Continuous Clinical Monitoring Research Articles

Visual field loss and falls requiring hospitalisation: results from the eFOVID study.

Visual fields are important for postural stability and ability to manoeuvre around objects. Examine the association between visual field loss and falls requiring hospitalisation in adults aged 50 +. Older adults aged 50+ with and without visual field loss were identified using a fields database obtained from a cross-section of ophthalmologists' practices in Western Australia (WA). Data were linked to the Hospital Morbidity Data Collection and WA Hospital Mortality System to identify participants who experienced falls-related hospitalisations between 1990 and 2019. A generalised linear negative binomial regression model examined the association between falls requiring hospitalisation for those with and without field loss, based on the better eye mean deviation (mild: -2 to -6dB, moderate: -6.01dB to -12dB, severe < -12.01dB) in the most contemporaneous visual field test (3years prior or if not available, 2years after the fall), after adjusting for potential confounders. A total of 31 021 unique individuals of whom 6054 (19.5%) experienced 11 818 falls requiring hospitalisation during a median observation time of 14.1years. Only mean deviation index of <-12.01dB (severe) was significantly associated with an increased rate of falls requiring hospitalisations by 14% (adjusted IRR 1.14, 95% CI 1.0-1.25) compared with no field loss, after adjusting for potential confounders. Other factors included age, with those aged 80+ having an increased rate (IRR 29.16, 95% CI 21.39-39.84), other comorbid conditions (IRR 1.49, 95% CI 1.38-1.60) and diabetes (IRR 1.25, 95% CI 1.14-1.37). Previous cataract surgery was associated with a decreased rate of falls that required hospitalisations by 13% (IRR 0.87, 95% CI 0.81-0.95) compared with those who did not have cataract surgery. The findings highlight the importance of continuous clinical monitoring of visual field loss and injury prevention strategies for older adults with visual field loss.

Sustained chronic inflammation and altered childhood vaccine responses in children exposed to Zika virus

Congenital Zika virus (ZIKV) infection leads to severe newborn abnormalities, but its long-term impact on childhood immunity is not well understood. This study aims to investigate the serum proteomics in children exposed to ZIKV during pregnancy to understand potential immunological consequences during early childhood. The study included ZIKV-exposed infants (ZEI) at birth (n=42) and children exposed to ZIKV (ZEC) at two years of age (n=20) exposed to ZIKV during pregnancy, as well as healthy controls. Serum proteomic analysis was performed on these groups to assess inflammation and immune profiles. Additionally, antibody titres against two common childhood vaccines, DTaP and MMR, were measured in healthy controls (n=50) and ZEC (n=92) to evaluate vaccine-induced immunity. Results showed elevated inflammation in ZEI with birth abnormalities. Among ZEC, despite most having normal clinical outcomes at two years, their serum proteomics indicated a bias towards Th1-mediated immune responses. Notably, ZEC displayed reduced anti-Diphtheria toxin and anti-Clostridium tetani IgG levels against DTaP and MMR vaccines. They also exhibited lower antibody titres particularly against Th2-biased DTaP vaccines, but not Th1-biased MMR vaccines. In conclusion, the study highlights the long-term immunological consequences of congenital ZIKV exposure. Heightened inflammation was observed in ZEI with abnormalities at birth, while ZEC maintained a chronic Th1-biased immune profile. The impaired response to Th2-biased vaccines raises concerns about lasting effects of ZIKV exposure on immune responses. Consequently, there is a need for continued longitudinal clinical monitoring to identify potential immune-related complications arising from prenatal exposure to ZIKV. This work was partially funded by the National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Dental and Craniofacial Research (NIDCR).

Assessing the Efficacy and Stability of Rapid Maxillary Expansion and the Delaire Appliance in Skeletal Class III Malocclusion: A Narrative Review

