Factors Influencing US Hospital and Medical School Participation in Pediatric COVID-19 Research

BACKGROUND AND OBJECTIVES: Literature suggests that funding for pediatric clinical trials is inequitably awarded. Furthermore, although coronavirus disease 2019 (COVID-19) affected all hospitals, institutions with already limited resources were more severely impacted. We hypothesized that there would be difference in schools and hospitals that were able to participate in the initial round of pediatric COVID-19 clinical research. METHODS: We searched online databases for preregistered studies using the keywords “COVID-19,” “COVID,” “SARS-CoV-2,” “2019-nCov,” “2019 novel coronavirus,” and “severe acute respiratory syndrome coronavirus 2.” Search results were limited to studies enrolling participants from birth to 17 years, studies started in 2020, and studies originating in the United states. We calculated the proportion of institutions with active COVID-19 pediatric clinical studies in 2020 and compared institutional characteristics between institutions with and without at least one qualifying COVID-19 study, using rank-sum tests, χ2 tests, or Fisher’s exact tests, as appropriate. RESULTS: We identified 150 allopathic medical schools, 34 osteopathic medical schools, and 178 children’s hospitals meeting inclusion criteria. Among included institutions, 25% of medical schools and 20% children’s hospitals participated in 1 of the registered pediatric COVID-19 studies the year before the study period. Institutions that participated in pediatric COVID-19 studies had more publications, more National Institutes of Health funding, and more studies registered on Clinicaltrials.gov in 2019. CONCLUSIONS: Despite the pandemic affecting everyone, participation in early clinical research on the impact of COVID-19 in pediatric populations was concentrated in a few well-resourced institutions that were highly experienced in research.

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THE EPIDEMIOLOGY OF PEDIATRIC MENISCAL ALLOGRAFT TRANSPLANTATION IN THE UNITED STATES

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967121s00040 ◽

2021 ◽

Vol 9 (7_suppl3) ◽

pp. 2325967121S0004

Author(s):

Haley E. Smith ◽

Madeline M. Lyons ◽

Neeraj M. Patel

Keyword(s):

United States ◽

Pediatric Population ◽

The United States ◽

National Database ◽

Control Group ◽

Meniscal Allograft Transplantation ◽

Children's Hospitals ◽

Allograft Transplantation ◽

Meniscal Allograft ◽

Children’S Hospitals

Background: Meniscal allograft transplantation (MAT) is an option to slow the progression of degenerative disease in the setting of substantial meniscal deficiency. This may be especially important in children and adolescents, but there is little literature on MAT in this population. Hypothesis/Purpose: The purpose of this study was to evaluate the epidemiology of MAT in the pediatric population, with specific attention to regional and demographic trends. Methods: The Pediatric Health Information System, a national database consisting of 49 children’s hospitals, was queried for all patients undergoing MAT between 2011 and 2018. Demographic information was collected for each subject as well as data regarding previous and subsequent surgeries. The database was also queried for all meniscus surgeries (including repairs and meniscectomies) performed during the study period. Demographic and geographic data from this control group were compared to that of children undergoing MAT. Univariate analysis was followed by purposeful entry multivariate regression to adjust for confounding factors. Results: A total of 27,168 meniscus surgeries were performed in 47 hospitals, with MAT performed 67 times in 17 hospitals. Twelve patients (18%) underwent a subsequent procedure after transplantation. In multivariate analysis, each year of increasing age resulted in 1.1 times higher odds of having undergone MAT rather than repair or meniscectomy (95% CI 1.03-1.1, p=0.002). Patients that underwent transplantation had 2.0 times higher odds of being female (95% CI 1.2-3.3, p=0.01) and 2.0 times higher odds of being commercially insured (95% CI 1.1-3.6, p=0.02). MAT was performed most frequently in the Northeast (4.9/1000 meniscus surgeries) and least often in the South (1.1/1000 meniscus surgeries, p<0.001). Furthermore, transplantation was more likely to be performed in larger cities. The median pediatric population of cities in which MAT was performed was 983,268 (range 157,253-3,138,870) compared to 662,290 (range 4,420-4,311,500) in cities where it was not (p=0.04). Conclusion: In the United States, patients that underwent MAT were older, more likely to be female, and have commercial insurance than those undergoing meniscus repair or meniscectomy. MAT was only done in 17/47 children’s hospitals that perform meniscus surgery and was most frequently performed in the Northeast and in larger cities. These trends highlight the need for further research, especially regarding differences along the lines of sex and insurance status.

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Communications and Screening for 2019 Novel Coronavirus at a Tertiary-Care Medical Center

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2020.578 ◽

2020 ◽

Vol 41 (S1) ◽

pp. s84-s84

Author(s):

Lorinda Sheeler ◽

Mary Kukla ◽

Oluchi Abosi ◽

Holly Meacham ◽

Stephanie Holley ◽

...

