Rationale and design of the SenseWhy project: A passive sensing and ecological momentary assessment study on characteristics of overeating episodes.

Objectives: Overeating interventions and research often focus on single determinants and use subjective or nonpersonalized measures. We aim to (1) identify automatically detectable features that predict overeating and (2) build clusters of eating episodes that identify theoretically meaningful and clinically known problematic overeating behaviors (e.g., stress eating), as well as new phenotypes based on social and psychological features. Method: Up to 60 adults with obesity in the Chicagoland area will be recruited for a 14-day free-living observational study. Participants will complete ecological momentary assessments and wear 3 sensors designed to capture features of overeating episodes (e.g., chews) that can be visually confirmed. Participants will also complete daily dietitian-administered 24-hour recalls of all food and beverages consumed. Analysis: Overeating is defined as caloric consumption exceeding 1 standard deviation of an individual's mean consumption per eating episode. To identify features that predict overeating, we will apply 2 complementary machine learning methods: correlation-based feature selection and wrapper-based feature selection. We will then generate clusters of overeating types and assess how they align with clinically meaningful overeating phenotypes. Conclusions: This study will be the first to assess characteristics of eating episodes in situ over a multiweek period with visual confirmation of eating behaviors. An additional strength of this study is the assessment of predictors of problematic eating during periods when individuals are not on a structured diet and/or engaged in a weight loss intervention. Our assessment of overeating episodes in real-world settings is likely to yield new insights regarding determinants of overeating that may translate into novel interventions.

Bourbon Virus Transmission, New York, USA.

In July 2019, Bourbon virus RNA was detected in an Amblyomma americanum tick removed from a resident of Long Island, New York, USA. Tick infection and white-tailed deer (Odocoileus virginianus) serosurvey results demonstrate active transmission in New York, especially Suffolk County, emphasizing a need for surveillance anywhere A. americanum ticks are reported.

SmokeMon: Unobtrusive Extraction of Smoking Topography Using Wearable Energy-Efficient Thermal.

Smoking is the leading cause of preventable death worldwide. Cigarette smoke includes thousands of chemicals that are harmful and cause tobacco-related diseases. To date, the causality between human exposure to specific compounds and the harmful effects is unknown. A first step in closing the gap in knowledge has been measuring smoking topography, or how the smoker smokes the cigarette (puffs, puff volume, and duration). However, current gold-standard approaches to smoking topography involve expensive, bulky, and obtrusive sensor devices, creating unnatural smoking behavior and preventing their potential for real-time interventions in the wild. Although motion-based wearable sensors and their corresponding machine-learned models have shown promise in unobtrusively tracking smoking gestures, they are notorious for confounding smoking with other similar hand-to-mouth gestures such as eating and drinking. In this paper, we present SmokeMon, a chest-worn thermal-sensing wearable system that can capture spatial, temporal, and thermal information around the wearer and cigarette all day to unobtrusively and passively detect smoking events. We also developed a deep learning-based framework to extract puffs and smoking topography. We evaluate SmokeMon in both controlled and free-living experiments with a total of 19 participants, more than 110 hours of data, and 115 smoking sessions achieving an F1-score of 0.9 for puff detection in the laboratory and 0.8 in the wild. By providing SmokeMon as an open platform, we provide measurement of smoking topography in free-living settings to enable testing of smoking topography in the real world, with potential to facilitate timely smoking cessation interventions.

Heartland Virus Transmission, Suffolk County, New York, USA.

During 2018, Heartland virus RNA was detected in an Amblyomma americanum tick removed from a resident of Suffolk County, New York, USA. The person showed seroconversion. Tick surveillance and white-tailed deer (Odocoileus virginianus) serosurveys showed widespread distribution in Suffolk County, emphasizing a need for disease surveillance anywhere A. americanum ticks are established or emerging.

Association of number of bites and eating speed with energy intake: Wearable technology results under free-living conditions.

