Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1): a pragmatic stepped-wedge, cluster randomized controlled registry trial.

BACKGROUND: The shortage of available organs for life-saving transplants persists worldwide. While a majority support donating their organs or tissue when they die, many have not registered their wish to do so. When registered, next of kin are much more likely to follow-through with the decision to donate. In many countries, most people visit their family physician office each year and this setting is a promising, yet underused, site where more people could register for deceased organ donation. Our primary aim was to evaluate the effectiveness of an intervention to promote organ donation registration in family physician's offices. METHODS: We developed an intervention to address barriers and enablers to organ donation registration that involved physician office reception staff inviting patients to register on a tablet in the waiting room while they waited for their appointment. We conducted a cross-sectional stepped-wedge cluster randomized controlled registry trial to evaluate the intervention. We recruited six family physician offices in Canada. All offices began with usual care and then every two weeks, one office (randomly assigned) started the intervention until all offices delivered the intervention. The primary outcome was registration for deceased organ donation in the provincial organ registration registry, assessed within the 7 days of the physician visit. At the end of the trial, we also conducted interviews with clinic staff to assess any barriers and enablers to delivering the intervention. RESULTS: The trial involved 24,616 patient visits by 13,562 unique patients: 12,484 visits in the intervention period and 12,132 in the control period. There was no statistically significant difference in the percentage of patients registered for deceased organ donation in the intervention versus control period (48.0% vs 46.2%; absolute difference after accounting for the secular trend: 0.12%; 95% CI: - 2.30, 2.54; p=0.92). Interviews with clinic staff indicated location of the tablet within a waiting room, patient rapport, existing registration, confidence and motivation to deliver the intervention and competing priorities as barriers and enablers to delivery. CONCLUSIONS: Our intervention did not increase donor registration. Nonetheless, family physician offices may still remain a promising setting to develop and evaluate better interventions to increase organ donation registration. TRIAL REGISTRATION: NCT03213171.

Current Progress in Therapeutic Gene Editing for Monogenic Diseases.

Programmable nucleases allow defined alterations in the genome with ease-of-use, efficiency, and specificity. Their availability has led to accurate and widespread genome engineering, with multiple applications in basic research, biotechnology, and therapy. With regard to human gene therapy, nuclease-based gene editing has facilitated development of a broad range of therapeutic strategies based on both nonhomologous end joining and homology-dependent repair. This review discusses current progress in nuclease-based therapeutic applications for a subset of inherited monogenic diseases including cystic fibrosis, Duchenne muscular dystrophy, diseases of the bone marrow, and hemophilia and highlights associated challenges and future prospects.

The authority of next-of-kin in explicit and presumed consent systems for deceased organ donation: an analysis of 54 nations.

BACKGROUND: The degree of involvement by the next-of-kin in deceased organ procurement worldwide is unclear. We investigated the next-of-kin's authority in the procurement process in nations with either explicit or presumed consent. METHODS: We collected data from 54 nations, 25 with presumed consent and 29 with explicit consent. We characterized the authority of the next-of-kin in the decision to donate deceased organs. Specifically, we examined whether the next-of-kin's consent to procure organs was always required and whether the next-of-kin were able to veto procurement when the deceased had expressed a wish to donate. RESULTS: The next-of-kin are involved in the organ procurement process in most nations regardless of the consent principle and whether the wishes of the deceased to be a donor were expressed or unknown. Nineteen of the 25 nations with presumed consent provide a method for individuals to express a wish to be a donor. However, health professionals in only four of these nations responded that they do not override a deceased's expressed wish because of a family's objection. Similarly, health professionals in only four of the 29 nations with explicit consent proceed with a deceased's pre-existing wish to be a donor and do not require next-of-kin's consent, but caveats still remain for when this is done. CONCLUSIONS: The next-of-kin have a considerable influence on the organ procurement process in both presumed and explicit consent nations.

Worldwide variability in deceased organ donation registries.

The variability in deceased organ donation registries worldwide has received little attention. We considered all operating registries, where individual wishes about organ donation were recorded in a computerized database. We included registries which recorded an individual's decision to be a donor (donor registry), and registries which only recorded an individual's objection (non-donor registry). We collected information on 15 characteristics including history, design, use and number of registrants for 27 registries (68%). Most registries are nationally operated and government-owned. Registrations in five nations expire and require renewal. Some registries provide the option to make specific organ selections in the donation decision. Just over half of donor registries provide legally binding authorization to donation. In all national donor registries, except one, the proportion of adults (15+) registered is modest (<40%). These proportions can be even lower when only affirmative decisions are considered. One nation provides priority status on the transplant waiting list as an incentive to affirmative registration, while another nation makes registering a donation decision mandatory to obtain a driver's license. Registered objections in non-donor registries are rare (<0.5%). The variation in organ donor registries worldwide necessitates public discourse and quality improvement initiatives, to identify and support leading practices in registry use.

Evaluation of a Hockey Deceased Organ Donation Awareness Campaign: A Population-Based Cohort Study.

