Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD): Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial.

Background: Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) is a quality improvement intervention designed to enhance access to kidney transplantation and living kidney donation. We conducted a cluster-randomized clinical trial to evaluate the effect of the intervention versus usual care on completing key steps toward receiving a kidney transplant. Objective: To prespecify the statistical analysis plan for the EnAKT LKD trial. Design: The EnAKT LKD trial is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority, clinical trial. Randomization was performed at the level of the chronic kidney disease (CKD) programs (the "clusters"). Setting: Twenty-six CKD programs in Ontario, Canada. Participants: More than 10 000 patients with advanced CKD (ie, patients approaching the need for dialysis or receiving maintenance dialysis) with no recorded contraindication to receiving a kidney transplant. Methods: The trial data (including patient characteristics and outcomes) will be obtained from linked administrative health care databases (the "registry"). Stratified covariate-constrained randomization was used to allocate the 26 CKD programs (1:1) to provide the intervention or usual care from November 1, 2017, to December 31, 2021 (4.17 years). CKD programs in the intervention arm received the following: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Outcomes: The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant waitlist, and (4) patient receives a kidney transplant from a living or deceased donor. Analysis plan: Using an intent-to-treat approach, the primary outcome will be analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs. Trial Status: The EnAKT LKD trial period is November 1, 2017, to December 31, 2021. We expect to analyze and report the results once the data for the trial period is available in linked administrative health care databases. Trial Registration: The EnAKT LKD trial is registered with the U.S. National Institute of Health at clincaltrials.gov (NCT03329521 available at https://clinicaltrials.gov/ct2/show/NCT03329521). Statistical Analytic Plan: Version 1.0 August 26, 2022.

Contexte: EnAKT LKD est une intervention d'amélioration de la qualité visant à améliorer l'accès à la transplantation rénale et au don vivant de rein. Nous avons mené un essai clinique randomisé par grappes afin d'évaluer l'effet de l'intervention, par rapport aux soins habituels, sur le taux d'étapes clés réalisées dans le processus de réception d'une greffe de rein. Objectif: Exposer les grandes lignes du plan d'analyse statistique de l'essai EAKT LKD. Conception: EAKT LKD est un essai clinique pragmatique ouvert, à deux bras, en groupes parallèles, basé sur un registre, et randomisé en grappes. La randomisation a été réalisée au niveau des programmes d'insuffisance rénale chronique (IRC) (les « grappes ¼). Cadre: 26 programmes d'IRC en Ontario (Canada). Sujets: Plus de 10 000 patients atteints d'IRC de stade avancé (des patients approchant le besoin de dialyse ou recevant une hémodialyse d'entretien) sans contre-indication documentée à la greffe rénale. Méthodologie: Les données de l'essai (y compris les caractéristiques et les résultats des patients) seront obtenues à partir de bases de données administratives en santé (le « registre ¼). La randomisation stratifiée avec contraintes de covariables a servi à répartir les 26 programmes d'IRC (1:1) selon qu'ils allaient fournir l'intervention ou les soins habituels entre le 1er novembre 2017 et le 31 décembre 2021 (4,17 ans). Les programmes d'IRC du bras d'intervention ont eu droit au soutien suivant: (1) des équipes locales d'amélioration de la qualité et du soutien administratif; (2) de l'information et des ressources sur mesure pour le personnel, les patients et les donneurs vivants; (3) du soutien de la part de receveurs et de donneurs vivants; et (4) des rapports sur le rendement au niveau du programme et une surveillance assurée par les chefs de programme. Résultats: Le principal critère d'évaluation est le taux d'étapes clés accomplies vers la réception d'une greffe de rein, où jusqu'à quatre étapes uniques par patient seront comptabilisées: (1) le patient est aiguillé vers un centre de transplantation pour évaluation; (2) un possible donneur vivant de rein contacte un centre de transplantation pour un receveur en particulier et amorce son évaluation; (3) le patient est ajouté à la liste d'attente pour une transplantation d'un donneur décédé, et (4) le patient reçoit une greffe de rein d'un donneur vivant ou décédé. Plan d'analyse: Selon une approche fondée sur l'intention de traiter, le critère d'évaluation principal sera analysé au niveau du patient en utilisant un modèle multiétats contraint, corrigé dans les programmes d'IRC en fonction du regroupement. Statut de l'essai: L'essai EnAKT LKD s'est tenu du 1er novembre 2017 au 31 décembre 2021. Nous analyserons les résultats et en rendrons compte dès que les données seront disponibles dans les bases de données administratives couplées du système de santé.

