How mHealth can facilitate collaboration in diabetes care: qualitative analysis of co-design workshops.

BACKGROUND: Individuals with diabetes are using mobile health (mHealth) to track their self-management. However, individuals can understand even more about their diabetes by sharing these patient-gathered data (PGD) with health professionals. We conducted experience-based co-design (EBCD) workshops, with the aim of gathering end-users' needs and expectations for a PGD-sharing system. METHODS: N = 15 participants provided feedback about their experiences and needs in diabetes care and expectations for sharing PGD. The first workshop (2017) included patients with Type 2 Diabetes (T2D) (n = 4) and general practitioners (GPs) (n = 3). The second workshop (2018) included patients with Type 1 Diabetes (T1D) (n = 5), diabetes specialists (n = 2) and a nurse. The workshops involved two sessions: separate morning sessions for patients and healthcare providers (HCPs), and afternoon session for all participants. Discussion guides included questions about end-users' perceptions of mHealth and expectations for a data-sharing system. Activities included brainstorming and designing paper-prototypes. Workshops were audio recorded, transcribed and translated from Norwegian to English. An abductive approach to thematic analysis was taken. RESULTS: Emergent themes were mHealth technologies' impacts on end-users, and functionalities of a data-sharing system. Within these themes, similarities and differences between those with T1D and T2D, and between HCPs, were revealed. Patients and providers agreed that HCPs could use PGD to provide more concrete self-management recommendations. Participants' paper-prototypes revealed which data types should be gathered and displayed during consultations, and how this could facilitate shared-decision making. CONCLUSION: The diverse and differentiated results suggests the need for flexible and tailorable systems that allow patients and providers to review summaries, with the option to explore details, and identify an individual's challenges, together. Participants' feedback revealed that both patients and HCPs acknowledge that for mHealth integration to be successful, not only must the technology be validated but feasible changes throughout the healthcare education and practice must be addressed. Only then can both sides be adequately prepared for mHealth data-sharing in diabetes consultations. Subsequently, the design and performance of the joint workshop sessions demonstrated that involving both participant groups together led to efficient and concrete discussions about realistic solutions and limitations of sharing mHealth data in consultations.

Measuring the Effects of Sharing Mobile Health Data During Diabetes Consultations: Protocol for a Mixed Method Study.

BACKGROUND: There is rising demand for health care's limited resources. Mobile health (mHealth) could be a solution, especially for those with chronic illnesses such as diabetes. mHealth can increases patients' options to self-manage their health, improving their health knowledge, engagement, and capacity to contribute to their own care decisions. However, there are few solutions for sharing and presenting patients' mHealth data with health care providers (HCPs) in a mutually understandable way, which limits the potential of shared decision making. OBJECTIVE: Through a six-month mixed method feasibility study in Norway, we aim to explore the impacts that a system for sharing patient-gathered data from mHealth devices has on patients and HCPs during diabetes consultations. METHODS: Patients with diabetes will be recruited through their HCPs. Participants will use the Diabetes Diary mobile phone app to register and review diabetes self-management data and share these data during diabetes consultations using the FullFlow data-sharing system. The primary outcome is the feasibility of the system, which includes HCP impressions and expectations (prestudy survey), usability (System Usability Scale), functionalities used and data shared during consultations, and study-end focus group meetings. Secondary outcomes include a change in the therapeutic relationship, patient empowerment and wellness, health parameters (HbA1c and blood pressure), and the patients' own app-registered health measures (blood glucose, medication, physical activity, diet, and weight). We will compare measures taken at baseline and at six months, as well as data continuously gathered from the app. Analysis will aim to explain which measures have changed and how and why they have changed during the intervention. RESULTS: The Full Flow project is funded for 2016 to 2020 by the Research Council of Norway (number 247974/O70). We approached 14 general practitioner clinics (expecting to recruit 1-2 general practitioners per clinic) and two hospitals (expecting to recruit 2-3 nurses per hospital). By recruiting through the HCPs, we expect to recruit 74 patients with type 2 and 33 patients with type 1 diabetes. Between November 2018 and July 2019, we recruited eight patients and 15 HCPs. During 2020, we aim to analyze and publish the results of the collected data from our patient and HCP participants. CONCLUSIONS: We expect to better understand what is needed to be able to share data. This includes potential benefits that sharing patient-gathered data during consultations will have on patients and HCPs, both individually and together. By measuring these impacts, we will be able to present the possibilities and challenges related to a system for sharing mHealth data for future interventions and practice. Results will also demonstrate what needs to be done to make this collaboration between HCPs and patients successful and subsequently further improve patients' health and engagement in their care.

