Thoracic epidural analgesia in intensive care unit patients with acute pancreatitis: the EPIPAN multicenter randomized controlled trial.

BACKGROUND: Findings from preclinical studies and one pilot clinical trial suggest potential benefits of epidural analgesia in acute pancreatitis. We aimed to assess the efficacy of thoracic epidural analgesia, in addition to usual care, in improving clinical outcomes of intensive care unit patients with acute pancreatitis. METHODS: A multicenter, open-label, randomized, controlled trial including adult patients with a clinical diagnosis of acute pancreatitis upon admission to the intensive care unit. Participants were randomly assigned (1:1) to a strategy combining thoracic epidural analgesia and usual care (intervention group) or a strategy of usual care alone (control group). The primary outcome was the number of ventilator-free days from randomization until day 30. RESULTS: Between June 2014 and January 2019, 148 patients were enrolled, and 135 patients were included in the intention-to-treat analysis, with 65 patients randomly assigned to the intervention group and 70 to the control group. The number of ventilator-free days did not differ significantly between the intervention and control groups (median [interquartile range], 30 days [15-30] and 30 days [18-30], respectively; median absolute difference of - 0.0 days, 95% CI - 3.3 to 3.3; p = 0.59). Epidural analgesia was significantly associated with longer duration of invasive ventilation (median [interquartile range], 14 days [5-28] versus 6 days [2-13], p = 0.02). CONCLUSIONS: In a population of intensive care unit adults with acute pancreatitis and low requirement for intubation, this first multicenter randomized trial did not show the hypothesized benefit of epidural analgesia in addition to usual care. Safety of epidural analgesia in this setting requires further investigation. TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT02126332 , April 30, 2014.

Positive communication behaviour during handover and team-based clinical performance in critical situations: a simulation randomised controlled trial.

BACKGROUND: Positive communication behaviour within anaesthesia teams may decrease stress response and improve clinical performance. We aimed to evaluate the effect of positive communication during medical handover on the subsequent team-based clinical performance in a simulated critical situation. We also assessed the effect of positive communication behaviour on stress response. METHODS: This single-centre RCT involved anaesthesia teams composed of a resident and a nurse in a high-fidelity scenario of anaesthesia-related paediatric laryngospasm after a standardised handover. During the handover, similar information was provided to all teams, but positive communication behaviour was adopted only for teams in the intervention group. Primary outcome was team-based clinical performance, assessed by an independent blinded observer, using video recordings and a 0-to 100-point scenario-specific scoring tool. Three categories of tasks were considered: safety checks before the incision, diagnosis/treatment of laryngospasm, and crisis resource management/non-technical skills. Individual stress response was monitored by perceived level of stress and HR variability. RESULTS: The clinical performance of 64 anaesthesia professionals (grouped into 32 teams) was analysed. The mean (standard deviation) team-based performance score in the intervention group was 44 (10) points vs 35 (12) in the control group (difference: +8.4; CI95% [0.4-16.4]; P=0.04). The effects were homogeneous over the three categories of tasks. Perceived level of stress and HR variability were not significantly different between groups. CONCLUSIONS: Positive communication behaviour between healthcare professionals during medical handover improved team-based performance in a simulation-based critical situation. CLINICAL TRIAL REGISTRATION: NCT03375073.

Impact of advance directives on the variability between intensivists in the decisions to forgo life-sustaining treatment.

BACKGROUND: There is wide variability between intensivists in the decisions to forgo life-sustaining treatment (DFLST). Advance directives (ADs) allow patients to communicate their end-of-life wishes to physicians. We assessed whether ADs reduced variability in DFLSTs between intensivists. METHODS: We conducted a multicenter, prospective, simulation study. Eight patients expressed their wishes in ADs after being informed about DFLSTs by an intensivist-investigator. The participating intensivists answered ten questions about the DFLSTs of each patient in two scenarios, referring to patients' characteristics without ADs (round 1) and then with (round 2). DFLST score ranged from 0 (no-DFLST) to 10 (DFLST for all questions). The main outcome was variability in DFLSTs between intensivists, expressed as relative standard deviation (RSD). RESULTS: A total of 19,680 decisions made by 123 intensivists from 27 ICUs were analyzed. The DFLST score was higher with ADs than without (6.02 95% CI [5.85; 6.19] vs 4.92 95% CI [4.75; 5.10], p < 0.001). High inter-intensivist variability did not change with ADs (RSD: 0.56 (round 1) vs 0.46 (round 2), p = 0.84). Inter-intensivist agreement on DFLSTs was weak with ADs (intra-class correlation coefficient: 0.28). No factor associated with DFLSTs was identified. A qualitative analysis of ADs showed focus on end-of-life wills, unwanted things and fear of pain. CONCLUSIONS: ADs increased the DFLST rate but did not reduce variability between the intensivists. In the decision-making process using ADs, the intensivist's decision took priority. Further research is needed to improve the matching of the physicians' decision with the patient's wishes. Trial registration ClinicalTrials.gov Identifier: NCT03013530. Registered 6 January 2017; https://clinicaltrials.gov/ct2/show/NCT03013530 .

