380 results on '"Bosson JL"'
Search Results
2. Risk factors for nosocomial COVID-19 in a French university hospital
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Dinh, C, Gallouche, M, Terrisse, H, Gam, K, Giner, C, Nemoz, B, Larrat, S, Giai, J, Bosson, JL, and Landelle, C
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- 2023
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3. The risk of recurrent venous thromboembolism after discontinuation of anticoagulant therapy in patients with cancer-associated thrombosis:a systematic review and meta-analysis
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Vlieg, MAMV, Nasserinejad, K, Visser, C, Bramer, WM, Ashrani, AA, Bosson, JL, Crusan, DJ, D'Alessio, A, Fluharty, ME, Gibietis, V, Hansson, PO, Hara, N, Jara-Palomares, L, Kraaijpoel, N, Mahé, I, Marshall, A, Ogino, Y, Otero, R, Versmissen, J, Klok, FA, Kruip, MHA, van der Rijt, CCD, Geijtemana, ECT, Vlieg, MAMV, Nasserinejad, K, Visser, C, Bramer, WM, Ashrani, AA, Bosson, JL, Crusan, DJ, D'Alessio, A, Fluharty, ME, Gibietis, V, Hansson, PO, Hara, N, Jara-Palomares, L, Kraaijpoel, N, Mahé, I, Marshall, A, Ogino, Y, Otero, R, Versmissen, J, Klok, FA, Kruip, MHA, van der Rijt, CCD, and Geijtemana, ECT
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Background: The optimal duration of anticoagulation in patients with active cancer and venous thromboembolism (VTE) is unknown. Current clinical guidelines advocate anticoagulant therapy for 3–6 months and to continue anticoagulant therapy for as long as the cancer is active. However, an adequate systematic review on the rate of recurrent VTE after discontinuation of anticoagulant therapy has not been performed. Methods: For this systemic review and meta-analysis, we searched Embase.com, Medline (Ovid), Web of Science, Cochrane Library, and Google Scholar, from database inception to February 16, 2023, for studies on anticoagulant therapy in patients with cancer and the recurrence of venous thromboembolism after discontinuation of this therapy. We included randomised controlled trials and cohort studies published in English that reported on patients who met the following: cancer and a first VTE, completed at least 3 months of anticoagulant therapy, were followed after discontinuation of anticoagulant therapy, and with symptomatic recurrent VTE as an outcome during follow-up. Study-level data were requested from study authors. The primary outcome was the rate of recurrent VTE after discontinuation of anticoagulant therapy. A Bayesian random-effects meta-analysis was used to estimate the rate of recurrent VTE per 100 person-years for the pooled studies at different time intervals after discontinuation of anticoagulation therapy. We also calculated the cumulative VTE recurrence rate at different time intervals. Forest plots were mapped and the results were summarized by the median and 95% credible interval (CIs). This study was registered with PROSPERO, CRD42021249060. Findings: Of 3856 studies identified in our search, 33 studies were identified for inclusion. After requesting study-level data, 14 studies involving 1922 patients with cancer-associated thrombosis were included. The pooled rate of recurrent VTE per 100 person-years after discontinuation of anticoagula
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- 2023
4. Use of a smart electrically assisted bicycle (VELIS) in the health field -Proof of concept-
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Rey-Barth, S, Eychenne, C, Rolland, C, Pinsault, N, and Bosson, JL
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- 2020
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5. A prospective study of Epstein–Barr virus load in 85 hematopoietic stem cell transplants
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Sirvent-von Bueltzingsloewen, A, Morand, P, Buisson, M, Souillet, G, Chambost, H, Bosson, JL, and Bordigoni, P
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- 2002
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6. Spa therapy for knee osteoarthritis – a fair test?
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Pittler, MH and Bosson, JL
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- 2010
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7. Effect of flapless surgery on pain experienced in implant placement using an image-guided system.
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Fortin T, Bosson JL, Isidori M, and Blanchet E
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PURPOSE: The aim of this study was to compare the pain experienced after implant placement with 2 different surgical procedures: a flapless surgical procedure using an image-guided system based on a template and an open-flap procedure. MATERIALS AND METHODS: The study population consisted of 60 patients who were referred for implant placement. One group consisted of 30 patients who were referred for the placement of 80 implants and treated with a flapless procedure. The other group consisted of 30 patients who were referred for the placement of 72 implants with a conventional procedure. Patients were selected randomly. They were requested to fill out a questionnaire using a visual analog scale (VAS) to assess the pain experienced and to indicate the number of analgesic tablets taken every postoperative day from the day of the surgery (DO) to 6 days after surgery (D6). RESULTS: The results showed a significant difference in pain measurements, with higher scores on the VAS with open-flap surgery (P < .01). Pain decreased faster with the flapless procedure (P = .05). The number of patients who felt no pain (VAS = 0) was higher with the flapless procedure (43% at DO versus 20%). With the flapless procedure, patients took fewer pain tablets (P = .03) and the number of tablets taken decreased faster (P = .04). DISCUSSION: Minimally invasive procedures may be requested by patients to reduce their anxiety and the pain experienced and thus increase the treatment acceptance rate. CONCLUSION: With the flapless procedure, patients experienced pain less intensely and for shorter periods of time. [ABSTRACT FROM AUTHOR]
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- 2006
8. Médecine vasculaire et psychiatrie : des liens à renforcer
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l’Amevah and Bosson Jl
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business.industry ,MEDLINE ,Library science ,Medicine ,Interdisciplinary communication ,Cooperative behavior ,Cardiology and Cardiovascular Medicine ,business - Published
- 2013
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9. Les pontages périmalléolaires dans les sauvetages de membre.Résultats tardifs*1Communication présentée à l’Académie nationale de chirurgie au cours de la séance du 2 février 2000
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Jean-Luc Magne, I. Farah, H. Guidicelli, C. Sessa, Chichignoud B, Bosson Jl, M Martin, and S. Penillon
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Gynecology ,medicine.medical_specialty ,business.industry ,medicine ,Surgery ,business ,Lower limb ,Surgical revascularization - Abstract
Resume But de l’etude : L’objectif de cette etude retrospective etait de rapporter les resultats tardifs des revascularisations distales des arteres du pied chez les patients ayant une ischemie critique par thrombose des arteres de jambe. Patients et methode : De janvier 1989 a novembre 1999, 50 pontages perimalleolaires ont ete realises chez 49 patients, 14 femmes et 35 hommes ayant un âge moyen de 75 ans (extremes 51 et 95 ans). Vingt-cinq patients (50 %) etaient diabetiques. L’indication de revascularisation etait une ischemie critique chronique dans tous les cas. L’axe revascularise etait l’artere tibiale posterieure retromalleolaire dans 28 cas (56 %), l’artere pedieuse dans 20 cas (40 %), et l’artere fibulaire distale dans deux cas (4 %). Le greffon utilise etait la veine saphene interne dans 38 cas (76 %), une allogreffe arterielle cryopreservee dans neuf cas (18 %), un pontage composite (veine et allogreffe) dans deux cas (4 %) et un greffon prothetique en PTFE dans un cas (2 %). Resultats : Deux patients sont decedes dans la periode postoperatoire (4 %). Une rupture septique de l’anastomose distale survenue a j+5 dans un cas a conduit a une amputation de jambe. Quatre thromboses postoperatoires ont entraine une amputation dans trois cas (6 %). Quarante trois pontages ont ete suivis chez 42 patients sur une periode moyenne de 26,7 mois (de 1 a 86 mois). Aucun patient n’a ete perdu de vue. Pendant ce suivi, 15 pontages se sont thromboses entrainant six amputations. La permeabilite etait de 72 % a un an et de 61 % a trois ans. Le taux de sauvetage de membre etait de 80 % a trois ans. La survie actuarielle etait de 53 % a trois ans (Kaplan-Meyer). Conclusion : Les pontages perimalleolaires representent une alternative a l’amputation chez les patients en ischemie critique. Le taux de sauvetage de membre a trois ans est satisfaisant dans cette population a risque, ce qui justifie la recherche systematique par une arteriographie ou par une exploration chirurgicale d’une artere distale permeable.
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- 2000
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10. Valeur de l'interrogatoire dans le depistage de la maladie de willebrand
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Vencatassin, H, primary, Polack, B, additional, Bosson, JL, additional, Jacquot, C, additional, and Payen, JF, additional
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- 1997
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11. Facteurs de risque, modalités de la prévention et prévalence des thromboses veineuses profondes en milieu médical
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Bosson, JL, primary, Calop, J, additional, Schenone, A, additional, Dodde, X, additional, Carpentier, P, additional, and Franco, A, additional
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- 1997
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12. Apport du scanner hélicoïdal pour le diagnostic de l'embolie pulmonaire en complément de la scintigraphie et de l'échodoppler
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Bosson, JL, primary, Coulomb, M, additional, Pison, C, additional, Cornet, M, additional, Carpentier, P, additional, Guignier, M, additional, and Franco, A, additional
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- 1997
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13. Hyperthermie maligne et spectroscopie RMN31P : II
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de la Garanderie, JF Payen, primary and Bosson, JL, additional
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- 1997
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14. Évaluation prospective d'un score RMN dans le dépistage de la sensibilité à l'hyperthermie maligne. Résultats préliminaires
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Payen, JF, primary, Bosson, JL, additional, and Stieglitz, P, additional
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- 1996
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15. P 052 Pseudo-tumoral presentation of a neurological Behçet's disease. Case report
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Bosson, JL., primary, Jiguet, M., additional, Carpentier, P., additional, and Franco, A., additional
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- 1993
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16. Subthalamic stimulation in Parkinson's disease: restoring the balance of motivated behaviours.
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Lhommée E, Klinger H, Thobois S, Schmitt E, Ardouin C, Bichon A, Kistner A, Fraix V, Xie J, Aya Kombo M, Chabardès S, Seigneuret E, Benabid AL, Mertens P, Polo G, Carnicella S, Quesada JL, Bosson JL, Broussolle E, and Pollak P
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- 2012
17. Corticosteroid after etomidate in critically ill patients: a randomized controlled trial.
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Payen JF, Dupuis C, Trouve-Buisson T, Vinclair M, Broux C, Bouzat P, Genty C, Monneret D, Faure P, Chabre O, and Bosson JL
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- 2012
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18. Do patients still require admission to an intensive care unit after elective craniotomy for brain surgery?
