Effect of TELEmedicine for Inflammatory Bowel Disease on Patient Activation and Self-Efficacy.

INTRODUCTION: Limitations in inflammatory bowel disease (IBD) care necessitate greater patient activation and self-efficacy, measures associated with positive health outcomes. METHODS: We assessed change in patient activation and general self-efficacy from baseline to 12 months through our TELEmedicine for IBD trial, a multicenter, randomized controlled trial consisting of a web-based monitoring system that interacts with participants via text messaging. A total of 222 adults with IBD who had experienced an IBD flare within 2 years prior to the trial were randomized into either a control arm that received standard care (SC) or an intervention arm that completed self-testing through the TELE-IBD system every other week (EOW) or weekly (W). RESULTS: Changes in self-efficacy scores were not significantly different between control and experimental groups. Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03). CONCLUSIONS: Use of remote monitoring did not improve self-efficacy or patient activation compared to routine care.

Correction to: Effect of TELEmedicine for Inflammatory Bowel Disease on Patient Activation and Self-Efficacy.

This manuscript is a secondary analysis of a large multicenter randomized controlled trial. The primary study is Cross RK et al., A Randomized Controlled Trial of TELEmedicine for patients with Inflammatory Bowel Disease (TELE-IBD). Am J Gastroenterol, 2019 Mar.

Brief Pain Inventory-Short Form: A New Method for Assessing Pain in the Emergency Department.

OBJECTIVE: The numeric rating scale (NRS), which does not capture the multidimensional experience of pain, is commonly used to measure pain in the emergency department (ED). In this study, we assess the utility and feasibility of the Brief Pain Inventory-Short Form (BPI-SF) in the ED. METHODS: This was a cross-sectional, prospective, convenience sample study of adult patients presenting to the ED with chest, abdominal, or musculoskeletal pain. Using confirmatory factor analysis, we investigated the construct validity of the BPI-SF. We determined the association between NRS and BPI-SF scores. We assessed the feasibility and utility of administering the BPI-SF in the ED setting by evaluating 1) the time required to complete the BPI-SF and 2) how patients perceive the BPI-SF compared with the NRS. RESULTS: One hundred participants were included for analysis. The median NRS pain level on ED arrival (interquartile range [IQR]) was 7 (5-8). The median BPI-SF score (IQR) was 57 (43-73) on a 0-110 scale. Fit indices for the two-factor structure were statistically superior when compared with the one-factor model of the BPI-SF (comparative fit index 0.90 vs 0.64). Higher pain severity score, pain interference score, and total BPI-SF score were associated with higher NRS scores (P < 0.01). The mean time needed to complete the BPI-SF (SD) was 3 minutes 47 seconds (1 minute 35 seconds). Seventy-three percent of the patients preferred the BPI-SF to the NRS for pain assessment in the ED. CONCLUSIONS: Our study demonstrates the validity, feasibility, and utility of the BPI-SF in the ED setting.

The Impact of Music on Nociceptive Processing.

OBJECTIVE: Music has been shown to modulate pain, although the impact of music on specific aspects of nociceptive processing is less well understood. Using quantitative sensory testing (QST), we assessed the impact of a novel music app on specific aspects of nociceptive processing. DESIGN: Within-subjects paired comparison of pain processing in control vs music condition. SETTING: Human psychophysical laboratory. SUBJECTS: Sixty healthy adult volunteers. METHODS: Subjects were assessed for baseline anxiety, depression, and catastrophizing using validated questionnaires. QSTs measured included 1) pain threshold and tolerance to deep muscle pressure, 2) pain with mechanical pinprick, 3) temporal summation of pain (TSP) with a repeated pain stimulus, and 4) conditioned pain modulation (CPM) with a second painful stimulus. QSTs were performed in the absence and presence of music delivered through a music app. RESULTS: We found an increase in pressure pain thresholds in both the forearm (P = 0.007) and trapezius (P = 0.002) with music, as well as a decrease in the amount of pinprick pain (P < 0.001) and TSP (P = 0.01) with music. Interestingly, CPM was also significantly diminished (P < 0.001) in the music condition. No significant difference in cold pain, anxiety, or situational catastrophizing was observed with music. Higher baseline pain catastrophizing scores were associated with less music-induced pressure pain reduction. CONCLUSIONS: Several measures of mechanical pain sensitivity were reduced with music. TSP, a measure of central sensitization, also decreased with music, but CPM, a measure of descending modulation of pain, was not further augmented by music.

