How to Retain Participants in User-Centered Design? Towards Recommendations for Minimizing Dropouts.

Dropout and fatigue is present in most research projects. The present project Chronic Pain includes Fibromyalgia patients and applies a user-centered design approach. Surprisingly to the research group, two years into the project there is zero dropout. As a step towards designing a survey to investigate the patient adherence to the project, the characteristics of the user-centered design process are described in this paper.

Bringing spatiotemporal gait analysis into clinical practice: Instrument validation and pilot study of a commercial sensorized carpet.

BACKGROUND AND OBJECTIVE: We illustrate a low-cost platform easing the estimation of spatio-temporal parameters (GA-STP) ready for large-scale deployment in fall prevention. METHODS: We used a commercial sensorized carpet with a limited cost and a very coarse resolution. An instrument validation test was accomplished: the Wilcoxon test for paired samples and the correlation test with Spearman method were used to compare the values computed by the platform with reference ones. Hierarchical clustering using Ward's method and ROC curves have been used to assess the performance in a pilot study enrolling patients. RESULTS: Validation shows no significant difference between computed and reference values of gait speed (ρ-value:0.99; p-value:2.2E-16), step number (ρ-value:0.91; p-value:5.8E-16) and stride-length (ρ-value:0.92; p-value:7.5E-9). The clinical pilot study confirms that the platform may also be used to track the improvements occurring during a rehabilitation program. CONCLUSIONS: We believe that the use of a commercial carpet makes the solution proposed ready to be deployed on a large scale for effectively bringing GA into the clinical practice.

Patient-Generated Health Data Integration and Advanced Analytics for Diabetes Management: The AID-GM Platform.

Diabetes is a high-prevalence disease that leads to an alteration in the patient's blood glucose (BG) values. Several factors influence the subject's BG profile over the day, including meals, physical activity, and sleep. Wearable devices are available for monitoring the patient's BG value around the clock, while activity trackers can be used to record his/her sleep and physical activity. However, few tools are available to jointly analyze the collected data, and only a minority of them provide functionalities for performing advanced and personalized analyses. In this paper, we present AID-GM, a web application that enables the patient to share with his/her diabetologist both the raw BG data collected by a flash glucose monitoring device, and the information collected by activity trackers, including physical activity, heart rate, and sleep. AID-GM provides several data views for summarizing the subject's metabolic control over time, and for complementing the BG profile with the information given by the activity tracker. AID-GM also allows the identification of complex temporal patterns in the collected heterogeneous data. In this paper, we also present the results of a real-world pilot study aimed to assess the usability of the proposed system. The study involved 30 pediatric patients receiving care at the Fondazione IRCCS Policlinico San Matteo Hospital in Pavia, Italy.

Eliciting and Exploiting Utility Coefficients in an Integrated Environment for Shared Decision-Making.

BACKGROUND: In shared decision-making, a key step is quantifying the patient's preferences in relation to all the possible outcomes of the compared clinical options. According to utility theory, this can be done by eliciting utility coefficients (UCs) from the patient. The obtained UCs are then used in decision models (e.g., decision trees). The elicitation process involves the choice of one or more elicitation methods, which is not easy for decision-makers who are unfamiliar with the theoretical framework. Moreover, to our knowledge there are no tools that integrate functionalities for UC elicitation with functionalities to run decision models that include the elicited values. OBJECTIVES: The first aim of this work is to provide decision support to the clinicians for the selection of the elicitation method. The second aim is to bridge the gap between UC elicitation and the exploitation of those UCs in shared decision-making. METHODS: Based on evidence from the utility theory literature, we developed a set of production rules that recommend the optimal elicitation method(s) according to the patient's profile and health state. We then complemented this decision support tool with a functionality for quantifying and running decision trees defined through the commercial software TreeAge. RESULTS: The result is an integrated framework for shared decision-making. Given the primary aim of this work, we focus for result evaluation on the elicitation tool. It was tested on 51 volunteers, who expressed UCs for four purposely selected health states. The insights on the collected UCs validated the rules included in the decision support system. The usability of the tool was assessed through the System Usability Scale, obtaining positive results. CONCLUSION: We developed an integrated environment to facilitate shared decision-making in the clinical practice. The next step is the validation of the entire framework and its use besides shared decision-making. As a matter of fact, it may also be exploited to target cost-utility analysis to a specific patient population.

Permutation Entropy Applied to Fitbit Data: Long-Term Sleep Analysis on One Healthy Subject.

