Search results for: proof obligation

Authors: Pippa Sipanoun, Jo Wray, Kate Oulton, Faith Gibson

Abstract:

Background: With rapidly evolving digital health innovation, there is a need for digital health transformation that is accessible and sustainable, that demonstrates utility for all stakeholders while maintaining data safety. Great Ormond Street Hospital for Children aimed to future-proof the hospital by transitioning to an electronic patient record (EPR) system with a tethered patient portal (MyGOSH) in April 2019. MyGOSH patient portal enables patients 12 years or older (with their parent's consent) to access their digital health data. This includes access to results, documentation, and appointments that facilitate communication with their care team. As part of the Going Digital Study conducted between 2018-2021, data were collected from a sample of all relevant stakeholders before and after EPR and MyGOSH implementation. Data collection reach was wide and included the hospital legal and ethics teams. Aims: This study aims to understand the ethical and legal implications of young people and their parents accessing their digital health data. Methods: A focus group was conducted. Recruited participants were members of the Great Ormond Street Hospital Paediatric Bioethics Centre. Participants included expert and lay members from the Committee from a variety of professional or academic disciplines. Written informed consent was provided by all participants (n=7). The focus group was recorded, transcribed verbatim, and analyzed using thematic analysis. Results: Six themes were identified: access, competence and capacity - granting access to the system; inequalities in access resulting in inequities; burden, uncertainty and responding to change - managing expectations; documenting, risks and data safety; engagement, empowerment and understanding – how to use and manage personal information; legal considerations and obligations. Discussion: If healthcare professionals are to empower young people to be more engaged in their care, the importance of including them in decisions about their health is paramount, especially when they are approaching the age of becoming the consenter for treatment. Complexities exist in assessing competence or capacity when granting system access, when disclosing sensitive information, and maintaining confidentiality. Difficulties are also present in managing clinician burden, managing user expectations whilst providing an equitable service, and data management that meets professional and legal requirements. Conclusion: EPR and tethered-portal implementation at Great Ormond Street Hospital for Children was not only timely, due to the need for a rapid transition to remote consultations during the COVID-19 pandemic, which would not have been possible had EPR/MyGOSH not been implemented, but also integral to the digital health revolution required in healthcare today. This study is highly relevant in understanding the complexities around young people and their parents accessing their digital health data and, although the focus of this research related to portal use and access, the findings translate to young people in the wider digital health context. Ongoing support is required for all relevant stakeholders following MyGOSH patient portal implementation to navigate the ethical and legal complexities. Continued commitment is needed to balance the benefits and burdens, promote inclusion and equity, and ensure portal utility for patient benefit, whilst maintaining an individualized approach to care.

Keywords: patient portal, young people and their parents, ethical, legal

Procedia PDF Downloads 99

Authors: Sherif Keddis, Rafik Mitry, Norbert Schwesinger

Abstract:

