119 research outputs found
Ten years of the International Patient Decision Aid Standards Collaboration: evolution of the core dimensions for assessing the quality of patient decision aids
In 2003, the International Patient Decision Aid Standards (IPDAS) Collaboration was established to enhance the quality and effectiveness of patient decision aids by establishing an evidence-informed framework for improving their content, development, implementation, and evaluation. Over this 10 year period, the Collaboration has established: a) the background document on 12 core dimensions to inform the original modified Delphi process to establish the IPDAS checklist (74 items); b) the valid and reliable IPDAS instrument (47 items); and c) the IPDAS qualifying (6 items), certifying (6 items + 4 items for screening), and quality criteria (28 items). The objective of this paper is to describe the evolution of the IPDAS Collaboration and discuss the standardized process used to update the background documents on the theoretical rationales, evidence and emerging issues underlying the 12 core dimensions for assessing the quality of patient decision aids. © 2013 Volk et al; licensee BioMed Central Ltd
Human Cell Atlas and cell-type authentication for regenerative medicine
In modern biology, the correct identification of cell types is required for the developmental study of tissues and organs and the production of functional cells for cell therapies and disease modeling. For decades, cell types have been defined on the basis of morphological and physiological markers and, more recently, immunological markers and molecular properties. Recent advances in single-cell RNA sequencing have opened new doors for the characterization of cells at the individual and spatiotemporal levels on the basis of their RNA profiles, vastly transforming our understanding of cell types. The objective of this review is to survey the current progress in the field of cell-type identification, starting with the Human Cell Atlas project, which aims to sequence every cell in the human body, to molecular marker databases for individual cell types and other sources that address cell-type identification for regenerative medicine based on cell data guidelines
Access to stem cell data and registration of pluripotent cell lines: the Human Pluripotent Stem Cell Registry (hPSCreg)
The value of human pluripotent stem cells (hPSC) in regenerative medicine has yet to reach its full potential. The road from basic research tool to clinically validated PSC-derived cell therapy products is a long and winding one, leading researchers, clinicians, industry and regulators alike into undiscovered territory. All stakeholders must work together to ensure the development of safe and effective cell therapies. Similarly, utilization of hPSC in meaningful and controlled disease modeling and drug screening applications requires information on the quality and suitability of the applied cell lines. Central to these common goals is the complete documentation of hPSC data, including the ethical provenance of the source material, the hPSC line derivation, culture conditions and genetic constitution of the lines. Data surrounding hPSC is scattered amongst diverse sources, including publications, supplemental data, researcher lab books, accredited lab reports, certificates of analyses and public data repositories. Not all of these data sources are publicly accessible nor associated with metadata nor stored in a standard manner, such that data can be easily found and retrieved. The Human Pluripotent Stem Cell Registry (hPSCreg; https://hpscreg.eu/) was started in 2007 to impart provenance and transparency towards hPSC research by registering and collecting standard properties of hPSC lines. In this chapter, we present a short primer on the history of stem cell-based products, summarize the ethical and regulatory issues introduced in the course of working with hPSC-derived products and their associated data, and finally present the Human Pluripotent Stem Cell Registry as a valuable resource for all stakeholders in therapies and disease modeling based on hPSC-derived cells
hPSCreg - the human pluripotent stem cell registry
The human pluripotent stem cell registry (hPSCreg), accessible at
http://hpscreg.eu, is a public registry and data portal for human embryonic
and induced pluripotent stem cell lines (hESC and hiPSC). Since their first
isolation the number of hESC lines has steadily increased to over 3000 and new
iPSC lines are generated in a rapidly growing number of laboratories as a
result of their potentially broad applicability in biomedicine and drug
testing. Many of these lines are deposited in stem cell banks, which are
globally established to store tens of thousands of lines from healthy and
diseased donors. The Registry provides comprehensive and standardized
biological and legal information as well as tools to search and compare
information from multiple hPSC sources and hence addresses a translational
research need. To facilitate unambiguous identification over different
resources, hPSCreg automatically creates a unique standardized name for each
cell line registered. In addition to biological information, hPSCreg stores
extensive data about ethical standards regarding cell sourcing and conditions
for application and privacy protection. hPSCreg is the first global registry
that holds both, manually validated scientific and ethical information on hPSC
lines, and provides access by means of a user-friendly, mobile-ready web
application
Validating a conceptual model for an inter-professional approach to shared decision making: a mixed methods study
Rationale, aims and objectives Following increased interest in having inter-professional
(IP) health care teams engage patients in decision making, we developed a conceptual
model for an IP approach to shared decision making (SDM) in primary care. We assessed
the validity of the model with stakeholders in Canada.
Methods In 15 individual interviews and 7 group interviews with 79 stakeholders, we
asked them to: (1) propose changes to the IP-SDM model; (2) identify barriers and
facilitators to the model’s implementation in clinical practice; and (3) assess the model
using a theory appraisal questionnaire.We performed a thematic analysis of the transcripts
and a descriptive analysis of the questionnaires.
Results Stakeholders suggested placing the patient at its centre; extending the concept of
family to include significant others; clarifying outcomes; highlighting the concept of time;
merging the micro, meso and macro levels in one figure; and recognizing the influence of
the environment and emotions. The most common barriers identified were time constraints,
insufficient resources and an imbalance of power among health professionals. The most
common facilitators were education and training in inter-professionalism and SDM, motivation
to achieve an IP approach to SDM, and mutual knowledge and understanding of
disciplinary roles. Most stakeholders considered that the concepts and relationships
between the concepts were clear and rated the model as logical, testable, having clear
schematic representation, and being relevant to inter-professional collaboration, SDM and
primary care.
