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2.
J Perinatol ; 44(2): 195-202, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38040875

ABSTRACT

OBJECTIVE: To evaluate the impact of antenatal corticosteroid therapy (ACS) on birth outcomes in term infants exposed during pregnancy. STUDY DESIGN: Exposed newborns were compared with non-exposed controls in a 1 to 2 design. Multivariate analysis was used to assess the effect of ACS exposure on neonatal outcomes. RESULT: 408 newborns were included (136 exposed to ACS, 272 non-exposed). Mean ± SD head circumference (HC) was 33.7 ± 1.4 vs 34.3 ± 1.6 cm, p = 0.001 in exposed vs controls; birth weight was 3.1 ± 0.4 vs 3.3 ± 0.4 kg, p = 0.0001; and birth height was 47.9 ± 2.1 vs. 49.1 ± 2.0 cm, p < 0.0001. Hypocalcemia (4.4 vs 0.7%, p = 0.019) and feeding difficulties (5.1 vs 1.5%, p = 0.047) were significantly more common in exposed newborns. Multivariate analysis for HC showed a significant independent association with ACS exposure (ß = -0.5, p = 0.009). CONCLUSION: Term newborns exposed to ACS have lower birth HC and higher risk of neonatal complications. CLINICAL TRIAL REGISTRATION: NCT05640596.


Subject(s)
Obstetric Labor, Premature , Premature Birth , Infant , Infant, Newborn , Humans , Female , Pregnancy , Adrenal Cortex Hormones/adverse effects , Birth Weight , Multivariate Analysis , Retrospective Studies , Gestational Age
3.
Crit Care ; 27(1): 470, 2023 11 30.
Article in English | MEDLINE | ID: mdl-38037130

ABSTRACT

BACKGROUND: Intra-abdominal candidiasis (IAC) is difficult to predict in critically ill patients with intra-abdominal infection, leading to the overuse of antifungal treatments. Serum and peritoneal 1.3-beta-D-glucan (sBDG and pBDG) have been proposed to confirm or invalidate the diagnosis of IAC, but clinical studies have reported inconsistent results, notably because of heterogeneous populations with a low IAC prevalence. This study aimed to identify a high-risk IAC population and evaluate pBDG and sBDG in diagnosing IAC. METHODS: This prospective multicenter noninterventional French study included consecutive critically ill patients undergoing abdominal surgery for abdominal sepsis. The primary objective was to establish the IAC prevalence. The secondary objective was to explore whether sBDG and pBDG could be used to diagnose IAC. Wako® beta-glucan test (WT, Fujifilm Wako Chemicals Europe, Neuss, Germany) was used for pBDG measurements. WT and Fungitell® beta-D-glucan assay (FA, Associate of Cape Cod, East Falmouth, USA) were used for sBDG measurements. RESULTS: Between 1 January 2020 and 31 December 2022, 199 patients were included. Patients were predominantly male (63%), with a median age of 66 [54-72] years. The IAC prevalence was 44% (87/199). The main IAC type was secondary peritonitis. Septic shock occurred in 63% of cases. After multivariate analysis, a nosocomial origin was associated with more IAC cases (P = 0.0399). The median pBDG level was significantly elevated in IAC (448 [107.5-1578.0] pg/ml) compared to non-IAC patients (133 [16.0-831.0] pg/ml), P = 0.0021. For a pBDG threshold of 45 pg/ml, the negative predictive value in assessing IAC was 82.3%. The median sBDG level with WT (n = 42) at day 1 was higher in IAC (5 [3.0-9.0] pg/ml) than in non-IAC patients (3 [3.0-3.0] pg/ml), P = 0.012. Similarly, median sBDG level with FA (n = 140) at day 1 was higher in IAC (104 [38.0-211.0] pg/ml) than in non-IAC patients (50 [23.0-141.0] pg/ml), P = 0.009. Combining a peritonitis score < 3, sBDG < 3.3 pg/ml (WT) and pBDG < 45 pg/ml (WT) yielded a negative predictive value of 100%. CONCLUSION: In critically ill patients with intra-abdominal infection requiring surgery, the IAC prevalence was 44%. Combining low sBDG and pBDG with a low peritonitis score effectively excluded IAC and could limit unnecessary antifungal agent exposure. TRIAL REGISTRATION: The study was registered with ClinicalTrials.gov (ID number 03997929, first registered on June 24, 2019).


