The Dewey Monitor: Pulse Oximetry can Warn of Hypoxia in an Immersed Rebreather Diver in Multiple Scenarios.

Divers who wish to prolong their time underwater while carrying less equipment often use devices called rebreathers, which recycle the gas expired after each breath instead of discarding it as bubbles. However, rebreathers' need to replace oxygen used by breathing creates a failure mechanism that can and frequently does lead to hypoxia, loss of consciousness, and death. The purpose of this study was to determine whether a pulse oximeter could provide a useful amount of warning time to a diver with a rebreather after failure of the oxygen addition mechanism. Twenty-eight volunteer human subjects breathed on a mixed-gas rebreather in which the oxygen addition system had been disabled. The subjects were immersed in water in four separate environmental scenarios, including cold and warm water, and monitored using pulse oximeters placed at multiple locations. Pulse oximeters placed on the forehead and clipped on the nasal ala provided a mean of 32 s (±10 s SD) of warning time to divers with falling oxygen levels, prior to risk of loss of consciousness. These devices, if configured for underwater use, could provide a practical and inexpensive alarm system to warn of impending loss of consciousness in a manner that is redundant to the rebreather.

Deep learning enabled classification of real-time respiration signals acquired by MoSSe quantum dot-based flexible sensors.

Respiration rate is a vital parameter which is useful for the earlier identification of diseases. In this context, various types of devices have been fabricated and developed to monitor different breath rates. However, the disposability and biocompatibility of such sensors and the poor classification of different breath rates from sensor data are significant issues in medical services. This report attempts to focus on two important things: the classification of respiration signals from sensor data using deep learning and the disposability of devices. The use of the novel Janus MoSSe quantum dot (MoSSe QD) structure allows for stable respiration sensing because of unchanged wear rates under humid conditions, and also, the electron affinity and work function values suggest that MoSSe has a higher tendency to donate electrons and interact with the hydrogen molecule. Furthermore, for the real-time classification of different respiration signals, a 1D convolutional neural network (1D CNN) was incorporated. This algorithm was applied to four different breath patterns which achieved a state-of-the-art 10-trial accuracy of 98.18% for normal, 95.25% for slow, 97.64% for deep, and 98.18% for fast breaths. The successful demonstration of a stable, low-cost, and disposable respiration sensor with a highly accurate classification of signals is a major step ahead in developing wearable respiration sensors for future personal healthcare monitoring systems.

Tympanic thermometers support fast and accurate temperature monitoring in acute and alternative care.

This article explores body temperature and the physiological process of thermoregulation. Normal body temperature and body temperature changes are discussed, including comorbidities associated with body temperature and signs of hyperthermia and hypothermia, and the factors that affect intraoperative temperature regulation. The evidence base behind thermometry is discussed and is applied to contemporary clinical conditions and symptoms, including: sepsis and suspected COVID-19. After discussing clinical considerations and regulations that encompass thermometry, three case studies present the use of the Genius 3 Tympanic Thermometer in clinical practice, with user feedback supporting its benefits, which include speed, accuracy and ease of use.

[Remote patient monitoring in dialysis patients: the "change of pace" for home dialysis.] / Monitoraggio da remoto del paziente in dialisi: il cambio di passo per la dialisi domiciliare?

