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

ABSTRACT: 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.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.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.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.

SUBMITTER: Tong A

PROVIDER: S-EPMC5604246 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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

Tong Allison A Gill John J Budde Klemens K Marson Lorna L Reese Peter P PP Rosenbloom David D Rostaing Lionel L Wong Germaine G Josephson Michelle A MA Pruett Timothy L TL Warrens Anthony N AN Craig Jonathan C JC Sautenet Benedicte B Evangelidis Nicole N Ralph Angelique F AF Hanson Camilla S CS Shen Jenny I JI Howard Kirsten K Meyer Klemens K Perrone Ronald D RD Weiner Daniel E DE Fung Samuel S Ma Maggie K M MKM Rose Caren C Ryan Jessica J Chen Ling-Xin LX Howell Martin M Larkins Nicholas N Kim Siah S Thangaraju Sobhana S Ju Angela A Chapman Jeremy R JR

Transplantation 20170801 8

<h4>Background</h4>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.<h4>Methods</h4>We convened 2 international Standardized Outcomes in Nephrology-Kidney Transplantation stakehold ...[more]

PMID: 28737661

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Project description:Background and objectivesOutcomes reported in trials in adults with glomerular disease are often selected with minimal patient input, are heterogeneous, and may not be relevant for clinical decision making. The Standardized Outcomes in Nephrology-Glomerular Disease (SONG-GD) initiative aimed to establish a core outcome set to help ensure that outcomes of critical importance to patients, care partners, and clinicians are consistently reported.Design, setting, participants, and measurementsWe convened two 1.5-hour workshops in Melbourne, Australia, and Washington, DC, United States. Attendees were identified purposively with 50 patients/care partners and 88 health professionals from 19 countries; 51% were female. Patients and care partners were from the United States, Australia, and Canada, and had experience of a glomerular disease with systemic features (n=9), kidney-limited nephrotic disease (n=9), or other kidney-limited glomerular disease (n=8). Attendees reviewed the results of the SONG-GD Delphi survey and aims of the workshop and then discussed potential core outcomes and their implementation in trials among moderated breakout groups of eight to 12 people from diverse backgrounds. Transcripts of discussions were analyzed thematically.ResultsThree themes were identified that supported the proposed core outcomes: limiting disease progression, stability and control, and ensuring universal relevance (i.e., applicable across diverse populations and settings). The fourth theme, preparedness for implementation, included engaging with funders and regulators, establishing reliable and validated measures, and leveraging existing endorsements for patient-reported outcomes.ConclusionsWorkshop themes demonstrated support for kidney function, disease activity, death, life participation, and cardiovascular disease, and these were established as the core outcomes for trials in adults with glomerular disease. Future work is needed to establish the core measures for each domain, with funders and regulators central to the uptake of the core outcome set in trials.

Project description:The health workforce is the cornerstone of any health care system. An adequately trained and sufficiently staffed workforce is essential to reach universal health coverage. In particular, a nephrology workforce is critical to meet the growing worldwide burden of kidney disease. Despite some attempts, the global nephrology workforce and training capacity remains widely unknown. This multinational cross-sectional survey was part of the Global Kidney Health Atlas project, a new initiative administered by the International Society of Nephrology (ISN). The objective of this study was to address the existing global nephrology workforce and training capacity. The questionnaire was administered online, and all data were analyzed and presented by ISN regions and World Bank country classification. Overall, 125 United Nations member states responded to the entire survey, with 121 countries responding to survey questions pertaining to the nephrology workforce. The global nephrologist density was 8.83 per million population (PMP); high-income countries reported a nephrologist density of 28.52 PMP compared with 0.31 PMP in low-income countries. Similarly, the global nephrologist trainee density was 1.87 PMP; high-income countries reported a 30 times greater nephrology trainee density than low-income countries (6.03 PMP vs. 0.18 PMP). Countries reported a shortage in all care providers in nephrology. A nephrology training program existed in 79% of countries, ranging from 97% in high-income countries to 41% in low-income countries. In countries with a training program, the majority (86%) of programs were 2 to 4 years, and the most common training structure (56%) was following general internal medicine. We found significant variation in the global density of nephrologists and nephrology trainees and shortages in all care providers in nephrology; the gap was more prominent in low-income countries, particularly in African and South Asian ISN regions. These findings point to significant gaps in the current nephrology workforce and opportunities for countries and regions to develop and maintain a sustainable workforce.

Dataset Information

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

Publications

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

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