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Rhondali O, Genty C, Halle C, Gardellin M, Ollinet C, Oddoux M, Carcey J, Francony G, Fauvage B, Gay E, Bosson JL, and Payen JF
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- 2011
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19. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study).
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Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A, TeleDiab Study Group, Charpentier, Guillaume, Benhamou, Pierre-Yves, Dardari, Dured, Clergeot, Annie, Franc, Sylvia, Schaepelynck-Belicar, Pauline, and Catargi, Bogdan
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Objective: To demonstrate that Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support significantly improves HbA(1c) in poorly controlled type 1 diabetic patients.Research Design and Methods: In a six-month open-label parallel-group, multicenter study, adult patients (n = 180) with type 1 diabetes (>1 year), on a basal-bolus insulin regimen (>6 months), with HbA(1c) ≥ 8%, were randomized to usual quarterly follow-up (G1), home use of a smartphone recommending insulin doses with quarterly visits (G2), or use of the smartphone with short teleconsultations every 2 weeks but no visit until point end (G3).Results: Six-month mean HbA(1c) in G3 (8.41 ± 1.04%) was lower than in G1 (9.10 ± 1.16%; P = 0.0019). G2 displayed intermediate results (8.63 ± 1.07%). The Diabeo system gave a 0.91% (0.60; 1.21) improvement in HbA(1c) over controls and a 0.67% (0.35; 0.99) reduction when used without teleconsultation. There was no difference in the frequency of hypoglycemic episodes or in medical time spent for hospital or telephone consultations. However, patients in G1 and G2 spent nearly 5 h more than G3 patients attending hospital visits.Conclusions: The Diabeo system gives a substantial improvement to metabolic control in chronic, poorly controlled type 1 diabetic patients without requiring more medical time and at a lower overall cost for the patient than usual care. [ABSTRACT FROM AUTHOR]- Published
- 2011
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20. Pain assessment is associated with decreased duration of mechanical ventilation in the intensive care unit: a post Hoc analysis of the DOLOREA study.
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Payen JF, Bosson JL, Chanques G, Mantz J, Labarere J, and DOLOREA Investigators
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BACKGROUND: Critically ill patients frequently experience pain, but assessment rates remain below 40% in mechanically ventilated patients. Whether pain assessment affects patient outcomes is largely unknown. METHODS: As part of a prospective cohort study of mechanically ventilated patients who received analgesia on day 2 of their stay in the intensive care unit (ICU), the investigators performed propensity-adjusted score analysis to compare the duration of ventilator support and duration of ICU stay between 513 patients who were assessed for pain and 631 patients who were not assessed for pain. RESULTS: Patients assessed for pain on day 2 were more likely to receive sedation level assessment, nonopioids, and dedicated analgesia during painful procedures than patients whose pain was not assessed. They also received fewer hypnotics and lower daily doses of midazolam. Patients with pain assessment had a shorter duration of mechanical ventilation (8 vs. 11 days; P < 0.01) and a reduced duration of stay in the ICU (13 vs. 18 days; P < 0.01). In propensity-adjusted score analysis, pain assessment was associated with increased odds of weaning from the ventilator (odds ratio, 1.40; 95% confidence interval, 1.00-1.98) and of discharge from the ICU (odds ratio, 1.43; 95% confidence interval, 1.02-2.00). CONCLUSIONS: Pain assessment in mechanically ventilated patients is independently associated with a reduction in the duration of ventilator support and of duration of ICU stay. This might be related to higher concomitant rates of sedation assessments and a restricted use of hypnotic drugs when pain is assessed. [ABSTRACT FROM AUTHOR]
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- 2009
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21. D-dimer level is not a prognostic biomarker specific of pulmonary embolism.
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Kabbara R, Labarere J, Pernod G, and Bosson JL
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- 2008
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22. Nitrous oxide-oxygen mixture during care of bedsores and painful ulcers in the elderly: a randomized, crossover, open-label pilot study.
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Paris A, Horvath R, Basset P, Thiery S, Couturier P, Franco A, and Bosson JL
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Bedsore and ulcer care can often be painful and no standardized analgesic method exists today for pain relief during treatment in adults and the elderly. To evaluate the analgesic efficacy of a nitrous oxide-oxygen mixture vs. morphine during painful bedsore and ulcer care in adult and elderly patients, we conducted a randomized, crossover, multicenter, prospective, open-label, pilot study. Thirty-four inpatients, aged 53-96 years (median 84 years), were recruited in Grenoble University Hospital, Annecy Hospital and Chambéry Hospital, France, from January to June 2001. Each of the 34 patients received morphine (M), nitrous oxide-oxygen mixture (E), or morphine+nitrous oxide-oxygen mixture (ME) during painful care in a crossover protocol. Treatments were changed every two days and the study duration was six days. Analgesia was evaluated before and after each care session using a behavioral scale to evaluate pain in noncommunicating adults (ECPA), a visual analog scale (VAS), a global hetero-evaluation scale (GHES), and the DOLOPLUS-2 scale. There was a significant overall difference (P<0.01) among the three treatments. On the ECPA, the average difference after and before care was +5.2+/-8.6 (M), -0.3+/-8 (E), and -0.6+/-7.4 (ME), respectively. There was a significant difference between M and E, and M and ME (each P<0.01). No difference was found between E and ME (P=0.97). There were similar significant differences in the GHES and DOLOPLUS-2 scales (all tests P<0.01). Post hoc comparisons showed a significant difference (P<0.01) between M and E, and between M and ME without any additional effect for M+E. No differences were found with regard to safety or tolerability. This pilot study demonstrates the superiority of nitrous oxide-oxygen mixture over morphine for analgesia. This experience suggests that this mixture has ease of use, rapid effect, and limited contraindications when used during painful bedsore and ulcer care in elderly patients. Furthermore, it is well accepted by these patients and by nursing staff. © 2008 U.S. Cancer Pain Relief Committee. [ABSTRACT FROM AUTHOR]
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- 2008
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23. Updates in the perioperative and emergency management of non-vitamin K antagonist oral anticoagulants
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Sophie Susen, Anne Godier, Pierre Fontana, Andre Vincentelli, Juan V. Llau, Pierre SIE, David Faraoni, Nadia Rosencher, Dominique LASNE, Jean-Francois Schved, Groupe d'Intérêt en Hémostase Périopératoire, Albaladejo, P., Jebara, S., Steib, A., Godier, A., Pernod, G., Belisle, S., Blais, N., Bonhomme, F., Borel-Derlon, A., Borg, JY., Bosson, JL., Collet, JP., De Maistre, E., De Moerloose, P., Fontana, P., Gruel, Y., Guay, J., Huet, Y., Ickx, B., Jude, B., Lasne, D., Longrois, D., Hardy, JF., Marret, E., Mismetti, P., Motte, S., Nathan, N., Rosencher, N., Samama, CM., Jesel-Morel, L., Schved, JF., Schlumberger, S., Sie, P., Susen, S., Van der Linden, P., Vincentelli, A., Zufferey, P., Cohen, A., Pitarch, JV., Vanbelle, E., Legal, G., Laporte, S., Lecompte, TP., Ozier, Y., Nguyen, P., Roullet, S., and Faraoni, D.
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Drug ,medicine.medical_specialty ,Vitamin K ,medicine.drug_class ,Medication Therapy Management ,Pyridones ,media_common.quotation_subject ,Oral Medicine ,Hemorrhage ,Critical Care and Intensive Care Medicine ,Antithrombins ,Perioperative Care ,Viewpoint ,Pharmacokinetics ,Rivaroxaban ,Medication therapy management ,medicine ,Humans ,Intensive care medicine ,media_common ,ddc:616 ,business.industry ,Anticoagulants ,Multimodal therapy ,Perioperative ,Vitamin K antagonist ,Pyrazoles ,business ,Oral medicine ,medicine.drug ,Factor Xa Inhibitors - Abstract
Perioperative management of patients treated with the non-vitamin K antagonist oral anticoagulants is an ongoing challenge. Due to the lack of good clinical studies involving adequate monitoring and reversal therapies, management requires knowledge and understanding of pharmacokinetics, renal function, drug interactions, and evaluation of the surgical bleeding risk. Consideration of the benefit of reversal of anticoagulation is important and, for some low risk bleeding procedures, it may be in the patient’s interest to continue anticoagulation. In case of major intra-operative bleeding in patients likely to have therapeutic or supra-therapeutic levels of anticoagulation, specific reversal agents/antidotes would be of value but are currently lacking. As a consequence, a multimodal approach should be taken which includes the administration of 25 to 50 U/kg 4-factor prothrombin complex concentrates or 30 to 50 U/kg activated prothrombin complex concentrate (FEIBA®) in some life-threatening situations. Finally, further studies are needed to clarify the ideal therapeutic intervention.
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24. Very long-term risk of moderate-to-severe postthrombotic syndrome after deep vein thrombosis.