Disagreement Between Clinicians and Score in Decision-Making Capacity of Critically Ill Patients.

OBJECTIVES: To compare the assessment of decision-making capacity of ICU patients by attending clinicians (physicians, nurses, and residents) with a capacity score measured by the Mini-Mental Status Examination, completed by Aid to Capacity Evaluation if necessary. The primary outcome was agreement between physicians' assessments and the score. Secondary outcomes were agreement between nurses' or residents' assessments and the score and identification of factors associated with disagreement. DESIGN: A 1-day prevalence study. SETTING: Nineteen ICUs in France. SUBJECTS: All patients hospitalized in the ICU on the study day and the attending clinicians. INTERVENTIONS: The decision-making capacity of patients was assessed by the attending clinicians and independently by an observer using the score. MEASUREMENTS AND MAIN RESULTS: A total of 206 patients were assessed by 213 attending clinicians (57 physicians, 97 nurses, and 59 residents). Physicians designated more patients as having decision-making capacity (n = 92/206 [45%]) than score (n = 34/206 [17%]; absolute difference 28% [95% CI, 20-37%]; p = 0.001). There was a high disagreement between assessments of all clinicians and score (Kappa coefficient 0.39 [95% CI, 0.29-0.50] for physicians; 0.39 [95% CI, 0.27-0.52] for nurses; and 0.46 [95% CI, 0.35-0.58] for residents). The main factor associated with disagreement was a Glasgow Coma Scale score between 10 and 15 (odds ratio, 2.92 [1.18-7.19], p = 0.02 for physicians; 4.97 [1.50-16.45], p = 0.01 for nurses; and 3.39 [1.12-10.29], p = 0.03 for residents) without differentiating between the Glasgow Coma Scale scores from 10 to 15. CONCLUSIONS: The decision-making capacity of ICU patients was largely overestimated by all attending clinicians as compared with a score. The main factor associated with disagreement was a Glasgow Coma Scale score between 10 and 15, suggesting that clinicians confused consciousness with decision-making capacity.

Quality of life, fatigue and changes therein as predictors of return to work during breast cancer treatment.

PURPOSE: To our knowledge, only one study has assessed Quality of Life (QOL) as a predictor of return to work (RTW) during breast cancer treatment and one has evaluated multidimensional cancer-related fatigue (CRF) as a determinant of RTW. However, no study has assessed the impact of changes in these variables on RTW. The objective of this study was to evaluate QOL, multidimensional CRF and changes in these variables as determinants of RTW during breast cancer treatment. METHODS: We performed a longitudinal study of 68 patients with a mean age of 46.97 years (SD = 6.92), who were employed at the time of diagnosis. Women were assessed at the beginning of adjuvant treatments (T0) and followed up with by telephone at three (T1) and 6 months later (T2), using questionnaires (QLQ-C30; MFI-20). RESULTS: Global QOL, OR = 1.12 [1.01-1.25], sleep disturbance, OR = 1.04 [1.002-1.08], fatigue (QLQ-C30), OR = 0.93 [0.88-0.99], nausea-vomiting, OR = 0.84 [0.73-0.97], reduced motivation, OR = 1.49 [1.05-2.11] and general fatigue, OR = 0.79 [0.63-0.99] at T0 were associated with RTW at T1. At T2 global QOL, OR = 1.09 [1.01-1.17], cognitive functioning, OR = 1.10 [1.03-1.17], general fatigue, OR = 1.82 [1.04-3.17] and mental fatigue, OR = 0.29 [0.11-0.81] were associated with RTW. Furthermore, changes in mental fatigue were associated with RTW at T2, OR = 0.02 [0.001-0.29]. CONCLUSIONS: Quality of life, fatigue and their changes in them, especially cognitive functioning and mental fatigue, can play an important role in predicting the RTW of women with breast cancer. This confirms the importance of multidisciplinary care for cancer and the emergence of a theoretical psychological model of RTW.

