Management of neo-esophagus-airway fistula after esophagectomy for oesophageal cancer: systematic literature review and meta-analysis.

OBJECTIVES: Neo-oesophageal-airway fistula (NEAF) between gastric conduit and airway is a rare but life-threatening complication of oesophagectomy for oesophageal cancer. Optimal treatment remains unknown. A meta-analysis of good-quality case series may help determine whether nonoperative management (NOM) only, upfront surgery (S), or NOM followed by surgery is associated with better 1-year post-treatment mortality, resumption of oral diet and fistula recurrence. METHODS: We systematically searched PubMed, EMBASE and Web of Science for publications in English reporting case series of management and survival in patients with NEAF. Of the 177 identified studies, 62 were duplicates and 95 were not relevant to our topic. Three studies were excluded after a full-text review, due to absence of reporting of 1-year survival. Exclusion criteria to identified publications were: abstract only, malignant NEAF, absence of oesophagectomy and esogastric anastomosis, fewer than 5 patients and NEAF not the main focus of the study. Data-extraction was conducted in accordance with MOOSE guidelines. Data were pooled using random-effects model. RESULTS: Seventeen studies (302 patients) were included. One-year post-treatment mortality was considerably lower with NOM followed by surgery [33%; 95% confidence interval (CI), 0.17-0.48] than with NOM (68%; 95% CI, 0.39-0.97) or S (67%; 95% CI, 0.36-0.98). Fistula location was not associated with 1-year mortality. Neither resumption of an oral diet nor fistula recurrence differed significantly across treatment strategies. CONCLUSIONS: NOM to prepare patients for surgery followed by surgical repair may provide the highest 1-year survival of patients with NEAF. However, patient selection criteria to each of 3 treatment strategies may have affected our findings.

Collaborative and privacy-enhancing workflows on a clinical data warehouse: an example developing natural language processing pipelines to detect medical conditions.

OBJECTIVE: To develop and validate a natural language processing (NLP) pipeline that detects 18 conditions in French clinical notes, including 16 comorbidities of the Charlson index, while exploring a collaborative and privacy-enhancing workflow. MATERIALS AND METHODS: The detection pipeline relied both on rule-based and machine learning algorithms, respectively, for named entity recognition and entity qualification, respectively. We used a large language model pre-trained on millions of clinical notes along with annotated clinical notes in the context of 3 cohort studies related to oncology, cardiology, and rheumatology. The overall workflow was conceived to foster collaboration between studies while respecting the privacy constraints of the data warehouse. We estimated the added values of the advanced technologies and of the collaborative setting. RESULTS: The pipeline reached macro-averaged F1-score positive predictive value, sensitivity, and specificity of 95.7 (95%CI 94.5-96.3), 95.4 (95%CI 94.0-96.3), 96.0 (95%CI 94.0-96.7), and 99.2 (95%CI 99.0-99.4), respectively. F1-scores were superior to those observed using alternative technologies or non-collaborative settings. The models were shared through a secured registry. CONCLUSIONS: We demonstrated that a community of investigators working on a common clinical data warehouse could efficiently and securely collaborate to develop, validate and use sensitive artificial intelligence models. In particular, we provided an efficient and robust NLP pipeline that detects conditions mentioned in clinical notes.

Doppler echocardiography for surveillance of acute cardiac allograft rejection: a 28-year single-center experience.

