Laura Mariani1, Bénédicte Stengel2, Christian Combe3, Ziad A Massy4, Helmut Reichel5, Danilo Fliser6, Roberto Pecoits-Filho7, Antonio A Lopes8, Kunihiro Yamagata9, Takashi Wada10, Michelle M Y Wong11, Elodie Speyer11, Friedrich K Port12, Ronald L Pisoni11, Bruce M Robinson12. 1. Arbor Research Collaborative for Health, Ann Arbor, MI; University of Michigan, Ann Arbor, MI. Electronic address: laura.mariani@arborresearch.org. 2. University Paris-Saclay, University Paris-Sud, UVSQ, CESP, Centre for Research in Epidemiology and Population Health, Inserm UMR1018, F-CRIN-INI-CRCT, Villejuif, France. 3. Service de Néphrologie Transplantation Dialyse, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France; Inserm, U1026, Universitaire Bordeaux, Bordeaux, France. 4. University Paris-Saclay, University Paris-Sud, UVSQ, CESP, Centre for Research in Epidemiology and Population Health, Inserm UMR1018, F-CRIN-INI-CRCT, Villejuif, France; Division of Nephrology, Ambroise Paré University Hospital, APHP, University of Paris Ouest-Versailles-St-Quentin-en-Yvelines (UVSQ), Boulogne-Billancourt/Paris, France. 5. Nephrological Center, Villingen-Schwenningen, Germany. 6. Internal Medicine IV - Renal and Hypertensive Diseases, Saarland University Medical Centre, Homburg/Saar, Germany. 7. School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil. 8. Faculdade de Medicina da Bahia, Universidade Federal da Bahia, Salvador, BA, Brazil. 9. Department of Nephrology, University of Tsukuba, Tsukuba, Japan. 10. Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan. 11. Arbor Research Collaborative for Health, Ann Arbor, MI. 12. Arbor Research Collaborative for Health, Ann Arbor, MI; University of Michigan, Ann Arbor, MI.
Abstract
BACKGROUND: Minimizing 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 DESIGN: The 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 & PARTICIPANTS: CKDopps 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. PREDICTORS: Demographic, 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. OUTCOMES: Outcomes 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. RESULTS: For 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. LIMITATIONS: CKDopps does not capture care provided in settings outside nephrology clinics (eg, primary care) or patients with CKD not receiving medical care. CONCLUSIONS: CKDopps 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.
BACKGROUND: Minimizing 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 DESIGN: The 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 & PARTICIPANTS: CKDopps 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. PREDICTORS: Demographic, 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. OUTCOMES: Outcomes 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. RESULTS: For 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. LIMITATIONS: CKDopps does not capture care provided in settings outside nephrology clinics (eg, primary care) or patients with CKD not receiving medical care. CONCLUSIONS: CKDopps 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.
Authors: Nidhi Sukul; Elodie Speyer; Charlotte Tu; Brian A Bieber; Yun Li; Antonio A Lopes; Koichi Asahi; Laura Mariani; Maurice Laville; Hugh C Rayner; Bénédicte Stengel; Bruce M Robinson; Ronald L Pisoni Journal: Clin J Am Soc Nephrol Date: 2019-04-11 Impact factor: 8.237
Authors: Sankar D Navaneethan; Julia M Akeroyd; David Ramsey; Sarah T Ahmed; Shiva Raj Mishra; Laura A Petersen; Paul Muntner; Christie Ballantyne; Wolfgang C Winkelmayer; Venkat Ramanathan; Salim S Virani Journal: Clin J Am Soc Nephrol Date: 2018-11-29 Impact factor: 8.237
Authors: Aminu K Bello; Paul E Ronksley; Navdeep Tangri; Alexander Singer; Allan Grill; Dorothea Nitsch; John A Queenan; Cliff Lindeman; Boglarka Soos; Elizabeth Freiheit; Delphine Tuot; Dee Mangin; Neil Drummond Journal: BMJ Open Date: 2017-08-04 Impact factor: 2.692
Authors: Murilo Guedes; Daniel G Muenz; Jarcy Zee; Brian Bieber; Benedicte Stengel; Ziad A Massy; Nicolas Mansencal; Michelle M Y Wong; David M Charytan; Helmut Reichel; Sandra Waechter; Ronald L Pisoni; Bruce M Robinson; Roberto Pecoits-Filho Journal: J Am Soc Nephrol Date: 2021-07-08 Impact factor: 14.978
Authors: Roberto Pecoits-Filho; Glen James; Juan Jesus Carrero; Eric Wittbrodt; Steven Fishbane; Alyshah Abdul Sultan; Hiddo J L Heerspink; Katarina Hedman; Eiichiro Kanda; Hungta Tony Chen; Naoki Kashihara; James Sloand; Mikhail Kosiborod; Supriya Kumar; Mitja Lainscak; Matthew Arnold; Carolyn S P Lam; Björn Holmqvist; Carol Pollock; Peter Fenici; Peter Stenvinkel; Jennie Medin; David C Wheeler Journal: Clin Kidney J Date: 2021-04-11