Search

Copyright of EMC-Medecine is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Examines the prevalence of serum hepatitis C virus antibodies in patients with Hashimoto's thyroiditis. Assessment on thyroid function using standard radioimmunoassay; Detection of receptor antibodies for thyroid stimulating hormone using radioreceptor assay; Use of laser nephelometry in immunoglobulin assays.

Background: Little is known about the impact of hospital trajectory on survival and functional decline of older critically ill patients. We evaluate 6-month outcomes after admission to: intensive care units (ICU), intermediate care units (IMCU) or acute medical wards (AMW)., Methods: Data from the randomised prospective multicentre clinical trial ICE-CUB2 was secondarily analysed. Inclusion criteria were: presenting at emergency departments in critical condition; age ≥ 75 years; activity of daily living (ADL) ≥ 4; preserved nutritional status; and no active cancer. A Cox model was fitted to compare survival according to admission destination adjusting for patient characteristics. Sensitivity analysis using multiple imputation for missing data and propensity score matching were performed., Results: Among 3036 patients, 1675 (55%) were women; median age was 85 [81-99] years; simplified acute physiology score (SAPS-3) 62 [55-69]; 1448 (47%) were hospitalised in an ICU, 504 in IMCU (17%), and 1084 (36%) in AMW. Six-month mortality was 629 (44%), 155 (31%) and 489 (45%) after admission in an ICU, IMCU and AMW (p < 0.001), respectively. In multivariate analysis, AMW admission was associated with worse 6-month survival (HR 1.31, 95% CI 1.04-1.63) in comparison with IMCU admission, after adjusting for age, gender, comorbidities, ADL, SAPS-3 and diagnosis. Survival was not significantly different between patients admitted in an ICU and an IMCU (HR 1.17, 95% CI 0.95-1.46). Sensitivity analysis using multiple imputation for missing data and propensity score matching found similar results. Hospital destination was not significantly associated with the composite criterion loss of 1-point ADL or mortality. Physical and mental components of the 12-Item Short-Form Health Survey were significantly lower in the acute medical ward group (34.3 [27.5-41.7], p = 0.037 and 44.3 [38.6-48.6], p = 0.028, respectively) than in the ICU group (34.7 [28.4-45.3] and 45.5 [40.0-50.0], respectively) and IMCU group (35.7 [29.7-43.8] and 44.5 [39.7-48.4], respectively)., Conclusions: Admission in an AMW was associated with worse 6-month survival in older critically ill patients in comparison with IMCU admission, with no difference of survival between ICU and IMCU admission. There were no clinically relevant differences in quality of life in each group. These results should be confirmed in specific studies and raise the question of dedicated geriatric IMCUs., (© 2022. The Author(s).)

Background: The first COVID-19 wave started in February 2020 in France. The influx of patients requiring emergency care and high-level technicity led healthcare professionals to fear saturation of available care. In that context, the multidisciplinary E thics- S upport C ell (EST) was created to help medical teams consider the decisions that could potentially be sources of ethical dilemmas., Objectives: The primary objective was to prospectively collect information on requests for EST assistance from 23 March to 9 May 2020. The secondary aim was to describe the Cell's functions during that period., Research Design: This observational, real-time study of requests for Cell consultations concerned ethical dilemmas arising during a public health crisis. The EST created a grid to collect relevant information (clinical, patient's/designated representative's preferences and ethical principles strained by the situation), thereby assuring that each EST asked the same questions, in the same order., Participants and Research Context: Only our university hospital's clinicians could request EST intervention., Ethical Considerations: The hospital Research Ethics Committee approved this study (no. CER-2020-107). The patient, his/her family, or designated representative was informed of this ethics consultation and most met with EST members, which enabled them to express their preferences and/or opposition., Findings/results: 33 requests (patients' mean age: 80.8 years; 29 had COVID-19: 24 with dyspnea, 30 with comorbidities). 17 Emergency Department solicitations concerned ICU admission, without reference to resource constraints; others addressed therapeutic proportionality dilemmas., Discussion: Intervention-request motives concerned limited resources and treatment intensity. Management revolved around three axes: the treatment option most appropriate for the patient, the feasibility of implementation, and dignified care for the patient., Conclusions: COVID-19 crisis forced hospitals to envisage prioritization of ICU access. Established decision-making criteria and protocols do not enable healthcare professionals to escape ethical dilemmas. That acknowledgement highlights ethical risks, enhances the added-value of nursing and encourages all players to be vigilant to pursue collective deliberations to achieve clear and transparent decisions.