Personalized weight management strategies are gaining interest. However, knowledge is limited regarding eating habits and association with energy intake, and current technologies limit assessment in free-living situations. We assessed associations between eating behavior and time of day with energy intake using a wearable camera under free-living conditions and explored if obesity modifies the associations. Sixteen participants (50% with obesity) recorded free-living eating behaviors using a wearable fish-eye camera for 14 days. Videos were viewed by trained annotators who confirmed number of bites, eating speed, and time of day for each eating episode. Energy intake was determined by a trained dietitian performing 24-h diet recalls. Greater number of bites, reduced eating speed, and increased BMI significantly predicted higher energy intake among all participants (P < 0.05, each). There were no significant interactions between obesity and number of bites, eating speed, or time of day (p > 0.05). Greater number of bites and reduced eating speed were significantly associated with higher energy intake in participants without obesity. Results show that under free-living conditions, more bites and slower eating speed predicted higher energy intake when examining consumption of foods with beverages. Obesity did not modify these associations. Findings highlight how eating behaviors can impact energy balance and can inform weight management interventions using wearable technology.

Validation Study of the Transfusion Risk and Clinical Knowledge (TRACK) Tool in Cardiac Surgery Patients: A Retrospective Analysis.

OBJECTIVE: The Transfusion Risk and Clinical Knowledge (TRACK) scoring system has been developed for predicting perioperative blood transfusions. However, the TRACK score needs to be validated externally in the US population. The primary objective of this study is to validate TRACK at the authors' institution. DESIGN: This study was a single-center retrospective analysis. SETTING: Operating room and intensive care units of academic medical center. PARTICIPANTS: Adult cardiac surgery patients. INTERVENTIONS: The authors retrospectively queried all cardiac surgeries at the authors' institution between 2010 and 2015 from the Society of Thoracic Surgeons database. The TRACK scores were determined for all patients. The authors used receiver operating characteristic (ROC) curves to assess the discriminatory power of TRACK in predicting any perioperative, intraoperative, and postoperative transfusions. The maximum Youden's index was used to determine optimal cutoff scores for predicting perioperative transfusions. MEASUREMENTS AND MAIN RESULTS: The authors analyzed 2,776 cardiac surgery patients with 51.8% transfused perioperatively. The average TRACK score (mean ± standard deviation) in transfused versus non-transfused patients was 12.4 ± 7.2 versus 6.1 ± 5.4, respectively (p < 0.001). The area under the ROC curve was 0.768 (95% confidence interval 0.800-0.835, p < 0.001) for any perioperative transfusion. Optimal sensitivity (67%) and specificity (73%) for predicting any perioperative transfusions was achieved with a TRACK score cutoff of greater than or equal to 22 of 32. CONCLUSION: This study demonstrates the validity of the TRACK score in predicting blood perioperative transfusions in cardiac surgery patients at the authors' institution. This study supports the external validity of TRACK and adds to its clinical utility by establishing cutoff scores for identifying patients at high risk of transfusion.

Modeling and Surveillance of Reporting Delays of Mosquitoes and Humans Infected With West Nile Virus and Associations With Accuracy of West Nile Virus Forecasts.

Importance: West Nile virus (WNV) is the leading cause of domestically acquired arboviral disease. Objective: To develop real-time WNV forecasts of infected mosquitoes and human cases. Design, Setting, and Participants: Real-time forecasts of WNV in 4 geographically dispersed locations in the United States were generated using a WNV model-inference forecasting system previously validated with retrospective data. Analysis was performed to evaluate how observational reporting delays of mosquito WNV assay results and human medical records were associated with real-time forecast accuracy. Exposures: Mosquitoes positive for WNV and human cases. Main Outcomes and Measures: Delays in reporting mosquito WNV assay results and human medical records and the association of these delays with real-time WNV forecast accuracy. Results: Substantial delays in data reporting exist for both infected mosquitoes and human WNV cases. For human cases, confirmed data (n = 37) lagged behind the onset of illness by a mean (SD) of 5.5 (2.3) weeks (range, 2-14 weeks). These human case reporting lags reduced mean forecast accuracy for the total number of human cases over the season in 110 simulated outbreaks for 2 forecasting systems by 26% and 14%, from 2 weeks before to 3 weeks after the predicted peak of infected mosquitoes. This period is the time span during which 47% of human cases are reported. Of 7064 mosquito pools, 500 (7%) tested positive; the reporting lag for these data associated with viral testing at a state laboratory was a mean (SD) of 6.6 (2.6) days (range, 4-11 days). This reporting lag was associated with decreased mean forecast accuracy for the 3 mosquito infection indicators, timing, magnitude, and season, by approximately 5% for both forecasting systems. Conclusions and Relevance: Delays in reporting human WNV disease and infected mosquito information are associated with difficulties in outbreak surveillance and decreased real-time forecast accuracy. Infected mosquito lags were short enough that skillful forecasts could still be generated for mosquito infection indicators, but the human WNV case lags were too great to support accurate forecasting in real time. Forecasting WNV is potentially an important evidence-based decision support tool for public health officials and mosquito abatement districts; however, to operationalize real-time forecasting, more resources are needed to reduce human case reporting lags between illness onset and case confirmation.

