The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods

PRESERVE seeks to provide new knowledge to inform shared decision-making regarding blood pressure (BP) management for pediatric chronic kidney disease (CKD). PRESERVE will compare the effectiveness of alternative strategies for monitoring and treating hypertension on preserving kidney function; expa...

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Bibliographic Details
Published in:	Kidney medicine Vol. 5; no. 11; p. 100722
Main Authors:	Denburg, Michelle R., Razzaghi, Hanieh, Goodwin Davies, Amy J., Dharnidharka, Vikas, Dixon, Bradley P., Flynn, Joseph T., Glenn, Dorey, Gluck, Caroline A., Harshman, Lyndsay, Jovanovska, Aneta, Katsoufis, Chryso Pefkaros, Kratchman, Amy L., Levondosky, Mark, Levondosky, Rebecca, McDonald, Jill, Mitsnefes, Mark, Modi, Zubin J., Musante, Jordan, Neu, Alicia M., Pan, Cynthia G., Patel, Hiren P., Patterson, Larry T., Schuchard, Julia, Verghese, Priya S., Wilson, Amy C., Wong, Cynthia, Forrest, Christopher B.
Format:	Journal Article
Language:	English
Published:	Elsevier Inc 01-11-2023 Elsevier
Subjects:	blood pressure children chronic kidney disease hypertension kidney function Original Research Pediatric blood pressure chronic kidney disease kidney function children Pediatric hypertension
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Summary:	PRESERVE seeks to provide new knowledge to inform shared decision-making regarding blood pressure (BP) management for pediatric chronic kidney disease (CKD). PRESERVE will compare the effectiveness of alternative strategies for monitoring and treating hypertension on preserving kidney function; expand the National Patient-Centered Clinical Research Network (PCORnet) common data model by adding pediatric- and kidney-specific variables and linking electronic health record data to other kidney disease databases; and assess the lived experiences of patients related to BP management. Multicenter retrospective cohort study (clinical outcomes) and cross-sectional study (patient-reported outcomes [PROs]). PRESERVE will include approximately 20,000 children between January 2009-December 2022 with mild-moderate CKD from 15 health care institutions that participate in 6 PCORnet Clinical Research Networks (PEDSnet, STAR, GPC, PaTH, CAPRiCORN, and OneFlorida+). The inclusion criteria were≥1 nephrologist visit and≥2 estimated glomerular filtration rate (eGFR) values in the range of 30 to<90mL/min/1.73m2 separated by≥90 days without an intervening value≥90mL/min/1.73m2 and no prior dialysis or kidney transplant. BP measurements (clinic-based and 24-hour ambulatory BP); urine protein; and antihypertensive treatment by therapeutic class. The primary outcome is a composite event of a 50% reduction in eGFR, eGFR of<15mL/min/1.73m2, long-term dialysis or kidney transplant. Secondary outcomes include change in eGFR, adverse events, and PROs. Longitudinal models for dichotomous (proportional hazards or accelerated failure time) and continuous (generalized linear mixed models) clinical outcomes; multivariable linear regression for PROs. We will evaluate heterogeneity of treatment effect by CKD etiology and degree of proteinuria and will examine variation in hypertension management and outcomes based on socio-demographics. Causal inference limited by observational analyses. PRESERVE will leverage the PCORnet infrastructure to conduct large-scale observational studies that address BP management knowledge gaps for pediatric CKD, focusing on outcomes that are meaningful to patients. Hypertension is a major modifiable contributor to loss of kidney function in chronic kidney disease (CKD). The purpose of PRESERVE is to provide evidence to inform shared decision-making regarding blood pressure management for children with CKD. PRESERVE is a consortium of 16 health care institutions in PCORnet, the National Patient-Centered Clinical Research Network, and includes electronic health record data for>19,000 children with CKD. PRESERVE will (1) expand the PCORnet infrastructure for research in pediatric CKD by adding kidney-specific variables and linking electronic health record data to other kidney disease databases; (2) compare the effectiveness of alternative strategies for monitoring and treating hypertension on preserving kidney function; and (3) assess the lived experiences of patients and caregivers related to blood pressure management.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2590-0595 2590-0595
DOI:	10.1016/j.xkme.2023.100722