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ImportancePharmacologic agents are often used to treat newborns with prenatal opioid exposure (POE) despite known adverse effects on neurodevelopment. Alternative nonpharmacological interventions are needed.ObjectiveTo examine efficacy of a vibrating crib mattress for treating newborns with POE.Design, Setting, and ParticipantsIn this dual-site randomized clinical trial, 208 term newborns with POE, enrolled from March 9, 2017, to March 10, 2020, were studied at their bedside throughout hospitalization.InterventionsHalf the cohort received treatment as usual (TAU) and half received standard care plus low-level stochastic (random) vibrotactile stimulation (SVS) using a uniquely constructed crib mattress with a 3-hour on-off cycle. Study initiated in the newborn unit where newborns were randomized to TAU or SVS within 48 hours of birth. All infants whose symptoms met clinical criteria for pharmacologic treatment received morphine in the neonatal intensive care unit per standard care.Main Outcomes and MeasuresThe a priori primary outcomes analyzed were pharmacotherapy (administration of morphine treatment [AMT], first-line medication at both study sites [number of infants treated], and cumulative morphine dose) and hospital length of stay. Intention-to-treat analysis was conducted.ResultsAnalyses were performed on 181 newborns who completed hospitalization at the study sites (mean [SD] gestational age, 39.0 [1.2] weeks; mean [SD] birth weight, 3076 (489) g; 100 [55.2%] were female). Of the 181 analyzed infants, 121 (66.9%) were discharged without medication and 60 (33.1%) were transferred to the NICU for morphine treatment (31 [51.7%] TAU and 29 [48.3%] SVS). Treatment rate was not significantly different in the 2 groups: 35.6% (31 of 87 infants who received TAU) and 30.9% (29 of 94 infants who received SVS) (P = .60). Adjusting for site, sex, birth weight, opioid exposure, and feed type, infant duration on the vibrating mattress in the newborn unit was associated with reduction in AMT (adjusted odds ratio, 0.88 hours per day; 95% CI, 0.81-0.93 hours per day). This translated to a 50% relative reduction in AMT for infants who received SVS on average 6 hours per day. Among 32 infants transferred to the neonatal intensive care unit for morphine treatment who completed treatment within 3 weeks, those assigned to SVS finished treatment nearly twice as fast (hazard ratio, 1.96; 95% CI, 1.01-3.81), resulting in 3.18 fewer treatment days (95% CI, −0.47 to −0.04 days) and receiving a mean 1.76 mg/kg less morphine (95% CI, −3.02 to −0.50 mg/kg) than the TAU cohort. No effects of condition were observed among infants treated for more than 3 weeks (n = 28).Conclusions and RelevanceThe findings of this clinical trial suggest that SVS may serve as a complementary nonpharmacologic intervention for newborns with POE. Reducing pharmacotherapy with SVS has implications for reduced hospitalization stays and costs, and possibly improved infant outcomes given the known adverse effects of morphine on neurodevelopment.Trial RegistrationClinicalTrials.gov Identifier: NCT02801331

It is important to document the performance of rapid antigen tests (Ag-RDTs) in detecting SARS-CoV-2 variants.To compare the performance of Ag-RDTs in detecting the Delta (B.1.617.2) and Omicron (B.1.1.529) variants of SARS-CoV-2.Secondary analysis of a prospective cohort study that enrolled participants between 18 October 2021 and 24 January 2022. Participants did Ag-RDTs and collected samples for reverse transcriptase polymerase chain reaction (RT-PCR) testing every 48 hours for 15 days.The parent study enrolled participants throughout the mainland United States through a digital platform. All participants self-collected anterior nasal swabs for rapid antigen testing and RT-PCR testing. All Ag-RDTs were completed at home, whereas nasal swabs for RT-PCR were shipped to a central laboratory.Of 7349 participants enrolled in the parent study, 5779 asymptomatic persons who tested negative for SARS-CoV-2 on day 1 of the study were eligible for this substudy.Sensitivity of Ag-RDTs on the same day as the first positive (index) RT-PCR result and 48 hours after the first positive RT-PCR result.A total of 207 participants were positive on RT-PCR (58 Delta, 149 Omicron). Differences in sensitivity between variants were not statistically significant (same day: Delta, 15.5% [95% CI, 6.2% to 24.8%] vs. Omicron, 22.1% [CI, 15.5% to 28.8%]; at 48 hours: Delta, 44.8% [CI, 32.0% to 57.6%] vs. Omicron, 49.7% [CI, 41.6% to 57.6%]). Among 109 participants who had RT-PCR-positive results for 48 hours, rapid antigen sensitivity did not differ significantly between Delta- and Omicron-infected participants (48-hour sensitivity: Delta, 81.5% [CI, 66.8% to 96.1%] vs. Omicron, 78.0% [CI, 69.1% to 87.0%]). Only 7.2% of the 69 participants with RT-PCR-positive results for shorter than 48 hours tested positive by Ag-RDT within 1 week; those with Delta infections remained consistently negative on Ag-RDTs.A testing frequency of 48 hours does not allow a finer temporal resolution of the analysis of test performance, and the results of Ag-RDTs are based on self-report.The performance of Ag-RDTs in persons infected with the SARS-CoV-2 Omicron variant is not inferior to that in persons with Delta infections. Serial testing improved the sensitivity of Ag-RDTs for both variants. The performance of rapid antigen testing varies on the basis of duration of RT-PCR positivity.National Heart, Lung, and Blood Institute of the National Institutes of Health.

