Human Epidemiology and Response to SARS-CoV-2 (HEROS): objectives, design, and enrollment results of a 12-city remote observational surveillance study of households with children, using direct-to-participant methods.

The Human Epidemiology and Response to SARS-CoV-2 (HEROS) Study is a prospective, multicity, 6-month incidence study conducted from May 2020 to February 2021. The objectives were to identify risk factors for SARS-CoV-2 infection and household transmission among children and people with asthma and allergic diseases, and to use the host nasal transcriptome sampled longitudinally to understand infection risk and sequelae at the molecular level. To overcome challenges of clinical study implementation due to the coronavirus pandemic, this surveillance study used direct-to-participant methods to remotely enroll and prospectively follow eligible children who are participants in other National Institutes of Health-funded pediatric research studies and their household members. Households participated in weekly surveys and biweekly nasal sampling regardless of symptoms. The aim of this report is to widely share the methods and study instruments and to describe the rationale, design, execution, logistics, and characteristics of a large, observational, household-based, remote cohort study of SARS-CoV-2 infection and transmission in households with children. The study enrolled a total of 5598 individuals, including 1913 principal participants (children), 1913 primary caregivers, 729 secondary caregivers, and 1043 other household children. This study was successfully implemented without necessitating any in-person research visits and provides an approach for rapid execution of clinical research. Trial registration: ClinicalTrials.gov. Identifier: NCT04375761.

Prospective study of an amino acid-based elemental diet in an eosinophilic gastritis and gastroenteritis nutrition trial.

BACKGROUND: Eosinophilic gastritis/gastroenteritis (EoG/EoGE) are rare disorders with pathologic gastric and/or small intestinal eosinophilia lacking an approved therapy. An allergic mechanism is postulated but underexplored mechanistically and therapeutically. OBJECTIVE: We evaluated the effectiveness of a food allergen-free diet (elemental formula) in controlling gastrointestinal eosinophilia in adult EoG/EoGE. METHODS: Adults aged 18 to 65 years with histologically active EoG/EoGE (≥30 eosinophils per high-power field) in the stomach and/or duodenum and gastrointestinal symptoms within the month preceding enrollment were prospectively enrolled onto a single-arm clinical trial to receive elemental formula for 6 consecutive weeks. The primary end point was percentage of participants with complete histologic remission (<30 eosinophils per high-power field in both stomach and duodenum). Exploratory outcomes were improvement in symptoms, endoscopy results, blood eosinophilia, quality of life, Physician Global Assessment score, and EoG-relevant gastric transcriptome and microbiome. RESULTS: Fifteen adults (47% male, average age 37.7 years, average symptom duration 8.8 years) completed the trial. Multi-gastrointestinal segment involvement affected 87%. All subjects had complete histologic remission in the stomach (P = .002) and duodenum (P = .001). Scores improved in overall PhGA (P = .002); EGREFS (P = .003); EGDP (P = .002); SODA pain intensity (P = .044), non-pain (P = .039), and satisfaction (P = .0024); and PROMIS depression (P = .0078) and fatigue (P = .04). Food reintroduction reversed these improvements. The intervention was well tolerated in 14 subjects, with 1 serious adverse event reported in 1 subject. CONCLUSION: An amino acid-based elemental diet improves histologic, endoscopic, symptomatic, quality-of-life, and molecular parameters of EoG/EoGE; these findings and disease recurrence with food trigger reintroduction support a dominant role for food allergens in disease pathogenesis. CLINICALTRIALS: gov Identifier: NCT03320369.

Common and Best Nail Practices Among Nail Care Providers: A Descriptive Study.

PURPOSE: The purpose of this project was to identify common and best practices for safe nail care among nail care providers. DESIGN: Descriptive study using online survey. SUBJECTS AND SETTING: The study was conducted by 2 credentialed foot and wound care nurses within a large Midwest healthcare system. Participants were nurses and physicians who provide nail care to patients and individuals in the hospital and community setting such as private homes and nursing homes and hospice agencies. METHODS: Email invitations with a link to the survey were sent to eligible individuals and organizations in which wound care specialists were employed. Information about the survey was posted on the Certified Foot Care Specialty homepage, and on the Wound, Ostomy and Continence Nursing (WOCN) Members-only Forum and Facebook page. RESULTS: An estimated 1000 surveys were sent of which 246 surveys were returned. Fifty-three percent (121/229) of respondents were certified through the WOCN Certification Board and 41% (93/229) were certified through the American Foot Care Nurse Association. Most respondents reported using some form of self-protection when filing (225/246, 91.5%), trimming (215/246; 87.4%), or using a rotary tool (204/246, 82.9%) on patients' nails. However, approximately one-fourth of respondents reported offering some type of protection for patients when filing (63/246, 25.6%), trimming (41/246, 16.7%), or using a rotary tool (64/246, 26.0%). Most of the nurses surveyed provided nail care in outpatient and foot care clinics, acute care settings, private homes, and nursing homes/hospice. CONCLUSIONS: When providing nail care, the patient/client protections should closely mirror the personal protective equipment used by the nurse. Future research is needed to contribute to a national consensus guideline for best practices and protections at all levels of nail care in the acute care and community settings.

