OUTCOMES FOR CLINICAL TRIALS INVOLVING ADULTS WITH CHRONIC KIDNEY DISEASE: A MULTINATIONAL DELPHI SURVEY INVOLVING PATIENTS, CAREGIVERS AND HEALTH PROFESSIONALS
Miss Andrea Matus1,2, Mrs Nicole Evangelidis1,2, Mr Martin Howel1,2, Mrs Allison Jaure1,2
1Sydney School of Public Health, The University of Sydney, Sydney, Australia, 2Centre for Kidney Research, The Children’s Hospital at Westmead, Sydney, Australia
Aim: To generate consensus among patients/caregivers and health professionals (HP) on critically important outcome domains for trials in Chronic Kidney Disease (CKD) prior to the need for Kidney replacement therapy (KRT), and to describe the reasons for their choices.
Background: Many outcomes of high priority to patients and clinicians are infrequently and inconsistently reported across trials in CKD, which generates research waste and limits evidence-informed decision making.
Methods: This was an online two-round international Delphi survey. Adult patients with CKD (all stages and diagnoses), caregivers and HP who could read English, Spanish or French were eligible. Participants rated the importance of outcomes using a Likert scale (7–9 indicating critical importance) and a Best–Worst Scale. Comments were analysed thematically.
Results: In total, 1399 participants from 73 countries completed Round 1 of the Delphi survey, including 628 (45%) patients/caregivers and 771 (55%) HP. In Round 2,790 participants (56% response rate) from 63 countries completed the survey including 383 (48%) patients/caregivers and 407 (52%) HP. The overall top five outcomes were: kidney function, need for dialysis/transplant, life participation, cardiovascular disease and death. In the final round, patients/caregivers indicated higher scores for most outcomes, and HP gave higher priority to mortality, hospitalization and cardiovascular disease (mean difference > 0.3).Four themes reflected the reasons for their priorities: imminent threat of a health catastrophe, signifying diminishing capacities, ability to self-manage and cope, and tangible and direct consequences.
Conclusion: Across trials in CKD, the outcomes of highest priority to patients, caregivers and HP were kidney function, need for dialysis/transplant, life participation, cardiovascular disease and death.
Presentation Slides PDF – Click here
Biography:
Andrea Matus Gonzalez is a renal dietitian from Chile currently living in Sydney, PhD candidate and Research assistant in the Centre for Kidney Research at Sydney University. Andrea is a member of the global SONG initiative, currently working as a project coordinator for the SONG-Chronic Kidney Disease study, establishing a core outcome set for trials in patients with chronic kidney disease and not requiring kidney replacement therapy.