Epidemiology of Lyme disease among US Veterans in Long Island, New York.

In North America, Lyme disease (LD) is caused predominantly by the spirochete Borrelia burgdorferisensu stricto, and is transmitted by blacklegged ticks. Long Island, New York, is highly endemic for the disease. The C6 peptide (C6P) is currently used as a screening test for LD in our institution. Our objective was to examine how screening with C6P concorded with diagnosis of LD at the Veterans Affairs Medical Center, Northport, Long Island. A retrospective chart-review of 2558 C6P tests was performed during the period of 1/1/2010 to 12/31/2016. Patients were categorized by Lyme Disease (LD) or no LD groups. LD group was defined as having an erythema migrans (EM) rash, or ≥ 2 IgM bands or ≥ 5 IgG bands on immunoblot. Out of the 409 patients with positive or equivocal C6P, 181 patients with LD were based on presence of EM, or Western blot IgM and IgG test results; 228 did not have LD. The positive predictive value of C6P was 44.5%. EM was the most common presentation. In the LD group, history of tick bite (P: 0.0001), headache (P: 0.0036), joint swelling (P: 0.0086) and myalgias (P: 0.0005) were more likely to be present. Zip code mapping of our cases mirrored those previously reported in the Suffolk County Department of Health. In our review we encountered a significant number of false positive C6 assays. False positive C6P tests were ordered by primary care physicians (PCP) (37%) followed by neurologists (33%). A history of tick exposure and clinical findings of early Lyme disease such as headaches or joint aches were more likely to denote a true positive C6 peptide test. Rigorous education of physicians about Lyme disease and pitfalls of our available diagnostic tests are needed for their proper utilization.

A Randomized Comparison of Pain Control and Functional Mobility between Proximal and Distal Adductor Canal Blocks for Total Knee Replacement.

BACKGROUND: Adductor canal blocks (ACBs) have become a popular technique for postoperative pain control in total knee arthroplasty patients. Proximal and distal ACB have been compared previously, but important postoperative outcomes have yet to be assessed. AIMS: The primary objective of this study is to compare postoperative analgesia between proximal and distal ACB. Secondary outcomes include functional mobility, length of stay (LOS), and adverse events. SETTINGS AND DESIGN: This study was a single-center, assessor-blinded, randomized trial. SUBJECTS AND METHODS: Fifty-seven patients were randomly assigned to receive a proximal (n = 28) or distal (n = 29) ACB. A 20 mL bolus of 5 mg/mL ropivacaine was injected at the respective location followed by 2.0 mg/mL ropivacaine infusion for 24 h. STATISTICAL ANALYSIS: The primary outcome was intra- and postoperative 24-h opioid consumption in intravenous (IV) morphine equivalents. Secondary outcomes include percentage change in timed "Up and Go" (TUG) times, LOS, and average postoperative pain scores. Continuous variables were compared using Student's t-test. RESULTS: The mean (±standard deviation) 24-h intra-and postoperative opioid consumption showed no difference between the proximal and distal groups (39.72 ± 23.6 and 41.28 ± 19.6 mg IV morphine equivalents, respectively, P = 0.793). There was also no significant difference in the median [minimum, maximum] percentage change in TUG times relative to preoperative performance comparing proximal and distal ACB (334.0 [131, 1084] %-change and 458.5 [169, 1696] %-change, respectively, P = 0.130). In addition, there were no differences in postoperative pain scores or LOS. CONCLUSIONS: ACB performed at either proximal or distal locations shows no difference in postoperative pain measured by opioid consumption or pain scores. Better TUG performance seen in the proximal group was not statistically significant but might represent a clinically important difference in functional mobility.