Prevalence of Fecal Incontinence in the Acute Care Setting.

PURPOSE: The aim of this study was to determine the prevalence of fecal incontinence (FI) and its associated risk factors in acutely ill adult hospitalized patients. METHODS: A cross-sectional design was used to collect data at 2 time points in 7 hospitals in the Midwestern United States. An investigator-developed tool was used by trained data collectors to identify pertinent patient characteristics, the presence of FI, and potential associated factors. RESULTS: The prevalence of FI in the 1083 patients assessed was 20% (n = 221). Prevalence rates from the 7 individual hospitals ranged from 16% to 30%. Medications were the most common associated factor (49%; n = 109), followed by neurologic diseases (40%; n = 89), and bowel motility disorders (30%; n = 67). The majority of patients with FI had stool consistency described as "loose unformed" (59%; n = 130) or "liquid" (25%; n = 55). Many patients had multiple potential risk factors for FI; 48% (n = 107) had 1 associated factor, 37% (n = 82) had 2 associated factors, and 8% (n = 18) had 3 or more associated factors. Age was associated with an increased likelihood of FI; the chances for FI increase 1.7% with each year of age. Unit type was also a significant associated with FI; patients managed in the intensive care unit were 78% more likely to have FI as compared to patients care for in a medical-rehabilitation unit. CONCLUSIONS: Fecal incontinence is a common problem in hospitalized adult patients. Previously identified risk factors were also found in our sample.

Human Epidemiology and RespOnse to SARS-CoV-2 (HEROS): Objectives, Design and Enrollment Results of a 12-City Remote Observational Surveillance Study of Households with Children using Direct-to-Participant Methods.

The Human Epidemiology and Response to SARS-CoV-2 (HEROS) is a prospective multi-city 6-month incidence study which was conducted from May 2020-February 2021. The objectives were to identify risk factors for SARS-CoV-2 infection and household transmission among children and people with asthma and allergic diseases, and to use the host nasal transcriptome sampled longitudinally to understand infection risk and sequelae at the molecular level. To overcome challenges of clinical study implementation due to the coronavirus pandemic, this surveillance study used direct-to-participant methods to remotely enroll and prospectively follow eligible children who are participants in other NIH-funded pediatric research studies and their household members. Households participated in weekly surveys and biweekly nasal sampling regardless of symptoms. The aim of this report is to widely share the methods and study instruments and to describe the rationale, design, execution, logistics and characteristics of a large, observational, household-based, remote cohort study of SARS-CoV-2 infection and transmission in households with children. The study enrolled a total of 5,598 individuals, including 1,913 principal participants (children), 1,913 primary caregivers, 729 secondary caregivers and 1,043 other household children. This study was successfully implemented without necessitating any in-person research visits and provides an approach for rapid execution of clinical research.

The Asthma Control and Communication Instrument: a clinical tool developed for ethnically diverse populations.

BACKGROUND: Lower levels of quality asthma care among racially diverse populations might be due to inaccurate disease status assessments. The Asthma Control and Communication Instrument (ACCI) is a new tool that captures patient report of disease status during routine care. OBJECTIVE: We sought to test the ACCI's psychometric properties in a racially diverse population. METHODS: We performed a cross-sectional study. Subjects were recruited from specialist and generalist urban outpatient clinics. The ACCI and measures of asthma control, quality of life, lung function, and specialist rating of asthma status were collected. Four ACCI domains were separately validated: Acute Care, Bother, Control, and Direction. Principal component analysis, internal consistency, concurrent, discriminative, known-groups validity, and accuracy were evaluated. RESULTS: Two hundred seventy asthmatic patients (77% female subjects, 55% black) participated. ACCI Control domain internal consistency was 0.80. ACCI Bother, Control, and Direction domains showed strong concurrent validity with asthma control and quality-of-life measures (all P < .001). ACCI Acute Care and Direction domains showed strong concurrent validity with individual validation items (all P < .001). The ACCI Control domain discriminated clinically important levels of disease status measured by asthma control, quality of life (both P < .001), and percent predicted peak expiratory flow rate (P = .005) and was associated with specialist rating of disease status (P < .001), confirming known-groups validity. The accuracy of the ACCI Control domain in classifying patients with uncontrolled asthma was very good (area under the curve, 0.851; 95% CI, 0.742-0.95870). Results were similar for both black and white subjects. CONCLUSION: The ACCI is a promising clinical tool that measures asthma disease status during routine health care and is valid for use in both black and white populations.

