Individual Signs Research Articles

Wearable devices could be used to continuously monitor vital signs in patients who are hospitalized, but they require validation. This study aimed to evaluate the clinical validity of the prototype of a semiautomated wearable wrist device (ChroniSense Polso) to measure vital signs and provide National Early Warning Scores (NEWSs). Vital signs and NEWSs measured using the wearable device were compared with standard, nurse-lead manual measurements. We enrolled adult patients (aged ≥18 years) who required vital sign measurements at least every 6 hours in a UK teaching district general hospital. Wearable device measurements were not used for clinical decision-making. The primary outcome was the agreement on the individual National Early Warning parameter scores and vital sign measurements: respiratory rate, oxygen saturation, body temperature, systolic blood pressure, and heart rate. Secondary outcomes were the agreement on the total NEWS, incidence of adverse events, and user acceptance. To compare the wearable device measurements with the standard measurements, we analyzed vital sign measurements by limits of agreement (Bland-Altman analysis) and conducted κ agreement analyses for NEWSs. A user experience survey was conducted with questions about comfort of the wrist device, safety, preference, and use. We included 132 participants in the study, with a mean age of 62 (SD 15.81) years; most of them were men (102/132, 77.3%). The highest weighted κ values were found for heart rate (0.69, 95% CI 0.57-0.81 for all 385 measurements) and systolic blood pressure (0.39, 95% CI 0.30-0.47 for all 339 measurements). Weighted κ values were low for respiration rate (0.03, 95% CI -0.001 to 0.05 for all 445 measurements), temperature (0, 95% CI 0-0 for all 231 measurements), and oxygen saturation (-0.11, 95% CI -0.20 to -0.02 for all 187 measurements). Weighted κ using Cicchetti-Allison weights showed κ of 0.20 (95% CI 0.03-0.38) when using all 56 total NEWSs. The user acceptance survey found that approximately half (45/91, 49%) of the participants found it comfortable to wear the device and liked its appearance. Most (85/92, 92%) of them said that they would wear the device during their next hospital visit, and many (74/92, 80%) said that they would recommend it to others. This study shows the promising use of a prototype wearable device to measure vital signs in a hospital setting. Agreement between the standard measurements and wearable device measurements was acceptable for systolic blood pressure and heart rate, but needed to be improved for respiration rate, temperature, and oxygen saturation. Future studies need to improve the clinical validity of this wearable device. Large studies are required to assess clinical outcomes and cost-effectiveness of wearable devices for vital sign measurement. RR2-10.1136/bmjopen-2018-028219.

Erythrodermic atopic dermatitis (AD) is a severe AD subtype defined by extensive skin involvement, leading to complications and sometimes hospitalization. To assess dupilumab's efficacy and safety in patients with erythrodermic AD in clinical trials. This post hoc analysis included patients enrolled in 6 multicenter, multinational, randomized, double-blind, placebo-controlled trials. Patients included in this analysis met erythrodermic AD criteria of 90% or greater body surface area (BSA) affected by AD and Global Individual Sign Score for erythema of 1 or higher. Data analyses for this post hoc analysis were conducted between March 5, 2019, and October 24, 2020. Dupilumab once weekly or every 2 weeks, or placebo, either as monotherapy or with concomitant topical corticosteroids (TCS). Efficacy (BSA, Eczema Area and Severity Index [EASI] score, Peak Pruritus Numerical Rating Scale [PP-NRS] score), changes in serum biomarkers (thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase), and safety (incidence of adverse events) at week 16. Data were pooled within each regimen; monotherapy and concomitant TCS results are shown separately. Of 3075 randomized patients, 209 met criteria for erythrodermic AD at baseline, with the median age being 31 and 39 years in the monotherapy and concomitant TCS trials, respectively, similar to the overall populations (34 and 36 years, respectively); 71.3% (n = 97) and 74.0% (n = 54) of patients, respectively, were male (compared with 58.7% and 60.6% in the overall populations). In patients with erythrodermic AD, dupilumab once weekly and every 2 weeks vs placebo significantly improved percentage of BSA affected by AD (least squares mean percent change [SE]) with monotherapy (-42.0% [7.7%] and -39.9% [6.5%] vs -17.2% [11.0%]; P = .03) and concomitant TCS (-63.2% [6.7%] and -56.1% [9.1%] vs -14.5% [7.3%]; P < .001); EASI score with monotherapy (-58.5% [9.0%] and -58.3% [7.9%] vs -22.3% [12.4%]; P = .004 and P = .003, respectively) and concomitant TCS (-78.9% [7.8%] and -70.6% [10.1%] vs 19.3% [8.2%]; P < .001); and PP-NRS score in monotherapy (-45.9% [7.8%] and -33.9% [6.6%] vs -0.6% [9.4%]; P < .001) and concomitant therapy (-53.0% [8.1%] and -55.7% [10.8%] vs -26.0% [8.8%]; P = .006 and P = .01, respectively). Nominally statistically significant improvement was seen as early as week 1 (EASI and PP-NRS scores with monotherapy). Biomarker levels were significantly reduced vs placebo. The most frequent adverse events in dupilumab-treated patients were injection-site reaction, conjunctivitis, and nasopharyngitis. In this post hoc analysis of 6 randomized clinical trials, treatment with dupilumab resulted in rapid, sustained improvements in AD signs and symptoms with acceptable safety in patients with erythrodermic AD, similar to those in the trials' overall patient population. ClinicalTrials.gov Identifiers: NCT01859988, NCT02277743, NCT02277769, NCT03054428, NCT02260986, NCT02755649.

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Individual Signs Research Articles

Related Topics

Articles published on Individual Signs

Perspectives on Evolving Gene Therapy for X-Linked Retinitis Pigmentosa

Blood Pressure and Glaucoma—A Complex Relationship

Differentiating Activity From Damage—The Morphological Challenge of Morphea

It Is Time for the Light to Shine on Organ Procurement Organizations

Walking Exercise for Peripheral Artery Disease

Addressing Disparities in Resident Attrition

Manufacturer Spending on Direct-to-Consumer Advertising for Pharmaceutical Products

Adverse Pregnancy Outcomes—Risk Enhancers Whose Time Has Finally Arrived

Anti–Vascular Endothelial Growth Factor Therapy for Complications of Diabetic Retinopathy—From Treatment to Prevention?

ChroniSense National Early Warning Score Study: Comparison Study of a Wearable Wrist Device to Measure Vital Signs in Patients Who Are Hospitalized.

New Directions for Improving the Minimal Clinically Important Difference in Patient-Reported Outcome Measures for Use in Clinical Care and Research

The structural and dynamic analysis of the clinical-psychopathological components of emotional burnout and professional disappointment in psychiatrists during the war

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Therapeutic Relief for Erythrodermic Atopic Dermatitis

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