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.

On digital intimacy: redefining provider-patient relationships in remote monitoring.

Remote monitoring has often been thought to lead to a highly structured and standardised care process. Several studies have stressed that patient-provider communication could be hindered if mediated by technologies, leading to an impoverished relationship. We argue that while remote monitoring leads to a redefinition of the patient-provider relationship, it could also offer the opportunity to develop a more intimate acquaintance not possible via only routine visits. The study is part of a clinical trial aimed at assessing the acceptability of a remote monitoring platform for type 1 diabetes. Drawing on practice-based studies, we focused our analysis on the practice of text message exchange between patients and providers. The 396 conversations were coded with a template analysis, leading to the identification of two main categories: 'knowing the patient' and 'knowing about the patient'. The analysis reveals that the practice of messaging led to the development of a 'digital intimacy', a relationship characterised by a thorough familiarity made possible by electronic devices that extends to face-to-face encounters. Drawing on our case, we argue that remote monitoring can foster greater intimacy between patients and providers, which is made possible by the overall increase in the quantity and quality of communication between patients and providers.

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.

The co-production of a workplace health promotion program: expected benefits, contested boundaries.

Workplace health promotion (WHP) are often depicted as an opportunity for pursuing a better and broader well-being condition under the assumption that working environments affect the physical, mental, and social well-being of individuals who spend large proportion of waking hours at work. While most empirical studies provided medical evidence to the effectiveness of WHP programs, scholars question the instrumental purposes of these programs founded on the belief that "healthy workers are better workers". Little is known, for instance, about the design of WHP programs and their acceptance by workers. Our study addresses this gap, analyzing the co-production of a WHP program in an Italian research institute promoted by the healthcare authority, the local government and the national center for prevention and security in the workplaces. To this aim, we adopt the notion of boundary object investigate how different stakeholders reclaim to take part and being involved in this process, re-shaping their goals and their boundaries and why a WHP program or parts of it may be rejected or re-negotiated by its recipients. Our analysis reveals how each stakeholder contributes to re-shape the WHP program which emerges as the modular product of the composition of each matter of concern. Most notably, the strong rooting in a clinical perspective and the original focus on only workers at risk is gradually flanked by initiatives to involve all employees. Moreover, workers draw a line as for the legitimacy of employers' intervention in the personal sphere of health promotion, embracing interventions addressing diet and physical activity while rejecting measures targeting smoking and alcohol consumption.

Influence of Parental Health Locus of Control on Behavior, Self-Management and Metabolic Control, in Pediatric Patients with Type 1 Diabetes.

Background: Precision medicine in type 1 diabetes (T1D) treatment considers context and environmental data to subclassify patients. Parental Health Locus of Control PHLOC) could influence behavior, self-management, and metabolic control of children with T1D. Methods: No. 135 pediatric patients with T1D (No. 57 with HbA1c ≤ 7.0%, "optimal" group, and No. 78 with >7.0%, "sub-optimal" group) were enrolled in the study. History, anthropometric and diabetes management data were collected, as well as caregiver's data about socioeconomic status (SES). The PHLOC scale questionnaire and a semi-structured interview were administered. Results: Access to technology was lower in the "sub-optimal" group and, in particular, in the ethnic minority subgroup, only 8% used them. In the "sub-optimal" group ethnic minority status was higher (24%), the caregiver had a lower SES and showed lower internal HLOC. Conclusions: New care models have to be implemented to ensure equity in diabetes care and precision treatment, particularly for ethnic minority groups, because SES and external PHLOC are still an important barrier to "optimal" diabetes control. In the "sub-optimal" group, we have to implement strategies aimed at increasing self-efficacy, while in the "optimal" one, a personalised approach should be considered to facilitate the shifting of responsibilities within the family, avoiding psychological distress.

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.

Implementation of tele visit healthcare services triggered by the COVID-19 emergency: the Trentino Province experience.

AIM: In response to the SARS-CoV-2 emergency, the Competence Centre on digital health 'TrentinoSalute4.0' has developed TreC_Televisita, a tele visit solution that meets the needs of the Trentino healthcare system and maintains high-quality patient-doctor interactions while respecting social distancing. This paper highlights how 'TreC_Televisita' was integrated into the Trentino healthcare system and its potential to become a structural and durable solution for the future local healthcare service provisioning. SUBJECT AND METHODS: This paper presents the multifactorial context that TreC_Televisita has faced for its implementation and the strategies adopted for its structural integration into the healthcare system. The analysis focuses on the main issues faced for the integration of the tele visits (e.g. privacy, payments) and how the context of TrentinoSalute4.0 permitted responding quickly to its implementation during the pandemic. It also describes how TreC_Televisita fits into the healthcare continuum from the organisational and technological standpoint, the end-user perspective and the barriers that could hamper the solution scalability. RESULTS: TreC_Televisita has demonstrated to be a technological solution that can be contextualised for different clinical domains beyond SARS-CoV-2. Moreover, it has shown its potential to scale up the solution beyond the COVID-19 emergency to the whole healthcare provisioning system in the long term. CONCLUSION: Being a positive experience in the first months of its implementation, the long-term goal is to transform TreC_Televisita into a structural pillar of the Trentino healthcare system, setting the bases for a sustainable, win-win situation for all the stakeholders involved in healthcare service provisioning.

