BACKGROUND

Chronic kidney disease (CKD) is a health condition characterized by progressive decline in kidney function. As kidney function worsens, patients with CKD experience increasing levels of physical and emotional distress, a variety of co-morbidities, and ultimately the need for dialysis and kidney transplantation. 

​

In 2003 the NIDDK initiated the CKiD study, an ongoing Cohort Study of Children with Chronic Kidney Disease, which is examining risk factors for progression of pediatric CKD and the evolution of related co-morbidities. The CKiD study has enrolled 891children from over 50 pediatric nephrology centers, making it a unique, national network for evaluating PROMIS Pediatric measures.

​

STUDY AIMS

• The purpose of the CKiD-PEPR project is to evaluate the content validity, clinical meaning, responsiveness, and longitudinal construct validity of four PROMIS pediatric instruments (fatigue, sleep, psychological stress experiences and life satisfaction) in 200 children aged 8-21 years with an increased risk of accelerated kidney function decline

​

• If our aims are achieved through the clinical validation of the PROMIS instruments in the well-phenotyped children in the CKiD study, we will take major steps toward facilitating the use of PROMIS as standard endpoints in therapeutic clinical trials and routine clinical practice

GOALS & RESULTS

• Content Validation:

  • We have enrolled and evaluated 30 children and 32 parents for our Content Validation (Aim 1) study activities

  • Data collection (including semi-structured interviews and an online card sorting task) and data analysis has been completed

  • The qualitative nature of Aim 1 activities allows researchers understand if children with CKD experience fatigue and sleep differently than children in the general population

• Clinical Validation:

  • Longitudinal construct validity of PROMIS PRO measures of experienced well-being for CKD patients will be tested by 1) evaluating the associations between change in disease phenotype and experienced wellbeing, and 2) evaluating the longitudinal change for presence of response shift in clinical status and PRO scores

  • Enrollment for the CKiD-PEPR Longitudinal study began in June 2017 

  • Currently there are 212 parent-child dyads enrolled at 15 participating sites