BackgroundPerformance of rapid antigen tests for SARS-CoV-2 (Ag-RDT) varies over the course of an infection, and their performance in screening for SARS-CoV-2 is not well established. We aimed to evaluate performance of Ag-RDT for detection of SARS-CoV-2 for symptomatic and asymptomatic participants.MethodsParticipants >2 years old across the United States enrolled in the study between October 2021 and February 2022. Participants completed Ag-RDT and molecular testing (RT-PCR) for SARS-CoV-2 every 48 hours for 15 days. This analysis was limited to participants who were asymptomatic and tested negative on their first day of study participation. Onset of infection was defined as the day of first positive RT-PCR result. Sensitivity of Ag-RDT was measured based on testing once, twice (after 48-hours), and thrice (after 96 hours). Analysis was repeated for different Days Post Index PCR Positivity (DPIPP) and stratified based on symptom-status.ResultsIn total, 5,609 of 7,361 participants were eligible for this analysis. Among 154 participants who tested positive for SARS-CoV-2, 97 were asymptomatic and 57 had symptoms at infection onset. Serial testing with Ag-RDT twice 48-hours apart resulted in an aggregated sensitivity of 93.4% (95% CI: 89.1-96.1%) among symptomatic participants on DPIPP 0-6. Excluding singleton positives, aggregated sensitivity on DPIPP 0-6 for two-time serial-testing among asymptomatic participants was lower at 62.7% (54.7-70.0%) but improved to 79.0% (71.0-85.3%) with testing three times at 48-hour intervals.DiscussionPerformance of Ag-RDT was optimized when asymptomatic participants tested three-times at 48-hour intervals and when symptomatic participants tested two-times separated by 48-hours.

BackgroundThere is a need to understand the performance of rapid antigen tests (Ag-RDT) for detection of the Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) SARS-CoV-2 variants.MethodsParticipants without any symptoms were enrolled from October 18, 2021 to January 24, 2022 and performed Ag-RDT and RT-PCR tests every 48 hours for 15 days. This study represents a non-pre-specified analysis in which we sought to determine if sensitivity of Ag-RDT differed in participants with Delta compared to Omicron variant. Participants who were positive on RT-PCR on the first day of the testing period were excluded. Delta and Omicron variants were defined based on sequencing and date of first RT-PCR positive result (RT-PCR+). Comparison of Ag-RDT performance between the variants was based on sensitivity, defined as proportion of participants with Ag-RDT+ results in relation to their first RT-PCR+ result, for different duration of testing with rapid Ag-RDT. Subsample analysis was performed based on the result of participants’ second RT-PCR test within 48 hours of the first RT-PCR+ test.ResultsFrom the 7,349 participants enrolled in the parent study, 5,506 met the eligibility criteria for this analysis. A total of 153 participants were RT-PCR+ (61 Delta, 92 Omicron); among this group, 36 (23.5%) tested Ag-RDT+ on the same day, and 84 (54.9%) tested Ag-RDT+ within 48 hours as first RT-PCR+. The differences in sensitivity between variants were not statistically significant (same-day: Delta 16.4% [95% CI: 8.2-28.1] vs Omicron 28.2% [95% CI: 19.4-38.6]; and 48-hours: Delta 45.9% [33.1-59.2] vs. Omicron 60.9% [50.1-70.9]). This trend continued among the 86 participants who had consecutive RT-PCR+ result (48-hour sensitivity: Delta 79.3% [60.3-92.1] vs. Omicron: 89.5% [78.5-96.0]). Conversely, the 38 participants who had an isolated RT-PCR+ remained consistently negative on Ag-RDT, regardless of the variant.ConclusionsThe performance of Ag-RDT is not inferior among individuals infected with the SARS-CoV-2 Omicron variant as compared to the Delta variant. The improvement in sensitivity of Ag-RDT noted with serial testing is consistent between Delta and Omicron variant. Performance of Ag-RDT varies based on duration of RT-PCR+ results and more studies are needed to understand the clinical and public health significance of individuals who are RT-PCR+ for less than 48 hours.

Introduction: Heart healthy diets are important in the prevention and treatment of hypertension (HTN). In pregnant women, the lifestyle barriers to healthy eating are not well-described in literature. Hypothesis: There are personal, environmental, and economic barriers impacting adherence to a healthy diet in pregnant women with HTN, hypertensive disorders of pregnancy (HDP), or risk factors for HDP. Methods: Pregnant women, aged 20-50 (N=28), diagnosed with HTN, HDP, or risk factors for HDP were recruited from a large academic medical center. Participants completed an electronic survey assessing personal, environmental, and economic barriers to healthy eating. A 5-point Likert scale was used, ranging from strongly agree to strongly disagree. Results: The average age of participants was 31.8 (SD=4.5) from urban (34.6%), suburban (34.6%), and rural (30.8%) communities. Finances and time were major barriers to healthy eating, reported by 39.3% and 28.6% of participants, respectively, with 17.8% reporting that they could not afford to eat healthy consistently for all meals (Figure 1). Additionally, 10.7% and 7.1% were unaware of factors promoting healthy eating such as awareness of outside healthy eating resources and confidence in their ability to eat healthy given a new pregnancy. Meanwhile, 28.6% and 17.9% reported ambivalence towards these factors. Conclusion: Time management and financial costs emerged as the greatest challenges to healthy eating in pregnant women with or at risk for HDP. These barriers, in addition to certain factors promoting healthy eating, may represent areas of intervention that can help mitigate the obstacles to healthy eating in this vulnerable group.