Lockdown and self-isolation are to date the only solution to limit the spread of recent outbreak of coronavirus disease (CoViD-19), highlighting the great advantage of home dialysis in a patient otherwise forced to travel from / to the dialysis center to receive this "life-saving" treatment. Indeed, to prevent spreading of CoViD-19 infection among extremely fragile dialysis patients, as well as among dialysis workers, hemodialysis (HD) centers are adopting specific procedures ("dedicated" dialysis facilities, portable osmosis, etc.) with a great economic and organizational commitment. Peritoneal dialysis (PD) represents a type of home dialysis therapy not yet adequately implemented to date, in spite of safe and simple practice, as well as similar dialytic efficiency vs in-center hemodialysis. Remote patient monitoring (RPM) systems have been developed in automated PD (APD) cyclers in order to improve the acceptance of this dialysis method, to increase the compliance to the prescribed therapy and to control treatment adequacy. In this review we assess the potential advantages of RPM in APD, that are the chance for patients to acquire greater independence and safety in the home treatment, to allow better access to care for residents in remote areas, faster resolution of problems, reduction in hospitalizations and mortality rates, as well as time and cost saving for both the patient and the staff. The use of medical devices (sphygmomanometer, glucometer, balance, etc.), connected by wireless to the clinician's portal, might also allow a wider diffusion of incremental dialysis, an integrated therapy that combines conservative management of ESKD patients with a soft dialysis based on the residual kidney function and symptomatology, with potential prognosis and economic benefits. Although the majority of the studies are small and observational, a wider use of RPM systems is desirable to broaden the spread of home dialysis, as we learnt from Coronavirus pandemic.

Holistically Engineered Polymer-Polymer and Polymer-Ion Interactions in Biocompatible Polyvinyl Alcohol Blends for High-Performance Triboelectric Devices in Self-Powered Wearable Cardiovascular Monitorings.

The capability of sensor systems to efficiently scavenge their operational power from stray, weak environmental energies through sustainable pathways could enable viable schemes for self-powered health diagnostics and therapeutics. Triboelectric nanogenerators (TENG) can effectively transform the otherwise wasted environmental, mechanical energy into electrical power. Recent advances in TENGs have resulted in a significant boost in output performance. However, obstacles hindering the development of efficient triboelectric devices based on biocompatible materials continue to prevail. Being one of the most widely used polymers for biomedical applications, polyvinyl alcohol (PVA) presents exciting opportunities for biocompatible, wearable TENGs. Here, the holistic engineering and systematic characterization of the impact of molecular and ionic fillers on PVA blends' triboelectric performance is presented for the first time. Triboelectric devices built with optimized PVA-gelatin composite films exhibit stable and robust triboelectricity outputs. Such wearable devices can detect the imperceptible skin deformation induced by the human pulse and capture the cardiovascular information encoded in the pulse signals with high fidelity. The gained fundamental understanding and demonstrated capabilities enable the rational design and holistic engineering of novel materials for more capable biocompatible triboelectric devices that can continuously monitor vital physiological signals for self-powered health diagnostics and therapeutics.

Wireless Motion Sensors-Useful in Assessing the Effectiveness of Physiotherapeutic Methods Used in Patients with Knee Osteoarthritis-Preliminary Report.

Osteoarthritis of the knee (OAK) is characterized by pain, limitation of joint mobility, and significant deterioration of proprioception resulting in functional decline. This study assessed proprioception in OAK patients following two ten-day rehabilitation programs using the Orthyo® system. Fifty-four study participants with clinical symptoms and radiological signs of OAK were randomly divided into an exercise group (n = 27) or a manual therapy group (n = 27). The control group consisted of 27 volunteers with radiological signs of OAK, but with no clinical symptoms or prior history of rehabilitation. The following parameters were assessed: knee proprioception using inertial sensors and a mobile application, patients' function using Western Ontario and McMaster Universities osteoarthritis index (WOMAC), and pain intensity using the visual analog scale (VAS). Following rehabilitation, knee proprioception tests did not improve in either study group. Both study groups showed significant improvement of the WOMAC-assessed function (exercise group: p < 0.01, manual therapy group: p = 0.01) and a significant decrease (p < 0.01) of VAS-assessed pain following rehabilitation, but the post-therapy results did not differ significantly between the aforementioned groups. The Orthyo® system provided a quick and accurate assessment of the knee joint position sense. There was no direct relationship between functionality, pain, and proprioception threshold in the knee joint.

Biofeedback Treatment App for Pediatric Migraine: Development and Usability Study.