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Galanaud JP, Krebs-Drouot L, Genty-Vermorel C, Geerts W, Abdulrehman J, Blaise S, Böge G, Carpentier P, Rolland C, Sevestre-Pietri MA, Pernod G, Giai J, and Bosson JL
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- Humans, Female, Male, Middle Aged, Risk Factors, Time Factors, Aged, Risk Assessment, Venous Insufficiency complications, Adult, France epidemiology, Follow-Up Studies, Postthrombotic Syndrome etiology, Postthrombotic Syndrome diagnosis, Venous Thrombosis complications, Venous Thrombosis etiology, Venous Thrombosis diagnosis, Severity of Illness Index
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Background: Postthrombotic syndrome (PTS) refers to manifestations of chronic venous insufficiency after a deep vein thrombosis (DVT). The risk of developing moderate-to-severe PTS in the very long term is largely unknown and particularly in case of distal DVT. Furthermore, the impact of DVT vs other causes of chronic venous insufficiency on long-term manifestations of PTS is also unknown., Objectives: To assess the very long-term risk of moderate-to-severe PTS after DVT and the role that DVT plays in PTS symptoms., Methods: Patients with lower-limb DVT enrolled in the multicenter Optimisation de l'interrogatoire dans l'evaluation du risque thromboembolique veineux (OPTIMEV) study underwent a very long-term telephone follow-up. We assessed i) the proportion of moderate-to-severe PTS (assessed with the patient-reported Villalta score) according to DVT extent and ii) the population attributable fraction that DVT plays in patients' moderate-to-severe PTS manifestations., Results: Fourteen years after DVT, moderate-to-severe PTS developed in 35 of 185 patients with distal DVT (18.9%; 95% CI, 13.5%-25.3%), 11 of 47 patients with popliteal DVT (23.4%; 95% CI, 12.3%-38.0%), and 27 of 74 patients with iliofemoral DVT (36.5%; 95% CI, 25.6%-48.5%). The population attributable fraction of DVT in moderate-to-severe symptoms of PTS was 25.7% (-18.1% to 53.3%) in patients with distal DVT, 27.3% (-63.7% to 67.7%) in patients with popliteal DVT, and 43.1% (+0.7%-67.4%) in patients with iliofemoral DVT., Conclusion: In the very long term after DVT, a quarter of patients have moderate-to-severe PTS manifestations. However, the impact of the DVT on these manifestations appears nonpredominant and varies according to DVT extent. Distal DVT does not significantly increase the risk of developing moderate-to-severe PTS., Competing Interests: Declaration of competing interests There are no competing interests to disclose., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2024
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25. Patients treated with vitamin K oral anticoagulants in family practice: a new approach to bleeding risk assessment. An ancillary study by the CACAO prospective general practice cohort.
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Gaboreau Y, Frappé P, Vermorel C, Foote A, Bosson JL, and Pernod G
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Background: The ability of bleeding risk scores to predict major bleeding (MB) or clinically relevant nonmajor bleeding (CRNMB) remains a topic of contention, particularly in nonselected patients in family practice. In addition, the capacity to predict bleeding risk using simple variables has yet to be established., Objectives: The main objective was to confirm that severe anemia was the most predictive factor for the estimation of bleeding risk in patients treated with vitamin K antagonists (VKAs). Secondary objectives were to test the capacity of different bleeding scores to detect high-risk patients. Subsequently, the impact of functional decline on bleeding incidence was explored., Methods: The CACAO study was a multicenter prospective cohort study of patients who, due to nonvalvular atrial fibrillation (NVAF) and/or venous thromboembolism (VTE), had been prescribed an oral anticoagulant by their general practitioner (GP) as a prophylactic measure. Patient characteristics were collected at the time of inclusion by GPs, who then monitored them in accordance with standard practice for one year. MB and CRNMB were the main outcomes for one year. By applying this approach, a total of 13 scores were analyzed., Results: Aaemia was found to be strongly associated with MB (HR: 2.77, 95% CI: 1.2-6.36), with a particularly pronounced association observed in cases of severe anemia (HR: 12.9, 95% CI: 2.76-60.35). Twelve out of 27 MB cases were not identified by at least half of the scores. By contrast, functional decline was identified as a novel factor associated with MB (HR: 2.45, 95% CI: 1.13-5.31)., Conclusions: Preexisting anemia is a major prognostic factor associated with the occurrence of bleeding. It seems relevant to suggest that functional decline should be considered by GPs when assessing bleeding risk., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
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- 2024
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26. Rationale and design of the multicentric randomized EVAOLD trial: Evaluation of a strategy guided by imaging versus routine invasive strategy in elderly patients with ischemia.
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Barone-Rochette G, Vanzetto G, Danchin N, Steg PG, Hanon O, Charlon C, David-Tchouda S, Gavazzi G, Simon T, and Bosson JL
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Background: The management of myocardial infarction without ST segment elevation (NSTEMI) in elderly patients remains challenging, in particular the benefit/risk balance of routine revascularization remains uncertain., Study Design: EVAOLD is s a multicenter, prospective, open-label trial with 2 parallel arms in NSTEMI patients ≥80 years of age. The aim of the trial is to test whether a strategy of selective invasive management guided by ischemia stress imaging (IMG group) will be noninferior in preventing Major Adverse Cardiac and Cerebrovascular Events (MACCE, ie all-cause death, nonfatal myocardial infarction, nonfatal stroke) rates at 1 year compared with a routine invasive strategy (INV Group). Geriatric assessment and cost- effectiveness analysis will also be performed. A sample size of 1,756 patients (assuming a 10% rate of patients lost to follow-up) is needed to show noninferiority with 80% power. Noninferiority based on exponential survival curves will be declared if the upper limit of the 1-sided 97.5% confidence interval for the hazard ratio is lower than 1.24, corresponding to a noninferiority margin of 7% in absolute difference and an event rate of 40% in the INV group., Conclusion: EVAOLD is a nationwide, prospective, open-label trial testing the noninferiority of a strategy of selective invasive management guided by ischemia stress imaging versus routine invasive strategy in elderly NSTEMI patients., Clinicaltrials: gov Identifier: NCT03289728., Competing Interests: Declaration of competing interest GBR received research grants from the company MSD, Pfizer, Abbott vascular, and consulting fees from the companies Bayer, Abbott Vascular, NovoNordisk, Sanofi, General Electric, Medis imaging, and Amgen., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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27. [Construction of a methodology for clinical evaluation of medical devices using simulation tools and illustration through three studies].
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Salomez-Ihl C, Chapuis C, Albaladejo P, Picard M, Baron A, Garcia PP, Evain JN, Giai J, Barbado M, Moreau-Gaudry A, Bosson JL, Picard J, and Bedouch P
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Introduction: European regulations have recently moved towards more stringent requirements for demonstrating the safety and performance of medical devices (MDs)., Objective: To apply an innovative testing method using medical simulation to the evaluation of three medical devices at different stages of their life cycle., Method: The methodology for evaluating DMs using simulation is based on seven stages: definition of the context, training, construction of a scenario to test the DM, validation of the scenario, realization of the scenario, evaluation of the scenario by the players and validation and exploitation of the results., Results: Our evaluation methodology enabled us to assess three DMs at different stages of their development: a respiratory protection device at the initial stage (prototype definition), a respiratory protection mask (prototype optimization) and bottle adapters (post-marketing)., Conclusion: Simulation is a valuable tool for evaluating DM. The proposed methodology enables it to be used and adapted to different contexts. It responds to the specificities of clinical evaluation of this class of products, and helps to better anticipate certain risks., (Copyright © 2024 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)
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- 2024
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28. Prediction of neurocritical care intensity through automated infrared pupillometry and transcranial doppler in blunt traumatic brain injury: the NOPE study.
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Banco P, Taccone FS, Sourd D, Privitera C, Bosson JL, Teixeira TL, Adolle A, Payen JF, Bouzat P, and Gauss T
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- Humans, Pilot Projects, Male, Female, Adult, Middle Aged, Aged, Injury Severity Score, Brain Injuries, Traumatic diagnostic imaging, Brain Injuries, Traumatic physiopathology, Ultrasonography, Doppler, Transcranial methods, Glasgow Coma Scale, Critical Care methods
- Abstract
Purpose: This pilot study aimed to determine the capacity of automated infrared pupillometry (AIP) alone and in combination with transcranial doppler (TCD) on admission to rule out need for intense neuroAQ2 critical care (INCC) in severe traumatic brain injury (TBI)., Methods: In this observational pilot study clinicians performed AIP and TCD measurements on admission in blunt TBI patients with a Glasgow Coma Score (GCS) < 9 and/or motor score < 6. A Neurological Pupil index (NPi) < 3, Pulsatility Index (PI) > 1,4 or diastolic blood flow velocity (dV) of < 20 cm/s were used to rule out the need for INCC (exceeding the tier 0 Seattle Consensus Conference). The primary outcome was the negative likelihood ratio (nLR) of NPi < 3 alone or in combination with TCD to detect need for INCC., Results: A total of 69 TBI patients were included from May 2019 to September 2020. Of those, 52/69 (75%) median age was 45 [28-67], median prehospital GCS of 7 [5-8], median Injury Severity Scale of 13.0 [6.5-25.5], median Marshall Score of 4 [3-5], the median Glasgow Outcome Scale at discharge was 3 [1-5]. NPi < 3 was an independent predictor of INCC. NPi demonstrated a nLR of 0,6 (95%CI 0.4-0.9; AUROC, 0.65, 95% CI 0.51-0.79), a combination of NPi and TCD showed a nLR of 0.6 (95% CI 0.4-1.0; AUROC 0.67 95% CI 0.52-0.83) to predict INCC., Conclusion: This pilot study suggests a possible useful contribution of NPi to determine the need for INCC in severe blunt TBI patients on admission., (© 2024. The Author(s).)
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- 2024
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29. Adolescent- and adult-onset neuroblastic tumor: A retrospective multicenter observational study of patients diagnosed in France between 2000 and 2020.
