Establishing a Core Outcome Measure for Life Participation: A Standardized Outcomes in Nephrology-kidney Transplantation Consensus Workshop Report.
Ju A., Josephson MA., Butt Z., Jowsey-Gregoire S., Tan J., Taylor Q., Fowler K., Dobbels F., Caskey F., Jha V., Locke J., Knoll G., Ahn C., Hanson CS., Sautenet B., Manera K., Craig JC., Howell M., Rutherford C., Tong A., Harden P., Hawley C., Holdaas H., Israni A., Jesse M., Kane B., Kanellis J., Kiberd B., Kim J., Larsen C., Leichtman A., Lentine K., Malone A., Mannon R., Oberbauer R., Patzer R., Peipert JD., Phan HA., Poggio E., Reed R., Scandling J., Tang I., Watson C., Contrares D., Contreras P., Cross D., Juodvalkis E., Koide D., Koide J., Kozarewicz A., Kozarewicz L., Kozarewicz R., Koritala A., Lisiecki E., Lipuma C., Lyman M., Mueller R., Mueller G., Noble L., Nolan N., Nolan S., Thomas J., Urbancyzk L., Zerante J., Zerante S., SONG-Tx Life Participation Workshop Investigators None., Health professionals (*includes 2 patients from the SONG-Tx Graft Health Expert Working Group) None., Patients and family members None.
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.