A Brief Music App to Address Pain in the Emergency Department: Prospective Study.

BACKGROUND: Emergency physicians face the challenge of relieving acute pain daily. While opioids are a potent treatment for pain, the opioid epidemic has ignited a search for nonopioid analgesic alternatives that may decrease the dose or duration of opioid exposure. While behavioral therapies and complementary medicine are effective, they are difficult to deploy in the emergency department. Music is a potential adjunctive therapy that has demonstrated effectiveness in managing pain. OBJECTIVE: Our objective was to understand the feasibility and potential for an effect of a novel music app to address acute pain and anxiety in patients admitted to an emergency department observation unit. METHODS: This prospective cohort study enrolled patients admitted to an emergency department observation unit with pain who had received orders for opioids. We gathered baseline pain and psychosocial characteristics including anxiety, sleep disturbance, and pain catastrophizing using validated questionnaires. Participants received a smartphone-based music intervention and listened to the music in either a supervised (research assistant-delivered music session 3 times during their stay) or unsupervised manner (music used ad lib by participant). The app collected premusic and postmusic pain and anxiety scores, and participants provided qualitative feedback regarding acceptability of operating the music intervention. RESULTS: We enrolled 81 participants and randomly assigned 38 to an unsupervised and 43 to a supervised group. Mean pain in both groups was 6.1 (1.8) out of a possible score of 10. A total of 43 (53%) reported previous use of music apps at home. We observed an overall modest but significant decrease in pain (mean difference -0.81, 95% CI -0.45 to -1.16) and anxiety (mean difference -0.72, 95% CI -0.33 to -1.12) after music sessions. Reduction of pain and anxiety varied substantially among participants. Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief. Changes in pain were correlated to changes in anxiety (Pearson ρ=0.3, P=.02) but did not vary between supervised and unsupervised groups. Upon conclusion of the study, 46/62 (74%) reported they liked the music intervention, 57/62 (92%) reported the app was easy to use, and 49/62 (79%) reported they would be willing to use the music intervention at home. CONCLUSIONS: A smartphone-based music intervention decreased pain and anxiety among patients in an emergency department observation unit, with no difference between supervised and unsupervised use. Individuals reporting the greatest reduction in pain after music sessions included those scoring highest on baseline assessment of catastrophic thinking, suggesting there may be specific patient populations that may benefit more from using music as an analgesic adjunct in the emergency department. Qualitative feedback suggested that this intervention was feasible and acceptable by emergency department patients.

A Randomized Controlled Trial of TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD).

INTRODUCTION: Telemedicine has shown promise in inflammatory bowel disease (IBD). The objective of this study was to compare disease activity and quality of life (QoL) in a 1-year randomized trial of IBD patients receiving telemedicine vs. standard care. METHODS: Patients with worsening symptoms in the prior 2 years were eligible for randomization to telemedicine (monitoring via texts EOW or weekly) or standard care. The primary outcomes were the differences in change in disease activity and QoL between the groups; change in healthcare utilization among groups was a secondary aim. RESULTS: 348 participants were enrolled (117 control group, 115 TELE-IBD EOW, and 116 TELE-IBD weekly). 259 (74.4%) completed the study. Age was 38.9 ± 12.3 years, 56.6% were women, 91.9% were Caucasian, 67.9% had Crohn's disease (CD) and 42.5% had active disease at baseline. In CD, all groups experienced a decrease in disease activity (control -5.2 ± 5.0 to 3.7 ± 3.6, TELE-IBD EOW 4.7 ± 4.1 to 4.2 ± 3.9, and TELE-IBD weekly 4.2 ± 4.2 to 3.2 ± 3.4, p < 0.0001 for each of the groups) In UC, only controls had a significant decrease in disease activity (control 2.9 ± 3.1 to 1.4 ± 1.4, p = 0.01, TELE-IBD EOW 2.7 ± 3.1 to 1.7 ± 1.9, p = 0.35, and TELE-IBD Weekly 2.5 ± 2.5 to 2.0 ± 1.8, p = 0.31). QoL increased in all groups; the increase was significant only in TELE-IBD EOW (control 168.1 ± 34.0 to 179.3 ± 28.2, p = 0.06, TELE-IBD EOW 172.3 ± 33.1 to 181.5 ± 28.2, p = 0.03, and TELE-IBD Weekly 172.3 ± 34.5 to 179.2 ± 32.8, p = 0.10). Unadjusted and adjusted changes in disease activity and QoL were not significantly different among groups. Healthcare utilization increased in all groups. TELE-IBD weekly were less likely to have IBD-related hospitalizations and more likely to have non-invasive diagnostic tests and electronic encounters compared to controls; both TELE-IBD groups had decreased non-IBD related hospitalizations and increased telephone calls compared to controls. DISCUSSION: Disease activity and QoL, although improved in all participants, were not improved further through use of the TELE-IBD system. TELE-IBD participants experienced a decrease in hospitalizations with an associated increase in non-invasive diagnostic tests, telephone calls and electronic encounters. Research is needed to determine if TELE-IBD can be improved through patient engagement and whether it can decrease healthcare utilization by replacing standard care.