Keyword(s):

Screening Tool ◽

Medical Center ◽

Academic Medical Center ◽

Tertiary Care ◽

The United States ◽

World Health ◽

Communication Campaign ◽

Electronic Screening ◽

Novel Coronavirus ◽

The Impact

Background: In December of 2019, the World Health Organization reported a novel coronavirus (severe acute respiratory coronavirus virus 2 [SARS-CoV-2)]) causing severe respiratory illness originating in Wuhan, China. Since then, an increasing number of cases and the confirmation of human-to-human transmission has led to the need to develop a communication campaign at our institution. We describe the impact of the communication campaign on the number of calls received and describe patterns of calls during the early stages of our response to this emerging infection. Methods: The University of Iowa Hospitals & Clinics is an 811-bed academic medical center with >200 outpatient clinics. In response to the coronavirus disease 2019 (COVID-19) outbreak, we launched a communications campaign on January 17, 2020. Initial communications included email updates to staff and a dedicated COVID-19 webpage with up-to-date information. Subsequently, we developed an electronic screening tool to guide a risk assessment during patient check in. The screening tool identifies travel to China in the past 14 days and the presence of symptoms defined as fever >37.7°C plus cough or difficulty breathing. The screening tool was activated on January 24, 2020. In addition, university staff contacted each student whose primary residence record included Hubei Province, China. Students were provided with medical contact information, signs and symptoms to monitor for, and a thermometer. Results: During the first 5 days of the campaign, 3 calls were related to COVID-19. The number of calls increased to 18 in the 5 days following the implementation of the electronic screening tool. Of the 21 calls received to date, 8 calls (38%) were generated due to the electronic travel screen, 4 calls (19%) were due to a positive coronavirus result in a multiplex respiratory panel, 4 calls (19%) were related to provider assessment only (without an electronic screening trigger), and 2 calls (10%) sought additional information following the viewing of the web-based communication campaign. Moreover, 3 calls (14%) were for people without travel history but with respiratory symptoms and contact with a person with recent travel to China. Among those reporting symptoms after travel to China, mean time since arrival to the United States was 2.7 days (range, 0–11 days). Conclusion: The COVID-19 outbreak is evolving, and providing up to date information is challenging. Implementing an electronic screening tool helped providers assess patients and direct questions to infection prevention professionals. Analyzing the types of calls received helped tailor messaging to frontline staff.Funding: NoneDisclosures: None

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Preparation of Children for Hospitalization in Acute Care Hospitals in the United States

PEDIATRICS ◽

10.1542/peds.68.3.361 ◽

1981 ◽

Vol 68 (3) ◽

pp. 361-368

Author(s):

Pat Azarnoff ◽

Patricia D. Woody

Keyword(s):

United States ◽

Acute Care ◽

Group Discussion ◽

Acute Care Hospitals ◽

The United States ◽

Pediatric Care ◽

Children's Hospitals ◽

General Hospitals ◽

Psychological Preparation ◽

Children’S Hospitals

To study the prevalence and nature of psychological preparation for pediatric care, children's hospitals and acute care general hospitals were surveyed, and 24 hospitals were visited. Of 1,427 hospitals responding, 468 (33%) provided regular, planned preparation services. Prior to hospitalization, group tours and group discussion were the two most frequently used methods. During hospitalization, children learned informally as events occurred, usually through conversations.

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Barriers to symptom management care pathway implementation in pediatric Cancer

BMC Health Services Research ◽

10.1186/s12913-021-07047-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

L. Lee Dupuis ◽

Allison Grimes ◽

Emily Vettese ◽

Lisa M. Klesges ◽

Lillian Sung

Keyword(s):

Clinical Research ◽

Pediatric Oncology ◽

Pediatric Cancer ◽

Symptom Management ◽

Care Pathway ◽

The United States ◽

Care Pathways ◽

Research Activities ◽

Pediatric Cancer Patients ◽

The Impact

Abstract Background Objectives were to describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. Methods We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators prior to randomization to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree. Results Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P = 0.003). Conclusions The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic may not be a major barrier to clinical research activities in pediatric oncology.

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The Need for Shared Nomenclature on Racism and Related Terminology in Psychology

Perspectives on Psychological Science ◽

10.1177/17456916211000760 ◽

2021 ◽

Vol 16 (5) ◽

pp. 886-892

Author(s):

Angela M. Haeny ◽

Samantha C. Holmes ◽

Monnica T. Williams

Keyword(s):

Clinical Research ◽

Negative Impact ◽

Racial Microaggressions ◽

The United States ◽

Multiple Forms ◽

Social Construct ◽

Racial Hierarchy ◽

The Social ◽

The Many ◽

The Impact

With the increased desire to engage in antiracist clinical research, there is a need for shared nomenclature on racism and related constructs to help move the science forward. This article breaks down the factors that contributed to the development and maintenance of racism (including racial microaggressions), provides examples of the many forms of racism, and describes the impact of racism for all. Specifically, in the United States, racism is based on race, a social construct that has been used to categorize people on the basis of shared physical and social features with the assumption of a racial hierarchy presumed to delineate inherent differences between groups. Racism is a system of beliefs, practices, and policies that operate to advantage those at the top of the racial hierarchy. Individual factors that contribute to racism include racial prejudices and racial discrimination. Racism can be manifested in multiple forms (e.g., cultural, scientific, social) and is both explicit and implicit. Because of the negative impact of racism on health, understanding racism informs effective approaches for eliminating racial health disparities, including a focus on the social determinants of health. Providing shared nomenclature on racism and related terminology will strengthen clinical research and practice and contribute to building a cumulative science.

