A Remote Monitoring System to Optimize the Home Management of Oral Anticancer Therapies (ONCO-TreC): Prospective Training-Validation Trial.

BACKGROUND: A platform designed to support the home management of oral anticancer treatments and provide a secure web-based patient-health care professional communication modality, ONCO-TreC, was tested in 3 cancer centers in Italy. OBJECTIVE: The overall aims of the trial are to customize the platform; assess the system's ability to facilitate the shared management of oral anticancer therapies by patients and health professionals; and evaluate system usability and acceptability by patients, caregivers, and health care professionals. METHODS: Patients aged ≥18 years who were candidates for oral anticancer treatment as monotherapy with an Eastern Cooperative Oncology Group performance status score of 0 to 1 and a sufficient level of familiarity with mobile devices were eligible. ONCO-TreC consisted of a mobile app for patients and a web-based dashboard for health care professionals. Adherence to treatment (pill count) and toxicities reported by patients through the app were compared with those reported by physicians in medical records. Usability and acceptability were evaluated using questionnaires. RESULTS: A total of 40 patients were enrolled, 38 (95%) of whom were evaluable for adherence to treatment. The ability of the system to measure adherence to treatment was high, with a concordance of 97.3% (95% CI 86.1%-99.9%) between the investigator and system pill count. Only 60% (3/5) of grade 3, 54% (13/24) of grade 2, and 19% (7/36) of grade 1 adverse events reported by physicians in the case report forms were also reported in the app directly by patients. In total, 94% (33/35) of patients had ≥1 app launch each week, and the median number of daily accesses per patient was 2. Approximately 71% (27/38) and 68% (26/38) of patients used the app for messages and vital sign entering, respectively, at least once during the study period. CONCLUSIONS: ONCO-TreC is an important tool for measuring and monitoring adherence to oral anticancer drugs. System usability and acceptability were very high, whereas its reliability in registering toxicity could be improved. TRIAL REGISTRATION: ClinicalTrials.gov NCT02921724; https://www.clinicaltrials.gov/ct2/show/NCT02921724.

TreC platform. An integrated and evolving care model for patients' empowerment and data repository.

INTRODUCTION: Health care has been deeply revolutionized by the new wave of information and communication technology (ICT) development, particularly related to the electronic/personal health record (PHR). The present paper describes the original design and implementation approach followed in the Trentino Province (Italy) to promote an Integrated Care Model for patients' empowerment and data repository, by means of an evolving Personal Health Record - PHR platform, named TreC (Trentino Citizens Clinical Record). MATERIALS AND METHODS: The TreC Platform is conceived as a communication hub among different stakeholders. The core assumption of the TreC platform strategy is to consider the citizen/patient as main manager and owner of both his/her own health and his/her contacts with the health care systems. RESULTS: Over the years, the TreC platform has represented the core pillar in the digitalization process promoted at Province level. This has been strategically embedded in the multi-faceted e-government strategy endorsed by the Province of Trento. So far (October 2018), more than 89,000 citizens within the Province of Trento are using TreC platform as a way to communicate with the health care system and access their own personal health records. CONCLUSIONS: The experience gained through the TreC platform implementation and its results are promising, supporting the idea that a PHR platform can represent a key driving factor in improving health care quality and efficiency, both from a patient and a health care staff perspective.

PerKApp: A general purpose persuasion architecture for healthy lifestyles.

Automatically monitoring and supporting healthy lifestyle is a recent research trend, fostered by the availability of low-cost monitoring devices, and it can significantly contribute to the prevention of chronic diseases deriving from incorrect diet and lack of physical activity. In this paper, we present a general purpose architecture for persuasion scenarios and behavioral change. The architecture is designed to be easily portable across languages and domains and has been implemented and evaluated in a specific system for Workplace Health Promotion (WHP) called PerKApp. PerKApp provides a fully fledged platform supporting the remote monitoring of workers lifestyle by providing real-time feedback through persuasive context-based messages when necessary.

Integrating mHealth in Oncology: Experience in the Province of Trento.