An Internet of Things Buttons to Measure and Respond to Restroom Cleanliness in a Hospital Setting: Descriptive Study.

BACKGROUND: Restroom cleanliness is an important factor in hospital quality. Due to its dynamic process, it can be difficult to detect the presence of dirty restrooms that need to be cleaned. Using an Internet of Things (IoT) button can permit users to designate restrooms that need cleaning and in turn, allow prompt response from housekeeping to maintain real-time restroom cleanliness. OBJECTIVE: This study aimed to describe the deployment of an IoT button-based notification system to measure hospital restroom cleanliness reporting system usage and qualitative feedback from housekeeping staff on IoT button use. METHODS: We deployed IoT buttons in 16 hospital restrooms. Over an 8-month period, housekeeping staff received real-time notifications and responded to button presses for restroom cleaning. All button presses were recorded. We reported average button usage by hospital area, time of day, and day of week. We also conducted interviews with housekeeping supervisors and staff to understand their acceptance of and experience with the system. RESULTS: Over 8 months, 1920 requests to clean restrooms in the main hospital lobby and satellite buildings were received. The hospital lobby IoT buttons received over half (N=1055, 55%) of requests for cleaning. Most requests occurred in afternoon hours from 3 PM to midnight. Requests for cleaning remained stable throughout the work week with fewer requests occurring over weekends. IoT button use was sustained throughout the study period. Interviews with housekeeping supervisors and staff demonstrated acceptance of the IoT buttons; actual use was centered around asynchronous communication between supervisors and staff in response to requests to clean restrooms. CONCLUSIONS: An IoT button system is a feasible method to generate on-demand request for restroom cleaning that is easy to deploy and that users will consistently engage with. Data from this system have the potential to enable responsive scheduling for restroom service and anticipate periods of high restroom utilization in a hospital.

Internet of Things Buttons for Real-Time Notifications in Hospital Operations: Proposal for Hospital Implementation.

BACKGROUND: Hospital staff frequently performs the same process hundreds to thousands of times a day. Customizable Internet of Things buttons are small, wirelessly-enabled devices that trigger specific actions with the press of an integrated button and have the potential to automate some of these repetitive tasks. In addition, IoT buttons generate logs of triggered events that can be used for future process improvements. Although Internet of Things buttons have seen some success as consumer products, little has been reported on their application in hospital systems. OBJECTIVE: We discuss potential hospital applications categorized by the intended user group (patient or hospital staff). In addition, we examine key technological considerations, including network connectivity, security, and button management systems. METHODS: In order to meaningfully deploy Internet of Things buttons in a hospital system, we propose an implementation framework grounded in the Plan-Do-Study-Act method. RESULTS: We plan to deploy Internet of Things buttons within our hospital system to deliver real-time notifications in public-facing tasks such as restroom cleanliness and critical supply restocking. We expect results from this pilot in the next year. CONCLUSIONS: Overall, Internet of Things buttons have significant promise; future rigorous evaluations are needed to determine the impact of Internet of Things buttons in real-world health care settings.

Risk Factors for Vitamin D Deficiency and Impact of Repletion in a Tertiary Care Inflammatory Bowel Disease Population.