Effects of parenthood and gender on well-being and work productivity among Canadian academic research faculty amidst the COVID-19 pandemic

The coronavirus disease (COVID-19) pandemic has brought about enormous changes to all aspects of academic life. In spring 2020, we recruited faculty from Canadian universities who were asked to complete a survey about the perceived impact of the pandemic on aspects of their well-being and work productivity. Eight hundred ninety-nine academics from across Canada responded, reporting that the pandemic had had a significant negative impact on their mental health, work satisfaction, first-author publications, grants, and data collection. Overall weekly work hours dropped by 22% compared to prepandemic levels, from 45 hr/week to 35 hr. Though parents of children under the age of 13 managed to maintain an average of 30 hr/week despite juggling childcare and work duties, they nonetheless fared worse compared to nonparents and parents of older children on nearly all indicators of work productivity and well-being. Furthermore, mothers of young children reported having fewer uninterrupted work hours and spending more time as primary caregiver compared to fathers. Thus, the COVID-19 pandemic has had a considerable negative impact on the self-reported well-being and work productivity of Canadian academics, and even more so among parents of young children. Mothers of young children may be particularly in need of additional support. These findings highlight the importance of adopting policies at the federal and institutional levels aimed at "leveling the playing field" for these groups as well as instituting creative childcare solutions that maintain health and safety while not further disadvantaging young parents. (PsycInfo Database Record (c) 2023 APA, all rights reserved) Impact Statement Public Significance Statement: The current findings suggest that the COVID-19 pandemic has had a considerable negative impact on the self-reported well-being and work productivity of Canadian academics, and even more so among parents of young children. Mothers of young children may be particularly in need of additional support. (PsycInfo Database Record (c) 2023 APA, all rights reserved) (French) La pandemie de la maladie causee par le coronavirus (COVID-19) a suscite d'enormes changements dans tous les volets de la vie universitaire. Au printemps 2020, nous avons effectue un sondage parmi les membres du personnel d'universites canadiennes afin de connaitre les repercussions percues de la pandemie sur divers aspects de leur bien-etre et sur leur productivite. Ont repondu au questionnaire 899 personnes de partout au pays, lesquelles ont signale que la pandemie avait eu d'importantes repercussions negatives sur leur sante mentale, leur niveau de satisfaction au travail, le nombre de publications comme premier auteur, l'obtention de subventions et la collecte de donnees. Dans l'ensemble, le nombre d'heures travaillees par semaine a chute de 22 %, comparativement a celui d'avant la pandemie, passant de 45 a 35 heures. Bien que les parents d'enfants de moins de 13 ans aient reussi a maintenir un horaire moyen de 30 heures semaine, jonglant les services de garde et le travail, ils ont des resultats tres inferieurs aux personnes sans enfants ou aux parents d'enfants plus ages pour presque tous les indicateurs de productivite et de bien-etre. De plus, les meres de jeunes enfants ont rapporte avoir un nombre inferieur d'heures de travail ininterrompues et avoir consacre plus de temps comme principaux fournisseurs de soins en comparaison des peres. Ainsi, la pandemie de COVID-19 a eu d'importantes repercussions sur les niveaux autorapportes de bien-etre et de productivite des chercheurs universitaires canadiens, en particulier parmi les parents de jeunes enfants. Les meres de jeunes enfants ont peut-etre particulierement besoin de soutien supplementaire. Ces resultats mettent en relief l'importance d'adopter des politiques federales et institutionnelles visant a egaliser les chances pour ces groupes, de meme que d'etablir des solutions novatrices pour la garde d'enfants qui assurent la sante et la securite, sans desavantager les jeunes parents. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Community consensus on core open science practices to monitor in biomedicine.

The state of open science needs to be monitored to track changes over time and identify areas to create interventions to drive improvements. In order to monitor open science practices, they first need to be well defined and operationalized. To reach consensus on what open science practices to monitor at biomedical research institutions, we conducted a modified 3-round Delphi study. Participants were research administrators, researchers, specialists in dedicated open science roles, and librarians. In rounds 1 and 2, participants completed an online survey evaluating a set of potential open science practices, and for round 3, we hosted two half-day virtual meetings to discuss and vote on items that had not reached consensus. Ultimately, participants reached consensus on 19 open science practices. This core set of open science practices will form the foundation for institutional dashboards and may also be of value for the development of policy, education, and interventions.