BACKGROUND: The potential benefits of the introduction of electronic and mobile health (mHealth) information technologies, to support the safe delivery of intravenous chemotherapy or oral anticancer therapies, could be exponential in the context of a highly integrated computerized system. OBJECTIVE: Here we describe a safe therapy mobile (STM) system for the safe delivery of intravenous chemotherapy, and a home monitoring system for monitoring and managing toxicity and improving adherence in patients receiving oral anticancer therapies at home. METHODS: The STM system is fully integrated with the electronic oncological patient record. After the prescription of chemotherapy, specific barcodes are automatically associated with the patient and each drug, and a bedside barcode reader checks the patient, nurse, infusion bag, and drug sequence in order to trace the entire administration process, which is then entered in the patient's record. The usability and acceptability of the system was investigated by means of a modified questionnaire administered to nurses. The home monitoring system consists of a mobile phone or tablet diary app, which allows patients to record their state of health, the medications taken, their side effects, and a Web dashboard that allows health professionals to check the patient data and monitor toxicity and treatment adherence. A built-in rule-based alarm module notifies health care professionals of critical conditions. Initially developed for chronic patients, the system has been subsequently customized in order to monitor home treatments with capecitabine or sunitinib in cancer patients (Onco-TreC). RESULTS: The STM system never failed to match the patient/nurse/drug sequence association correctly, and proved to be accurate and reliable in tracing and recording the entire administration process. The questionnaires revealed that the users were generally satisfied and had a positive perception of the system's usefulness and ease of use, and the quality of their working lives. The pilot studies with the home monitoring system with 43 chronic patients have shown that the approach is reliable and useful for clinicians and patients, but it is also necessary to pay attention to the expectations that mHealth solutions may raise in users. The Onco-TreC version has been successfully laboratory tested, and is now ready for validation. CONCLUSIONS: The STM and Onco-TreC systems are fully integrated with our complex and composite information system, which guarantees privacy, security, interoperability, and real-time communications between patients and health professionals. They need to be validated in order to confirm their positive contribution to the safer administration of anticancer drugs.

Supporting patients and clinicians during the breast cancer care path with AI: The Arianna solution.

The onset of cancer disease is a traumatic experience for both patients and their families that suddenly change the patient's life and is accompanied by important physical, emotional, and psycho-social problems. The complexity of this scenario has been exacerbated by the COVID-19 pandemic which dramatically affected the continuity of the provision of optimal care to chronic patients. Telemedicine can support the management of oncology care paths by furnishing a suite of effective and efficient tools to monitor the therapies of cancer patients. In particular, this is a suitable setting for therapies that are administered at home. In this paper, we present an AI-based system, called Arianna, designed and implemented to support and monitor patients treated by the professionals belonging to the Breast Cancer Unit Network (BCU-Net) along the entire clinical path of breast cancer treatment. We describe in this work the three modules composing the Arianna system (the tools for patients and clinicians, and the symbolic AI-based module). The system has been validated in a qualitative way and we demonstrated how the Arianna solution reached a high level of acceptability by all types of end-users by making it suitable for a concrete integration into the daily practice of the BCU-Net.

Organisational models supported by technology for the management of diabetic disease and its complications in a diabetic clinic setting: study protocol for a randomised controlled trial targeting type 2 diabetes individuals with non-ideal glycaemic values (Telemechron study).

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a non-communicable disease representing one of the most serious public health challenges of the twenty-first century. Its incidence continues to rise in both developed and developing countries, causing the death of 1.5 million people every year. The use of technology (e.g. smartphone application-App) in the health field has progressively increased as it has been proved to be effective in helping individuals manage their long-term diseases. Therefore, it has the potential to reduce the use of health service and its related costs. The objective of this study is to evaluate the impact of using a digital platform called "TreC Diabete" embedded into a novel organisational asset targeting poorly controlled T2DM individuals in the Autonomous Province of Trento (PAT), Italy. METHODS: This trial was designed as a multi-centre, open-label, randomised, superiority study with two parallel groups and a 1:1 allocation ratio. Individuals regularly attending outpatient diabetes clinics, providing informed consent, are randomised to be prescribed TreC Diabete platform as part of their personalised care plan. Healthcare staff members will remotely assess the data shared by the participants through the App by using a dedicated online medical dashboard. The primary end-point is the evaluation of the Hb1Ac level at 12-month post-randomisation. Data will be analysed on an intention-to-treat (ITT) basis. DISCUSSION: This trial is the first conducted in the PAT area for the use of an App specifically designed for individuals with poorly controlled T2DM. If the effects of introducing this specific App within a new organisational asset are positive, the digital platform will represent a possible way for people diagnosed with T2DM to better manage their health in the future. Results will be disseminated through conferences and peer-reviewed journals once the study is completed. TRIAL REGISTRATION: ClinicalTrials.gov NCT05629221. Registered on November 29, 2022, prior start of inclusion.

