Response

We thank Raimondi et al. for their alternative interpretation of our results on the prognostic value of 25-hydroxyvitamin D3 (25[OH]D3) serum level in melanoma patients. With the observation that standardized value of 25(OH)D3 at diagnosis was not a prognostic factor, our major finding was that a change of 25(OH)D3 serum level upon time in both directions was associated with worse disease-free and overall survivals, with U-shaped curves. We postulated that this latter result was unlikely to be a direct consequence of vitamin D biological actions but rather reflected a global instability in patients’ metabolisms, which finally impact 25(OH)D3 serum level by any

0130: Mortality related to cardiogenic shock in critically ill patients in France, 1997-2012

IntroductionMost of data reporting epidemiology of cardiogenic shock (CS) concern patients with acute myocardial infarction admitted in intensive care unit of cardiology. However, CS patients managed in critical care unit (CCU) have often multiorgan failure and seem to have different characteristics and outcome. To our best knowledge no study reported characteristics and clinical outcomes of CS patients admitted in CCU.AimTo report key features, Mortality and Trends in mortality in a large cohort of patients with CS admitting in 33 French CCUs from 1997 to 2012.Methods and resultsWe queried the 1997–2012 database of Parisian area ICUs-the CubRea (Intensive Care Database User Group) database to identify all hospital stays with a principal or an associated diagnosis of CS (National classification of disease R 570). Among 303 314 hospital stays, 17 494 (5.8%) were CS. The patients were managed in 60% of cases in universitary centers. Mean age was 64.3±17.0. Men accounted for 11047 (63.1%). Mean SAPS II was 62.0±24.3. Among CS, only 535 (3.06%) were AMI whereas 2685 (15.3%) were cardiac arrest and 858 (4.9%) were drug intoxications. Mechanical ventilation was required in 12967 (74.1%) of cases, inotropes in 14640 (83.7%) of cases and renal support in 3886 (22.2%) of cases. Mean duration of hospital was 19.1 days±24.7. Intrahospital Mortality was high (46.2%). Predictors of intrahospital death are reported in Table. Over the 15-year period, mortality decreased (49.8% in 1997-2000 and 42.7% in 2009-2012, p<0.001) whereas the patients were more critically ill (SAPS II 58.8±25.4 in 1997-2000 vs 64.2 8±23.6 in 2009-2012, p<0.001).Conclusionit is the first study reporting the prevalence, determinants and prognostic factors of CS patients managed in reanimation. The mortality of these very critically ill patients remains high. However over the 15-year period, even if these patients are more and more critically ill, early mortality decreased.Abstratct 0130 – TableVariablesOR95% CIDrug intoxication.307.236.401Age (<60 yo).436.383.496Mechanical circulatory support.681.3781.228Sepsis.715.637.8022009-2012.998.8851.125SAPS II1.0361.0331.038Acidosis1.4531.2641.670Mechanical ventilation1.7181.4831.990Acute respiratory distress syndrome1.7941.5582.0661997-20001.8141.4522.267Hemodialysis1.8201.6092.060Inotropic use1.9821.1133.530Disseminated intravascular coagulation2.1191.5912.822Cardiac arrest4.3333.8404.88

Lawsuit and Traumatic Brain Injury: The Relationship Between Long-Lasting Sequelae and Financial Compensation in Litigants. Results From the PariS-TBI Study

Purpose: People with traumatic brain injury are frequently involved in a litigation because another person was at fault for causing the accident. A compensation amount will often be settled to compensate the victim for the past, present, future damages and losses suffered. We report descriptive data about the full and final personal compensation amount and investigated its association with patient's outcomes.Methods: We used a longitudinal prospective study of severe TBI patients injured in 2005–2007 (PariS-TBI). Questions regarding involvement in a litigation were asked concurrently with 4 and 8-year outcomes.Results: Among 160 participants assessed 4 and/or 8 years post-injury, a total of 67 persons declared being involved in a litigation, among which 38 people reported a compensation amount of a mean €292,653 (standard deviation = 436,334; interquartile 25–50–75 = 37,000–100,000–500,000; minimum = 1,500-maximum = 2,000,000). A higher compensation amount was associated with more severe disability and cognitive impairment in patients, and with more informal care time provided by caregivers. However, no significant association related to patient's gender, age, years of education, motor/balance impairment, return to work status, mood and related to caregiver's subjective burden was found.Conclusion: Financial compensation was related to victims' long-term severity of impairment, although some extreme cases with severe disability were granted very poor compensation