BACKGROUND The ongoing pandemic necessitates the development of accurate, rapid, and affordable diagnostics to help curb SARS-CoV-2 disease transmission, morbidity, and mortality, as well as safely navigate social re-engagement. OBJECTIVE To describe the feasibility and acceptability of serial self-testing for SARS-CoV-2, including need for assistance and reliability of self-interpretation. METHODS A total of 206 adults in the United States with Smartphones were enrolled in this single-arm feasibility study during February and March 2021. All participants were asked to self-test for Covid-19 at home daily using an antigen-detection rapid diagnostic test over a 14-day period and use a smartphone application for testing assistance and to report their results. The main outcomes were adherence to the testing schedule, acceptability of testing and Smartphone application experiences, and reliability of participant versus study team interpretation of test results. RESULTS Among the 206 participants, 52% of study participants were women, the average age was 40.7 years, 34.43% were non-White, and half the sample (56.8%) had received a Bachelor’s degree or higher. Most participants (64.6%) showed high testing adherence. Participants’ interpretations of test results demonstrated high agreement (98.9%) with the study verified results, with a kappa score of 0.29 (p CONCLUSIONS Participant’s high adherence to the recommended testing schedule, significant reliability between participant and study staff test interpretation, and acceptability of the smartphone application and self-test indicate that self-tests for SARS-CoV-2 with a smartphone application for assistance and reporting is highly feasible among a diverse population of adults in the United States.

Importance There are limited data to guide screen time recommendations after concussion. Objective To determine whether screen time in the first 48 hours after concussion has an effect on the duration of concussive symptoms. Design, Setting, and Participants This randomized clinical trial was conducted in the pediatric and adult emergency departments of a tertiary medical center between June 2018 and February 2020. Participants included a convenience sample of patients aged 12 to 25 years presenting to the emergency department within 24 hours of sustaining a concussion. A total of 162 patients were approached, 22 patients met exclusion criteria, and 15 patients declined participation; 125 participants were enrolled and randomized. Interventions Patients were either permitted to engage in screen time (screen time permitted group) or asked to abstain from screen time (screen time abstinent group) for 48 hours after injury. Main Outcomes and Measures The primary outcome was days to resolution of symptoms, defined as a total Post-Concussive Symptom Scale (PCSS) score of 3 points or lower. Patients completed the PCSS, a 22-symptom scale that grades each symptom from 0 (not present) to 6 (severe), each day for 10 days. Kaplan-Meier curves and Cox regression modeling were used to compare the 2 groups. A Wilcoxon rank sum test was also performed among participants who completed the PCSS each day through recovery or conclusion of the study period. Results Among 125 patients with concussion, the mean (SD) age was 17.0 (3.4) years; 64 participants (51.2%) were male. A total of 66 patients were randomized to the screen time permitted group, and 59 patients were randomized to the screen time abstinent group. The Cox regression model including the intervention group and the patient’s self-identified sex demonstrated a significant effect of screen time (hazard ratio [HR], 0.51; 95% CI, 0.29-0.90), indicating that participants who engaged in screen time were less likely to recover during the study period. In total, 91 patients were included in the Wilcoxon rank sum test (47 patients from the screen time permitted group, and 44 patients from the screen time abstinent group). The screen time permitted group had a significantly longer median recovery time of 8.0 days (interquartile range [IQR], 3.0 to >10.0 days) compared with 3.5 days (IQR, 2.0 to >10.0 days;P = .03) in the screen time abstinent group. The screen time permitted group reported a median screen time of 630 minutes (IQR, 415-995 minutes) during the intervention period compared with 130 minutes (IQR, 61-275 minutes) in the screen time abstinent group. Conclusions and Relevance The findings of this study indicated that avoiding screen time during acute concussion recovery may shorten the duration of symptoms. A multicenter study would help to further assess the effect of screen time exposure. Trial Registration ClinicalTrials.gov Identifier:NCT03564210

Introduction: Hypertension (HTN) is the most important modifiable risk factor of serious maternal mortality and morbidity. Social determinants, including economic stability and access to healthcare, influence HTN outcomes and are critical to understanding and addressing racial and ethnic differences in HTN control. Objective: To assess social determinants and co-morbidities in US women of child-bearing age with HTN by race/ethnicity Methods: We studied women (age 20-50) with HTN in the National Health and Nutrition Examination Surveys 2001-2018. Social determinants and co-morbid conditions were examined in groups categorized by race/ethnicity - Non-Hispanic White (White), Non-Hispanic Black (Black), and Hispanic. Demographics, anthropometric measures, and co-morbid conditions were compared with White women as reference. Results: In all women with HTN, the mean (SE) age was 36.0 (0.3) years and 63% were on BP medication. Compared to white women, Black and Hispanic women had lower food security, poverty income ratio, smoking use, and private insurance (all pTable ). Black women had higher BP medication use, BMI, and BP compared to White women (all p Conclusions: Despite effective diagnostics and therapy, health inequity is common in women of child-bearing age with HTN, with differences by race/ethnicity in social determinants and co-morbid conditions. Each racial/ethnic group with HTN brings social determinants and comorbid conditions important for providers to recognize.