Background: A Class III skeletal malocclusion is a very complex condition in orthodontics practice, and its solution is often carried out orthopedically. The most used orthopedic devices include rapid maxillary expansion (RME) and the Delaire Appliances to treat not only maxillary deficiency but also to correct the position of the upper jaw. Even if these interventions become sustainable in the short term, their long-term stability remains questionable. Aim: reveal a pretty complicated relationship between orthopaedic and orthodontic surgeries and their influences on the volume of the upper respiratory tract and craniofacial correction. Methods: We searched multiple online databases including; Web of Science, Scopus, Google Scholar, PubMed, and Cochrane Library. We used the following search strategy; "Rapid maxillary expansion" OR RME AND ("sleep apnea" OR "sleep-disordered breathing" OR "sleep-related breathing disorders" OR "sleep apnea-hypopnea syndrome" OR SAHS) AND (children OR pediatric) AND ("orthodontic treatment" OR "orthopaedic treatment" OR "maxillary expansion") AND (oximetry OR polysomnography). Results: RME and the Delaire appliance were seen to be promising in the short term with an outcome of correction of maxillary transverse deficiency and skeletal relationships. Nevertheless, the issue of the long-term stability was spotted, including with regard to growth. But nevertheless both interventions exhibited some really valuable additions in general treatment of skeletal class III malocclusion. Scientific Novelty: This literature review synthesizes and summarizes the current knowledge on the effectiveness and durability of RME and the Delaire splint concerning skeletal class III malocclusion, presenting perspectives on their short-term impact and long-term performance. With its emphasis on poorly understood issues and new research, it greatly assists in updating our knowledge about orthopedic treatments. Conclusion: In a relatively short period of time, the rapid maxillary expansion method as well as the Delaire appliance can produce positive outcomes in terms of correcting the retroposition in cranial base class III malocclusion. Although, long lasting stability issues remain a worry and make the case for continued research and clinical monitoring for achieving better treatment outcomes and evidence-based practices in orthodontics.

Prediction of Occult Hemorrhage in the Lower Body Negative Pressure Model: Initial Validation of Machine Learning Approaches.

Detection of occult hemorrhage (OH) before progression to clinically apparent changes in vital signs remains an important clinical problem in managing trauma patients. The resource-intensiveness associated with continuous clinical patient monitoring and rescue from frank shock makes accurate early detection and prediction with noninvasive measurement technology a desirable innovation. Despite significant efforts directed toward the development of innovative noninvasive diagnostics, the implementation and performance of the newest bedside technologies remain inadequate. This poor performance may reflect the limitations of univariate systems based on one sensor in one anatomic location. It is possible that when signals are measured with multiple modalities in multiple locations, the resulting multivariate anatomic and temporal patterns of measured signals may provide additional discriminative power over single technology univariate measurements. We evaluated the potential superiority of multivariate methods over univariate methods. Additionally, we utilized machine learning-based models to compare the performance of noninvasive-only to noninvasive-plus-invasive measurements in predicting the onset of OH. We applied machine learning methods to preexisting datasets derived using the lower body negative pressure human model of simulated hemorrhage. Employing multivariate measured physiological signals, we investigated the extent to which machine learning methods can effectively predict the onset of OH. In particular, we applied 2 ensemble learning methods, namely, random forest and gradient boosting. Analysis of precision, recall, and area under the receiver operating characteristic curve showed a superior performance of multivariate approach to that of the univariate ones. In addition, when using both invasive and noninvasive features, random forest classifier had a recall 95% confidence interval (CI) of 0.81 to 0.86 with a precision 95% CI of 0.65 to 0.72. Interestingly, when only noninvasive features were employed, the results worsened only slightly to a recall 95% CI of 0.80 to 0.85 and a precision 95% CI of 0.61 to 0.73. Multivariate ensemble machine learning-based approaches for the prediction of hemodynamic instability appear to hold promise for the development of effective solutions. In the lower body negative pressure multivariate hemorrhage model, predictions based only on noninvasive measurements performed comparably to those using both invasive and noninvasive measurements.

P-65 A case of relapse of Graves ophthalmopathy due to an ophthalmic herpes zoster infection in a thyroidectomized patient with multiple comorbidities

