Critical pathway for deceased donors: An analysis in three regions of Colombia / Ruta crítica de donantes fallecidos: un análisis de tres regiones en Colombia

Introduction. The critical pathway for deceased donation offers a methodical framework for guiding the donation process. It not only serves to assess performance but also to identify areas of potential improvement. Therefore, the identification and selection of potential organ donors (POD) is a key process. This study aims to describe the critical pathway for deceased donation in a cohort of POD in three regions (CRT1, CRT2, and CRT5) of Colombia. Methods. We retrospectively reviewed data of POD assessed from January 2022 to December 2022. General characteristics of POD, diagnosis, contraindication causes, and organ procurement were described. Analysis was conducted using the Chi-squared test for categorical variables and the Mann-Whitney test for quantitative variables. Results. Within the cohort of 1451 assessed POD, 441 (30.3%) were diagnosed with brain death. Among potential donors after brain death, 198 (44.9%) were eligible donors (medically suitable). Of these, 157 donors (79.3%) became actual donors (undergoing operative incision for organ recovery), with 147 (93,6 %) having at least one organ recovered (actual donors with organ recovery). Ultimately, 411 utilized organs were utilized. Additionally, there were observed differences in the characteristics of donors from different regions. Conclusion. This study reports the critical pathway for deceased donation in a cohort of POD in three regions of Colombia. This provides useful information and helps to gain insight and understanding into the process of organ donation and organ procurement in order to take actions that could improve the donation rates.

Introducción. La ruta crítica de donantes fallecidos permite un enfoque sistemático para la donación de riñón, y, proporciona una herramienta para evaluar el rendimiento de áreas de mejora potencial. La selección de posibles donantes de órganos (PDO) es un proceso clave. El objetivo de este estudio fue describir la ruta crítica para la donación de fallecidos en una cohorte de PDO en tres regiones de Colombia. Métodos. Estudio retrospectivo de PDO evaluados durante 2022. Se describieron las características generales de los PDO, el diagnóstico y las causas de contraindicación. El análisis se llevó a cabo utilizando la prueba de Chi-cuadrado para las variables categóricas y la prueba de Mann-Whitney para las variables cuantitativas. Resultados. Entre los 1451 POD evaluados, 441 (30,3 %) fueron diagnosticados con muerte cerebral. De los posibles donantes después de la muerte cerebral, 198 (44,9 %) fueron donantes elegibles (adecuados desde el punto de vista médico). Entre ellos, 157 donantes (79,3 %) fueron donantes reales (en quienes se realizó una incisión operatoria con la intención de recuperar órganos) y 147 (93,6 %) tuvieron al menos un órgano recuperado (donantes reales con recuperación de órganos). Finalmente, se identificaron 411 órganos utilizados. Conclusión. Este estudio reporta la ruta crítica para la donación de fallecidos en una cohorte de POD en tres regiones de Colombia. Esto proporciona información útil, ayuda a obtener conocimientos y comprender el proceso de donación y obtención de órganos, para tomar medidas que puedan mejorar las tasas de donación.

Understanding the dynamics of deceased organ donation and utilization in Colombia / Examen de la dinámica de la donación y utilización de órganos de personas fallecidas en Colombia / Entendendo a dinâmica da doação e do aproveitamento de órgãos de pessoas falecidas na Colômbia

ABSTRACT Objective. To obtain a comprehensive overview of organ donation, organ utilization, and discard in the entire donation process in Colombia. Methods. A retrospective study of 1 451 possible donors, distributed in three regions of Colombia, evaluated in 2022. The general characteristics, diagnosis, and causes of contraindication for potential donors were described. Results. Among the 1 451 possible donors, 441 (30.4%) fulfilled brain death criteria, constituting the potential donor pool. Families consented to organ donation in 141 medically suitable cases, while 60 instances utilized legal presumption, leading to 201 eligible donors (13.9%). Of those, 160 (11.0%) were actual donors (in whom operative incision was made with the intent of organ recovery or who had at least one organ recovered). Finally, we identified 147 utilized donors (10.1%) (from whom at least one organ was transplanted). Statistically significant differences were found between age, sex, diagnosis of brain death, and donor critical pathway between regions. A total of 411 organs were transplanted from 147 utilized donors, with kidneys being the most frequently procured and transplanted organs, accounting for 280 (68.1%) of the total. This was followed by 85 livers (20.7%), 31 hearts (7.5%), 14 lungs (3.4%), and 1 pancreas (0.2%). The discard rate of procured deceased donors was 8.1%. Conclusions. About one-tenth of donors are effectively used for transplantation purposes. Our findings highlight areas of success and challenges, providing a basis for future improvements in Colombia.

RESUMEN Objetivo. Presentar una descripción integral de la donación, utilización y descarte de órganos en todo el proceso de donación en Colombia. Métodos. Estudio retrospectivo de 1 451 donantes posibles, distribuidos en tres regiones de Colombia, que fueron evaluados en el 2022. Se describen las características generales, el diagnóstico y las causas de contraindicación de los donantes potenciales. Resultados. De los 1 451 donantes posibles, 441 (30,4%) cumplían con los criterios de muerte encefálica y constituyeron el conjunto de donantes potenciales. Las familias consintieron la donación de órganos en 141 casos aptos desde el punto de vista médico, mientras que en 60 casos se recurrió a la presunción legal, con lo que se llegó a 201 donantes aptos (13,9%). De estos, 160 (11,0%) fueron donantes reales (en los que se les practicó una incisión quirúrgica para la extracción de órganos o se obtuvo al menos un órgano). En última instancia, hubo 147 donantes utilizados (10,1%) (de los que se trasplantó al menos un órgano). Se observaron diferencias estadísticamente significativas entre las regiones en cuanto a edad, sexo, diagnóstico de muerte encefálica y vía crítica del donante. Se trasplantaron un total de 411 órganos procedentes de 147 donantes utilizados; los riñones fueron los órganos obtenidos y trasplantados con mayor frecuencia, ya que supusieron 280 (68,1%) del total de órganos, seguidos del hígado (85, 20,7%), el corazón (31 , 7,5%), los pulmones (14, 3,4%) y el páncreas (1, 0,2%). La tasa de descarte de los donantes fallecidos disponibles fue del 8,1%. Conclusiones. Aproximadamente una décima parte de los donantes son utilizados, de hecho, para realizar trasplantes. Estos datos destacan las áreas en las que se han obtenido buenos resultados y aquellas en las que se presentan desafíos, lo cual proporciona una base para futuras mejoras en Colombia.

