Standardization of thyroid ultrasound reporting in the community setting decreases biopsy rates.

OBJECTIVE: With the rising incidence of thyroid cancer, a standardized approach to the evaluation of thyroid nodules is essential. Despite the presence of multiple national guidelines detailing evaluation and management of these nodules, significant variability exists in the information that is collected and reported to clinicians from diagnostic imaging. The aim of this study was to evaluate the impact of thyroid ultrasound standardization on thyroid cancer detection in a community practice setting. DESIGN: As part of a physician-driven quality improvement project, a multidisciplinary team created an electronic worksheet to be utilized by sonographers to capture suspicious findings based on societal guidelines and agreed on institutional criteria for recommending fine needle aspiration (FNA) of thyroid nodules. PATIENTS: For a one-year period prior to and after the intervention, all ultrasounds performed for suspected thyroid pathology, excluding patients undergoing follow-up imaging, were reviewed at two affiliated community hospitals served by a single radiology and pathology group. MEASUREMENTS: The number of fine needle biopsies recommended and performed, as well as the percentage of FNAs positive for malignancy were evaluated. RESULTS: A total of 608 and 675 ultrasounds were reviewed in pre- and post-standardization periods, respectively. Following standardization, there was a similar percentage of FNAs recommended (35% vs. 37%, p = .68), fewer FNAs per total ultrasounds performed (36% vs. 31%, p = .03), fewer FNAs performed when FNA was not explicitly recommended (9.9% vs. 2.8%, p = .000046) and an increased detection of cytology consistent with, or suspicious for, malignancy (5% vs. 11.5%, p = .0028). CONCLUSIONS: Standardization of thyroid imaging protocol and management recommendations can reduce the number of FNAs performed and increase the percentage of positive tests in a community setting.

Energy intake estimation from counts of chews and swallows.

Current, validated methods for dietary assessment rely on self-report, which tends to be inaccurate, time-consuming, and burdensome. The objective of this work was to demonstrate the suitability of estimating energy intake using individually-calibrated models based on Counts of Chews and Swallows (CCS models). In a laboratory setting, subjects consumed three identical meals (training meals) and a fourth meal with different content (validation meal). Energy intake was estimated by four different methods: weighed food records (gold standard), diet diaries, photographic food records, and CCS models. Counts of chews and swallows were measured using wearable sensors and video analysis. Results for the training meals demonstrated that CCS models presented the lowest reporting bias and a lower error as compared to diet diaries. For the validation meal, CCS models showed reporting errors that were not different from the diary or the photographic method. The increase in error for the validation meal may be attributed to differences in the physical properties of foods consumed during training and validation meals. However, this may be potentially compensated for by including correction factors into the models. This study suggests that estimation of energy intake from CCS may offer a promising alternative to overcome limitations of self-report.

The application of biomedical engineering techniques to the diagnosis and management of tropical diseases: a review.

This paper reviews a number of biomedical engineering approaches to help aid in the detection and treatment of tropical diseases such as dengue, malaria, cholera, schistosomiasis, lymphatic filariasis, ebola, leprosy, leishmaniasis, and American trypanosomiasis (Chagas). Many different forms of non-invasive approaches such as ultrasound, echocardiography and electrocardiography, bioelectrical impedance, optical detection, simplified and rapid serological tests such as lab-on-chip and micro-/nano-fluidic platforms and medical support systems such as artificial intelligence clinical support systems are discussed. The paper also reviewed the novel clinical diagnosis and management systems using artificial intelligence and bioelectrical impedance techniques for dengue clinical applications.

Incomplete Home Health Care Referral After Hospitalization Among Medicare Beneficiaries.

