This page has only limited features, please log in for full access.
Dr. Freedman is Professor of Pediatrics and Emergency Medicine at the University of Calgary. He completed his residency at The Hospital for Sick Children (Toronto) in 2000 and a pediatric emergency medicine fellowship in 2003 at Children’s Memorial Hospital (Chicago). He obtained a Master’s of Science in Clinical Investigation at Northwestern University. He is currently the Past-Chair of Pediatric Emergency Research Canada and has been the Alberta Children’s Hospital Foundation Professor in Child Health and Wellness since 2016. His research focus is on applying clinical research to improve outcomes in children seeking emergency department care. His focus is on the use of innovative, multidisciplinary approaches to solve complex problems. He has published over 150 peer-reviewed manuscripts and is the principal investigator on numerous multicentre clinical trials with funding support from CIHR and the NIH. Most recently he has received CIHR funding to lead two multi-national study of pediatric COVID-19 disease.
Objective To determine if low household income is associated with disease severity following emergency department (ED) discharge in children with acute gastroenteritis (AGE). Methods We conducted a secondary analysis employing data collected in ten US-based tertiary-care, pediatric EDs between 2014 and 2017. Participants were aged 3–48 months and presented for care due to AGE. Income status was defined based on 1)home ZIP Code median annual home income and 2)percentage of home ZIP Code households below the poverty threshold. The primary outcome was moderate-to-severe AGE, defined by a post-ED visit Modified Vesikari Scale (MVS) score ≥9. Secondary outcomes included in-person revisits, revisits with intravenous rehydration, hospitalization, and etiologic pathogens. Results 943 (97%) participants with a median age of 17 months (IQR 10, 28) completed follow-up. Post-ED visit MVS scores were lower for the lowest household income group (adjusted: -0.59; 95%CI: -1.09, -0.08). Odds of experiencing an MVS score ≥9 did not differ between groups (adjusted OR: 0.91; 95%CI: 0.53, 1.56). No difference in the post-ED visit MVS score or the proportion of participants with scores ≥9 were observed using the national poverty threshold definition. For both income definitions, there were no differences in terms of revisits following discharge, hospitalizations and intravenous rehydration. Bacterial enteropathogens were more commonly identified in the lowest socio-economic group using both definitions. Conclusions Lower household income was not associated with increased disease severity or resource use. Economic disparities do not appear to result in differences in the disease course of children with AGE seeking ED care.
Thomas H. Chun; David Schnadower; T. Charles Casper; Robert Sapién; Phillip I. Tarr; Karen O'Connell; Cindy Roskind; Alexander Rogers; Seema Bhatt; Prashant Mahajan; Cheryl Vance; Cody S. Olsen; Elizabeth C. Powell; Stephen B. Freedman. Lack of Association of Household Income and Acute Gastroenteritis Disease Severity in Young Children: A Cohort Study. Academic Pediatrics 2021, 1 .
AMA StyleThomas H. Chun, David Schnadower, T. Charles Casper, Robert Sapién, Phillip I. Tarr, Karen O'Connell, Cindy Roskind, Alexander Rogers, Seema Bhatt, Prashant Mahajan, Cheryl Vance, Cody S. Olsen, Elizabeth C. Powell, Stephen B. Freedman. Lack of Association of Household Income and Acute Gastroenteritis Disease Severity in Young Children: A Cohort Study. Academic Pediatrics. 2021; ():1.
Chicago/Turabian StyleThomas H. Chun; David Schnadower; T. Charles Casper; Robert Sapién; Phillip I. Tarr; Karen O'Connell; Cindy Roskind; Alexander Rogers; Seema Bhatt; Prashant Mahajan; Cheryl Vance; Cody S. Olsen; Elizabeth C. Powell; Stephen B. Freedman. 2021. "Lack of Association of Household Income and Acute Gastroenteritis Disease Severity in Young Children: A Cohort Study." Academic Pediatrics , no. : 1.
Objectives The Pediatric Emergency Research Network (PERN) was launched in 2009 with the intent for existing national and regional research networks in pediatric emergency care to organize globally for the conduct of collaborative research across networks. Methods The Pediatric Emergency Research Network has grown from 5- to 8-member networks over the past decade. With an executive committee comprising representatives from all member networks, PERN plays a supportive and collaborative rather than governing role. The full impact of PERN's facilitation of international collaborative research, although somewhat difficult to quantify empirically, can be measured indirectly by the observed growth of the field, the nature of the increasingly challenging research questions now being addressed, and the collective capacity to generate and implement new knowledge in treating acutely ill and injured children. Results Beginning as a pandemic response with a high-quality retrospective case-controlled study of H1N1 influenza risk factors, PERN research has progressed to multiple observational studies and ongoing global randomized controlled trials. As a recent example, PERN has developed sufficient network infrastructure to enable the rapid initiation of a prospective observational study in response to the current coronavirus disease 2019 pandemic. In light of the ongoing need for translation of research knowledge into equitable clinical practice and to promote health equity, PERN is committed to a coordinated international effort to increase the uptake of evidence-based management of common and treatable acute conditions in all emergency department settings. Conclusions The Pediatric Emergency Research Network's successes with global research, measured by prospective observational and interventional studies, mean that the network can now move to improve its ability to promote the implementation of scientific advances into everyday clinical practice. Achieving this goal will involve focus in 4 areas: (1) expanding the capacity for global randomized controlled trials; (2) deepening the focus on implementation science; (3) increasing attention to healthcare disparities and their origins, with growing momentum toward equity; and (4) expanding PERN's global reach through addition of sites and networks from resource-restricted regions. Through these actions, PERN will be able to build on successes to face the challenges ahead and meet the needs of acutely ill and injured children throughout the world.
Terry Klassen; Stuart R. Dalziel; Franz E. Babl; Javier Benito; Silvia Bressan; James Chamberlain; Todd P. Chang; Stephen B. Freedman; Guillermo Kohn-Loncarica; Mark D. Lyttle; Santiago Mintegi; Rakesh D. Mistry; Lise E. Nigrovic; Rianne Oostenbrink; Amy C. Plint; Pedro Rino; Damian Roland; Gregory Van De Mosselaer; Nathan Kuppermann. The Pediatric Emergency Research Network. Pediatric Emergency Care 2021, Publish Ah, 389 -396.
AMA StyleTerry Klassen, Stuart R. Dalziel, Franz E. Babl, Javier Benito, Silvia Bressan, James Chamberlain, Todd P. Chang, Stephen B. Freedman, Guillermo Kohn-Loncarica, Mark D. Lyttle, Santiago Mintegi, Rakesh D. Mistry, Lise E. Nigrovic, Rianne Oostenbrink, Amy C. Plint, Pedro Rino, Damian Roland, Gregory Van De Mosselaer, Nathan Kuppermann. The Pediatric Emergency Research Network. Pediatric Emergency Care. 2021; Publish Ah (7):389-396.
Chicago/Turabian StyleTerry Klassen; Stuart R. Dalziel; Franz E. Babl; Javier Benito; Silvia Bressan; James Chamberlain; Todd P. Chang; Stephen B. Freedman; Guillermo Kohn-Loncarica; Mark D. Lyttle; Santiago Mintegi; Rakesh D. Mistry; Lise E. Nigrovic; Rianne Oostenbrink; Amy C. Plint; Pedro Rino; Damian Roland; Gregory Van De Mosselaer; Nathan Kuppermann. 2021. "The Pediatric Emergency Research Network." Pediatric Emergency Care Publish Ah, no. 7: 389-396.