Objective: Hemorrhage is the leading cause of death after terrorist attack, and the immediacy of labile blood product (LBP) administration has a decisive impact on patients' outcome. The main objective of this study was to evaluate the transfusion patterns of the Paris terrorist attack victims, November 13, 2015., Methods: We performed a retrospective analysis including all casualties admitted to hospital, aiming to describe the transfusion patterns from admission to the first week after the attack., Results: Sixty-eight of 337 admitted patients were transfused. More than three quarters of blood products were consumed in the initial phase (until November 14, 11:59 PM), where 282 packed red blood cell (pRBC) units were transfused along with 201 plasma and 25 platelet units, to 55 patients (16% of casualties). Almost 40% of these LBPs (134 pRBC, 73 plasma, 8 platelet units) were transfused within the first 6 hours after the attack. These early transfusions were massive transfusion (MT) for 20 (6%) of 337 patients, and the average plasma/red blood cell ratio was 0.8 for MT patients who received 366 (72%) of 508 LBPs.The median time from admission to pRBC transfusion was 57 (25-108) minutes and 208 (52-430) minutes for MT and non-MT patients, respectively. These same time intervals were 119 (66-202) minutes and 222 (87-381) minutes for plasma and 225 (131-289) minutes and 198 (167-230) minutes for platelets., Conclusion: Our data suggest that improving transfusion procedures in mass casualty setting should rely more on shortening the time to bring LBP to the bedside than in increasing the stockpile., Level of Evidence: Epidemiological study, Therapeutic IV.

SARS-CoV-2 has caused a global pandemic unprecedented in size, spread, severity, and mortality. The influx of patients with severe or life-threatening disease means that in some cases, the available medical resources are not sufficient to meet the needs of all patients. Hence, healthcare providers may be forced to make difficult choices about which patients should be referred to the ICU. This document is intended to provide conceptual support to all healthcare teams currently engaged in the frontline management of the COVID-19 pandemic. It aims to assist physicians in the decision-making process for ICU admission and to help them provide uninterrupted and high-quality care.

Purpose: The majority of terrorist acts are carried out by explosion or shooting. The objective of this study was first, to describe the management implemented to treat a large number of casualties and their flow together with the injuries observed, and second, to compare these resources according to the mechanism of trauma., Methods: This retrospective cohort study collected medical data from all casualties of the attacks on November 13th 2015 in Paris, France, with physical injuries, who arrived alive at any hospital within the first 24 h after the events. Casualties were divided into two groups: explosion injuries and gunshot wounds., Results: 337 casualties were admitted to hospital, 286 (85%) from gunshot wounds and 51 (15%) from explosions. Gunshot casualties had more severe injuries and required more in-hospital resources than explosion casualties. Emergency surgery was required in 181 (54%) casualties and was more frequent for gunshot wounds than explosion injuries (57% vs. 35%, p < 0·01). The types of main surgery needed and their delay following hospital admission were as follows: orthopedic [n = 107 (57%); median 744 min]; general [n = 27 (15%); 90 min]; vascular [n = 19 (10%); median 53 min]; thoracic [n = 19 (10%); 646 min]; and neurosurgery [n = 4 (2%); 198 min]., Conclusion: The resources required to deal with a terrorist attack vary according to the mechanism of trauma. Our study provides a template to estimate the proportion of various types of surgical resources needed overall, as well as their time frame in a terrorist multisite and multitype attack., Funding: Assistance Publique-Hôpitaux de Paris.

