Resumption of Cardiac Activity after Withdrawal of Life-Sustaining Measures.

BACKGROUND: The minimum duration of pulselessness required before organ donation after circulatory determination of death has not been well studied. METHODS: We conducted a prospective observational study of the incidence and timing of resumption of cardiac electrical and pulsatile activity in adults who died after planned withdrawal of life-sustaining measures in 20 intensive care units in three countries. Patients were intended to be monitored for 30 minutes after determination of death. Clinicians at the bedside reported resumption of cardiac activity prospectively. Continuous blood-pressure and electrocardiographic (ECG) waveforms were recorded and reviewed retrospectively to confirm bedside observations and to determine whether there were additional instances of resumption of cardiac activity. RESULTS: A total of 1999 patients were screened, and 631 were included in the study. Clinically reported resumption of cardiac activity, respiratory movement, or both that was confirmed by waveform analysis occurred in 5 patients (1%). Retrospective analysis of ECG and blood-pressure waveforms from 480 patients identified 67 instances (14%) with resumption of cardiac activity after a period of pulselessness, including the 5 reported by bedside clinicians. The longest duration after pulselessness before resumption of cardiac activity was 4 minutes 20 seconds. The last QRS complex coincided with the last arterial pulse in 19% of the patients. CONCLUSIONS: After withdrawal of life-sustaining measures, transient resumption of at least one cycle of cardiac activity after pulselessness occurred in 14% of patients according to retrospective analysis of waveforms; only 1% of such resumptions were identified at the bedside. These events occurred within 4 minutes 20 seconds after a period of pulselessness. (Funded by the Canadian Institutes for Health Research and others.).

Early experiences of deemed consent legislation for organ donation in Nova Scotia: a qualitative study.

PURPOSE: In 2021, Nova Scotia, Canada, became the first jurisdiction in North America to adopt a deemed consent organ donation system under its revised Human Organ and Tissue Donation Act. This study sought to understand the early experiences of program staff and clinicians involved in implementing this legislation. METHODS: We conducted semistructured interviews with members of the provincial organ donation program and intensive care unit and emergency department clinicians (n = 14). Two investigators coded transcripts of interviews, then categorized the coded data into themes. RESULTS: We identified four key themes: 1) legislation has limited impact on daily practice; 2) legislation does not address existing barriers; 3) legislation aids conversations with donor families; and 4) legislation should provide more autonomy to patients and families, not less. CONCLUSION: Deemed consent legislation had limited impact on clinician's day-to-day practices, because of lack of infrastructure changes and infrequent donation opportunities. Nevertheless, participants felt the introduction of deemed consent in Nova Scotia eased conversations between families of potential donors and clinicians. These findings should be used to inform ongoing implementation of deemed consent and be considered by those contemplating similar legislative changes.

RéSUMé: OBJECTIF: En 2021, la Nouvelle-Écosse, au Canada, est devenue la première juridiction nord-américaine à adopter un système de don d'organes avec consentement présumé dans le cadre de sa version révisée de la Loi sur le don d'organes et de tissus humains. Cette étude visait à comprendre les premières expériences du personnel du programme et des clinicien·nes participant à la mise en œuvre de cette loi. MéTHODE: Nous avons mené des entrevues semi-structurées avec des membres du programme provincial de don d'organes, ainsi qu'avec des clinicien·nes de l'unité de soins intensifs et des services d'urgence (n = 14). Deux personnes de l'équipe de recherche ont codé les transcriptions des entrevues, puis ont classé les données codées en thèmes. RéSULTATS: Nous avons identifié quatre thèmes clés : 1) la législation a un impact limité sur la pratique quotidienne; 2) la législation ne s'attaque pas aux obstacles existants; 3) la législation facilite les conversations avec les familles des donneurs et donneuses; et 4) la législation devrait accorder plus d'autonomie aux patient·es et aux familles, et non moins. CONCLUSION: La législation sur la présomption de consentement a eu une incidence limitée sur les pratiques quotidiennes des cliniciennes et cliniciens, en raison du manque de changements à l'infrastructure et des possibilités de dons peu fréquentes. Néanmoins, les participant·es ont estimé que l'introduction du consentement présumé en Nouvelle-Écosse facilitait les conversations entre les familles des donneurs et donneuses potentiel·les et les clinicien·nes. Ces constatations devraient être utilisées pour éclairer la mise en œuvre continue de la présomption de consentement et être prises en compte par les autorités qui envisagent des modifications législatives similaires.