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Emergence of SARS-CoV-2 variants of concern in the pediatric population of the United States

10.1101/2021.05.22.21257660 ◽

2021 ◽

Author(s):

Jennifer Dien Bard ◽

Moiz Bootwalla ◽

Amy Leber ◽

Paul Planet ◽

Ahmed Moustafa ◽

...

Keyword(s):

United States ◽

Young Children ◽

Pediatric Population ◽

The United States ◽

Surveillance Program ◽

Children's Hospitals ◽

Prevalence Data ◽

Children’S Hospitals ◽

Report Data

The evolution of SARS-CoV2 virus has led to the emergence of variants of concern (VOC). Children, particularly <12 years old not yet eligible for vaccines, continue to be important reservoirs of SARS-CoV-2 yet VOC prevalence data in this population is lacking. We report data from a genomic surveillance program that includes 9 U.S. children's hospitals. Analysis of SARS-CoV-2 genome from 2119 patients <19 years old between 03/20 to 04/21 identified 252 VOCs and 560 VOC signature mutations, most from 10/20 onwards. From 02/21 to 04/21, B.1.1.7 prevalence increased from 3.85% to 72.22% corresponding with the decline of B.1.429/B.1.427 from 51.82% to 16.67% at one institution. 71.74% of the VOC signature mutations detected were in children <12 years old, including 33 cases of B.1.1.7 and 119 of B.1.429/B.1.427. There continues to be a need for ongoing genomic surveillance, particularly among young children who will be the last groups to be vaccinated.

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Variability in Spinal Surgery Outcomes Among Children’s Hospitals in the United States

Journal of Pediatric Orthopaedics ◽

10.1097/bpo.0b013e318269c537 ◽

2013 ◽

Vol 33 (1) ◽

pp. 80-90 ◽

Cited By ~ 17

Author(s):

Mark A. Erickson ◽

Elaine H. Morrato ◽

Elizabeth J. Campagna ◽

Benefield Elise ◽

Nancy H. Miller ◽

...

Keyword(s):

United States ◽

Spinal Surgery ◽

The United States ◽

Children's Hospitals ◽

Children’S Hospitals ◽

Surgery Outcomes

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Epidemiology of pediatric hospitalizations at general hospitals and freestanding children's hospitals in the United States

Journal of Hospital Medicine ◽

10.1002/jhm.2624 ◽

2016 ◽

Vol 11 (11) ◽

pp. 743-749 ◽

Cited By ~ 63

Author(s):

JoAnna K. Leyenaar ◽

Shawn L. Ralston ◽

Meng-Shiou Shieh ◽

Penelope S. Pekow ◽

Rita Mangione-Smith ◽

...

Keyword(s):

United States ◽

The United States ◽

Children's Hospitals ◽

General Hospitals ◽

Children’S Hospitals

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2069

Journal of Clinical and Translational Science ◽

10.1017/cts.2017.158 ◽

2017 ◽

Vol 1 (S1) ◽

pp. 43-44

Author(s):

Carlton Hornung ◽

Carolyn Thomas Jones ◽

Terri Hinkley ◽

Vicki Ellingrod ◽

Nancy Calvin-Naylor

Keyword(s):

Clinical Research ◽

Data Management ◽

Core Competencies ◽

Safety Data ◽

The United States ◽

Education And Training ◽

Development Ethics ◽

The Impact ◽

And Training ◽

Research Professionals

OBJECTIVES/SPECIFIC AIMS: Clinical research in the 21st century will require a well-trained workforce to insure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel, and others. While the Clinical Research Appraisal Inventory assesses the self-confidence of physician scientists to be clinical investigators, no such index exists to assess the competence of clinical research professionals who coordinate, monitor, and administer clinical trials. We developed the Competency Index for Clinical Research Professionals (CICRP) as a general index of competency (ie, GCPs) as well as sub-scales to assess competency in the specific domains of Medicines Development; Ethics and Participant Safety; Data Management; and Research Methods. METHODS/STUDY POPULATION: We analyzed data collected by the Joint Task Force on the Harmonization of Core Competencies from a survey of research professionals working in the United States and Canada. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies. Factor analyzes identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. RESULTS/ANTICIPATED RESULTS: Factor analysis identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. DISCUSSION/SIGNIFICANCE OF IMPACT: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors, and other clinical research team members.

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