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Item A multicenter study to evaluate the pharmacokinetics and safety of liposomal bupivacaine for postsurgical analgesia in pediatric patients aged 6 to less than 17 years (PLAY)(Elsevier, 2021) Tirotta, Christopher F.; de Armendi, Alberto J.; Horn, Nicole D.; Hammer, Gregory B.; Szczodry, Michal; Matuszczak, Maria; Wang, Natalie Q.; Scranton, Richard; Ballock, Robert Tracy; Anesthesia, School of MedicineStudy objective: To evaluate the pharmacokinetics and safety of liposomal bupivacaine in pediatric patients undergoing spine or cardiac surgery. Design: Multicenter, open-label, phase 3, randomized trial (PLAY; NCT03682302). Setting: Operating room. Patients: Two separate age groups were evaluated (age group 1: patients 12 to <17 years undergoing spine surgery; age group 2: patients 6 to <12 years undergoing spine or cardiac surgery). Intervention: Randomized allocation of liposomal bupivacaine 4 mg/kg or bupivacaine hydrochloride (HCl) 2 mg/kg via local infiltration at the end of spine surgery (age group 1); liposomal bupivacaine 4 mg/kg via local infiltration at the end of spine or cardiac surgery (age group 2). Measurements: The primary and secondary objectives were to evaluate the pharmacokinetics (eg, maximum plasma bupivacaine concentrations [Cmax], time to Cmax) and safety of liposomal bupivacaine, respectively. Main results: Baseline characteristics were comparable across groups. Mean Cmax after liposomal bupivacaine administration was lower versus bupivacaine HCl in age group 1 (357 vs 564 ng/mL); mean Cmax in age group 2 was 320 and 447 ng/mL for spine and cardiac surgery, respectively. Median time to Cmax of liposomal bupivacaine occurred later with cardiac surgery versus spine surgery (22.7 vs 7.4 h). In age group 1, the incidence of adverse events (AEs) was comparable between liposomal bupivacaine (61% [ 19/31] ) and bupivacaine HCl (73% [ 22/30 ]). In age group 2, 100% (5/5) and 31% (9/29) of patients undergoing spine and cardiac surgery experienced AEs, respectively. AEs were generally mild or moderate, with no discontinuations due to AEs or deaths. Conclusions: Plasma bupivacaine levels following local infiltration with liposomal bupivacaine remained below the toxic threshold in adults (~2000-4000 ng/mL) across age groups and procedures. AEs were mild to moderate, supporting the safety of liposomal bupivacaine in pediatric patients undergoing spine or cardiac surgery.Item A patient- and parent-centered approach to urinary and fecal incontinence in children and adolescents with spina bifida: understanding experiences in the context of other competing care issue(Elsevier, 2023) Szymanski, Konrad M.; Carroll, Aaron E.; Misseri, Rosalia; Moore, Courtney M.; Hawryluk, Bridget A.; Wiehe, Sarah E.; Pediatrics, School of MedicineIntroduction: Despite significant and known challenges to urinary and fecal incontinence (UI and FI, respectively) among children with spina bifida (SB) and their families, few studies have identified patient-centered measures and approaches to assessing them. This study represents the first stage of a larger study to develop a patient-centered goal-setting tool to guide incontinence management (Figure). Our aim was to understand patient experiences of UI and FI, and what goals should be included in the tool. Methods: We used a qualitative research approach integrated with human-centered design methods. We recruited, in clinic and online, children with SB (8-17 years old) and parents (>=18 years old) of children with SB (8-17 years old). Online activities were analyzed by four experienced design researchers using affinity diagramming, group analysis and modeling activities (mind maps, challenge maps, experience maps). Recruitment and thematic qualitative analysis continued until saturation was reached. Results: Seventeen children with SB participated (9 female, 12 shunted, 13 using bladder catheterizations, 6 using Malone antegrade continence enema, median age: 15 years old). Fifteen parents participated (13 mothers/2 fathers, median age: 42 years old), including six mother-child dyads. Five major themes each were identified for UI and FI experiences: (1) negative emotional impact of incontinence, (2) unpredictability of incontinence, (3) challenging/unpleasant incontinence management, (4) inconvenient/unreliable incontinence management, (5) UI management having unpleasant complications and FI putting much responsibility on parents. We identified six UI goal domains and five FI goal domains. Four overlapping domains included: