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Browsing by Author "Jone, Pei-Ni"
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Item Can Multisystem Inflammatory Syndrome in Children Be Managed in the Outpatient Setting? An EHR-Based Cohort Study From the RECOVER Program(Oxford University Press, 2023) Jhaveri, Ravi; Webb, Ryan; Razzaghi, Hanieh; Schuchard, Julia; Mejias, Asuncion; Bennett, Tellen D.; Jone, Pei-Ni; Thacker, Deepika; Schulert, Grant S.; Rogerson, Colin; Cogen, Jonathan D.; Bailey, L. Charles; Forrest, Christopher B.; Lee, Grace M.; Rao, Suchitra; RECOVER consortium; Pediatrics, School of MedicineUsing electronic health record data combined with primary chart review, we identified seven children across nine participant pediatric medical centers with a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) managed exclusively as outpatients. These findings should raise awareness of mild presentations of MIS-C and the option of outpatient management.Item Examination of Adverse Reactions After COVID-19 Vaccination Among Patients With a History of Multisystem Inflammatory Syndrome in Children(American Medical Association, 2023-01-03) Elias, Matthew D.; Truong, Dongngan T.; Oster, Matthew E.; Trachtenberg, Felicia L.; Mu, Xiangyu; Jone, Pei-Ni; Mitchell, Elizabeth C.; Dummer, Kirsten B.; Sexson Tejtel, S. Kristen; Osakwe, Onyekachukwu; Thacker, Deepika; Su, Jennifer A.; Bradford, Tamara T.; Burns, Kristin M.; Campbell, M. Jay; Connors, Thomas J.; D'Addese, Laura; Forsha, Daniel; Frosch, Olivia H.; Giglia, Therese M.; Goodell, Lauren R.; Handler, Stephanie S.; Hasbani, Keren; Hebson, Camden; Krishnan, Anita; Lang, Sean M.; McCrindle, Brian W.; McHugh, Kimberly E.; Morgan, Lerraughn M.; Payne, R. Mark; Sabati, Arash; Sagiv, Eyal; Sanil, Yamuna; Serrano, Faridis; Newburger, Jane W.; Dionne, Audrey; Pediatric Heart Network MUSIC Study Investigators; Pediatrics, School of MedicineImportance: Data are limited regarding adverse reactions after COVID-19 vaccination in patients with a history of multisystem inflammatory syndrome in children (MIS-C). The lack of vaccine safety data in this unique population may cause hesitancy and concern for many families and health care professionals. Objective: To describe adverse reactions following COVID-19 vaccination in patients with a history of MIS-C. Design, setting, and participants: In this multicenter cross-sectional study including 22 North American centers participating in a National Heart, Lung, and Blood Institute, National Institutes of Health-sponsored study, Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children (MUSIC), patients with a prior diagnosis of MIS-C who were eligible for COVID-19 vaccination (age ≥5 years; ≥90 days after MIS-C diagnosis) were surveyed between December 13, 2021, and February 18, 2022, regarding COVID-19 vaccination status and adverse reactions. Exposures: COVID-19 vaccination after MIS-C diagnosis. Main outcomes and measures: The main outcome was adverse reactions following COVID-19 vaccination. Comparisons were made using the Wilcoxon rank sum test for continuous variables and the χ2 or Fisher exact test for categorical variables. Results: Of 385 vaccine-eligible patients who were surveyed, 185 (48.1%) received at least 1 vaccine dose; 136 of the vaccinated patients (73.5%) were male, and the median age was 12.2 years (IQR, 9.5-14.7 years). Among vaccinated patients, 1 (0.5%) identified as American Indian/Alaska Native, non-Hispanic; 9 (4.9%) as Asian, non-Hispanic; 45 (24.3%) as Black, non-Hispanic; 59 (31.9%) as Hispanic or Latino; 53 (28.6%) as White, non-Hispanic; 2 (1.1%) as multiracial, non-Hispanic; and 2 (1.1%) as other, non-Hispanic; 14 (7.6%) had unknown or undeclared race and ethnicity. The median time from MIS-C diagnosis to first vaccine dose was 9.0 months (IQR, 5.1-11.9 months); 31 patients (16.8%) received 1 