Abstract Introduction Graves ophthalmopathy usually occurs in patients with hyperthyroidism or a history of Graves disease, but it can appear in euthyroid patients or patients with chronic thyroiditis also. It is a possible cause of sight-threatening eye disease. Its incidence is 16 for women and 3 cases for men, per 100 000 population but more severe in men, and it's higher among smokers. In mild forms, treatment can be local, but in severe cases and recurrences, systemic glucocorticoids are compulsory, with or without immunosuppressive drugs, surgery or radiotherapy. in recurrences. Clinical Case We present the case of a 76-year-old male, former smoker, diagnosed with Graves disease in 2017. He was treated with anti-thyroid treatment and in 2018 he was thyroidectomized. He also developed a progressive Graves ophthalmopathy from April to July 2017 with a reduced visual acuity for both eyes, conjunctival erythema, palpebral edema and erythema. He received methyl-prednisolone (MP) pulse therapy 6×125 mg weekly with favorable outcome. In 2019, he underwent a recession of internal rectus and inferior rectus for both eyes to correct a divergent strabism and his eye-sight improved. He presents now for an aggravation of the ophthalmopathy after an episode of a herpes zoster infection affecting the ophthalmic branch of the trigeminal nerve. He also suffers from heart failure NYHA III, permanent atrial fibrillation, large aortic stenosis, asymptomatic hyperuricemia, secondary pulmonary hypertension and chronic kidney disease stage IIIb. His medical history revealed hypercholesterolemia, hyperuricemia, heart failure, insufficient status of vitamin D3 and confirmed the chronic kidney disease stage IIIb; normal thyroid function but with high anti TSH receptor antibodies (TRAb=18.37 U/L). Given the age and the comorbidities but also the high activity of the Graves disease and the orbital CT that revealinged a great hypertrophy of the ocular muscles, our ophthalmologist suggested methyl-prednisolone pulse therapy in a standard regimen, but our cardiologist contradicted it because of the heart conditions. As the patient's left eye sight was only 2% and for the right one 20%, we decided to adapt the doses of the pulse therapy and closely monitor the patient. The first dose was 125mg MP, after that 7 doses of 250mg MP weekly was followed by 3 doses of 125mg MP weekly. After a total of 2250 mg MP at a 3 months follow-up, the patients’ eyesight improved to 60% on the left eye and 75% on the right eye and a lower level of TRAb=5.59 UI/L. Conclusion Even in patients with comorbidities where corticosteroid therapy may be detrimental, there is a possibility to adapt the doses in a safe way and with a continuous clinical monitoring so that the patients’ eyesight can be saved, therefore increasing the quality of life.

A disproportionality analysis of adverse events caused by GnRHas from the FAERS and JADER databases.

Gonadotrophin-releasing hormone analogs (GnRHas) play a significant role in addressing gynecological diseases, central precocious puberty, and cancer. However, ensuring the safety of GnRHas in real-world applications requires continuous vigilance. In light of this, we undertook a disproportionality analysis focused on adverse events (AEs) associated with GnRHas using data from both the FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER). We evaluated GnRHas-associated AEs and characterized the clinical priority of unlisted AEs caused by each GnRHa from the different databases. In the disproportionality analysis, we applied two adjusted algorithms to identify signals related to GnRHas in the FAERS and JADER databases from 2004 to 2023. Additionally, we utilized the Statistical Analysis System (SAS, 9.4) to examine potential and high-aROR (adjusted reporting odds ratio) signals associated with GnRHas. We performed clinical priority assessment for suspicious PTs and an analysis of serious/non-serious outcomes. We also gathered information on the onset times of AEs linked with GnRHas from both databases. From January 2004 to September 2023, FAERS and JADER recorded a total of 50,360,413 and 1,440,200 AEs, respectively. Employing two algorithms, the suspicious preferred terms (PTs) related to leuprolide (Leu) were 562 potential PTs (44 unlisted in specifications), followed by goserelin (Gos) with 189PTs (28 unlisted), triptorelin (Tri) with 172PTs (28 unlisted), and Leu-JADER with 85PTs (10 unlisted). At the same PT level, the differences in GnRHas between the two databases were observed, such as cardiac failure, diabetes mellitus, liver disorder, dementia, suicidal ideation, interstitial lung disease, urinary disorders, and hypertensive crisis. In an analysis of serious vs. non-serious outcomes, a total of 43 AEs of Leu were more likely to be reported as serious AEs with p < 0.05 (such as asthenia, urinary retention, diabetes mellitus, interstitial lung disease, gait disturbance, and so on), following by Tri (6 AEs), and Gos (4 AEs). Based on the clinical priority score, 41PTs of Leu, 26PTs of Tri, 24PTs of Gos, and 8PTs of Leu-JADER were graded as weak. There were 3PTs of Leu, 2PTs of Tri, 4PTs of Gos, and 2PTs of Leu-JADER that were graded as moderate. Notably, in the assessment of the relevant evidence, 2PTs (loss of libido and urinary tract toxicity caused by Leu), 1PT (electrolyte imbalance caused by Tri), and 2PTs (anorexia and suicidal ideation caused by Gos) showed a strong level of evidence with "++." The differences in the signal strength of the same PTs from two databases were also worth noting. Moreover, the median onset time for GnRHas (Leu, Tri, and Gos) was 23days (0, 298), 22days (0, 181), and 217days (29, 706), respectively, as median (Q1, Q3). An examination of two databases revealed suspicious AEs associated with GnRHas. Our study found potential new AE signals of GnRHas and supported continuous clinical monitoring, pharmacovigilance, regional differences, and further studies of GnRHas.

