Vital Sign Measurements Research Articles

Low compliance to a vital sign safety protocol on general hospital wards: A retrospective cohort study

BackgroundPeriodic vital sign monitoring is commonly used to detect clinical deterioration. Incomplete assessment of Early Warning Score (EWS) and poor protocol compliance may negatively impact nurses’ responsiveness to critical situations. ObjectiveThis study assesses the quality of recorded EWSs and the degree of overall protocol compliance and protocol compliance in adverse event patients, in a centre that is an early adopter of an EWS safety protocol. DesignRetrospective single-centre cohort study. SettingGeneral hospital wards of a tertiary referral university medical centre. Participants48,864 patients admitted to general wards between 2015 and 2018. MethodsVital sign and Modified EWS (MEWS) data were collected from the electronic health record. MEWS completeness was evaluated by determining the proportion of missing values for each vital sign. To evaluate protocol compliance, we assessed whether the elapsed time between consecutive MEWSs was within the protocollary time as dictated by the MEWS protocol. Outcome measures were overall MEWS completeness, and both overall protocol compliance and protocol compliance specifically in the 24 h before adverse events. ResultsAll required items to calculate a MEWS were present in 76 percent of the 1,663,743 vital sign measurements. Overall protocol compliance was 62 percent. For the low, mid-range and high MEWS groups, protocol compliances were 67, 47 and 30 percent, respectively. Time-to-next-MEWS exceeded protocol-recommended timing by up to 9 h for a substantial amount of MEWSs in the mid- and high-range MEWS groups. In patients with adverse events, compliance to the MEWS protocol during the 24 h prior to the events was 66 percent in aggregate, ranging from 80% in low MEWS groups, 74% in the mid-range, and 49% in the high MEWS groups. In the high MEWS group, improvements in protocol compliance were primarily noted in five hours immediately preceding the event. ConclusionsEWS assessments were incomplete in one-quarter of measurements. Compliance to a MEWS safety protocol was generally low, specifically when the protocol mandated more frequent MEWS assessments. Although more MEWSs were recorded in patients with adverse events, the increase in vital sign measurements’ frequency mostly occurred shortly before the event manifested. This finding suggests missed opportunities to detect clinical deterioration.

Target Range Selection of FMCW Radar for Accurate Vital Information Extraction

Frequency modulated continuous wave (FMCW) radar, which can detect the range and small displacement of a target, has been used for contactless vital information extraction. For accurate vital sign (respiration and heartbeat) measurement, a precise selection of the target range bin, where vital information exists, is important. In this paper, an effective method for selecting the range bin with accurate vital information is proposed. The proposed method is based on the newly introduced magnitude-phase coherency (MPC) index. The experimental results show that the vital information extracted by the proposed method is more accurate than those by conventional methods, indicating that the proposed range bin selection based on MPC is an effective method for extracting accurate respiration and heartbeat rates.

Vision-Based Patient Monitoring and Management in Mental Health Settings

Successful adoption of novel noncontact physiological measurement and physical monitoring requires analysis of how they support patient care. We review available technologies and present our vision-based patient monitoring and management system, supported by a framework enabling its integration within clinical workflows. The framework links tasks such as assessing patients to elements of the patient journey (eg, risk factors and early warning signs). The system enabled insights from patient activity reports and noncontact vital sign measurements. It supports staff in ensuring patients' health follows desired trajectories, avoiding adverse events, making observations without disrupting patients' rest, intervening proactively, and learning from incidents.

Clinical features and medical care factors associated with mortality in French nursing homes during the COVID-19 outbreak

ObjectivesThis study aimed to identify demographic, clinical and medical care factors associated with mortality in three nursing homes in France. MethodsTwo nursing homes were hospital-dependent, had connections with infection prevention and control departments, and had permanent physicians. A third nursing home had no direct connection with a general hospital, no infection control practitioner, and no permanent physician. The main outcome was death. ResultsDuring the first 3 months of the outbreak, 224 of 375 (59.7%) residents were classified as COVID-19 cases and 57 of 375 (15.2%) died. The hospital-dependent nursing homes had lower COVID-19 case fatality rates in comparison with the non-hospital-dependent nursing home (15 [6.6%] vs 38 [25.8%], OR 0.20 [0.11–0.38], p = 0.001). During the first 3 weeks of the outbreak, mortality in COVID-19 patients decreased if they had a daily clinical examination (OR: 0.09 [0.03–0.35], p = 0.01), three vital signs measurement per day (OR: 0.06 [0.01–0.30], p = 0.001) and prophylactic anticoagulation (OR: 0 [0.00–0.24], p = 0.001). ConclusionsThis study suggested that high mortality rates in some nursing homes during the COVID-19 outbreak might have been contributed by a lack of medical care management. Increasing human and material resources, encouraging presence of nursing home physicians and establishing a connection with general hospitals should be considered to deal with present and future health disasters in nursing homes.

