Chest patch for continuous vital-sign monitoring: A clinical validation study during movement and controlled hypoxia. (Preprint)

2021 ◽  
Author(s):  
Carlos Morgado Areia ◽  
Mauro Santos ◽  
Sarah Vollam ◽  
Marco Pimentel ◽  
Louise Young ◽  
...  
Keyword(s):  
Gold Standard ◽  
Improve Patient Safety ◽  
Ambulatory Monitoring ◽  
Absolute Error ◽  
Controlled Environment ◽  
Clinical Implementation ◽  
Monitoring Frequency ◽  
Sit To Stand ◽  
Gold Standard Reference ◽  
General Wards

BACKGROUND Early warning scores in general wards are commonly limited by intermittent manual measurements; these are recognised as being time consuming and for impacting monitoring frequency. Wearable devices may support healthcare staff, improve patient safety and promote early deterioration detection. However available ambulatory monitoring devices need to be tested and validated before clinical implementation. OBJECTIVE The objective of this study is to determine the agreement between a chest-worn patch (VitalPatch®) and gold standard reference device for heart rate (HR) and respiratory rate (RR) measurements during movement and during gradual de-saturation in a controlled environment. METHODS After both VitalPatch and gold standard device (Philips MX450) were placed, participants performed 7 different movements: At rest, Sit-to-Stand, Tapping, Rubbing, Drinking, Turning Pages, and Using a Tablet. In a controlled environment. Participants were then made hypoxic gradually down to 80% peripheral oxygen saturations. The primary outcome measures were the accuracy, defined as the mean absolute error (MAE) of the VitalPatch estimates when compared with their gold-standards. We defined these to be clinical acceptable if within 5 beats per minute (bpm) for HR and 3 respirations per minute (rpm) for RR. RESULTS We acquired complete datasets of 29 participants. In the movement phase, HR estimates were within the pre-specified limits for all movements. For RR, estimates were also inside the acceptable range, with the exception of the Sit-to-Stand and Turning Pages movements, showing a MAE (95% CI) of 3.05 (2.48, 3.58) rpm and 3.45 (2.71, 4.11) rpm, respectively. For the hypoxia phase, these were always within the limits with an overall MAE for HR and RR of 0.72 (0.66, 0.78) bpm and 1.89 (1.75, 2.03) rpm, respectively. There were no significant differences in the VitalPatch performance across a range of oxygen desaturations. CONCLUSIONS The VitalPatch was highly accurate throughout movement tests except for its RR estimation during two movements. This device was reliable throughout the hypoxia stages, with no significant accuracy differences in normoxia (≥ 90%), mild (89.9 - 85%) and severe hypoxia (< 85%). CLINICALTRIAL ISRCTN61535692

scholarly journals Accuracy of Consumer Wearable Heart Rate Measurement During an Ecologically Valid 24-Hour Period: Intraindividual Validation Study (Preprint)

2018 ◽  
Author(s):  
Benjamin W Nelson ◽  
Nicholas B Allen
Keyword(s):  
Heart Rate ◽  
Gold Standard ◽  
Mean Absolute Error ◽  
Reference Method ◽  
Absolute Error ◽  
Wearable Devices ◽  
Mean Difference ◽  
Gold Standard Reference ◽  
Consumer Device ◽  
Device Use

