A Randomized Controlled Trial to Assess the Impact of Enhanced Recovery After Surgery on Patients Undergoing Elective Spine Surgery.

OBJECTIVE: To conduct a prospective, randomized controlled trial (RCT) of an enhanced recovery after surgery (ERAS) protocol in an elective spine surgery population. BACKGROUND: Surgical outcomes such as length of stay (LOS), discharge disposition, and opioid utilization greatly contribute to patient satisfaction and societal healthcare costs. ERAS protocols are multimodal, patient-centered care pathways shown to reduce postoperative opioid use, reduced LOS, and improved ambulation; however, prospective ERAS data are limited in spine surgery. METHODS: This single-center, institutional review board-approved, prospective RCT-enrolled adult patients undergoing elective spine surgery between March 2019 and October 2020. Primary outcomes were perioperative and 1-month postoperative opioid use. Patients were randomized to ERAS (n=142) or standard-of-care (SOC; n=142) based on power analyses to detect a difference in postoperative opioid use. RESULTS: Opioid use during hospitalization and the first postoperative month was not significantly different between groups (ERAS 112.2 vs SOC 117.6 morphine milligram equivalent, P =0.76; ERAS 38.7% vs SOC 39.4%, P =1.00, respectively). However, patients randomized to ERAS were less likely to use opioids at 6 months postoperatively (ERAS 11.4% vs SOC 20.6%, P =0.046) and more likely to be discharged to home after surgery (ERAS 91.5% vs SOC 81.0%, P =0.015). CONCLUSION: Here, we present a novel ERAS prospective RCT in the elective spine surgery population. Although we do not detect a difference in the primary outcome of short-term opioid use, we observe significantly reduced opioid use at 6-month follow-up as well as an increased likelihood of home disposition after surgery in the ERAS group.

Prevalence and determinants of hepatitis delta virus infection among HIV/hepatitis B-coinfected adults in care in the United States.

Hepatitis delta virus (HDV) infection increases the risk of liver complications compared to hepatitis B virus (HBV) alone, particularly among persons with human immunodeficiency virus (HIV). However, no studies have evaluated the prevalence or determinants of HDV infection among people with HIV/HBV in the US. We performed a cross-sectional study among adults with HIV/HBV coinfection receiving care at eight sites within the Center for AIDS Research Network of Integrated Clinical Systems (CNICS) between 1996 and 2019. Among patients with available serum/plasma specimens, we selected the first specimen on or after their initial HBV qualifying test. All samples were tested for HDV IgG antibody and HDV RNA. Multivariable log-binomial generalized linear models were used to estimate prevalence ratios (PRs) with 95% CIs of HDV IgG antibody-positivity associated with determinants of interest (age, injection drug use [IDU], high-risk sexual behaviour). Among 597 adults with HIV/HBV coinfection in CNICS and available serum/plasma samples (median age, 43 years; 89.9% male; 52.8% Black; 42.4% White), 24/597 (4.0%; 95% CI, 2.4%-5.6%) were HDV IgG antibody-positive, and 10/596 (1.7%; 95% CI, 0.6%-2.7%) had detectable HDV RNA. In multivariable analysis, IDU was associated with exposure to HDV infection (adjusted PR = 2.50; 95% CI, 1.09-5.74). In conclusion, among a sample of adults with HIV/HBV coinfection in care in the US, 4.0% were HDV IgG antibody-positive, among whom 41.7% had detectable HDV RNA. History of IDU was associated with exposure to HDV infection. These findings emphasize the importance of HDV testing among persons with HIV/HBV coinfection, especially those with a history of IDU.

Maternal Depressive Risk in Prenatal versus Postnatal Surgical Closure of Myelomeningocele: Associations with Parenting Stress and Child Outcomes.

