New Early Warning Score: EMS Off-Label Use in Out-Of-Hospital Patients

Journal of Clinical Medicine

Article New Early Warning Score: EMS Off-Label Use in Out-of-Hospital Patients

Federico Semeraro 1,* , Giovanni Corona 2, Tommaso Scquizzato 3,4, Lorenzo Gamberini 1 , Anna Valentini 5, Marco Tartaglione 1, Andrea Scapigliati 6, Giuseppe Ristagno 7,8, Carmela Martella 5 , Carlo Descovich 9, Cosimo Picoco 1 and Giovanni Gordini 1

1 Department of Anaesthesia, Intensive Care and Emergency Medical Services, Ospedale Maggiore, 40133 Bologna, Italy; [email protected] (L.G.); [email protected] (M.T.); [email protected] (C.P.); [email protected] (G.G.) 2 Endocrinology Unit, Maggiore-Bellaria Hospital, 3-40139 Bologna, Italy; [email protected] 3 Department of Anaesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy; [email protected] 4 School of Medicine, Vita-Salute San Raffaele University, 20132 Milan, Italy 5 Department of Medical and Surgical Sciences, Alma Mater Studiorum University, 40126 Bologna, Italy; [email protected] (A.V.); [email protected] (C.M.) 6 Institute of Anaesthesia and Intensive Care, Catholic University of the Sacred Heart, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00168 Rome, Italy; [email protected] 7 Department of Pathophysiology and Transplantation, University of Milan, 00168 Milan, Italy; [email protected] 8 Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca’ GrandaOspedale Maggiore Policlinico, 20122 Milan, Italy 9 Clinical Governance and Quality Unit, Bologna Local Healthcare Authority Staff, 40133 Bologna, Italy; [email protected] Citation: Semeraro, F.; Corona, G.; * Correspondence: [email protected]; Tel.: +39-0516478868 Scquizzato, T.; Gamberini, L.; Valentini, A.; Tartaglione, M.; Abstract: Background: The National Early Warning Score (NEWS) is an assessment scale of in- Scapigliati, A.; Ristagno, G.; hospital patients’ conditions. The purpose of this study was to assess the appropriateness of a Martella, C.; Descovich, C.; et al. New potential off-label use of NEWS by the emergency medical system (EMS) to facilitate the identification Early Warning Score: EMS Off-Label Use in Out-of-Hospital Patients. J. of critical patients and to trigger appropriate care in the pre-hospital setting. Methods: A single Clin. Med. 2021, 10, 2617. https:// centre, longitudinal, prospective study was carried out between July and August 2020 in the EMS doi.org/10.3390/jcm10122617 service of Bologna. Home patients with age ≥ 18 years old were included in the study. The exclusion criterion was the impossibility to collect all the parameters needed to measure NEWS. Results: A Academic Editor: Marcello Covino total of 654 patients were enrolled in the study. The recorded NEWS values increased along with the severity of dispatch priority code, the EMS return code, the emergency department triage code, Received: 4 April 2021 and with patients’ age (r = 0.135; p = 0.001). The aggregated value of NEWS was associated with Accepted: 9 June 2021 an increased risk of hospitalization (OR = 1.30 (1.17; 1.34); p < 0.0001). Conclusion: This study Published: 14 June 2021 showed that the use of NEWS in the urgent and emergency care services can help patient assessment while not affecting EMS crew operation and might assist decision making in terms of severity-code Publisher’s Note: MDPI stays neutral assignment and resources utilization. with regard to jurisdictional claims in published maps and institutional affil- Keywords: cardiac arrest; EMS; National Early Warning Score; NEWS; ambulance; apps; out-of-hospital iations.

1. Introduction Copyright: © 2021 by the authors. Licensee MDPI, Basel, Switzerland. Early identiﬁcation of clinical deterioration has proven to improve outcomes in the This article is an open access article treatment of acute illnesses [1]. Especially in the pre-hospital emergency system, it is essen- distributed under the terms and tial to guarantee appropriate assistance through an efﬁcient coordination of the emergency conditions of the Creative Commons team. Recently, based on a systematic review, the International Liaison Committee on Attribution (CC BY) license (https:// Resuscitation (ILCOR) suggested that hospitals should consider the introduction of a rapid creativecommons.org/licenses/by/ response system (rapid response team/medical emergency team) to reduce the incidence 4.0/). of in-hospital cardiac arrest and in-hospital mortality [2]. Several Early Warning Scores

