Search

Background: Involving users has become a prominent principle in the development of Health Information Technologies (HIT) and has led to an uprise in agile and cocreation methods. Previous literature shows how the two can be combined in one method, but also suggest that using such a method may come with challenges, for which the solutions are unclear., Purpose: To identify the challenges of using a method that combines agile and cocreation, provide solutions for these challenges, and evaluate its usage., Methods and Materials: The setting for this research was the Agile Cocreation of Robots for Aging (ACCRA) project. The research consisted of three phases: 1) evaluating the Agile Cocreation method to identify challenges in its usage, by analysing documents from the project (e-mails, meeting notes), 2) solving the challenges to improve the method, by designing solutions in a cocreation session; and 3) evaluating the usage of the improved version via a survey among engineers and user researchers involved in the project., Results: We identified three main challenges and developed three solutions, which were used in the next phase of the project. First, to engage all stakeholders in cocreation, we implemented more fun and playful materials. Second, to bridge the differences between engineers and user researchers we invested in face-to-face meetings. Third, to manage knowledge in the project we intensified our meeting schedule to weekly meetings. In the quantitative evaluation of the improved cocreation method, the engineers and user researchers were positive about the agile cocreation method and about our improvements., Conclusion: When developing HIT, a method that combines agile and cocreation is useful because it helps to identify user needs and to translate these needs into technology. To identify the needs of these users and other stakeholders it is important to involve them as active partners in cocreation using fun and playful materials. Engineers and user researchers should bridge their differences and meet face-to-face as much as possible., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

The successful introduction of medical devices (MDs) in real-world settings hinges on designing service processes that cater to stakeholders' needs. While human-centered design (HCD) approaches have been widely applied to service process innovation, the literature lacks a methodology that leverages MDs' key features to design service processes that meet stakeholders' needs. This study aims to fill this gap by developing a framework for the HCD of service processes enabled by MDs. The proposed framework mixes and adapts methodological elements from HCD and technology-enabled design approaches and proposes four new tools. The five-phase framework was applied to the design of a new Parkinson's disease diagnosis and treatment process (PD-DTP) enabled by two wearable MDs for the detection of motor symptoms. The case study lasted five months and involved 42 stakeholders in 21 meetings (interviews, focus groups, etc.). Thanks to the case study, the framework was tested, and a new PD-DTP that could benefit all stakeholders involved was identified. This study provides a framework that, in addition to contributing to theory, could assist MDs developers and healthcare managers in designing service processes that cater to stakeholders' needs by leveraging MDs' key features.

Background: Considering the growing population of older adults, addressing the influence of loneliness among this demographic group has become imperative, especially due to the link between social isolation and deterioration of mental and physical well-being. Technology has the potential to be used to create innovative solutions to increase socialization and potentially promote healthy aging., Objective: This 6-month study examined the usability and acceptability of a technology-based socialization service and explored how stress and living situation affect older adults' and their ecosystem's perceptions of technology, investigating cross-sectional and longitudinal differences among and across user groups., Methods: Participants were recruited in Tuscany and Apulia (Italy) through a network of social cooperatives and a research hospital, respectively. A total of 20 older adults were provided with the same technology installed on a tablet and on a smart television. The technology has three functionalities: video calling, playing games, and sharing news. Additionally, 20 informal caregivers (IC) and 13 formal caregivers (FC) connected to the older adults were included in the study. After both initial training in the use of the system (T0) and 6 months of using the system (T6), questionnaires on usability, acceptability, and technostress were filled in by older adults, IC, and FC. Nonparametric or parametric tests were conducted to investigate group differences at both time points and changes over time. Additional analyses on older adults were done to assess whether differences in usability and acceptability were related to living situation (ie, alone or with someone). Furthermore, correlation analyses were performed between usability, acceptability, and stress toward technology at T0 and T6., Results: At both T0 and T6, older adults had lower usability scores than IC and FC and higher anxiety than IC. Over time, there was a significant decrease in older adults' attitudes toward technology score, depicting a negative attitude over time (T0 median 4.2, IQR 0.5; T6 median 3.7, IQR 0.8; Cohen d=0.7), while there was no change for IC and FC. At T0, those living alone had lower acceptability than those living with someone but this difference disappeared at T6. People or participants living with someone had a decline in anxiety, attitudes toward technology, enjoyment, and perceived usefulness. Stress toward technology affected usability and acceptability in the older adult group entering the study (ρ=-.85) but this was not observed after 6 months. In the IC group, stress affected trust at T0 (ρ=-.23) but not at T6., Conclusions: At the start of the study, older adults judged the system to be less usable and more stressful than did the caregivers. Indeed, at first, technostress was correlated with usability and acceptability; however, with repeated use, technostress did not influence the perception of technology. Overall, getting accustomed to technology decreased anxiety and stress toward technology., (© Jasmine Pani, Letizia Lorusso, Lara Toccafondi, Grazia D'Onofrio, Filomena Ciccone, Sergio Russo, Francesco Giuliani, Daniele Sancarlo, Novella Calamida, Gianna Vignani, Tarmo Pihl, Erika Rovini, Filippo Cavallo, Laura Fiorini. Originally published in JMIR Aging (https://aging.jmir.org).)

Background: Social robots are becoming increasingly important as companions in our daily lives. Consequently, humans expect to interact with them using the same mental models applied to human-human interactions, including the use of cospeech gestures. Research efforts have been devoted to understanding users' needs and developing robot's behavioral models that can perceive the user state and properly plan a reaction. Despite the efforts made, some challenges regarding the effect of robot embodiment and behavior in the perception of emotions remain open., Objective: The aim of this study is dual. First, it aims to assess the role of the robot's cospeech gestures and embodiment in the user's perceived emotions in terms of valence (stimulus pleasantness), arousal (intensity of evoked emotion), and dominance (degree of control exerted by the stimulus). Second, it aims to evaluate the robot's accuracy in identifying positive, negative, and neutral emotions displayed by interacting humans using 3 supervised machine learning algorithms: support vector machine, random forest, and K-nearest neighbor., Methods: Pepper robot was used to elicit the 3 emotions in humans using a set of 60 images retrieved from a standardized database. In particular, 2 experimental conditions for emotion elicitation were performed with Pepper robot: with a static behavior or with a robot that expresses coherent (COH) cospeech behavior. Furthermore, to evaluate the role of the robot embodiment, the third elicitation was performed by asking the participant to interact with a PC, where a graphical interface showed the same images. Each participant was requested to undergo only 1 of the 3 experimental conditions., Results: A total of 60 participants were recruited for this study, 20 for each experimental condition for a total of 3600 interactions. The results showed significant differences (P<.05) in valence, arousal, and dominance when stimulated with the Pepper robot behaving COH with respect to the PC condition, thus underlying the importance of the robot's nonverbal communication and embodiment. A higher valence score was obtained for the elicitation of the robot (COH and robot with static behavior) with respect to the PC. For emotion recognition, the K-nearest neighbor classifiers achieved the best accuracy results. In particular, the COH modality achieved the highest level of accuracy (0.97) when compared with the static behavior and PC elicitations (0.88 and 0.94, respectively)., Conclusions: The results suggest that the use of multimodal communication channels, such as cospeech and visual channels, as in the COH modality, may improve the recognition accuracy of the user's emotional state and can reinforce the perceived emotion. Future studies should investigate the effect of age, culture, and cognitive profile on the emotion perception and recognition going beyond the limitation of this work., (©Laura Fiorini, Grazia D'Onofrio, Alessandra Sorrentino, Federica Gabriella Cornacchia Loizzo, Sergio Russo, Filomena Ciccone, Francesco Giuliani, Daniele Sancarlo, Filippo Cavallo. Originally published in JMIR Human Factors (https://humanfactors.jmir.org), 26.01.2024.)