Implementation Plan for a High-Frequency, Low-Touch Care Model at Specialized Type 1 Diabetes Clinics: Model Development.

BACKGROUND: Individuals with type 1 diabetes (T1D) are more likely to achieve optimal glycemic management when they have frequent visits with their health care team. There is a potential benefit of frequent, telemedicine interventions as an effective strategy to lower hemoglobin A1c (HbA1c). OBJECTIVE: The objective is this study was to understand the provider- and system-level factors affecting the successful implementation of a virtual care intervention in type 1 diabetes (T1D) clinics. METHODS: Semistructured interviews were conducted with managers and certified diabetes educators (CDEs) at diabetes clinics across Southern Ontario before the COVID-19 pandemic. Deductive analysis was carried out using the Theoretical Domains Framework, followed by mapping to behavior change techniques to inform potential implementation strategies for high-frequency virtual care for T1D. RESULTS: There was considerable intention to deliver high-frequency virtual care to patients with T1D. Participants believed that this model of care could lead to improved patient outcomes and engagement but would likely increase the workload of CDEs. Some felt there were insufficient resources at their site to enable them to participate in the program. Member checking conducted during the pandemic revealed that clinics and staff had already developed strategies to overcome resource barriers to the adoption of virtual care during the pandemic. CONCLUSIONS: Existing enablers for high-frequency virtual care for T1D can be leveraged, and barriers can be overcome with targeted clinical incentives and support.

Service-level barriers to and facilitators of access to services for the treatment of alcohol use disorder and problematic alcohol use: protocol for a scoping review.

INTRODUCTION: Prior to the COVID-19 pandemic, substance use health services for treatment of alcohol use disorder and problematic alcohol use (AUD/PAU) were fragmented and challenging to access. The pandemic magnified system weaknesses, often resulting in disruptions of treatment as alcohol use during the pandemic rose. When treatment services were available, utilisation was often low for various reasons. Virtual care was implemented to offset the drop in in-person care, however accessibility was not universal. Identification of the characteristics of treatment services for AUD/PAU that impact accessibility, as perceived by the individuals accessing or providing the services, will provide insights to enable improved access. We will perform a scoping review that will identify characteristics of services for treatment of AUD/PAU that have been identified as barriers to or facilitators of service access from the perspectives of these groups. METHODS AND ANALYSIS: We will follow scoping review methodological guidance from the Joanna Briggs Institute. Using the OVID platform, we will search Ovid MEDLINE including Epub Ahead of Print and In-Process and Other Non-Indexed Citations, Embase Classic+Embase, APA PsychInfo, Cochrane Register of Controlled Trials, the Cochrane Database of Systematic Reviews and CINAHL (Ebsco Platform). Multiple reviewers will screen citations. We will seek studies reporting data collected from individuals with AUD/PAU or providers of treatment for AUD/PAU on service-level factors affecting access to care. We will map barriers to and facilitators of access to AUD/PAU treatment services identified in the relevant studies, stratified by service type and key measures of inequity across service users. ETHICS AND DISSEMINATION: This research will enhance awareness of existing evidence regarding barriers to and facilitators of access to services for the treatment of alcohol use disorder and problematic alcohol use. Findings will be disseminated through publications, conference presentations and a stakeholder meeting. As this is a scoping review of published literature, no ethics approval was required.

Understanding national trends in COVID-19 vaccine hesitancy in Canada: results from five sequential cross-sectional representative surveys spanning April 2020-March 2021.

OBJECTIVE: To examine rates of vaccine hesitancy and their correlates among Canadian adults between April 2020 and March 2021. DESIGN: Five sequential cross-sectional age, sex and province-weighted population-based samples who completed online surveys. SETTING: Canada. PARTICIPANTS: A total of 15 019 Canadians aged 18 years and over were recruited through a recognised polling firm (Leger Opinion). Respondents were 51.5% female with a mean age of 48.1 (SD 17.2) years (range 18-95 years) and predominantly white (80.8%). PRIMARY AND SECONDARY OUTCOME MEASURES: Rates of vaccine hesitancy over the five surveys (time points) and their sociodemographic, clinical and psychological correlates. RESULTS: A total of 42.2% of respondents reported some degree of vaccine hesitancy, which was lowest during surveys 1 (April 2020) and 5 (March 2021) and highest during survey 3 (November 2020). Fully adjusted multivariate logistic regression analyses revealed that women, those aged 50 and younger, non-white, those with high school education or less, and those with annual household incomes below the poverty line in Canada were significantly more likely to report vaccine hesitancy, as were essential and healthcare workers, parents of children under the age of 18 and those who do not get regular influenza vaccines. Endorsing prevention behaviours as important for reducing virus transmission and high COVID-19 health concerns were associated with 77% and 54% reduction in vaccine hesitancy, respectively. Having high personal financial concerns was associated with 1.33 times increased odds of vaccine hesitancy. CONCLUSIONS: Results highlight the importance of targeting vaccine efforts to specific groups by emphasising the outsized health benefits compared with risks of vaccination. Future research should monitor changes in vaccine intentions and behaviour to better understand underlying factors.

