Nicole Evangelidis1, Allison Tong2, Braden Manns3, Brenda Hemmelgarn3, David C Wheeler4, Peter Tugwell5, Sally Crowe6, Tess Harris7, Wim Van Biesen8, Wolfgang C Winkelmayer9, Benedicte Sautenet10, Donal O'Donoghue11, Helen Tam-Tham3, Sajeda Youssouf11, Sreedhar Mandayam9, Angela Ju2, Carmel Hawley12, Carol Pollock13, David C Harris14, David W Johnson12, Dena E Rifkin15, Francesca Tentori16, John Agar17, Kevan R Polkinghorne18, Martin Gallagher19, Peter G Kerr20, Stephen P McDonald21, Kirsten Howard22, Martin Howell2, Jonathan C Craig2. 1. Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia. Electronic address: nicole.evangelidis@sydney.edu.au. 2. Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia. 3. Departments of Medicine and Community Health Sciences; Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada. 4. Centre for Nephrology, University College London, London, United Kingdom. 5. Department of Medicine, University of Ottawa, Ottawa, Canada. 6. Crowe Associates, Oxon, United Kingdom. 7. PKD International, Geneva, Switzerland. 8. Renal Division, Ghent University Hospital, Ghent, Belgium. 9. Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX. 10. Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia; INSERM, U1153, Paris, France; Department of Nephrology and Clinical Immunology, University Hospital of Tours, Tours, France. 11. Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, United Kingdom. 12. Queensland School of Medicine, University of Queensland at Princess Alexandra Hospital; Translational Research Institute; Metro South and Ipswich Nephrology and Transplant Services (MINTS), Princess Alexandra Hospital, Brisbane, Australia. 13. Renal Division, Kolling Institute, Sydney, Australia. 14. Centre for Transplantation and Renal Research, The Westmead Institute for Medical Research, University of Sydney, Westmead, New South Wales, Australia. 15. Division of Nephrology, University of California, San Diego, CA; Division of Preventive Medicine, University of California, San Diego, CA. 16. Arbor Research Collaborative for Health, Ann Arbor, MI. 17. University Hospital Geelong, Geelong, Australia. 18. Monash Medical Centre and Monash University, Clayton, Australia; Department of Epidemiology & Preventative Medicine, Monash University, Clayton, Australia. 19. Concord Clinical School, The University of Sydney, Sydney, Australia. 20. Monash Medical Centre and Monash University, Clayton, Australia. 21. Central Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, Australia; Faculty of Health Science, University of Adelaide, Adelaide, Australia. 22. Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.
Abstract
BACKGROUND: Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis. STUDY DESIGN: In a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents' scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated. SETTING & PARTICIPANTS: 1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3. OUTCOMES & MEASUREMENTS: Outcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score ≥ 8, mean score ≥ 7.5, proportion rating the outcome as critically important ≥ 75%, and median score in the forced ranking question < 10. RESULTS: Patients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively). LIMITATIONS: The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection. CONCLUSIONS: Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions.
BACKGROUND: Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis. STUDY DESIGN: In a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents' scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated. SETTING & PARTICIPANTS: 1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3. OUTCOMES & MEASUREMENTS: Outcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score ≥ 8, mean score ≥ 7.5, proportion rating the outcome as critically important ≥ 75%, and median score in the forced ranking question < 10. RESULTS:Patients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively). LIMITATIONS: The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection. CONCLUSIONS:Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions.
Authors: Jennifer E Flythe; Tandrea Hilliard; Elena Lumby; Graciela Castillo; Jazmine Orazi; Emaad M Abdel-Rahman; Amy Barton Pai; Matthew Bertrand Rivara; Wendy L St Peter; Steven Darrow Weisbord; Caroline M Wilkie; Rajnish Mehrotra Journal: Clin J Am Soc Nephrol Date: 2018-11-05 Impact factor: 8.237
Authors: Karine E Manera; David W Johnson; Jonathan C Craig; Jenny I Shen; Lorena Ruiz; Angela Yee-Moon Wang; Terence Yip; Samuel K S Fung; Matthew Tong; Achilles Lee; Yeoungjee Cho; Andrea K Viecelli; Benedicte Sautenet; Armando Teixeira-Pinto; Edwina Anne Brown; Gillian Brunier; Jie Dong; Tony Dunning; Rajnish Mehrotra; Saraladevi Naicker; Roberto Pecoits-Filho; Jeffrey Perl; Martin Wilkie; Allison Tong Journal: Clin J Am Soc Nephrol Date: 2018-12-20 Impact factor: 8.237
Authors: Bénédicte Sautenet; Allison Tong; Karine E Manera; Jeremy R Chapman; Anthony N Warrens; David Rosenbloom; Germaine Wong; John Gill; Klemens Budde; Lionel Rostaing; Lorna Marson; Michelle A Josephson; Peter P Reese; Timothy L Pruett; Camilla S Hanson; Donal O'Donoghue; Helen Tam-Tham; Jean-Michel Halimi; Jenny I Shen; John Kanellis; John D Scandling; Kirsten Howard; Martin Howell; Nick Cross; Nicole Evangelidis; Philip Masson; Rainer Oberbauer; Samuel Fung; Shilpa Jesudason; Simon Knight; Sreedhar Mandayam; Stephen P McDonald; Steve Chadban; Tasleem Rajan; Jonathan C Craig Journal: Transplantation Date: 2017-08 Impact factor: 4.939
Authors: Jennifer E Flythe; Adeline Dorough; Julia H Narendra; Rebecca L Wingard; Lorien S Dalrymple; Darren A DeWalt Journal: Qual Life Res Date: 2018-09-18 Impact factor: 4.147
Authors: Pietro A Canetta; Jonathan P Troost; Shannon Mahoney; Amy J Kogon; Noelle Carlozzi; Sharon M Bartosh; Yi Cai; T Keefe Davis; Hilda Fernandez; Alessia Fornoni; Rasheed A Gbadegesin; Emily Herreshoff; John D Mahan; Patrick H Nachman; David T Selewski; Christine B Sethna; Tarak Srivastava; Katherine R Tuttle; Chia-Shi Wang; Ronald J Falk; Ali G Gharavi; Brenda W Gillespie; Larry A Greenbaum; Lawrence B Holzman; Matthias Kretzler; Bruce M Robinson; William E Smoyer; Lisa M Guay-Woodford; Bryce Reeve; Debbie S Gipson Journal: Kidney Int Date: 2019-02-27 Impact factor: 10.612
Authors: Karine E Manera; Allison Tong; Jonathan C Craig; Jenny Shen; Shilpa Jesudason; Yeoungjee Cho; Benedicte Sautenet; Armando Teixeira-Pinto; Martin Howell; Angela Yee-Moon Wang; Edwina A Brown; Gillian Brunier; Jeffrey Perl; Jie Dong; Martin Wilkie; Rajnish Mehrotra; Roberto Pecoits-Filho; Saraladevi Naicker; Tony Dunning; Nicole Scholes-Robertson; David W Johnson Journal: Kidney Int Date: 2019-03-29 Impact factor: 10.612
Authors: Jennifer E Flythe; Tandrea Hilliard; Graciela Castillo; Kourtney Ikeler; Jazmine Orazi; Emaad Abdel-Rahman; Amy Barton Pai; Matthew B Rivara; Wendy L St Peter; Steven D Weisbord; Caroline Wilkie; Rajnish Mehrotra Journal: Clin J Am Soc Nephrol Date: 2018-03-20 Impact factor: 8.237