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Article: Evolution of the Collaborative Pediatric Critical Care Research Network.

Dean, J Michael

Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies

2022 Volume 23, Issue 12, Page(s) 1049–1055

Abstract: The Collaborative Pediatric Critical Care Research Network (CPCCRN) was established by the Eunice Kennedy Shriver National Institute of Child Health and Human Development in May 2005 to develop an infrastructure for collaborative clinical trials and ... ...

Abstract	The Collaborative Pediatric Critical Care Research Network (CPCCRN) was established by the Eunice Kennedy Shriver National Institute of Child Health and Human Development in May 2005 to develop an infrastructure for collaborative clinical trials and meaningful descriptive studies in pediatric critical care. This article describes the history of CPCCRN, discusses its financial and organizational structure, illustrates how funds were efficiently used to carry out studies, and describes CPCCRN public use datasets and future directions, concluding with the development of the PeRsonalizEd Immunomodulation in PediatriC SepsIS-InducEd MODS study.
MeSH term(s)	United States ; Child ; Humans ; Critical Care ; National Institute of Child Health and Human Development (U.S.) ; Sepsis
Language	English
Publishing date	2022-11-03
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2052349-X
ISSN	1947-3893 ; 1529-7535
ISSN (online)	1947-3893
ISSN	1529-7535
DOI	10.1097/PCC.0000000000003098
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Zs.MO 472: Show issues

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Article ; Online: Demonstration Project: Transitioning a Research Network to New Single IRB Platforms.

Burr, Jeri S / Johnson, Ann / Risenmay, Annie / Bisping, Stephanie / Serdoz, Emily S / Coleman, Whit / Sward, Katherine A / Rothwell, Erin / Dean, J Michael

Ethics & human research

2023 Volume 44, Issue 6, Page(s) 32–38

Abstract: Since the 2016 National Institutes of Health (NIH) mandate to use a single IRB (sIRB) in multicenter research, institutions have struggled to operationalize the process. In this demonstration project, the University of Utah Trial Innovation Center ... ...

Abstract	Since the 2016 National Institutes of Health (NIH) mandate to use a single IRB (sIRB) in multicenter research, institutions have struggled to operationalize the process. In this demonstration project, the University of Utah Trial Innovation Center assisted the Collaborative Pediatric Critical Care Research Network to transition from using individually negotiated reliance agreements and paper-based documentation to a new sIRB master agreement and an informatics platform to capture reliance documentation. Lessons learned that can guide other academic institutions and IRBs as they operationalize sIRBs included the need for sites to understand what type of engagement or reliance is required and their need to understand the difference between reliance and activation. Requirements around local review remain poorly understood. Further research is needed to determine approaches that can achieve the NIH vision of reviews becoming more efficient and improving study start-up times, relieving administrative burden while advancing human research protections.
MeSH term(s)	United States ; Child ; Humans ; Ethics Committees, Research ; National Institutes of Health (U.S.)
Language	English
Publishing date	2023-11-22
Publishing country	United States
Document type	Multicenter Study ; Journal Article
ISSN	2578-2363
ISSN (online)	2578-2363
DOI	10.1002/eahr.500149
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Article: The Design of Nested Adaptive Clinical Trials of Multiple Organ Dysfunction Syndrome Children in a Single Study.

VanBuren, John M / Hall, Mark / Zuppa, Athena F / Mourani, Peter M / Carcillo, Joseph / Dean, J Michael / Watt, Kevin / Holubkov, Richard

Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies

2023 Volume 24, Issue 12, Page(s) e635–e646

Abstract: Objectives: Describe the statistical design of the Personalized Immunomodulation in Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS) (PRECISE) study.: Design: Children with sepsis-induced MODS undergo real-time immune testing followed by ... ...

