Establishing a Core Outcome Measure for Life Participation: A Standardized Outcomes in Nephrology-kidney Transplantation Consensus Workshop Report

Angela Ju^{1

2}, Michelle A Josephson³, Zeeshan Butt⁴, Sheila Jowsey-Gregoire⁵, Jane Tan⁶, Quinetta Taylor⁷, Kevin Fowler⁸, Fabienne Dobbels⁹, Fergus Caskey¹⁰, Vivekanand Jha¹¹, Jayme Locke¹², Greg Knoll¹³, Curie Ahn¹⁴, Camilla S Hanson^{1

2}, Benedicte Sautenet^{15

16}, Karine Manera^{1

2}, Jonathan C Craig^{1

2}, Martin Howell^{1

2}, Claudia Rutherford¹⁷, Allison Tong^{1

2}, Paul Harden, Carmel Hawley, Hallvard Holdaas, Ajay Israni, Michelle Jesse, Brenna Kane, John Kanellis, Bryce Kiberd, Joseph Kim, Chris Larsen, Alan Leichtman, Krista Lentine, Andrew Malone, Roslyn Mannon, Rainer Oberbauer, Rachel Patzer, John Devin Peipert, Hai An Phan, Emilio Poggio, Rihannon Reed, John Scandling, Ignatius Tang, Chris Watson, Daniel Contrares, Patricia Contreras, Daley Cross, Egle Juodvalkis, Den Koide, Jinny Koide, Adam Kozarewicz, Laura Kozarewicz, Richard Kozarewicz, Andrea Koritala, Elizabeth Lisiecki, Christine Lipuma, Margaret Lyman, Robert Mueller, Gloria Mueller, Larry Noble, Nancy Nolan, Stephen Nolan, Jim Thomas, Lynda Urbancyzk, James Zerante, Susan Zerante; SONG-Tx Life Participation Workshop Investigators; Health professionals (*includes 2 patients from the SONG-Tx Graft Health Expert Working Group); Patients and family members

Affiliations

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 Department of Medicine, The University of Chicago Medicine, Chicago, IL.
⁴ Departments of Medical Social Sciences, Surgery and Psychiatry & Behavioral sciences, Northwestern University, Evanston, IL.
⁵ Department of Psychiatry & Psychology, Mayo Clinic, Jacksonville, FL.
⁶ Department of Medicine, Stanford University, Stanford, CA.
⁷ Standardised Outcomes in Nephrology (Patient Partner), Chicago, IL.
⁸ Kidney Health Initiative, Patient Family Partnership Council, Washington, DC.
⁹ Department of Public Health and Primary Care, KU Leuven, Belgium.
¹⁰ School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
¹¹ The George Institute for Global Health, New Delhi, India.
¹² School of Medicine, University of Alabama at Birmingham, Birmingham, AL.
¹³ Division of Nephrology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
¹⁴ Transplantation Center, Seoul National University Hospital, Seoul, South Korea.
¹⁵ Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours Hospital, Tours, France.
¹⁶ INSERM, U1246, Tours, Franc Tours, France.
¹⁷ School of Psychology, The University of Sydney, Sydney, Australia.

PMID: 30300284
DOI: 10.1097/TP.0000000000002476

Establishing a Core Outcome Measure for Life Participation: A Standardized Outcomes in Nephrology-kidney Transplantation Consensus Workshop Report

Angela Ju et al. Transplantation. 2019 Jun.

. 2019 Jun;103(6):1199-1205.

doi: 10.1097/TP.0000000000002476.

Authors

Affiliations

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 Department of Medicine, The University of Chicago Medicine, Chicago, IL.
⁴ Departments of Medical Social Sciences, Surgery and Psychiatry & Behavioral sciences, Northwestern University, Evanston, IL.
⁵ Department of Psychiatry & Psychology, Mayo Clinic, Jacksonville, FL.
⁶ Department of Medicine, Stanford University, Stanford, CA.
⁷ Standardised Outcomes in Nephrology (Patient Partner), Chicago, IL.
⁸ Kidney Health Initiative, Patient Family Partnership Council, Washington, DC.
⁹ Department of Public Health and Primary Care, KU Leuven, Belgium.
¹⁰ School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
¹¹ The George Institute for Global Health, New Delhi, India.
¹² School of Medicine, University of Alabama at Birmingham, Birmingham, AL.
¹³ Division of Nephrology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
¹⁴ Transplantation Center, Seoul National University Hospital, Seoul, South Korea.
¹⁵ Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours Hospital, Tours, France.
¹⁶ INSERM, U1246, Tours, Franc Tours, France.
¹⁷ School of Psychology, The University of Sydney, Sydney, Australia.

PMID: 30300284
DOI: 10.1097/TP.0000000000002476

Abstract

Background: Kidney transplantation confers substantial survival and quality of life benefits for many patients with end-stage kidney disease compared with dialysis, but complications and side effects of immunosuppression can impair participation in daily life activities. Life participation is a critically important patient-reported outcome for kidney transplant recipients but is infrequently and inconsistently measured in trials. We convened a consensus workshop on establishing an outcome measure for life participation for use in all trials in kidney transplantation.

Methods: Twenty-five (43%) kidney transplant recipients/caregivers and 33 (57%) health professionals from 8 countries participated in 6 facilitated breakout group discussions. Transcripts were analyzed thematically.

Results: Four themes were identified. Returning to normality conveyed the patients' goals to fulfill their roles (ie, in their family, work, and community) and reestablish a normal lifestyle after transplant. Recognizing the diverse meaning and activities of "life" explicitly acknowledged life participation as a subjective concept that could refer to different activities (eg, employment, recreation, family duties) for each individual patient. Capturing vulnerability and fluctuations posttransplant (eg, due to complications and side-effects) distinguished between experiences in the first year posttransplant and the long-term impact of transplantation. Having a scientifically rigorous, feasible, and meaningful measure was expected to enable consistent and frequent assessment of life participation in trials in kidney transplantation.

Conclusions: A feasible and validated core outcome measure for life participation is needed so that this critically important patient-reported outcome can be consistently and meaningfully assessed in trials in kidney transplantation to inform decision making and care of recipients.

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Comment in

Everyday People Sing a Simple Song: Establishing a Core Outcome for Life Participation.
Aala A, Brennan DC. Aala A, et al. Transplantation. 2019 Jun;103(6):1078-1079. doi: 10.1097/TP.0000000000002477. Transplantation. 2019. PMID: 30300281 No abstract available.

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Establishing a Core Outcome Measure for Life Participation: A Standardized Outcomes in Nephrology-kidney Transplantation Consensus Workshop Report

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Establishing a Core Outcome Measure for Life Participation: A Standardized Outcomes in Nephrology-kidney Transplantation Consensus Workshop Report

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Medical