Allison Tong1, John Gill, Klemens Budde, Lorna Marson, Peter P Reese, David Rosenbloom, Lionel Rostaing, Germaine Wong, Michelle A Josephson, Timothy L Pruett, Anthony N Warrens, Jonathan C Craig, Benedicte Sautenet, Nicole Evangelidis, Angelique F Ralph, Camilla S Hanson, Jenny I Shen, Kirsten Howard, Klemens Meyer, Ronald D Perrone, Daniel E Weiner, Samuel Fung, Maggie K M Ma, Caren Rose, Jessica Ryan, Ling-Xin Chen, Martin Howell, Nicholas Larkins, Siah Kim, Sobhana Thangaraju, Angela Ju, Jeremy R Chapman. 1. 1 Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia. 2 Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, Australia. 3 Division of Nephrology, University of British Columbia, Vancouver, BC, Canada. 4 Department of Nephrology, Charité-Universitätsmedizin Berlin, Germany. 5 Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom. 6 Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States. 7 ESRD Network 18, Los Angeles, CA. 8 Clinique Universitaire de Nephrologie, CHU Michallon, Grenoble, France. 9 Centre for Transplant and Renal Research, Westmead Hospital, NSW, Westmead, Australia. 10 Department of Medicine, The University of Chicago, Chicago, IL. 11 Department of Surgery, University of Minnesota, Minneapolis, MN. 12 School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom. 13 Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours Hospital, Tours, France. 14 INSERM, U1246, Tours, Franc Tours, France. 15 Department of Nephrology, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles, CA. 16 William B. Schwartz Division of Nephrology, Tufts Medical Center, Boston, MA. 17 Jockey Club Nephrology & Urology Centre, Princess Margaret Hospital, Hong Kong. 18 The University of Hong Kong, Queen Mary Hospital, Hong Kong. 19 Department of Nephrology, Monash Medical Centre, Melbourne, Australia. 20 Depatment of Renal Medicine, Singapore General Hospital, Singapore.
Abstract
BACKGROUND: Treatment decisions in kidney transplantation requires patients and clinicians to weigh the benefits and harms of a broad range of medical and surgical interventions, but the heterogeneity and lack of patient-relevant outcomes across trials in transplantation makes these trade-offs uncertain, thus, the need for a core outcome set that reflects stakeholder priorities. METHODS: We convened 2 international Standardized Outcomes in Nephrology-Kidney Transplantation stakeholder consensus workshops in Boston (17 patients/caregivers; 52 health professionals) and Hong Kong (10 patients/caregivers; 45 health professionals). In facilitated breakout groups, participants discussed the development and implementation of core outcome domains for trials in kidney transplantation. RESULTS: Seven themes were identified. Reinforcing the paramount importance of graft outcomes encompassed the prevailing dread of dialysis, distilling the meaning of graft function, and acknowledging the terrifying and ambiguous terminology of rejection. Reflecting critical trade-offs between graft health and medical comorbidities was fundamental. Contextualizing mortality explained discrepancies in the prioritization of death among stakeholders-inevitability of death (patients), preventing premature death (clinicians), and ensuring safety (regulators). Imperative to capture patient-reported outcomes was driven by making explicit patient priorities, fulfilling regulatory requirements, and addressing life participation. Specificity to transplant; feasibility and pragmatism (long-term impacts and responsiveness to interventions); and recognizing gradients of severity within outcome domains were raised as considerations. CONCLUSIONS: Stakeholders support the inclusion of graft health, mortality, cardiovascular disease, infection, cancer, and patient-reported outcomes (ie, life participation) in a core outcomes set. Addressing ambiguous terminology and feasibility is needed in establishing these core outcome domains for trials in kidney transplantation.
BACKGROUND: Treatment decisions in kidney transplantation requires patients and clinicians to weigh the benefits and harms of a broad range of medical and surgical interventions, but the heterogeneity and lack of patient-relevant outcomes across trials in transplantation makes these trade-offs uncertain, thus, the need for a core outcome set that reflects stakeholder priorities. METHODS: We convened 2 international Standardized Outcomes in Nephrology-Kidney Transplantation stakeholder consensus workshops in Boston (17 patients/caregivers; 52 health professionals) and Hong Kong (10 patients/caregivers; 45 health professionals). In facilitated breakout groups, participants discussed the development and implementation of core outcome domains for trials in kidney transplantation. RESULTS: Seven themes were identified. Reinforcing the paramount importance of graft outcomes encompassed the prevailing dread of dialysis, distilling the meaning of graft function, and acknowledging the terrifying and ambiguous terminology of rejection. Reflecting critical trade-offs between graft health and medical comorbidities was fundamental. Contextualizing mortality explained discrepancies in the prioritization of death among stakeholders-inevitability of death (patients), preventing premature death (clinicians), and ensuring safety (regulators). Imperative to capture patient-reported outcomes was driven by making explicit patient priorities, fulfilling regulatory requirements, and addressing life participation. Specificity to transplant; feasibility and pragmatism (long-term impacts and responsiveness to interventions); and recognizing gradients of severity within outcome domains were raised as considerations. CONCLUSIONS: Stakeholders support the inclusion of graft health, mortality, cardiovascular disease, infection, cancer, and patient-reported outcomes (ie, life participation) in a core outcomes set. Addressing ambiguous terminology and feasibility is needed in establishing these core outcome domains for trials in kidney transplantation.