Abstract	Objectives: Describe the statistical design of the Personalized Immunomodulation in Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS) (PRECISE) study. Design: Children with sepsis-induced MODS undergo real-time immune testing followed by assignment to an immunophenotype-specific study cohort. Interventional cohorts include the granulocyte macrophage-colony stimulating factor (GM-CSF) for the Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS (GRACE)-2 trial, which uses the drug GM-CSF (or placebo) to reverse immunoparalysis; and the Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS) trial, which uses the drug anakinra (or placebo) to reverse systemic inflammation. Both trials have adaptive components and use a statistical framework in which frequent data monitoring assesses futility and efficacy, allowing potentially earlier stopping than traditional approaches. Prespecified simulation-based stopping boundaries are customized to each trial to preserve an overall one-sided type I error rate. The TRIPS trial also uses response-adaptive randomization, updating randomization allocation proportions to favor active arms that appear more efficacious based on accumulating data. Setting: Twenty-four U.S. academic PICUs. Patients: Septic children with specific immunologic derangements during ongoing dysfunction of at least two organs. Interventions: The GRACE-2 trial compares GM-CSF and placebo in children with immunoparalysis. The TRIPS trial compares four different doses of anakinra to placebo in children with moderate to severe systemic inflammation. Measurements and main results: Both trials assess primary efficacy using the sum of the daily pediatric logistic organ dysfunction-2 score over 28 days. Ranked summed scores, with mortality assigned the worst possible value, are compared between arms using the Wilcoxon Rank Sum test (GRACE-2) and a dose-response curve (TRIPS). We present simulation-based operating characteristics under several scenarios to demonstrate the behavior of the adaptive design. Conclusions: The adaptive design incorporates innovative statistical features that allow for multiple active arms to be compared with placebo based on a child's personal immunophenotype. The design increases power and provides optimal operating characteristics compared with traditional conservative methods.
MeSH term(s)	Humans ; Child ; Multiple Organ Failure/etiology ; Granulocyte-Macrophage Colony-Stimulating Factor/therapeutic use ; Interleukin 1 Receptor Antagonist Protein/therapeutic use ; Sepsis/complications ; Sepsis/drug therapy ; Inflammation
Chemical Substances	Granulocyte-Macrophage Colony-Stimulating Factor (83869-56-1) ; Interleukin 1 Receptor Antagonist Protein
Language	English
Publishing date	2023-07-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	2052349-X
ISSN	1947-3893 ; 1529-7535
ISSN (online)	1947-3893
ISSN	1529-7535
DOI	10.1097/PCC.0000000000003332
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Article: The Pediatric Critical Care Trauma Scientist Development: Building a Community of Scientists for the Fields of Pediatric Critical Care and Trauma Surgery.

Keenan, Heather T / Albertine, Kurt H / Upperman, Jeffrey S / Dean, J Michael

Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies

2020 Volume 21, Issue 7, Page(s) 672–678

Abstract: Objectives: To assess the National Institute of Child Health and Human Development's Pediatric Critical Care Trauma Scientist Development Program national K12 program.: Design: Mixed-methods study.: Setting: Pediatric Critical Care Trauma ... ...

Abstract	Objectives: To assess the National Institute of Child Health and Human Development's Pediatric Critical Care Trauma Scientist Development Program national K12 program. Design: Mixed-methods study. Setting: Pediatric Critical Care Trauma Scientist Development Program participants from 2005 to 2018. Subjects: Past participants in the Pediatric Critical Care Trauma Scientist Development Program, including those who received funding (scholars), those who did not receive funding (applicants), and those who participated as diversity fellows. Interventions: None. Measurements and main results: Thirty-four past scholars, participants, and fellows in the Pediatric Critical Care Trauma Scientist Development were interviewed, including 19 women (56%) and 15 men (44%) via Skype. Interviews were audio recorded and transcribed, with permission. Codes were developed, using qualitative methods, that included the following: Community Building and Mentorship, Career and Research Development, and Tensions and Growth Opportunities. Quantitative data about physician-scholar grant success were retrieved from the National Institutes of Health system to search for funded grants, RePORT, physician-scholar curriculum vitae, and university websites. Since inception of the program, 46 scholars have been appointed. Scholars are equally split between women and men. Four members of the total cohort (9%) are from under-represented minority groups in medicine. Among the total past 46 participants, 72% of those who completed the K12 achieved an National Institutes of Health K-award and 36% of those not on K-level funding achieved at least one Research Program Grant-level award. All scholars, except one, remain academically active, as noted by recent publications in the peer reviewed literature; scholars from 2005 to 2013 are progressing in their careers, with 60% promoted to associate or full professor. Conclusions: The Pediatric Critical Care Trauma Scientist Development Program is reaching its programmatic goals of buildin g a community of scientists in pediatric critical care and trauma surgery as shown by the qualitative analysis. Key challenges include increasing the diversity of applicants, encouraging applicants who are not funded, increasing the rate of K- to R-conversion, and preserving National Institute of Child Health and Human Development Program priorities for national K12 programs and individual K-awards.
MeSH term(s)	Biomedical Research ; Child ; Critical Care ; Female ; Humans ; Male ; Mentors ; National Institutes of Health (U.S.) ; Research Personnel ; United States
Language	English
Publishing date	2020-05-25
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2052349-X
ISSN	1947-3893 ; 1529-7535
ISSN (online)	1947-3893
ISSN	1529-7535
DOI	10.1097/PCC.0000000000002348
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Zs.A 5600: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: An Approach to Reviewing Local Context for Exception from Informed Consent Trials Using a Single IRB.