OBJECTIVES: Patients who are referred to home health care after an acute care hospitalization may not receive home health care, resulting in incomplete home health referrals. This study examines the prevalence of incomplete referrals to home health, defined as not receiving home health care within 7 days after an initial hospital discharge, and investigates the relationship between home health referral completion and patient outcomes. DESIGN: Retrospective cohort study. SETTING AND PARTICIPANTS: Medicare beneficiaries who are discharged from short-term acute care hospitals between October 2015 and December 2016 with a discharge status code on the hospital claim indicating home health care. METHODS: Patient characteristics and outcomes were compared between Medicare beneficiaries with complete and incomplete home health referrals after hospital discharge. The outcomes included mortality, readmission rate, and total spending over a 1-year episode following hospitalization. These outcomes were risk-adjusted using patient demographic, socioeconomic, clinical characteristic, hospital characteristic, and state fixed effects. RESULTS: Approximately 29% of the 724,700 hospitalizations in the analytic dataset had incomplete home health referrals after discharge. The rate of incomplete home health referrals varied among clinical conditions, ranging from 17% among joint/musculoskeletal patients and 38% among digestive/endocrine patients. Risk-adjusted 1-year mortality and readmission rates were 1.4 and 2.4 percentage points lower and total spending was $1053 higher among patients with complete home health referrals as compared with those with incomplete home health referrals after hospital discharge. CONCLUSIONS AND IMPLICATIONS: The analysis revealed that almost 1 in 3 patients discharged from a hospital with a discharge status of home health does not receive home health care. In addition, complete home health referrals are associated with lower mortality and readmission rates and higher spending. As home health care utilization increases, policymakers should pay attention to the tradeoff between quality and cost when implementing alternative policies and payment models.

Predicting Weight Loss and Comorbidity Improvement 7 Years Following Laparoscopic Sleeve Gastrectomy: Does Early Weight Loss Matter?

BACKGROUND: Predicting the variables that affect the outcomes following laparoscopic sleeve gastrectomy (LSG) would allow focused resource allocation with a view to improving results. Whilst greater early post-operative weight loss following LSG is associated with greater short-term weight loss, the relationship between early results and long-term outcomes has not been described. METHODS: A retrospective cohort analysis was performed on patients who underwent LSG 7 years before a follow-up telephone interview was performed. Multivariate regression analysis was used to explore the relationship between early weight loss at 4 weeks following surgery and weight loss at 7 years. A non-inferiority analysis assessed whether early weight loss was associated with either improvement or resolution of hypertension or type 2 diabetes mellitus (T2DM) at 7 years after surgery. RESULTS: Of the 156 patients identified between April and October 2012, 130 (83.3%) met the inclusion criteria and were included in the analysis. The average preoperative BMI was 42.5 kg/m2 (standard deviation 5.2). The change in BMI was 4.6 kg/m2 (4.0) at 4 weeks and 12.2 kg/m2 (5.4) at 7 years. There was improvement or resolution in 19/31 (61.3%) patients with T2DM and 14/26 (53.8%) patients with hypertension. Whilst younger age was associated with greater weight loss at 7 years follow-up, no such relationship was identified with early post-operative weight loss. Early post-operative weight loss was also not associated with long-term improvement or resolution in hypertension or T2DM. CONCLUSIONS: Early weight loss does not appear to be associated with greater weight loss nor comorbidity improvement 7 years following LSG. TRIAL REGISTRATION: ClinicalTrials.gov (SZMC-95/19).

Precursors of cardiorespiratory events in infants detected by home memory monitor.

In 1,079 infants monitored for >700,000 hr at home for apnea or bradycardia, we found an association between infants having multiple events exceeding conventional or a priori defined more extreme thresholds and less favorable developmental outcome at 1 year of age than infants with few or no events. If it is necessary to prevent such events to minimize risk for developmental morbidity, there is reason to determine whether there are disturbances in advance of the apnea or bradycardia that herald their onset. In the 85 infants with at least 1 extreme event and 1 conventional event, we hypothesized that apnea and bradycardia do not occur de novo but rather are preceded by cardiorespiratory and hemoglobin O2 saturation changes. We compared recorded time intervals preceding these events, and we analyzed three preceding time intervals for each conventional and extreme event, and each non-event recording: Time-2 hr: up to 2 hr before; Time-1 hr: up to 1 hr before; and Time-75 sec: the 75 sec immediately preceding each event. O2 saturation progressively decreased preceding both conventional and extreme events, and progressive increases occurred in heart and breathing rate variability. Duration of respiratory pauses and of periodic breathing progressively increased preceding conventional events, respiratory rate variability increased immediately preceding conventional events and at 1 hr preceding extreme events, and O2 saturation decreased immediately preceding both conventional and extreme events. Thus, conventional and extreme events do not occur de novo but rather are preceded by autonomic instability of the cardiorespiratory system.