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Magnier O, Schiff I, Cristante J, Chabre O, Veloso M, Bosson JL, Defachelles AS, Cordero C, Cao CD, Thebaud E, Drui D, Berlanga P, Dumont B, Chastagner P, Tandonnet J, Gambart M, Jannier S, Pluchart C, Andry L, Laithier V, Klein S, Carausu L, Akbaraly T, Probert J, Habert-Dantigny R, and Plantaz D
- Subjects
- Humans, Retrospective Studies, Adolescent, Male, Female, Adult, Young Adult, France epidemiology, Survival Rate, Middle Aged, Adrenal Gland Neoplasms therapy, Adrenal Gland Neoplasms epidemiology, Adrenal Gland Neoplasms pathology, Adrenal Gland Neoplasms mortality, Adrenal Gland Neoplasms diagnosis, Pheochromocytoma therapy, Pheochromocytoma epidemiology, Pheochromocytoma pathology, Pheochromocytoma mortality, Follow-Up Studies, Combined Modality Therapy, Prognosis, Age of Onset, Ganglioneuroblastoma therapy, Ganglioneuroblastoma pathology, Ganglioneuroblastoma epidemiology, Ganglioneuroblastoma mortality, Aged, Neuroblastoma therapy, Neuroblastoma epidemiology, Neuroblastoma pathology, Neuroblastoma mortality, Neuroblastoma diagnosis
- Abstract
Background: Adult- and adolescent-onset neuroblastomas are rare, with no established therapy. In addition, rare pheochromocytomas may harbor neuroblastic components. This study was designed to collect epidemiological, diagnostic and therapeutic data in order to better define the characteristics of malignant peripheral neuroblastic tumors (MPNT) and composite pheochromocytomas (CP) with MPNT., Procedure: Fifty-nine adults and adolescents (aged over 15 years) diagnosed with a peripheral or composite neuroblastic tumor, who were treated in one of 17 institutions between 2000 and 2020, were retrospectively studied., Results: Eighteen patients with neuroblastoma (NB) or ganglioneuroblastoma (GNB) had locoregional disease, and 28 patients had metastatic stage 4 NB. Among the 13 patients with CP, 12 had locoregional disease. Fifty-eight percent of the population were adolescents and young adults under 24 years of age. The probability of 5-year event-free survival (EFS) was 40% (confidence interval: 27%-53%)., Conclusions: Outcomes were better for patients with localized tumor than for patients with metastases. For patients with localized tumor, in terms of survival, surgical treatment was the best therapeutic option. Multimodal treatment with chemotherapy, surgery, radiotherapy, and immunotherapy-based maintenance allowed long-term survival for some patients. Adolescent- and adult-onset neuroblastoma appeared to have specific characteristics associated with poorer outcomes compared to pediatric neuroblastoma. Nevertheless, complete disease control improved survival. The presence of a neuroblastic component in pheochromocytoma should be considered when making therapeutic management decisions. The development of specific tools/resources (Tumor Referral Board, Registry, biology, and trials with new agents or strategies) may help to improve outcomes for patients., (© 2024 The Authors. Pediatric Blood & Cancer published by Wiley Periodicals LLC.)
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- 2024
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30. Molecular Hydrogen for Outpatients with COVID-19 (Hydro-COVID): A Phase 3 Randomised, Triple-Blinded, Pragmatic, Placebo-Controlled, Multicentre Trial.
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Gaboreau Y, Milovančev A, Rolland C, Eychenne C, Alcaraz JP, Ihl C, Mazet R, Boucher F, Vermorel C, Ostojic SM, Borel JC, Cinquin P, and Bosson JL
- Abstract
Background . Due to its antioxidant, anti-inflammatory, anti-apoptosis, and anti-fatigue properties, molecular hydrogen (H
2 ) is potentially a novel therapeutic nutrient for patients with coronavirus acute disease 2019 (COVID-19). We determined the efficacy and safety profile of hydrogen-rich water (HRW) to reduce the risk of COVID-19 progression. Methods : We also conducted a phase 3, triple-blind, randomised, placebo-controlled trial to evaluate treatment with HRW initiated within 5 days after the onset of signs or symptoms in primary care patients with mild-to-moderate, laboratory-confirmed COVID-19. Participants were randomised to receive HRW or placebo twice daily for 21 days. The incidence of clinical worsening and adverse events were the primary endpoints. Results : A total of 675 participants were followed up to day 30. HRW was not superior to placebo in preventing clinical worsening at day 14: in H2 group, 46.1% in the H2 group, 43.5% in the placebo group, hazard ratio 1.09, 90% confidence interval [0.90-1.31]. One death was reported at day 30 in the H2 group and two in the placebo group at day 30. Adverse events were reported in 91 (27%) and 89 (26.2%) participants, respectively. Conclusions : HRW taken twice daily from the onset of COVID-19 symptoms for 21 days did not reduce clinical worsening.- Published
- 2024
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31. Staphylococcus aureus screening and preoperative decolonisation with Mupirocin and Chlorhexidine to reduce the risk of surgical site infections in orthopaedic surgery: a pre-post study.
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Portais A, Gallouche M, Pavese P, Caspar Y, Bosson JL, Astagneau P, Pailhé R, Tonetti J, Duval BR, and Landelle C
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- Humans, Retrospective Studies, Female, Male, Middle Aged, Aged, Risk Factors, Preoperative Care, Carrier State drug therapy, Mass Screening, France, Mupirocin administration & dosage, Mupirocin therapeutic use, Chlorhexidine therapeutic use, Chlorhexidine administration & dosage, Surgical Wound Infection prevention & control, Staphylococcal Infections prevention & control, Staphylococcus aureus drug effects, Orthopedic Procedures adverse effects, Anti-Bacterial Agents therapeutic use, Anti-Bacterial Agents administration & dosage
- Abstract
Background: Nasal carriage of Staphylococcus aureus is a risk factor for surgical site infections (SSI) in orthopaedic surgery. The efficacy of decolonisation for S. aureus on reducing the risk of SSI is uncertain in this speciality. The objective was to evaluate the impact of a nasal screening strategy of S. aureus and targeted decolonisation on the risk of S. aureus SSI., Methods: A retrospective pre-post and here-elsewhere study was conducted between January 2014 and June 2020 in 2 adult orthopaedic surgical sites (North and South) of a French university hospital. Decolonisation with Mupirocin and Chlorhexidine was conducted in S. aureus carriers starting February 2017 in the South site (intervention group). Scheduled surgical procedures for hip, knee arthroplasties, and osteosyntheses were included and monitored for one year. The rates of S. aureus SSI in the intervention group were compared to a historical control group (South site) and a North control group. The risk factors for S. aureus SSI were analysed by logistic regression., Results: A total of 5,348 surgical procedures was included, 100 SSI of which 30 monomicrobial S. aureus SSI were identified. The preoperative screening result was available for 60% (1,382/2,305) of the intervention group patients. Among these screenings, 25.3% (349/1,382) were positive for S. aureus and the efficacy of the decolonisation was 91.6% (98/107). The rate of S. aureus SSI in the intervention group (0.3%, 7/2,305) was not significantly different from the historical control group (0.5%, 9/1926) but differed significantly from the North control group (1.3%, 14/1,117). After adjustment, the risk factors of S. aureus SSI occurrence were the body mass index (ORa
per unit , 1.05; 95%CI, 1.0-1.1), the Charlson comorbidity index (ORaper point , 1.34; 95%CI, 1.0-1.8) and operative time (ORaper minute , 1.01; 95%CI, 1.00-1.02). Having benefited from S. aureus screening/decolonisation was a protective factor (ORa, 0.24; 95%CI, 0.08-0.73)., Conclusions: Despite the low number of SSI, nasal screening and targeted decolonisation of S. aureus were associated with a reduction in S. aureus SSI., (© 2024. The Author(s).)- Published
- 2024
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32. Suprapubic versus transurethral catheterization for bladder drainage in male rectal cancer surgery (GRECCAR10), a randomized clinical trial.
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Trilling B, Tidadini F, Lakkis Z, Jafari M, Germain A, Rullier E, Lefevre J, Tuech JJ, Kartheuser A, Leonard D, Prudhomme M, Piessen G, Regimbeau JM, Cotte E, Duprez D, Badic B, Panis Y, Rivoire M, Meunier B, Portier G, Bosson JL, Vilotitch A, Foote A, Caspar Y, Rouanet P, and Faucheron JL
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- Humans, Male, Middle Aged, Aged, Urinary Bladder surgery, Belgium, Rectal Neoplasms surgery, Urinary Catheterization methods, Urinary Catheterization adverse effects, Drainage methods, Urinary Tract Infections etiology, Urinary Tract Infections prevention & control, Urinary Tract Infections epidemiology, Postoperative Complications etiology, Postoperative Complications epidemiology
- Abstract
Background: Bladder drainage is systematically used in rectal cancer surgery; however, the optimal type of drainage, transurethral catheterization (TUC) or suprapubic catheterization (SPC), is still controversial. The aim was to compare the rates of urinary tract infection on the fourth postoperative day (POD4) between TUC and SPC, after rectal cancer surgery regardless of the day of removal of the urinary drain., Methods: This randomized clinical trial in 19 expert colorectal surgery centers in France and Belgium was performed between October 2016 and October 2019 and included 240 men (with normal or subnormal voiding function) undergoing mesorectal excision with low anastomosis for rectal cancer. Patients were followed at postoperative days 4, 30, and 180., Results: In 208 patients (median age 66 years [IQR 58-71]) randomized to TUC (n = 99) or SPC (n = 109), the rate of urinary infection at POD4 was not significantly different whatever the type of drainage (11/99 (11.1%) vs. 8/109 (7.3%), 95% CI, - 4.2% to 11.7%; p = 0.35). There was significantly more pyuria in the TUC group (79/99 (79.0%) vs. (60/109 (60.9%), 95% CI, 5.7-30.0%; p = 0.004). No difference in bacteriuria was observed between the groups. Patients in the TUC group had a shorter duration of catheterization (median 4 [2-5] vs. 4 [3-5] days; p = 0.002). Drainage complications were more frequent in the SPC group at all followup visits., Conclusions: TUC should be preferred over SPC in male patients undergoing surgery for mid and/or lower rectal cancers, owing to the lower rate of complications and shorter duration of catheterization., Trial Registration: ClinicalTrials.gov identifier NCT02922647., (© 2024. Springer Nature Switzerland AG.)
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- 2024
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33. Oral anticoagulant safety in family practice: prognostic accuracy of Bleeding Risk Scores (from the CACAO study).