Background: Endomyocardial biopsies (EMB) are recommended for the detection of acute cardiac rejection (ACR) despite limited sensitivity. We report the long-term post-transplant results of Doppler echocardiography as a noninvasive alternative of routine EMB. Methods: Two cohorts of heart transplantation (HT) recipients were chronologically defined as follows: the Dual Monitoring Cohort (DMC) from January 1990 to December 1997 included patients who underwent routine EMB and Doppler echocardiography within 24 hours for ACR surveillance; and the "Echo-First Cohort" (EFC), including patients transplanted from January 1998 to December 2018 with Doppler echocardiography as first-line approach for ACR surveillance. Echocardiographic measurements of interest were collected: early diastolic (E) wave peak velocity; pressure half time (PHT) and isovolumetric relaxation time (IVRT). Post-transplant outcomes were reviewed and the Kaplan-Meier approach was used for survival estimates. Inter-operator variability for ultrasound measurements was investigated. Data were collected from medical records from January 2019 to December 2020. Results: A total of 228 patients were included, 99 patients in the DMC and 129 in the EFC. Overall, 5-, 10- and 15-year survival rates were 65.4%, 55.5% and 44.1% respectively, without any significant difference between the two cohorts (log rank test, P=0.71). Echocardiography variables and EMB findings were associated with a mean area under the receiver operating characteristic curve (AUC-ROC) of 0.73 [95% confidence interval (CI): 0.54-0.91], 0.74 (95% CI: 0.54-0.94) and 0.75 (95% CI: 0.57-0.94) respectively for E wave, PHT and IVRT. IVRT and PHT were significantly decreased, and E wave significantly increased, in case of histologically proven ACR. Inter-operator variability was not significant for E wave and IVRT measurements (P=0.13 and 0.30 respectively). Conclusions: Doppler echocardiography as a first-line method for surveillance of ACR did not impair long-term results after HT. These findings suggest that this non-invasive approach might be a reasonable alternative to systematic EMB, limiting risk and improving the quality of life.

Impact of the Sars-Cov-2 outbreak on the initial clinical presentation of new solid cancer diagnoses: a systematic review and meta-analysis.

BACKGROUND: The COVID-19 pandemic might have delayed cancer diagnosis and management. The aim of this systematic review was to compare the initial tumor stage of new cancer diagnoses before and after the pandemic. METHODS: We systematically reviewed articles that compared the tumor stage of new solid cancer diagnoses before and after the initial pandemic waves. We conducted a random-effects meta-analysis to compare the rate of metastatic tumors and the distribution of stages at diagnosis. Subgroup analyses were performed by primary tumor site and by country. RESULTS: From 2,013 studies published between January 2020 and April 2022, we included 58 studies with 109,996 patients. The rate of metastatic tumors was higher after the COVID-19 outbreak than before (pooled OR: 1.29 (95% CI, 1.06-1.57), I2: 89% (95% CI, 86-91)). For specific cancers, common ORs reached statistical significance for breast (OR: 1.51 (95% CI 1.07-2.12)) and gynecologic (OR: 1.51 (95% CI 1.04-2.18)) cancers, but not for other cancer types. According to countries, common OR (95% CI) reached statistical significance only for Italy: 1.55 (1.01-2.39) and Spain:1.14 (1.02-1.29). Rates were comparable for stage I-II versus III-IV in studies for which that information was available, and for stages I-II versus stage III in studies that did not include metastatic patients. CONCLUSIONS: Despite inter-study heterogeneity, our meta-analysis showed a higher rate of metastatic tumors at diagnosis after the pandemic. The burden of social distancing policies might explain those results, as patients may have delayed seeking care.

Impact of the COVID-19 pandemic on clinical presentation, treatments, and outcomes of new breast cancer patients: A retrospective multicenter cohort study.

BACKGROUND: The SARS CoV-2 pandemic disrupted healthcare systems. We compared the cancer stage for new breast cancers (BCs) before and during the pandemic. METHODS: We performed a retrospective multicenter cohort study on the data warehouse of Greater Paris University Hospitals (AP-HP). We identified all female patients newly referred with a BC in 2019 and 2020. We assessed the timeline of their care trajectories, initial tumor stage, and treatment received: BC resection, exclusive systemic therapy, exclusive radiation therapy, or exclusive best supportive care (BSC). We calculated patients' 1-year overall survival (OS) and compared indicators in 2019 and 2020. RESULTS: In 2019 and 2020, 2055 and 1988, new BC patients underwent cancer treatment, and during the two lockdowns, the BC diagnoses varied by -18% and by +23% compared to 2019. De novo metastatic tumors (15% and 15%, p = 0.95), pTNM and ypTNM distributions of 1332 cases with upfront resection and of 296 cases with neoadjuvant therapy did not differ (p = 0.37, p = 0.3). The median times from first multidisciplinary meeting and from diagnosis to treatment of 19 days (interquartile 11-39 days) and 35 days (interquartile 22-65 days) did not differ. Access to plastic surgery (15% and 17%, p = 0.08) and to treatment categories did not vary: tumor resection (73% and 72%), exclusive systemic therapy (13% and 14%), exclusive radiation therapy (9% and 9%), exclusive BSC (5% and 5%) (p = 0.8). Among resected patients, the neoadjuvant therapy rate was lower in 2019 (16%) versus 2020 (20%) (p = 0.02). One-year OS rates were 99.3% versus 98.9% (HR = 0.96; 95% CI, 0.77-1.2), 72.6% versus 76.6% (HR = 1.28; 95% CI, 0.95-1.72), 96.6% versus 97.8% (HR = 1.09; 95% CI, 0.61-1.94), and 15.5% versus 15.1% (HR = 0.99; 95% CI, 0.72-1.37), in the treatment groups. CONCLUSIONS: Despite a decrease in the number of new BCs, there was no tumor stage shift, and OS did not vary.

