Dataset Information

Research protocol for the validation of a new portable technology for real-time continuous monitoring of Early Warning Score (EWS) in hospital practice and for an early-stage multistakeholder assessment.

ABSTRACT:

Introduction

The real-time continuous monitoring of vital parameters in patients affected by multiple chronic conditions and/or COVID-19 can lead to several benefits to the Italian National Healthcare System (IT-NHS). The UBiquitous Integrated CARE (UBICARE) technology is a novel health digital platform at the validation stage in hospital setting. UBICARE might support the urgent need for digitalisation and early intervention, as well as minimise the face-to-face delivery of care in both hospital and community-based care settings. This research protocol aims to design an early-stage assessment of the multidimensional impact induced by UBICARE within the IT-NHS alongside technology validation in a hospital ward.

Methods and analysis

The targeted patients will be medium/high-risk hypertensive individuals as an illustrative first example of how UBICARE might bring benefits to susceptible patients. A mixed-method study will be applied to incorporate to the validation study a multistakeholder perspective, including perceived patient experiences and preferences, and facilitate technology adoption. First, semistructured interviews will be undertaken with a variety of stakeholders including clinicians, health managers and policy-makers to capture views on the likely technology utility, economic sustainability, impact of adoption in hospital practice and alternative adoption scenarios. Second, a monocentric, non-randomised and non-comparative clinical study, supplemented by the administration of standardised usability questionnaires to patients and health professionals, will validate the use of UBICARE in hospital practice. Finally, the results of the previous stages will be discussed in a multidisciplinary-facilitated workshop with IT-NHS relevant stakeholders to reconcile stakeholders' perspectives. Limitations include a non-random recruitment strategy in the clinical study, small sample size of the key stakeholders and potential stakeholder recruitment bias introduced by the research technique.

Ethics and dissemination

The Ethics Committee for Clinical Experimentation of Tuscany Region approved the protocol. Participation in this study is voluntary. Study results will be disseminated through peer-reviewed publications and academic conferences.

SUBMITTER: Manetti S

PROVIDER: S-EPMC7716668 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Research protocol for the validation of a new portable technology for real-time continuous monitoring of Early Warning Score (EWS) in hospital practice and for an early-stage multistakeholder assessment.

Manetti Stefania S Vainieri Milena M Guidotti Elisa E Zuccarino Sara S Ferré Francesca F Morelli Maria Sole MS Emdin Michele M

BMJ open 20201203 12

<h4>Introduction</h4>The real-time continuous monitoring of vital parameters in patients affected by multiple chronic conditions and/or COVID-19 can lead to several benefits to the Italian National Healthcare System (IT-NHS). The UBiquitous Integrated CARE (UBICARE) technology is a novel health digital platform at the validation stage in hospital setting. UBICARE might support the urgent need for digitalisation and early intervention, as well as minimise the face-to-face delivery of care in both ...[more]

PMID: 33273048

Similar Datasets

Project description:ObjectivesPrevious studies have looked at National Early Warning Score performance in predicting in-hospital deterioration and death, but data are lacking with respect to patient outcomes following implementation of National Early Warning Score. We sought to determine the effectiveness of National Early Warning Score implementation on predicting and preventing patient deterioration in a clinical setting.DesignRetrospective cohort study.SettingTertiary care academic facility and a community hospital.PatientsPatients 18 years old or older hospitalized from March 1, 2014, to February 28, 2015, during preimplementation of National Early Warning Score to August 1, 2015, to July 31, 2016, after National Early Warning Score was implemented.InterventionsImplementation of National Early Warning Score within the electronic health record and associated best practice alert.Measurements and main resultsIn this study of 85,322 patients (42,402 patients pre-National Early Warning Score and 42,920 patients post-National Early Warning Score implementation), the primary outcome of rate of ICU transfer or death did not change after National Early Warning Score implementation, with adjusted hazard ratio of 0.94 (0.84-1.05) and 0.90 (0.77-1.05) at our academic and community hospital, respectively. In total, 175,357 best practice advisories fired during the study period, with the best practice advisory performing better at the community hospital than the academic at predicting an event within 12 hours 7.4% versus 2.2% of the time, respectively. Retraining National Early Warning Score with newly generated hospital-specific coefficients improved model performance.ConclusionsAt both our academic and community hospital, National Early Warning Score had poor performance characteristics and was generally ignored by frontline nursing staff. As a result, National Early Warning Score implementation had no appreciable impact on defined clinical outcomes. Refitting of the model using site-specific data improved performance and supports validating predictive models on local data.