Effects of parenthood and gender on well-being and work productivity among Canadian academic research faculty amidst the COVID-19 pandemic

The coronavirus disease (COVID-19) pandemic has brought about enormous changes to all aspects of academic life. In spring 2020, we recruited faculty from Canadian universities who were asked to complete a survey about the perceived impact of the pandemic on aspects of their well-being and work productivity. Eight hundred ninety-nine academics from across Canada responded, reporting that the pandemic had had a significant negative impact on their mental health, work satisfaction, first-author publications, grants, and data collection. Overall weekly work hours dropped by 22% compared to prepandemic levels, from 45 hr/week to 35 hr. Though parents of children under the age of 13 managed to maintain an average of 30 hr/week despite juggling childcare and work duties, they nonetheless fared worse compared to nonparents and parents of older children on nearly all indicators of work productivity and well-being. Furthermore, mothers of young children reported having fewer uninterrupted work hours and spending more time as primary caregiver compared to fathers. Thus, the COVID-19 pandemic has had a considerable negative impact on the self-reported well-being and work productivity of Canadian academics, and even more so among parents of young children. Mothers of young children may be particularly in need of additional support. These findings highlight the importance of adopting policies at the federal and institutional levels aimed at "leveling the playing field" for these groups as well as instituting creative childcare solutions that maintain health and safety while not further disadvantaging young parents. (PsycInfo Database Record (c) 2022 APA, all rights reserved) (French) La pandemie de la maladie causee par le coronavirus (COVID-19) a suscite d'enormes changements dans tous les volets de la vie universitaire. Au printemps 2020, nous avons effectue un sondage parmi les membres du personnel d'universites canadiennes afin de connaitre les repercussions percues de la pandemie sur divers aspects de leur bien-etre et sur leur productivite. Ont repondu au questionnaire 899 personnes de partout au pays, lesquelles ont signale que la pandemie avait eu d'importantes repercussions negatives sur leur sante mentale, leur niveau de satisfaction au travail, le nombre de publications comme premier auteur, l'obtention de subventions et la collecte de donnees. Dans l'ensemble, le nombre d'heures travaillees par semaine a chute de 22 %, comparativement a celui d'avant la pandemie, passant de 45 a 35 heures. Bien que les parents d'enfants de moins de 13 ans aient reussi a maintenir un horaire moyen de 30 heures semaine, jonglant les services de garde et le travail, ils ont des resultats tres inferieurs aux personnes sans enfants ou aux parents d'enfants plus ages pour presque tous les indicateurs de productivite et de bien-etre. De plus, les meres de jeunes enfants ont rapporte avoir un nombre inferieur d'heures de travail ininterrompues et avoir consacre plus de temps comme principaux fournisseurs de soins en comparaison des peres. Ainsi, la pandemie de COVID-19 a eu d'importantes repercussions sur les niveaux autorapportes de bien-etre et de productivite des chercheurs universitaires canadiens, en particulier parmi les parents de jeunes enfants. Les meres de jeunes enfants ont peut-etre particulierement besoin de soutien supplementaire. Ces resultats mettent en relief l'importance d'adopter des politiques federales et institutionnelles visant a egaliser les chances pour ces groupes, de meme que d'etablir des solutions novatrices pour la garde d'enfants qui assurent la sante et la securite, sans desavantager les jeunes parents. (PsycInfo Database Record (c) 2022 APA, all rights reserved) Impact Statement Public Significance Statement: The current findings suggest that the COVID-19 pandemic has had a considerable negative impact on the self-reported well-being and work productivity of Canadian academics, and even more so among parents of young children. Mothers of young children may be particularly in need of additional support. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

Ending the Pandemic: How Behavioural Science Can Help Optimize Global COVID-19 Vaccine Uptake.