Digital Health Service for Identification of Frailty Risk Factors in Community-Dwelling Older Adults: The SUNFRAIL+ Study Protocol.

This article reports the study protocol of a nationwide multicentric study in seven Italian regions aimed at assessing the effectiveness of a digitally supported approach for the early screening of frailty risk factors in community-dwelling older adults. SUNFRAIL+ is a prospective observational cohort study aimed at carrying out a multidimensional assessment of community-dwelling older adults through an IT platform, which allows to connect the items of the SUNFRAIL frailty assessment tool with a cascading multidimensional in-depth assessment of the bio-psycho-social domains of frailty. Seven centers in seven Italian regions will administer the SUNFRAIL questionnaire to 100 older adults. According to the answers provided by older adults, they will be subjected to one or more validated in-depth scale tests in order to perform further diagnostic or dimensional evaluations. The study aims to contribute to the implementation and validation of a multiprofessional and multistakeholder service model for the screening of frailty in community-dwelling older adult population.

Food Frequency Questionnaire Personalisation Using Multi-Target Regression.

Fondazione Bruno Kessler is developing a mobile app prototype for empowering citizens to improve their health conditions through different lifestyle interventions that will be incorporated into a mobile application for lifestyle promotion of the Province of Trento in the context of the Trentino Salute 4.0 Competence Center. The envisioned interventions are based on promoting behaviour change in various domains such as physical activity, mental health and nutrition. In particular, the nutrition component is a self-monitoring module that collects dietary habits to analyse them and recommend healthier eating behaviours. Dietary assessment is completed using a Food Frequency Questionnaire on the Mediterranean diet that is presented to the user as a grid of images. The questionnaire returns feedback on 11 aspects of nutrition. Although the questionnaire used in the application only consists of 24 questions, it still could be a bit overwhelming and a bit crowded when shown on the screen. In this paper, we tried to find a machine-learning-based solution to reduce the number of questions in the questionnaire. We proposed a method that uses the user's previous answers as additional information to find the goals that need more attention. We compared this method with a case where the subset of questions is randomly selected and with a case where the subset is chosen using feature selection. We also explored how large the subset should be to obtain good predictions. All the experiments are conducted as a multi-target regression problem, which means several goals are predicted simultaneously. The proposed method adjusts well to the user in question and has the slightest error when predicting the goals.

Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial.

INTRODUCTION: ONCO-TreC platform consists of a mobile application delivered to patients as electronic diary and a web-based dashboard managed by healthcare professionals. We aim to compare the effectiveness of ONCO-TreC electronic diary with a standard paper diary, in improving adherence to oral cancer therapy in patients with solid and haematological tumours. METHODS AND ANALYSIS: This is an open label, superiority, randomised controlled trial conducted in two Italian oncology units. Patients will be randomised with a 1:1 ratio to electronic or paper diary. For both groups a counsellor will be responsible for drug and diary delivery. The evaluation period will end after six cycles of therapy. The primary aim is to compare the proportion of non-adherent patients in the two arms. Adherence will be measured through pill count; anyone who takes less than 90% of the total prescribed drug dose will be considered non-adherent. Assuming a percentage of non-adherent patients to oral therapy of 40% in arm B, and a 60% reduction in this percentage in arm A, a sample of 124 patients will provide 80% power to identify an absolute difference greater than 24 percentage points using a bilateral Fisher's exact test with a significance level of 0.05. Considering a dropout rate of 10%, approximately 136 patients will have to be enrolled. The primary analysis will be performed on the intention-to-treat population. Secondary aims are to describe the reasons for non-adherence, the level of satisfaction of patients and healthcare professionals with the paper and electronic diary, and the impact of non-adherence in terms of healthcare costs. ETHICS AND DISSEMINATION: Ethical approval was obtained from Romagna Ethics Committee (CEROM), study ID 2108, prot. n. IRST 100.28 of 10/04/2020. Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. PROTOCOL VERSION: Version 2, 6 April 2021. TRIAL REGISTRATION NUMBER: NCT04826458.