Adaptive Phage Therapy for the Prevention of Recurrent Nosocomial Pneumonia: Novel Protocol Description and Case Series.

Nowadays there is a growing interest worldwide in using bacteriophages for therapeutic purposes to combat antibiotic-resistant bacterial strains, driven by the increasing ineffectiveness of drugs against bacterial infections. Despite this fact, no novel commercially available therapeutic phage products have been developed in the last two decades, as it is extremely difficult to register them under the current legal regulations. This paper presents a description of the interaction between a bacteriophage manufacturer and a clinical institution, the specificity of which is the selection of bacteriophages not for an individual patient, but for the entire spectrum of bacteria circulating in the intensive care unit with continuous clinical and microbiological monitoring of efficacy. The study presents the description of three clinical cases of patients who received bacteriophage complex via inhalation for 28 days according to the protocol without antibiotic use throughout the period. No adverse effects were observed and the elimination of multidrug-resistant microorganisms from the bronchoalveolar lavage contents was detected in all patients. A decrease in such inflammatory markers as C-reactive protein (CRP) and procalcitonin was also noted. The obtained results demonstrate the potential of an adaptive phage therapy protocol in intensive care units for reducing the amount of antibiotics used and preserving their efficacy.

A disproportionality analysis of adverse events associated to pertuzumab in the FDA Adverse Event Reporting System (FAERS)

BackgroundPertuzumab is widely used for the treatment of HER2 + breast cancer. But its safety in the real world should be continuously monitored. So, we evaluated the safety of pertuzumab by pharmacovigilance analyze based on related adverse events (AEs) from the FDA Adverse Event Reporting System (FAERS) and find whether potential or uncertain adverse events were present.MethodsIn disproportionality analysis, four algorithms were employed to detect the signals of pertuzumab from the FAERS between 2012 and 2022. In addition, we also used MYSQL 8.0, Navicat Premium 15, and Microsoft EXCEL 2019 to analyze the potential and high-ROR (reporting odds ratio) signals of pertuzumab. We also collected the onset times of pertuzumab-associated AEs.ResultsFrom January 2012 to December 2022, there are 39,190,598 AEs reported from the FAERS database, of which 14,707 AEs listed pertuzumab as the ‘primary suspected (PS)’ drug. A total of 115 (46 potential) significant disproportionality preferred terms (PTs) conforming to the four algorithms were retained. Finally, we detected that the pertuzumab-induced AEs occurred in 12 organ systems. For pertuzumab, unexpected and significant PTs of AEs were found, including but not limited to below PTs: haematotoxicity, cardiotoxicity, cardiomyopathy, mitral valve incompetence, tachycardia, intestinal perforation, hemorrhoids, erysipelas, dehydration, pneumonitis, skin toxicity, onychomadesis, cyanosis, and circulatory collapse. We found there were 9 strong signals (5 potential safety signals) and 68 medium intensity signals (21 potential safety signals) according to IC025 (information component). The potential strong signals (IC025 > 3.0) were myelosuppression, cardiotoxicity, cardiac dysfunction, ejection fraction decreased, interstitial lung disease, and onychomadesis. Excluding unreported or unreasonable onset time reports, a total of 2016 AEs reported onset time and the median onset time was 117 days (4, 96), as median (Q1, Q3). Notably, most of the all AEs (n = 1133, 56%) and cardiac-related events (n = 405, 53%) all occurred within one month after pertuzumab therapy.ConclusionAnalysis of FAERS data identified pertuzumab-associated AEs, and our findings supported continuous clinical monitoring, pharmacovigilance, and further studies of pertuzumab. A significant association was detected between pertuzumab and some potential adverse events which should be regarded with some care. We have to pay attention to the first month after pertuzumab therapy and prepare emergency measures, especially for the elderly and patients with cardiovascular diseases.

Abstract 19130: Is Early Hospital Discharge Safe After Adult Heart Transplantation?

