About

Justine Shults, Ph.D., is a Professor of Biostatistics in the Department of Biostatistics and Epidemiology at the Hospital of the University of Pennsylvania, within the Perelman School of Medicine. She is also a member of the Biomedical Graduate Studies in the same department and serves as a Senior Scholar at the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania Perelman School of Medicine. Her academic affiliations include the Graduate Group in Epidemiology and Biostatistics. Dr. Shults's educational background includes a B.S. in Mathematics from the University of Notre Dame, a M.S. in Applied and Computational Mathematics from Old Dominion University, and a Ph.D. in the same field from Old Dominion University. She has also studied at the United States Naval Academy. Her research focus and key contributions are not detailed on the page.

Research topics

• Medicine
• Internal medicine
• Emergency medicine
• Anesthesia
• Psychiatry
• Psychology
• Pediatrics
• Intensive care medicine
• Demography
• Physical therapy
• Physical medicine and rehabilitation
• Family medicine
• Nursing

Selected publications

• The Association of Teamwork and Adverse Tracheal Intubation–Associated Events (TIAEs) in Advanced Airway Management in the Pediatric ICU

  Journal of Pediatric Intensive Care · 2026-01-29

  article

  Background: Tracheal intubation in critically ill children is a life-saving, but high-risk procedure that involves multiple team members with diverse clinical skills. We aim to examine the association between the provider-reported teamwork rating and the occurrence of adverse tracheal intubation–associated events (TIAEs). Methods: A retrospective analysis of prospectively collected data from 45 pediatric intensive care units (PICUs) in the National Emergency Airway Registry for Children (NEAR4KIDS) database from January 2013 to March 2018 was performed. A composite teamwork score was generated using the average of each of five (7-point Likert scale) domains in the teamwork assessment tool. Poor teamwork was defined as an average score of 4 or lower. Team provider stress data were also recorded with each intubation. Results: 12,536 tracheal intubations (TIs) were reported from 2013 to 2018. Approximately 4.1% (n=520) rated a poor teamwork score. TIs indicated for shock were more commonly associated with a poor teamwork score, while those indicated for procedures and those utilizing neuromuscular blockade were less commonly associated with a poor teamwork score. TIs with poor teamwork were associated with a higher occurrence of adverse TIAE (24.4% vs. 14.4%, p<0.001), severe TIAE (13.7% vs. 5.9%, p<0.001), and peri-intubation hypoxemia < 80% (26.4% vs. 17.9%, p<0.001). After adjusting for indication, provider type, and neuromuscular blockade use, poor teamwork was associated with higher odds of adverse TIAEs (OR 1.77, 95% CI 1.35-2.34), severe TIAEs (OR 2.23, 95% CI 1.47-3.37) and hypoxemia (OR 1.63, 95% CI 1.25-2.03). Conclusion: TIs with poor teamwork were independently associated with a higher occurrence of TIAEs, severe TIAEs, and hypoxemia.

  PublisherDOI

• Mitigation and Outcomes of Difficult Bag-Mask Ventilation in Critically Ill Children

  Journal of Pediatric Intensive Care · 2026-02-17

  articleOpen access

  Objectives: Difficult bag-mask ventilation (BMV) occurs in 10% of pediatric intensive care unit (PICU) tracheal intubations (TI). The reasons clinicians identify difficult BMV in the PICU and the interventions used to mitigate that difficulty have not been well-studied. Methods: This is a prospective, observational, single-center study. A patient-specific data form was sent to PICU physicians supervising TIs from November 2019 through December 2020 to identify the presence of difficult BMV, attempted interventions used, and perceptions about intervention success. The dataset was linked and merged with the local TI quality database to assess safety outcomes. Results: Among 305 TIs with response (87% response rate), 267 (88%) clinicians performed BMV during TI. Difficult BMV was reported in 28/267 (10%). Commonly reported reasons for difficult BMV included: facial structure (50%), high inspiratory pressure (36%), and improper mask fit (21%). Common interventions were jaw thrust (96%) and an airway adjunct (oral airway 50%, nasal airway 7%, supraglottic airway 11%), with ventilation improvement in 44% and 73%, respectively. Most difficult BMV was identified before neuromuscular blockade (NMB) administration (96%) and 67% (18/27) resolved after NMB administration. The overall success in improving ventilation was 27/28 (96%). TI adverse outcomes (hemodynamic events, emesis, and/or hypoxemia <80%) are associated with the presence of difficult BMV (10/28, 36%) vs. non-difficult BMV (20/239, 8%, p<0.001). Conclusion: Difficult BMV is common in critically ill children and is associated with increased TI adverse outcomes. Airway adjunct placement and NMB use are often effective in improving ventilation.