Objective: This study investigates the possibility of adopting motor and cognitive dual-task (MCDT) approaches to identify subjects with mild cognitive impairment (MCI) and subjective cognitive impairment (SCI)., Methods: The upper and lower motor performances of 44 older adults were assessed using the SensHand and SensFoot wearable system during three MCDTs: forefinger tapping (FTAP), toe-tapping heel pin (TTHP), and walking 10 m (GAIT). We developed five pooled indices (PIs) based on these MCDTs, and we included them, along with demographic data (age) and clinical scores (Frontal Assessment Battery (FAB) scores), in five logistic regression models., Results: Models which consider cognitively normal adult (CNA) vs MCI subjects have accuracies that range from 67% to 78%. The addition of clinical scores stabilised the accuracies, which ranged from 85% to 89%. For models which consider CNA vs SCI vs MCI subjects, there are great benefits to considering all three regressors (age, FAB score, and PIs); the overall accuracies of the three-class models range between 50% and 59% when just PIs and age are considered, whereas the overall accuracy increases by 18% when all three regressors are utilised., Conclusion: Logistic regression models that consider MCDT PIs and age have been effective in distinguishing between CNA and MCI subjects. The inclusion of clinical scores increased the models' accuracy. Particularly high performances in distinguishing among CNA, SCI, and MCI subjects were obtained by the TTHP PI. This study suggests that a broader framework for MCDTs, which should encompass a greater selection of motor tasks, could provide clinicians with new appropriate tools., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Mancioppi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

50% of older adults over 60 years old are experiencing social isolation. Assistive technology can provide solutions that promote the connection with their families and other stakeholders. In this context, this paper presents a pilot study of a socialization service with 3 functions tested by 10 older adults and 10 informal caregivers. After a short training, participants were requested to use the system in their daily life for six months. At the beginning (T0) and at the end (T6) of the trial, qualitative structured questionnaires were addressed to investigate training, usability, acceptance (i.e. trust, anxiety, facilitating condition, enjoyment, and attitude), and user experience. Collected results underline good training, good usability of the system (SUS>68), and user experience for both groups. Furthermore, the values associated with acceptance domains are higher than 3.5 for intention to use and trust, at the end of the tests. We can observe a decreasing trend in stress associated with technology use. Informal caregivers have a higher evaluation of the system novelty with respect to older adults. Overall, qualitative feedback collected remarked the good impression of this service among the study's participants. Finally, this study represents a promising starting point for better investigating technology-based services that can improve the quality of life of older people living alone providing them with tools that can decrease their social isolation.Clinical Relevance- The results suggest the potential use of this type of service for promoting socialization among older adults thus reducing their loneliness.

Physical therapy is strongly recommended for patients with neurological disorders. Tai Chi-based treatments seem to improve physical functions like gait speed and balance. However, assessments after treatment rely on semi-quantitative clinical scales affected by subjectivity with controversial results. This study aims at investigating whether Tai Chi could be a valid alternative to traditional physiotherapy rehabilitation. We propose a wearable system composed of two inertial devices able to objectively measure the effect of the rehabilitation treatment on the range of movement of the trunk. Seventeen patients with Parkinson's Disease (PD) were recruited and assessed. They have been randomly divided into two groups: group 1 followed a Tai Chi-based treatment, while group 2 underwent a traditional physiotherapy rehabilitation. The two groups have been assessed before (t0) and after the treatment (t1). No statistical differences have been found in the relative range of motion between the upper and lower sensors between the two groups at the baseline. Both treatments resulted in a significant improvement in the trunk range of movement (on the right side). Notably, the improvement in the effect size of the treatment was greater in group 1 than in group 2. In fact, even if both the groups benefited from their treatment group 1 gained larger mobility of the trunk if compared to group 2. Interestingly, no differences have been accounted adopting the traditional UPDRS III for motor symptoms of PD, strengthening the idea that objective measurement coming from wearable biomedical sensors could detect information otherwise neglected by traditional clinical tools.Clinical Relevance- This study preliminary confirms that beneficial motor effects after a Tai Chi rehabilitation program are comparable and quite better than after traditional physiotherapy, promoting Tai Chi as a valid alternative treatment for PD patients.

Assistive devices could promote independent living and support the active and healthy aging of an older population; however, several factors can badly influence the long-term use of new technologies. In this context, this paper presents a two-step methodology called “pre-validation” that aims to identify the factors that can bias the use of new services, thus minimizing the risk of an unsuccessful longer trial. The proposed pre-validation methodology is composed of two main phases that aim to assess the usability and the reliability of the technology assessed in a laboratory environment and the usability, acceptability, user experience, and reliability of the technology in real environments. The tested services include the socialization scenario, in which older adults are better connected to the community via technological solutions (i.e., socialization applications), and the monitoring scenario, which allows for the introduction of timely interventions (technologies involved include environmental monitoring sensors, a telepresence robot, wearable sensors, and a personalized dashboard). The obtained results underline an acceptable usability level (average System Usability Scale score > 65) for the tested technologies (i.e., socialization applications and a telepresence robot). Phase Two also underlines the good acceptability, user experience, and usability of the tested services. The statistical analysis underlines a correlation between the stress related to the use of technology, digital skills, and intention of use, among other factors. Qualitative feedback also remarks on a correlation between older adults with low digital skills and an anxiety about using technology. Positive correlation indexes were highlighted between the trust and usability scores. Eventually, future long-term trials with assistive technology should rely on motivated caregivers, be founded on a strong recruitment process, and should reassure older adults—especially the ones with low digital literacy—about the use of technology by proposing personalized training and mentoring, if necessary, to increase the trust.

Social companion robots are getting more attention to assist elderly people to stay independent at home and to decrease their social isolation. When developing solutions, one remaining challenge is to design the right applications that are usable by elderly people. For this purpose, co-creation methodologies involving multiple stakeholders and a multidisciplinary researcher team (e.g., elderly people, medical professionals, and computer scientists such as roboticists or IoT engineers) are designed within the ACCRA (Agile Co-Creation of Robots for Ageing) project. This paper will address this research question: How can Internet of Robotic Things (IoRT) technology and co-creation methodologies help to design emotional-based robotic applications? This is supported by the ACCRA project that develops advanced social robots to support active and healthy ageing, co-created by various stakeholders such as ageing people and physicians. We demonstra this with three robots, Buddy, ASTRO, and RoboHon, used for daily life, mobility, and conversation. The three robots understand and convey emotions in real-time using the Internet of Things and Artificial Intelligence technologies (e.g., knowledge-based reasoning)., (© The Author(s), under exclusive licence to Springer Nature B.V. 2021.)

Socially Assistive Robots (SARs) are designed to support us in our daily life as a companion, and assistance but also to support the caregivers' work. SARs should show personalized and human-like behavior to improve their acceptance and, consequently, their use. Additionally, they should be trustworthy by caregivers and professionals to be used as support for their work (e.g. objective assessment, decision support tools). In this context the aim of the paper is dual. Firstly, this paper aims to present and discuss the robot behavioral model based on sensing, perception, decision support, and interaction modules. The novel idea behind the proposed model is to extract and use the same multimodal features set for two purposes: (i) to profile the user, so to be used by the caregiver as a decision support tool for the assessment and monitoring of the patient; (ii) to fine-tune the human-robot interaction if they can be correlated to the social cues. Secondly, this paper aims to test in a real environment the proposed model using a SAR robot, namely ASTRO. Particularly, it measures the body posture, the gait cycle, and the handgrip strength during the walking support task. Those collected data were analyzed to assess the clinical profile and to fine-tune the physical interaction. Ten older people (65.2 ± 15.6 years) were enrolled for this study and were asked to walk with ASTRO at their normal speed for 10 m. The obtained results underline a good estimation ( p  < 0.05) of gait parameters, handgrip strength, and angular excursion of the torso with respect to most used instruments. Additionally, the sensory outputs were combined in the perceptual model to profile the user using non-classical and unsupervised techniques for dimensionality reduction namely T-distributed Stochastic Neighbor Embedding (t-SNE) and non-classic multidimensional scaling (nMDS). Indeed, these methods can group the participants according to their residual walking abilities., Competing Interests: Conflict of interestThe authors declare that they have no conflict of interest., (© The Author(s) 2022.)