accidents, independence, interruptions at school and social/friends. Unique domains were: urinary tract infections (UI), catheterizations (UI) and enemas (FI). Comment: Findings of our study improve our understanding of children's and parents' experiences associated with incontinence in SB and potential continence goals. Conclusions: Children with SB experience incontinence as distressing and unpredictable. Incontinence management can be challenging and unreliable. Patient-centered continence goals cluster in domains, indicating how incontinence intermeshes with other life areas and offering potential approaches to structure continence goals in a goals-selection tool.Item A Systematic Approach to Developing Virtual Patient Vignettes for Pediatric Health Equity Research(Mary Ann Liebert, 2022-11-22) Mulchan, Siddika S.; Miller, Megan; Theriault, Christopher B.; Zempsky, William T.; Hirsh, Adam; Psychology, School of ScienceObjective: The aim of this study was to describe a systematic approach to developing virtual patient (VP) vignettes for health equity research in pediatric pain care. Methods: VPs were initially developed to depict the body posture and movements of actual children experiencing pain. Researchers and clinicians with expertise in pediatric pain worked closely with a professional animator to portray empirically supported pain expression in four, full-motion, virtual male characters of two races (i.e., White and Black). Through an iterative process, VPs were refined to (1) appear realistic in a clinical setting and (2) display archetypal pain behavior and expression during a 1-min video clip without sound. Text vignettes were developed with consultation from experts in pain care and presented alongside VPs to assess clinical decision-making. VP vignettes were piloted in a sample of pediatric providers (N=13). Results: Informed by the literature and expertise of stakeholders, several revisions were made to improve VPs' facial grimacing and realism before piloting. VPs appeared to accurately capture important aspects of pain expression and behavior common among pediatric patients with pain disorders. Additional refinements to the text vignettes were made based on provider feedback to improve clarity and clinical relevance. Conclusions: This article presents a working framework to facilitate a systematic approach to developing VP vignettes. This framework is a first step toward advancing health equity research by isolating psychosocial and interpersonal factors affecting provider behavior and decision-making. Future research is needed to validate the use of VP vignettes for assessing provider behavior contributing to health inequities for youth with pain disorders.Item Addressing Gaps in Pediatric Scientist Development: The Department Chair View of Two AMSPDC-Sponsored Programs(Elsevier, 2020) Barrett, Katherine J.; Cooley, Michelle; Schwartz, Alan L.; Hostetter, Margaret K.; Clapp, D. Wade; Permar, Sallie R.; Pediatrics, School of MedicinePediatric physician-scientists are important members of the biomedical workforce who are instrumental in translating research advances into novel patient treatment strategies, yet their numbers have been declining over the past four decades. In order to increase the pipeline of pediatric physician-scientists, the Association of Medical School Pediatric Department Chairs (AMSPDC) leads the Frontiers in Science (FIS) and Pediatric Scientist Development Program (PSDP). These programs provide mentorship, networking, and funding opportunities for pediatric residents and fellows who are interested in pursuing research careers. To assess perceptions of program accessibility and efficacy, FIS and PSDP leadership surveyed AMSPDC membership between November 2018 and April 2019; 66 active department chairs responded. The decline in pediatric physician-scientists was identified as a common concern, and responding chairs identified several individual and institutional barriers to the physician-scientist career pathway and to participation in FIS and PSDP. Common barriers to participation included: undefined career paths for physician-scientists, a limited number of FIS slots annually, a perception that these programs support primarily basic science rather than other types of research, and competing funding through institutional T32 and K12 programs. To address these barriers, FIS and PSDP leadership will work with AMSPDC to explore ways to increase access to FIS, promote PSDP alumni mentoring of participating residents and fellows, and expand the scope of research supported