Wireless Remote Home Monitoring of Vital Signs in Patients Discharged Early After Esophagectomy: Observational Feasibility Study.

BackgroundHospital stays after major surgery are shorter than ever before. Although enhanced recovery and early discharge have many benefits, some complications will now first manifest themselves in home settings. Remote patient monitoring with wearable sensors in the first days after hospital discharge may capture clinical deterioration earlier but is largely uncharted territory.ObjectiveThis study aimed to assess the technical feasibility of patients, discharged after esophagectomy, being remotely monitored at home with a wireless patch sensor and the experiences of these patients. In addition, we determined whether observing vital signs with a wireless patch sensor influences clinical decision making.MethodsIn an observational feasibility study, vital signs of patients were monitored with a wearable patch sensor (VitalPatch, VitalConnect Inc) during the first 7 days at home after esophagectomy and discharge from hospital. Vital signs trends were shared with the surgical team once a day, and they were asked to check the patient’s condition by phone each morning. Patient experiences were evaluated with a questionnaire, and technical feasibility was analyzed on a daily basis as the percentage of data loss and gap durations. In addition, the number of patients for whom a change in clinical decision was made based on the results of remote vital signs monitoring at home was assessed.ResultsPatients (N=20) completed 7 days each of home monitoring with the wearable patch sensor. Each of the patients had good recovery at home, and remotely observed vital signs trends did not alter clinical decision making. Patients appreciated that surgeons checked their vital signs daily (mean 4.4/5) and were happy to be called by the surgical team each day (mean 4.5/5). Wearability of the patch was high (mean 4.4/5), and no reports of skin irritation were mentioned. Overall data loss of vital signs measurements at home was 25%; both data loss and gap duration varied considerably among patients.ConclusionsRemote monitoring of vital signs combined with telephone support from the surgical team was feasible and well perceived by all patients. Future studies need to evaluate the impact of home monitoring on patient outcome as well as the cost-effectiveness of this new approach.

P037 Efficacy and Safety of 1-L NER1006 Bowel Preparation in Patients with Inflammatory Bowel Disease: Analysis of 2 Phase 3 Studies.

BACKGROUND: NER1006 (Plenvu®, Salix Pharmaceuticals, Bridgewater, NJ), a 1-L polyethylene glycol (PEG)-based bowel preparation, is indicated in the United States for colon cleansing in preparation for colonoscopy in adults. Colonoscopy is an important tool for the diagnosis, management, and colon cancer screening/surveillance of patients with inflammatory bowel disease (IBD), and adequate bowel preparation is critical for effective performance of colonoscopy. The current data analysis was conducted to assess the efficacy and safety of 1-L NER1006 in an adult population who received this bowel preparation prior to colonoscopy, sub-grouped by IBD diagnosis. METHODS: NER1006 data were pooled from two phase 3, randomized studies (NOCT and MORA) of patients (aged 18-85 y) undergoing colonoscopy. Patients with ongoing severe, acute IBD were excluded. Patients received NER1006 as a 2-day evening/morning or 1-day morning/morning split-dosing regimen. Total NER1006 volume requirements were 64 oz plus clear liquids ad libitum. Colon cleansing was assessed by treatment-blinded central readers. The 2 primary endpoints of the studies were overall bowel cleansing success rate and ascending colon/cecum high-quality cleansing rate. Overall cleansing success was defined as Harefield Cleansing Scale (HCS) grade A/B (score = 3/4 [ie, clear liquid/empty and clean] in all 5 colonic segments or score = 2 [ie, brown liquid/removable semi-solid stools] for ≥1 segment with score 3/4 for remaining segments). High-quality cleansing in the ascending colon/cecum was defined as an HCS score = 3/4. Efficacy analyses were conducted in the modified full analysis set population, defined as all randomly assigned patients excluding those who failed to meet entry criteria post-randomization and who also did not receive any study drug. Safety was assessed in all randomly assigned patients in whom it could not be ruled out that they received ≥1 dose of NER1006 (per patient diary). Safety was assessed through 7 ± 1 days post-colonoscopy. Safety assessments included adverse event (AE) reporting, clinical laboratory evaluations, vital sign measurements, and physical examinations; urinalysis and electrocardiogram were performed at screening and on the day of colonoscopy. RESULTS: A total of 13 and 813 patients who did and did not have a medical history of IBD, respectively, were included in the pooled efficacy analysis, with a majority in each group receiving a 2-day split-dose regimen (61.5% and 66.8%, respectively). Overall cleansing success was achieved in 92.3% (12/13) of patients with IBD and 88.7% (721/813) of patients without IBD. High-quality cleansing of the ascending colon/cecum was reported in 38.5% (5/13) of patients with IBD and 33.7% (274/813) of patients without IBD. Based on post-colonoscopy diagnosis, safety was analyzed for 12 patients with IBD. Only 1 patient with IBD (NER1006 1-day split-dose group) experienced an AE (mild vomiting), and it did not result in study discontinuation. CONCLUSION: Data support the overall efficacy and safety profile of 1-L NER1006 as a bowel preparation in patients with IBD. Further studies in patients with IBD are warranted given the essential nature of careful mucosal evaluation for dysplasia surveillance and lesion detection in this patient population. NOTE: Plenvu® is a registered trademark of the Norgine group of companies used under license.

