How does the methodological clinical evaluation impact organ donation? Experience from 4 Organ Procurement Organizations (OPO)

INTRODUCTION: The lack of a clear and reproducible methodology for evaluating potential organ donors, which ensures traceability in the process, can compromise the number of utilized organ donors and the transplantation quality. METHODOLOGY: We developed a reproducible and safe method for the evaluation and validation of Potential Organ Donors (PD) based on 2 principles:1) Updated knowledge of absolute contraindications for organ donation and, 2) Decision making supported by 3 questions. The first principle was absolute contraindications. They were categorized into 4 groups: A) Serologies, B) Tumors, C) Infections, and D) Biological risk for transmission of infectious diseases and cancer. The second principle was the decision-making questions: A) What is the cause of death? B) Are there absolute contraindications to organ donation? and, C) Are there relative contraindications to organ donation? Each PD was subjected to the same methodology. The questions were answered after knowing the PD's clinical file. The PD was valid only if the set of answers adhered to an established matrix respecting different guidelines. The same physician evaluated each PD in all OPO. We applied in 4 different OPO, 3 of them in the State of São Paulo/Brazil and one in the United Arab Emirates, in different periods, including the SARS-COV 2 pandemic. RESULTS: OPO­SCSP, before the methodology (2007): 62 utilized donors, 205 transplants. After the methodology has been started (2008/2009/2010): 117, 154, 186 utilized donors and 348, 533, 487 transplants, respectively. 2) OPO-BTU, before the methodology (2009): 9 utilized donors and 19 transplants. After the methodology has been started (2010/2011/2012): 17, 36, 49 utilized donors and 38, 90, 143 transplants, respectively. 3) OPO-IDPC, before the methodology (2017): 93 utilized donors and 202 transplants. After the methodology has been started (2018/2019/2020): 107, 177, 187 utilized donors and 219, 395, 356 transplants, respectively. 4) UAE OPO, before the methodology (2020): 9 utilized donors and 35 transplants. After the methodology has been started (2021/2022): 39, 55 utilized donors and 147, 203 transplants, respectively. The percentage increase after the beginning of the methodology, considering the last year evaluated: 1) OPO-SCSP: 195% (Utilized donors) and 137% (Transplants); 2) OPO-BTU: 444% (Utilized donors) and 652% (Transplants); C) OPO-IDPC: 101% (Utilized Donors) and 76% (Transplants); 4) OPO-EOTC (United Arab Emirates): 511% (Utilized donors) and 480% (Transplants). CONCLUSION: The methodology used demonstrates that it can directly contribute to increasing the percentage of effective donors and transplants. The increase in donors ranged from 101% to 444%. The percentage growth of transplantation ranged from 76% to 652%. Indirectly, an increase the referrals was observed, motivated by frequent contact with OPO members and ICU professionals.

Leadership, management, quality, and innovation in organ donation: 2019 Kunming recommendations for One Belt & One Road countries.

The findings and recommendations of the 2019 consensus conference in organ donation, held in Kunming, China, are here reported. The main objective of the conference was to gather relevant information from experts involved in the field. The data and opinions provided allowed to propose a series of recommendations for "One Belt & One Road Countries" on how to achieve self-sufficiency in organ donation. Leadership in organ donation should be results-oriented and goal-driven based on the principles of excellence, empowerment, and engagement, providing the means, resources, and strategies necessary to reach the goal in earnest. Management includes good governance and transparency of a national registry of patients in the waiting list, donors, transplants, transplant teams, quality, and safety programs with continuous educational training of health care professionals. Mandatory monitoring, auditing and evaluation of quality must be incorporated into donation practices as relevant points in innovation, as well as the adoption of already established and novel processes and technologies. Achievement of self-sufficiency in organ donation is a crucial step to fight against transplant tourism and to prevent organ trafficking. Based on recommendations arising from the conference, each country could review and develop individualized action plans adjusted to its own circumstances and reality.

