Distinguishing features in the assessment of mHealth apps

Introduction: The unparalleled surge in digital health adoption during the COVID-19 pandemic has emphasized the potential of mHealth apps. However, the quality of available evidence is generally low, and regulatory frameworks have focused on apps with medical purposes only, overlooking apps with significant interactions with patients that may require stronger oversight. Areas covered: To support this expanded evidence generation process, we identified the reasons that distinguish mHealth apps compared to medical devices at large and that should differentially feature their assessment. mHealth apps are characterized by the iterative nature of the corresponding interventions, frequent user interactions with a non-linear relationship between technology usage, engagement and outcomes, significant organizational implications, as well as challenges associated with genericization, their broad diagnostic potential, and price setting. Expert Opinion: The renewed reliance experienced during the pandemic and the unprecedented injection of resources through recovery instruments can further boost the development of apps. Only robust evidence of the benefits of mHealth apps will persuade health-care professionals and beneficiaries to systematically deploy them. Regulatory bodies will need to question their current approaches by adopting comprehensive evaluation processes that adequately consider the specific features of mHealth apps

Distinguishing features in the assessment of mHealth apps

Introduction: The unparalleled surge in digital health adoption during the COVID-19 pandemic has emphasized the potential of mHealth apps. However, the quality of available evidence is generally low, and regulatory frameworks have focused on apps with medical purposes only, overlooking apps with significant interactions with patients that may require stronger oversight. Areas covered: To support this expanded evidence generation process, we identified the reasons that distinguish mHealth apps compared to medical devices at large and that should differentially feature their assessment. mHealth apps are characterized by the iterative nature of the corresponding interventions, frequent user interactions with a non-linear relationship between technology usage, engagement and outcomes, significant organizational implications, as well as challenges associated with genericization, their broad diagnostic potential, and price setting. Expert Opinion: The renewed reliance experienced during the pandemic and the unprecedented injection of resources through recovery instruments can further boost the development of apps. Only robust evidence of the benefits of mHealth apps will persuade health-care professionals and beneficiaries to systematically deploy them. Regulatory bodies will need to question their current approaches by adopting comprehensive evaluation processes that adequately consider the specific features of mHealth apps

Development features and study characteristics of mobile health apps in the management of chronic conditions:A systematic review of randomised trials

COVID-19 pandemic challenges have accelerated the reliance on digital health fuelling the expanded incorporation of mobile apps into healthcare services, particularly for the management of long-term conditions such as chronic diseases (CDs). However, the impact of health apps on outcomes for CD remains unclear, potentially owing to both the poor adoption of formal development standards in the design process and the methodological quality of studies. A systematic search of randomised trials was performed on Medline, ScienceDirect, the Cochrane Library and Scopus to provide a comprehensive outlook and review the impact of health apps on CD. We identified 69 studies on diabetes (n = 29), cardiovascular diseases (n = 13), chronic respiratory diseases (n = 13), cancer (n = 10) or their combinations (n = 4). The apps rarely adopted developmental factors in the design stage, with only around one-third of studies reporting user or healthcare professional engagement. Apps differed significantly in content, with a median of eight behaviour change techniques adopted, most frequently pertaining to the 'Feedback and monitoring' (91%) and 'Shaping knowledge' (72%) categories. As for the study methodologies, all studies adopted a traditional randomised control trial (RCT) design, with relatively short follow-ups and limited sample sizes. Findings were not significant for the majority of studies across all CD, with most RCTs revealing a high risk of bias. To support the adoption of apps for CD management, this review reinforces the need for more robust development and appropriate study characteristics to sustain evidence generation and elucidate whether study results reflect the true benefits of apps or a biased estimate due to unsuitable designs

Spatial distribution of surface EMG on trapezius and lumbar muscles of violin and cello players in single note playing

Musicians activate their muscles in different patterns, depending on their posture, the instrument being played, and their experience level. Bipolar surface electrodes have been used in the past to monitor such activity, but this method is highly sensitive to the location of the electrode pair. In this work, the spatial distribution of surface EMG (sEMG) of the right trapezius and right and left erector spinae muscles were studied in 16 violin players and 11 cello players. Musicians played their instrument one string at a time in sitting position with/without backrest support. A 64 sEMG electrode (16x4) grid, 10mm inter-electrode distance (IED), was placed over the middle and lower trapezius (MT and LT) of the bowing arm. Two 16x2 electrode grids (IED=10mm) were placed on the left and right erector spinae muscles. Subjects played each of the four strings of the instrument either in large (1bow/s) or detaché tip/tail (8bows/s) bowing in two sessions (two days). In each of two days, measurements were repeated after half an hour of exercise to see the effect of exercise on the muscle activity and signal stability. A “muscle activity index” (MAI) was defined as the spatial average of the segmented active region of the RMS map. Spatial maps were automatically segmented using the watershed algorithm and thresholding. Results showed that, for violin players, sliding the bow upward from the tip toward the tail results in a higher MAI for the trapezius muscle than a downward bow. On the contrary, in cello players, higher MAI is produced in the tail to tip movement. For both instruments, an increasing MAI in the trapezius was observed as the string position became increasingly lateral, from string 1 (most medial) toward string 4 (most lateral). Half an hour of performance did not cause significant differences between the signal quality and the MAI values measured before and after the exercise. The MAI of the left and right erector spinae was smaller in the case of backrest support, especially for violin players. Back muscles of violin and cello players were activated asymmetrically, specifically in fast movements (detaché tip/tail). These findings demonstrate the sensitivity and stability of the technique and justify more extensive investigation following this proof of concept

