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Decentralized clinical trials (DCTs) are becoming increasingly popular. Digital clinical trial platforms are software environments where users complete designated clinical trial tasks, providing investigators and trial participants with efficient tools to support trial activities and streamline trial processes. In particular, digital platforms with a modular architecture lend themselves to DCTs, where individual trial activities can correspond to specific platform modules. While design features can allow users to customize their platform experience, the real strengths of digital platforms for DCTs are enabling centralized data capture and remote monitoring of trial participants and in using digital technologies to streamline workflows and improve trial management. When selecting a platform for use in a DCT, sponsors and investigators must consider the specific trial requirements. All digital platforms are limited in their functionality and technical capabilities. Integrating additional functional modules into a central platform may solve these challenges, but few commercial platforms are open to integrating third-party components. The lack of common data standardization protocols for clinical trials will likely limit the development of one-size-fits-all digital platforms for DCTs. This viewpoint summarizes the current role of digital platforms in supporting decentralized trial activities, including a discussion of the potential benefits and challenges of digital platforms for investigators and participants. We will highlight the role of the digital platform in the development of DCTs and emphasize where existing technology is functionally limiting. Finally, we will discuss the concept of the ideal fully integrated and unified DCT and the obstacles developers must address before it can be realized.

Abstract Background The national e-prescription system in Greece is one of the most important achievements in the e-health sector. Healthcare professionals’ feedback is essential to ensure the introduced system tends to their needs and reduces their everyday workload. The number of surveys collecting the users’ views is limited, while the existing studies include only a small number of participants. Methods In this study, healthcare professionals’ perceptions on e-prescription are explored. For this, a questionnaire was distributed online, containing closed- and open-ended questions aiming to address strengths and identify drawbacks in e-prescription. Answers were collected from primary health care physicians, specialized medical doctors and pharmacists. Results In total, 430 answers were collected (129 from primary health care physicians, 164 responses from specialized medical doctors and 137 pharmacists). Analysis of the collected answers reveals that the views of the three groups of healthcare professionals mostly converge. The positive impact e-prescribing systems have on the overall prescribing procedure in preventing errors and providing automation is commented. Among gaps identified and proposed improvements, health care professionals note the need for access to information on adverse drug reactions, side effects, drug-to-drug interactions and allergies. Flexible interaction with Therapeutic Prescription Protocols is desired to ameliorate monitoring and decision-making, while drug dosing features, and simplified procedures for copying, repeating, canceling a prescription, are perceived as useful to incorporate. Conclusions Collecting healthcare professionals’ feedback is important, as their views can be transcribed to system requirements, to further promote e-prescribing and improve the provided health care services by facilitating decision making through safer and more efficient e-prescription. Introduction of the identified improvements can simplify the everyday workflow of healthcare professionals. To the best of our knowledge, a survey with more than 400 answered questionnaires on the use of e-prescription systems by healthcare professionals has never been conducted in Greece before.

The ADReSS-M Signal Processing Grand Challenge was held at the 2023 IEEE International Conference on Acoustics, Speech and Signal Processing, ICASSP 2023. The challenge targeted difficult automatic prediction problems of great societal and medical relevance, namely, the detection of Alzheimer's Dementia (AD) and the estimation of cognitive test scoress. Participants were invited to create models for the assessment of cognitive function based on spontaneous speech data. Most of these models employed signal processing and machine learning methods. The ADReSS-M challenge was designed to assess the extent to which predictive models built based on speech in one language generalise to another language. The language data compiled and made available for ADReSS-M comprised English, for model training, and Greek, for model testing and validation. To the best of our knowledge no previous shared research task investigated acoustic features of the speech signal or linguistic characteristics in the context of multilingual AD detection. This paper describes the context of the ADReSS-M challenge, its data sets, its predictive tasks, the evaluation methodology we employed, our baseline models and results, and the top five submissions. The paper concludes with a summary discussion of the ADReSS-M results, and our critical assessment of the future outlook in this field.