Development of a natural language processing model for deriving breast cancer quality indicators : A cross-sectional, multicenter study.

OBJECTIVES: Medico-administrative data are promising to automate the calculation of Healthcare Quality and Safety Indicators. Nevertheless, not all relevant indicators can be calculated with this data alone. Our feasibility study objective is to analyze 1) the availability of data sources; 2) the availability of each indicator elementary variables, and 3) to apply natural language processing to automatically retrieve such information. METHOD: We performed a multicenter cross-sectional observational feasibility study on the clinical data warehouse of Assistance Publique - Hôpitaux de Paris (AP-HP). We studied the management of breast cancer patients treated at AP-HP between January 2019 and June 2021, and the quality indicators published by the European Society of Breast Cancer Specialist, using claims data from the Programme de Médicalisation du Système d'Information (PMSI) and pathology reports. For each indicator, we calculated the number (%) of patients for whom all necessary data sources were available, and the number (%) of patients for whom all elementary variables were available in the sources, and for whom the related HQSI was computable. To extract useful data from the free text reports, we developed and validated dedicated rule-based algorithms, whose performance metrics were assessed with recall, precision, and f1-score. RESULTS: Out of 5785 female patients diagnosed with a breast cancer (60.9 years, IQR [50.0-71.9]), 5,147 (89.0%) had procedures related to breast cancer recorded in the PMSI, and 3732 (72.5%) had at least one surgery. Out of the 34 key indicators, 9 could be calculated with the PMSI alone, and 6 others became so using the data from pathology reports. Ten elementary variables were needed to calculate the 6 indicators combining the PMSI and pathology reports. The necessary sources were available for 58.8% to 94.6% of patients, depending on the indicators. The extraction algorithms developed had an average accuracy of 76.5% (min-max [32.7%-93.3%]), an average precision of 77.7% [10.0%-97.4%] and an average sensitivity of 71.6% [2.8% to 100.0%]. Once these algorithms applied, the variables needed to calculate the indicators were extracted for 2% to 88% of patients, depending on the indicators. DISCUSSION: The availability of medical reports in the electronic health records, of the elementary variables within the reports, and the performance of the extraction algorithms limit the population for which the indicators can be calculated. CONCLUSIONS: The automated calculation of quality indicators from electronic health records is a prospect that comes up against many practical obstacles.

Systematic Review and Meta-analysis of Clinical Outcomes After Endovascular Treatment in Patients With Femoropopliteal Lesions Greater Than 150 mm.