Conclusions Stakeholders validated the new IP-SDM model for primary care settings and
proposed few modifications. Future research should assess if the model helps implement
SDM in IP clinical practice
Perspective: The Role of Cryopreservation Techniques in Manufacturing, Transport, and Storage of Car-T Therapy Products
Several clinical trials have proved the efficacy and safety of T-cells chimeric antigen receptor (CAR-T cells) in treatment of malignant lymphoma and the first products were registered in the European Union in 2018. The shelf-life of CAR-T cell products in the liquid state is short,
so cryopreservation offers a significant benefit for logistics in manufacturing and patient management. Direct shipment of the cryopreserved CAR-T cell therapy products to the clinical department is feasible, nevertheless, intermediate storage in the hospital cryostorage facility gives significant
advantage in planning of their administration to patients. Moreover, some manufacturers prefer transport of the starting material cryopreserved at the collection site. The cryopreservation protocol used for starting material by the authors is based on combining dimethyl sulphoxide (DMSO) with
hydroxyethyl starch (HES) and slow controlled cooling in cryobags housed in metal cassettes. This achieves the mononuclear cell post-thaw viability of 98.8 ± 0.5 % and recovery of 72.8, ± 10.2 %. Transport of the starting material to the manufactures and return
transport of the CAR-T therapy product is performed by authorized courier companies. Intermediate cryostorage of the final CAR-T cell therapy product is performed in a separate dry-storage liquid nitrogen container. On the day of infusion, the cryopreserved products are transported to the
clinical department in a dry shipper. On the wards the product is removed from the cassette, inserted into a sterile plastic bag, thawed in a 37 °C water bath followed by immediate intravenous administration. The authors discuss the adherence of the used technology to good manufacturing
practice (GMP) principles and genetic safety assurance rules
A Manually Curated Database on Clinical Studies Involving Cell Products Derived from Human Pluripotent Stem Cells
The last 5 years have witnessed a significant increase in the number of clinical studies based on human pluripotent stem cells (hPSCs). In parallel, concern is increasing about the proliferation of unregulated stem cell treatments worldwide. Regulated clinical testing is a de facto standard to establish the safety and efficacy of new cell therapies, yet reliable information on clinical studies involving hPSCs is scattered. Our analysis of a multitude of resources found 54 clinical studies involving several types of hPSCs, which are performed in ten countries. While the majority of those studies is based on human embryonic stem cells (hESCs), clinical studies involving human induced pluripotent stem cells increased more strongly in the past 2 years than the number of hESC-based studies. A publicly accessible database was created using the human pluripotent stem cell registry (https://hpscreg.eu) platform, providing a steadily updated comprehensive overview on hPSC-based clinical studies performed worldwide
Integrated Collection of Stem Cell Bank Data, a Data Portal for Standardized Stem Cell Information
世界中で樹立されたiPS細胞の数や疾患の種類が明らかに. 京都大学プレスリリース. 2021-03-19.The past decade has witnessed an extremely rapid increase in the number of newly established stem cell lines. However, due to the lack of a standardized format, data exchange among stem cell line resources has been challenging, and no system can search all stem cell lines across resources worldwide. To solve this problem, we have developed the Integrated Collection of Stem Cell Bank data (ICSCB) (http://icscb.stemcellinformatics.org/), the largest database search portal for stem cell line information, based on the standardized data items and terms of the MIACARM framework. Currently, ICSCB can retrieve >16, 000 cell lines from four major data resources in Europe, Japan, and the United States. ICSCB is automatically updated to provide the latest cell line information, and its integrative search helps users collect cell line information for over 1, 000 diseases, including many rare diseases worldwide, which has been a formidable task, thereby distinguishing itself from other database search portals
Arduous implementation: Does the Normalisation Process Model explain why it's so difficult to embed decision support technologies for patients in routine clinical practice
Background: decision support technologies (DSTs, also known as decision aids) help patients and professionals take part in collaborative decision-making processes. Trials have shown favorable impacts on patient knowledge, satisfaction, decisional conflict and confidence. However, they have not become routinely embedded in health care settings. Few studies have approached this issue using a theoretical framework. We explained problems of implementing DSTs using the Normalization Process Model, a conceptual model that focuses attention on how complex interventions become routinely embedded in practice.Methods: the Normalization Process Model was used as the basis of conceptual analysis of the outcomes of previous primary research and reviews. Using a virtual working environment we applied the model and its main concepts to examine: the 'workability' of DSTs in professional-patient interactions; how DSTs affect knowledge relations between their users; how DSTs impact on users' skills and performance; and the impact of DSTs on the allocation of organizational resources.Results: conceptual analysis using the Normalization Process Model provided insight on implementation problems for DSTs in routine settings. Current research focuses mainly on the interactional workability of these technologies, but factors related to divisions of labor and health care, and the organizational contexts in which DSTs are used, are poorly described and understood.Conclusion: the model successfully provided a framework for helping to identify factors that promote and inhibit the implementation of DSTs in healthcare and gave us insights into factors influencing the introduction of new technologies into contexts where negotiations are characterized by asymmetries of power and knowledge. Future research and development on the deployment of DSTs needs to take a more holistic approach and give emphasis to the structural conditions and social norms in which these technologies are enacte
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