  PublisherOA PDFDOI

• Procedural Outcomes of Minimally Invasive Surfactant Therapy: An International Matched Cohort Study

  The Journal of Pediatrics · 2026-02-18

  article
  PublisherDOI

• Quality of Bag-Mask Ventilation for Children Before Intubation: Single-Center PICU Pilot Observational Study, 2019–2022

  Pediatric Critical Care Medicine · 2026-03-23 · 1 citations

  articleOpen access

  OBJECTIVES: To characterize the quality of bag-mask ventilation (BMV) before tracheal intubation in children in the PICU and to evaluate the association between poor BMV quality and adverse airway outcomes. DESIGN: Single-center, pilot observational study, 2019-2022. SETTING: Large, urban quaternary care PICU. PATIENTS: Pediatric patients requiring BMV before tracheal intubation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Using a respiratory function monitor, we collected flow and pressure data from 8446 BMV breaths before tracheal intubation in 85 children in the PICU (median age, 3.3 yr [interquartile range, 1.4-8.3 yr]). Adverse airway outcomes (i.e., tracheal intubation-associated event and/or pulse oximetry desaturation < 80%) occurred in 14 of 85 patients (16.5%). Low-quality BMV breaths were defined as: 1) inadequate or excessive exhaled tidal volume (VTe < 4 or > 12 mL/kg); 2) excessive peak inspiratory pressure (PIP) and excessive VTe; 3) excessive facemask leak (> 40%); or 4) failure to relieve upper airway obstruction. Overall, 78.0% of BMV breaths met at least one low-quality criterion; most frequently inadequate or excessive VTe (55.5%), followed by excessive leak (46.2%). Infants (< 1 yr) and young children (1-7 yr), compared with older children (8-17 yr), had a higher proportion of low-quality BMV breaths overall (86.0%, 85.5% vs. 57.9%; p < 0.001 for both), with inadequate or excessive VTe (57.7%, 61.1% vs. 43.7%; p < 0.001 for both), excessive leak (50.6%, 49.2% vs. 37.0%; p < 0.001 for both), and excessive PIP with excessive VTe (17.5%, 19.4% vs. 6.4%; p < 0.001). After controlling for respiratory pathology, low-quality BMV was associated with 2.8-times greater odds of adverse airway outcome (adjusted odds ratio, 2.8 [95% CI, 1.2-6.2]; p = 0.01). CONCLUSIONS: The majority of BMV breaths delivered to children before tracheal intubation in the PICU were of low-quality. And, such breaths, were more frequent in younger children and were associated with greater odds of adverse airway outcomes.

  PublisherOA PDFDOI

• Characterizing Engagement With a Mobile Health Application Designed for Adolescents and Young Adults With Sickle Cell Disease: Findings From the COMETS Study

  Pediatric Blood & Cancer · 2026-03-17

  article

  The transition from pediatric to adult care for adolescents with sickle cell disease is marked by increased disease complexity. The effectiveness of a mobile health (mHealth) application in supporting transition was evaluated in the COMETS (Community Health Worker and Mobile Health Programs) trial. Participant engagement with the mHealth application was evaluated in this study. The component SMS Text Messages had the highest number of unique users (n = 94), and interaction with application health and behavior tracking challenges had the highest median interactions per user (median = 4.5). Most participants engaged with the mHealth application at least once, yet engagement varied across components and declined over the course of the study.

