Establishing a core outcome measure for life participation: a Standardized outcomes in Nephrology – kidney transplantation (SONG-Tx) consensus workshop report

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 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 in six facilitated breakout group discussions. Transcripts were analyzed thematically. Results: Four themes were identified. Returning to normality conveyed the patients’ goals to fulfill their given roles (i.e. in their family, work, and community) and re-establish 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 (e.g. employment, recreation, family duties) for each individual patient. Capturing vulnerability and fluctuations post-transplant (e.g. due to complications and side-effects) distinguished between experiences in the first year post-transplant 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 critically important patient-reported outcome can be consistently and meaningfully assessed in trials in kidney transplantation to inform decision-making and care of recipients