DEVELOPING CONSENSUS-BASED OUTCOME DOMAINS FOR TRIALS IN PERITONEAL DIALYSIS: AN INTERNATIONAL DELPHI SURVEY

K MANERA1,2, A TONG1,2, J CRAIG1,2, J SHEN3, S JESUDASON4,5, Y CHO6,7,8, B SAUTENET1,2,9,M HOWELL1,2, A WANG10, E BROWN11, G BRUNIER12, J PERL13, J DONG14, M WILKIE15, R MEHROTRA16, R PECOITS-FILHO17, S NAICKER18, T DUNNING19, D JOHNSON6,7,8,20,21
1Sydney School of Public Health, The University Of Sydney, Sydney, Australia, 2Centre for Kidney Research, The Children’s Hospital at Westmead, Westmead, Australia, 3Division of Nephrology and Hypertension, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrence, USA, 4Central and Northern Adelaide Renal and Transplantation Service (CNARTS), Royal Adelaide Hospital, Adelaide, Australia, 5School of Medicine, University of Adelaide, Adelaide, Australia, 6Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia, 7Australian Kidney Trials Network, University of Queensland, Brisbane, Australia, 8Translational Research Institute, Brisbane, Australia, 9Department of Nephrology and Clinical Immunology, , France, 10Department of Medicine, Queen Mary Hospital, University of Hong Kong, , Hong Kong, 11Imperial College Renal and Transplant Centre, Hammersmith Hospital, , United Kingdom, 12Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada, 13Division of Nephrology, Department of Medicine, St. Michael’s Hospital, University of Toronto, Toronto, Canada, 14Renal Division, Department of Medicine, Peking University First Hospital, , China, 15Department of Nephrology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom, 16Kidney Research Institute and Harborview Medical Center, Division of Nephrology/Department of Medicine, University of Washington, Seattle, USA, 17School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil, 18Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, , South Africa, 19South Bank TAFE, Brisbane, Austalia, 20Metro South and Ipswich Nephrology and Transplant Services (MINTS), Brisbane, Australia, 21Centre for Kidney Disease Research, University of Queensland at Princess Alexandra Hospital, Brisbane, Australia

Background: Major inconsistencies in the reporting of outcomes, the omission of patient-reported outcomes, and frequent reporting of surrogate outcomes in trials impedes evidence-informed decision making by patients and their clinicians.
Aim: To generate a consensus-based prioritised list of outcome domains for trials in peritoneal dialysis (PD).
Methods: In an international online 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcomes using a 9-point Likert scale and provided comments. In rounds 2 and 3, participants re-rated the outcomes after reviewing the scores and comments of other respondents. For each outcome we calculated the mean, median, and proportion rating 7-9 (critically important).
Results: In total, 873 participants (207 [24%] patients/caregivers and 666 [76%] health professionals) from 68 countries completed round 1, and 530 (61%) completed round 3. The top outcomes based on a threshold (mean >8; median ≥8; proportion >85% in both groups) were PD-infection, membrane functioning, PD failure, cardiovascular disease, mortality, catheter complications, and ability to do usual activities. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes: blood pressure (mean difference of 0.4), fatigue (0.3), membrane functioning (0.3), impact on family/friends (0.1), peritoneal thickening [EPS] (0.1), and usual activities (0.1).
Conclusion: Clinical outcomes were highly prioritised by both stakeholder groups. Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. This process will inform a core outcome set to improve the consistency and relevance of outcomes reported in trials in peritoneal dialysis.


Biography:
Karine Manera is a PhD candidate with The University of Sydney and research officer at the Centre for Kidney Research. She uses qualitative and quantitative research methods to generate evidence for improving shared decision-making in the area of peritoneal dialysis. She has applied this approach in global and multi-language studies.

 

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