RESUMO Objetivo. Obter uma visão geral e abrangente da doação, do aproveitamento e do descarte de órgãos em todo o processo de doação na Colômbia. Métodos. Estudo retrospectivo de 1 451 possíveis doadores em três regiões da Colômbia que foram avaliados em 2022. Foram descritas as características gerais, o diagnóstico e os motivos para a contraindicação de potenciais doadores. Resultados. Dentre os 1 451 possíveis doadores, 441 (30,4%) preencheram os critérios de morte encefálica, formando o grupo de potenciais doadores. Em 141 casos considerados clinicamente aptos, as famílias consentiram com a doação de órgãos, e em 60 casos utilizou-se o princípio da presunção legal, resultando em 201 doadores elegíveis (13,9%). Desses, 160 (11,0%) foram doadores efetivos (ou seja, doadores nos quais foi feita uma incisão cirúrgica com a intenção de remover um órgão ou pessoas com pelo menos um órgão removido). Por fim, foram identificados 147 doadores utilizados (10,1%) (ou seja, que doaram pelo menos um órgão que foi transplantado). Foram encontradas diferenças estatisticamente significantes entre idade, sexo, diagnóstico de morte encefálica e itinerário crítico de doação entre as regiões. Um total de 411 órgãos foram transplantados de 147 doadores utilizados. Os rins foram os órgãos mais frequentemente removidos e transplantados, representando 280 (68,1%) do total, seguido de 85 fígados (20,7%), 31 corações (7,5%), 14 pulmões (3,4%) e 1 pâncreas (0,2%). A taxa de descarte de doadores falecidos com órgãos removidos foi de 8,1%. Conclusões. Cerca de um décimo dos doadores são efetivamente usados para fins de transplante. Nossos achados destacam áreas de sucesso e desafios, oferecendo uma base para futuras melhorias na Colômbia.

Recusa familiar para doação de córneas para transplante: fatores associados e tendência / Negativa familiar para donación de córneas para trasplante: factores asociados y tendencia / Family refusal to donate a cornea for transplantation: associated factors and trends

Resumo Objetivo Analisar a recusa familiar de doação de córnea para transplante em uma Organização de Procura de Órgãos. Métodos Estudo quantitativo do tipo transversal sobre as recusas de córnea de doadores em situação de morte encefálica. A fonte de dados foi constituída pelos Termos de Autorização de Doação de Órgãos e Tecidos firmados entre janeiro de 2001 a dezembro de 2020 em uma Organização de Procura de Órgãos. Os dados foram coletados, tabulados e analisados de forma descritiva e inferencial. O presente estudo foi aprovado pelo Comitê de Ética em Pesquisa. Resultados Dos 2.447 Termos de Autorização de Doação de Órgãos e Tecidos firmados no período, 620 (25.34%) recusaram a doação de córneas. Com relação à tendência temporal de recusas de doação de córneas, o único período que apresentou significância foi de 2001 a 2009, quando as faixas etárias de zero a 11 anos e 12 a 19 anos demonstraram tendência decrescente, e a faixa etária maior ou igual a 60 anos, mostrou-se crescente. No período total de 2001 a 2020, as faixas etárias dos 20 a 40 anos, 41 a 59 anos e maior ou igual a 60 anos apresentaram, 48%, 59% e 73%, respectivamente, menores chances de recusa da doação de córneas. Conclusão A faixa etária apresentou associação com a recusa, tendo em vista que os indivíduos de maior idade apresentaram maiores índices.

Resumen Objetivo Analizar la negativa familiar de donación de córneas para trasplante en una Organización de Búsqueda de Órganos. Métodos: Estudio cuantitativo tipo transversal sobre la negativa de córnea de donantes en situación de muerte encefálica. La fuente de datos estuvo compuesta por los Términos de Autorización de Donación de Órganos y Tejidos firmados entre enero de 2001 y diciembre de 2020 en una Organización de Búsqueda de Órganos. Se recopilaron los datos, luego se tabularon y se analizaron de forma descriptiva e inferencial. El presente estudio fue aprobado por el Comité de Ética en Investigación. Resultados De los 2447 Términos de Autorización de Donación de Órganos y Tejidos firmados en el período, 620 (25,34 %) negaron la donación de córneas. Con relación a la tendencia temporal de negativas de donación de córneas, el único período que presentó significación fue de 2001 a 2009, cuando los grupos de edad de 0 a 11 años y de 12 a 19 años demostraron una tendencia decreciente, y el grupo de edad mayor o igual a 60 años se mostró creciente. En el período total de 2001 a 2020, los grupos de edad de 20 a 40 años, de 41 a 59 años y mayor o igual a 60 años presentaron un 48 %, un 59 % y un 73 %, respectivamente, menor probabilidad de negativa de donación de córneas. Conclusión El grupo de edad presentó relación con la negativa, considerando que los individuos de mayor edad presentan mayores índices.

Abstract Objective To analyze family refusals to donate a cornea for transplantation in an Organ Procurement Organization. Methods This was a quantitative cross-sectional study on corneal donation refusals from potential brain-dead donors. The data source was based on the Terms of Authorization for Donation of Organs and Tissues signed from January 2001 to December 2020 in an Organ Procurement Organization. Data were collected, tabulated, and analyzed in a descriptive and inferential manner. The present study was approved by the Research Ethics Committee. Results Of the 2,447 Terms of Authorization for Donation of Organs and Tissues signed in the above period, 620 (25.34%) of them refused to donate a cornea. Regarding the time trend of corneal donation refusals, the period 2001-2009 was the only one that showed significance, when the 0-11 and 12-19 age groups showed a decreasing trend and that of 60 years or older showed an increasing trend. In the period 2001-2020, the age groups of 20-40, 41-59, and 60 years or older had lower rates of refusal to donate a cornea (48%, 59%, and 73%, respectively). Conclusion The age group is associated with refusal because older individuals had the highest refusal rates.

Efficacy，safety and cost-effectiveness evaluation of voriconazole original and generic drugs / 中国药房

OBJECTIVE To evaluate the efficacy， safety and cost-effectiveness of generic drugs and original drugs of voriconazole. METHODS The information of patients who used voriconazole generic drugs selected in National Centralized Drug Procurement （generic drug group） or non-selected original drugs （original drug group） in the treatment of fungal infection was collected from the our hospital. The propensity score matching was carried out to eliminate bias. The comprehensive efficacy was evaluated according to clinical efficacy， image findings and microbiological test， and stratified analysis of different populations was conducted based on fungal species， underlying diseases， etc.， the efficacy of different stratifications was evaluated. Evaluation of safety was performed by using the incidence of adverse reactions. The total cost， defined daily doses （DDDs） and defined daily dose cost （DDDc） were used to evaluate the cost-effectiveness. RESULTS A total of 436 patients were included， and there were 190 patients in each group after matching. In terms of efficacy， the effective rates of voriconazole generic drugs and original drugs were 62.63% and 59.47% （P＝0.528）； in terms of safety， the incidence of adverse reactions caused by generic drugs and original drugs of voriconazole was 13.68% and 7.89%， respectively（P＝0.069）. In terms of cost-effectiveness， the average total cost of generic drugs was 4 636.26 yuan， and that of original drugs was 8 613.20 yuan （P＜0.001）. After the implementation of National Centralized Drug Procurement， replacement rate of generic drugs increased to 87.30%， and DDDc decreased by 59.08%. CONCLUSIONS The efficacy and safety of voriconazole generic drugs are similar to those of original drugs in the treatment of fungal infection， and it is more cost-effective in terms of treatment cost.