BACKGROUND: The role of changes in gut microflora on upper gastrointestinal (UGI) perforations is not known. We conducted a retrospective case-control study to examine the relationship between antibiotic exposure—a proxy for microbiome modulation— and UGI perforations in a national sample. METHODS: We queried a 5% random sample of Medicare (2009–2013) to identify patients ≥ 65 years old hospitalized with UGI (stomach or small intestine) perforations using International Classification of Diseases diagnosis codes. Cases with UGI perforations were matched with 4 controls, each based on age and sex. Exposure to outpatient antibiotics (0–30, 31–60, 61–90 days) prior to case patients’ index hospitalization admission data was determined with Part D claims. Univariate and multivariable regression analyses were performed to evaluate the effect of antibiotic exposure on UGI perforation. RESULTS: Overall, 504 cases and 2016 matched controls were identified. Compared to controls, more cases had antibiotic exposure 0–30 days (19% vs. 3%, p < 0.001) and 31–60 days (5% vs. 2%, p < 0.001) prior to admission. In adjusted analyses, antibiotic exposure 0–30 days prior to admission was associated with 6.8 increased odds of an UGI perforation (95% CI 4.8, 9.8); 31–60 days was associated with 1.9 increased odds (95% CI 1.1, 3.3); and 61–90 days was associated with 3.7 increased odds (95% CI 2.0, 6.9). CONCLUSIONS: Recent outpatient antibiotic use, in particular in the preceding 30 days, is associated with UGI perforation among Medicare beneficiaries. Exposure to antibiotics, one of the most modifiable determinants of the microbiome, should be minimized in the outpatient setting.

Background Hypertension (HTN) in pregnancy is a leading cause of maternal morbidity and mortality in the United States. Although the Dietary Approaches to Stop Hypertension (DASH) diet is recommended for all adults with HTN, rates of DASH adherence and antihypertensive medication use in women of child-bearing age are unknown. Our objectives were to determine DASH adherence and antihypertensive medication use in women of child-bearing age. Methods In the National Health and Nutrition Examination Surveys from 2001 to 2016, we estimated DASH adherence among women of child-bearing age (20–50 years). We derived a DASH score (0–9) based on 9 nutrients, with DASH adherence defined as DASH score ≥4.5. HTN was defined by blood pressure (BP) ≥130/80 mm Hg or antihypertensive medication use. DASH scores were compared across BP categories and antihypertensive medication use was categorized. Results Of the 7,782 women, the mean age (SE) was 32.8 (0.2) years, 21.4% were non-Hispanic Black, and 20.3% had HTN. The mean DASH score was 2.11 (0.06) for women with self-reported HTN and 2.40 (0.03) for women with normal BP (P < 0.001). DASH adherence was prevalent in 6.5% of women with self-reported HTN compared with 10.1% of women with normal BP (P < 0.05). Self-reported HTN is predominantly managed with medications (84.8%), while DASH adherence has not improved in these women from 2001 to 2016. Moreover, 39.5% of US women of child-bearing age are taking medications contraindicated in pregnancy. Conclusions Given the benefits of optimized BP during pregnancy, this study highlights the critical need to improve DASH adherence and guide prescribing among women of child-bearing age.

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

Additional file 6. ICD-9 and ICD-10 Diagnosis Codes Used to Identify Emergency General Surgery Cases.

Additional file 8. ICD-9 and ICD-10 Procedure Codes for Emergency General Surgery Cases.

Additional file 1. Interview Template for 18 semi-structured interviews conducted to inform survey development.

Additional file 3. Questionnaire from National Survey of 2811 Acute Care General Hospitals in the US where an Adult with a General Surgery Emergency Might Receive Emergency General Surgery Care.

Additional file 4. Cover Letter Included with National Survey.

Additional file 2. Questionnaire from Pilot Survey of University Health Systems Consortium (now Vizient) Hospitals.

Additional file 7. ICD-9 and ICD-10 Diagnoses and Procedure Codes Used to Identify Complications.

Additional file 5. Matrixed Table of Survey Question Alignment with Structure and Process Domains.

Acute care surgery (ACS) was proposed to address a general surgery workforce crisis; however, the ACS workforce composition is unknown. A national survey was conducted to determine the differences in the emergency general surgery (EGS) workforce between ACS and non-ACS hospitals.The American Hospital Association (AHA) Annual Survey of Hospitals database was queried to identify acute care general hospitals. A hybrid mail/electronic survey was sent to 2811 acute care hospitals that met the inclusion criteria of hospitals that care for adult patients (≥18 years old) with an emergency room (ER), ≥ 1 operating room (OR), and 24-h ER access. Hospitals were queried on whether they utilized an ACS model. The workforce composition among ACS and non-ACS hospitals was evaluated using XSurvey response was 60% (N = 1690). ACS hospitals had a higher proportion of emergency surgeons who were female (20% vs. 14%, p 0.0001), newly-trained (17% vs 10%, p 0.0001), critical care trained (78% vs. 31%, p 0.0001), and who had an additional degree (35% vs. 13%, p 0.0001). More ACS hospitals had 24/7 in-house OR nursing staff (72% vs. 15%, p 0.0001) and ancillary staff.ACS and non-ACS hospitals differ in their surgical workforce. It is clear that ACS hospitals have more human capital, which suggests that ACS hospitals may require more dedicated resources compared to non-ACS hospitals.

Background Elderly Americans suffer increased mortality from sepsis. Given that beta-blockers have been shown to be cardioprotective in critical care, we investigated outpatient beta-blocker prescriptions and mortality among Medicare beneficiaries admitted for sepsis. Methods We queried a 5% random sample of Medicare beneficiaries for patients admitted with sepsis. We used in-hospital and outpatient prescription drug claims to compare in-hospital and 30-day mortality based on pre-admission beta-blocker prescription and class of beta-blocker prescribed using univariate tests of comparison and multivariable logistic regression models and another class of medications for control. Results Outpatient beta-blocker prescription was associated with a statistically significant decrease in in-hospital and 30-day mortality. In multivariable modeling, beta-blocker prescription was associated with 31% decrease in in-hospital mortality and 41% decrease in 30-day mortality. Both cardioselective and non-selective beta-blockers conferred mortality benefit. Conclusions Our data suggests that there may be a role for preadmission beta-blockers in reducing sepsis-related mortality.