INTRODUCTION: Depressive risk is higher for mothers of infants with chronic medical conditions. The present study examined maternal depressive risk and associations with parent and child outcomes among mothers of young children who were randomized to either prenatal or postnatal surgical closure for myelomeningocele. METHODS: Using the Management of Myelomeningocele Study database, maternal depressive risk was examined at 3 time points as follows: prior to birth, 12 months, and 30 months post birth. Separate multivariate analyses examined associations among change in depressive risk (between baseline and 30 months), parenting stress, and child outcomes at 30 months. RESULTS: Mean scores were in the minimal depressive risk range at all the time points. Post birth depressive risk did not differ by prenatal versus postnatal surgery. Mean change scores reflected a decrease in depressive risk during the first 30 months. Only 1.1-4.5% of mothers reported depressive risk in the moderate to severe range across time points. Increased depressive risk during the first 30 months was associated with increased parenting stress scores and slightly lower child cognitive scores at 30 months. CONCLUSION: Most mothers reported minimal depressive risk that decreased over time, regardless of whether their infant underwent prenatal or postnatal surgery. Only a small percentage of mothers endorsed moderate to severe depressive risk, but an increase in depressive risk over time was associated with higher parental stress and slightly lower child cognitive development.

Influence of Gestational Age and Mode of Delivery on Neonatal Outcomes in Prenatally Diagnosed Isolated Congenital Diaphragmatic Hernia.

AIM: The optimal gestational age (GA) at delivery and mode of delivery (MoD) for pregnancies with fetal congenital diaphragmatic hernia (CDH) is undetermined. The impact of early term (37-38 weeks 6 days) versus full term (39-40 weeks 6 days) and MoD on immediate neonatal outcomes in prenatally diagnosed isolated CDH cases was evaluated. MATERIAL AND METHODS: A retrospective chart review of pregnancies evaluated and delivered with the prenatal diagnosis of CDH between July 1, 2008, and December 31, 2018. The primary outcome was survival to hospital discharge. Secondary outcomes included neonatal intensive care unit (NICU) length of stay (LOS), extracorporeal membrane oxygenation (ECMO) requirement and need for supplemental oxygen at day 30 of life. RESULTS: A total of 296 patients were prenatally evaluated for CDH and delivered in a single center during the study period. After applying exclusion criteria, data were available on 113 women who delivered early term and 72 women who delivered full term. Survival to hospital discharge was comparable between the 2 groups - 83.2% in the early term versus 93.1% in the full term (p = 0.07; 95% CI of 0.13-1.04). No difference was observed in any other secondary outcomes. MoD was stratified into spontaneous vaginal, induced vaginal, unplanned cesarean and scheduled cesarean delivery with associated neonatal survival rates of 74.2, 90.6, 89.7 and 88.2%, respectively, p = 0.13. The 5-min Apgar score was higher in the elective cesarean group (7.94) followed by the induced vaginal delivery group (7.8) compared to 7.17 and 7.18 in the spontaneous vaginal and unplanned cesarean groups, respectively (p = 0.03). The GA and MoD did not influence survival to hospital discharge nor NICU LOS in multivariate analysis. CONCLUSIONS: Though there were no significant differences in neonatal outcomes for early term compared to full term deliveries of CDH neonates, a trend toward improved survival rates and lower ECMO requirements in the full term group may suggest an underlying importance GA at delivery. Further studies are warranted to validate these findings.

Reduction of Postoperative Opioid Use After Elective Spine and Peripheral Nerve Surgery Using an Enhanced Recovery After Surgery Program.

OBJECTIVE: Enhanced recovery after surgery (ERAS) pathways have previously been shown to be feasible and safe in elective spinal procedures. As publications on ERAS pathways have recently emerged in elective neurosurgery, long-term outcomes are limited. We report on our 18-month experience with an ERAS pathway in elective spinal surgery. METHODS: A historical cohort of 149 consecutive patients was identified as the control group, and 1,141 patients were prospectively enrolled in an ERAS protocol. The primary outcome was the need for opioid use one month postoperation. Secondary outcomes were opioid and nonopioid consumption on postoperative day (POD) 1, opioid use at three and six months postoperation, inpatient pain scores, patient satisfaction scores, postoperative Foley catheter use, mobilization/ambulation on POD0-1, length of stay, complications, and intensive care unit admissions. RESULTS: There was significant reduction in use of opioids at one, three, and six months postoperation (38.6% vs 70.5%, P < 0.001, 36.5% vs 70.9%, P < 0.001, and 23.6% vs 51.9%, P = 0.008) respectively. Both groups had similar surgical procedures and demographics. PCA use was nearly eliminated in the ERAS group (1.4% vs 61.6%, P < 0.001). ERAS patients mobilized faster on POD0 compared with control (63.5% vs 20.7%, P < 0.001). Fewer patients in the ERAS group required postoperative catheterization (40.7% vs 32.7%, P < 0.001). The ERAS group also had decreased length of stay (3.4 vs 3.9 days, P = 0.020). CONCLUSIONS: ERAS protocols for all elective spine and peripheral nerve procedures are both possible and effective. This standardized approach to patient care decreases opioid usage, eliminates the use of PCAs, mobilizes patients faster, and reduces length of stay.