Project description:We sought to validate prognostic scores in coronavirus disease 2019 including National Early Warning Score, Modified Early Warning Score, and age-based modifications, and define their performance characteristics.DesignWe analyzed prospectively collected data from the Adaptive COVID-19 Treatment Trial. National Early Warning Score was collected daily during the trial, Modified Early Warning Score was calculated, and age applied to both scores. We assessed prognostic value for the end points of recovery, mechanical ventilation, and death for score at enrollment, average, and slope of score over the first 48 hours.SettingA multisite international inpatient trial.PatientsA total of 1,062 adult nonpregnant inpatients with severe coronavirus disease 2019 pneumonia.InterventionsAdaptive COVID-19 Treatment Trial 1 randomized participants to receive remdesivir or placebo. The prognostic value of predictive scores was evaluated in both groups separately to assess for differential performance in the setting of remdesivir treatment.Measurements and main resultsFor mortality, baseline National Early Warning Score and Modified Early Warning Score were weakly to moderately prognostic (c-index, 0.60-0.68), and improved with addition of age (c-index, 0.66-0.74). For recovery, baseline National Early Warning Score and Modified Early Warning Score demonstrated somewhat better prognostic ability (c-index, 0.65-0.69); however, National Early Warning Score+age and Modified Early Warning Score+age further improved performance (c-index, 0.68-0.71). For deterioration, baseline National Early Warning Score and Modified Early Warning Score were weakly to moderately prognostic (c-index, 0.59-0.69) and improved with addition of age (c-index, 0.63-0.70). All prognostic performance improvements due to addition of age were significant (p < 0.05).ConclusionsIn the Adaptive COVID-19 Treatment Trial 1 cohort, National Early Warning Score and Modified Early Warning Score demonstrated moderate prognostic performance in patients with severe coronavirus disease 2019, with improvement in predictive ability for National Early Warning Score+age and Modified Early Warning Score+age. Area under receiver operating curve for National Early Warning Score and Modified Early Warning Score improved in patients receiving remdesivir versus placebo early in the pandemic for recovery and mortality. Although these scores are simple and readily obtainable in myriad settings, in our data set, they were insufficiently predictive to completely replace clinical judgment in coronavirus disease 2019 and may serve best as an adjunct to triage, disposition, and resourcing decisions.

Project description:BackgroundModified Early Warning Score (MEWS) and National Early Warning Score (NEWS) are widely used in predicting the mortality and intensive care unit (ICU) admission of critically ill patients. This study was conducted to evaluate and compare the prognostic value of NEWS and MEWS for predicting ICU readmission, mortality, and related outcomes in critically ill patients at the time of ICU discharge.MethodsThis multicenter, prospective, observational study was conducted over a year, from April 2019 to March 2020, in the general ICUs of two university-affiliated hospitals in Northwest Iran. MEWS and NEWS were compared based on the patients' outcomes (including mortality, ICU readmission, time to readmission, discharge type, mechanical ventilation (MV), MV duration, and multiple organ failure after readmission) using the univariable and multivariable binary logistic regression. The receiver operating characteristic (ROC) curve was used to determine the outcome predictability of MEWS and NEWS.ResultsA total of 410 ICU patients were enrolled in this study. According to multivariable logistic regression analysis, both MEWS and NEWS were predictors of ICU readmission, time to readmission, MV status after readmission, MV duration, and multiple organ failure after readmission. The area under the ROC curve (AUC) for predicting mortality was 0.91 (95% CI = 0.88-0.94, P < 0.0001) for the NEWS and 0.88 (95% CI = 0.84-0.91, P < 0.0001) for the MEWS. There was no significant difference between the AUC of the NEWS and the MEWS for predicting mortality (P = 0.082). However, for ICU readmission (0.84 vs. 0.71), time to readmission (0.82 vs. 0.67), MV after readmission (0.83 vs. 0.72), MV duration (0.81 vs. 0.67), and multiple organ failure (0.833 vs. 0.710), the AUCs of MEWS were significantly greater (P < 0.001).ConclusionNational Early Warning Score and MEWS values of >4 demonstrated high sensitivity and specificity in identifying the risk of mortality for the patients' discharge from ICU. However, we found that the MEWS showed superiority over the NEWS score in predicting other outcomes. Eventually, MEWS could be considered an efficient prediction score for morbidity and mortality of critically ill patients.

