The ethical perspectives of using animals in pediatric health.

While there are ethical standards for human biomedical research, animals have historically not benefitted from the same levels of protection. Cultural shifts in response to studies demonstrating animal capacity to suffer have resulted in laws defining minimum ethical standards for the treatment of various animal populations. However, none of these pertain to service or therapy animals nor do they define ethical considerations regarding training, placement, environment, and duty limitations specific to this population. The potential for harm and inability to provide consent should raise ethical questions of animal assisted interventions (AAI), including how to best balance the risk: benefit ratio for both animal and human participants. While service animals have specific definitions, therapy and emotional support animals are much less clearly defined and therefore have far less standardized practices regarding their training, certification, and process for matching to handlers. This can lead to animals being inadequately trained to cope with the stresses of their jobs or being placed in incompatible environments. Meanwhile, service animals' duties are constant, and the animal has little ability to consent to or withdraw from participation, leading to overwork, without the opportunity to engage in activities that align with the animals' natural preferences. Emotional support animals are the least defined of these populations, receive no formal training, and are at increased risk of inadequate care, unstable housing, and abuse from handlers who may also be poorly prepared to properly handle their needs. To uphold our moral obligations to the animals that serve to improve our own mental wellness and physical independence, urgent actions are needed to improve the protections in place for these populations.

Connect: Cultivating Academic-Community Partnerships to Address Our Communities' Complex Needs During Public Health Crises.

BACKGROUND: Black and Latino communities have been disproportionately impacted by coronavirus disease 2019 and we sought to understand perceptions and attitudes in four heavily impacted New Jersey counties to develop and evaluate engagement strategies to enhance access to testing. OBJECTIVE: To establish a successful academic/community partnership team during a public health emergency by building upon longstanding relationships and using principles from community engaged research. METHODS: We present a case study illustrating multiple levels of engagement, showing how we successfully aligned expectations, developed a commitment of cooperation, and implemented a research study, with community-based and health care organizations at the center of community engagement and recruitment. LESSONS LEARNED: This paper describes successful approaches to relationship building including information sharing and feedback to foster reciprocity, diverse dissemination strategies to enhance engagement, and intergenerational interaction to ensure sustainability. CONCLUSIONS: This model demonstrates how academic/community partnerships can work together during public health emergencies to develop sustainable relationships.

Impact of COVID-19 Pandemic on Management and Outcomes of Acute Cholecystitis at US Academic Centers.

BACKGROUND: The COVID-19 pandemic has had wide-ranging effects on management of medical conditions. Many hospitals encountered staffing shortages, limited operating room availability, and shortage of hospital beds. There was increased psychological stress and fear of contracting COVID-19 infection, leading to delay in medical care for various disease processes. The objective of this study was to examine changes in management and outcomes attributed to the COVID-19 pandemic in patients presenting with acute calculus cholecystitis at US academic centers. STUDY DESIGN: Using the Vizient database, patients with the diagnosis of acute calculus cholecystitis who underwent intervention during the 15 months before the pandemic (prepandemic, October 2018 to December 2019) were compared with 15 months during the pandemic (pandemic, March 2020 to May 2021). Outcomes measures included demographics, characteristics, type of intervention, length of stay, in-hospital mortality, and direct cost. RESULTS: There were 146,459 patients with acute calculus cholecystitis identified (prepandemic: 74,605 vs pandemic: 71,854). Patients in the pandemic group were more likely to undergo medical management (29.4% vs 31.8%; p < 0.001) or percutaneous cholecystostomy tube placement (21.5% vs 18%; p < 0.001) and less likely to undergo laparoscopic cholecystectomy (69.8% vs 73.0%; p < 0.001). Patients in the pandemic group who underwent procedural intervention had longer length of stay (6.5 days vs 5.9 days; p < 0.001), higher in-hospital death (3.1% vs 2.3%; p < 0.001), and higher cost ($14,609 vs $12,570; p < 0.001). CONCLUSIONS: In this analysis of patients with acute calculus cholecystitis, there were distinct changes in the management and outcomes of patients due to the COVID-19 pandemic. Changes in the type of intervention and outcomes are likely related to delayed presentation with increases in the severity and complexity of the disease.