As a consequence of the COVID-19 emergency, frail citizens felt isolated because of social isolation, suspended and/or strongly reduced home assistance, and limited access to hospitals. In this sense, assistive technology could play a pivotal role in empowering frail older adults reducing their isolation, as well as in reinforcing the work of formal caregivers and professionals. In this context, the goal of this paper is to present four pilot studies-conducted from March 2020 to April 2021-to promptly react to COVID-19 by providing assistive technology solutions, aiming to (1) guarantee high-quality service to older adults in-home or in residential facility contexts, (2) promote social inclusion, and (3) reduce the virus transmission. In particular, four services, namely, telepresence service, remote monitoring service, virtual visit, and environmental disinfection, were designed, implemented, and tested in real environments involving 85 end-users to assess the user experience and/or preliminary assess the technical feasibility. The results underlined that all the proposed services were generally accepted by older adults and professionals. Additionally, the results remarked that the use of telepresence robots in private homes and residential facilities increased enjoyment reducing anxiety, whereas the monitoring service supported the clinicians in monitoring the discharged COVID-19 patients. It is also worth mentioning that two new services/products were developed to disinfect the environment and to allow virtual visits within the framework of a hospital information system. The virtual visits service offered the opportunity to expand the portfolio of hospital services. The main barriers were found in education, technology interoperability, and ethical/legal/privacy compliance. It is also worth mentioning the key role played by an appropriate design and customer needs analysis since not all assistive devices were designed for older persons.

By 2030, the World Health Organization (WHO) foresees a worldwide workforce shortfall of healthcare professionals, with dramatic consequences for patients, economies, and communities. Research in assistive robotics has experienced an increasing attention during the last decade demonstrating its utility in the realization of intelligent robotic solutions for healthcare and social assistance, also to compensate for such workforce shortages. Nevertheless, a challenge for effective assistive robots is dealing with a high variety of situations and contextualizing their interactions according to living contexts and habits (or preferences) of assisted people. This study presents a novel cognitive system for assistive robots that rely on artificial intelligence (AI) representation and reasoning features/services to support decision-making processes of healthcare assistants. We proposed an original integration of AI-based features, that is, knowledge representation and reasoning and automated planning to 1) define a human-in-the-loop continuous assistance procedure that helps clinicians in evaluating and managing patients and; 2) to dynamically adapt robot behaviors to the specific needs and interaction abilities of patients. The system is deployed in a realistic assistive scenario to demonstrate its feasibility to support a clinician taking care of several patients with different conditions and needs., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Sorrentino, Fiorini, Mancioppi, Cavallo, Umbrico, Cesta and Orlandini.)

This study investigates the adoption of innovative Motor and Cognitive Dual-Task (MCDT) based on the combination of increasing motor and cognitive tasks to discern between subjects with Mild Cognitive Impairment (MCI) and Cognitively Normal Adults (CNA). We aim to adopt new MCDT protocols and to compare their performance against the gold standard (a walking based MCDT, called GAIT). 27 older adults have been assessed through a customized wearable system during 4 MCDTs. We developed as many pooled indices (PIs), based on MCDTs perfomance, demographic data, and clinical scores. We use these parameters as regressors in 4 different logistic regression models. The regression models that encompassed features from innovative MCDT overcame the gold standard classification performance. In particular, models based on the heel tapping and the alternate heel-toe tapping reach the best outputs, namely +8% of accuracy if compared to the gold standard (a walking task). The use of logistic regression models based on MCDT PI have been effective in discerning between CNA vs MCI. Our results suggest that the gold standard MCDT may represents a too demanding exercise to highlight differences between CNA and MCI. It seems that MCDT based on an intermediate level of motor difficulty could represent the sweet spot for the identification of MCI against CNA. Clinical relevance- The combination of innovative digital devices and innovative approach on data analysis (PIs) opened a new scenarios to the early detection and prediction of dementia. Their use would standardize the assessment procedure, lightening the physician from the burden of cumbersome testing sessions. This study suggests that a broader framework for MCDT, which should encompass an ampler selection of motor tasks with different possibilities in terms of difficulties levels, could provide clinicians with a new appropriate set of tools for the early detection of dementia.

Cognitive disability strongly reduces people's autonomy in performing desired as well as daily activities. The use of Social Assistive Robots (SARs) for cognitive rehabilitation therapy for disabled people could be a valuable gateway for the residential facility of the future. In this work, we design and develop a SAR that can be used for cognitive therapy proposing music and game activities. The results confirm that participants were positively engaged during the proposed activities and satisfied by the robot, despite the low perception of its usability. Professional caregivers noticed and confirmed the high level of engagement and the positive acceptance of the robot within the session, suggesting future tasks for SAR. Clinical Relevance- The results suggest the potential use of SAR also with disabled people proposing cognitive games as a part of the cognitive rehabilitation program.

This paper makes the VISTA database, composed of inertial and visual data, publicly available for gesture and activity recognition. The inertial data were acquired with the SensHand, which can capture the movement of wrist, thumb, index and middle fingers, while the RGB-D visual data were acquired simultaneously from two different points of view, front and side. The VISTA database was acquired in two experimental phases: in the former, the participants have been asked to perform 10 different actions; in the latter, they had to execute five scenes of daily living, which corresponded to a combination of the actions of the selected actions. In both phase, Pepper interacted with participants. The two camera point of views mimic the different point of view of pepper. Overall, the dataset includes 7682 action instances for the training phase and 3361 action instances for the testing phase. It can be seen as a framework for future studies on artificial intelligence techniques for activity recognition, including inertial-only data, visual-only data, or a sensor fusion approach., (© 2022. The Author(s).)

Background: eHealth ecosystems are becoming increasingly important for national and international healthcare. In such ecosystems, different actors are connected and work together to create mutual value. However, it is important to be aware of the goals that each actor pursues within the ecosystem., Method: This study describes the outcomes of a workshop (30 participants) and two surveys (completed by 54 and 100 participants), which investigated how different types of industry stakeholders, namely social services, healthcare, technology developers and researchers, rated potential value propositions for an eHealth ecosystem. Both the feasibility and the importance of each proposition was taken into account., Results: Interoperability between services was highly valued across industry types but there were also vast differences concerning other propositions., Conclusion: Jointly reflecting on the different perceived values of an ehealth ecosystem can help actors working together to form an ecosystem., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Oberschmidt K et al.)