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(EWS) have been carried out in different in-hospital settings, each one based on the concept of the track and trigger system (TTS), an approach built on the detection of abnormalities in the main vital signs in order to predict the occurrence of acute adverse events [3]. The EWS is included in the aggregate weighted TTS (AWTTS), in which points are allocated in a weighted manner according to the derangement of variables in the patients’ vital signs from a considered normal range. The sum of the allocated points is known as the Early Warning Score (EWS). Since multiple and different EWS were used within the British National Health Service and worldwide, in 2012, the Royal College of Physicians (RCP) introduced the National Early Warning Score (NEWS) to standardize the approach nationwide [4] (AppendixA: example of table with the score structure). The NEWS variables for which points are allocated in the score include respiratory rate, oxygen saturation, temperature, systolic blood pressure, heart rate, level of consciousness, plus an additional two points added for any patient requiring supplemental oxygen. Based on the severity of the vital sign, a score ranging from 0 to 3 can be assigned to each parameter. The RCP recommends four trigger levels to alert for requiring clinician assessment. In particular, an aggregate NEWS of 5 or more is a critical threshold that should demand for the call of an urgent clinical evaluation; a NEWS of 7 or more should trigger a high-level clinical alert, i.e., an emergency clinical review. The main aim of NEWS, according to RCP, is to improve the assessment of acute illness severity, the detection of clinical deterioration, and the initiation of a timely and competent clinical response for inpatients. NEWS may help to trigger the most appropriate care in the pre-hospital setting, such as the activation or the denial of the advanced response team; in addition, it may help to choose the appropriate receiving hospital for the patient. Moreover, it could help anticipate the involvement of the senior emergency department or critical-care staff in the receiving hospital. However, its use in the pre-hospital setting is controversial partly due to of lack of evidence. This study aims to investigate whether the pre-hospital use of NEWS by the emergency medical system (EMS) can facilitate the identiﬁcation of critical patients during hospital admission.

2. Materials and Methods 2.1. Study Design This single center, longitudinal, prospective study was approved by the local ethical committee on 22 April 2020, and it was carried out simultaneously on three ambulances of the local EMS. The overall recruitment period of the study was 2 months (July and August 2020). The study included all patients aged ≥18 years old evaluated on the field by the EMS ambulance crews. The only exclusion criterion was the inability of the ambulance personnel to collect all the parameters needed to calculate NEWS. The EMS personnel collected data on all the requested parameters at the first evaluation of the patient. The NEWS data were recorded using forms on a specifically created web app.

2.2. Setting The Emilia Est Emergency Dispatch Centre (EEE-DC) manages the emergency calls and dispatches vehicles for the three provinces of Bologna, Ferrara, and Modena, covering a total of 2.5 million inhabitants. The urban area of Bologna has a population of 450,739 inhabitants. EMS is composed of eight ambulances equipped with BLS-skilled rescuers (BLS vehicles), four ambulances equipped with immediate life-support experienced nurses (ILS vehicles), two medical cars carrying an enhanced critical-care team composed of an emergency physician (emergency medicine or anaesthesia and intensive care specialists) and a nurse with advanced life-support skills (ALS vehicles). Two BLS vehicles and 1 ILS vehicle were included in the study as a representative sample of the overall activities. In our emergency-call-handling chain, the patient was assessed three times by our emergency system, which led to identiﬁcation of three main severity codes. First of all, to activate the appropriate vehicle, the EEE-DC delivered an EMS dispatch priority code based on emergency call information; the code can be white, green, yellow, or red depending on the J. Clin. Med. 2021, 10, 2617 3 of 13

severity of patient conditions as evaluated by the dispatch algorithm. Then, the rescuers on the ﬁeld assign the so-called return code after completion of patient evaluation; it consists of a number ranging from 0 and 4, where zero represents patient who has been treated on scene or refused the transport; a number from one to three stands for a lower severity to a higher one, respectively; and, lastly, number 4 indicates that the patient died. Finally, when in the Emergency Department, a triage code completes the chain, which can be a green, yellow, or red, indicating increasing severity of the clinical conditions.

2.3. Materials and Training A web application dedicated to NEWS collection data was created. It was developed by a team of volunteers during the national COVID-19 lockdown in Italy between March and May 2020 and named CovidUP19 project, since its original purpose was to collect data from patients quarantined at home [5]. The ambulance crew could use the software with every browser directly on smartphones. The data collection form was designed to collect data in an anonymous way and with a user-friendly approach (AppendixB: CovidUP19 web-app screenshot). The training of all the ambulance crews involved in the study was performed with the use of virtual meetings on Teams (Microsoft Redmond, Washington, DC, USA), accordingly with the COVID-19 local rules for training. The crew members were also invited to use the web app on the ﬁeld in the training period (June 2020) to warm up and get familiar with it. Overall, sixty-nine EMS personnel were trained on the aim of the study, the study protocol, and the rules to measure vital parameters with a standardized approach and to collect data for NEWS with the web application.

2.4. Endpoint The primary endpoint was the evaluation of the prognostic capacity of NEWS score in identifying patients with high risk of clinical deterioration in the pre-hospital setting. The secondary outcome was to evaluate the correlation between the NEWS values and the EMS dispatch, and the return priority codes, respectively. Moreover, NEWS score data were compared to emergency department triage evaluation.

2.5. Data Collection The NEWS score was collected with the use of the CovidUP19 web application directly on the ﬁeld by EMS personnel. The data were stored anonymously on a remote server and included patient age and sex; the NEWS parameters; the date, hours, and minutes of the compilation of the forms; and EMS identiﬁcation number generated automatically by EMS central database and manually inserted by EMS personnel. To gather all the relevant information for each patient, the NEWS values were associated with the EMS central database and with hospital data by the means of a pseudo-anonymized approach. The data from EMS central database were: EMS ID (this code was used to connect web app data with EMS central database), personal data, ambulance number, dispatch priority code, call location, suspected pathology code, severity return code based on ambulance personnel criteria, outcome of calls, admission emergency department triage code, and hospital outcome.

