Dataset Information

Adjusting Early Warning Score by clinical assessment: a study protocol for a Danish cluster-randomised, multicentre study of an Individual Early Warning Score (I-EWS).

ABSTRACT: INTRODUCTION:Track and trigger systems (TTSs) based on vital signs are implemented in hospitals worldwide to identify patients with clinical deterioration. TTSs may provide prognostic information but do not actively include clinical assessment, and their impact on severe adverse events remain uncertain. The demand for prospective, multicentre studies to demonstrate the effectiveness of TTSs has grown the last decade. Individual Early Warning Score (I-EWS) is a newly developed TTS with an aggregated score based on vital signs that can be adjusted according to the clinical assessment of the patient. The objective is to compare I-EWS with the existing National Early Warning Score (NEWS) algorithm regarding clinical outcomes and use of resources. METHOD AND ANALYSIS:In a prospective, multicentre, cluster-randomised, crossover, non-inferiority study. Eight hospitals are randomised to use either NEWS in combination with the Capital Region of Denmark NEWS Override System (CROS) or implement I-EWS for 6.5 months, followed by a crossover. Based on their clinical assessment, the nursing staff can adjust the aggregated score with a maximum of -4 or +6 points. We expect to include 150 000 unique patients. The primary endpoint is all-cause mortality at 30 days. Coprimary endpoint is the average number of times per day a patient is NEWS/I-EWS-scored, and secondary outcomes are all-cause mortality at 48 hours and at 7 days as well as length of stay. ETHICS AND DISSEMINATION:The study was presented for the Regional Ethics committee who decided that no formal approval was needed according to Danish law (J.no. 1701733). The I-EWS study is a large prospective, randomised multicentre study that investigates the effect of integrating a clinical assessment performed by the nursing staff in a TTS, in a head-to-head comparison with the internationally used NEWS with the opportunity to use CROS. TRIAL REGISTRATION NUMBER:NCT03690128.

SUBMITTER: Nielsen PB

PROVIDER: S-EPMC6955532 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Adjusting Early Warning Score by clinical assessment: a study protocol for a Danish cluster-randomised, multicentre study of an Individual Early Warning Score (I-EWS).

Nielsen Pernille B PB Schultz Martin M Langkjaer Caroline Sophie CS Kodal Anne Marie AM Pedersen Niels Egholm NE Petersen John Asger JA Lange Theis T Arvig Michael Dan MD Meyhoff Christian Sahlholt CS Bestle Morten M Hølge-Hazelton Bibi B Bunkenborg Gitte G Lippert Anne A Andersen Ove O Rasmussen Lars Simon LS Iversen Kasper Karmark KK

BMJ open 20200107 1

<h4>Introduction</h4>Track and trigger systems (TTSs) based on vital signs are implemented in hospitals worldwide to identify patients with clinical deterioration. TTSs may provide prognostic information but do not actively include clinical assessment, and their impact on severe adverse events remain uncertain. The demand for prospective, multicentre studies to demonstrate the effectiveness of TTSs has grown the last decade. Individual Early Warning Score (I-EWS) is a newly developed TTS with an ...[more]

PMID: 31915173

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Project description:BackgroundPatients' evolving critical illness can be predicted and prevented. However, failure to identify the signs of critical illness and subsequent lack of appropriate action for patients developing acute and critical illness remain a problem. Challenges in assessing whether a child is critically ill may be due to children's often uncharacteristic symptoms of serious illness. Children may seem relatively unaffected until shortly before circulatory and respiratory failure and cardiac arrest. The Bedside Paediatric Early Warning Score has been validated in a large multinational study and is used in two regions in Denmark. However, healthcare professionals experience difficulties in relation to measuring blood pressure and to the lack of assessment of children's level of consciousness. In addition, is it noteworthy that in 23,288-hour studies, all seven items of the Bedside Paediatric Early Warning Score were recorded in only 5.1% of patients. This trial aims to compare two Paediatric Early Warning Score (PEWS) models to identify the better model for identifying acutely and critically ill children. The hypothesis is that the Central Denmark Region PEWS model is superior to the Bedside PEWS in terms of reducing unplanned transfers to intensive care or transfers from regional hospitals to the university hospital among already hospitalised children.Methods/designThis is a multicentre, randomised, controlled clinical trial where children are allocated to one of two different PEWS models. The study involves all paediatric departments and one emergency department in the Central Denmark Region. The primary outcome is unplanned transfer to the paediatric intensive care unit or transfer from regional hospitals to the university hospital. Based on preliminary data, 14,000 children should be included to gain a power of 80% (with a 5% significance level) and to detect a clinically significant difference of 30% of unplanned transfers to intensive care or from regional hospitals to the paediatric department at the university department. A safety interim analysis will be performed after inclusion of 7000 patients.DiscussionThis is the first randomised trial to investigate two different PEWS models. This study demonstrates the safety and effectiveness of a new PEWS model and contributes to knowledge of hospitalised children's clinical deterioration.Trial registrationClinicalTrials.gov, NCT02433327 . Registered on 27 April 2015.

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: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:IntroductionThe 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 analysisThe 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 disseminationThe 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.

Project description:ObjectivesIdentifying patients with a possible SARS-CoV-2 infection in the emergency department (ED) is challenging. Symptoms differ, incidence rates vary and test capacity may be limited. As PCR-testing all ED patients is neither feasible nor effective in most centres, a rapid, objective, low-cost early warning score to triage ED patients for a possible infection is developed.DesignCase-control study.SettingSecondary and tertiary hospitals in the Netherlands.ParticipantsThe study included patients presenting to the ED with venous blood sampling from July 2019 to July 2020 (n=10 417, 279 SARS-CoV-2-positive). The temporal validation cohort covered the period from July 2020 to October 2021 (n=14 080, 1093 SARS-CoV-2-positive). The external validation cohort consisted of patients presenting to the ED of three hospitals in the Netherlands (n=12 061, 652 SARS-CoV-2-positive).Primary outcome measuresThe primary outcome was one or more positive SARS-CoV-2 PCR test results within 1 day prior to or 1 week after ED presentation.ResultsThe resulting 'CoLab-score' consists of 10 routine laboratory measurements and age. The score showed good discriminative ability (AUC: 0.930, 95% CI 0.909 to 0.945). The lowest CoLab-score had high sensitivity for COVID-19 (0.984, 95% CI 0.970 to 0.991; specificity: 0.411, 95% CI 0.285 to 0.520). Conversely, the highest score had high specificity (0.978, 95% CI 0.973 to 0.983; sensitivity: 0.608, 95% CI 0.522 to 0.685). The results were confirmed in temporal and external validation.ConclusionsThe CoLab-score is based on routine laboratory measurements and is available within 1 hour after presentation. Depending on the prevalence, COVID-19 may be safely ruled out in over one-third of ED presentations. Highly suspect cases can be identified regardless of presenting symptoms. The CoLab-score is continuous, in contrast to the binary outcome of lateral flow testing, and can guide PCR testing and triage ED patients.

Dataset Information

Adjusting Early Warning Score by clinical assessment: a study protocol for a Danish cluster-randomised, multicentre study of an Individual Early Warning Score (I-EWS).

Publications

Adjusting Early Warning Score by clinical assessment: a study protocol for a Danish cluster-randomised, multicentre study of an Individual Early Warning Score (I-EWS).

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