The Management of Myelomeningocele Study: Short-Term Neonatal Outcomes.

INTRODUCTION: The Management of Myelomeningocele Study was a multicenter randomized trial to compare prenatal and standard postnatal repair of myelomeningocele (MMC). Neonatal outcome data for 158 of the 183 randomized women were published in The New England Journal of Medicine in 2011. OBJECTIVE: Neonatal outcomes for the complete trial cohort (N = 183) are presented outlining the similarities with the original report and describing the impact of gestational age as a mediator. METHODS: Gestational age, neonatal characteristics at delivery, and outcomes including common complications of prematurity were assessed. RESULTS: Analysis of the complete cohort confirmed the initial findings that prenatal surgery was associated with an increased risk for earlier gestational age at birth. Delivery occurred before 30 weeks of gestation in 11% of neonates that had fetal MMC repair. Adverse pulmonary sequelae were rare in the prenatal surgery group despite an increased rate of oligohydramnios. There was no significant difference in other complications of prematurity including patent ductus arteriosus, sepsis, necrotizing enterocolitis, periventricular leukomalacia, and intraventricular hemorrhage. CONCLUSION: The benefits of prenatal surgery outweigh the complications of prematurity.

Intra- and Interrater Reliability and Concurrent Validity of a New Tool for Assessment of Breast Cancer-Related Lymphedema of the Upper Extremity.

OBJECTIVE: The goal of this study was to develop and assess intra- and interrater reliability and validity of a clinical evaluation tool for breast cancer-related lymphedema, for use in the context of outcome evaluation in clinical trials. DESIGN: Blinded repeated measures observational study. SETTING: Outpatient research laboratory. PARTICIPANTS: Breast cancer survivors with and without lymphedema (N=71). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The assessment of intraclass correlation coefficients (ICCs) for the Breast Cancer-Related Lymphedema of the Upper Extremity (CLUE) standardized clinical evaluation tool. RESULTS: Intrarater reliability for the CLUE tool was ICC: 0.88 (95% confidence interval [95% CI], 0.71-0.96). Interrater reliability for the CLUE tool was ICC: 0.90 (95% CI, 0.79-0.95). Concurrent validity of the CLUE score (Pearson r) was 0.79 with perometric interlimb difference and 0.53 with the Norman lymphedema overall score. CONCLUSIONS: The CLUE tool shows excellent inter- and intrarater reliability. The overall CLUE score for the upper extremity also shows moderately strong concurrent validity with objective and subjective measures. This newly developed clinical, physical assessment of upper extremity lymphedema provides standardization and a single score that accounts for multiple constructs. Next steps include evaluation of sensitivity to change, which would establish usefulness to evaluate intervention efficacy.

Where do U.S. households purchase healthy foods? An analysis of food-at-home purchases across different types of retailers in a nationally representative dataset.

Food shopping decisions are pathways between food environment, diet and health outcomes, including chronic diseases such as diabetes and obesity. The choices of where to shop and what to buy are interrelated, though a better understanding of this dynamic is needed. The U.S. Department of Agriculture's nationally representative Food Acquisitions and Purchase Survey food-at-home dataset was joined with other databases of retailer characteristics and Healthy Eating Index-2010 (HEI) of purchases. We used linear regression models with general estimating equations to assess relationships between trip, store, and shopper characteristics with trip HEI scores. We examined HEI component scores for conventional supermarkets and discount/limited assortment retailers with descriptive statistics. Overall, 4962 shoppers made 11,472 shopping trips over one-week periods, 2012-2013. Trips to conventional supermarkets were the most common (53.6%), followed by supercenters (18.6%). Compared to conventional supermarkets, purchases at natural/gourmet stores had significantly higher HEI scores (ß = 6.48, 95% CI = [4.45, 8.51], while those from "other" retailers (including corner and convenience stores) were significantly lower (-3.89, [-5.87, -1.92]). Older participants (versus younger) and women (versus men) made significantly healthier purchases (1.19, [0.29, 2.10]). Shoppers with less than some college education made significantly less-healthy purchases, versus shoppers with more education, as did households participating in SNAP, versus those with incomes above 185% of the Federal Poverty Level. Individual, trip, and store characteristics influenced the healthfulness of foods purchased. Interventions to encourage healthy purchasing should reflect these dynamics in terms of how, where, and for whom they are implemented.

