Organ Donation Organization Architecture: Recommendations From an International Consensus Forum.

This report contains recommendations from 1 of 7 domains of the International Donation and Transplantation Legislative and Policy Forum (the Forum). The purpose is to provide expert guidance on the structure and function of Organ and Tissue Donation and Transplantation (OTDT) systems. The intended audience is OTDT stakeholders working to establish or improve existing systems. Methods: The Forum was initiated by Transplant Québec and co-hosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. This domain group included administrative, clinical, and academic experts in OTDT systems and 3 patient, family, and donor partners. We identified topic areas and recommendations through consensus, using the nominal group technique. Selected topics were informed by narrative literature reviews and vetted by the Forum's scientific committee. We presented these recommendations publicly, with delegate feedback being incorporated into the final report. Results: This report has 33 recommendations grouped into 10 topic areas. Topic areas include the need for public and professional education, processes to assure timely referral of patients who are potential donors, and processes to ensure that standards are properly enforced. Conclusions: The recommendations encompass the multiple roles organ donation organizations play in the donation and transplantation process. We recognize the diversity of local conditions but believe that they could be adapted and applied by organ donation organizations across the world to accomplish their fundamental objectives of assuring that everyone who desires to become an organ donor is given that opportunity in a safe, equitable, and transparent manner.

Tissue and Cell Donation: Recommendations From an International Consensus Forum.

Organ, tissue, and cell donation and transplantation legislation and policies vary substantially worldwide, as do performance outcomes in various jurisdictions. Our objective was to create expert, consensus guidance that links evidence and ethical concepts to legislative and policy reform for tissue and cell donation and transplantation systems. Methods: We identified topic areas and recommendations through consensus, using nominal group technique. The proposed framework was informed by narrative literature reviews and vetted by the project's scientific committee. The framework was presented publicly at a hybrid virtual and in-person meeting in October 2021 in Montréal, Canada, where feedback provided by the broader Forum participants was incorporated into the final manuscript. Results: This report has 13 recommendations regarding critical aspects affecting the donation and use of human tissues and cells that need to be addressed internationally to protect donors and recipients. They address measures to foster self-sufficiency, ensure the respect of robust ethical principles, guarantee the quality and safety of tissues and cells for human use, and encourage the development of safe and effective innovative therapeutic options in not-for-profit settings. Conclusions: The implementation of these recommendations, in total or in part, by legislators and governments would benefit tissue transplantation programs by ensuring access to safe, effective, and ethical tissue- and cell-based therapies for all patients in need.

Research and Innovation in Organ Donation: Recommendations From an International Consensus Forum.

This report provides recommendations from the Research and Innovation domain as part of the International Donation and Transplantation Legislative and Policy Forum (hereafter the Forum) to provide expert guidance on the structure of an ideal organ and tissue donation and transplantation system. The recommendations focus on deceased donation research and are intended for clinicians, investigators, decision-makers, and patient, family, and donor (PFD) partners involved in the field. Methods: We identified topics impacting donation research through consensus using nominal group technique. Members performed narrative reviews and synthesized current knowledge on each topic, which included academic articles, policy documents, and gray literature. Using the nominal group technique, committee members discussed significant findings, which provided evidence for our recommendations. The Forum's scientific committee then vetted recommendations. Results: We developed 16 recommendations in 3 key areas to provide stakeholders guidance in developing a robust deceased donor research framework. These include PFD and public involvement in research; donor, surrogate, and recipient consent within a research ethics framework; and data management. We highlight the importance of PFD and public partner involvement in research, we define the minimum ethical requirements for the protection of donors and recipients of both target and nontarget organ recipients, and we recommend the creation of a centrally administered donor research oversight committee, a single specialist institutional review board, and a research oversight body to facilitate coordination and ethical oversight of organ donor intervention research. Conclusions: Our recommendations provide a roadmap for developing and implementing an ethical deceased donation research framework that continually builds public trust. Although these recommendations can be applied to jurisdictions developing or reforming their organ and tissue donation and transplantation system, stakeholders are encouraged to collaborate and respond to their specific jurisdictional needs related to organ and tissue shortages.