OBJECTIVE: The objective of this study was to develop and investigate the usability of a biofeedback treatment smartphone app for adolescent migraine sufferers. BACKGROUND: Biofeedback is effective in treating pediatric migraine. However, biofeedback is not widely used due to the necessity of a trained therapist and specialized equipment. Emerging digital technology, including smartphones and wearables, enables new ways of administering biofeedback. METHODS: In a prospective open-label development and usability study, 10 adolescent migraine sufferers used a newly developed biofeedback app with wearable sensors that measured their muscle tension, finger temperature, and heart rate. Three iterative rounds of usability testing, including a 2-week home testing period, were completed. A biofeedback algorithm, combining and optimizing the 3 physiological modalities, and several algorithms for sham-treatment were created. Usability was evaluated statistically and summarized thematically. RESULTS: Five of ten participants completed all 3 rounds of usability testing. A total of 72 biofeedback sessions were completed. Usability scoring was consistently high, with median scores ranging from 3.5 to 4.5 on a 5-point scale. The biofeedback optimization algorithm correlated excellently to the raw physiological measurements (r = 0.85, P < .001). The intervention was safe and tolerable. CONCLUSION: We developed an app for young migraine sufferers to receive therapist-independent biofeedback. The app underwent a rigorous development process as well as usability and feasibility testing. It is now ready for clinical trials.

Accuracy of transcutaneous bilirubin on covered skin in preterm and term newborns receiving phototherapy using a JM-105 bilirubinometer.

OBJECTIVE: Determine the suitability of transcutaneous bilirubin (TCB) as a tool to assess the effectiveness of phototherapy on patched skin. STUDY DESIGN: A prospective observational study was conducted. We covered a fragment of skin (sternum) with a photo-opaque patch. Several simultaneous TCB and TSB measurements were performed with the JM-105 bilirubinometer. Bland and Altman test evaluated the agreement between bilirubin levels. RESULT: A total of 217 patients were studied, 48.8% were preterm. The mean difference between TSB and TCB before the start of treatment was 1.07 mg/dL. During phototherapy, differences on covered skin were 0.52, 0.27, and 0.39 mg/dL at 24, 48, and 72 h of therapy respectively. The best correlation was observed at 48 h in preterm infants. CONCLUSION: The measurement of TCB on patched skin (PTCB) is useful for monitoring the response to phototherapy in term and preterm infants. We use a patch with a removable flap that eases successive measures without disturbing the patients.

Wearable SiPM-Based NIRS Interface Integrated With Pulsed Laser Source.

We present the design of a miniaturized probe integrating silicon photomultiplier and light-pulsing electronics in a single 2 × 2 mm2 complementary metal-oxide-semiconductor (CMOS) chip which includes functional blocks such as a fast pulse-laser driver and synchronized single-photon detection circuit. The photon pulses can be either counted on-chip or processed by an external high-speed electronic module such as time-corelated single photon counting (TCSPC) unit. The integrated circuit was assembled on a printed circuit board (PCB) and also on a 2.5D silicon interposer platform of size 1 cm and interfaced with a silicon photomultiplier (SiPM), vertical cavity surface emitting laser (VCSEL) and other ancillary components such as capacitors and resistors. Our approach of integrating an optical interface to optimize light collection on the small active area and light emission from the vertical-cavity surface-emitting laser (VSCEL) will facilitate clinical adoption in many applications and change the landscape of Near Infrared Spectroscopy (NIRS) hardware commercially due to significant optode-size reduction and the elimination of optical fibers.

Biofeedback-Assisted Resilience Training for Traumatic and Operational Stress: Preliminary Analysis of a Self-Delivered Digital Health Methodology.

