Novel Endpoints in Solid Organ Transplantation: Targeting Patient-reported Outcome Measures.

Although solid organ transplantation improves survival and quality of life in many patients with organ failure, treatment complications and side effects can have debilitating consequences for patients. Patient-reported outcome measures (PROMs) capture how patients feel and function, including quality of life, symptoms, and side effects that are assessed directly by patients. Yet, they remain infrequently reported in trials in solid organ transplantation. Barriers to implementing PROMs in trials include uncertainty in selecting appropriate PROMs, concerns about resources limitations, patient burden, and limited evidence to support the psychometric robustness of measures for use in transplant recipients. In recent years, there have been increasing efforts to include patient-reported outcomes that are important to patients in trials to ensure that trials provide patient-centered information for decision-making. This article will provide an overview of PROMs, discuss PROs that are important to solid organ transplant recipients and those that are used in trials in solid organ transplantation, and outline approaches for selecting PROMs for clinical trials.