BACKGROUND Wrist-worn smart watches and fitness monitors (ie, wearables) have become widely adopted by consumers and are gaining increased attention from researchers for their potential contribution to naturalistic digital measurement of health in a scalable, mobile, and unobtrusive way. Various studies have examined the accuracy of these devices in controlled laboratory settings (eg, treadmill and stationary bike); however, no studies have investigated the heart rate accuracy of wearables during a continuous and ecologically valid 24-hour period of actual consumer device use conditions. OBJECTIVE The aim of this study was to determine the heart rate accuracy of 2 popular wearable devices, the Apple Watch 3 and Fitbit Charge 2, as compared with the gold standard reference method, an ambulatory electrocardiogram (ECG), during consumer device use conditions in an individual. Data were collected across 5 daily conditions, including sitting, walking, running, activities of daily living (ADL; eg, chores, brushing teeth), and sleeping. METHODS One participant, (first author; 29-year-old Caucasian male) completed a 24-hour ecologically valid protocol by wearing 2 popular wrist wearable devices (Apple Watch 3 and Fitbit Charge 2). In addition, an ambulatory ECG (Vrije Universiteit Ambulatory Monitoring System) was used as the gold standard reference method, which resulted in the collection of 102,740 individual heartbeats. A single-subject design was used to keep all variables constant except for wearable devices while providing a rapid response design to provide initial assessment of wearable accuracy for allowing the research cycle to keep pace with technological advancements. Accuracy of these devices compared with the gold standard ECG was assessed using mean error, mean absolute error, and mean absolute percent error. These data were supplemented with Bland-Altman analyses and concordance class correlation to assess agreement between devices. RESULTS The Apple Watch 3 and Fitbit Charge 2 were generally highly accurate across the 24-hour condition. Specifically, the Apple Watch 3 had a mean difference of −1.80 beats per minute (bpm), a mean absolute error percent of 5.86%, and a mean agreement of 95% when compared with the ECG across 24 hours. The Fitbit Charge 2 had a mean difference of −3.47 bpm, a mean absolute error of 5.96%, and a mean agreement of 91% when compared with the ECG across 24 hours. These findings varied by condition. CONCLUSIONS The Apple Watch 3 and the Fitbit Charge 2 provided acceptable heart rate accuracy (<±10%) across the 24 hour and during each activity, except for the Apple Watch 3 during the daily activities condition. Overall, these findings provide preliminary support that these devices appear to be useful for implementing ambulatory measurement of cardiac activity in research studies, especially those where the specific advantages of these methods (eg, scalability, low participant burden) are particularly suited to the population or research question.

Caring for Your Baby and Young Child: Birth to Age 5

2019 ◽  
Author(s):  
◽  
Tanya Remer Altmann ◽  
David L. Hill
Keyword(s):  
Young Child ◽  
American Academy ◽  
Gold Standard ◽  
Child Birth ◽  
Seventh Edition ◽  
Reference Guide ◽  
American Academy Of Pediatrics ◽  
Gold Standard Reference

The seventh edition of Caring for Your Baby and Young Child, Birth to Age 5 is the gold-standard reference guide for parents from the most trusted source available - the 67,000-member American Academy of Pediatrics. https://shop.aap.org/caring-for-your-baby-and-young-child-paperback/

Clinical validation of the self-reported Glasgow Antipsychotic Side-effect Scale using the clinician-rated UKU side-effect scale as gold standard reference

2020 ◽  
Vol 34 (8) ◽  
pp. 820-828
Author(s):  
Marlene Schouby Bock ◽  
Oona Nørgaard Van Achter ◽  
David Dines ◽  
Maria Simonsen Speed ◽  
Christoph U Correll ◽  
...  
Keyword(s):  
Side Effects ◽  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Gold Standard ◽  
Side Effect ◽  
Self Report ◽  
Measurement Based Care ◽  
Gold Standard Reference ◽  
Antipsychotic Side Effects

