Toward Establishing Core Outcome Domains For Trials in Kidney Transplantation: Report of the Standardized Outcomes in Nephrology-Kidney Transplantation Consensus Workshops - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Transplantation Année : 2017

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

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

Résumé

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.

Dates et versions

hal-03158164 , version 1 (03-03-2021)

Identifiants

Citer

Allison Tong, John Gill, Klemens Budde, Lorna Marson, Peter P. Reese, et al.. Toward Establishing Core Outcome Domains For Trials in Kidney Transplantation: Report of the Standardized Outcomes in Nephrology-Kidney Transplantation Consensus Workshops. Transplantation, 2017, 101 (8), pp.1887-1896. ⟨10.1097/TP.0000000000001774⟩. ⟨hal-03158164⟩
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