Current challenges in cell and gene therapy: a joint view from the European Committee of the International Society for Cell & Gene Therapy (ISCT) and the European Society for Blood and Marrow Transplantation (EBMT).

Cell and gene therapy poses evolving challenges. The current article summarizes the discussions held by European Regional Committee of the International Society for Cell & Gene Therapy and the European Society for Blood and Marrow Transplantation (EBMT) on the current challenges in this field, focusing on the European setting. This article emphasizes the imperative assessment of real-world cell and gene therapy activity, advocating for expanded registries beyond hematopoietic transplantation and chimeric antigen receptor-T-cell therapy. Accreditation's role in ensuring standardized procedures, as exemplified by JACIE (The Joint Accreditation Committee of ISCT-Europe and EBMT), is crucial for safety. Access to commercial products and reimbursement variations among countries underscore the need for uniform access to advanced therapy medical products (ATMPs). Academic product development and point-of-care manufacturing face barriers to patient access. Hospital Exemption's potential, demonstrated by some initial experiences, may increase patient accessibility in individual situations. Regulatory challenges, including the ongoing European ATMPs legislation review, necessitate standardized criteria for Hospital Exemption and mandatory reporting within registries. Efforts to combat unproven therapies and fraud involve collaboration between scientific societies, regulatory bodies and patient groups. Finally, is important to highlight the vital role of education and workforce development in meeting the escalating demand for specialized professionals in the ATMP field. Collaboration among scientific societies, academic institutions, industry, regulatory bodies and patient groups is crucial for overcoming all these challenges to increase gene and cell therapy activity in Europe.

A guide to the collection of T-cells by apheresis for ATMP manufacturing-recommendations of the GoCART coalition apheresis working group.

Autologous chimeric antigen receptor-modified T-cells (CAR-T) provide meaningful benefit for otherwise refractory malignancies. As clinical indications for CAR-T cells are expanding, hospitals hitherto not active in the field of immune effector cell therapy will need to build capacity and expertise. The GoCART Coalition seeks to disseminate knowledge and skills to facilitate the introduction of CAR-T cells and to standardize management and documentation of CAR-T cell recipients, in order to optimize outcomes and to be able to benchmark clinical results against other centers. Apheresis generates the starting material for CAR-T cell manufacturing. This guide provides some initial suggestions for patient's apheresis readiness and performance to collect starting material and should thus facilitate the implementation of a CAR-T-starting material apheresis facility. It cannot replace, of course, the extensive training needed to perform qualitative apheresis collections in compliance with national and international regulations and assess their cellular composition and biological safety.

Benchmarking of survival outcomes following Haematopoietic Stem Cell Transplantation (HSCT): an update of the ongoing project of the European Society for Blood and Marrow Transplantation (EBMT) and Joint Accreditation Committee of ISCT and EBMT (JACIE).

From 2016 EBMT and JACIE developed an international risk-adapted benchmarking program of haematopoietic stem cell transplant (HSCT) outcome to provide individual EBMT Centers with a means of quality-assuring the HSCT process and meeting FACT-JACIE accreditation requirements relating to 1-year survival outcomes. Informed by previous experience from Europe, North America and Australasia, the Clinical Outcomes Group (COG) established criteria for patient and Center selection, and a set of key clinical variables within a dedicated statistical model adapted to the capabilities of the EBMT Registry. The first phase of the project was launched in 2019 to test the acceptability of the benchmarking model through assessment of Centers' performance for 1-year data completeness and survival outcomes of autologous and allogeneic HSCT covering 2013-2016. A second phase was delivered in July 2021 covering 2015-2019 and including survival outcomes. Reports of individual Center performance were shared directly with local principal investigators and their responses were assimilated. The experience thus far has supported the feasibility, acceptability and reliability of the system as well as identifying its limitations. We provide a summary of experience and learning so far in this 'work in progress', as well as highlighting future challenges of delivering a modern, robust, data-complete, risk-adapted benchmarking program across new EBMT Registry systems.

The impact of interprofessional education on students' current and desired competence in diabetes care.

AIM: To explore the impact of interprofessional education (IPE) on undergraduate nursing and medical students' knowledge, competence and targeted competence in diabetes care. DESIGN: Mixed methods design. METHODS: A voluntary IPE course of diabetes management was organized for nursing (n = 15) and medical (n = 15) students, who performed a diabetes knowledge test and self-evaluation of diabetes competence before and after the course and were compared with non-participating students. The participating students' focus-group interviews were analysed using inductive content analysis. RESULTS: The IPE course improved nursing students' diabetes knowledge and self-evaluated competence among nursing and medical students. The baseline differences in self-evaluated competence between the groups disappeared. The non-participating students evaluated their competence higher than the participants, though they scored lower or equally in the knowledge test. In conclusion, IPE showed potential in increasing students' self-evaluated competence, motivation to learn more and nursing students' diabetes knowledge, offering better prospects for future interprofessional diabetes management.

Worldwide Network for Blood and Marrow Transplantation Special Article on Key Elements in Quality and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy.