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Gaboreau Y, Frappé P, Vermorel C, Foote A, Bosson JL, and Pernod G
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- Humans, Prognosis, Prospective Studies, Family Practice, Hemorrhage chemically induced, Anticoagulants adverse effects, Risk Factors, Cacao, Atrial Fibrillation complications, Atrial Fibrillation drug therapy, Venous Thromboembolism chemically induced, Venous Thromboembolism drug therapy
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Background: To assess bleeding risk of patients treated by oral anticoagulants, several scores have been constructed to assist physicians in the evaluation of the benefit risk. Most of these scores lack a strong enough level of evidence for use in family practice., Objective: To assess the predictive prognostic accuracy of 13 scores designed to assess the risk of major or clinically relevant non-major (CRNM) bleeding events in a French ambulatory cohort receiving Vitamin-K antagonists (VKA) or direct oral anticoagulants (DOACs) in a family practice setting., Methods: CACAO (Comparison of Accidents and their Circumstances with Oral Anticoagulants) was a multicentre prospective cohort of ambulatory patients prescribed oral anticoagulants. We selected patients from the cohort who had received an oral anticoagulant because of non-valvular atrial fibrillation (NVAF) and/or venous thromboembolism (VTE) to be followed during one year by their GP. The following scores were calculated: mOBRI, Shireman, Kuijer, HEMORR2HAGES, ATRIA, HAS-BLED, RIETE, VTE-BLEED, ACCP score, Rutherford, ABH-Score, GARFIEL-AF, and Outcomes Registry for Better InformedTreatment of Atrial Fibrillation (ORBIT). Prognostic accuracy was assessed by using receiver operating characteristic curves and c-statistics., Results: During 1 year, 3,082 patients were followed. All of the scores demonstrated only poor to moderate ability to predict major bleeding or CRNM in NVAF patients on DOACs (c-statistic: 0.41-0.66 and 0.45-0.58), respectively. The results were only slightly better for patients prescribed VKA (0.47-0.66 and 0.5-0.55, respectively) in this indication. The results were also unsatisfactory in patients treated for VTE., Conclusion: None of the scores demonstrated satisfactory discriminatory ability when used in family practice., Clinical Trial Registration: ClinicalTrials.gov NCT02376777., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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34. Early prediction of in-hospital mortality utilizing multivariate predictive modelling of electronic medical records and socio-determinants of health of the first day of hospitalization.
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Stoessel D, Fa R, Artemova S, von Schenck U, Nowparast Rostami H, Madiot PE, Landelle C, Olive F, Foote A, Moreau-Gaudry A, and Bosson JL
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- Adult, Humans, Hospital Mortality, Logistic Models, Hospitals, University, Retrospective Studies, Electronic Health Records, Hospitalization
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Background: In France an average of 4% of hospitalized patients die during their hospital stay. To aid medical decision making and the attribution of resources, within a few days of admission the identification of patients at high risk of dying in hospital is essential., Methods: We used de-identified routine patient data available in the first 2 days of hospitalization in a French University Hospital (between 2016 and 2018) to build models predicting in-hospital mortality (at ≥ 2 and ≤ 30 days after admission). We tested nine different machine learning algorithms with repeated 10-fold cross-validation. Models were trained with 283 variables including age, sex, socio-determinants of health, laboratory test results, procedures (Classification of Medical Acts), medications (Anatomical Therapeutic Chemical code), hospital department/unit and home address (urban, rural etc.). The models were evaluated using various performance metrics. The dataset contained 123,729 admissions, of which the outcome for 3542 was all-cause in-hospital mortality and 120,187 admissions (no death reported within 30 days) were controls., Results: The support vector machine, logistic regression and Xgboost algorithms demonstrated high discrimination with a balanced accuracy of 0.81 (95%CI 0.80-0.82), 0.82 (95%CI 0.80-0.83) and 0.83 (95%CI 0.80-0.83) and AUC of 0.90 (95%CI 0.88-0.91), 0.90 (95%CI 0.89-0.91) and 0.90 (95%CI 0.89-0.91) respectively. The most predictive variables for in-hospital mortality in all three models were older age (greater risk), and admission with a confirmed appointment (reduced risk)., Conclusion: We propose three highly discriminating machine-learning models that could improve clinical and organizational decision making for adult patients at hospital admission., (© 2023. The Author(s).)
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- 2023
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35. Intracranial pressure monitoring with and without brain tissue oxygen pressure monitoring for severe traumatic brain injury in France (OXY-TC): an open-label, randomised controlled superiority trial.
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Payen JF, Launey Y, Chabanne R, Gay S, Francony G, Gergele L, Vega E, Montcriol A, Couret D, Cottenceau V, Pili-Floury S, Gakuba C, Hammad E, Audibert G, Pottecher J, Dahyot-Fizelier C, Abdennour L, Gauss T, Richard M, Vilotitch A, Bosson JL, and Bouzat P
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- Humans, Intracranial Pressure, Brain, France, Hematoma, Death, Oxygen, Brain Injuries, Traumatic therapy
- Abstract
Background: Optimisation of brain oxygenation might improve neurological outcome after traumatic brain injury. The OXY-TC trial explored the superiority of a strategy combining intracranial pressure and brain tissue oxygen pressure (PbtO
2 ) monitoring over a strategy of intracranial pressure monitoring only to reduce the proportion of patients with poor neurological outcome at 6 months., Methods: We did an open-label, randomised controlled superiority trial at 25 French tertiary referral centres. Within 16 h of brain injury, patients with severe traumatic brain injury (aged 18-75 years) were randomly assigned via a website to be managed during the first 5 days of admission to the intensive care unit either by intracranial pressure monitoring only or by both intracranial pressure and PbtO2 monitoring. Randomisation was stratified by age and centre. The study was open label due to the visibility of the intervention, but the statisticians and outcome assessors were masked to group allocation. The therapeutic objectives were to maintain intracranial pressure of 20 mm Hg or lower, and to keep PbtO2 (for those in the dual-monitoring group) above 20 mm Hg, at all times. The primary outcome was the proportion of patients with an extended Glasgow Outcome Scale (GOSE) score of 1-4 (death to upper severe disability) at 6 months after injury. The primary analysis was reported in the modified intention-to-treat population, which comprised all randomly assigned patients except those who withdrew consent or had protocol violations. This trial is registered with ClinicalTrials.gov, NCT02754063, and is completed., Findings: Between June 15, 2016, and April 17, 2021, 318 patients were randomly assigned to receive either intracranial pressure monitoring only (n=160) or both intracranial pressure and PbtO2 monitoring (n=158). 27 individuals with protocol violations were not included in the modified intention-to-treat analysis. Thus, the primary outcome was analysed for 144 patients in the intracranial pressure only group and 147 patients in the intracranial pressure and PbtO2 group. Compared with intracranial pressure monitoring only, intracranial pressure and PbtO2 monitoring did not reduce the proportion of patients with GOSE score 1-4 (51% [95% CI 43-60] in the intracranial pressure monitoring only group vs 52% [43-60] in the intracranial pressure and PbtO2 monitoring group; odds ratio 1·0 [95% CI 0·6-1·7]; p=0·95). Two (1%) of 144 participants in the intracranial pressure only group and 12 (8%) of 147 participants in the intracranial pressure and PbtO2 group had catheter dysfunction (p=0.011). Six patients (4%) in the intracranial pressure and PbtO2 group had an intracrebral haematoma related to the catheter, compared with none in the intracranial pressure only group (p=0.030). No significant difference in deaths was found between the two groups at 12 months after injury. At 12 months, 33 deaths had occurred in the intracranial pressure group: 25 (76%) were attributable to the brain trauma, six (18%) were end-of-life decisions, and two (6%) due to sepsis. 34 deaths had occured in the intracranial pressure and PbtO2 group at 12 months: 25 (74%) were attributable to the brain trauma, six (18%) were end-of-life decisions, one (3%) due to pulmonary embolism, one (3%) due to haemorrhagic shock, and one (3%) due to cardiac arrest., Interpretation: After severe non-penetrating traumatic brain injury, intracranial pressure and PbtO2 monitoring did not reduce the proportion of patients with poor neurological outcome at 6 months. Technical failures related to intracerebral catheter and intracerebral haematoma were more frequent in the intracranial pressure and PbtO2 group. Further research is needed to assess whether a targeted approach to multimodal brain monitoring could be useful in subgroups of patients with severe traumatic brain injury-eg, those with high intracranial pressure on admission., Funding: The French National Program for Clinical Research, La Fondation des Gueules Cassées, and Integra Lifesciences., Competing Interests: Declaration of interests J-FP reports honoraria from Integra Lifesciences, Sedana Medical, and IDD CDM-Lavoisier. PB and TG report honoraria from Laboratoire du Biomédicament Français. RC reports consulting fees from Roche Diagnostics and Sophysa, and receives support for attending meetings from UCB. LG reports grants from La Fondation des Gueules Cassées, Ramsay Santé, and Sophysa; consulting fees from Sophysa; honoraria for lectures from Sophysa and Fresenius; support for attending meeting from Pfizer and Sophysa; and receipt of equipment from Atys Medical. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)- Published
- 2023
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36. Assessment of the Objective Effect of Virtual Reality for Preoperative Anxiety in Interventional Cardiology.
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Larsson CE, Cabassut V, Peretout P, Marliere S, Vautrin E, Piliero N, Salvat M, Riou L, Vanzetto G, Vilotitch A, Bosson JL, and Barone-Rochette G
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- Humans, Anxiety, Anxiety Disorders, Cardiology, Coronary Artery Disease, Virtual Reality
- Abstract
The management of anxiety because of upcoming invasive coronary angiography (ICA) remains suboptimal. Previously published studies investigating the potential of virtual reality (VR) for the reduction of anxiety in ICA procedures used a subjective evaluation method. The purpose of this study was to determine whether the use of a VR program before ICA objectively decreases anxiety as assessed by the SD of normal to normal (SDNN). Lower SDNN is associated with worse anxiety. A total of 156 patients referred for ICA after a positive noninvasive test for coronary disease were included in the present randomized study. The interventional group benefited from the use of a VR mask in the transfer room before ICA, whereas the control group underwent the procedure as usual. In both groups, SDNN was measured before ICA. No statistical difference in SDNN was observed between the VR and control groups (45.5 ± 17.8 vs 50.6 ± 19.5, p = 0.12). The preoperative use of a VR mask for anxiolytic purposes in the setting of ICA did not result in a decrease in anxiety., Competing Interests: Declaration of Competing Interest Dr. Barone-Rochette has received research grants from Merck Sharp and Dohme, Abbott vascular, Pfizer, and consulting fees from Bayer, General Electric, Boehringer Ingelheim, MEDIS medical imaging, Abbott vascular, Novo Nordisk, Sanofi, Novartis, and Amgen. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2023
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37. Evidence-Based Pharmaceutical Care in Community Pharmacies: A Survey of 595 French Pharmacists.
