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Despite 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 (Tc<36°C) admitted to the RR remains high (around 50%), and that was the consequence of a warming device underutilization and/or was related to the type of health facilities. An 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) <36°C on admission to the recovery room (RR). Among 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 Tc<36°C included age≥70 years (OR = 1.41 [CI95%: 1.02-1.94]), duration of anesthesia from 1 to 2 hours (OR = 1.94 [CI95%: 1.04-3.64]) and a decrease in Tc of >0.5°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 Tc<36°C (OR = 0.48 [CI95%: 0.24-0.96]). The 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.

Duration of treatment for patients with vertebral osteomyelitis is mainly based on expert recommendation rather than evidence. We aimed to establish whether 6 weeks of antibiotic treatment is non-inferior to 12 weeks in patients with pyogenic vertebral osteomyelitis. In this open-label, non-inferiority, randomised controlled trial, we enrolled patients aged 18 years or older with microbiologically confirmed pyogenic vertebral osteomyelitis and typical radiological features from 71 medical care centres across France. Patients were randomly assigned to either 6 weeks or 12 weeks of antibiotic treatment (physician's choice in accordance with French guidelines) by a computer-generated randomisation list of permuted blocks, stratified by centre. The primary endpoint was the proportion of patients who were classified as cured at 1 year by a masked independent validation committee, analysed by intention to treat. Non-inferiority would be declared if the proportion of cured patients assigned to 6 weeks of treatment was not less than the proportion of cured patients assigned to 12 weeks of treatment, within statistical variability, by an absolute margin of 10%. This trial is registered with EudraCT, number 2006-000951-18, and Clinical Trials.gov, number NCT00764114. Between Nov 15, 2006, and March 15, 2011, 359 patients were randomly assigned, of whom six in the 6-week group and two in the 12-week group were excluded after randomisation. 176 patients assigned to the 6-week treatment regimen and 175 to the 12-week treatment regimen were analysed by intention to treat. 160 (90·9%) of 176 patients in the 6-week group and 159 (90·9%) of 175 of those in the 12-week group met the criteria for clinical cure. The difference between the groups (0·05%, 95% CI −6·2 to 6·3) showed the non-inferiority of the 6-week regimen when compared with the 12-week regimen. 50 patients in the 6-week group and 51 in the 12-week group had adverse events, the most common being death (14 [8%] in the 6-week group vs 12 [7%] in the 12-week group), antibiotic intolerance (12 [7%] vs 9 [5%]), cardiorespiratory failure (7 [4%] vs 12 [7%]), and neurological complications (7 [4%] vs 3 [2%]). 6 weeks of antibiotic treatment is not inferior to 12 weeks of antibiotic treatment with respect to the proportion of patients with pyogenic vertebral osteomyelitis cured at 1 year, which suggests that the standard antibiotic treatment duration for patients with this disease could be reduced to 6 weeks. French Ministry of Health.

ObjectiveTo determine whether an invasive approach is associated with favourable long-term outcomes among elderly medical patients in the intensive care unit (ICU), compared with a conservative approach.DesignNationwide observational study (OCTO-REVERSE study) using data prospectively collected in the National French Healthcare Database (covering 99% of the population, 66 million people).SettingComprehensive multicentre study through the linkage of large-scale national registries (including all public or private facilities) from 2013 to 2018 to avoid ambiguities related to the COVID-19 pandemic.ParticipantsAll non-surgical patients aged 80 years or older admitted to an ICU in France during the period (n=107 014 patients at 822 hospitals).Outcome measuresThe main outcome was the 1-year survival rate. The association of the two approaches with 1-year survival was estimated using a time-dependent Cox model and a propensity score (PS) adapted to time-to-event analysis, yielding the average treatment effect in the treated and extended weighted Kaplan–Meier curves.Results107 014 patients were categorised into two groups based on the type of care received: invasive (n=51 680 (48%) received invasive ventilation and/or vasopressor support) or conservative (n=55 334 (52%) received neither). 1-year survival rate was significantly lower in the invasive group than in the conservative group (27% vs 59% estimated with extended time-dependent Kaplan–Meier method). The risk of death in the invasive group remained significantly higher after time-dependent PS weighting (HR 1.64; 95% CI 1.60 to 1.69; p<0.001). The loss in restricted mean survival time was 67.7 days (95% CI 65.7 to 69.8) in this group and 31% of deaths occurred the day of initiation of the procedure, or the following day.ConclusionAmong the whole population of critically ill elderly medical patients in France, the invasive approach was unknowingly associated with end-of-life care in nearly three quarters of cases. Further research is needed to align intensive care with compassionate goals.