Readmission and Disposition in Patients With Malignant Bowel Obstructions Following Gastrostomy Tube.

BACKGROUND: Patients with peritoneal carcinomatosis (PC) can develop malignant bowel obstructions (MBOs) requiring inpatient admission and nasogastric tube decompression. Palliative decompressive gastrostomy tubes (G-tubes) may affect patient disposition, allowing for self-management and reduction in inpatient services. Therefore, we sought to assess disposition and inpatient readmission rates in patients admitted with PC and MBO following G-tube placement. METHODS: The Vizient® Clinical Data Base was queried for inpatient admissions from October 2018 to May 2022 utilizing ICD-10 codes to identify patients admitted with PC and bowel obstruction, with or without G-tube placement. Demographics and hospital outcomes were recorded. Descriptive statistics and multivariate logistic regression analysis were performed. RESULTS: From 750 patients, 59 (7.9%) had a G-tube placed. Compared to patients without G-tubes, those with G-tubes had lower rates of disposition to home (32.2% vs 70.0%, P < .001) and higher rates of disposition to hospice (home: 30.5% vs 7.8%, P < .001, facility: 10.2% vs 3.9%, P = .02). There was no significant difference in the rate (17.3% vs 22.3%, P = .40) or risk (OR = 1.44, 95% CI .69-3.01) of 30-day readmissions with G-tubes. However, palliative care consultation (OR 33.77, 95% CI 19.16-59.52) and G-tube placement (OR 5.82, 95% CI 2.56-13.25) were independent predictors for hospice. DISCUSSION: Placement of G-tubes in patients with PC and MBO was associated with higher rates of disposition to hospice but there is no difference in 30-day readmission rates compared to those without G-tubes. Further prospective studies are needed to understand the role of G-tube placement in patients with MBO in relation to outcomes and disposition.

Confusion and anxiety in between abnormal cervical cancer screening results and colposcopy: "The land of the unknown".

OBJECTIVE: Attendance to colposcopy after abnormal cervical cancer screening is essential to cervical cancer prevention. This qualitative study explored patients' understanding of screening results, their experiences of the time leading up to the colposcopy appointment, and colposcopy. METHODS: We recruited women referred for colposcopy from two urban practices in an academic health system. Individual interviews (N = 15) with participants were conducted after colposcopy appointments about their cervical cancer screening histories, current results, and colposcopy experiences. A team analyzed and summarized interviews and coded transcripts in Atlas.ti. RESULTS: We found that most women were confused about their screening results, did not know what a colposcopy was before being referred for one, and experienced anxiety in the interval between receiving their results and having their colposcopy. Most women searched for information online, but found "misinformation," "worst-case scenarios" and generic information that did not resolve their confusion. CONCLUSION: Women had little understanding of their cervical cancer risk and experienced anxiety looking for information and waiting for the colposcopy. Educating patients about cervical precancer and colposcopy, providing tailored information about their abnormal screening test results and potential next steps, and helping women manage distress may alleviate uncertainty while waiting for follow-up appointments. PRACTICE IMPLICATIONS: Interventions to manage uncertainty and distress in the interval between receiving an abnormal screening test result and attending colposcopy are needed, even among highly adherent patients.

Plasma Exosome Gene Signature Differentiates Colon Cancer from Healthy Controls.