A Prospective Study on Skin-Sparing Mastectomy for Immediate Breast Reconstruction with Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy in Invasive Breast Carcinoma.

BACKGROUND: Skin-sparing mastectomy (SSM) with immediate breast reconstruction (IBR) is increasingly used in invasive breast cancer. However, adjuvant chemotherapy (CT) and radiotherapy (RT) can increase the rate of local complications. OBJECTIVE: The aim of this study was to assess the morbidity of SSM-IBR after neoadjuvant CT and RT. METHODS: A French prospective pilot study of women aged 18-75 years with invasive breast cancer requiring mastectomy after CT and RT. Reconstruction was performed using autologous latissimus dorsi flap with or without prosthesis. The primary endpoint was the skin necrosis rate within 6 months, while secondary endpoints included pathological complete response rate (pCR) and global morbidity. RESULTS: Among 94 patients included in this study, 83 were analyzed (mean age 45.2 ± 9.5 years, T1 23.6 %, T2 55.6 %, T3 18.1 %). All but one patient received anthracyclines and taxanes, and all patients received RT (49.3 ± 5.2 Gy) before SSM-IBR. Prostheses were used for IBR in 32 patients (mean volume 256 ± 73 mm(3)). Five patients had necrosis (≤2 cm(2), 2-10 cm(2) and >10 cm(2), in three, one, and one cases, respectively), and they all recovered without revision surgery. Among 50 patients who underwent upfront mastectomy, 36 % achieved pCR. CONCLUSIONS: SSM-IBR performed after CT and RT is safe, with an acceptable local morbidity rate. Long-term data are needed to evaluate recurrence rates.

Heart rate regulation processed through wavelet analysis and change detection: some case studies.

Heart rate variability (HRV) is an indicator of the regulation of the heart, see Task Force (Circulation 93(5):1043-1065, 1996). This study compares the regulation of the heart in two cases of healthy subjects within real life situations: Marathon runners and shift workers. After an update on the state of the art on HRV processing, we specify our probabilistic model: We choose modeling heartbeat series by locally stationary Gaussian process (Dahlhaus in Ann Stat 25, 1997). HRV is then processed by the combination of two statistical methods: (1) Continuous wavelet transform for calculating the spectral density energy in the high frequency (HF) and low frequency (LF) bands and (2) Change point analysis to detect changes of heart regulation. Next, we plot the variations of the HF and LF energy in extreme conditions for both populations. This puts in light, that physical activities (rest, moderate sport, marathon race) can be ordered in a logical continuum. This allows to define a new index based on HF and LF energy that is log HF + log LF which appears relevant to measure HR regulation. The results obtained are pertinent but have to be completed by further studies.

Prevalence and Main Clinical Characteristics of Fully Vaccinated Patients Admitted to Hospital for Delta Variant COVID-19.

Objectives: The Delta variant of the novel beta coronavirus responsible for the current coronavirus pandemic (COVID-19) spread across Europe during the summer of 2021. Little is known of vaccine efficacy on this variant. Our aim was to study the prevalence and clinical characteristics of fully vaccinated subjects admitted to hospital for Delta variant COVID-19. Methods: We identified patients admitted to Cannes hospital for Delta-variant-related Covid-19 infection from July to September 2021. Their main demographic parameters, inflammatory markers, and clinical characteristics were recorded. Differences between fully vaccinated subjects and unvaccinated or incompletely vaccinated individuals were analyzed. Results: We included 126 patients (57% male, mean age 64 years, mean delay since symptoms onset 7.8 days). Among admitted patients, 94 (75%) were not vaccinated, 11 (8%) incompletely so and 21 (17%) were fully vaccinated. Fully vaccinated patients were older (77 vs. 61 vs. 62 years, p = 0.003), with fewer days since symptoms onset (5.9 vs. 8.0 vs. 9.3 days, p = 0.035) than unvaccinated or incompletely vaccinated patients, respectively. Severe pneumonia was less frequent among completely vaccinated subjects (67 vs. 84 vs. 100%, p = 0.038), while rates of transfer to the ICU, mechanical ventilation or death did not differ. Thirteen fully vaccinated patients underwent a thoracic CT scan, revealing involvement of lung parenchyma in four of them. Discussion: Prevalence of hospitalization for Delta-variant COVID-19 in fully vaccinated subjects was low and, despite their age and comorbid conditions, these patients had a high rate of favorable outcome.