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Bosson L, Veyer F, Bardet JD, Vermorel C, Foote A, Allenet B, and Bosson JL
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We assessed the use of evidence-based practice (EBP) among pharmacists working in community pharmacies in France and the factors linked to this practice. During 3 months in 2018, an online survey was sent to over 7000 active pharmacists and posted on pharmacists' social media sites. In total, 595 pharmacists completed the questionnaire. The responders were on average younger than the general population of community pharmacists. The 40-item questionnaire described four fictional clinical cases reflecting typical situations (conventional medicine and complementary and alternative medicine) encountered daily by community pharmacists. Multiple-choice responses were proposed and scored according to whether they reflected EBP. A high total score indicated behaviour in line with EBP. We observed 344/595 participants with a positive EBP score (57.8% [53.7-61.8%]). Univariate and multivariate analyses were used to evaluate factors that might explain adherence to EPB (the pharmacy's characteristics, the pharmacist's status, the mode of continuing education and sources of information). The majority relied on pharmaceutical industry and other biased and/or non-evidence-based sources, particularly concerning information on homeopathic products. The consultation of independent reviews, health agency recommendations and peer-reviewed scientific journals was associated with evidence-based decisions. In contrast, reliance on pharmaceutical industry documents, personal experience and informal handbooks was linked to lower EBP scores. The level of EBP use by French community pharmacists needs to be improved to ensure that good-quality, science-based advice is given to customers.
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- 2023
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38. The risk of recurrent venous thromboembolism after discontinuation of anticoagulant therapy in patients with cancer-associated thrombosis: a systematic review and meta-analysis.
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van Hylckama Vlieg MAM, Nasserinejad K, Visser C, Bramer WM, Ashrani AA, Bosson JL, Crusan DJ, D'Alessio A, Fluharty ME, Ģībietis V, Hansson PO, Hara N, Jara-Palomares L, Kraaijpoel N, Mahé I, Marshall A, Ogino Y, Otero R, Versmissen J, Klok FA, Kruip MJHA, van der Rijt CCD, and Geijteman ECT
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Background: The optimal duration of anticoagulation in patients with active cancer and venous thromboembolism (VTE) is unknown. Current clinical guidelines advocate anticoagulant therapy for 3-6 months and to continue anticoagulant therapy for as long as the cancer is active. However, an adequate systematic review on the rate of recurrent VTE after discontinuation of anticoagulant therapy has not been performed., Methods: For this systemic review and meta-analysis, we searched Embase.com, Medline (Ovid), Web of Science, Cochrane Library, and Google Scholar, from database inception to February 16, 2023, for studies on anticoagulant therapy in patients with cancer and the recurrence of venous thromboembolism after discontinuation of this therapy. We included randomised controlled trials and cohort studies published in English that reported on patients who met the following: cancer and a first VTE, completed at least 3 months of anticoagulant therapy, were followed after discontinuation of anticoagulant therapy, and with symptomatic recurrent VTE as an outcome during follow-up. Study-level data were requested from study authors. The primary outcome was the rate of recurrent VTE after discontinuation of anticoagulant therapy. A Bayesian random-effects meta-analysis was used to estimate the rate of recurrent VTE per 100 person-years for the pooled studies at different time intervals after discontinuation of anticoagulation therapy. We also calculated the cumulative VTE recurrence rate at different time intervals. Forest plots were mapped and the results were summarized by the median and 95% credible interval (CIs). This study was registered with PROSPERO, CRD42021249060., Findings: Of 3856 studies identified in our search, 33 studies were identified for inclusion. After requesting study-level data, 14 studies involving 1922 patients with cancer-associated thrombosis were included. The pooled rate of recurrent VTE per 100 person-years after discontinuation of anticoagulant therapy was 14.6 events (95% credible interval 6.5-22.8) in the first three months, decreasing to 1.1 events (95% CI 0.3-2.1) in year 2-3, and 2.2 events (95% CI 0.0-4.4) in year 3-5 after discontinuation of anticoagulant therapy. The cumulative VTE recurrence rate was 28.3% (95% CI 15.6-39.6%) at 1 year; 31.1% (95% CI 16.5-43.8%) at 2 years; 31.9% (95% CI 16.8-45.0%) at 3 years; and 35.0% (95% CI 16.8-47.4%) at 5 years after discontinuation of anticoagulant therapy., Interpretation: This meta-analysis demonstrates a high rate of recurrent VTE over time after discontinuation of anticoagulant therapy in patients with cancer-associated thrombosis. Our results support the current clinical guidelines to continue anticoagulant therapy in patients with active cancer., Funding: Erasmus MC., Competing Interests: All authors have completed the ICMJE uniform disclosure form. Luis Jara-Palomares: has received support for the present manuscript from MSD; grants from Leo Pharma; honoraria from Actelion Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Leo Pharma, MSD, Pfizer, ROVI, and Bristol-Myers Squibb. Isabelle Mahé: has received grants from BMS Pfizer; honoraria from BMS Pfizer, Leo Pharma, and Sanofi; support for attending meetings/travel from BMS Pfizer and Leo Pharma. Andrea Marshall: my institution received unrestricted educational grant from Bayer AG for the select-D trial. Remedios Otero Candelera: LEO-PHARMA was partially involved in the financial support to Hispalis Study without interfering in the intellectual conception, design and data analysis; received financial support for attendance to congresses and scientific meetings, payment to conferences or advisory board from BAYER HISPANIA, MSD, LEO-PHARMA and ROV; participated on a Data Safety Monitoring Board or Advisory Board. Frederikus Klok: has received research support from Bayer, Bristol-Myers Squibb, Actelion, Boston Scientific, Leo Pharma, PharmX, The Netherlands Organisation for Health Research and Development, The Dutch Thrombosis Association, The Dutch Heart Foundation and the Horizon Europe program, all outside this work and paid to his institution. Marieke Kruip: has received an unrestricted research grant from Sobi; research grants from Netherlands Thrombosis Foundation and the Netherlands Organization for Health Research and Development; speakers fee from Sobi, Roche, and BMS; all grants and fees are paid to her institution (Erasmus MC). Carin van der Rijt: has received a payment to the institution from the Netherlands Organization for Health Research and Development for a project on deprescription of medication at the end of life; is Chair of the Dutch Association for Professional Palliative Care (unpaid); is member of the Supervisory Board of the Foundation Roparun (attendance fee is paid). Eric Geijteman: has received an internal grant from the Erasmus MC (50.000 euro). This is a payment to finance this study (together with an interview- and questionnaire study about the perspectives of patient, caregivers and healthcare professionals on anticoagulation therapy). All other authors report no conflict of interest., (© 2023 The Author(s).)
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- 2023
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39. Cohort profile for development of machine learning models to predict healthcare-related adverse events (Demeter): clinical objectives, data requirements for modelling and overview of data set for 2016-2018.
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Artemova S, von Schenck U, Fa R, Stoessel D, Nowparast Rostami H, Madiot PE, Januel JM, Pagonis D, Landelle C, Gallouche M, Cancé C, Olive F, Moreau-Gaudry A, Prieur S, and Bosson JL
- Subjects
- Cohort Studies, Humans, Male, Female, Risk Assessment, Datasets as Topic, Machine Learning, Computer Simulation, Length of Stay, Iatrogenic Disease
- Abstract
Purpose: In-hospital health-related adverse events (HAEs) are a major concern for hospitals worldwide. In high-income countries, approximately 1 in 10 patients experience HAEs associated with their hospital stay. Estimating the risk of an HAE at the individual patient level as accurately as possible is one of the first steps towards improving patient outcomes. Risk assessment can enable healthcare providers to target resources to patients in greatest need through adaptations in processes and procedures. Electronic health data facilitates the application of machine-learning methods for risk analysis. We aim, first to reveal correlations between HAE occurrence and patients' characteristics and/or the procedures they undergo during their hospitalisation, and second, to build models that allow the early identification of patients at an elevated risk of HAE., Participants: 143 865 adult patients hospitalised at Grenoble Alpes University Hospital (France) between 1 January 2016 and 31 December 2018., Findings to Date: In this set-up phase of the project, we describe the preconditions for big data analysis using machine-learning methods. We present an overview of the retrospective de-identified multisource data for a 2-year period extracted from the hospital's Clinical Data Warehouse, along with social determinants of health data from the National Institute of Statistics and Economic Studies, to be used in machine learning (artificial intelligence) training and validation. No supplementary information or evaluation on the part of medical staff will be required by the information system for risk assessment., Future Plans: We are using this data set to develop predictive models for several general HAEs including secondary intensive care admission, prolonged hospital stay, 7-day and 30-day re-hospitalisation, nosocomial bacterial infection, hospital-acquired venous thromboembolism, and in-hospital mortality., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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40. A comparative study of two automated solutions for cross-sectional skeletal muscle measurement from abdominal computed tomography images.
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Charrière K, Boulouard Q, Artemova S, Vilotitch A, Ferretti GR, Bosson JL, Moreau-Gaudry A, Giai J, Fontaine E, and Bétry C
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- Male, Female, Humans, Retrospective Studies, Reproducibility of Results, Cross-Sectional Studies, Muscle, Skeletal diagnostic imaging, Artificial Intelligence, Tomography, X-Ray Computed methods
- Abstract
Background: Measurement of cross-sectional muscle area (CSMA) at the mid third lumbar vertebra (L3) level from computed tomography (CT) images is becoming one of the reference methods for sarcopenia diagnosis. However, manual skeletal muscle segmentation is tedious and is thus restricted to research. Automated solutions are required for use in clinical practice., Purpose: The aim of this study was to compare the reliability of two automated solutions for the measurement of CSMA., Methods: We conducted a retrospective analysis of CT images in our hospital database. We included consecutive individuals hospitalized at the Grenoble University Hospital in France between January and May 2018 with abdominal CT images and sagittal reconstruction. We used two types of software to automatically segment skeletal muscle: ABACS, a module of the SliceOmatic software solution "ABACS-SliceOmatic," and a deep learning-based solution called "AutoMATiCA." Manual segmentation was performed by a medical expert to generate reference data using "SliceOmatic." The Dice similarity coefficient (DSC) was used to measure overlap between the results of the manual and the automated segmentations. The DSC value for each method was compared with the Mann-Whitney U test., Results: A total of 676 hospitalized individuals was retrospectively included (365 males [53.8%] and 312 females [46.2%]). The median DSC for SliceOmatic vs AutoMATiCA (0.969 [5th percentile: 0.909]) was greater than the median DSC for SliceOmatic vs. ABACS-SliceOmatic (0.949 [5th percentile: 0.836]) (p < 0.001)., Conclusions: AutoMATiCA, which used artificial intelligence, was more reliable than ABACS-SliceOmatic for skeletal muscle segmentation at the L3 level in a cohort of hospitalized individuals. The next step is to develop and validate a neural network that can identify L3 slices, which is currently a fastidious process., (© 2023 American Association of Physicists in Medicine.)
