Patient-led teledermatology for skin lesion triage: a service evaluation of the DyplensTM dermoscope.

Despite the huge improvement in smartphone cameras, there has not been any real interest in the UK in pursuing patient-facing teledermatology within the sphere of skin lesion triage. High-specification dermoscopic images can be generated with smartphone attachments, but, to date, no formal clinical trial has been performed to establish the efficacy and feasibility of these consumer-level dermoscopes in skin lesion triage. The objectives of this study were to assess the ability of patients to capture dermoscopic images using a smartphone attachment, and to identify the safety and diagnostic accuracy of consumer-level dermoscopy in triaging out benign skin lesions from the 2-week-wait (2WW) cancer pathway. We recruited 78 patients already attending a face-to-face clinic at two locations. They were provided with instruction leaflets and asked to obtain dermoscopic and macroscopic images of their lesion(s) using their own smartphones. The images (and a brief history) were distributed to five experienced blinded assessors (consultants), who were asked to state their working diagnosis and outcome (reassurance, routine review or 2WW pathway), as they would in teledermatology. We compared their outcomes to the gold-standard in-person diagnosis and/or histological diagnosis, where available. The device achieved 100% sensitivity in diagnosing melanoma and squamous cell carcinoma (SCC). The specificity for the diagnoses of melanoma (89%) and SCC (83%) was high. The overall diagnostic accuracy was 77% for both benign and malignant lesions, The diagnostic accuracy was high for seborrhoeic keratosis (91%) and simple naevi (81%). Patient-captured dermoscopic images using bespoke smartphone attachments could be the future in safely triaging out benign lesions.

Feasibility and acceptability of measuring prenatal stress in daily life using smartphone-based ecological momentary assessment and wearable physiological monitors.

High levels of stress during pregnancy can have lasting effects on maternal and offspring health, which disproportionately impacts families facing financial strain, systemic racism, and other forms of social oppression. Developing ways to monitor daily life stress during pregnancy is important for reducing stress-related health disparities. We evaluated the feasibility and acceptability of using mobile health (mHealth) technology (i.e., wearable biosensors, smartphone-based ecological momentary assessment) to measure prenatal stress in daily life. Fifty pregnant women (67% receiving public assistance; 70% Black, 6% Multiracial, 24% White) completed 10 days of ambulatory assessment, in which they answered smartphone-based surveys six times a day and wore a chest-band device (movisens EcgMove4) to monitor their heart rate, heart rate variability, and activity level. Feasibility and acceptability were evaluated using behavioral meta-data and participant feedback. Findings supported the feasibility and acceptability of mHealth methods: Participants answered approximately 75% of the surveys per day and wore the device for approximately 10 hours per day. Perceived burden was low. Notably, participants with higher reported stressors and financial strain reported lower burden associated with the protocol than participants with fewer life stressors, highlighting the feasibility of mHealth technology for monitoring prenatal stress among pregnant populations living with higher levels of contextual stressors. Findings support the use of mHealth technology to measure prenatal stress in real-world, daily life settings, which shows promise for informing scalable, technology-assisted interventions that may help to reduce health disparities by enabling more accessible and comprehensive care during pregnancy.

Media Use Behavior Mediates the Association Between Family Health and Intention to Use Mobile Health Devices Among Older Adults: Cross-Sectional Study.