  PublisherDOI

• The natural history of variable subtypes in pediatric-onset TUBB4A-related leukodystrophy

  Molecular Genetics and Metabolism · 2025-02-01 · 9 citations

  articleOpen access
  PublisherOA PDFDOI

• Community Health Worker and Mobile Health Interventions for Quality of Life Among Young Adults With Sickle Cell Disease

  JAMA Network Open · 2025-11-17 · 2 citations

  articleOpen access

  Importance: Young adults with sickle cell disease (SCD) experience challenges transitioning from pediatric to adult care, leading to increased morbidity and mortality. Objective: To evaluate the effectiveness of community health worker (CHW) support or a mobile health application (mHealth) compared with enhanced usual care (EUC) in improving health-related quality of life (HRQOL) for young adults with SCD transitioning to adult care. Design, Setting, and Participants: The Community Health Workers and Mobile Health for Emerging Adults Transitioning Sickle Cell Disease Care study was an observer-blinded, multicenter, randomized clinical trial performed at 5 US children's hospitals with a recruitment period from January 15, 2019, to December 31, 2022, and data analysis performed from September 30, 2024, to June 30, 2025. Participants were 17 years or older with SCD. Interventions: Participants were randomized 1:1:1 to 6 months of EUC, CHW plus EUC, or mHealth plus EUC. Both interventions included goal setting, self-management, skill development, symptom tracking, and transition support. The CHW plus EUC intervention provided weekly synchronous support primarily via phone calls, while mHealth plus EUC offered virtual peer support via interaction with discussion boards. The EUC group received standard care consisting of a transition checklist for consistency across sites. Main Outcomes and Measures: The main outcome was HRQOL, assessed using the Pediatric Quality of Life Inventory (PedsQL) for SCD module. Clinically meaningful improvement was prespecified as a 10-point change. Secondary outcomes included SCD knowledge, transition readiness, and social support. All outcomes were collected at baseline and follow-ups at 6, 12, and 18 months. Results: Of the 700 eligible patients across the 5 sites, 405 were enrolled, and 375 participants with SCD were randomized, 191 (51.5%) of whom were women. The mean (SD) age was 18.9 (1.9) years; the median age was 18.0 (IQR, 17-20) years. Baseline demographic data, clinical characteristics, and markers of disease severity were comparable across the study groups. At 6 months, the CHW plus EUC group showed modest improvements in HRQOL compared with the EUC group at 2.67 (95% CI, 0.25-5.09) at 6 months; there was no change for the mHealth plus EUC group at 0.73 (95% CI, -1.48 to 2.93) at 6 months; and the EUC group had a decline of 2.58 (95% CI, -4.67 to -0.49). CHW support demonstrated the greatest improvement in PedsQL scores compared with EUC at 6 (5.25 [95% CI, 2.05-8.45] points), 12 (5.56 [95% CI, 1.52-9.61] points), and 18 (6.14 [95% CI, 1.75-10.54] points) months. The mHealth plus EUC intervention demonstrated improvement in PedsQL scores at 6 months only (3.31 [95% CI, 0.27-6.35] points). Throughout the study, the HRQOL for the EUC group declined. No significant differences were found in secondary outcomes. Conclusions and Relevance: Although neither intervention met the prespecified 10-point threshold for a large clinical effect, the CHW intervention produced a significant and durable improvement in HRQOL that halted the decline observed in EUC. This sustained effect during the 18 months of follow-up suggests that CHW support provides a clinically relevant benefit for young adults with SCD during their transition to adult care. Integrating such programs into routine care could improve outcomes for this vulnerable population. Trial Registration: ClinicalTrials.gov Identifier: NCT03648710.