Introduction: The impact of early hospital discharge (EHD) after adult heart transplantation (HT) on longitudinal outcomes is unclear. Many HT recipients are intentionally kept in the hospital for extended stays for continued clinical monitoring. However, there is growing interest in implementing EHD protocols and initiatives to improve patient throughput, optimize hospital resources and bed capacity, and reduce costs. Hypothesis: This study evaluated the impact of EHD on HT outcomes. Methods: The United Network for Organ Sharing (UNOS) database was utilized to identify adult (≥ 18 years old) HT recipients surviving to hospital discharge between January 2010 and December 2022. EHD was defined as occurring within 7 days of HT. Kaplan-Meier analysis was used to estimate survival probability of EHD recipients at 30-days, 90-days, 1-year, 1-year conditional on 30-day survival and 1-year conditional on 90-day survival. Multivariable Cox regression was used for risk adjustment. Results: Of the 31,638 total HTs performed in the study period, 30,720 (97.1%) survived to hospital discharge of which 1,033 (3.36%) were classified as EHD. In an unadjusted analysis, HT recipients survival rates were: [(30-days: ED 99.5% vs non-EHD 98.4%, log-rank p= 0.004), (90-days: EHD 98.8% vs non-EHD 96.4%, log-rank p&lt; 0.001), (1-year: EHD 96.5% vs non-EHD 92.9%, log-rank p&lt; 0.001), (1-year conditional on 30-day survival: EHD 96.9% vs non-EHD 94.5%, log-rank p&lt; 0.001), and (1-year conditional on 90-day survival: EHD 97.6% vs non-EHD 96.4%, log-rank p= 0.036)] (Figure 1). After risk adjustment, the Hazard Ratio (HR) of mortality for EHD recipients was: [30-days HR: 0.37 (0.15-0.89, p=0.027), 90-days HR: 0.39 (0.22-0.70, p=0.001), 1-year HR: 0.57 (0.39-0.82, p=0.003), 1-year conditional on 30-day survival HR: 0.60 (0.40-0.90, p=0.013), and 1-year conditional on 90-day survival HR: 0.75 (0.47-1.18, p=0.213)]. Conclusions: HT patients with EHD have lower complication rates than non-EHD patients. Although a minority of patients have EHD after HT, these data suggest it can be done safely with excellent longitudinal outcomes. Efforts to share best practices and protocols allowing for EHD may be prudent to broadening this practice nationwide in appropriate cases.

Post-marketing safety of anti-IL-5 monoclonal antibodies (mAbs): an analysis of the FDA Adverse Event Reporting System (FAERS)

ABSTRACT Background Anti-IL-5 monoclonal antibodies (mAbs) targeting IL-5 or IL-5 R α (including mepolizumab, benralizumab, and reslizumab) are widely used for inflammatory diseases such as asthma, eosinophilia, and polyangiitis. However, real-world data regarding its safety in a large sample population are incomplete. So, we evaluated the safety of anti-IL-5 mAbs by pharmacovigilance analyzes based on related adverse events (AEs) from the FDA Adverse Event Reporting System (FAERS). Methods In disproportionality analysis, four algorithms were employed to detect the signals of anti-IL-5 mAbs from the FAERS between 2016 and 2022. In addition, we also used MYSQL 8.0, Navicat Premium 15, and Microsoft EXCEL 2019 to analyze the signals of anti-IL-5 mAbs systematically. Results There are 9,476,351 reports collected from the FAERS database, of which 22,174 reports listed anti-IL-5 mAbs as the ‘primary suspected (PS)’ drug. A total of 59 (20 new signals, mepolizumab) and 62 (19 new signals, benralizumab) significant disproportionality preferred terms (PTs) conforming to the four algorithms were retained synchronously. Finally, we detected that the anti-IL-5 mAbs-induced AEs occurred in 31 organ systems (mepolizumab) and 30 organ systems (benralizumab). For mepolizumab and reslizumab, unexpected and new significant PTs of AEs were found, such as asthmatic crisis, chronic obstructive pulmonary disease (COPD), pneumonia, COVID-19, pneumothorax, adrenal insufficiency and so on. Notably, the risk signal of asthmatic crisis for mepolizumab was stronger than benralizumab (ROR 108.04 [95%CI, 96.09–121.47] vs 26.83 [95%CI, 18.91–38.06]). Comparing with mepolizumab and benralizumab, we found the proportion of serious adverse events in mepolizumab was both greater than benralizumab in each age group (≤20, 20–65, and ≥ 65). The median onset time of mepolizumab was 280 days (interquartile range [IQR] 1–367 days). Conclusion Analysis of FAERS data identified anti-IL-5 mAbs-associated AEs, and our findings supported continuous clinical monitoring, pharmacovigilance, and further studies of anti-IL-5 mAbs. In addition, clinicians may be more aware of the limitations of use in package inserts of anti-IL-5 mAbs: Not for relief of acute bronchospasm or status asthmaticus. Because of some limitations in the FAERS such as self-reports from patients and other confounding factors, the safety of anti-IL-5 mAbs needed more studies in different dimensions, especially the risk of cancer.

