Toward Establishing Core Outcome Domains for Trials in Kidney Transplantation: Report of the Standardized Outcomes in Nephrology-Kidney Transplantation Consensus Workshops

Allison Tong, John Gill, Klemens Budde, Lorna Marson, Peter P. Reese, David Rosenbloom, Lionel Rostaing, Germaine Wong, Michelle A. Josephson, Timothy L. Pruett, Anthony N. Warrens, Jonathan C. Craig, Benedicte Sautenet, Nicole Evangelidis, Angelique F. Ralph, Camilla S. Hanson, Jenny I. Shen, Kirsten Howard, Klemens Meyer, Ronald D. PerroneDaniel E. Weiner, Samuel Fung, Maggie K.M. Ma, Caren Rose, Jessica Ryan, Ling-Xin Chen, Martin Howell, Nicholas Larkins, Siah Kim, Sobhana Thangaraju, Angela Ju, Jeremy R. Chapman

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Background Treatment decisions in kidney transplantation requires patients and clinicians to weigh the benefits and harms of a broad range of medical and surgical interventions, but the heterogeneity and lack of patient-relevant outcomes across trials in transplantation makes these trade-offs uncertain, thus, the need for a core outcome set that reflects stakeholder priorities. Methods We convened 2 international Standardized Outcomes in Nephrology-Kidney Transplantation stakeholder consensus workshops in Boston (17 patients/caregivers; 52 health professionals) and Hong Kong (10 patients/caregivers; 45 health professionals). In facilitated breakout groups, participants discussed the development and implementation of core outcome domains for trials in kidney transplantation. Results Seven themes were identified. Reinforcing the paramount importance of graft outcomes encompassed the prevailing dread of dialysis, distilling the meaning of graft function, and acknowledging the terrifying and ambiguous terminology of rejection. Reflecting critical trade-offs between graft health and medical comorbidities was fundamental. Contextualizing mortality explained discrepancies in the prioritization of death among stakeholders-inevitability of death (patients), preventing premature death (clinicians), and ensuring safety (regulators). Imperative to capture patient-reported outcomes was driven by making explicit patient priorities, fulfilling regulatory requirements, and addressing life participation. Specificity to transplant; feasibility and pragmatism (long-term impacts and responsiveness to interventions); and recognizing gradients of severity within outcome domains were raised as considerations. Conclusions Stakeholders support the inclusion of graft health, mortality, cardiovascular disease, infection, cancer, and patient-reported outcomes (ie, life participation) in a core outcomes set. Addressing ambiguous terminology and feasibility is needed in establishing these core outcome domains for trials in kidney transplantation.

Original languageEnglish (US)
Pages (from-to)1887-1896
Number of pages10
JournalTransplantation
Volume101
Issue number8
DOIs
StatePublished - Aug 1 2017
Externally publishedYes

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Consensus Development Conferences
Nephrology
Kidney Transplantation
Transplants
Health
Terminology
Caregivers
Cardiovascular Infections
Premature Mortality
Mortality
Hong Kong
Comorbidity
Dialysis
Cardiovascular Diseases
Transplantation
Safety
Neoplasms

ASJC Scopus subject areas

  • Transplantation

Cite this

Toward Establishing Core Outcome Domains for Trials in Kidney Transplantation : Report of the Standardized Outcomes in Nephrology-Kidney Transplantation Consensus Workshops. / Tong, Allison; Gill, John; Budde, Klemens; Marson, Lorna; Reese, Peter P.; Rosenbloom, David; Rostaing, Lionel; Wong, Germaine; Josephson, Michelle A.; Pruett, Timothy L.; Warrens, Anthony N.; Craig, Jonathan C.; Sautenet, Benedicte; Evangelidis, Nicole; Ralph, Angelique F.; Hanson, Camilla S.; Shen, Jenny I.; Howard, Kirsten; Meyer, Klemens; Perrone, Ronald D.; Weiner, Daniel E.; Fung, Samuel; Ma, Maggie K.M.; Rose, Caren; Ryan, Jessica; Chen, Ling-Xin; Howell, Martin; Larkins, Nicholas; Kim, Siah; Thangaraju, Sobhana; Ju, Angela; Chapman, Jeremy R.

In: Transplantation, Vol. 101, No. 8, 01.08.2017, p. 1887-1896.