Sleep versus wake classification from heart rate variability using computational intelligence: consideration of rejection in classification models.

Reliability of classification performance is important for many biomedical applications. A classification model which considers reliability in the development of the model such that unreliable segments are rejected would be useful, particularly, in large biomedical data sets. This approach is demonstrated in the development of a technique to reliably determine sleep and wake using only the electrocardiogram (ECG) of infants. Typically, sleep state scoring is a time consuming task in which sleep states are manually derived from many physiological signals. The method was tested with simultaneous 8-h ECG and polysomnogram (PSG) determined sleep scores from 190 infants enrolled in the collaborative home infant monitoring evaluation (CHIME) study. Learning vector quantization (LVQ) neural network, multilayer perceptron (MLP) neural network, and support vector machines (SVMs) are tested as the classifiers. After systematic rejection of difficult to classify segments, the models can achieve 85%-87% correct classification while rejecting only 30% of the data. This corresponds to a Kappa statistic of 0.65-0.68. With rejection, accuracy improves by about 8% over a model without rejection. Additionally, the impact of the PSG scored indeterminate state epochs is analyzed. The advantages of a reliable sleep/wake classifier based only on ECG include high accuracy, simplicity of use, and low intrusiveness. Reliability of the classification can be built directly in the model, such that unreliable segments are rejected.

Non-invasive monitoring of chewing and swallowing for objective quantification of ingestive behavior.

A methodology of studying of ingestive behavior by non-invasive monitoring of swallowing (deglutition) and chewing (mastication) has been developed. The target application for the developed methodology is to study the behavioral patterns of food consumption and producing volumetric and weight estimates of energy intake. Monitoring is non-invasive based on detecting swallowing by a sound sensor located over laryngopharynx or by a bone-conduction microphone and detecting chewing through a below-the-ear strain sensor. Proposed sensors may be implemented in a wearable monitoring device, thus enabling monitoring of ingestive behavior in free-living individuals. In this paper, the goals in the development of this methodology are two-fold. First, a system comprising sensors, related hardware and software for multi-modal data capture is designed for data collection in a controlled environment. Second, a protocol is developed for manual scoring of chewing and swallowing for use as a gold standard. The multi-modal data capture was tested by measuring chewing and swallowing in 21 volunteers during periods of food intake and quiet sitting (no food intake). Video footage and sensor signals were manually scored by trained raters. Inter-rater reliability study for three raters conducted on the sample set of five subjects resulted in high average intra-class correlation coefficients of 0.996 for bites, 0.988 for chews and 0.98 for swallows. The collected sensor signals and the resulting manual scores will be used in future research as a gold standard for further assessment of sensor design, development of automatic pattern recognition routines and study of the relationship between swallowing/chewing and ingestive behavior.

Sustainable urban systems: Co-design and framing for transformation.

Rapid urbanisation generates risks and opportunities for sustainable development. Urban policy and decision makers are challenged by the complexity of cities as social-ecological-technical systems. Consequently there is an increasing need for collaborative knowledge development that supports a whole-of-system view, and transformational change at multiple scales. Such holistic urban approaches are rare in practice. A co-design process involving researchers, practitioners and other stakeholders, has progressed such an approach in the Australian context, aiming to also contribute to international knowledge development and sharing. This process has generated three outputs: (1) a shared framework to support more systematic knowledge development and use, (2) identification of barriers that create a gap between stated urban goals and actual practice, and (3) identification of strategic focal areas to address this gap. Developing integrated strategies at broader urban scales is seen as the most pressing need. The knowledge framework adopts a systems perspective that incorporates the many urban trade-offs and synergies revealed by a systems view. Broader implications are drawn for policy and decision makers, for researchers and for a shared forward agenda.