Analysis of influential factors for purchasing quantity changes in the procurement varieties of the first batch of drug centralized procurement / 中国药房

OBJECTIVE To investigate the factors influencing the changes in purchasing quantity in the procurement varieties of the first batch of volume-based drug centralized procurement （hereinafter referred to as centralized procurement）. METHODS Using 25 procurement varieties of the “4+7” policy as research objects， the changes in purchasing quantity of procurement varieties were analyzed before and after the implementation of the “4+7” pilot， renewal and expansion policies. The influential factors were determined from the three levels of drugs， medical institutions and regions； and the multiple linear regression model was used to analyze the influential factors for the changes in the purchasing quantity of procurement varieties. RESULTS Before and after the implementation of the “4+7” pilot， renewal and expansion policies， the purchasing quantity increased by 52.1， －0.2， 85.8 ten thousand DDDs on average， compared with base period. During pilot， renewal and expansion period， DDDc decrease in procurement varieties was positively correlated with the increase in purchasing quantity （P＜0.01）. During the pilot and renewal period， the number of absolutely alternative varieties was positively correlated with the increase in purchasing quantity （P＜0.1）. During the pilot and expansion period， the number of alternative varieties to a certain extent was negatively correlated with the increase in purchasing quantity （P＜0.05）. During the renewal period， the increment of purchasing quantity in tertiary hospitals was smaller than that of primary medical institutions （P＜0.05）. CONCLUSIONS There is a relationship between the decline of DDDc and the changes in the purchasing quantity， that is， the more the drug price dropped， the more the purchasing quantity increased. The number of alternative varieties for centralized procurement will affect the changes in their purchasing quantity， but it is not always stable. With the implementation of the policy， the volume of primary medical institutions gradually exceeds that of tertiary institutions， indicating that the consumption of centralized purchased varieties is transferred to the primary medical institutions， and centralized procurement has promoted the implementation of the hierarchical diagnosis and treatment system.

Analysis of the effects of national centralized drug volume-based procurement policy in public medical institutions of the Guangxi Zhuang Autonomous Region / 中国药房

OBJECTIVE To investigate the implementation effects of the national centralized drug volume-based procurement policy （abbreviated as “national centralized procurement policy”） in Guangxi Zhuang Autonomous Region prefecture， and to provide a reference for the future centralized drug procurement work of the medical institution. METHODS Drug procurement data before and after policy implementation were included in the study. The six secondary indicators （such as availability， affordability， and drug safety） and eighteen third-level indicators （such as completion rate of agreed purchase volume， affordability level， drug revenue proportion） were introduced， guided by the policy objectives and issues of concern to policy beneficiaries. Descriptive statistics was adopted to analyze the data before and after policy implementation （in 2019 and 2020） in terms of differences and change trends. RESULTS In terms of accessibility， the participation rate of medical institutions in Guangxi Zhuang Autonomous Region was 92.55%， the proportion of diseases involved and median completed procurement rate were 40.16%， and 287.82% respectively， and the total centralized delivery rate was 97.20%. In terms of affordability， the total reduction amplitude in drug price was 74.80% from 2019 to 2022； the charge for medicine per capita in hospitalization， the proportion of medicine used for outpatient service and hospitalization， decreased by 17.61%， 10.22%， and 20.10% in order； the burden levels on medical fares for patients were all below 1 in addition to chronic diseases， and anti-tumor drugs. In terms of the impact on medicine， the ratio of adverse drug reaction event cases in 2022 was 66.00%， an increase of 1.29% compared to the previous； since the implementation of the policy， 12 drugs from local pharmaceutical enterprises from Guangxi Zhuang Autonomous Region had passed the consistency evaluation， and the market concentration rate of the top 8 pharmaceutical companies was less than 20.00%. In terms of the impact on healthcare and medical insurance， the public medical institutions achieved generic substitution for originator drugs mostly until 2022； about 9.12% of drugs that were non- centrally purchased in the same category were used； 63.39% of people under investigation did not show a need for a second dressing change； drug expenditure decreased by 2.459 billion yuan. CONCLUSIONS The national centralized procurement policy achieves a significant effect in Guangxi Zhuang Autonomous Region. On the other hand， attention should be paid to these suggestions as follows: expanding the category of drugs used in clinic， conducting clinically comprehensive evaluation of selected drugs， and improving reasonable allocation strategy， etc.

Research report of living donor kidney harvesting in Bama miniature pigs with six gene modified / 器官移植

Objective To summarize the experience and practical value of living donor kidney harvesting in Bama miniature pigs with six gene modified. Methods The left kidney of Bama miniature pigs with six gene modified was obtained by living donor kidney harvesting technique. First, the ureter was occluded, and then the inferior vena cava and abdominal aorta were freed. During the harvesting process, the ureter, renal vein and renal artery were exposed and freed in sequence. The vascular forceps were used at the abdominal aorta and inferior vena cava, and the renal artery and vein were immediately perfused with 4℃ renal preservation solution, and stored in ice normal saline for subsequent transplantation. Simultaneously, the donor abdominal aorta and inferior vena cava gap were sutured. The operation time, blood loss, warm and cold ischemia time, postoperative complications and the survival of donors and recipients were recorded. Results The left kidney of the genetically modified pig was successfully harvested. Intraoperative bleeding was 5 mL, warm ischemia time was 45 s, and cold ischemia time was 2.5 h. Neither donor nor recipient pig received blood transfusion, and urinary function of the kidney transplanted into the recipient was recovered. The donor survived for more than 8 months after the left kidney was resected. Conclusions Living donor kidney harvesting is safe and reliable in genetically modified pigs. Branch blood vessels could be processed during kidney harvesting, which shortens the process of kidney repair and the time of cold ischemia. Living donor kidney harvesting contributes to subsequent survival of donors and other scientific researches.

Progress in quality management and control of donor organ procurement in foreign countries / 器官移植

Since the 20th century, organ transplantation has become a breakthrough technology to effectively save the lives of patients with end-stage organ failure, which has significantly enhanced the quality of life of patients. Organ donation is an important source of organ transplantation. Improving the quality of donor organ procurement is the key to promote the translation of donor organs and improve the prognosis of organ transplantation recipients. The United States, Spain and other countries have put forward a series of policies and standards in the quality management and control of donor organ procurement and achieved positive results. In this article, related concepts of medical quality management and control, advanced strategies and models of international donor organ procurement quality management, and quality control measures of Organ Procurement Organization, donors and donor organs were reviewed, aiming to provide reference for establishing a quality management and control system of donor organs with "Chinese characteristics" and advancing high-speed and high-quality development of donor organ procurement.