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- 2023
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41. Early extubation in extracorporeal life support patients: A propensity score-matched study.
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Behouche A, Gaide-Chevronnay L, Piot J, Durost M, Adolle A, Le Guen Y, Vilotitch A, Bosson JL, Sebestyen A, Durand M, and Albaladejo P
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- Humans, Cohort Studies, Retrospective Studies, Propensity Score, Airway Extubation adverse effects, Extracorporeal Membrane Oxygenation
- Abstract
Background: Extubation strategy in extracorporeal life support patients remains unclear, and literature only reports studies with significant biases., Objectives: To explore the prognostic impact of an early ventilator-weaning strategy in assisted patients after controlling for confounding factors., Methods: A 10-year retrospective study included 241 patients receiving extracorporeal life support for at least 48 h, corresponding to a total of 977 days spent on assistance. The a priori probability of extubation for each day of assistance was calculated according to daily biological examinations, drug doses, clinical observations, and admission data to pair each day containing an extubation with one on which the patient was not extubated. The primary outcome was survival at day 28. The secondary outcomes were survival at day 7, respiratory infections, and safety criteria., Results: Two similar cohorts of 61 patients were generated. Survival at day 28 was better in patients extubated under assistance in univariate and multivariate (HR = 0.37 [0.2-0.68], p-value = 0.002) analyses. Patients who underwent failed early extubation did not have a different prognosis from those without early extubation. Successful early extubation was associated with a better outcome than a failed or no attempt at early extubation. Survival at day 7 and the rate of respiratory infections were better in early-extubated patients. Safety data did not differ between the two groups., Conclusions: Early extubation during assistance was associated with a superior outcome in our propensity-matched cohort study. The safety data were reassuring. However, due to the lack of prospective randomized studies, the causality remains uncertain., (© 2023 The Authors. Artificial Organs published by International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)
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- 2023
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42. A randomized controlled trial of the intraoperative use of noninvasive ventilation versus supplemental oxygen by face mask for procedural sedation in an electrophysiology laboratory.
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Moury PH, Pasquier V, Greco F, Arvieux JL, Alves-Macedo S, Richard M, Casez-Brasseur M, Skaare K, Jacon P, Durand M, Bedague D, Jaber S, Bosson JL, and Albaladejo P
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- Humans, Masks adverse effects, Apnea, Hypoxia epidemiology, Hypoxia etiology, Hypoxia prevention & control, Oxygen, Electrophysiology, Noninvasive Ventilation methods, Respiration Disorders, Respiratory Insufficiency therapy
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Purpose: The efficacy of noninvasive ventilation (NIV) during procedures that require sedation and analgesia has not been established. We evaluated whether NIV reduces the incidence of respiratory events., Methods: In this randomized controlled trial, we included 195 patients with an American Society of Anesthesiologists Physical Status of III or IV during electrophysiology laboratory procedures. We compared NIV with face mask oxygen therapy for patients under sedation. The primary outcome was the incidence of respiratory events determined by a computer-driven blinded analysis and defined by hypoxemia (peripheral oxygen saturation < 90%) or apnea/hypopnea (absence of breathing for 20 sec on capnography). Secondary outcomes included hemodynamic variables, sedation, patient safety (composite scores of major or minor adverse events), and adverse outcomes at day 7., Results: A respiratory event occurred in 89/98 (95%) patients in the NIV group and in 69/97 (73%) patients with face masks (risk ratio [RR], 1.29; 95% confidence interval [CI], 1.13 to 1.47; P < 0.001). Hypoxemia occurred in 40 (42%) patients in the NIV group and in 33 (34%) patients with face masks (RR, 1.21; 95% CI, 0.84 to 1.74; P = 0.30). Apnea/hypopnea occurred in 83 patients (92%) in the NIV group vs 65 patients (70%) with face masks (RR, 1.32; 95% CI, 1.14 to 1.53; P < 0.001). Hemodynamic variables, sedation, major or minor safety events, and patient outcomes were not different between the groups., Conclusions: Respiratory events were more frequent among patients receiving NIV without any safety or outcome impairment. These results do not support the routine use of NIV intraoperatively., Study Registration: ClinicalTrials.gov (NCT02779998); registered 4 November 2015., (© 2023. Canadian Anesthesiologists' Society.)
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- 2023
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43. Development of Indirect Health Data Linkage on Health Product Use and Care Trajectories in France: Systematic Review.
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Ranchon F, Chanoine S, Lambert-Lacroix S, Bosson JL, Moreau-Gaudry A, and Bedouch P
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- Humans, Registries, Hospitals, Big Data, Artificial Intelligence, Information Storage and Retrieval
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Background: European national disparities in the integration of data linkage (ie, being able to match patient data between databases) into routine public health activities were recently highlighted. In France, the claims database covers almost the whole population from birth to death, offering a great research potential for data linkage. As the use of a common unique identifier to directly link personal data is often limited, linkage with a set of indirect key identifiers has been developed, which is associated with the linkage quality challenge to minimize errors in linked data., Objective: The aim of this systematic review is to analyze the type and quality of research publications on indirect data linkage on health product use and care trajectories in France., Methods: A comprehensive search for all papers published in PubMed/Medline and Embase databases up to December 31, 2022, involving linked French database focusing on health products use or care trajectories was realized. Only studies based on the use of indirect identifiers were included (ie, without a unique personal identifier available to easily link the databases). A descriptive analysis of data linkage with quality indicators and adherence to the Bohensky framework for evaluating data linkage studies was also realized., Results: In total, 16 papers were selected. Data linkage was performed at the national level in 7 (43.8%) cases or at the local level in 9 (56.2%) studies. The number of patients included in the different databases and resulting from data linkage varied greatly, respectively, from 713 to 75,000 patients and from 210 to 31,000 linked patients. The diseases studied were mainly chronic diseases and infections. The objectives of the data linkage were multiple: to estimate the risk of adverse drug reactions (ADRs; n=6, 37.5%), to reconstruct the patient's care trajectory (n=5, 31.3%), to describe therapeutic uses (n=2, 12.5%), to evaluate the benefits of treatments (n=2, 12.5%), and to evaluate treatment adherence (n=1, 6.3%). Registries are the most frequently linked databases with French claims data. No studies have looked at linking with a hospital data warehouse, a clinical trial database, or patient self-reported databases. The linkage approach was deterministic in 7 (43.8%) studies, probabilistic in 4 (25.0%) studies, and not specified in 5 (31.3%) studies. The linkage rate was mainly from 80% to 90% (reported in 11/15, 73.3%, studies). Adherence to the Bohensky framework for evaluating data linkage studies showed that the description of the source databases for the linkage was always performed but that the completion rate and accuracy of the variables to be linked were not systematically described., Conclusions: This review highlights the growing interest in health data linkage in France. Nevertheless, regulatory, technical, and human constraints remain major obstacles to their deployment. The volume, variety, and validity of the data represent a real challenge, and advanced expertise and skills in statistical analysis and artificial intelligence are required to treat these big data., (©Florence Ranchon, Sébastien Chanoine, Sophie Lambert-Lacroix, Jean-Luc Bosson, Alexandre Moreau-Gaudry, Pierrick Bedouch. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 18.05.2023.)
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- 2023
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44. Efficacy and Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With Trauma at Risk of Massive Transfusion: The PROCOAG Randomized Clinical Trial.
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Bouzat P, Charbit J, Abback PS, Huet-Garrigue D, Delhaye N, Leone M, Marcotte G, David JS, Levrat A, Asehnoune K, Pottecher J, Duranteau J, Courvalin E, Adolle A, Sourd D, Bosson JL, Riou B, Gauss T, and Payen JF
- Subjects
- Adult, Female, Humans, Male, Middle Aged, Retrospective Studies, Thromboembolism etiology, Treatment Outcome, Double-Blind Method, Administration, Intravenous, Blood Coagulation Factors administration & dosage, Blood Coagulation Factors adverse effects, Blood Coagulation Factors therapeutic use, Blood Transfusion methods, Factor IX administration & dosage, Factor IX adverse effects, Hemorrhage etiology, Hemorrhage prevention & control, Hemorrhage therapy, Wounds and Injuries complications, Wounds and Injuries therapy
- Abstract
Importance: Optimal transfusion strategies in traumatic hemorrhage are unknown. Reports suggest a beneficial effect of 4-factor prothrombin complex concentrate (4F-PCC) on blood product consumption., Objective: To investigate the efficacy and safety of 4F-PCC administration in patients at risk of massive transfusion., Design, Setting, and Participants: Double-blind, randomized, placebo-controlled superiority trial in 12 French designated level I trauma centers from December 29, 2017, to August 31, 2021, involving consecutive patients with trauma at risk of massive transfusion. Follow-up was completed on August 31, 2021., Interventions: Intravenous administration of 1 mL/kg of 4F-PCC (25 IU of factor IX/kg) vs 1 mL/kg of saline solution (placebo). Patients, investigators, and data analysts were blinded to treatment assignment. All patients received early ratio-based transfusion (packed red blood cells:fresh frozen plasma ratio of 1:1 to 2:1) and were treated according to European traumatic hemorrhage guidelines., Main Outcomes and Measures: The primary outcome was 24-hour all blood product consumption (efficacy); arterial or venous thromboembolic events were a secondary outcome (safety)., Results: Of 4313 patients with the highest trauma level activation, 350 were eligible for emergency inclusion, 327 were randomized, and 324 were analyzed (164 in the 4F-PCC group and 160 in the placebo group). The median (IQR) age of participants was 39 (27-56) years, Injury Severity Score was 36 (26-50 [major trauma]), and admission blood lactate level was 4.6 (2.8-7.4) mmol/L; prehospital arterial systolic blood pressure was less than 90 mm Hg in 179 of 324 patients (59%), 233 patients (73%) were men, and 226 (69%) required expedient hemorrhage control. There was no statistically or clinically significant between-group difference in median (IQR) total 24-hour blood product consumption (12 [5-19] U in the 4F-PCC group vs 11 [6-19] U in the placebo group; absolute difference, 0.2 U [95% CI, -2.99 to 3.33]; P = .72). In the 4F-PCC group, 56 patients (35%) presented with at least 1 thromboembolic event vs 37 patients (24%) in the placebo group (absolute difference, 11% [95% CI, 1%-21%]; relative risk, 1.48 [95% CI, 1.04-2.10]; P = .03)., Conclusions and Relevance: Among patients with trauma at risk of massive transfusion, there was no significant reduction of 24-hour blood product consumption after administration of 4F-PCC, but thromboembolic events were more common. These findings do not support systematic use of 4F-PCC in patients at risk of massive transfusion., Trial Registration: ClinicalTrials.gov Identifier: NCT03218722.
