An international Delphi survey helped develop consensus-based core outcome domains for trials in peritoneal dialysis

Karine E Manera; Allison Tong; Jonathan C Craig; Jenny Shen; Shilpa Jesudason; Yeoungjee Cho; Benedicte Sautenet; Armando Teixeira-Pinto; Martin Howell; Angela Yee-Moon Wang; Edwina A Brown; Gillian Brunier; Jeffrey Perl; Jie Dong; Martin Wilkie; Rajnish Mehrotra; Roberto Pecoits-Filho; Saraladevi Naicker; Tony Dunning; Nicole Scholes-Robertson; David W Johnson

doi:10.1016/j.kint.2019.03.015

An international Delphi survey helped develop consensus-based core outcome domains for trials in peritoneal dialysis

Kidney Int. 2019 Sep;96(3):699-710. doi: 10.1016/j.kint.2019.03.015. Epub 2019 Mar 29.

Authors

Karine E Manera¹, Allison Tong², Jonathan C Craig³, Jenny Shen⁴, Shilpa Jesudason⁵, Yeoungjee Cho⁶, Benedicte Sautenet⁷, Armando Teixeira-Pinto², Martin Howell², Angela Yee-Moon Wang⁸, Edwina A Brown⁹, Gillian Brunier¹⁰, Jeffrey Perl¹¹, Jie Dong¹², Martin Wilkie¹³, Rajnish Mehrotra¹⁴, Roberto Pecoits-Filho¹⁵, Saraladevi Naicker¹⁶, Tony Dunning¹⁷, Nicole Scholes-Robertson¹⁸, David W Johnson¹⁹

Affiliations

¹ Sydney School of Public Health, The University of Sydney, Sydney, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia. Electronic address: karine.manera@sydney.edu.au.
² Sydney School of Public Health, The University of Sydney, Sydney, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.
³ College of Medicine and Public Health, Flinders University, Adelaide, Australia.
⁴ Division of Nephrology and Hypertension, Los Angeles Biomedical Research Institute at Harbor-University of California Los Angeles Medical Center, Torrance, California, USA.
⁵ Central and Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital and University of Adelaide, Adelaide, Australia.
⁶ Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia; Australian Kidney Trials Network, University of Queensland, Brisbane, Australia.
⁷ University François Rabelais, Tours, France; Department of Nephrology-Hypertension, Dialysis, Kidney Transplantation, Tours Hospital, Tours, France; Methods in Patient-Centered Outcomes & Health Research, Institut National de la Santé et de la Recherche Médicale, U1246, Tours, France.
⁸ Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, China.
⁹ Imperial College Renal and Transplant Centre, Hammersmith Hospital, London, United Kingdom.
¹⁰ Sunnybrook Health Sciences Centre (retired), Toronto, Ontario, Canada.
¹¹ Division of Nephrology, Department of Medicine, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
¹² Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.
¹³ Department of Nephrology, Sheffield Teaching Hospitals National Health Service Foundation Trust, Sheffield, United Kingdom.
¹⁴ Kidney Research Institute and Harborview Medical Center, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, USA.
¹⁵ School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Paraná, Brazil; Arbor Research Collaborative for Health, Ann Arbor, Michigan, USA.
¹⁶ Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
¹⁷ South Bank Technical and Further Education, Brisbane, Australia.
¹⁸ Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.
¹⁹ Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia; Australian Kidney Trials Network, University of Queensland, Brisbane, Australia; Translational Research Institute, Brisbane, Australia; Centre for Kidney Disease Research, University of Queensland at Princess Alexandra Hospital, Brisbane, Australia.

Abstract

Shared decision-making about clinical care options in end-stage kidney disease is limited by inconsistencies in the reporting of outcomes and the omission of patient-important outcomes in trials. Here we generated a consensus-based prioritized list of outcomes to be reported during trials in peritoneal dialysis (PD). In an international, online, three-round Delphi survey, patients/caregivers and health professionals rated the importance of outcomes using a 9-point Likert scale (with 7-9 indicating critical importance) and provided comments. Using a Best-Worst Scale (BWS), the relative importance of outcomes was estimated. Comments were analyzed thematically. In total, 873 participants (207 patients/caregivers and 666 health professionals) from 68 countries completed round one, 629 completed round two and 530 completed round three. The top outcomes were PD-related infection, membrane function, peritoneal dialysis failure, cardiovascular disease, death, catheter complications, and the ability to do usual activities. Compared with health professionals, patients/caregivers gave higher priority to six outcomes: blood pressure (mean difference, 0.4), fatigue (0.3), membrane function (0.3), impact on family/friends (0.1), peritoneal thickening (0.1) and usual activities (0.1). Four themes were identified that underpinned the reasons for ratings: contributing to treatment longevity, preserving quality of life, escalating morbidity, and irrelevant and futile information and treatment. Patients/caregivers and health professionals gave highest priority to clinical outcomes. In contrast to health professionals, patients/caregivers gave higher priority to lifestyle-related outcomes including the impact on family/friends and usual activities. Thus, prioritization will inform a core outcome set to improve the consistency and relevance of outcomes for trials in PD.

Keywords: core outcome sets; kidney disease; outcomes; patient-centered care; peritoneal dialysis; trials.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Adult
Aged
Consensus*
Decision Making, Shared
Delphi Technique
Female
Humans
Kidney Failure, Chronic / therapy*
Male
Middle Aged
Outcome Assessment, Health Care / standards*
Peritoneal Dialysis / adverse effects*
Quality of Life
Randomized Controlled Trials as Topic / standards*
Surveys and Questionnaires
Young Adult

Grants and funding

K23 DK103972/DK/NIDDK NIH HHS/United States