BACKGROUND: Psychological resilience is critical to minimize the health effects of traumatic events. Trauma may induce a chronic state of hyperarousal, resulting in problems such as anxiety, insomnia, or posttraumatic stress disorder. Mind-body practices, such as relaxation breathing and mindfulness meditation, help to reduce arousal and may reduce the likelihood of such psychological distress. To better understand resilience-building practices, we are conducting the Biofeedback-Assisted Resilience Training (BART) study to evaluate whether the practice of slow, paced breathing with or without heart rate variability biofeedback can be effectively learned via a smartphone app to enhance psychological resilience. OBJECTIVE: Our objective was to conduct a limited, interim review of user interactions and study data on use of the BART resilience training app and demonstrate analyses of real-time sensor-streaming data. METHODS: We developed the BART app to provide paced breathing resilience training, with or without heart rate variability biofeedback, via a self-managed 6-week protocol. The app receives streaming data from a Bluetooth-linked heart rate sensor and displays heart rate variability biofeedback to indicate movement between calmer and stressful states. To evaluate the app, a population of military personnel, veterans, and civilian first responders used the app for 6 weeks of resilience training. We analyzed app usage and heart rate variability measures during rest, cognitive stress, and paced breathing. Currently released for the BART research study, the BART app is being used to collect self-reported survey and heart rate sensor data for comparative evaluation of paced breathing relaxation training with and without heart rate variability biofeedback. RESULTS: To date, we have analyzed the results of 328 participants who began using the BART app for 6 weeks of stress relaxation training via a self-managed protocol. Of these, 207 (63.1%) followed the app-directed procedures and completed the training regimen. Our review of adherence to protocol and app-calculated heart rate variability measures indicated that the BART app acquired high-quality data for evaluating self-managed stress relaxation training programs. CONCLUSIONS: The BART app acquired high-quality data for studying changes in psychophysiological stress according to mind-body activity states, including conditions of rest, cognitive stress, and slow, paced breathing.

Predictability of individual circadian phase during daily routine for medical applications of circadian clocks.

BACKGROUNDCircadian timing of treatments can largely improve tolerability and efficacy in patients. Thus, drug metabolism and cell cycle are controlled by molecular clocks in each cell and coordinated by the core body temperature 24-hour rhythm, which is generated by the hypothalamic pacemaker. Individual circadian phase is currently estimated with questionnaire-based chronotype, center-of-rest time, dim light melatonin onset (DLMO), or timing of core body temperature (CBT) maximum (acrophase) or minimum (bathyphase).METHODSWe aimed at circadian phase determination and readout during daily routines in volunteers stratified by sex and age. We measured (a) chronotype, (b) every minute (q1min) CBT using 2 electronic pills swallowed 24 hours apart, (c) DLMO through hourly salivary samples from 1800 hours to bedtime, and (d) q1min accelerations and surface temperature at anterior chest level for 7 days, using a teletransmitting sensor. Circadian phases were computed using cosinor and hidden Markov modeling. Multivariate regression identified the combination of biomarkers that best predicted core temperature circadian bathyphase.RESULTSAmong the 33 participants, individual circadian phases were spread over 5 hours, 10 minutes (DLMO); 7 hours (CBT bathyphase); and 9 hours, 10 minutes (surface temperature acrophase). CBT bathyphase was accurately predicted, i.e., with an error less than 1 hour for 78.8% of the subjects, using a new digital health algorithm (INTime), combining time-invariant sex and chronotype score with computed center-of-rest time and surface temperature bathyphase (adjusted R2 = 0.637).CONCLUSIONINTime provided a continuous and reliable circadian phase estimate in real time. This model helps integrate circadian clocks into precision medicine and will enable treatment timing personalization following further validation.FUNDINGMedical Research Council, United Kingdom; AP-HP Foundation; and INSERM.

Recommendation of New Medical Alarms Based on Audibility, Identifiability, and Detectability in a Randomized, Simulation-Based Study.