dose, 142 (76.8%) received 2 doses, and 12 (6.5%) received 3 doses. Almost all patients received the BNT162b2 vaccine (347 of 351 vaccine doses [98.9%]). Minor adverse reactions were observed in 90 patients (48.6%) and were most often arm soreness (62 patients [33.5%]) and/or fatigue (32 [17.3%]). In 32 patients (17.3%), adverse reactions were treated with medications, most commonly acetaminophen (21 patients [11.4%]) or ibuprofen (11 [5.9%]). Four patients (2.2%) sought medical evaluation, but none required testing or hospitalization. There were no patients with any serious adverse events, including myocarditis or recurrence of MIS-C. Conclusions and relevance: In this cross-sectional study of patients with a history of MIS-C, no serious adverse events were reported after COVID-19 vaccination. These findings suggest that the safety profile of COVID-19 vaccination administered at least 90 days following MIS-C diagnosis appears to be similar to that in the general population.Item Infliximab versus second intravenous immunoglobulin for treatment of resistant Kawasaki disease in the USA (KIDCARE): a randomised, multicentre comparative effectiveness trial(Elsevier, 2021-12) Burns, Jane C.; Roberts, Samantha C.; Tremoulet, Adriana H.; He, Feng; Printz, Beth F.; Ashouri, Negar; Jain, Supriya S.; Michalik, David E.; Sharma, Kavita; Truong, Dongngan T.; Wood, James B.; Kim, Katherine K.; Jain, Sonia; Anand, Vikram; Anderson, Marsha; Ang, Jocelyn; Ansusinha, Emily; Arditi, Moshe; Bartlett, Allison; Baker, Annette; Chatterjee, Archana; DeBiasi, Roberta; De Ferranti, Sarah; Dekker, Cornelia; DeZure, Chandani; Dominguez, Samuel; Erdem, Guliz; Halasa, Natasha; Harahsheh, Ashraf S.; Hite, Michelle; Jaggi, Preeti; Jone, Pei-Ni; Jones, Jessica; Kaushik, Neeru; Kumar, Madan; Kurio, Gregory; Lloyd, David; Manaloor, John; McNelis, Amy; Nadipuram, Santhosh; Newburger, Jane; Newcomer, Charles; Perkins, Tiffany; Portman, Michael; Romero, José R.; Rometo, Allison; Ronis, Tova; Rosenkranz, Margalit; Rowley, Anne; Samuy, Nichole; Scalici, Paul; Schuster, Jennifer; Sexson Tejtel, S. Kristen; Simonsen, Kari; Szmuszkovicz, Jacqueline; Yeh, Sylvia; Pediatrics, School of MedicineBackground Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease, 10–20% of patients have recrudescent fever as a sign of persistent inflammation and require additional treatment. We aimed to compare infliximab with a second infusion of IVIG for treatment of resistant Kawasaki disease. Methods In this multicentre comparative effectiveness trial, patients (aged 4 weeks to 17 years) with IVIG resistant Kawasaki disease and fever at least 36 h after completion of their first IVIG infusion were recruited from 30 hospitals across the USA. Patients were randomly assigned (1:1) to second IVIG (2 g/kg over 8–12 h) or intravenous infliximab (10 mg/kg over 2 h without premedication), by using a randomly permuted block randomisation design with block size of two or four. Patients with fever 24 h to 7 days following completion of first study treatment crossed over to receive the other study treatment. The primary outcome measure was resolution of fever at 24 h after initiation of study treatment with no recurrence of fever attributed to Kawasaki disease within 7 days post-discharge. Secondary outcome measures included duration of fever from enrolment, duration of hospitalisation after randomisation, and changes in markers of inflammation and coronary artery Z score. Efficacy was analysed in participants who received treatment and had available outcome values. Safety was analysed in all randomised patients who did not withdraw consent. This clinical trial is registered with ClinicalTrials.gov, NCT03065244. Findings Between March 1, 2017, and Aug 31, 2020, 105 patients were randomly assigned to treatment and 103 were included in the intention-to-treat population (54 in the infliximab group, 49 in the second IVIG group). Two patients randomised to infliximab did not receive allocated treatment. The primary outcome was met by 40 (77%) of 52 patients in the infliximab group and 25 (51%) of 49 patients in the second IVIG infusion group (odds ratio 0·31, 95% CI 0·13–0·73, p=0·0076). 