Dataset of wearable sensors with possibilities for data exchange.

We performed a search to identify available wearable sensors systems that can collect patient health data and have data sharing capabilities. Findings available in "Wearable sensors with possibilities for data exchange: Analyzing status and needs of different actors in mobile health monitoring systems" [1]. We performed an initial search of the Vandrico wearable database, and supplemented the resulting device list with an internet search. In addition to relevant meta-data (i.e. name, description, manufacturer, web-link, etc.) for each device, we also collected data on 13 attributes related to data exchange. I.e. device type, communication interface, data transfer protocol, smartphone and/or PC integration, direct integration to open health platform, 3rd platform integration with open health platform, support for health care system/middleware connection, recorded health data types, integrated sensors, medical device certification, whether or not the use can access collected data, device developer access, and device availability on the market. In addition, we grouped each device into three groups of actors that these devices are relevant for: electronic health record providers, software developers, and patients. The collected data can be used as an overview of available devices for future researchers with interest in the mobile health (mHealth) area.

Wearable sensors with possibilities for data exchange: Analyzing status and needs of different actors in mobile health monitoring systems.

BACKGROUND: Wearable devices with an ability to collect various type of physiological data are increasingly becoming seamlessly integrated into everyday life of people. In the area of electronic health (eHealth), many of these devices provide remote transfer of health data, as a result of the increasing need for ambulatory monitoring of patients. This has a potential to reduce the cost of care due to prevention and early detection. OBJECTIVE: The objective of this study was to provide an overview of available wearable sensor systems with data exchange possibilities. Due to the heterogeneous capabilities these systems possess today, we aimed to systematize this in terms of usage, where there is a need of, or users benefit from, transferring self-collected data to health care actors. METHODS: We searched for and reviewed relevant sensor systems (i.e., devices) and mapped these into 13 selected attributes related to data-exchange capabilities. We collected data from the Vandrico database of wearable devices, and complemented the information with an additional internet search. We classified the following attributes of devices: type, communication interfaces, data protocols, smartphone/PC integration, connection to smartphone health platforms, 3rd party integration with health platforms, connection to health care system/middleware, type of gathered health data, integrated sensors, medical device certification, access to user data, developer-access to device, and market status. Devices from the same manufacturer with similar functionalities/characteristics were identified under the same device family. Furthermore, we classified the systems in three subgroups of relevance for different actors in mobile health monitoring systems: EHR providers, software developers, and patient users. RESULTS: We identified 362 different mobile health monitoring devices belonging to 193 device families. Based on an analysis of these systems, we identified the following general challenges: CONCLUSIONS: Few of the identified mobile health monitoring systems use standardized, open communication protocols, which would allow the user to directly acquire sensor data. Use of open protocols can provide mobile health (mHealth) application developers an alternative to proprietary cloud services and communication tools, which are often closely integrated with the devices. Emerging new types of sensors, often intended for everyday use, have a potential to supplement health records systems with data that can enrich patient care.

Possible Usages of Smart Contracts (Blockchain) in Healthcare and Why No One Is Using Them.

Security, privacy, transparency, consent, and data sharing are major challenges that healthcare institutions must address today. The explosion of the Internet of Things (IoT), the enactment of the General Data Protection Regulation (GDPR), the growing trend of patients self-managing their diseases, and the eagerness of patients to share their self-collected health data with primary and secondary health organisations further increase the complexity of these challenges. Smart contracts, based on blockchain technology, can be a legitimate approach for addressing these challenges. Smart contracts define rules and penalties in an agreement, enforce those rules, and render them irrevocable. This paper presents a state-of-the-art review (as of May 2018) of the possible usages of smart contracts in healthcare and focuses on data sharing between patients, doctors, and institutions.

Design and Prestudy Assessment of a Dashboard for Presenting Self-Collected Health Data of Patients With Diabetes to Clinicians: Iterative Approach and Qualitative Case Study.