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- 2023
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45. Development of artificial intelligence powered apps and tools for clinical pharmacy services: A systematic review.
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Ranchon F, Chanoine S, Lambert-Lacroix S, Bosson JL, Moreau-Gaudry A, and Bedouch P
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- Humans, Artificial Intelligence, Pharmacists, Hospitals, Pharmacy Service, Hospital, Physicians, Community Pharmacy Services
- Abstract
Objective: Artificial Intelligence (AI) offers potential opportunities to optimize clinical pharmacy services in community or hospital settings. The objective of this systematic literature review was to identify and analyse quantitative studies using or integrating AI for clinical pharmacy services., Materials and Methods: A systematic review was conducted using PubMed/Medline and Web of Science databases, including all articles published from 2000 to December 2021. Included studies had to involve pharmacists in the development or use of AI-powered apps and tools.., Results: 19 studies using AI for clinical pharmacy services were included in this review. 12 out of 19 articles (63.1%) were published in 2020 or 2021. Various methodologies of AI were used, mainly machine learning techniques and subsets (natural language processing and deep learning). The datasets used to train the models were mainly extracted from electronic medical records (6 studies, 32%). Among clinical pharmacy services, medication order review was the service most targeted by AI-powered apps and tools (9 studies), followed by health product dispensing (4 studies), pharmaceutical interviews and therapeutic education (2 studies). The development of these tools mainly involved hospital pharmacists (12/19 studies)., Discussion and Conclusion: The development of AI-powered apps and tools for clinical pharmacy services is just beginning. Pharmacists need to keep abreast of these developments in order to position themselves optimally while maintaining their human relationships with healthcare teams and patients. Significant efforts have to be made, in collaboration with data scientists, to better assess whether AI-powered apps and tools bring value to clinical pharmacy services in real practice., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier B.V. All rights reserved.)
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- 2023
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46. Using national data to describe characteristics and determine acceptance factors of pharmacists' interventions: a six-year longitudinal study.
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Bouzeid M, Clarenne J, Mongaret C, Pluchart H, Chanoine S, Vermorel C, Bosson JL, and Bedouch P
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- Humans, Pharmacists, Longitudinal Studies, Hospitals, Observational Studies as Topic, Medication Errors prevention & control, Pharmacy Service, Hospital
- Abstract
Background: In France, hospital pharmacists perform medication order reviews during patients' hospital stays. This activity can be centralized in the pharmacy or carried out directly in the ward, in collaboration with the healthcare team. During this review, pharmacists can make recommendations to optimize therapeutics. Since 2006, they can document their interventions, via the national Act-IP© observatory., Aim: To determine the characteristics of pharmacists' interventions and their acceptance by physicians in French hospitals., Method: A 6-year observational study of pharmacists' interventions documented on the Act-IP© French observatory between 2009 and 2014 was performed. Multiple logistic regression was undertaken to determine the predictors of physicians' acceptance of interventions., Results: A total of 194,684 pharmacists' interventions were documented and concerned mainly "dosage adjustment" (25.6%). These interventions were mostly related to drugs from the central nervous system (23.7%). Seventy percent of pharmacists' interventions were accepted by physicians. Acceptance rate was higher when conducted by a pharmacist regularly practicing in the ward (ORa = 1.60, CI 95 [1.57-1.64]). Physicians' acceptance was significantly associated with (1) ward specialty: emergency (ORa = 1.24, CI 95 [1.14-1.35]); (2) type of intervention: "drug discontinuation", "drug switch" (ORa = 1.15, CI 95 [1.12-1.19]) and "addition of a new drug" (ORa = 1.15, CI 95 [1.12-1.19]); (3) drug group: antineoplastic and immunomodulators (ORa = 3.67, CI 95 [3.44-3.92])., Conclusion: This 6-year longitudinal study highlights the role of clinical pharmacists, and particularly the impact of those integrated into wards. This was found to improve intervention acceptance, potentially through collaboration with physicians in pursuit of patient care and drug safety., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)
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- 2023
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47. Towards real-time monitoring of COVID-19 nosocomial clusters using SARS-CoV-2 genomes in a university hospital of the French Alps.
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Gallouche M, Landelle C, Larrat S, Truffot A, Bosson JL, and Caporossi A
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- Humans, SARS-CoV-2 genetics, Hospitals, University, COVID-19 diagnosis, COVID-19 epidemiology, COVID-19 prevention & control, Cross Infection epidemiology
- Abstract
Objectives: Experience of Nextstrain [1,2] and its approach adapted to the local context encouraged us to carry out real-time monitoring of COVID-19 nosocomial clusters in our establishment, the Grenoble Alpes University Hospital., Patients and Methods, Results: Through identification from electronic health records of nosocomial pathways and clusters and calculation of genetic distances from sequenced samples of COVID-19 patients, we were able to identify potential nosocomial clusters in very close to real time with a significant time saving compared to classical epidemiological surveillance, and to better understand and characterize nosocomial clusters., Conclusion: Through early detection and characterization of clusters, we may prevent infection of our patients by further implementing the appropriate measures., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)
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- 2023
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48. Correction: Procalcitonin to reduce exposure to antibiotics and individualise treatment in hospitalised old patients with pneumonia: a randomised study.
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Gavazzi G, Drevet S, Debray M, Bosson JL, Tidadini F, Paccalin M, de Wazieres B, Celarier T, Bonnefoy M, and Vitrat V
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- 2023
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49. Isolated distal deep vein thrombosis: What have we learnt from the OPTIMEV study?
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Galanaud JP, Sevestre MA, Pernod G, Vermorel C, Rolland C, Soudet S, Laroche JP, and Bosson JL
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- Humans, Prospective Studies, Risk Factors, Venous Thromboembolism complications, Venous Thrombosis diagnostic imaging, Venous Thrombosis etiology, Venous Thrombosis therapy, Neoplasms complications
- Abstract
The OPTIMEV (OPTimisation de l'Interrogatoire dans l'évaluation du risque throMbo-Embolique Veineux) study has provided some important and innovative information for the management of lower extremity isolated distal deep vein thrombosis (distal DVT). Indeed, if distal deep-vein thrombosis (DVT) therapeutic management is nowadays still debated, before the OPTIMEV study, the clinical relevance of these DVT itself was questioned. Via the publication of 6 articles, between 2009 and 2022, assessing risk factors, therapeutic management, and outcomes of 933 patients with distal DVT we were able to demonstrate that: - When distal deep veins are systematically screened for suspicion of DVT, distal DVT are the most frequent clinical presentation of the venous thromboembolic disease (VTE). This is also true in case of combined oral contraceptive related VTE. - Distal DVT share the same risk factors as proximal DVT and constitute two different clinical expressions of the same disease: the VTE disease. However, the weight of these risk factors differs: distal DVT are more often associated with transient risk factors whereas proximal DVT are more associated with permanent risk factors. - Deep calf vein and muscular DVT share the same risk factors, short and long-term prognoses. - In patients without history of cancer, risk of unknown cancer is similar in patients with a first distal or proximal DVT. - After 3years and once anticoagulation has been stopped, distal DVT recur twice less as proximal DVT and mainly as distal DVT; However, in cancer patients, prognosis of distal and proximal DVT appear similar in terms of death and VTE recurrence., (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)
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- 2023
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50. Procalcitonin to reduce exposure to antibiotics and individualise treatment in hospitalised old patients with pneumonia: a randomised study.
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Gavazzi G, Drevet S, Debray M, Bosson JL, Tidadini F, Paccalin M, de Wazieres B, Celarier T, Bonnefoy M, and Vitrat V
- Subjects
- Humans, Aged, Procalcitonin, Anti-Bacterial Agents therapeutic use, Anti-Bacterial Agents adverse effects, Prospective Studies, Biomarkers, Bacterial Infections, Pneumonia
- Abstract
Background: Treating pneumonia in old patients remains challenging for clinicians. Moreover, bacterial antimicrobial resistance is a major public health threat., Objective: The PROPAGE study evaluated the interest of a strategy using serial measurements of procalcitonin (PCT) to reduce the duration of antibiotic therapy in old patients with pneumonia., Methods: PROPAGE took place from Dec.-2013 to Jun.-2016 in eight French geriatric units. It was a prospective, comparative, randomised, open-label study involving old patients (≥ 80 years) who had initiated antibiotic treatment for pneumonia in the previous 48 h. PCT was monitored in all patients and two decision-making PCT-based algorithms guided antibiotic therapy in patients from the PCT group., Results: 107 patients were randomised (PCT, n = 50; Control, n = 57). Antibiotic therapy exposure was reduced in the PCT group as compared to the Control group (median duration of antibiotic therapy, 8 vs. 10 days [rank-test, p = 0.001]; antibiotic persistence rates on Days 6 and 8, 54% and 44% vs. 91% and 72%) and no significant difference was found in recovery rate (84% vs. 89.5%; Pearson Chi² test, p = 0.402)., Conclusion: Although, the superiority of the strategy was not tested using a composite criterion combining antibiotic therapy duration and recovery rate was not tested due to the small sample size, the present study showed that monitoring associated with PCT-guided algorithm could help shorten antibiotic treatment duration in the very old patients without detrimental effects. Measuring PCT levels between Day 4 and Day 6 could be helpful when making the decision regarding antibiotic discontinuation., Trial Registration: NCT02173613. This study was first registered on 25/06/2014., (© 2022. The Author(s).)
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- 2022
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