Adverse Events Reporting Systems in Cells, Organs, and Tissues Donation and Transplantation: Scoping Review.

BACKGROUND: This study aimed to map adverse events reporting systems in cells, organs, and tissues donation and transplantation, including the terms applicable in each system and scientific literature. METHODS: This was a scoping review using the Joanna Briggs Institute method. A search strategy in 3 phases was used, and searches were conducted in PubMed, Embase, LILACS, Scholar Google, and government and organ donations and transplantation associations' sites during June and August 2021. Data collection and analysis were independently made by 2 researchers. The scoping review protocol was registered. RESULTS: Twenty-four articles and other materials were selected for data collection. Eleven reporting systems were analyzed, and terms were identified. CONCLUSIONS: Adverse reporting systems in cells, organs, and tissues donation and transplantation were mapped. The main features are presented, which can help develop new and better systems, with an important discussion about the terms used.

Time Elapsed Between Cells, Tissues, and Organs Donation and Transplantation and Adverse Events Detection.

BACKGROUND: This study was designed to discuss the time elapsed between cell, tissue, and organ donation and transplantation and detection of adverse events notified in São Paulo, Brazil. METHODS: This is a descriptive study with a quantitative approach. Data were provided by the Transplant Center of the state of São Paulo from the "Individual notification form of adverse reactions in Biovigilance" between 2016 and 2019. Analysis was performed using descriptive statistics. RESULTS: Fifty-two notifications were analyzed, and 3 categories were formed: (1) adverse events detected on the same day of the transplant, 8; (2) adverse events detected between 1 week and 1.5 years after transplant, 40; and (3) adverse events detected 2 years after transplant, 4. CONCLUSION: The discussion on the topic is beginning; however, it is important. Clinical management of transplant recipients and comprehending what is considered an adverse event and the natural course of a patient's life can impact clinical decision-making, public policies, and patient safety research. This study highlights the need to investigate related factors to adverse events, especially the time between the transplant procedure and adverse event detection, to establish clinical guidelines.

Defining Quality Criteria for Success in Organ Donation Programs: A Scoping Review.

BACKGROUND: Well-established performance measures for organ donation programs do not fully address the complexity and multifactorial nature of organ donation programs such as the influence of relationships and organizational attributes. OBJECTIVE: To synthesize the current evidence on key organizational attributes and processes of international organ donation programs associated with successful outcomes and to generate a framework to categorize those attributes. DESIGN: Scoping Review using a mixed methods approach for data extraction. SETTING: Databases included PubMed, CINAHL, Embase, LILACS, ABI Business ProQuest, Business Source Premier, and gray literature (organ donation association websites, Google Scholar-first 8 pages), and searches for gray literature were performed, and relevant websites were perused. SAMPLE: Organ donation programs or processes. METHODS: We systematically searched the literature to identify any research design, including text and opinion papers and unpublished material (research data, reports, institutional protocols, government documents, etc). Searches were completed on January 2018, updated it in May 2019, and lastly in March 2020. Title, abstracts, and full texts were screened independently by 2 reviewers with disagreements resolved by a third. Data extraction followed a mixed method approach in which we extracted specific details about study characteristics such as type of research, year of publication, origin/country of study, type of journal published, and key findings. Studies included considered definitions and descriptions of success in organ donation programs in any country by considering studies that described (1) attributes associated with success or effectiveness, (2) organ donation processes, (3) quality improvement initiatives, (4) definitions of organ donation program effectiveness, (5) evidence-based practices in organ donation, and (6) improvements or success in such programs. We tabulated the type and frequency of the presence or absence of reported improvement quality indicators and used a qualitative thematic analysis approach to synthesize results. RESULTS: A total of 84 articles were included. Quantitative analysis identified that most of the included articles originated from the United States (n = 32, 38%), used quantitative approaches (n = 46, 55%), and were published in transplant journals (n = 34, 40.5%). Qualitative analysis revealed 16 categories that were described as positively influencing success/effectiveness of organ donation programs. Our thematic analysis identified 16 attributes across the 84 articles, which were grouped into 3 categories influencing organ donation programs' success: context (n = 39, 46%), process (n = 48, 57%), and structural (n = 59, 70%). LIMITATIONS: Consistent with scoping review methodology, the methodological quality of included studies was not assessed. CONCLUSIONS: This scoping review identified a number of factors that led to successful outcomes. However, those factors were rarely studied in combination representing a gap in the literature. Therefore, we suggest the development and reporting of primary research investigating and measuring those attributes associated with the performance of organ donation programs holistically. TRIAL REGISTRATION: Not applicable.