Johnson, Ann R / Rigtrup, Lisa M / VanBuren, John / Rothwell, Erin / Dean, J Michael

Ethics & human research

2021 Volume 43, Issue 6, Page(s) 42–48

Abstract: In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed ... ...

Abstract	In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed consent is that the reviewing IRB must review and approve a community consultation and public disclosure plan. It is critical that an IRB serving as the single IRB (sIRB) for multisite research be thoroughly versed in the local context concerns for each participating site to determine whether the site's community is being adequately consulted about the research in which individuals will be enrolled under an exception to the informed consent requirement. We designed an sIRB review model for evaluating site-specific community consultation plans that included a local evaluation and feedback step, and we piloted the model with a four-site, pediatric exception from informed consent (EFIC) clinical trial. We identified three key roles for the model: the sIRB, the investigators, and the representative of the institution's human research protection program (HRPP). We successfully collected the information and local input needed to evaluate each site's community consultation plan and applied the information to a thorough IRB review, despite the geographic distance between the study site and the sIRB.
MeSH term(s)	Child ; Disclosure ; Emergencies ; Ethics Committees, Research ; Humans ; Informed Consent ; Referral and Consultation
Language	English
Publishing date	2021-11-10
Publishing country	United States
Document type	Journal Article
ISSN	2578-2363
ISSN (online)	2578-2363
DOI	10.1002/eahr.500109
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Article ; Online: Consent Builder

Sward, Katherine A / Enriquez, Rene / Burr, Jeri / Ozier, Julie / Roebuck, Megan / Elliott, Carrie / Dean, J Michael

JAMIA open

2022 Volume 5, Issue 3, Page(s) ooac069

Abstract: Objective: To describe process innovations related to research informed consent documents, and development and formative evaluation of : Materials and methods: Analysis of Institutional Review Board workflows and documents, followed by process ... ...

Abstract	Objective: To describe process innovations related to research informed consent documents, and development and formative evaluation of Materials and methods: Analysis of Institutional Review Board workflows and documents, followed by process redesign, document redesign, and software development. Locally developed software leverages REDCap and LaTeX. A small-scale usability study was conducted. Results: Process innovations were combining document types, and conceptualizing 2-part informed consent documents: part 1 standardizing the study description and part 2 with local site verbiage. Discussion: The process changes were generally well accepted. The software implementation uncovered un-accounted for assumptions, and variability in IRB review workflow across centers. Technical modifications may be needed before widespread implementation. Conclusion: We demonstrated proof-of-concept of an approach to generate research consent documents that are consistent across sites in study description, but which allow for customization of local site verbiage. The
Language	English
Publishing date	2022-07-27
Publishing country	United States
Document type	Journal Article
ISSN	2574-2531
ISSN (online)	2574-2531
DOI	10.1093/jamiaopen/ooac069
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Article ; Online: Using single IRB consultations to meet the educational needs of investigative teams.

Johnson, Ann R / Pautler, Mary / Burr, Jeri S / Abdelsamad, Nael / VanBuren, John M / Rigtrup, Lisa M / Dean, J Michael / Rothwell, Erin

Contemporary clinical trials communications

2022 Volume 29, Page(s) 100971

Abstract: Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the ... ...

Abstract	Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the written consultation materials and meeting minutes revealed the most common areas of education needed by investigative teams, including (a) the differences and relationships between the IRB and a Human Research Protection Program (HRPP); (b) the main phases of the SIRB process; and (c) the use of technology platforms for documentation of SIRB review processes. For investigative teams who are inexperienced with using a SIRB, such consultation in the pre-award period is likely to fill in knowledge gaps and improve the study start-up process.
Language	English
Publishing date	2022-08-11
Publishing country	Netherlands
Document type	Journal Article
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2022.100971
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Article ; Online: Development of a risk assessment and risk management tool for an academic research organization.

VanBuren, John M / Roalstad, Shelly / Kay, Marie T / Zuspan, Sally Jo / Dean, J Michael / Brulotte, Maryse

Contemporary clinical trials

2022 Volume 119, Page(s) 106812

Abstract: Background: In the past decade, regulatory agencies have released guidance around risk-based management with the goal of focusing on risks to critical aspects of a research study. Several tools have been developed aimed at implementing these guidelines. ...