OBJECTIVE: Indications for endovascular treatment of femoropopliteal (FP) lesions have steadily increased over the past decade. Accordingly, the number of devices has also increased but the choice of the best endovascular treatment remains to be defined. The aim of this meta-analysis was to summarize all studies investigating endovascular treatment of FP lesions greater than 150 mm from 2010 to 2021. METHODS: Articles were searched using PubMed, Scopus, and Cochrane. Included studies were randomized controlled trials (RCTs), cohort studies, and case series (prospective and retrospective) that evaluated any endovascular procedure in patients with long FP lesions classified TASC (Trans-Atlantic Inter-Society Consensus document II on management of peripheral arterial disease) C and/or D, and a mean length >150 mm, primary outcome had to be the 1-year primary patency. Overall estimate of primary patency, secondary patency, and freedom from target lesion revascularization (TLR) at 1 year depending on the different devices were investigated. The meta-analysis was conducted following the requirements of the MOOSE (Meta-analysis of Observational Studies in Epidemiology) checklist. RESULTS: Forty-four papers comprising 4847 patients and 5282 treated limbs were included. Mean lesions length ranged from 150.5 to 330 mm. The pooled 1-year primary and secondary patencies, and freedom from TLR rates were 0.71 (95% CI: 0.67-0.74), 0.87 (95% CI: 0.83-0.91), and 0.79 (95% CI: 0.74-0.84), respectively. Primary permeability at 1 year were 0.68 (95% CI: 0.62-0.73), 0.67 (95% CI: 0.60-0.74), 0.74 (95% CI: 0.64-0.84), and 0.83 (95% CI: 0.78-0.88) for bare metal stents, covered stents (CSs), drug-eluting stents, and drug-coated balloons (DCBs), respectively. Lesions treated with DCB had the highest 1-year primary patency rate. CONCLUSIONS: At 1-year, endovascular procedures for FP lesions greater than 150 mm obtain satisfactory results. High primary patency rates were obtained with drug-coated devices, while CSs obtained less favorable results. Randomized studies comparing different devices in the treatment of long FP lesions remain necessary to determine the most optimal approach for the management of these patients. CLINICAL IMPACT: This paper highlights on the one hand the satisfactory results of endovascular treatment on complex femoropopliteal lesions formerly reserved for conventional surgery. On the other hand, among the available devices, paclitaxel-eluting devices seem to show superior results which should make them recommended as first-line treatment.

No changes in clinical presentation, treatment strategies and survival of pancreatic cancer cases during the SARS-COV-2 outbreak: A retrospective multicenter cohort study on real-world data.

The SARS-COV-2 pandemic disrupted healthcare systems. We assessed its impact on the presentation, care trajectories and outcomes of new pancreatic cancers (PCs) in the Paris area. We performed a retrospective multicenter cohort study on the data warehouse of Greater Paris University Hospitals (AP-HP). We identified all patients newly referred with a PC between January 1, 2019, and June 30, 2021, and excluded endocrine tumors. Using claims data and health records, we analyzed the timeline of care trajectories, the initial tumor stage, the treatment categories: pancreatectomy, exclusive systemic therapy or exclusive best supportive care (BSC). We calculated patients' 1-year overall survival (OS) and compared indicators in 2019 and 2020 to 2021. We included 2335 patients. Referral fell by 29% during the first lockdown. The median time from biopsy and from first MDM to treatment were 25 days (16-50) and 21 days (11-40), respectively. Between 2019 and 2020 to 2021, the rate of metastatic tumors (36% vs 33%, P = .39), the pTNM distribution of the 464 cases with upfront tumor resection (P = .80), and the proportion of treatment categories did not vary: tumor resection (32% vs 33%), exclusive systemic therapy (49% vs 49%), exclusive BSC (19% vs 19%). The 1-year OS rates in 2019 vs 2020 to 2021 were 92% vs 89% (aHR = 1.42; 95% CI, 0.82-2.48), 52% vs 56% (aHR = 0.88; 95% CI, 0.73-1.08), 13% vs 10% (aHR = 1.00; 95% CI, 0.78-1.25), in the treatment categories, respectively. Despite an initial decrease in the number of new PCs, we did not observe any stage shift. OS did not vary significantly.

Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial.

Background: Prostatic artery embolisation (PAE) is a minimally invasive treatment of symptomatic benign prostatic hyperplasia (BPH). Our aim was to compare patient's symptoms improvement after PAE and medical treatment. Methods: A randomised, open-label, superiority trial was set in 10 French hospitals. Patients with bothersome lower urinary tract symptoms (LUTS) defined by International Prostatic Symptom Score (IPSS) > 11 and quality of life (QoL) > 3, and BPH ≥50 ml resistant to alpha-blocker monotherapy were randomly assigned (1:1) to PAE or Combined Therapy ([CT], oral dutasteride 0.5 mg/tamsulosin hydrochloride 0.4 mg per day). Randomisation was stratified by centre, IPSS and prostate volume with a minimisation procedure. The primary outcome was the 9-month IPSS change. Primary and safety analysis were done according to the intention-to-treat (ITT) principle among patients with an evaluable primary outcome. ClinicalTrials.gov Identifier: NCT02869971. Findings: Ninety patients were randomised from September 2016 to February 2020, and 44 and 43 patients assessed for primary endpoint in PAE and CT groups, respectively. The 9-month change of IPSS was -10.0 (95% confidence interval [CI]: -11.8 to -8.3) and -5.7 (95% CI: -7.5 to -3.8) in the PAE and CT groups, respectively. This reduction was significantly greater in the PAE group than in the CT group (-4.4 [95% CI: -6.9 to -1.9], p = 0.0008). The IIEF-15 score change was 8.2 (95% CI: 2.9-13.5) and -2.8 (95% CI: -8.4 to 2.8) in the PAE and CT groups, respectively. No treatment-related AE or hospitalisation was noticed. After 9 months, 5 and 18 patients had invasive prostate re-treatment in the PAE and CT group, respectively. Interpretation: In patients with BPH ≥50 ml and bothersome LUTS resistant to alpha-blocker monotherapy, PAE provides more urinary and sexual symptoms benefit than CT up to 24 months. Funding: French Ministry of Health and a complementary grant from Merit Medical.