TreC - a REST-based regional PHR.

The Personal Health Record (PHR) is progressively becoming a fundamental tool to allow people to control their health. User needs, however, impose to design a PHR solution that must offer a great flexibility in terms of managing heterogeneous health data, composing data in higher level concepts and interfacing the PHR with different devices to collect and visualize data. We propose to adopt REST as core of a regional PHR architecture and present a PHR based on this architecture implemented and tested in our Province.

Explainable AI meets persuasiveness: Translating reasoning results into behavioral change advice.

Explainable AI aims at building intelligent systems that are able to provide a clear, and human understandable, justification of their decisions. This holds for both rule-based and data-driven methods. In management of chronic diseases, the users of such systems are patients that follow strict dietary rules to manage such diseases. After receiving the input of the intake food, the system performs reasoning to understand whether the users follow an unhealthy behavior. Successively, the system has to communicate the results in a clear and effective way, that is, the output message has to persuade users to follow the right dietary rules. In this paper, we address the main challenges to build such systems: (i) the Natural Language Generation of messages that explain the reasoner inconsistency; and, (ii) the effectiveness of such messages at persuading the users. Results prove that the persuasive explanations are able to reduce the unhealthy users' behaviors.

Embedding oncologic protocols into the provision of care: the Oncocure project.

A computerized Decision Support System (CDSS) can improve the adherence of the clinicians to clinical guidelines and protocols. Integrating it within the clinical workflow can reduce the workload of the physicians, and improve the acceptance of the system. The building of a prescriptive CDSS and its integration with a legacy cancer patient management system is the aim of the Oncocure project, which implements the existing protocol for the medical treatment of breast cancer in the Asbru language, and interfaces the Asbru interpreter with the Electronic Patient Record (EPR) in use in an oncologic unit. Our work is not constrained to a specific domain or EPR implementation, but can be generalized to other fields of medicine and patient management systems. When implemented, our CDSS is expected to reduce the cost of care while improving the adherence to the guideline and the quality of the documentation.

Over Expressed TKTL1, CIP-2A, and B-MYB Proteins in Uterine Cervix Epithelium Scrapings as Potential Risk Predictive Biomarkers in HR-HPV-Infected LSIL/ASCUS Patients.

High oncogenic risk human papillomaviruses (HR-HPVs) promote cervical carcinoma development, the fourth most common feminine cancer. A slow oncodevelopmental phase-defined histopathologically as Cervical Intraepithelial Neoplasia (CIN) grades 1-3, or cytologically as Low- or High-grade Squamous Intraepithelial Lesions (LSIL or HSIL)-precedes the malignancy. Cervical carcinoma screenings through HR-HPV genotyping and Pap smears are regularly performed in Western countries. Faulty cytology screening or genotyping or patients' non-compliance with follow-ups can let slip an oncoprogression diagnosis. Novel biomarker tests flanking HR-HPV genotyping and cytology could objectively predict the risk of disease progression thus helping triage LSIL/ASCUS patients. Here, anonymized leftovers of fresh cervical epithelium scrapings from twice (LSIL/ASCUS and HR-HPV DNA)-positive and twice (Pap smear- and HR-HPV DNA)-negative (control) patients in a proteome-preserving solution served to assess the biomarker worth of three cervical carcinoma-related proteins, i.e., B-MYB (or MYBL2), Cancerous Inhibitor of PP2A (CIP-2a), and transketolase-like1 (TKTL1). Leftovers anonymity was strictly kept and storage at -80°C, protein extraction, immunoblotting, and band densitometry were blindly performed. Only after tests completion, the anonymous yet code-corresponding HR-HPV-genotyping and cytology data allowed to assign each sample to the twice-positive or twice-negative group. Descriptive statistics showed that the three proteins levels significantly increased in the twice-positive vs. twice-negative scrapings. Diagnostic ROC curve analysis identified each protein's Optimal Decision Threshold (OTD) showing that TKTL1 and CIP-2a are stronger risk predictive biomarkers (Sensitivity, 0.91-0.93; Specificity, 0.77-0.83) than B-MYB. Logistic Regression coupled with Likelihood-Ratio Tests confirmed that a highly significant relation links increasing TKTL1/CIP-2a/B-MYB protein levels in twice-positive cervical scrapings to the risk of HR-HPV-driven oncoprogression. Finally, a 3 year clinical follow-up showed that 13 patients (50% of total) of the twice-positive group with biomarker values over OTDs compliantly underwent scheduled colposcopy and biopsy. Of these, 11 (i.e., 84.7%) received a positive histological diagnosis, i.e., CIN1 (n = 5; 38.5%) or CIN2/CIN2+ (n = 6; 46,2%). Therefore, TKTL1/CIP-2a/B-MYB protein levels could objectively predict oncoprogression risk in twice (HR-HPV- and Pap smear)-positive women. Further studies will assess the translatability of these findings into clinical settings.