BACKGROUND: The Kidney Foundation of Canada developed a pilot campaign to educate persons attending junior hockey league games in London, Ontario, Canada, on deceased organ donation. OBJECTIVE: To evaluate the impact of a hockey campaign on the number of new organ and tissue donor registrants. DESIGN: Population-based retrospective cohort study. SETTING: Residents of London, Ontario. PATIENTS: We included 255 476 individuals eligible to register for organ donation with a London, Ontario postal code. MEASUREMENTS: We compared the number of new deceased organ donor registrants in London, Ontario, during the campaign period (March 12 to April 16, 2015) with 3 different time periods (December 30, 2014 to February 3, 2015; February 4 to March 11, 2015; April 17 to May 22, 2015). We also compared registration rates in London with 2 Ontario cities (Kitchener-Waterloo and Hamilton) matching in a 1:1 ratio on age, sex, and income quintile. METHODS: To compare registrations across time periods, we used binomial regression with an identity link function and generalized estimating equations with an independence correlation structure. We used modified Poisson regression to compare registration rates between cities. RESULTS: During the campaign period, there were slightly more registrations (1218 registered of 252 832 unregistered individuals [0.48%]) compared with an earlier time period (risk difference: 0.09%; 95% confidence interval [CI]: 0.05%-0.12%). However, there was no significant difference compared with 2 time periods immediately before and after the campaign. London had slightly more registrations during the campaign period compared with the matched city of Hamilton (1180 registered of 236 582 unregistered individuals [0.50%] vs 490 registered of 236 582 unregistered individuals [0.21%]; risk ratio: 2.41; 95% CI: 2.17-2.68). The registration rate in London did not significantly differ from Kitchener-Waterloo. LIMITATIONS: Unable to conclude whether the minor increase in deceased organ donor registration was the result of the campaign or other factors (e.g., simultaneous organ registration events, seasonality). CONCLUSIONS: Overall, a minor increase in deceased organ donor registration was observed during the hockey organ donation awareness campaign; however, the specific impact of the campaign on organ donor registration could not be determined.

CONTEXTE: La Fondation canadienne du rein a développé une campagne pilote pour sensibiliser les gens qui assistent à des matchs de hockey junior à London en Ontario (Canada) sur le don d'organes post-mortem. OBJECTIF DE L'ÉTUDE: Évaluer l'impact qu'une campagne de sensibilisation auprès des gens assistant à des parties de hockey pouvait avoir sur le nombre de nouvelles inscriptions à la liste des donneurs d'organes et de tissus. TYPE D'ÉTUDE: Il s'agit d'une étude rétrospective de cohorte menée au sein de la population. CADRE DE L'ÉTUDE: L'étude a été réalisée auprès de résidents de London en Ontario. PARTICIPANTS: Nous avons inclus un total de 255 476 individus ayant un code postal inscrit à London en Ontario et qui étaient admissibles à faire un don d'organe. MESURES: Nous avons répertorié le nombre de nouvelles inscriptions à la liste de donneurs d'organes à London en Ontario au cours de la période de la campagne, soit du 12 mars au 16 avril 2015. Nous avons comparé ce résultat aux nombres de nouvelles inscriptions obtenus lors de trois autres périodes, soit du 30 décembre 2014 au 3 février 2015; du 4 février au 11 mars 2015 et du 17 avril au 22 mai 2015. De plus, nous avons comparé le taux de nouvelles inscriptions de London à celui de deux autres villes de l'Ontario, soit Kitchener-Waterloo et Hamilton. La comparaison a été établie selon un ratio de 1:1 où les participants étaient appariés sur la base de leur âge, de leur sexe et de leur revenu. MÉTHODOLOGIE: Pour comparer le nombre de nouvelles inscriptions entre les périodes choisies, nous avons utilisé un modèle de régression binomiale comportant une fonction de lien d'identité, de même que des équations d'estimation généralisées avec structure de corrélation de l'indépendance. Une version modifiée du modèle de régression de Poisson a été utilisée pour comparer les taux d'inscription entre les villes. RÉSULTATS: Au cours de la campagne de sensibilisation, nous avons observé une faible hausse des inscriptions (1 218 nouvelles inscriptions [0,48%]) par rapport à une période antérieure (différence de risque: 0,09%; IC 95%: 0,05% - 0,12%). Cependant, aucune différence significative n'a été observée par rapport aux périodes immédiatement avant et après la campagne de sensibilisation. Un nombre légèrement plus élevé d'inscriptions a eu lieu dans la ville de London pour la période étudiée par rapport à la ville de Hamilton (1 180 inscrits et 236 582 non-inscrits [0,50%] contre 490 inscrits et 236 582 non-inscrits [0,21%]; risque relatif = 2,41; IC 95% = 2,17-2,68). Aucune différence significative n'a été observée entre le taux d'inscription à London et celui de Kitchener-Waterloo. LIMITES DE L'ÉTUDE: Il a été impossible de déterminer si la campagne de sensibilisation a contribué à la légère augmentation du nombre d'inscriptions à la liste de donneurs d'organes post-mortem ou si celle-ci résulte d'autres facteurs (p. ex. événements spontanés d'inscriptions à la liste des donneurs, caractère saisonnier). CONCLUSIONS: Dans l'ensemble, une légère augmentation du nombre d'inscriptions à la liste des donneurs d'organes post-mortem a été observée au cours de la campagne de sensibilisation menée pendant les parties de hockey. Toutefois, il a été impossible d'établir si la campagne de sensibilisation a eu un effet réel sur le nombre d'inscriptions.

Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry.

BACKGROUND: There is a worldwide shortage of organs available for transplant, leading to preventable mortality associated with end-stage organ disease. While most citizens in many countries with an intent-to-donate "opt-in" system support organ donation, registration rates remain low. In Canada, most Canadians support organ donation but less than 25% in most provinces have registered their desire to donate their organs when they die. The family physician office is a promising yet underused setting in which to promote organ donor registration and address known barriers and enablers to registering for deceased organ and tissue donation. We developed a protocol to evaluate an intervention to promote registration for organ and tissue donation in family physician waiting rooms. METHODS/DESIGN: This protocol describes a planned, stepped-wedge, cluster randomized registry trial in six family physician offices in Ontario, Canada to evaluate the effectiveness of reception staff providing patients with a pamphlet that addresses barriers and enablers to registration including a description of how to register for organ donation. An Internet-enabled tablet will also be provided in waiting rooms so that interested patients can register while waiting for their appointments. Family physicians and reception staff will be provided with training and/or materials to support any conversations about organ donation with their patients. Following a 2-week control period, the six offices will cross sequentially into the intervention arm in randomized sequence at 2-week intervals until all offices deliver the intervention. The primary outcome will be the proportion of patients visiting the office who are registered organ donors 7 days following their office visit. We will evaluate this outcome using routinely collected registry data from provincial administrative databases. A post-trial qualitative evaluation process will assess the experiences of reception staff and family physicians with the intervention and the stepped-wedge trial design. DISCUSSION: Promoting registration for organ donation in family physician offices is a potentially useful strategy for increasing registration for organ donation. Increased registration may ultimately help to increase the number of organs available for transplant. The results of this trial will provide important preliminary data on the effectiveness of using family physician offices to promote registration for organ donation. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03213171 . Registered on 11 July 2017.

Registration for deceased organ and tissue donation among Ontario immigrants: a population-based cross-sectional study.

BACKGROUND: Canada has low rates of deceased organ and tissue donation. Immigrants to Canada may differ in their registered support for deceased organ donation based on their country of origin. METHODS: We used linked administrative databases in Ontario (about 11 million residents aged ≥ 16 yr) to study the proportion of immigrants and long-term residents registered for deceased organ and tissue donation as of October 2013. We used modified Poisson regression to identify and quantify predictors of donor registration. RESULTS: Compared with long-term residents (n = 9 244 570), immigrants (n = 1 947 646) were much less likely to register for deceased organ and tissue donation (11.9% v. 26.5%). Immigrants from the United States, Australia and New Zealand had the highest registration rate (40.0%), whereas immigrants with the lowest registration rates were from Eastern Europe and Central Asia (9.4%), East Asia and Pacific (8.4%) and sub-Saharan Africa (7.9%). The largest numbers of unregistered immigrants were from India (n = 202 548), China (n = 186 678) and the Philippines (n = 125 686). Characteristics among the immigrant population associated with a higher likelihood of registration included economic immigrant status, living in a rural area (population < 10 000), living in an area with a lower ethnic concentration, less material deprivation, a higher education, ability to speak English and French, and more years residing in Canada. INTERPRETATION: Immigrants in Ontario were less likely to register for deceased organ and tissue donation than long-term residents. There is a need to better understand reasons for lower registration rates among Canadian immigrants and to create culture-sensitive materials to build support for deceased organ and tissue donation.

Deceased Organ Donation Registration and Familial Consent among Chinese and South Asians in Ontario, Canada.

OBJECTIVE: For various reasons, people of Chinese (China, Hong Kong or Taiwan) and South Asian (Indian subcontinent) ancestry (the two largest ethnic minority groups in Ontario, Canada) may be less likely to register for deceased organ donation than the general public, and their families may be less likely to consent for deceased organ donation at the time of death. METHODS: We conducted two population-based studies: (1) a cross-sectional study of deceased organ donor registration as of May 2013, and (2) a cohort study of the steps in proceeding with deceased organ donation for patients who died in hospital from October 2008 to December 2012. RESULTS: A total of 49 938 of 559 714 Chinese individuals (8.9%) and 47 774 of 374 291 South Asians (12.8%) were registered for deceased organ donation, proportions lower than the general public (2 676 260 of 10 548 249 (25.4%). Among the 168 703 Ontarians who died in a hospital, the families of 33 of 81 Chinese (40.1%; 95% CI: 30.7%-51.6%) and 39 of 72 South Asian individuals (54.2%; 95% CI: 42.7-65.2%) consented for deceased organ donation, proportions lower than the general public (68.3%; 95% CI: 66.4%-70.0%). CONCLUSIONS: In Ontario, Canada Chinese and South Asian individuals are less likely to register and their families are less likely to consent to deceased organ donation compared to the remaining general public. There is an opportunity to build support for organ and tissue donation in these two large ethnic communities in Canada.