Introduction: This study protocol describes a trial designed to investigate whether antihistamine alone in patients with acute urticaria does not increase the 7-day Urticaria Activity Score (UAS7) in comparison with an association of antihistamine and glucocorticoids and reduces short-term relapses and chronic-induced urticaria., Methods and Analysis: This is a prospective, double-blind, parallel-group, multicentre non-inferiority randomised controlled trial. Two-hundred and forty patients with acute urticaria admitted to emergency department will be randomised in a 1:1 ratio to receive levocetirizine or an association of levocetirizine and prednisone. Randomisation will be stratified by centre. The primary outcome will be the UAS7 at day 7. The secondary outcomes will encompass recurrence of hives and/or itch at day 7; occurrence of spontaneous hives or itch for >6 weeks; patients with angioedema at day 7, and 2, 6, 12 and 24 weeks; new emergency visits for acute urticaria recurrences at days 7 and 14, and 3 months; Dermatology Life Quality Index at days 7 and 14, and 3 and 6 months; and Chronic Urticaria Quality of Life Questionnaire at 6 weeks., Ethics and Dissemination: The protocol has been approved by the Comité de Protection des Personnes Sud-Méditerranée II and will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. A steering committee will oversee the progress of the study. Findings will be disseminated through national and international scientific conferences and publication in peer-reviewed journals., Trial Registration Number: NCT03545464., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Life threatening complications can occur at any stage of cirrhosis progression. There are few studies on the prognosis of cirrhotic patients managed in an Emergency Department (ED) although management of patients will occur in the ED. The objective of our study was to determine the risk factors for mortality in cirrhotic patients who visited to the ED., Methods: All cirrhotic patients attending ED in three different university hospitals of Assistance Publique - Hôpitaux de Paris between January 2014 and June 2015 were identified by a retrospective analysis of digital records and included in the study. The primary end-point was 30-day mortality in all cirrhotic patients who visited the ED., Results: A total of 609 ED visits were analyzed among 224 patients: 115 (51%) presented a cirrhosis of alcoholic origin, 43 (19%) were caused by Hepatitis C, 28 (13%) of mixed origin (viral and alcoholic), 17 (8%) were caused by Hepatitis B and 21 (9%) of other origins. Fifty-five (25%) of these patients died within 30 days of their initial presentation to the ED. In multivariate analysis, the age (Odds Ratio: 1.04 [1.01-1.07]), cirrhosis associated with hepatocellular carcinoma (OR: 3.07 [1.37-6.91]), serum creatinine at admission (OR: 1.01 [1.01-1.02]), serum bilirubin at admission (OR: 1.01 [1.01-1.02]) and health impairment (OR: 2.57 [1.28-5.16]) were associated with mortality., Conclusions: The mortality rate of cirrhotic patients attending an ED was high. The prognosis of cirrhotic patients admitted to the ED depended on the severity of the liver and other organ dysfunction. The presence of a hepatocellular carcinoma on admission was also a risk factor for death., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Some studies have demonstrated an association between poor continuity of care, high likelihood of 'inappropriate' use of emergency departments (EDs) and avoidable hospitalization. However, we lack data concerning primary care use after an ED visit., Objective: Identify the determinants of a visit to the general practitioner (GP) after an ED visit.Methods., Design: Observational study (single-centre cohort)., Setting: One emergency department in Paris, France., Subjects: All adult patients who presented at the ED and were discharged., Main Outcome Measure: We collected data by the use of a standardized questionnaire, patients' medical records and a telephonic follow-up. Descriptive analyses were performed to compare individuals with and without a GP. Then, for those with a GP, multivariate logistic regression was used to identify the determinants of the GP consultation., Results: We included 243 patients (mean age 45 years [±19]); 211 (87%) reported having a GP. Among those who reported having a GP, 52% had consulted their GP after the ED visit. Not having a GP was associated with young age, not having complementary health insurance coverage, and being single. GP consultation was associated with increasing age [adjusted odds ratios (aOR) = 1.03], poor self-reported health status (aOR = 2.25), medical complaints versus traumatic injuries (aOR = 2.24) and prescription for sick note (aOR = 5.74)., Conclusion: Not having a GP was associated with factors of social vulnerability such as not having complementary health insurance coverage. For patients with a GP, consultation in the month after an ED visit seems appropriate, because it was associated with poor health status and medical complaints., (© The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: Interest in ultrasonography in emergency medicine has increased in recent years, as reflected by a marked increase in publications on the topic. The aim of this study was to 1) describe and evaluate methodological characteristics of randomized controlled trials (RCTs) evaluating an ultrasound intervention in emergency department and 2) estimate whether the reports adequately described the intervention to allow replication., Methods: We searched MEDLINE via PubMed for RCTs published in 2015 assessing an ultrasound intervention, regardless of type, that were performed in an emergency department or evaluated in an emergency situation. Two researchers independently screened titles, abstracts and full texts. Data from all included studies were independently extracted. The Cochrane Collaboration Risk of Bias tool was used to assess risk of bias of reports, and the intervention reporting was evaluated by using the Template for Intervention Description and Replication checklist., Results: We identified 11 reports. The most frequent topic was vascular access/identification (n = 4). Random sequence generation and allocation concealment were performed correctly in 55% and 27% trials. Three quarters of reports (73%) showed improper reporting or absence of participant blinding. Risk of bias due to assessor blinding was rated low for 3 RCTs (27%), risk of attrition bias low for all reports, and risk of selective outcome reporting unclear for most reports (n = 10). Only 3 reports (27%) provided an optimal description of the intervention., Conclusion: The quality of these trials raises questions. In our sample, the authors did not correctly report blinding of participants and assessors or allocation concealment., (Copyright © 2018 Elsevier Inc. All rights reserved.)