Objectives The aim of this study was to quantify the effect of the COVID-19 pandemic on pediatric emergency department (ED) utilization and outcomes. Methods This study is an interrupted-time-series observational study of children presenting to 11 Canadian tertiary-care pediatric EDs. Data were grouped into weeks in 3 study periods: prepandemic (January 1, 2018–January 27, 2020), peripandemic (January 28, 2020–March 10, 2020), and early pandemic (March 11, 2020–April 30, 2020). These periods were compared with the same time intervals in the 2 preceding calendar years. Primary outcomes were number of ED visits per week. The secondary outcomes were triage acuity, hospitalization, intensive care unit (ICU) admission, mortality, length of hospital stay, ED revisits, and visits for trauma and mental health concerns. Results There were 577,807 ED visits (median age, 4.5 years; 52.9% male). Relative to the prepandemic period, there was a reduction [−58%; 95% confidence interval (CI), −63% to −51%] in the number of ED visits during the early-pandemic period, with concomitant higher acuity. There was a concurrent increase in the proportion of ward [odds ratio (OR), 1.39; 95% CI, 1.32–1.45] and intensive care unit (OR, 1.20; 95% CI, 1.01–1.42) admissions, and trauma-related ED visits among children less than 10 years (OR, 1.51; 95% CI, 1.45–1.56). Mental health–related visits in children declined in the early-pandemic period (in <10 years, −60%; 95% CI, −67% to −51%; in children ≥10 years: −56%; 95% CI, −63% to −47%) relative to the pre–COVID-19 period. There were no differences in mortality or length of stay; however, ED revisits within 72 hours were reduced during the early-pandemic period (percent change: −55%; 95% CI, −61% to −49%; P < 0.001). Conclusions After the declaration of the COVID-19 pandemic, dramatic reductions in pediatric ED visits occurred across Canada. Children seeking ED care were sicker, and there was an increase in trauma-related visits among children more than 10 years of age, whereas mental health visits declined during the early-pandemic period. When faced with a future pandemic, public health officials must consider the impact of the illness and the measures implemented on children's health and acute care needs.
Yaron Finkelstein; Bryan Maguire; Roger Zemek; Esli Osmanlliu; April J. Kam; Andrew Dixon; Neil Desai; Scott Sawyer; Jason Emsley; Tim Lynch; Ahmed Mater; Suzanne Schuh; Maggie Rumantir; Stephen B. Freedman. Effect of the COVID-19 Pandemic on Patient Volumes, Acuity, and Outcomes in Pediatric Emergency Departments. Pediatric Emergency Care 2021, Publish Ah, 427 -434.
AMA StyleYaron Finkelstein, Bryan Maguire, Roger Zemek, Esli Osmanlliu, April J. Kam, Andrew Dixon, Neil Desai, Scott Sawyer, Jason Emsley, Tim Lynch, Ahmed Mater, Suzanne Schuh, Maggie Rumantir, Stephen B. Freedman. Effect of the COVID-19 Pandemic on Patient Volumes, Acuity, and Outcomes in Pediatric Emergency Departments. Pediatric Emergency Care. 2021; Publish Ah (8):427-434.
Chicago/Turabian StyleYaron Finkelstein; Bryan Maguire; Roger Zemek; Esli Osmanlliu; April J. Kam; Andrew Dixon; Neil Desai; Scott Sawyer; Jason Emsley; Tim Lynch; Ahmed Mater; Suzanne Schuh; Maggie Rumantir; Stephen B. Freedman. 2021. "Effect of the COVID-19 Pandemic on Patient Volumes, Acuity, and Outcomes in Pediatric Emergency Departments." Pediatric Emergency Care Publish Ah, no. 8: 427-434.
BACKGROUND: Between-country variation in health care resource use and its impact on outcomes in acute care settings have been challenging to disentangle from illness severity by using administrative data. METHODS: We conducted a preplanned analysis employing patient-level emergency department (ED) data from children enrolled in 2 previously conducted clinical trials. Participants aged 3 to <48 months with <72 hours of gastroenteritis were recruited in pediatric EDs in the United States (N = 10 sites; 588 participants) and Canada (N = 6 sites; 827 participants). The primary outcome was an unscheduled health care provider visit within 7 days; the secondary outcomes were intravenous fluid administration and hospitalization at or within 7 days of the index visit. RESULTS: In adjusted analysis, unscheduled revisits within 7 days did not differ (adjusted odds ratio [aOR]: 0.72; 95% confidence interval (CI): 0.50 to 1.02). At the index ED visit, although participants in Canada were assessed as being more dehydrated, intravenous fluids were administered more frequently in the United States (aOR: 4.6; 95% CI: 2.9 to 7.1). Intravenous fluid administration rates did not differ after enrollment (aOR: 1.4; 95% CI: 0.7 to 2.8; US cohort with Canadian as referent). Overall, intravenous rehydration was higher in the United States (aOR: 3.8; 95% CI: 2.5 to 5.7). Although hospitalization rates during the 7 days after enrollment (aOR: 1.1; 95% CI: 0.4 to 2.6) did not differ, hospitalization at the index visit was more common in the United States (3.9% vs 2.3%; aOR: 3.2; 95% CI: 1.6 to 6.8). CONCLUSIONS: Among children with gastroenteritis and similar disease severity, revisit rates were similar in our 2 study cohorts, despite lower rates of intravenous rehydration and hospitalization in Canadian-based EDs.
Stephen B. Freedman; Cindy G. Roskind; Suzanne Schuh; John M. VanBuren; Jesse G. Norris; Phillip I. Tarr; Katrina Hurley; Adam C. Levine; Alexander Rogers; Seema Bhatt; Serge Gouin; Prashant Mahajan; Cheryl Vance; Elizabeth C. Powell; Ken J. Farion; Robert Sapien; Karen O’Connell; Naveen Poonai; David Schnadower. Comparing Pediatric Gastroenteritis Emergency Department Care in Canada and the United States. Pediatrics 2021, 147, 1 .
AMA StyleStephen B. Freedman, Cindy G. Roskind, Suzanne Schuh, John M. VanBuren, Jesse G. Norris, Phillip I. Tarr, Katrina Hurley, Adam C. Levine, Alexander Rogers, Seema Bhatt, Serge Gouin, Prashant Mahajan, Cheryl Vance, Elizabeth C. Powell, Ken J. Farion, Robert Sapien, Karen O’Connell, Naveen Poonai, David Schnadower. Comparing Pediatric Gastroenteritis Emergency Department Care in Canada and the United States. Pediatrics. 2021; 147 (6):1.
Chicago/Turabian StyleStephen B. Freedman; Cindy G. Roskind; Suzanne Schuh; John M. VanBuren; Jesse G. Norris; Phillip I. Tarr; Katrina Hurley; Adam C. Levine; Alexander Rogers; Seema Bhatt; Serge Gouin; Prashant Mahajan; Cheryl Vance; Elizabeth C. Powell; Ken J. Farion; Robert Sapien; Karen O’Connell; Naveen Poonai; David Schnadower. 2021. "Comparing Pediatric Gastroenteritis Emergency Department Care in Canada and the United States." Pediatrics 147, no. 6: 1.
