The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods
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 p...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-11-01
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| Series: | Kidney Medicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2590059523001401 |
| _version_ | 1827781679239921664 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Michelle R. Denburg |
| collection | DOAJ |
| description | 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: 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 <90 mL/min/1.73 m2 separated by ≥90 days without an intervening value ≥90 mL/min/1.73 m2 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: The primary outcome is a composite event of a 50% reduction in eGFR, eGFR of <15 mL/min/1.73 m2, 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. |
| first_indexed | 2024-03-11T15:22:06Z |
| format | Article |
| id | doaj.art-7092f5a8597f413db3c9329e59459dcc |
| institution | Directory Open Access Journal |
| issn | 2590-0595 |
| language | English |
| last_indexed | 2024-03-11T15:22:06Z |
| publishDate | 2023-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Kidney Medicine |
| spelling | doaj.art-7092f5a8597f413db3c9329e59459dcc2023-10-28T05:09:37ZengElsevierKidney Medicine2590-05952023-11-01511100722The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and MethodsMichelle R. Denburg0Hanieh Razzaghi1Amy J. Goodwin Davies2Vikas Dharnidharka3Bradley P. Dixon4Joseph T. Flynn5Dorey Glenn6Caroline A. Gluck7Lyndsay Harshman8Aneta Jovanovska9Chryso Pefkaros Katsoufis10Amy L. Kratchman11Mark Levondosky12Rebecca Levondosky13Jill McDonald14Mark Mitsnefes15Zubin J. Modi16Jordan Musante17Alicia M. Neu18Cynthia G. Pan19Hiren P. Patel20Larry T. Patterson21Julia Schuchard22Priya S. Verghese23Amy C. Wilson24Cynthia Wong25Christopher B. Forrest26Children’s Hospital of Philadelphia, Philadelphia, PA; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Address for Correspondence: Michelle Denburg, MD, MSCE, 3501 Civic Center Blvd, Philadelphia, PA 19104, United States.Children’s Hospital of Philadelphia, Philadelphia, PAChildren’s Hospital of Philadelphia, Philadelphia, PASt. Louis Children’s Hospital, Washington University in St. Louis School of Medicine, St. Louis, MOChildren’s Hospital Colorado, University of Colorado School of Medicine, Aurora, COSeattle Children’s Hospital, University of Washington School of Medicine, Seattle, WAUniversity of North Carolina School of Medicine, Chapel Hill, NCNemours Children’s Health, Wilmington, DEUniversity of Iowa Stead Family Children’s Hospital, Iowa City, IAChildren’s Hospital of Philadelphia, Philadelphia, PAUniversity of Miami, Holtz Children’s Hospital, Miami, FLChildren’s Hospital of Philadelphia, Philadelphia, PAChildren’s Hospital of Philadelphia, Philadelphia, PAChildren’s Hospital of Philadelphia, Philadelphia, PAChildren’s Hospital of Philadelphia, Philadelphia, PACincinnati Children’s Hospital Medical Center, University of Cincinnati, Cincinnati, OHC.S. Mott Children’s Hospital, University of Michigan, Ann Arbor, MIChildren’s Hospital of Philadelphia, Philadelphia, PAJohns Hopkins Children’s Center, Johns Hopkins School of Medicine, Baltimore, MDMedical College of Wisconsin, Children’s Wisconsin, Milwaukee, WINationwide Children’s Hospital, The Ohio State University College of Medicine, Columbus, OHUniversity of Florida, Shands Children’s Hospital, Gainesville, FLChildren’s Hospital of Philadelphia, Philadelphia, PALurie Children’s Hospital, Northwestern University Feinberg School of Medicine, Chicago, ILRiley Children’s Health, Indiana University School of Medicine, Indianapolis, INStanford Children’s Health, Stanford University School of Medicine, Palo Alto, CAChildren’s Hospital of Philadelphia, Philadelphia, PA; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PARationale & 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: 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 <90 mL/min/1.73 m2 separated by ≥90 days without an intervening value ≥90 mL/min/1.73 m2 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: The primary outcome is a composite event of a 50% reduction in eGFR, eGFR of <15 mL/min/1.73 m2, 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.http://www.sciencedirect.com/science/article/pii/S2590059523001401Pediatricchildrenchronic kidney diseaseblood pressurehypertensionkidney function |
| spellingShingle | 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 The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods Kidney Medicine Pediatric children chronic kidney disease blood pressure hypertension kidney function |
| title | The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods |
| title_full | The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods |
| title_fullStr | The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods |
| title_full_unstemmed | The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods |
| title_short | The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods |
| title_sort | preserving kidney function in children with ckd preserve study rationale design and methods |
| topic | Pediatric children chronic kidney disease blood pressure hypertension kidney function |
| url | http://www.sciencedirect.com/science/article/pii/S2590059523001401 |
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