ObjectivesNo consensus criteria describe the medical eligibility of the patients to intermediate care units (IMCUs). In this first part of the UNISURC project, we aimed to develop criteria based on a consensus of physicians from the main specialties involved in IMCU admission decisions.DesignWe selected criteria from IMCU literature, scoring systems and intensive care unit nursing workload. We submitted these criteria to a panel of experts in a Delphi survey. We used a two-round Delphi survey procedure to assess the validity and feasibility of each criterion.SettingMedical practitioners in either public or private French institutions and proposed by the national scientific societies of anaesthesiology, emergency medicine and intensive care. The Delphi rounds took place in 2015–2016.Outcome measuresValidity and feasibility of the proposed criteria; uniformity of the judgement across the primary specialty and the hospital category of the responders.ResultsThe criteria submitted to vote were classified as one of: chronic factor (CF); acute factor (AF); specific pathway (SP); nursing activity (NA) and hospital environment (HE). Of 189 experts invited, 81 (41%) responded to the first round and 62 of them (76%) responded to the second round. A definite selection of 63 items was made, distributed across 6 CF, 18 AF, 31 SP, 3 NA and 5 HE. Validity and feasibility were influenced by the specialty or the public/private status of the institution of the responders for a few items.ConclusionWe created a set of 63 consensus criteria with acceptable validity and feasibility to assess the medical eligibility of the patients to IMCUs. The second part of the UNISURC project will assess the distribution of each criterion in a prospective multicentre national cohort.Trial registration numberNCT02590172.

The purpose of digital remote monitoring (DRM) is improving cancer care management. However, its effectiveness largely depends on the role of nurse navigators (NNs) within these systems to process data and lead action. This study aims to fill gaps in our understanding of the role of NNs within a specific system, drawing on the Cancérologie parcours région Ile-de-France (CAPRI) DRM program applied to oncology patients. The CAPRI DRM, targeting patients taking oral anticancer agents, combines digital interfaces with NN interventions. A phase 3 randomized controlled trial involving 559 patients assessed its safety and efficacy, with the primary end point being the relative dose intensity. This report focuses on patients in the CAPRI arm, evaluating the impact of NN interventions on outcomes such as toxicity, hospitalization, and emergency visits. Data on patient characteristics, NN interventions, and patient satisfaction surveys were analyzed using structural equation modeling. The study included 187 patients. Patient characteristics were significantly correlated with outcomes. Across all the models we used, the quality of NN interventions was consistently associated with higher patient satisfaction, with correlation coefficients ranging from 0.332 (95% CI 0.154-0.510; P<.001) to 0.366 (95% CI 0.182-0.550; P<.001). The number of grade ≥3 toxicity events correlated positively with NN referrals to oncologists. Hospitalization length was positively related to NN referral (coefficient 0.102, 95% CI 0.051-0.153; P<.001) and inversely to NN advice (coefficient -0.045, 95% CI -0.096 to 0.006; P=.08). Emergency visits showed a negative correlation with NN actions (coefficient -0.478, 95% CI -0.923 to 0.033; P=.04) and a positive correlation with NN calls and referrals (coefficient 0.516, 95% CI 0.069-0.963; P=.02). This study shows the central role of NNs in making DRM effective. Despite the study's limitations, these results support the design of DRM as a hybrid model of automated digital tools and human support. Future research should explore the applicability of such a DRM model in various clinical settings to clarify the optimal association between automated systems and NN expertise. ClinicalTrials.gov NCT02828462; https://www.clinicaltrials.gov/study/NCT02828462.

Background Rheumatoid arthritis (RA) is characterized by increased cardiovascular (CV) mortality. CV events are particularly high in patients with RA-specific autoimmunity, including rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA), raising the question whether RA-specific autoimmunity itself is associated with CV events. Methods New CV events (myocardial infarction, stroke or death by CV cause) were recorded in 20,625 subjects of the Electricité de France – Gaz de France (GAZEL) cohort. Self-reported RA cases in the GAZEL cohort were validated by phone interview on the basis of a specific questionnaire. In 1618 subjects, in whom plasma was available, RF and ACPA were measured. A piecewise exponential Poisson regression was used to analyze the association of CV events with presence of RA as well as RA-specific autoimmunity (without RA). Results CV events in GAZEL were associated with age, male sex, smoking, hypertension, hyperlipidemia, and diabetes mellitus (HR from 1.06 to 1.87, p < 0.05). Forty-two confirmed RA cases were identified. Confirmed RA was significantly associated with CV risk increase (HR of 3.03; 95% CI: 1.13–8.11, p  = 0.03) independently of conventional CV risk factors. One hundred seventy-eight subjects showed RF or ACPA positivity without presence of RA. CV events were not associated with ACPA positivity (HR: 1.52, 95% CI: 0.47–4.84, p  = 0.48) or RF positivity (HR: 1.15, 95% CI: 0.55–2.40, p  = 0.70) in the absence of RA. Conclusions RA, as a clinical chronic inflammatory disease, but not mere positivity for RF or ACPA in the absence of clinical disease is associated with increased CV risk.