Background Few diseases truly require emergency surgery today. We investigated the relationship between access to operating room (OR) and outcomes for patients with life-threatening emergency general surgery (LT-EGS) diseases at US hospitals. Methods In 2015, we surveyed 2,811 US hospitals on EGS practices, including how OR access is assured (e.g., OR staffing, block time). There were 1,690 (60%) hospitals that responded. We anonymously linked survey data to 2015 Statewide Inpatient Sample data (17 states) using American Hospital Association identifiers. Adults admitted with life-threatening diagnoses (e.g., necrotizing fasciitis, perforated viscus) who underwent operative intervention the same calendar day as hospital admission were included. Primary outcome was in-hospital mortality. Univariate and multivariable regression analyses, clustered by treating hospital and adjusted for patient factors, were performed to examine hospital-level OR access variables. Results Overall, 3,620 patients were admitted with LT-EGS diseases. The median age was 63 years (interquartile range, 51-75), with half having three or more comorbidities (50%). Thirty-four percent had one or more major systemic complication, and 5% died. The majority got care at hospitals with less than 1 day of EGS block time but with policies to ensure emergency access to the OR. After adjusting for age, sex, race, insurance status, comorbidities, systemic complications, and surgical complications, we found that less presence of an in-house EGS surgeon, compared with around the clock, was associated with increased mortality (rarely/never in-house surgeon: odds ratio, 2.4; 95% confidence interval [CI],1.1-5.3; sometimes in-house surgeon: odds ratio, 1.6; 95% CI, 1.1-2.3). In addition, after controlling for other factors, on-call overnight recovery room nurse, compared with in-house, was associated with an increased mortality (odds ratio, 2.2; 95% CI, 1.5-3.1). Conclusion Round-the-clock availability of personnel, specifically emergency general surgeons and recovery room nurses, is associated with decreased mortality. These findings have implications for the creation of EGS patient triage criteria and Acute Care Surgery Centers of Excellence. Level of evidence Therapeutic, level III.

The incidence of Neonatal Abstinence Syndrome (NAS) continues to rise and there remains a critical need to develop non-pharmacological interventions for managing opioid withdrawal in newborns. Objective physiologic markers of opioid withdrawal in the newborn remain elusive. Optimal treatment strategies for improving short-term clinical outcomes and promoting healthy neurobehavioral development have yet to be defined. This dual-site randomized controlled trial ({"type":"clinical-trial","attrs":{"text":"NCT02801331","term_id":"NCT02801331"}}NCT02801331) is designed to evaluate the therapeutic efficacy of stochastic vibrotactile stimulation (SVS) for reducing withdrawal symptoms, pharmacological treatment, and length of hospitalization, and for improving developmental outcomes in opioid-exposed neonates. Hospitalized newborns (n = 230) receiving standard clinical care for prenatal opioid exposure will be randomly assigned within 48-hours of birth to a crib with either: 1) Intervention (SVS) mattress: specially-constructed SVS crib mattress that delivers gentle vibrations (30–60 Hz, ~12 μm RMS surface displacement) at 3-hr intervals; or 2) Control mattress (treatment as usual; TAU): non-oscillating hospital-crib mattress. Infants will be studied throughout their hospitalization and post discharge to 14-months of age. The study will compare clinical measures (i.e., withdrawal scores, cumulative dose and duration of medications, velocity of weight gain) and characteristic progression of physiologic activity (i.e., limb movement, cardio-respiratory, temperature, blood-oxygenation) throughout hospitalization between opioid-exposed infants who receive SVS and those who receive TAU. Developmental outcomes (i.e., physical, social, emotional and cognitive) within the first year of life will be evaluated between the two study groups. Findings from this randomized controlled trial will determine whether SVS reduces in-hospital severity of NAS, improves physiologic function, and promotes healthy development.

Introduction Despite three million adults in the United States (US) being admitted annually for emergency general surgery (EGS) conditions, which disproportionately affect vulnerable populations, we lack an understanding of the barriers to round-the-clock EGS care. Our objective was to measure gaps in round-the-clock EGS care. Methods From August 2015 to December 2015, we surveyed all US-based, adult acute care general hospitals that have an emergency room and ≥1 operating room and provide EGS care, utilizing paper and electronic methods. Surgeons or chief medical officers were queried regarding EGS practices. Results Of 2,811 hospitals, 1,634 (58.1%) responded; 279 (17.1%) were unable to always provide round-the-clock EGS care. Rural location, smaller bed size, and non-teaching status were associated with lack of round-the-clock care. Inconsistent surgeon coverage was the primary reason for lacking round-the-clock EGS care (n=162; 58.1%). However, lack of a tiered system for booking emergency cases, no anesthesia availability overnight, and no stipend for EGS call were also associated with the inability to provide round-the-clock EGS care. Discussion We found significant gaps in access to EGS care, often attributable to workforce deficiencies.

To examine national adherence to emergency general surgery (EGS) best practices.There is a national crisis in access to high-quality care for general surgery emergencies. Acute care surgery (ACS), a specialty leveraging strengths of trauma systems, may ameliorate this crisis. A critical component of trauma care is adherence to clinical guidelines. We previously established best practices for EGS using RAND Appropriateness Methodology and pilot data.A hybrid (postal/electronic) questionnaire measuring adherence to 20 EGS best practices was administered to respondents overseeing EGS at all eligible adult acute care general hospitals across the US (N = 2811). Questionnaire responses were analyzed using bivariate methods and multiple logistic regression.The response rate was 60.1%. Adherence ranged from 8.5% for having an EGS registry to 86.2% for auditing 30-day postoperative readmissions. Adherence was higher for practices not restricted to EGS (eg, auditing readmissions) compared to EGS-specific practices (eg, registry, activation system). Adopting an ACS model of care increased adherence to practices for deferring elective cases; tiering urgent operations; following National Comprehensive Cancer Network guidelines; reversing anticoagulants; auditing returns to intensive care, time to evaluation, time to operation, and time to source control; and having transfer agreements to receive patients, ICU admission protocols, as well as EGS-specific activation systems, outpatient clinics, morbidity and mortality conferences, and registries.There is substantial room for performance improvement, and adopting an ACS model predicts better performance. This novel overview of adherence to EGS best practices will enable surgeons and policymakers to address variations in EGS care nationally.