Basic human values during the COVID-19 outbreak, perceived threat and their relationships with compliance with movement restrictions and social distancing.

This study examines the evolution of Schwartz's Basic Human Values during the COVID-19 outbreak, and their relationships with perceived threat, compliance with movement restrictions and social distancing. An online questionnaire was administered to a heterogeneous sample of French citizens (N = 1025) during the first French lockdown related to the outbreak. Results revealed a significant evolution of values; the conservation value was higher during the outbreak than usual, and both self-enhancement and openness-to-change values were lower during the COVID-19 outbreak than usual. Conservation and perceived threat during the outbreak were robustly and positively related to both compliance with movement restrictions and social distancing. Conservation during the outbreak emerged as a significant partial mediator of the relationship between perceived threat and outcomes (i.e., compliance with movement restrictions and social distancing). Implications of these results for the malleability of values and the COVID-19 modelling are discussed.

Quality of life in patients with uveitis: data from the ULISSE study (Uveitis: cLInical and medico-economic evaluation of a Standardised Strategy for the Etiological diagnosis).

AIMS: To assess vision-related (VR-QOL) and health-related quality of life (HR-QOL) in a large series of patients with de novo uveitis at baseline and 6-month follow-up. METHODS: Non-inferiority, prospective, multicentre, cluster randomised controlled trial registered under the Unique Identifier: NCT01162070. VR-QOL and HR-QOL were assessed by the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) and the Medical Outcomes Study 36-item Short Form Survey (SF-36). RESULTS: At inclusion, 466 patients completed the VFQ-25. The mean composite score was 80.0 (±16.7). In multivariate analysis, higher age, female sex and insidious onset were significantly associated with lower QOL. At 6 months, 138 patients completed the VFQ-25, with a significantly higher mean composite score of 82.6 (±16.7). SF-36 mental component was 42.9 (±11.3) and physical component was 47.2 (±8.5) at inclusion (n=425). HR-QOL improvement at 6 months was not clinically significant. CONCLUSION: QOL seems relatively well preserved in this cohort; only VR-QOL improved significantly at 6 months, especially in patients with low initial visual acuity.

When to do surgical resection for atypical breast lesions: Results of a prospective cohort of 518 lesions.

AIM: There is no consensual indication for surgical resection after diagnosis on per-cutaneous biopsy of borderline breast lesions (B3). We evaluate under-evaluation rate of per-cutaneous biopsy and predictive factors of under-evaluation. We analyze accuracy of reported decision-making tools. METHODS: We conduct a prospective multicentric study including, atypic-ductal hyperplasia (ADH), atypic-lobular hyperplasia (ALH), atypic-cylindro-cubic metaplasia (FEA), papilloma, radial scars (RS) and phyllod tumors. When several B3 lesions were associated, the more severe lesion was used to classify the lesion. We determined breast cancers (BC) rate and histologic type. Among 478 patients, 518 B3 lesions were studied: 15.1% (78) FEA, 48.6% (252) ADH, 16.8% (n = 87) ALH, 5.4% (n = 28) RS, 12% (n = 62) papilloma, 0.8% (n = 4) phyllod tumors and 0,8% (n = 4) with a suspicious low grade DCIS. More than 1 lesion was identified in 31.9% (165) of cases. A surgical resection was performed for 86.3% (447/518) lesions. Significant factors of surgical resection were: residual micro-calcification after biopsy (OR: 2.7) and type of B3 lesion. RESULTS: Overall BC rate was 15.3% (68/445) with 79.4% (54) in-situ carcinomas. According to B3 lesions, BC rates were 12.9% for FEA, 20% for ADH, 11.6% for ALH, 3.7% for RS, 8.8% for papilloma and 25% for suspicious in-situ carcinoma. A score has been calculated and patients were distributed in 3 groups. Patient's rates without BC were respectively: 100%, 80.4% and 80.6% (p = 0.029). CONCLUSION: In conclusion, it could be suggested to avoided complementary surgical resection in case of good radio-pathologic concordance and low probability of BC.

Uveitis: Autoimmunity and beyond.