Family and emergency physicians' knowledge and attitudes toward organ donation and deemed consent: Human Organ and Tissue Donation Act in Nova Scotia.

OBJECTIVE: To understand Nova Scotian family physicians' and emergency department (ED) physicians' knowledge of, attitudes about, and experience with organ donation and transplantation in the context of the Human Organ and Tissue Donation Act (HOTDA). DESIGN: An electronic, self-administered survey. SETTING: Nova Scotia. PARTICIPANTS: All family physicians and ED physicians practising in Nova Scotia. MAIN OUTCOME MEASURES: Demographic characteristics, experience with organ donation and transplantation, knowledge about organ donation and HOTDA, attitudes toward organ donation and HOTDA, and opportunities for and barriers to the implementation of the HOTDA in clinical practice. Survey results were analyzed using descriptive statistics. RESULTS: Overall, 211 family physicians and 73 ED physicians responded to the survey. Most respondents had favourable attitudes around organ donation and most supported a deemed consent model. Nearly three-quarters of family physicians indicated they have a conversation around organ donation only if it is initiated by the patient. In the ED setting, the most common barriers to organ donation and deemed consent were lack of familiarity with the organ donation referral process, refusal of permission from families, and unknown wishes of the deceased. CONCLUSION: Family physicians and ED physicians had positive attitudes toward organ donation, including high support for a deemed consent model. However, specific knowledge gaps and training topics were identified that should be addressed within the context of this model.

Nurse knowledge and attitudes towards organ donation and deemed consent: the Human Organ and Tissue Donation Act in Nova Scotia.

PURPOSE: In April 2019, the Human Organ and Tissue Donation Act (HOTDA) in Nova Scotia was modified to incorporate a deemed consent model. In this study, we sought to understand intensive care unit (ICU) and emergency department (ED) nurses' knowledge of and confidence around organ donation and transplantation, experiences with organ donors and recipients, attitudes toward organ donation and deemed consent, and perceived opportunities and barriers to a deemed consent approach in view of the legislative change. METHODS: We sent an electronic, self-administered survey to all ICU and ED nurses in Nova Scotia. The survey queried respondents on their knowledge of, experience with, and attitudes around organ donation and HOTDA, and opportunities and barriers to the implementation of HOTDA in clinical practice. Survey results were analyzed using descriptive statistics. RESULTS: One-hundred and ninety-four nurses responded to the survey. Nearly all (98%) supported organ donation, with 86% having signed an organ donor card to donate organs and/or tissues after death. A considerable majority (89%) also supported the new legislation. Nevertheless, a minority of respondents (13%) believed that deemed consent legislation would be considered a violation of the general principles of freedom and autonomy. The three most identified topics for ongoing training were coordination of the donation process (70%), clinical management of donors (70%), and family issues in decision-making (70%). CONCLUSION: Intensive care unit and ED nurses had positive attitudes toward organ donation, including deemed consent model. The findings should inform educational initiatives in Nova Scotia and beyond to optimize organ donation processes and outcomes.