BACKGROUND: With the advent of a new era for health and medical treatment, characterized by the integration of mobile technology, a significant digital divide has surfaced, particularly in the engagement of older individuals with mobile health (mHealth). The health of a family is intricately connected to the well-being of its members, and the use of media plays a crucial role in facilitating mHealth care. Therefore, it is important to examine the mediating role of media use behavior in the connection between the family health of older individuals and their inclination to use mHealth devices. OBJECTIVE: This study aims to investigate the impact of family health and media use behavior on the intention of older individuals to use mHealth devices in China. The study aims to delve into the intricate dynamics to determine whether media use behavior serves as a mediator in the relationship between family health and the intention to use mHealth devices among older adults. The ultimate goal is to offer well-founded and practical recommendations to assist older individuals in overcoming the digital divide. METHODS: The study used data from 3712 individuals aged 60 and above, sourced from the 2022 Psychology and Behavior Investigation of Chinese Residents study. Linear regression models were used to assess the relationships between family health, media use behavior, and the intention to use mHealth devices. To investigate the mediating role of media use behavior, we used the Sobel-Goodman Mediation Test. This analysis focused on the connection between 4 dimensions of family health and the intention to use mHealth devices. RESULTS: A positive correlation was observed among family health, media use behavior, and the intention to use mHealth devices (r=0.077-0.178, P<.001). Notably, media use behavior was identified as a partial mediator in the relationship between the overall score of family health and the intention to use mHealth devices, as indicated by the Sobel test (z=5.451, P<.001). Subgroup analysis further indicated that a complete mediating effect was observed specifically between family health resources and the intention to use mHealth devices in older individuals with varying education levels. CONCLUSIONS: The study revealed the significance of family health and media use behavior in motivating older adults to adopt mHealth devices. Media use behavior was identified as a mediator in the connection between family health and the intention to use mHealth devices, with more intricate dynamics observed among older adults with lower education levels. Going forward, the critical role of home health resources must be maximized, such as initiatives to develop digital education tailored for older adults and the creation of media products specifically designed for them. These measures aim to alleviate technological challenges associated with using media devices among older adults, ultimately bolstering their inclination to adopt mHealth devices.

Oral hygiene changes & compliance with telemonitoring device in individuals with intellectual/developmental disabilities: a randomized controlled crossover trial.

OBJECTIVE: Advances in mobile technology are helping with health management practices, and smart toothbrushes provide proper dental care by collecting and analyzing users' toothbrushing data. The purpose of this study is to assess the effect of a telemonitoring device on oral hygiene management in individuals with intellectual or developmental disabilities and its role in promoting oral health. MATERIALS AND METHODS: Participants were split into two groups: one initially using the telemonitoring device (telemonitoring device/manual toothbrush) and the other using it later (manual toothbrush/telemonitoring device), with a one-month washout period. The study compared plaque index, halitosis, changes in oral microbiota, and guardian questionnaire responses between the groups. RESULTS: In period 1, the QHI index score significantly decreased from 1.93 to 0.83 in the group using the remote monitoring device, compared to an increase from 1.75 to 2.01 in the manual toothbrush group. Additionally, toothbrushing frequency, time, and cooperation increased by 0.82 ± 0.60, 0.82 ± 1.16, and 1.09 ± 0.94, respectively, with initial telemonitoring device use. However, these measures decreased by -1.45 ± 0.68, -1.09 ± 0.70, and - 1.00 ± 1.00 after switching to a manual toothbrush, and decreased by -0.64 ± 0.67, -0.27 ± 1.19, and 0.09 ± 0.94 overall, respectively. However, there were no significant differences in oral microbiota between the groups at these different time points. CONCLUSIONS: The study shows that telemonitoring devices effectively reduce plaque index and improve toothbrushing frequency, time, and cooperation. However, these benefits decrease after switching to a manual toothbrush. Follow-up is needed to assess satisfaction and compliance with telemonitoring device use. CLINICAL RELEVANCE: Using telemonitoring devices in the oral health management of individuals with intellectual and developmental disabilities can improve their oral health quality.

RADAR-IoT: An Open-Source, Interoperable, and Extensible IoT Gateway Framework for Health Research.