Which transfers can we avoid: Multi-state analysis of factors associated with discharge home without procedure after ED to ED transfer for traumatic injury.

OBJECTIVE: Among injured patients transferred from one emergency department (ED) to another, we determined factors associated with being discharged from the second ED without procedures, or admission or observation. METHODS: We analyzed all patients with injury diagnosis codes transferred between two EDs in the 2011 Healthcare Utilization Project State Emergency Department and State Inpatient Databases for 6 states. Multivariable hierarchical logistic regression evaluated the association between patient (demographics and clinical characteristics) and hospital factors, and discharge from the second ED without coded procedures. RESULTS: In 2011, there were a total of 48,160 ED-to-ED injury transfers, half of which (49%) were transferred to non-trauma centers, including 23% with major trauma. A total of 22,011 transfers went to a higher level of care, of which 36% were discharged from the ED without procedures. Relative to torso injuries, discharge without procedures was more likely for patients with soft tissue (OR 6.8, 95%CI 5.6-8.2), head (OR 3.7, 95%CI 3.1-4.6), facial (OR 3.8, 95%CI 3.1-4.7), or hand (OR 3.1, 95%CI 2.6-3.8) injuries. Other factors included Medicaid (OR 1.3, 95%CI 1.2-1.5) or uninsured (OR 1.3, 95%CI 1.2-1.5) status. Treatment at the receiving ED added an additional $2859 on average (95% CI $2750-$2968) per discharged patient to the total charges for injury care, not including the costs of ambulance transport between facilities. CONCLUSION: Over a third of patients transferred to another ED for traumatic injury are discharged from the second ED without admission, observation, or procedures. Telemedicine consultation with sub-specialists might reduce some of these transfers.

Risk of liver decompensation with cumulative use of mitochondrial toxic nucleoside analogues in HIV/hepatitis C virus coinfection.

PURPOSE: Among patients dually infected with human immunodeficiency virus (HIV) and chronic hepatitis C virus (HCV), use of antiretroviral therapy (ART) containing mitochondrial toxic nucleoside reverse transcriptase inhibitors (mtNRTIs) might induce chronic hepatic injury, which could accelerate HCV-associated liver fibrosis and increase the risk of hepatic decompensation and death. METHODS: We conducted a cohort study among 1747 HIV/HCV patients initiating NRTI-containing ART within the Veterans Aging Cohort Study (2002-2009) to determine if cumulative mtNRTI use increased the risk of hepatic decompensation and death among HIV-/HCV-coinfected patients. Separate marginal structural models were used to estimate hazard ratios (HRs) of each outcome associated with cumulative exposure to ART regimens that contain mtNRTIs versus regimens that contain other NRTIs. RESULTS: Over 7033 person-years, we observed 97 (5.6%) decompensation events (incidence rate, 13.8/1000 person-years) and 125 (7.2%) deaths (incidence rate, 17.8 events/1000 person-years). The risk of hepatic decompensation increased with cumulative mtNRTI use (1-11 mo: HR, 1.79 [95% confidence interval (CI), 0.74-4.31]; 12-35 mo: HR, 1.39 [95% CI, 0.68-2.87]; 36-71 mo: HR, 2.27 [95% CI, 0.92-5.60]; >71 mo: HR, 4.66 [95% CI, 1.04-20.83]; P = .045) versus nonuse. Cumulative mtNRTI use also increased risk of death (1-11 mo: HR, 2.24 [95% CI, 1.04-4.81]; 12-35 mo: HR, 2.05 [95% CI, 0.68-6.20]; 36-71 mo: HR, 3.04 [95% CI, 1.12-8.26]; >71 mo: HR, 3.93 [95% CI, 0.75-20.50]; P = .030). CONCLUSIONS: These findings suggest that cumulative mtNRTI use may increase the risk of hepatic decompensation and death in HIV/HCV coinfection. These drugs should be avoided when alternatives exist for HIV/HCV patients.