Recommendations for developing a lifecycle, multidimensional assessment framework for mobile medical apps

Digital health and mobile medical apps (MMAs) have shown great promise in transforming health care, but their adoption in clinical care has been unsatisfactory, and regulatory guidance and coverage decisions have been lacking or incomplete. A multidimensional assessment framework for regulatory, policymaking, health technology assessment, and coverage purposes based on the MMA lifecycle is needed. A targeted review of relevant policy documents from international sources was conducted to map current MMA assessment frameworks, to formulate 10 recommendations, subsequently shared amongst an expert panel of key stakeholders. Recommendations go beyond economic dimensions such as cost and economic evaluation and also include MMA development and update, classification and evidentiary requirements, performance and maintenance monitoring, usability testing, clinical evidence requirements, safety and security, equity considerations, organizational assessment, and additional outcome domains (patient empowerment and environmental impact). The COVID‐19 pandemic greatly expanded the use of MMAs, but temporary policies governing their use and oversight need consolidation through well‐developed frameworks to support decision‐makers, producers and introduction into clinical care processes, especially in light of the strong international, cross‐border character of MMAs, the new EU medical device and health technology assessment regulations, and the Next Generation EU funding earmarked for health digitalization

Gallstones Ileus

The ileus of gallstones is a rare complication of cholelithiasis which occurs in less than 1% of patients and is the cause of 1–4% of cases of obstruction of the small intestine. The pathogenesis involves the formation of a bilioenteric fistula. Abdominal computed tomography (CT) shows pneumobilia, dilated loops of small intestine, and ectopic gallstones that obstruct the intestinal lumen. In literature, enterolithotomy is the most frequently used procedure for the ileum of gallstones. Enterolithotomy plus cholecystectomy and/or fistulectomy are indicated only in selected patients. The clinical signs and symptoms depend on the site of the obstruction and usually include abdominal pain, nausea, and vomiting. The diagnostic test of choice is an abdominal CT scan

La signoria rurale nell’Italia del tardo medioevo, 2, Archivi e poteri feudali nel Mezzogiorno (XIV-XVI sec.).

By studying the archives of the feudal Lords of Southern Italian between the 14th-16th centuries you can understand the real nature of their power and how it was expressed. The volume, which takes into account the most recent historiography, relies on the study and inventory of important documentary collections held in the Archivio di Stato of Naples, such as the Sommaria (Relevi with the files for feudal succession; Dipendenze, I, Conti erariali dei feudi and Diversi, with the seigneurial account books acquired by the State of those lord who had been rebellious or had died without heirs). The authors deal also with the cartularies (‘platee’) of aristocratic dynasties as the Ruffo and the Sanseverino, based in Calabria, and with the parchments of the Albertini from Nola. Thanks to the rich information derived by these archival series and account books, the authors bring new light on the seigneurial powers, the typology of the records produced by and for the Lords, the administration of their estates, the strategy for elaborating the family memory. Studiare gli archivi dei signori rurali del Mezzogiorno d’Italia tra XIV e XV secolo significa cogliere la natura del loro potere, il modo in cui esso si diceva. Il volume, che accoglie le sollecitazioni della storiografia più recente, è fondato sulla repertoriazione di importanti complessi documentari dell’Archivio di Stato di Napoli, fondo Sommaria (Relevi, con i dossier per la successione feudale; Dipendenze, I, Conti erariali dei feudi e Diversi, con registri signorili pervenuti al Fisco per confisca o morte senza eredi). Sono inoltre oggetto di studio i cartulari e le platee calabresi, tipici «libri-archivio» che inglobano repertori più antichi (famiglie Ruffo e Sanseverino), e le pergamene degli Albertini di Nola. La ricchezza informativa dei fondi archivistici e dei registri presi in considerazione consente agli autori di concentrarsi sulla sostanza dei poteri signorili, la tipologia delle scritture prodotte dai signori e per i signori, la loro gestione del patrimonio, le strategie di costruzione della memoria