OBJECTIVE: Uveitis is the most common ophthalmological finding in the practice of rheumatology and clinical immunology. The condition is frequently idiopathic but about 60 causes of uveitis have been described. Our aim was to analyze the clinical patterns and etiologies of uveitis in a tertiary referral center. METHODS: The records of 912 consecutive patients referred to the department of internal medicine (Lyon University Hospital, Lyon, France) for the diagnostic work-up of uveitis were examined. Demographic, clinical, anatomical, and etiological features of uveitis were analyzed. RESULTS: The mean age at onset was 48.8 years; 59.8% of the patients were women and 78.2% were Caucasians. Anterior uveitis was the most common type of uveitis (40.6%), followed by panuveitis (31.7%), posterior (18.75%) and intermediate uveitis (9%). 46.9% of the patients had idiopathic uveitis. The most common etiologies were systemic diseases (37.3%), such as sarcoidosis (17.1%), HLA-B27-related uveitis and/or spondyloarthritis (12.5%), and tuberculosis (7.5%). CONCLUSION: We describe one of the largest cohorts of consecutive uveitis patients referred to a department of internal medicine. The high percentage of uveitis associated with underlying (systemic) diseases highlights the need for a multidisciplinary approach, in order to reduce the diagnostic delay.

Weak turbulence theory and simulation of the gyro-water-bag model.

The thermal confinement time of a magnetized fusion plasma is essentially determined by turbulent heat conduction across the equilibrium magnetic field. To achieve the study of turbulent thermal diffusivities, Vlasov gyrokinetic description of the magnetically confined plasmas is now commonly adopted, and offers the advantage over fluid models (MHD, gyrofluid) to take into account nonlinear resonant wave-particle interactions which may impact significantly the predicted turbulent transport. Nevertheless kinetic codes require a huge amount of computer resources and this constitutes the main drawback of this approach. A unifying approach is to consider the water-bag representation of the statistical distribution function because it allows us to keep the underlying kinetic features of the problem, while reducing the Vlasov kinetic model into a set of hydrodynamic equations, resulting in a numerical cost comparable to that needed for solving multifluid models. The present paper addresses the gyro-water-bag model derived as a water-bag-like weak solution of the Vlasov gyrokinetic models. We propose a quasilinear analysis of this model to retrieve transport coefficients allowing us to estimate turbulent thermal diffusivities without computing the full fluctuations. We next derive another self-consistent quasilinear model, suitable for numerical simulation, that we approximate by means of discontinuous Galerkin methods.

Comparing the demands of destination entry using Google Glass and the Samsung Galaxy S4 during simulated driving.

The relative impact of using a Google Glass based voice interface to enter a destination address compared to voice and touch-entry methods using a handheld Samsung Galaxy S4 smartphone was assessed in a driving simulator. Voice entry (Google Glass and Samsung) had lower subjective workload ratings, lower standard deviation of lateral lane position, shorter task durations, faster remote Detection Response Task (DRT) reaction times, lower DRT miss rates, and resulted in less time glancing off-road than the primary visual-manual interaction with the Samsung Touch interface. Comparing voice entry methods, using Google Glass took less time, while glance metrics and reaction time to DRT events responded to were similar. In contrast, DRT miss rate was higher for Google Glass, suggesting that drivers may be under increased distraction levels but for a shorter period of time; whether one or the other equates to an overall safer driving experience is an open question.

Epidural analgesia in critically ill patients with acute pancreatitis: the multicentre randomised controlled EPIPAN study protocol.

BACKGROUND: Acute pancreatitis (AP) is associated with high morbidity and mortality in its most severe forms. Most patients with severe AP require intubation and invasive mechanical ventilation, frequently for more than 7 days, which is associated with the worst outcome. Recent increasing evidence from preclinical and clinical studies support the beneficial effects of epidural analgesia (EA) in AP, such as increased gut barrier function and splanchnic, pancreatic and renal perfusion, decreased liver damage and inflammatory response, and reduced mortality. Because recent studies suggest that EA might be a safe procedure in the critically ill, we sought to determine whether EA reduced AP-associated respiratory failure and other major clinical outcomes in patients with AP. METHODS AND ANALYSIS: The Epidural Analgesia for Pancreatitis (EPIPAN) trial is an investigator-initiated, prospective, multicentre, randomised controlled two-arm trial with assessor-blinded outcome assessment. The EPIPAN trial will randomise 148 patients with AP requiring admission to an intensive care unit (ICU) to receive EA (with patient-controlled epidural administration of ropivacaine and sufentanil) combined with standard care based on current recommendations on the treatment of AP (interventional group), or standard care alone (reference group). The primary outcome is the number of ventilator-free days at day 30. Secondary outcomes include main complications of AP (eg, organ failure and mortality, among others), levels of biological markers of systemic inflammation, epithelial lung injury, renal failure, and healthcare-associated costs. ETHICS AND DISSEMINATION: The study was approved by the appropriate ethics committee (CPP Sud-Est VI). Informed consent is required. If the combined application of EA and standard care proves superior to standard care alone in patients with AP in the ICU, the use of EA may become standard practice in experienced centres, thereby decreasing potential complications related to AP and its burden in critically ill patients. The results will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02126332.