IoT sensors offer a wide range of sensing capabilities, many of which have potential health applications. Existing solutions for IoT in healthcare have notable limitations, such as closed-source, limited I/O protocols, limited cloud platform support, and missing specific functionality for health use cases. Developing an open-source internet of things (IoT) gateway solution that addresses these limitations and provides reliability, broad applicability, and utility is highly desirable. Combining a wide range of sensor data streams from IoT devices with ambulatory mHealth data would open up the potential to provide a detailed 360-degree view of the relationship between patient physiology, behavior, and environment. We have developed RADAR-IoT as an open-source IoT gateway framework, to harness this potential. It aims to connect multiple IoT devices at the edge, perform limited on-device data processing and analysis, and integrate with cloud-based mobile health platforms, such as RADAR-base, enabling real-time data processing. We also present a proof-of-concept data collection from this framework, using prototype hardware in two locations. The RADAR-IoT framework, combined with the RADAR-base mHealth platform, provides a comprehensive view of a user's health and environment by integrating static IoT sensors and wearable devices. Despite its current limitations, it offers a promising open-source solution for health research, with potential applications in managing infection control, monitoring chronic pulmonary disorders, and assisting patients with impaired motor control or cognitive ability.

Validation of an mHealth System for Monitoring Fundamental Physiological Parameters in the Clinical Setting.

The aim of this work was to validate the measurements of three physiological parameters, namely, body temperature, heart rate, and peripheral oxygen saturation, captured with an out-of-the-lab device using measurements taken with clinically proven devices. The out-of-the-lab specialized device was integrated into a customized mHealth application, e-CoVig, developed within the AIM Health project. To perform the analysis, single consecutive measurements of the three vital parameters obtained with e-CoVig and with the standard devices from patients in an intensive care unit were collected, preprocessed, and then analyzed through classical agreement analysis, where we used Lin's concordance coefficient to assess the agreement correlation and Bland-Altman plots with exact confidence intervals for the limits of agreement to analyze the paired data readings. The existence of possible systematic errors was also addressed, where we found the presence of additive errors, which were corrected, and weak proportional biases. We obtained the mean overall agreement between the measurements taken with the novel e-CoVig device and the reference devices for the measured quantities. Although some limitations in this study were encountered, we present more advanced methods for their further assessment.

Advances in Portable and Wearable Acoustic Sensing Devices for Human Health Monitoring.

The practice of auscultation, interpreting body sounds to assess organ health, has greatly benefited from technological advancements in sensing and electronics. The advent of portable and wearable acoustic sensing devices marks a significant milestone in telemedicine, home health, and clinical diagnostics. This review summarises the contemporary advancements in acoustic sensing devices, categorized based on varied sensing principles, including capacitive, piezoelectric, and triboelectric mechanisms. Some representative acoustic sensing devices are introduced from the perspective of portability and wearability. Additionally, the characteristics of sound signals from different human organs and practical applications of acoustic sensing devices are exemplified. Challenges and prospective trends in portable and wearable acoustic sensors are also discussed, providing insights into future research directions.

IoT-Based Heartbeat Rate-Monitoring Device Powered by Harvested Kinetic Energy.

Remote patient-monitoring systems are helpful since they can provide timely and effective healthcare facilities. Such online telemedicine is usually achieved with the help of sophisticated and advanced wearable sensor technologies. The modern type of wearable connected devices enable the monitoring of vital sign parameters such as: heart rate variability (HRV) also known as electrocardiogram (ECG), blood pressure (BLP), Respiratory rate and body temperature, blood pressure (BLP), respiratory rate, and body temperature. The ubiquitous problem of wearable devices is their power demand for signal transmission; such devices require frequent battery charging, which causes serious limitations to the continuous monitoring of vital data. To overcome this, the current study provides a primary report on collecting kinetic energy from daily human activities for monitoring vital human signs. The harvested energy is used to sustain the battery autonomy of wearable devices, which allows for a longer monitoring time of vital data. This study proposes a novel type of stress- or exercise-monitoring ECG device based on a microcontroller (PIC18F4550) and a Wi-Fi device (ESP8266), which is cost-effective and enables real-time monitoring of heart rate in the cloud during normal daily activities. In order to achieve both portability and maximum power, the harvester has a small structure and low friction. Neodymium magnets were chosen for their high magnetic strength, versatility, and compact size. Due to the non-linear magnetic force interaction of the magnets, the non-linear part of the dynamic equation has an inverse quadratic form. Electromechanical damping is considered in this study, and the quadratic non-linearity is approximated using MacLaurin expansion, which enables us to find the law of motion for general case studies using classical methods for dynamic equations and the suitable parameters for the harvester. The oscillations are enabled by applying an initial force, and there is a loss of energy due to the electromechanical damping. A typical numerical application is computed with Matlab 2015 software, and an ODE45 solver is used to verify the accuracy of the method.

