Trajectories of health-related quality of life among renal transplant patients associated with graft failure and symptom distress: Analysis of the BENEFIT and BENEFIT-EXT trials

Abstract

Understanding the correlation between transplant symptoms, health‐related quality of life (HRQoL), and graft outcomes is needed to support patient‐focused drug development and posttransplant management. A post‐hoc analysis of patient‐reported outcomes from the Phase III belatacept trials was conducted in order to investigate the interrelationship between trajectories of HRQoL, symptom experience, and allograft outcomes. HRQoL and symptom experience were evaluated using Short‐Form 36 Survey (SF‐36) and Modified Transplant Symptom Occurrence and Distress Scale (MTSOSD‐59R), respectively. HRQoL was captured in 831 eligible renal transplant patients at baseline, 12, 24, and 36 months posttransplant. Following transplantation, patients reported improvements in all SF‐36 subscales compared to baseline. Latent class analysis revealed four trajectories in perceived general health, which were associated with graft failure after adjustment. Compared to patients with good perceived health, patients with fair and poor perceived health had 4.7 (95% confidence interval [CI] 1.5‐14.8, P < .01) and 19.8 (95% CI 5.9‐66.0, P < .01) times the risk of graft failure, respectively. Using multinomial logistic regression, different sets of symptoms were associated with perceived general health at baseline and 12 months posttransplant. The study supports monitoring HRQoL and symptom experience to capture each patient's health perspective, improve drug development, and optimize posttransplant management.

A Canadian Survey on Adverse Symptoms Experienced by Solid Organ Transplant Recipients

“…Consistent with previous reports, this finding confirms the important impact that adverse symptoms can have on a patient’s well-being. 3,4…”

“…Our results also seem to be in line with prior literature, in that female respondents reported more symptoms and a higher perceived distress than men. 4,17…”

“…A comprehensive assessment of symptom experience is warranted since adverse symptoms can cause significant patient distress and impact patient quality of life (QoL). 3,4 The patient’s subjective feelings about immunosuppressants have also been shown to be a crucial factor in medication adherence. 3,5 –7 Medication-taking behavior could possibly be impacted when immunosuppressant medications are perceived to cause adverse symptoms.…”

“…7 Previous studies have focused on patients with only one type of organ transplant or have restricted their questions to symptom prevalence and distress only. 4 –8 Other factors such as the perceived cause of the troubling symptom or whether it is considered to be treatable remain unexplored.…”

Amplifying the Patient Voice: Key Priorities and Opportunities for Improved Transplant and Living Donor Advocacy and Outcomes During COVID-19 and Beyond

“…Additionally, by integrating patient-reported outcomes (PROs) into clinical systems, the patient voice can be indirectly captured through data, highlighting areas in need of improvement such as side effects or challenges adhering to complex regimens [26]. For example, PROs from clinical trials have shown high rates of symptoms post-transplant including and mental health-related symptoms (e.g., depression, anxiety, and fatigue) [27]. Development and validation of measures for transplant-related and donation-related PROs should be a patient advocacy priority.…”