A pilot study of a smartphone-based monitoring intervention on head and neck cancer patients undergoing concurrent chemo-radiotherapy.

BACKGROUND: Multidisciplinary treatment for head and neck carcinoma offers the best curative results but generates acute toxicities, which negatively affect both patients' quality of life and treatment compliance. Usually, the patient's clinical condition is recorded during scheduled, time-limited office visits and patients might forget to discuss symptoms occurred weeks before. They could also have difficulties contacting their clinicians outside of these limited encounters. Technology-based interventions for oncological patients have already been proved to encourage accurate symptoms report through regular inquiries of their clinical conditions. OBJECTIVES: The aim of this work is to present the results of a pilot study about the assessment of a novel mobile application for reporting clinical parameters, quality of life, and symptoms of home patients affected by head and neck carcinoma, during chemo-radiotherapy and the subsequent follow-up period. Results will inform app designers about the necessary modifications to face a full-scale trial. METHODS: Ten patients used the app for the foreseen period (up to 65 days, median 50.5), at the end of which they answered a paper questionnaire addressing user satisfaction with the app. The questionnaire included 8 questions and a free text comment field. Patients were followed by three clinicians, who also answered a similar paper questionnaire at the end of the pilot study. Questionnaires total score ranged 0-25 and a threshold of 16 was set in the study protocol to represent an overall positive outcome. However, to consider the individual constructs, questions about usability, perceived usefulness and user acceptance were also analyzed separately, and association among them was investigated. Finally, the feasibility of the intervention was analyzed in terms of the actual use of the app, i.e. dropout rates and compliance with the required data input. Statistics were only performed on patients' data, due to the small number of doctors involved in the study. RESULTS: The median of the total score per patient was 18.5 (interquartile range 11.2-20.5), and per doctor was 16 (range 11-20), thus showing a positive overall satisfaction with the app. Concerning patients, only 4 out of a total of 80 answers (10 patients × 8 questions) expressed a definite negative feeling. Perceived usefulness was a critical issue for some patients. It was positively correlated with usability, and both aspects were independent predictors of acceptance. Feasibility was demonstrated by the low percentage of dropouts (9%) and noncompliance with assignments (10%). A significant (p = 0.007) negative correlation between the severity of reported symptoms and the EuroQoL questionnaire scores was found, supporting the consistency of the entered data. Free comments were reported by 6 Patients. CONCLUSIONS: This study was meant to explore the context of outpatients' remote monitoring through the collection of patient-reported outcomes. The intervention for a proactive approach to symptoms monitoring in curatively treated head and neck cancer patients resulted feasible and acceptable by both patients and oncologists. The study revealed a criticality on the perceived usefulness, but, at the same time, the patients' comments suggested how to improve this aspect. Further actions will need to focus on measuring the impact of HeNeA on the process of care and on the health outcomes.

An mHealth Application for Educating and Monitoring Patients Treated with a Ketogenic Diet Regimen.

Ketogenic Diet (KD) is a high-fat diet used to treat refractory epilepsy in patients, also including children. Because of the inherent differences with a balanced diet, patients starting KD face an abrupt switch of dietary habits. Moreover, KD is associated with several side effects that should be closely monitored. In this paper, we propose an mHealth application for training and empowering patients in managing KD. The application also acts as a bridge connecting patients with the health care staff for coaching and monitoring purposes.

An Environment for Guideline-based Decision Support Systems for Outpatients Monitoring.

OBJECTIVES: We propose an architecture for monitoring outpatients that relies on mobile technologies for acquiring data. The goal is to better control the onset of possible side effects between the scheduled visits at the clinic. METHODS: We analyze the architectural components required to ensure a high level of abstraction from data. Clinical practice guidelines were formalized with Alium, an authoring tool based on the PROforma language, using SNOMED-CT as a terminology standard. The Alium engine is accessible through a set of APIs that may be leveraged for implementing an application based on standard web technologies to be used by doctors at the clinic. Data sent by patients using mobile devices need to be complemented with those already available in the Electronic Health Record to generate personalized recommendations. Thus a middleware pursuing data abstraction is required. To comply with current standards, we adopted the HL7 Virtual Medical Record for Clinical Decision Support Logical Model, Release 2. RESULTS: The developed architecture for monitoring outpatients includes: (1) a guideline-based Decision Support System accessible through a web application that helps the doctors with prevention, diagnosis and treatment of therapy side effects; (2) an application for mobile devices, which allows patients to regularly send data to the clinic. In order to tailor the monitoring procedures to the specific patient, the Decision Support System also helps physicians with the configuration of the mobile application, suggesting the data to be collected and the associated collection frequency that may change over time, according to the individual patient's conditions. A proof of concept has been developed with a system for monitoring the side effects of chemo-radiotherapy in head and neck cancer patients. CONCLUSIONS: Our environment introduces two main innovation elements with respect to similar works available in the literature. First, in order to meet the specific patients' needs, in our work the Decision Support System also helps the physicians in properly configuring the mobile application. Then the Decision Support System is also continuously fed by patient-reported outcomes.