INTRODUCTION: Many patients with inflammatory bowel disease (IBD) are vitamin D deficient. The purpose of our study was to identify risk factors for vitamin D deficiency in IBD and to assess the impact of vitamin D repletion on disease activity and quality of life (QOL). METHODS: Patients with at least one 25-OH vitamin D level measured between 2004 and 2011 were included. Patients with a level <30 ng/ml at baseline were followed until the time of repletion. QOL and disease activity scores were measured at baseline and repletion. RESULTS: A total of 255 patients were identified. 33, 29, and 39% had a vitamin D level of ≥30, 20-29, and <20 ng/ml, respectively. When adjusting for disease type and duration, gender, smoking, and race, non-Caucasians had 5.3 (2.3-12.3) and UC patients had a 0.59 (0.33-1.03) odds of having a vitamin D <30 ng/ml. Women were 1.7 times more likely to have a 25-OH vitamin D level <20 ng/ml than men. 55 patients underwent repletion. In CD patients, the HBI and SIBDQ prior to repletion was 5.5 ± 4.9 and 44.3 ± 16.4, respectively; these improved to 3.6 ± 3.4 and 48.6 ± 14.2 after repletion (p = 0.0154 and p = 0.0684). CONCLUSIONS: In this tertiary care IBD cohort, the majority of patients have low vitamin D levels. Non-Caucasian race and female gender are associated with low vitamin D. UC was associated with lower risk of vitamin D insufficiency. In CD, vitamin D repletion is associated with decreased disease activity and increased QOL.

The Use of Temporary Fecal Diversion in Colonic and Perianal Crohn's Disease Does Not Improve Outcomes.

AIMS: To determine whether temporary fecal diversion for refractory colonic and/or perianal Crohn's disease can lead to clinical remission and restoration of intestinal continuity after optimization of medical therapy. METHODS: We retrospectively reviewed our prospectively maintained database of patients treated at the University of Maryland for Crohn's disease between May 2004 and July 2014. Patients with colonic, perianal, or colonic and perianal Crohn's disease, who had fecal diversion for control of medically refractory and/or severe disease, were included. Outcomes, including disease activity and rate of ileostomy reversal, were evaluated up to 24 months from stoma formation. RESULTS: Thirty patients were identified. Fecal diversion was performed for perianal disease in 37%, colonic disease in 33%, and both in 30% of patients. Twelve (40%) patients underwent ileostomy reversal. Twenty-five percent of patients with perianal disease had their ostomies reversed compared to 70% of patients with colonic disease alone. More patients with complex compared to simple perianal disease remained diverted (p = 0.02). Six (20%) patients required colectomy. Of these, 50% had complex perianal disease, all had received two or more biologics, and two-thirds were on combination therapy pre-diversion. CONCLUSIONS: Our study found that nearly two-thirds of patients with medically refractory colonic and/or severe perianal Crohn's disease treated with fecal diversion and optimization of postoperative medical therapy remain diverted or require colectomy within two years after ileostomy formation. In patients with severe, refractory perianal disease and those treated with combination therapy and >1 biologic exposure pre-diversion, colectomy rather than temporary fecal diversion should be considered.

Psoriasiform Skin Lesions Are Caused by Anti-TNF Agents Used for the Treatment of Inflammatory Bowel Disease.

BACKGROUND: Tumor necrosis factor (TNF) antagonists used for the treatment of inflammatory bowel disease (IBD) have been associated with the development of psoriasiform skin lesions. We assessed the demographic and clinical characteristics associated with and outcomes of patients with anti-TNF-induced psoriasiform lesions. METHODS: Patients with Crohn's disease (CD) and ulcerative colitis (UC) receiving treatment with anti-TNF therapy (infliximab, adalimumab, or certolizumab pegol) at a tertiary referral center were identified using an IRB-approved clinical data repository. Patients that developed psoriasiform skin lesions after initiation of anti-TNF therapy were included as cases. A group of anti-TNF-treated patients without drug-related psoriasiform lesions were identified as controls. The association between demographic and clinical variables and psoriasiform lesions was assessed using Chi-square analyses and multivariable logistic regression. RESULTS: Five hundred twenty-one patients with IBD undergoing treatment with anti-TNF therapy were identified; of these, 18 (3.5%) had psoriasiform lesions (16 CD and 2 UC). Seventy-two patients were identified as controls. Lesions developed a mean of 58 weeks (range 4-240 weeks) after starting anti-TNF therapy. The majority of patients were female and Caucasian (63 and 78%, respectively). Thirty-nine percent of patients had upper tract disease location. Forty-five patients (50%) were current or former smokers. Location of psoriasiform lesions included palmo-plantar (53%), trunk (47%), and scalp (53%), with 88% reporting involvement of ≥2 locations. Treatment of psoriasiform lesions was instituted with topical therapy in eight patients and systemic therapy (± phototherapy) in five patients. Discontinuation of anti-TNF therapy was recommended in nine patients (50%); of those, three were retreated with a second anti-TNF agent and all had recurrence of psoriasiform lesions. When adjusted for multiple variables, upper GI tract disease was significantly associated with psoriasiform lesions. CONCLUSIONS: Anti-TNF-induced psoriasiform lesions developed in 3.5% of patients with IBD at a tertiary referral center. Similar to prior published studies, most patients were female, had involvement of the palmo-plantar and scalp regions, and did not have severe IBD activity. The presence of upper tract disease was associated with the development of psoriasiform lesions. Skin lesions led to discontinuation of anti-TNF therapy in 50% of patients. Based upon these results, IBD providers should educate patients about this adverse effect, refer to dermatology for treatment, and discuss alternative IBD therapeutic options early if a severe psoriasiform rash develops.