An Evaluation of e-Health Service Performance through the Integration of 5G IoT, Fog, and Cloud Computing.

In recent years, Internet of Things (IoT) advancements have led to the development of vastly improved remote healthcare services. Scalability, high bandwidth, low latency, and low power consumption are all essential features of the applications that make these services possible. An upcoming healthcare system and wireless sensor network that can fulfil these needs is based on fifth-generation network slicing. For better resource management, organizations can implement network slicing, which partitions the physical network into distinct logical slices according to quality of service (QoS) needs. Based on the findings of this research, an IoT-fog-cloud architecture is proposed for use in e-Health services. The framework is made up of three different but interconnected systems: a cloud radio access network, a fog computing system, and a cloud computing system. A queuing network serves as a model for the proposed system. The model's constituent parts are then subjected to analysis. To assess the system's performance, we run a numerical example simulation using Java modelling tools and then analyze the results to identify the key performance parameters. The analytical formulas that were derived ensure the precision of the results. Finally, the results show that the proposed model improves eHealth services' quality of service in an efficient way by selecting the right slice compared to the traditional systems.

Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation.

BACKGROUND: Optical sensors on wearable devices can detect irregular pulses. The ability of a smartwatch application (app) to identify atrial fibrillation during typical use is unknown. METHODS: Participants without atrial fibrillation (as reported by the participants themselves) used a smartphone (Apple iPhone) app to consent to monitoring. If a smartwatch-based irregular pulse notification algorithm identified possible atrial fibrillation, a telemedicine visit was initiated and an electrocardiography (ECG) patch was mailed to the participant, to be worn for up to 7 days. Surveys were administered 90 days after notification of the irregular pulse and at the end of the study. The main objectives were to estimate the proportion of notified participants with atrial fibrillation shown on an ECG patch and the positive predictive value of irregular pulse intervals with a targeted confidence interval width of 0.10. RESULTS: We recruited 419,297 participants over 8 months. Over a median of 117 days of monitoring, 2161 participants (0.52%) received notifications of irregular pulse. Among the 450 participants who returned ECG patches containing data that could be analyzed - which had been applied, on average, 13 days after notification - atrial fibrillation was present in 34% (97.5% confidence interval [CI], 29 to 39) overall and in 35% (97.5% CI, 27 to 43) of participants 65 years of age or older. Among participants who were notified of an irregular pulse, the positive predictive value was 0.84 (95% CI, 0.76 to 0.92) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular pulse notification and 0.71 (97.5% CI, 0.69 to 0.74) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular tachogram. Of 1376 notified participants who returned a 90-day survey, 57% contacted health care providers outside the study. There were no reports of serious app-related adverse events. CONCLUSIONS: The probability of receiving an irregular pulse notification was low. Among participants who received notification of an irregular pulse, 34% had atrial fibrillation on subsequent ECG patch readings and 84% of notifications were concordant with atrial fibrillation. This siteless (no on-site visits were required for the participants), pragmatic study design provides a foundation for large-scale pragmatic studies in which outcomes or adherence can be reliably assessed with user-owned devices. (Funded by Apple; Apple Heart Study ClinicalTrials.gov number, NCT03335800.).

The effect of a decision-support mHealth application on maternal and neonatal outcomes in two district hospitals in Rwanda: pre - post intervention study.