Subject(s)
Candidiasis , Intraabdominal Infections , Peritonitis , beta-Glucans , Humans , Male , Middle Aged , Aged , Female , Prospective Studies , Glucans , Critical Illness/therapy , Candidiasis/drug therapy , Antifungal Agents/therapeutic use , Intraabdominal Infections/diagnosis , Peritonitis/diagnosis , beta-Glucans/analysis , Sensitivity and Specificity
4.
United European Gastroenterol J ; 11(8): 797-806, 2023 10.
Article in English | MEDLINE | ID: mdl-37670487

ABSTRACT

BACKGROUND AND AIMS: The accumulation of multiple randomized controlled trials in the field of inflammatory bowel diseases provides an opportunity to compare treatment effects between phase 2 and 3 trials. We aimed to determine whether treatment effects observed in phase 3 investigating biologics and small molecule drugs differed from those in their preceding phase 2 trial. METHODS: We first performed a review of phase 2 and phase 3 trials enrolling ulcerative colitis (UC) or Crohn's disease (CD) patients. We compared the percent overall success for key endpoints between phases (several phase 3 could be matched to a single phase 2 trial). Then, we compared the percent overall success in the matched phase 2 and 3 trials (ratio 1:1), and performed sensitivity analysis. RESULTS: We identified 14 phase 2 (8 CD; 6 UC) and 24 phase 3 (13 CD; 11 UC) trials. In CD, the different analyses suggest that the percentage of overall success of clinical remission and clinical response was significantly higher in phase 2 than in phase 3 trials. In UC, the analyses suggest collectively that the percent of treatment effect seemed similar for clinical remission, clinical response and histologic outcomes between phases but with a lower percentage of overall success in phase 2 than in phase 3 trials for endoscopic endpoints. CONCLUSIONS: In UC, we observed a similar percentage of treatment effect for clinical and histologic outcomes between phase 2 and 3 trials but not for endoscopic outcomes. Whereas in CD, we showed a failure to reproduce similar results between phases. These results may help sponsors in the design of future drug development programs.


Subject(s)
Biological Products , Colitis, Ulcerative , Crohn Disease , Inflammatory Bowel Diseases , Humans , Inflammatory Bowel Diseases/drug therapy , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/drug therapy , Colitis, Ulcerative/pathology , Crohn Disease/therapy , Endoscopy , Biological Products/therapeutic use , Clinical Trials, Phase III as Topic , Clinical Trials, Phase II as Topic
5.
BMC Public Health ; 23(1): 1823, 2023 09 19.
Article in English | MEDLINE | ID: mdl-37726674

ABSTRACT

BACKGROUND: The COVID-19 pandemic placed important challenges on parents, as they had to meet various demands during lockdown, including childcare, work and homeschooling. Therefore, the current study aimed to investigate perceived stress levels among the parents of school-aged children and explore their association with sociodemographic, environmental and psychological factors during lockdown. METHODS: A cross-sectional study was conducted among the parents of school-aged children ages 8 to 18, who lived in the Grand Est region of France during the first wave of the pandemic. An online survey collected sociodemographic data, living and working conditions, and exposure to COVID-19 as well as parent's levels of perceived stress (PSS-10), self-perceived health status (SF-12), social support (MSPSS) and resilience (BRS). Multivariable logistic regression models were conducted to evaluate the association between moderate to severe perceived stress and various factors. RESULTS: In total, 734 parents were included. The results indicated that 47% were experiencing moderate stress and 7.2% were experiencing severe stress. Factors most strongly associated with risk of moderate to severe levels of stress were lower levels of parental resilience (OR = 3.8, 95% CI: 2.2-6.6) and poor self-perceived mental health status (OR = 7.3, 95% CI: 5.0-10.8). The following risk factors were also identified: female sex; being in the age range of 35-44; difficulties isolating and contracting COVID-19, which involved hospitalization and separation or isolation from family. The support of friends (OR = 0.8, 95% CI: 0.7-1.0) and family (OR = 0.5, 95% CI: 0.3-0.8) were protective factors. CONCLUSIONS: These findings suggest that supportive and preventive programs should focus on the improvement of resilience and mental health management to promote parents' wellbeing. Research has to focus both on individuals' inner potential for increasing resilience and the environmental resources to be activated. Building and boosting resilience among parents could serve as a protective factor against negative outcomes for them and their families.