RéSUMé: OBJECTIF: En avril 2019, la Loi sur le don d'organes et de tissus humains (Human Organ and Tissue Donation Act ­ HOTDA) de la Nouvelle-Écosse a été modifiée pour intégrer un modèle de consentement présumé. Dans cette étude, nous avons cherché à comprendre les connaissances et l'aisance du personnel infirmier des unités de soins intensifs (USI) et des services d'urgence en matière de don et de transplantation d'organes, leurs expériences avec les donneurs et les receveurs d'organes, leurs attitudes à l'égard du don d'organes et du consentement présumé, ainsi que les occasions et les obstacles perçus à une approche de consentement présumé compte tenu de la modification législative. MéTHODE: Nous avons envoyé un sondage électronique auto-administré à tout le personnel infirmier des soins intensifs et des urgences de Nouvelle-Écosse. Le sondage a interrogé les répondant.e.s sur leurs connaissances, leur expérience et leurs attitudes à l'égard du don d'organes et de la HOTDA, ainsi que sur les occasions et les obstacles à la mise en œuvre de l'HOTDA dans la pratique clinique. Les réponses au sondage ont été analysées à l'aide de statistiques descriptives. RéSULTATS: Cent-quatre-vingt-quatorze infirmières et infirmiers ont répondu au questionnaire. Presque toutes les personnes ayant répondu (98 %) appuient le don d'organes, 86 % ayant signé une carte de don d'organes pour donner des organes et/ou des tissus après leur décès. Une majorité considérable (89 %) soutient également la nouvelle législation. Néanmoins, une minorité de répondant.e.s (13 %) estime que la législation sur la présomption de consentement serait considérée comme une violation des principes généraux de liberté et d'autonomie. Les trois sujets de formation continue les plus fréquemment mentionnés étaient la coordination du processus de don (70 %), la prise en charge clinique des donneurs et donneuses (70 %) et les questions familiales dans la prise de décision (70 %). CONCLUSION: Le personnel infirmier des soins intensifs et des urgences avait une attitude positive à l'égard du don d'organes, y compris du modèle de consentement présumé. Ces résultats devraient éclairer les initiatives éducatives en Nouvelle-Écosse et ailleurs afin d'optimiser les processus et les issues du don d'organes.

Death determination by neurologic criteria-what do families understand?

PURPOSE: Currently, there is little empirical data on family understanding about brain death and death determination. The purpose of this study was to describe family members' (FMs') understanding of brain death and the process of determining death in the context of organ donation in Canadian intensive care units (ICUs). METHODS: We conducted a qualitative study using semistructured, in-depth interviews with FMs who were asked to make an organ donation decision on behalf of adult or pediatric patients with death determination by neurologic criteria (DNC) in Canadian ICUs. RESULTS: From interviews with 179 FMs, six main themes emerged: 1) state of mind, 2) communication, 3) DNC may be counterintuitive, 4) preparation for the DNC clinical assessment, 5) DNC clinical assessment, and 6) time of death. Recommendations on how clinicians can help FMs to understand and accept DNC through communication at key moments were described including preparing FMs for death determination, allowing FMs to be present, and explaining the legal time of death, combined with multimodal strategies. For many FMs, understanding of DNC unfolded over time, facilitated with repeated encounters and explanation, rather than during a single meeting. CONCLUSION: Family members' understanding of brain death and death determination represented a journey that they reported in sequential meeting with health care providers, most notably physicians. Modifiable factors to improve communication and bereavement outcomes during DNC include attention to the state of mind of the family, pacing and repeating discussions according to families' expressed understanding, and preparing and inviting families to be present for the clinical determination including apnea testing. We have provided family-generated recommendations that are pragmatic and can be easily implemented.

RéSUMé: OBJECTIF: À l'heure actuelle, il y a peu de données empiriques sur la compréhension des familles de la mort cérébrale et de la détermination du décès. Le but de cette étude était de décrire la compréhension des membres de la famille de la mort cérébrale et du processus de détermination du décès dans le contexte du don d'organes dans les unités de soins intensifs (USI) canadiennes. MéTHODE: Nous avons mené une étude qualitative à l'aide d'entrevues semi-structurées et approfondies avec des membres de la famille à qui on a demandé de prendre une décision de don d'organes au nom de patients adultes ou pédiatriques dont le décès avait été déterminé selon des critères neurologiques (DCN) dans les unités de soins intensifs canadiennes. RéSULTATS: Sur la base d'entrevues avec 179 membres de la famille, six thèmes principaux ont émergé : 1) l'état d'esprit, 2) la communication, 3) le DCN peut être contre-intuitif, 4) la préparation à l'évaluation clinique pour un DCN, 5) l'évaluation clinique pour un DCN et 6) le moment du décès. Des recommandations sur la façon dont les cliniciens peuvent aider les membres de la famille à comprendre et à accepter un DCN par la communication à des moments clés ont été décrites, y compris la préparation des membres de la famille à la détermination du décès, l'autorisation de la présence des membres de la famille et l'explication de l'heure légale du décès, combinées à des stratégies multimodales. Pour de nombreux membres de la famille, la compréhension du DCN s'est développée au fil du temps et a été facilitée par des rencontres et des explications répétées plutôt qu'au cours d'une seule rencontre. CONCLUSION: La compréhension qu'ont les membres de la famille de la mort cérébrale et de la détermination du décès représente un parcours qu'ils ont décrit lors de rencontres successives avec des acteurs de soins de santé, et particulièrement avec des médecins. Les facteurs modifiables pour améliorer la communication et les issues du deuil pendant un DCN comprennent l'attention portée à l'état d'esprit de la famille, le rythme et la répétition des discussions en fonction de la compréhension exprimée par les familles, ainsi que la préparation et l'invitation des familles à être présentes pour la détermination clinique, y compris pendant le test d'apnée. Nous avons fourni des recommandations familiales qui sont pragmatiques et peuvent être facilement mises en œuvre.

