Preserving Kidney Function in Children with Chronic Kidney Disease (PRESERVE), United States, 2009-2024 (ICPSR 39689)
Version Date: Mar 30, 2026 View help for published
Principal Investigator(s): View help for Principal Investigator(s)
Christopher B. Forrest, Children's Hospital of Philadelphia
https://doi.org/10.3886/ICPSR39689.v1
Version V1
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Summary View help for Summary
The Preserving Kidney Function in Children With Chronic Kidney Disease (PRESERVE) study was designed to provide new knowledge to inform shared decision-making regarding blood pressure (BP) management for pediatric chronic kidney disease (CKD). PRESERVE compared the effectiveness of alternative strategies for monitoring and treating hypertension on preserving kidney function; expanded 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 assessed the lived experiences of patients related to BP management.
Participants were recruited from 15 clinical institutions across the United States. The research team analyzed electronic health record (EHR) data from 11,851 children with CKD and their caregivers to compare different ways to monitor and treat BP to preserve kidney function. In addition, a subset of patients and caregivers completed an online survey detailing patient-reported outcomes, such as fatigue, life satisfaction, pain levels, sleep disturbance, anxiety, and peer relationships (n=395).
Due to the risk of re-identification based on unique patterns in the individual-level PCORnet electronic health record (EHR) data, patient privacy regulations prohibit the public release of the individual-level data. This collection contains the code underlying the analysis; instructions, codesets, and output lists for the PCORnet queries; and the survey questionnaires for patients and family members.
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Data Collection Notes View help for Data Collection Notes
- Please visit the PRESERVE Coordinating Center GitHub repository for materials related to the PRESERVE study, including concept sets, code-based definitions, and analytic code.
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Files in this collection have been released in a zipped package as received by ICPSR. Please refer to the ICPSR README for more information about the files.
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Keywords provided by Children's Hospital of Philadelphia as listed on ClinicalTrials.gov:
- Chronic
- Child
- Pediatric
- Hypertension
- Proteinuria
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Additional relevant Medical Subject Headings (MeSH) terms as listed on ClinicalTrials.gov:
- Renal Insufficiency
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Chronic Disease
- Disease Attributes
- Pathologic Processes
- Pathologic Conditions, Signs, and Symptoms
- Organizing Pneumonia
- Bronchiolitis Obliterans
- Bronchiolitis
- Bronchitis
- Bronchial Diseases
- Respiratory Tract Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Graft vs Host Disease
- Immune System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Urination Disorders
- Urological Manifestations
- Signs and Symptoms
- Renal Insufficiency, Chronic
- Bronchiolitis Obliterans Syndrome
- Hypertension
- Proteinuria
- Vital Signs
- Physical Examination
- Diagnostic Techniques and Procedures
- Diagnosis
- Hemodynamics
- Cardiovascular Physiological Phenomena
- Circulatory and Respiratory Physiological Phenomena
- Blood Pressure
Study Purpose View help for Study Purpose
The aims of the PRESERVE study were to:
- Enhance the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model for pediatric and rare kidney disease research
- Describe and examine the effectiveness of consistent blood pressure and urine protein monitoring for preserving kidney function
- Compare the effectiveness of blood pressure medication strategies for preserving kidney function
- Assess patients' lived experiences related to blood pressure management
Study Design View help for Study Design
A multi-center, retrospective cohort study design was used. Participants were recruited from 15 institutions affiliated with National Patient-Centered Clinical Research Network (PCORnet) across the United States. Electronic health record (EHR) visit data between January 1, 2009 and January 31, 2023 were collected for chart review. A random stratified sample of 100 patients per institution were selected; stratum was stage of chronic kidney disease (CKD). The recruitment sample was extracted May 2023, and the analytic sample was extracted in April 2024. The EHR data were harmonized to the PCORnet Common Data Model (v6.0).
Three queries were run against PCORnet 6.0 as the data source. Query 1 (Jan-Mar 2020) was run to gather information about the overall PCORnet patient population and provided patient counts of children with at least one healthcare encounter between January 2009 and December 2018. Query 2 (May 2020) was run to assess study feasibility and site selection, producing counts of patients with a CKD diagnosis, dialysis, and transplant. Query 3 was run to extend the study period from January 2022 to January 2023.
Patient and family survey data were collected at a single timepoint from a subset of the larger PRESERVE study population (n=395). Children aged 8 to 21 years old across all study sites were recruited for survey completion. If children were aged 8 to 17, their parent/legal guardian was also required to complete the survey. Study staff at each site contacted potential participants via email, phone call, face-to-face contact, mail, electronic portal, or text message. Once enrolled, participants completed the survey online through REDCap and received a $25 gift card as compensation. Survey responses were linked to electronic health records for analysis.
Sample View help for Sample
The overall study inclusion criteria included at least one visit with a nephrologist during the study period and two or more estimated glomerular filtration rate (eGFR) values of 30 to 90 mL/min/1.73 m2 (using the CKiD U25 formula) at least 90 days apart (mild-to-moderate chronic kidney disease).
Exclusion criteria included eGFR values greater than 90 mL/min/1.73 m2 between the two qualifying values, no nephrology visit during the study period, long-term dialysis or kidney transplant on or before the study start, and ages younger than 1 year or older than 18 years at study start.
For the patient and family survey, additional inclusion criteria were ability to read and respond to questions in English; parent or legal guardian relationship to focal child (family member); during the study period, at least one hypertension diagnosis code (child), at least one exposure to an anti-hypertensive medication (child), and at least one blood pressure measurement (child).
Time Method View help for Time Method
Universe View help for Universe
Children with chronic kidney disease (CKD) and caregiver (if child was 8-17 at time of study).
Unit(s) of Observation View help for Unit(s) of Observation
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Description of Variables View help for Description of Variables
Primary outcome: reduced kidney function (50 percent reduction in estimated glomerular filtration rate (eGFR), eGFR of less than 15 mL/min/1.73 m2, long-term dialysis, or kidney transplant). Secondary outcomes: change in eGFR over the study period, adverse events during treatment, and patient-reported outcomes (PROMIS).
Patient and family survey measures include items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue, Sleep Disturbance, Anxiety, Global Health, and Life Satisfaction forms; National Survey of Children's Health; Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE); and Hunger Vital Scale (parent/guardian survey only). Respondents also reported the number of anti-hypertensive medications currently taking.
Presence of Common Scales View help for Presence of Common Scales
- Patient-Reported Outcomes Measurement Information System (PROMIS): Fatigue, Sleep Disturbance, Anxiety, Global Health, Life Satisfaction
- National Survey of Children's Health
- Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE)
- Hunger Vital Scale
Notes
The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution.
ICPSR usually offers files in multiple formats for researchers to be able to access data and documentation in formats that work well within their needs. If you have questions about the accessibility of materials distributed by ICPSR or require further assistance, please visit ICPSR’s Accessibility Center.
This study is maintained and distributed by the Patient-Centered Outcomes Data Repository (PCODR). PCODR is the official data repository of the Patient-Centered Outcomes Research Initiative (PCORI).