  PublisherOA PDFDOI

• Tracheal Intubation by Attending Physicians in a U.S. Registry, 2016–2020: Analysis by PICU Participation in a Skills Maintenance Program and Fellowship Training

  Pediatric Critical Care Medicine · 2025-02-01 · 2 citations

  articleOpen access

  OBJECTIVES: Tracheal intubation (TI) is a critical skill for PICU attending physicians to maintain. We hypothesize that attendings perform fewer TIs and have lower success rate in PICU programs with a Pediatric Critical Care Medicine (PCCM) fellowship. DESIGN: Retrospective study using the National Emergency Airway Registry for Children (NEAR4KIDS) from July 2016 to June 2020. Exposures were presence of PCCM fellowship and attending TI skill maintenance program (SMP). The primary outcome was attending's first attempt success and the secondary outcome was adverse airway outcome in the first attempt. SETTING: Thirty-three PICUs in North America. PATIENTS: Children receiving TI. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Overall, 23 of 33 PICUs had a PCCM fellowship with three of 23 having an attending TI SMP. Attendings performed TI in 24.1% (2,728/11,323): 13.9% (13.8 TI/yr per PICU) in PICUs with a fellowship vs. 66.0% (36.6 TI/yr per PICU) without a fellowship (p < 0.001). Attending first attempt success in PICUs with vs. without fellowships was 70.5% vs. 81.3% (difference, 10.8% [95% CI, 7.6-14.0%]; p < 0.0001). After controlling for confounders, attendings in a PICU with a fellowship had lower odds for first attempt success (adjusted odds ratio [aOR], 0.65 [95% CI, 0.47-0.90]). We failed to find an association between attending first attempt success and PICU program type, with vs. without a TI SMP (74.0% vs. 69.5%; p = 0.146). The adverse airway outcome rate of the TI with attending's first attempt was lower in PICU programs with vs. without a TI SMP (32.8% vs. 40.3%; p = 0.020). However, after adjusting for confounders, we failed to exclude the possibility of near halving of odds of adverse outcome (aOR, 0.75 [95% CI, 0.55-1.01]; p = 0.058). CONCLUSIONS: Attendings in PICU programs with a fellowship have fewer opportunities to perform TI and lower first attempt success rates. Opportunities exist for attending TI skill maintenance, especially in PICUs with a PCCM fellowship.

  PublisherOA PDFDOI

• Innovative Web-Based Future Planning and Well-Being for Caregivers of Individuals With Intellectual and Developmental Disabilities: Protocol of a Pragmatic Randomized Controlled Trial (Preprint)

  2025-05-09

  preprint

  <sec> <title>BACKGROUND</title> Nearly three-quarters of the estimated 4.9 million people with intellectual and developmental disabilities (IDDs) in the United States live with family caregivers, 25% of whom are aged older than 60 years. People with IDDs experience disproportionately high rates of mortality, morbidity, and acute care use, often due to a lack of accessible, tailored resources to support them throughout the lifespan. Few caregivers engage in long-term care (LTC) planning, often due to a lack of information and support. </sec> <sec> <title>OBJECTIVE</title> This protocol describes the design and methods of the Future Planning and Well-Being for Individuals with Intellectual Disabilities and Family Caregivers study, a randomized controlled trial evaluating the effectiveness of the Map Our Life web-based LTC planning tool compared to an attention control website on caregiver-reported burden, caregiver-reported well-being, and progress in and communication of future plans for the individual with an IDD. </sec> <sec> <title>METHODS</title> The Future Planning and Well-Being for Individuals with Intellectual Disabilities and Family Caregivers study is a national, multisite, randomized controlled clinical trial with a target enrollment of 1050 family caregivers of individuals with IDDs at 6 sites across the United States. Participants are randomly assigned (1:1) to either the Map Our Life web-based LTC planning tool plus enhanced usual care or an attention control group consisting of a Centers for Disease Control and Prevention–sponsored health promotion website for people with disabilities plus enhanced usual care. Primary outcomes, including caregiver-reported burden, caregiver-reported well-being, and LTC planning behaviors, are assessed at baseline and at 1, 6, and 18 months. Data will be analyzed using mixed-effects models to accommodate the repeated measures design. </sec> <sec> <title>RESULTS</title> This study was funded in July 2022, received initial Institutional Review Board approval in August 2023, and was registered on ClinicalTrials.gov in December 2023. Recruitment began in December 2023 and is scheduled to conclude in December 2025. Primary outcome analyses will commence immediately following the completion of final follow-up surveys. </sec> <sec> <title>CONCLUSIONS</title> LTC planning is an important component of addressing health disparities among individuals with disabilities and their family caregivers. By focusing on using an innovative and accessible tool for LTC planning, the study addresses a critical gap in available resources with the potential to improve quality of life and reduce caregiver burden. </sec> <sec> <title>CLINICALTRIAL</title> ClinicalTrials.gov NCT06065527; https://clinicaltrials.gov/study/NCT06065527 </sec> <sec> <title>INTERNATIONAL REGISTERED REPORT</title> DERR1-10.2196/77184 </sec>