Background As children with isolated vomiting are rarely able to provide a specimen suitable for routine pathogen testing, we have limited knowledge about their infecting pathogens. Methods Between December 2014 and August 2018, children <18 years old with presumed acute gastroenteritis who presented to 2 emergency departments (EDs) in Alberta, Canada, were recruited. Eligible participants had ≥3 episodes of vomiting and/or diarrhea in a 24-hour period, <7 days of symptoms, and provided a rectal swab or stool specimen. We quantified the proportion of children with isolated vomiting in whom an enteropathogen was identified, and analyzed clinical characteristics, types of enteropathogens, resources used, and alternative diagnoses. Results Of the 2695 participants, at the ED visit, 295 (10.9%), 1321 (49.0%), and 1079 (40.0%) reported having isolated diarrhea, vomiting and diarrhea, or isolated vomiting, respectively. An enteropathogen was detected most commonly in those with vomiting and diarrhea (1067/1321; 80.8%); detection did not differ between those with isolated diarrhea (170/295; 57.6%) and isolated vomiting (589/1079; 54.6%) (95% confidence interval of the difference: −3.4%, 9.3%). Children with isolated vomiting most often had a virus (557/1077; 51.7%), most commonly norovirus (321/1077; 29.8%); 5.7% (62/1079) had a bacterial pathogen. X-rays, ultrasounds, and urine tests were most commonly performed in children with isolated vomiting. Alternate etiologies were most common in those with isolated vomiting (5.7%; 61/1079). Conclusions The rate of enteropathogen identification in children with isolated vomiting using molecular diagnostic tests and rectal swabs is substantial. Molecular diagnostics offer an emerging diagnostic strategy in children with isolated vomiting.
Stephen B Freedman; Jianling Xie; Bonita E Lee; Samina Ali; Xiao-Li Pang; Linda Chui; Ran Zhuo; Otto G Vanderkooi; Raymond Tellier; Anna L Funk; Phillip I Tarr. Microbial Etiologies and Clinical Characteristics of Children Seeking Emergency Department Care Due to Vomiting in the Absence of Diarrhea. Clinical Infectious Diseases 2021, 1 .
AMA StyleStephen B Freedman, Jianling Xie, Bonita E Lee, Samina Ali, Xiao-Li Pang, Linda Chui, Ran Zhuo, Otto G Vanderkooi, Raymond Tellier, Anna L Funk, Phillip I Tarr. Microbial Etiologies and Clinical Characteristics of Children Seeking Emergency Department Care Due to Vomiting in the Absence of Diarrhea. Clinical Infectious Diseases. 2021; ():1.
Chicago/Turabian StyleStephen B Freedman; Jianling Xie; Bonita E Lee; Samina Ali; Xiao-Li Pang; Linda Chui; Ran Zhuo; Otto G Vanderkooi; Raymond Tellier; Anna L Funk; Phillip I Tarr. 2021. "Microbial Etiologies and Clinical Characteristics of Children Seeking Emergency Department Care Due to Vomiting in the Absence of Diarrhea." Clinical Infectious Diseases , no. : 1.
While electrolyte maintenance solution is recommended and commonly used in pediatric gastroenteritis, it can be more costly and less palatable than preferred fluids such as apple juice. To assess the incremental cost-effectiveness of apple juice/preferred fluids versus electrolyte maintenance solution in reducing treatment failures in children in an emergency department from societal and health care perspectives. A probabilistic cost-effectiveness analysis was performed using clinical trial and chart data. All intervention, and direct and indirect costs were included, with a 14-day time horizon. Cost-effectiveness was examined by calculating the difference in mean number of treatment failures and mean cost/patient between treatment groups. The probabilistic point estimate and 95% confidence intervals for incremental costs and incremental effectiveness were determined. The apple juice strategy was less costly than electrolytes with average per child savings of CAD $171 (95% CI $22 to $1097) from a societal perspective, and $147 (95% CI $23 to $1056) from a health care perspective. There were 0.08 fewer treatment failures per child (95% CI − 0.15 to − 0.02). The higher electrolyte maintenance solution cost was due to more frequent hospitalizations, ongoing care, and greater lost parental productivity due to additional medical visits. Apple juice/preferred fluids strategy was dominant over electrolytes in the treatment of children with minimal dehydration secondary to acute gastroenteritis as this option yielded fewer treatment failures and a lower societal cost. Given the high prevalence of acute gastroenteritis, this approach may result in significant cost savings while leading to improved clinical outcomes.
Myla E. Moretti; Wendy J. Ungar; Stephen B. Freedman; Suzanne Schuh. Cost-effectiveness of preferred fluids versus electrolytes in pediatric gastroenteritis. Canadian Journal of Emergency Medicine 2021, 1 -9.
AMA StyleMyla E. Moretti, Wendy J. Ungar, Stephen B. Freedman, Suzanne Schuh. Cost-effectiveness of preferred fluids versus electrolytes in pediatric gastroenteritis. Canadian Journal of Emergency Medicine. 2021; ():1-9.
Chicago/Turabian StyleMyla E. Moretti; Wendy J. Ungar; Stephen B. Freedman; Suzanne Schuh. 2021. "Cost-effectiveness of preferred fluids versus electrolytes in pediatric gastroenteritis." Canadian Journal of Emergency Medicine , no. : 1-9.
IntroductionRelatively limited data are available regarding paediatric COVID-19. Although most children appear to have mild or asymptomatic infections, infants and those with comorbidities are at increased risk of experiencing more severe illness and requiring hospitalisation due to COVID-19. The recent but uncommon association of SARS-CoV-2 infection with development of a multisystem inflammatory syndrome has heightened the importance of understanding paediatric SARS-CoV-2 infection.Methods and analysisThe Paediatric Emergency Research Network-COVID-19 cohort study is a rapid, global, prospective cohort study enrolling 12 500 children who are tested for acute SARS-CoV-2 infection. 47 emergency departments across 12 countries on four continents will participate. At enrolment, regardless of SARS-CoV-2 test results, all children will have the same information collected, including clinical, epidemiological, laboratory, imaging and outcome data. Interventions and outcome data will be collected for hospitalised children. For all children, follow-up at 14 and 90 days will collect information on further medical care received, and long-term sequelae, respectively. Statistical models will be designed to identify risk factors for infection and severe outcomes.Ethics and disseminationSites will seek ethical approval locally, and informed consent will be obtained. There is no direct risk or benefit of study participation. Weekly interim analysis will allow for real-time data sharing with regional, national, and international policy makers. Harmonisation and sharing of investigation materials with WHO, will contribute to synergising global efforts for the clinical characterisation of paediatric COVID-19. Our findings will enable the implementation of countermeasures to reduce viral transmission and severe COVID-19 outcomes in children.Trial registration numberNCT04330261
Anna L. Funk; Todd A. Florin; Stuart R. Dalziel; Santiago Mintegi; Marina I. Salvadori; Daniel Joseph Tancredi; Mark I. Neuman; Daniel C. Payne; Amy C. Plint; Terry P. Klassen; Richard Malley; Lilliam Ambroggio; Kelly Kim; Nathan Kuppermann; Stephen B. Freedman. Prospective cohort study of children with suspected SARS-CoV-2 infection presenting to paediatric emergency departments: a Paediatric Emergency Research Networks (PERN) Study Protocol. BMJ Open 2021, 11, e042121 .