BACKGROUND: Introducing self-collected health data from patients with diabetes into consultation can be beneficial for both patients and clinicians. Such an initiative can allow patients to be more proactive in their disease management and clinicians to provide more tailored medical services. Optimally, electronic health record systems (EHRs) should be able to receive self-collected health data in a standard representation of medical data such as Fast Healthcare Interoperability Resources (FHIR), from patients systems like mobile health apps and display the data directly to their users-the clinicians. However, although Norwegian EHRs are working on implementing FHIR, no solution or graphical interface is available today to display self-collected health data. OBJECTIVE: The objective of this study was to design and assess a dashboard for displaying relevant self-collected health data from patients with diabetes to clinicians. METHODS: The design relied on an iterative participatory process involving workshops with patients, clinicians, and researchers to define which information should be available and how it should be displayed. The assessment is based on a case study, presenting an instance of the dashboard populated with data collected from one patient with diabetes type 1 (in-house researcher) face-to-face by 14 clinicians. We performed a qualitative analysis based on usability, functionality, and expectation by using responses to questionnaires that were distributed to the 14 clinicians at the end of the workshops and collected before the participants left. The qualitative assessment was guided by the Standards for Reporting Qualitative Research. RESULTS: We created a dashboard permitting clinicians to assess the reliability of self-collected health data, list all collected data including medical calculations, and highlight medical situations that need to be investigated to improve the situation of the patients. The dashboard uses a combination of tables, graphs, and other visual representations to display the relevant information. Clinicians think that this type of solution will be useful during consultations every day, especially for patients living in remote areas or those who are technologically interested. CONCLUSIONS: Displaying self-collected health data during consultations is not enough for clinicians; the data reliability has to be assured and the relevant information needs to be extracted and displayed along with the data to ease the introduction during a medical encounter. The prestudy assessment showed that the system provides relevant information to meet clinicians' need and that clinicians were eager to start using it during consultations. The system has been under testing in a medical trial since November 2018, and the first results of its assessment in a real-life situation are expected in the beginning of next year (2020).

Design and Development of a Context-Aware Knowledge-Based Module for Identifying Relevant Information and Information Gaps in Patients With Type 1 Diabetes Self-Collected Health Data.

BACKGROUND: Patients with diabetes use an increasing number of self-management tools in their daily life. However, health institutions rarely use the data generated by these services mainly due to (1) the lack of data reliability, and (2) medical workers spending too much time extracting relevant information from the vast amount of data produced. This work is part of the FullFlow project, which focuses on self-collected health data sharing directly between patients' tools and EHRs. OBJECTIVE: The main objective is to design and implement a prototype for extracting relevant information and documenting information gaps from self-collected health data by patients with type 1 diabetes using a context-aware approach. The module should permit (1) clinicians to assess the reliability of the data and to identify issues to discuss with their patients, and (2) patients to understand the implication their lifestyle has on their disease. METHODS: The identification of context and the design of the system relied on (1) 2 workshops in which the main author participated, 1 patient with type 1 diabetes, and 1 clinician, and (2) a co-design session involving 5 patients with type 1 diabetes and 4 clinicians including 2 endocrinologists and 2 diabetes nurses. The software implementation followed a hybrid agile and waterfall approach. The testing relied on load, and black and white box methods. RESULTS: We created a context-aware knowledge-based module able to (1) detect potential errors, and information gaps from the self-collected health data, (2) pinpoint relevant data and potential causes of noticeable medical events, and (3) recommend actions to follow to improve the reliability of the data issues and medical issues to be discussed with clinicians. The module uses a reasoning engine following a hypothesize-and-test strategy built on a knowledge base and using contextual information. The knowledge base contains hypotheses, rules, and plans we defined with the input of medical experts. We identified a large set of contextual information: emotional state (eg, preferences, mood) of patients and medical workers, their relationship, their metadata (eg, age, medical specialty), the time and location of usage of the system, patient-collected data (eg, blood glucose, basal-bolus insulin), patients' goals and medical standards (eg, insulin sensitivity factor, in range values). Demonstrating the usage of the system revealed that (1) participants perceived the system as useful and relevant for consultation, and (2) the system uses less than 30 milliseconds to treat new cases. CONCLUSIONS: Using a knowledge-based system to identify anomalies concerning the reliability of patients' self-collected health data to provide information on potential information gaps and to propose relevant medical subjects to discuss or actions to follow could ease the introduction of self-collected health data into consultation. Combining this reasoning engine and the system of the FullFlow project could improve the diagnostic process in health care.