E.W. "Al" Thrasher
Status: Funded - Open
Reliability and clinical validity of the consensus classification system for urinary tract dilation
Caleb Nelson, M.D., MPH
BACKGROUND: Urinary tract dilation (UTD) refers to dilation of the kidneys, ureters and bladder, and may indicate pathologic obstruction, retrograde reflux, or other anomalies of the urinary system that can lead to infection, kidney damage, incontinence, and other urological and renal diseases. Although UTD has been observed on antenatal screening ultrasounds for decades, scientific progress has been limited by the variety of grading and classifications systems used, causing difficulty for both clinicians and researchers. To address this problem, a multi-disciplinary team developed a unified grading system for prenatal and postnatal UTD called the Consensus Classification System for Urinary Tract Dilation (CCSUTD).
GAP: The CCSUTD was based on an extensive review of the literature, but has not been independently evaluated for reliability or validity, which is required for further clinical/research use
1) The reliability of the CCSUTD will be excellent (Kappa > 0.8)
2) There will be a strong association of high-risk CCSUTD classification with adverse clinical outcomes (hazard ratio ≥ 2.0)
METHODS: For Aim 1, ultrasound tests in patients aged ≤ 3 months will be independently reviewed and graded using the CCSUTD by five physicians from five different institutions, with inter-rater consistency and reliability evaluated (Kappa test). For Aim 2, postnatal ultrasounds of infants with a history of prenatal UTD will be graded using the CCSUTD, and the association of CCSUTD risk score with a composite endpoint of adverse clinical events during the first 2 years of life will be analyzed (Survival analysis).
IMPACT: The validation of the CCSUTD has the potential to revolutionize both clinical management and research on this extremely prevalent and costly condition; the results of this project will facilitate prospective studies incorporating both prenatal and postnatal findings, providing a practical tool that can be put into use immediately for predicting clinical outcomes among infants and young children with UTD.