2.6. Statistical Analysis Descriptive statistics were used to summarize the available data. Categorical variables are described as count and proportion (%), while continuous variables are expressed as median (quartiles) when not-normally distributed or as mean ± SD when normally distributed. Kolmogorov–Smirnov test was used to assess the parametric distribution. Where applicable, one-way ANOVA or the chi-square test were used to compare values or proportions between groups. Correlations were assessed using Pearson’s or Spearman’s method for normally or non-normally distributed data, respectively. Stepwise multiple linear, logistic binary regression or analysis of covariance (ANCOVA) with Bonferroni correction were applied for multivariate analyses whenever appropriate. NEWS score J. Clin. Med. 2021, 10, 2617 4 of 13

was used as the main dependent variable. All the analyses were adjusted for possible confounders, including age and gender. Receiving operating curve (ROC) analysis was used to determine the best NEWS value for patient hospitalization; moreover, accuracy, sensitivity, and speciﬁcity at that threshold were calculated. All analyses were performed using SPSS version 25 (SPSS Inc., Chicago, IL, USA). The Youden index calculated as (sensitivity + speciﬁcity − 1) was used to identify the best cut off [6]. It represents the performance of a diagnostic test: the maximum value of the index is used for selecting the optimum cut-off point. The corresponding positive and negative predicting values were calculated.

2.7. Ethics Statement This study complies with the Declaration of Helsinki, and its protocol was approved by the Azienda USL di Bologna, Maggiore Hospital Institutional Review Board (402-2020- OSS-AUSLBO). Patients’ consent was obtained by EMS crew at arrival on the scene.

3. Results 3.1. Descriptive Statistics The overall characteristics of the included subjects are reported in Table1.

Table 1. Overall characteristics of the included subjects.

EMS Dispatch Priority Emergency Department Patients (%) Patients (%) Codes Triage Code White 8 (1.2%) White 17 (3.9%) Green 237 (36.2%) Green 229 (52.3%) Yellow 295 (45.1%) Yellow 160 (36.5%) Red 114 (17.4%) Red 32 (7.3%) Total 654 Total 438 Emergency Department Place of calls Patients (%) Patients (%) Outcome Residence 477 (72.9%) Discharged at home 223 (50.9%) Work/Ofﬁce 18 (2.8%) Admitted to the hospital 168 (38.4%) Public building 15 (2.3%) Refused hospital admission 43 (9.8%) Street 101 (15.4%) Deceased in ED 4 (0.9%) Sport facilities 2 (0.3%) Total 438 Other 41 (6.3%) Total 654 Suspected pathology code Patients (%) Return code Patients (%) Traumatic 165 (25.2%) 0 130 (19.9%) Cardiovascular 105 (16.1%) 1 459 (70.2%) Respiratory 58 (8.9%) 2 63 (9.6%) Neurologic 51 (7.8%) 3 2 (0.3%) Psychiatric 27 (4.1%) Neoplastic 7 (1.1%) Intoxication 17 (2.6%) Metabolic 6 (0.9%) Gastroenteric 48 (7.3%) Urologic 10 (3.7%) Ophthalmic 1 (0.2%) ENT 4 (0.6%) Obstetric 16 (2.4%) Infectious 7 (1.1%) Other pathologies 115 (17.6%) Not identiﬁed 3 (0.5%) Total 654 J. Clin. Med. 2021, 10, 2617 5 of 13

Of the 1486 patients assisted from the local EMS during the study period, six hundred and fifty-four were enrolled in the study (44%). The dispatch priority codes for EMS were categorized in four grades (white, green, yellow, red) based on the increasing severity of the patients’ conditions and, in the studied population, were 1.2%, 36.2%, 45.1%, and 17.4%, respectively. The location of calls was mainly from home (72.9%), and the majority of suspected pathology codes were traumatic (25.2%), cardiovascular (16.1%), and respiratory (8.9%) (Table1). The Maggiore Hospital is the trauma center of Bologna and for this reason, the sample size of the patients included a high percentage of trauma patients. Among the 654 patients evaluated on the field, 130 (19.8%) were treated on scene and/or refused to be transported to the emergency department, while 52 patients were admitted to other hospitals not included in the study. The remaining 472 subjects were referred to our hospital according to the local emergency protocol. Among patients transported to the emergency department, 459 (70.2%) were classified as code 1 (preserved vital functions with low evolution risk and hospitalization with low priority), 63 (9.6%) as code 2 (preserved critical functions with high evolution risk and hospitalization with high priority), and 2 (0.3%) as code 3 (unstable vital signs). Based on traditional in-hospital NEWS thresholds and triggers, the aggregate NEWS value of clinical risk was low (aggregate 0–4) in 558 (58%), medium (aggregate 5–6 or less if at least one individual parameter scored 3) in 207 (38%), and high (aggregate more than 6) in 42 (4%). Indeed, among patients with medium risk, NEWS values scored 3 in a single parameter in 153 (74%) cases, while the aggregate had a value of 5–6 in 54 (26%). In addition, NEWS progressively increased along with the increasing age (r = 0.135; p = 0.001). Among the 472 patients admitted to the hospital, 13 and 3 were directly referred to the obstetric or cardiac department, respectively. In addition, 18 refused triage evaluations. The remaining 438 patients were classified according to the emergency department code priority protocol as white (17, 3.9%), green (229, 52.3%), yellow (160, 36.5%), or red (32, 7.3%). Finally, among the 438 patients evaluated at triage, 223 (50.9%) were discharged at home from the ED, 168 (38.4%) admitted to the hospital, J. Clin. Med. 2021, 10, x FOR PEER REVIEW 6 of 14 43 (9.8%) refused hospital admission, and 4 (0.9%) died in the emergency department (Figures1 and2).