31 patients with fever beyond 24 h received crossover treatment: nine (17%) in the infliximab group received second IVIG and 22 (45%) in second IVIG group received infliximab (p=0·0024). Three patients randomly assigned to infliximab and two to second IVIG with fever beyond 24h did not receive crossover treatment. Mean fever days from enrolment was 1·5 (SD 1·4) for the infliximab group and 2·5 (2·5) for the second IVIG group (p=0·014). Mean hospital stay was 3·2 days (2·1) for the infliximab group and 4·5 days (2·5) for the second IVIG group (p<0·001). There was no difference between treatment groups for markers of inflammation or coronary artery outcome. 24 (44%) of 54 patients in the infliximab group and 33 (67%) of 49 in the second IVIG group had at least one adverse event. A drop in haemoglobin concentration of at least 2g/dL was seen in 19 (33%) of 58 patients who received IVIG as either their first or second study treatment (three of whom required transfusion) and in three (7%) of 43 who received only infliximab (none required transfusion; p=0·0028). Haemolytic anaemia was the only serious adverse events deemed definitely or probably related to study treatment, and was reported in nine (15%) of 58 patients who received IVIG as either their first or second study treatment and none who received infliximab only. Interpretation Infliximab is a safe, well tolerated, and effective treatment for patients with IVIG resistant Kawasaki disease, and results in shorter duration of fever, reduced need for additional therapy, less severe anaemia, and shorter hospitalisation compared with second IVIG infusion.Item The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial: A phase III, randomized trial of second intravenous immunoglobulin versus infliximab for resistant Kawasaki disease(Elsevier, 2019-04) Roberts, Samantha C.; Jain, Sonia; Tremoulet, Adriana H.; Kim, Katherine K.; Burns, Jane C.; Anand, Vikram; Anderson, Marsha; Ang, Jocelyn; Ansusinha, Emily; Arditi, Moshe; Ashouri, Negar; Bartlett, Allison; Chatterjee, Archana; DeBiasi, Roberta; Dekker, Cornelia; DeZure, Chandani; Didion, Lisa; Dominguez, Samuel; El Feghaly, Rana; Erdem, Guliz; Halasa, Natasha; Harahsheh, Ashraf; Jackson, Mary Anne; Jaggi, Preeti; Jain, Supriya; Jone, Pei-Ni; Kaushik, Neeru; Kurio, Gregory; Lillian, Anna; Lloyd, David; Manaloor, John; McNelis, Amy; Michalik, David E.; Newburger, Jane; Newcomer, Charles; Perkins, Tiffany; Portman, Michael; Romero, Jose; Ronis, Tova; Rowley, Anne; Schneider, Kathryn; Schuster, Jennifer; Sexson Tejtel, S. Kristen; Sharma, Kavita; Simonsen, Kari; Szmuszkovicz, Jacqueline; Truong, Dongngan; Wood, James; Yeh, Sylvia; Pediatrics, School of MedicineBackground Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease (KD), the most common cause of acquired heart disease in children, 10–20% of patients are IVIG-resistant and require additional therapy. This group has an increased risk of coronary artery aneurysms (CAA) and there has been no adequately powered, randomized clinical trial in a multi-ethnic population to determine the optimal therapy for IVIG-resistant patients. Objectives The primary outcome is duration of fever in IVIG-resistant patients randomized to treatment with either infliximab or a second IVIG infusion. Secondary outcomes include comparison of inflammatory markers, duration of hospitalization, and coronary artery outcome. An exploratory aim records parent-reported outcomes including signs, symptoms and treatment experience. Methods The KIDCARE trial is a 30-site randomized Phase III comparative effectiveness trial