Caracterização epidemiológica e causas da não doação por potenciais doadores de órgãos em morte encefálica / Epidemiological characterization and causes of non-donation by potential brain-dead organ donors / Caracterización epidemiológica y causas de la no donación de potenciales donantes de órganos en muerte cerebral

Objetivo: analisar as características epidemiológicas e causas da não efetivação do processo de doação de órgãos e tecidos de potenciais doadores em morte encefálica. Método: estudo transversal, com dados secundários do ano de 2019, obtidos de formulários de notificação de morte encefálica de pacientes com idade igual e superior a 18 anos, analisados descritiva e inferencialmente, após aprovação pelo comitê de ética. Resultados: notificadas 231 mortes encefálicas, com maior incidência de pessoas do sexo masculino, idade média de 48 anos e notificações dos hospitais públicos. Em Campo Grande, Mato grosso do Sul, observou-se maior número de notificações e o menor tempo entre a notificação e o primeiro exame clínico (RR: 4,01; IC 2,17-7,41; p<0,001). Entre os casos de não doação, 75,8% ocorreram por contraindicação médica e recusa familiar. Conclusão: houve predomínio de adultos jovens, não doadores de órgãos, cuja negativa da família deu-se pela vontade de manter o corpo íntegro.(AU)

Objective: to analyze the epidemiological characteristics and causes of non-completion of the organ and tissue donation process from potential brain-dead donors. Method: cross-sectional study, with secondary data from 2019, obtained from brain death notification forms of patients aged 18 years and over, analyzed descriptively and inferentially, after approval by the ethics committee. Results: 231 brain deaths were reported, with a higher incidence of males, average age of 48 years and notifications from public hospitals. In Campo Grande, Mato grosso do Sul, Brazil, there was a greater number of notifications and a shorter time between notification and the first clinical examination (RR: 4.01; CI 2.17-7.41; p<0.001). Among cases of non-donation, 75.8% occurred due to medical contraindication and family refusal. Conclusion: there was a predominance of young adults, non-organ donors, whose family's refusal was due to the desire to keep the body intact(AU)

Objetivo: analizar las características epidemiológicas y las causas de la no finalización del proceso de donación de órganos y tejidos de potenciales donantes en muerte cerebral. Método: estudio transversal, con datos secundarios del año 2019, obtenidos de formularios de notificación de muerte encefálica de pacientes de 18 años y más, analizados de manera descriptiva e inferencial, previa aprobación del comité de ética. Resultados: Se reportaron 231 muertes encefálicas, con mayor incidencia de hombres, edad promedio de 48 años y notificaciones de los hospitales públicos. En Campo Grande, Mato grosso do Sul, hubo mayor número de notificaciones y menor tiempo entre la notificación y el primer examen clínico (RR: 4,01; IC 2,17-7,41; p<0,001). Entre los casos de no donación, el 75,8% se produjo por contraindicación médica y negativa familiar. Conclusión: hubo predominio de adultos jóvenes, no donantes de órganos, cuya negativa familiar se debió al deseo de mantener el cuerpo íntegro(AU)

Nefrectomía totalmente laparoscópica para donante vivo de riñón: Características y desenlaces en una institución de alta complejidad en Colombia. Serie de casos / Total laparoscopic nephrectomy for a living kidney donor: Characteristics and outcomes in a single center from Colombia. Case series

Introducción. El trasplante es la mejor opción de tratamiento para los pacientes con enfermedad renal terminal, sin embargo, existe discrepancia entre las listas de espera y la disponibilidad de órganos a partir de la donación cadavérica. Buscando aumentar el número de órganos disponibles se implementó el trasplante con donante vivo. A partir de la introducción de técnicas mínimamente invasivas para la nefrectomía, el donante vivo ha logrado cifras cercanas al 50 % de los trasplantes realizados en muchas instituciones, debido a los beneficios propios del procedimiento. El objetivo de este estudio fue describir los resultados después de la incorporación del procedimiento totalmente laparoscópico en nuestra institución. Métodos. Se hizo un análisis retrospectivo de las características de los pacientes llevados a nefrectomía para obtención de injerto por técnica totalmente laparoscópica y los resultados en un solo centro en Cali, Colombia, desde noviembre de 2019 hasta octubre de 2022. Los datos fueron obtenidos mediante la revisión de las historias clínicas electrónicas. Resultados. Se realizaron 78 nefrectomías para obtención de injerto con técnica totalmente laparoscópica. El tiempo operatorio promedio fue de 152 minutos, el sangrado promedio fue de 12 ml, la estancia hospitalaria promedio del donante fue de 2,8 días. La tasa de complicaciones fue de 7,6 % (4 pacientes con complicación Clavien-Dindo I y 2 pacientes Clavien-Dindo IIIb). No se presentó ningún caso de mortalidad. Conclusiones. La técnica totalmente laparoscópica resulta ser una técnica segura con baja tasa de morbilidad y excelentes beneficios para los donantes.

Introduction. Kidney transplant is the best treatment option for end-stage renal disease. However, the discrepancy between waiting lists and the availability of organs from cadaveric donation is well known. Organ transplantation with a living donor was implemented to increase the number of organs available. Since the introduction of minimally invasive techniques for nephrectomy, living donors have achieved figures close to 50% of transplants performed in many institutions due to the procedure's benefits. In our country, the experiences described are from the hand-assisted technique. This is the first description after incorporating the laparoscopic procedure. Methods. A retrospective analysis of the characteristics and results of all patients undergoing nephrectomy to obtain a graft using a laparoscopic technique was carried at a single center in Cali, Colombia, from November 2019 to October 2022. The electronic medical records were reviewed to obtain the data. Results. Seventy-eight nephrectomies were performed to obtain a graft with a laparoscopic technique. The mean operating time was 152 minutes, the average bleeding was 12 cc, and the average hospital stay was 2.8 days. The complication rate was 7.6% (four patients with Clavien-Dindo I complication and two Clavien-Dindo IIIb patients). There were no cases of mortality. Conclusions. The laparoscopic technique is safe, with a low morbidity rate and excellent benefits.

Caracterização do processo de doação de órgãos em uma região do nordeste brasileiro / Caracterización del proceso de donación de órganos en una región de Brasil / Caracterization of the organ donation process in a region of northeast Brazil

Introdução: O processo de doação de órgãos e tecidos é definido por ações a fim de transformar um Potencial Doador (PD) em doador efetivo e inicia-se com o diagnóstico de morte encefálica. Objetivo: Analisar o perfil clínico e sociodemográfico dos potenciais doadores de órgãos, como também os fatores que influenciam na doação de órgãos. Métodos: Trata-se de uma pesquisa quantitativa, transversal, retrospectiva e analítica realizada através da coleta de dados de 455 prontuários de pacientes com diagnóstico de Morte Encefálica, de uma Região do Nordeste brasileiro, utilizando formulário estruturado. Posteriormente realizaram-se análises descritivas e nas associações entre as variáveis independentes e dependente, utilizou-se o teste qui-quadrado de Pearson Resultados: As faixas etárias de maior incidência foram entre 21 a 40 anos e 41 a 60 anos, com 33,8% cada, prevalecendo o sexo masculino (64,1%). Em relação à causa da morte, predominou o Trauma Cranioencefálico com 36,5%. Foram entrevistados 83,3% dos familiares e desses, 53,5% autorizaram a doação. Quanto à relação das respostas das entrevistas com os familiares e o sexo dos PD o sexo masculino se destacou com 59,01% das entrevistas positivas, quanto a entrevista e faixa etária, não foram encontradas diferenças significativas. Correlacionando o resultado das entrevistas familiares e a causa da morte, 40,63% destas tinham como causa o trauma cranioencefálico, e desse total, 63,63% tiveram a doação autorizada. Conclusão: A maioria dos doadores efetivos foram jovens e do sexo masculino, com prevalência do trauma craneoencefálico como causa da morte encefálica e da aceitação familiar para a doação.