OBJECTIVES: Accurate and timely identification of existing audible medical alarms is not adequate in clinical settings. New alarms that are easily heard, quickly identifiable, and discernable from one another are indicated. The "auditory icons" (brief sounds that serve as metaphors for the events they represent) have been proposed as a replacement to the current international standard. The objective was to identify the best performing icons based on audibility and performance in a simulated clinical environment. DESIGN: Three sets of icon alarms were designed using empirical methods. Subjects participated in a series of clinical simulation experiments that examined the audibility, identification accuracy, and response time of each of these icon alarms. A statistical model that combined the outcomes was used to rank the alarms in overall efficacy. We constructed the "best" and "worst" performing sets based on this ranking and prospectively validated these sets in a subsequent experiment with a new subject sample. SETTING: Experiments were conducted in simulated ICU settings at the University of Miami. SUBJECTS: Medical trainees were recruited from a convenience sample of nursing students and anesthesia residents at the institution. INTERVENTIONS: In Experiment 1 (formative testing), subjects were exposed to one of the three sets of alarms; identical setting and instruments were used throughout. In Experiment 2 (summative testing), subjects were exposed to one of the two sets of alarms, assembled from the best and worst performing alarms from Experiment 1. MEASUREMENTS AND MAIN RESULTS: For each alarm, we determined the minimum sound level to reach audibility threshold in the presence of background clinical noise, identification accuracy (percentage), and response time (seconds). We enrolled 123 medical trainees and professionals for participation (78 with < 6 yr of training). We identified the best performing icon alarms for each category, which matched or exceeded the other candidate alarms in identification accuracy and response time. CONCLUSIONS: We propose a set of eight auditory icon alarms that were selected through formative testing and validated through summative testing for adoption by relevant regulatory bodies and medical device manufacturers.

Skin-Mountable Biosensors and Therapeutics: A Review.

Miniaturization of electronic components and advances in flexible and stretchable materials have stimulated the development of wearable health care systems that can reflect and monitor personal health status by health care professionals. New skin-mountable devices that offer seamless contact onto the human skin, even under large deformations by natural motions of the wearer, provide a route for both high-fidelity monitoring and patient-controlled therapy. This article provides an overview of several important aspects of skin-mountable devices and their applications in many medical settings and clinical practices. We comprehensively describe various transdermal sensors and therapeutic systems that are capable of detecting physical, electrophysiological, and electrochemical responses and/or providing electrical and thermal therapies and drug delivery services, and we discuss the current challenges, opportunities, and future perspectives in the field. Finally, we present ways to protect the embedded electronic components of skin-mountable devices from the environment by use of mechanically soft packaging materials.

Multi-dry-electrode plate sensor for non-invasive electrocardiogram and heart rate monitoring for the assessment of drug responses in freely behaving mice.

Monitoring of electrocardiogram (ECG) and heart rate (HR) is essential in a wide range of experiments. For conscious animal studies, telemetry is the preferred approach; however, it requires 1-3 weeks of recovery after surgical device-implantation. The present paper describes a novel multi-dry-electrode plate (MDEP) sensor system to monitor ECG/HR in freely behaving mice without the need for surgery for device/electrode implantation. The MDEP sensor is a rectangular plate with 15 gold-plated stripe pattern electrodes, on which a mouse can walk around freely, and detects ECG whenever ≥2 paws (footpads) come in contact with the electrodes. Here we show that the MDEP sensor detected distinct QRS complexes which, were fragmented due to locomotion and insufficient perspiration on the footpads. Nonetheless, the HR calculated from the QRS complexes were similar to the HR calculated from R-R intervals simultaneously recorded from lead-II ECG (difference = 0.0 ±â€¯0.16 ms) as part of the validation exercise. Also, the archetypal responses to isoproterenol and metoprolol injections were successfully detected as a significantly elevation (+151 ±â€¯15 bpm) and reduction (-77 ±â€¯6 bpm) in HR, respectively, compared to vehicle at 20-60 min postdose. Conversely, the P wave was rarely identifiable unless signal averaging was undertaken. These results indicate a potential utility for the MDEP-sensor system for cardiac pharmacological studies. In addition, signal averaging appeared to be effective for detection of ECG intervals such as PR and QT, although the QT cannot be measured in the mouse heart as there is no T wave.

