title: Current state of clinical end-points assessment in transplant: Key points.
abstract: Solid organ transplantation is the treatment of choice for patients with end-stage organ disease. However, organ transplantation can stress the cardiovascular system and decrease immune surveillance, leading to early mortality and graft loss due to multiple underlying comorbidities. Clinical end-points in transplant include death and graft failure. Thus, generating accurate predictive models through regression models is crucial to test for definitive clinical post-transplantation end-points. Survival predictive models should assemble efficient surrogate markers or prognostic factors to generate a minimal set of variables derived from a proper modeling strategy through regression models. However, a few critical points should be considered when reporting survival analyses and regression models to achieve proper discrimination and calibration of the predictive models. Additionally, population-based risk scores may underestimate risk prediction in transplant. The application of predictive models in these patients should therefore incorporate both classical and non-classical risk factors, as well as community-based health indicators and transplant-specific factors to quantify the outcomes in terms of survival properly. This review focuses on assessment of clinical end-points in transplant through regression models by combining predictive and surrogate variables, and considering key points in these analyses to accurately predict definitive end-points, which could aid clinicians in decision making.
authors.affiliation: Department of Nephrology, Carlos Haya Regional University Hospital and University of Malaga, IBIMA, REDinREN (RD12/0021/0015). Avda. Carlos Haya s/n., 29010, Málaga, Spain. Electronic address: domingohernandez@gmail.com.
authors.forename: Domingo
authors.initials: D
authors.lastname: Hernández
authors.affiliation: Clinical Biostatistic Unit, Hospital Ramón y Cajal, IRYCIS, CIBERESP, Crta. Colmenar km 9.1, 28034, Madrid, Spain.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Muriel
authors.affiliation: Clinical Biostatistic Unit, Hospital Ramón y Cajal, IRYCIS, CIBERESP, Crta. Colmenar km 9.1, 28034, Madrid, Spain.
authors.forename: Víctor
authors.initials: V
authors.lastname: Abraira
mesh_terms: D006085:Graft Survival; D006801:Humans; D016377:Organ Transplantation; D017063:Outcome Assessment, Health Care; D012042:Registries; D012307:Risk Factors