AMA StyleAnna L. Funk, Todd A. Florin, Stuart R. Dalziel, Santiago Mintegi, Marina I. Salvadori, Daniel Joseph Tancredi, Mark I. Neuman, Daniel C. Payne, Amy C. Plint, Terry P. Klassen, Richard Malley, Lilliam Ambroggio, Kelly Kim, Nathan Kuppermann, Stephen B. Freedman. Prospective cohort study of children with suspected SARS-CoV-2 infection presenting to paediatric emergency departments: a Paediatric Emergency Research Networks (PERN) Study Protocol. BMJ Open. 2021; 11 (1):e042121.
Chicago/Turabian StyleAnna L. Funk; Todd A. Florin; Stuart R. Dalziel; Santiago Mintegi; Marina I. Salvadori; Daniel Joseph Tancredi; Mark I. Neuman; Daniel C. Payne; Amy C. Plint; Terry P. Klassen; Richard Malley; Lilliam Ambroggio; Kelly Kim; Nathan Kuppermann; Stephen B. Freedman. 2021. "Prospective cohort study of children with suspected SARS-CoV-2 infection presenting to paediatric emergency departments: a Paediatric Emergency Research Networks (PERN) Study Protocol." BMJ Open 11, no. 1: e042121.
The objective of this study was to characterize the etiological role of human adenovirus (HAdV) serotypes in pediatric gastroenteritis. Using a case-control design, we compared the frequencies of HAdV serotypes between children with ≥3 episodes of vomiting or diarrhea within 24 h and <7 days of symptoms (i.e., cases) and those with no infectious symptoms (i.e., controls). Stool samples and/or rectal swabs underwent molecular serotyping with cycle threshold (Ct) values provided by multiplex real-time reverse transcription-PCR testing.
Kanti Pabbaraju; Raymond Tellier; Xiao-Li Pang; Jianling Xie; Bonita E. Lee; Linda Chui; Ran Zhuo; Otto G. Vanderkooi; Samina Ali; Phillip I. Tarr; Anna Funk; Stephen B. Freedman. A Clinical Epidemiology and Molecular Attribution Evaluation of Adenoviruses in Pediatric Acute Gastroenteritis: a Case-Control Study. Journal of Clinical Microbiology 2020, 59, 1 .
AMA StyleKanti Pabbaraju, Raymond Tellier, Xiao-Li Pang, Jianling Xie, Bonita E. Lee, Linda Chui, Ran Zhuo, Otto G. Vanderkooi, Samina Ali, Phillip I. Tarr, Anna Funk, Stephen B. Freedman. A Clinical Epidemiology and Molecular Attribution Evaluation of Adenoviruses in Pediatric Acute Gastroenteritis: a Case-Control Study. Journal of Clinical Microbiology. 2020; 59 (1):1.
Chicago/Turabian StyleKanti Pabbaraju; Raymond Tellier; Xiao-Li Pang; Jianling Xie; Bonita E. Lee; Linda Chui; Ran Zhuo; Otto G. Vanderkooi; Samina Ali; Phillip I. Tarr; Anna Funk; Stephen B. Freedman. 2020. "A Clinical Epidemiology and Molecular Attribution Evaluation of Adenoviruses in Pediatric Acute Gastroenteritis: a Case-Control Study." Journal of Clinical Microbiology 59, no. 1: 1.
IntroductionChildren and youth with mental health and addiction crises are a vulnerable patient group that often are brought to the hospital for emergency department care. We propose to evaluate the effect of a novel, acute care bundle that standardises a patient-centred approach to care.Methods and analysisTwo paediatric emergency departments in Alberta, Canada are involved in this prospective, pragmatic, 29-month interventional quasi-experimental study. The acute care bundle comprises three components, applied when appropriate: (1) assessing self-harm risk at triage using the Ask Suicide-Screening Questionnaire (ASQ) to standardise the questions administered, enabling risk stratification; (2) use of the HEADS-ED (Home, Education, Activities/peers, Drug/alcohol, Suicidality, Emotions and behaviour, Discharge Resources) to focus mental health evaluations for those who screen high risk on the ASQ; and (3) implementation of a Choice And Partnership Approach to enable shared decision making in care following the emergency department visit. The overarching goal is to deliver the right care at the right place and time for the patients. The study design involves a longitudinal collection of data 12 months before and after the introduction of the bundle and the use of quality improvement strategies such as Plan-Do-Study-Act cycles during a 5-month run-in period to test and implement changes. The primary study end-point is child/youth well-being 1 month after the emergency department visit. Secondary outcomes include family functioning, child/youth well-being at 3 and 6 months, satisfaction with emergency department care, and health system outcomes (hospital admissions, length of emergency department stays, emergency department revisits).Ethics and disseminationThe study is registered at www.ClinicalTrials.gov and has received ethics and operational approvals from study sites. The results of the study will be reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology statement. Results will be shared broadly with key policy and decision makers and disseminated in peer-reviewed academic journals and presentations at conferences.Trial registration numberNCT04292379.
Stephen Freedman; Jennifer Thull-Freedman; Teresa Lightbody; Kassi Prisnie; Bruce Wright; Angela Coulombe; Linda M Anderson; Antonia S Stang; Angelo Mikrogianakis; Lindy VanRiper; Michael Stubbs; Amanda Newton. Introducing an innovative model of acute paediatric mental health and addictions care to paediatric emergency departments: a protocol for a multicentre prospective cohort study. BMJ Open Quality 2020, 9, e001106 .
AMA StyleStephen Freedman, Jennifer Thull-Freedman, Teresa Lightbody, Kassi Prisnie, Bruce Wright, Angela Coulombe, Linda M Anderson, Antonia S Stang, Angelo Mikrogianakis, Lindy VanRiper, Michael Stubbs, Amanda Newton. Introducing an innovative model of acute paediatric mental health and addictions care to paediatric emergency departments: a protocol for a multicentre prospective cohort study. BMJ Open Quality. 2020; 9 (4):e001106.
Chicago/Turabian StyleStephen Freedman; Jennifer Thull-Freedman; Teresa Lightbody; Kassi Prisnie; Bruce Wright; Angela Coulombe; Linda M Anderson; Antonia S Stang; Angelo Mikrogianakis; Lindy VanRiper; Michael Stubbs; Amanda Newton. 2020. "Introducing an innovative model of acute paediatric mental health and addictions care to paediatric emergency departments: a protocol for a multicentre prospective cohort study." BMJ Open Quality 9, no. 4: e001106.