Background An association between lack of insurance and inferior outcomes has been well described for a number of surgical emergencies, yet little is known about the relationship of payor status and outcomes of patients undergoing emergent surgical repair for upper gastrointestinal (UGI) perforations. We evaluated the association of payor status and in-hospital mortality for patients undergoing emergency surgery for UGI perforations in the United States. Methods Nationwide Inpatient Sample (NIS) was queried to identify patients between 18 and 64 years of age who underwent emergent (open or laparoscopic) repair for UGI perforations secondary to peptic ulcer disease (2010–2014). Primary outcome was in-hospital mortality. Secondary outcomes were major and minor postoperative complications. The main predictor outcome was insurance status (Private, Medicaid, Uninsured). Univariate and multivariable regression analyses were performed. Data were weighted to provide national estimates. Results 21,005 patients underwent surgical repair for UGI perforations. Patients with private insurance represented the largest payor group (47%). After adjustment of other factors, payor status was not a statistically significant predictor of in-hospital mortality (Medicaid vs. Private: [OR] 1.1; 95% [CI] 0.67–1.81; Uninsured vs. Private: OR 0.9, 95% CI 0.52–1.61). However, payor status remained a statistically significant predictor of major postoperative complications (Medicaid vs. Private [OR] 1.4; 95% CI 1.1, 1.8; Uninsured vs. Private [OR]1.2, 95% CI 0.9, 1.5) and minor postoperative complications (Medicaid vs. Private [OR] 1.4; 95% CI 1.1, 1.9; Uninsured vs. Private [OR]1.2, 95% CI 0.9, 1.6). Conclusions Emergency surgery for UGI perforations is associated with high mortality and morbidity across all payor classes; however, Medicaid is a predictor for both major and minor postoperative complications. Preventing perforation through preventative measures will be key to reducing the burden of peptic ulcer disease across all populations.

BACKGROUND Acute appendicitis is the most common indication for emergency general surgery (EGS) in the United States. We examined the role of acute care surgery (ACS) on interventions and outcomes for acute appendicitis at a national sample of university-affiliated hospitals. METHODS We surveyed senior surgeons responsible for EGS coverage at University HealthSystems Consortium hospitals, representing more than 90% of university-affiliated hospitals in the United States. The survey elicited data on resources allocated for EGS during 2013. Responses were linked to University HealthSystems Consortium outcomes data by unique hospital identifiers. Patients treated at hospitals reporting hybrid models for EGS coverage were excluded. Differences in interventions and outcomes between patients with acute appendicitis treated at ACS hospitals versus hospitals with a general surgeon on-call model (GSOC) were analyzed using univariate comparisons and multivariable logistic regression models adjusted for patient demographics, clinical acuity, and hospital characteristics. RESULTS We found 122 hospitals meeting criteria for analysis where 2,565 patients were treated for acute appendicitis. Forty-eight percent of hospitals had an ACS model (n = 1,414), and 52% had a GSOC model (n = 1,151). Hospitals with ACS models were more likely to treat minority patients than those with GSOC models. Patients treated at ACS hospitals were more likely to undergo laparoscopic appendectomy. In multivariable modeling of patients who had surgery (n = 2,258), patients treated at ACS hospitals had 1.86 (95% confidence interval, 1.23-2.80) greater odds of undergoing laparoscopic appendectomy. CONCLUSION In an era when laparoscopic appendectomy is increasingly accepted for treating uncomplicated acute appendicitis, particularly in low-risk patients, it is concerning that patients treated at GSOC model hospitals are more likely to undergo traditional open surgery at the time of presentation. Furthermore, hospitals with ACS are functioning as safety-net hospitals for vulnerable patients with acute appendicitis. LEVEL OF EVIDENCE Therapeutic study, level IV.

Background Acute care surgery (ACS) was proposed to improve emergency general surgery (EGS) care; however, the extent of ACS model adoption in the United States is unknown. A national survey was conducted to ascertain factors associated with variations in EGS models of care, with particular focus on ACS use. Methods A hybrid mail/electronic survey was sent in 2015 to 2,811 acute care hospitals with an emergency room and an operating room. If a respondent indicated that the approach to EGS was a dedicated clinical team whose scope encompasses EGS (± trauma, ± elective general surgery, ± burns), the hospital was considered an ACS hospital. Results Survey response was 60.1% (n = 1,690); 272 (16.1%) of these hospitals reported having used an ACS model of care for EGS patients. Teaching status and general hospital practices (for example, interventional radiology available within one hour) were associated with ACS use. In bivariate analyses, ACS use was associated with many EGS–specific practices (40.1% of ACS hospitals freed their surgeons of daytime clinical responsibilities after operating overnight vs. 4.7% of general surgeon on call (GSOC) hospitals; p Conclusion There are wide variations in EGS practices in the United States, with use of an ACS model of care being relatively low despite reported benefits of ACS models of care on EGS access, quality, and costs. Hospital factors associated with using ACS models are overall size and higher level of existing resources. These findings could be applied to the development of centers of excellence for EGS care.