A Randomized Clinical Trial of an Intensive Behavior Education Program in Gestational Diabetes Mellitus Women Designed to Improve Glucose Levels on the 2-Hour Oral Glucose Tolerance Test.

Objective To evaluate whether women with gestational diabetes mellitus (GDM) enrolled in an intensive behavior education program (IBEP) demonstrate lower mean fasting glucose levels on the 2-hour 75 g oral glucose tolerance test (2-hour OGTT) at 6 to 12 weeks postpartum compared with women who undergo routine GDM management. Study Design A prospective randomized controlled trial of women diagnosed with GDM was conducted. Exclusion criteria were GDM diagnosis ≥ 33 weeks or < 20 weeks. Women were randomly assigned to one of two treatment arms: (1) routine GDM management or (2) an IBEP. Women underwent a 2-hour OGTT at 6 to 12 weeks postpartum. Fisher exact test, t-test, and Wilcoxon rank sum test were used as appropriate. Results Of the 101 women randomized, 49 were assigned to IBEP and 52 received routine GDM management. There was no difference in mean fasting and 2-hour glucose levels on the postpartum 2-hour OGTT between the IBEP and routine management group (88.5 ± 22.9 mg/dL vs. 85.2 ± 13.3 mg/dL, p = 0.49 and 109.8 ± 38.5 mg/dL vs. 109.4 ± 40.8 mg/dL, p = 0.97, respectively). Conclusion GDM women enrolled in a healthy lifestyle intervention program did not demonstrate lower glucose values on the postpartum 2-hour OGTT.

Do hospital service areas and hospital referral regions define discrete health care populations?

BACKGROUND: Effective measurement of health care quality, access, and cost for populations requires an accountable geographic unit. Although Hospital Service Areas (HSAs) and Hospital Referral Regions (HRRs) have been extensively used in health services research, it is unknown whether these units accurately describe patterns of hospital use for patients living within them. OBJECTIVES: To evaluate the ability of HSAs, HRRs, and counties to define discrete health care populations. RESEARCH DESIGN: Cross-sectional geographic analysis of hospital admissions. SUBJECTS: All hospital admissions during the year 2011 in Washington, Arizona, and Florida. MEASURES: The main outcomes of interest were 3 metrics that describe patient movement across HSA, HRR, and county boundaries: localization index, market share index, and net patient flow. Regression models tested the association of these metrics with different HSA characteristics. RESULTS: For 45% of HSAs, fewer than half of the patients were admitted to hospitals located in their HSA of residence. For 16% of HSAs, more than half of the treated patients lived elsewhere. There was an equivalent degree of movement across county boundaries but less movement across HRR boundaries. Patients living in populous, urban HSAs with multiple, large, and teaching hospitals tended to remain for inpatient care. Patients admitted through the emergency department tended to receive care at local hospitals relative to other patients. CONCLUSIONS: HSAs and HRRs are geographic units commonly used in health services research yet vary in their ability to describe where patients receive hospital care. Geographic models may need to account for differences between emergent and nonemergent care.

The relationship between hospital volume and mortality in severe sepsis.

RATIONALE: Severe sepsis is increasing in incidence and has a high rate of inpatient mortality. Hospitals that treat a larger number of patients with severe sepsis may offer a survival advantage. OBJECTIVES: We sought to assess the effect of severe sepsis case volume on mortality, hypothesizing that higher volume centers would have lower rates of inpatient death. METHODS: We performed a retrospective cohort study over a 7-year period (2004-2010), using a nationally representative sample of hospital admissions, examining the relation between volume, urban location, organ dysfunction, and survival. MEASUREMENTS AND MAIN RESULTS: To identify potential differences in outcomes, hospitals were divided into five categories (<50, 50-99, 100-249, 250-499, and 500+ annual cases) and adjusted mortality was compared by volume. A total of 914,200 patients with severe sepsis were identified over a 7-year period (2004-2010). Overall in-hospital mortality was 28.1%. In a fully adjusted model, there was an inverse relationship between severe sepsis case volume and inpatient mortality. Hospitals in the highest volume category had substantially improved survival compared with hospitals with the lowest case volume (adjusted odds ratio, 0.64; 95% confidence interval, 0.60-0.69). In cases of severe sepsis with one reported organ dysfunction, a mortality of 18.9% was found in hospitals with fewer than 50 annual cases compared with 10.4% in hospitals treating 500+ cases (adjusted odds ratio, 0.54; 95% confidence interval, 0.49-0.59). Similar differences were found in patients with up to three total organ dysfunctions. CONCLUSIONS: Patients with severe sepsis treated in hospitals with higher case volumes had improved adjusted outcomes.