Subject(s)
COVID-19 , Humans , Child , Female , COVID-19/epidemiology , Communicable Disease Control , Cross-Sectional Studies , Pandemics , France/epidemiology , Parents
6.
Intensive Care Med Exp ; 11(1): 51, 2023 Aug 14.
Article in English | MEDLINE | ID: mdl-37574520

ABSTRACT

BACKGROUND: The immuno-receptor Triggering Expressed on Myeloid cells-1 (TREM-1) is activated during bacterial infectious diseases, where it amplifies the inflammatory response. Small studies suggest that TREM-1 could be involved in viral infections, including COVID-19. We here aim to decipher whether plasma concentration of the soluble form of TREM-1 (sTREM-1) could predict the outcome of hospitalized COVID-19 patients. METHODS: We conducted a multicentre prospective observational study in 3 university hospitals in France. Consecutive hospitalized patients with confirmed infection with SARS-CoV-2 were enrolled. Plasma concentration of sTREM-1 was measured on admission and then at days 4, 6, 8, 14, 21, and 28 in patients admitted into an ICU (ICU cohort: ICUC) or 3 times a week for patients hospitalized in a medical ward (Conventional Cohort: ConvC). Clinical and biological data were prospectively recorded and patients were followed-up for 90 days. For medical ward patients, the outcome was deemed complicated in case of requirement of increased oxygen supply > 5 L/min, transfer to an ICU, or death. For Intensive Care Unit (ICU) patients, complicated outcome was defined by death in the ICU. RESULTS: Plasma concentration of sTREM-1 at inclusion was higher in ICU patients (n = 269) than in medical ward patients (n = 562) (224 pg/mL (IQR 144-320) vs 147 pg/mL (76-249), p < 0.0001), and higher in patients with a complicated outcome in both cohorts: 178 (94-300) vs 135 pg/mL (70-220), p < 0.0001 in the ward patients, and 342 (288-532) vs 206 pg/mL (134-291), p < 0.0001 in the ICU patients. Elevated sTREM-1 baseline concentration was an independent predictor of complicated outcomes (Hazard Ratio (HR) = 1.5 (1.1-2.1), p = 0.02 in ward patients; HR = 3.8 (1.8-8.0), p = 0.0003 in ICU patients). An sTREM-1 plasma concentration of 224 pg/mL had a sensitivity of 42%, and a specificity of 76% in the ConvC for complicated outcome. In the ICUC, a 287 pg/mL cutoff had a sensitivity of 78%, and a specificity of 74% for death. The sTREM-1 concentrations increased over time in the ConvC patients with a complicated outcome (p = 0.017), but not in the ICUC patients. CONCLUSIONS: In COVID-19 patients, plasma concentration of sTREM-1 is an independent predictor of the outcome, although its positive and negative likelihood ratio are not good enough to guide clinical decision as a standalone marker.

7.
United European Gastroenterol J ; 11(4): 361-370, 2023 05.
Article in English | MEDLINE | ID: mdl-37078395

ABSTRACT

BACKGROUND: Patients with inflammatory bowel disease (IBD) consider that their diet is important for controlling symptoms and frequently ask their physician for additional guidance on this matter. The objectives of the present study of patients with IBD were to characterize the prevalence of exclusion diets and fasting and to identify associated risk factors. METHODS: Using an anonymous questionnaire, we screened patients attending our IBD nutrition clinic between November 2021 and April 2022 for exclusion diets. The avoidance of a food category completely was defined as total exclusion and avoidance most of the time was defined as partial exclusion. We also asked patients whether they fasted totally, intermittently, or partially. RESULT: A total of 434 patients with IBD were included. On inclusion, 159 patients (36.6%) totally excluded at least one food category and 271 (62.4%) partially excluded at least one food. Intermittent, total, or partial fasting was reported by 30.8% of the patients. Disease activity (odds ratio (OR) [95% confidence interval] = 1.7 [1.1-2.7], p = 0.0130) and treatment with a small-molecule or an investigational drug (OR = 4.0 [1.5-10.6], p = 0.0059) were independently associated with an exclusion diet. A history of stenosis (OR = 2.0 [1.2-3.2], p = 0.0063) and active disease (OR = 1.9 [1.2-3.1], p = 0.0059) were associated with fasting. CONCLUSION: In this real-world study, approximately two-thirds of our patients with IBD reported the partial or total exclusion of at least one food category and one third reported fasting. A systematic nutritional evaluation might improve clinical management and quality of care for patients with IBD both Crohn's disease and ulcerative colitis.