IntroductionAssessing functional decline related to activities of daily living (ADLs) is deemed significant for the early diagnosis of dementia. As current assessment methods for ADLs often lack the ability to capture subtle changes, technology-based approaches are perceived as advantageous. Specifically, digital biomarkers are emerging, offering a promising avenue for research, as they allow unobtrusive and objective monitoring.MethodsA study was conducted with the involvement of 36 participants assigned to three known groups (Healthy Controls, participants with Subjective Cognitive Decline and participants with Mild Cognitive Impairment). Participants visited the CERTH-IT Smart Home, an environment that simulates a fully functional residence, and were asked to follow a protocol describing different ADL Tasks (namely Task 1 – Meal, Task 2 – Beverage and Task 3 – Snack Preparation). By utilizing data from fixed in-home sensors installed in the Smart Home, the identification of the performed Tasks and their derived features was explored through the developed CARL platform. Furthermore, differences between groups were investigated. Finally, overall feasibility and study satisfaction were evaluated.ResultsThe composition of the ADLs was attainable, and differentiation among the HC group compared to the SCD and the MCI groups considering the feature “Activity Duration” in Task 1 – Meal Preparation was possible, while no difference could be noted between the SCD and the MCI groups.DiscussionThis ecologically valid study was determined as feasible, with participants expressing positive feedback. The findings additionally reinforce the interest and need to include people in preclinical stages of dementia in research to further evolve and develop clinically relevant digital biomarkers.

Diabetic foot ulcers (DFUs) pose a significant challenge in diabetes care, demanding advanced approaches for effective prevention and management. Smart insoles using sensor technology have emerged as promising tools to address the challenges associated with DFU and neuropathy. By recognizing the pivotal role of smart insoles in successful prevention and healthcare management, this scoping review aims to present a comprehensive overview of the existing evidence regarding DFU studies related to smart insoles, offloading sensors, and actuator technologies. This systematic review identified and critically evaluated 11 key studies exploring both sensor technologies and offloading devices in the context of DFU care through searches in CINAHL, MEDLINE, and ScienceDirect databases. Predominantly, smart insoles, mobile applications, and wearable technologies were frequently utilized for interventions and patient monitoring in diabetic foot care. Patients emphasized the importance of these technologies in facilitating care management. The pivotal role of offloading devices is underscored by the majority of the studies exhibiting increased efficient monitoring, prevention, prognosis, healing rate, and patient adherence. The findings indicate that, overall, smart insoles and digital technologies are perceived as acceptable, feasible, and beneficial in meeting the specific needs of DFU patients. By acknowledging the promising outcomes, the present scoping review suggests smart technologies can potentially redefine DFU management by emphasizing accessibility, efficacy, and patient centricity.

Activities of daily living (ADLs) are fundamental routine tasks that the majority of physically and mentally healthy people can independently execute. In this paper, we present a semantic framework for detecting problems in ADLs execution, monitored through smart home sensors. In the context of this work, we conducted a pilot study, gathering raw data from various sensors and devices installed in a smart home environment. The proposed framework combines multiple Semantic Web technologies (i.e., ontology, RDF, triplestore) to handle and transform these raw data into meaningful representations, forming a knowledge graph. Subsequently, SPARQL queries are used to define and construct explicit rules to detect problematic behaviors in ADL execution, a procedure that leads to generating new implicit knowledge. Finally, all available results are visualized in a clinician dashboard. The proposed framework can monitor the deterioration of ADLs performance for people across the dementia spectrum by offering a comprehensive way for clinicians to describe problematic behaviors in the everyday life of an individual.

