8 results on '"Consigny M"'
Search Results
2. Development of a web-based ecological momentary assessment tool to measure day-to-day variability of the symptoms in patients with Sjögren's disease.
- Author
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Georgel L, Benyoussef AA, Berrouiguet S, Guellec D, Carvajal Alegria G, Marhadour T, Jousse-Joulin S, Cochener-Lamard B, Labetoulle M, Gottenberg JE, Bourcier T, Nocturne G, Saraux A, Mariette X, Consigny M, Gravey M, Devauchelle-Pensec V, Seror R, and Cornec D
- Subjects
- Humans, Female, Middle Aged, Male, Aged, Pilot Projects, Surveys and Questionnaires, Severity of Illness Index, Patient Reported Outcome Measures, Symptom Assessment, Sjogren's Syndrome diagnosis, Sjogren's Syndrome complications, Ecological Momentary Assessment, Internet
- Abstract
Objectives: To develop and validate a web-based ecological momentary assessment (EMA) tool to enhance symptoms monitoring among patients with Sjögren's disease (SjD)., Methods: Consecutive adults with SjD were enrolled in this pilot observational study. Participants used the WebApp over a 3-month period, for the daily collection of individual EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scales and separate assessment of eyes and mouth dryness, using 0-10 numerical scales. Primary outcome was the measure of the interdaily variability of symptoms. Data collected through the WebApp were compared with those obtained with paper-based questionnaires administered during a final visit, using distinct approaches (predicted error, maximum negative error and maximum positive error). User experience was assessed using the System Usability Scale (SUS) score., Results: Among the 45 participants, 41 (91.1%) were women. Median age was 57 years (IQR: 49-66). Daily variability of symptoms ranged between 0.5 and 0.8 points across the scales. Over the 3-month period, the predicted error ranged between -1.2 and -0.3 points of the numerical scales. The greatest differences were found for fatigue (-1.2 points (IQR: -2.3 to -0.2)) and ESSPRI score (-1.2 points (IQR: -1.7 to -0.3)). Over the last 2 weeks, the predicted error ranged between - 1.2 and 0.0 points. Maximum negative error ranged between -2.0 and -1.0 points, and maximum positive error between -0.3 and 0.0 points. Median SUS score was 90 (IQR: 85-95)., Conclusion: Our results demonstrate the usability and the relevance of our web-based EMA tool for capturing data that closely reflects daily experiences of patients with SjD., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2024
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3. Prophylactic platelet transfusion response in critically ill patients: a prospective multicentre observational study.
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Reizine F, Le Marec S, Le Meur A, Consigny M, Berteau F, Bodenes L, Geslain M, McQuilten Z, Le Niger C, Huntzinger J, Seguin P, Thibert JB, Simon D, Reignier J, Egreteau PY, Tadié JM, Huet O, Asfar P, Ehrmann S, and Aubron C
- Subjects
- Humans, Hemorrhage complications, Platelet Transfusion, Prospective Studies, Critical Illness therapy, Thrombocytopenia therapy, Hematologic Neoplasms therapy, Hematologic Neoplasms complications
- Abstract
Background: Response to prophylactic platelet transfusion is suspected to be inconsistent in critically ill patients questioning how to optimize transfusion practices. This study aimed to describe prophylactic platelet transfusion response, to identify factors associated with a suboptimal response, to analyse the correlation between corrected count increment and platelet count increment and to determine the association between poor platelet transfusion response and clinical outcomes., Methods: This prospective multicentre observational study recruited patients who received at least one prophylactic platelet transfusion in one of the nine participating intensive care units for a period up to 16 months. Poor platelet transfusion response was defined as a corrected count increment (CCI) that adjusts for platelet dose and body surface area, less than 7 at 18-24 h after platelet transfusion. Factors associated with poor platelet transfusion response were assessed in a mixed-effect model. Sensitivity analyses were conducted in patients with and without haematology malignancy and chemotherapy., Results: Poor platelet transfusion response occurred in 349 of the 472 (73.9%) prophylactic platelet transfusions and in 141/181 (77.9%) patients. The mixed-effect model identified haemoglobin at ICU admission (odds ratio (OR): 0.79 [95% confidence interval (CI) 0.7-0.89]) and body mass index (BMI) (OR: 0.93 [0.89-0.98]) being positively and independently associated with platelet transfusion response, while a haematological malignancy (OR 1.93 [1.09-3.43]), sepsis as primary ICU admission diagnosis (OR: 2.81 [1.57-5.03]), SOFA score (OR 1.10 [1.03; 1.17]) and maximum storage duration of platelet (OR: 1.24 [1.02-1.52]) were independently associated with a suboptimal platelet increment. Clinical outcomes did not differ between groups, nor the requirement for red blood cells. Poor platelet transfusion response was found in 93.5% of patients with haematology malignancy and chemotherapy., Conclusions: In this study of critically ill patients, of whom more than half had bone marrow failure, almost three quarters of prophylactic platelet transfusions led to suboptimal platelet increment measured 18 to 24 h following platelet transfusion. Platelet storage duration was the only factor associated with poor platelet response that may be accessible to intervention. Trial registration in October 2017: ClinicalTrials.gov: NCT03325140., (© 2023. BioMed Central Ltd., part of Springer Nature.)