Variability of Intensive Care Admission Decisions for the Very Elderly

Although increasing numbers of very elderly patients are requiring intensive care, few large sample studies have investigated ICU admission of very elderly patients. Data on pre triage by physicians from other specialities is limited. This observational cohort study aims at examining inter-hospital variability of ICU admission rates and its association with patients' outcomes. All patients over 80 years possibly qualifying for ICU admission who presented to the emergency departments (ED) of 15 hospitals in the Paris (France) area during a one-year period were prospectively included in the study. Main outcome measures were ICU eligibility, as assessed by the ED and ICU physicians; in-hospital mortality; and vital and functional status 6 months after the ED visit. 2646 patients (median age 86; interquartile range 83–91) were included in the study. 94% of participants completed follow-up (n = 2495). 12.4% (n = 329) of participants were deemed eligible for ICU admission by ED physicians and intensivists. The overall in-hospital and 6-month mortality rates were respectively 27.2% (n = 717) and 50.7% (n = 1264). At six months, 57.5% (n = 1433) of patients had died or had a functional deterioration. Rates of patients deemed eligible for ICU admission ranged from 5.6% to 38.8% across the participating centers, and this variability persisted after adjustment for patients' characteristics. Despite this variability, we found no association between level of ICU eligibility and either in-hospital death or six-month death or functional deterioration. In France, the likelihood that a very elderly person will be admitted to an ICU varies widely from one hospital to another. Influence of intensive care admission on patients' outcome remains unclear

Essais de non-infériorité et d’équivalence : points clés de méthodologie

International audienceNon-inferiority and equivalence trials aim to promote new treatments that are not expected to be superior to existing ones in a given indication. In order to compensate for a possible loss of efficacy, the new treatment should offer other advantages compared to the reference treatment, a better safety of use for example. Their methods somewhat differ from those of superiority trials, often better known to the medical community. This article presents the key points of the methodology of non-inferiority and equivalence trials in order to inform the readers of such trials about the issues and critical points. The general methodology (hypotheses, decision rules, number of subjects required, and strategy of analysis) is presented using examples and graphic illustrations. The issues and critical points are identified and discussed, in particular the choice of the comparator and of the margin of non-inferiority

A patient-based national survey on postoperative pain management in France reveals significant achievements and persistent challenges.

International audienceWe carried out a national survey on postoperative pain (POP) management in a representative sample (public/private, teaching/non-teaching, size) of 76 surgical centers in France. Based on medical records and questionnaires, we evaluated adult patients 24h after surgery, concerning information: pre and postoperative pain, evaluation, treatment and side effects. A local consultant provided information about POP management. Data were recorded for 1900 adult patients, 69.3% of whom remembered information on POP. Information was mainly delivered orally (90.3%) and rarely noted on the patient's chart (18.2%). Written evaluations of POP were frequent on the ward (93.7%) with appropriate intervals (4.1 (4.0)h), but not frequently prescribed (32.7%). Pain evaluations were based on visual analog scale (21.1%), numerical scale (41.2%), verbal scale (13.8%) or non-numerical tool (24%). Pain was rarely a criterion for recovery room discharge (19.8%). Reported POP was mild at rest (2.7 (1.3)), moderate during movement (4.9 (1.9)) and intense at its maximal level (6.4 (2.0)). Incidence of side effects was similar according to patient (26.4%) or medical chart (25.1%) including mostly nausea and vomiting (83.3%). Analgesia was frequently initiated during anesthesia (63.6%). Patient-controlled analgesia (21.4%) was used less frequently than subcutaneous morphine (35.1%) whose prescription frequently did not follow guidelines. Non-opioid analgesics used included paracetamol (90.3%), ketoprofen (48.5%) and nefopam (21.4%). Epidural (1.5%) and peripheral (4.7%) nerve blocks were under used. Evaluation (63.4%) or treatment (74.1%) protocols were not available for all patients. This national, prospective, patient-based, survey reveals both progress and persistent challenges in POP management

Two Phenotypes Are Identified by Cluster Analysis in Early Inflammatory Back Pain Suggestive of Spondyloarthritis: Results From the DESIR Cohort

International audienc

Prevalence of hypothermia on admission to recovery room remains high despite a large use of forced-air warming devices: Findings of a non-randomized observational multicenter and pragmatic study on perioperative hypothermia prevalence in France.