BACKGROUND: Liquid biopsies have become an integral part of cancer management as minimally invasive options to detect molecular and genetic changes. However, current options show poor sensitivity in peritoneal carcinomatosis (PC). Novel exosome-based liquid biopsies may provide critical information on these challenging tumors. In this initial feasibility analysis, we identified an exosome gene signature of 445 genes (ExoSig445) from colon cancer patients, including those with PC, that is distinct from healthy controls. METHODS: Plasma exosomes from 42 patients with metastatic and non-metastatic colon cancer and 10 healthy controls were isolated and verified. RNAseq analysis of exosomal RNA was performed and differentially expressed genes (DEGs) were identified by the DESeq2 algorithm. The ability of RNA transcripts to discriminate control and cancer cases was assessed by principal component analysis (PCA) and Bayesian compound covariate predictor classification. An exosomal gene signature was compared with tumor expression profiles of The Cancer Genome Atlas. RESULTS: Unsupervised PCA using exosomal genes with greatest expression variance showed stark separation between controls and patient samples. Using separate training and test sets, gene classifiers were constructed capable of discriminating control and patient samples with 100% accuracy. Using a stringent statistical threshold, 445 DEGs fully delineated control from cancer samples. Furthermore, 58 of these exosomal DEGs were found to be overexpressed in colon tumors. CONCLUSIONS: Plasma exosomal RNAs can robustly discriminate colon cancer patients, including patients with PC, from healthy controls. ExoSig445 can potentially be developed as a highly sensitive liquid biopsy test in colon cancer.

The Five-4-Life Quality Improvement Program: Improving Frontline Nurses' Cardiopulmonary Resuscitation Leadership and Team Management Skills.

BACKGROUND: Poor leadership and teamwork in cardiopulmonary resuscitation (CPR) are associated with poor patient outcomes. PROBLEM: Frontline nursing staff frequently identify patients in cardiac arrest but may not have the initial leadership and teamwork skills to organize their initial rescue response. APPROACH: The Five-4-Life Quality Improvement (QI) program was pilot tested in a pediatric unit within a 510-bed acute care hospital in 2 phases: first, an educational program focused on leadership, team dynamics, and CPR skills, followed by sustaining interventions in the unit. Video recordings of 12 mock codes (4 pre-, 4 post-, 4 follow-up) were analyzed by trained observers. OUTCOMES: Descriptive statistical tests indicated a significant improvement in leadership, teamwork, and task management scores pre- and post-program, and sustained after the program. CONCLUSION: Implementing the Five-4-Life QI program is feasible in improving leadership, teamwork, and task management of first responding frontline nurses.

Circulating Tumor DNA is Unreliable to Detect Somatic Gene Alterations in Gastrointestinal Peritoneal Carcinomatosis.

INTRODUCTION: Tumor agnostic circulating tumor DNA (ctDNA) is routinely used to guide treatment decisions in gastrointestinal (GI) cancers, especially metastatic cancers. The amount of ctDNA detected in plasma is affected by stage, tumor burden, and tumor vascularization. We hypothesized that peritoneal carcinomatosis (PC) is associated with lower ctDNA levels than other metastatic sites in GI cancers due to the plasma-peritoneal barrier. METHODS: We conducted a retrospective analysis of patients with stage II-IV GI cancers treated at our institution between 2015 and 2020 with available panel-based ctDNA results (Guardant 360TM). ctDNA analysis was performed on early and pretreatment samples. We compared the reported maximum variant allele frequency (mVAF) of somatic mutations across metastatic sites. RESULTS: Of the 279 patients with GI cancers (colorectal, upper GI, pancreaticobiliary), 212 had stage IV disease (PC: n = 61; visceral metastases: n = 138; other metastases: n = 13). Mean mVAF increased with increasing stages of disease (stage II: 3.6 ± 7; stage III: 6.4 ± 10; stage IV: 28.0 ± 51; p < 0.01). Among patients with stage IV disease, PC was associated with lower ctDNA levels independent of primary tumor site (PC only: 12.1%; PC+ visceral metastases: 26.8%; and visceral metastases only: 35.0%; p < 0.01). In a subset of patients (n = 27, matched pair analysis of genomic alterations (GAs) showed fewer GAs were detected in plasma compared with tissue. CONCLUSIONS: PC of GI origin is associated with significantly lower ctDNA levels compared with visceral metastasis. Caution is warranted when interpreting ctDNA results from patients with PC due to lower sensitivity for detecting actionable mutations.

Assessment of Medical Industry Compensation to US Physicians by Gender.