Intelligent networking of devices has rapidly been gaining importance over the past years and with recent advances in the fields of microcontrollers, integrated circuits and wireless communication, low power applications have emerged, enabling this trend even more. Connected devices provide a much larger database thus enabling highly intelligent and accurate systems. Ensuring safe drinking water is one of the fields that require constant monitoring and can benefit from an increased accuracy. Monitoring is mainly achieved either through complex measures, such as collecting samples from the points of use, or through metering systems typically distant to the points of use which deliver less accurate assessments of the quality of water. Constant metering near the points of use is complicated due to their inaccessibility; e.g. buried water pipes, locked spaces, which makes system maintenance extremely difficult and often unviable. The research presented here attempts to overcome this challenge by providing these systems with enough energy through a flow harvester inside the pipe thus eliminating the maintenance requirements in terms of battery replacements or containment of leakage resulting from wiring such systems. The proposed flow harvester exploits the piezoelectric properties of polyvinylidene difluoride (PVDF) films to convert turbulence induced oscillations into electrical energy. It is intended to be used in standard water pipes with diameters between 0.5 and 1 inch. The working principle of the harvester uses a ring shaped bluff body inside the pipe to induce pressure fluctuations. Additionally the bluff body houses electronic components such as storage, circuitry and RF-unit. Placing the piezoelectric films downstream of that bluff body causes their oscillation which generates electrical charge. The PVDF-film is placed as a multilayered wrap fixed to the pipe wall leaving the top part to oscillate freely inside the flow. The warp, which allows for a larger active, consists of two layers of 30µm thick and 12mm wide PVDF layered alternately with two centered 6µm thick and 8mm wide aluminum foil electrodes. The length of the layers depends on the number of windings and is part of the investigation. Sealing the harvester against liquid penetration is achieved by wrapping it in a ring-shaped LDPE-film and welding the open ends. The fabrication of the PVDF-wraps is done by hand. After validating the working principle using a wind tunnel, experiments have been conducted in water, placing the harvester inside a 1 inch pipe at water velocities of 0.74m/s. To find a suitable placement of the wrap inside the pipe, two forms of fixation were compared regarding their power output. Further investigations regarding the number of windings required for efficient transduction were made. Best results were achieved using a wrap with 3 windings of the active layers which delivers a constant power output of 0.53µW at a 2.3MΩ load and an effective voltage of 1.1V. Considering the extremely low power requirements of sensor applications, these initial results are promising. For further investigations and optimization, machine designs are currently being developed to automate the fabrication and decrease tolerance of the prototypes.

Keywords: maintenance-free sensors, measurements at point of use, piezoelectric flow harvesting, universal micro generator, wireless metering systems

Procedia PDF Downloads 177

Authors: Inna Kornienko, Svetlana Guryeva, Natalia Danilova, Elena Petersen

Abstract:

Drug toxicity often goes undetected until clinical trials, the most expensive and dangerous phase of drug development. Both human cell culture and animal studies have limitations that cannot be overcome by improvements in drug testing protocols. Tissue engineering is an emerging alternative approach to creating models of human malignant tumors for experimental oncology, personalized medicine, and drug discovery studies. This new generation of bioengineered tumors provides an opportunity to control and explore the role of every component of the model system including cell populations, supportive scaffolds, and signaling molecules. An area that could greatly benefit from these models is cancer research. Recent advances in tissue engineering demonstrated that decellularized tissue is an excellent scaffold for tissue engineering. Decellularization of donor organs such as heart, liver, and lung can provide an acellular, naturally occurring three-dimensional biologic scaffold material that can then be seeded with selected cell populations. Preliminary studies in animal models have provided encouraging results for the proof of concept. Decellularized Organs preserve organ microenvironment, which is critical for cancer metastasis. Utilizing 3D tumor models results greater proximity of cell culture morphological characteristics in a model to its in vivo counterpart, allows more accurate simulation of the processes within a functioning tumor and its pathogenesis. 3D models allow study of migration processes and cell proliferation with higher reliability as well. Moreover, cancer cells in a 3D model bear closer resemblance to living conditions in terms of gene expression, cell surface receptor expression, and signaling. 2D cell monolayers do not provide the geometrical and mechanical cues of tissues in vivo and are, therefore, not suitable to accurately predict the responses of living organisms. 3D models can provide several levels of complexity from simple monocultures of cancer cell lines in liquid environment comprised of oxygen and nutrient gradients and cell-cell interaction to more advanced models, which include co-culturing with other cell types, such as endothelial and immune cells. Following this reasoning, spheroids cultivated from one or multiple patient-derived cell lines can be utilized to seed the matrix rather than monolayer cells. This approach furthers the progress towards personalized medicine. As an initial step to create a new ex vivo tissue engineered model of a cancer tumor, optimized protocols have been designed to obtain organ-specific acellular matrices and evaluate their potential as tissue engineered scaffolds for cultures of normal and tumor cells. Decellularized biomatrix was prepared from animals’ kidneys, urethra, lungs, heart, and liver by two decellularization methods: perfusion in a bioreactor system and immersion-agitation on an orbital shaker with the use of various detergents (SDS, Triton X-100) in different concentrations and freezing. Acellular scaffolds and tissue engineered constructs have been characterized and compared using morphological methods. Models using decellularized matrix have certain advantages, such as maintaining native extracellular matrix properties and biomimetic microenvironment for cancer cells; compatibility with multiple cell types for cell culture and drug screening; utilization to culture patient-derived cells in vitro to evaluate different anticancer therapeutics for developing personalized medicines.