Whole blood genome-wide transcriptome profiling and metagenomics next-generation sequencing in young infants with suspected sepsis in a low-and middle-income country: A study protocol.

Conducting collaborative and comprehensive epidemiological research on neonatal sepsis in low- and middle-income countries (LMICs) is challenging due to a lack of diagnostic tests. This prospective study protocol aims to obtain epidemiological data on bacterial sepsis in newborns and young infants at Kamuzu Central Hospital in Lilongwe, Malawi. The main goal is to determine if the use of whole blood transcriptome host immune response signatures can help in the identification of infants who have sepsis of bacterial causes. The protocol includes a detailed clinical assessment with vital sign measurements, strict aseptic blood culture protocol with state-of-the-art microbial analyses and RNA-sequencing and metagenomics evaluations of host responses and pathogens, respectively. We also discuss the directions of a brief analysis plan for RNA sequencing data. This study will provide robust epidemiological data for sepsis in neonates and young infants in a setting where sepsis confers an inordinate burden of disease.

Health assessment validation: Challenging tradition.

Undergraduate health assessment courses aim to prepare nursing students to conduct systematic physical assessment of patients. Competency in the undergraduate health assessment course is traditionally validated by student demonstration of a memorized, comprehensive physical examination. Often, this validation requires performance of an exhaustive list of physical examination skills rather than the typical physical assessment performed by the generalist nurse in the hospital setting. This precedent to "do it all" does not align with competency-based education and may cause students to be ill-prepared for clinical practice. Faculty in a 12-month second-degree accelerated BSN program adapted the comprehensive physical assessment validation to better reflect a clinically relevant bedside assessment. The process, results, challenges, and recommendations are described. Here, the redefined comprehensive physical assessment included evaluation of the patient's general appearance, activity, vital sign measurements, pain, and key assessment of the neurologic, respiratory, cardiovascular, integumentary, gastrointestinal, and genitourinary systems. In alignment with the AACN recommendations, students were also validated on focused assessments. This change improved the students transition to clinical practice. We challenge faculty to prepare students for real-world nursing assessment by adapting validations to closely mirror bedside practice.

Abstract 300: Detection of Hemodynamic Status Using a Novel Analytic Based Solely on a Single Ecg Waveform

Introduction: Delayed identification of hemodynamic deterioration remains a persistent issue for in-hospital patient care. Unfortunately, no continuously measured non-invasive method of detecting hemodynamic deterioration currently exists. Clinicians rely on vital signs associated with tachycardia and hypotension to identify hemodynamically unstable patients. However, the collection of non-invasive vital signs remains labor-intensive, inconsistent, and error-prone in practice. In contrast, the Analytic for Hemodynamic Instability (AHI) depends only on the continuous ECG signal from a typical bedside monitor. Hypothesis: Continuous real-time hemodynamic status obtained from the analysis of existing ECG monitor data can accurately detect the combination of hypotension and tachycardia without the need for continuous direct measurement of blood pressure. Methods: 28,348 5-minute windows of the analytic output were analyzed from 222 consecutive adult patients receiving continuous ECG and arterial line monitoring at an academic medical center. AHI outputs were compared to vital sign indication of tachycardia and hypotension in the same window. Results: The observed sensitivity and specificity of AHI compared to vital signs measurement were 95.6% and 84.9%, respectively, with an area under the curve (AUC) of 0.90 and an accuracy of 85.6%. The false-negative rate was 4.4%. The false-positive rate was 15.1%. Conclusions: The AHI derived hemodynamic status correlated well with vital sign derived hemodynamic status for both invasive and non-invasive methods. In patients who had their blood pressure monitored non-invasively, AHI provided continuous hemodynamic monitoring in patients who usually have vitals measured only every few hours. Footnote: The Analytic for Hemodynamic Instability is currently pending US FDA review and is not yet for sale in the US.