How to Improve Cancer Patients ENrollment in Clinical Trials From rEal-Life Databases Using the Observational Medical Outcomes Partnership Oncology Extension: Results of the PENELOPE Initiative in Urologic Cancers.

PURPOSE: To compare the computability of Observational Medical Outcomes Partnership (OMOP)-based queries related to prescreening of patients using two versions of the OMOP common data model (CDM; v5.3 and v5.4) and to assess the performance of the Greater Paris University Hospital (APHP) prescreening tool. MATERIALS AND METHODS: We identified the prescreening information items being relevant for prescreening of patients with cancer. We randomly selected 15 academic and industry-sponsored urology phase I-IV clinical trials (CTs) launched at APHP between 2016 and 2021. The computability of the related prescreening criteria (PC) was defined by their translation rate in OMOP-compliant queries and by their execution rate on the APHP clinical data warehouse (CDW) containing data of 205,977 patients with cancer. The overall performance of the prescreening tool was assessed by the rate of true- and false-positive cases of three randomly selected CTs. RESULTS: We defined a list of 15 minimal information items being relevant for patients' prescreening. We identified 83 PC of the 534 eligibility criteria from the 15 CTs. We translated 33 and 62 PC in queries on the basis of OMOP CDM v5.3 and v5.4, respectively (translation rates of 40% and 75%, respectively). Of the 33 PC translated in the v5.3 of the OMOP CDM, 19 could be executed on the APHP CDW (execution rate of 58%). Of 83 PC, the computability rate on the APHP CDW reached 23%. On the basis of three CTs, we identified 17, 32, and 63 patients as being potentially eligible for inclusion in those CTs, resulting in positive predictive values of 53%, 41%, and 21%, respectively. CONCLUSION: We showed that PC could be formalized according to the OMOP CDM and that the oncology extension increased their translation rate through better representation of cancer natural history.

Why Are Data Missing in Clinical Data Warehouses? A Simulation Study of How Data Are Processed (and Can Be Lost).

In recent years, the development of clinical data warehouses (CDW) has put Electronic Health Records (EHR) data in the spotlight. More and more innovative technologies for healthcare are based on these EHR data. However, quality assessments on EHR data are fundamental to gain confidence in the performances of new technologies. The infrastructure developed to access EHR data - CDW - can affect EHR data quality but its impact is difficult to measure. We conducted a simulation on the Assistance Publique - Hôpitaux de Paris (AP-HP) infrastructure to assess how a study on breast cancer care pathways could be affected by the complexity of the data flows between the AP-HP Hospital Information System, the CDW, and the analysis platform. A model of the data flows was developed. We retraced the flows of specific data elements for a simulated cohort of 1,000 patients. We estimated that 756 [743;770] and 423 [367;483] patients had all the data elements necessary to reconstruct the care pathway in the analysis platform in the "best case" scenarios (losses affect the same patients) and in a random distribution scenario (losses affect patients at random), respectively.

MyGood Trip, a Telemedicine Intervention for Physical Activity Recovery After Bariatric Surgery: Randomized Controlled Trial.