CONTEXTE: Les mesures de rendement bien établies pour les programmes de dons d'organes ne tiennent pas entièrement compte de la complexité et de la nature multifactorielle de ces programmes, notamment de l'influence des relations et des attributs organisationnels. OBJECTIF: Synthétiser les données actuelles sur les processus et les principaux attributs organisationnels des programmes internationaux de dons d'organes qui sont associés à des résultats favorables, et générer un cadre pour classer ces attributs. TYPE D'ÉTUDE: Examen de la portée où une approche à méthodes mixtes a servi à l'extraction des données. SOURCES: Ont été consultées les bases de données PubMed, CINAHL, Embase, LILAS, ABI Business ProQuest et Business Source Premier, ainsi que la littérature grise (huit premières pages de Google Scholar) et les sites Web pertinents (sites Web d'associations de dons d'organes). ÉCHANTILLON: Les programmes ou processus de don d'organes. MÉTHODOLOGIE: Nous avons procédé à une recherche systématique de la documentation pour répertorier tout plan de recherche pertinent, y compris les manuscrits, articles d'opinion et documents non publiés (données de recherche, rapports, protocoles institutionnels, documents gouvernementaux, etc.). Les recherches se sont terminées en janvier 2018 et ont été mises à jour en mai 2019 et en mars 2020. Les titres, les abrégés et les textes complets ont été révisés de façon indépendante par deux examinateurs; les désaccords ayant été résolus par un troisième. Une combinaison de méthodes a été employée pour l'extraction des données, lesquelles incluaient notamment des détails concernant l'étude (type de recherche, année de publication, pays/origine de l'étude, type de publication, principales conclusions). Les études retenues définissaient et donnaient une description du succès des programmes de dons d'organes dans tout pays; l'examen s'est concentré sur les études décrivant: 1) les attributs associés au succès ou à l'efficacité; 2) les processus de don d'organes; 3) les initiatives d'amélioration de la qualité; 4) les définitions de l'efficacité du programme; 5) les pratiques fondées sur des données probantes, et; 6) les améliorations ou le succès des programmes. Pour chaque amélioration mentionnée, le type et la fréquence de la présence ou de l'absence d'indicateurs de la qualité ont été colligés pour chaque amélioration mentionnée, et une méthode d'analyse thématique qualitative a servi à synthétiser les résultats. RÉSULTATS: En tout, 84 articles ont été inclus. L'analyse quantitative a révélé qu'en majorité, les articles provenaient des États-Unis (n=32 [38 %]), qu'ils utilisaient des approches quantitatives (n=46 [55 %]) et qu'ils avaient été publiés dans des revues de transplantation (n=34 [40,5 %]). L'analyse qualitative a dégagé 16 catégories décrites comme ayant une influence positive sur le succès et l'efficacité des programmes de dons d'organes, alors que l'analyse thématique a permis de répertorier 16 attributs. Ces derniers ont été classés dans trois catégories influençant le succès des programmes de dons d'organes: le contexte (n=39 [46 %]), le processus (n=48 [57 %]) et la structure (n=59 [70 %]). LIMITES: Conformément à la méthodologie d'un examen de la portée, la qualité méthodologique des études incluses n'a pas été évaluée. CONCLUSION: Cet examen de la portée a permis de dégager un certain nombre de facteurs menant à des résultats favorables; ceux-ci ont cependant rarement été étudiés en combinaison, ce qui constitue une lacune dans la littérature. Dès lors, nous suggérons l'élaboration et la présentation de rapports de recherche visant à étudier et à mesurer les attributs associés au rendement des programmes de dons d'organes de façon holistique.

An analysis of the quality indicators of the organ donation process in São Paulo, Brazil.

BACKGROUND: Few studies have investigated whether quality initiatives in the process of organ donation yield better results of the organ donation process. OBJECTIVE: To analyze whether the indicators of the organ donation process in Brazilian hospitals meet the standards established by the Organ Donation European Quality System (ODEQUS). DESIGN: We evaluated the quality of the organ donation in a selected group of Brazilian hospitals served by the Nucleus of Organ Procurement (NOP) using standards of the ODEQUS. RESULTS: Structural and process indicators had 100% conformity. Indicators of results showed a family consent rate of 61% (29% lower than ODEQUS goal); a conversion rate of potential donors to effective donors of 47% (28% below the goal); and a 12% rate of sudden cardiac arrest (higher than the quality limit). CONCLUSIONS: Our findings highlight the importance for the development of quality initiatives in identifying gaps and weaknesses in the process that should be corrected or even restructured, therefore maximizing the number of donors and organs transplanted. Hospitals that participate in the NOP process met 61% of the quality indicators proposed by ODEQUS. Identification of potential donors, family consent, conversion, and sudden cardiac arrest rates are areas that did not conform to ODEQUS standard and revealed a great opportunity for improvement.