Introducción: El proceso de donación de órganos y tejidos se define por las acciones encaminadas a transformar a una persona donante potencial (DP) en donante efectiva. Este proceso comienza con el diagnóstico de muerte encefálica. Objetivo: Analizar el perfil clínico y sociodemográfico de potenciales donantes de órganos, así como los factores que influyen en la donación de órganos. Métodos: Se trata de una investigación cuantitativa, transversal, retrospectiva y analítica realizada a partir de la recopilación de datos de 455 prontuarios de pacientes con diagnóstico de muerte encefálica, en una región del Nordeste de Brasil, utilizando un formulario estructurado. Posteriormente, se realizaron análisis descriptivos y, en las asociaciones entre las variables independiente y dependiente, se utilizó la prueba chi-cuadrado de Pearson Resultados: Los grupos de edad con mayor incidencia fueron de 21 a 40 años y de 41 a 60 años, con un 33.8 % cada uno, con predominio del sexo masculino (64.1 %). En cuanto a la causa de muerte, predominó el trauma craneoencefálico con un 36.5 %. Se entrevistó al 83.3 % de familiares y, de este grupo, el 53.5 % autorizó la donación. En cuanto a la relación entre las respuestas de las entrevistas a familiares y el sexo del TP, se destacó el sexo masculino con un 59.01 % de las entrevistas positivas; en cuanto a la entrevista y grupo de edad no se encontraron diferencias significativas. Correlacionando los resultados de las entrevistas familiares y la causa de muerte, el 40.63 % fue por trauma craneoencefálico y, de ese total, el 63.63 % tenía autorizada la donación. Conclusión: Los donantes más efectivos fueron jóvenes y varones, con predominio del traumatismo craneoencefálico como causa de muerte encefálica y aceptación familiar de la donación.

Introduction: The process of organ and tissue donation is defined by actions to transform a Potential Donor (PD) into an effective donor and begins with the diagnosis of brain death. Objective: To analyze the clinical and sociodemographic profile of potential organ donors, as well as the factors that influence organ donation. Methods: This is a quantitative, cross-sectional, retrospective, and analytical research carried out in a region of Northeast Brazil by collecting data from 455 medical records of patients with brain death, who were diagnosed using a structured form. Subsequently, descriptive analyzes were carried out and for the associations between the independent and dependent variables, the Pearson's chi-square test was used. Results: The age groups with the highest incidence were between 21 to 40 years old and 41 to 60 years old, with a 33.8 % each, with a predominance of males (64.1%). Regarding the cause of death, traumatic brain injury was the most common with a 36.5% of the sample. From the 83.3% of the family members that were interviewed, 53.5% of them authorized the donation. Male potential donors constituted the 59.01% of the authorized donations (positive interviews). There was no relationship between the interview results and the age group of the PD. When correlating the results of family interviews and the cause of death, 40.63% of them were caused by traumatic brain injury and, out of this total, 63.63% had the donation authorized. Conclusion: The most effective donors were young and male whose cause of brain death was traumatic brain injury and whose families allowed the donation.

Ethics of the use of dead human bodies in anatomy teaching in India

The study of the human anatomy predominantly requires the use of remains of the dead. Unclaimed bodies are easily available in India; however, there is a lack of clear ethical guidelines governing their transport and exchange. We raise pertinent questions about the ethical implications of using unclaimed bodies in teaching anatomy, their transport, transfer and storage, ethical and legal issues regarding the voluntary donation of bodies and dry human bones, as well as the commercial aspects of body donation. We also examine existing practices in anatomy departments in India, and explore the available legal safeguards. We detail practical and ethical challenges in the existing practices and safeguards and attempt to provide solutions.

Potenciais doadores de órgãos em morte encefálica: caracterização e identificação de diagnósticos de enfermagem / Potential brain-dead organ donors: characterization and identification of nursing diagnoses / Donantes potenciales de órganos en muerte cerebral: caracterización e identificación de los diagnósticos de enfermería

RESUMO Objetivo: Identificar os diagnósticos de enfermagem de potenciais doadores de órgãos em morte encefálica segundo a Taxonomia NANDA-I. Método: Estudo observacional, transversal realizado em hospital público no interior do Ceará, Brasil. Coleta de dados nos meses de outubro e novembro de 2021, em 23 prontuários de potenciais doadores de órgãos. Dados foram analisados por estatística descritiva. Resultados: Identificaram-se 22 diferentes diagnósticos, em cinco dos 13 domínios da taxonomia da NANDA-I. Prevaleceram: risco de glicemia instável; risco de função hepática prejudicada; troca de gases prejudicada; mobilidade no leito prejudicada; padrão respiratório ineficaz; risco de infecção; risco de lesão por pressão; risco de aspiração; risco de débito cardíaco diminuído; risco de quedas, eliminação urinária prejudicada; risco de desequilíbrio eletrolítico e risco de pressão arterial instável. Conclusão: A identificação dos diagnósticos poderá favorecer o aprimoramento da prática e a aplicação do processo de enfermagem diante da assistência aos potenciais doadores de órgãos.

ABSTRACT Objective: To identify the nursing diagnoses of potential organ donors in brain death according to the NANDA-I Taxonomy. Method: Observational, cross-sectional study conducted in a public hospital in the interior of Ceará, Brazil. Data collection was realized in October and November 2021 in 23 medical records of potential organ donors. Descriptive statistics analyzed data. Results: Twenty-two diagnoses were identified in five of the 13 domains of the NANDA-I taxonomy. The following were prevalent: risk of unstable blood glucose; risk of impaired liver function; impaired gas exchange; impaired bed mobility; ineffective breathing pattern; risk of infection; risk of pressure injury; risk of aspiration; risk of decreased cardiac output; risk of falls, impaired urinary elimination; risk of electrolyte imbalance and risk of unstable blood pressure. Conclusion: The identification of diagnoses may favor the improvement of practice and the application of the nursing process in the care of potential organ donors.