Hepatic decompensation in antiretroviral-treated patients co-infected with HIV and hepatitis C virus compared with hepatitis C virus-monoinfected patients: a cohort study.

BACKGROUND: The incidence and determinants of hepatic decompensation have been incompletely examined among patients co-infected with HIV and hepatitis C virus (HCV) in the antiretroviral therapy (ART) era, and few studies have compared outcome rates with those of patients with chronic HCV alone. OBJECTIVE: To compare the incidence of hepatic decompensation between antiretroviral-treated patients co-infected with HIV and HCV and HCV-monoinfected patients and to evaluate factors associated with decompensation among co-infected patients receiving ART. DESIGN: Retrospective cohort study. SETTING: Veterans Health Administration. PATIENTS: 4280 co-infected patients who initiated ART and 6079 HCV-monoinfected patients receiving care between 1997 and 2010. All patients had detectable HCV RNA and were HCV treatment-naive. MEASUREMENTS: Incident hepatic decompensation, determined by diagnoses of ascites, spontaneous bacterial peritonitis, or esophageal variceal hemorrhage. RESULTS: The incidence of hepatic decompensation was greater among co-infected than monoinfected patients (7.4% vs. 4.8% at 10 years; P < 0.001). Compared with HCV-monoinfected patients, co-infected patients had a higher rate of hepatic decompensation (hazard ratio [HR] accounting for competing risks, 1.56 [95% CI, 1.31 to 1.86]). Co-infected patients who maintained HIV RNA levels less than 1000 copies/mL still had higher rates of decompensation than HCV-monoinfected patients (HR, 1.44 [CI, 1.05 to 1.99]). Baseline advanced hepatic fibrosis (FIB-4 score >3.25) (HR, 5.45 [CI, 3.79 to 7.84]), baseline hemoglobin level less than 100 g/L (HR, 2.24 [CI, 1.20 to 4.20]), diabetes mellitus (HR, 1.88 [CI, 1.38 to 2.56]), and nonblack race (HR, 2.12 [CI, 1.65 to 2.72]) were each associated with higher rates of decompensation among co-infected patients. LIMITATION: Observational study of predominantly male patients. CONCLUSION: Despite receiving ART, patients co-infected with HIV and HCV had higher rates of hepatic decompensation than HCV-monoinfected patients. Rates of decompensation were higher for co-infected patients with advanced liver fibrosis, severe anemia, diabetes, and nonblack race. PRIMARY FUNDING SOURCE: National Institutes of Health.

Child passenger safety practices and injury risk in crashes with father versus mother drivers.

In order to test stereotypes that mothers are more safety conscious than fathers, this study aimed to explore differences in restraint patterns, front-row seating and injury for children in crashes when driven by fathers versus mothers, both when driving alone and with other adults. From 15 January 2003 to 30 November 2007, data were collected via insurance claims records and telephone surveys on a weighted sample of 10,715 child passengers in crashes. When riding with children and no other adults, father drivers in crashes were more likely than mother drivers to transport children <9 years old unrestrained or suboptimally restrained (35.0% vs 26.1%, p=0.001) and to seat children <13 years old in the front row (23.7% vs 14.3%, p<0.001). For children <16 years, no statistically significant difference in injury risk was noted for father versus mother drivers, regardless of adult passenger presence. Further improvements in child passenger safety might be gained with campaigns directed at both fathers and mothers.

Benchmarking the incidence and mortality of severe sepsis in the United States.

