Evaluating the impact of physical activity apps and wearables: interdisciplinary review

Background: Although many smartphone apps and wearables have been designed to improve physical activity, their rapidly evolving nature and complexity present challenges for evaluating their impact. Traditional methodologies, such as randomized controlled trials (RCTs), can be slow. To keep pace with rapid technological development, evaluations of mobile health technologies must be efficient. Rapid alternative research designs have been proposed, and efficient in-app data collection methods, including in-device sensors and device-generated logs, are available. Along with effectiveness, it is important to measure engagement (ie, users’ interaction and usage behavior) and acceptability (ie, users’ subjective perceptions and experiences) to help explain how and why apps and wearables work. Objectives: This study aimed to (1) explore the extent to which evaluations of physical activity apps and wearables: employ rapid research designs; assess engagement, acceptability, as well as effectiveness; use efficient data collection methods; and (2) describe which dimensions of engagement and acceptability are assessed. Method: An interdisciplinary scoping review using 8 databases from health and computing sciences. Included studies measured physical activity, and evaluated physical activity apps or wearables that provided sensor-based feedback. Results were analyzed using descriptive numerical summaries, chi-square testing, and qualitative thematic analysis. Results: A total of 1829 abstracts were screened, and 858 articles read in full. Of 111 included studies, 61 (55.0%) were published between 2015 and 2017. Most (55.0%, 61/111) were RCTs, and only 2 studies (1.8%) used rapid research designs: 1 single-case design and 1 multiphase optimization strategy. Other research designs included 23 (22.5%) repeated measures designs, 11 (9.9%) nonrandomized group designs, 10 (9.0%) case studies, and 4 (3.6%) observational studies. Less than one-third of the studies (32.0%, 35/111) investigated effectiveness, engagement, and acceptability together. To measure physical activity, most studies (90.1%, 101/111) employed sensors (either in-device [67.6%, 75/111] or external [23.4%, 26/111]). RCTs were more likely to employ external sensors (accelerometers: P=.005). Studies that assessed engagement (52.3%, 58/111) mostly used device-generated logs (91%, 53/58) to measure the frequency, depth, and length of engagement. Studies that assessed acceptability (57.7%, 64/111) most often used questionnaires (64%, 42/64) and/or qualitative methods (53%, 34/64) to explore appreciation, perceived effectiveness and usefulness, satisfaction, intention to continue use, and social acceptability. Some studies (14.4%, 16/111) assessed dimensions more closely related to usability (ie, burden of sensor wear and use, interface complexity, and perceived technical performance). Conclusions: The rapid increase of research into the impact of physical activity apps and wearables means that evaluation guidelines are urgently needed to promote efficiency through the use of rapid research designs, in-device sensors and user-logs to assess effectiveness, engagement, and acceptability. Screening articles was time-consuming because reporting across health and computing sciences lacked standardization. Reporting guidelines are therefore needed to facilitate the synthesis of evidence across disciplines

Audit-based Compliance Control (AC2) for EHR Systems

Traditionally, medical data is stored and processed using paper-based files. Recently, medical facilities have started to store, access and exchange medical data in digital form. The drivers for this change are mainly demands for cost reduction, and higher quality of health care. The main concerns when dealing with medical data are availability and confidentiality. Unavailability (even temporary) of medical data is expensive. Physicians may not be able to diagnose patients correctly, or they may have to repeat exams, adding to the overall costs of health care. In extreme cases availability of medical data can even be a matter of life or death. On the other hand, confidentiality of medical data is also important. Legislation requires medical facilities to observe the privacy of the patients, and states that patients have a final say on whether or not their medical data can be processed or not. Moreover, if physicians, or their EHR systems, are not trusted by the patients, for instance because of frequent privacy breaches, then patients may refuse to submit (correct) information, complicating the work of the physicians greatly. \ud \ud In traditional data protection systems, confidentiality and availability are conflicting requirements. The more data protection methods are applied to shield data from outsiders the more likely it becomes that authorized persons will not get access to the data in time. Consider for example, a password verification service that is temporarily not available, an access pass that someone forgot to bring, and so on. In this report we discuss a novel approach to data protection, Audit-based Compliance Control (AC2), and we argue that it is particularly suited for application in EHR systems. In AC2, a-priori access control is minimized to the mere authentication of users and objects, and their basic authorizations. More complex security procedures, such as checking user compliance to policies, are performed a-posteriori by using a formal and automated auditing mechanism. To support our claim we discuss legislation concerning the processing of health records, and we formalize a scenario involving medical personnel and a basic EHR system to show how AC2 can be used in practice. \ud \ud This report is based on previous work (Dekker & Etalle 2006) where we assessed the applicability of a-posteriori access control in a health care scenario. A more technically detailed article about AC2 recently appeared in the IJIS journal, where we focussed however on collaborative work environments (Cederquist, Corin, Dekker, Etalle, & Hartog, 2007). In this report we first provide background and related work before explaining the principal components of the AC2 framework. Moreover we model a detailed EHR case study to show its operation in practice. We conclude by discussing how this framework meets current trends in healthcare and by highlighting the main advantages and drawbacks of using an a-posteriori access control mechanism as opposed to more traditional access control mechanisms

Human Factors Standards and the Hard Human Factor Problems: Observations on Medical Usability Standards

With increasing variety and sophistication of computer-based medical devices, and more diverse users and use environments, usability is essential, especially to ensure safety. Usability standards and guidelines play an important role. We reviewed several, focusing on the IEC 62366 and 60601 sets. It is plausible that these standards have reduced risks for patients, but we raise concerns regarding: (1) complex design trade-offs that are not addressed, (2) a focus on user interface design (e.g., making alarms audible) to the detriment of other human factors (e.g., ensuring users actually act upon alarms they hear), and (3) some definitions and scope restrictions that may create “blind spots”. We highlight potential related risks, e.g. that clear directives on “easier to understand” risks, though useful, may preclude mitigating other, more “difficult” ones; but ask to what extent these negative effects can be avoided by standard writers, given objective constraints. Our critique is motivated by current research and incident reports, and considers standards from other domains and countries. It is meant to highlight problems, relevant to designers, standards committees, and human factors researchers, and to trigger discussion about the potential and limits of standards