Beyond Cohort Selection: An Analytics-Enabled i2b2.

The i2b2 software is a widely adopted solution for secondary use of clinical data for clinical research, specifically designed for cohort identification. i2b2 is still lacking functionalities for data analysis. The aim of this work is to empower the i2b2 framework enabling clinical researchers to perform statistical analyses for accelerating the process of hypothesis testing. To this aim we have developed a flexible extension of i2b2 able to exploit different statistical engines. We have implemented some first applications for basic statistics and survival analyses, exploiting this extension and accessible through suitable user interfaces designed with a special consideration for usability.

Shape memory behavior of novel (L-lactide-glycolide-trimethylene carbonate) terpolymers.

Bioresorbable new terpolymers of L-lactide, glycolide, and trimethylene carbonate with different compositions were synthesized via ring-opening polymerization reaction of the cyclic monomers using low-toxicity zirconium(IV) acetylacetonate as initiator. The thermal and mechanical properties were investigated by means of thermogravimetry, differential scanning calorimetry, stress-strain measurements, and dynamical mechanical analysis. The glass transition temperature of the terpolymers changes with composition from 12 to 42 degrees C in a predictable manner. All terpolymers display shape memory properties and, after undergoing 100% deformation, they recover the permanent shape in a time frame of seconds. Terpolymers with high L-lactide content show a glass transition in the range of 38-42 degrees C, recovery temperature close to body temperature, and good recovery ratio (>0.89). Low-toxicity bioresorbable terpolymers with shape memory properties are promising new materials for biomedical applications.

Biodegradable polyesters reinforced with surface-modified vegetable fibers.

Flax fibers are investigated as reinforcing agents for biodegradable polyesters (Bionolle and poly(lactic acid) plasticized with 15 wt.-% of acetyltributyl citrate, p-PLLA). The composites are obtained either by high temperature compression molding fiber mats sandwiched between polymer films, or by batch mixing fibers with the molten polymer. Fibers in composites obtained by the latter method are much shorter (140-200 microm) than those of the mats (5,000 microm). Flax fibers are found to reinforce both p-PLLA and Bionolle (i.e. tensile modulus and strength increase) when composites based on fiber mats are investigated. Conversely, analogous composites obtained by batch mixing show poor mechanical properties. The observed behavior is attributed to the combined effect of fiber length and fiber-matrix adhesion. If flax fibers with a modified surface chemistry are used, the strength of short fiber composites is seen to improve significantly because the interface strengthens and load is more efficiently transferred. Appropriate surface modifications are performed by heterogeneous acylation reactions or by grafting poly(ethylene glycol) chains (PEG, molecular weight 350 and 750). The highest tensile strength of p-PLLA composites is reached when PEG-grafted flax fibers are used, whereas in the case of Bionolle the best performance is observed with acylated fibers.

Heterogeneous acylation of flax fibers. Reaction kinetics and surface properties.

Flax fibers composed mainly of cellulose were subjected to heterogeneous valerylation reaction. The progress of the chemical modification was assessed by transmission FTIR. The heterogeneous esterification reaction followed first-order kinetics, and a plateau was reached already after 30 min. The intensity of the FTIR hydroxyl absorption band (nu = 3400 cm(-1)) did not appreciably decrease during the acylation reaction, showing that only a small fraction of the fiber hydroxyls was involved in the reaction. The degree of valerate substitution (DS) at the fiber surface (50 A thick layer) was evaluated by means of ESCA. Surface valerylation increased with reaction time and leveled off at DS around 1 after 30 min, in agreement with the FTIR data. The chemically modified fibers maintain the Cellulose I crystal structure and the original crystallinity degree up to the longest reaction time investigated (180 min). Dynamic contact angle measurements showed that surface hydrophobicity as indicated by advancing contact angle rapidly increased upon valerylation reaching a plateau after about 10 min. Chemical modification does not appreciably alter fiber thermal stability (by TGA) and morphology (by SEM).