Subject(s)
Colitis, Ulcerative , Crohn Disease , Inflammatory Bowel Diseases , Humans , Inflammatory Bowel Diseases/therapy , Inflammatory Bowel Diseases/complications , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/therapy , Colitis, Ulcerative/complications , Crohn Disease/therapy , Crohn Disease/complications , Food , Fasting
8.
Article in English | MEDLINE | ID: mdl-37107826

ABSTRACT

Anxiety disorders remain underdiagnosed and undertreated, especially in child and adolescent populations. This study aimed to examine the construct validity of the Generalized Anxiety Disorder Scale 7 (GAD-7) in a sample of French adolescents by combining the Classical Test Theory (CTT) and the Item Response Theory (IRT) and to assess the invariance of items. A total of 284 adolescents enrolled in school in the Lorraine region were randomly selected to participate in a cross-sectional study. A psychometric evaluation was performed using a combination of CTT and IRT analyses. The study of psychometric properties of GAD-7 revealed poor adequation to the sample population, and engendered the deletion of one item (#7) and the merger of two response modalities (#2 and #3). These modifications generated the new GAD-6 scale, which had a good internal consistency reliability (Cronbach α = 0.85; PSI = 0.83), acceptable goodness-of-fit indices (χ2 = 28.89, df = 9, P = 0.001; RMSEA (90% CI) = 0.088 [0.054; 0.125]; SRMR = 0.063; CFI = 0.857), and an acceptable convergent validity (r = -0.62). Only one item (#5) had a consistent Differential Item Functioning (DIF) by gender. This study evaluated the structure of the GAD-7 scale, which was essentially intended at discriminating adolescent patients with high levels of anxiety, and adapted it to a population of adolescents from the general population. The GAD-6 scale presents better psychometric properties in this general population than the original GAD-7 version.


Subject(s)
Anxiety Disorders , Anxiety , Child , Humans , Adolescent , Reproducibility of Results , Cross-Sectional Studies , Anxiety Disorders/diagnosis , Anxiety Disorders/epidemiology , Anxiety/diagnosis , Anxiety/epidemiology , Patient Health Questionnaire , Psychometrics , Surveys and Questionnaires
9.
Br J Anaesth ; 131(1): 150-158, 2023 07.
Article in English | MEDLINE | ID: mdl-36967281

ABSTRACT

BACKGROUND: Neuromuscular blocking agents (NMBAs) are among the leading cause of perioperative anaphylaxis, and most of these reactions are IgE mediated. Allergic sensitisation induced by environmental exposure to other quaternary ammonium-containing compounds, such as pholcodine, has been suggested. The aim of this study was to assess the relationship between pholcodine exposure and NMBA-related anaphylaxis. METHODS: ALPHO was a multicentre case-control study, comparing pholcodine exposure within a year before anaesthesia between patients with NMBA-related perioperative anaphylaxis (cases) and control patients with uneventful anaesthesia in France. Each case was matched to two controls by age, sex, type of NMBA, geographic area, and season. Pholcodine exposure was assessed by a self-administered questionnaire and pharmaceutical history retrieved from pharmacy records. The diagnostic values of anti-pholcodine and anti-quaternary ammonium specific IgE (sIgE) were also evaluated. RESULTS: Overall, 167 cases were matched with 334 controls. NMBA-related anaphylaxis was significantly associated with pholcodine consumption (odds ratio 4.2; 95% confidence interval 2.3-7.0) and occupational exposure to quaternary ammonium compounds (odds ratio 6.1; 95% confidence interval 2.7-13.6), suggesting that apart from pholcodine, other environmental factors can also lead to sensitisation to NMBAs. Pholcodine and quaternary ammonium sIgEs had a high negative predictive value (99.9%) but a very low positive predictive value (<3%) for identifying NMBA-related reactions. CONCLUSIONS: Patients exposed to pholcodine 12 months before NMBA exposure have a significantly higher risk of an NMBA-related anaphylaxis. The low positive predictive values of pholcodine and quaternary ammonium sIgEs precludes their use to identify a population with a high risk of NMBA-related anaphylaxis. CLINICAL TRIAL REGISTRATION: NCT02250729.