BACKGROUND: Despite bariatric surgery showing significant weight loss trajectories for many patients, a substantial proportion regain weight after the first year following surgery. The addition of telemedicine to standard care could support patients with engaging in a more active lifestyle and thus improve clinical outcomes. OBJECTIVE: Our aim was to evaluate a telemedicine intervention program dedicated to the promotion of physical activity including digital devices, teleconsultation, and telemonitoring the first 6 months following bariatric surgery. METHODS: This study employed a mixed methods design based on an open-label randomized controlled trial. Patients were included during the first week after bariatric surgery; then, they were randomized into 2 intervention groups: The TelePhys group received a monthly telemedicine consultation focusing on physical activity coaching, while the TeleDiet group received a monthly telemedicine consultation involving diet coaching. Data were collected using a watch pedometer and body weight scale, both of which were connected wirelessly. The primary outcome was the difference between the 2 groups in the mean numbers of steps at the first and sixth postoperative months. Weight change was also evaluated, and focus groups and interviews were conducted to enrich the results and capture perceptions of the telemedicine provided. RESULTS: Among the 90 patients (mean age 40.6, SD 10.4 years; 73/90, 81% women; 62/90, 69% gastric bypass), 70 completed the study until the sixth month (n=38 TelePhys; n=32 TeleDiet), and 18 participants agreed to be interviewed (n=8 Telephys; n=10 TeleDiet). An increase in the mean number of steps between the first and sixth months was found in both groups, but this change was significant only in the TeleDiet group (P=.01). No difference was found when comparing both intervention groups. Interviewed participants reported having appreciated the teleconsultations, as the individualized tailored counseling helped them to make better choices about behaviors that could increase their likelihood of a daily life in better health. Weight loss followed by social factors (such as social support) were identified as the main facilitators to physical activity. Family responsibilities, professional constraints as well as poor urban policies promoting physical activity, and lack of accessibility to sport infrastructure were their major barriers to postoperative lifestyle adherence. CONCLUSIONS: Our study did not show any difference in mobility recovery after bariatric surgery related to a telemedicine intervention dedicated to physical activity. The early postoperative timing for our intervention may explain the null findings. eHealth interventions aiming to change behaviors and carried out by clinicians require support from structured public health policies that tackle patients' obesogenic environment in order to be efficient in their struggle against sedentary lifestyle-related pathologies. Further research will need to focus on long-term interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT02716480, https://clinicaltrials.gov/ct2/show/NCT02716480.

Intentional R1 resection of liver metastases: A new treatment paradigm for patients with advanced colorectal cancer based on a propensity score-Matched case-control analysis.

BACKGROUND: Clinical outcomes of colorectal cancer (CRC) patients after an incomplete microscopic (R1) resection of liver metastases may not differ from those following a microscopically margin negative (R0) resection, when the latest is not feasible because of anatomic issues. We aimed at comparing the clinical outcomes of CRC patients with an intentional R1 or with a R0 resection of liver metastases. METHODS: All patients with advanced in CRC and liver metastases consecutively treated by liver resection between February 2005 and January 2019 at in the department of Digestive and Hepatobiliary Surgery of Henri Mondor University Hospital (Créteil, France) were included in this retrospective case-control study. Overall survival (OS) and event-free survival (EFS) were compared between patients who underwent an intentional (pre-operative decision) R1 resection (iR1) to those who had a R0 resection of liver metastases. To account for confounding, comparison between the 2 groups was performed after adjustment using propensity score analysis. RESULTS: Twenty-six CRC patients treated by iR1 resection of liver metastases were compared to 98 patients treated by R0 resection. Median OS reached 39 months [95% confidence interval (CI): 25-67] and 63 months [95% CI: 52-76] in the iR1 and R0 groups, respectively. After adjustment by inverse probability of treatment weighting, patients' OS and EFS did not differ significantly between the iR1 and R0 groups (hazard ratio (HR): 1.19 [0.54-2.62] and 1.67 [0.93-3.03]), respectively. CONCLUSION: iR1 resection of liver metastases in advanced CRC patients is an acceptable therapeutic strategy, when R0 resection is not feasible.

Epidemiological Study to Assess the Prevalence of Lung Cancer in patients with smoking-associated atherosclerotic cardiovascular diseases: PREVALUNG study protocol.

