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BACKGROUND: To better define the risk of malignancy transmission through organ transplantation, we review the Spanish experience on donor malignancies. METHODS: We analyzed the outcomes of recipients of organs obtained from deceased donors diagnosed with a malignancy during 2013-2018. The risk of malignancy transmission was classified as proposed by the Council of Europe. RESULTS: Of 10 076 utilized deceased donors, 349 (3.5%) were diagnosed with a malignancy. Of those, 275 had a past (n = 168) or current (n = 107) history of malignancy known before the transplantation of organs into 651 recipients. Ten malignancies met high-risk criteria. No donor-transmitted cancer (DTC) was reported after a median follow-up of 24 (interquartile range [IQR]: 19-25) mo. The other 74 donors were diagnosed with a malignancy after transplantation. Within this group, 64 donors (22 with malignancies of high or unacceptable risk) whose organs were transplanted into 126 recipients did not result in a DTC after a median follow-up of 26 (IQR: 22-37) mo, though a prophylactic transplantectomy was performed in 5 patients. The remaining 10 donors transmitted an occult malignancy to 16 of 25 recipients, consisting of lung cancer (n = 9), duodenal adenocarcinoma (n = 2), renal cell carcinoma (n = 2), extrahepatic cholangiocarcinoma (n = 1), prostate cancer (n = 1), and undifferentiated cancer (n = 1). After a median follow-up of 14 (IQR: 11-24) mo following diagnosis, the evolution was fatal in 9 recipients. In total, of 802 recipients at risk, 16 (2%) developed a DTC, which corresponds to 6 cases per 10 000 organ transplants. CONCLUSIONS: Current standards may overestimate the risk of malignancy transmission. DTC is an infrequent but difficult to eliminate complication.

STUDY QUESTIONCan risks associated with novelties in assisted reproduction technologies (ARTs) be assessed in a systematic and structured way?SUMMARY ANSWERAn ART-specific risk assessment tool has been developed to assess the risks associated with the development of novelties in ART (EuroGTP II-ART).WHAT IS KNOWN ALREADYHow to implement new technologies in ART is well-described in the literature. The successive steps should include testing in animal models, executing pre-clinical studies using supernumerary gametes or embryos, prospective clinical trials and finally, short- and long-term follow-up studies on the health of the offspring. A framework categorizing treatments from experimental through innovative to established according to the extent of the studies conducted has been devised. However, a systematic and standardized methodology to facilitate risk evaluation before innovations are performed in a clinical setting is lacking.STUDY DESIGN, SIZE, DURATIONThe EuroGTP II-ART risk assessment tool was developed on the basis of a generic risk assessment algorithm developed for tissue and cell therapies and products (TCTPs) in the context of the project ‘Good Practices for demonstrating safety and quality through recipient follow-up European Good Tissue and cells Practices II (EuroGTP II)’. For this purpose, a series of four meetings was held in which eight ART experts participated. In addition, several tests and simulations were undertaken to fine-tune the final tool.PARTICIPANTS/MATERIALS, SETTING, METHODSThe three steps comprising the EuroGTP II methodology were evaluated against its usefulness and applicability in ART. Ways to improve and adapt the methodology into ART risk assessment were agreed and implemented.MAIN RESULTS AND THE ROLE OF CHANCEAssessment of the novelty (Step 1), consisting of seven questions, is the same as for other TCTPs. Practical examples were included for better understanding. Identification of potential risks and consequences (Step 2), consisting of a series of risks and risk consequences to consider during risk assessment, was adapted from the generic methodology, adding more potential risks for processes involving gonadic tissues. The algorithm to score risks was also adapted, giving a specific range of highest possible risk scores. A list of strategies for risk reduction and definition of extended studies required to ensure effectiveness and safety (Step 3) was also produced by the ART experts, based on generic EuroGTP II methodology. Several explanations and examples were provided for each of the steps for better understanding within this field.LIMITATIONS, REASONS FOR CAUTIONA multidisciplinary team is needed to perform risk assessment, to interpret results and to determine risk mitigation strategies and/or next steps required to ensure the safety in the clinical use of novelties.WIDER IMPLICATIONS OF THE FINDINGSThis is a dynamic tool whose value goes beyond assessment of risk before implementing a novel ART in clinical practice, to re-evaluate risks based on information collected during the process.STUDY FUNDING / COMPETING INTEREST(S)This study was called EUROGTP II and was funded by the European Commission (Grant agreement number 709567). The authors declare no competing interests concerning the results of this study.

The failure mode and effect analysis (FMEA) may improve the safety of the continuous renal replacement therapies (CRRT) in the intensive care unit. We use this tool in three phases: 1) Retrospective observational study. 2) A process FMEA, with implementation of the improvement measures identified. 3) Cohort study after FMEA. We included 54 patients in the pre-FMEA group and 72 patients in the post-FMEA group. Comparing the risks frequencies per patient in both groups, we got less cases of under 24 hours of filter survival time in the post-FMEA group (31 patients 57.4% vs. 21 patients 29.6%; p < 0.05); less patients suffered circuit coagulation with inability to return the blood to the patient (25 patients [46.3%] vs. 16 patients [22.2%]; p < 0.05); 54 patients (100%) versus 5 (6.94%) did not get phosphorus levels monitoring (p < 0.05); in 14 patients (25.9%) versus 0 (0%), the CRRT prescription did not appear on medical orders. As a measure of improvement, we adopt a dynamic dosage management. After the process FMEA, there were several improvements in the management of intensive care unit patients receiving CRRT, and we consider it a useful tool for improving the safety of critically ill patients.