Retrospective mortality among refugees from the Central African Republic arriving in Chad, 2014.

BACKGROUND: The Central African Republic has known long periods of instability. In 2014, following the fall of an interim government installed by the Séléka coalition, a series of violent reprisals occurred. These events were largely directed at the country's Muslim minority and led to a massive displacement of the population. In 2014, we sought to document the retrospective mortality among refugees arriving from the CAR into Chad by conducting a series of surveys. METHODS: The Sido camp was surveyed exhaustively in March-April 2014 and a systematic sampling strategy was used in the Goré camp in October 2014. The survey recall period began November 1, 2013, just before the major anti-Balaka offensive. Heads of households were asked to describe their household composition at the beginning of and throughout the recall period. For household members reported as dying, further information about the date and circumstances of death was obtained. RESULTS: In Sido, 3449 households containing 25 353 individuals were interviewed. A total of 2599 deaths were reported, corresponding to a crude mortality rate of 6.0/10000 persons/day, and 8% of the population present at the beginning of the recall period died. Most (82.4%) deaths occurred among males, most deaths occurred in December 2013 and January 2014, and 92% were due to violence in the CAR. In Goré, 1383 households containing 8614 individuals were interviewed. A total of 1203 deaths were reported, corresponding to a crude mortality rate of 3.7/10000 persons/day [95%CI 3.5-3.9], and 12% of the population present at the beginning of the recall period died. Most (77.1%) deaths occurred among males. As in Sido, most deaths occurred in December 2013 and January 2014, and 86% of all deaths were due to violence in the CAR. CONCLUSIONS: The results of these two surveys describe a part of the toll of the violent events of December 2013 and January 2014 in the Central African Republic.

Quantitative survey on health and violence endured by refugees during their journey and in Calais, France.

Background: In 2015, more than 1 million refugees arrived in Europe. During their travels, refugees often face harsh conditions, violence and torture in transit countries, but there is a lack of quantitative evidence on their experiences. We present the results of a retrospective survey among refugees in the 'Jungle' of Calais, France, to document their health problems and the violence they endured during their journeys. Methods: We conducted a cross-sectional population-based survey in November and December 2015. The sample size was set at 402 individuals, and geospatial simple random sampling was used. We collected data on demographics, routes travelled, health status, violence and future plans. Results: Departures from the country of origin increased beginning in September 2015. Sixty-one percent of respondents reported having at least one health problem, especially while in Calais. Overall, 65.6% (95% CI 60.3-70.6) experienced at least one violent event en route; 81.5% of refugees wanted to go to the UK. Conclusions: This first quantitative survey conducted among refugees in Europe provides important socio-demographic data on refugees living in Calais and describes the high rate of violence they encountered during their journeys. Similar documentation should be repeated throughout Europe in order to better respond to the needs of this vulnerable population.

Factors that influence use of a home cardiorespiratory monitor for infants: the collaborative home infant monitoring evaluation.

BACKGROUND: As part of the Collaborative Home Infant Monitoring Evaluation, a home monitor was developed to record breathing, heart rate, other physiologic variables, and the time the monitor was used. OBJECTIVE: To determine the frequency of monitor use, factors that influence use, and validity of a model developed to predict use. DESIGN: We developed a model to predict monitor use using multiple linear regression analysis; we then tested the validity of this model to predict adherence for the first week of monitoring and for the subsequent 4-week period (weeks 2-5). SETTING: Clinical research centers in Chicago, Ill; Cleveland, Ohio; Honolulu, Hawaii; Los Angeles, Calif; and Toledo, Ohio. Patients Preterm infants, infants younger than 1 month with a history of autopsy-confirmed sudden infant death syndrome in a sibling, and infants with an idiopathic apparent life-threatening event were divided into 2 cohorts based on enrollment date. Main Outcome Measure Mean hours of monitor use per week. RESULTS: In cohort 1, the variables available before monitoring were only weakly associated with total hours of monitor use in weeks 2 to 5 (total model r(2) = 0.08). However, when hours of monitor use in week 1 were included as a variable to predict monitor use in weeks 2 to 5, the r(2) increased to 0.64 for hours of monitor use per week. CONCLUSIONS: Our data show that monitor use in the first week was the most important variable for predicting subsequent monitor use. The study suggests that a major focus of home monitoring should be adherence in the first week, although it remains to be tested whether this adherence can be altered.