ObjectivesMeditation imparts relaxation and constitutes an important non-pharmacological intervention for people with cognitive impairment. Moreover, EEG has been widely used as a tool for detecting brain changes even at the early stages of Alzheimer’s Disease (AD). The current study investigates the effect of meditation practices on the human brain across the AD spectrum by using a novel portable EEG headband in a smart-home environment.MethodsForty (40) people (13 Healthy Controls—HC, 14 with Subjective Cognitive Decline—SCD and 13 with Mild Cognitive Impairment—MCI) participated practicing Mindfulness Based Stress Reduction (Session 2-MBSR) and a novel adaptation of the Kirtan Kriya meditation to the Greek culture setting (Session 3-KK), while a Resting State (RS) condition was undertaken at baseline and follow-up (Session 1—RS Baseline and Session 4—RS Follow-Up). The signals were recorded by using the Muse EEG device and brain waves were computed (alpha, theta, gamma, and beta).ResultsAnalysis was conducted on four-electrodes (AF7, AF8, TP9, and TP10). Statistical analysis included the Kruskal–Wallis (KW) nonparametric analysis of variance. The results revealed that both states of MBSR and KK lead to a marked difference in the brain’s activation patterns across people at different cognitive states. Wilcoxon Signed-ranks test indicated for HC that theta waves at TP9, TP10 and AF7, AF8 in Session 3-KK were statistically significantly reduced compared to Session 1-RS Z = –2.271, p = 0.023, Z = −3.110, p = 0.002 and Z = −2.341, p = 0.019, Z = −2.132, p = 0.033, respectively.ConclusionThe results showed the potential of the parameters used between the various groups (HC, SCD, and MCI) as well as between the two meditation sessions (MBSR and KK) in discriminating early cognitive decline and brain alterations in a smart-home environment without medical support.

[This corrects the article DOI: 10.1371/journal.pone.0285807.].

IntroductionClinical research with remote monitoring technologies (RMTs) has multiple advantages over standard paper-pencil tests, but also raises several ethical concerns. While several studies have addressed the issue of governance of big data in clinical research from the legal or ethical perspectives, the viewpoint of local research ethics committee (REC) members is underrepresented in the current literature. The aim of this study is therefore to find which specific ethical challenges are raised by RECs in the context of a large European study on remote monitoring in all syndromic stages of Alzheimer's disease, and what gaps remain.MethodsDocuments describing the REC review process at 10 sites in 9 European countries from the project Remote Assessment of Disease and Relapse-Alzheimer's Disease (RADAR-AD) were collected and translated. Main themes emerging in the documents were identified using a qualitative analysis approach.ResultsFour main themes emerged after analysis: data management, participant's wellbeing, methodological issues, and the issue of defining the regulatory category of RMTs. Review processes differed across sites: process duration varied from 71 to 423 days, some RECs did not raise any issues, whereas others raised up to 35 concerns, and the approval of a data protection officer was needed in half of the sites.DiscussionThe differences in the ethics review process of the same study protocol across different local settings suggest that a multi-site study would benefit from a harmonization in research ethics governance processes. More specifically, some best practices could be included in ethical reviews across institutional and national contexts, such as the opinion of an institutional data protection officer, patient advisory board reviews of the protocol and plans for how ethical reflection is embedded within the study.

We have designed a platform to aid people with motor disabilities to be part of digital environments, in order to create digitally and socially inclusive activities that promote their quality of life. To evaluate in depth the impact of the platform on social inclusion indicators across patients with various motor disabilities, we constructed a questionnaire in which the following indicators were assessed: (i) Well Being, (ii) Empowerment, (iii) Participation, (iv) Social Capital, (v) Education, and (vi) Employment. In total 30 participants (10 with Neuromuscular Disorders-NMD, 10 with Spinal Cord Injury-SCI, and 10 with Parkinson's Disease-PD) used the platform for ~1 month, and its impact on social inclusion indicators was measured before and after the usage. Moreover, monitoring mechanisms were used to track computer usage as well as an online social activity. Finally, testimonials and experimenter input were collected to enrich the study with qualitative understanding. All participants were favorable to use the suggested platform, while they would prefer it for longer periods of time in order to become “re-awakened” to possibilities of expanded connection and inclusion, while it became clear that the platform has to offer them further the option to use it in a reclining position. The present study has clearly shown that the challenge of social inclusion cannot be tackled solely with technology and it needs to integrate persuasive design elements that foster experimentation and discovery.