Patient factors that physicians use to assign asthma treatment.

BACKGROUND: Asthma guidelines recommend severity assessment to assign treatment, often quantified as current control. It is unknown how strongly control assessment affects clinician treatment decisions, nor if control is sufficient. METHODS: To determine patient factors used by physicians to assign treatment, we surveyed pulmonary specialists (PSs) and family physicians (FPs) using vignettes. We tested whether recent acute care (hospitalization 6 months ago), bother (patient bothered by asthma), control (symptom or reliever medication frequency), and direction (change since last visit) influence treatment decisions. Factors used for stepping up and stepping down were assessed. RESULTS: A total of 461 physicians participated (236 PSs and 225 FPs). As expected, physicians indicated a greater likelihood of stepping up treatment for persistent (4-5 times per week) than for intermittent (1 time per 2 weeks) symptoms (PSs 97% vs 24%, P < .001; FPs 97% vs 33%, P < .001). All else being equal, physicians were more likely to step up treatment of a patient with intermittent symptoms if the patient reported recent acute care (PSs 49% vs 24%; FPs 72% vs 33%), was bothered (PSs 81% vs 24%; FPs 80% vs 33%), or was worse since the last visit (PSs 68% vs 24%; FPs 66% vs 33%) (all P < .001). These factors were also predictive of stepping down from high-intensity therapy and remained significant in multivariate analyses (all P < .05). CONCLUSIONS: Asthma control greatly influences physician decisions about asthma treatments. However, recent acute care, bother, and direction of illness also influence decisions, particularly those that involve increasing the amount of medication prescribed. Further work is needed to determine if use of these additional indicators leads to better asthma outcomes.

Augmenting Predictive Modeling Tools with Clinical Insights for Care Coordination Program Design and Implementation.

CONTEXT: The Center for Medicare and Medicaid Innovation (CMMI) awarded Denver Health's (DH) integrated, safety net health care system $19.8 million to implement a "population health" approach into the delivery of primary care. This major practice transformation builds on the Patient Centered Medical Home (PCMH) and Wagner's Chronic Care Model (CCM) to achieve the "Triple Aim": improved health for populations, care to individuals, and lower per capita costs. CASE DESCRIPTION: This paper presents a case study of how DH integrated published predictive models and front-line clinical judgment to implement a clinically actionable, risk stratification of patients. This population segmentation approach was used to deploy enhanced care team staff resources and to tailor care-management services to patient need, especially for patients at high risk of avoidable hospitalization. Developing, implementing, and gaining clinical acceptance of the Health Information Technology (HIT) solution for patient risk stratification was a major grant objective. FINDINGS: In addition to describing the Information Technology (IT) solution itself, we focus on the leadership and organizational processes that facilitated its multidisciplinary development and ongoing iterative refinement, including the following: team composition, target population definition, algorithm rule development, performance assessment, and clinical-workflow optimization. We provide examples of how dynamic business intelligence tools facilitated clinical accessibility for program design decisions by enabling real-time data views from a population perspective down to patient-specific variables. CONCLUSIONS: We conclude that population segmentation approaches that integrate clinical perspectives with predictive modeling results can better identify high opportunity patients amenable to medical home-based, enhanced care team interventions.

The pulmonary endothelial glycocalyx regulates neutrophil adhesion and lung injury during experimental sepsis.

Sepsis, a systemic inflammatory response to infection, commonly progresses to acute lung injury (ALI), an inflammatory lung disease with high morbidity. We postulated that sepsis-associated ALI is initiated by degradation of the pulmonary endothelial glycocalyx, leading to neutrophil adherence and inflammation. Using intravital microscopy, we found that endotoxemia in mice rapidly induced pulmonary microvascular glycocalyx degradation via tumor necrosis factor-α (TNF-α)-dependent mechanisms. Glycocalyx degradation involved the specific loss of heparan sulfate and coincided with activation of endothelial heparanase, a TNF-α-responsive, heparan sulfate-specific glucuronidase. Glycocalyx degradation increased the availability of endothelial surface adhesion molecules to circulating microspheres and contributed to neutrophil adhesion. Heparanase inhibition prevented endotoxemia-associated glycocalyx loss and neutrophil adhesion and, accordingly, attenuated sepsis-induced ALI and mortality in mice. These findings are potentially relevant to human disease, as sepsis-associated respiratory failure in humans was associated with higher plasma heparan sulfate degradation activity; moreover, heparanase content was higher in human lung biopsies showing diffuse alveolar damage than in normal human lung tissue.

