Banking of corneal stromal lenticules: a risk-analysis assessment with the EuroGTP II interactive tool.

We evaluated the feasibility and performed a risk-benefit analysis of the storage and widespread distribution of stromal lenticules for clinical application using a new systematic tool (European Good Tissue and cells Practices II-EuroGTP II tool), specifically designed for assessing the risk, safety and efficacy of substances of human origin. Three types of potential tissue preparations for human stromal lenticules were evaluated: cryopreserved, dehydrated and decellularized. The tool helps to identify an overall risk score (0-2: negligible; 2-6: low; 6-22: moderate; > 22: high) and suggests risk reduction strategies. For all the three types of products, we found the level of risk to be as "moderate". A process validation, pre-clinical in vitro and in vivo evaluations and a clinical study limited to a restricted number of patients should therefore be performed in order to mitigate the risks. Our study allowed to establish critical points and steps necessary to implement a new process for safe stromal lenticule preparation by the eye banks to be used in additive keratoplasty. Moreover, it shows that the EuroGTP II tool is useful to assess and identify risk reduction strategies for introduction of new Tissue and Cellular Therapies and Products into the clinical practice.

Quality by Design: Development of Safe and Efficacious Full-Thickness Acellular Dermal Matrix Based on EuroGTPII Methodologies.

Background: The activities of tissue establishments are constantly and rapidly evolving. The development of a new type of allograft, full-thickness acellular dermal matrix, with high mechanical properties to be used in tendon repair surgeries and abdominal wall reconstruction, has determined the need for quality by design process in order to assess evidence of quality, safety and efficacy. The EuroGTPII methodologies were specifically tailored to perform the risk assessment, identify and suggest tests in order to mitigate the potential risk consequences of a novel tissue preparation implementation. Methods: The new allograft and associated preparation processes were assessed using the EuroGTP methodologies and characterized to properly evaluate the novelty (Step 1), identify and quantify the potential risks and risk consequences (Step 2), and define the extent of pre-clinical and clinical assessments required to mitigate the risks identified in the assessment (Step 3). Results: Four risk consequences associated with the preparation process were identified: (i) implant failure related with tissue procurement and the reagents used during the decellularization protocol; (ii) unwanted immunogenicity related with the processing; (iii) disease transmission linked with the processing, reagents used, reduction in the reliability of microbiology testing and the storage conditions; and (iv) toxicity related to the reagents used and handling of the tissue during clinical application. The outcome of the risk assessment was a low level of risk. Nevertheless, it determined the need for a series of risk mitigation strategies proposed to reduce each individual risk and to provide additional evidence of the safety and efficacy of full-thickness acellular dermal matrix grafts. Conclusion: EuroGTPII methodologies allow us to identify the risks and ensure the correct definition of pre-clinical assessments required to address and mitigate the potential risk consequences, before proceeding with clinical use of the new allografts in patients.

Envelhecimento e adesão terapêutica como foco de atenção educativa em enfermagem no intercâmbio estudantil internacional / Aging and therapeutic adherence as care focus on education in nursing international student exchange / Envejecimiento y adherencia terapéutica como foco de atención educativa en enfermería en el intercambio estudiantil internacional

Objetivos: identificar as necessidades e os problemas de saúde da população idosa, prevalentes no risco de não adesão terapêutica, e implementar estratégias educativas. Método: estudo descritivo de nível II, com 25 clientes da Freguesia de São Martinho de Árvore ­ Coimbra - Portugal. Os dados foram colhidos nas consultas de enfermagem, por meio do instrumento "Avaliação do risco de não adesão ao tratamento", e submetidos à análise de conteúdo. O estudo foi aprovado pelo Comitê de Ética em Pesquisa, sob o CAEE nº 05164212.2.0000.5243. Resultados: as necessidades de saúde estão relacionadas com atividade física, regime alimentar e esquema terapêutico medicamentoso. Diagnósticos de enfermagem mais evidentes: regime de tratamento complexo (96%) e déficit de conhecimentos (60%). Conclusão: 28% da população estudada apresentava o fenômeno de não adesão terapêutica, fundamental para a caracterização da amostra. É incontestável a importância de atividades educativas realizadas pelo enfermeiro para adesão terapêutica no envelhecimento. (AU)

Objectives: to identify the health needs and problems of the elderly population, prevalent in the risk of nonadherence, and to implement educational strategies. Method: a descriptive study level II, with 25 clients from Freguesia de São Martinho de Árvore ­ Coimbra - Portugal. Data were collected in the nursing consultations, through the instrument "Risk evaluation of non-adherence to treatment", and submitted to content analysis. The study was approved by the Ethics Committee, in Research under CAEE number 05164212.2.0000.5243. Results: health needs are related to physical activity, diet and medication regimen. The more evident nursing diagnosis were: complex treatment regimen (96%) and lack of knowledge (60%). Conclusion: 28% of the study population had the phenomenon of non-adherence, fundamental to characterize the sample. It is very important the educational activities performed by nurses for therapeutic adherence in elderly. (AU)

Objetivos: identificar las necesidades y los problemas de salud de la población anciana, prevalentes en el risco de no adhesión terapéutica, e implementar estrategias educativas. Método: estudio descriptivo de nivel II, con 25 clientes de la Freguesia de São Martinho de Árvore ­ Coimbra - Portugal. Los datos fueron recogidos en las consultas de enfermería, por medio del instrumento "Evaluación del riesgo de no adhesión al tratamiento", y sometidos al análisis de contenido. El estudio fue aprobado por el Comité de Ética en Investigación, sobre CAEE número 05164212.2.0000.5243. Resultados: las necesidades de salud están relacionadas con actividad física, régimen alimenticio y esquema terapéutico medicamentoso. Diagnósticos de enfermería más evidentes: régimen de tratamiento complejo (96%) y déficit de conocimientos (60%). Conclusión: 28% de la población estudiada presentaba el fenómeno de no adhesión terapéutica, fundamental para la caracterización de la muestra. Es indiscutible la importancia de actividades educativas realizadas por el enfermero para adhesión terapéutica en el envejecimiento. (AU)