Figure 1. Infographics of the descriptive statistics. Figure 1. Infographics of the descriptive statistics.

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Figure 2. Results ﬂowchart.

3.2. On-Site NEWS Evaluation and Outcome NEWS scores were not different between female and male (Table2); however, it was signiﬁcantly higher inFigure older 2. Results subjects flowchart. when compared to younger (Table2). Similar to what was observed in the general population, no difference in NEWS score according to the gender was observed3.2. On-Site in older NEWS or younger Evaluation subjects and Outcome (1.85 ± 2.09 vs. 1.94 ± 1.99 and 2.64 ± 3.01 vs. 2.42 ± 2.87NEWS for female scores vs. were male not in different younger between and older female subjects, and male respectively; (Table 2); however, it was both p = NS). However,significantly some of higher theitems in older composing subjects when the co NEWSmpared total to younger score differed (Table 2). Similar to what according to gender orwas median observed age in (Table the general2). Hence, population, all the following no difference data werein NEWS adjusted score according to the for sex and gender. Atgender univariate was analysis,observed NEWSin older values or younger progressively subjects increased(1.85 ± 2.09 according vs. 1.94 ± 1.99 and 2.64 ± to EMS return-code severity3.01 vs. (Figure2.42 ± 2.873). for female vs. male in younger and older subjects, respectively; both p

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J. Clin. Med. 2021, 10, x FORTable PEER 2. NEWS REVIEW total score and sub-domain score according to population median age or gender. 8 of 14

Female Male p <68 Years Old ≥68 Years Old p Respiratory rate 0.29 ± 0.79 0.24 ± 0.72 0.413 0.26 ± 0.74 0.27 ± 0.77 0.775 Oxygen saturation 0.43 ± 0.86 0.34 ± 0.76 0.161 0.20 ± 0.61 0.57 ± 0.94 0.000 SystolicTemperature Pressure 0.39 0.23 ±± 0.740.55 0.260.52± 0.56 ± 0.80 0.5010.038 0.23 ±0.440.53 ± 0.71 0.26 ± 0.580.48 0.551± 0.84 0.483 HeartSystolic rate Pressure 0.54 0.39 ±± 0.750.74 0.520.53± 0.80 ± 0.78 0.0380.803 0.44 ±0.620.71 ± 0.79 0.48 ± 0.840.45 0.483± 0.73 0.006 Heart rate 0.54 ± 0.75 0.53 ± 0.78 0.803 0.62 ± 0.79 0.45 ± 0.73 0.006 ConsciousnessConsciousness 0.20 0.20 ±± 0.750.75 0.200.20± 0.76 ± 0.76 0.9690.969 0.10 ±0.100.54 ± 0.54 0.30 ± 0.910.30 0.001± 0.91 0.001 Total Totalscore score 2.19 2.19 ±± 2.512.51 2.212.21± 2.58 ± 2.58 0.9360.936 1.89 ±1.892.05 ± 2.05 2.51 ± 2.932.51 0.002± 2.93 0.002

Figure 3. Relation between NEWS value and return code (0 = patient treated on scene or refused the Figuretransport, 3. Relation 1 = low severity, between 2 = highNEWS severity). value and return code (0 = patient treated on scene or refused the transport, 1 = low severity, 2 = high severity). The latter association was confirmed even after the adjustment for age and gender (R2 = 0.195; p < 0.0001). SimilarSimilar resultsresults were were observed observed when when considering considering dispatch dispatch priority codespriority or thosecodes or those at- tributedattributed to to emergency emergency department department triage triage code (Figurecode (Figure4A,B). All 4 theseA, B). differences All these were differences were confirmedconfirmed even even after after the the adjustment adjustment for age for and age gender and (R gender2 = 0.105 (R and2 = 0.251,0.105 respectively; and 0.251, respectively; bothboth pp < 0.0001). Moreover, aggregated value of NEWS was associated with an increased risk of hospitalization even after the adjustment for confounders (OR = 1.30 (1.17; 1.34); p < 0.0001). Hence, the risk of hospitalization increased by 30% for each unit increment in the NEWS score. In particular, among NEWS values with a single parameter scoring 3, peripheral oxygen saturation and consciousness evaluation were the best predictors of hospitalization (Figure5). By applying ROC curve analysis, we found that a NEWS value higher than 2 predicted hospitalization with an accuracy of 67.5 (62.0; 72.9%) ± 0.03% (p < 0.0001) and a specificity and sensitivity of 63% and 62%, respectively (Figure6). Corresponding positive and negative predicting values were 64.9% and negative predictive value of 67.4%; p < 0.0001. The Youden Index at that threshold was 0.25 and the corresponding risk ratio 3.83 (2.2.47; 5.94).

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Systolic Pressure 0.39 ± 0.74 0.52 ± 0.80 0.038 0.44 ± 0.71 0.48 ± 0.84 0.483 Heart rate 0.54 ± 0.75 0.53 ± 0.78 0.803 0.62 ± 0.79 0.45 ± 0.73 0.006 Consciousness 0.20 ± 0.75 0.20 ± 0.76 0.969 0.10 ± 0.54 0.30 ± 0.91 0.001 Total score 2.19 ± 2.51 2.21 ± 2.58 0.936 1.89 ± 2.05 2.51 ± 2.93 0.002

Figure 3. Relation between NEWS value and return code (0 = patient treated on scene or refused the transport, 1 = low severity, 2 = high severity).