Research output: Contribution to journalArticle

Tong, A, Gill, J, Budde, K, Marson, L, Reese, PP, Rosenbloom, D, Rostaing, L, Wong, G, Josephson, MA, Pruett, TL, Warrens, AN, Craig, JC, Sautenet, B, Evangelidis, N, Ralph, AF, Hanson, CS, Shen, JI, Howard, K, Meyer, K, Perrone, RD, Weiner, DE, Fung, S, Ma, MKM, Rose, C, Ryan, J, Chen, L-X, Howell, M, Larkins, N, Kim, S, Thangaraju, S, Ju, A & Chapman, JR 2017, 'Toward Establishing Core Outcome Domains for Trials in Kidney Transplantation: Report of the Standardized Outcomes in Nephrology-Kidney Transplantation Consensus Workshops', Transplantation, vol. 101, no. 8, pp. 1887-1896. https://doi.org/10.1097/TP.0000000000001774
Tong, Allison ; Gill, John ; Budde, Klemens ; Marson, Lorna ; Reese, Peter P. ; Rosenbloom, David ; Rostaing, Lionel ; Wong, Germaine ; Josephson, Michelle A. ; Pruett, Timothy L. ; Warrens, Anthony N. ; Craig, Jonathan C. ; Sautenet, Benedicte ; Evangelidis, Nicole ; Ralph, Angelique F. ; Hanson, Camilla S. ; Shen, Jenny I. ; Howard, Kirsten ; Meyer, Klemens ; Perrone, Ronald D. ; Weiner, Daniel E. ; Fung, Samuel ; Ma, Maggie K.M. ; Rose, Caren ; Ryan, Jessica ; Chen, Ling-Xin ; Howell, Martin ; Larkins, Nicholas ; Kim, Siah ; Thangaraju, Sobhana ; Ju, Angela ; Chapman, Jeremy R. / Toward Establishing Core Outcome Domains for Trials in Kidney Transplantation : Report of the Standardized Outcomes in Nephrology-Kidney Transplantation Consensus Workshops. In: Transplantation. 2017 ; Vol. 101, No. 8. pp. 1887-1896.
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abstract = "Background Treatment decisions in kidney transplantation requires patients and clinicians to weigh the benefits and harms of a broad range of medical and surgical interventions, but the heterogeneity and lack of patient-relevant outcomes across trials in transplantation makes these trade-offs uncertain, thus, the need for a core outcome set that reflects stakeholder priorities. Methods We convened 2 international Standardized Outcomes in Nephrology-Kidney Transplantation stakeholder consensus workshops in Boston (17 patients/caregivers; 52 health professionals) and Hong Kong (10 patients/caregivers; 45 health professionals). In facilitated breakout groups, participants discussed the development and implementation of core outcome domains for trials in kidney transplantation. Results Seven themes were identified. Reinforcing the paramount importance of graft outcomes encompassed the prevailing dread of dialysis, distilling the meaning of graft function, and acknowledging the terrifying and ambiguous terminology of rejection. Reflecting critical trade-offs between graft health and medical comorbidities was fundamental. Contextualizing mortality explained discrepancies in the prioritization of death among stakeholders-inevitability of death (patients), preventing premature death (clinicians), and ensuring safety (regulators). Imperative to capture patient-reported outcomes was driven by making explicit patient priorities, fulfilling regulatory requirements, and addressing life participation. Specificity to transplant; feasibility and pragmatism (long-term impacts and responsiveness to interventions); and recognizing gradients of severity within outcome domains were raised as considerations. Conclusions Stakeholders support the inclusion of graft health, mortality, cardiovascular disease, infection, cancer, and patient-reported outcomes (ie, life participation) in a core outcomes set. Addressing ambiguous terminology and feasibility is needed in establishing these core outcome domains for trials in kidney transplantation.",
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T1 - Toward Establishing Core Outcome Domains for Trials in Kidney Transplantation

T2 - Report of the Standardized Outcomes in Nephrology-Kidney Transplantation Consensus Workshops

AU - Tong, Allison

AU - Gill, John

AU - Budde, Klemens

AU - Marson, Lorna

AU - Reese, Peter P.

AU - Rosenbloom, David

AU - Rostaing, Lionel

AU - Wong, Germaine

AU - Josephson, Michelle A.

