International consensus definitions of clinical trial outcomes for kidney failure: 2020.

Kidney failure is an important outcome for patients, clinicians, researchers, healthcare systems, payers, and regulators. However, no harmonized international consensus definitions of kidney failure and key surrogates of progression to kidney failure exist specifically for clinical trials. The International Society of Nephrology convened an international multi-stakeholder meeting to develop consensus on this topic. A core group, experienced in design, conduct, and outcome adjudication of clinical trials, developed a database of 64 randomized trials and the 163 included definitions relevant to kidney failure. Using an iterative process, a set of proposed consensus definitions were developed and subsequently vetted by the larger multi-stakeholder group of 83 participants representing 18 different countries. The consensus of the meeting participants was that clinical trial kidney failure outcomes should be comprised of a composite that includes receipt of a kidney transplant, initiation of maintenance dialysis, and death from kidney failure; it may also include outcomes based solely on laboratory measurements of glomerular filtration rate: a sustained low glomerular filtration rate and a sustained percent decline in glomerular filtration rate. Discussion included important considerations, such as (i) recognition of existing nomenclature for kidney failure; (ii) applicability across resource settings; (iii) ease of understanding for all stakeholders; and (iv) avoidance of inappropriate complexity so that the definitions can be used across ranges of populations and trial methodologies. The final definitions reflect the consensus for use in clinical trials.

A RAND-Modified Delphi on Key Indicators to Measure the Efficiency of Living Kidney Donor Candidate Evaluations.

BACKGROUND AND OBJECTIVES: Many patients, providers, and potential living donors perceive the living kidney donor evaluation process to be lengthy and difficult to navigate. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We sought consensus on key terms and process and outcome indicators that can be used to measure how efficiently a transplant center evaluates persons interested in becoming a living kidney donor. Using a RAND-modified Delphi method, 77 participants (kidney transplant recipients or recipient candidates, living kidney donors or donor candidates, health care providers, and health care administrators) completed an online survey to define the terms and indicators. The definitions were then further refined during an in-person meeting with ten stakeholders. RESULTS: We identified 16 process indicators (e.g., average time to evaluate a donor candidate), eight outcome indicators (e.g., annual number of preemptive living kidney donor transplants), and two measures that can be considered both process and outcome indicators (e.g., average number of times a candidate visited the transplant center for the evaluation). Transplant centers wishing to implement this set of indicators will require 22 unique data elements, all of which are either readily available or easily collected prospectively. CONCLUSIONS: We identified a set of indicators through a consensus-based approach that may be used to monitor and improve the performance of a transplant center in how efficiently it evaluates persons interested in becoming a living kidney donor.

Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD): Form and Function.

PURPOSE OF REVIEW: This article serves to describe the Can-SOLVE CKD network, a program of research projects and infrastructure that has excited patients and given them hope that we can truly transform the care they receive. ISSUE: Chronic kidney disease (CKD) is a complex disorder that affects more than 4 million Canadians and costs the Canadian health care system more than $40 billion per year. The evidence base for guiding care in CKD is small, and even in areas where evidence exists, uptake of evidence into clinical practice has been slow. Compounding these complexities are the variations in outcomes for patients with CKD and difficulties predicting who is most likely to develop complications over time. Clearly these gaps in our knowledge and understanding of CKD need to be filled, but the current state of CKD research is not where it needs to be. A culture of clinical trials and inquiry into the disease is lacking, and much of the existing evidence base addresses the concerns of the researchers but not necessarily those of the patients. PROGRAM OVERVIEW: The Canadian Institutes of Health Research (CIHR) has launched the national Strategy for Patient-Oriented Research (SPOR), a coalition of federal, provincial, and territorial partners dedicated to integrating research into care. Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD) is one of five pan-Canadian chronic kidney disease networks supported through the SPOR. The vision of Can-SOLVE CKD is that by 2020 every Canadian with or at high risk for CKD will receive the best recommended care, experience optimal outcomes, and have the opportunity to participate in studies with novel therapies, regardless of age, sex, gender, location, or ethnicity. PROGRAM OBJECTIVE: The overarching objective of Can-SOLVE CKD is to accelerate the translation of knowledge about CKD into clinical research and practice. By focusing on the patient's voice and implementing relevant findings in real time, Can-SOLVE CKD will transform the care that CKD patients receive, and will improve kidney health for future generations.

OBJECTIF DE LA REVUE: Le présent article décrit le réseau Can-SOLVE CKD, un réseau basé sur un programme de projets et d'infrastructures de recherche qui ont soulevé l'enthousiasme des patients et qui nourrissent leur espoir de voir une réelle réforme des soins qu'ils reçoivent. CONTEXTE: L'insuffisance rénale chronique (IRC) est un trouble complexe qui affecte plus de quatre millions de Canadiens et qui engendre au système de santé canadien des coûts annuels de l'ordre de 40 milliards de dollars. Les données probantes sous-tendant les soins en IRC sont rares, et dans les branches où ces données existent, leur intégration à la pratique clinique se montre insuffisante. Ces problèmes sont aggravés d'abord par la grande variabilité du pronostic de la maladie, puis par la difficulté de prévoir quels patients seront les plus susceptibles de développer des complications. Ces lacunes de connaissances et de compréhension de l'IRC doivent manifestement être comblées; cependant, force est de constater que la recherche actuelle sur l'IRC est inadéquate. Outre l'absence d'une culture médicale qui encourage les essais cliniques, les données recueillies rejoignent les préoccupations des chercheurs sans nécessairement refléter celles des patients. PRÉSENTATION DU PROGRAMME: Lancée par l'Institut de recherche en santé du Canada (IRSC), la Stratégie de recherche axée sur le patient (SRAP) consiste en une coalition de partenaires fédéraux, provinciaux et territoriaux visant l'intégration des résultats de la recherche dans les soins prodigués aux patients. Le réseau Can-SOLVE CKD (Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease) est l'un des cinq réseaux de recherche pancanadiens sur les maladies chroniques soutenus par la SRAP. L'objectif du réseau Can-SOLVE CKD est tripartite : on souhaite que, d'ici 2020, tous les Canadiens atteints d'IRC (ou à haut risque de développer la maladie) 1- reçoivent les meilleurs soins; 2- obtiennent des résultats de santé optimaux; 3- aient l'occasion de participer à des études cliniques pertinentes (et ce, sans égard à leur âge, leur sexe, leur ethnicité ou leur lieu de résidence). OBJECTIF DU PROGRAMME: L'objectif principal du réseau Can-SOLVE CKD est d'accélérer l'application des connaissances sur l'IRC, tant en recherche qu'en pratique clinique. En s'intéressant aux préoccupations des patients et en appliquant en temps réel les résultats pertinents de la recherche, Can-SOLVE CKD transformera la façon dont seront soignés les patients atteints d'IRC et améliorera la santé rénale globale des générations futures.