Leadership, management, quality, and innovation in organ donation: 2019 Kunming recommendations for One Belt & One Road countries

ABSTRACT The findings and recommendations of the 2019 consensus conference in organ donation, held in Kunming, China, are here reported. The main objective of the conference was to gather relevant information from experts involved in the field. The data and opinions provided allowed to propose a series of recommendations for "One Belt & One Road Countries" on how to achieve self-sufficiency in organ donation. Leadership in organ donation should be results-oriented and goal-driven based on the principles of excellence, empowerment, and engagement, providing the means, resources, and strategies necessary to reach the goal in earnest. Management includes good governance and transparency of a national registry of patients in the waiting list, donors, transplants, transplant teams, quality, and safety programs with continuous educational training of health care professionals. Mandatory monitoring, auditing and evaluation of quality must be incorporated into donation practices as relevant points in innovation, as well as the adoption of already established and novel processes and technologies. Achievement of self-sufficiency in organ donation is a crucial step to fight against transplant tourism and to prevent organ trafficking. Based on recommendations arising from the conference, each country could review and develop individualized action plans adjusted to its own circumstances and reality.

The SPIKES protocol does not influence the tolerance or effectiveness of intra-articular corticosteroid injection in the knees of osteoarthritis patients: A prospective, controlled, randomized single-blinded trial.

BACKGROUND: Patient user embracement involves behaviours of including and listening to the patient, appreciating their complaints, and identifying their needs, whether individual or collective. The aim of this study was to evaluate the influence of a user embracement protocol (SPIKES protocol) for patients with knee osteoarthritis (OA) immediately before intra-articular injection (IAI) relative to procedure tolerance and its effectiveness in the immediate, short and medium terms. METHODS: This was a randomized controlled trial. Patients received IAIs with triamcinolone hexacetonide (40 mg) preceded or not by the SPIKES protocol. The outcomes measured were: visual analogue scale for pain at rest, pain on movement and joint swelling; morning stiffness; Western Ontario McMaster Universities Index Functional Questionnaire (WOMAC); pain catastrophizing scale; McGill pain questionnaire; SF-36 questionnaire on quality of life; Trace State Anxiety Inventory (IDATE); and a Timed Up and Go functional test. RESULTS: One hundred patients were randomized in the user embracement group (n = 50) or the control group (n = 50); 89% were women and 60% white, mean age was 67.1 (±7.3) years, and mean disease time was 6.3 (±6.2) years. No statistically significant differences were found between the groups for any variables at pre-procedure time, nor did the groups differ in their tolerance to the procedure or during the 12 weeks of follow up for any evaluated variables. CONCLUSIONS: No benefit was identified by applying a user embracement protocol to patients with knee OA prior to IAI with corticosteroid, neither to tolerance at the time of the procedure nor to its effectiveness in the immediate, short, and medium terms.

The SPIKES protocol does not influence the tolerance or effectiveness of intra-articular corticosteroid injection in the knees of osteoarthritis patients: A prospective, controlled, randomized single-blinded trial

BACKGROUND: Patient user embracement involves behaviours of including and listening to the patient, appreciating their complaints, and identifying their needs, whether individual or collective. The aim of this study was to evaluate the influence of a user embracement protocol (SPIKES protocol) for patients with knee osteoarthritis (OA) immediately before intra-articular injection (IAI) relative to procedure tolerance and its effectiveness in the immediate, short and medium terms. METHODS: This was a randomized controlled trial. Patients received IAIs with triamcinolone hexacetonide (40 mg) preceded or not by the SPIKES protocol. The outcomes measured were: visual analogue scale for pain at rest, pain on movement and joint swelling; morning stiffness; Western Ontario McMaster Universities Index Functional Questionnaire (WOMAC); pain catastrophizing scale; McGill pain questionnaire; SF-36 questionnaire on quality of life; Trace State Anxiety Inventory (IDATE); and a Timed Up and Go functional test. RESULTS: One hundred patients were randomized in the user embracement group (n = 50) or the control group (n = 50); 89% were women and 60% white, mean age was 67.1 (±7.3) years, and mean disease time was 6.3 (±6.2) years. No statistically significant differences were found between the groups for any variables at pre-procedure time, nor did the groups differ in their tolerance to the procedure or during the 12 weeks of follow up for any evaluated variables. CONCLUSIONS: No benefit was identified by applying a user embracement protocol to patients with knee OA prior to IAI with corticosteroid, neither to tolerance at the time of the procedure nor to its effectiveness in the immediate, short, and medium terms.