Background: Emotion recognition skills are predicted to be fundamental features in social robots. Since facial detection and recognition algorithms are compute-intensive operations, it needs to identify methods that can parallelize the algorithmic operations for large-scale information exchange in real time. The study aims were to identify if traditional machine learning algorithms could be used to assess every user emotions separately, to relate emotion recognizing in two robotic modalities: static or motion robot, and to evaluate the acceptability and usability of assistive robot from an end-user point of view., Methods: Twenty-seven hospital employees (M = 12; F = 15) were recruited to perform the experiment showing 60 positive, negative, or neutral images selected in the International Affective Picture System (IAPS) database. The experiment was performed with the Pepper robot. Concerning experimental phase with Pepper in active mode, a concordant mimicry was programmed based on types of images (positive, negative, and neutral). During the experimentation, the images were shown by a tablet on robot chest and a web interface lasting 7 s for each slide. For each image, the participants were asked to perform a subjective assessment of the perceived emotional experience using the Self-Assessment Manikin (SAM). After participants used robotic solution, Almere model questionnaire (AMQ) and system usability scale (SUS) were administered to assess acceptability, usability, and functionality of robotic solution. Analysis wasperformed on video recordings. The evaluation of three types of attitude (positive, negative, andneutral) wasperformed through two classification algorithms of machine learning: k-nearest neighbors (KNN) and random forest (RF)., Results: According to the analysis of emotions performed on the recorded videos, RF algorithm performance wasbetter in terms of accuracy (mean ± sd = 0.98 ± 0.01) and execution time (mean ± sd = 5.73 ± 0.86 s) than KNN algorithm. By RF algorithm, all neutral, positive and negative attitudes had an equal and high precision (mean = 0.98) and F-measure (mean = 0.98). Most of the participants confirmed a high level of usability and acceptability of the robotic solution., Conclusions: RF algorithm performance was better in terms of accuracy and execution time than KNN algorithm. The robot was not a disturbing factor in the arousal of emotions.

Background: Information and communication technology solutions have the potential to support active and healthy aging and improve monitoring and treatment outcomes. To make such solutions acceptable, all stakeholders must be involved in the requirements elicitation process. Due to the COVID-19 situation, alternative approaches to commonly used face-to-face methods must often be used. One aim of the current article is to share a unique experience from the Pharaon project where due to the COVID-19 outbreak alternative elicitation methods were used. In addition, an overview of common functional, quality, and emotional goals identified by six pilot sites is presented to complement the knowledge about the needs of older adults., Methods: Originally planned face-to-face co-creation seminars were impossible to carry out, and all pilot sites chose alternative requirements elicitation methods that were most suitable in their situation. The elicited requirements were presented in the form of goal models. In one summary goal model, we provide an overview of common functional, quality, and emotional goals., Results: Different elicitation methods were combined based on the digital literacy of the target group and their access to digital tools. Methods applied without digital technologies were phone interviews, reviews of literature and previous projects, while by means of digital technologies online interviews, online questionnaires, and (semi-)virtual co-creation seminars were conducted. The combination of the methods allowed to involve all planned stakeholders. Virtual and semi-virtual co-creation seminars created collaborative environment comparable to face-to-face situations, while online participation helped to save the time of the participants. The most prevalent functional goals elicited were "Monitor health," "Receive advice," "Receive information." "Easy to use/comfortable," "personalized/tailored," "automatic/smart" were identified as most prevalent quality goals. Most frequently occurring emotional goals were "involved," "empowered," and "informed.", Conclusion: There are alternative methods to face-to-face co-creation seminars, which effectively involve older adults and other stakeholders in the requirements elicitation process. Despite the used elicitation method, the requirements can be easily transformed into goal models to present the results in a uniform way. The common requirements across different pilots provided a strong foundation for representing detailed requirements and input for further software development processes., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Mooses, Camacho, Cavallo, Burnard, Dantas, D’Onofrio, Fernandes, Fiorini, Gama, Perandrés Gómez, Gonzalez, Guardado, Iqbal, Sanchez Melero, Melero Muñoz, Moreno Muro, Nijboer, Ortet, Rovini, Toccafondi, Tunc and Taveter.)

Background: The Pilots for Healthy and Active Ageing (PHArA-ON) project aimsto ensure reality smart and active living for Europe's ageing population by creating a set of integrated and highly customizable interoperable open platforms with advanced services, devices, and technologies and tools. The aim of the present study was to determine the needs and preferences of older people and their caregivers for improving healthy and active aging and guiding the technological development of thePHArA-ON system., Methods: A pre-structured interview was administered to older adults, informal caregivers and professional caregivers (including social operators) taking part in the piloting sessions., Results: Interviews were carried out in Umana Persone Social Enterprise R&D Network (UP) in Tuscany, and Ospedale Casa SollievodellaSofferenza (CSS) in Apulia. A total of 22 older adults, 22 informal caregivers, 13 professional caregivers and 4 social operators were recruited. A prioritization analysis of services, according to the stakeholder's needs, has determined two fundamental need categories: Heath Management (i.e., stimulation and monitoring), and Socialisation (i.e., promoting social inclusion)., Conclusions: The main scientific contributions to this study are the following: to design and evaluate technology in the context of healthy and active ageing, to acquire relevant knowledge on user needs to develop technologies that can handle the real life situations of older people, obtain useful insights about the attitude and availability of end-users in using technologies in clinical practice, and to provide important guidelines to improve the PHArA-ON system. Specific experimentation stages were also carried out to understand which kind of technology is more acceptable, and to obtain feedback regarding the development priority related to the impact of the proposed services. Research through fruitful and continuous interaction with the different subjects involved in the development process of the system, as well as with stakeholders, enabled the implementation of a platform which could be further and easily integrated and improved.

Introduction: Parkinson's disease (PD) is one of the most frequent causes of disability among older people, characterized by motor disorders, rigidity, and balance problems. Recently, dance has started to be considered an effective exercise for people with PD. In particular, Irish dancing, along with tango and different forms of modern dance, may be a valid strategy to motivate people with PD to perform physical activity. The present protocol aims to implement and evaluate a rehabilitation program based on a new system called "SI-ROBOTICS," composed of multiple technological components, such as a social robotic platform embedded with an artificial vision setting, a dance-based game, environmental and wearable sensors, and an advanced AI reasoner module. Methods and Analysis: For this study, 20 patients with PD will be recruited. Sixteen therapy sessions of 50 min will be conducted (two training sessions per week, for 8 weeks), involving two patients at a time. Evaluation will be primarily focused on the acceptability of the SI-ROBOTICS system. Moreover, the analysis of the impact on the patients' functional status, gait, balance, fear of falling, cardio-respiratory performance, motor symptoms related to PD, and quality of life, will be considered as secondary outcomes. The trial will start in November 2021 and is expected to end by April 2022. Discussions: The study aims to propose and evaluate a new approach in PD rehabilitation, focused on the use of Irish dancing, together with a new technological system focused on helping the patient perform the dance steps and on collecting kinematic and performance parameters used both by the physiotherapist (for the evaluation and planning of the subsequent sessions) and by the system (to outline the levels of difficulty of the exercise). Ethics and Dissemination: The study was approved by the Ethics Committee of the IRCCS INRCA. It was recorded in ClinicalTrials.gov on the number NCT05005208. The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings., Competing Interests: GM, AF, NM, and LRosse, were employed by company Exprivia S.p.A. PD and AP were employed by company Grifo Multimedia Srl. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Bevilacqua, Benadduci, Bonfigli, Riccardi, Melone, La Forgia, Macchiarulo, Rossetti, Marzorati, Rizzo, Di Bitonto, Potenza, Fiorini, Cortellessa Loizzo, La Viola, Cavallo, Leone, Rescio, Caroppo, Manni, Cesta, Cortellessa, Fracasso, Orlandini, Umbrico, Rossi and Maranesi.)