INTRODUCTION: Eligibility criteria definition for a lung cancer screening (LCS) is an unmet need. We hypothesised that patients with a history of atheromatous cardiovascular disease (ACVD) associated with tobacco consumption are at risk of lung cancer (LC). The main objective is to assess LC prevalence among patients with ACVD and history of tobacco consumption by using low-dose chest CT scan. Secondary objectives include the evaluation LCS in this population and the constitution of a biological biobank to stratify risk of LC. METHODS AND ANALYSIS: We are performing a monocentric 'single-centre' prospective study among patients followed up in adult cardiovascular programmes of vascular surgery, cardiology and cardiac surgery recruited from 18 November 2019 to 18 May 2021. The inclusion criteria are (1) age 45-75 years old, (2) history of ACVD and (3) history of daily tobacco consumption for 10 years prior to onset of ACVD. Exclusion criteria are symptoms of LC, existing follow-up for pulmonary nodule, fibrosis, pulmonary hypertension, resting dyspnoea and active pulmonary infectious disease. We targeted the inclusion of 500 patients. After inclusion (V0), patients are scheduled for a low-dose chest CT and blood and faeces harvesting within 7 months (V1). Each patient is scheduled for a follow-up by telephonic visits at month 3 (V2), month 6 (V3) and month 12 (V4) after V1. Each patient is followed up until 1 year after V1 (14 February 2023). We measure LC prevalence and quantify the National Lung Screening Trial and Dutch-Belgian Randomized Lung Cancer Screening Trial (NELSON) trial eligibility criteria, radiation, positive screening, false positivity, rate of localised LC diagnosis, quality of life with the Short Form 12 (SF-12) and anxiety with the Spielberger State-Trait Anxiety Inventory A and B (STAI-YA and STAI-YB, respectively), smoking cessation and onset of cardiovascular and oncological events within 1 year of follow-up. A case-control study nested in the cohort is performed to identify clinical or biological candidate biomarkers of LC. ETHICS AND DISSEMINATION: The study was approved according the French Jardé law; the study is referenced at the French 'Agence Nationale de Sécurité du Médicament et des Produits de Santé' (reference ID RCB: 2019-A00262-55) and registered on clinicaltrial.gov. The results of the study will be presented after the closure of the follow-up scheduled on 14 February 2023 and disseminated through peer-reviewed journals and national and international conferences. TRIAL REGISTRATION NUMBER: NCT03976804.

Head computed tomography for elderly patients with acute altered mental status in the emergency setting: value for decision-making and predictors of abnormal findings.

OBJECTIVE: This study evaluated the impact of head computed tomography (CT) on clinical decision-making about older adults with acute altered mental status (AMS) in the emergency department in terms of CT's diagnostic yield, emergency department length of stay, and changes in medical strategy. It also attempted to find predictors of an acute imaging abnormality. METHODS: This was a 1-year, retrospective, single-center observational study of patients aged ≥75 years who underwent noncontrast head CT because of an isolated episode of AMS. The acute positive CT findings were ischemic strokes, hemorrhages, tumors, demyelinating lesions, hydrocephalus, and intracranial infections. RESULTS: A total of 594 CTs were performed, of which 38 (6.4%) were positive. The main etiology of AMS was sepsis (29.1%). Changes in medical strategy were more common in patients with a positive CT, and the major changes were ordering additional neuro exams (odds ratio [OR], 95.3; 95% confidence interval [CI], 38.4-233.8; P<0.001), adjusting treatments (OR, 12.2; 95% CI, 5.0-29.5; P<0.001), and referral to a neurologic unit (OR, 7.3; 95% CI, 3.0-17.5; P<0.01). Three factors were significantly associated with a positive outcome: Glasgow Coma Scale <13 (OR, 8.5; 95% CI, 2.3-28.9; P<0.001), head wound (OR, 3.1; 95% CI, 1.1-8.2; P=0.025), and dehydration (OR, 0.3; 95% CI, 0.1-0.4; P=0.021). For elderly patients with a Glasgow Coma Scale ≥13 and no head wound or clinical dehydration, the probability of a positive CT was 0.02 (95% CI, 0.01-0.04). Considering only those patients, the diagnostic yield fell to 1.7%. CONCLUSION: In elderly patients, the causes of AMS are primarily extracerebral. Randomized clinical trials are needed to validate a clinical pathway for selecting patients who require emergent neuroimaging.

