Browsing by Author "Remy, Kenneth E."

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    Challenges in institutional ethical review process and approval for international multicenter clinical studies in lower and middle-income countries: the case of PARITY study
    (Frontiers Media, 2024-11-05) Lopez-Baron, Eliana; Abbas, Qalab; Caporal, Paula; Agulnik, Asya; Attebery, Jonah E.; Holloway, Adrian; Kissoon, Niranjan Tex; Mulgado-Aguas, Celia Isabel; Amegan-Aho, Kokou; Majdalani, Marianne; Ocampo, Carmen; Pascal, Havugarurema; Miller, Erika; Kanyamuhunga, Aimable; Tekleab, Atnafu Mekonnen; Bacha, Tigist; González-Dambrauskas, Sebastian; Bhutta, Adnan T.; Kortz, Teresa B.; Murthy, Srinivas; Remy, Kenneth E.; Global Health Subgroup of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network; Pediatrics, School of Medicine
    Background: One of the greatest challenges to conducting multicenter research studies in low and middle-income countries (LMICs) is the heterogeneity in regulatory processes across sites. Previous studies have reported variations in requirements with a lack of standardization in the Institutional Review Board (IRB) processes between centers, imposing barriers for approval, participation, and development of multicenter research. Objectives: To describe the regulatory process, variability and challenges faced by pediatric researchers in LMICs during the IRB process of an international multicenter observational point prevalence study (Global PARITY). Design: A 16-question multiple-choice online survey was sent to site principal investigators (PIs) at PARITY study participating centers to explore characteristics of the IRB process, costs, and barriers to research approval. A shorter survey was employed for sites that expressed interest in participating in Global PARITY and started the approval process, but ultimately did not participate in data collection (non-participating sites) to assess IRB characteristics. Results: Of the 91 sites that sought IRB approval, 46 were successful in obtaining approval and finishing the data collection process. The survey was completed by 46 (100%) participating centers and 21 (47%) non-participating centers. There was a significant difference between participating and non-participating sites in IRB approval of a waiver consent and in the requirement for a legal review of the protocol. The greatest challenge to research identified by non-participating sites was a lack of research time and the lack of institutional support. Conclusions: Global collaborative research is crucial to increase our understanding of pediatric critical care conditions in hospitals of all resource-levels and IRBs are required to ensure that this research complies with ethical standards. Critical barriers restrict research activities in some resource limiting countries. Increasing the efficiency and accessibility of local IRB review could greatly impact participation of resource limited sites and enrollment of vulnerable populations.
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    Changes in Pediatric ICU Utilization and Clinical Trends During the Coronavirus Pandemic
    (Elsevier, 2021) Zee-Cheng, Janine; McCluskey, Casey K.; Klein, Margaret J.; Scanlon, Matthew C.; Rotta, Alexandre T.; Shein, Steven L.; Pineda, Jose A.; Remy, Kenneth E.; Carroll, Christopher L.; Pediatrics, School of Medicine
    Background Children have been less affected by the COVID-19 pandemic, but its repercussions on pediatric illnesses may have been significant. This study examines the indirect impact of the pandemic on a population of critically ill children in the United States. Research Question Were there significantly fewer critically ill children admitted to PICUs during the second quarter of 2020, and were there significant changes in the types of diseases admitted? Study Design and Methods This retrospective observational cohort study used the Virtual Pediatric Systems database. Participants were 160,295 children admitted to the PICU at 77 sites in the United States during quarters 1 (Q1) and 2 (Q2) of 2017 to 2019 (pre-COVID-19) and 2020 (COVID-19). Results The average number of admissions was similar between pre-COVID-19 Q1 and COVID-19 Q1 but decreased by 32% from pre-COVID-19 Q2 to COVID-19 Q2 (20,157 to 13,627 admissions per quarter). The largest decreases were in respiratory conditions, including asthma (1,327 subjects in pre-COVID-19 Q2 (6.6% of patients) vs 241 subjects in COVID-19 Q2 (1.8%; P < .001) and bronchiolitis (1,299 [6.5%] vs 121 [0.9%]; P < .001). The percentage of trauma admissions increased, although the raw number of trauma admissions decreased. Admissions for diabetes mellitus and poisoning/ingestion also increased. In the multivariable model, illness severity-adjusted odds of ICU mortality for PICU patients during COVID-19 Q2 increased compared with pre-COVID-19 Q2 (OR, 1.165; 95% CI, 1.00-1.357; P = .049). Interpretation Pediatric critical illness admissions decreased substantially during the second quarter of 2020, with significant changes in the types of diseases seen in PICUs in the United States. There was an increase in mortality in children admitted to the PICU during this period.