Background: The progressive ageing of the population is leading to an increasing number of people affected by cognitive decline, including disorders in executive functions (EFs), such as action planning. Current procedures to evaluate cognitive decline are based on neuropsychological tests, but novel methods and approaches start to be investigated. Reach-to-grasp (RG) protocols have shown that intentions can influence the EFs of action planning. In this work, we proposed a novel ring-shaped wearable inertial device, SensRing, to measure kinematic parameters during RG and after-grasp (AG) tasks with different end-goals. The aim is to evaluate whether SensRing can characterize the motor performances of people affected by Mild Neurocognitive Disorder (MND) with impairment in EFs., Methods: Eight Individuals with dysexecutive MND, named d-MND, were compared to ten older healthy subjects (HC). They were asked to reach and grasp a can with three different intentions: to drink (DRINK), to place it on a target (PLACE), or to pass it to a partner (PASS). Twenty-one kinematic parameters were extracted from SensRing inertial data., Results: Seven parameters resulted able to differentiate between HC and d-MND in the RG phase, and 8 features resulted significant in the AG phase. d-MND, indeed, had longer reaction times (in RG PLACE), slower peak velocities (in RG PLACE and PASS, in AG DRINK and PLACE), longer deceleration phases (in all RG and AG DRINK), and higher variability (in RG PLACE, in AG DRINK and PASS). Furthermore, d-MND showed no significant differences among conditions, suggesting that impairments in EFs influence their capabilities in modulating the action planning based on the end-goal., Conclusions: Based on this explorative study, the system might have the potential for objectifying the clinical assessment of people affected by d-MND by administering an easy motor test. Although these preliminary results have to be investigated in-depth in a larger sample, the portability, wearability, accuracy, and ease-of use of the system make the SensRing potentially appliable for remote applications at home, including analysis of protocols for neuromotor rehabilitation in patients affected by MND., (© 2021. The Author(s).)

Motor and Cognitive Dual-Task (MCDT) represents an innovative chance to assess Mild Cognitive Impairment (MCI). We compare two novel MCDTs, fore-finger tapping (FTAP), toe-tapping (TTHP), to gold standards for cognitive screening (Mini-Mental State Examination-MMSE), and to a well-established MCDT (GAIT). We administered the aforementioned MCDTs to 44 subjects (MCIs and controls). Motor parameters were extracted, and correlations with MMSE investigated. Logistic regression models were built, and AUC areas computed. Spearman's correlation demonstrated that FTAP and TTHP significantly correlate with MMSE, at each cognitive load. AUC areas computed report similar (FTAP, 0.87), and even higher (TTHP, 0.97) capability to identify MCIs, if compared to GAIT (0.92). We investigated the use of novel MCDT approaches to assess MCI, aiming to enrich the clinical repertoire with objective and non-invasive tools. Our protocol shows good correlations with MMSE, and reaches high performances in identifying MCI, adopting simpler exercises.

Background: More than 70% of elderly people age 80 and older are experiencing problems in personal mobility. Assistive robotics can represent a concrete support providing also a support for caregivers, clinicians and nurses by reducing their burden., Methods: A total of 20 older people and 34 caregivers (formal and informal) were interviewed in Italy and the Netherlands to investigate and prioritize their needs concerning the personal mobility domains and their attitudes towards assistive robots. The data were analysed from a user point of view by means of thematic content analysis by underlying recurrent topics., Results: The results revealed four categories of needs from the perspective of the older individuals: instrumental needs, rehabilitation needs, personal safety and indoor activities of daily life. Additionally, the results underline how personal mobility issues influence different aspects of daily life. Complementarily, three categories of caregiver needs were also distinguished: instrumental needs, rehabilitation monitoring needs and checkup needs. The highest percentage of participants showed a positive expectation towards assistive robotics., Conclusions: The results were clustered according to the robot abilities (i.e., motion, interaction, manipulation, decision support and perception abilities) as a list of functional and technical requirements that should be developed to address all the needs related to the personal mobility. Robotic developer teams that work in this context could take advantage of this research. Additionally, this work can be used as a basis for clinicians and nurses working in geriatric units to understand how the robots can support and enhance their work. Implications for rehabilitation The incidence of personal mobility limitations affects 35% of adults age 70 and older and 72% of people over 80 years of age. Assistive robots can support elderly people during daily tasks: they could promote their personal mobility acting as a supporting tool. The results of the needs analysis revealed four categories of needs from the perspective of the older individuals: instrumental needs, rehabilitation needs, personal safety, and indoor activities of daily life. Three categories of caregiver needs were also distinguished: instrumental needs, rehabilitation monitoring needs, and check-up needs.

Dementia and Alzheimer's Disease (AD) represent a health emergency. The identification of valid and noninvasive markers to identify people with Mild Cognitive Impairment (MCI) is profoundly advocated. This review outlines the use of quantitative Motor and Cognitive Dual-Task (MCDT) on MCI, by technologies aid. We describe the framework and the most valuable researches, displaying the adopted protocols, and the available technologies. PubMed Central, Web of Science, and Scopus were inspected between January 2010 and May 2020. 1939 articles were found in the initial quest. Exclusion criteria allowed the selection of the most relevant papers; 38 papers were included. The articles, regarding four technological solutions "wearable sensors", "personal devices", "optokinetic systems", and "electronic walkways", are organized into three categories: "Quantitative MCDT", "MCDT Inspired by Neuropsychological Test", and "MCDT for MCI Stimulation". MCDT might furnish clinical landmarks, supplying aid for disease stratication, risk prediction, and intervention optimization. Such protocols could foster the use of data mining and machine learning techniques. Notwithstanding, there is still a need to standardize and harmonize such protocols., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Social apathy, a reduction in initiative in proposing or engaging in social activities or interactions, is common in mild neurocognitive disorders (MND). Current apathy assessment relies on self-reports or clinical scales, but growing attention is devoted to defining more objective, measurable and non-invasive apathy proxies., Objective: In the present study we investigated the interest of recording action kinematics in a social reach-to-grasp task for the assessment of social apathy., Methods: Thirty participants took part in the study: 11 healthy controls (HC; 6 females, mean age = 68.3±10.5 years) and 19 subjects with MND (13 females, mean age = 75.7±6.3 years). Based on the Diagnostic Criteria for Apathy, MND subjects were classified as socially apathetic (A-MND, N = 9) versus non-apathetic (NA-MND, N = 10). SensRing, a ring-shaped wearable sensor, was placed on their index finger, and subjects were asked to reach and grasp a can to place it into a cup (individual condition) and pass it to a partner (social condition)., Results: In the reach-to-grasp phase of the action, HC and NA-MND showed different acceleration and velocity profiles in the social versus individual condition. No differences were found for A-MND., Conclusion: Previous studies showed the interest of recording patients' level of weekly motor activity for apathy assessment. Here we showed that a 10-min reach-to-grasp task may provide information to differentiate socially apathetic and non-apathetic subjects with MND, thus providing a tool easily usable in the clinical practice. Future studies with a bigger sample are needed to better characterize these findings.

Background: Cognitive training (CT) is defined as guided practice on a set of standard tasks designed to stimulate particular cognitive functions. Recent studies have shown that physical exercise is beneficial for cognitive activity in older adults and patients with degenerative diseases., Aims: The main objective of the present study is to create a new cognitive tool able to provide training for cognitive functions that take advantage of the physical activity involved in the execution of the task. A study concerning the application of a new CT tool for episodic memory is presented and divided in two parts. The first one aims at developing a new sensorized device, called SmartTapestry, for physical and cognitive training. The second part aims at understanding its technical viability and level of sensitivity in stimulating the same cognitive domain covered by the standardized tests, despite the introduction of the physical activity variable., Methods: The SmartTapestry device was tested with a total of 53 subjects, 29 healthy subjects and 24 subjects suffering from mild cognitive impairment., Results and Discussions: The results show a good correlation between the two approaches (p < 0.005), suggesting that SmartTapestry can stimulate the same cognitive functions of traditional cognitive tasks, with the addition of physical exercise., Conclusions: The results of this study may be useful in designing ecological and combined cognitive-physical tools, which can be used daily at home, reducing the presence of clinical staff, to train at the same time the brain and the body so as to improve the cognitive treatments efficacy.