[Synchronous gastric and oesophageal cancer: a case report]. / Neoplasia sincrona dello stomaco e dell'esofago: caso clinico.

We describe the case of a male patient, aged 50, affected by an undifferentiated cancer of the gastric stump of a Billroth II gastric resection associated with a well-differentiated squamous-cell cancer of the oesophagus. The patient was submitted to gastrectomy and removal of the oesophagus together with reconstruction trough colon interposition. The association of the two synchronous neoplasms of the stomach and oesophagus is a very uncommon event, as the evidence in the medical literature demonstrates. Nevertheless, for the purposes of achieving in the right surgical planning, it is important to take this possibility into consideration in the preoperative management of oesophageal cancer, through the study of the organs which could be used to reconstruct the transit (stomach, colon). The association with a gastric neoplasm implies the use of the other organs (colon, ileum). However, for a number of selected cases of association with early gastric cancer, Japanese authors have suggested using the stomach in place of the oesophagus.

Design and implementation of a tool for translating SBML into the biochemical stochastic pi-calculus.

MOTIVATION: SBML is becoming a standard 'de-facto' to represent and store biological models. Although SBML is very useful in defining ways of exchanging and storing biological information, it is not formal enough to allow direct translation into non ambiguous formal representation languages to perform analysis and simulation of models. We here suggest to map SBML models into process calculi representations. RESULTS: We implemented and validated a tool that translates SBML descriptions into stochastic pi-calculus specifications. AVAILABILITY: Source code is freely available for academic use by contacting the authors.

Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study.

INTRODUCTION: Despite the growing number of oral agents available for cancer treatment, their efficacy may be reduced due to the lack of adherence, inappropriate adverse event self-management and arbitrary dose adjustment. The management of anticancer therapies could exponentially benefit from the introduction of mobile health technologies in a highly integrated electronic oncology system. METHODS AND ANALYSIS: We plan to customise and fine-tune an existing monitoring TreC platform used in different chronic diseases in the oncology setting. This project follows a multistep approach with two major purposes: 1. participatory design techniques driven by Health Literacy and Patient Reported Outcomes principles in order to adapt the system to the oncology setting involving patients and healthcare providers; 2. a prospective training-validation, interventional, non-pharmacological, multicentre study on a series of consecutive patients with cancer (20 and 60 patients in the training and validation steps, respectively) in order to assess system capability, usability and acceptability. The novel Onco-TreC 2.0 is expected to contribute to improving the adherence and safety of cancer care, promoting patient empowerment and patient-doctor communication. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Independent Ethics Committees of the participating institutions (CEIIAV protocol Number 2549/2015; reference Number 1315-PU). Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT02921724); (Pre-results). Other study ID Number: IRST100.18.

Ontologies supporting continuity of care: the case of heart failure.