In this work we exploited an algorithm, already present in the literature, and based on the notion of signal permutation entropy, to analyze a very long time series of sleep data from a single subject. The aim of the work is to explore methods for personalizing alerts related to sleep anomalies, and recommendations for improving sleep quality. As a matter of fact, sleep duration and sleep quality may differently affect daily performance of different people, as well as daily activities may differently affect sleeping during the night. Data have been collected from a Fitbit Alta HR activity tracker worn by the subject for about three years. Results show that personalized inferences may be very different from the generic (population-based) ones, and that correlations found may suggest subject-specific life-style modifications useful to improve sleep quality.

AID-GM: An Advanced System Supporting Continuous Monitoring of T1DM Patients.

In this paper, we present AID-GM, a web application for the analysis and summarization of continuous blood glucose monitoring data in patients with Type 1 Diabetes. AID-GM allows patients and their care providers to share data and analyze them thanks to a set of advanced and personalized intelligent data analysis tools. Such tools enable the extraction of complex multivariate temporal patterns from data. We present a preliminary evaluation of the functionalities of the tool, both on a set of healthy volunteers, and on real patients' data in the pediatric context.

The role of attachment insecurity in the emergence of anxiety symptoms in children and adolescents with migraine: an empirical study.

BACKGROUND: It is widely recognised that there are associations between headache, psychiatric comorbidity and attachment insecurity in both adults and children. The aims of this study were: 1) to compare perceived attachment security and anxiety in children and adolescents with migraine without aura and a healthy control group; 2) to test whether the child's perceived security of attachment to the mother and the father mediated the association between migraine and anxiety. METHODS: One hundred children and adolescents with Migraine without Aura were compared with a control group of 100 children without headache. The Security Scale (measures perceived security of attachments) and the Self-Administered Psychiatric Scales for Children and Adolescents, a measure of anxiety symptoms, were administered to all participants. RESULTS: The clinical group had lower attachment security than the control group and higher scores on all anxiety scales. Anxiety was negatively correlated with attachment. Children's attachment to their mother mediated the increase in global anxiety in the clinical group. Insecure paternal attachment was associated with greater insecurity in maternal attachment, suggesting that there is a complex pathway from migraine to anxiety symptoms mediated by perceived insecurity of paternal attachment and hence also by perceived insecurity of maternal attachment. CONCLUSION: These results suggest that insecure parental attachment may exacerbate anxiety in children and adolescents with migraine and point to the importance of multimodal interventions, perhaps taking account of family relationships, for children and adolescents with migraine.

Usefulness of the organ culture system when villous height/crypt depth ratio, intraepithelial lymphocyte count, or serum antibody tests are not diagnostic for celiac disease.

The existence of mild forms of celiac disease (CD) can make the histology-based diagnosis difficult to reach. Since anti-endomysium (EMA) and anti-tissue transglutaminase (anti-tTG) are detectable in culture supernatants of duodenal biopsies from CD patients, our aim was to assess if this system can support the histology in the diagnostic work-up. A total of 559 suspected CD patients underwent serum EMA/anti-tTG detection, upper endoscopy with duodenal biopsy sampling, histologic analysis, and organ culture to detect EMA/anti-tTG in supernatants. A subgroup of 30 patients with organ culture positive results were put on a gluten-free diet (GFD). Their gluten-dependency was evaluated by the psychological general well-being and beck depression inventory indexes. Statistical analysis was performed by Cohen k inter-test, Friedman test, and Dunn multiple comparison. Two hundred forty-one out of 559 (43.1%) patients showed intestinal villous atrophy, whereas serum and organ culture EMA/anti-tTG were positive in 293/559 (52.4%) and 334/559 (59.7%) patients, respectively. The strength of agreement resulted good for serology vs histology (k = 0.730), good for organ culture vs histology (k = 0.662), and very good for serology vs organ culture (k = 0.852). After 12 months of GFD, psychological general well-being index significantly increased, and beck depression inventory index significantly decreased (P < 0.001 for each one). Data highlight the organ culture system as a useful tool to assist the histology in diagnosing CD, mainly in cases without villous atrophy or in seronegative patients. The marked improvement in quality of life after a GFD further supports the reliability of this system in diagnosing CD.

Gender, migraine and affective disorders in the course of the life cycle.

The relationships existing between migraine and affective disorders are still far from clear. Despite the evidence of a high prevalence, in association, of both conditions, many questions remain unanswered. To what extent is the coexistence of migraine and affective disorders, in particular depression, genetically determined? How important a role is played by pregnancy? What interactions occur between genetic and epigenetic factors? The authors analyse all these open questions and review the state of the art on this intriguing topic.