Importance: It has been well established that female physicians earn less than their male counterparts in all specialties and ranks despite controlling for confounding variables. Objective: To investigate payments made from highest-grossing medical industry companies to female and male physicians and to assess compensation and engagement disparities based on gender. Design, Setting, and Participants: This retrospective, population-based cross-sectional study used data from the Open Payments database for the 5 female and 5 male physicians who received the most financial compensation from each of the 15 highest-grossing medical supply companies in the US from January 2013 to January 2019. Main Outcomes and Measures: The primary outcome was total general payments received by female and male physicians from medical industry over time and across industries. The secondary outcome was trends in industry payment to female and male physicians from 2013 to 2019. Results: Among the 1050 payments sampled, 1017 (96.9%) of the 5 highest earners were men and 33 (3.1%) were women. Female physicians were paid a mean (SD) of $41 320 ($88 695), and male physicians were paid a mean (SD) of $1 226 377 ($3 377 957) (P < .001). On multivariate analysis, male gender was significantly associated with higher payment after adjusting for rank, h-index, and specialty (mean [SD], $1 025 413 [$162 578]; P < .001). From 2013 to 2019, the payment gap between female and male physicians increased from $54 343 to $166 778 (P < .001). Conclusions and Relevance: This study found that male physicians received significantly higher payments from the highest-grossing medical industry companies compared with female physicians. This disparity persisted across all medical specialties and academic ranks. The health care industry gender payment gap continued to increase from 2013 to 2019, with a wider compensation gap in 2019.

Prevalence of Primary Liver Cancer is Affected by Place of Birth in Hispanic People Residing in the United States: All of Us Research Program Report.

BACKGROUND: Hispanic individuals have a disproportionately higher incidence and mortality for stomach, cervix, and liver cancers compared to Non-Hispanic White people. Since disparities in cancer incidence are influenced by multiple factors including immigration, elucidating the effect of birthplace and exposure to risk factors on the prevalence of these cancers is crucial for identifying high-risk populations and target risk reduction interventions. METHODS: The National Institutes of Health All of Us Research Program is a prospective, multidimensional biomedical data resource of underrepresented, minoritized people. The Registered Tier Dataset v5 was utilized to evaluate the prevalence and risk of stomach, cervix, and liver cancers among United States (US) born and non-US born Hispanic participants. RESULTS: Of over 434 000 current participants, 60 540 are Hispanic; 30 803 (50.9%) reported being US born and 29 294 (48.4%) non-US born. Non-US born Hispanic participants had significantly higher prevalence (.39% vs .21%, P < .001) and associated risk (OR 1.84, 95% CI 1.29-2.64, P < .001) of liver cancer, and trend towards higher prevalence of stomach (.14% vs .09%, P = .076) and cervix cancers (.27% vs .20%, P = .083) compared to US born counterparts. US born Hispanic patients with these 3 cancers were significantly younger than non-US born cohort (mean age 56.8 vs 61.7 years, P < .001). DISCUSSION: This is the first report using All of Us data to show that non-US born Hispanic participants have a higher risk of liver cancer compared to US born participants. Further analyses, including genomic studies, are necessary to understand these differences and identify targets for risk reduction interventions.

Surgical Outcome in Laparoscopic Abdominal Surgical Operations with Clostridium Difficile Infection.

Introduction: Postoperative Clostridium difficile infection (CDI) has associated morbidity, but it is unknown how it impacts different operations. We sought to determine the incidence and postoperative morbidity following abdominal surgery.Method: The National Surgical Quality Improvement Program database (2015-2019) was utilized to evaluate adult (≥18 years-old) patients who developed CDI following laparoscopic abdominal operations. Univariate and multivariate analysis were performed to evaluate outcomes.Results: A total of 973 338 patients were studied and the overall incidence of CDI was .3% within 30 days of operation. Colorectal surgery had the highest incidence of CDI (1601/167 949,1.0%) with significantly longer mean length of stay (LOS) (8.0 days± 9.0, P < .01) compared to other surgical procedures. CDI patients also had a longer mean length of stay (6.6± 8.0 vs 2.1 ± 3.6 days, P < .01) and increased mortality (1.8% vs .2%, AOR: 4.64, CI: 3.45-5.67, P < .01) compared to patients without CDI.Conclusions: This national analysis demonstrates that CDI is a significant complication following abdominal surgery and is associated with increased LOS and mortality. Furthermore, laparoscopic colorectal surgery appears to have the greatest risk of CDI. Future research is needed to determine the exact cause in order to decrease the incidence of CDI by reconsidering the protocol of antibiotic use within the high-risk population.

