Clinical Evaluation of PROMIS in CKD

The National Institutes of Health (NIH)-sponsored Patient-Reported Outcomes Measurement
Information System (PROMIS) network has developed over 20 pediatric instruments, both
child-report and parent-proxy editions. Cross-sectional evaluations of the validity of the
instruments have established that they are ready for integration into clinical research and
practice. The next step in their ongoing evaluation is to assess their prospective clinical
validity in a variety of health conditions. This study addresses the clinical evaluation of
the measures in children with chronic kidney disease (CKD).

Through baseline surveys and six follow-up surveys over a two-year period, Investigators are
collecting self-report (child) and parent-proxy report of 11 pediatric PROMIS measures. Each
of these PROMIS measures is described in the Main Outcome Measures section. Investigators are
also collecting assessments of disease activity from clinical data. The selection of
self-report and parent proxy patient-reported outcome (PRO) measures were determined through
qualitative content validation. The analytic goal of this project is to evaluate baseline
(cross-sectional) and longitudinal associations between PROMIS pediatric outcome measures and
changes in the clinical status of patients with CKD. Our primary hypothesis is that as kidney
function declines, self-reported health will worsen.

Inclusion Criteria:

- Child is 8-21 years old at time of enrollment

- Child is a Chronic Kidney Disease in Children (CKiD) patient OR a child who receives
pediatric nephrology care at a CKiD site that participates in PEDSnet, a national
pediatric learning health system

- Child seen by a pediatric nephrologist in the past 24 months

- Child has two eGFR readings (computed from serum creatinine) between 6-89 ml/min at
least 3 months apart (eGFR of this level indicates CKD)

- Child speaks English

- Parent is the parent or legal guardian for the child

- Parent speaks English

Exclusion Criteria:

- Child is currently receiving dialysis

- Child received a kidney transplant

- Child has a parent-reported cognitive limitation that would preclude them from
completing a questionnaire

- Child does not speak English

- Parent does not speak English

- Parent is not the parent of legal guardian for the child