Mobile health divide between clinicians and patients in cancer care: results from a cross-sectional international survey

Background: Mobile technologies are increasingly being used to manage chronic diseases, including cancer, with the promise of improving the efficiency and effectiveness of care. Among the myriad of mobile technologies in health care, we have seen an explosion of mobile apps. The rapid increase in digital health apps is not paralleled by a similar trend in usage statistics by clinicians and patients. Little is known about how much and in what ways mobile health (mHealth) apps are used by clinicians and patients for cancer care, what variables affect their use of mHealth, and what patients’ and clinicians’ expectations of mHealth apps are. Objective: This study aimed to describe the patient and clinician population that uses mHealth in cancer care and to provide recommendations to app developers and regulators to generally increase the use and efficacy of mHealth apps. Methods: Through a cross-sectional Web-based survey, we explored the current utilization rates of mHealth in cancer care and factors that explain the differences in utilization by patients and clinicians across the United States and 5 different countries in Europe. In addition, we conducted an international workshop with more than 100 stakeholders and a roundtable with key representatives of international organizations of clinicians and patients to solicit feedback on the survey results and develop insights into mHealth app development practices. Results: A total of 1033 patients and 1116 clinicians participated in the survey. The proportion of cancer patients using mHealth (294/1033, 28.46%) was far lower than that of clinicians (859/1116, 76.97%). Accounting for age and salary level, the marginal probabilities of use at means are still significantly different between the 2 groups and were 69.8% for clinicians and 38.7% for patients using the propensity score–based regression adjustment with weighting technique. Moreover, our analysis identified a gap between basic and advanced users, with a prevalent use for activities related to the automation of processes and the interaction with other individuals and a limited adoption for side-effect management and compliance monitoring in both groups. Conclusions: mHealth apps can provide access to clinical and economic data that are low cost, easy to access, and personalized. The benefits can go as far as increasing patients’ chances of overall survival. However, despite its potential, evidence on the actual use of mobile technologies in cancer care is not promising. If the promise of mHealth is to be fulfilled, clinician and patient usage rates will need to converge. Ideally, cancer apps should be designed in ways that strengthen the patient-physician relationship, ease physicians’ workload, be tested for validity and effectiveness, and fit the criteria for reimbursement

An electronic patient-reported outcome mobile app for data collection in type a hemophilia:Design and usability study

BACKGROUND: There is currently limited evidence on the level and intensity of physical activity in individuals with hemophilia A. Mobile technologies can offer a rigorous and reliable alternative to support data collection processes but they are often associated with poor user retention. The lack of longitudinal continuity in their use can be partly attributed to the insufficient consideration of stakeholder inputs in the development process of mobile apps. Several user-centered models have been proposed to guarantee that a thorough knowledge of the end user needs is considered in the development process of mobile apps. OBJECTIVE: The aim of this study is to design and validate an electronic patient-reported outcome mobile app that requires sustained active input by individuals during POWER, an observational study that aims at evaluating the relationship between physical activity levels and bleeding in patients with hemophilia A. METHODS: We adopted a user-centered design and engaged several stakeholders in the development and usability testing of this mobile app. During the concept generation and ideation phase, we organized a need-assessment focus group (FG) with patient representatives to elicit specific design requirements for the end users. We then conducted 2 exploratory FGs to seek additional inputs for the app’s improvement and 2 confirmatory FGs to validate the app and test its usability in the field through the mobile health app usability questionnaire. RESULTS: The findings from the thematic analysis of the need-assessment FG revealed that there was a demand for sense making, for simplification of app functionalities, for maximizing integration, and for minimizing the feeling of external control. Participants involved in the later stages of the design refinement contributed to improving the design further by upgrading the app’s layout and making the experience with the app more efficient through functions such as chatbots and visual feedback on the number of hours a wearable device had been worn, to ensure that the observed data were actually registered. The end users rated the app highly during the quantitative assessment, with an average mobile health app usability questionnaire score of 5.32 (SD 0.66; range 4.44-6.23) and 6.20 (SD 0.43; range 5.72-6.88) out of 7 in the 2 iterative usability testing cycles. CONCLUSIONS: The results of the usability test indicated a high, growing satisfaction with the electronic patient-reported outcome app. The adoption of a thorough user-centered design process using several types of FGs helped maximize the likelihood of sustained retention of the app’s users and made it fit for data collection of relevant outcomes in the observational POWER study. The continuous use of the app and the actual level of engagement will be evaluated during the ongoing trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT04165135; https://clinicaltrials.gov/ct2/show/NCT0416513