Background Gastroenteritis is a common and impactful disease in childhood. Probiotics are often used to treat acute gastroenteritis (AGE); however, in a large multicenter randomized controlled trial (RCT) in 971 children, Lactobacillus rhamnosus GG (LGG) was no better than placebo in improving patient outcomes. Objectives We sought to determine whether the effect of LGG is associated with age, weight z score and weight percentile adjusted for age and sex, or dose per kilogram administered. Methods This was a preplanned secondary analysis of a multicenter double-blind RCT of LGG 1 × 1010 CFU twice daily for 5 d or placebo in children 3–48 mo of age with AGE. Our primary outcome was moderate to severe gastroenteritis. Secondary outcomes included diarrhea and vomiting frequency and duration, chronic diarrhea, and side effects. We used multivariable linear and nonlinear models testing for interaction effects to assess outcomes by age, weight z score and weight percentile adjusted for age and sex, and dose per kilogram of LGG received. Results A total of 813 children (84%) were included in the analysis; 413 received placebo and 400 LGG. Baseline characteristics were similar between treatment groups. There were no differential interaction effects across ranges of age (P-interaction = 0.32), adjusted weight z score (P-interaction = 0.43), adjusted weight percentile (P-interaction = 0.45), or dose per kilogram of LGG received (P-interaction = 0.28) for the primary outcome. Whereas we found a statistical association favoring placebo at the extremes of adjusted weight z scores for the number of vomiting episodes (P-interaction = 0.02) and vomiting duration (P-interaction = 0.0475), there were no statistically significant differences in other secondary outcome measures (all P-interactions > 0.05). Conclusions LGG does not improve outcomes in children with AGE regardless of the age, adjusted weight z score, and adjusted weight percentile of participants, or the probiotic dose per kilogram received. These results further strengthen the conclusions of low risk of bias clinical trials which demonstrate that LGG provides no clinical benefit in children with AGE. This trial was registered at clinicaltrials.gov as NCT01773967.
David Schnadower; Robert E Sapien; T Charles Casper; Cheryl Vance; Phillip I Tarr; Karen J O'connell; Adam C Levine; Cindy G Roskind; Alexander J Rogers; Seema R Bhatt; Prashant Mahajan; Elizabeth C Powell; Cody S Olsen; Marc H Gorelick; J Michael Dean; Stephen B Freedman; for the Pediatric Emergency Care Applied Research Network (PECARN) Probiotics Study. Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis. The Journal of Nutrition 2020, 151, 65 -72.
AMA StyleDavid Schnadower, Robert E Sapien, T Charles Casper, Cheryl Vance, Phillip I Tarr, Karen J O'connell, Adam C Levine, Cindy G Roskind, Alexander J Rogers, Seema R Bhatt, Prashant Mahajan, Elizabeth C Powell, Cody S Olsen, Marc H Gorelick, J Michael Dean, Stephen B Freedman, for the Pediatric Emergency Care Applied Research Network (PECARN) Probiotics Study. Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis. The Journal of Nutrition. 2020; 151 (1):65-72.
Chicago/Turabian StyleDavid Schnadower; Robert E Sapien; T Charles Casper; Cheryl Vance; Phillip I Tarr; Karen J O'connell; Adam C Levine; Cindy G Roskind; Alexander J Rogers; Seema R Bhatt; Prashant Mahajan; Elizabeth C Powell; Cody S Olsen; Marc H Gorelick; J Michael Dean; Stephen B Freedman; for the Pediatric Emergency Care Applied Research Network (PECARN) Probiotics Study. 2020. "Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis." The Journal of Nutrition 151, no. 1: 65-72.
Norovirus is a major pathogen identified in children with acute gastroenteritis (AGE), little is known about the strain’s diversity and their clinical severity. Stool and/or rectal swabs were collected from children ≤18 years of age recruited at emergency departments (ED), and a provincial nursing advice phone line due to AGE symptoms in the province of Alberta, Canada between December 2014 and August 2018. Specimens were tested using a reverse transcription real time PCR and genotyped by Sanger sequencing. The Modified Vesikari Scale score (MVS) was used to evaluate the disease severity. The objectives are to identify the Genogroup and Genotype distribution and to compare illness severity between the GI and GII genogroups and to complete further analyses comparing the GII genotypes identified. GII.4 was the genotype most commonly identified. Children with GII.4 had higher MVS scores (12.0 (10.0, 14.0; p = 0.002)) and more prolonged diarrheal (5 days (3.0, 7.8)) and vomiting (3.2 days (1.7, 5.3; p< 0.001)) durations compared to other non GII.4 strains. The predominant strain varied by year with GII.4 Sydney[P31] predominant in 2014/15, GII.4 Sydney[P16] in 2015/16 and 2017/18, and GII.3[P12] in 2016/17. Genogroup II norovirus strains predominated in children with AGE with variance between years; clinical severity associated with different strains varied with episodes being most severe among GII.4 infected children.
Sudha Bhavanam; Stephen Freedman; Bonita Lee; Ran Zhuo; Yuanyuan Qiu; Linda Chui; Jianling Xie; Samina Ali; Otto Vanderkooi; Xiaoli Pang; on behalf of the Alberta Provincial Pediatric Enteric Infection Team (APPETITE). Differences in Illness Severity among Circulating Norovirus Genotypes in a Large Pediatric Cohort with Acute Gastroenteritis. Microorganisms 2020, 8, 1873 .
AMA StyleSudha Bhavanam, Stephen Freedman, Bonita Lee, Ran Zhuo, Yuanyuan Qiu, Linda Chui, Jianling Xie, Samina Ali, Otto Vanderkooi, Xiaoli Pang, on behalf of the Alberta Provincial Pediatric Enteric Infection Team (APPETITE). Differences in Illness Severity among Circulating Norovirus Genotypes in a Large Pediatric Cohort with Acute Gastroenteritis. Microorganisms. 2020; 8 (12):1873.
Chicago/Turabian StyleSudha Bhavanam; Stephen Freedman; Bonita Lee; Ran Zhuo; Yuanyuan Qiu; Linda Chui; Jianling Xie; Samina Ali; Otto Vanderkooi; Xiaoli Pang; on behalf of the Alberta Provincial Pediatric Enteric Infection Team (APPETITE). 2020. "Differences in Illness Severity among Circulating Norovirus Genotypes in a Large Pediatric Cohort with Acute Gastroenteritis." Microorganisms 8, no. 12: 1873.
Background Acute gastroenteritis is a leading cause of emergency department visits and hospitalizations among children in North America. Oral-rehydration therapy is recommended for children with mild-to-moderate dehydration, but children who present with vomiting are frequently offered intravenous rehydration in the emergency department (ED). Recent studies have demonstrated that the anti-emetic ondansetron can reduce vomiting, intravenous rehydration, and hospitalization when administered in the ED to children with dehydration. However, there is little evidence of additional benefit from prescribing ondansetron beyond the initial ED dose. Moreover, repeat dosing may increase the frequency of diarrhea. Despite the lack of evidence and potential adverse side effects, many physicians across North America provide multiple doses of ondansetron to be taken following ED disposition. Thus, the Multi-Dose Oral Ondansetron for Pediatric Gastroenteritis (DOSE-AGE) trial will evaluate the effectiveness of prescribing multiple doses of ondansetron to treat acute gastroenteritis-associated vomiting. This article specifies the statistical analysis plan (SAP) for the DOSE-AGE trial and was submitted before the outcomes of the study were available for analysis. Methods/design The DOSE-AGE study is a phase III, 6-center, placebo-controlled, double-blind, parallel design randomized controlled trial designed to determine whether participants who are prescribed multiple doses of oral ondansetron to administer, as needed, following their ED visit have a lower incidence of experiencing moderate-to-severe gastroenteritis, as measured by the Modified Vesikari Scale score, compared with a placebo. To assess safety, the DOSE-AGE trial will investigate the frequency and maximum number of diarrheal episodes following ED disposition, and the occurrence of palpitations, pre-syncope/syncope, chest pain, arrhythmias, and serious adverse events. For the secondary outcomes, the DOSE-AGE trial will investigate the individual elements of the Modified Vesikari Scale score and caregiver satisfaction with the therapy. Discussion The DOSE-AGE trial will provide evidence on the effectiveness of multiple doses of oral ondansetron, taken as needed, following an initial ED dose in children with acute gastroenteritis-associated vomiting. The data from the DOSE-AGE trial will be analyzed using this SAP. This will reduce the risk of producing data-driven results and bias in our reported outcomes. The DOSE-AGE study was registered on ClinicalTrials.gov on February 22, 2019. Trial registration ClinicalTrials.gov NCT03851835. Registered on 22 February 2019.