The objective of this study was to characterize retracted publications in emergency medicine. We searched MEDLINE, Web of Science and Cochrane Central Register of Controlled Trials to identify all retracted publications in the field of emergency medicine. We also searched an independent website that reports and archives retracted scientific publications. Two researchers independently screened titles, abstracts and full text of search results. Data from all included studies were then independently extracted. We identified 28 retraction notes. Eleven (39%) articles were published by authors from Europe. The oldest retracted article was published in 2001. The 28 retracted papers were published by 22 different journals. Two authors were named on multiples retractions. The median impact factor of journals was 1.03 (0.6-1.9). Almost all studies were available online [26/28 (93%)], but only 40% had watermarking on the article. The retraction notification was available for all articles. Three (11%) retraction notices did not clearly report the retraction reasons, and most retraction notices were issued by the editors [14 (56%)]. The most frequent retraction reasons were plagiarism [eight (29%)], duplicate publication [three (11%)] and overlap [two (2%)]. Retracted articles were cited on average 14 times. In most cases, the retraction cause did not invalidate the study's results [17 (60%)]. The most common reason for retraction was related to a misconduct by the authors. These results can question the necessity to normalize retraction procedures among the large number of biomedical editors and to educate future researchers on research integrity.

Study Objective: This study compares the effectiveness and cost-effectiveness of nurse-driven targeted HIV screening alongside physician-directed diagnostic testing (intervention strategy) with diagnostic testing alone (control strategy) in 8 emergency departments., Methods: In this cluster-randomized, 2-period, crossover trial, 18- to 64-year-old patients presenting for reasons other than potential exposure to HIV were included. The strategy applied first was randomly assigned. During both periods, diagnostic testing was prescribed by physicians following usual care. During the intervention periods, patients were asked to complete a self-administered questionnaire. According to their answers, the triage nurse suggested performing a rapid test to patients belonging to a high-risk group. The primary outcome was the proportion of new diagnoses among included patients, which further refers to effectiveness. A secondary outcome was the intervention's incremental cost (health care system perspective) per additional diagnosis., Results: During the intervention periods, 74,161 patients were included, 16,468 completed the questionnaire, 4,341 belonged to high-risk groups, and 2,818 were tested by nurses, yielding 13 new diagnoses. Combined with 9 diagnoses confirmed through 97 diagnostic tests, 22 new diagnoses were established. During the control periods, 74,166 patients were included, 92 were tested, and 6 received a new diagnosis. The proportion of new diagnoses among included patients was higher during the intervention than in the control periods (3.0 per 10,000 versus 0.8 per 10,000; difference 2.2 per 10,000, 95% CI 1.3 to 3.6; relative risk 3.7, 95% CI 1.4 to 9.8). The incremental cost was €1,324 per additional new diagnosis., Conclusion: The combined strategy of targeted screening and diagnostic testing was effective., (Copyright © 2017 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

