Adjudication vs enrollment
How participants are classified at enrollment and how the Adjudication Committee assigns a primary kidney disease category.
Enrollment category vs Primary adjudicated category
This topic outlines the categorization of KPMP participants following enrollment and adjudication.
The goal of the KPMP Adjudication Committee is to review participants enrolled in KPMP and classify them into kidney disease categories that are considered the primary cause of the participant’s kidney disease based on clinical and pathological data. Additional causes noted in adjudication are available in the Core Clinical File and can be made available with a signed Data Use Agreement (DUA).
Categorization
Each participant is sub-categorized in different cohorts or disease classes at different steps of assessment
Enrollment categories
Participants enter the study classified in the following broad categories prior to kidney biopsy. Recruitment site investigators and research coordinators use study inclusion/exclusion criteria to determine the participant’s enrollment category. [See the KPMP protocol for more details on inclusion criteria.]
- Healthy Reference (HRT): participant donating a kidney or undergoing treatment for kidney stones
- Chronic Kidney Disease (CKD): clinical diagnosis of diabetes OR hypertension (based on inclusion criteria)
- Acute Kidney Injury (AKI): clinical evidence of acute kidney injury (based on inclusion criteria)
- Diabetes Mellitus - Resilience (DM-R): participant has had diabetes for more than 25 years and has no clinical signs of kidney disease (based on inclusion criteria)
- Type 1 Diabetes (T1D): clinical diagnosis of type 1 diabetes OR at risk of kidney disease OR DM-R (based on inclusion criteria)
Primary Adjudicated categories
Upon review of the clinical and pathologic characteristics, participants are categorized using primary and secondary disease categories. The primary disease category reflects a consensus of pathologists and nephrologists on the primary cause of the participant’s kidney disease.
The primary adjudicated categories are the following:
- Acute Interstitial Nephritis (AIN): clinical and morphologic parameters of an inflammatory process affecting the tubulointerstitium considered to be caused by drug exposure or other etiologies
- Acute Tubular Injury (ATI): clinical and morphologic parameters of acute tubular injury
- Cannot be determined: the pattern of injury did not fit any known kidney disease agreed upon by the adjudication committee, or the predominant pattern of injury could not be determined amongst several plausible underlying kidney diseases, or there was not enough information (clinical or limited tissue sample).
There are multiple reasons why a participant has been categorized as “Cannot be determined”. We have summarized this into 4 categories, and more than 1 may be true:- Insufficient tissue
- Non-specific findings
- No significant pathological abnormalities to explain clinical presentation
- Findings of several conditions unable to attribute a primary cause
- Diabetic Kidney Disease (DKD): morphologic parameters consistent with diabetic kidney disease in an individual with a history of diabetes
- Hypertensive Kidney Disease (HKD): morphologic parameters consistent with hypertensive kidney disease in an individual with a history of hypertension
- Diabetes Mellitus - Resilience (DM-R): no morphologic changes characteristic of diabetic nephropathy, while other minimal or minor structural changes can be present, in an individual with a history of diabetes for 25 or more years
- Other: another kidney condition, including IgA nephropathy, focal segmental glomerulosclerosis, membranous nephropathy, fibrillary glomerulonephritis, etc. More specific diagnoses are available for release with a DUA.
Adjudication process
The Adjudication Team at KPMP comprises a group of Pathologists and Clinicians. Each participant’s case is reviewed with the following information:
- Pathology Packet: Diagnostic core disease category assessment REDCap form
- Recruitment Site Pathologist generated pathology report
- Whole Slide Images in Digital Pathology Repository (DPR)
- Electron Microscopy (EM) Images
- Immunofluorescence (IF) as reported in RedCap and reviewed in the pathology report
- Clinical Packet: REDCap participant reported medical history, medications, and lab data completed by the recruitment site
Upon review of the materials, the KPMP adjudicators (clinicians and pathologists) meet and reach a consensus of primary and secondary categories and record in KPMP’s REDCAP Adjudication form.
Data is available in our Core Clinical File and is accessible with a DUA.
Enrollment vs. Primary adjudication
The KPMP Enrollment Category reflects how each participant is enrolled in the KPMP study prior to biopsy based on inclusion criteria. For more details on the KPMP study criteria, visit our Clinician Resources page. KPMP biopsies of participants enrolled in the CKD, AKI, or DM-R cohorts (“Enrollment categories”) are adjudicated through a comprehensive review of the participant’s clinical history and kidney biopsy pathology by expert nephrologists and renal pathologists on a consensus basis (“Primary Adjudicated categories”). Enrollment category and Primary Adjudicated category may, and often do, differ.
For example, take a participant presenting with AKI enrolled in the AKI enrollment category. Upon adjudication:
- Clinical history reveals a long-standing history of hypertension and diabetes.
- Pathology review shows significant diabetic, global, and segmental glomerulosclerosis and severe arteriolosclerosis with moderate arteriolar hyalinosis. While mild to moderate tubular and interstitial injury in this case is present, and therefore the enrollment category is correct, the chronic damage and long-standing clinical history are more notable. The adjudication team ascertains that the primary driver of this participant’s kidney disease is diabetic kidney disease.
- This participant would have an Enrollment category of AKI and a Primary Adjudicated category of Diabetic Kidney Disease.
This adjudication process ensures a more accurate classification of kidney disease by integrating both clinical and pathologic insights, which is crucial for research, treatment decisions, and understanding disease progression.