BACKGROUND: Globally, mobile health (mHealth) applications are known for their potential to improve healthcare providers' access to relevant and reliable health information. Besides, electronic decision support tools, such as the Safe Delivery mHealth Application (SDA), may help to reduce clinical errors and to ensure quality care at the point of service delivery. The current study investigated the use of the SDA and its relationship to basic emergency obstetric and newborn care (BEmONC) outcomes for the most frequent complications in Rwanda; post-partum haemorrhage (PPH) and newborn asphyxia. METHODS: The study adopted a pre-post intervention design. A pre-intervention record review of BEmONC outcomes: Apgar score and PPH progressions, was conducted for 6 months' period (February 2019 - July 2019). The intervention took place in two district hospitals in Rwanda and entails the implementation of the SDA for 6 months (October 2019- March 2020), and included 54 nurses and midwives using the SDA to manage PPH and neonatal resuscitation. Six months' post-SDA intervention, the effect of the SDA on BEmONC outcomes was evaluated. The study included 327 participants (114 cases of PPH and 213 cases of neonatal complications). The analysis compared the outcome variables between the baseline and the endline data. Fisher's exact test was used to compare the proportions and test between-group differences and significance level set at p < 0.05. RESULTS: Unstable newborn outcomes following neonatal resuscitation were recorded in 62% newborns cases at baseline and 28% newborns cases at endline, P-value = 0.000. Unstable maternal outcomes following PPH management were recorded in 19% maternal cases at baseline and 6% maternal cases at endline, P-value = 0.048. There was a significant association between the SDA intervention and newborns' and maternal' outcomes following neonatal resuscitation and PPH management, 6 months after baseline. CONCLUSION: The use of the SDA supported nurses and midwives in the management of PPH and neonatal resuscitation which may have contributed to improved maternal and neonatal outcomes during 6 months of the SDA intervention. The findings of this study are promising as they contribute to a broader knowledge about the effectiveness of SDA in low and middle income hospital settings.

The effect of display size on ultrasound interpretation.

OBJECTIVES: Ultrasound (US) is an essential component of emergency department patient care. US machines have become smaller and more affordable. Handheld ultrasound (HUS) machines are even more portable and easy to use at the patient's bedside. However, miniaturization may come with consequences. The ability to accurately interpret ultrasound on a smaller screen is unknown. This pilot study aims to assess how screen size affects the ability of emergency medicine clinicians to accurately interpret US videos. METHODS: This pilot study enrolled a prospective convenience sample of emergency medicine physicians. Participants completed a survey and were randomized to interpret US videos starting with either a phone-sized screen or a laptop-sized screen, switching to the other device at the halfway point. 50 unique US videos depicting right upper quadrant (RUQ) views of the Focused Assessment with Sonography in Trauma (FAST) examination were chosen for inclusion in the study. There were 25 US videos per device. All of the images were previously obtained on a cart-based machine (Mindray M9) and preselected by the study authors. Participants answered "Yes" or "No" in response to whether they identified free fluid. The time that each participant took to interpret each video was also recorded. Following the assessment, participants completed a post-interpretation survey. The goal of the pilot was to determine the accuracy of image interpretation on a small screen as compared to a laptop-sized screen. Statistical analyses were performed using MATLAB (The MathWorks, Inc., Natick, MA). Nonparametric statistical tests were utilized to compare subgroups, with a Wilcoxon signed rank test used for paired data and a Wilcoxon rank sum test for unpaired data. RESULTS: 52 emergency medicine physicians were enrolled in the study. The median accuracy of US interpretation for phone versus laptop image screen was 88.0% and 87.6% (p = 0.67). The mean time to interpret with phone versus laptop screen was 293 and 290 s (p = 0.66). CONCLUSIONS: The study found no statistically significant difference in the accuracy of US interpretation nor time spent interpreting when the pre-selected RUQ videos generated on a cart-based ultrasound machine were reviewed on a phone-sized versus a laptop-sized screen. This pilot study suggests that the accuracy of US interpretation may not be dependent upon the size of the screen utilized.