BackgroundDespite the availability of effective warming systems, the prevalence of hypothermia remains high in patients undergoing surgery. Occurrence of perioperative hypothermia may influence the rate of postoperative complications. Recommendations for the prevention of inadvertent perioperative hypothermia have been developed and are effective to reduce the frequency of perioperative hypothermia when professionals comply with. French Society of Anesthesiology (SFAR) decided to promote guidelines for the prevention of inadvertent hypothermia, and to conduct beforehand a pragmatic assessment of the prevalence of hypothermia in France. The hypothesis was that the rate of hypothermic patients (TcMethodsAn observational, prospective and multi-centric study was conducted in France between October 2014 and May 2016 among patients over 45 years undergoing non-cardiac, non-outpatient surgery with anesthesia lasting >30 minutes in 52 centers. Patients undergoing pulmonary or proctologic surgery and those having non-invasive procedures performed under general anesthesia (for example, digestive endoscopy) were excluded from our study. Patients being operated under plexus anesthesia alone, surgeries involving hemorrhaging or infection, and patients presenting at least one organ failure were also excluded. The primary endpoint was the percentage of patients with a core temperature (Tc) ResultsAmong 893 subjects (median age 66.9 years), prevalence of hypothermia on admission to the RR was 53.5%. At least one warming system was used for 90.4% of the patients. Identified risk factors for Tc0.5°C between anesthesia induction and surgical incision (OR = 1.82 [CI95%: 1.15-2.89]). Only a combination of pre-warming and intraoperative warming prevented a TcConclusionsThe prevalence of hypothermia among patients admitted to the RR remains high. Our results suggest that only the combination of pre-warming and intraoperative warming significantly decreases it

Assessing the implementation and effectiveness of early integrated palliative care in long-term care facilities in France: an interventional mixed-methods study protocol

Abstract Background Majority of residents in long-term care facilities (LTCF) have limited and delayed access to palliative care even though many suffer from incurable chronic illnesses that will likely require the provision of palliative care. We present the study protocol of “PADI-Palli”, an intervention aims to advance early integrated palliative care into standard care delivered in LTCF. This study will assess the effectiveness of early integrated palliative care on palliative care accessibility for older persons in LTCF, and identify the key factors for the successful implementation of early integrated palliative care and its sustainability in the LTCF context. Methods This multicentre interventional study utilises a pragmatic research design with a convergent parallel mixed-methods approach. The qualitative study will use a case study design and the quantitative study will use a stepped wedge cluster randomised trial. In total, 21 participating LTCF from three French regions will be randomly allocated to one of seven clusters. The clusters will cross over from the usual care to the active intervention condition over the course of the study. The primary outcome relates to the accurate identification of palliative care needs and early access to palliative care for LTCF residents. Secondary outcomes are quality of care, quality of life for residents and their families, and quality of life at work for professionals. Measurements will be performed before and after the intervention. Implementation and evaluation of PADI-Palli intervention is grounded in the Consolidated Framework for Implementation Research. Discussion Existing evidence demonstrates that early integrated palliative care in cancer care leads to a significant improvement in patient outcomes and processes of care. Little is known, however, about early integrated palliative care in the context of LTCF for older persons. This study has the potential to fill this gap in the literature by providing evidence on the effectiveness of early integrated palliative care for older persons in LTCF. Moreover, this study will provide a better understanding of the relevant contextual elements that facilitate or hinder early integrated palliative care implementation and transferability. If proven effective, this intervention can be scaled to other care settings in which older persons require palliative care. Trial registration ClinicalTrials.gov ID: NCT04708002; National registration: ID-RCB number: 2020-A01832-37