The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods
Year: 2023
Type: article
Abstract: Rationale & Objective: 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. Study Design: Multicenter retrospective cohort study (clinical outcomes) and cross-sectional study (patient-reported outcomes [PROs]). Setting & Participants: and no prior dialysis or kidney transplant. Exposures: BP measurements (clinic-based and 24-hour ambulatory BP); urine protein; and antihypertensive treatment by therapeutic class. Outcomes: , long-term dialysis or kidney transplant. Secondary outcomes include change in eGFR, adverse events, and PROs. Analytical Approach: 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. Limitations: Causal inference limited by observational analyses. Conclusions: 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. Plain-Language Summary: 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.
Source: Kidney Medicine
Authors: Michelle R. Denburg, Hanieh Razzaghi, Amy J. Goodwin Davies, Vikas Dharnidharka, Bradley P. Dixon, Joseph T. Flynn, Dorey Glenn, Caroline A. Gluck, Lyndsay Harshman, Aneta Jovanovska, Chryso Pefkaros Katsoufis, Amy L. Kratchman, Mark Levondosky, Rebecca Levondosky, Jill McDonald, Mark Mitsnefes, Zubin J. Modi, Jordan Musante, Alicia M. Neu, Cynthia G. Pan, Hiren P. Patel, Larry T. Patterson, Julia Schuchard, Priya S. Verghese, Amy C. Wilson, Cynthia Wong, Christopher B. Forrest
Institutions: Children's Hospital of Philadelphia, University of Pennsylvania, St. Louis Children's Hospital, Washington University in St. Louis, Children's Hospital Colorado, University of Colorado Anschutz, Seattle Children's Hospital, University of Washington, University of North Carolina at Chapel Hill, Nemours Children's Health System, University of Iowa Stead Family Children’s Hospital, University of Miami, Cincinnati Children's Hospital Medical Center, University of Cincinnati, University of Michigan, C. S. Mott Children's Hospital, Johns Hopkins University, Johns Hopkins Medicine, Johns Hopkins Children's Center, Medical College of Wisconsin, Nationwide Children's Hospital, The Ohio State University, UF Health Shands Hospital, University of Florida, Northwestern University, Lurie Children's Hospital, Riley Hospital for Children, Indiana University School of Medicine, Stanford Medicine, Stanford University
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,400
OpenAlex ID: W4386701366