- Published
- 2023
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4. Dexmedetomidine after Cardiac Surgery for Prevention of Delirium (EXACTUM) trial protocol: a multicentre randomised, double-blind, placebo-controlled trial.
- Author
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Gargadennec T, Oilleau JF, Rozec B, Nesseler N, Lasocki S, Futier E, Amour J, Durand M, Bougle A, Kerforne T, Consigny M, Eddi D, and Huet O
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- Aged, Double-Blind Method, Humans, Multicenter Studies as Topic, Quality of Life, Randomized Controlled Trials as Topic, Cardiac Surgical Procedures adverse effects, Delirium epidemiology, Delirium etiology, Delirium prevention & control, Dexmedetomidine therapeutic use
- Abstract
Introduction: Incidence of delirium after cardiac surgery remains high and delirium has a significant burden on short-term and long-term outcomes. Multiple causes can trigger delirium occurence, and it has been hypothesised that sleep disturbances can be one of them. Preserving the circadian rhythm with overnight infusion of low-dose dexmedetomidine has been shown to lower the occurrence of delirium in older patients after non-cardiac surgery. However, these results remain controversial. The aim of this study was to demonstrate the usefulness of sleep induction by overnight infusion of dexmedetomidine to prevent delirium after cardiac surgery., Methods and Analysis: Dexmedetomidine after Cardiac Surgery for Prevention of Delirium is an investigator-initiated, randomised, placebo-controlled, parallel, multicentre, double-blinded trial. Nine centres in France will participate in the study. Patients aged 65 years or older and undergoing cardiac surgery will be enrolled in the study. The intervention starts on day 0 (the day of surgery) until intensive care unit (ICU) discharge; the treatment is administered from 20:00 to 08:00 on the next day. Infusion rate is modified by the treating nurse or the clinician with an objective of Richmond Agitation and Sedation Scale score from -1 to +1. The primary outcome is delirium occurrence evaluated with confusion assessment method for the ICU two times per day during 7 days following surgery. Secondary outcomes include incidence of agitation related events, self-evaluated quality of sleep, cognitive evaluation 3 months after surgery and quality of life 3 months after surgery. The sample size is 348., Ethics and Dissemination: The study was approved for all participating centers by the French Central Ethics Committee (Comité de Protection des Personnes Ile de France VI, registration number 2018-000850-22). The results will be submitted for publication in peer-reviewed journals., Trial Registration Number: NCT03477344., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2022
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5. PTSD in French Adolescent Victims Following the London Attack in March 2017: Data From the First Step of the AVAL Study.
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Coulon N, Grenon M, Consigny M, and Simson JP
- Abstract
Background: The terrorist attack at Westminster Bridge on March 22
nd , 2017 impacted on French high school students on a school trip in London. This terrorist attack was claimed by the Islamic State. The aim of the study was to assess the mental health consequences of the attack on the French adolescents who were directly exposed (criteria A for Post-Traumatic Stress Disorder , PTSD). This involved three dimensions, namely: (1) clinical; (2) epidemiological; and (3) prevention and therapeutic., Material and Method: The investigation was the first observational step of AVAL ( Adolescents Victimes de l'Attentat de Londres ) study, a cohort monitoring project and it was then a monocentric, cross sectional, non interventional survey, at only one-year post-trauma. The study was carried out utilizing self- and clinician-administered questionnaires. Volunteers from the medico-psychological emergency unit provided support for these victims during the study protocol., Results: From the target population ( n = 53), 39 adolescents (73.6%) agreed to participate, with a median age 16.9 years. 12 months after the attack, 25.6% of teenagers suffered from current PTSD ( p < 0.0001). Those with, vs. without, PTSD showed several significant differences: (1) heightened levels of major depressive episodes ( p = 0.0266) and suicidality ( p = 0.0164); (2) increased substance use, including tobacco ( p = 0.0284) and cannabis ( p = 0.0449); and (3) impaired functioning in school ( p = 0.0203), social ( p < 0.0001) and family ( p < 0.0001) settings. Sixty four percentage of directly exposed teenagers also had a current psychiatric disorder other than PTSD., Discussion: The heightened levels of PTSD, psychiatric disorders, and substance use at 12 months highlight the importance of early intervention in adolescents exposed to terrorist-linked potentially traumatic events., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Coulon, Grenon, Consigny and Simson.)- Published
- 2022
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6. The newborn infant parasympathetic evaluation index for acute procedural pain assessment in preterm infants.
