategies; (2) patient interactions surrounding pain management; and (3) the multifactorial nature of trauma on pain management approaches. Conclusion: Providers and staff at four Wisconsin trauma centers called for trauma-specific opioid prescribing guidelines in the setting of trauma and acute care. The ubiquitous prescription of opioids and challenges in long-term pain management in these settings necessitate additional community-integrated research to inform development of federal guidelines. Level of evidence: Therapeutic/care management, level V.

15.
PLoS One ; 19(2): e0296083, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38394279

RESUMEN

OBJECTIVE: The purpose of this study is to examine the efficacy of BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery) vs. usual transitional care management among diverse adults with traumatic brain injury (TBI) discharged home from acute hospital care and families. METHODS: This will be a single-site, two-arm, randomized controlled trial (N = 436 people, 218 patient/family dyads, 109 dyads per arm) of BETTER, a culturally- and linguistically-tailored, patient- and family-centered, TBI transitional care intervention for adult patients with TBI and families. Skilled clinical interventionists will follow a manualized protocol to address patient/family needs. The interventionists will co-establish goals with participants; coordinate post-hospital care, services, and resources; and provide patient/family education and training on self- and family-management and coping skills for 16 weeks following hospital discharge. English- and Spanish-speaking adult patients with mild-to-severe TBI who are discharged directly home from the hospital without inpatient rehabilitation or transfer to other settings (community discharge) and associated family caregivers are eligible and will be randomized to treatment or usual transitional care management. We will use intention-to-treat analysis to determine if patients receiving BETTER have a higher quality of life (primary outcome, SF-36) at 16-weeks post-hospital discharge than those receiving usual transitional care management. We will conduct a descriptive, qualitative study with 45 dyads randomized to BETTER, using semi-structured interviews, to capture perspectives on barriers and facilitators to participation. Data will be analyzed using conventional content analysis. Finally, we will conduct a cost/budget impact analysis, evaluating differences in intervention costs and healthcare costs by arm. DISCUSSION: Findings will guide our team in designing a future, multi-site trial to disseminate and implement BETTER into clinical practice to enhance the standard of care for adults with TBI and families. The new knowledge generated will drive advancements in health equity among diverse adults with TBI and families. TRIAL REGISTRATION: NCT05929833.


Asunto(s)
Lesiones Traumáticas del Encéfalo , Cuidado de Transición , Adulto , Humanos , Calidad de Vida , Lesiones Traumáticas del Encéfalo/rehabilitación , Cuidadores , Alta del Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto
16.
Surgery ; 175(2): 258-264, 2024 02.
Artículo en Inglés | MEDLINE | ID: mdl-38040596

RESUMEN

BACKGROUND: The purpose of this study was to (1) compare post-treatment outcomes of operative and nonoperative management of acute appendicitis in multi-morbid patients and (2) evaluate the generalizability of prior clinical trials by determining whether outcomes differ in multi-morbid patients compared to the young and healthy patients who resemble prior clinical trial participants. METHODS: We conducted a retrospective cohort study using the National Inpatient Sample from 2004 to 2017. We included 368,537 patients with acute, uncomplicated appendicitis who were classified as having 0 or 2+ comorbidities. We compared inpatient morbidity, mortality, length of stay, and costs using propensity scores. Unmeasured confounding was addressed with probabilistic sensitivity analysis. RESULTS: Overall, 5% of patients without comorbidities were treated nonoperatively versus 20% of multi-morbid patients. Compared to surgery, nonoperative management was associated with a 3.5% decrease in complications (95% confidence interval 3%-4%) for multi-morbid patients, but there was no significant difference for patients without comorbidity. However, nonoperative management was associated with a 1.5% increase in mortality for multimorbid patients (95% confidence interval 1.3%-1.7%). Costs and length of stay were lower for all patients treated with surgery. Probabilistic sensitivity analysis showed that results were robust to the effects of unmeasured confounding. CONCLUSION: Our results raise concerns about the generalizability of clinical trials that compared nonoperative and operative management of appendicitis because (1) those trials enrolled mostly young and healthy patients, and (2) results in multi-morbid patients differ from outcomes in younger and healthier patients.