Let Sleeping Patients Lie, avoiding unnecessary overnight vitals monitoring using a clinically based deep-learning model

Impaired sleep for hospital patients is an all too common reality. Sleep disruptions due to unnecessary overnight vital sign monitoring are associated with delirium, cognitive impairment, weakened immunity, hypertension, increased stress, and mortality. It is also one of the most common complaints of hospital patients while imposing additional burdens on healthcare providers. Previous efforts to forgo overnight vital sign measurements and improve patient sleep used providers’ subjective stability assessment or utilized an expanded, thus harder to retrieve, set of vitals and laboratory results to predict overnight clinical risk. Here, we present a model that incorporates past values of a small set of vital signs and predicts overnight stability for any given patient-night. Using data obtained from a multi-hospital health system between 2012 and 2019, a recurrent deep neural network was trained and evaluated using ~2.3 million admissions and 26 million vital sign assessments. The algorithm is agnostic to patient location, condition, and demographics, and relies only on sequences of five vital sign measurements, a calculated Modified Early Warning Score, and patient age. We achieved an area under the receiver operating characteristic curve of 0.966 (95% confidence interval [CI] 0.956–0.967) on the retrospective testing set, and 0.971 (95% CI 0.965–0.974) on the prospective set to predict overnight patient stability. The model enables safe avoidance of overnight monitoring for ~50% of patient-nights, while only misclassifying 2 out of 10,000 patient-nights as stable. Our approach is straightforward to deploy, only requires regularly obtained vital signs, and delivers easily actionable clinical predictions for a peaceful sleep in hospitals.

Whole blood genome-wide transcriptome profiling and metagenomics next-generation sequencing in young infants with suspected sepsis in a low-and middle-income country: A study protocol

Conducting collaborative and comprehensive epidemiological research on neonatal sepsis in low- and middle-income countries (LMICs) is challenging due to a lack of diagnostic tests. This prospective study protocol aims to obtain epidemiological data on bacterial sepsis in newborns and young infants at Kamuzu Central Hospital in Lilongwe, Malawi. The main goal is to determine if the use of whole blood transcriptome host immune response signatures can help in the identification of infants who have sepsis of bacterial causes. The protocol includes a detailed clinical assessment with vital sign measurements, strict aseptic blood culture protocol with state-of-the-art microbial analyses and RNA-sequencing and metagenomics evaluations of host responses and pathogens, respectively. We also discuss the directions of a brief analysis plan for RNA sequencing data. This study will provide robust epidemiological data for sepsis in neonates and young infants in a setting where sepsis confers an inordinate burden of disease.

A Phase 3, Open-Label, Randomized Study Evaluating the Efficacy and Safety of Navitoclax Plus Ruxolitinib Versus Best Available Therapy in Patients with Relapsed/Refractory Myelofibrosis (TRANSFORM-2)