IntroductionAutism and neurodevelopmental disorders (NDDs) are complex conditions that manifest as significant impairments in social communication and behaviour. Early detection and intervention play a pivotal role in improving outcomes, largely due to the high brain plasticity in infants. The PRECO-TSA study aims to validate the effectiveness of systematic use of the Prévention de l’Autisme (PREAUT) grid for early screening and referral strategies for autism and NDDs in infants, focusing on a coordinated approach that integrates maternal and child protection centre with medical-psychological centres. The goal is to evaluate a streamlined referral system to improve early detection and facilitate effective interventions for children at higher risk of autism.Methods and analysisThe PRECO-TSA study is a prospective, pragmatic, multicentre, cluster-randomised controlled trial using an incomplete stepped-wedge design, which maximises external validity. The study includes a 6-month baseline phase, a 3-month semiobservation phase and a 6-month follow-up phase. The 36-month patient inclusion period is followed by a 48-month passive follow-up through the National Health Data System, data collection includes demographic and clinical information, with hierarchical mixed models used to analyse the impact of early screening and referral for autism and NDDs.Ethics and disseminationThis study was funded by the French Ministry of Health (PREPS-20-0186) and was approved by Ile de France I Ethics Committee CPP (number CPPIDF1-2023-DI29-Cat2). The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT05815095.

Objective Early diagnosis of spondyloarthritis (SpA) is sometimes difficult owing to the lack of reliable diagnostic criteria. The objective of this study was to determine the diagnostic accuracy of detecting enthesitis by power Doppler ultrasonography (PDUS) in patients with suspected SpA. Methods A prospective single-centre cohort study was performed in patients with symptoms suggestive of SpA (inflammatory back pain, arthritis, enthesitis or dactylitis, HLAB27+ uveitis) who underwent clinical examination, pelvic x-ray, MRI of lumbar spine/sacroiliac joints, HLA-B typing and other tests judged useful for diagnosis. Blinded PDUS examination of seven sites of enthesitis was performed at baseline. The gold standard was the diagnosis made by the referring rheumatologist according to the development of symptoms and findings, blinded to PDUS results, during routine follow-up for up to 2 years. Results Between November 2002 and October 2004, 118 patients were included in the study. After 2 years a definite diagnosis was retained for 99 patients (51 SpA and 48 non-SpA). PDUS detection of at least one vascularised enthesis provided good predictive value for diagnosing SpA (sensitivity 76.5%; specificity 81.3%; positive likelihood ratio 4.1; OR 14.1; p<0.0001). Vascularised enthesitis detected by PDUS and Amor's criteria were the only independent contributors to a diagnosis of SpA in multivariate logistic regression (c-index=0.87). Alternatively, CART analysis resulted in a highly sensitive and specific diagnostic tree by combining PDUS with Amor's criteria. Conclusions PDUS appears to be a valuable first-line diagnostic tool to confirm a diagnosis of SpA.

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.

BackgroundAs hospital-based home care is a complex intervention, we critically appraised the key elements that could ensure the completeness of assessment and explain the heterogeneity of the literature results about the comparison between home and hospital setting for the anticancer drugs injection within the same standards of clinical care.MethodsSystematic review was conducted. Medline, Embase, Cochrane Library, Web of Sciences, and Cumulative Index of Nursing and Allied Health (Cinahl) searched to February 1, 2019, and combined with grey literature. Methodological quality has been rated using the “Quality Assessment Tool for Quantitative Studies” developed by the Effective Public Health Practice Project (EPHHP) in addition to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement for economic studies and the consolidated criteria for reporting qualitative research (COREQ) checklist for qualitative studies.ResultsOf 400 records identified, we identified 13 relevant studies (nine quantitative and four mixed-method studies). The quality of studies was hardly strong. The home-based anticancer injection involved highly heterogeneous home care interventions that generally kept a strong link with the hospital setting. The study schemes limited the comparison of clinical outcomes (OS, PFS, toxicity). Unlike the quality of life remaining similar, patients preferred to be treated at home. Cost savings were in favor of Hospital at Home, but the charge categories used to compare or the home intervention were heterogeneous and rarely integrating relatives’ duties and hospital staff’s time. Qualitative studies highlighted about benefits and barriers of home.ConclusionThe current state of evidence shows as it still remains difficult to appraise the anticancer injection at home when considering the details of this complex intervention, the role of each stakeholder, and the missing data.