Importance Owing to lack of adequate emergency care infrastructure and decline in general surgery workforce, the United States faces a crisis in access to emergency general surgery (EGS) care. Acute care surgery (ACS), an organized system of trauma, general surgery, and critical care, is a proposed solution; however, ACS diffusion remains poorly understood. Objective To investigate geographic diffusion of ACS models of care and characterize the communities in which ACS implementation is lagging. Design, Setting, and Participants A national survey on EGS practices was developed, tested, and administered at all 2811 US acute care hospitals providing EGS to adults between August 2015 and October 2015. Surgeons responsible for EGS coverage at these hospitals were approached. If these surgeons failed to respond to the initial survey implementation, secondary surgeons or chief medical officers at hospitals with only 1 general surgeon were approached. Interventions Survey responses on ACS implementation were linked with geocoded hospital data and national census data to determine geographic diffusion of and access to ACS. Main Outcomes and Measures We measured the distribution of hospitals with ACS models of care vs those without over time (diffusion) and by US counties characterized by sociodemographic characteristics of county residents (access). Results Survey response rate was 60% (n = 1690); 272 responding hospitals had implemented ACS by 2015, steadily increasing from 34 in 2001 to 125 in 2010. Acute care surgery implementation has not been uniform. Rural regions have limited ACS access, with hospitals in counties with greater than the 75th percentile population having 5.4 times higher odds (95% CI, 1.66-7.35) of implementing ACS than hospitals in counties with less than 25th percentile population. Communities with greater percentages of adults without a college degree also have limited ACS access (OR, 3.43; 95% CI, 1.81-6.48). However, incorporating EGS into ACS models may be a potential equalizer for poor, black, and Hispanic communities. Conclusions and Relevance Understanding and addressing gaps in ACS implementation across communities will be crucial to ensuring health equity for US residents experiencing general surgery emergencies.

BACKGROUND: C. difficile (CDI) has surpassed methicillin-resistant staph aureus as the most common nosocomial infection with recurrence reaching 30% and the elderly being disproportionately affected. We hypothesized that post-discharge antibiotic therapy for continued CDI treatment reduces readmissions. STUDY DESIGN: We queried a 5% random sample of Medicare claims (2009–2011 Part A and Part D; n = 864,604) for hospitalizations with primary or secondary diagnosis of CDI. We compared demographics, comorbidities, and post-discharge CDI treatment (no CDI treatment, oral metronidazole only, oral vancomycin only, or both) between patients readmitted with a primary diagnosis of CDI within 90 days and patients not readmitted for any reason using univariate tests of association and multivariable models. RESULTS: Of 7042 patients discharged alive, 945 were readmitted ≤90 days with CDI (13%), while 1953 were not readmitted for any reason (28%). Patients discharged on dual therapy had the highest rates of readmission (50%), followed by no post-discharge CDI treatment (43%), vancomycin only (28%), and metronidazole only (19%). Patients discharged on only metronidazole (OR 0.28) or only vancomycin (OR 0.42) had reduced odds of 90-day readmission compared to patients discharged on no CDI treatment. Patients discharged on dual therapy did not vary in odds of readmission. CONCLUSIONS: Thirteen percent of patients discharged with CDI are readmitted within 90 days. Patients discharged with single-drug therapy for CDI had lower readmission rates compared to patients discharged on no ongoing CDI treatment suggesting that short-term monotherapy may be beneficial in inducing eradication and preventing relapse. Half of patients requiring dual therapy required readmission, suggesting patients with symptoms severe enough to warrant discharge on dual therapy may benefit from longer hospitalization.

Background As fewer surgeons take emergency general surgery call and hospitals decrease emergency services, a crisis in access looms in the United States. We examined national emergency general surgery capacity and county-level determinants of access to emergency general surgery care with special attention to disparities. Methods To identify potential emergency general surgery hospitals, we queried the database of the American Hospital Association for “acute care general hospital,” with “surgical services,” and “emergency department,” and ≥1 “operating room.” Internet search and direct contact confirmed emergency general surgery services that covered the emergency room 7 days a week, 24 hours a day. Geographic and population-level emergency general surgery access was derived from Geographic Information Systems and US Census. Results Of the 6,356 hospitals in the 2013 American Hospital Association database, only 2,811 were emergency general surgery hospitals. Counties with greater percentages of black, Hispanic, uninsured, and low-education individuals and rural counties disproportionately lacked access to emergency general surgery care. For example, counties above the 75th percentile of African American population (10.2%) had >80% odds of not having an emergency general surgery hospital compared with counties below the 25th percentile of African American population (0.6%). Conclusion Gaps in access to emergency general surgery services exist across the United States, disproportionately affecting underserved, rural communities. Policy initiatives need to increase emergency general surgery capacity nationwide.

Rates of Clostridium difficile (CD) infections are increasing. Elderly patients may be at particular risk of recurrent CD infection. Little is known about the risk for CD readmission specifically in this age group.A 5% random sample of Medicare data (2009-2011) was queried for patients surviving a hospitalization for CD by ICD-9 code. Demographic (age, sex, gender), clinical (Elixhauser index, gastrointestinal comorbidities), and hospitalization (length of stay, ICU admission) characteristics as well as exposure to antibiotics and interim non-CD hospitalization were compared for those with and without a readmission for CD. A multivariable survival analysis was used to determine predictors of readmission.Of 7,564 patients surviving a CD hospitalization, 8.5% were readmitted with CD in a median of 25 days (interquartile range (IQR) 14-57). In multivariable survival analyses, interim non-CD hospital exposure was the strongest predictor of CD readmission (hazard ration (HR) 3.75 95%, confidence interval (CI) 3.2-4.42). Oral and intravenous/intramuscular (IV/IM) antibiotic use, Elixhauser index, and CD as the primary diagnosis also increased the risk of CD readmission. Discharge to hospice, long-term care or a skilled nursing facility decreased the odds of CD readmission.Hospital exposure and antibiotic use put elderly patients at risk of CD readmission. Exposure to these factors should be minimized in the immediate post discharge period.