Hematopoietic stem cell transplantation (HSCT) represents an example of a highly complex and costly medical procedure with major applications in hematology and oncology. It is associated with life-threatening complications and, consequently, increased demands on healthcare resources. Although improving quality is an integral component of healthcare strategic planning, drivers of quality may be variable, and there is logical debate as to what drives quality in HSCT. Moreover, HSCT programs differ in structure and availability of resources, which drive the type of transplantations provided and determine what is affordable and/or economically feasible. The complexity of HSCT procedures with involvement of different stakeholders necessitates not only regulatory frameworks, but also robust quality systems to ensure consistent standards, demonstrate transparency for regulators, and define what quality means within the HSCT program. In an era of escalating healthcare complexity and heightened fiscal responsibility, transparency and accountability, accreditation contributes to ensuring that care meets the highest standards and can serve as a risk mitigation strategy. Quality management has become an indispensable tool for the management of a complex medical intervention such as HSCT. It allows the transplantation team to monitor its activities and identify areas for continuous improvement. The Worldwide Network for Blood and Marrow Transplantation invited a group of international experts in HSCT and quality management to work on providing a summary document about the key elements in quality and accreditation in HSCT and highlight the foremost challenges of implementing them, with a special focus on low- and middle-income economies.

Students' perceptions of interprofessional collaboration on the care of diabetes: A qualitative study.

Interprofessional education can promote healthcare professionals' competence to work in interprofessional collaboration, which is essential for the quality and safety of care. An interprofessional approach is particularly important in complex, chronic diseases like diabetes. This qualitative study evaluated changes in medical and nursing students' perceptions of interprofessional collaboration, induced by a novel interprofessional education course on diabetes care with practical elements. Data from focus-group interviews of 30 students before and after the course were analyzed by using inductive and deductive content analysis. The students' perceptions were illustrated as Elements of Collaborative Care (e.g. Quality of professional care relationship) and Elements of Interprofessional Collaboration (e.g. Importance of communication and Valuation of collaboration). The post-course interviews added one subcategory (Need of resources) to the pre-course perceptions, and there was improvement in ten areas of self-perceived competence in performing or understanding interprofessional collaboration on diabetes care. The course improved the students' self-perceived competence and confidence in interprofessional collaboration on the care of patients with diabetes, and their understanding of interprofessional collaboration changed towards a more patient-centred and holistic perspective. The findings support further implementation of IPE with practical elements in future health professionals' education.

An integrative systematic review of interprofessional education on diabetes.

Interprofessional education (IPE) aims at enhancing the ability of healthcare professionals from different disciplines to work together effectively, improving the quality of patient care. An interprofessional approach is essential in diabetes management, but there is only limited evidence of the effects of diabetes-specific IPE. The aim of this integrative review is to gather all relevant recent data on the outcomes of IPE on diabetes management. The search in the CINAHL, Medline and PsycINFO databases resulted in 1136 potential studies. An inductive content analysis was used to synthesize the key findings of the 14 studies found to fulfill the inclusion criteria of the systematic review. Two main categories and four subcategories of findings were identified. Firstly, the achieved outcomes included individual gain (e.g., learner´s confidence and motivation to treat patients with diabetes) and external benefits (e.g., benefits for the patient). Secondly, the experiences of IPE included both challenges (e.g., competing interests of different professions) and strengths (e.g., practical approach to diabetes management). In conclusion, the findings indicate that both learners and patients with diabetes benefit from IPE on diabetes management. Educators are encouraged to adopt practical IP approaches in diabetes education. However, it is necessary to estimate the resources available. More research is needed on the cost-effectiveness, long-term effects, and patient perspective of IPE on diabetes management.

Challenges in combining different data sets during analysis when using grounded theory.

AIM: To describe the challenges in combining two data sets during grounded theory analysis. BACKGROUND: The use of grounded theory in nursing research is common. It is a suitable method for studying human action and interaction. It is recommended that many alternative sources of data are collected to create as rich a dataset as possible. DATA SOURCES: Data from interviews with people with diabetes (n=19) and their family members (n=19). REVIEW METHODS: Combining two data sets. DISCUSSION: When using grounded theory, there are numerous challenges in collecting and managing data, especially for the novice researcher. One challenge is to combine different data sets during the analysis. There are many methodological textbooks about grounded theory but there is little written in the literature about combining different data sets. CONCLUSION: Discussion is needed on the management of data and the challenges of grounded theory. IMPLICATIONS FOR RESEARCH/PRACTICE: This article provides a means for combining different data sets in the grounded theory analysis process.

Interrelation between adult persons with diabetes and their family: a systematic review of the literature.

Diabetes mellitus is a common chronic disease all over the world. Self-management plays a crucial role in diabetes management. The purpose of this systematic review was to summarize what is known about the interactions between adult persons with diabetes, their family, and diabetes self-management. MEDLINE, CINAHL, PSYCHINFO, LINDA, and MEDIC databases were searched for the years 2000 to 2011 and for English language articles, and the reference lists of the studies included were reviewed to capture additional studies. The findings indicate that family members have influence on the self-management of adult persons with diabetes. The support from family members plays a crucial role in maintaining lifestyle changes and optimizing diabetes management. Diabetes and its treatment also affect the life of family members in several ways, causing, for example, different types of psychological distress. More attention should be paid to family factors in diabetes management among adult persons.

Everyday living with diabetes described by family members of adult people with type 1 diabetes.

The aim of this study was to explore family members' experiences of everyday life in families with adult people living with type 1 diabetes. The grounded theory method was used to gather and analyse data from the interviews of nineteen family members. Six concepts describing the family members' views on everyday living with diabetes were generated on the basis of the data. Everyday life with diabetes is described as being intertwined with hypoglycemia. Becoming acquainted with diabetes takes place little by little. Being involved in the management and watching self-management from the sidelines are concepts describing family members' participation in the daily management of diabetes. The family members are also integrating diabetes into everyday life. Living on an emotional roller-coaster tells about the thoughts and feelings that family members experience. Family members of adult people with diabetes are involved in the management of the diabetes in many ways and experience many concerns. The family members' point of view is important to take into consideration when developing education for adults with diabetes.