Background: Myelofibrosis (MF) is a rare myeloproliferative neoplasm with limited treatment options and a poor prognosis. Although allogeneic hematopoietic stem cell transplantation (allo-HSCT) offers a potential cure, most patients remain ineligible; other therapies, including approved JAK inhibitors (JAKi), do not control the broad array of manifestations associated with MF. Navitoclax is a potent, small molecule inhibitor of the antiapoptotic B-cell lymphoma 2 (BCL-2) family members BCL-XL, BCL-2, and BCL-w and has been shown to potently enhance cytotoxicity of chemotherapy and radiation in cells derived from multiple tumor types. Preclinical data indicate that navitoclax may overcome JAK2 inhibitor resistance. Preliminary data from a Phase 2 study (NCT03222609) of navitoclax with ruxolitinib, a JAK1/2i, for patients with primary or secondary MF who have previously received ruxolitinib suggest favorable spleen response rates and an acceptable safety profile (Harrison et al. EHA 2020. EP1081). TRANSFORM-2 aims to evaluate the combination of navitoclax and ruxolitinib vs best available therapy (BAT) in adults with relapsed or refractory MF that is resistant to JAK2 inhibition. Study Design and Methods: This Phase 3, open-label study (NCT04468984) is designed to recruit patients aged ≥18 years with intermediate-2 or high-risk MF, measurable splenomegaly, and who are experiencing MF-related symptoms. Patients must have received a single prior JAK2i for ≥24 weeks that was stopped due to lack of efficacy or for <24 weeks with disease progression while on therapy. Candidates for allo-HSCT, patients who have received prior treatment with a BH3-mimetic compound or >1 prior JAK2i, and patients with platelets <100 × 109/L will be excluded. The study will be conducted at approximately 173 sites in 23 countries. The planned sample size is 330 patients. Patients will be randomized 1:1 to receive either navitoclax plus ruxolitinib, or BAT. Navitoclax will be administered orally at a starting dose of 200 mg (platelet count >150 × 109/L) or 100 mg escalated to 200 mg once daily if tolerated after ≥7 days (platelet count ≤150 × 109/L); navitoclax may be increased to 300 mg once daily after Week 25 Day 1 at the investigator's discretion, based on platelet count for patients with suboptimal spleen response; ruxolitinib will be administered orally at the prior stable dose if on ruxolitinib at study entry or at a dose of 10 mg twice daily if no longer on ruxolitinib. BAT options include hydroxyurea, interferon, ruxolitinib, fedratinib, or danazol, which will be administered at standard doses. Randomization stratification will be by region (US vs Japan vs EU vs rest of world), by Dynamic International Prognostic Scoring System Plus score at randomization (intermediate-2 vs high risk), and by stable ruxolitinib dosing at randomization vs not on ruxolitinib/JAK2i. Treatment can continue until the end of clinical benefit, unacceptable toxicity, or discontinuation criteria have been met; disease assessments will be performed after 12 and 24 weeks even if discontinuing therapy, after which patients will enter posttreatment follow-up (discontinuation without progression) or survival follow-up (after progression). The primary endpoint is ≥35% reduction in spleen volume from baseline (SVR35) at Week 24, measured by magnetic resonance imaging, per International Working Group criteria. Secondary endpoints include ≥50% reduction in total symptom score from baseline at Week 24, SVR35, duration of SVR35, change in fatigue from baseline, time to deterioration of physical functioning, anemia response, overall survival, leukemia-free survival, overall response, composite response, and reduction in grade of bone marrow fibrosis from baseline. Safety will be assessed via adverse event (AE) monitoring, physical examinations, vital sign measurements, electrocardiogram variables, and clinical laboratory testing. AEs will be graded per National Cancer Institute Common Terminology Criteria for AEs v5.0. Statistical analysis of the primary endpoint and binary secondary endpoints will be conducted using a stratified Cochran-Mantel-Haenszel test. Time-to-event secondary endpoints will be analyzed using a stratified log-rank test and Kaplan-Meier methodology. Hazard ratios will be estimated using stratified Cox proportional hazards model. Disclosures Dilley: AbbVie Inc.: Current Employment, Other: may hold stock or stock options. Harb:AbbVie: Current Employment, Other: may hold stock or stock options. Jalaluddin:AbbVie: Current Employment, Other: may hold stock or stock options. Hutti:AbbVie Inc.: Current Employment, Other: may hold stock or stock options. Potluri:AbbVie: Current Employment, Other: may hold stock or stock options. OffLabel Disclosure: Navitoclax is an investigational drug for the treatment of myelofibrosis

A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study Evaluating Navitoclax in Combination with Ruxolitinib in Patients with Myelofibrosis (TRANSFORM-1)