Background/aim: Technological solutions can support the elderly, improve their quality of life and reduce isolation and loneliness. The Euro-Japan ACCRA (Agile Co-Creation for Robots and Aging) project has the objective of building a reference co-creation methodology for the development of robotic solutions for ageing. The aim of this study is to provide a pilot qualitative analysis of the real needs of elderly people and their caregivers when exposed to conversational activities with robots and to identify priority needs that should be developed from end-user perspectives., Methods: A qualitative research design was adopted to define a pre-structured questionnaire that was administered to the elderly taking part in the piloting sessions. Three groups of end-users were included: subjects with an age ≥ 60 years, informal caregivers and formal caregivers., Results: The interviews were carried out in Italy and Japan. A total of 17 elderly and 36 caregivers were recruited. Common needs in the two sites were categorized into 3 groups: Communication; Emotion Detection and Safety. General robot acceptance level is good and perception is positive among participants in the pilot sites., Conclusion: A positive perception of the elderly on the application of a robotic solution was found and many are the needs that could be addressed by an appropriate and careful robotic development taking into account the real needs and capabilities of the involved subjects.

Objective: In the past decade, cognitive training tools have been used to improve brain functioning, and some have been applied to cognitive decline in dementia. Recently, research studies have demonstrated that aerobic exercise could play an important restorative role toward cognitive impairments. Therefore, the main objective of this paper is to present the innovative use of the SmartWalk tool, which combines aerobic exercise and cognitive protocols traditionally used to stimulate cognitive function., Methods: The primary goal of this study to demonstrate if our tool is correlated with traditional computerized test in stimulating the cognitive system similarly, despite the fact that SmartWalk adds a supplementary physical load on the task. The SmartWalk tool was tested with a total of 49 subjects-29 healthy subjects and 20 subjects with Mild Cognitive Impairments. The participants were asked to perform both the tests to fulfil the proposed goal., Results: The results obtained considering the overall population show a good and significant (p < 0.05) correlation for the "correct," "error," and "omitted" scores (r = 0.54, r = 0.34, and r = 0.39, respectively)., Conclusion: The results suggest a good correlation between the two approaches with the advantage of adding aerobic exercise to the traditional cognitive task., Significance: The results of this study may be useful in designing ecological and combined cognitive-physical tool to personalize interventions and delay the onset of cognitive disorders like dementia.

Introduction: Worldwide population is getting older. The older persons want to stay independent and wish to increase their engagement in social activities to tackle loneliness, depression, and isolation. Starting from these assumptions, we developed the ACCRA project (Agile Co-Creation for Robots and Aging) with the aim to enable the development of advanced ICT Robotics-based solutions for extending active and healthy aging in daily life by defining, developing and demonstrating an agile co-creation development process., Methods: ACCRA robotics solutions will be designed and developed to be tested in three different domains: mobility, daily life, socialization support in four countries (i.e., France, Netherlands, Italy, and Japan). The proposed approach identifies four different phases: (1) needs analysis, (2) agile co-creation, (3) experimentation, and (4) sustainability analysis. Currently, the first two phases were almost completed. For the needs phase, we have used the following recruitment criteria: (1) for mobility: age ≥ 60 years, the and presence of mobility issues assessed by Older Mobility Scale (EMS) with a score > 13; (2) for daily life: age ≥ 60 years, and the presence of difficulties engaging in housework assessed by Autonomie Gérontologie Groupes Iso-Ressources (AGGIR) with a GIR score ≥ 4; (3) for socialization support: age ≥ 60 years, and the absence or mild level of cognitive impairment assessed by Mini Mental State Examination (MMSE) with a score ≥ 24., Results: The needs analysis and first co-creation sessions focus attention on the experience of older in the four countries. Preliminary results showed how, in all the pilot sites, many expectations were raised from older, formal and informal caregivers about the application of the technology into their life. Minor concerns existed about privacy, real efficacy and modularity in a real-world environment. Overall, a good attitude was recorded towards the use of technologies to support life and promote independent living. Moreover, the older engaged in our studies showed a great interest to be actively involved in the developing phase of something built based on their needs., Conclusions: The availability of new solutions to increase independence and quality of life in a sustainable manner appears to be mandatory in the actual society considering the actual socio-economic situation over the industrial countries., Competing Interests: The authors declare that there are no conflicts of interests regarding the publication of this article.All procedures performed in this study were in accordance with the ethical standards of the Research Committee of the four participant institutions and with the Helsinki declaration and its later amendments or comparable ethical standards.Informed consent was obtained from all individual participants included in the study.

Background: Endometrial cancer is the fourth most common cancer in European women. The major risk factors for endometrial cancer are related to the exposure of endometrium to estrogens not opposed to progestogens, that can lead to a chronic endometrial inflammation. Diet may play a role in cancer risk by modulating chronic inflammation., Methods: In the framework of a case-control study, we recruited 297 women with newly diagnosed endometrial cancer and 307 controls from Northern Italy. Using logistic regression, we investigated the role of fruit and vegetable intake, adherence to the Mediterranean diet (MD), and the dietary inflammatory index (DII) in endometrial cancer risk., Results: Women in the highest quintile of vegetable intake had a statistically significantly lower endometrial cancer risk (adjusted OR 5th quintile vs 1st quintile: 0.34, 95% CI 0.17-0.68). Women with high adherence to the MD had a risk of endometrial cancer that was about half that of women with low adherence to the MD (adjusted OR: 0.51, 95% CI 0.39-0.86). A protective effect was detected for all the lower quintiles of DII, with the highest protective effect seen for the lowest quintile (adjusted OR 5th quintile vs 1st quintile: 3.28, 95% CI 1.30-8.26)., Conclusions: These results suggest that high vegetable intake, adherence to the MD, and a low DII are related to a lower endometrial cancer risk, with several putative connected biological mechanisms that strengthen the biological plausibility of this association.

The goal of this study is to address two major issues that undermine the large scale deployment of smart home sensing solutions in people's homes. These include the costs associated with having to install and maintain a large number of sensors, and the pragmatics of annotating numerous sensor data streams for activity classification. Our aim was therefore to propose a method to describe individual users' behavioural patterns starting from unannotated data analysis of a minimal number of sensors and a "blind" approach for activity recognition. The methodology included processing and analysing sensor data from 17 older adults living in community-based housing to extract activity information at different times of the day. The findings illustrate that 55 days of sensor data from a sensor configuration comprising three sensors, and extracting appropriate features including a "busyness" measure, are adequate to build robust models which can be used for clustering individuals based on their behaviour patterns with a high degree of accuracy (>85%). The obtained clusters can be used to describe individual behaviour over different times of the day. This approach suggests a scalable solution to support optimising the personalisation of care by utilising low-cost sensing and analysis. This approach could be used to track a person's needs over time and fine-tune their care plan on an ongoing basis in a cost-effective manner.

Recognition of activities of daily living plays an important role in monitoring elderly people and helping caregivers in controlling and detecting changes in daily behaviors. Thanks to the miniaturization and low cost of Microelectromechanical systems (MEMs), in particular of Inertial Measurement Units, in recent years body-worn activity recognition has gained popularity. In this context, the proposed work aims to recognize nine different gestures involved in daily activities using hand and wrist wearable sensors. Additionally, the analysis was carried out also considering different combinations of wearable sensors, in order to find the best combination in terms of unobtrusiveness and recognition accuracy. In order to achieve the proposed goals, an extensive experimentation was performed in a realistic environment. Twenty users were asked to perform the selected gestures and then the data were off-line analyzed to extract significant features. In order to corroborate the analysis, the classification problem was treated using two different and commonly used supervised machine learning techniques, namely Decision Tree and Support Vector Machine, analyzing both personal model and Leave-One-Subject-Out cross validation. The results obtained from this analysis show that the proposed system is able to recognize the proposed gestures with an accuracy of 89.01% in the Leave-One-Subject-Out cross validation and are therefore promising for further investigation in real life scenarios.