Similar results were observed when considering dispatch priority codes or those at- tributed to emergency department triage code (Figure 4A, B). All these differences were confirmed even after the adjustment for age and gender (R2 = 0.105 and 0.251, respectively; J. Clin. Med. 2021, 10, 2617 8 of 13 both p < 0.0001). J. Clin. Med. 2021, 10, x FOR PEER REVIEW 9 of 14

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Figure 4. Relation between NEWS value and dispatch priority codes (A) and emergency department triage code (B).

Moreover, aggregated value of NEWS was associated with an increased risk of hospitalization even after the adjustment for confounders (OR = 1.30 (1.17; 1.34); p < 0.0001). Hence, the risk of hospitalization increased by 30% for each unit increment in the NEWS score. In particular, among NEWS values with a single parameter scoring 3, peripheral oxygen saturation and consciousness evaluation were the best predictors of hospitalization (Figure 5). By applying ROC curve analysis, we found that a NEWS value higher than 2 predicted hospitalization with an accuracy of 67.5 (62.0; 72.9%) ± 0.03% (p < 0.0001) and a specificity and sensitivity of 63% and 62%, respectively (Figure 6). Corresponding positive and negative predicting values were 64.9% and negative predictive value of 67.4%; p Figure 4. Relation between NEWS value and dispatch priority codes (A) and emergency department < 0.0001. The Youden Index at that threshold was 0.25 and the corresponding risk ratio triage code (B). Figure3.83 4(2.2.47;. Relation 5.94 between). NEWS value and dispatch priority codes (A) and emergency department triage code (B).

Moreover, aggregated value of NEWS was associated with an increased risk of hospitalization even after the adjustment for confounders (OR = 1.30 (1.17; 1.34); p < 0.0001). Hence, the risk of hospitalization increased by 30% for each unit increment in the NEWS score. In particular, among NEWS values with a single parameter scoring 3, peripheral oxygen saturation and consciousness evaluation were the best predictors of hospitalization (Figure 5). By applying ROC curve analysis, we found that a NEWS value higher than 2 predicted hospitalization with an accuracy of 67.5 (62.0; 72.9%) ± 0.03% (p < 0.0001) and a specificity and sensitivity of 63% and 62%, respectively (Figure 6). Corresponding positive and negative predicting values were 64.9% and negative predictive value of 67.4%; p < 0.0001. The Youden Index at that threshold was 0.25 and the corresponding risk ratio 3.83 (2.2.47; 5.94).

FigureFigure 5. NEWS 5. NEWS value value with with a 3- asingle 3-single parameter parameter and and predictors predictors of hospitalization. of hospitalization.

Figure 5. NEWS value with a 3-single parameter and predictors of hospitalization.