The number of trials assessing Simulation-Based Medical Education (SBME) interventions has rapidly expanded. Many studies show that potential flaws in design, conduct and reporting of randomized controlled trials (RCTs) can bias their results. We conducted a methodological review of RCTs assessing a SBME in Emergency Medicine (EM) and examined their methodological characteristics. We searched MEDLINE via PubMed for RCT that assessed a simulation intervention in EM, published in 6 general and internal medicine and in the top 10 EM journals. The Cochrane Collaboration risk of Bias tool was used to assess risk of bias, intervention reporting was evaluated based on the "template for intervention description and replication" checklist, and methodological quality was evaluated by the Medical Education Research Study Quality Instrument. Reports selection and data extraction was done by 2 independents researchers. From 1394 RCTs screened, 68 trials assessed a SBME intervention. They represent one quarter of our sample. Cardiopulmonary resuscitation (CPR) is the most frequent topic (81%). Random sequence generation and allocation concealment were performed correctly in 66 and 49% of trials. Blinding of participants and assessors was performed correctly in 19 and 68%. Risk of attrition bias was low in three-quarters of the studies (n = 51). Risk of selective reporting bias was unclear in nearly all studies. The mean MERQSI score was of 13.4/18.4% of the reports provided a description allowing the intervention replication. Trials assessing simulation represent one quarter of RCTs in EM. Their quality remains unclear, and reproducing the interventions appears challenging due to reporting issues.

Importance: The high mortality rate in critically ill elderly patients has led to questioning of the beneficial effect of intensive care unit (ICU) admission and to a variable ICU use among this population., Objective: To determine whether a recommendation for systematic ICU admission in critically ill elderly patients reduces 6-month mortality compared with usual practice., Design, Setting, and Participants: Multicenter, cluster-randomized clinical trial of 3037 critically ill patients aged 75 years or older, free of cancer, with preserved functional status (Index of Independence in Activities of Daily Living ≥4) and nutritional status (absence of cachexia) who arrived at the emergency department of one of 24 hospitals in France between January 2012 and April 2015 and were followed up until November 2015., Interventions: Centers were randomly assigned either to use a program to promote systematic ICU admission of patients (n=1519 participants) or to follow standard practice (n=1518 participants)., Main Outcomes and Measures: The primary outcome was death at 6 months. Secondary outcomes included ICU admission rate, in-hospital death, functional status, and quality of life (12-Item Short Form Health Survey, ranging from 0 to 100, with higher score representing better self-reported health) at 6 months., Results: One patient withdrew consent, leaving 3036 patients included in the trial (median age, 85 [interquartile range, 81-89] years; 1361 [45%] men). Patients in the systematic strategy group had an increased risk of death at 6 months (45% vs 39%; relative risk [RR], 1.16; 95% CI, 1.07-1.26) despite an increased ICU admission rate (61% vs 34%; RR, 1.80; 95% CI, 1.66-1.95). After adjustments for baseline characteristics, patients in the systematic strategy group were more likely to be admitted to an ICU (RR, 1.68; 95% CI, 1.54-1.82) and had a higher risk of in-hospital death (RR, 1.18; 95% CI, 1.03-1.33) but had no significant increase in risk of death at 6 months (RR, 1.05; 95% CI, 0.96-1.14). Functional status and physical quality of life at 6 months were not significantly different between groups., Conclusions and Relevance: Among critically ill elderly patients in France, a program to promote systematic ICU admission increased ICU use but did not reduce 6-month mortality. Additional research is needed to understand the decision to admit elderly patients to the ICU., Trial Registration: clinicaltrials.gov Identifier: NCT01508819.

Pain in children is underestimated and undertreated because of lack of pain assessment tools. Pain assessment depends on the cognitive development of the child being tested, clinical context, and pain typology. For children older than age 6 years, pain assessment is based on a self-report. For children younger than age 6 years, behavioral pain scales are needed to assess pain. Numerous pain scales exist. Many are reliable and some are recommended, but all have specific conditions for their use. In this article, we review the available pain scales for children from birth to adolescence. We provide the validity criteria of each pain scale to help caregivers use the adapted tools. We then propose a synthesis of the reliable tools to use based on the pain context. [Pediatr Ann. 2017;46(10):e387-e395.]., (Copyright 2017, SLACK Incorporated.)