Background: Myelofibrosis (MF) is a rare myeloproliferative neoplasm with poor clinical outcomes. It is characterized by bone marrow fibrosis and an array of constitutional symptoms that impair quality of life. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only potential curative therapy for MF, but HSCT is only accessible to a minority of patients and is associated with high morbidity and high rates of transplant-related mortality. JAK inhibitors (JAKi), including the JAK1/2i ruxolitinib and JAK2i fedratinib, are approved for the treatment of primary and secondary MF based on reduction in splenomegaly and disease-related symptoms; however, they have little impact on bone marrow fibrosis and are not effective at managing all clinical manifestations of MF. Therefore, a substantial clinical need for novel therapies to improve the disease course of MF exists. Navitoclax is an oral, potent, small-molecule inhibitor of the antiapoptotic B-cell lymphoma 2 (BCL-2) family proteins BCL-XL, BCL-2, and BCL-w and has demonstrated cell-killing activity in myeloproliferative neoplasm-derived cell lines and primary specimens ex vivo. Preliminary data from a Phase 2 study (NCT03222609) of ruxolitinib-experienced patients with primary or secondary MF have shown favorable spleen responses and tolerability with navitoclax plus ruxolitinib (Harrison et al. EHA 2020. EP1081). TRANSFORM-1 aims to evaluate the combination of navitoclax and ruxolitinib vs placebo and ruxolitinib in adults with primary or secondary MF who have not previously received a JAK2i. Study Design and Methods: In this Phase 3, double-blind, placebo-controlled study (NCT04472598), patients aged ≥18 years with intermediate-2 or high-risk MF with measurable splenomegaly, evidence of MF-related symptoms, no prior treatment with JAK2i, and Eastern Cooperative Oncology Group Performance Score ≤2 will be eligible for enrollment. Candidates for allo-HSCT and those who have received prior treatment with a BH3-mimetic compound or BET inhibitor will be excluded. Patients will be enrolled across 130 sites in approximately 17 countries. Planned target enrollment is 230 patients. Patients will be randomized 1:1 to receive navitoclax or placebo, plus ruxolitinib. Randomization stratification factors include intermediate-2 vs high-risk MF and platelet count ≤200 × 109/L vs >200 × 109/L. Navitoclax will be administered orally at a starting dose of 200 mg (platelet count >150 × 109/L) or 100 mg escalated to 200 mg once daily if tolerated after ≥7 days (platelet count ≤150 × 109/L). Ruxolitinib will be administered orally at a starting dose of 20 mg (platelet count >200 × 109/L) or 15 mg (platelet count 100-200 × 109/L) twice daily. Treatment may continue until the end of clinical benefit, unacceptable toxicity, or discontinuation criteria have been met. Patients who discontinue without progression will enter post-treatment follow-up; after disease progression or initiation of post-treatment cancer therapy, patients will enter survival follow-up. The primary endpoint of the study is ≥35% reduction in spleen volume from baseline (SVR35) at Week 24, as measured by magnetic resonance imaging or computed tomography, per International Working Group (IWG) criteria. Secondary endpoints include ≥50% reduction in total symptom score from baseline at Week 24 (measured by Myelofibrosis Symptom Assessment Form v4.0), duration of SVR35, change in fatigue from baseline, time to deterioration of physical functioning, anemia response per IWG criteria, SVR35 per IWG, reduction in grade of bone marrow fibrosis from baseline, overall survival, leukemia-free survival, and overall response and composite response per IWG criteria. Exploratory endpoints include progression-free survival. Safety will be assessed throughout the study via adverse event (AE) monitoring, physical examinations, vital sign measurements, electrocardiogram variables, and clinical laboratory testing. AEs will be graded per National Cancer Institute Common Terminology Criteria for AEs v5.0. The primary statistical analysis will be conducted using a stratified Cochran-Mantel-Haenszel test, and time-to-event secondary endpoints will be analyzed using a stratified log-rank test and Kaplan-Meier methodology. Hazard ratios will be estimated using stratified Cox proportional hazards model. Disclosures Potluri: AbbVie: Current Employment, Other: may hold stock or stock options. Harb:AbbVie: Current Employment, Other: may hold stock or stock options. Masud:AbbVie: Current Employment, Other: may hold stock or stock options . Hutti:AbbVie Inc.: Current Employment, Other: may hold stock or stock options. OffLabel Disclosure: Navitoclax is an investigational drug for the treatment of myelofibrosis

Multi-Resident Non-Contact Vital Sign Monitoring Using Radar: A Review

Vital signs are inarguably accepted as important key constituents to improve the health condition. Worldwide medical institutions and clinical observations have emphasized the need for continuous monitoring of vital signs such as heart rate (HR) and respiration rate (RR) for better health management. Radars are investigated as one of the potential technologies for non-contact continuous monitoring of vital signs. This paper provides a comprehensive technological review on the current state-of-art of non-contact vital sign (NCVS) measurements using radar. We highlight the need to move towards higher frequency for high accuracy in a multi-resident environment and analyze the implications of mmWave exposure on human health and the effect of environmental attenuation. Significant challenges associated with hardware and signal processing algorithm are discussed in detail. Finally, we conclude the review with future directions and challenges associated with the detection of vital signs in a multi-resident indoor environment.