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Figure 6. ROC curveFigure analysis 6. ROC and curveprediction analysis of hospitalization. and prediction of hospitalization. 4. Discussion 4. Discussion The main finding of this study was that the NEWS could be used in a pre-hospital The main findingsetting, of withthis stud acceptabley was that sensitivity the NEWS and could specificity, be used to estimatein a pre-hospital the outcome at hospital setting, with acceptableadmission sensitivity and discharge. and specificity Interestingly,, to estimate peripheral the outcome oxygen at saturation hospital ad- and consciousness mission and discharge.evaluation Interestingly, resulted as peripheralthe key components oxygen saturation of the score and that consciousness best predicted hospitalization. evaluation resultedAs as anticipated, the key components there was a of great the score deal of that evidence best predicted proving itshospitalization. efficacy in identifying patients As anticipated, therewith was a high a great risk deal of clinical of evidence deterioration proving inits in-hospitalefficacy in setting.identifying For pa- instance, a NEWS tients with a highscore risk of > 7clinicalat the deterioration time of ICU in discharge in-hospital was setting. a strong For instance, independent a NEWS predictor of clinical score >7 at the timedeterioration of ICU discharge within was 24 h a [ 7strong]. Similar independent to the in-hospital predictor use, of clinical in our pre-hospitaldete- setting, a rioration within 24NEWS h [7]. >Similar 6 or a to single the in NEWS-hospital item use, equal in our to 3pre corresponded-hospital setting to patients, a NEWS with unstable vital >6 or a single NEWSsigns, item and equal NEWS to values3 corresponded progressively to patients increased with according unstable tovital EMS signs return-code, severity. and NEWS valuesFurthermore, progressively NEWS increased has proven according to be easyto EMS to employ return- ascode a readily severity. available Fur- tool that can be thermore, NEWSused has proven for predicting to be easy in-hospital to employ mortality as a readily on all available patients admitted tool that tocan the be general ward [8]. used for predicting in-Thishospital study mortality reports itson potentialall patients off-label admitted use to by the EMS general to evaluate ward [ prehospital8]. patients, This study reportsfacilitating its potential the identification off-label use of thoseby EMS needing to evaluate admission prehospital to hospital patients, and procurement of facilitating the identificationmore appropriate of those care, needing as other admission retrospective to hospital studies and hypothesized procurement [9 of–12 ]. For instance, more appropriatea care, retrospective as other retrospective cohort study studies conducted hypothesized in West London [9–12]. For affirmed instance, that a NEWS could be retrospective cohortsuccessfully study conducted utilized in West the pre-hospital London affirmed emergency that NEWS setting could to predict be suc- those patients who cessfully utilizedwere in the most pre-hospital likely to emergency deteriorate setting and to to thus predict support those the patients clinicians’ who were decision-making pro- most likely to deterioratecess [13]. and The to present thus support study hasthe nowclinicians’ showed decision prospectively-making the process possibility [13]. to use NEWS in The present studythe has pre-hospital now showed setting, prospectively demonstrating the possibility its utility to together use NEWS with in the the simplicity pre- of use. hospital setting, demonstratingMoreover, its NEWS utility has together proved with to be the useful simplicity to detect of use. early sepsis in pre-hospital emer- Moreover, NEWSgency has care, proved confirmed to be useful by a study to detect carried early out sepsis in UK in pre that-hospital demonstrated emer- how NEWS in gency care, confirmedprehospital by a study care carried was associated out in UK with that improveddemonstrated outcomes how NEWS in patients in pre- with suspicion of hospital care wassepsis associated [14]. Inwith our improved cohort, only outcomes 1.1% of in patients patients were with at suspicion risk for infection/sepsis, of sepsis while the [14]. In our cohortmajority, only 1.1% had of a patients traumatic were or a at cardiovascular risk for infection injury./sepsis, while the majority had a traumatic or Nowadays,a cardiovascular there areinjury. several scales used by the emergency crew to assess the criticality Nowadays, thereof patients, are several such scales as the used Glasgow by the coma emergency scale (GCS), crew to the assess revised the critical- trauma score (RTS), the ity of patients, suchquick as the sequential Glasgow organ coma failure scale (GCS), assessment the revised (qSOFA). trauma All ofscore them, (RTS), without the any doubts, are quick sequential theorgan basis failure for patientassessment assessment, (qSOFA). but, All on of thethem, other without hand, any there doubt is evidences, are that NEWS is the basis for patientsuperior assessment, in a pre-hospital but, on the environment other hand at, there identifying is evidence patients that at NEWS risk of is adverse outcomes, superior in a pre-inhospital particular, environment in comparison at identifying with qSOFA patients [11 at].To risk the of best adverse of our outcomes, knowledge, this study is in particular, in comparisonone of the few with prospective, qSOFA [11 observational].To the best of cohort our know studiesledge, that this evaluated study is the use of NEWS one of the few prospectivein pre-hospital, observational settings to cohort assess studies the predictive that evaluated value ofthe vital use of parameters NEWS measurement in pre-hospital settingsby an to ambulance assess the crewpredictive directly value on of the vital field. parameters In this study, measurement as in similar by observational retrospective studies, we enrolled a significant sample of pre-hospital patients, and we

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described the prevalence and the distribution of NEWS in a representative population of emergency calls received from our dispatch center [9–12]. Interestingly, our results show that, in most of the pre-hospital settings, high scores are reasonably uncommon, and NEWS scores in a pre-hospital setting are much lower than those calculated inside the hospital [8]. Furthermore, the results highlighted the coherence of NEWS with the current organizational activity of the urgent and emergency-care services. This is deduced by several correlations. First, NEWS increased as a function of the given dispatch priority code following the emergency calls; secondly, the same relation was observed according to EMS return code; and, finally, it increased with the increase of the emergency department triage code. These links seem to support the capability of NEWS in identifying patients with high risk of clinical deterioration even in the pre-hospital setting and to predict the subsequent evolution of severity assessment from the dispatch priority to the pre-hospital-care phase and finally to hospital triage. We also tested the capability to use web-app technology to get an immediate score-minimizing time factor, which plays a vital role in the urgent and emergency care set. NEWS sees its greatest application in all cases in which specific factors that explicitly highlight the critical clinical condition of the patient are absent, not to overlook potential signs of critical disease or severe damage that may not be intercepted in initial evaluation [15]. At the same time, it should not be used as a substitute of critical thinking but as an integrative and supportive tool for ambulance crews in the assessment of the patients. The main limitations of this study lie in its monocentric design and in the limited sampling of potentially recruitable cases (44%). This was mainly due to the dispatch of ambulances not involved in the present study, while less than 1% of cases was due to missed data collection from the attending ambulance crew. Another concern is not having calculated the sample size; however, this was a preliminary study aiming to evaluate prospectively the feasibility of the proposed approach to the pre-hospital critical patient. Hence, further studies are advisable in order to validate the score. Nevertheless, the collected sample is sufficiently representative of the average distribution of the dispatch priority codes sent by our dispatch center. In any case, it should be recognized that the validity of NEWS in non-hospital settings should be confirmed by other studies before drawing final conclusions. On the other hand, the main strengths of this study are its prospective observational design and the implementation of data collection tools in order to minimize the risk of interfering with clinical practice (AppendixC). Further studies will be needed to confirm these results and to evaluate the application of NEWS in specific sub-settings, such as ALS teams’ activation.

5. Conclusions This prospective, observational study showed that the use of NEWS in urgent and emergency-care services is promising, as it does not affect operation time; moreover, it creates a direct and standardized language between the different ﬁgures operating in the pre-hospital setting (nurses, doctors, and rescuers) and might assist decision making in terms of severity-code assignment and resource utilization. The potential implementation should be validated in a wider network of critical patients that connects the out-of-hospital emergency with the intra-hospital setting.