[Impact of Home Return Assistance Service in Heart Failure (PRADO-IC) on the one year re-hospitalisation and mortality in a heart failure hospitalized population of patients]. / Impact du programme d'aide au retour à domicile-insuffisance cardiaque (PRADO-IC) sur la mortalité et la réhospitalisation à un an dans une population de patients insuffisants cardiaques.

INTRODUCTION: Congestive heart failure (CHF) is associated with prolonged and recurrent hospitalizations; the prognosis remains poor. Since 2013, the Caisse Primaire d'Assurance Maladie (CPAM) has set up a support program PRADO-IC (support program for returning home after hospitalisation for heart failure). The aim of this study was to evaluate the impact of PRADO-IC on the heart failure readmission rate and death rate at one year. METHODS: From September 2016 to September 2018, all patients hospitalized for heart failure at Saint-Joseph Hospital were included in an observational study. The inclusion in PRADO-IC program was at physician's discretion. Two groups were compared according to the inclusion in PRADO-IC or not (T). The primary endpoints were the comparison of one-year mortality and heart failure readmission rate between the two groups. RESULTS: Six hundred and thirty-three patients were included, 262 in the PRADO-IC group and 371 in the non-PRADO group. Patients in the PRADO-IC cohort more frequently present severity criteria (age, weight, BNP level, arrhythmia, anemia, renal failure). Mortality at one year (19.5% vs 16.2%, p = 0.28) are equivalent in both groups. There were no significant differences in one-year rehospitalization rate for heart failure (HF) (35.1% in PRADO cohort vs 28% in T group, p = 0.06), the time to first hospitalization (74.5 days in PRADO vs 54.5 days in T, p = 0.55) and the length of hospitalization (6.0 days in PRADO vs 7.0 days in T, p = 0.29) between the two groups. Age, hyponatremia, anemia, cancer, HF re-hospitalization were variables linked to a risk of mortality, in a multivariable analysis. CONCLUSION: Our study shows that the PRADO-IC program concerned to the most severe patients. Despite this, the one-year mortality and the HF readmission rate are similar between the two groups.

Influence of the SARS-CoV-2 outbreak on management and prognosis of new lung cancer cases, a retrospective multicentre real-life cohort study.

INTRODUCTION: The SARS-CoV-2 pandemic has impacted the care of cancer patients. This study sought to assess the pandemic's impact on the clinical presentations and outcomes of newly referred patients with lung cancer from the Greater Paris area. METHODS: We retrospectively retrieved the electronic health records and administrative data of 11.4 million patients pertaining to Greater Paris University Hospital (AP-HP). We compared indicators for the 2018-2019 period to those of 2020 in regard to newly referred lung cancer cases. We assessed the initial tumour stage, the delay between the first multidisciplinary tumour board (MTB) and anticancer treatment initiation, and 6-month overall survival (OS) rates depending on the anticancer treatment, including surgery, palliative systemic treatment, and best supportive care (BSC). RESULT: Among 6240 patients with lung cancer, 2179 (35%) underwent tumour resection, 2069 (33%) systemic anticancer therapy, 775 (12%) BSC, whereas 1217 (20%) did not receive any treatment. During the first lockdown, the rate of new diagnoses decreased by 32% compared with that recorded in 2018-2019. Initial tumour stage, repartition of patients among treatment categories, and MTB-related delays remained unchanged. The 6-month OS rates of patients diagnosed in 2018-2019 who underwent tumour resection were 98% versus 97% (HR = 1.2; 95% CI: 0.7-2.0) for those diagnosed in 2020; the respective rates for patients who underwent systemic anticancer therapy were 78% versus 79% (HR = 1.0; 95% CI: 0.8-1.2); these rates were 20% versus 13% (HR = 1.3; 95% CI: 1.1-1.6) for those who received BSC. COVID-19 was associated with poorer OS rates (HR = 2.1; 95% CI: 1.6-3.0) for patients who received systemic anticancer therapy. CONCLUSIONS: The SARS-CoV-2 pandemic has not exerted any deleterious impact on 6-month OS of new lung cancer patients that underwent active anticancer therapy in Greater Paris University hospitals.

Circulating IL-6 but not neutrophil extracellular traps levels can predict anakinra effectiveness in patients with severe COVID-19.

Added data on circulating IL-6 levels can predict COVID-19 severity and IL1RA efficiency.