Anna Heath; Juan David Rios; Sarah Williamson-Urquhart; Petros Pechlivanoglou; Martin Offringa; Christopher McCabe; Gareth Hopkin; Amy C. Plint; Andrew Dixon; Darcy Beer; Serge Gouin; Gary Joubert; Terry P. Klassen; Stephen B. Freedman; Tannis Erickson; Rick Watts; Pam Marples; David Rios; Chris McCabe; Tremaine Rowe; Leslie Boisvert; Marie-Christine Auclair; Manasi Rajagopal; Mithra Sivakumar; Jeannine Schellenberg; on behalf of the PERC-KIDSCAN DOSE-AGE Study Group. A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan. Trials 2020, 21, 1 -8.
AMA StyleAnna Heath, Juan David Rios, Sarah Williamson-Urquhart, Petros Pechlivanoglou, Martin Offringa, Christopher McCabe, Gareth Hopkin, Amy C. Plint, Andrew Dixon, Darcy Beer, Serge Gouin, Gary Joubert, Terry P. Klassen, Stephen B. Freedman, Tannis Erickson, Rick Watts, Pam Marples, David Rios, Chris McCabe, Tremaine Rowe, Leslie Boisvert, Marie-Christine Auclair, Manasi Rajagopal, Mithra Sivakumar, Jeannine Schellenberg, on behalf of the PERC-KIDSCAN DOSE-AGE Study Group. A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan. Trials. 2020; 21 (1):1-8.
Chicago/Turabian StyleAnna Heath; Juan David Rios; Sarah Williamson-Urquhart; Petros Pechlivanoglou; Martin Offringa; Christopher McCabe; Gareth Hopkin; Amy C. Plint; Andrew Dixon; Darcy Beer; Serge Gouin; Gary Joubert; Terry P. Klassen; Stephen B. Freedman; Tannis Erickson; Rick Watts; Pam Marples; David Rios; Chris McCabe; Tremaine Rowe; Leslie Boisvert; Marie-Christine Auclair; Manasi Rajagopal; Mithra Sivakumar; Jeannine Schellenberg; on behalf of the PERC-KIDSCAN DOSE-AGE Study Group. 2020. "A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan." Trials 21, no. 1: 1-8.
Purpose of review The aim of this review is to provide an update of nonantibiotic therapies for acute gastroenteritis (AGE), focusing on antiemetics and probiotics. Recent findings The mainstay of therapy for nonsevere AGE remains oral rehydration therapy (ORT). Recent randomized controlled trials and metaanalyses have further strengthened the evidence-base supporting single-dose ondansetron administration in emergency departments to facilitate ORT based on evidence that it safely reduces intravenous fluid administration and hospitalization rates. Intravenous ondansetron administration and multiple-dose use should be avoided. A bimodal release ondansetron formulation was shown to improve outcomes in adolescents and adults with AGE in one study, but further evidence is required to support use. Recent large trials evaluating probiotic administration demonstrated a lack of benefit and guidelines that recommend their use should reevaluate their positions in light of this evidence. Furthermore, caution should be exercised when use is considered in high-risk populations and settings. Summary The benefits, dosing/route, and target populations most likely to benefit from ondansetron have been further clarified. Optimization of the real-life effectiveness of this therapy will require implementation strategies. Recent high-quality evidence showing a lack of efficacy and potential harm associated with probiotic use suggests that routine use for AGE should be discouraged.
Anna Funk; David Schnadower; Stephen B. Freedman. Update on nonantibiotic therapies for acute gastroenteritis. Current Opinion in Infectious Diseases 2020, 33, 1 .
AMA StyleAnna Funk, David Schnadower, Stephen B. Freedman. Update on nonantibiotic therapies for acute gastroenteritis. Current Opinion in Infectious Diseases. 2020; 33 (5):1.
Chicago/Turabian StyleAnna Funk; David Schnadower; Stephen B. Freedman. 2020. "Update on nonantibiotic therapies for acute gastroenteritis." Current Opinion in Infectious Diseases 33, no. 5: 1.
To determine if the clinical characteristics of children with gastroenteritis and influenza identified in their stool differ from those whose stool was influenza-negative. Children <18-years with gastroenteritis whose stool tested negative for enteropathogen were tested for influenza in stool. The clinical features between influenza-positive and influenza-negative gastroenteritis cases were compared. Stools from controls without infection were also tested for influenza. Among the 440 gastroenteritis cases, those who were influenza test-positive were older [median age 4.0 (IQR: 2.3, 5.5) vs. 1.5 (IQR: 0.5, 4.0) years; P = 0.008], more likely to present in fall or winter (92.3 % vs. 48.0 %; P = 0.001), be febrile (84.6 % vs. 30.6 %; P < 0.001), have respiratory symptoms (91.7 % vs. 44.8 %; P = 0.002), have dehydration [median Clinical Dehydration Scale score: 4 (IQR: 1.5, 4.5) vs. 2 (IQR: 0, 3); P = 0.034], and have higher Modified Vesikari Scale scores [median: 13 (IQR: 10.5, 14.0) vs. 10 (IQR: 9.0, 13.0); P = 0.044], than those who tested negative. Thirteen gastroenteritis cases (13/440; 3.0 %) including one child without respiratory symptoms vs. one control (1/250; 0.4 %) were influenza stool positive. Fever, respiratory symptoms, more severe illness, and older age were more common in children with gastroenteritis with influenza detected in stool, compared to those tested negative
Jianling Xie; Xiao-Li Pang; Gillian A.M. Tarr; Yuan Mu; Ran Zhuo; Linda Chui; Bonita E. Lee; Otto G. Vanderkooi; Phillip I. Tarr; Samina Ali; Shannon E. MacDonald; Stephen B. Freedman. Influenza virus detection in the stool of children with acute gastroenteritis. Journal of Clinical Virology 2020, 131, 104565 .
AMA StyleJianling Xie, Xiao-Li Pang, Gillian A.M. Tarr, Yuan Mu, Ran Zhuo, Linda Chui, Bonita E. Lee, Otto G. Vanderkooi, Phillip I. Tarr, Samina Ali, Shannon E. MacDonald, Stephen B. Freedman. Influenza virus detection in the stool of children with acute gastroenteritis. Journal of Clinical Virology. 2020; 131 ():104565.