  PublisherDOI

• Innovative Web-Based Future Planning and Well-Being for Caregivers of Individuals With Intellectual and Developmental Disabilities: Protocol of a Pragmatic Randomized Controlled Trial

  JMIR Research Protocols · 2025-09-06 · 1 citations

  articleOpen access

  BACKGROUND: Nearly three-quarters of the estimated 4.9 million people with intellectual and developmental disabilities (IDDs) in the United States live with family caregivers, 25% of whom are aged older than 60 years. People with IDDs experience disproportionately high rates of mortality, morbidity, and acute care use, often due to a lack of accessible, tailored resources to support them throughout the lifespan. Few caregivers engage in long-term care (LTC) planning, often due to a lack of information and support. OBJECTIVE: This protocol describes the design and methods of the Future Planning and Well-Being for Individuals with Intellectual Disabilities and Family Caregivers study, a randomized controlled trial evaluating the effectiveness of the Map Our Life web-based LTC planning tool compared to an attention control website on caregiver-reported burden, caregiver-reported well-being, and progress in and communication of future plans for the individual with an IDD. METHODS: The Future Planning and Well-Being for Individuals with Intellectual Disabilities and Family Caregivers study is a national, multisite, randomized controlled clinical trial with a target enrollment of 1050 family caregivers of individuals with IDDs at 6 sites across the United States. Participants are randomly assigned (1:1) to either the Map Our Life web-based LTC planning tool plus enhanced usual care or an attention control group consisting of a Centers for Disease Control and Prevention-sponsored health promotion website for people with disabilities plus enhanced usual care. Primary outcomes, including caregiver-reported burden, caregiver-reported well-being, and LTC planning behaviors, are assessed at baseline and at 1, 6, and 18 months. Data will be analyzed using mixed-effects models to accommodate the repeated measures design. RESULTS: This study was funded in July 2022, received initial Institutional Review Board approval in August 2023, and was registered on ClinicalTrials.gov in December 2023. Recruitment began in December 2023 and is scheduled to conclude in December 2025. Primary outcome analyses will commence immediately following the completion of final follow-up surveys. CONCLUSIONS: LTC planning is an important component of addressing health disparities among individuals with disabilities and their family caregivers. By focusing on using an innovative and accessible tool for LTC planning, the study addresses a critical gap in available resources with the potential to improve quality of life and reduce caregiver burden. TRIAL REGISTRATION: ClinicalTrials.gov NCT06065527; https://clinicaltrials.gov/study/NCT06065527. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/77184.

  PublisherDOI

Recent grants

• NIH Grant R01CA096885

  NIH · $531k · 2008

• Biostatistics for Renal and Urologic Diseases

  NIH · $1.9M · 2001–2020

Frequent coauthors

• Mary B. Leonard

  Lucile Packard Children's Hospital

  272 shared

• Babette S. Zemel

  University of Pennsylvania

  154 shared

• Vinay Nadkarni

  Children's Hospital of Philadelphia

  116 shared

• Peter P. Reese

  University of Pennsylvania

  95 shared

• Akira Nishisaki

  University of Pennsylvania

  77 shared

• Harold I. Feldman

  University of Illinois Chicago

  69 shared

• Rachel Rogers

  56 shared

• Alexis A. Topjian

  56 shared