Emotions and personal health information management: some implications for design.

This work reflects on the translation of a paper-based information system into an electronic one, taking account of the emotional dimension of material artifacts. A qualitative analysis carried out through semi-structured interviews enabled us to describe laypeople's healthcare practices, and specifically the use of "pediatric booklets", which are paper health diaries designed to provide parents with a repository of the most relevant clinical data about their children. Our analysis reveals that parents' use of the booklet does not depend only on the clinical relevance of the information contained in it. Its success rather depends on practices that reshape the booklet's original meaning. In particular, parents use booklets as containers for other clinical records, and they consider them more as objects of affection and symbols of their caring for their children than as clinical tools with instrumental value in themselves. In the discussion we consider the risks of dematerializing health information tools by underestimating the relevance of the emotional side.

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.

School Interventions for Bullying-Cyberbullying Prevention in Adolescents: Insights from the UPRIGHT and CREEP Projects.

BACKGROUND: Several challenges and emotional demands characterize adolescence, affecting the mental well-being of youths. Among these, bullying and cyberbullying are recognized nowadays as a major social problem, affecting more than one-third of adolescents, with extensive negative consequences for the victims involved, such as lower self-esteem, increased loneliness, depression, and anxiety. School programs and interventions that foster resilience, coping, and well-being are particularly important during adolescence as protective and preventive factors against the consequences of (cyber)bullying. The paper presents two recent co-designed interventions for (cyber)bullying prevention deployed in Europe, targeting early adolescents and their school communities. METHODS: The UPRIGHT project developed an evidence-based, whole-school intervention to train resilience as a protective factor to promote mental well-being in adolescents, in a cross-national perspective. The CREEP project designed and implemented digital interventions to support schools in (i) early detection of cyberbullying events on social media and (ii) coaching adolescents (victims, bullies, bystanders) on how to cope with (cyber)bullying behaviors. RESULTS: The main challenges and insights collected during the design and implementation of both interventions are discussed to inform future research and practice. CONCLUSION: The feasibility and acceptance of prevention programs are key to the reducing risk of (cyber)bullying and improving the psychological well-being of early adolescents.

Electronic Medical Record-Assisted Telephone Follow-Up of Breast Cancer Survivors During the COVID-19 Pandemic: A Single Institution Experience.

PURPOSE: The COVID-19 outbreak rapidly became a public health emergency and led to radical changes in patient management. From the start of the pandemic, we used electronic medical record-assisted telephone follow-up (E-TFU) of cancer survivors (CS) to minimize hospital exposure. The aim of this prospective study was to assess how breast cancer survivors (bCSs) perceived E-TFU. MATERIALS AND METHODS: A 15-item survey was e-mailed to bCSs who had been managed with E-TFU. The responses were measured using Likert-like scales and were correlated with the main characteristics of the bCS using Pearson's test. RESULTS: One hundred thirty-seven of 343 bCSs (40%) completed the survey between March 9 and June 2, 2020. Their median age was 59 years. Although 80.3% of bCSs were satisfied with E-TFU, only 43.8% would like to have E-TFU in the future. A low educational level was correlated with higher COVID-19-related anxiety (P = .025). An older age (P = .002) and a low educational level (P < .0001) were correlated with the need to be accompanied to reach the hospital. A personal history of second cancer was inversely correlated with understanding medical advice (P = .015) and the expectation of feeling relief after a follow-up visit (P = .0027). Furthermore, pandemic phase II was correlated with satisfaction with E-TFU (P = .010). CONCLUSION: E-TFU was an important means of avoiding hospital contacts during the COVID-19 pandemic, and the majority of bCSs in the survey were satisfied with this procedure. Further studies are needed to investigate the implementation of telemedicine even outside an emergency situation.

Beyond self-tracking: Exploring and unpacking four emerging labels of patient data work.

Despite the growing attention of researchers, healthcare managers and policy makers, data gathering and information management practices are largely untheorized areas. In this work are presented and discussed some early-stage conceptualizations: patient-generated health data, observations of daily living, quantified self and personal health information management. As I shall try to demonstrate, these labels are not neutral; rather, they underpin quite different perspectives with respect to health, patient-doctor relationship and the status of data.