Keywords: 3D models, decellularization, drug discovery, drug toxicity, scaffolds, spheroids, tissue engineering

Procedia PDF Downloads 283

Authors: L. Malic, X. Zhang, D. Brassard, L. Clime, J. Daoud, C. Luebbert, V. Barrere, A. Boutin, S. Bidawid, N. Corneau, J. Farber, T. Veres

Abstract:

The incidence of infections caused by foodborne pathogens such as Listeria monocytogenes (L. monocytogenes) poses a great potential threat to public health and safety. These issues are further exacerbated by legal repercussions due to “zero tolerance” food safety standards adopted in developed countries. Unfortunately, a large number of related disease outbreaks are caused by pathogens present in extremely low counts currently undetectable by available techniques. The development of highly sensitive and rapid detection of foodborne pathogens is therefore crucial, and requires robust and efficient pre-analytical sample preparation. Immunomagnetic separation is a popular approach to sample preparation. Microfluidic chips combined with external magnets have emerged as viable high throughput methods. However, external magnets alone are not suitable for the capture of nanoparticles, as very strong magnetic fields are required. Devices that incorporate externally applied magnetic field and microstructures of a soft magnetic material have thus been used for local field amplification. Unfortunately, very complex and costly fabrication processes used for integration of soft magnetic materials in the reported proof-of-concept devices would prohibit their use as disposable tools for food and water safety or diagnostic applications. We present a sample preparation magnetic microfluidic device implemented in low-cost thermoplastic polymers using fabrication techniques suitable for mass-production. The developed magnetic capture chip (M-chip) was employed for rapid capture and release of L. monocytogenes conjugated to immunomagnetic nanoparticles (IMNs) in buffer and beef filtrate. The M-chip relies on a dense array of Nickel-coated high-aspect ratio pillars for capture with controlled magnetic field distribution and a microfluidic channel network for sample delivery, waste, wash and recovery. The developed Nickel-coating process and passivation allows generation of switchable local perturbations within the uniform magnetic field generated with a pair of permanent magnets placed at the opposite edges of the chip. This leads to strong and reversible trapping force, wherein high local magnetic field gradients allow efficient capture of IMNs conjugated to L. monocytogenes flowing through the microfluidic chamber. The experimental optimization of the M-chip was performed using commercially available magnetic microparticles and fabricated silica-coated iron-oxide nanoparticles. The fabricated nanoparticles were optimized to achieve the desired magnetic moment and surface functionalization was tailored to allow efficient capture antibody immobilization. The integration, validation and further optimization of the capture and release protocol is demonstrated using both, dead and live L. monocytogenes through fluorescence microscopy and plate- culture method. The capture efficiency of the chip was found to vary as function of listeria to nanoparticle concentration ratio. The maximum capture efficiency of 30% was obtained and the 24-hour plate-culture method allowed the detection of initial sample concentration of only 16 cfu/ml. The device was also very efficient in concentrating the sample from a 10 ml initial volume. Specifically, 280% concentration efficiency was achieved in 17 minutes only, demonstrating the suitability of the system for food safety applications. In addition, flexible design and low-cost fabrication process will allow rapid sample preparation for applications beyond food and water safety, including point-of-care diagnosis.

Keywords: array of pillars, bacteria isolation, immunomagnetic sample preparation, polymer microfluidic device

Procedia PDF Downloads 257