A Pilot of Digital Whiteboards for Improving Patient Satisfaction in the Emergency Department: Nonrandomized Controlled Trial.

BACKGROUND: Electronic paper (E-paper) screens use electrophoretic ink to provide paper-like low-power displays with advanced networking capabilities that may potentially serve as an alternative to traditional whiteboards and television display screens in hospital settings. E-paper may be leveraged in the emergency department (ED) to facilitate communication. Providing ED patient status updates on E-paper screens could improve patient satisfaction and overall experience and provide more equitable access to their health information. OBJECTIVE: We aimed to pilot a patient-facing digital whiteboard using E-paper to display relevant orienting and clinical information in real time to ED patients. We also sought to assess patients' satisfaction after our intervention and understand our patients' overall perception of the impact of the digital whiteboards on their stay. METHODS: We deployed a 41-inch E-paper digital whiteboard in 4 rooms in an urban, tertiary care, and academic ED and enrolled 110 patients to understand and evaluate their experience. Participants completed a modified Hospital Consumer Assessment of Health Care Provider and Systems satisfaction questionnaire about their ED stay. We compared responses to a matched control group of patients triaged to ED rooms without digital whiteboards. We designed the digital whiteboard based on iterative feedback from various departmental stakeholders. After establishing IT infrastructure to support the project, we enrolled patients on a convenience basis into a control and an intervention (digital whiteboard) group. Enrollees were given a baseline survey to evaluate their comfort with technology and an exit survey to evaluate their opinions of the digital whiteboard and overall ED satisfaction. Statistical analysis was performed to compare baseline characteristics as well as satisfaction. RESULTS: After the successful prototyping and implementation of 4 digital whiteboards, we screened 471 patients for inclusion. We enrolled 110 patients, and 50 patients in each group (control and intervention) completed the study protocol. Age, gender, and racial and ethnic composition were similar between groups. We saw significant increases in satisfaction on postvisit surveys when patients were asked about communication regarding delays (P=.03) and what to do after discharge (P=.02). We found that patients in the intervention group were more likely to recommend the facility to family and friends (P=.04). Additionally, 96% (48/50) stated that they preferred a room with a digital whiteboard, and 70% (35/50) found the intervention "quite a bit" or "extremely" helpful in understanding their ED stay. CONCLUSIONS: Digital whiteboards are a feasible and acceptable method of displaying patient-facing data in the ED. Our pilot suggested that E-paper screens coupled with relevant, real-time clinical data and packaged together as a digital whiteboard may positively impact patient satisfaction and the perception of the facility during ED visits. Further study is needed to fully understand the impact on patient satisfaction and experience. TRIAL REGISTRATION: ClinicalTrials.gov NCT04497922; https://clinicaltrials.gov/ct2/show/NCT04497922.

Reducing COVID-19 Health Inequities by Identifying Social Needs and Clinical Deterioration of Discharged Emergency Department Patients.