'Homemade': Building, mending, and coordinating a care network.

In recent decades, longer life expectancy, the consequent greater number of patients with often concurrent diseases, and the need of healthcare institutions to reduce the costs of services, have engendered changes in all European healthcare systems. On one side, healthcare systems increasingly rely on the self-management skills of patients, who undertake a growing amount of 'sickness work' from which they are relieved only in the case of severe illness. On the other, the inability of public healthcare systems to satisfy the increased demand for care has led to the growth of private healthcare organizations as well as cooperatives of health professionals who offer their services privately. The care of citizens, therefore, is increasingly distributed across networks of actors with very different objectives, logics of action and professional backgrounds (public and private healthcare organizations, community medical services, voluntary organizations). Despite the attention devoted by social studies of medicine to the work done by citizens in supporting the work of clinicians and nurses, the work performed in connection to the management of care networks have been only marginally investigated. Drawing on a qualitative research carried out in the Province of Trento (Italy) and focused on the different ways in which elderly people with chronic conditions manage their conditions outside the healthcare and welfare institutions, in this paper we are interested in deepening the understanding of the invisible work citizens perform in connection to the management of care services and professionals. That is, the work needed in order to activate, mend and coordinate complex networks of care.

Text Messaging and Type 1 Diabetes Management: Qualitative Study Exploring Interactions Among Patients and Health Care Professionals.

BACKGROUND: The diffusion of information and communication technologies (ICTs) in type 1 diabetes (T1D) management has generated a debate on the ways in which ICTs can support the patient-provider relationship. Several studies have focused on text messages. Most of the literature proposes quantitative analysis of the impact of text messaging on the clinical conditions of patients and/or their satisfaction with the technology, while the qualitative studies have focused mainly on patients' perceptions about strengths and weaknesses of this technology. OBJECTIVE: In contrast to past studies, we adopted a qualitative approach for the in-depth examination of patient-health care professionals' interactions in text messaging. METHODS: The study focused on the use of the Trento Cartella Clinica del Cittadino Diabetes System (TreC-DS), a digital platform with a built-in messaging system, in two diabetes centers, integrating message analysis with interviews with patients and health care professionals. Each center focused on a specific patient profile: the first one focused on pregnant women with T1D and the second one focused on adult patients with poorly controlled diabetes. RESULTS: The main results of the study were as follows: (1) Health care professionals and patients perceived the messaging system as useful for sharing information (ie, pregnant women for prescriptions and adults with poorly controlled diabetes for advice); (2) The content and communication styles of the two centers differed: in the case of pregnant women, interactions via text messaging were markedly prescriptive, while in the case of adult patients with poorly controlled diabetes, they were conceived as open dialogues; and (3) Conversations were initiated mainly by professionals; in the cases considered, it was mainly the diabetes center that decided whether a messaging conversation was needed. CONCLUSIONS: The results show how the features of interactions of text messaging changed based on the patient profiles in two different centers. In addition, in both diabetes centers that were involved, the system seems to have laid a foundation for a closer relationship between patients and health care professionals.

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.

A mobile logbook to diagnose masked hypertension: a pilot application.

In the last years, there has been a growing interest in health mobile applications. Great benefits could be gained by seemingly "simple" solutions if these were designed to build a bridge between doctors and patients. In this paper, we describe a mobile health solution for patients allowing them to measure and record accurately their blood pressure at home, helping doctors to diagnose hypertension. An accurate measurement of the blood pressure, in fact, is a prerequisite for appropriate management of hypertension, a condition causing many serious diseases. The peculiarity of the hypertension kit is that the system requires interaction between the patients and their general practitioner. Finally, we present a pilot study carried out to evaluate the acceptability of the technologies, the compliance of patient to the self-monitoring procedure and the perceived benefits and disadvantages of both doctor and patients in using this kit.

Managing complex therapies outside hospitals. An analysis of GPs practices of how to support medication at home.

Support systems for the management of prescriptions are commonplace in hospitals, whilst they are rarely found in general practice. This exploratory study draws on a qualitative survey conducted with focus groups to investigate the information needs of General Practitioners (GPs) in regard to the therapeutic management of complex patients, the purpose being to identify possible areas of application. The question addressed is whether the systems existing in hospitals can be usefully adapted and used by GPs or if a different approach needs to be adopted to design other tools. The analysis shows that the information needs of GPs relative to medication management are significantly different from those of their hospital colleagues because the former are not directly responsible for the administration but instead operate within a care network on which they cannot exercise direct control. This study suggests that support systems for therapy management should be designed on the assumption that it derives from cooperative work by a heterogeneous network of actors, and therefore with functionalities intended to satisfy the coordination needs of all the actors involved in the process.