The hemodynamic changes during cupping therapy monitored by using an optical sensor embedded cup.

Cupping therapy is one form of alternative medicine that is used widely across the world. Although the applications of cupping therapy including pain relief have a 1000-year history, the therapeutic effect of cupping is still questionable due to a lack of scientific evidence. Therefore, in the present study, we embedded a near-infrared spectroscopic sensor into a suction cup to monitor the hemodynamic changes on the treated site while the hemodynamics at the surrounding tissue of the cup was also simultaneously monitored by another near-infrared spectroscopic sensor. The results from 10 healthy male subjects show a dramatic increase of the oxy-hemoglobin (OHb) and deoxy-hemoglobin (RHb) concentrations at the treatment site while the OHb and RHb levels were decreased at the surrounding tissue. Moreover, after the treatment, we observed that the OHb concentrations were maintained at a higher level than before treatment at both sites, which may demonstrate how cupping therapy works for treatment. In summary, the results showed that cupping therapy increases blood volume and tissue oxygenation at the treatment site while those were slightly decreased at the surrounding tissue. This study showed that the embedding of near-infrared spectroscopy in a cupping system could offer a better understanding of the mechanism of cupping therapy.

A Wearable Multifunctional Pulse Monitor Using Thermosensation-Based Flexible Sensors.

OBJECTIVE: This study proposes a novel wearable pulse monitoring system, which can realize the synchronous measurements of pulse wave, skin, temperature, and pulse wave velocity (PWV). METHODS: A flexible sensor based on thermosensation is used to detect pressure and temperature stimuli simultaneously. A total of two sensors are integrated to detect pulse transit along two specific points of the artery, e.g., Cun and Chi at a wrist, the data of which are subsequently used to figure out the PWV by using a tailor-designed algorithm conducted in a microprocessor. Calibration experiments and application cases are conducted to validate the effectiveness of the monitor. RESULTS: The developed monitor detects the physiological signals of pulse wave, PWV, and skin temperature simultaneously. In addition, the monitor can measure the pulse changes before and after exercises and track skin temperature variations when warming and cooling. Moreover, the monitor can be also used to detect the local PWV at the wrist. CONCLUSION: The synchronous measurements of pulse wave, skin temperature, and PWV using a wearable monitor are feasible. SIGNIFICANCE: The monitor is small, simple-structured, with multifunction, and thus provides a promising auxiliary approach for traditional Chinese medicine pulse diagnosis.

Four-dimensional optoacoustic monitoring of tissue heating with medium intensity focused ultrasound.

Medium-intensity focused ultrasound (MIFU) concerns therapeutic ultrasound interventions aimed at stimulating physiological mechanisms to reinforce healing responses without reaching temperatures that can cause permanent tissue damage. The therapeutic outcome is strongly affected by the temperature distribution in the treated region and its accurate monitoring represents an unmet clinical need. In this work, we investigate on the capacities of four-dimensional optoacoustic tomography to monitor tissue heating with MIFU. Calibration experiments in a tissue-mimicking phantom have confirmed that the optoacoustically-estimated temperature variations accurately match the simultaneously acquired thermocouple readings. The performance of the suggested approach in real tissues was further shown with bovine muscle samples. Volumetric temperature maps were rendered in real time, allowing for dynamic monitoring of the ultrasound focal region, estimation of the peak temperature and the size of the heat-affected volume.

Health management and pattern analysis of daily living activities of people with dementia using in-home sensors and machine learning techniques.