Persistence of medical change at implementation of clinical guidelines on medical practice: a controlled study in a cancer network.

PURPOSE: A cancer network of general or private hospitals of a French region was started in 1995 for improving quality of care and rationalizing medical prescriptions. The impact of implementing a clinical practice guidelines (CPG) project assessed conformity with guidelines in medical practice; significant changes were observed within the network, whereas no changes were observed in a control region without cancer network. In the present study, we evaluated the persistence of conformity to guidelines through a new medical audit. PATIENTS AND METHODS: In 1999, the hospitals of the previously compared experimental and control groups accepted to reassess the impact of CPG. A controlled transversal study was performed in the experimental group (cancer network) and in the control group (no regional cancer network). In 1996 (first audit) and in 1999 (present audit), all new patients with colon cancer (177 and 200 in experimental group and 118 and 100 in control group, respectively) and early breast cancer (444 and 381 in experimental group and 172 and 204 in control group, respectively) were selected. RESULTS: In the experimental group, the compliance of medical decisions with CPG was significantly higher in 1999 than in 1996 for colon cancer (73%; 95% CI, 67% to 79% v 56%; 95% CI, 49% to 63%, respectively; P = .003) and similar for the two periods for breast cancer (36%; 95% CI, 31% to 41% v 40%; 95% CI, 35% to 44%, respectively; P = .24). In the control group, compliance was significantly higher in 1999 than in 1996 for colon cancer (67%; 95% CI, 58% to 76% v 38%; 95% CI, 29% to 47%, respectively; P < .001) and identical for the two periods for breast cancer (4%; 95% CI, 1% to 7% v 7%; 95% CI, 3% to 11%, respectively; P = .19). CONCLUSION: The CPG program for cancer management produced persistent changes in medical practice in our cancer network in terms of conformity with CPG.

A Dimensionally Reduced Clustering Methodology for Heterogeneous Occupational Medicine Data Mining.

Clustering is a set of techniques of the statistical learning aimed at finding structures of heterogeneous partitions grouping homogenous data called clusters. There are several fields in which clustering was successfully applied, such as medicine, biology, finance, economics, etc. In this paper, we introduce the notion of clustering in multifactorial data analysis problems. A case study is conducted for an occupational medicine problem with the purpose of analyzing patterns in a population of 813 individuals. To reduce the data set dimensionality, we base our approach on the Principal Component Analysis (PCA), which is the statistical tool most commonly used in factorial analysis. However, the problems in nature, especially in medicine, are often based on heterogeneous-type qualitative-quantitative measurements, whereas PCA only processes quantitative ones. Besides, qualitative data are originally unobservable quantitative responses that are usually binary-coded. Hence, we propose a new set of strategies allowing to simultaneously handle quantitative and qualitative data. The principle of this approach is to perform a projection of the qualitative variables on the subspaces spanned by quantitative ones. Subsequently, an optimal model is allocated to the resulting PCA-regressed subspaces.

Epidural analgesia in the intensive care unit: An observational series of 121 patients.

