Development of an international Delphi survey to establish core outcome domains for trials in adults with glomerular disease

Simon A Carter; Charlotte Logeman; Martin Howell; Dan Cattran; Liz Lightstone; Arvind Bagga; Sean J Barbour; Jonathan Barratt; John Boletis; Dawn J Caster; Rosanna Coppo; Fernando C Fervenza; Jürgen Floege; Michelle A Hladunewich; Jonathan J Hogan; A Richard Kitching; Richard A Lafayette; Ana Malvar; Jai Radhakrishnan; Brad H Rovin; Nicole Scholes-Robertson; Hérnan Trimarchi; Hong Zhang; Yeoungjee Cho; Louese Dunn; Debbie S Gipson; Adrian Liew; Benedicte Sautenet; Andrea K Viecelli; David Harris; David W Johnson; Angela Yee-Moon Wang; Armando Teixeira-Pinto; Stephen I Alexander; Adam Martin; Allison Tong; Jonathan C Craig

doi:10.1016/j.kint.2021.04.027

Development of an international Delphi survey to establish core outcome domains for trials in adults with glomerular disease

Kidney Int. 2021 Oct;100(4):881-893. doi: 10.1016/j.kint.2021.04.027. Epub 2021 May 5.

Authors

Simon A Carter¹, Charlotte Logeman², Martin Howell³, Dan Cattran⁴, Liz Lightstone⁵, Arvind Bagga⁶, Sean J Barbour⁷, Jonathan Barratt⁸, John Boletis⁹, Dawn J Caster¹⁰, Rosanna Coppo¹¹, Fernando C Fervenza¹², Jürgen Floege¹³, Michelle A Hladunewich¹⁴, Jonathan J Hogan¹⁵, A Richard Kitching¹⁶, Richard A Lafayette¹⁷, Ana Malvar¹⁸, Jai Radhakrishnan¹⁹, Brad H Rovin²⁰, Nicole Scholes-Robertson³, Hérnan Trimarchi²¹, Hong Zhang²², Yeoungjee Cho²³, Louese Dunn²⁴, Debbie S Gipson²⁵, Adrian Liew²⁶, Benedicte Sautenet²⁷, Andrea K Viecelli²⁸, David Harris²⁹, David W Johnson²³, Angela Yee-Moon Wang³⁰, Armando Teixeira-Pinto³, Stephen I Alexander², Adam Martin², Allison Tong³, Jonathan C Craig³¹

Affiliations

¹ Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, New South Wales, Australia. Electronic address: [email protected].
² Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.
³ Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.
⁴ Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada; Toronto General Research Institute, Toronto, Ontario, Canada.
⁵ Centre for Inflammatory Disease, Faculty of Medicine, Imperial College London, London, UK.
⁶ Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.
⁷ Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
⁸ Department of Cardiovascular Sciences, University of Leicester, Leicester, UK; John Walls Renal Unit, Leicester General Hospital, Leicester, UK.
⁹ Nephrology Department and Renal Transplantation Unit, Medical School, University of Athens, Laiko Hospital, Athens, Greece.
¹⁰ Division of Nephrology, University of Louisville, Louisville, Kentucky, USA.
¹¹ Fondazione Ricerca Molinette, Regina Margherita Hospital, Turin, Italy.
¹² Division of Nephrology and Hypertension, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.
¹³ Department of Nephrology and Clinical Immunology, Rheinisch-Westfälische Technische Hochschule University Hospital, Aachen, Germany.
¹⁴ Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada; Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
¹⁵ Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
¹⁶ Department of Nephrology, Monash Health, Melbourne, Victoria, Australia; Centre for Inflammatory Diseases, Monash University Department of Medicine, Melbourne, Victoria, Australia.
¹⁷ Department of Medicine, Division of Nephrology, Stanford University Medical Center, Stanford, California, USA.
¹⁸ Department of Nephrology, Hospital Fernández, Buenos Aires, Argentina.
¹⁹ Division of Nephrology, Columbia University Medical Center, New York, New York, USA.
²⁰ Department of Internal Medicine, Division of Nephrology, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
²¹ Nephrology Service and Kidney Transplantation Unit, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina.
²² Renal Division of Peking University First Hospital, Beijing, China.
²³ Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Australasian Kidney Trials Network, University of Queensland, Brisbane, Queensland, Australia; Translational Research Institute, Brisbane, Queensland, Australia.
²⁴ Sheffield Kidney Institute, Sheffield Teaching Hospitals National Health Service Foundation Trust, Sheffield, UK.
²⁵ Department of Pediatrics, University of Michigan, Ann Arbor, Michigan, USA.
²⁶ The Kidney and Transplant Practice, Mount Elizabeth Novena Hospital, Singapore.
²⁷ Faculty of Medicine, University of Tours, Tours, France; Department of Nephrology and Clinical Immunology, Tours Hospital, Tours, France.
²⁸ Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Australasian Kidney Trials Network, University of Queensland, Brisbane, Queensland, Australia.
²⁹ Westmead Institute for Medical Research, The University of Sydney, Sydney, New South Wales, Australia; Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
³⁰ Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong.
³¹ College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.

PMID: 33964313
DOI: 10.1016/j.kint.2021.04.027

Abstract

Outcomes relevant to treatment decision-making are inconsistently reported in trials involving glomerular disease. Here, we sought to establish a consensus-derived set of critically important outcomes designed to be reported in all future trials by using an online, international two-round Delphi survey in English. To develop this, patients with glomerular disease, caregivers and health professionals aged 18 years and older rated the importance of outcomes using a Likert scale and a Best-Worst scale. The absolute and relative importance was assessed and comments were analyzed thematically. Of 1198 participants who completed Round 1, 734 were patients/caregivers while 464 were health care professionals from 59 countries. Of 700 participants that completed Round 2, 412 were patients/caregivers and 288 were health care professionals. Need for dialysis or transplant, kidney function, death, cardiovascular disease, remission-relapse and life participation were the most important outcomes to patients/caregivers and health professionals. Patients/caregivers rated patient-reported outcomes higher while health care professionals rated hospitalization, death and remission/relapse higher. Four themes explained the reasons for their priorities: confronting death and compounded suffering, focusing on specific targets in glomerular disease, preserving meaning in life, and fostering self-management. Thus, consistent reporting of these critically important outcomes in all trials involving glomerular disease is hoped to improve patient-centered decision-making.

Keywords: consensus; glomerulonephritis; patient outcome assessment; treatment outcome; trials.

Publication types

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

MeSH terms

Adult
Caregivers*
Delphi Technique
Humans
Outcome Assessment, Health Care
Renal Dialysis*
Surveys and Questionnaires