AU - Pruett, Timothy L.

AU - Warrens, Anthony N.

AU - Craig, Jonathan C.

AU - Sautenet, Benedicte

AU - Evangelidis, Nicole

AU - Ralph, Angelique F.

AU - Hanson, Camilla S.

AU - Shen, Jenny I.

AU - Howard, Kirsten

AU - Meyer, Klemens

AU - Perrone, Ronald D.

AU - Weiner, Daniel E.

AU - Fung, Samuel

AU - Ma, Maggie K.M.

AU - Rose, Caren

AU - Ryan, Jessica

AU - Chen, Ling-Xin

AU - Howell, Martin

AU - Larkins, Nicholas

AU - Kim, Siah

AU - Thangaraju, Sobhana

AU - Ju, Angela

AU - Chapman, Jeremy R.

PY - 2017/8/1

Y1 - 2017/8/1

N2 - Background Treatment decisions in kidney transplantation requires patients and clinicians to weigh the benefits and harms of a broad range of medical and surgical interventions, but the heterogeneity and lack of patient-relevant outcomes across trials in transplantation makes these trade-offs uncertain, thus, the need for a core outcome set that reflects stakeholder priorities. Methods We convened 2 international Standardized Outcomes in Nephrology-Kidney Transplantation stakeholder consensus workshops in Boston (17 patients/caregivers; 52 health professionals) and Hong Kong (10 patients/caregivers; 45 health professionals). In facilitated breakout groups, participants discussed the development and implementation of core outcome domains for trials in kidney transplantation. Results Seven themes were identified. Reinforcing the paramount importance of graft outcomes encompassed the prevailing dread of dialysis, distilling the meaning of graft function, and acknowledging the terrifying and ambiguous terminology of rejection. Reflecting critical trade-offs between graft health and medical comorbidities was fundamental. Contextualizing mortality explained discrepancies in the prioritization of death among stakeholders-inevitability of death (patients), preventing premature death (clinicians), and ensuring safety (regulators). Imperative to capture patient-reported outcomes was driven by making explicit patient priorities, fulfilling regulatory requirements, and addressing life participation. Specificity to transplant; feasibility and pragmatism (long-term impacts and responsiveness to interventions); and recognizing gradients of severity within outcome domains were raised as considerations. Conclusions Stakeholders support the inclusion of graft health, mortality, cardiovascular disease, infection, cancer, and patient-reported outcomes (ie, life participation) in a core outcomes set. Addressing ambiguous terminology and feasibility is needed in establishing these core outcome domains for trials in kidney transplantation.

AB - Background Treatment decisions in kidney transplantation requires patients and clinicians to weigh the benefits and harms of a broad range of medical and surgical interventions, but the heterogeneity and lack of patient-relevant outcomes across trials in transplantation makes these trade-offs uncertain, thus, the need for a core outcome set that reflects stakeholder priorities. Methods We convened 2 international Standardized Outcomes in Nephrology-Kidney Transplantation stakeholder consensus workshops in Boston (17 patients/caregivers; 52 health professionals) and Hong Kong (10 patients/caregivers; 45 health professionals). In facilitated breakout groups, participants discussed the development and implementation of core outcome domains for trials in kidney transplantation. Results Seven themes were identified. Reinforcing the paramount importance of graft outcomes encompassed the prevailing dread of dialysis, distilling the meaning of graft function, and acknowledging the terrifying and ambiguous terminology of rejection. Reflecting critical trade-offs between graft health and medical comorbidities was fundamental. Contextualizing mortality explained discrepancies in the prioritization of death among stakeholders-inevitability of death (patients), preventing premature death (clinicians), and ensuring safety (regulators). Imperative to capture patient-reported outcomes was driven by making explicit patient priorities, fulfilling regulatory requirements, and addressing life participation. Specificity to transplant; feasibility and pragmatism (long-term impacts and responsiveness to interventions); and recognizing gradients of severity within outcome domains were raised as considerations. Conclusions Stakeholders support the inclusion of graft health, mortality, cardiovascular disease, infection, cancer, and patient-reported outcomes (ie, life participation) in a core outcomes set. Addressing ambiguous terminology and feasibility is needed in establishing these core outcome domains for trials in kidney transplantation.

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