Análise da qualidade das córneas doadas e do intervalo entre óbito, enucleação e preservação após a implantação de novas normas técnicas e sanitárias em Banco de Olhos Universitário / Comparative analysis of the donor cornea quality and of the interval between death and preservation before and after new sanitary and technique rules in a University Eye Bank

OBJETIVO: Comparar o intervalo entre o óbito e a enucleação (ΔT-O-E), entre a enucleação e a preservação (ΔT-E-P) e a qualidade da córnea antes e após a implantação de novas normas técnicas e sanitárias baseadas na Resolução RDC 347. MÉTODOS: Estudo retrospectivo em que foram avaliados os prontuários dos doadores de córnea do Banco de Tecidos Oculares da Santa Casa de São Paulo, 2 anos antes e 2 anos depois da implementação de novas normas sanitárias. RESULTADOS: Foi observado aumento do número absoluto de 205 para 374 doadores após as mudanças adotadas. Não foi observada diferença estatisticamente significante no Δt-O-E e ΔT-E-P antes e após as mudanças implantadas. Do total de 1.105 córneas doadas, foi observado 388 córneas doadas antes das mudanças e 717 córneas doadas após as mudanças implementadas. Foi observado aumento estatisticamente significante da graduação da qualidade da córnea doada de 1,76 ± 0,90 para 1,94 ± 0,88 após a implementação das novas normas da Resolução. CONCLUSÃO: Após as mudanças técnicas e sanitárias exigidas pela Resolução 347, houve grande aumento no número de córneas doadas, captadas e preservadas. O Banco de Tecidos Oculares não diminuiu os ΔT O-E e ΔT E-P. A qualidade da córnea apresentou-se inferior após as mudanças realizadas no setor.

PURPOSE: To compare the interval between death and enucleation (ΔT-O-E), between enucleation and preservation (ΔT-E-P) and the quality of the cornea before and after the implantation of new technique and sanitary rules. METHODS: A retrospective study that evaluated the records of cornea donors in Sao Paulo's Santa Casa Eye Tissue Bank 2 years before and 2 years after the implementation new sanitary rules. RESULTS: An increase was observed in the absolute number of 205 to 374 donors following the adopted changes. There was no statistically significant difference in Δt-O-E and ΔT-E-P before and after the implemented changes. Of the total of 1,105 donor corneas, 388 donor corneas were observed before the changes and 717 donor corneas after the implemented changes. We observed a statistically significant increase in grading of donor cornea quality from 1.76 ± 0.90 to 1.94 ± 0.88 after the implementation of new standards of resolution. CONCLUSION: After the changes required by Resolution 347, there was a large increase in the number of donated, taken and preserved corneas. The BTO has not diminished the ΔT O-E and ΔT E-P. Cornea quality presented itself lower after the new rules.

[Comparative analysis of the donor cornea quality and of the interval between death and preservation before and after new sanitary and technique rules in a University Eye Bank]. / Análise da qualidade das córneas doadas e do intervalo entre óbito, enucleação e preservação após a implantação de novas normas técnicas e sanitárias em Banco de Olhos Universitário.