RESUMEN Objetivo: Identificar los diagnósticos de enfermería de los posibles donantes de órganos en muerte encefálica según la Taxonomía NANDA-I. Método: Estudio observacional, transversal, realizado en un hospital público del interior de Ceará, Brasil. Recogida de datos en octubre y noviembre de 2021, en 23 historias clínicas de posibles donantes de órganos. Los datos se analizaron mediante estadísticas descriptivas. Resultados: Se identificaron 22 diagnósticos diferentes, en cinco de los 13 dominios de la taxonomía NANDA-I. Predominaron los siguientes: riesgo de glucemia inestable; riesgo de deterioro de la función hepática; deterioro del intercambio gaseoso; deterioro de la movilidad en la cama; patrón respiratorio ineficaz; riesgo de infección; riesgo de lesión por presión; riesgo de aspiración; riesgo de disminución del gasto cardíaco; riesgo de caídas, deterioro de la eliminación urinaria; riesgo de desequilibrio electrolítico y riesgo de tensión arterial inestable. Conclusión: La identificación de diagnósticos puede favorecer la mejora de la práctica y la aplicación del proceso de enfermería en el cuidado de los donantes potenciales de órganos.

Resultados en receptores de trasplante renal de donantes cadavéricos con infección por SARS-CoV-2: Una serie de casos en un centro de trasplante en Colombia / Results in kidney transplant recipients from cadaveric donors with SARS-CoV-2 infection: A case series in a transplant center in Colombia

Introducción. La pandemia por COVID-19 ha causado la muerte de 6,5 millones de personas en el mundo y la donación de órganos se ha visto ampliamente afectada, reflejándose en una disminución importante en el número de trasplantes. Colombia no ha sido ajena a dicha problemática. Ante este desafío, el Instituto Nacional de Salud ha permitido tomar donantes cadavéricos con reacción en cadena de la polimerasa con transcripción reversa (RT-PCR) positiva para Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), sin enfermedad activa. El objetivo de este estudio fue describir una serie de pacientes trasplantados de riñón con donantes cadavéricos con RT-PCR SARS-CoV-2 positivo y sus principales desenlaces clínicos. Métodos. Serie de casos de pacientes que fueron llevados a trasplante renal con donante cadavérico con SARS-CoV-2 positivo, sin enfermedad activa, entre mayo y agosto de 2022. Se recolectaron las variables demográficas y clínicas y se evaluó la infección y la mortalidad asociada a SARS-CoV-2 en un mes de seguimiento. Resultados. Un total de 5 receptores de trasplante renal con 5 donantes cadavéricos SARS-CoV-2 positivos fueron evaluados. No se presentó mortalidad ni pérdida del injerto renal. Se registraron dos casos de función retardada del injerto y un caso de rechazo agudo. Ninguno de los pacientes presentó RT-PCR SARS-CoV-2 positiva en el seguimiento posterior al trasplante. Conclusión. Con nuestra serie de casos mostramos que el trasplante de riñón proveniente de donante cadavérico con prueba positiva para RT-PCR SARS-CoV-2, sin evidencia de enfermedad COVID-19 activa, es un procedimiento seguro y una estrategia eficaz para aumentar el número de donantes en pandemia

Introduction. Coronavirus Disease-2019 (COVID-19) pandemic have caused the death of 6.5 million of people worldwide. The organ donation was extremely affected reflecting in the number of transplants. Colombia has not been immune to this problem. Facing this challenge, the National Institute of Health (Instituto Nacional de Salud, INS) allowed to assign cadaveric donors with reverse transcription-polymerase chain reaction (RT-PCR) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive without COVID-19. We aim to describe a case series of kidney transplant patients with RT-PCR SARS-CoV-2 positive cadaveric donors, and their main clinical outcomes. Methods. A case series of five patients who underwent kidney transplantation of cadaveric donors with positive RT-PCR SARS-CoV-2 during the study period from May to august of 2022. Demographics and clinical characteristics were collected from the institutional medical records, and we evaluated the mortality and infection associated with SARS-CoV-2. Results. A total of five kidney transplant recipients and five cadaveric donors with positive RT-PCR SARS-CoV-2 were described in the present study. There were not mortality reported and none of the patients had graft loss. Two cases of delayed graft function and one case of acute kidney rejection were documented. None of the patients had positive RT-PCR SARS-CoV-2 in the follow-up. Conclusion. Our series demonstrated that the kidney transplant of cadaveric donors with positive RT-PCR SARS-CoV-2 without clinical evidence of active COVID-19 disease is a safe procedure and an efficient strategy to increase donors during a pandemic

Tecnologías de información para lucha anticorrupción: análisis de la contratación pública costarricense / Tecnologias da informação para a luta contra a corrupção: análise da contratação pública costarriquenha / Information technologies for countering corruption: analysis of the Costa Rican public procurement system

Resumen La corrupción es un fenómeno con consecuencias desastrosas para el bienestar económico, social y político de nuestras sociedades. En particular, la contratación pública es vulnerable debido al elevado valor económico de sus transacciones. La presente investigación analiza el rol que las tecnologías de información pueden jugar en la lucha anticorrupción. Desarrollamos un caso basado en datos abiertos de contrataciones públicas en Costa Rica, con la finalidad de identificar los conceptos principales asociados al sistema de información subyacente. El caso muestra el potencial de las herramientas tecnológicas de análisis de redes sociales para contrarrestar la complejidad de las redes de corrupción. Asimismo, se evidencia la necesidad de disponer de un ecosistema rico en datos anticorrupción, preferiblemente en formato abierto.

Resumo: A corrupção é um fenômeno com consequências desastrosas para o bem-estar econômico, social e político das nossas sociedades. Em particular, a contratação pública é um fator altamente vulnerável devido ao alto valor econômico de suas transações. A pesquisa analisa o papel que as tecnologias da informação podem desempenhar no combate à corrupção. Além disso, desenvolvemos um caso baseado em dados abertos sobre compras públicas na Costa Rica, a fim de identificar os principais conceitos associados ao sistema de informação subjacente. O caso mostra o potencial das ferramentas tecnológicas de análise de redes sociais para ir de encontro a complexidade das redes de corrupção. Mostra também a necessidade de um ecossistema diversificado e sustentável de dados anticorrupção - preferencialmente em formato aberto.

Abstract Corruption has disastrous consequences for the well-being of societies. In particular, public procurement is a highly vulnerable factor due to the high value of its transactions. This research analyzes the role that information technologies can play in the fight against corruption. We developed a case based on open data on public procurement in Costa Rica to identify the main concepts associated with the underlying information system. The case shows the potential of technological tools for social network analysis to counter the complexity of corruption networks. It also shows the need for a rich ecosystem of anti-corruption data - preferably in an open format.

The impact of COVID-19 on kidney transplant activities in Brazil: a descriptive study

ABSTRACT BACKGROUND: The coronavirus 19 (COVID-19) pandemic has reached services, systems, and world society. Despite its certified efficiency, the Brazilian National Transplant System is not exempt from the side effects of COVID-19. OBJECTIVE: To compare kidney transplantation activity registered in Brazil between the pandemic (2020) and pre-pandemic (2019) periods. DESIGN AND SETTING: A descriptive study was conducted in March 2021. The annual reports of the Brazilian Transplantation Registry for 2019 and 2020 were included in this study. METHODS: We conducted a descriptive study of kidney transplant activity in Brazil in 2019 and 2020. RESULTS: A 23.9% decrease in kidney transplants per million population was observed during the pandemic period (22.9 in 2020 versus 30.1 in 2019). Kidney transplants with a living donor (-58.8%) and in the North Region (-79.5%) experienced the greatest declines. The pandemic waiting list increased by 6.8%, and deaths during the waiting period increased by 36.8%. The number of patients on the waiting list and transplant teams decreased by 31.3% and 9.5%, respectively. CONCLUSION: The COVID-19 pandemic drastically affected Brazil and had a significant negative impact on KT activities in the country.