Asunto(s)
Apendicitis , Humanos , Enfermedad Aguda , Apendicitis/terapia , Morbilidad , Estudios Retrospectivos , Resultado del Tratamiento , Ensayos Clínicos como Asunto
17.
J Surg Res ; 293: 121-127, 2024 01.
Artículo en Inglés | MEDLINE | ID: mdl-37738853

RESUMEN

INTRODUCTION: Severe traumatic injury requires rapid and extensive deployment of resources to save the lives of the critically injured. The sequelae of traumatic injuries frequently require extensive intervention obligating patients to a complicated recovery process devoid of meaningful nutrition. In this setting, parenteral nutrition (PN) is key in enabling appropriate wound healing, recovery, and rehabilitation. We sought to examine the use of PN in adult trauma management and to highlight any disparities in the utilization of PN in adult trauma patients. METHODS: We queried the 2017-2019 Trauma Quality Improvement Program (TQIP) for adult patients (aged > 18 y) who sustained blunt or penetrating traumatic injuries and received PN as part of their hospitalization. We compared time to PN administration based on demographics. We then used a multivariable logistic regression model to identify factors associated with the use of PN. We hypothesized that PN would be less commonly employed in the uninsured and minority groups. RESULTS: We identified 2,449,498 patients with sufficient data for analysis. Of these, 1831 patients were treated with PN. On univariate analysis, PN patients were more commonly male (74.7% PN versus 60.2% non-PN; P < 0.001). PN use was more frequent in the Black population (24.3% PN versus 15.5% non-PN; P < 0.001) and less frequent in the White population (72.7% PN versus 81.2% non-PN; P < 0.001). PN use was also much more common among patients covered by Medicaid. Penetrating trauma was over twice as common among PN recipients relative to non-PN patients (% PN versus % non-PN). PN patients had higher injury severity scores (ISSs), more intensive care unit days, longer hospitalizations, and increased mortality compared to non-PN patients. PN patients were half as likely to discharge home and twice as likely to discharge to a long-term care facility. Multivariable analysis including age, race, trauma mechanism, primary payer, and ISS, demonstrated an association of PN use with increasing age (OR 1.01, P < 0.001), cases of penetrating trauma (odds ratio [OR], 2.47; P < 0.001), and patients with high ISS (OR, 0.1.06; P < 0.001). There was decreased use in Uninsured patient (OR, 0.54; P < 0.001). CONCLUSIONS: PN use following traumatic injury is rarely required. Patients treated with PN typically have a resource-intense hospital course. More severe injuries, penetrating trauma, and increased age are more likely to result in PN use. Variations in PN use are apparent based on insurance payer, further examination into allocation of hospital and intensive care resources, as it pertains to patient socioeconomic status, is warranted in light of these findings.


Asunto(s)
Heridas Penetrantes , Adulto , Estados Unidos/epidemiología , Humanos , Masculino , Heridas Penetrantes/terapia , Heridas Penetrantes/epidemiología , Medicaid , Grupos Minoritarios , Pacientes no Asegurados , Nutrición Parenteral , Estudios Retrospectivos , Puntaje de Gravedad del Traumatismo
18.
J Surg Res ; 294: 1-8, 2024 02.
Artículo en Inglés | MEDLINE | ID: mdl-37852139

RESUMEN

INTRODUCTION: Firearm injury is a public health crisis. Most victims are minorities in underserved neighborhoods. Measuring firearm injury by mortality underestimates its impact, as most victims survive to discharge. This study was done to determine if race and insurance status are associated with discharge disposition for gunshot wound (GSW)-related trauma. METHODS: Using the 2019 Trauma Quality Improvement Program database, we identified GSW patients with Abbreviated Injury Scale (AIS) = 1-3. Exclusion criteria included patients who died in hospital and routine home discharge. We compared discharge patterns of patients based on demographics (age, gender, race, ethnicity, payor, AIS, hospital designation, and length of stay [LOS]) and injury severity. Multivariable logistic regression models identified factors associated with discharge disposition. RESULTS: Our sample included 2437 patients with GSWs. On univariable analysis, Black patients were more likely to discharge to home with home health (64.1% Black versus 34.7% White; P < 0.001). White patients were more likely to discharge to skilled nursing facility (SNF) (51.4% White versus 44.6% Black; P < 0.001). Controlling for age, race, Latin ethnicity, primary payor, LOS, AIS severity, and injury severity score factors independently associated with discharge to SNF included age (0.0462, P < 0.001), Medicaid (1.136, P < 0.0003), Medicare (1.452, P < 0.001), and LOS (0.03745, P < 0.001). CONCLUSIONS: Postacute care following traumatic injuries is essential to recovery. Black GSW victims are more likely to be discharged to home health than White patients, who are more likely to be discharged to SNF. Targeted programs to reduce barriers to appropriate aftercare are necessary to eliminate this bias and improve the care of underserved populations.


