Toward establishing core outcome domains for trials in kidney transplantation: Report of the Standardized Outcomes in Nephrology – Kidney Transplantation (SONG-Tx) Consensus workshops

Allison Tong, John Gill, Klemens Budde, Lorna Marson, Peter P.P. Reese, David Rosenbloom, Lionel Rostaing, Germaine Wong, Michelle A.A. Josephson, Timothy L.L. Pruett, Anthony N.N. Warrens, Jonathan C. Craig, Benedicte Sautenet, Nicole Evangelidis, Angelique F.F. Ralph, Camilla S.S. Hanson, Jenny I.I. Shen, Kirsten Howard, Klemens Meyer, Ronald D.D. Perrone & 13 others Daniel E.E. Weiner, Samuel Fung, Maggie KM Ma, Caren Rose, Jessica Ryan, Ling Xin Chen, Martin Howell, Nicholas Larkins, Siah Kim, Sobhana Thangaraju, Angela Ju, Jeremy R. Chapman, on behalf of the SONG-Tx Investigators*

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 SONG-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
Pages (from-to)1887-1896
JournalTransplantation
Volume101
Issue number8
DOIs
Publication statusPublished - 1 Aug 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

Cite this

Tong, Allison ; Gill, John ; Budde, Klemens ; Marson, Lorna ; Reese, Peter P.P. ; Rosenbloom, David ; Rostaing, Lionel ; Wong, Germaine ; Josephson, Michelle A.A. ; Pruett, Timothy L.L. ; Warrens, Anthony N.N. ; Craig, Jonathan C. ; Sautenet, Benedicte ; Evangelidis, Nicole ; Ralph, Angelique F.F. ; Hanson, Camilla S.S. ; Shen, Jenny I.I. ; Howard, Kirsten ; Meyer, Klemens ; Perrone, Ronald D.D. ; Weiner, Daniel E.E. ; Fung, Samuel ; Ma, Maggie KM ; Rose, Caren ; Ryan, Jessica ; Chen, Ling Xin ; Howell, Martin ; Larkins, Nicholas ; Kim, Siah ; Thangaraju, Sobhana ; Ju, Angela ; Chapman, Jeremy R. ; on behalf of the SONG-Tx Investigators*. / Toward establishing core outcome domains for trials in kidney transplantation : Report of the Standardized Outcomes in Nephrology – Kidney Transplantation (SONG-Tx) Consensus workshops. In: Transplantation. 2017 ; Vol. 101, No. 8. pp. 1887-1896.
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title = "Toward establishing core outcome domains for trials in kidney transplantation: Report of the Standardized Outcomes in Nephrology – Kidney Transplantation (SONG-Tx) Consensus workshops",
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 SONG-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.",
author = "Allison Tong and John Gill and Klemens Budde and Lorna Marson and Reese, {Peter P.P.} and David Rosenbloom and Lionel Rostaing and Germaine Wong and Josephson, {Michelle A.A.} and Pruett, {Timothy L.L.} and Warrens, {Anthony N.N.} and Craig, {Jonathan C.} and Benedicte Sautenet and Nicole Evangelidis and Ralph, {Angelique F.F.} and Hanson, {Camilla S.S.} and Shen, {Jenny I.I.} and Kirsten Howard and Klemens Meyer and Perrone, {Ronald D.D.} and Weiner, {Daniel E.E.} and Samuel Fung and Ma, {Maggie KM} and Caren Rose and Jessica Ryan and Chen, {Ling Xin} and Martin Howell and Nicholas Larkins and Siah Kim and Sobhana Thangaraju and Angela Ju and Chapman, {Jeremy R.} and {on behalf of the SONG-Tx Investigators*}",
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Tong, A, Gill, J, Budde, K, Marson, L, Reese, PPP, Rosenbloom, D, Rostaing, L, Wong, G, Josephson, MAA, Pruett, TLL, Warrens, ANN, Craig, JC, Sautenet, B, Evangelidis, N, Ralph, AFF, Hanson, CSS, Shen, JII, Howard, K, Meyer, K, Perrone, RDD, Weiner, DEE, Fung, S, Ma, MKM, Rose, C, Ryan, J, Chen, LX, Howell, M, Larkins, N, Kim, S, Thangaraju, S, Ju, A, Chapman, JR & on behalf of the SONG-Tx Investigators* 2017, 'Toward establishing core outcome domains for trials in kidney transplantation: Report of the Standardized Outcomes in Nephrology – Kidney Transplantation (SONG-Tx) Consensus workshops' Transplantation, vol. 101, no. 8, pp. 1887-1896. https://doi.org/10.1097/TP.0000000000001774

Toward establishing core outcome domains for trials in kidney transplantation : Report of the Standardized Outcomes in Nephrology – Kidney Transplantation (SONG-Tx) Consensus workshops. / Tong, Allison; Gill, John; Budde, Klemens; Marson, Lorna; Reese, Peter P.P.; Rosenbloom, David; Rostaing, Lionel; Wong, Germaine; Josephson, Michelle A.A.; Pruett, Timothy L.L.; Warrens, Anthony N.N.; Craig, Jonathan C.; Sautenet, Benedicte; Evangelidis, Nicole; Ralph, Angelique F.F.; Hanson, Camilla S.S.; Shen, Jenny I.I.; Howard, Kirsten; Meyer, Klemens; Perrone, Ronald D.D.; Weiner, Daniel E.E.; Fung, Samuel; Ma, Maggie KM; Rose, Caren; Ryan, Jessica; Chen, Ling Xin; Howell, Martin; Larkins, Nicholas; Kim, Siah; Thangaraju, Sobhana; Ju, Angela; Chapman, Jeremy R.; on behalf of the SONG-Tx Investigators*.

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

Research output: Contribution to journalArticle

TY - JOUR

T1 - Toward establishing core outcome domains for trials in kidney transplantation

T2 - Report of the Standardized Outcomes in Nephrology – Kidney Transplantation (SONG-Tx) Consensus workshops

AU - Tong, Allison

AU - Gill, John

AU - Budde, Klemens

AU - Marson, Lorna

AU - Reese, Peter P.P.

AU - Rosenbloom, David

AU - Rostaing, Lionel

AU - Wong, Germaine

AU - Josephson, Michelle A.A.

AU - Pruett, Timothy L.L.

AU - Warrens, Anthony N.N.

AU - Craig, Jonathan C.

AU - Sautenet, Benedicte

AU - Evangelidis, Nicole

AU - Ralph, Angelique F.F.

AU - Hanson, Camilla S.S.

AU - Shen, Jenny I.I.

AU - Howard, Kirsten

AU - Meyer, Klemens

AU - Perrone, Ronald D.D.

AU - Weiner, Daniel E.E.

AU - Fung, Samuel

AU - Ma, Maggie KM

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.

AU - on behalf of the SONG-Tx Investigators

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 SONG-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 SONG-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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DO - 10.1097/TP.0000000000001774

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