Chicago/Turabian StyleJianling Xie; Xiao-Li Pang; Gillian A.M. Tarr; Yuan Mu; Ran Zhuo; Linda Chui; Bonita E. Lee; Otto G. Vanderkooi; Phillip I. Tarr; Samina Ali; Shannon E. MacDonald; Stephen B. Freedman. 2020. "Influenza virus detection in the stool of children with acute gastroenteritis." Journal of Clinical Virology 131, no. : 104565.
Background Norovirus is a leading cause of acute gastroenteritis. With vaccines in development, population-based estimates of norovirus burden are needed to identify target populations, quantify potential benefits, and understand disease dynamics. Methods We estimated the attributable fraction (AF) for norovirus infections in children, defined as the proportion of children testing positive for norovirus whose gastroenteritis was attributable to norovirus. We calculated the standardized incidence and emergency department (ED) visit rates attributable to norovirus using provincial gastroenteritis visit administrative data. Results From 3731 gastroenteritis case patients and 2135 controls we determined that the AFs were 67.0% (95% confidence interval [CI], 31.5%–100%) and 91.6% (88.8%–94.4%) for norovirus genogroups I (GI) and II (GII), respectively. Norovirus GII AF varied by season but not age. We attributed 116 episodes (95% CI, 103–129) and 59 (51–67) ED visits per 10 000 child-years to norovirus GII across all ages, accounting for 20% and 18% of all medically attended gastroenteritis episodes and ED visits, respectively. Conclusions In children, a large proportion of norovirus GII detections reflect causation, demonstrating significant potential for norovirus GII vaccines. Seasonal variation in the norovirus GII AF may have implications for understanding the role asymptomatic carriage plays in disease dynamics.
Gillian A M Tarr; Xiao-Li Pang; Ran Zhuo; Bonita E Lee; Linda Chui; Samina Ali; Otto G Vanderkooi; Christine Michaels-Igbokwe; Phillip I Tarr; Shannon E MacDonald; Gillian Currie; Judy MacDonald; Kelly Kim; Stephen B Freedman. Attribution of Pediatric Acute Gastroenteritis Episodes and Emergency Department Visits to Norovirus Genogroups I and II. Journal of Infectious Diseases 2020, 223, 452 -461.
AMA StyleGillian A M Tarr, Xiao-Li Pang, Ran Zhuo, Bonita E Lee, Linda Chui, Samina Ali, Otto G Vanderkooi, Christine Michaels-Igbokwe, Phillip I Tarr, Shannon E MacDonald, Gillian Currie, Judy MacDonald, Kelly Kim, Stephen B Freedman. Attribution of Pediatric Acute Gastroenteritis Episodes and Emergency Department Visits to Norovirus Genogroups I and II. Journal of Infectious Diseases. 2020; 223 (3):452-461.
Chicago/Turabian StyleGillian A M Tarr; Xiao-Li Pang; Ran Zhuo; Bonita E Lee; Linda Chui; Samina Ali; Otto G Vanderkooi; Christine Michaels-Igbokwe; Phillip I Tarr; Shannon E MacDonald; Gillian Currie; Judy MacDonald; Kelly Kim; Stephen B Freedman. 2020. "Attribution of Pediatric Acute Gastroenteritis Episodes and Emergency Department Visits to Norovirus Genogroups I and II." Journal of Infectious Diseases 223, no. 3: 452-461.
Stephen B. Freedman; Amanda S. Newton. Screening for suicide risk – The need, the possibilities, and a call for resources. Canadian Journal of Emergency Medicine 2020, 22, 269 -270.
AMA StyleStephen B. Freedman, Amanda S. Newton. Screening for suicide risk – The need, the possibilities, and a call for resources. Canadian Journal of Emergency Medicine. 2020; 22 (3):269-270.
Chicago/Turabian StyleStephen B. Freedman; Amanda S. Newton. 2020. "Screening for suicide risk – The need, the possibilities, and a call for resources." Canadian Journal of Emergency Medicine 22, no. 3: 269-270.
Background There are limited treatment options that clinicians can provide to children presenting to emergency departments with vomiting secondary to acute gastroenteritis. Based on evidence of effectiveness and safety, clinicians now routinely administer ondansetron in the emergency department to promote oral rehydration therapy success. However, clinicians are also increasingly providing multiple doses of ondansetron for home use, creating unquantified cost and health system resource use implications without any evidence to support this expanding practice. Methods/design DOSE-AGE is a randomized, placebo-controlled, double-blinded, six-center, pragmatic clinical trial being conducted in six Canadian pediatric emergency departments (EDs). In September 2019 the study began recruiting children aged 6 months to 18 years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72 h of gastroenteritis symptoms and who were administered a dose of ondansetron during their ED visit. We are recruiting 1030 children (1:1 allocation via an internet-based, third-party, randomization service) to receive a 48-h supply (i.e., six doses) of ondansetron oral solution or placebo, administered on an as-needed basis. All participants, caregivers and outcome assessors will be blinded to group assignment. Outcome data will be collected by surveys administered to caregivers 24, 48 and 168 h following enrollment. The primary outcome is the development of moderate-to-severe gastroenteritis in the 7 days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale). Secondary outcomes include duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety. A preplanned economic evaluation will be conducted alongside the trial. Discussion Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis. Usage is increasing, despite the absence of supportive evidence. The incumbent additional costs associated with use, and potential side effects such as diarrhea and repeat visits, create an urgent need to evaluate the effect and safety of multiple doses of ondansetron in children focusing on post-emergency department visit and patient-centered outcomes. Trial Registration ClinicalTrials.gov: NCT03851835. Registered on 22 February 2019.
Stephen B. Freedman; on behalf of the KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study Group; Sarah Williamson-Urquhart; Anna Heath; Petros Pechlivanoglou; Gareth Hopkin; Serge Gouin; Amy C. Plint; Andrew Dixon; Darcy Beer; Gary Joubert; Christopher McCabe; Yaron Finkelstein; Terry P. Klassen. Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial. Trials 2020, 21, 1 -13.
AMA StyleStephen B. Freedman, on behalf of the KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study Group, Sarah Williamson-Urquhart, Anna Heath, Petros Pechlivanoglou, Gareth Hopkin, Serge Gouin, Amy C. Plint, Andrew Dixon, Darcy Beer, Gary Joubert, Christopher McCabe, Yaron Finkelstein, Terry P. Klassen. Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial. Trials. 2020; 21 (1):1-13.
Chicago/Turabian StyleStephen B. Freedman; on behalf of the KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study Group; Sarah Williamson-Urquhart; Anna Heath; Petros Pechlivanoglou; Gareth Hopkin; Serge Gouin; Amy C. Plint; Andrew Dixon; Darcy Beer; Gary Joubert; Christopher McCabe; Yaron Finkelstein; Terry P. Klassen. 2020. "Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial." Trials 21, no. 1: 1-13.