Impact of Sao2/Fio2 Delta Value on Mortality in Critically III Patients with ARDS and COVID-19 in Prone Position

Introduction: The COVID 19 pandemic generated in December 2019 has come to change paradigms in terms of ventilatory support measures worldwide, continuous clinical monitoring allows timely decision making impacting mortality in patients with ARDS. Objective: To identify the relationship between the SO2/FiO2 delta and mortality in critically ill patients with ARDS and COVID-19 in prone position. Material and methods: Retrospective, observational, comparative, analytical study, where all patients who met the inclusion criteria were evaluated: under mechanical ventilation and prone position for acute respiratory failure secondary to SARS-CoV-2 infection, measuring the value of SO2/FiO2 before and after the change of position to prone position, also mortality was recorded. Results: A total of 74 patients were analyzed, 33 corresponding to the survivors and 41 to the non-survivors group. The median age was 53.5 ± 12.77, with a male predominance. The mean days of mechanical ventilation were 10.64 ±5.16. A ROC curve was also performed for D SaO2/FiO2 and survival (AUC 0.668, p=0.013) for predicting patient survival. Conclusion: Continuous clinical monitoring is necessary to optimize resources in the different hospital and out-of-hospital areas. D SO2/FiO2 can be very useful for the continuous monitoring and prognosis in COVID-19 critical patients.

Heart Disease Classification and Recommendation by Optimized Features and Adaptive Boost Learning

In recent decades, cardiovascular diseases have eclipsed all others as the main reason for death in both low and middle income countries. Early identification and continuous clinical monitoring can reduce the death rate associated with heart disorders. Neither service is yet accessible, as it requires more intellect, time, and skill to effectively detect cardiac disorders in all circumstances and to advise a patient for 24 hours. In this study, researchers suggested a Machine Learning-based approach to forecast the development of cardiac disease. For precise identification of cardiac disease, an efficient ML technique is required. The proposed method works on five classes, one normal and four diseases. In the research, all classes were assigned a primary task, and recommendations were made based on that. The proposed method optimises feature weighting and selects efficient features. Following feature optimization, adaptive boost learning using tree and KNN bases is used. In the trial, sensitivity improved by 3-4%, specificity by 4-5%, and accuracy by 3-4% compared to the previous approach.

Abstract 14606: Accurate Detection of Acute Psychological Stress Events Using Single Lead ECG Data

Introduction: Stress has been linked to numerous health conditions, including heart disease, diabetes, and mental health issues. By monitoring changes in physiological signals, such as heart rate (HR) and heart rate variability (HRV), wearable biosensing technology allows acute stress to be non-invasively tracked over long periods, providing valuable insights for preventative healthcare. Methods: This two-phase study comprised several protocols designed to induce varying levels of psychological stress in participants (N=39). HR and HRV metrics, derived from electrocardiogram (ECG) data collected throughout the protocol on the single lead HeartKey ® Chest Module, were used by the HeartKey Stress algorithm to generate a relative stress score (0-100), which was validated against two clinically recognized methodologies for assessing patient stress: i) state-trait anxiety index (STAI), a questionnaire that subjectively measured the individual’s perceptual stress after each stage of the protocol, and ii) electrodermal activity (EDA), which continuously monitored conductive changes at the skin’s surface with an Empatica ® E4 wrist wearable. Results: Over both phases, participant STAI scores increased significantly during stress protocols (49.9 ± 23.3) relative to the baseline (30.0 ± 10.0). Mean HR showed a similar significant increase ( p &lt; 0.001), and HRV gradually decreased throughout the testing protocol. HeartKey Stress scores derived from HR and HRV data showed a strong correlation to STAI scores. Furthermore, the HeartKey Stress trend closely replicated that of the EDA data. Conclusions: HeartKey Stress algorithm consistently generated accurate and reliable stress scores in response to events of induced, acute psychological stress. The results suggest that the algorithm has potential utility for continuous clinical monitoring of patients with stress-related illnesses.

