Toward Establishing Core Outcome Domains For Trials in Kidney Transplantation
- 1 August 2017
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Transplantation
- Vol. 101 (8), 1887-1896
- https://doi.org/10.1097/tp.0000000000001774
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.Keywords
This publication has 50 references indexed in Scilit:
- Trial design and endpoints in clinical transplant researchTransplant International, 2016
- A core outcome set for all types of cardiac surgery effectiveness trials: a study protocol for an international eDelphi survey to achieve consensus on what to measure and the subsequent selection of measurement instrumentsTrials, 2015
- Updating the OMERACT Filter: Implications for Patient-reported OutcomesThe Journal of Rheumatology, 2014
- How to increase value and reduce waste when research priorities are setThe Lancet, 2014
- Outcome measures in rheumatoid arthritis randomised trials over the last 50 yearsTrials, 2013
- Comparison of the long-term outcomes of kidney transplantation: USA versus SpainNephrology Dialysis Transplantation, 2012
- Patient-reported outcomes in rheumatoid arthritisCurrent Opinion in Rheumatology, 2012
- Fish oil intake compared with olive oil intake in late pregnancy and asthma in the offspring: 16 y of registry-based follow-up from a randomized controlled trialThe American Journal of Clinical Nutrition, 2008
- OMERACT: An international initiative to improve outcome measurement in rheumatologyTrials, 2007
- Disease-Specific Questionnaire for Patients with a Renal TransplantNephron, 1993