BACKGROUND: In 1992, the first consensus definition of severe sepsis was published. Subsequent epidemiologic estimates were collected using administrative data, but ongoing discrepancies in the definition of severe sepsis produced large differences in estimates. OBJECTIVES: We seek to describe the variations in incidence and mortality of severe sepsis in the United States using four methods of database abstraction. We hypothesized that different methodologies of capturing cases of severe sepsis would result in disparate estimates of incidence and mortality. DESIGN, SETTING, PARTICIPANTS: Using a nationally representative sample, four previously published methods (Angus et al, Martin et al, Dombrovskiy et al, and Wang et al) were used to gather cases of severe sepsis over a 6-year period (2004-2009). In addition, the use of new International Statistical Classification of Diseases, 9th Edition (ICD-9), sepsis codes was compared with previous methods. MEASUREMENTS: Annual national incidence and in-hospital mortality of severe sepsis. RESULTS: The average annual incidence varied by as much as 3.5-fold depending on method used and ranged from 894,013 (300/100,000 population) to 3,110,630 (1,031/100,000) using the methods of Dombrovskiy et al and Wang et al, respectively. Average annual increase in the incidence of severe sepsis was similar (13.0% to 13.3%) across all methods. In-hospital mortality ranged from 14.7% to 29.9% using abstraction methods of Wang et al and Dombrovskiy et al. Using all methods, there was a decrease in in-hospital mortality across the 6-year period (35.2% to 25.6% [Dombrovskiy et al] and 17.8% to 12.1% [Wang et al]). Use of ICD-9 sepsis codes more than doubled over the 6-year period (158,722 - 489,632 [995.92 severe sepsis], 131,719 - 303,615 [785.52 septic shock]). CONCLUSION: There is substantial variability in incidence and mortality of severe sepsis depending on the method of database abstraction used. A uniform, consistent method is needed for use in national registries to facilitate accurate assessment of clinical interventions and outcome comparisons between hospitals and regions.

Safety in numbers: are major cities the safest places in the United States?

STUDY OBJECTIVES: Many US cities have experienced population reductions, often blamed on crime and interpersonal injury. Yet the overall injury risk in urban areas compared with suburban and rural areas has not been fully described. We begin to investigate this evidence gap by looking specifically at injury-related mortality risk, determining the risk of all injury death across the rural-urban continuum. METHODS: A cross-sectional time-series analysis of US injury deaths from 1999 to 2006 in counties classified according to the rural-urban continuum was conducted. Negative binomial generalized estimating equations and tests for trend were completed. Total injury deaths were the primary comparator, whereas differences by mechanism and age were also explored. RESULTS: A total of 1,295,919 injury deaths in 3,141 US counties were analyzed. Injury mortality increased with increasing rurality. Urban counties demonstrated the lowest death rates, significantly less than rural counties (mean difference=24.0 per 100,000; 95% confidence interval 16.4 to 31.6 per 100,000). After adjustment, the risk of injury death was 1.22 times higher in the most rural counties compared with the most urban (95% confidence interval 1.07 to 1.39). CONCLUSION: Using total injury death rate as an overall safety metric, US urban counties were safer than their rural counterparts, and injury death risk increased steadily as counties became more rural. Greater emphasis on elevated injury-related mortality risk outside of large cities, attention to locality-specific injury prevention priorities, and an increased focus on matching emergency care needs to emergency care resources are in order.

Dynamic prediction modeling of postoperative mortality among patients undergoing surgical aortic valve replacement in a statewide cohort over a 12-year period.

Objective: Clinical prediction models for surgical aortic valve replacement mortality, are valuable decision tools but are often limited in their ability to account for changes in medical practice, patient selection, and the risk of outcomes over time. Recent research has identified methods to update models as new data accrue, but their effect on model performance has not been rigorously tested. Methods: The study population included 44,546 adults who underwent an isolated surgical aortic valve replacement from January 1, 1999, to December 31, 2018, statewide in Pennsylvania. After chronologically splitting the data into training and validation sets, we compared calibration, discrimination, and accuracy measures amongst a nonupdating model to 2 methods of model updating: calibration regression and the novel dynamic logistic state space model. Results: The risk of mortality decreased significantly during the validation period (P < .01) and the nonupdating model demonstrated poor calibration and reduced accuracy over time. Both updating models maintained better calibration (Hosmer-Lemeshow χ2 statistic) than the nonupdating model: nonupdating (156.5), calibration regression (4.9), and dynamic logistic state space model (8.0). Overall accuracy (Brier score) was consistently better across both updating models: dynamic logistic state space model (0.0252), calibration regression (0.0253), and nonupdating (0.0256). Discrimination improved with the dynamic logistic state space model (area under the curve, 0.696) compared with the nonupdating model (area under the curve, 0.685) and calibration regression method (area under the curve, 0.687). Conclusions: Dynamic model updating can improve model accuracy, discrimination, and calibration. The decision as to which method to use may depend on which measure is most important in each clinical context. Because competing therapies have emerged for valve replacement models, updating may guide clinical decision making.