Cervical collars are essential in the treatment of patients with suspicion or verification of acute cervical spine injury (ACSI). One of the complications of these devices is the development of pressure scores (PS). This study aims to determine its incidence in our unit, the characteristics of patients with ACSI who suffer PS due to the collar and to describe aspects related with these injuries. We include 92 patients with ACSI hospitalized more than 24 hours from January 2002 to December 2003. We analyze demographic variables, incidence, risk factors and characteristics of the PS that develop. The incidence of these lesions was 23.9%. Patients with PS presented: a higher injury severity score (ISS) (37.5 9.8 vs. 31.3 14.9), a greater percentage of catheter carriers of intracraneal pressure (ICP) (55.6% vs. 16.2%), longer time of mechanical ventilation (15.4 8.2 vs. 6.1 9) and longer stays (24.6 10.9 vs. 10 10.3), all statistically significant (p< 0.05). A total of 38 PS were detected, 7 (RI 5-13.8) being the median of the detection day. The chin, occipital and suprascapular zone were the most frequent locations. A total of 42.1% were grade II and 39.5% grade III. The occipital injuries were the most serious and those detected the latest. We conclude that a high index of suspicion of PS due to collar in patients with ACSI, elevated ISS, monitoring of ICP, mechanical ventilation and prolonged stays is required. The occipital zone requires special attention due to the seriousness of the injuries recorded. We suggest a specific multidisciplinary protocol for this problem.

The continuous renal replacement techniques (CRRT) aim to substitute the altered renal function during a period of time, presenting advantages compared to conventional hemodialysis (CH). This study aims to determine the situation of the CRRT in the Intensive care units (ICU) of the Madrid Community (MC) using a survey distributed to nurses (n = 131) of 14 ICU. It evaluates four aspects of the CRRT: management model, knowledge, problems and degree of satisfaction. It identified four models, the most frequent is that in which ICU nurse and intensivist participate (60%). Self-evaluation of knowledge was fair in 55.7% of the cases and the mean of correct responses in an evaluation of 10 questions was 4.19 and 5.45 in those with previous courses. A total of 84.7% think that CRRT significantly increases the workloads and 62.6% believe that they should be done by the ICU nurses. The main problem is the lack of knowledge to resolve complications during the technique. We conclude that the ICU nursing can handle the CRRT, adapting the nurse/patient ratio; training programs should be established and the role of the teaching nurse defined in critical renal cares.

Cervical collars are essential in the treatment of patients with suspicion or verification of acute cervical spine injury (ACSI). One of the complications of these devices is the development of pressure scores (PS). This study aims to determine its incidence in our unit, the characteristics of patients with ACSI who suffer PS due to the collar and to describe aspects related with these injuries. We include 92 patients with ACSI hospitalized more than 24 hours from January 2002 to December 2003. We analyze demographic variables, incidence, risk factors and characteristics of the PS that develop. The incidence of these lesions was 23.9%. Patients with PS presented: a higher injury severity score (ISS) (37.5 9.8 vs. 31.3 14.9), a greater percentage of catheter carriers of intracraneal pressure (ICP) (55.6% vs. 16.2%), longer time of mechanical ventilation (15.4 8.2 vs. 6.1 9) and longer stays (24.6 10.9 vs. 10 10.3), all statistically significant (p0.05). A total of 38 PS were detected, 7 (RI 5-13.8) being the median of the detection day. The chin, occipital and suprascapular zone were the most frequent locations. A total of 42.1% were grade II and 39.5% grade III. The occipital injuries were the most serious and those detected the latest. We conclude that a high index of suspicion of PS due to collar in patients with ACSI, elevated ISS, monitoring of ICP, mechanical ventilation and prolonged stays is required. The occipital zone requires special attention due to the seriousness of the injuries recorded. We suggest a specific multidisciplinary protocol for this problem.

The continuous renal replacement techniques (CRRT) aim to substitute the altered renal function during a period of time, presenting advantages compared to conventional hemodialysis (CH). This study aims to determine the situation of the CRRT in the Intensive care units (ICU) of the Madrid Community (MC) using a survey distributed to nurses (n = 131) of 14 ICU. It evaluates four aspects of the CRRT: management model, knowledge, problems and degree of satisfaction. It identified four models, the most frequent is that in which ICU nurse and intensivist participate (60%). Self-evaluation of knowledge was fair in 55.7% of the cases and the mean of correct responses in an evaluation of 10 questions was 4.19 and 5.45 in those with previous courses. A total of 84.7% think that CRRT significantly increases the workloads and 62.6% believe that they should be done by the ICU nurses. The main problem is the lack of knowledge to resolve complications during the technique. We conclude that the ICU nursing can handle the CRRT, adapting the nurse/patient ratio; training programs should be established and the role of the teaching nurse defined in critical renal cares.