Establishing a Core Outcome Measure for Life Participation: a Standardized Outcomes in Nephrology – Kidney Transplantation (SONG-Tx) Consensus Workshop Report
Angela Ju1,2, Michelle A Josephson3, Sheila Jowsey-Gregoire4, Jane Tan5, Quinetta Taylor6, Kevin Flower7, Fabienne Dobbels8, Fergus Caskey9, Vivekanand Jha10, Jayme Locke11, Greg Knoll12, Curie Ahn 13, Camilla S Hanson1,2, Karine Manera1,2, Benedicte Sautenet14, Jonathan C Craig1,2, Allison Tong1,2.
1School of Public Health, The University of Sydney , Sydney, Australia; 2Centre for Kidney Research, Children's Hospital at Westmead, Westmead, Australia; 3Department of Medicine, The University of Chicago, Chicago, IL, United States; 4Northwestern University , Evanston , IL, United States; 5Mayo Clinic, Rochester, MN, United States; 6Department of Medicine, Stanford University School of Medicine, Stanford, CA, United States; 7Patient Family Partnership Council, Kidney Health Initiative , Chicago, IL, United States; 8University of Leuven, Leuven, Belgium; 9School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom; 10The George Institute for Global Health, University of Oxford, Oxford, United Kingdom; 11School of Medicine, University of Alabama, Birmingham, AL, United States; 12Division of Nephrology, The Ottawa Hospital and University of Ottawa, Ottawa, ON, Canada; 13Seoul National University Hospital, Seoul, Korea; 14Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours, France
Background: Life participation is a critically important outcome for kidney transplant recipients but it is inconsistently and infrequently measured in trials. We convened a consensus workshop on establishing a core 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 eight countries participated. Transcripts were analyzed thematically.
Results: Four themes were identified. Returning to normality illustrated the patients’ desires to fulfil their given role and re-establish a normal lifestyle. Recognizing the diverse meaning of ‘life’ explicitly acknowledged life participation as a subjective outcome that may refer to different activities for different patients. Capturing fluctuations in issues post-transplant recognized the long-term impact of transplantation and emphasized the need to consider time since receiving the transplant. Having a scientifically rigorous, feasible and meaningful measure would facilitate the consistent and frequent assessment of life participation in trials.
Conclusions: A simple and inexpensive core outcome measure for life participation will allow this important outcome to be consistently and meaningfully assessed in trials in kidney transplantation to inform decision-making and care of patients
