ExplorinG frailty and mild cognitive impairmEnt in kidney tRansplantation to predict biomedicAl, psychosocial and health cost outcomeS (GERAS): protocol of a nationwide prospective cohort study

Aim: To present the rationale, design and methodology of the GERAS project, which examines whether assessment of frailty and mild cognitive impairment could enhance risk prediction for biomedical, psychosocial outcomes and foster efficient resource allocation in kidney transplantation. Background: For the burgeoning cohort of older patients considered for kidney transplantation, evidence gaps regarding frailty and mild cognitive impairment limit clinical decision-making and medical management. As known risk factors for ‘hard’ clinical outcomes in chronic illness, both require further study in transplantation. Integrating these and other bio-psychosocial factors into a comprehensive pre-transplant patient assessment will provide insights regarding economic implications and may improve risk prediction. Design: A nation-wide multi-centre prospective cohort study nested in the Swiss Transplant Cohort Study. Methods: Our nationally representative convenience sample includes 250 adult kidney transplant recipients. Data sources include the Swiss Transplant Cohort Study and primary data collected at time of transplantation, 6 months, 1 and 2 years post-transplant via established measures (the Montreal Cognitive Assessment, Psychosocial Questionnaire, Fried Frailty Instrument and a blood analysis), investigator-developed instruments and datasets compiled by hospitals’ management control units, sickness funds, the Swiss Federal Statistical Office and the European Renal Association. Descriptive, competing risk survival and mixed effects analyses will be performed. Research Ethics Committee approval was obtained in January 2016. Discussion: This pioneering project jointly examines frailty and mild cognitive impairment from bio-psychosocial and health economic perspectives. Results may significantly inform risk prediction, care tailoring and resource optimization to improve health outcomes in the ageing kidney transplant cohort.