Background There is an increasing need to integrate patient-generated health data (PGHD) into health information systems (HISs). The use of health information standards based on the dual model allows the achievement of semantic interoperability among systems. Although there is evidence in the use of the Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources (SMART on FHIR) framework for standardized communication between mobile apps and electronic health records (EHRs), the use of European Norm/International Organization for Standardization (EN/ISO) 13606 has not been explored yet, despite some advantages over FHIR in terms of modeling and formalization of clinical knowledge, as well as flexibility in the creation of new concepts. Objective This study aims to design and implement a methodology based on the dual-model paradigm to communicate clinical information between a patient mobile app (Xemio Research) and an institutional ontology-based clinical repository (OntoCR) without loss of meaning. Methods This paper is framed within Artificial intelligence Supporting CAncer Patients across Europe (ASCAPE), a project that aims to use artificial intelligence (AI)/machine learning (ML) mechanisms to support cancer patients’ health status and quality of life (QoL). First, the variables “side effect” and “daily steps” were defined and represented with EN/ISO 13606 archetypes. Next, ontologies that model archetyped concepts and map them to the standard were created and uploaded to OntoCR, where they were ready to receive instantiated patient data. Xemio Research used a conversion module in the ASCAPE Local Edge to transform data entered into the app to create EN/ISO 13606 extracts, which were sent to an Application Programming Interface (API) in OntoCR that maps each element in the normalized XML files to its corresponding location in the ontology. This way, instantiated data of patients are stored in the clinical repository. Results Between December 22, 2020, and April 4, 2022, 1100 extracts of 47 patients were successfully communicated (234/1100, 21.3%, extracts of side effects and 866/1100, 78.7%, extracts of daily activity). Furthermore, the creation of EN/ISO 13606–standardized archetypes allows the reuse of clinical information regarding daily activity and side effects, while with the creation of ontologies, we extended the knowledge representation of our clinical repository. Conclusions Health information interoperability is one of the requirements for continuity of health care. The dual model allows the separation of knowledge and information in HISs. EN/ISO 13606 was chosen for this project because of the operational mechanisms it offers for data exchange, as well as its flexibility for modeling knowledge and creating new concepts. To the best of our knowledge, this is the first experience reported in the literature of effective communication of EN/ISO 13606 EHR extracts between a patient mobile app and an institutional clinical repository using a scalable standard-agnostic methodology that can be applied to other projects, data sources, and institutions.

Purpose: To assess the usability and preferences of the contents of mHealth software developed for breast cancer patients as a tool to obtain patient-reported outcomes (PROMs), improve the patient’s knowledge about the disease and its side effects, increase adherence to treatment, and facilitate communication with the doctor. Intervention: an mHealth tool called the Xemio app provides side effect tracking, social calendars, and a personalized and trusted disease information platform to deliver evidence-based advice and education for breast cancer patients. Method: A qualitative research study using semi-structured focus groups was conducted and evaluated. This involved a group interview and a cognitive walking test using Android devices, with the participation of breast cancer survivors. Results: The ability to track side effects and the availability of reliable content were the main benefits of using the application. The ease of use and the method of interaction were the primary concerns; however, all participants agreed that the application would be beneficial to users. Finally, participants expressed their expectations of being informed by their healthcare providers about the launch of the Xemio app. Conclusion: Participants perceived the need for reliable health information and its benefits through an mHealth app. Therefore, applications for breast cancer patients must be designed with accessibility as a key consideration.

BACKGROUND The field of mHealth has grown exponentially in the last decade due to the widespread use of smartphones and the advancements in mobile technology, which has created opportunities to find solutions to unmet healthcare needs for patients with chronic diseases. Furthermore, healthcare is entering a new value-based paradigm, founded on three main pillars: efficiency, safety, and value for patients. OBJECTIVE The objective of this review is to summarize the current knowledge on the impact of mHealth on patient-reported outcomes in breast cancer (BC) patients. METHODS Three databases were systematically searched to identify studies that met eligibility criteria: PubMed, PsychInfo, and Google Scholar. Relevant systematic reviews and the references of the research articles they contained were also searched in case that studies were missed during the initial search. Searches were made on December 17th, 2021. Two investigators independently reviewed the titles and abstracts of the identified studies and then read the full text of all selected papers. In case a discrepancy was found, It was discussed with a third investigator in order to make a final decision. The quality of the included studies was analyzed by the Cochrane Collaboration Risk of Bias Tool and the Methodological Index for Non-Randomized Studies. RESULTS Twenty-two unique studies involving 3,502 patients were included. The focus of the interventions in the studies included in the review were physical activity (11 studies), tailored information for better self-management of the disease (8 studies), mental health therapies (6 studies), symptom tracker (4 studies), and others (6 studies). All interventions were at least 8 weeks long of duration, with a median duration of 12 weeks (interquartile range 4-18 weeks). mHealth interventions showed better results on symptom burden, fatigue, quality of life and physical activity. Likewise, tailored information, symptom tracker, nutrition and physical activity were the interventions that yielded better results. Apps with interactive support had a higher rate of positive findings, while interventions targeted to survivors showed worse results. CONCLUSIONS mHealth applications in BC patients is a highly heterogeneous field. Our study suggests that interventions focused on newly diagnosed patients or patients while on chemotherapy, interventions with interactive human support and those with a duration of 12 weeks or more showed better results in terms of patient-reported outcome. Interventions must be adapted to each patient’s characteristics and disease stage to meet their specific needs at the time of deployment. Positive impact on endpoints show what can be achieved with the right mHealth intervention. The reproducibility of the studies reporting mHealth interventions is currently uncertain.

UNSTRUCTURED Purpose: To assess usability, feasibility, and acceptability of patients with breast cancer of a mobile health technology as a tool to help obtain patient-reported results (PROM), follow-up of side effects and results in the quality of life, reinforcing adherence to treatment and communication with the doctor. Approach: Focus groups. Setting: Hospital Clinic from Barcelona. Participants: Survivors n=5 (M ¼ 63.2 years; 100% female; 100% European Spanish) of breast cancer. Intervention: A fully functional mHealth app prototype. Xemio App provides side effect tracking, social agendas, and personalized disease information for breast cancer patients. Method: Semi-structured focus groups were conducted and assessed using thematic data analysis to identify the benefits, concerns, needs, and expectations of the Xemio App. Results: convenience and reliable content were the main benefits of using the application, while the difficulty of use and the means of interaction were the main concern. Participants felt positive adding a calendar network to the app and downloading the recorded symptoms. Finally, participants were waiting to hear release news about Xemio App from their healthcare provider. Conclusion: Guidance and credible health information on breast cancer survivors should be accessible and convenient for all people affected by the disease. The next step is to investigate how the use of the Xemio App affects the quality of life of breast cancer survivors, involving the continuous evolution of the app to provide better and adapted content.