Pharmacokinetics, pharmacodynamics, andtolerability of JY09 in healthy Chinese subjects: A titrating, dose-escalating study.

To evaluate the pharmacokinetics, pharmacodynamics, and tolerability of JY09, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, in healthy subjects. Healthy subjects were enrolled into 5 cohorts (0.3, 0.7, 1.5, 3.0, and 6.0 mg JY09) and received subcutaneous JY09 or placebo according to a randomized, double-blind, placebo-controlled, single-center, dose-escalating phase I trial design. Blood samples were collected over a 42-day period, and JY09 in plasma was determined by an electrochemical luminescence method. For the pharmacodynamic evaluation, oral glucose tolerance tests (OGTTs) were conducted predose and on day 5 after the target dose, during which plasma glucose, insulin, C-peptide, and glucagon concentrations were analyzed. Tolerability was assessed using physical examination and queries, vital sign measurements, laboratory analysis, and detection of immunogenicity. In healthy Chinese subjects, JY09 exhibited a dose-dependent increase in AUC0-inf and Cmax from 0.7to6.0 mg JY09. The half-life of JY09 was ~9.3 days, and the peak concentration was reached at ~60-72 hours. Following the OGTT, an increase in C-peptide concentration was observed after exposure to JY09 at the dose of 6.0mg compared to the placebo group. JY09 was well tolerated in healthy Chinese subjects following a single dose of up to 6.0mg. No symptomatic hypoglycemia was reported, and the most commonly observed adverse event was suppressed appetite, and its incidence was dose-dependent. Four subjects (13%) developed anti-JY09 antibodies. JY09 has a long half-life of ~9.3 days, with an acceptable safety profile.

The Role of Telenephrology in the Management of CKD.

CKD is a common illness across societies, affecting an estimated 13% of the population worldwide (1). The prevalence of CKD is thought to be rising, likely due to a combination of an aging population and increases in comorbid chronic conditions—such as obesity, diabetes, and hypertension—that contribute to its pathogenesis. In the United States, the prevalence of CKD is estimated at nearly 15%, and Medicare spent $114 billion on CKD and ESKD in 2018 (2). Whereas studies indicate that early referral to nephrologists may improve outcomes in CKD, many patients do not see nephrologists until late in the course of their disease. Barriers to early referral include geographic remoteness, with patients living far from available nephrologic care, and difficulties in traveling due to the burden of comorbidities (3⇓⇓–6). Rural patients with CKD have been found to have poorer quality-of-care markers, including timely measurement of urinary albumin excretion and appropriate use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and experience a greater risk for hospitalization and all-cause mortality than urban patients with CKD (5,6). Telemedicine, a video-based healthcare delivery technology, has the potential to attenuate these disparities and has been used in multiple chronic illnesses, including heart failure, diabetes mellitus, and chronic obstructive pulmonary disease. Although the approach is not appropriate for all encounters, nephrology is, in many ways, particularly suited for telemedicine. The longitudinal follow-up of patients with CKD is heavily dependent on repeat laboratory evaluations and detailed history taking. Although questions regarding changes in weight or edema can be critical, the majority of visits do not center on extensive physical examinations. Similarly, patient appointments for the management of hypertension are typically focused on reviews of BP logs and office measurements of vital signs, whereas encounters for nephrolithiasis involve appraisal of laboratory evaluations …

The Design and Simulation of FBG Sensors for Medical Application

Fiber Bragg Grating sensors have a wide range of applications, ranging from their use for health monitoring, in medical applications and also as biomedical sensors, among others. Moreover, since fiber Bragg gratings have many advantages that qualify them to be of great benefit, of course, the most important of these applications are vital signs of human health condition Such as blood pressure, heart rate (pulse rate), and body temperature. The Vital-signs are noticeable variables. The temperature and blood pressure are changed according to the physical, involuntary, nervous and psychological state of the person. Therefore, the measurement of vital signs is very necessary, In this work, fiber Bragg grating sensor has been designed and simulated to study the performance of fiber Bragg grating sensor as a Body temperature of human beings ranged from (35°C to 40°C, which is from hypothermia to hyperthermia) and blood pressure that ranged between lower and higher extremities (40 to 190 mmHg ) from hypotension to hypertension, using optigrating and optisystem simulation softwar. The designed sensor was very sensitive to human temperature and blood pressure ranges which were 13.632 pm/oC and 15.75 pm/mmHg, respectively.