Avaliação do tempo de realização do diagnóstico de mortes encefálicas notificadas à Central de Transplantes do Rio Grande do Sul / Evaluation of the time of diagnosis of brain deaths notified to the Center for Transplants of Rio Grande do Sul, Brazil

Objetivos: Avaliar o tempo de realização do diagnóstico de mortes encefálicas notificadas à Central de Transplantes do Rio Grande do Sul e correlacionar o tempo da conclusão desse diagnóstico com os órgãos captados e, consequentemente implantados. Métodos: O estudo incluiu as mortes encefálicas notificadas à Central de Transplantes do Rio Grande do Sul dos doadores efetivos no período de 2003 a 2013. Foram obtidos dados dos doadores (procedência, idade, cor, sexo e causa da morte) e, também, informações sobre o diagnóstico de morte encefálica (data e período do dia em que foi aberto o protocolo, horários do primeiro e segundo teste clínico e horário do exame complementar), bem como os órgãos e tecidos captados e implantados. As comparações de médias entre grupos foram realizadas por meio dos testes t-Student e Anova, ou seus equivalentes não paramétricos Mann-Whitney e Kruskal-Wallis. Resultados: Foram incluídos no estudo 492 doadores efetivos, sendo 275 (55,9%) do sexo masculino. A faixa etária predominante foi a de 40 a 59 anos, com 222 doadores (45,2%). A principal causa de morte foi o acidente vascular encefálico, 276 (56,1%) e o exame complementar mais utilizado foi a angiotomografia, em 177 (36,0%). O rim foi o órgão mais captado, 968 (98,4% da amostra) sendo implantados 94% dos captados; e o coração foi o menos captado, 35 (7,1%), com 100% de implantação. As médias de tempo entre os testes clínicos e a conclusão do diagnóstico de morte encefálica foram de 8,9 e 14,1 horas, respectivamente. Protocolos iniciados à noite e realizados com angiorressonância e eletroencefalograma tiveram um tempo para a conclusão significantemente superior aos demais. Não houve diferença significativa quando correlacionado o tempo de para a conclusão do diagnóstico com os órgãos captados e implantados. Conclusões: O tempo médio total entre os testes clínicos que contemplam o diagnóstico de morte encefálica foi superior ao recomendado pelo Conselho Federal de Medicina. O tempo médio total de realização do diagnóstico de morte encefálica não foi um fator determinante para o número de órgãos captados e implantados.

Aims: To evaluate how long it takes for the diagnosis of brain deaths notified to the Center for Transplants of Rio Grande do Sul, southern Brazil, and to establish a relationship between the time eeded for the diagnosis and the harvest of organs and their transplantation. Methods: The study included brain death notifications to the Center for Transplants of Rio Grande do Sul for donors from 2003 to 2013. Information about the donors (place of origin, age, complexion, sex, and cause of death), about the diagnosis of brain death (date and time of day at which the protocol was created, time of the first and second clinical tests, and time of complementary examination), and about the harvested and transplanted organs and tissues was collected. The means between groups were compared by Student's t test and ANOVA or by their nonparametric counterparts, i.e., Mann-Whitney and Kruskal-Wallis tests. Results: A total of 492 donors were included in the study, among whom 275 (55.9%) were male. There was a predominance of individuals aged 40 to 59 years (222 donors or 45.2%). Stroke was the main cause of death (276 or 56.1%), and CT angiography was the most widely used complementary exam, performed in 177 (36%) individuals. Kidneys were the most frequently harvested organs (968 or 98.4%), being transplanted in 910 (94%) cases. Heart was the least frequently harvested organ (35 or 7.1%), with a transplantation rate of 100%. The average time between the clinical tests and the determination of brain death amounted to 8.9 and 14.1 hours, respectively. Protocols initiated during the night which included magnetic resonance angiography and electroencephalogram presented a higher average time. No significant difference was observed between the time needed for brain death diagnosis and organ harvest and transplantation. Conclusions: The overall average time between clinical tests for the diagnosis of brain death was greater than that recommended by the Brazilian National Medical Council. However, the average time for the diagnosis of brain death was not a determining factor for the number of harvested and transplanted organs.