Governments, public health officials and pharmaceutical companies have all mobilized resources to address the COVID-19 pandemic. Lockdowns, social distancing, and personal protective behaviours have been helpful but have shut down economies and disrupted normal activities. Vaccinations protect populations from COVID-19 and allow a return to pre-pandemic ways of living. However, vaccine development, distribution and promotion have not been sufficient to ensure maximum vaccine uptake. Vaccination is an individual choice and requires acceptance of the need to be vaccinated in light of any risks. This paper presents a behavioural sciences framework to promote vaccine acceptance by addressing the complex and ever evolving landscape of COVID-19. Effective promotion of vaccine uptake requires understanding the context-specific barriers to acceptance. We present the AACTT framework (Action, Actor, Context, Target, Time) to identify the action needed to be taken, the person needed to act, the context for the action, as well as the target of the action within a timeframe. Once identified a model for identifying and overcoming barriers, called COM-B (Capability, Opportunity and Motivation lead to Behaviour), is presented. This analysis identifies issues associated with capability, opportunity and motivation to act. These frameworks can be used to facilitate action that is fluid and involves policy makers, organisational leaders as well as citizens and families.

Benefits and obstacles to cell therapy in neonates: The INCuBAToR (Innovative Neonatal Cellular Therapy for Bronchopulmonary Dysplasia: Accelerating Translation of Research).

Cell-based therapies hold promise to substantially curb complications from extreme preterm birth, the main cause of death in children below the age of 5 years. Exciting preclinical studies in experimental neonatal lung injury have provided the impetus for the initiation of early phase clinical trials in extreme preterm infants at risk of developing bronchopulmonary dysplasia. Clinical translation of promising therapies, however, is slow and often fails. In the adult population, results of clinical trials so far have not matched the enticing preclinical data. The neonatal field has experienced many hard-earned lessons with the implementation of oxygen therapy or postnatal steroids. Here we briefly summarize the preclinical data that have permitted the initiation of early phase clinical trials of cell-based therapies in extreme preterm infants and describe the INCuBAToR concept (Innovative Neonatal Cellular Therapy for Bronchopulmonary Dysplasia: Accelerating Translation of Research), an evidence-based approach to mitigate the risk of translating advanced therapies into this vulnerable patient population. The INCuBAToR addresses several of the shortcomings at the preclinical and the clinical stage that usually contribute to the failure of clinical translation through (a) systematic reviews of preclinical and clinical studies, (b) integrated knowledge transfer through engaging important stakeholders early on, (c) early economic evaluation to determine if a novel therapy is viable, and (d) retrospective and prospective studies to define and test ideal eligibility criteria to optimize clinical trial design. The INCuBAToR concept can be applied to any novel therapy in order to enhance the likelihood of success of clinical translation in a timely, transparent, rigorous, and evidence-based fashion.

A Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) in Patients With Chronic Kidney Disease: Clinical Research Protocol of a Cluster-Randomized Clinical Trial.

BACKGROUND: Many patients with kidney failure will live longer and healthier lives if they receive a kidney transplant rather than dialysis. However, multiple barriers prevent patients from accessing this treatment option. OBJECTIVE: To determine if a quality improvement intervention provided in chronic kidney disease (CKD) programs (vs. usual care) enables more patients with no recorded contraindications to kidney transplant to complete more steps toward receiving a kidney transplant. DESIGN: This protocol describes a pragmatic 2-arm, parallel-group, open-label, registry-based, cluster-randomized clinical trial-the Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial. SETTING: All 26 CKD programs in Ontario, Canada, with a trial start date of November 1, 2017. The original end date of March 31, 2021 (3.4 years) has been extended to December 31, 2021 (4.1 years) due to the COVID-19 pandemic. PARTICIPANTS: During the trial, the 26 CKD programs are expected to care for more than 10 000 adult patients with CKD (including patients approaching the need for dialysis and patients receiving dialysis) with no recorded contraindications to a kidney transplant. INTERVENTION: Programs were randomly allocated to provide a quality improvement intervention or usual care. The intervention has 4 main components: (1) local quality improvement teams and administrative support; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. PRIMARY OUTCOME: The primary outcome is the number of key steps completed toward receiving a kidney transplant analyzed at the cluster level (CKD program). The following 4 unique steps per patient will be counted: (1) patient referred to a transplant center for evaluation, (2) at least one living kidney donor candidate contacts a transplant center for an intended recipient and completes a health history questionnaire to begin their evaluation, (3) patient added to the deceased donor transplant wait list, and (4) patient receives a kidney transplant from a living or deceased donor. PLANNED PRIMARY ANALYSIS: Study data will be obtained from Ontario's linked administrative healthcare databases. An intent-to-treat analysis will be conducted comparing the primary outcome between randomized groups using a 2-stage approach. First stage: residuals are obtained from fitting a regression model to individual-level variables ignoring intervention and clustering effects. Second stage: residuals from the first stage are aggregated at the cluster level as the outcome. LIMITATIONS: It may not be possible to isolate independent effects of each intervention component, the usual care group could adopt intervention components leading to contamination bias, and the relatively small number of clusters could mean the 2 arms are not balanced on all baseline prognostic factors. CONCLUSIONS: The EnAKT LKD trial will provide high-quality evidence on whether a multi-component quality improvement intervention helps patients complete more steps toward receiving a kidney transplant. TRIAL REGISTRATION: Clinicaltrials.gov; identifier: NCT03329521.