Objective:To identify predictors associated with survival in civilian penetrating traumatic brain injury (pTBI) utilizing a contemporary, large, diverse 2-center cohort, and to develop a parsimonious survival prediction score for pTBI.Methods:Our cohort comprised 413 pTBI patients retrospectively identified from the local trauma registries at 2 US level 1 trauma centers, of which one was predominantly urban and the other predominantly rural. Predictors of in-hospital and 6-month survival identified in univariate and multivariable logistic regression were used to develop the simple Surviving Penetrating Injury to the Brain (SPIN) score.Results:The mean age was 33 ± 16 years and patients were predominantly male (87%). Survival at hospital discharge as well as 6 months post pTBI was 42.4%. Higher motor Glasgow Coma Scale subscore, pupillary reactivity, lack of self-inflicted injury, transfer from other hospital, female sex, lower Injury Severity Score, and lower international normalized ratio were independently associated with survival (all p < 0.001; model area under the curve 0.962). Important radiologic factors associated with survival were also identified but their addition to the full multivariable would have resulted in model overfitting without much gain in the area under the curve.Conclusions:The SPIN score, a logistic regression–based clinical risk stratification scale estimating survival after pTBI, was developed in this large, diverse 2-center cohort. While this preliminary clinical survival prediction tool does not include radiologic factors, it may support clinical decision-making after civilian pTBI if external validation confirms the probability estimates.

To date, no studies have reported nationwide adoption of acute care surgery (ACS) or identified structural and/or process variations for the care of emergency general surgery (EGS) patients within such models.We surveyed surgeons responsible for EGS coverage at University Health Systems Consortium hospitals using an eight-page postal/e-mail questionnaire querying respondents on hospital and EGS structure/process measures. Survey responses were analyzed using descriptive statistics, univariate comparisons, and multivariable regression models.Of 319 potential respondents, 258 (81%) completed the surveys. A total of 81 hospitals (31%) had implemented ACS, while 134 (52%) had a traditional general surgeon on-call (GSOC) model. Thirty-eight hospitals (15%) had another model (hybrid). Larger-bed, university-based, teaching hospitals with Level 1 trauma center verification status located in urban areas were more likely to have adopted ACS. In multivariable modeling, hospital type, setting, and trauma center verification predicted ACS implementation. EGS processes of care varied, with 28% of the GSOC hospitals having block time versus 67% of the ACS hospitals (p0.0001), 45% of the GSOC hospitals providing ICU [intensive care unit] care to EGS patients in a surgical/trauma ICU versus 93% of the ACS hospitals (p0.0001), 5.7 ± 3.2 surgeons sharing call at GSOC hospitals versus 7.9 ± 2.3 surgeons at ACS hospitals (p0.0001), and 13% of the GSOC hospitals requiring in-house EGS call versus 75% of the ACS hospitals (p0.0001). Among ACS hospitals, there were variations in patient cohorting (EGS patients alone, 25%; EGS + trauma, 21%; EGS + elective, 17%; and EGS + trauma + elective, 30%), data collection (26% had prospective EGS registries), patient hand-offs (56% had attending surgeon presence), and call responsibilities (averaging 4.8 ± 1.3 calls per month, with 60% providing extra call stipend and 40% with no postcall clinical duties).The potential of the ACS on the national crisis in access to EGS care is not fully met. Variations in EGS processes of care among adopters of ACS suggest that standardized criteria for ACS implementation, much like trauma center verification criteria, may be beneficial.

Background The incidence of community-acquired Clostridium difficile (CACD) is increasing in the United States. Many CACD infections occur in the elderly, who are predisposed to poor outcomes. We aimed to describe the epidemiology and outcomes of CACD in a nationally representative sample of Medicare beneficiaries. Study Design We queried a 5% random sample of Medicare beneficiaries (2009−2011 Part A inpatient and Part D prescription drug claims; n = 864,604) for any hospital admission with a primary ICD-9 diagnosis code for C difficile (008.45). We examined patient sociodemographic and clinical characteristics, preadmission exposure to oral antibiotics, earlier treatment with oral vancomycin or metronidazole, inpatient outcomes (eg, colectomy, ICU stay, length of stay, mortality), and subsequent admissions for C difficile . Results A total of 1,566 (0.18%) patients were admitted with CACD. Of these, 889 (56.8%) received oral antibiotics within 90 days of admission. Few were being treated with oral metronidazole (n = 123 [7.8%]) or vancomycin (n = 13 [0.8%]) at the time of admission. Although 223 (14%) patients required ICU admission, few (n = 15 [1%]) underwent colectomy. Hospital mortality was 9%. Median length of stay among survivors was 5 days (interquartile range 3 to 8 days). One fifth of survivors were readmitted with C difficile , with a median follow-up time of 393 days (interquartile range 129 to 769 days). Conclusions Nearly half of the Medicare beneficiaries admitted with CACD have no recent antibiotic exposure. High mortality and readmission rates suggest that the burden of C difficile on patients and the health care system will increase as the US population ages. Additional efforts at primary prevention and eradication might be warranted.