BackgroundLiving Labs are user-centered, open innovation ecosystems based on a systematic user cocreation approach, which integrates research and innovation processes in real-life communities and settings. The Horizon 2020 Project VITALISE (Virtual Health and Wellbeing Living Lab Infrastructure) unites 19 partners across 11 countries. The project aims to harmonize Living Lab procedures and enable effective and convenient transnational and virtual access to key European health and well-being research infrastructures, which are governed by Living Labs. The VITALISE consortium will conduct joint research activities in the fields included in the care pathway of patients: rehabilitation, transitional care, and everyday living environments for older adults. This protocol focuses on health and well-being research in everyday living environments. ObjectiveThe main aim of this study is to cocreate and test a harmonized research protocol for developing big data–driven hybrid persona, which are hypothetical user archetypes created to represent a user community. In addition, the use and applicability of innovative technologies will be investigated in the context of various everyday living and Living Lab environments. MethodsIn phase 1, surveys and structured interviews will be used to identify the most suitable Living Lab methods, tools, and instruments for health-related research among VITALISE project Living Labs (N=10). A series of web-based cocreation workshops and iterative cowriting processes will be applied to define the initial protocols. In phase 2, five small-scale case studies will be conducted to test the cocreated research protocols in various real-life everyday living settings and Living Lab infrastructures. In phase 3, a cross-case analysis grounded on semistructured interviews will be conducted to identify the challenges and benefits of using the proposed research protocols. Furthermore, a series of cocreation workshops and the consensus seeking Delphi study process will be conducted in parallel to cocreate and validate the acceptance of the defined harmonized research protocols among wider Living Lab communities. ResultsAs of September 30, 2021, project deliverables Ethics and safety manual and Living lab standard version 1 have been submitted to the European Commission review process. The study will be finished by March 2024. ConclusionsThe outcome of this research will lead to harmonized procedures and protocols in the context of big data–driven hybrid persona development among health and well-being Living Labs in Europe and beyond. Harmonized protocols enable Living Labs to exploit similar research protocols, devices, hardware, and software for interventions and complex data collection purposes. Economies of scale and improved use of resources will speed up and improve research quality and offer novel possibilities for open data sharing, multidisciplinary research, and comparative studies beyond current practices. Case studies will also provide novel insights for implementing innovative technologies in the context of everyday Living Lab research. International Registered Report Identifier (IRRID)DERR1-10.2196/34567

Background: This review describes the diagnostic and interventional procedures conducted in two university memory clinics (established network of G. Papanikolaou Hospital: 1988–2017 and AHEPA hospital: 2017–today) and 2 day care centers (established network of DCCs: 2005–today) in North Greece and their contribution in the scientific field of dementia. The aims of this work are (1) to provide a diagnosis and treatment protocol established in the network of memory clinics and DCCs and (2) to present further research conducted in the aforementioned network during the last 30 years of clinical practice.Methods: The guidelines to set a protocol demand a series of actions as follows: (1) set the diagnosis criteria, neuropsychological assessment, laboratory examinations, and examination of neurophysiological, neuroimaging, cerebrospinal fluid, blood, and genetic markers; and (2) apply non-pharmacological interventions according to the needs and specialized psychosocial interventions of the patient to the caregivers of the patient.Results: In addition to the guidelines followed in memory clinics at the 1st and 3rd Department of Neurology and two DCCs, a database of patients, educational programs, and further participation in international research programs, including clinical trials, make our contribution in the dementia field strong.Conclusion: In the current paper, we provide useful guidelines on how major and minor neurocognitive disorders are being treated in Thessaloniki, Greece, describing successful practices which have been adapted in the last 30 years.

Background: Alzheimer's Disease (AD) impairs the ability to carry out daily activities, reduces independence and quality of life and increases caregiver burden. Our understanding of functional decline has traditionally relied on reports by family and caregivers, which are subjective and vulnerable to recall bias. The Internet of Things (IoT) and wearable sensor technologies promise to provide objective, affordable, and reliable means for monitoring and understanding function. However, human factors for its acceptance are relatively unexplored.Objective: The Public Involvement (PI) activity presented in this paper aims to capture the preferences, priorities and concerns of people with AD and their caregivers for using monitoring wearables. Their feedback will drive device selection for clinical research, starting with the study of the RADAR-AD project.Method: The PI activity involved the Patient Advisory Board (PAB) of the RADAR-AD project, comprised of people with dementia across Europe and their caregivers (11 and 10, respectively). A set of four devices that optimally represent various combinations of aspects and features from the variety of currently available wearables (e.g., weight, size, comfort, battery life, screen types, water-resistance, and metrics) was presented and experienced hands-on. Afterwards, sets of cards were used to rate and rank devices and features and freely discuss preferences.Results: Overall, the PAB was willing to accept and incorporate devices into their daily lives. For the presented devices, the aspects most important to them included comfort, convenience and affordability. For devices in general, the features they prioritized were appearance/style, battery life and water resistance, followed by price, having an emergency button and a screen with metrics. The metrics valuable to them included activity levels and heart rate, followed by respiration rate, sleep quality and distance. Some concerns were the potential complexity, forgetting to charge the device, the potential stigma and data privacy.Conclusions: The PI activity explored the preferences, priorities and concerns of the PAB, a group of people with dementia and caregivers across Europe, regarding devices for monitoring function and decline, after a hands-on experience and explanation. They highlighted some expected aspects, metrics and features (e.g., comfort and convenience), but also some less expected (e.g., screen with metrics).