by these programs. Assessments of FIS and PSDP will be ongoing, with the goal of improving program access in order to increase and diversify the pediatric physician-scientist workforce.Item Adolescent Interview With a Medical Interpreter: A Standardized Patient Encounter for Pediatric Residents(Springer Nature, 2023-10-18) Hudson, Tristin; Hecht, Shaina M.; Robbins, Cynthia; McHenry, Megan S.; Byrne, Bobbi; Pediatrics, School of MedicineBackground: Pediatricians can cultivate a more trusting relationship with their non-English speaking patients by emphasizing the importance of upholding patient confidentiality in the presence of an interpreter. We designed a case for pediatric residents to increase comfort when conducting an adolescent interview using a medical interpreter, emphasizing the importance of upholding patient confidentiality, specifically when discussing sensitive health topics. Methods: We developed a standardized patient encounter (SPE) for pediatric residents at a large academic institution that focused on exploring sensitive health topics with an adolescent, non-English speaking female patient using an interpreter. A validated survey was administered upon completion of the case, prompting participants to reflect on their comfort and skills with specific activities before and after the case, and was analyzed using paired t-tests. Results: Eighty-nine residents participated; 66 were interns and 23 were in their second year of residency. The mean scores of all paired survey items significantly increased after the case (p<0.01), indicating perceived personal growth in all educational objective categories. The majority of the participants (97%, N=86) agreed that they built skills in understanding cultural humility and caring for future patients (mean Likert scores: 4.91 and 5.10, respectively). Conclusions: Upon completion of the case, residents reported increased comfort and skills using a medical interpreter for non-English speaking patients within the context of patient-centered care, discussing various sensitive health topics, emphasizing the importance of upholding patient confidentiality, and demonstrating skills in adolescent interviewing. Both medical confidentiality and cultural humility education can be integrated into simulation-based medical education to improve the quality of care for diverse patient populations.Item Advances in pediatric acute kidney injury pathobiology: a report from the 26th Acute Disease Quality Initiative (ADQI) conference(Springer, 2024) Starr, Michelle C.; Barreto, Erin; Charlton, Jennifer; Vega, Molly; Brophy, Patrick D.; Bignall, O. N. Ray, II; Sutherland, Scott M.; Menon, Shina; Devarajan, Prasad; Arikan, Ayse Akcan; Basu, Rajit; Goldstein, Stuart; Soranno, Danielle E.; ADQI 26 workgroup; Pediatrics, School of MedicineBackground: In the past decade, there have been substantial advances in our understanding of the pathobiology of pediatric acute kidney injury (AKI). In particular, animal models and studies focused on the relationship between kidney development, nephron number, and kidney health have identified a number of heterogeneous pathophysiologies underlying AKI. Despite this progress, gaps remain in our understanding of the pathobiology of pediatric AKI. Methods: During the 26th Acute Disease Quality Initiative (ADQI) Consensus conference, a multidisciplinary group of experts discussed the evidence and used a modified Delphi process to achieve consensus on recommendations for opportunities to advance translational research in pediatric AKI. The current state of research understanding as well as gaps and opportunities for advancement in research was discussed, and recommendations were summarized. Results: Consensus was reached that to improve translational pediatric AKI advancements, diverse teams spanning pre-clinical to epidemiological scientists must work in concert together and that results must be shared with the community we serve with patient involvement. Public and private research support and meaningful partnerships with adult research efforts are required. Particular focus is warranted to investigate the pediatric nuances of AKI, including the effect of development as a biological variable on AKI incidence, severity, and outcomes. Conclusions: Although AKI is common and associated with significant morbidity, the biologic basis of the disease spectrum throughout varying nephron developmental stages remains poorly understood. An incomplete understanding of factors contributing to kidney health, the diverse pathobiologies underlying AKI in