INTRODUCTION: The decision to discharge a patient from the hospital with confirmed or suspected coronavirus 2019 (COVID-19) is fraught with challenges. Patients who are discharged home must be both medically stable and able to safely isolate to prevent disease spread. Socioeconomically disadvantaged patient populations in particular may lack resources to safely quarantine and are at high risk for COVID-19 morbidity. METHODS: We developed a telehealth follow-up program for emergency department (ED) patients who received testing for COVID-19 from April 24-June 29, 2020 and were discharged home. Patients who were discharged with a pending COVID-19 test received follow-up calls on Days 1, 4, and 8. The objective of our program was to screen and provide referrals for health-related social needs (HRSN), conduct clinical screening for worsening symptoms, and deliver risk-reduction strategies for vulnerable individuals. We conducted retrospective chart reviews on all patients in this cohort to collect demographic information, testing results, and outcomes of clinical symptom and HRSN screening. Our primary outcome measurement was the need for clinical reassessment and referral for an unmet HRSN. RESULTS: From April 24-June 29, 2020, we made calls to 1,468 patients tested for COVID-19 and discharged home. On Day 4, we reached 67.0% of the 1,468 patients called. Of these, 15.9% were referred to a physician's assistant (PA) out of concern for clinical worsening and 12.4% were referred to an emergency department (ED) patient navigator for HRSNs. On Day 8, we reached 81.8% of the 122 patients called. Of these, 19.7% were referred to a PA for clinical reassessment and 14.0% were referred to an ED patient navigator for HRSNs. Our intervention reached 1,069 patients, of whom 12.6% required referral for HRSNs and 1.3% (n = 14) were referred to the ED or Respiratory Illness Clinic due to concern for worsening clinical symptoms. CONCLUSION: In this patient population, the demand for interventions to address social needs was as high as the need for clinical reassessment. Similar ED-based programs should be considered to help support patients' interdependent social and health needs beyond those related to COVID-19.

The Effect of Noise-Masking Earbuds (SleepBuds) on Reported Sleep Quality and Tension in Health Care Shift Workers: Prospective Single-Subject Design Study.

BACKGROUND: Shift work is associated with sleep disorders, which impair alertness and increase risk of chronic physical and mental health disease. In health care workers, shift work and its associated sleep loss decrease provider wellness and can compromise patient care. Pharmacological sleep aids or substances such as alcohol are often used to improve sleep with variable effects on health and well-being. OBJECTIVE: We tested whether use of noise-masking earbuds can improve reported sleep quality, sleepiness, and stress level in health care shift workers, and increase alertness and reaction time post night shift. METHODS: Emergency medicine resident physicians were recruited for a prospective, single-subject design study. Entrance surveys on current sleep habits were completed. For 14 days, participants completed daily surveys reporting sleep aid use and self-rated perceived sleepiness, tension level, and last nights' sleep quality using an 8-point Likert scale. After overnight shifts, 3-minute psychomotor vigilance tests (PVT) measuring reaction time were completed. At the end of 14 days, participants were provided noise-masking earbuds, which they used in addition to their baseline sleep regimens as they were needed for sleep for the remainder of the study period. Daily sleep surveys, post-overnight shift PVT, and earbud use data were collected for an additional 14 days. A linear mixed effects regression model was used to assess changes in the pre- and postintervention outcomes with participants serving as their own controls. RESULTS: In total, 36 residents were recruited, of whom 26 participants who completed daily sleep surveys and used earbuds at least once during the study period were included in the final analysis. The median number of days of earbud use was 5 (IQR 2-9) days of the available 14 days. On days when residents reported earbud use, previous nights' sleep quality increased by 0.5 points (P<.001, 95% CI 0.23-0.80), daily sleepiness decreased by 0.6 points (P<.001, 95% CI -0.90 to -0.34), and total daily tension decreased by 0.6 points (P<.001, 95% CI -0.81 to -0.32). These effects were more pronounced in participants who reported worse-than-average preintervention sleep scores. CONCLUSIONS: Nonpharmacological noise-masking interventions such as earbuds may improve daily sleepiness, tension, and perceived sleep quality in health care shift workers. Larger-scale studies are needed to determine this interventions' effect on other populations of shift workers' post-night shift alertness, users' long-term physical and mental health, and patient outcomes.

Prospective Validation of a Rapid Host Gene Expression Test to Discriminate Bacterial From Viral Respiratory Infection.