Conflict of Interest Disclosure Among the Highest Earning Physicians Receiving Compensation From Vascular Device Companies.

OBJECTIVE: To characterize the association between payments made by vascular device companies to clinicians, and the conflict of interest (COI) declarations on relevant publications. SUMMARY BACKGROUND DATA: Close association between medical device companies and clinicians is essential in the advancement of surgical technology. When evaluating the efficacy of novel equipment, identification of these relationships can minimize the risk of bias in relevant studies. METHODS: Using the Open Payments Database (OPD), the 10 highest compensated clinicians from 10 vascular device companies were identified. In the population based bibliometric analysis, general payments, number of payments, h-index, and academic rank were identified. PubMed and Scopus were queried to identify author publications. Relevance to payment received and COI disclosures were identified for each article. RESULTS: The physicians identified earned $33,442,266.74 with a median of $92,500 in 2017. The authors published an average of 6.46+/-9.08 articles in 2018. Relevant COI was identified in 74%. In 50.5% of the relevant publications was a COI declared. The median h index of authors was 18+/-23. Community based physicians had a higher rate of COI disclosure (65.6%) compared to academic physicians (47.6%) (P = .008). Low h-index authors had a higher rate of COI declaration (71.4%) compared to high h-index (43.6%) (P = .001). CONCLUSION: A high degree of inconsistency was found between self-declared COI and relevant articles published by the highest compensated physicians. We propose a policy of full disclosure and the addition of a link to each author's OPD page on all publications to increase access to potential COI.

Comparison of Same and Different Level Height Falls on Subsequent Midline Shift in Pediatric Traumatic Brain Injury.

OBJECTIVES: Up to 44% of pediatric traumatic brain injury occurs as a result of a fall. We hypothesized that a fall from height is associated with higher risk for subsequent midline shift in pediatric traumatic brain injury compared with a fall from same level. METHODS: The Pediatric Trauma Quality Improvement Program 2016 was queried for kids younger than 16 years with an injury in the abbreviated injury scale for the head after a fall. Patients with midline shift were identified. A logistic regression model was used for analysis. RESULTS: The risk of a midline shift was lower in those with a fall from a height (odds ratio, 0.64; 95% confidence interval, 0.46-0.91, P = 0.01). In kids older than 4 years, there was no association between the level of height of the fall and subsequent midline shift (P = 0.62). The risk for midline shift in kids younger than 4 years after a fall from same level was lower (odds ratio, 0.40; 95% confidence interval, 0.24-0.67; P = 0.001). CONCLUSIONS: In kids with traumatic brain injury, trauma activations due to falls from the same level are associated with a 2.5-fold higher risk of subsequent midline shift, compared with falling from height.

Experiences of Black and Latinx health care workers in support roles during the COVID-19 pandemic: A qualitative study.

Black and Latinx individuals, and in particular women, comprise an essential health care workforce often serving in support roles such as nursing assistants and dietary service staff. Compared to physicians and nurses, they are underpaid and potentially undervalued, yet play a critical role in health systems. This study examined the impact of the coronavirus disease 2019 (COVID-19) pandemic from the perspective of Black and Latinx health care workers in support roles (referred to here as HCWs). From December 2020 to February 2021, we conducted 2 group interviews (n = 9, 1 group in English and 1 group in Spanish language) and 8 individual interviews (1 in Spanish and 7 in English) with HCWs. Participants were members of a high-risk workforce as well as of communities that suffered disproportionately during the pandemic. Overall, they described disruptive changes in responsibilities and roles at work. These disruptions were intensified by the constant fear of contracting COVID-19 themselves and infecting their family members. HCWs with direct patient care responsibilities reported reduced opportunities for personal connection with patients. Perspectives on vaccines reportedly changed over time, and were influenced by peers' vaccination and information from trusted sources. The pandemic has exposed the stress endured by an essential workforce that plays a critical role in healthcare. As such, healthcare systems need to dedicate resources to improve the work conditions for this marginalized workforce including offering resources that support resilience. Overall working conditions and, wages must be largely improved to ensure their wellbeing and retain them in their roles to manage the next public health emergency. The role of HCWs serving as ambassadors to provide accurate information on COVID-19 and vaccination among their coworkers and communities also warrants further study.