Author Contributions: Conceptualization: F.S.; Data curation, G.C., L.G., A.V., M.T. and C.P.; Formal analysis, F.S., G.C., T.S., L.G. and C.P.; Investigation, F.S., G.C., A.V. and M.T.; Methodology, F.S., G.C., T.S., L.G., A.V., M.T., A.S., G.R., C.M., C.D. and C.P.; Project administration, C.M., C.D., C.P. and G.G; Resources, G.R., C.D. and G.G.; Supervision, F.S. and C.D.; Validation, G.C., T.S., L.G., A.S. and C.M.; Visualization, T.S.; Writing—original draft, F.S., G.C., T.S., L.G., A.V., M.T., A.S., G.R., C.D., C.P. and G.G.; Writing—review & editing, F.S., G.C., T.S., L.G., A.V., M.T., A.S., G.R., C.D., C.P. and G.G. All authors have read and agreed to the published version of the manuscript. Funding: This research received no external funding. J. Clin. Med. 2021, 10, x FOR PEER REVIEW 12 of 14

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Funding: This research received no external funding. Funding:Institutional This Review research Board received Statement: no external The studyfunding was. conducted according to the guidelines of the J. Clin. Med. 2021, 10, 2617 11 of 13 Declaration of Helsinki and approved by the Institutional Review Board (or Ethics Committee) of Institutional Review Board Statement: The study was conducted according to the guidelines of the Azienda USL di Bologna (402-2020-OSS-AUSLBO). Declaration of Helsinki and approved by the Institutional Review Board (or Ethics Committee) of InstitutionalAziendaInformed USL Review Consent di Bologna Board Statement: Statement: (402-2020 InformedThe-OSS study-AUSLBO). was consent conducted was according obtained to the from guidelines all subjects of the involved in the study. DeclarationInformed of Consent Helsinki andStatement: approved byInformed the Institutional consent Review was Board obtained (or Ethics from Committee) all subjects of involved in the Azienda USL di Bologna (402-2020-OSS-AUSLBO). study.Data Availability Statement: Internal EMS and Maggiore Hospital digital database is not available Informedas public Consent archive. Statement: Informed consent was obtained from all subjects involved in the study. Data Availability Statement: Internal EMS and Maggiore Hospital digital database is not available Data Availability Statement: Internal EMS and Maggiore Hospital digital database is not available asasAcknowledgments: public public archive. archive. We want to thank all the nurses and rescuers who worked hard to collect data in this difficult time and have continued to save lives from the field to the hospital during the Acknowledgments:Acknowledgments:We want We towant thank to all thank the nurses all the and nurses rescuers and who workedrescuers hard who to collect worked data hard in to collect data COVID-19 pandemic. We also want to thank all the members of CovidUP19 team. thisin thisdifficult difficult time and time have andcontinued have to continued save lives from to the save field lives to the from hospital the during field the to COVID-19 the hospital during the pandemic.COVIDConflicts-19 We of pandemic. also Interest: want to FWe thank.S. alsois all Chair thewant members-Elect to thank and of CovidUP19 Scienceall the members and team. Education of Covid CommitteeUP19 team. BLS co-Chair of the ConflictsEuropean of Interest: ResuscitationF.S. is Chair-Elect Council, and ILCOR Science BLS and EducationWorking CommitteeGroup member, BLS co-Chair and of Scientific the Committee Conflicts of Interest: F.S. is Chair-Elect and Science and Education Committee BLS co-Chair of the Europeanmember Resuscitation of Italian Resuscitation Council, ILCOR Council. BLS Working L.G. Groupis Scientific member, Committee and Scientific me Committeember of Italian Resuscita- European Resuscitation Council, ILCOR BLS Working Group member, and Scientific Committee membertion Council. of Italian A Resuscitation.S. is the Past Council. President L.G. isScientific of the Italian Committee Resuscitation member of Italian Council Resuscitation and Science and Educa- Council.member A.S. of isItalian the Past Resuscitation President of the Council. Italian Resuscitation L.G. is Scientific Council Committee and Science and me Educationmber of Italian Resuscita- tion Committee BLS member of the European Resuscitation Council. G.R. is the President of the Committeetion Council. BLS memberA.S. is ofthe the Past European President Resuscitation of the Italian Council. Resuscitation G.R. is the President Council of the and Italian Science and Educa- Italian Resuscitation Council, ILCOR BLS Working Group member, and Science and Education Resuscitationtion Committee Council, BLS ILCOR member BLS Working of the Group European member, Resuscitation and Science and Council. Education G Committee.R. is the President of the Committee BLS member of the European Resuscitation Council. G.C., T.S., A.V., M.T., C.M., C.D., BLSItalian member Resuscitation of the European Council, Resuscitation ILCOR Council. BLS G.C., Working T.S., A.V., Group M.T., member,C.M., C.D., and C.P. andScience G.G. and Education haveC.P. no, and conflicts G.G of. have interest. no conflicts of interest. Committee BLS member of the European Resuscitation Council. G.C., T.S., A.V., M.T., C.M., C.D., C.P., and G.G. have no conflicts of interest. AppendixAppendix A A -National Early Warning Score (Royal College of Physicians, 2012) Appendix A -National Early Warning Score (Royal College of Physicians, 2012)