Heart Failure Monitoring System Based on Wearable and Information Technologies

In Europe, Cardiovascular Diseases (CVD) are the leading source of death, causing 45% of all deceases. Besides, Heart Failure, the paradigm of CVD, mainly affects people older than 65. In the current aging society, the European MyHeart Project was created, whose mission is to empower citizens to fight CVD by leading a preventive lifestyle and being able to be diagnosed at an early stage. This paper presents the development of a Heart Failure Management System, based on daily monitoring of Vital Body Signals, with wearable and mobile technologies, for the continuous assessment of this chronic disease. The System makes use of the latest technologies for monitoring heart condition, both with wearable garments (e.g. for measuring ECG and Respiration); and portable devices (such as Weight Scale and Blood Pressure Cuff) both with Bluetooth capabilitie

Emotions in context: examining pervasive affective sensing systems, applications, and analyses

Pervasive sensing has opened up new opportunities for measuring our feelings and understanding our behavior by monitoring our affective states while mobile. This review paper surveys pervasive affect sensing by examining and considering three major elements of affective pervasive systems, namely; “sensing”, “analysis”, and “application”. Sensing investigates the different sensing modalities that are used in existing real-time affective applications, Analysis explores different approaches to emotion recognition and visualization based on different types of collected data, and Application investigates different leading areas of affective applications. For each of the three aspects, the paper includes an extensive survey of the literature and finally outlines some of challenges and future research opportunities of affective sensing in the context of pervasive computing

Process of designing robust, dependable, safe and secure software for medical devices: Point of care testing device as a case study

This article has been made available through the Brunel Open Access Publishing Fund.Copyright © 2013 Sivanesan Tulasidas et al. This paper presents a holistic methodology for the design of medical device software, which encompasses of a new way of eliciting requirements, system design process, security design guideline, cloud architecture design, combinatorial testing process and agile project management. The paper uses point of care diagnostics as a case study where the software and hardware must be robust, reliable to provide accurate diagnosis of diseases. As software and software intensive systems are becoming increasingly complex, the impact of failures can lead to significant property damage, or damage to the environment. Within the medical diagnostic device software domain such failures can result in misdiagnosis leading to clinical complications and in some cases death. Software faults can arise due to the interaction among the software, the hardware, third party software and the operating environment. Unanticipated environmental changes and latent coding errors lead to operation faults despite of the fact that usually a significant effort has been expended in the design, verification and validation of the software system. It is becoming increasingly more apparent that one needs to adopt different approaches, which will guarantee that a complex software system meets all safety, security, and reliability requirements, in addition to complying with standards such as IEC 62304. There are many initiatives taken to develop safety and security critical systems, at different development phases and in different contexts, ranging from infrastructure design to device design. Different approaches are implemented to design error free software for safety critical systems. By adopting the strategies and processes presented in this paper one can overcome the challenges in developing error free software for medical devices (or safety critical systems).Brunel Open Access Publishing Fund

A Novel Low-Cost Sensor Prototype for Nocturia Monitoring in Older People

Indexación: Scopus.This work was supported in part by CORFO - CENS 16CTTS-66390 through the National Center on Health Information Systems, in part by the National Commission for Scientific and Technological Research (CONICYT) through the program STIC-AMSUD 17STIC-03: ‘‘e-MONITOR âĂŞ Chronic Disease: Ambient Assisted Living and vital teleMONOTORing for e-health,’’ FONDEF ID16I10449 ‘‘Sistema inteligente para la gestión y análisis de la dotación de camas en la red asistencial del sector público,’’ and MEC80170097 ‘‘Red de colaboración científica entre universidades nacionales e internacionales para la estructuración del doctorado y magister en informática médica en la Universidad de Valparaíso.’’ The work of V. H. C. de Albuquerque was supported by the Brazilian National Council for Research and Development (CNPq) under Grant #304315/2017-6.Nocturia is frequently defined as the necessity to get out of bed at least one time during the night to urinate, with each of these episodes being preceded and continued by sleep. Several studies suggest that an increase of nocturia is seen with the onset of age, occurring in around 70% of adults over the age of 70. Its appearance is associated with detrimental quality of life for those who present nocturia, since it leads to daytime sleepiness, cognitive dysfunction, among others. Currently, a voiding diary is necessary for nocturia assessment; these are prone to bias due to their inherent subjectivity. In this paper, we present the design of a low-cost device that automatically detects micturition events. The device obtained 73% in sensibility and 81% in specificity; these results show that systems such as the proposed one can be a valuable tool for the medical team when evaluating nocturia. © 2013 IEEE.https://ieeexplore.ieee.org/document/845445

Data collection methods for task-based information access in molecular medicine

An important area of improving access to health information is the study of task-based information access in the health domain. This is a significant challenge towards developing focused information retrieval (IR) systems. Due to the complexities of this context, its study requires multiple and often tedious means of data collection, which yields a lot of data for analysis, but also allows triangulation so as to increase the reliability of the findings. In addition to traditional means of data collection, such as questionnaires, interviews and observation, there are novel opportunities provided by lifelogging technologies such as the SenseCam. Together they yield an understanding of information needs, the sources used, and their access strategies. The present paper examines the strengths and weaknesses of the traditional and the more novel means of data collection and addresses the challenges in their application in molecular medicine, which intensively uses digital information sources