KNOWLEDGE AND ADHERENCE TO WARFARIN’S TREATMENT REGIMEN AMONG PATIENTS IN ALSHAAB AND AHMED GASIM HOSPITALS, SUDAN, 2018

OBEJCTIVE: Warfarin is an oral anticoagulant drug that needs continuous clinical and laboratory monitoring due to its narrow therapeutic index and life-threatening complications. This study aims to assess knowledge and adherence of patients to their warfarin treatment regimen and to identify barriers that prevent patients to take their warfarin therapy regularly. METHODS: In this cross-sectional study, a systematic random sample of 307 patients was selected from Alshaab teaching hospital heart section and Ahmed Gasim Hospital. Data was collected by anonymous interview-based questionnaires. RESULTS: Male patients (52.5%) exceeded females (44.8%), the mean age was 48.79. About 57.98% of the studied patients had moderate overall knowledge score, and more than half of them had good adherence levels (62.2%). The study shows that: Forgetting (43.7%) was the main barrier preventing the patients from taking their medication, followed by drug unavailability (36.8%) and high cost (19.5%). There are statistically significant differences between patient’s age/education and their level of knowledge (p=0.008/p=0.011). The correlations between patients’ adherence to warfarin oral anticoagulant and their level of knowledge is statistically insignificant (r=0.647, p=0.739). There are significant association between patients' level of adherence and the time from which the patient starts to take warfarin (p-value= .034). CONCLUSION: The majority of the studied patients had moderate overall knowledge score about Warfarin oral anticoagulant, and more than half of them had good adherence levels. “Forgetting” was the main barrier preventing the patients from taking their medication. DESCRIPTORS: Warfarin, Knowledge, Adherence, Barriers.

Neurofibromatosis: New Clinical Challenges in the Era of COVID-19

Rare diseases constitute a wide range of disorders thus defined for their low prevalence. However, taken together, rare diseases impact a considerable percentage of the world population, thus representing a public healthcare problem. In particular, neurofibromatoses are autosomal-dominant genetic disorders that include type 1 neurofibromatosis (NF1), type 2 neurofibromatosis (NF2) and schwannomatosis. Each of the three types is a genetically distinct disease with an unpredictable clinical course and for which there is still no resolutive cure. Therefore, a personalized therapeutic approach directed at improving the symptomatology as well as the search for new pharmacological strategies for the management of neurofibromatosis represents a priority for positive outcomes for affected patients. The coronavirus disease 2019 (COVID-19) pandemic has severely affected health systems around the world, impacting the provision of medical care and modifying clinical surveillance along with scientific research procedures. COVID-19 significantly worsened exchanges between healthcare personnel and neurofibromatosis patients, precluding continuous clinical monitoring in specialized clinic centers. In this new scenario, our article presents, for the first time, a comprehensive literature review on the clinical challenges for neurofibromatosis clinical care and research during the COVID-19 pandemic health emergency. The review was performed through PubMed (Medline) and Google Scholar databases until December 2021.

Organization and management of nursing services in NICU, levels of transport

Neonatal Intensive Care is defined as, “care for medically unstable and critically ill newborns requiring constant nursing, complicated surgical procedures, continual respiratory support, or other intensive interventions.” A NICU is a unit that provides high quality skilled care to critically ill neonates by offering facilities for continuous clinical, biochemical and radio logical monitoring and use of life support systems with the aim of improving survival of these babies. Intermediate care includes care of ill infants requiring less constant nursing care, but does not exclude respiratory support. Care of ill infants requiring less constant nursing care, but does not exclude respiratory support. When an intensive care nursery is available, the intermediate nursery serves as a “step down unit” from the intensive care area.

A hybrid neural network for continuous and non-invasive estimation of blood pressure from raw electrocardiogram and photoplethysmogram waveforms

Background and objectives: Continuous and non-invasive blood pressure monitoring would revolutionize healthcare. Currently, blood pressure (BP) can only be accurately monitored using obtrusive cuff-based devices or invasive intra-arterial monitoring. In this work, we propose a novel hybrid neural network for the accurate estimation of blood pressure (BP) using only non-invasive electrocardiogram (ECG) and photoplethysmogram (PPG) waveforms as inputs.Methods: This work proposes a hybrid neural network combines the feature detection abilities of temporal convolutional layers with the strong performance on sequential data offered by long short-term memory layers. Raw electrocardiogram and photoplethysmogram waveforms are concatenated and used as network inputs. The network was developed using the TensorFlow framework. Our scheme is analysed and compared to the literature in terms of well known standards set by the British Hypertension Society (BHS) and the Association for the Advancement of Medical Instrumentation (AAMI).Results: Our scheme achieves extremely low mean absolute errors (MAEs) of 4.41 mmHg for SBP, 2.91 mmHg for DBP, and 2.77 mmHg for MAP. A strong level of agreement between our scheme and the gold-standard intra-arterial monitoring is shown through Bland Altman and regression plots. Additionally, the standard for BP devices established by AAMI is met by our scheme. We also achieve a grade of ‘A’ based on the criteria outlined by the BHS protocol for BP devices.Conclusions: Our CNN-LSTM network outperforms current state-of-the-art schemes for non-invasive BP measurement from PPG and ECG waveforms. These results provide an effective machine learning approach that could readily be implemented into non-invasive wearable devices for use in continuous clinical and at-home monitoring.

