Study protocol: rationale and design of the community-based prospective cohort study of kidney function and diabetes in rural New Mexico, the COMPASS study

Abstract

BackgroundRural areas in the state of New Mexico have been the “ground-zero” for the epidemic of diabetic Chronic Kidney Disease (CKD) in the United States. However, there is limited research about risk factors of diabetic CKD in this area and scarce data regarding the performance of emerging markers of renal filtration and epigenetic biomarkers of renal function and diabetes in this area with its unique ethnic/racial population. We designed the COMPASS study as a community-based program in rural New Mexico aiming to screen for CKD and to discover CKD-related translational biomarkers.Methods/designThe study involves a prospective, longitudinal cohort design involving individuals living in rural New Mexico. Participants undergo a screening for kidney disease using markers of abnormal renal filtration (impaired glomerular filtration rate) or damage (albuminuria). Those found to have CKD on the basis of these tests or those at risk for CKD are enrolled in a prospective longitudinal cohort. We measure markers of renal function, insulin resistance and epigenetics (microRNAs) on patients. Individuals are invited to participate in interviews and focus groups in order to characterize their attitudes towards research and barriers or facilitators to participation in future research studies about kidney disease.DiscussionThis study will provide important data about the local epidemiology of kidney disease in a high-risk rural setting and the utility of emerging renal filtration markers (Beta 2 Microglobulin and Cystatin C), while generating data and methods for the analyses of microRNA biomarkers. The qualitative research subproject will identify factors associated with increased willingness to participate in future translational research projects. With its geographical focus, this study will address a critical disparity in kidney disease research, while generating novel epigenetic data that are relevant for future studies in the general population.

Comparison of Glomerular Filtration Rate Equations in a Rural New Mexico Cohort: Results from the COMPASS Study

“…The state of New Mexico (NM) in the United States (US) is a disproportionately rural, low-income geographic region, with most of the population identifying as Native American and/or Hispanic American. Unsurprisingly, NM has one of the highest prevalence of diabetes which is one of the leading causes of ESKD in the US with over 60% of ESKD patients suffering from diabetes 12 . According to the American Diabetes Association approximately 200,548 people in NM (12.3% of the adults) have the diagnosis of diabetes with detrimental health-related and financial implications.…”

“…The National Kidney Foundation - American Society of Nephrology (NKF-ASN) Task Force recommends that kidney function be estimated by an approach that is accurate, in a manner that does not introduce bias through racial adjustments 17 . In order to fully understand how current eGFR equations that use SCr as a plasma filtration marker are a good predictor of kidney function compared to equations that use non-creatinine markers, we conducted a sub-analysis from the COMPASS study in rural northern NM 12 . In the COMPASS study population with the majority identifying as Hispanic and Native American and in a region with extremely high prevalence of glucose intolerance and diabetes, we hypothesized that the various eGFR equations that use different serum biomarkers (serum SCr, CysC, or B2M) will evaluate kidney function differently.…”

Community engagement in kidney research: Guatemalan experience

“…Community engagement has emerged as an evidencebased approach in conducting research with the community as a lead partnering to better respond to complex issues arising in the community [1,4]. While developing an engagement program, the community members become a part of the research team, ensuring the focus remains on the important issues faced by the constituents [6][7][8][9][10][11]. The value of engaging helps to re-orient and to improve research enterprise goals, patient care, decision-making process, and health outcomes by increasing the relevance of the research to the community [3,6,[11][12][13].…”

“…While developing an engagement program, the community members become a part of the research team, ensuring the focus remains on the important issues faced by the constituents [6][7][8][9][10][11]. The value of engaging helps to re-orient and to improve research enterprise goals, patient care, decision-making process, and health outcomes by increasing the relevance of the research to the community [3,6,[11][12][13]. It also assists with the knowledge translation of the research outcomes as the stakeholders are already engaged and knowledgeable [5,[14][15][16][17].…”

Community Engagement in Kidney Research: Guatemalan Experience

“…Community engagement has emerged as an evidence-based approach to conduct research using the community as a lead partner to better respond to complex issues arising in the community [1,4]. While developing an engagement program, the community members become a part of the research team, ensuring the focus remains on the important issues faced by the constituents [6][7][8][9][10][11]. The value of engaging helps to re-orient and to improve research enterprise goals, patient care, decision-making process, and health outcomes by increasing the relevance of the research to the community [3,6,[11][12][13].…”