Development of a consortium to examine organ donation legislative and system reforms: A report from the LEADDR consortium.

In April 2019, the province of Nova Scotia became the first jurisdiction in North America to pass legislation that incorporated deemed consent for deceased organ donation. The reform included many other important updates, including the hierarchy for consent, enabled donor and recipient contact, and mandatory referral of potential deceased donors. Additionally, system reforms were implemented to improve the deceased donation system in Nova Scotia. A collection of national colleagues identified the magnitude of the opportunity to develop a comprehensive strategy to measure and evaluate the impact of the legislative and system reforms. This article describes the successful development of a consortium from both national and provincial jurisdictions that included experts from a variety of backgrounds and clinical and administrative disciplines. In describing the creation of this group, we hope to offer our case example as a model for the evaluation of other health system reforms from a multidisciplinary perspective.

The experiences of family members of deceased organ donors and suggestions to improve the donation process: a qualitative study.

BACKGROUND: Decisions about organ donation are stressful for family members of potential organ donors. We sought to comprehensively explore the donation process from interviews conducted with family members of patients admitted to pediatric and adult intensive care units in Canada. METHODS: We conducted a qualitative study using semistructured, in-depth interviews with 271 family members asked to make an organ donation decision. We recruited participants from all provinces with an organ donation organization (n = 10), and analyzed themes using a modified grounded theory approach. On the basis of these interviews, suggestions were made by researchers and family members on how to improve the process of organ donation. RESULTS: We identified 3 main themes and 9 subthemes. Families need more comprehensive support around the time of donation, including having access to someone with shared experiences, support during specific moments as needed and better support during critical transitions (e.g., when the donor body goes to the operating room). The theme of better connection to recipient(s) included receiving information about the donation surgery (e.g., which organs were recovered), establishing connection with recipients (e.g., via social networks or letters) and planned encounters. Support after donation, such as updates on organ transplantation, early mental health checks and continued connection to donor organizations, could be improved. We derived 20 suggestions for improving the organ donation process, derived from interviews with family members of pediatric and adult organ donors. INTERPRETATION: We found gaps in family support during end-of-life and donation care. Feelings of abandonment, lack of support and poor-to-little follow-up provide the empirical findings needed for hospitals and organ donor organizations to provide better support to donor families.

An ex-ante cost-utility analysis of the deemed consent legislation compared to expressed consent for kidney transplantations in Nova Scotia.

BACKGROUND: This study was an ex-ante cost-utility analysis of deemed consent legislation for deceased organ donation in Nova Scotia, a province in Canada. The legislation became effective in January 2021. The study's objective was to assess the conditions necessary for the legislation change's cost-effectiveness compared to expressed consent, focusing on kidney transplantation (KT). METHOD: We performed a cost-utility analysis using a Markov model with a lifetime horizon. The study was from a Canadian payer perspective. The target population was patients with end-stage kidney disease (ESKD) in Atlantic Canada waitlisted for KT. The intervention was the deemed consent and accompanying health system transformations. Expressed consent (before the change) was the comparator. We simulated the minimum required increase in deceased donor KT per year for the cost-effectiveness of the deemed consent. We also evaluated how changes in dialysis and maintenance immunosuppressant drug costs and living donor KT per year impacted cost-effectiveness in sensitivity analyses. RESULTS: The expected lifetime cost of an ESKD patient ranged from $177,663 to $553,897. In the deemed consent environment, the expected lifetime cost per patient depended on the percentage increases in the proportion of ESKD patients on the waitlist getting a KT in a year. The incremental cost-utility ratio (ICUR) increased with deceased donor KT per year. Cost-effectiveness of deemed consent compared to expressed consent required a minimum of a 1% increase in deceased donor KT per year. A 1% increase was associated with an ICUR of $32,629 per QALY (95% CI: - $64,279, $232,488) with a 81% probability of being cost-effective if the willingness-to-pay (WTP) was $61,466. Increases in dialysis and post-KT maintenance immunosuppressant drug costs above a threshold impacted value for money. The threshold for immunosuppressant drug costs also depended on the percent increases in deceased donor KT probability and the WTP threshold. CONCLUSIONS: The deemed consent legislation in NS for deceased organ donation and the accompanying health system transformations are cost-effective to the extent that they are anticipated to contribute to more deceased donor KTs than before, and even a small increase in the proportion of waitlist patients receiving a deceased donor KT than before the change represents value for money.