Multidrug resistance has appeared to mitigate the efficiency of anticancer drugs and the possibility of successful cancer chemotherapy. The Hedgehog receptor Patched is a multidrug transporter expressed in several cancers and as such it represents a new target to circumvent chemotherapy resistance. In this chapter, we describe the screening test developed to identify molecules able to inhibit the drug efflux activity of Patched. This screening test uses yeast overexpressing functional human Patched that have been shown to resist to chemotherapeutic agents. This test can be adapted to other MDR transporters.

Multidrug resistance has appeared to mitigate the efficiency of anticancer drugs and the possibility of successful cancer chemotherapy. The Hedgehog receptor Patched is a multidrug transporter expressed in several cancers and as such it represents a new target to circumvent chemotherapy resistance. We report herein that paniceins and especially panicein A hydroquinone, natural meroterpenoids produced by the Mediterranean sponge Haliclona (Soestella) mucosa, inhibit the doxorubicin efflux activity of Patched and enhance the cytotoxicity of this chemotherapeutic agent on melanoma cells in vitro. These results are supported by the molecular docking performed on the structure of the bacterial drug efflux pump AcrB and on the Patched model built from AcrB structure. Docking calculations show that panicein A hydroquinone interacts with AcrB and Patched model close to the doxorubicin binding site. This compound thus appears as the first antagonist of the doxorubicin efflux activity of Patched. The use of inhibitors of Patched drug efflux activity in combination with classical chemotherapy could represent a novel approach to reduce tumor drug resistance, recurrence and metastasis.

Isothiocyanates (ITCs) found in cruciferous vegetables have been associated with a reduced cancer risk in humans. We determined serum albumin adducts of allyl isothiocyanate (AITC), benzylisothiocyanate (BITC), phenylethylisothiocyanate (PEITC) and sulforaphane (SFN) in 85 healthy men from a dietary, randomized, controlled trial. After enzymatic digestion of albumin we determined the adducts of the ITCs with lysine (Lys) using liquid chromatography-tandem mass spectrometry. At the beginning of the study (and after 4 weeks) 4.7% (2.4%), 48.2% (35.3%), 5.9% (10.6%), and 24.7% (23.5%) of the samples were found positive for AITC-Lys, BITC-Lys, PEITC-Lys and SFN-Lys, respectively. This method enables the quantification of ITC adducts in albumin from large, prospective studies on diet and cancer.

A diet rich in fruit and vegetables can be effective in the reduction of oxidative stress, through the antioxidant effects of phytochemicals and other mechanisms. Protection against the carcinogenic effects of chemicals may also be exerted by an enhancement of detoxification and DNA damage repair mechanisms. To investigate a putative effect of flavonoids, a class of polyphenols, on the regulation of the gene expression of DNA repair and metabolic genes, a 1-month flavonoid-rich diet was administered to thirty healthy male smokers, nine of whom underwent gene expression analysis. We postulated that tobacco smoke is a powerful source of reactive oxygen species. The expression level of twelve genes (APEX, ERCC1, ERCC2, ERCC4, MGMT, OGG1, XPA, XPC, XRCC1, XRCC3, AHR, CYP1A1) was investigated. We found a significant increase (P < 0.001) in flavonoid intake. Urinary phenolic content and anti-mutagenicity did not significantly change after diet, nor was a correlation found between flavonoid intake and urinary phenolic levels or anti-mutagenicity. Phenolic levels showed a significant positive correlation with urinary anti-mutagenicity. AHR levels were significantly reduced after the diet (P = 0.038), whereas the other genes showed a generalized up regulation, significant for XRCC3 gene (P = 0.038). Also in the context of a generalized up regulation of DNA repair genes, we found a non-significant negative correlation between flavonoid intake and the expression of all the DNA repair genes. Larger studies are needed to clarify the possible effects of flavonoids in vivo; our preliminary results could help to better plan new studies on gene expression and diet.

We have conducted a randomized trial which investigated the ability of dietary changes (in particular diets rich in cruciferous vegetables and flavonoids), to increase urinary antimutagenicity and inhibit DNA damage in smokers. Ninety heavy smokers were recruited and randomly assigned to three groups, and were given three different diets. The first diet was based on flavonoid-rich foods, particularly cruciferous vegetables, but not based on supplementation; the second was a normal isocaloric diet (with an adequate administration of fruits and vegetables); and the third was based on supplementation of flavonoids in the form of green tea and soy products. DNA adducts were measured by (32)P-postlabelling in exfoliated bladder cells at different times since the start of the trial. In spite of randomization, subjects in the control group smoked more than those in the experimental groups, and this can explain the higher adduct levels at baseline. A slight decrease in bulky DNA adducts in exfoliated bladder cells was observed after 1 year since the end in the supplementation group and after 1 month in white blood cells. The only statistically significant association was found in a regression model that adjusted for smoking, in which the increase in flavonoid intake was associated with a decrease in adducts after 1 year (P = 0.02). These data suggest that adherence to a diet rich in cruciferous vegetables and flavonoids might reduce genotoxicity in the human urinary bladder of smokers, but they should be interpreted with caution owing to small numbers and the uneven distribution of smoking habits in the experimental groups. Smoking is the most important single preventable cause of cancer; at the present stage of knowledge it is totally unlikely that certain dietary habits can seriously counteract the effects of tobacco smoking.

Objectives: To investigate the effectiveness of a non-structured 15-min educational intervention by general practitioners (GPs) on modifications of daily diet among healthy adults., Design: Two arms randomized trial lasting 12 months., Setting: Italian general practitioner wards. Subjects A total of 3,186 men and women aged 18-65 years recruited in the medical ward by their GPs., Interventions: An educational intervention and a brochure on the basics of a healthy diet based on the Italian Guidelines for a Correct Nutrition, 1998. The main study goal was to attain an intake of fruits and vegetables >5 servings per day. Follow-up visit every 6 months. Main outcome measures Weight, blood pressure, and a 40-items Food Frequency Questionnaire., Results: The intervention group showed a slightly reduced net intake of meat and a slightly increased net intake of fruits and vegetables, fish products, and olive oil. Body mass index (BMI) changed only in the treatment arm [-0.41 95% confidence interval (95% CI) -0.11 to -0.53]. The net change at 1 year in the intervention arm was +1.31 (CI 0.90-4.39) for fruits and vegetables, and -0.22 (-0.11 to -0.69) for meat (portions per week). We also computed a 'healthy diet score' reflecting compliance with recommended dietary habits. In the intervention group, the mean score at recruitment was significantly lower than the mean score at the end of follow-up (Crude score change = 0.29; CI 0.19-0.48). No differences were observed in the control group (Crude score change = -0.04; CI -0.22-0.02). The difference in score from baseline to the final visit, comparing the intervention vs the control group, was statistically significant (P < 0.001) (MANOVA adjusted by sex, BMI, education, and time)., Conclusions: A brief educational intervention by GPs can induce multiple diet changes that may lower BMI and potentially reduce chronic disease risk in generally healthy adults.