Background: Antipsychotics are key for the treatment of psychotic and several non-psychotic disorders. Unfortunately, antipsychotic medications are associated with side effects, which may reduce quality of life and treatment adherence. Therefore, regular screening of antipsychotic side effects is essential. The Glasgow Antipsychotic Side-effect Scale is a patient self-report scale developed for this purpose. However, the Glasgow Antipsychotic Side-effect Scale has only been validated against another self-report side effect measure, which is suboptimal. Objective: We aimed to validate the Glasgow Antipsychotic Side-effect Scale using the clinician-rated Udvalg for Kliniske Undersøgelser side-effect rating scale as the gold standard reference. Results: 81 antipsychotic-treated outpatients with schizophrenia-spectrum disorders (age = 42±13 years; males = 43%, schizophrenia = 77%, illness duration: median = 11 years) completed the Glasgow Antipsychotic Side-effect Scale and were subsequently scored on the Udvalg for Kliniske Undersøgelser by trained raters. Sensitivity, specificity, positive predictive value and negative predictive value were calculated for paired Glasgow Antipsychotic Side-effect Scale and Udvalg for Kliniske Undersøgelser items. Sensitivity of Glasgow Antipsychotic Side-effect Scale items ranged from 33–96%, with 19 (86%) having >75% sensitivity. Lowest sensitivity emerged for “nocturnal enuresis” (33%), “galactorrhea” (50%) and “hyperkinesia” 14–99%, with 14 items (64%) having >75% specificity, being lowest for “asthenia” (14%), “polyuria/polydipsia” (35%), “sedation” (41%), “akathisia” (53%), “dystonia” (65%), “hyperkinesia” (68%), “hypokinesia” (70%) and “accommodation” (70%). Positive predictive value ranged from 7–85%, with six items (27%) having a positive predictive value >75%. Negative predictive value ranged from 40–98%, with 21 items (95%) having a negative predictive value >75%. The mean time to complete the Glasgow Antipsychotic Side-effect Scale was 4±2 minutes. Conclusion: The Glasgow Antipsychotic Side-effect Scale demonstrated satisfactory validity as a self-rated tool for antipsychotic side effects and may aid measurement-based care and decision-making.

scholarly journals Validation of OraQuick HCV Rapid Antibody Test in Postmortem Specimens

2020 ◽  
Vol 10 (2) ◽  
pp. 81-86
Author(s):  
Claire E. Rose ◽  
Lisa Duncan ◽  
Amy M. Hawes
Keyword(s):  
Hepatitis C ◽  
Gold Standard ◽  
Rapid Test ◽  
Antibody Test ◽  
Acquisition Time ◽  
Hepatitis C Infection ◽  
Postmortem Blood ◽  
Gold Standard Reference ◽  
Antibody Positivity ◽  
Rapid Antibody

INTRODUCTION: The objective of this study is to evaluate the performance of OraQuick HCV Rapid Antibody Test against a “gold-standard”, FDA-approved, laboratory-based serum immunoassay (SI) in postmortem blood. To date, OraQuick HCV Rapid Antibody Test has not been evaluated for use in postmortem testing. This OraQuick test is a manually performed, visually interpreted, single use immunoassay for the qualitative detection of antibodies to the hepatitis C virus (HCV). METHODS: Blood was collected from 51 decedents whose deaths were investigated in the jurisdiction of the Knox and Anderson County Medical Examiner’s Office (MEO) January 2017 through April 2017. For each consented case, blood was tested using both the OraQuick HCV Rapid Antibody Test and a laboratory-based hepatitis C serum immunoassay (“gold standard” reference assay). Results from the OraQuick HCV Rapid Antibody Test were compared against a laboratory-based hepatitis C serum immunoassay. RESULTS: Using the laboratory-based serum immunoassay (SI) as the “gold standard” for assessing true HCV antibody positivity, and comparing SI against OraQuick rapid test, sensitivity for the OraQuick rapid test was 95.65% and specificity was 96.15% in postmortem blood. DISCUSSION: Our results demonstrate that OraQuick HCV rapid antibody test is reliable for diagnosis of hepatitis C infection in postmortem blood with a relatively short (less than approximately 21.5 hours) postmortem sample acquisition time. The OraQuick in some cases may be superior to traditional, laboratory-based HCV SI due to potential increased viscosity of postmortem blood.

scholarly journals Evaluation of the Diagnostic Value of Contrast-Enhanced Voiding Urosonography with Regard to the Further Therapy Regime and Patient Outcome—A Single-Center Experience in an Interdisciplinary Uroradiological Setting

Medicina ◽  
2021 ◽  
Vol 57 (1) ◽  
pp. 56
Author(s):  
Constantin A. Marschner ◽  
Vincent Schwarze ◽  
Regina Stredele ◽  
Matthias F. Froelich ◽  
Johannes Rübenthaler ◽  
...  
Keyword(s):  
Gold Standard ◽  
High Sensitivity ◽  
Diagnostic Value ◽  
Voiding Cystourethrography ◽  
Single Center ◽  
Clinical Implementation ◽  
Single Center Experience ◽  
Experienced Radiologist ◽  
Contrast Enhanced ◽  
Tract Infections