Importance: Bacterial and viral causes of acute respiratory illness (ARI) are difficult to clinically distinguish, resulting in the inappropriate use of antibacterial therapy. The use of a host gene expression-based test that is able to discriminate bacterial from viral infection in less than 1 hour may improve care and antimicrobial stewardship. Objective: To validate the host response bacterial/viral (HR-B/V) test and assess its ability to accurately differentiate bacterial from viral infection among patients with ARI. Design, Setting, and Participants: This prospective multicenter diagnostic study enrolled 755 children and adults with febrile ARI of 7 or fewer days' duration from 10 US emergency departments. Participants were enrolled from October 3, 2014, to September 1, 2019, followed by additional enrollment of patients with COVID-19 from March 20 to December 3, 2020. Clinical adjudication of enrolled participants identified 616 individuals as having bacterial or viral infection. The primary analysis cohort included 334 participants with high-confidence reference adjudications (based on adjudicator concordance and the presence of an identified pathogen confirmed by microbiological testing). A secondary analysis of the entire cohort of 616 participants included cases with low-confidence reference adjudications (based on adjudicator discordance or the absence of an identified pathogen in microbiological testing). Thirty-three participants with COVID-19 were included post hoc. Interventions: The HR-B/V test quantified the expression of 45 host messenger RNAs in approximately 45 minutes to derive a probability of bacterial infection. Main Outcomes and Measures: Performance characteristics for the HR-B/V test compared with clinical adjudication were reported as either bacterial or viral infection or categorized into 4 likelihood groups (viral very likely [probability score <0.19], viral likely [probability score of 0.19-0.40], bacterial likely [probability score of 0.41-0.73], and bacterial very likely [probability score >0.73]) and compared with procalcitonin measurement. Results: Among 755 enrolled participants, the median age was 26 years (IQR, 16-52 years); 360 participants (47.7%) were female, and 395 (52.3%) were male. A total of 13 participants (1.7%) were American Indian, 13 (1.7%) were Asian, 368 (48.7%) were Black, 131 (17.4%) were Hispanic, 3 (0.4%) were Native Hawaiian or Pacific Islander, 297 (39.3%) were White, and 60 (7.9%) were of unspecified race and/or ethnicity. In the primary analysis involving 334 participants, the HR-B/V test had sensitivity of 89.8% (95% CI, 77.8%-96.2%), specificity of 82.1% (95% CI, 77.4%-86.6%), and a negative predictive value (NPV) of 97.9% (95% CI, 95.3%-99.1%) for bacterial infection. In comparison, the sensitivity of procalcitonin measurement was 28.6% (95% CI, 16.2%-40.9%; P < .001), the specificity was 87.0% (95% CI, 82.7%-90.7%; P = .006), and the NPV was 87.6% (95% CI, 85.5%-89.5%; P < .001). When stratified into likelihood groups, the HR-B/V test had an NPV of 98.9% (95% CI, 96.1%-100%) for bacterial infection in the viral very likely group and a positive predictive value of 63.4% (95% CI, 47.2%-77.9%) for bacterial infection in the bacterial very likely group. The HR-B/V test correctly identified 30 of 33 participants (90.9%) with acute COVID-19 as having a viral infection. Conclusions and Relevance: In this study, the HR-B/V test accurately discriminated bacterial from viral infection among patients with febrile ARI and was superior to procalcitonin measurement. The findings suggest that an accurate point-of-need host response test with high NPV may offer an opportunity to improve antibiotic stewardship and patient outcomes.

Deployment of a wearable biosensor system in the emergency department: a technical feasibility study.

Wearable devices to detect changes in health status are increasingly adopted by consumers, yet hospitals remain slow to assimilate these devices into clinical practice. Despite the clear benefits of capturing clinical information in acutely ill patients, such technology remains difficult to implement in emergency medicine. To improve adoption, barriers must first be removed. In our technical feasibility and acceptability trial, we studied the deployment of a wearable wireless biosensor that collects physiological data. We enrolled 44 adult patients receiving care in an emergency department observation unit. After we consented patients for participation, we applied biosensors to their chest and collected basic demographic and clinical information. We then collected biosensor data on an isolated system and measured patient experience via an exit survey. Throughout this process we documented and studied technical challenges. Overall, the technology was feasible to deploy in the emergency department observation unit and was acceptable to participants. Such technologies have tremendous future operational and clinical implications in settings ranging from emergency to home-care.

Electronic Paper Displays in Hospital Operations: Proposal for Deployment and Implementation.

