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

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

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 COS.

Aim

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.

Contributors

Tathiana Santana Shiguemoto, Tania Janaudis-Ferreira, Neha Dewan, and Sunita Mathur

Publication

Journal: Progress in Transplantation
Volume:
Issue:
Pages: -
Year: 2022
DOI: 10.1177/15269248221145032

Further Study Information

Current Stage: Completed
Date:
Funding source(s): The author(s) received no financial support for the research, authorship, and/or publication of this article.

Health Area

Disease Category: Other

Disease Name: Solid Organ Transplant

Target Population

Age Range: 18

Sex: Either

Nature of Intervention: Physical, Rehabilitation

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Delphi process

We used a 2-round Delphi method to identify which outcome domains were most important. The electronic survey was distributed by email from a university