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Establishing a Core Outcome Measure for Life Participation

A Standardized Outcomes in Nephrology-kidney Transplantation Consensus Workshop Report

Ju, Angela, BSc (Hons)1,2; Josephson, Michelle A., MD3; Butt, Zeeshan, PhD4; Jowsey-Gregoire, Sheila, MD5; Tan, Jane, PhD6; Taylor, Quinetta7; Fowler, Kevin, BS8; Dobbels, Fabienne, PhD9; Caskey, Fergus, MD10; Jha, Vivekanand, MD11; Locke, Jayme, MD12; Knoll, Greg, MD13; Ahn, Curie, MD14; Hanson, Camilla S., PhD1,2; Sautenet, Benedicte, MD15,16; Manera, Karine, MIPH1,2; Craig, Jonathan C., PhD1,2; Howell, Martin, PhD1,2; Rutherford, Claudia, PhD17; Tong, Allison, PhD1,2; Harden, Paul; Hawley, Carmel; Holdaas, Hallvard; Israni, Ajay; Jesse, Michelle; Kane, Brenna; Kanellis, John; Kiberd, Bryce; Kim, Joseph; Larsen, Chris; Leichtman, Alan; Lentine, Krista; Malone, Andrew; Mannon, Roslyn; Oberbauer, Rainer; Patzer, Rachel; Peipert, John Devin; Phan, Hai An; Poggio, Emilio; Reed, Rihannon; Scandling, John; Tang, Ignatius; Watson, Chris; Contrares, Daniel; Contreras, Patricia; Cross, Daley; Juodvalkis, Egle; Koide, Den; Koide, Jinny; Kozarewicz, Adam; Kozarewicz, Laura; Kozarewicz, Richard; Koritala, Andrea; Lisiecki, Elizabeth; Lipuma, Christine; Lyman, Margaret; Mueller, Robert; Mueller, Gloria; Noble, Larry; Nolan, Nancy; Nolan, Stephen; Thomas, Jim; Urbancyzk, Lynda; Zerante, James; Zerante, Susan on behalf of the SONG-Tx Life Participation Workshop Investigators Health professionals (*includes 2 patients from the SONG-Tx Graft Health Expert Working Group) Patients and family members

doi: 10.1097/TP.0000000000002476
Original Clinical Science—General
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SDC

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.

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.

Received 14 June 2018. Revision received 7 August 2018.

Accepted 16 August 2018.

The authors declare no conflicts of interest.

This project was supported by a National Health and Medical Research Council project grant 1128564 and program grant 1092597.

A.J. participated in the research design, data collection, data analysis, and drafted the article. M.A.J. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing. Z.B. participated in participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. S.J.G. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. J.T. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. Q.T. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. K.F. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. F.D. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. F.C. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. V.J. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. J.L. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. G.K. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing. C.A. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. C.S.H. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing. B.S. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. K.M. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing. J.C.C. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. M.H. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. C.R. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. A.T. participated in the research design, data collection, data analysis, and provided intellectual input on the article and contributed to article writing.

* A complete list of the SONG-Tx Life Participation Workshop Investigators is provided in SDC, Materials and Methods 1, http://links.lww.com/TP/B641.

Supplemental digital content (SDC) is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Web site (www.transplantjournal.com).

Correspondence: Angela Ju, Centre for Kidney Research, The Children’s Hospital at Westmead, Westmead, NSW 2145 Sydney, Australia. (angela.ju@sydney.edu.au).

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