PURPOSE: To compare the interval between death and enucleation (ΔT-O-E), between enucleation and preservation (ΔT-E-P) and the quality of the cornea before and after the implantation of new technique and sanitary rules. METHODS: A retrospective study that evaluated the records of cornea donors in Sao Paulo's Santa Casa Eye Tissue Bank 2 years before and 2 years after the implementation new sanitary rules. RESULTS: An increase was observed in the absolute number of 205 to 374 donors following the adopted changes. There was no statistically significant difference in Δt-O-E and ΔT-E-P before and after the implemented changes. Of the total of 1,105 donor corneas, 388 donor corneas were observed before the changes and 717 donor corneas after the implemented changes. We observed a statistically significant increase in grading of donor cornea quality from 1.76 ± 0.90 to 1.94 ± 0.88 after the implementation of new standards of resolution. CONCLUSION: After the changes required by Resolution 347, there was a large increase in the number of donated, taken and preserved corneas. The BTO has not diminished the ΔT O-E and ΔT E-P. Cornea quality presented itself lower after the new rules.

Macroscopic alteretions in kidneys retrieved for transplant / Alteraciones macroscópicas en riñones recibidos para trasplante

El análisis de alteraciones macroscópicas en riñones recibidos para trasplante es de gran importancia debido a que estas anomalías pueden impedir usar el órgano Ciento cincuenta y cinco (1 55) descripciones de riñones recibidos para trasplante en el hospital de Santa Casa de Sao Paulo fueron realizadas entre enero y diciembre 2009. De los 155 riñones recibidos desde donantes cadáveres durante el periodo, 22 (1 5 por ciento) presentaron alteraciones macroscópicas. La alteración más frecuente fue la presencia de quistes renales. Encontrados en 12 (7,7 por ciento). Se reportaron otras alteraciones menos frecuentes, incluyendo hidroureteronefrosis en 4 (2,55 por ciento) casos, agenesia renal en 2 (1 ,3 por ciento), hematoma renal en 3 (1 .93 por ciento) y un caso de trauma sólido (0,64 por ciento). De tos riñones que presentaron alteración 15 (68 por ciento) fueron usados para trasplante y 7 (32 por ciento) se descañaron. Conclusión: La alteración macroscópica más común identificada en los riñones recibidos fue el quiste renal en 1 2 (7,7por ciento) de los casos, un hallazgo que está en la línea de lo reportado en la literatura para el hallazgo de quistes renales en la población. La mayoría de los riñones con alteraciones (1 5/68 por ciento) fueron usados para el trasplante. demostrando que la mayor parte de las alteraciones no comprometen la viabilidad del Órgano...

The analysis of macroscopic alterations in kidneys for transplants is of great importance since such anomalies can preclude organ use. One hundred and fifty-five (1 55) surgical descriptions of kidneys retrieved for transplant at the Santa Casa de Sao Paulo hospital were carried out between January and December 2009. Of the 155 kidneys retrieved from deceased donors during this analysis period, 22 (1 5 percent) showed macroscopic alterations. The most frequent isolated alteration was the presence of renal cysts. found ¡n 12 (7.7 percent) cases. Other less frequent alterations were reported including ureterohydronephrosis in 4 (2 .58 percent) cases. renal agenesis 2 (1 .3 percent) cases, hematoma in 3 (1.93 percent) cases, and 1 (0.64 percent) case of sold injury Of all kidneys that presented alterations, 15 (68 percent) were still used for transplants and 7 (32 percent) were discarded. The most common macroscopic alteration identified in retrieved kidneys was renal cyst. occurring in12 (7.7 percent) cases, a finding in line with incidence of renal cysts reported in the literature. The majority of the kidneys with alterations (1 5 - 68 percent) were still used for transplants. demonstrating that most alterations do not compromise organ viability...