Perinatal follow up and neonatal outcomes of pregnancies with obstetric cholestasis

Introduction. Obstetric cholestasis is the most common liver disease during pregnancy, which is predominantly associated with fetal complications. Material and Methods. This retrospective study included a total of 44 pregnant women with obstetric cholestasis who gave birth at the Clinic of Obstetrics and Gynecology, Clinical Center of Vojvodina, Novi Sad, from January 1, 2014 to December 31, 2018. Results. The average maternal age was 34 years. The mean gestational age at diagnosis of obstetric cholestasis was 31 weeks, and at the time of delivery 35 weeks of gestation. Abdominal pruritus was the main symptom of the disease affecting 72.72% of patients. The mean bile acid level in the blood at the time of diagnosis was 25.26 ?mol/L. Twenty nine patients (65.90%) gave birth vaginally, while 15 (34.09%) underwent cesarean section. The main maternal complication was postpartum hemorrhage. The average blood loss was 567 ml. There were no maternal deaths or stillbirths. The average newborn birth weight was 2830 g. Respiratory distress syndrome was diagnosed in 8 newborns (15.09%). The mean Apgar score at 1minute was 7, while at 5 minutes it was 9. Conclusion. Individual approach, continuous clinical and laboratory monitoring with adequate therapeutic treatment are necessary in patients with obstetric cholestasis.

Risk assessment in patients with pulmonary arterial hypertension in the era of COVID 19 pandemic and the telehealth revolution: State of the art review

Patients affected by pulmonary arterial hypertension (PAH) benefit from intensive, continuous clinical monitoring to guide escalation of treatments that carry the potential to improve survival and quality of life. During the coronavirus disease 2019 pandemic, the need for physical distancing has fueled the expeditious expansion of various telehealth modalities, which may apply in a unique manner to individuals with PAH. Performance of objective risk assessments in patients with PAH remotely via telemedical visits and other telehealth mechanisms is unprecedented and not yet rigorously validated. The uniquely high risk for rapid deterioration in patients with PAH demands a high degree of sensitivity to detect changes in functional assessments. In this review, several telehealth modalities for potential utilization in risk assessment and treatment titration in patients with PAH are explored, yet additional study is needed for their validation with the pre-pandemic care paradigm.

An Implementation Science Approach to Promote Optimal Implementation, Adoption, Use, and Spread of Continuous Clinical Monitoring System Technology.

This study aimed to apply implementation science tenets to guide the deployment and use of in-hospital Clinical Monitoring System Technology (CMST) and to develop a toolkit to promote optimal implementation, adoption, use, and spread of CMST. Six steps were carried out to (1) establish leadership support; (2) identify, educate, and sustain champions; (3) enlist clinical staff users to learn barriers and facilitators; (4) examine initial qualitative data from 11 clinician group interviews; (5) validate barriers/facilitators to CMST use and toolkit content; and (6) propose a toolkit to promote utilization. Clinical Monitoring System Technology output before and after implementation were compared. The top 3 barriers to effective CMST use were as follows: (1) inadequate education/training/support, (2) clinical workflow challenges, and (3) lack of communication. Facilitators to CMST implementation and adoption included the following: (1) providing comprehensive and consistent CMST education, (2) presenting evidence early and often, (3) tailoring device and usage expectations to individual environments, and (4) providing regular feedback about progress. Empirical data drove the development of a CMST implementation toolkit covering 6 areas: (1) why, (2) readiness, (3) readiness and implementation, (4) patient/family introduction, (5) champions, (6) care team saves, and (7) troubleshooting. Clinical Monitoring System Technology positively impacted failure to rescue events. Monthly median cardiac alert responses decreased from 30 to 3.64 minutes (87.9%), and respiratory alert responses decreased from 26 to 4.85 minutes (81.4%). Using implementation science tenets to concurrently guide deployment and study performance of 2 CMST devices and impact on workload was effective for both learning CMST efficacy at 2 hospital systems and developing a toolkit to promote optimal implementation, adoption, use, and spread.