Bénédicte Sautenet1, 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. 1. 1 Sydney School of Public Health, The University of Sydney, Sydney, Australia.2 Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.3 Faculté de Médecine, Université Francois Rabelais, Tours, France.4 Department of Nephrology and Clinical Immunology, Tours Hospital, Tours, France.5 INSERM, U1246, Tours, France.6 Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.7 School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.8 ESRD Network 18, Los Angeles, CA.9 Division of Nephrology, University of British Columbia, Vancouver, Canada.10 Department of Nephrology, Charité - Universitätsmedizin Berlin, Germany.11 Department of Nephrology, Dialysis and Organ Transplantation, Centre Hospitalier Universitaire, Rangueil, Toulouse, France.12 Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom.13 Department of Medicine, The University of Chicago, Chicago, IL.14 Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.15 Department of Surgery, University of Minnesota, Minneapolis, MN.16 Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, United Kingdom.17 Department Community Health Sciences, University of Calgary, Calgary, Canada.18 Department of Nephrology, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles, CA.19 Department of Nephrology, Monash Health and Centre for Inflammatory Diseases, Department of Medicine, Monash University, Clayton, Victoria, Australia.20 Department of Medicine, Stanford University School of Medicine, Stanford, CA.21 Department of Nephrology, Christchurch Hospital, Christchurch, New Zealand.22 Department of Renal Medicine, Royal Infirmary of Edinburgh, Edinburgh, Scotland, United Kingdom.23 Department of Internal Medicine, Division of Nephrology, University of Vienna, Austria.24 Jockey Club Nephrology and Urology Centre, Princess Margaret Hospital, Hong Kong.25 Central and Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, South Australia, Australia.26 Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.27 Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.28 Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.29 ANZDATA Registry, South Australia Health and Medical Research Institute, Adelaide, Australia.30 Renal Medicine and Transplantation, Royal Prince Alfred Hospital, Sydney, Australia.
Abstract
BACKGROUND: Inconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals. METHODS: In a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During rounds 2 and 3, participants rerated the outcomes after reviewing their own score, the distribution of the respondents' scores, and comments. We calculated the median, mean, and proportion rating 7 to 9 (critically important), and analyzed comments thematically. RESULTS: One thousand eighteen participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed round 1, and 779 (77%) completed round 3. The top 8 outcomes that met the consensus criteria in round 3 (mean, ≥7.5; median, ≥8; proportion, >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin), and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes (mean difference of 0.5 or more): skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified 5 themes: capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps. CONCLUSIONS: Graft complications and severe comorbidities were critically important for both stakeholder groups. These stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation.
BACKGROUND: Inconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals. METHODS: In a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During rounds 2 and 3, participants rerated the outcomes after reviewing their own score, the distribution of the respondents' scores, and comments. We calculated the median, mean, and proportion rating 7 to 9 (critically important), and analyzed comments thematically. RESULTS: One thousand eighteen participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed round 1, and 779 (77%) completed round 3. The top 8 outcomes that met the consensus criteria in round 3 (mean, ≥7.5; median, ≥8; proportion, >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin), and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes (mean difference of 0.5 or more): skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified 5 themes: capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps. CONCLUSIONS: Graft complications and severe comorbidities were critically important for both stakeholder groups. These stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation.
Authors: P Masson; F A Duthie; L P Ruster; P J Kelly; A Merrifield; J C Craig; A C Webster Journal: Am J Transplant Date: 2013-09-18 Impact factor: 8.086
Authors: Nicole Evangelidis; Allison Tong; Braden Manns; Brenda Hemmelgarn; David C Wheeler; Peter Tugwell; Sally Crowe; Tess Harris; Wim Van Biesen; Wolfgang C Winkelmayer; Benedicte Sautenet; Donal O'Donoghue; Helen Tam-Tham; Sajeda Youssouf; Sreedhar Mandayam; Angela Ju; Carmel Hawley; Carol Pollock; David C Harris; David W Johnson; Dena E Rifkin; Francesca Tentori; John Agar; Kevan R Polkinghorne; Martin Gallagher; Peter G Kerr; Stephen P McDonald; Kirsten Howard; Martin Howell; Jonathan C Craig Journal: Am J Kidney Dis Date: 2017-02-24 Impact factor: 8.860
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: Paula R Williamson; Douglas G Altman; Jane M Blazeby; Mike Clarke; Declan Devane; Elizabeth Gargon; Peter Tugwell Journal: Trials Date: 2012-08-06 Impact factor: 2.279
Authors: Helge H Müller; Matthias Englbrecht; Michael S Wiesener; Stephanie Titze; Katharina Heller; Teja W Groemer; Georg Schett; Kai-Uwe Eckardt; Johannes Kornhuber; Juan Manuel Maler Journal: PLoS One Date: 2015-11-11 Impact factor: 3.240
Authors: Angus G K McNair; Robert N Whistance; Rachael O Forsythe; Rhiannon Macefield; Jonathan Rees; Anne M Pullyblank; Kerry N L Avery; Sara T Brookes; Michael G Thomas; Paul A Sylvester; Ann Russell; Alfred Oliver; Dion Morton; Robin Kennedy; David G Jayne; Richard Huxtable; Roland Hackett; Susan J Dutton; Mark G Coleman; Mia Card; Julia Brown; Jane M Blazeby Journal: PLoS Med Date: 2016-08-09 Impact factor: 11.069
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: Allison Tong; 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 Journal: Transplantation Date: 2017-08 Impact factor: 4.939
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: Tracey Ying; Bree Shi; Patrick J Kelly; Helen Pilmore; Philip A Clayton; Steven J Chadban Journal: J Am Soc Nephrol Date: 2020-09-09 Impact factor: 10.121
Authors: Karine E Manera; Allison Tong; Jonathan C Craig; Edwina A Brown; Gillian Brunier; Jie Dong; Tony Dunning; Rajnish Mehrotra; Sarala Naicker; Roberto Pecoits-Filho; Jeffrey Perl; Angela Y Wang; Martin Wilkie; Martin Howell; Benedicte Sautenet; Nicole Evangelidis; Jenny I Shen; David W Johnson Journal: Perit Dial Int Date: 2017-08-01 Impact factor: 1.756
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: Mary Labib; Clara Bohm; Jennifer M MacRae; Paul N Bennett; Kenneth R Wilund; Mara McAdams-DeMarco; Manisha Jhamb; Stefan Mustata; Stephanie Thompson Journal: Kidney Int Rep Date: 2020-12-18
Authors: John G Rizk; Jose G Lazo; David Quan; Steven Gabardi; Youssef Rizk; Elani Streja; Csaba P Kovesdy; Kamyar Kalantar-Zadeh Journal: Rev Endocr Metab Disord Date: 2021-07-22 Impact factor: 6.514