Background and Objectives: Vesicoureteral reflux (VUR) describes a common pediatric anomaly in pediatric urology with a prevalence of 1–2%. In diagnostics, in addition to the gold standard of voiding cystourethrography (VCUG), contrast-enhanced urosonography (ceVUS) offers a radiation-free procedure, which, despite its advantages, is not yet widely used. In the present single-center study, subsequent therapeutic procedures and outcomes after ceVUS of 49 patients were investigated. The aim of the study is to investigate the efficacy of ceVUS with the intention of broader clinical implementation. Materials and Methods: Between 2016 and 2020, 49 patients were retrospectively included and received a ceVUS to evaluate VUR. With a distribution of 47:2 (95.9%), a clear female predominance was present. The age of the patients varied between 5 months and 60 years at the time of ceVUS. All examinations were all performed and subsequently interpreted by a single experienced radiologist (EFSUMB level 3). Results: Compared to intraoperative findings, ceVUS shows a sensitivity of 95.7% with a specificity of 100%. Allergic reactions to the contrast medium could not be observed. Conclusion: With its high sensitivity and intraoperative validation, ceVUS offers an excellent alternative to VCUG, the gold standard in the diagnosis of VUR. In addition, ceVUS is a radiation-free examination method with a low risk profile that offers an exceptional diagnostic tool in the diagnostic clarification of recurrent urinary tract infections with the suspected diagnosis of VUR and should also be included in the consideration of a diagnosis next to the established VCUG, especially in younger children.

scholarly journals Accuracy and Acceptability of Wearable Motion Tracking Smartwatches for Inpatient Monitoring

2020 ◽  
Author(s):  
Chaiyawan Auepanwiriyakul ◽  
Sigourney Waibel ◽  
Joanna Songa ◽  
Paul Bentley ◽  
Aldo A. Faisal
Keyword(s):  
Gold Standard ◽  
Motion Tracking ◽  
Low Cost ◽  
Clinical Test ◽  
Motion Sensors ◽  
Natural Behaviour ◽  
Study Results ◽  
Hospital Patients ◽  
Gold Standard Reference ◽  
Optical Motion

: Inertial Measurement Units (IMUs) within an everyday consumer smartwatch offer a convenient and low-cost method to monitor the natural behaviour of hospital patients. However, their accuracy at quantifying limb motion, and clinical acceptability, have not yet been demonstrated. To this end we conducted a two-stage study: First, we compared the inertial accuracy of wrist-worn IMUs, both research-grade (Xsens MTw Awinda, and Axivity AX3) and consumer-grade (Apple Watch Series 3 and 5), relative to gold-standard optical motion tracking (OptiTrack). Given the moderate to the strong performance of the consumer-grade sensors we then evaluated this sensor and surveyed the experiences and attitudes of hospital patients (N=44) and staff (N=15) following a clinical test in which patients wore smartwatches for 1.5-24 hours in the second study. Results indicate that for acceleration, Xsens is more accurate than the Apple smartwatches and Axivity AX3 (RMSE 0.17+/-0.01 g; R2 0.88+/-0.01; RMSE 0.22+/-0.01 g; R2 0.64+/-0.01; RMSE 0.42+/-0.01 g; R2 0.43+/-0.01, respectively). However, for angular velocity, the smartwatches are marginally more accurate than Xsens (RMSE 1.28+/-0.01 rad/s; R2 0.85+/-0.00; RMSE 1.37+/-0.01 rad/s; R2 0.82+/-0.01, respectively). Surveys indicated that in-patients and healthcare professionals strongly agreed that wearable motion sensors are easy to use, comfortable, unobtrusive, suitable for long term use, and do not cause anxiety or limit daily activities. Our results suggest that smartwatches achieved moderate to strong levels of accuracy compared to a gold-standard reference and are likely to be accepted as a pervasive measure of motion/behaviour within hospitals.

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