How Are Albertans "Adjusting to and Coping With" Dialysis? A Cross-Sectional Survey.

Background: Depression and anxiety are commonly reported (40% and 11%-52%) among adults receiving dialysis, compared with ~10% among all Canadians. Mental health in dialysis care is underrecognized and undertreated. Objective: (1) To describe preferences for mental health support reported by Albertans receiving dialysis; (2) to compare depression, anxiety, and quality-of-life (QOL) domains for people who would or would not engage in support for mental health; and (3) to explore sociodemographic, mental health, and QOL domains that explain whether people would or would not engage in support for mental health. Design: A cross-sectional survey. Setting: Alberta, Canada. Patients: Adults receiving all modalities of dialysis (N = 2972). Measurements: An online survey with questions about preferences for mental health support and patient-reported outcome measures (Patient Health Questionnaire-9 [PHQ-9], Generalized Anxiety Disorder-7 [GAD-7], and Kidney Disease QOL Instrument-36 [KDQOL-36]). Methods: To address objectives 1 and 2, we conducted chi-square tests (for discrete variables) and t tests (for continuous variables) to compare the distributions of the above measures for two groups: Albertans receiving dialysis who would engage or would not engage in support for mental health. We subsequently conducted a series of binary logistic regressions guided by the purposeful variable selection approach to identify a subset of the most relevant explanatory variables for determining whether or not people are more likely to engage in support for mental health (objective 3). To further explain differences between the two groups, we analyzed open-text comments following a summative content analysis approach. Results: Among 384 respondents, 72 did not provide a dialysis modality or answer the PHQ-9. The final data set included responses from 312 participants. Of these, 59.6% would consider engaging in support, including discussing medication with a family doctor (72.1%) or nephrologist (62.9%), peer support groups (64.9%), and talk therapy (60%). Phone was slightly favored (73%) over in person at dialysis (67.6%), outpatient (67.2%), or video (59.4%). Moderate to severe depressive symptoms (PHQ-9 score ≥10) was reported by 33.4%, and most respondents (63.9%) reported minimal anxiety symptoms; 36.1% reported mild to severe anxiety symptoms (GAD-7 score ≥5). The mean (SD) PHQ-9 score was 8.9 (6.4) for those who would engage in support, and lower at 5.8 (4.8) for those who would not. The mean (SD) GAD-7 score was 5.2 (5.6) for those who would engage in support and 2.8 (4.1) for those who would not. In the final logistic regression model, people who were unable to work had 2 times the odds of engaging in support than people who are able to work. People were also more likely to engage in support if they had been on dialysis for fewer years and had lower (worse) mental health scores (odds ratios = 1.06 and 1.38, respectively). The final model explained 15.5% (Nagelkerke R2) of the variance and with 66.6% correct classification. We analyzed 146 comments in response to the question, "Is there anything else you like to tell us." The top 2 categories for both groups were QOL and impact of dialysis environment. The third category differed: those who would engage wrote about support, whereas those who would not engage wrote about "dialysis is the least of my worries." Limitations: A low response rate of 12.9% limits representativeness; people who chose not to participate may have different experiences of mental health. Conclusions: Incorporating patients' preferences and willingness to engage in support for mental health will inform future visioning for person-centered mental health care in dialysis.