Abstract	Background: In the past decade, regulatory agencies have released guidance around risk-based management with the goal of focusing on risks to critical aspects of a research study. Several tools have been developed aimed at implementing these guidelines. We designed a risk management tool to meet the demands of our academic data coordinating center. Methods: We developed the Risk Assessment and Risk Management (RARM) tool on three fundamental criteria of our risk/quality program: (1) Quality by Design concepts applies to all employees, regardless of the employee's role; (2) the RARM process must be economically feasible and dynamically flexible during the study startup and implementation process; and (3) responsibility of the RARM lay with the entire study team as opposed to a single quality expert. Results: The RARM tool has 20 elements for both risk assessment and risk management. The incorporation of both aspects of risk management allow for a seamless transition from identifying risks to actively monitoring risks throughout enrollment. Conclusion: The RARM tool achieves a simplified, seamless approach to risk assessment and risk management. The tool incorporates the concept of Quality by Design into daily work by having every team member contribute to the RARM tool. It also combines the risk assessment and risk management processes into a single tool which allows for a seamless transition from identifying risks to managing the risks throughout the life of the study. The instructions facilitate documentation of de-risking protocols early in development and the tool can be implemented in any platform and organization.
MeSH term(s)	Humans ; Risk Assessment ; Risk Management
Language	English
Publishing date	2022-05-31
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2182176-8
ISSN	1559-2030 ; 1551-7144
ISSN (online)	1559-2030
ISSN	1551-7144
DOI	10.1016/j.cct.2022.106812
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Article ; Online: Hypothermia after In-Hospital Cardiac Arrest in Children.

Moler, Frank W / Silverstein, Faye S / Dean, J Michael

The New England journal of medicine

2017 Volume 376, Issue 17, Page(s) 1696–1697

MeSH term(s)	Cardiopulmonary Resuscitation ; Child ; Heart Arrest ; Humans ; Hypothermia, Induced ; Treatment Outcome
Language	English
Publishing date	2017--27
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc1702364
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Article ; Online: A Randomized Clinical Trial Testing Hydroxychloroquine for Reduction of SARS-CoV-2 Viral Shedding and Hospitalization in Early Outpatient COVID-19 Infection.

Spivak, Adam M / Barney, Bradley J / Greene, Tom / Holubkov, Richard / Olsen, Cody S / Bridges, Jordan / Srivastava, Raj / Webb, Brandon / Sebahar, Frances / Huffman, Ainsley / Pacchia, Christina F / Dean, J Michael / Hess, Rachel

Microbiology spectrum

2023 , Page(s) e0467422

Abstract: Early in the COVID-19 pandemic, no effective treatment existed to prevent clinical worsening of COVID-19 among recently diagnosed outpatients. At the University of Utah, Salt Lake City, Utah, we conducted a phase 2 prospective parallel group randomized ... ...

Abstract	Early in the COVID-19 pandemic, no effective treatment existed to prevent clinical worsening of COVID-19 among recently diagnosed outpatients. At the University of Utah, Salt Lake City, Utah, we conducted a phase 2 prospective parallel group randomized placebo-controlled trial (NCT04342169) to determine whether hydroxychloroquine given early in disease reduces the duration of SARS-CoV-2 shedding. We enrolled nonhospitalized adults (≥18 years of age) with a recent positive diagnostic test for SARS-CoV-2 (within 72 h of enrollment) and adult household contacts. Participants received either 400 mg hydroxychloroquine by mouth twice daily on day 1 followed by 200 mg by mouth twice daily on days 2 to 5 or oral placebo with the same schedule. We performed SARS-CoV-2 nucleic acid amplification testing (NAAT) on oropharyngeal swabs on days 1 to 14 and 28 and monitored clinical symptomatology, rates of hospitalization, and viral acquisition by adult household contacts. We identified no overall differences in the duration of oropharyngeal carriage of SARS-CoV-2 (hazard ratio of viral shedding time comparing hydroxychloroquine to placebo, 1.21; 95% confidence interval [CI], 0.91, 1.62). Overall, 28-day hospitalization incidence was similar between treatments (4.6% hydroxychloroquine versus 2.7% placebo). No differences were seen in symptom duration, severity, or viral acquisition in household contacts between treatment groups. The study did not reach the prespecified enrollment target, which was likely influenced by a steep decline in COVID-19 incidence corresponding to the initial vaccine rollout in the spring of 2021. Oropharyngeal swabs were self-collected, which may introduce variability in these results. Placebo treatments were not identical to hydroxychloroquine treatments (capsules versus tablets) which may have led to inadvertent participant unblinding. In this group of community adults early in the COVID-19 pandemic, hydroxychloroquine did not significantly alter the natural history of early COVID-19 disease. (This study has been registered at ClinicalTrials.gov under registration no. NCT04342169).
Language	English
Publishing date	2023-03-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	2807133-5
ISSN	2165-0497 ; 2165-0497
ISSN (online)	2165-0497
ISSN	2165-0497
DOI	10.1128/spectrum.04674-22
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