We have undertaken a randomized trial to confirm the ability of a class of phenolics, flavonoids, to increase urinary anti-mutagenicity in smokers. Ninety heavy smokers were recruited and randomly assigned to three groups, who were given three different diets. One diet was rich in flavonoids, but not based on supplementation ('flavonoid'), one was a normal iso-caloric diet with an adequate administration of fruit and vegetables ('normal'), and one was based on supplementation of flavonoids in the form of green tea and soy products ('supplement'). The urinary anti-mutagenicity-as inhibiting effect of the urinary extracts on the mutations induced by MeIQx-was measured in Salmonella typhimurium YG1024 in the presence of liver S9 from male Sprague-Dawley rats treated with Aroclor 1254. The amount of total phenolics in the urinary extracts was measured by use of spectrometric analysis. We found that important dietary modifications can be achieved through special recipes and instructions given by a cook during an intensive course. The intervention was focused on increasing the flavonoid intake, and it was successful in that respect. In fact, differences in flavonoid intake were appreciated mainly between the first group (normal diet) and the other two (flavonoid-rich and supplemented diet), suggesting that dietary modification can be as effective as supplementation. However, both urinary anti-mutagenicity and the amounts of urinary phenolics did not change as a consequence of the trial. These results suggest that only a small fraction of urinary phenolics is influenced by dietary changes in the intake of flavonoids, and that most urinary anti-mutagens and phenolics are metabolites of dietary flavonoids, whose formation is more affected by the activity and diversity of bacterial flora in the colon than by the quantity and type of intake. A strong correlation was found between urinary phenolics and anti-mutagenicity in all the groups involved in the trial. Such correlation was not explained by dietary variables.

EPIC-Italy is the Italian section of a larger project known as EPIC (European Prospective Investigation into Cancer and Nutrition), a prospective study on diet and cancer carried out in 10 European countries. In the period 1993-1998, EPIC-Italy completed the recruitment of 47,749 volunteers (15,171 men, 32,578 women, aged 35-65 years) in 4 different areas covered by cancer registries: Varese (12,083 volunteers) and Turin (10,604) in the Northern part of the country; Florence (13,597) and Ragusa (6,403) in Central and Southern Italy, respectively. An associate center in Naples enrolled 5,062 women. Detailed information for each individual volunteer about diet and life-style habits, anthropometric measurements and a blood sample was collected, after signing an informed consent form. A food frequency questionnaire specifically developed for the Italian dietary pattern was tested in a pilot phase. A computerized data base with the dietary and life-style information of each participant was completed. Blood samples were processed in the same day of collection, aliquoted (RBC, WBC, serum and plasma) and stored in liquid nitrogen containers. Follow-up procedures were validated and implemented for the identification of newly diagnosed cancer cases. Cancer incidence was related to dietary habits and biochemical markers of food consumption and individual susceptibility in order to test the role of diet-related exposure in the etiology of cancer and its interaction with other environmental or genetic determinants. The comparability of information in a prospective study design is much higher than in other studies. The availability of such a large biological bank linked to individual data on dietary and life-style exposures also provides the unique opportunity of evaluating the role of selected genotypes involved in the metabolism of chemical compounds and DNA repair, potentially related to the risk of cancer, in residents of geographic areas of Italy characterized by specific cancer risk and different dietary patterns. Baseline characteristics of participants are briefly described.

One of the aims of the EPIC study is to produce accurate descriptions of the dietary habits of the participants recruited in the 27 EPIC centers of 10 European countries. To do this, different dietary assessment instruments were developed and applied to capture the wide range of diets characterizing the different European populations. Three different food frequency questionnaires were developed for Italy: one for the centers of Varese, Turin and Florence, one for Ragusa and one for Naples. These inquired about eating habits over the previous year and were completed by 46,839 Italian EPIC participants. Specially developed software analyzed the responses and linked them to food composition tables in order to provide a nutritional breakdown of individual and collective diets. A further aim of EPIC was to develop a method of rendering data from different dietary questionnaires comparable. To do this, dietary data were collected from a sample of about 8% of the Italian EPIC cohort, using a standardized computer-driven 24-hour dietary recall interview, and then compared with the dietary data collected by the questionnaires. This paper provides an extensive description of the technical features and performance of the food frequency questionnaires and the 24-hour recall interview, including a comparison of estimates of the intake of different food groups provided by the two instruments. From this comparison, the repeatability and reliability of consumption estimates was assessed, resulting in indications for improving data comparability. The paper also presents food frequency questionnaire estimates of the daily intake of foods and nutrients by center, sex and age group, as well as information on dietary habits such as place and time of intake, and food preparation and preservation methods as provided by the 24-hour recall interview. The picture that emerged is that Italian eating habits are undergoing marked changes, with a tendency to less healthy eating. Documentation of these changes in relation to age, sex and region provides an essential starting point for investigating the influence of diet on the development of cancer and other chronic diseases.

Background: EPIC-Italy cohort study recruited subjects who voluntarily accepted to participate in the project. From the self-selected bases of the population sample, some bias could derive in the data interpretation when risk estimation for cancer disease related to life-style factors is the principal concern. Knowledge of the bias related to self-selected sampling is important for better directing the interpretation of the EPIC-Italy study results., Methods: We investigated the characteristics of volunteer subjects recruited in the EPIC-Italy cohorts and compared them with those of the randomly selected subjects recruited in the Multipurpose ISTAT Surveys realized in the same period (1993-1998) in which the EPIC-cohorts were recruited., Results: We found some differences, and in particular a different attitude towards cigarettes smoking and wine consumption, between the EPIC cohort and the Multipurpose ISTAT Surveys, as well as among geographical areas within the EPIC cohort., Conclusions: The uneven distribution of some characteristics suggests that the self-selected subjects were characterized by an overall lower consumption of wine and cigarette smoking even when the educational level was considered. This could suggest a generally more healthy life-style among subjects recruited on a volountary bases.

A large number of studies have investigated the factors correlated to age at natural menopause in several populations. However, information on genetics and life-style factors influencing the age of onset of menopause in different populations is of current scientific interest. Specifically, for Italian women there are no large population-based data. The EPIC-Italy collaboration is a source of data of this kind; moreover, the geographical distribution of the cohorts (recruited in northern, central and southern Italy) is an added value as regards the scientific interest of these data. A number of biological and life-style-related factors have been analyzed to evaluate their association to the age at natural menopause in 14,454 menopausal women of the EPIC-Italy collaboration. As regards life-style and environmental factors, the main results are: a) women living in different areas of the country have different ages of onset of natural menopause; b) educational level is significantly associated to this age and may explain part of the between-center difference; c) cigarette smoking appears as a major correlate and probably determinant of the age at natural menopause across all the Italian cohorts; d) alcohol consumption does not have any relationship with the age at natural menopause; e) the use of oral contraceptives may influence age at natural menopause. As regards biological factors, short cycles and low parity have been found associated with earlier menopause. Overall, the results concerning menstrual cycles, parity, and cigarette smoking are consistent with the hypothesis that the number of oocytes in the ovary is pre-determined and any acceleration or impairment of the ovarian function leads to reduce the duration of the reproductive life.

Background: Exposure to environmental tobacco smoke (ETS) is associated with an increased risk of lung cancer, ischemic heart disease and respiratory diseases in non-smokers. Exposure is likely to be uneven in the population. Knowledge of its distribution is important for a better planning of preventive activities., Methods: In the context of the Italian branch of the EPIC prospective investigation, in which we enrolled 47,000 volunteers, we have surveyed exposure to ETS and its determinants (age, social class, occupation). The purpose of the present paper is to contribute to identify the main sources of exposure in Italy., Results: We found, in a sample of 21,588 Italian non-smokers, a prevalence of 0.337 (95% confidence interval, 0.336-0.337) in women and 0.537 (0.529-0.544) in men. Exposure was defined as at least 1 hr/day for at least one year. Exposure at work is by far the commonest source of exposure to ETS, with a strong difference between full-time and part-time jobs. The distribution of exposure by social class was uneven, with statistically significant odds ratios for higher social groups in the order of 0.4-0.5. White-collar workers are the occupational category mostly exposed, suggesting that the implementation of anti-smoking legislation is still incomplete in Italian offices., Conclusions: The uneven distribution of ETS in the population is a matter of concern, since it contributes to the unequal distribution of health in different social groups.