Patient factors used by pediatricians to assign asthma treatment.

OBJECTIVE: Although asthma is often inappropriately treated in children, little is known about what information pediatricians use to adjust asthma therapy. The purpose of this work was to assess the importance of various dimensions of patient asthma status as the basis of pediatrician treatment decisions. PATIENTS AND METHODS: We conducted a cross-sectional, random-sample survey, between November 2005 and May 2006, of 500 members of the American Academy of Pediatrics using standardized case vignettes. Vignettes varied in regard to (1) acute health care use (hospitalized 6 months ago), (2) bother (parent bothered by the child's asthma status), (3) control (frequency of symptoms and albuterol use), (4) direction (qualitative change in symptoms), and (5) wheezing during physical examination. Our primary outcome was the proportion of pediatricians who would adjust treatment in the presence or absence of these 5 factors. RESULTS: Physicians used multiple dimensions of asthma status other than symptoms to determine treatment. Pediatricians were significantly more likely to increase treatment for a recently hospitalized patient (45% vs 18%), a bothered parent (67% vs 18%), poorly controlled symptoms (4-5 times per week; 100% vs 18%), or if there was wheezing on examination (45% vs 18%) compared with patients who only had well-controlled symptoms. Pediatricians were significantly less likely to decrease treatment for a child with well-controlled symptoms and recent hospitalization (28%), parents who reported being bothered (43%), or a child whose symptoms had worsened since the last doctor visit (10%) compared with children with well-controlled symptoms alone. CONCLUSIONS: Pediatricians treat asthma on the basis of multiple dimensions of asthma status, including hospitalization, bother, symptom frequency, direction, and wheezing but use these factors differently to increase and decrease treatment. Tools that systematically assess multiple dimensions of asthma may be useful to help further improve pediatric asthma care.

Community-associated methicillin-resistant Staphylococcus aureus in the patient with HIV infection.

The prevalence of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) has increased alarmingly in both the general population and the HIV-infected community. We look at the background of MRSA including the mechanisms of resistance, genetics, and trends in the individual with HIV infection. Numerous studies have investigated the risk factors for CA-MRSA. Other studies have further characterized the incidence of and risk factors for MRSA infections in the HIV community. Although one might not readily associate advanced HIV infection with increased susceptibility to bacterial pathogens, a number of studies have explained the mechanisms of this B-cell-mediated susceptibility. Invasive MRSA infections have spread into communities, are increasingly prevalent, and pose a public health challenge for their containment, prevention, and treatment.

Analytical techniques and method validation for the measurement of selected semivolatile and nonvolatile organofluorochemicals in air.

The widespread use of semi- and nonvolatile organofluorochemicals in industrial facilities, concern about their persistence, and relatively recent advancements in liquid chromatography/mass spectrometry (LC/MS) technology have led to the development of new analytical methods to assess potential worker exposure to airborne organofluorochemicals. Techniques were evaluated for the determination of 19 organofluorochemicals and for total fluorine in ambient air samples. Due to the potential biphasic nature of most of these fluorochemicals when airborne, Occupational Safety and Health Administration (OSHA) versatile sampler (OVS) tubes were used to simultaneously trap fluorochemical particulates and vapors from workplace air. Analytical methods were developed for OVS air samples to quantitatively analyze for total fluorine using oxygen bomb combustion/ion selective electrode and for 17 organofluorochemicals using LC/MS and gas chromatography/mass spectrometry (GC/MS). The experimental design for this validation was based on the National Institute of Occupational Safety and Health (NIOSH) Guidelines for Air Sampling and Analytical Method Development and Evaluation, with some revisions of the experimental design. The study design incorporated experiments to determine analytical recovery and stability, sampler capacity, the effect of some environmental parameters on recoveries, storage stability, limits of detection, precision, and accuracy. Fluorochemical mixtures were spiked onto each OVS tube over a range of 0.06-6 microg for each of 12 compounds analyzed by LC/MS and 0.3-30 microg for 5 compounds analyzed by GC/MS. These ranges allowed reliable quantitation at 0.001-0.1 mg/m3 in general for LC/MS analytes and 0.005-0.5 mg/m3 for GC/MS analytes when 60 L of air are sampled. The organofluorochemical exposure guideline (EG) is currently 0.1 mg/m3 for many analytes, with one exception being ammonium perfluorooctanoate (EG is 0.01 mg/m3). Total fluorine results may be used to determine if the individual compounds quantified provide a suitable mass balance of total airborne organofluorochemicals based on known fluorine content. Improvements in precision and/or recovery as well as some additional testing would be needed to meet all NIOSH validation criteria. This study provided valuable information about the accuracy of this method for organofluorochemical exposure assessment.