BACKGROUND: Display signage is ubiquitous and essential in hospitals to serve several clerical, operational, and clinical functions, including displaying notices, providing directions, and presenting clinical information. These functions improve efficiency and patient engagement, reduce errors, and enhance the continuity of care. Over time, signage has evolved from analog approaches such as whiteboards and handwritten notices to digital displays such as liquid crystal displays, light emitting diodes, and, now, electronic ink displays. Electronic ink displays are paper-like displays that are not backlit and show content by aligning microencapsulated color beads in response to an applied electric current. Power is only required to generate content and not to retain it. These displays are very readable, with low eye strain; minimize the emission of blue light; require minimal power; and can be driven by several data sources, ranging from virtual servers to electronic health record systems. These attributes make adapting electronic ink displays to hospitals an ideal use case. OBJECTIVE: In this paper, we aimed to outline the use of signage and displays in hospitals with a focus on electronic ink displays. We aimed to assess the advantages and limitations of using these displays in hospitals and outline the various public-facing and patient-facing applications of electronic ink displays. Finally, we aimed to discuss the technological considerations and an implementation framework that must be followed when adopting and deploying electronic ink displays. METHODS: The public-facing applications of electronic ink displays include signage and way-finders, timetables for shared workspaces, and noticeboards and bulletin boards. The clinical display applications may be smaller form factors such as door signs or bedside cards. The larger, ≥40-inch form factors may be used within patient rooms or at clinical command centers as a digital whiteboard to display general information, patient and clinician information, and care plans. In all these applications, such displays could replace analog whiteboards, noticeboards, and even other digital screens. RESULTS: We are conducting pilot research projects to delineate best use cases and practices in adopting electronic ink displays in clinical settings. This will entail liaising with key stakeholders, gathering objective logistical and feasibility data, and, ultimately, quantifying and describing the effect on clinical care and patient satisfaction. CONCLUSIONS: There are several use cases in a clinical setting that may lend themselves perfectly to electronic ink display use. The main considerations to be studied in this adoption are network connectivity, content management, privacy and security robustness, and detailed comparison with existing modalities. Electronic ink displays offer a superior opportunity to future-proof existing practices. There is a need for theoretical considerations and real-world testing to determine if the advantages outweigh the limitations of electronic ink displays.

Epidemiological and Immunological Features of Obesity and SARS-CoV-2.

Obesity is a key correlate of severe SARS-CoV-2 outcomes while the role of obesity on risk of SARS-CoV-2 infection, symptom phenotype, and immune response remain poorly defined. We examined data from a prospective SARS-CoV-2 cohort study to address these questions. Serostatus, body mass index, demographics, comorbidities, and prior COVID-19 compatible symptoms were assessed at baseline and serostatus and symptoms monthly thereafter. SARS-CoV-2 immunoassays included an IgG ELISA targeting the spike RBD, multiarray Luminex targeting 20 viral antigens, pseudovirus neutralization, and T cell ELISPOT assays. Our results from a large prospective SARS-CoV-2 cohort study indicate symptom phenotype is strongly influenced by obesity among younger but not older age groups; we did not identify evidence to suggest obese individuals are at higher risk of SARS-CoV-2 infection; and remarkably homogenous immune activity across BMI categories suggests immune protection across these groups may be similar.

Discrete SARS-CoV-2 antibody titers track with functional humoral stability.

Antibodies serve as biomarkers of infection, but if sustained can confer long-term immunity. Yet, for most clinically approved vaccines, binding antibody titers only serve as a surrogate of protection. Instead, the ability of vaccine induced antibodies to neutralize or mediate Fc-effector functions is mechanistically linked to protection. While evidence has begun to point to persisting antibody responses among SARS-CoV-2 infected individuals, cases of re-infection have begun to emerge, calling the protective nature of humoral immunity against this highly infectious pathogen into question. Using a community-based surveillance study, we aimed to define the relationship between titers and functional antibody activity to SARS-CoV-2 over time. Here we report significant heterogeneity, but limited decay, across antibody titers amongst 120 identified seroconverters, most of whom had asymptomatic infection. Notably, neutralization, Fc-function, and SARS-CoV-2 specific T cell responses were only observed in subjects that elicited RBD-specific antibody titers above a threshold. The findings point to a switch-like relationship between observed antibody titer and function, where a distinct threshold of activity-defined by the level of antibodies-is required to elicit vigorous humoral and cellular response. This response activity level may be essential for durable protection, potentially explaining why re-infections occur with SARS-CoV-2 and other common coronaviruses.