What are the short-term annual cost savings associated with kidney transplantation?

BACKGROUND: Kidney transplantation (KT) is often reported in the literature as associated with cost savings. However, existing studies differ in their choice of comparator, follow-up period, and the study perspective. Also, there may be unobservable heterogeneity in health care costs in the patient population which may divide the population into groups with differences in cost distributions. This study estimates the cost savings associated with KT from a payer perspective and identifies and characterizes both high and low patient cost groups. METHOD: The current study was a population-based retrospective before-and-after study. The timespan involved at most three years before and after KT. The sample included end-stage kidney disease patients in Nova Scotia, a province in Canada, who had a single KT between January 1, 2011, and December 31, 2018. Each patient served as their control. The primary outcome measure was total annual health care costs. We estimated cost savings using unadjusted and adjusted models, stratifying the analyses by donor type. We quantified the uncertainty around the estimates using non-parametric and parametric bootstrapping. We also used finite mixture models to identify data-driven cost groups based on patients' pre-transplantation annual inpatient costs. RESULTS: The mean annual cost savings per patient associated with KT was $19,589 (95% CI: $14,013, $23,397). KT was associated with a 24-29% decrease in mean annual health care costs per patient compared with the annual costs before KT. We identified and characterized patients in three cost groups made of 2.9% in low-cost (LC), 51.8% in medium-cost (MC) and 45.3% in high-cost (HC). Cost group membership did not change after KT. Comparing costs in each group before and after KT, we found that KT was associated with 17% mean annual cost reductions for the LC group, 24% for the MC group and 26% for the HC group. The HC group included patients more likely to have a higher comorbidity burden (Charlson comorbidity index ≥ 3). CONCLUSIONS: KT was associated with reductions in annual health care costs in the short term, even after accounting for costs incurred during KT.

The variable impact of the overdose crisis on organ donation among five Canadian provinces: a retrospective study.

BACKGROUND: While most overdose deaths in Canada occur in the community, some patients are resuscitated, admitted to intensive care units having sustained severe anoxic brain injury, and have the potential to be organ donors. The purpose of this study was to determine the impact of the overdose crisis on organ donation in selected Canadian provinces. METHODS: We obtained data on the total number of organ donors and those dying because of overdose in five Canadian provinces from 2014 to 2018. We also obtained data for January-June 2019 for four of five provinces (Quebec excepted). We accessed federal and provincial data on the number of overdose deaths and compared the proportion of organ donors who died of an overdose both over time and between provinces. The number of organ transplants resulting from donors dying of an overdose from three provinces was also determined. RESULTS: From 2014 to 2017, there was a 35% increase (554 to 747) in total deceased organ donors but a 294% increase (31 to 122) in organ donors dying of an overdose. While the proportion of organ donors dying from an overdose increased overall, this varied from 35% (42 of 121) in British Columbia to < 5% in both Quebec (9 of 182) and Nova Scotia (< 2 of 16). There were 1,043 organ transplants resulting from organ donors dying of overdose in BC, Ontario and Alberta although only 2.5-3.5% (297 of 10,858) of those dying of an overdose became organ donors. CONCLUSIONS: There has been an increase in organ donors dying from drug overdose in Canada. Regional variation mirrors differences in total opiate-related death.