Rationale and design of a digital trial using smartphones to detect subclinical atrial fibrillation in a population at risk: The eHealth-based bavarian alternative detection of Atrial Fibrillation (eBRAVE-AF) trial.

Current guidelines recommend opportunistic screening for subclinical atrial fibrillation (AF) taking advantage of e-health-based technologies. However, the efficacy of a fully scalable e-health-based strategy for AF detection in a head-to-head comparison with routine symptom-based screening is unknown. eBRAVE-AF is an investigator-initiated, digital, prospective, randomized, siteless, open-label, cross-over study to evaluate an e-health-based strategy for detection of AF in a real-world setting. 67,488 policyholders of a large German health insurance company (Versicherungskammer Bayern, Germany) selected by age ≥ 50 years and a CHA2DS2-VASc score ≥ 1 (females ≥2) are invited to participate. Subjects with known AF or on treatment with oral anticoagulation are excluded. After obtaining electronic informed consent, at least 4,400 participants will be randomly assigned to an e-health-based screening strategy or routine symptom-based screening. The e-health-based strategy consists of repetitive one-minute photoplethysmographic (PPG) pulse wave assessments using a certified smartphone app (Preventicus Heartbeats, Preventicus, Jena, Germany), followed by a confirmatory 14-day ECG patch (CardioMem CM 100 XT, Getemed, Teltow, Germany) in case of abnormal findings. After 6 months, participants are crossed over to the other study arm. Primary endpoint is the incidence of newly diagnosed AF leading to oral anticoagulation indicated by an independent physician. Clinical follow-up will be at least 12 months. In both groups, follow-up is performed by 4-week app-based questionnaires, personal contact in case of abnormal findings, and matching with claim-based insurance data and medical reports. At time of writing enrollment is completed. First results are expected to be available in mid-2021.

Changes in sleep phase and body weight of mobile health App users during COVID-19 mild lockdown in Japan.

OBJECTIVE AND METHOD: The stay-at-home order during the COVID-19 pandemic has restricted individuals' social behaviors, and therefore, effected their lifestyle including sleep, diet, and physical activity. Using the cross-sectional study design with a large sample size (N = 30,275) from the mobile health App users in Japan, we show age-dependent lifestyle changes during a nonpunitive "mild lockdown" (from April to May 2020). RESULTS: Sleep onset and offset were delayed on work-days but not on free-days with increased sleep duration and decreased social jetlag, and the changes were more evident in the younger population. Although average weight change was close to none because of the users' characteristic (95% of App users try to lose weight), we investigated an association between lifestyle change and body-weight change. Participants who reported advanced sleep phase during mild lockdown described a weight decrease. In contrast, the delayed sleep phase reported a weight gain. The results were significant after adjustment of confounding factors including physical activity and meal changes. CONCLUSIONS: Although there is cumulative evidence showing a relationship between late chronotype and obesity, it is still unclear about the potential benefit of the chronotype management to control body weight. Thus, to the best of our knowledge, this is the first study investigating the association between chronotype and weight changes by leveraging a large cohort.

Chronic disease management in heart failure: focus on telemedicine and remote monitoring.

In the context of the COVID-19 pandemic, many barriers to telemedicine disappeared. Virtual visits and telemonitoring strategies became routine. Evidence is accumulating regarding the safety and efficacy of virtual visits to replace in-person visits. A structured approach to virtual encounters is recommended. Telemonitoring includes patient reported remote vital sign monitoring, information from wearable devices, cardiac implantable electronic devices and invasive remote hemodynamic monitoring. The intensity of the monitoring should match the risk profile of the patient. Attention to cultural and educational barriers is important to prevent disparities in telehealth implementation.

Use of Telemedicine for the Physical Examination of Children With Fetal Alcohol Spectrum Disorders.