Background: Upper gastrointestinal bleeding (UGB) is common in emergency departments (EDs) and can be caused by many eso-gastro-duodenal lesions. Most available epidemiological data and data on the management of UGB comes from specialized departments (intensive care units or gastroenterology departments), but little is known from the ED perspective. We aimed to determine the distribution of symptoms revealing UGB in EDs and the hemorrhagic lesions identified by endoscopy. We also describe the characteristics of patients consulting for UGB, UGB management in the ED and patients outcomes., Method: This was a prospective, observational, multicenter study covering 4 consecutive days in November 2013. Participating EDs were part of the Initiatives de Recherche aux Urgences network coordinated by the French Society of Emergency Medicine. All patients with suspected UGB in these EDs were included., Results: In total, 110 EDs participated, including 194 patients with suspected UGB (median age 66 years [Q1-Q3: 51-81]). Overall, 104 patients (54%) had hematemesis and 75 (39%) melena. Endoscopy revealed lesions in 121 patients, mainly gastroduodenal ulcer or ulcerations (41%) or bleeding lesions due to portal hypertension (20%). The final diagnosis of UGB was reversed by endoscopy in only 3% of cases. Overall, 67 patients (35%) had at least one severity sign. Twenty-one patients died (11%); 40 (21%) were hospitalized in intensive care units and 126 (65%) in medicine departments; 28 (14%) were outpatients. Mortality was higher among patients with clinical and biological severity signs., Conclusion: Most of the UGB cases in EDs are revealed by hematemesis. The emergency physician diagnosis of UGB is rarely challenged by the endoscopic findings.

The aim of the present study was to investigate the epidemiological characteristics of blood or fluid exposure (BFE) and occupational infection risk among emergency medicine (EM) residents and young physicians (<35 years old) in France. We led a cross-sectional, anonymous, online survey. 1779 participants were contacted with a response rate of 36 % (n = 633). Among the respondents, 459 (72 %) reported at least one BFE. Among participants with at least one BFE, 35 % (n = 163) never reported the exposure to the relevant medical authorities or support. Among participants who reported exposure, 63 % (n = 232) did it immediately. Among participants who never or not systematically reported their BFE, most of them (62 %, n = 181/289) did not do so because the procedure was too long, and 28 % (n = 82/289) estimated the risk as low even if only one-third (n = 166/458) checked their HIV status even though the BFE was at a transmission risk. Circumstances in which the participants had the most BFE were: suturing 57 % (n = 262/457) and when making precipitated gestures 24 % (n = 111/457). The latest exposures were caused by a solid needle in 42 % (n = 191/455) or hollow-bore needle in 27 % (n = 123/455). Post-exposure reporting rates were low. Reporting procedure itself and self-management were the main reasons for BFE underreporting. Simplifying procedures might increase BFE reporting, and allow appropriate post-exposure counseling and/or prophylaxis.

Background: The benefit of ICU admission for elderly patients remains controversial. This report highlights the methodology, the feasibility of and the ethical and logistical constraints in designing and conducting a cluster-randomized trial of intensive care unit (ICU) admission for critically ill elderly patients., Methods: We designed an interventional open-label cluster-randomized controlled trial in 24 centres in France. Clusters were healthcare centres with at least one emergency department (ED) and one ICU. Healthcare centres were randomly assigned either to recommend a systematic ICU admission (intervention group) or to follow standard practices regarding ICU admission (control group). Clusters were stratified by the number of ED annual visits (<44,616 or >44,616 visits), the presence or absence of a geriatric ward and the geographical area (Paris area vs other regions in France). All elderly patients (≥75 years of age) who got to the ED were assessed for eligibility. Patients were included if they had one of the pre-established critical conditions, a preserved functional status as assessed by an ADL scale ≥4 (0 = very dependent, 6 = independent), a preserved nutritional status (subjectively assessed by physicians) and without active cancer. Exclusion criteria were an ED stay >24 h, a secondary referral to the ED and refusal to participate. The primary outcome was the mortality at 6 months calculated at the individual patient level. Secondary outcomes were ICU and hospital mortality, as well as ADL scale and quality of life (as assessed by the SF-12 Health Survey) at 6 months., Results: Between January 2012 and April 2015, 3036 patients were included in the trial, 1518 patients in 11 clusters allocated to intervention group and 1518 patients in 13 clusters allocated to standard care. There were 51 protocol violations., Conclusions: The ICE-CUB 2 trial was deemed feasible and ethically acceptable. The ICE-CUB 2 trial will be the first cluster-randomized trial to assess the benefits of ICU admission for selected elderly patients on long-term mortality. Trial registration Clinical trials.gov identifier: NCT01508819.