Análise crítica dos 10 anos de regulamentação da lei de transplante nº 9434 / Critical review of the 10 years since the regulation of transplant law No 9034

Desde a antiguidade, o interesse do homem pelo seu corpo e pelo dos outros pode ser comprovado através de escritos filosóficos, teológicos, médicos e de enfermagem, que documentam os cuidados, as experiências e as curiosidades do homem em relação aos tecidos do corpo humano, segmento corporal ou órgão em particular, nos diversos períodos históricos. O transplante (TX) é um procedimento cirúrgico que consiste na substituição de um órgão ou de um tecido doente (receptor) por outro saudável de outra pessoa viva ou morta (doador). O presente objetivo é avaliar a legislação vigente relativa aos transplantes de órgãos, tecidos e partes do corpo (lei 9434/97), juntamente com outras Resoluções e Protocolos, analisando suas aplicabilidades e suas controvérsias. Este trabalho foi desenvolvido através de revisão bibliográfica, em que foram considerados materiais existentes e pertinentes ao tema em estudo. A lei 9434, relativa aos transplantes de órgãos, tecidos e partes do corpo, foi utilizada como base para análise. Da mesma forma a definição de morte encefálica e implicações de seu contexto foram empregadas para discussão respeitando-se a Resolução do CfM 1480/97 - Resultados e Discussão da lei de Transplante: a) Apesar da exigência da lei, nem sempre é possível a realização de todos os testes de triagem por dificuldades que o sistema apresenta e muitas vezes por falta de recursos financeiros e equipamentos devidos; b) O Brasil opera em sistema altruístico e voluntário, no qual os pacientes ou suas fammas podem escolher entre doar ou não os órgãos após a morte. E muito importante que a pessoa que deseja doar seus órgãos após sua morte comunique à sua famma. Existe grande diferença entre as pessoas que são favoráveis à doação e o percentual daqueles que realmente a consentem; c) Sobre o paciente incapaz como potencial doador, acreditamos que se a autorização puder ser decidida apenas por quem tiver a guarda legal, isso facilitaria em muito os meios para doação...

Priority for children in cadaveric kidney sharing: the strategy adopted in Sao Paulo, Brazil.

Early kidney transplantation is crucial in order to accomplish both optimal mental development and the best adult height in children with end-stage renal disease. The aim was to evaluate the efficacy of the child priority policy for cadaveric kidney sharing adopted in the State of Sao Paulo (Brazil). We performed a retrospective study of data collected by the Government Transplant Department in São Paulo, involving all patients included in the waiting list from August 13, 1998 to December 31, 2001. During the study period, the child priority policy had been changed giving: period A--from the outset up to March 14, 2001, where the rule was to direct cadaveric kidneys obtained from children <12 yr, to recipients <12 yr; period B--from March 14, 2001 onwards, where the policy had been broadened to include cadaveric donors <18 yr, destined for recipients <18 yr. We performed the analysis of the data comprising 8940 patients, 8622 being adults (mean age = 48.6 +/- 14.1 yr, 3594 females) and 318 children (mean age = 11.9 +/- 5.1 yr, 156 females). Over the 3.5-yr follow-up there were 1964 deaths [1933 adults and 31 children, odds ratio (OR) 0.37; 95% CI 0.25-0.55], 1032 living donor kidney transplants (963 adults and 69 children, OR 2.20; 95% CI 1.66-2.93), and 556 cadaveric kidney transplants (444 adults and 112 children, OR 10.11; 95% CI 7.75-12.94). Three and a half years after being enrolled on the list, 24% of the children and 75% of the adults, respectively, were still awaiting a cadaveric kidney transplant (log rank test = 539, p < 0.00001). The analysis of period A vs. period B, suggests that the raising of the inclusion age upper limit to 18 yr, resulted in a twofold increase in the percentage of children being grafted within 6 months of enrollment. Overall, our data shows a slow rate of cadaveric kidney transplantation activity in Sao Paulo. Children's chances of receiving a living donor kidney almost doubled. Moreover, 19.5% of pediatric recipients had received their kidney within the first year of being enrolled on the waiting list. The scheme adopted in Sao Paulo is encouraging, but the results remain less favorable than those observed in other countries. The adoption of the priority policy did not result in an unacceptable increase of adult waiting time, given that the number of adults on our waiting list outweighs by far the number of children.