Authors: Akinlolu O Ojo; José María Morales; Miguel González-Molina; Diane E Steffick; Fu L Luan; Robert M Merion; Tammy Ojo; Francesc Moreso; Manuel Arias; Josep María Campistol; Domingo Hernandez; Daniel Serón Journal: Nephrol Dial Transplant Date: 2012-07-02 Impact factor: 5.992
Authors: John R Kirwan; Susan J Bartlett; Dorcas E Beaton; Maarten Boers; Ailsa Bosworth; Peter M Brooks; Ernest Choy; Maarten de Wit; Francis Guillemin; Sarah Hewlett; Tore K Kvien; Robert B Landewé; Amye L Leong; Anne Lyddiatt; Lyn March; James May; Pamela Lesley Montie; Enkeleida Nikaï; Pam Richards; Marieke M J H Voshaar; Wilma Smeets; Vibeke Strand; Peter Tugwell; Laure Gossec Journal: J Rheumatol Date: 2014-03-01 Impact factor: 4.666
Authors: Iain Chalmers; Michael B Bracken; Ben Djulbegovic; Silvio Garattini; Jonathan Grant; A Metin Gülmezoglu; David W Howells; John P A Ioannidis; Sandy Oliver Journal: Lancet Date: 2014-01-08 Impact factor: 79.321
Authors: Simon A Carter; Talia Gutman; Charlotte Logeman; Dan Cattran; Liz Lightstone; Arvind Bagga; Sean J Barbour; Jonathan Barratt; John Boletis; Dawn Caster; Rosanna Coppo; Fernando C Fervenza; Jürgen Floege; Michelle Hladunewich; Jonathan J Hogan; A Richard Kitching; Richard A Lafayette; Ana Malvar; Jai Radhakrishnan; Brad H Rovin; Nicole Scholes-Robertson; Hérnan Trimarchi; Hong Zhang; Karolis Azukaitis; Yeoungjee Cho; Andrea K Viecelli; Louese Dunn; David Harris; David W Johnson; Peter G Kerr; Paul Laboi; Jessica Ryan; Jenny I Shen; Lorena Ruiz; Angela Yee-Moon Wang; Achilles Hoi Kan Lee; Samuel Fung; Matthew Ka-Hang Tong; Armando Teixeira-Pinto; Martin Wilkie; Stephen I Alexander; Jonathan C Craig; Allison Tong Journal: Clin J Am Soc Nephrol Date: 2020-04-30 Impact factor: 8.237
Authors: Vishnu S Potluri; David S Goldberg; Sumit Mohan; Roy D Bloom; Deirdre Sawinski; Peter L Abt; Emily A Blumberg; Chirag R Parikh; James Sharpe; K Rajender Reddy; Miklos Z Molnar; Meghan Sise; Peter P Reese Journal: J Am Soc Nephrol Date: 2019-09-12 Impact factor: 10.121
Authors: Simon A Carter; Liz Lightstone; Dan Cattran; Allison Tong; Arvind Bagga; Sean J Barbour; Jonathan Barratt; John Boletis; Dawn J Caster; Rosanna Coppo; Fernando C Fervenza; Jürgen Floege; Michelle A Hladunewich; Jonathan J Hogan; A Richard Kitching; Richard A Lafayette; Ana Malvar; Jai Radhakrishnan; Brad H Rovin; Nicole Scholes-Robertson; Hernán Trimarchi; Hong Zhang; Samaya Anumudu; Yeoungjee Cho; Talia Gutman; Emma O'Lone; Andrea K Viecelli; Eric Au; Karolis Azukaitis; Amanda Baumgart; Amelie Bernier-Jean; Louese Dunn; Martin Howell; Angela Ju; Charlotte Logeman; Melissa Nataatmadja; Benedicte Sautenet; Ankit Sharma; Jonathan C Craig Journal: Clin J Am Soc Nephrol Date: 2021-12-30 Impact factor: 8.237
Authors: Allison Tong; Nicole Scholes-Robertson; Carmel Hawley; Andrea K Viecelli; Simon A Carter; Adeera Levin; Brenda R Hemmelgarn; Tess Harris; Jonathan C Craig Journal: Nat Rev Nephrol Date: 2022-06-06 Impact factor: 42.439
Authors: Allison Tong; Braden Manns; Angela Yee Moon Wang; Brenda Hemmelgarn; David C Wheeler; John Gill; Peter Tugwell; Robert Pecoits-Filho; Sally Crowe; Tess Harris; Wim Van Biesen; Wolfgang C Winkelmayer; Adeera Levin; Aliza Thompson; Vlado Perkovic; Angela Ju; Talia Gutman; Amelie Bernier-Jean; Andrea K Viecelli; Emma O'Lone; Jenny Shen; Michelle A Josephson; Yeoungjee Cho; David W Johnson; Bénédicte Sautenet; Marcello Tonelli; Jonathan C Craig Journal: Kidney Int Date: 2018-10-22 Impact factor: 10.612
Authors: Yiman Wang; Jaapjan D Snoep; Marc H Hemmelder; Koen E A van der Bogt; Willem Jan W Bos; Paul J M van der Boog; Friedo W Dekker; Aiko P J de Vries; Yvette Meuleman Journal: Clin Kidney J Date: 2021-01-20