Gastroenteritis accounts for nearly 500,000 deaths in children younger than 5 years annually. Although probiotics have been touted as having the potential to expedite diarrhea resolution, recent clinical trials question their effectiveness. A potential explanation is a shift in pathogens following the introduction of a rotavirus vaccine. Here, we report the results of a multi-center, double-blind trial of 816 children with acute gastroenteritis who completed follow-up and provided multiple stool specimens. Participants were randomized to receive a probiotic containing Lactobacillus rhamnosus and Lactobacillus helveticus or placebo. We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment. We provide pathophysiological and microbiologic evidence to support the clinical findings and conclude that our data do not support routine probiotic administration to children with acute gastroenteritis, regardless of the infecting virus.
Stephen B. Freedman; the Pediatric Emergency Research Canada Probiotic (PERC) Regimen for Outpatient Gastroenteritis Utility of Treatment (PROGUT) Trial Group; Jianling Xie; Alberto Nettel-Aguirre; Xiao-Li Pang; Linda Chui; Sarah Williamson-Urquhart; David Schnadower; Suzanne Schuh; Philip M. Sherman; Bonita E. Lee; Serge Gouin; Ken J. Farion; Naveen Poonai; Katrina F. Hurley; Yuanyuan Qiu; Binal Ghandi; Colin Lloyd; Yaron Finkelstein. A randomized trial evaluating virus-specific effects of a combination probiotic in children with acute gastroenteritis. Nature Communications 2020, 11, 2533 .
AMA StyleStephen B. Freedman, the Pediatric Emergency Research Canada Probiotic (PERC) Regimen for Outpatient Gastroenteritis Utility of Treatment (PROGUT) Trial Group, Jianling Xie, Alberto Nettel-Aguirre, Xiao-Li Pang, Linda Chui, Sarah Williamson-Urquhart, David Schnadower, Suzanne Schuh, Philip M. Sherman, Bonita E. Lee, Serge Gouin, Ken J. Farion, Naveen Poonai, Katrina F. Hurley, Yuanyuan Qiu, Binal Ghandi, Colin Lloyd, Yaron Finkelstein. A randomized trial evaluating virus-specific effects of a combination probiotic in children with acute gastroenteritis. Nature Communications. 2020; 11 (1):2533.
Chicago/Turabian StyleStephen B. Freedman; the Pediatric Emergency Research Canada Probiotic (PERC) Regimen for Outpatient Gastroenteritis Utility of Treatment (PROGUT) Trial Group; Jianling Xie; Alberto Nettel-Aguirre; Xiao-Li Pang; Linda Chui; Sarah Williamson-Urquhart; David Schnadower; Suzanne Schuh; Philip M. Sherman; Bonita E. Lee; Serge Gouin; Ken J. Farion; Naveen Poonai; Katrina F. Hurley; Yuanyuan Qiu; Binal Ghandi; Colin Lloyd; Yaron Finkelstein. 2020. "A randomized trial evaluating virus-specific effects of a combination probiotic in children with acute gastroenteritis." Nature Communications 11, no. 1: 2533.
Video Abstract BACKGROUND: The ability of the decades-old Boston and Philadelphia criteria to accurately identify infants at low risk for serious bacterial infections has not been recently reevaluated. METHODS: We assembled a multicenter cohort of infants 29 to 60 days of age who had cerebrospinal fluid (CSF) and blood cultures obtained. We report the performance of the modified Boston criteria (peripheral white blood cell count [WBC] ≥20 000 cells per mm3, CSF WBC ≥10 cells per mm3, and urinalysis with >10 WBC per high-power field or positive urine dip result) and modified Philadelphia criteria (peripheral WBC ≥15 000 cells per mm3, CSF WBC ≥8 cells per mm3, positive CSF Gram-stain result, and urinalysis with >10 WBC per high-power field or positive urine dip result) for the identification of invasive bacterial infections (IBIs). We defined IBI as bacterial meningitis (growth of pathogenic bacteria from CSF culture) or bacteremia (growth from blood culture). RESULTS: We applied the modified Boston criteria to 8344 infants and the modified Philadelphia criteria to 8131 infants. The modified Boston criteria identified 133 of the 212 infants with IBI (sensitivity 62.7% [95% confidence interval (CI) 55.9% to 69.3%] and specificity 59.2% [95% CI 58.1% to 60.2%]), and the modified Philadelphia criteria identified 157 of the 219 infants with IBI (sensitivity 71.7% [95% CI 65.2% to 77.6%] and specificity 46.1% [95% CI 45.0% to 47.2%]). The modified Boston and Philadelphia criteria misclassified 17 of 53 (32.1%) and 13 of 56 (23.3%) infants with bacterial meningitis, respectively. CONCLUSIONS: The modified Boston and Philadelphia criteria misclassified a substantial number of infants 29 to 60 days old with IBI, including those with bacterial meningitis.
Todd W. Lyons; Aris C. Garro; Andrea T. Cruz; Stephen Freedman; Pamela J. Okada; Prashant Mahajan; Fran Balamuth; Amy D. Thompson; Dina M. Kulik; Neil G. Uspal; Joseph L. Arms; Lise E. Nigrovic; FOR THE HERPES SIMPLEX VIRUS STUDY GROUP OF THE PEDIATRIC EMERGENCY MEDICINE COLLABORATIVE RESEARCH COMMITTEE (PEM CRC). Performance of the Modified Boston and Philadelphia Criteria for Invasive Bacterial Infections. Pediatrics 2020, 145, e20193538 .
AMA StyleTodd W. Lyons, Aris C. Garro, Andrea T. Cruz, Stephen Freedman, Pamela J. Okada, Prashant Mahajan, Fran Balamuth, Amy D. Thompson, Dina M. Kulik, Neil G. Uspal, Joseph L. Arms, Lise E. Nigrovic, FOR THE HERPES SIMPLEX VIRUS STUDY GROUP OF THE PEDIATRIC EMERGENCY MEDICINE COLLABORATIVE RESEARCH COMMITTEE (PEM CRC). Performance of the Modified Boston and Philadelphia Criteria for Invasive Bacterial Infections. Pediatrics. 2020; 145 (4):e20193538.
Chicago/Turabian StyleTodd W. Lyons; Aris C. Garro; Andrea T. Cruz; Stephen Freedman; Pamela J. Okada; Prashant Mahajan; Fran Balamuth; Amy D. Thompson; Dina M. Kulik; Neil G. Uspal; Joseph L. Arms; Lise E. Nigrovic; FOR THE HERPES SIMPLEX VIRUS STUDY GROUP OF THE PEDIATRIC EMERGENCY MEDICINE COLLABORATIVE RESEARCH COMMITTEE (PEM CRC). 2020. "Performance of the Modified Boston and Philadelphia Criteria for Invasive Bacterial Infections." Pediatrics 145, no. 4: e20193538.
This Viewpoint characterizes reasons for the lack of evidence about the health effects of probiotic supplements and cautions against a “can’t hurt, can’t help”
Stephen B. Freedman; David Schnadower; Phillip I. Tarr. The Probiotic Conundrum. JAMA 2020, 323, 823 -824.
AMA StyleStephen B. Freedman, David Schnadower, Phillip I. Tarr. The Probiotic Conundrum. JAMA. 2020; 323 (9):823-824.
Chicago/Turabian StyleStephen B. Freedman; David Schnadower; Phillip I. Tarr. 2020. "The Probiotic Conundrum." JAMA 323, no. 9: 823-824.