Care for potential brain-dead organ donors in an adult emergency room: a convergent care perspective / Asistencia a potenciales donantes de órganos en muerte encefálica en un servicio de urgencias de adultos: una perspectiva de asistencia convergente / Assistência ao potencial doador de órgãos em morte encefálica em pronto-socorro adulto: perspectiva convergente-assistencial

ABSTRACT Objective: to investigate situations that interfere with health professionals' performance, in the identification and maintenance of potential brain-dead donors in an Adult Emergency Care Unit, and to indicate actions, from the health team's perception, that can promote care for these patients. Method: this is a qualitative, convergent care research, carried out with health professionals from an adult emergency unit, a large public teaching hospital located in southern Brazil. Data were collected between February 2020 and January 2021 through structured participant observation, semi-structured interview and convergence group. Data analysis was performed according to the stages of gathering, synthesis, theorization and transfer. Results: based on data analysis, the difficulties in caring for brain-dead persons, lack of information, inadequate structure and difficulties in the work process were identified as situations that interfere with health professionals' performance in relation to brain-dead potential donors. Actions were signaled to promote care for these people through continuing education activities on the subject, dissemination of information, construction of technologies/protocols, organization of infrastructure and the work process with support for professionals who assist these people. Conclusion: it was evidenced that professional education, the organization of the donation process and systematized actions to improve the work are fundamental factors for the effective care for brain-dead potential organ donors.

RESUMEN Objetivo: investigar situaciones que interfieren en la actuación de los profesionales de la salud, en la identificación y mantenimiento de potenciales donantes en muerte encefálica en una unidad de emergencia de adultos y señalar acciones, en la percepción del equipo de salud, que puedan promover el cuidado de estos pacientes. Método: Investigación cualitativa, de asistencia convergente, realizada con profesionales de la salud de una unidad de emergencia de adultos, de un gran hospital público de enseñanza ubicado en el sur de Brasil. Los datos fueron recolectados entre febrero de 2020 y enero de 2021 a través de observación participante estructurada, entrevista semiestructurada y grupo de convergencia. El análisis de los datos se realizó según las etapas: aprehensión, síntesis, teorización y transferencia. Resultados: con base en el análisis de los datos, las dificultades en la asistencia a la persona con muerte encefálica, falta de información, estructura inadecuada y dificultades en el proceso de trabajo fueron identificadas como situaciones que interfieren en la actuación de los profesionales de la salud en relación al potencial donante en cerebro muerte. Se señalaron acciones para promover la asistencia a estas personas a través de actividades de educación continua en el tema, difusión de información, construcción de tecnologías/protocolos, organización de la infraestructura y del proceso de trabajo con apoyo a los profesionales que asisten a estas personas. Conclusión: se evidenció que la educación profesional, la organización del proceso de donación y acciones sistematizadas para mejorar el trabajo son factores fundamentales para la asistencia eficaz al potencial donante de órganos en muerte encefálica.

RESUMO Objetivo: investigar situações que interferem na atuação dos profissionais da saúde, na identificação e manutenção do potencial doador em morte encefálica em uma unidade de pronto-socorro adulto e sinalizar ações, na percepção da equipe de saúde, que possam promover a assistência a esses pacientes. Método: pesquisa qualitativa, convergente-assistencial, realizada com profissionais de saúde de uma unidade de pronto-socorro adulto, de um hospital-escola público e de grande porte localizado no Sul do Brasil. Os dados foram coletados entre fevereiro de 2020 e janeiro de 2021 por meio de observação estruturada participante, entrevista semiestruturada e grupo de convergência. A análise dos dados foi realizada de acordo com as etapas: apreensão, síntese, teorização e transferência. Resultados: a partir da análise dos dados identificaram-se como situações que interferem na atuação dos profissionais da saúde frente ao potencial doador em morte encefálica as dificuldades na assistência à pessoa em morte encefálica, a falta de informação, estrutura inadequada e as dificuldades no processo de trabalho. Houve sinalização de ações para promover a assistência a essas pessoas por meio de atividades de educação permanente sobre o tema, divulgação de informações, construção de tecnologias/protocolos, organização da infraestrutura e do processo de trabalho com suporte aos profissionais que atendem essas pessoas. Conclusão: evidenciou-se que a educação profissional, a organização do processo de doação e ações sistematizadas para aperfeiçoamento do trabalho são fatores fundamentais para a efetiva assistência ao potencial doador de órgãos em morte encefálica.

Morte, diagnóstico e evento / Death, diagnosis and event / Muerte, diagnóstico y evento

Resumo Vida e morte são compreendidas de maneiras distintas em diferentes culturas, religiões e sociedades, portanto padronizar o entendimento dos significados desses termos em sociedades multiculturais torna-se desafiador e complexo. Diante dessa realidade, esta pesquisa busca descobrir como a morte foi compreendida na história e quais valores eram associados a ela. Para isso, realizou-se revisão da literatura analítico-narrativa, com seleção de 69 publicações para leitura na íntegra. A sociedade e a medicina adquiriram uma visão dualista que considera a morte da função cerebral como irreversibilidade de existência de um eu psicológico. Diante da possibilidade de coletar órgãos e tecidos a partir de um corpo mantido vivo e operado, o suporte de vida deve sempre visar o benefício, mas sem causar danos a terceiros. Para que esses avanços sejam possíveis, a legislação deve ser clara e atualizada.

Abstract Life and death are viewed differently in different cultures, religions, and societies; therefore standardizing their meanings in multicultural societies is challenging and complex. Given this reality, this research investigated how death has been understood throughout history and its associated values. An analytic-narrative literature review was conducted, selecting 69 publications to be read in full. Society and medicine have assumed a dualistic perspective in which death of the brain function is viewed as irreversibility of the existence of a psychological self. Faced with the possibility of procuring organs and tissues from a body kept alive and operated on, life support should always aim to benefit, but without causing harm to others. For these advances to be possible, legislation must be clear and up-to-date.

Resumen La vida y la muerte se entienden de distintos modos en diferentes culturas, religiones y sociedades, por lo que estandarizar la comprensión del significado de estos términos en las sociedades multiculturales se vuelve desafiante y complejo. Ante esta realidad, esta investigación pretende conocer cómo se abordó la muerte en la historia y qué valores se asociaron a ella. Para ello, se realizó una revisión de la literatura analítico-narrativa, con una selección de 69 publicaciones para su lectura completa. La sociedad y la medicina tienen una visión dualista que considera la muerte de la función cerebral como una irreversibilidad de la existencia de un yo psicológico. Frente a la posibilidad de recolectar órganos y tejidos de un cuerpo mantenido vivo y operado, el soporte vital siempre debe estar dirigido al beneficio, sin causar daños a terceros. Para que estos avances sean posibles, la legislación debe ser clara y estar actualizada.