CONTEXTE: Plusieurs patients atteints d'insuffisance rénale vivront plus longtemps et en meilleure santé s'ils reçoivent une greffe de rein plutôt que des traitements de dialyze. De nombreux obstacles empêchent cependant les patients d'accéder à la transplantation. OBJECTIF: Déterminer si une intervention visant l'amélioration de la qualité menée dans les programs d'insuffisance rénale chronique (IRC) permettrait à davantage de patients sans contre-indications à une greffe d'aller plus loin (comparativement aux soins habituels) dans le processus menant à la transplantation. TYPE D'ÉTUDE: Ce protocole décrit un essai clinique pragmatique ouvert, à deux bras, en groupes parallèles, à répartition aléatoire en grappes et fondé sur un registre ­ l'essai Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD). CADRE: Les 26 programs d'IRC de l'Ontario (Canada). L'essai a débuté le 1er novembre 2017 et devait initialement se terminer le 31 mars 2021 (3,4 ans); cette date a été reportée au 31 décembre 2021 (4,1 ans) en raison de la pandémie de COVID-19. SUJETS: Au cours de l'essai, on estime que les 26 programs d'IRC prendront en charge plus de 10 000 adultes atteints d'IRC (y compris des patients approchant le besoin de dialyze et des patients dialysés) sans contre-indications à une greffe. INTERVENTIONS: Les programs ont été répartis aléatoirement pour intégrer une intervention d'amélioration de la qualité ou pour prodiguer les soins habituels. L'intervention consiste en quatre composantes principales: (1) des équipes locales d'amélioration de la qualité et de soutien administratif; (2) de l'information et des ressources sur mesure pour le personnel, les patients et les donneurs vivants; (3) du soutien pour les receveurs et les donneurs vivants; et (4) des rapports sur le rendement au niveau du program et une surveillance assurée par les chefs de program. PRINCIPAUX RÉSULTATS: Le principal critère d'évaluation est le nombre d'étapes clés complétées en vue de la réception d'une greffe de rein tel qu'analysé au niveau de la grappe (program d'IRC). Pour chaque patient, quatre étapes spécifiques seront comptabilisées: (I) le patient est aiguillé vers un center de transplantation pour évaluation; (II) au moins un donneur vivant de rein contacte un center de transplantation pour un receveur en particulier et amorce son évaluation en remplissant un questionnaire sur ses antécédents médicaux; (III) le patient est ajouté à la liste d'attente pour une transplantation d'un donneur décédé, et (IV) le patient reçoit une greffe de rein d'un donneur vivant ou décédé. PRINCIPALE ANALYZE ENVISAGÉE: Les données sont tirées des bases de données administratives du système de santé ontarien. Une analyze en intention de traiter sera effectuée en comparant le principal critère d'évaluation entre les groupes répartis aléatoirement à l'aide d'une approche en deux étapes. Première étape: obtention de valeurs résiduelles en adaptant un modèle de régression aux variables de niveau individuel et en ignorant les effets de l'intervention et du regroupement. Deuxième étape: les valeurs résiduelles de la première étape agrégées au niveau du groupe constitueront le résultat. LIMITES: Il pourrait ne pas être possible d'isoler les effets indépendants de chaque composante de l'intervention. L'équipe prodiguant les soins habituels pourrait adopter des composantes de l'intervention menant à un biais de contamination. Le nombre relativement faible de groupes pourrait signifier que les deux bras ne sont pas équilibrés sur tous les facteurs pronostiques de base. CONCLUSION: L'essai EnAKT LKD fournira des données de haute qualité sur la question de savoir si une intervention à composantes multiples visant l'amélioration de la qualité aide effectivement les patients à franchir davantage d'étapes vers une transplantation rénale.