Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design
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; 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
IMPORTANCE/UNASSIGNED:The prevalence, pathophysiology, and long-term outcomes of COVID-19 (post-acute sequelae of SARS-CoV-2 [PASC] or "Long COVID") in children and young adults remain unknown. Studies must address the urgent need to define PASC, its mechanisms, and potential treatment targets in children and young adults. OBSERVATIONS/UNASSIGNED:cohort incorporates three tiers of data collection: 1) remote baseline assessments (Tier 1, n=6000); 2) longitudinal follow-up for up to 4 years (Tier 2, n=6000); and 3) a subset of participants, primarily the most severely affected by PASC, who will undergo deep phenotyping to explore PASC pathophysiology (Tier 3, n=600). Youth enrolled in the ABCD study participate in Tier 1. The pediatric protocol was developed as a collaborative partnership of investigators, patients, researchers, clinicians, community partners, and federal partners, intentionally promoting inclusivity and diversity. The protocol is adaptive to facilitate responses to emerging science. CONCLUSIONS AND RELEVANCE/UNASSIGNED:RECOVER-Pediatrics seeks to characterize the clinical course, underlying mechanisms, and long-term effects of PASC from birth through 25 years old. RECOVER-Pediatrics is designed to elucidate the epidemiology, four-year clinical course, and sociodemographic correlates of pediatric PASC. The data and biosamples will allow examination of mechanistic hypotheses and biomarkers, thus providing insights into potential therapeutic interventions. CLINICAL TRIALSGOV IDENTIFIER/UNASSIGNED:Clinical Trial Registration: http://www.clinicaltrials.gov . Unique identifier: NCT05172011.
PMID: 37214806
CID: 5770522
Racial-ethnic disparities in outcomes of children hospitalized for COVID-19: A virus registry report [Meeting Abstract]
Dapul, H; Tripathi, S; Kuehne, J; Ramirez, M; Rajagopalan, L; Salameh, M; Tolopka, T; Garcia, M; Boman, K; Kumar, V; Dreyer, B; Bhalala, U S
INTRODUCTION: Adult racial and ethnic minorities in the U.S. with COVID-19 are known to have worse outcomes. The CDC reported higher incidence of COVID-19 among minority children, but data regarding disparities in pediatric COVID-19 outcomes remains limited.
METHOD(S): A total of 837 children < 18 years of age hospitalized with COVID-19 in the U.S. were entered into the SCCM VIRUS Registry from 03/2020 to 01/2021. They were grouped into either of the following: Hispanic, non-Hispanic White, non-Hispanic Black, non-Hispanic Asian, Other or Unknown. Demographic and clinical characteristics, interventions and outcomes were compared. Critical illness was defined using a composite index of in-hospital mortality and organ support requirement, including vasopressors/inotropes, ECMO and CRRT. Comparisons were made using ANOVA, Kruskal-Wallis or Pearson's Chi-square. We used multivariable logistic and linear regression analysis to examine associations between race and ethnicity and critical illness, hospital and ICU length of stay and hospital mortality.
RESULT(S): Fever was reported in 67%, with no difference among the groups. MIS-C was reported with a significantly higher proportion in non-Hispanic Blacks (36%) than in non- Hispanic Whites (26%) [p=0.02]. Adjusting for age, sex, obesity, immune compromise and asthma, the non-Hispanic Asian group was significantly associated with higher odds of critical illness [OR=5.83, 95% CI=2.13-15.81]. Non-Hispanic Blacks also had higher odds of critical illness than non-Hispanic Whites, though not significant [OR=1.59, 95% CI=0.99-2.54]. With each yearly increase in age, the odds of critical illness was higher [OR=1.04, 95% CI=0.99-1.07] given all other covariates remain the same. While there was a higher proportion of obesity in the Hispanic group, this did not increase their odds of critical illness. Non- Hispanic Blacks had longer hospital length of stay compared to non-Hispanic Whites, though not significant [OR=1.76, 95% CI=-0.17-3.68]. ICU length of stay and mortality were not significantly associated with race or ethnicity.
CONCLUSION(S): Racial and ethnic disparities in pediatric COVID-19 outcomes exist that are not associated with preexisting conditions. These findings may guide the allocation of critical care resources towards minority groups at higher risk for severe disease
EMBASE:637189999
ISSN: 1530-0293
CID: 5158352
Patient and Family-Centered I-PASS SCORE Program: Resident and Advanced Care Provider Training Materials
Lewis, Kheyandra D; Destino, Lauren; Everhart, Jennifer; Subramony, Anupama; Dreyer, Benard; Allair, Brenda; Anderson, Michele; Baird, Jennifer; Bismilla, Zia; Good, Brian; Hepps, Jennifer; Khan, Alisa; Kuzma, Nicholas; Landrigan, Christopher P; Litterer, Katherine; Sectish, Theodore C; Spector, Nancy D; Yin, H Shonna; Yu, Clifton E; Calaman, Sharon; O'Toole, Jennifer K
Introduction:Patient and family-centered rounds (PFCRs) are an important element of family-centered care often used in the inpatient pediatric setting. However, techniques and best practices vary, and faculty, trainees, nurses, and advanced care providers may not receive formal education in strategies that specifically enhance communication on PFCRs. Methods:Harnessing the use of structured communication, we developed the Patient and Family-Centered I-PASS Safer Communication on Rounds Every Time (SCORE) Program. The program uses a standardized framework for rounds communication via the I-PASS mnemonic, principles of health literacy, and techniques for patient/family engagement and bidirectional communication. The resident and advanced care provider training materials, a component of the larger SCORE Program, incorporate a flipped classroom approach as well as interactive exercises, simulations, and virtual learning options to optimize learning and retention via a 90-minute workshop. Results:Two hundred forty-six residents completed the training and were evaluated on their knowledge and confidence regarding key elements of the curriculum. Eighty-eight percent of residents agreed/strongly agreed that after training they could activate and engage families and all members of the interprofessional team to create a shared mental model; 90% agreed/strongly agreed that they could discuss the roles/responsibilities of various team members during PFCRs. Discussion:The Patient and Family-Centered I-PASS SCORE Program provides a structured framework for teaching advanced communication techniques that can improve provider knowledge of and confidence with engaging and communicating with patients/families and other members of the interprofessional team during PFCRs.
PMCID:9360201
PMID: 35990195
ISSN: 2374-8265
CID: 5331472