Post-operative neurosurgery outcomes by race/ethnicity among enhanced recovery after surgery (ERAS) participants.

OBJECTIVE: Prior work reveals that Enhanced Recovery After Surgery (ERAS) programs decrease opioid use, improve mobilization, and shorten length of stay (LOS) among patients undergoing spine surgery. The impact of ERAS on outcomes by race/ethnicity is unknown. This study examined outcomes by race/ethnicity among neurosurgical patients enrolled in an ERAS program. METHODS: Patients undergoing elective spine or peripheral nerve surgeries at a multi-hospital university health system from April 2017 to November 2020 were enrolled in an ERAS program that involves preoperative, perioperative, and postoperative phases focused on improving outcomes through measures such as specialty consultations for co-morbidities, multimodal analgesia, early mobilization, and wound care education. The following outcomes for ERAS patients were compared by race/ethnicity: length of stay, discharge disposition, complications, readmission, pain level at discharge, and post-operative health rating. We estimated the association between race/ethnicity and the outcomes using linear and logistic regression models adjusting for age, sex, insurance, BMI, comorbid conditions, and surgery type. RESULTS: Among participants (n = 3449), 2874 (83.3%) were White and 575 (16.7%) were Black, Indigenous, and people of color (BIPOC). BIPOC patients had significantly longer mean length of stay compared to White patients (3.8 vs. 3.4 days, p = 0.005) and were significantly more likely to be discharged to a rehab or subacute nursing facility compared to White patients (adjusted odds ratio (95% CI): 3.01 (2.26-4.01), p < 0.001). The complication rate did not significantly differ between BIPOC and White patients (13.7% vs. 15.5%, p = 0.29). BIPOC patients were not significantly more likely to be readmitted within 30 days compared to White patients in the adjusted model (adjusted odds ratio (95% CI): 1.30 (0.91-1.86), p = 0.15) CONCLUSION: BIPOC as compared to White ERAS participants in ERAS undergoing neurosurgical procedures had significantly longer hospital stays and were significantly less likely to be discharged home. ERAS protocols present an opportunity to provide consistent high quality post-operative care, however while there is evidence that it improves care in aggregate, our results suggest significant disparities in outcomes by patient race/ethnicity despite enrollment in ERAS. Future inquiry must identify contributors to these disparities in the recovery pathway.

Cardiovascular Substructure Dose and Cardiac Events following Proton- and Photon-Based Chemoradiotherapy for Non-Small Cell Lung Cancer.

Purpose: Radiation therapy (RT) plays a critical role in treating locally advanced non-small cell lung cancer but has been associated with deleterious cardiac effects. We hypothesized that RT dose to certain cardiovascular substructures may be higher among those who experience post-chemoradiation (CRT) cardiac events, and that dose to specific substructures-the great vessels, atria, ventricles, and left anterior descending coronary artery-may be lower with proton- versus photon-based RT. Methods and Materials: In this retrospective review, we selected 26 patients who experienced cardiac events after CRT for locally advanced non-small cell lung cancer and matched them to 26 patients who did not experience cardiac events after CRT. Matching was done based on RT technique (protons vs photons), age, sex, and cardiovascular comorbidity. For each patient, the whole heart and 10 cardiovascular substructures on the RT planning computerized tomography scan were manually contoured. Dosimetric comparisons were made between those who did and did not experience cardiac events and between the proton and photon groups. Results: There was no significant difference in heart or any cardiovascular substructure dose between those patients who experienced post-treatment cardiac events and those who did not (P > .05 for all). The mean heart dose in the patients receiving proton therapy was significantly lower than the mean heart dose in the patients receiving photon therapy (P = .032). The left ventricle, right ventricle, and the left anterior descending artery also had significantly lower doses (by multiple measures) when treated with protons (P = .0004, P < .0001, and P = .0002, respectively). Conclusions: Proton therapy may have a significant effect on decreasing dose to individual cardiovascular substructures compared with photon therapy. There was no significant difference in heart dose or dose to any cardiovascular substructure between patients who did and did not experience post-treatment cardiac events. Further research should be done to assess the association between cardiovascular substructure dose and post-treatment cardiac events.