User-Centered Development and Patient Acceptability Testing of a Health-Coaching Intervention to Enhance Cancer Survivorship Follow-up in Primary Care.

We describe an iterative three-phase approach used to develop a cancer survivorship health-coaching intervention to guide self-management and follow-up care for post-treatment breast, colorectal, and prostate cancer survivors. Informed by theory (e.g., Cognitive-Social Health Information Processing Model (C-SHIP)), relevant literature, and clinical guidelines, we engaged in a user-centered design process. In phase I, we conducted depth interviews with survivors of breast (n = 34), prostate (n = 4), and colorectal (n = 6) cancers to develop a health coaching prototype. In phase II, we utilized user-testing interviews (n = 9) to test and refine the health coaching prototype. For both phases, we used a template analysis independently coding each interview. In phase I, majority (n = 34, 81%) of survivors were positive about the utility of health coaching. Among these survivors (n = 34), the top areas of identified need were emotional support (44%), general health information (35.3%), changes in diet and exercise (29.3%), accountability and motivation (23.5%), and information about treatment effects (17.7%). The prototype was developed and user-tested and refined in phase III to address the following concerns: (1) the amount of time for calls, (2) density of reading materials, (3) clarity about health coaches' role, (4) customization. Collectively, this resulted in the development of the Extended Cancer Educational for Long-Term Cancer Survivors health-coaching (EXCELSHC) program, which represents the first cancer survivorship follow-up program to support follow-up care designed-for-dissemination in primary care settings. EXCELSHC is being tested in a clinical efficacy trial. Future research will focus on program refinement and testing for effectiveness in primary care.

Development and validation of machine learning models for the prediction of blunt cerebrovascular injury in children.

BACKGROUND: Blunt cerebrovascular injury (BCVI) is a rare finding in trauma patients. The previously validated BCVI (Denver and Memphis) prediction model in adult patients was shown to be inadequate as a screening option in injured children. We sought to improve the detection of BCVI by developing a prediction model specific to the pediatric population. METHODS: The National Trauma Databank (NTDB) was queried from 2007 to 2015. Test and training datasets of the total number of patients (885,100) with complete ICD data were used to build a random forest model predicting BCVI. All ICD features not used to define BCVI (2268) were included within the random forest model, a machine learning method. A random forest model of 1000 decision trees trying 7 variables at each node was applied to training data (50% of the dataset, 442,600 patients) and validated with test data in the remaining 50% of the dataset. In addition, Denver and Memphis model variables were re-validated and compared to our new model. RESULTS: A total of 885,100 pediatric patients were identified in the NTDB to have experienced blunt pediatric trauma, with 1,998 (0.2%) having a diagnosis of BCVI. Skull fractures (OR 1.004, 95% CI 1.003-1.004), extremity fractures (OR 1.001, 95% 1.0006-1.002), and vertebral injuries (OR 1.004, 95% CI 1.003-1.004) were associated with increased risk for BCVI. The BCVI prediction model identified 94.4% of BCVI patients and 76.1% of non-BCVI patients within the NTDB. This study identified ICD9/ICD10 codes with strong association to BCVI. The Denver and Memphis criteria were re-applied to NTDB data to compare validity and only correctly identified 13.4% of total BCVI patients and 99.1% of non BCVI patients. CONCLUSION: The prediction model developed in this study is able to better identify pediatric patients who should be screened with further imaging to identify BCVI. LEVEL OF EVIDENCE: Retrospective diagnostic study-level III evidence.