RéSUMé: CONTEXTE: Bien que la plupart des décès par surdose au Canada surviennent dans la collectivité, certains patients sont réanimés et admis dans des unités de soins intensifs après avoir subi de graves lésions cérébrales anoxiques, et peuvent devenir des donneurs d'organes. L'objectif de cette étude était de déterminer l'impact de la crise des surdoses sur le don d'organes dans certaines provinces canadiennes. MéTHODE: Nous avons obtenu des données concernant le nombre total de donneurs d'organes et de personnes décédées d'une surdose dans cinq provinces canadiennes de 2014 à 2018. Nous avons également obtenu des données pour la période de janvier à juin 2019 pour quatre des cinq provinces (à l'exception du Québec). Nous avons consulté les données fédérales et provinciales sur le nombre de décès par surdose et comparé la proportion de donneurs d'organes décédés d'une surdose au fil du temps et entre les provinces. Le nombre de greffes d'organes provenant de donneurs décédés par surdose dans trois provinces a également été déterminé. RéSULTATS: Entre 2014 et 2017, il y a eu une augmentation de 35 % (de 554 à 747) du nombre total de donneurs d'organes décédés, mais une augmentation de 294 % (de 31 à 122) du nombre de donneurs d'organes décédés d'une surdose. Bien que la proportion de donneurs d'organes décédés d'une surdose ait augmenté dans l'ensemble, cette proportion variait de 35 % (42 sur 121) en Colombie-Britannique à < 5 % au Québec (9 sur 182) et en Nouvelle-Écosse (< 2 sur 16). Il y a eu 1043 greffes d'organes provenant de donneurs décédés par surdose en Colombie-Britannique, en Ontario et en Alberta, bien que seulement 2,5 à 3,5 % (297 sur 10 858) des personnes décédées d'une surdose soient devenues donneurs d'organes. CONCLUSION: Il y a eu une augmentation du nombre de donneurs d'organes décédés d'une surdose de drogue au Canada. La variation régionale reflète les différences dans le nombre total de décès liés aux opiacés.

Deceased organ donation in Nova Scotia: Presumed consent and system transformation.

In recent years, rates of deceased organ donation in Nova Scotia have remained stagnant, falling behind provinces that have invested in their organ donation programs. The Nova Scotia provincial government has recently committed to health system transformation, which will include enactment of presumed consent legislation in 2020. Although impressive rates of deceased organ donation are often observed in countries with presumed consent legislation, improvements in performance can more often be attributed to the accompanying health system transformation. Key components of high performing deceased organ donation systems include highly trained organ donation specialists, practice guidelines, healthcare professional education, performance metric reviews, accountability frameworks, and public awareness campaigns in addition to adequate legislation. For Nova Scotia's organ donation program to succeed, the provincial government must also invest the frontline financial resources required to develop and maintain adequate program infrastructure and implement key strategies to support a culture of donation.

Nova Scotia's Deemed Consent for Deceased Organ Donation: Family Member Perspectives and Experiences in the ICU Setting.

Background: The purpose of this study was to explore the experience of family members of potential organ donors in the intensive care unit following the change to deemed consent legislation in Nova Scotia. Methods: This was a qualitative study with semistructured, in-depth interviews with 17 family members who were asked to make an organ donation decision on behalf of patients admitted to the intensive care unit in Nova Scotia. We analyzed themes using a descriptive approach. Participants were recruited from the organ donation organization in Nova Scotia, Canada. Results: Participant awareness and knowledge of the Human Organ and Tissue Donation Act legislation varied from individuals having no awareness and knowledge of the bill to those who had awareness and optimism that the legislation would be beneficial for increasing organ donation rates in the province. Other themes emerging from the interviews included (1) COVID context, (2) quality of healthcare professional care, (3) family support, and (4) barriers to donation (waiting, consent questionnaire, and patient transfers). Conclusions: The Human Organ and Tissue Donation Act legislation included enhanced support, which was viewed positively by family members. There is a need for continued evaluation as most participants felt it was too early to see the tangible impacts of the newly implemented legislation.

Views of leaders in under-represented and equity-denied communities on organ and tissue donation in Nova Scotia, Canada, in light of the Human Organ and Tissue Donation Act: a qualitative descriptive study.