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Gendras J, Lavenant P, Sicard-Cras I, Consigny M, Misery L, Anand KJS, Sizun J, and Roué JM
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- Acute Disease, Humans, Infant, Newborn, Neonatal Screening, Prospective Studies, Infant, Premature, Pain Measurement methods, Pain, Procedural physiopathology, Parasympathetic Nervous System physiopathology
- Abstract
Background: Accurate assessments of pain in hospitalized preterm infants present a major challenge in improving the short- and long-term consequences associated with painful experiences. We evaluated the ability of the newborn infant parasympathetic evaluation (NIPE) index to detect acute procedural pain in preterm infants., Methods: Different painful and stressful interventions were prospectively observed in preterm infants born at 25 + 0 to 35 + 6 weeks gestation. Pain responses were measured using the composite Premature Infant Pain Profile Revised (PIPP-R) scale, the NIPE index, and skin conductance responses (SCR). Outcome measures were correlations between the NIPE index, the PIPP-R score, and the SCR. Sensitivity/specificity analyses tested the accuracy of the NIPE index and SCR., Results: Two hundred and fifty-four procedures were recorded in 90 preterm infants. No significant correlation was found between PIPP-R and the NIPE index. PIPP-R and SCR were positively correlated (r = 0.27, P < 0.001), with stronger correlations for painful procedures (r = 0.68, P < 0.001) and especially for skin-breaking procedures (r = 0.82, P < 0.001). The NIPE index and SCR had high sensitivity and high negative predictive values to predict PIPP-R > 10, especially for skin-breaking painful procedures., Conclusions: We found no significant correlation between the NIPE index and PIPP-R during routine painful or stressful procedures in preterm infants., Impact: Exposure to repetitive pain can lead to neurodevelopmental sequelae. Behavior-based pain scales have limited clinical utility, especially for preterm infants. New devices for monitoring physiological responses to pain have not been validated sufficiently in preterm infants. This study found that the NIPE index was not significantly correlated to the validated PIPP-R scale during acute procedural pain. Secondary analysis of this study showed that NIPE index and SCRs may help to exclude severe pain in preterm infants. In clinical practice, measurements of physiological parameters should be combined with behavior-based scales for multidimensional pain assessments.
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- 2021
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7. Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study.
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L'Her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Consigny M, and Lellouche F
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- Humans, Hypoxia, Oximetry, Oxygen, Thoracic Surgery, Thoracic Surgical Procedures
- Abstract
Introduction: Hypoxaemia and hyperoxaemia may occur after surgery, with related complications. This multicentre randomised trial evaluated the impact of automated closed-loop oxygen administration after high-risk abdominal or thoracic surgeries in terms of optimising the oxygen saturation measured by pulse oximetry time within target range., Methods: After extubation, patients with an intermediate to high risk of post-operative pulmonary complications were randomised to "standard" or "automated" closed-loop oxygen administration. The primary outcome was the percentage of time within the oxygenation range, during a 3-day frame. The secondary outcomes were the time with hypoxaemia and hyperoxaemia under oxygen., Results: Among the 200 patients, time within range was higher in the automated group, both initially (≤3 h; 91.4±13.7% versus 40.2±35.1% of time, difference +51.0% (95% CI -42.8-59.2%); p<0.0001) and during the 3-day period (94.0±11.3% versus 62.1±23.3% of time, difference +31.9% (95% CI 26.3-37.4%); p<0.0001). Periods of hypoxaemia were reduced in the automated group (≤3 days; 32.6±57.8 min (1.2±1.9%) versus 370.5±594.3 min (5.0±11.2%), difference -10.2% (95% CI -13.9--6.6%); p<0.0001), as well as hyperoxaemia under oxygen (≤3 days; 5.1±10.9 min (4.8±11.2%) versus 177.9±277.2 min (27.0±23.8%), difference -22.0% (95% CI -27.6--16.4%); p<0.0001). Kaplan-Meier analysis depicted a significant difference in terms of hypoxaemia (p=0.01) and severe hypoxaemia (p=0.0003) occurrence between groups in favour of the automated group. 