BACKGROUND: The fetal alcohol spectrum disorders (FASD) are among the most prevalent causes of neurodevelopmental disorders. The diagnosis is based on assessment of prenatal alcohol exposure, specific physical features identified with a dysmorphology examination, and neurobehavioral assessment. Prompt diagnosis of affected children is necessary to provide early intervention services in a timely manner; however, the availability of diagnostic expertise is limited. We propose telemedicine (TM) as a valid and reliable mode by which the physical phenotype of FASD can be accurately assessed. METHODS: We compared face-to-face (F2F) physical examinations of the 3 key facial features and the resulting physical phenotype of the fetal alcohol syndrome (FAS) and partial FAS (pFAS), as well as 12 additional physical features seen more frequently in children with FAS than in the general population in 61 individuals with 2 different TM methods. These included a Transportable Examination Station system using a precision camera and a laptop and a Zoom secure connection system (ZOOM), using a smart phone and a tablet. We measured the percentages of agreement and the Cohen's K coefficient for each comparison. RESULTS: Agreements for most physical features and for the physical phenotype of FAS and pFAS were in the "almost perfect" range with some exceptions in the "substantial" range. Imprecision in measurement and subjectivity underlie lower agreement for some features, both F2F and using TM. We identified the optimal conditions for the F2F examinations in order to assure reliability using TM. CONCLUSIONS: TM is a valid and reliable method for the examination of the physical features of FAS that may contribute to greater access to an early diagnosis of FASD in children prenatally exposed to alcohol and/or with characteristic neurobehavioral deficits.

An Observational Analysis of a Novel Digital Rectoscope.

BACKGROUND: This is an analysis of the first 50 in-human uses of a novel digital rigid sigmoidoscope. The technology provides digital image capture, telemedicine capabilities, improved ergonomics, and the ability to biopsy under pneumorectum while maintaining the low cost of conventional rigid sigmoidoscopy. The primary outcome was adverse events, and the secondary outcome was diagnostic view. PRELIMINARY RESULTS: Fifty patients underwent outpatient (n = 25) and surgical rectal assessment (n = 25), with a mean age of 60 years. This included 31 men and 19 women with 12 different clinical use indications. No adverse events were reported, and no defects were reported with the instrumentation. Satisfactory diagnoses were obtained in 48 (96%) of 50 uses, images were captured in 48 (96%) of 50 uses, and biopsies were successfully taken in 13 uses (26%). No adverse events were recorded. Independent reviewers of recorded videos agreed on the quality and diagnostic value of the images with a κ of 0.225 (95% CI, 0.144-0.305) when assessing whether the target pathology was adequately visualized. IMPACT OF INNOVATION: The improved views afforded by digital rectoscopy facilitated a satisfactory clinical diagnosis in 96% of uses. The device was successfully deployed in the operating room and outpatients irrespective of bowel preparation method, where it has the potential to replace flexible sigmoidoscopy for specific use cases. The technology provides a high-quality image and video that can be securely recorded for documentation and medicolegal purposes with agreement between blinded users despite a lack of standardized training and heterogenous pathology. We perceive significant impact of this technology for the assessment of colorectal anastomoses, the office management of colitis, "watch and wait," and for diagnostic support in rectal cancer diagnosis. The technology has significant potential to facilitate proctoring and training, and it now requires prospective trials to validate its diagnostic accuracy against more costly flexible sigmoidoscopy systems.

Feasibility of using "SMARTER" methodology for monitoring precipitating conditions of pediatric migraine episodes.