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    Characteristics and Outcomes of Critically Ill Children With Multisystem Inflammatory Syndrome
    (Wolters Kluwer, 2022-11) Snooks, Kellie; Scanlon, Matthew C.; Remy, Kenneth E.; Shein, Steven L.; Klein , Margaret J.; Zee-Cheng, Janine; Rogerson, Colin M.; Rotta, Alexandre T.; Lin, Anna; McCluskey, Casey K.; Carroll , Christopher L.; Pediatrics, School of Medicine
    Objectives: To characterize the prevalence of pediatric critical illness from multisystem inflammatory syndrome in children (MIS-C) and to assess the influence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain on outcomes. Design: Retrospective cohort study. Setting: Database evaluation using the Virtual Pediatric Systems Database. Patients: All children with MIS-C admitted to the PICU in 115 contributing hospitals between January 1, 2020, and June 30, 2021. Measurements and Main Results: Of the 145,580 children admitted to the PICU during the study period, 1,338 children (0.9%) were admitted with MIS-C with the largest numbers of children admitted in quarter 1 (Q1) of 2021 (n = 626). The original SARS-CoV-2 viral strain and the D614G Strain were the predominant strains through 2020, with Alpha B.1.1.7 predominating in Q1 and quarter 2 (Q2) of 2021. Overall, the median PICU length of stay (LOS) was 2.7 days (25–75% interquartile range [IQR], 1.6–4.7 d) with a median hospital LOS of 6.6 days (25–75% IQR, 4.7–9.3 d); 15.2% received mechanical ventilation with a median duration of mechanical ventilation of 3.1 days (25–75% IQR, 1.9–5.8 d), and there were 11 hospital deaths. During the study period, there was a significant decrease in the median PICU and hospital LOS and a decrease in the frequency of mechanical ventilation, with the most significant decrease occurring between quarter 3 and quarter 4 (Q4) of 2020. Children admitted to a PICU from the general care floor or from another ICU/step-down unit had longer PICU LOS than those admitted directly from an emergency department. Conclusions: Overall mortality from MIS-C was low, but the disease burden was high. There was a peak in MIS-C cases during Q1 of 2021, following a shift in viral strains in Q1 of 2021. However, an improvement in MIS-C outcomes starting in Q4 of 2020 suggests that viral strain was not the driving factor for outcomes in this population.
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    Epidemiology and Outcomes of SARS-CoV-2 Infection or Multisystem Inflammatory Syndrome in Children vs Influenza Among Critically Ill Children
    (American Medical Association, 2022-06-01) Shein, Steven L.; Carroll, Christopher L.; Remy, Kenneth E.; Rogerson, Colin M.; McCluskey, Casey K.; Lin, Anna; Rotta, Alexandre T.; Pediatrics, School of Medicine
    This cohort study compares the epidemiology and outcomes of patients in the pediatric intensive care unit with SARS-CoV-2–related disease during the first 15 months of the COVID-19 pandemic vs children with critical influenza prior to the pandemic.