Contexte: La dépression et l'anxiété sont plus fréquemment signalées chez les adultes traités par dialyse (dépression: 40 %; anxiété: 11 à 52 %) comparativement à la population canadienne (environ 10 %). Les problèmes de santé mentale sont insuffisamment reconnus et traités dans les soins de dialyse. Objectifs: (1) décrire les préférences en matière de soutien en santé mentale des Albertains traités par dialyse; (2) comparer les domaines de la dépression, de l'anxiété et de la qualité de vie (QV) pour les personnes désirant obtenir ou non du soutien en santé mentale; (3) explorer les domaines sociodémographiques, de santé mentale et de QV qui expliquent pourquoi une personne désirerait obtenir ou non du soutien en santé mentale. Conception: Sondage transversal. Cadre: Alberta, Canada. Sujets: Adultes recevant toutes les modalités de dialyse (N=2972). Mesures: Un sondage en ligne comportant des questions sur les préférences en matière de soutien en santé mentale. Les mesures des résultats rapportés par les patients à trois questionnaires (questionnaire-9 sur la santé des patients [PHQ-9], questionnaire-7 sur les troubles anxieux généralisés [GAD-7] et l'instrument QOL-36 pour l'insuffisance rénale [KDQOL-36]). Méthodologie: Pour répondre aux objectifs 1 et 2, nous avons effectué des tests chi-carrés (pour les variables discrètes) et des tests t (pour les variables continues) pour comparer les distributions des mesures ci-dessus pour deux groupes: les Albertains sous dialyse désirant obtenir ou non du soutien en santé mentale. Une série de régressions logistiques binaires guidées par une approche de sélection ciblée des variables a ensuite été effectuée pour identifier un sous-ensemble des plus pertinentes variables explicatives permettant de déterminer si les gens sont plus susceptibles de vouloir obtenir du soutien en santé mentale (objectif 3). Pour expliquer plus précisément les différences entre les deux groupes, nous avons analysé les commentaires en texte ouvert en suivant une approche d'analyse de contenu sommative. Résultats: Des 384 répondants, 72 n'ont pas indiqué de modalité de dialyse ni répondu au questionnaire PHQ-9. L'ensemble de données final comprend les réponses de 312 patients. De ce nombre, 59,6 % envisageraient d'obtenir du soutien, notamment une discussion sur les médicaments avec un médecin de famille (72,1 %) ou un néphrologue (62,9 %), une participation à des groupes de soutien par les pairs (64,9 %) ou une psychothérapie (60 %). Les répondants préféraient le téléphone (73 %) plutôt qu'une visite en personne pendant la dialyse (67,6 %), qu'une consultation externe (67,2 %) ou qu'une consultation vidéo (59,4 %). Des symptômes dépressifs modérés à graves (score PHQ-9 ≥10) ont été rapportés par 33,4 % des répondants. La plupart des répondants (63,9 %) a signalé des symptômes minimes d'anxiété et 36,1 % ont signalé des symptômes d'anxiété légers à graves (score GAD-7 ≥5). Le score moyen (É-T) au PHQ-9 était de 8,9 (6,4) pour les sujets qui désiraient obtenir du soutien et de 5,8 (4,8) pour ceux qui n'en désiraient pas. Le score moyen (É-T) au GAD-7 était de 5,2 (5,6) pour les sujets qui désiraient obtenir du soutien et de 2,8 (4,1) pour ceux qui n'en désiraient pas. Dans le modèle final de régression logistique, les personnes qui ne pouvaient pas travailler étaient deux fois plus susceptibles de vouloir chercher du soutien que celles qui pouvaient travailler. Les répondants étaient également plus susceptibles de se faire aider s'ils étaient sous dialyse depuis moins longtemps et avaient des scores de santé mentale inférieurs (les plus faibles) (rapports de cotes respectifs: 1,06 et 1,38). Le modèle final expliquait 15,5 % (Nagelkerke R2) de la variance avec 66,6 % de classification correcte. Nous avons analysé 146 réponses à la question: « Y a-t-il autre chose que vous souhaiteriez nous dire? ¼ Dans les deux groupes, les deux principales catégories étaient la QV et l'impact de l'environnement de dialyse. La troisième catégorie différait: ceux qui en obtenaient écrivaient sur le soutien, alors que ceux qui n'en obtenaient pas ont indiqué que la « dialyse était le moindre de leurs soucis ¼. Limites: Le faible taux de réponse (12,9 %) limite la représentativité; les personnes qui ont choisi de ne pas participer pourraient avoir des expériences différentes en matière de santé mentale. Conclusion: L'intégration des préférences des patients et de leur volonté d'obtenir du soutien en santé mentale permettra d'éclairer la vision future des soins de santé mentale axés sur les patients traités par dialyse.