Brain Training games are increasingly gaining attention as a non-pharmacological intervention to promote well-being and quality of life in people living with dementia. Herein we present the COSMA software and a pilot study to evaluate its impact on the emotions of people in the spectrum of dementia. The software was created in accordance to the UK National Institute for Health and Care Excellence (NICE) guidelines as a ‘brain-stimulating’ software for use by people with cognitive impairment i.e., mild cognitive impairment (MCI) and early dementia. The pilot study aims to investigate whether the current COSMA game designs have an impact on emotions in people with MCI and early dementia. The emotional evaluation before and after playing COSMA games was carried out using the Positive and Negative Affect Schedule (PANAS). Our findings demonstrated a small, but significant increase in positive emotions (MCI: p= 0.041; early dementia: p= 0.042) and decrease in negative emotions (MCI: p= 0.001; early dementia: p< 0.001). These preliminary results showed that people with MCI and early dementia experienced positive emotions while playing the COSMA games, suggesting that people with cognitive impairment may benefit from using the COSMA software regularly.

We present a dataset that combines multimodal biosignals and eye tracking information gathered under a human-computer interaction framework. The dataset was developed in the vein of the MAMEM project that aims to endow people with motor disabilities with the ability to edit and author multimedia content through mental commands and gaze activity. The dataset includes EEG, eye-tracking, and physiological (GSR and Heart rate) signals collected from 34 individuals (18 able-bodied and 16 motor-impaired). Data were collected during the interaction with specifically designed interface for web browsing and multimedia content manipulation and during imaginary movement tasks. The presented dataset will contribute towards the development and evaluation of modern human-computer interaction systems that would foster the integration of people with severe motor impairments back into society.

In this paper, we demonstrate the potential of a knowledge-driven framework to improve the efficiency and effectiveness of care through remote and intelligent assessment. More specifically, we present a rule-based approach to detect health related problems from wearable lifestyle sensor data that add clinical value to take informed decisions on follow-up and intervention. We use OWL 2 ontologies as the underlying knowledge representation formalism for modelling contextual information and high-level concepts and relations among them. The conceptual model of our framework is defined on top of existing modelling standards, such as SOSA and WADM, promoting the creation of interoperable knowledge graphs. On top of the symbolic knowledge graphs, we define a rule-based framework for infusing expert knowledge in the form of SHACL constraints and rules to recognise patterns, anomalies and situations of interest based on the predefined and stored rules and conditions. A dashboard visualizes both sensor data and detected events to facilitate clinical supervision and decision making. Preliminary results on the performance and scalability are presented, while a focus group of clinicians involved in an exploratory research study revealed their preferences and perspectives to shape future clinical research using the framework.

Background: At present, the assessment of autonomy in daily living activities, one of the key symptoms in Alzheimer’s disease (AD), involves clinical rating scales. Methods: In total, 109 participants were included. In particular, 11 participants during a pre-test in Nice, France, and 98 participants (27 AD, 38 mild cognitive impairment—MCI—and 33 healthy controls—HC) in Thessaloniki, Greece, carried out a standardized scenario consisting of several instrumental activities of daily living (IADLs), such as making a phone call or preparing a pillbox while being recorded. Data were processed by a platform of video signal analysis in order to extract kinematic parameters, detecting activities undertaken by the participant. Results: The video analysis data can be used to assess IADL task quality and provide clinicians with objective measurements of the patients’ performance. Furthermore, it reveals that the HC statistically significantly outperformed the MCI, which had better performance compared to the AD participants. Conclusions: Accurate activity recognition data for the analyses of the performance on IADL activities were obtained.