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    Etiology of hospital mortality in children living in low- and middle-income countries: a systematic review and meta-analysis
    (Frontiers Media, 2024-06-07) Kortz, Teresa B.; Mediratta, Rishi P.; Smith, Audrey M.; Nielsen, Katie R.; Agulnik, Asya; Gordon Rivera, Stephanie; Reeves, Hailey; O'Brien, Nicole F.; Hau Lee, Jan; Abbas, Qalab; Attebery, Jonah E.; Bacha, Tigist; Bhutta, Emaan G.; Biewen, Carter J.; Camacho-Cruz, Jhon; Coronado Muñoz, Alvaro; deAlmeida, Mary L.; Owusu, Larko Domeryo; Fonseca, Yudy; Hooli, Shubhada; Wynkoop, Hunter; Leimanis-Laurens, Mara; Mally, Deogratius Nicholaus; McCarthy, Amanda M.; Mutekanga, Andrew; Pineda, Carol; Remy, Kenneth E.; Sanders, Sara C.; Tabor, Erica; Teixeira Rodrigues, Adriana; Yuee Wang, Justin Qi; Kissoon, Niranjan; Takwoingi, Yemisi; Wiens, Matthew O.; Bhutta, Adnan; Pediatrics, School of Medicine
    In 2019, 80% of the 7.4 million global child deaths occurred in low- and middle-income countries (LMICs). Global and regional estimates of cause of hospital death and admission in LMIC children are needed to guide global and local priority setting and resource allocation but are currently lacking. The study objective was to estimate global and regional prevalence for common causes of pediatric hospital mortality and admission in LMICs. We performed a systematic review and meta-analysis to identify LMIC observational studies published January 1, 2005-February 26, 2021. Eligible studies included: a general pediatric admission population, a cause of admission or death, and total admissions. We excluded studies with data before 2,000 or without a full text. Two authors independently screened and extracted data. We performed methodological assessment using domains adapted from the Quality in Prognosis Studies tool. Data were pooled using random-effects models where possible. We reported prevalence as a proportion of cause of death or admission per 1,000 admissions with 95% confidence intervals (95% CI). Our search identified 29,637 texts. After duplicate removal and screening, we analyzed 253 studies representing 21.8 million pediatric hospitalizations in 59 LMICs. All-cause pediatric hospital mortality was 4.1% [95% CI 3.4%–4.7%]. The most common causes of mortality (deaths/1,000 admissions) were infectious [12 (95% CI 9–14)]; respiratory [9 (95% CI 5–13)]; and gastrointestinal [9 (95% CI 6–11)]. Common causes of admission (cases/1,000 admissions) were respiratory [255 (95% CI 231–280)]; infectious [214 (95% CI 193–234)]; and gastrointestinal [166 (95% CI 143–190)]. We observed regional variation in estimates. Pediatric hospital mortality remains high in LMICs. Global child health efforts must include measures to reduce hospital mortality including basic emergency and critical care services tailored to the local disease burden. Resources are urgently needed to promote equity in child health research, support researchers, and collect high-quality data in LMICs to further guide priority setting and resource allocation.
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    The Temporal Relationship Between Local School Closure and Increased Incidence of Pediatric Diabetic Ketoacidosis
    (Frontiers Media, 2022-03-11) McCluskey, Casey K.; Zee-Cheng, Janine E.; Klein, Margaret J.; Scanlon, Matthew C.; Rotta, Alexandre T.; Remy, Kenneth E.; Carroll, Christopher L.; Shein, Steven L.; Pediatrics, School of Medicine
    Importance: The incidence of pediatric diabetic ketoacidosis (DKA) increased early in the COVID-19 pandemic, but the relative contribution of behavioral changes and viral-related pathophysiology are unknown. Objective: To evaluate the relationship between school closure date and onset of increased DKA to help clarify the etiology of the increased incidence. Design: A multi-center, quality-controlled Pediatric Intensive Care Unit (PICU) database was used to identify the number of admissions to a participating PICU with DKA on each calendar day from 60 days before local school closure to 90 days after, and compared to baseline data from the same periods in 2018-2019. Interrupted time series and multiple linear regression analyses were used to identify admission rates that differed significantly between 2020 and baseline. Setting: Eighty-one PICUs in the United StatesParticipants: Children ages 29 days to 17 years admitted to a PICU with DKAExposures: Statewide school closureMain outcome/measure: Rate of admission to the PICU for DKA. Results: There were 1936 admissions for children with DKA in 2020 and 1795 admissions/year to those same PICUs in 2018-2019. Demographics and clinical outcomes did not differ before school closure, but pandemic-era patients were less often white and had longer hospital length of stay in the post-school closure period. The difference between 2020 admissions and 2018-2019 admissions was not different than zero before school closure, and significantly higher than zero after school closure, but was significantly increased in 2020 at >30 days after school closure (p = 0.039). Conclusions/relevance: An increase in pediatric DKA admissions began one month after school closures. Given that behavioral changes started near school closure dates and viral activity peaked weeks after, this suggests that behavioral factors may not be the primary etiology and it is possible that SARS-CoV-2 infection may have direct effects on pediatric DKA.