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. *A complete list of the SONG-Tx Life Participation Workshop Investigators is provided in SDC, Materials and Methods 1, https://ift.tt/2OhZAak Address for correspondence: Angela Ju, Centre for Kidney Research. The Children's Hospital at Westmead, Westmead, NSW 2145, Sydney, Australia, Phone: +61 2 9845 1486 Fax: +61 2 9845 1491; Email: angela.ju@sydney.edu.au Authors' specific contributions: AJ participated in the research design, data collection, data analysis, and drafted the manuscript. MAJ participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. ZB participated in participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. SJG participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. JT participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. QT participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. KF participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. FD participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. FC participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. VJ participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. JL participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. GK participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. CA participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. CSH participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. BS participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. KM participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. JCC participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. MH participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. CR participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. AT participated in the research design, data collection, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. Disclosure: The authors declare no conflicts of interest. Funding: This project is supported by a National Health and Medical Research Council Project Grant 1128564 and Program Grant 1092597. 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 (https://ift.tt/2EZJQTY). Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
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