Heart failure can be the final stage of almost any type of cardiovascular diseases. Such diseases are the leading cause of recurrent hospital stay and mortality in developed countries, and an increasingly important cause of morbidity and mortality in developing countries. In consideration of the growing incidence of this syndrome, the Province of Trento (Northern Italy) supports a research project called e-Heart Failure. The aims of this project include the implementation of a web-based patient record management system which must allow all the professionals involved in the care process to provide a shared and continuous care. This paper emphasizes the role of ontologies in supporting the continuity of care. In a complex scenario where multiple agents co-operate in order to allow continuity of care, ontologies are the essential glue to ensure semantic consistency to data and knowledge shared by the different actors involved in the process, including patients and their families.

[Blunt liver trauma: therapeutic options]. / I traumi chiusi del fegato: opzioni terapeutiche.

Therapeutic options for management of blunt hepatic trauma include both non-operative and operative management, until liver transplantation. The presence of associated intraabdominal lesions increases mobility and mortality. A total of 58 patients with blunt hepatic injury, observed at the 2nd Surgical Unit of the "Santa Chiara Hospital" of Trento over a four-year period (1999-2003), were analyzed. Thirty-eight patients (65.5%) were treated conservatively with a 94.7% success rate. Twenty (34.5%) patients were surgically treated. Suture hepatorraphy was the most common procedure performed. The overall morbidity in surgical patients was 25%, with 20% of liver related complications. Four patients (20%) died with a liver related mortality of 10%. Advantages of non-operative management included a reduced need for transfusion (1.1 vs. 4.3 U), with 81.5% of patients not requiring transfusion, a reduced stay in the ICU and a reduced rate of morbidity and mortality (2.6% vs. 20%). Hemodynamic instability and the presence of an associated lesion in blunt hepatic trauma patients require emergency laparotomy. The widespread application of non-operative management has reduced the rate of morbidity and mortality related to unnecessary surgical approaches.

A multiple classifier system for early melanoma diagnosis.

Melanoma is the most dangerous skin cancer and early diagnosis is the key factor in its successful treatment. Well-trained dermatologists reach a diagnosis via visual inspection, and reach sensitivity and specificity levels of about 80%. Several computerised diagnostic systems were reported in the literature using different classification algorithms. In this paper, we will illustrate a novel approach by which a suitable combination of different classifiers is used in order to improve the diagnostic performances of single classifiers. We used three different kinds of classifiers, namely linear discriminant analysis (LDA), k-nearest neighbour (k-NN) and a decision tree, the inputs of which are 38 geometric and colorimetric features automatically extracted from digital images of skin lesions. Multiple classifiers were generated by combining the diagnostic outputs of single classifiers with appropriate voting schemata. This approach was evaluated on a set of 152 digital skin images. We compared the performances of multiple classifiers (2- and 3-classifier groups) between them and with respect to single ones (1-classifier group). We further compared the classifiers' performances with those of eight dermatologists. Classifiers' performances were measured in terms of distance from the ideal classifier. Compared with 1- and 2-classifier groups, performances of 3-classifier systems were significantly higher (P<0.0005 and P<0.001, respectively). No statistically significant differences were found between the 1- and 2-classifier groups (P=0.352). While the dermatologists group showed a level of performances significantly higher than the 1-classifier systems (P<0.020), no differences were found between the multiple classifier groups and the dermatologists groups, indicating comparable performances. This work suggests that a suitable combination of different kinds of classifiers can improve the performances of an automatic diagnostic system.

Implementation and evaluation of an Asbru-based decision support system for adjuvant treatment in breast cancer.

The domain of cancer treatment is a promising field for the implementation and evaluation of a protocol-based clinical decision support system, because of the algorithmic nature of treatment recommendations. However, many factors can limit such systems' potential to support the decision of clinicians: technical challenges related to the interoperability with existing electronic patient records and clinical challenges related to the inherent complexity of the decisions, often collectively taken by panels of different specialists. In this paper, we evaluate the performances of an Asbru-based decision support system implementing treatment protocols for breast cancer, which accesses data from an oncological electronic patient record. Focusing on the decision on the adjuvant pharmaceutical treatment for patients affected by early invasive breast cancer, we evaluate the matching of the system's recommendations with those issued by the multidisciplinary panel held weekly in a hospital.