Identifying Outcome Domains for Clinical Trials of Physical Rehabilitation Among Adults Undergoing Solid Organ Transplantation Using a Delphi Approach.

Abstract

Introduction: A core outcome set (COS) improves the quality of reporting in clinical trials; however, this has not been developed for clinical trials of exercise training among adults undergoing solid organ transplant. Research Question: To explore the perspectives of transplant patients and healthcare professionals on the key outcomes domains that are relevant for clinical trials of exercise in all recipients of transplanted organs. Methods: A Delphi approach was employed with 2 rounds of online questionnaires. Participants rated the importance of outcome domains using a 9-point Likert scale ranging from "not important" to "very important". A score of 7 to 9 (very important) by 70% or more participants and a score of 1 to 3 (not important) by less than 15% participants were required to keep an outcome domain from the first to the second round. Results: Thirty-six participants completed 2 rounds of questionnaires (90% response rate). After Round 1, 8 outcome domains were considered very important in the pretransplant phase; 16 in the early posttransplant; and 17 in the late posttransplant. Only 1 outcome domain, organ rejection in the early posttransplant phase, met the criteria to be considered very important after Round 2. Conclusion: Although consensus was not reached on the core outcome domains, this study provides preliminary information on which domains are higher priority for patients and professionals. Future work should consider a meeting with key stakeholders to allow for deeper discussion to reach consensus on a core outcome set.