OBJECTIVE: To explore the views of underserved and equity-denied communities in Nova Scotia, Canada, regarding organ and tissue donation and deemed consent legislation. DESIGN: A qualitative descriptive study was undertaken, employing both interviews and focus groups. SETTING: The province of Nova Scotia, Canada-the first jurisdiction in North America to implement deemed consent legislation for organ and tissue donation. PARTICIPANTS: Leaders of African Nova Scotian, Lesbian, Gay, Bisexual, Trans, Queer, Two Spirit (LGBTQ2S+) and Faith-based communities (Islam and Judaism) were invited to participate (n=11). Leaders were defined as persons responsible for community organisations or in other leadership roles, and were purposively recruited by the research team. RESULTS: Through thematic analysis, four main themes were identified: (1) alignment with personal values as well as religious beliefs and perspectives; (2) trust and relationships, which need to be acknowledged and addressed in the context of deemed consent legislation; (3) cultural competence, which is essential to the roll-out of the new legislation and (4) communication and information to combat misconceptions and misinformation, facilitate informed decision-making, and mitigate conflict within families. CONCLUSIONS: Leaders of African Nova Scotian, LGBTQ2S+ and Faith-based communities in Nova Scotia are highly supportive of deemed consent legislation. Despite this, many issues exemplify the need for cultural competence at all levels. These findings should inform ongoing implementation of the legislation and other jurisdictions considering a deemed consent approach to organ and tissue donation.

Development of the Nova Scotia Potential Donor Audit (PDA) Tool and 2020 Historic Performance Database: Lessons Learned From the First 1000 Medical Record Reviews.

Background: Legislation and accountability frameworks are key components of high-performing deceased-donation systems. In 2021, Nova Scotia (NS), Canada, became the first jurisdiction in North America to enact deemed consent legislation and concurrently implemented mandatory referral legislation similar to that found in other Canadian provinces. Frontline financial resources were provided by the government to support the development of program infrastructure, including implementation of means to evaluate system performance. Methods: The Organ Donation Program (ODP), in collaboration with other stakeholders, developed a Potential Donor Audit (PDA) tool and database for referral intake and manual performance audits. Medical record reviews of deaths in the year before legislative change were conducted to pilot and revise the PDA and evaluate missed donation opportunities. Results: The NS PDA was piloted on 1028 patient deaths. Of 518 patients (50.4%) who met clinical triggers for referral to the ODP, 72 (13.9%) were referred (86.1% missed referral rate). One hundred sixty-three patients met the NS definition of a potential donor; 53 (32.5%) were referred (110 missed potential donors). Referral consent rates reached 71.7% (n = 38 of 53 approaches). The actualized donation rate reported by Canadian Blood Services was 29.9 donors per million population (n = 34 donors). Discussion: We documented high rates of missed referrals and missed potential donors before the enactment of mandatory referral and deemed consent legislation. Conclusions: The ODP has intentionally broadened clinical criteria for referral to shift the responsibility of identifying medically suitable potential donors from bedside clinicians to organ donation specialists. Lessons learned from our experience developing a PDA include the importance of early involvement of multiple stakeholders and ongoing modification of fields and workflow based on data availability and utility for clinical, educational, research, and reporting purposes.

Organ and Tissue Donation Consent Model and Intent to Donate Registries: Recommendations From an International Consensus Forum.

Consent model and intent to donate registries are often the most public facing aspects of an organ and tissue donation and transplantation (OTDT) system. This article describes the output of an international consensus forum designed to give guidance to stakeholders considering reform of these aspects of their system. Methods: This Forum was initiated by Transplant Québec and cohosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. This article describes the output of the consent and registries domain working group, which is 1 of 7 domains from this Forum. The domain working group members included administrative, clinical, and academic experts in deceased donation consent models in addition to 2 patient, family, and donor partners. Topic identification and recommendation consensus was completed over a series of virtual meetings from March to September 2021. Consensus was achieved by applying the nominal group technique informed by literature reviews performed by working group members. Results: Eleven recommendations were generated and divided into 3 topic groupings: consent model, intent to donate registry structure, and consent model change management. The recommendations emphasized the need to adapt all 3 elements to the legal, societal, and economic realities of the jurisdiction of the OTDT system. The recommendations stress the importance of consistency within the system to ensure that societal values such as autonomy and social cohesion are applied through all levels of the consent process. Conclusions: We did not recommend one consent model as universally superior to others, although considerations of factors that contribute to the successful deployment of consent models were discussed in detail. We also include recommendations on how to navigate changes in the consent model in a way that preserves an OTDT system's most valuable resource: public trust.