Thin-film microelectronic wearable body sensors.

This review of various applications of well-established thin-film processing techniques to wearable body sensors gives examples of work done in the author's laboratory over many years. Sensors for the vital signs of body temperature, electrocardiogram, heart rate, breathing pattern and breathing rate are presented along with other applications. Thin-film based sensors have the advantage of small size, high surface area to mass ratio, flexibility, capability for batch production, and compatibility with other microelectronic technologies.

Ontogeny of arousal.

Ontogeny of arousal data constitute a vital supplement to the sparse literature on spontaneous neuronal activity. These data demonstrate that measurable infant spontaneous arousals (SAs) with an inherent oscillatory entrainment occur six times more in active sleep than in quiet sleep of the same duration and are identifiable as a human neurobiologic function. These SAs are not significantly associated with race or ethnicity, gender, total hours spent sleeping, percent time spent in active or quiet sleep, preterm status, history of a life-threatening event, having had a sibling who died of sudden infant death syndrome (SIDS), or having had a mother who smoked during this pregnancy. As measurable neurophysiologic events, SAs establish parameters for research at molecular and molar levels focusing on several critical areas: (1) the neuronal control of SA related to neurotransmitters, (2) as a significant antecedent factor in clinical cardiorespiratory events occurring in infants at high epidemiologic risk for SIDS; (3) as a regulatory biologic factor underlying temperament and executive cognitive functioning, and (4) morbidity and mortality effects possibly related to therapeutic interventions that alter SA levels.

Development and study of an amperometric biosensor for the in vitro measurement of low concentration of putrescine in blood.

An amperometric biosensor was developed for the in vitro determination of putrescine in blood samples because elevated level of putrescine in blood can be a diagnostic indicator of certain kinds of cancer. The electrochemical transducer consisted of a flat form, three electrode amperometric micro-cell fabricated with thin film photolithography on flexible Kapton substrate. An immobilized putrescine oxidase (PUO) layer provided the biocatalytic oxidation of the putrescine, while the generated hydrogen peroxide was detected on the platinum-working electrode. An electropolymerized poly(m-phenylenediamine) (pPDA) size-exclusion layer was used to protect the working electrode from fouling and to prevent signal generation by common electroactive interferents present in blood. The preparation of the biocatalytic enzyme- and outer protective layers was optimized for improved sensitivity and response time. A detection limit of 50 nM was achieved in pH-adjusted whole blood samples, which is below pathological levels.

Activity-based sleep-wake identification in infants.

Actigraphy offers one of the best-known alternatives to polysomnography for sleep-wake identification. The advantages of actigraphy include high accuracy, simplicity of use and low intrusiveness. These features allow the use of actigraphy for determining sleep-wake states in such highly sensitive groups as infants. This study utilizes a motion sensor (accelerometer) for a dual purpose: to determine an infant's position in the crib and to identify sleep-wake states. The accelerometer was positioned over the sacral region on the infant's diaper, unlike commonly used attachment to an ankle. Opposed to broadly used discriminant analysis, this study utilized logistic regression and neural networks as predictors. The accuracy of predicted sleep-wake states was established in comparison to the sleep-wake states recorded by technicians in a polysomnograph study. Both statistical and neural predictors of this study provide an accuracy of approximately 77-92% which is comparable to similar studies achieving prediction rates of 85-95%, thus validating the suggested methodology. The results support the use of body motion as a simple and reliable method for determining sleep-wake states in infants. Nonlinear mapping capabilities of the neural network benefit the accuracy of sleep-wake state identification. Utilization of the accelerometer for the dual purpose allows us to minimize intrusiveness of home infant monitors.

Neonatal heartbeat annunciator for use in the developing world.