Project description:BackgroundWireless vital sign sensors are increasingly being used to monitor patients on surgical wards. Although early warning scores (EWSs) are the current standard for the identification of patient deterioration in a ward setting, their usefulness for continuous monitoring is unknown.ObjectiveThis study aimed to explore the usability and predictive value of high-rate EWSs obtained from continuous vital sign recordings for early identification of postoperative complications and compares the performance of a sensor-based EWS alarm system with manual intermittent EWS measurements and threshold alarms applied to individual vital sign recordings (single-parameter alarms).MethodsContinuous vital sign measurements (heart rate, respiratory rate, blood oxygen saturation, and axillary temperature) collected with wireless sensors in patients on surgical wards were used for retrospective simulation of EWSs (sensor EWSs) for different time windows (1-240 min), adopting criteria similar to EWSs based on manual vital signs measurements (nurse EWSs). Hourly sensor EWS measurements were compared between patients with (event group: 14/46, 30%) and without (control group: 32/46, 70%) postoperative complications. In addition, alarms were simulated for the sensor EWSs using a range of alarm thresholds (1-9) and compared with alarms based on nurse EWSs and single-parameter alarms. Alarm performance was evaluated using the sensitivity to predict complications within 24 hours, daily alarm rate, and false discovery rate (FDR).ResultsThe hourly sensor EWSs of the event group (median 3.4, IQR 3.1-4.1) was significantly higher (P<.004) compared with the control group (median 2.8, IQR 2.4-3.2). The alarm sensitivity of the hourly sensor EWSs was the highest (80%-67%) for thresholds of 3 to 5, which was associated with alarm rates of 2 (FDR=85%) to 1.2 (FDR=83%) alarms per patient per day respectively. The sensitivity of sensor EWS-based alarms was higher than that of nurse EWS-based alarms (maximum=40%) but lower than that of single-parameter alarms (87%) for all thresholds. In contrast, the (false) alarm rates of sensor EWS-based alarms were higher than that of nurse EWS-based alarms (maximum=0.6 alarm/patient/d; FDR=80%) but lower than that of single-parameter alarms (2 alarms/patient/d; FDR=84%) for most thresholds. Alarm rates for sensor EWSs increased for shorter time windows, reaching 70 alarms per patient per day when calculated every minute.ConclusionsEWSs obtained using wireless vital sign sensors may contribute to the early recognition of postoperative complications in a ward setting, with higher alarm sensitivity compared with manual EWS measurements. Although hourly sensor EWSs provide fewer alarms compared with single-parameter alarms, high false alarm rates can be expected when calculated over shorter time spans. Further studies are recommended to optimize care escalation criteria for continuous monitoring of vital signs in a ward setting and to evaluate the effects on patient outcomes.

Dataset Information

Research protocol for the validation of a new portable technology for real-time continuous monitoring of Early Warning Score (EWS) in hospital practice and for an early-stage multistakeholder assessment.

Introduction

Methods and analysis

Ethics and dissemination

Publications

Research protocol for the validation of a new portable technology for real-time continuous monitoring of Early Warning Score (EWS) in hospital practice and for an early-stage multistakeholder assessment.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets