TY - JOUR
T1 - Establishing a core outcome measure for life participation
T2 - A standardized outcomes in nephrology-kidney transplantation consensus workshop report
AU - Ju, Angela
AU - Josephson, Michelle A.
AU - Butt, Zeeshan
AU - Jowsey-Gregoire, Sheila
AU - Tan, Jane
AU - Taylor, Quinetta
AU - Fowler, Kevin
AU - Dobbels, Fabienne
AU - Caskey, Fergus
AU - Jha, Vivekanand
AU - Locke, Jayme
AU - Knoll, Greg
AU - Ahn, Curie
AU - Hanson, Camilla S.
AU - Sautenet, Benedicte
AU - Manera, Karine
AU - Craig, Jonathan C.
AU - Howell, Martin
AU - Rutherford, Claudia
AU - Tong, Allison
N1 - Funding Information:
15Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours Hospital, Tours, France. 16INSERM, U1246, Tours, Franc Tours, France. 17School of Psychology, The University of Sydney, Sydney, Australia. 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
Publisher Copyright:
© 2019 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2019/6/1
Y1 - 2019/6/1
N2 - 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.
AB - 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.
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U2 - 10.1097/TP.0000000000002476
DO - 10.1097/TP.0000000000002476
M3 - Article
C2 - 30300284
AN - SCOPUS:85062344200
SN - 0041-1337
VL - 103
SP - 1199
EP - 1205
JO - Transplantation
JF - Transplantation
IS - 6
ER -