The majority of neonatal deaths occur in the developing countries. In many cases, unresponsive infants at birth are alive although birth attendants think they are dead and do not attempt to resuscitate them. In order to address this problem, training for birth attendant skills for resuscitation and having a device to determine the newborn heartbeat are necessary. In this project, a neonatal heartbeat annunciator has been designed and undergone preliminary evaluation. The device is quickly attached and uses electrodes to pick up the ECG signal from the infant's chest. Following electronic processing, the heartbeat is indicated as a flash of LED light and the sound of a high-frequency buzzer. It is hoped that this device will encourage birth attendants to attempt to resuscitate unresponsive babies and help to reduce neonatal mortality.

Grand challenges in interfacing engineering with life sciences and medicine.

This paper summarizes the discussions held during the First IEEE Life Sciences Grand Challenges Conference, held on October 4-5, 2012, at the National Academy of Sciences, Washington, DC, and the grand challenges identified by the conference participants. Despite tremendous efforts to develop the knowledge and ability that are essential in addressing biomedical and health problems using engineering methodologies, the optimization of this approach toward engineering the life sciences and healthcare remains a grand challenge. The conference was aimed at high-level discussions by participants representing various sectors, including academia, government, and industry. Grand challenges were identified by the conference participants in five areas including engineering the brain and nervous system; engineering the cardiovascular system; engineering of cancer diagnostics, therapeutics, and prevention; translation of discoveries to clinical applications; and education and training. A number of these challenges are identified and summarized in this paper.

The development of the circadian heart rate rhythm (CHR) in Asian infants.

OBJECTIVE: To test the hypothesis that term-born Asian infants, at reduced risk to die of Sudden Infant Death Syndrome (SIDS) exhibit a circadian heart rate rhythm (CHR) at a later age than non-Asian term infants. METHOD: Repeated overnight heart rate (HR) traces obtained with a battery-operated Polar S810i heart-rate monitor at home in 17 Asian Torajan infants in Indonesia, were compared with those of 52 non-Asian infants monitored as part of the Collaborative Home Infant Monitoring Evaluation (CHIME). HR was determined using a moving window averaging technique. A comparison of median HR during quiet sleep (QS) episodes (identified by minimum HR variability), established the presence of CHR. RESULTS: Seventy three percent of non-Asian CHIME infants ≤7 weeks exhibited CHR compared to 45% of Asian Torajan infants. Between 8 and 12 weeks, 94% of non-Asian CHIME infants exhibited CHR, compared to 33% of Asian Torajan infants (p<0.001). Forty seven and 56% of Asian Torajan infants exhibited the CHR at the age intervals of 16-20 weeks and 21-25 weeks respectively. Active wakefulness percentages as a function of the entire recording and median QS HR were not significantly different in the two groups. CONCLUSION: Despite the fact that Asian Torajan infants were on average a week older than non-Asian CHIME babies, between two and three months of age only one in three exhibited the CHR, compared to virtually all non-Asian CHIME infants. We speculate that the cause of this difference rests in the infants' environment rather than their genetic origin.

Powering biomedical devices with body motion.

Energy harvesting from body motion is an alternative power source that can be used to energize miniature electronic biomedical devices. This technology can make it possible to recharge batteries to reduce the frequency of or eliminate surgeries to replace depleted cells. Power availability evaluation from walking and running at several body locations and different speeds is presented. Treadmill tests were performed on 11 healthy subjects to measure the accelerations at the ankle, knee, hip, chest, wrist, elbow, upper arm, and side of the head. Power was estimated from the treadmill results since it is proportional to the acceleration magnitudes and the frequency of occurrence. Available power output from walking was found to be more than 0.5 mW/cm(3) for all body locations while being more than 10 mW/cm(3) for the ankle and knee. Running results were at least 10 times higher than those from walking. An axial flux miniature electric dynamo using electromagnetic induction was evaluated for power generation. The device was composed of a rotor with multiple-pole permanent magnets positioned on an annular ring having an eccentric mass, and stacked planar coils as a stator. A 2 cm(3) prototype was found to generate 117 microW of power from the generator placed laterally on the ankle while walking.