The Study of the Epidemiology of Pediatric Hypertension Registry (SUPERHERO): rationale and methods

Abstract

Despite increasing prevalence of hypertension in youth and high adult cardiovascular mortality rates, the long-term consequences of youth-onset hypertension remain unknown. This is due to limitations of prior research, such as small sample sizes, reliance on manual record review, and limited analytic methods, that did not address major biases. The Study of the Epidemiology of Pediatric Hypertension (SUPERHERO) is a multisite, retrospective registry of youth evaluated by subspecialists for hypertension disorders. Sites obtain harmonized electronic health record data using standardized biomedical informatics scripts validated with randomized manual record review. Inclusion criteria are index visit for International Classification of Diseases, 10th Revision (ICD-10) code-defined hypertension disorder on or after January 1, 2015, and age < 19 years. We exclude patients with ICD-10 code-defined pregnancy, kidney failure on dialysis, or kidney transplantation. Data include demographics, anthropomorphics, US Census Bureau tract, histories, blood pressure, ICD-10 codes, medications, laboratory and imaging results, and ambulatory blood pressure. SUPERHERO leverages expertise in epidemiology, statistics, clinical care, and biomedical informatics to create the largest and most diverse registry of youth with newly diagnosed hypertension disorders. SUPERHERO's goals are to reduce CVD burden across the life course and establish gold-standard biomedical informatics methods for youth with hypertension disorders.

Keywords: biomedical informatics; blood pressure; cardiovascular health; causal inference; child health; electronic health record; life course; youth.

Figure 1

Initial Study of the Epidemiology of Pediatric Hypertension Registry (SUPERHERO) sites as of March 2023. A map of the initial 15 SUPERHERO registry sites across North America is shown. Site names are standardized to represent both the academic affiliation and the children’s hospital. PI, principal investigator.

Figure 2

Study of the Epidemiology of Pediatric Hypertension Registry (SUPERHERO) design and workflow. A stepwise, iterative approach to the study design and workflow of the SUPERHERO registry was followed with feedback loops for data harmonization. Tasks completed locally at each site vs. centrally at the coordinating site are denoted by the inset boxes with Step number. The curved arrow and dashed arrows denote iterative feedback loops. CSV, comma separated value; EHR, electronic health record.

Figure 3

Study of the Epidemiology of Pediatric Hypertension Registry timeline and major data elements. The study timeline includes 3 major phases relative to the index visit. Phase 1 incorporates the evaluation period: the date of the index visit and up to 6 months after the index visit. Phase 2 includes the follow-in period leading up to the index visit. Phase 3 is the follow-up period starting the 6 months after the index visit. Major data elements are listed that are obtained in each sub-phase. ICD-10, International Classification of Diseases, 10th Revision.

Figure 4

Conceptual model of target data elements (theoretical estimands) versus study data elements (empirical estimands) in the Study of the Epidemiology of Pediatric Hypertension Registry. The conceptual model of what the data ultimately represent (target data elements) and the actual study data collected informed all aspects of the study design. The iterative study design improves the accuracy and precision of the study data elements so that, over the course of the study’s phases and sub-phases, the study data element validity more closely aligns with the target data elements. Box titles represent different domains for our target data elements, and specific study data elements are listed below the titles in each box. ICD-10, International Classification of Diseases, 10th Revision.

Figure 5

Conceptual model of the causal effects of the social determinants of health on health disparities in the Study of the Epidemiology of Pediatric Hypertension Registry. From the periphery moving inward, the rings represent 1) the 5 major domains of the social determinants of health; 2) neighborhood-level social risk factors, such as food deserts, that can be identified using US Census Bureau tracts; 3) individual-level social risk factors that can be screened for in the healthcare system, such as food insecurity; 4) immediate social needs that individuals prioritize; 5) health disparities and health care disparities. See Appendix S1 for definitions of these terms.

Figure 6

Blood pressure (BP) classification by US guideline era and age in the Study of the Epidemiology of Pediatric Hypertension Registry. The BP classifications are listed by participant age and era (before or after October 2017) to account for the change in the definitions used in US guidelines in youth and adults. Definitions for infants younger than 1 year are not shown, for simplicity. ^*Minimum of percentile-based or measured BP value. ACC, American College of Cardiology; CPG, clinical practice guideline; JNC, Joint National Committee.