Asunto(s)
Armas de Fuego , Heridas por Arma de Fuego , Anciano , Humanos , Estados Unidos/epidemiología , Alta del Paciente , Heridas por Arma de Fuego/epidemiología , Instituciones de Cuidados Especializados de Enfermería , Medicare , Estudios Retrospectivos
19.
Transl Pediatr ; 12(11): 2044-2052, 2023 Nov 28.
Artículo en Inglés | MEDLINE | ID: mdl-38130591

RESUMEN

Background: The use of a relevant emergency score can provide an accurate assessment of the patient's condition and prognosis. However, the status of related studies remains unclear. The current study analyzed the research status of emergency surgery score (ESS) of trauma patients by using bibliometric methods. Methods: The Science Citation Index Expanded (SCI-E) database in the Web of Science Core Collection (WOSCC) was searched using keywords "trauma" and "emergency surgery score". All records from the search results and cited references were exported to Excel, duplicate literature records were removed, information for the same author and organization in different signature forms were merged. The resulting literatures were analyzed by year of publication, citation, discipline, countries and research institutions, journals, authors, and use of keywords. The cooperation among countries, institutions, and authors was also examined. Results: A total of 2,175 document were retrieved. The number of published literature and the number of citations per year increased annually. The number of published documents (n=1,029) and research cooperation (centrality score, 0.44) in the United States were significantly ahead of those in other countries. The ten research institutions with the largest number of published documents were all from the United States, with much cooperation between research institutions and authors. There were many publications from China (n=108), but with few cooperations (centrality score, 0.22). The journals with the largest number of published articles were professional in the fields of trauma, emergency, and critical care. Keyword analysis showed that infection and shock were important issues besides surgery in the research related to ESS of trauma patients. Conclusions: Research related to ESS of trauma patients has been mainly conducted in the United States, and Chinese researchers should increase their level of cooperation.

20.
Surg Endosc ; 37(11): 8829-8840, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37626234

RESUMEN

BACKGROUND: Transparency around surgeon level data may align healthcare delivery with quality care for patients. Biliary surgery includes numerous procedures performed by both general surgeons and subspecialists alike. Cholecystectomy is a common surgical procedure and an optimal cohort to measure quality outcomes within a healthcare system. METHODS: Data were collected for 5084 biliary operations performed by 68 surgeons in 11 surgical divisions in a health system including a tertiary academic hospital, two regional community hospitals, and two ambulatory surgery centers. A privacy protected dashboard was developed to compare surgeon performance and cost between July 2018 and June 2022. A sample cohort of patients ≥ 18 years who underwent cholecystectomy were compared by operative time, cost, and 30-day outcomes. RESULTS: Over 4 years, 4568 cholecystectomy procedures were performed by 57 surgeons. Operations were done by 57 surgeons in four divisions and included 3846 (84.2%) laparoscopic cholecystectomies, 601 (13.2%) laparoscopic cholecystectomies with cholangiogram, and 121 (2.6%) open cholecystectomies. Patients were admitted from the emergency room in 2179 (47.7%) cases while 2389 (52.3%) cases were performed in the ambulatory setting. Individual surgeons were compared to peers for volume, intraoperative data, cost, and outcomes. Cost was lowest at ambulatory surgery centers, yet only 4.2% of elective procedures were performed at these facilities. Prepackaged kits with indocyanine green were more expensive than cholangiograms that used iodinated contrast. The rate of emergency department visits was lowest when cases were performed at ambulatory surgery centers. CONCLUSION: Data generated from clinical dashboards can inform surgeons as to how they compare to peers regarding quality metrics such as cost, time, and complications. In turn, this may guide strategies to standardize care, optimize efficiency, provide cost savings, and improve outcomes for cholecystectomy procedures. Future application of clinical dashboards can assist surgeons and administrators to define value-based care.


Asunto(s)
Sistema Biliar , Colecistectomía Laparoscópica , Humanos , Estudios Prospectivos , Colecistectomía , Colangiografía , Estudios Retrospectivos
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