BACKGROUND: Epidural analgesia (EA) has been more investigated during the perioperative period than in the intensive care unit (ICU) setting. Recent studies support beneficial effects for EA beyond analgesia itself. However, data on feasibility and safety are still lacking in the ICU. Our goal was to assess the feasibility and practice of EA in ICU patients. METHODS: Multicentre observational study in 3 ICUs over a 10-month period. Goals were to report the incidence of EA-related complications and EA duration. All ICU patients receiving EA were included, whether EA was initiated in the ICU or elsewhere, e.g. in the operating room. Demographics, clinical and biological data were prospectively recorded. Epidural catheter tips were sent to the microbiology laboratory for culture. RESULTS: One hundred and twenty-one patients were included (mean age 60 years), with mean SOFA and median SAPS II scores of 3.2 and 32, respectively. Reasons for EA initiation included trauma (14%), postoperative pain management after major surgery (42%), and pancreatitis (31%). No EA-related neurologic complication was recorded, and one case of epidural abscess is discussed. No other EA-related infectious complications were observed. Median duration of EA was 11 days. Reasons for EA discontinuation included efficient analgesia without EA (60%) and accidental catheter removal (17%). 22% of epidural catheter cultures were positive for skin flora bacteria. CONCLUSION: EA seems feasible in the ICU. Its apparent safety should be further validated in larger cohorts, but these preliminary results may stimulate more interest in the assessment of potential benefits associated with EA in the ICU setting.

'Do Well B.': Design Of WELL Being monitoring systems. A study protocol for the application in autism.

INTRODUCTION: Individuals with autism spectrum disorder (ASD) have difficulties in communication and social interaction resulting from atypical perceptual and cognitive information processing, leading to an accumulation of anxiety. Extreme overloading experienced internally may not be externally visible. Identifying stressful situations at an early stage may avoid socially problematic behaviour from occurring, such as self-injurious behaviour. Activation of the autonomous nervous system (ANS) is involved in the response to anxiety, which can be measured through heart rate variability and skin conductance with the use of portable devices, non-intrusively and pain-free. Thus, developing innovative analysis of signal perception and reaction is necessary, mainly for non-communicative individuals with autism. METHODS AND ANALYSIS: The protocol will take place in real life (home and social environments). We aim to associate modifications of the ANS with external events that will be recorded in a synchronous manner through a specific design (spy glasses with video/audio recording). Four phases will be carried out on ASD participants and aged-matched controls: (1) 24-hour baseline pre-experiment (physical activity, sleep), (2) 2 h in a real life situation, (3) 30 min in a quiet environment, interrupted by a few seconds of stressful sound, (4) an interview to record feelings about events triggering anxiety. ASD and control participants will be together for phases 2 and 3, revealing different physiological responses to the same situations, and thus identifying potentially problematic events. The novelty will be to apply time-series analyses (which led to several Nobel Prizes in quantitative finance) on ANS series (heart rate, heart rate variability, skin conductance) and wrist motion. ETHICS AND DISSEMINATION: Ethical approval has been obtained from Ethics Committee of Clermont-Ferrand (South-East I), France (2014-A00611-46). Trial findings will be disseminated via open-access peer-reviewed publications, conferences, clinical networks, public lectures and our websites. TRIAL REGISTRATION NUMBER: ClinicalTrials identifier NCT02275455.

Respective impact of no escalation of treatment, withholding and withdrawal of life-sustaining treatment on ICU patients' prognosis: a multicenter study of the Outcomerea Research Group.

PURPOSE: To assess the prevalence of decisions to forgo life-sustaining treatment (DFLST), the patients characteristics, and to estimate the impact of DFLST stages on mortality. METHODS: Observational study of a prospective database between 2005 and 2012 from 13 ICUs. DFLST were defined as follows: no escalation of treatment (stage 1), not to start or escalate treatment even if such treatment is considered in the future; withholding (stage 2), not to start or escalate necessary treatment; withdrawal (stage 3), to stop necessary treatment. The impact of daily DFLST stage on day-30 hospital mortality was tested with a discrete-time Cox's model and adjusted for admission severity and daily SOFA score. RESULTS: Of 10,080 patients, 1290 (13%) made DFLST. The highest DFLST stage during the ICU stay was no escalation of treatment in 339 (26%) patients, withholding in 502 (39%) patients, and withdrawal in 449 (35%) patients. Older patients, patients with at least one chronic disease, and patients with greater ICU severity were significantly more numerous in the DFLST group. Day-30 mortality was 13% for non-DFLST patients, 35% for no escalation of treatment, 75% for withholding, 93% for withdrawal. After adjustment, an increase in day-30 mortality was associated with withholding and withdrawal (hazard ratio 95% CI 5.93 [4.95-7.12] and 20.05 [15.58-25.79], P < 0.0001), but not with no escalation of treatment (HR 1.14 [0.91-1.44], P = 0.25). CONCLUSIONS: DFLST were made in 13% of ICU patients. Withholding, withdrawal, older age, more comorbidities, and higher severity of illness were associated with higher mortality. No escalation of treatment was not associated with increased mortality.