25 patients experienced hypoxaemia for >10% of the entire monitoring time during the 3 days within the standard group, as compared to the automated group (p<0.0001)., Conclusion: Automated closed-loop oxygen administration promotes greater time within the oxygenation target, as compared to standard manual administration, thus reducing the occurrence of hypoxaemia and hyperoxaemia., Competing Interests: Conflict of interest: E. L'Her reports other from Oxynov, during the conduct of the study; personal fees from Smiths Medical, personal fees and other from GE Healthcare, grants and personal fees from Sedana Medical, outside the submitted work. In addition, E. L'Her has a patent Method and device for delivering oxygen licensed to Oxynov. Conflict of interest: S. Jaber reports personal fees from Drager, Fisher-Paykel, Baxter, Fresenius-Xenios and Medtronic, during the conduct of the study. Conflict of interest: D. Verzilli has nothing to disclose. Conflict of interest: C. Jacob has nothing to disclose. Conflict of interest: B. Huiban has nothing to disclose. Conflict of interest: E. Futier reports consulting fees from Drager Medical, GE Healthcare, Orion Pharma and Edwards Lifesciences, lecture fees from Fresenius Kabi and Getinge, and non-financial support from Fisher and Paykel Healthcare, during the conduct of the study. Conflict of interest: T. Kerforne has nothing to disclose. Conflict of interest: V. Pateau reports other from OxyNov, during the conduct of the study. Conflict of interest: P-A. Bouchard has nothing to disclose. Conflict of interest: M. Consigny has nothing to disclose. Conflict of interest: F. Lellouche reports other from Oxynov, during the conduct of the study., (Copyright ©ERS 2021.)
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- 2021
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8. Impact of a Terrorist Attack on the Mental Health of Directly Exposed French Adolescents: Study Protocol for the First Step of the AVAL Cohort Study.
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Grenon M, Consigny M, Lemey C, Simson JP, and Coulon N
- Abstract
Background: Several terrorist attacks have recently taken place in France and Europe. Various studies have shown a high prevalence of Post-Traumatic Stress Disorder (PTSD) and other psychiatric disorders among the victims of these attacks. Nevertheless, research in this field is scarce and no cohort study has been conducted yet to evaluate the impact of a terrorist attack on teenagers directly exposed to this type of events. Therefore, we decided to work on the AVAL ( Adolescents Victimes de l'Attentat de Londres ) cohort study in order to measure the psycho-traumatic impact of this attack and to describe these adolescents' health care pathways. Material and method: The 53 students of a French high school who were directly exposed (criterion A1 of PTSD in DSM-5) to the terrorist attack perpetrated in London on March 22, 2017 constitute the target population of this monocentric cross-sectional observational study. We decided not to include the three students who were physically wounded and, therefore, didn't have the same sensorial exposition. The primary endpoint will be the prevalence of PTSD 12 to 15 months after the attack, measured by the PCL-5 (Post-traumatic stress disorder Check-List for DSM-5) global severity score: the diagnosis of PTSD will be retained when the score is > 32. We will also use an extensive battery of clinical tests to assess the prevalence of anxiety disorders, mood disorders, sleep disorders, addictions, suicide risk, and alterations in social, family, and school functioning 12 to 15 months after the attack. We will also describe these adolescents' health care pathways since the attack and collect data from the clinical evaluation performed during the initial intervention of the medico-psychological emergency cell within 10 days after the attack. Discussion: The findings of this study are intended to provide epidemiological data about the psycho-traumatic impact of a terrorist attack on the mental health of directly exposed adolescents and to describe these adolescents' health care pathways, thus contributing to improve the immediate, post-immediate, and delayed response strategies after a major psycho-traumatic event involving adolescents (and in particular after terrorist attacks), as well as the identification and psychiatric care of the young survivors requiring specialized care. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT03493243. Ethics and Dissemination: The regional ethics committee (Comité de Protection des Personnes Ouest IV-Nantes) approved the study protocol (Reference 10/18_3). All participants (and their legal guardians, for minors) must sign the informed consent to participate. The protocol was presented at the French congress of psychiatry in Nantes (France) in November 2018. After study completion, the results will be published and detailed in Marion Grenon's MD thesis in psychiatry., (Copyright © 2019 Grenon, Consigny, Lemey, Simson and Coulon.)
- Published
- 2019
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