Aim: To investigate for the first time the brain network in the Alzheimer’s disease (AD) spectrum by implementing a high-density electroencephalography (HD-EEG - EGI GES 300) study with 256 channels in order to seek if the brain connectome can be effectively used to distinguish cognitive impairment in preclinical stages. Methods: Twenty participants with AD, 30 with mild cognitive impairment (MCI), 20 with subjective cognitive decline (SCD) and 22 healthy controls (HC) were examined with a detailed neuropsychological battery and 10 min resting state HD-EEG. We extracted correlation matrices by using Pearson correlation coefficients for each subject and constructed weighted undirected networks for calculating clustering coefficient (CC), strength (S) and betweenness centrality (BC) at global (256 electrodes) and local levels (29 parietal electrodes). Results: One-way ANOVA presented a statistically significant difference among the four groups at local level in CC [F (3, 88) = 4.76, p = 0.004] and S [F (3, 88) = 4.69, p = 0.004]. However, no statistically significant difference was found at a global level. According to the independent sample t-test, local CC was higher for HC [M (SD) = 0.79 (0.07)] compared with SCD [M (SD) = 0.72 (0.09)]; t (40) = 2.39, p = 0.02, MCI [M (SD) = 0.71 (0.09)]; t (50) = 0.41, p = 0.004 and AD [M (SD) = 0.68 (0.11)]; t (40) = 3.62, p = 0.001 as well, while BC showed an increase at a local level but a decrease at a global level as the disease progresses. These findings provide evidence that disruptions in brain networks in parietal organization may potentially represent a key factor in the ability to distinguish people at early stages of the AD continuum. Conclusions: The above findings reveal a dynamically disrupted network organization of preclinical stages, showing that SCD exhibits network disorganization with intermediate values between MCI and HC. Additionally, these pieces of evidence provide information on the usefulness of the 256 HD-EEG in network construction.

Background: Alzheimer’s disease (AD) is the most common type of dementia, with progressive onset of clinical symptoms. The main pathological hallmarks are brain deposits of extracellular amyloid beta plaques and intracellular neurofibrillary tangles (NFT). Cerebrospinal fluid reflects pathological changes in the brain; amyloid beta 1-42 is a marker of amyloid plaques, while total and phosphorylated tau are markers of NFT formation. Additional biomarkers associated with disease pathogenesis are needed, for better prognosis, more specific diagnosis, prediction of disease severity and progression and for improved patient classification in clinical trials. The aim of the present study was to evaluate brain-specific proteins as potential biomarkers of progression of AD. Methods: Overall, 30 candidate proteins were quantified in cerebrospinal fluid (CSF) samples from patients with mild cognitive impairment (MCI) and mild, moderate and severe AD dementia (n=101) using mass spectrometry-based selected reaction monitoring assays. ELISA was used for neuronal pentraxin receptor-1 (NPTXR) confirmation. Results: The best discrimination between MCI and more advanced AD stages (moderate and severe dementia) was observed for protein NPTXR (area under the curve, AUC=0.799). A statistically different abundance of this protein was observed between the two groups, with severe AD patients having progressively lower levels (p

People with severe neurological impairments face many challenges in sensorimotor functions and communication with the environment; therefore they have increased demand for advanced, adaptive and personalized rehabilitation. During the last several decades, numerous studies have developed brain–computer interfaces (BCIs) with the goals ranging from providing means of communication to functional rehabilitation. Here we review the research on non-invasive, electroencephalography (EEG)-based BCI systems for communication and rehabilitation. We focus on the approaches intended to help severely paralyzed and locked-in patients regain communication using three different BCI modalities: slow cortical potentials, sensorimotor rhythms and P300 potentials, as operational mechanisms. We also review BCI systems for restoration of motor function in patients with spinal cord injury and chronic stroke. We discuss the advantages and limitations of these approaches and the challenges that need to be addressed in the future.