OBJECTIVE: To evaluate the feasibility in children of an intensive prospective data monitoring methodology for identifying precipitating conditions for migraine occurrence. BACKGROUND: Migraine headaches are a common pain condition in childhood and can become increasingly chronic and disabling with repeated episodes. Identifying conditions that forecast when a child's migraine is likely to occur may facilitate next-generation adaptive treatments to prevent future migraine attacks. METHODS: In this cohort study of a sample of 30 youth (ages 10-17) with migraine recruited through a pediatric headache clinic, smartphones supplemented with wearable biosensors were used over a period of 28 days to collect contextual data thought to be potentially relevant to headache occurrence. Self-reported data on headache occurrence, lifestyle, and perceptions of the environment were collected in 4 epochs per day using custom real-time reporting software. Data derived from the wearable biosensor included information on autonomic arousal and physical activity. Built-in sensors on participants' own phones also were used to indicate location and to quantify the sensory environment (e.g., ambient noise and light levels). Data fidelity was monitored to evaluate feasibility of the methods, and participant acceptability was assessed via an end-of-study survey. RESULTS: Self-report data were obtained on a mean of 88.9% (24.9/28) of assigned days (SD = 22.4%) and at a mean of 68.9% (77.2/112) of assigned moments (SD = 24.5%). Data from the wearable biosensor were obtained for a mean of 18.7 hours per day worn (SD = 2.3 hours), with participants on average wearing the sensor on 20.3 days (SD = 9.9). Fidelity of obtaining objective data from phone sensors on the sensory environment and other environmental conditions was highly variable, with these data obtainable from 5 to 22/30 (16.7%-73.3%) of participants' own phones. Most participants (63.3%-100%) responded with at least "somewhat agree" to questions about acceptability of the study methods. However, 5 to 7/30 (16.7%-23.3%) patients indicated difficulties with burden and remembering to wear the sensor. Almost all participants (29/30, 96.7%) agreed that they would want information about when a migraine might occur. CONCLUSIONS: A contemporary data sampling approach comprising ambulatory sensors and real-time reporting appears to be acceptable to most youth with migraine in this study. Reliability of acquiring some data sources from participants' own phones, however, was suboptimal. Further refining these data sampling methods may enable a novel means of predicting and preventing recurrences of migraine episodes in youth.

Remote electrical neuromodulation for acute treatment of migraine in adolescents.

OBJECTIVES: Migraine is a common disabling neurological disorder. Current acute treatments for migraine in adolescents are mostly pharmacological and may have limited effectiveness, can cause side effects, and may lead to medication overuse. There is an unmet need for effective and well-tolerated treatments. Remote electrical neuromodulation (REN) is a novel acute treatment of migraine that stimulates upper arm peripheral nerves to induce conditioned pain modulation (CPM)-an endogenous analgesic mechanism. The REN device (Nerivio® , Theranica Bio-Electronics Ltd., Israel) is a FDA-authorized device for acute treatment of migraine in adults. This study assessed the efficacy and safety of REN in adolescents with migraine. DESIGN AND METHODS: This was an open-label, single-arm, multicenter study in adolescents (ages 12-17 years) with migraine. Participants underwent a 4-week run-in phase. Eligible participants continued to an 8-week treatment phase with the device. Pain severity, associated symptoms, and functional disability were recorded at treatment initiation, and 2 and 24 hours post-treatment. The primary endpoints of this study were related to the safety and tolerability of REN. The secondary endpoints were related to device efficacy and included the proportion of participants who achieved pain relief at 2 hours post-treatment and the proportion of participants who achieved pain freedom at 2 hours. The presented results reflect an interim analysis with subsequent stopping of the rest of the study. RESULTS: Sixty participants were enrolled for the study; of these, 14 failed to meet the run-in criteria and 1 was lost to follow-up. Forty-five participants performed at least one treatment, of which 39 participants completed a test treatment with REN. One device-related adverse event (2%) was reported in which a temporary feeling of pain in the arm was felt. Pain relief and pain-free at 2 hours were achieved by 71% (28/39) and 35% (14/39) participants, respectively. At 2 hours, 69% (23/33) participants experienced improvement in functional ability. CONCLUSIONS: REN may offer a safe and effective non-pharmacological alternative for acute treatment in adolescents.