Protocol for a Process Evaluation of the Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) Cluster-Randomized Clinical Trial.

Background: Many patients who would benefit from a kidney transplant never receive one. The Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) pragmatic, cluster-randomized clinical trial is testing whether a multi-component quality improvement intervention, provided in chronic kidney disease (CKD) programs (vs. usual care), can help patients with CKD with no recorded contraindications to kidney transplant complete more steps toward receiving a transplant (primary outcome of the trial). The EnAKT LKD intervention has 4 components: (1) quality Improvement teams and administrative support, (2) improved transplant education for patients and healthcare providers, (3) access to support and (4) program-level performance monitoring. Objective: To conduct a process evaluation of the EnAKT LKD quality improvement intervention to determine if the components were delivered, received, and enacted as designed (fidelity), and if the intervention addressed intended barriers (mechanisms of change). Design: A mixed-methods process evaluation informed by new practice implementation and theories of behavior change. Setting: Chronic kidney disease programs in Ontario, Canada, began receiving the EnAKT LKD intervention on November 1, 2017 and will continue to receive it until December 31, 2021. The process evaluation (interviews and surveys) will occur alongside the trial, between December 2020 to May 2021. Participants: Healthcare providers (eg, dialysis nurses, nephrologists, members of the multi-care kidney clinic team) at Ontario's 27 CKD programs. Methods: We will survey and interview healthcare providers at each CKD program, and complete an intervention implementation checklist. Quantitative data from the surveys and the intervention implementation checklist will assess fidelity to the intervention, while quantitative and qualitative data from surveys and interviews will provide insight into the mechanisms of change. Limitations: The long trial period may result in poor participant recall. Conclusion: This process evaluation will enhance interpretation of the trial findings, guide improvements in the intervention components, and inform future implementation. Trial registration: Clinicaltrials.gov; identifier: NCT03329521.

Contexte: Plusieurs patients qui pourraient tirer profit d'une greffe de rein n'en reçoivent jamais une. L'essai clinique pragmatique et randomisé par grappes EnAKT LKD (Enhance Access to Kidney Transplantation and Living Kidney Donation) vise l'amélioration de l'accès à la transplantation rénale et au don de rein vivant. L'essai examine une intervention d'amélioration de la qualité (par rapport aux soins habituels) à composantes multiples réalisée dans le cadre des programs d'insuffisance rénale chronique (IRC) afin de déterminer si elle peut aider les patients atteints d'une néphropathie chronique sans contre-indications documentées à une greffe rénale à franchir davantage d'étapes vers la réception d'une greffe (principal critère d'évaluation de l'essai). L'intervention EAKT LKD comporte quatre composantes : 1) les équipes d'amélioration de la qualité et le soutien administratif; 2) l'amélioration de l'éducation sur la transplantation destinée aux patients et aux fournisseurs de soins; 3) l'accès au soutien; et 4) le suivi du rendement à l'échelle du program. Objectif: L'évaluation du processus de l'intervention d'amélioration de la qualité EnAKT LKD vise deux objectifs : déterminer si les composants ont été livrés, reçus et mis en œuvre comme prévu (fidélité) et vérifier si l'intervention a permis d'éliminer les obstacles prévus (mécanismes de changement). Type d'étude: Une évaluation de processus à méthodes mixtes fondée sur les théories concernant la mise en œuvre de nouvelles pratiques et les changements de comportement. Cadre: Les programs d'IRC ontariens (Canada) ont commencé à recevoir l'intervention EnAKT LKD le 1er novembre 2017 et ont continué de la recevoir jusqu'au 31 décembre 2021. L'évaluation du processus (sondages et entretiens) s'est effectuée parallèlement à l'essai, de décembre 2020 à mai 2021. Participants: Les fournisseurs de soins (infirmières en dialyze, néphrologues, membres du personnel des cliniques multidisciplinaires en santé rénale) des 27 programs d'IRC ontariens. Méthodologie: Nous allons sonder et interroger les fournisseurs de soins de chaque program d'IRC et nous complèterons une liste vérifiant la mise en œuvre de l'intervention. Les données quantitatives tirées des sondages et listes de vérification permettront d'évaluer la fidélité à l'intervention, alors que les données quantitatives et qualitatives extraites des sondages et des entretiens fourniront un aperçu des mécanismes de changement. Limites: La longue période de l'essai pourrait rendre difficile le rappel des participants. Conclusion: Cette évaluation du processus permettra d'améliorer l'interprétation des résultats de l'essai et de guider l'amélioration des composantes de l'intervention, en plus d'éclairer de futures mises en œuvre. Enregistrement de l'essai: ClinicalTrials.gov; identifiant : NCT03329521.

Critical impacts of pyrolysis conditions and activation methods on application-oriented production of wood waste-derived biochar.

Wood waste-derived biochar with tunable carbon structure and surface functionality has a great potential for various environmental applications and circular economy; however, a holistic understanding on the application-oriented production of high-efficacy biochar is lacking. Thus, the co-impacts of different pyrolysis conditions (temperature and duration) and activation methods (steam, CO2, and acid pretreatment) on the biochar properties were first investigated. A temperature of 650 ℃ was effective in forming carbonized structure in biochar, while 750 ℃ was critical for the porous structure development. A longer pyrolysis duration (>60 min) enhanced the pore volume without compromising the yield. The activated biochar exhibited a larger pore volume (2.1- to 2.9-fold of pristine biochar) for potential high-end emerging applications. The acid pretreatment effectively removed dissolved organic carbon and most metals from the biochar. This study provides an essential guidance on the fit-for-purpose designs of biochar production conditions for sustainable wood waste management.

Scaling-up the use of generic antiretrovirals in resource-limited countries: generic drugs for health.

The number of people living with HIV (PLHIV) continues to increase around the world because of the increasing number on antiretroviral therapy (ART) and their associated increase of life expectancy, in addition to the number of people newly infected with HIV each year. Unless a 'cure' can be found for HIV infection, PLHIV can anticipate the need to take antiretroviral drugs (ARVs) for the rest of their lives. Because ARVs are now being used for HIV prevention, as well as for therapeutic purposes, the need for effective, affordable ARVs with few adverse effects will continue to rise. It is important to note that the dramatic growth in treatment coverage of PLHIV seen during the past decade has been primarily due to the increased use of generic ARVs. Thus, there will be a need to scale-up the research and development, production, distribution and access to generic ARVs and ART regimens. However, these processes must occur within national and international regulated free-market economic systems and must deal with increasingly multifaceted patent issues affecting the price while ensuring the quality of the ARVs. National and international regulatory mechanisms will have to evolve, which will affect broader national and international economic and trade issues. Because of the complexity of these issues, the Editors of this Supplement conceived of asking experts in their fields to describe the various steps from relevant research and development, to production of generic ARVs, their delivery to countries and subsequently to PLHIV in low- and middle-income countries. A main objective was to highlight how these steps are interrelated, how the production and delivery of these drugs to PLHIV in resource-limited countries can be made more effective and efficient, and what the lessons are for the production and delivery of a broader set of drugs to people in low- and middle-income countries.