The number of people diagnosed with dementia is expected to rise in the coming years. Given that there is currently no definite cure for dementia and the cost of care for this condition soars dramatically, slowing the decline and maintaining independent living are important goals for supporting people with dementia. This paper discusses a study that is called Technology Integrated Health Management (TIHM). TIHM is a technology assisted monitoring system that uses Internet of Things (IoT) enabled solutions for continuous monitoring of people with dementia in their own homes. We have developed machine learning algorithms to analyse the correlation between environmental data collected by IoT technologies in TIHM in order to monitor and facilitate the physical well-being of people with dementia. The algorithms are developed with different temporal granularity to process the data for long-term and short-term analysis. We extract higher-level activity patterns which are then used to detect any change in patients' routines. We have also developed a hierarchical information fusion approach for detecting agitation, irritability and aggression. We have conducted evaluations using sensory data collected from homes of people with dementia. The proposed techniques are able to recognise agitation and unusual patterns with an accuracy of up to 80%.

Adherence to home fortification with micronutrient powders in Kenyan pre-school children: self-reporting and sachet counts compared to an electronic monitoring device.

BACKGROUND: The efficacy of home fortification with iron-containing micronutrient powders varies between trials, perhaps in part due to population differences in adherence. We aimed to assess to what extent adherence measured by sachet count or self-reporting forms is in agreement with adherence measured by electronic device. In addition, we explored how each method of adherence assessment (electronic device, sachet count, self-reporting forms) is associated with haemoglobin concentration measured at the end of intervention; and to what extent baseline factors were associated with adherence as measured by electronic device. METHODS: Three hundred thirty-eight rural Kenyan children aged 12-36 months were randomly allocated to three treatment arms (home fortification with two different iron formulations or placebo). Home fortificants were administered daily by parents or guardians over a 30 day-intervention period. We assessed adherence using an electronic device that stores and provides information of the time and day of opening of the container that was used to store the fortificants sachets in each child's residence. In addition, we assessed adherence by self-reporting and sachet counts. We also measured haemoglobin concentration at the end of intervention. RESULTS: Adherence, defined as having received at least 24 sachets (≥ 80%), during the 30-day intervention period was attained by only 60.6% of children as assessed by the electronic device. The corresponding values were higher when adherence was assessed by self-report (83.9%; difference: 23.3%, 95% CI: 18.8% to 27.8%) or sachet count (86.3%; difference: 25.7%, 95% CI: 21.0% to 30.4%). Among children who received iron, each 10 openings of the electronic cap of the sachet storage container were associated with an increase in haemoglobin concentration at the end of intervention by 1.2 g/L (95% CI: 0.0 to 1.9 g/L). Adherence was associated with the age of the parent but not with intervention group; with age, sex or anthropometric indices of the child; or with age or sex of the parent or guardian. CONCLUSIONS: The use of self -reporting and sachet count may lead to overestimates of adherence to home fortification. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov ( NCT02073149 ) on 25 February 2014.

Point-of-care device to diagnose and monitor neonatal jaundice in low-resource settings.

Newborns are at increased risk of jaundice, a condition in which excess bilirubin accumulates in blood. Left untreated, jaundice can lead to neurological impairment and death. Jaundice resulting from unconjugated hyperbilirubinemia is easily treated with exposure to blue light, and phototherapy systems have been developed for low-resource settings; however, there are no appropriate solutions to diagnose and monitor jaundice in these settings. To address this need we present BiliSpec, a low-cost reader and disposable lateral flow card designed to measure the concentration of total bilirubin from several drops of blood at the point of care. We evaluated the performance of BiliSpec, using blood from normal volunteers spiked with varying amounts of bilirubin; results measured using BiliSpec correlated well with a reference laboratory bilirubinometer (r = 0.996). We then performed a pilot clinical study using BiliSpec to measure total bilirubin in neonates at risk for jaundice at Queen Elizabeth Central Hospital in Blantyre, Malawi. Concentrations measured using BiliSpec correlated well with those measured using a laboratory reference standard in 94 patient samples ranging from 1.1 mg/dL to 23.0 mg/dL in concentration (r = 0.973). The mean difference between bilirubin levels measured with BiliSpec and the reference standard was 0.3 mg/dL (95[Formula: see text] CI: -1.7-2.2 mg/dL).