A Retrospective Analysis of Clinical Research Misconduct Using FDA-Issued Warning Letters and Clinical Investigator Inspection List From 2010 to 2014.

BACKGROUND: The US Food and Drug Administration (FDA) conducts inspections of clinical investigation sites as a component of clinical trial regulation. The FDA describes the results of these inspections in the Clinical Investigator Inspection List (CLIIL). More serious violations are followed up in FDA warning letters issued to investigators. The primary objective of the current study is to qualitatively and quantitatively describe the CLIIL data and contents of FDA-issued warning letters from 2010 to 2014. METHODS: We retrospectively analyzed the CLIIL and FDA warning letters. For the CLIIL, we quantified the frequency of each violation among other data points. We compared recent data (2010-2014) to the previous 5 years (2005-2009). To analyze FDA warning letters, we developed a coding system to quantify the frequency of violations found. RESULTS: We analyzed 3637 inspections in the CLIIL database and 60 warning letters. Overall, there was a decrease or no change in all violations in the CLIIL database. The largest violation code reported was "failure to follow investigational plan" in both the 2005-2009 and 2010-2014 timeframes. Coding of FDA warning letters shows that the most common violations reported were failing to maintain accurate case histories (10.82%), enrolling ineligible subjects (8.85%), and failing to perform required tests (8.52%). CONCLUSIONS: The overall decrease in violations is encouraging. But, the high proportion of violations related to failure to follow the investigational plan is concerning as the complexity of trials increases. We conclude that more detailed information is necessary to accurately evaluate these violations. The current study provides a model for creating more granular data of violations to better inform clinical investigators and improve clinical trials.

Application of outcome measures in international humanitarian aid: comparing indices through retrospective analysis of corrective surgical care cases.

It is common for international organizations to provide surgical corrective care to vulnerable populations in developing countries. However, a current worsening of the overall surgical burden of disease in developing countries reflects an increasing lack of sufficient numbers of trained healthcare personnel, and renders outside volunteer assistance more desirable and crucial than ever. Unfortunately, program evaluation and monitoring, including outcome indices and measures of effectiveness, is not measured commonly. In 2005, Operation Smile International implemented an electronic medical record system that helps monitor a number of critical indices during surgical missions that are essential for quality assurance reviews. This record system also provided an opportunity to retrospectively evaluate cases from previous missions. Review of data sets from >8,000 cases in 2005 and 2006 has provided crucial information regarding the priority of surgery, perioperative and operative complications, and surgical program development. The most common procedure provided was unilateral cleft lip repair, followed closely by cleft palate. A majority of these interventions occurred for patients who were older than routinely provided for in the western world. The average child treated had an age:weight ratio at or below the [US] Centers for Disease Control and Prevention (CDC) 50th percentile, with a small percentage falling below the CDC 20th percentile. A majority of children had acceptable levels of hemoglobin, but the relative decreased age:weight ratio nonetheless can reflect mild malnutrition. Complications requiring medical intervention were seen in 1.2% of cases in 2005 and 1.0% in 2006. Thirty percent were reported as anesthesia complications, and 61% reported as surgical complications. One death was reported, but occurred after discharge outside the perioperative period. Complication rates are similar to rates reported in the US and UK and emphasizes the importance of standardization with uniform indices to compare quality performance and equity of care. This study offers an important example of the importance of collecting, analyzing, and reporting measures of effectiveness in all surgical settings.

Spinal stabilization exercises for the injured worker.

Returning the injured worker to his previous occupation can be a difficult and complex rehabilitation process. The goal of standard stabilization exercises (SSE) is to facilitate the active system for improved dynamic spinal stability. Improving dynamic spinal stability can decrease the forces placed on the intervertebral joints, which minimizes the chance of reinjury. When used in conjunction with industrial rehabilitation, SSEs offer the optimal environment for an injured worker to practice his occupational demands while using appropriate spinal stabilization.