in KD patients with fever ≥36 h after the completion of their first IVIG treatment. Eligible patients will be randomized to receive either a second dose of IVIG (2 g/kg) or infliximab (10 mg/kg). Subjects with persistent or recrudescent fever at 24 h following completion of the first study treatment will cross-over to the other treatment arm. Subjects will exit the study after their first outpatient visit (5–18 days following last study treatment). The parent-reported outcomes, collected daily during hospitalization and at home, will be compared by study arm. Conclusion This trial will contribute to the management of IVIG-resistant patients by establishing the relative efficacy of a second dose of IVIG compared to infliximab and will provide data regarding the patient/parent experience of these treatments.Item Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design(Public Library of Science, 2023-06-23) Gross, Rachel; Thaweethai, Tanayott; Rosenzweig, Erika B.; Chan, James; Chibnik, Lori B.; Cicek, Mine S.; Elliott, Amy J.; Flaherman, Valerie J.; Foulkes, Andrea S.; Witvliet, Margot Gage; Gallagher, Richard; Gennaro, Maria Laura; Jernigan, Terry L.; Karlson, Elizabeth W.; Katz, Stuart D.; Kinser, Patricia A.; Kleinman, Lawrence C.; Lamendola-Essel, Michelle F.; Milner, Joshua D.; Mohandas, Sindhu; Mudumbi, Praveen C.; Newburger, Jane W.; Rhee, Kyung E.; Salisbury, Amy L.; Snowden, Jessica N.; Stein, Cheryl R.; Stockwell, Melissa S.; Tantisira, Kelan G.; Thomason, Moriah E.; Truong, Dongngan T.; Warburton, David; Wood, John C.; Ahmed, Shifa; Akerlundh, Almary; Alshawabkeh, Akram N.; Anderson, Brett R.; Aschner, Judy L.; Atz, Andrew M.; Aupperle, Robin L.; Baker, Fiona C.; Balaraman, Venkataraman; Banerjee, Dithi; Barch, Deanna M.; Baskin-Sommers, Arielle; Bhuiyan, Sultana; Bind, Marie-Abele C.; Bogie, Amanda L.; Buchbinder, Natalie C.; Bueler, Elliott; Bükülmez, Hülya; Casey, B. J.; Chang, Linda; Clark, Duncan B.; Clifton, Rebecca G.; Clouser, Katharine N.; Cottrell, Lesley; Cowan, Kelly; D'Sa, Viren; Dapretto, Mirella; Dasgupta, Soham; Dehority, Walter; Dummer, Kirsten B.; Elias, Matthew D.; Esquenazi-Karonika, Shari; Evans, Danielle N.; Faustino, E. Vincent S.; Fiks, Alexander G.; Forsha, Daniel; Foxe, John J.; Friedman, Naomi P.; Fry, Greta; Gaur, Sunanda; Gee, Dylan G.; Gray, Kevin M.; Harahsheh, Ashraf S.; Heath, Andrew C.; Heitzeg, Mary M.; Hester, Christina M.; Hill, Sophia; Hobart-Porter, Laura; Hong, Travis K. F.; Horowitz, Carol R.; Hsia, Daniel S.; Huentelman, Matthew; Hummel, Kathy D.; Iacono, William G.; Irby, Katherine; Jacobus, Joanna; Jacoby, Vanessa L.; Jone, Pei-Ni; Kaelber, David C.; Kasmarcak, Tyler J.; Kluko, Matthew J.; Kosut, Jessica S.; Laird, Angela R.; Landeo-Gutierrez, Jeremy; Lang, Sean M.; Larson, Christine L.; Lim, Peter Paul C.; Lisdahl, Krista M.; McCrindle, Brian W.; McCulloh, Russell J.; Mendelsohn, Alan L.; Metz, Torri D.; Morgan, Lerraughn M.; Müller-Oehring, Eva M.; Nahin, Erica R.; Neale, Michael C.; Ness-Cochinwala, Manette; Nolan, Sheila M.; Oliveira, Carlos R.; Oster, Matthew E.; Payne, R. Mark; Raissy, Hengameh; Randall, Isabelle G.; Rao, Suchitra; Reeder, Harrison T.; Rosas, Johana M.; Russell, Mark W.; Sabati, Arash A.; Sanil, Yamuna; Sato, Alice I.; Schechter, Michael S.; Selvarangan, Rangaraj; Shakti, Divya; Sharma, Kavita; Squeglia, Lindsay M.; Stevenson, Michelle D.; Szmuszkovicz, Jacqueline; Talavera-Barber, Maria M.; Teufel, Ronald J., II; Thacker, Deepika; Udosen, Mmekom M.; Warner, Megan R.; Watson, Sara E.; Werzberger, Alan; Weyer, Jordan C.; Wood, Marion J.; Yin, H. Shonna; Zempsky, William T.; Zimmerman, Emily; Dreyer, Benard P.; Pediatrics, School of MedicineImportance: SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis. Methods: RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms. Discussion: RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options.