A Program of Research to Evaluate the Impact of Deceased Organ Donation Legislative Reform in Nova Scotia: The LEADDR Program.

BACKGROUND: This is the first time deemed consent, where the entire population of a jurisdiction is considered to have consented for donation unless they have registered otherwise, will be implemented in North America. While relatively common in other regions of the world-notably Western Europe-it is uncertain how this practice will influence deceased donation practices and attitudes in Canada. METHODS: We describe a Health Canada funded program of research that will evaluate the implementation process and full impact of the deceased organ donation legislation and the health system transformation in Nova Scotia that includes opt-out consent. RESULTS: There is a need to evaluate the impact of these changes to inform not only Nova Scotia and Atlantic Canada, but also other provincial, national, and international stakeholders. CONCLUSIONS: We establish a rigorous academic framework that we will use to evaluate this significant health system transformation.

Factors associated with organ donation by trauma patients in Nova Scotia.

BACKGROUND: Trauma patients represent a significant pool of potential organ donors (PODs), and previous research suggests that this population is underutilized for organ donation (OD). Our objective was to assess factors associated with OD in the trauma population. METHODS: We retrospectively analyzed OD in Nova Scotia over a 7-year period (2009-2016) using data from the Nova Scotia Trauma Registry and Nova Scotia Legacy of Life Donor Registry. All trauma patients who died in the hospital were included. Multiple logistic regression was used to assess factors associated with donation. We also evaluated characteristics, donation types, and reasons for nondonation among trauma PODs. RESULTS: There were 689 trauma-related deaths in all hospitals in NS during the study period, of which 39.8% (274 of 689) met the Nova Scotia Trauma Registry definition of a POD. Data on OD were available for 108 of these patients who were referred to the Legacy of Life Program. The conversion rate was 84%. Compared with nondonors, organ donors were significantly younger, had a higher Abbreviated Injury Scale head score and a lower scene Glasgow Coma Scale score, were more likely to suffer ischemia from drowning or asphyxia and to require air transport, and were less likely to have comorbidities. Regression analysis showed that donation was associated with younger age (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.95-0.99) and lower Glasgow Coma Scale score at the scene (OR, 0.76; 95% CI, 0.66-0.88). Odds of donation were increased with air transport compared with land ambulance (OR, 8.27; 95% CI, 2.07-33.08) and injury within Halifax Regional Municipality compared with injury outside Halifax Regional Municipality (OR, 4.64; 95% CI, 1.42-15.10). Among the 60 referred PODs who did not donate, family refusal of consent was the most common reason (28 [46.7%] of 60). CONCLUSION: Younger age, greater severity of injury, and shorter time to tertiary care were associated with OD in trauma patients. LEVEL OF EVIDENCE: Prognostic and Epidemiological, Level III.

Patient-centred and family-centred care of critically ill patients who are potential organ donors: a qualitative study protocol of family member perspectives.

INTRODUCTION: In a patient-centred and family-centred approach to organ donation, compassion is paramount. Recent guidelines have called for more research, interventions and approaches aimed at improving and supporting the families of critically ill patients. The objective of this study is to help translate patient-centred and family-centred care into practice in deceased organ donation. METHODS AND ANALYSIS: This will be a national, qualitative study of family members of deceased organ donors in Canada. We will include family members who had been approached regarding an organ donation decision, including those who agreed and declined, at least 2 months and no later than 3 years after the patients' death. Data collection and analysis is ongoing and will continue until September 2020 to include approximately 250 participants. Family members will be identified and recruited from provincial organ donation organisation databases. Four experienced qualitative researchers will conduct telephone interviews in English or French with audio-recording for subsequent transcription. The research team will develop a codebook iteratively through this process using inductive methods, thus generating themes directly from the dataset. ETHICS AND DISSEMINATION: Local research ethics boards (REB) at all participating sites across Canada have approved this protocol. The main REB involved is the Ottawa Health Science Network REB. Data collection began in August 2018. Publication of results is anticipated in 2021. Study findings will help improve healthcare provider competency in caring for potential organ donors and their families and improve organ donation consent rates. Findings will also help with the development of educational materials for a competency-based curriculum for critical care residents.