children, and the historically siloed approach to research limit advances in the field. The recommendations outlined herein identify gaps and outline a strategic approach to advance the field of pediatric AKI via multidisciplinary translational research.Item Advances in pediatric acute kidney injury pharmacology and nutrition: a report from the 26th Acute Disease Quality Initiative (ADQI) consensus conference(Springer, 2024) Wong Vega, Molly; Starr, Michelle C.; Brophy, Patrick D.; Devarajan, Prasad; Soranno, Danielle E.; Akcan‑Arikan, Ayse; Basu, Rajit; Goldstein, Stuart L.; Charlton, Jennifer R.; Barreto, ErinBackground: In the past decade, there have been substantial advances in our understanding of pediatric AKI. Despite this progress, large gaps remain in our understanding of pharmacology and nutritional therapy in pediatric AKI. Methods: During the 26th Acute Disease Quality Initiative (ADQI) Consensus Conference, a multidisciplinary group of experts reviewed the evidence and used a modified Delphi process to achieve consensus on recommendations for gaps and advances in care for pharmacologic and nutritional management of pediatric AKI. The current evidence as well as gaps and opportunities were discussed, and recommendations were summarized. Results: Two consensus statements were developed. (1) High-value, kidney-eliminated medications should be selected for a detailed characterization of their pharmacokinetics, pharmacodynamics, and pharmaco-"omics" in sick children across the developmental continuum. This will allow for the optimization of real-time modeling with the goal of improving patient care. Nephrotoxin stewardship will be identified as an organizational priority and supported with necessary resources and infrastructure. (2) Patient-centered outcomes (functional status, quality of life, and optimal growth and development) must drive targeted nutritional interventions to optimize short- and long-term nutrition. Measures of acute and chronic changes of anthropometrics, body composition, physical function, and metabolic control should be incorporated into nutritional assessments. Conclusions: Neonates and children have unique metabolic and growth parameters compared to adult patients. Strategic investments in multidisciplinary translational research efforts are required to fill the knowledge gaps in nutritional requirements and pharmacological best practices for children with or at risk for AKI.Item An Accountable Care Organization Maintains Access for Appendicitis During the COVID-19 Pandemic(Elsevier, 2023) Menchaca, Alicia D.; Style, Candace C.; Wang, Ling; Cooper, Jennifer N.; Minneci, Peter C.; Olutoye, Oluyinka O.; Surgery, School of MedicineIntroduction: It has been reported that pediatric patients experienced a delay in treatment for acute appendicitis during the pandemic, resulting in increased rates of complicated appendicitis. We investigated the association of the COVID-19 pandemic and the incidence and severity of acute appendicitis among pediatric Medicaid patients using a population-based approach. Methods: The claims database of Partners For Kids, a pediatric Medicaid accountable care organization (ACO) in Ohio, was queried for cases of acute appendicitis from April to August 2017-2020. The monthly rate of acute appendicitis/100,000 covered lives was calculated each year and compared over time. Rates of complicated appendicitis were also compared. Diagnosis code validation for classification as complicated or uncomplicated appendicitis was performed for patients treated at our hospital. Results: During the study period, 465 unique cases of acute appendicitis were identified. Forty percent (186/465) were coded as complicated. No significant difference in the incidence of acute appendicitis cases was observed across the 4 y, either in an overall comparison or in pairwise comparisons (P > 0.15 for all). The proportion of acute appendicitis cases that were coded as complicated did vary significantly over the 4-year study period (P = 0.005); this was due to this proportion being significantly higher in 2018 than in either 2019 (P = 0.005 versus 2018) or 2020 (P = 0.03 versus 2018). Conclusions: The COVID-19 pandemic was not associated with reduced access to treatment for acute appendicitis among patients in a pediatric Medicaid ACO. This suggests that an ACO may promote continued healthcare access for their covered population during an unexpected crisis.Item An mHealth App to Support Caregivers in the Medical Management of Their Child With Cancer: Co-design and User Testing Study(JMIR, 