• Laura Mariani, Bénédicte Stengel, Christian Combe, Ziad A Massy, Helmut Reichel, Danilo Fliser, Roberto Pecoits-Filho, Antonio A Lopes, Kunihiro Yamagata, Takashi Wada, Michelle M Y Wong, Elodie Speyer, Friedrich K Port, Ronald L Pisoni, and Bruce M Robinson.
• Arbor Research Collaborative for Health, Ann Arbor, MI; University of Michigan, Ann Arbor, MI. Electronic address: laura.mariani@arborresearch.org.
• Am. J. Kidney Dis. 2016 Sep 1; 68 (3): 402-13.

BackgroundMinimizing clinical complications in patients with advanced chronic kidney disease (CKD) and improving the transition to dialysis therapy and transplantation represents a challenge, requiring reliable evidence regarding the effects of CKD care on outcomes.Study DesignThe CKD Outcomes and Practice Patterns Study (CKDopps) is a new international prospective cohort study designed to describe and evaluate variation in nephrologist-led CKD practices.Setting & ParticipantsCKDopps is underway in Brazil, France, Germany, Japan, and the United States. Diverse national samples of nephrology clinics are being recruited based on random selection stratified by geographic region and clinic characteristics. CKDopps aims to enroll 12,200 non-dialysis-dependent patients with CKD (75% and 25% with estimated glomerular filtration rates < 30 and 30-<60mL/min/1.73m(2), respectively) to be followed up for 3 to 5 years.PredictorsDemographic, comorbid condition, laboratory, and treatment-related variables are collected at 6-month intervals; patient-reported data are collected annually and more frequently near the transition to end-stage kidney disease; nephrologist practice surveys are collected annually.OutcomesOutcomes include mortality, end-stage kidney disease, other clinical events (eg, acute kidney injury, hospitalizations, infections, cardiovascular events, and transplant wait-listing), and patient-reported outcomes.ResultsFor the targeted sample size of 12,200 patients and 160 clinics, CKDopps has 80% power to detect HRs of 1.31 for mortality and 1.19 for mortality or transition to end-stage kidney disease.LimitationsCKDopps does not capture care provided in settings outside nephrology clinics (eg, primary care) or patients with CKD not receiving medical care.ConclusionsCKDopps is designed to characterize nephrology clinic practice variation and identify practices associated with better outcomes, with particular focus on advanced CKD, transition to end-stage kidney disease, and the patient experience. Because data will be collected during routine clinical care in real-world practice, analyses may yield practical readily implementable findings. CKDopps aims to establish a multinational infrastructure for research, collaboration, and ancillary investigation. Additional countries are encouraged to join.Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

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