Healthcare students’ use of an e-textbook open educational resource on vital sign measurement: a qualitative study

ABSTRACT Students desire free textbooks that incorporate multimedia and interactive experiences. Although there is an increased production of e-textbooks, these resources tend to replicate hard copy books and do not take advantage of the functions that technology offers. There is also a shift to creating e-textbooks that are considered open educational resources. A team of nursing educators and a nursing student created an interactive open educational resource e-textbook in vital sign measurement that was implemented within the curriculum of post-secondary health-related programmes. The goal of this paper is to report the study findings which sought to explore healthcare students’ experiences of using this open educational resource. Three discipline-specific focus groups were conducted with a convenience sample of 29 students. Using a qualitative thematic analysis, six interconnected themes describing students’ use of this resource were identified: (a) This Generation’s Learner, (b) Vital Signs Open Educational Resource influence, (c) Accessibility, (d) Convenience, (e) Design, and (f) Visual and Other Types of Learning Styles. Participants were positive about using the open educational resource to learn vital sign skills. Our study findings provide a foundation for e-textbook design standards that support student learning.

Continuous In-Bed Monitoring of Vital Signs Using a Multi Radar Setup for Freely Moving Patients

In hospitals, continuous monitoring of vital parameters can provide valuable information about the course of a patient’s illness and allows early warning of emergencies. To enable such monitoring without restricting the patient’s freedom of movement and comfort, a radar system is attached under the mattress which consists of four individual radar modules to cover the entire width of the bed. Using radar, heartbeat and respiration can be measured without contact and through clothing. By processing the raw radar data, the presence of a patient can be determined and movements are categorized into the classes “bed exit”, “bed entry”, and “on bed movement”. Using this information, the vital parameters can be assessed in sections where the patient lies calmly in bed. In the first step, the presence and movement classification is demonstrated using recorded training and test data. Next, the radar was modified to perform vital sign measurements synchronized to a gold standard device. The evaluation of the individual radar modules shows that, regardless of the lying position of the test person, at least one of the radar modules delivers accurate results for continuous monitoring.

Trajectories of vital status parameters and risk of mortality among acute organophosphorus poisoning patients \u2013 a latent class growth analysis

BackgroundAcute organophosphorus (OP) poisoning is one of the major causes of mortality among patients presenting to emergency departments in developing countries. Although various predictors of mortality among OP poisoning patients have been identified, the role of repeated measurements of vital signs in determining the risk of mortality is not yet clear.Therefore, the present study examined the relationship between trajectories of vital signs and mortality among OP poisoning patients using latent class growth analysis (LCGA).MethodsThis was a retrospective cohort study using data for 449 OP poisoning patients admitted to Civil-Hospital Karachi from Aug’10 to Sep’16. Demographic data and vital signs, including body temperature, blood pressure, heart rate, respiratory rate, and partial-oxygen pressure, were retrieved from medical records. The trajectories of vital signs were formed using LCGA, and these trajectories were applied as independent variables to determine the risk of mortality using Cox-proportional hazards models. P-values of < 0.05 were considered statistically significant.ResultsData for 449 patients, with a mean age of 25.4 years (range 13–85 years), were included. Overall mortality was 13.4%(n = 60). In trajectory analysis, a low-declining systolic blood pressure, high-declining heart rate trajectory, high-remitting respiratory rate trajectory and normal-remitting partial-oxygen pressure trajectory resulted in the greatest mortality, i.e. 38.9,40.0,50.0, and 60.0%, respectively, compared with other trajectories of the same parameters. Based on multivariable analysis, patients with low-declining systolic blood pressure were three times [HR:3.0,95%CI:1.2–7.1] more likely to die compared with those who had a normal-stable systolic blood pressure. Moreover, patients with a high-declining heart rate were three times [HR:3.0,95%CI:1.5–6.2] more likely to die compared with those who had a high-stable heart rate. Patients with a high-remitting respiratory rate were six times [HR:5.7,95%CI:1.3–23.8] more likely to die than those with a high-stable respiratory rate. Patients with normal-remitting partial oxygen pressure were five times [HR:4.7,95%CI:1.4–15.1] more likely to die compared with those who had a normal-stable partial-oxygen pressure.ConclusionThe trajectories of systolic blood pressure, heart rate, respiratory rate and partial-oxygen pressure were significantly associated with an increased risk of mortality among OP poisoning patients.