Figure A1. National Early Warning Score (Royal College of Physicians, 2012). Appendix B - CovidUP19 Web-App Screenshot AppendixAppendix B B - CovidUP19 Web-App Screenshot

Appendix C - Descriptive Analysis of the EMS Questionnaires about the Use of Figure A2. CovidUP19 Web-App Screenshot. AppendixNEWS C - Descriptive Analysis of the EMS Questionnaires about the Use of NEWS

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Appendix C

Figure A3. Descriptive Analysis of the EMS Questionnaires about the Use of NEWS. A crew personnel questionnaire was designed to collect feedback about the use of NEWS.A crew Each personnel participant questionnaire was asked was designed to complete to collect the feedback questionnaire about the usebased of on a seven-point NEWS.Likert Eachscale participant (LS) designed was asked to to explore complete the the applicability questionnaire based on the on a field, seven-point potential implementa- Likert scale (LS) designed to explore the applicability on the field, potential implementation astion a tool as toa measuretool to themeasure clinical situationthe clinical at scene, situation and time at spent scene in calculating, and time the spent score. in calculating the Thescore. questionnaire The questionnaire data were collected data were anonymously collected with anonymously a JotForm form with (JotForm, a JotForm San form (JotForm, Francisco,San Francisco, CA, USA) California, developed forUS theA)study. developed Forty-six for EMS the personnel study. outForty of sixty-nine-six EMS personnel out of (67%)sixty involved-nine (67%) in the involved study filled in out the the wholestudy questionnaire; filled out the among whole them, questionnaire; the majority among them, (80%) were BLS-skilled rescuers, while the remaining 20% were nurses attending the ILS vehicles.the majority Among (80%) the responders, were BLS 48%- recruitedskilled morerescuers than twenty, while cases the with remaining no mention 20% of were nurses at- anytending kind of the difficulties ILS vehicles. (98%). Since Among the majority the responders, of the responders 48% (74%) recruited had never more used than twenty cases thewith NEWS no before,mention we investigatedof any kind whether of difficulties the initial training (98%). phase Since had the been majority exhaustive of the responders enough in providing all the necessary contents to use NEWS properly: a total of 54% and 41%,(74%) respectively, had never agreed used and thestrongly NEWS agreed,before, according we investigated to the proposed whether Likert the scale. initial training phase Moreover,had been the exhaustive developed web enough application in turnedproviding out to all be clear, the comprehensible, necessary contents and to use NEWS easy-to-useproperly: fora total 50% and of 39%54% of and the responders,41%, respectively which, respectively,, agreed stronglyand strongly agreed and agreed, according to agreedthe proposed with the proposed Likert statements. scale. Moreover, Furthermore, the 54% developed agreed and 39%web strongly application agreed turned out to be that NEWS did not interfere with the usual clinical practice in terms of time; only 4% andclear, 2%, comprehensible, respectively, partially and agreed easy and-to-use were for uncertain. 50% and Concerning 39% of the its usefulness,responders, which, respec- 17%tively, and 50% strongly of answers agreed agreed and and stronglyagreed agreed, with respectively,the proposed in stating statements. that NEWS Furthermore, 54% couldagreed be aand potentially 39% strongly useful and agreed relevant that tool to NEWS assess patients did not in interfere out-of-hospital with settings. the usual clinical prac- Approximatelytice in terms half of oftime; the EMS only personnel 4% and who 2% completed, respectively the questionnaire, partially considered agreed theand were uncertain. use of NEWS as a valid supplementary tool to recruit ALS vehicles in those critical cases in whichConcerning advanced its life-support usefulness, skills 17% are required; and 50% an additionalof answers tool agreed to support and ambulance strongly agreed, respec- personneltively, in in stating decision makingthat NEWS about thecould severity be ofa thepotentially return code; useful and an and integrative relevant tool tool to assess pa- totients enhance, in outin terms-of-hospital of time and settings. suitability, Approximately the admission to the half emergency of the department EMS personnel who com- triage. Lastly, we asked whether participants would deploy the score into emergency out-of-hospitalpleted the questionnaire clinical practice. considered The results were the characterizeduse of NEWS by heterogeneity, as a valid supplemen since tary tool to 22%recruit answered ALS absolutely vehicles yes, in 39%those yes, critical 22% probably cases yes, in andwhich 11% probablyadvanced no. Fromlife-support the skills are re- results,quired; NEWS an additional application was tool not to perceived support as anambulance obstacle in terms personnel of time and in operativitydecision making about the duringseverity the of management the return of code; urgent and and emergencyan integrative situations. tool In to fact, enhance as 54%, agreed in terms and of time and suita- 39% strongly agreed that NEWS did not interfere with the usual clinical practice in terms of timebility but, the rather admission was a valid to adjunct the emergency to the clinical decisiondepartment for urgent triage. care and/orLastly, hospital we asked whether par- admissionticipants needs. would deploy the score into emergency out-of-hospital clinical practice. The results were characterized by heterogeneity, since 22% answered absolutely yes, 39% yes, 22% probably yes, and 11% probably no. From the results, NEWS application was not perceived as an obstacle in terms of time and operativity during the management of urgent and emergency situations. In fact, as 54% agreed and 39% strongly agreed that NEWS did not interfere with the usual clinical practice in terms of time but rather was a valid adjunct to the clinical decision for urgent care and/or hospital admission needs.

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