Biovigilância e notificação de eventos adversos na doação e transplante de órgãos: revisão sistemática / Biovigilancia y notificación de eventos adversos en la donación y trasplante de órganos: revisión sistemática / Biosurveillance and reporting of adverse events in organ donation and transplantation: a systematic review

Resumo Objetivo Sintetizar e avaliar criticamente as evidências científicas oriundas de estudos observacionais sobre sistemas de biovigilância e notificação de eventos adversos na doação e transplante de órgãos. Métodos Revisão sistemática de estudos observacionais seguindo as recomendações das Diretrizes Metodológicas (REBRATS) e Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA). Foram incluídos estudos primários e relatos de caso conduzidos sobre biovigilância e/ou eventos adversos na doação e/ou transplante de órgãos, sem restrição de data de publicação ou idioma. Foram utilizadas seis bases de dados eletrônicas para a realização das buscas na literatura científica: - Medical Literature Analysis and Retrieval System Online (MEDLINE) (via PubMed), Excerpta Medica Database (Embase), Web of Science, LILACS, Scopus e a biblioteca eletrônica Scielo. Realizou-se também busca de dados nas seguintes bases secundárias: Notify - World Health Organization (WHO), Organização Pan-Americana de Saúde (OPAS) e Google Scholar. Para a avaliação da qualidade dos estudos foi utilizada a ferramenta MINORS. Resultados Foram identificados 551 estudos, após as etapas de avaliação, foram incluídos oito deles para a revisão sistemática. Estes foram divididos entre resultados, processos e estratégias de prevenção de eventos adversos. Quanto a classificação da qualidade dos estudos, dois obtiveram classificação boa. Conclusão Os resultados apontam a ocorrência de eventos adversos ocorridos em alguma etapa do processo de doação e transplante de órgãos e tecidos, como: reações adversas relacionadas a medicamentos; neurotoxicidade; aumento do tempo de hospitalização; reintervenções cirúrgicas; queda; coma; óbito; falha ou perda do enxerto. Destaca-se que os eventos adversos possivelmente ainda são subnotificados.

Resumen Objetivo Sintetizar y evaluar críticamente las evidencias científicas provenientes de estudios observacionales sobre sistemas de biovigilancia y notificación de eventos adversos en la donación y trasplante de órganos. Métodos Revisión sistemática de estudios observacionales guiada por las recomendaciones de las Directrices Metodológicas (REBRATS) y Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA). Se incluyeron estudios primarios y relatos de caso realizados sobre biovigilancia o eventos adversos en la donación o trasplante de órganos, sin restricción de fecha de publicación o idioma. Se utilizaron seis bases de datos electrónicas para realizar las búsquedas en la literatura científica: Medical Literature Analysis and Retrieval System Online (MEDLINE) (via PubMed), Excerpta Medica Database (Embase), Web of Science, LILACS, Scopus y la biblioteca electrónica Scielo. También se realizó la búsqueda de datos en las siguientes bases secundarias: Notify - World Health Organization (WHO), Organización Panamericana de la Salud (OPS) y Google Scholar. Para evaluar la calidad de los estudios se utilizó la herramienta MINORS. Resultados Se identificaron 551 estudios y, luego de las etapas de evaluación, se incluyeron ocho en la revisión sistemática, que fueron divididos entre resultados, procesos y estrategias de prevención de eventos adversos. Respecto a la clasificación de la calidad de los estudios, dos obtuvieron una clasificación buena. Conclusión Los resultados indican casos de eventos adversos ocurridos en alguna etapa del proceso de donación y trasplante de órganos y tejidos, como: reacciones adversas relacionadas con medicamentos, neurotoxicidad, aumento del tiempo de hospitalización, reintervenciones quirúrgicas, caída, coma, fallecimiento, falla o pérdida del injerto. Se destaca que los eventos adversos probablemente aún son subnotificados.

Abstract Objective To synthesize and critically evaluate the scientific evidence from observational studies on biosurveillance systems and adverse event reporting in organ donation and transplantation. Methods Systematic review of observational studies following the recommendations of the Methodological Guidelines (REBRATS) and Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA). Primary studies and case reports on biosurveillance and/or adverse events in organ donation and/or transplantation, without restriction of publication date or language were included. Six electronic databases were used in the scientific literature search: Medical Literature Analysis and Retrieval System Online (MEDLINE) (via PubMed), Excerpta Medica Database (Embase), Web of Science, LILACS, Scopus and the electronic library Scielo. A data search was also performed in the following secondary databases: Notify - World Health Organization (WHO), Pan American Health Organization (PAHO) and Google Scholar. The MINORS tool was used to assess the quality of studies. Results 551 studies were identified, and after the evaluation steps, eight of them were included in the systematic review. These were divided into results, processes and strategies for preventing adverse events. Regarding the classification of the quality of studies, two obtained a good classification. Conclusion The results indicate the occurrence of adverse events at some stage of the organ and tissue donation and transplantation process, such as: adverse drug-related reactions; neurotoxicity; longer length of hospital stay; surgical reinterventions; falls; coma; death; graft failure or loss. The fact that adverse events are possibly still underreported is noteworthy.

Study on evaluation criteria for the quality of Chinese patent medicine purchased centrally by the Guangdong alliance / 中国药房

Since the Guangdong alliance launched the centralized procurement of Chinese patent medicine， manufacturers have engaged in fierce price competition to obtain the qualification for selection. In order to ensure that manufacturers have lowered the price without decreasing quality， the evaluation criteria for the quality of Chinese patent medicine is constructed on the basis of the characteristics of traditional Chinese medicine. The evaluation criteria consist of the production process and therapeutic effect evaluation. The evaluation indicators involve raw materials， processing and clinical use covering the whole life cycle of Chinese patent medicine. The evaluation of production process includes 3 secondary indicators （the quality of traditional Chinese medicine， the quality of traditional Chinese medicine decoction pieces and the quality of Chinese patent medicines） and 13 tertiary indicators （standardized production， quality inspection， processing specifications， technical processes， safety risk control， etc.）， which fully reflect the quality control of key links in the production of Chinese patent medicine. The therapeutic effect evaluation includes 5 secondary indicators （theoretical origin of formulation， proactive research by production enterprises， evidence-based medical evidence， clinical use， and technological embodiment） and 18 tertiary indicators （theoretical sources， post-market effectiveness re- evaluation， clinical guidelines， expert consensus， etc.） to assess the quality and efficacy of Chinese patent medicine from multiple perspectives and levels. This study is a useful supplement to the scheme of centralized procurement of Guangdong alliance， which can not only provide data support for selecting “low-cost and high-quality” Chinese patent medicine， but also provide information reference for hospitals to make procurement decisions.