2022-03-16) Mueller, Emily L.; Cochrane, Anneli R.; Campbell, Madison E.; Nikkhah, Sarah; Miller, Andrew D.; Pediatrics, School of MedicineBackground: Caregivers face new challenges and tasks when their child is diagnosed with cancer, which can be overwhelming. Mobile technology has the capacity to provide immediate support at their fingertips to aid in tracking symptoms, managing medication, and planning for emergencies. Objective: The objective of this study is to engage directly with end users and proxies to co-design and create a mobile technology app to support caregivers in the medical management of their child with cancer. Methods: We engaged directly with caregivers of children with cancer and pediatric oncology nurse coordinators (proxy end users) to co-design and create the prototype of the Cope 360 mobile health app. Alpha testing was accomplished by walking the users through a series of predetermined tasks that encompassed all aspects of the app including tracking symptoms, managing medications, and planning or practicing for a medical emergency that required seeking care in the emergency department. Evaluation was accomplished through recorded semistructured interviews and quantitative surveys to capture demographic information and measure the system usability score. Interviews were transcribed and analyzed iteratively using NVivo (version 12; QSR International). Results: This study included 8 caregivers (aged 33-50 years) of children with cancer, with most children receiving chemotherapy, and 6 nurse coordinators, with 3 (50%) of them having 11 to 20 years of nursing experience. The mean system usability score given by caregivers was 89.4 (95% CI 80-98.8). Results were grouped by app function assessed with focus on specific attributes that were well received and those that required refinement. The major issues requiring refinement included clarity in the medical information and terminology, improvement in design of tasks, tracking of symptoms including adjusting the look and feel of certain buttons, and changing the visual graph used to monitor symptoms to include date anchors. Conclusions: The Cope 360 app was well received by caregivers of children with cancer but requires further refinement for clarity and visual representation. After refinement, testing among caregivers in a real-world environment is needed to finalize the Cope 360 app before its implementation in a randomized controlled trial.Item ANCA-associated vasculitis with cardiac valve vegetations in two teenage males: two case reports and a literature review(BMC, 2022-10-28) Theisen, Alexandra; Phillips, Carrie L.; Rodriguez, Martha; Pediatrics, School of MedicineBackground: Anti-neutrophil cytoplasm antibody (ANCA)-associated vasculitis is a term used to describe systemic vasculitides that affect small and medium-sized blood vessels. Granulomatosis with Polyangiitis (GPA), a type of ANCA-associated vasculitis (AAV), is rare in children with an estimated prevalence of 3-4 per million, and even more rare is the manifestation of cardiac abnormalities secondary to ANCA-associated vasculitis in the pediatric population. Case presentation: We discuss the cases of two teenage males who presented with cardiac valvular lesions secondary to GPA in addition to sinus, pulmonary, renal, and cutaneous involvement. These findings of cardiac valvular abnormalities in GPA have rarely been described in the literature in pediatrics. Both patients were treated with rituximab, high-dose methylprednisolone, and therapeutic plasma exchange and showed improvement in their disease manifestations. Conclusions: A review of the literature revealed only five pediatric cases of ANCA-associated vasculitis with cardiac manifestations, and interestingly, three of the five had valvular involvement. Subsequent valvular involvement makes obtaining the diagnosis of ANCA-Associated Vasculitis difficult due to concern for underlying infectious endocarditis and can lead to misdiagnosis given the rarity of cardiac involvement in ANCA-associated vasculitis. Routine echocardiogram is not always completed in newly diagnosed AAV, yet cardiac involvement can lead to severe consequences as was seen with our first patient in the form of thromboembolic stroke. We discuss the importance of keeping AAV on the differential when cardiac lesions are present as well as the importance of regular cardiac screening in newly diagnosed patients with AAV, as it is a major factor of cardiac morbidity and mortality in the adult population and can contribute substantially to management decisions.