Subject(s)
Ammonium Compounds , Anaphylaxis , Drug Hypersensitivity , Neuromuscular Blocking Agents , Humans , Ammonium Compounds/adverse effects , Anaphylaxis/chemically induced , Anaphylaxis/epidemiology , Anaphylaxis/diagnosis , Case-Control Studies , Drug Hypersensitivity/epidemiology , Drug Hypersensitivity/etiology , Drug Hypersensitivity/diagnosis , Immunoglobulin E , Neuromuscular Blocking Agents/adverse effects , Quaternary Ammonium Compounds/adverse effects
10.
Neurology ; 100(20): e2045-e2059, 2023 05 16.
Article in English | MEDLINE | ID: mdl-36963841

ABSTRACT

BACKGROUND AND OBJECTIVES: It remains unknown to what extent ictal scalp EEG can accurately predict the localization of the intracerebral seizure onset in presurgical evaluation of drug-resistant epilepsies. In this study, we aimed to define homogeneous ictal scalp EEG profiles (based on their first ictal abnormality) and assess their localizing value using simultaneously recorded scalp EEG and stereo-EEG. METHODS: We retrospectively included consecutive patients with drug-resistant focal epilepsy who had simultaneous stereo-EEG and scalp EEG recordings of at least 1 seizure in the epileptology unit in Nancy, France. We analyzed 1 seizure per patient and used hierarchical cluster analysis to group similar seizure profiles on scalp EEG and then performed a descriptive analysis of their intracerebral correlates. RESULTS: We enrolled 129 patients in this study. The hierarchical cluster analysis showed 6 profiles on scalp EEG first modification. None were specific to a single intracerebral localization. The "normal EEG" and "blurred EEG" clusters (early muscle artifacts) comprised only 5 patients each and corresponded to no preferential intracerebral localization. The "temporal discharge" cluster (n = 46) was characterized by theta or delta discharges on ipsilateral anterior temporal scalp electrodes and corresponded to a preferential mesial temporal intracerebral localization. The "posterior discharge" cluster (n = 42) was characterized by posterior ipsilateral or contralateral rhythmic alpha discharges or slow waves on scalp and corresponded to a preferential temporal localization. However, this profile was the statistically most frequent scalp EEG correlate of occipital and parietal seizures. The "diffuse suppression" cluster (n = 9) was characterized by a bilateral and diffuse background activity suppression on scalp and corresponded to mesial, and particularly insulo-opercular, localization. Finally, the "frontal discharge" cluster (n = 22) was characterized by bilateral frontal rhythmic fast activity or preictal spike on scalp and corresponded to preferential ventrodorsal frontal intracerebral localizations. DISCUSSION: The hierarchical cluster analysis identified 6 seizure profiles regarding the first abnormality on scalp EEG. None of them were specific of a single intracerebral localization. Nevertheless, the strong relationships between the "temporal," "frontal," "diffuse suppression," and "posterior" profiles and intracerebral discharge localizations may contribute to hierarchize hypotheses derived from ictal scalp EEG analysis regarding intracerebral seizure onset.


Subject(s)
Drug Resistant Epilepsy , Epilepsy, Temporal Lobe , Humans , Epilepsy, Temporal Lobe/surgery , Scalp , Retrospective Studies , Patient Discharge , Seizures/diagnosis , Electroencephalography
11.
Child Youth Serv Rev ; 147: 106842, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36741817

ABSTRACT

Nearly 1.6 billion of children and young people in more than 190 countries have been affected by school closures under the first lockdown due to the coronavirus disease. This study aimed to investigate child-reported and parent-rated health-related quality of life among 8- to 18-year-olds and the agreement between the children's assessments and those of their parents during lockdown. A cross-sectional study was conducted among French children living in the Grand Est area. An online survey was used to collect data on the children's sociodemographics, living environments, education and HRQoL. The latter was assessed with KIDSCREEN-27, which consists of five domains. Sex and age differences in parent ratings and child-reported data were analyzed using Mann-Whitney tests. Child-parent agreement was analyzed using the intraclass correlation coefficient (ICC). In total, 471 child-parent pairs from 341 households were included. Compared to European norms, children scored lower on all dimensions during the first lockdown: physical well-being (45.9/49.94 EU), psychological well-being (48.8/49.77 EU), parent relations and autonomy (47.7/49.99 EU), social support and peers (36.4/49.94 EU) and school (48.2/50 EU). Significant child-reported sex and age differences were identified for both psychological and physical well-being dimensions. Moderate to good agreement existed between children's and parents' ratings on all KIDSCREEN dimensions (ICC ranged from 0.60 to 0.76). The study suggests the need to focus on children's social support and peers during epidemics and to consider the children's self-reported HRQoL. Additional research should be conducted to identify ways of minimizing the gap between mental health needs and the services available and to help more children maintain their physical and mental health during the current crisis.

12.
Article in English | MEDLINE | ID: mdl-36768059

ABSTRACT

Recovery from substance use disorder requires access to effective coping resources. The most widely self-reported questionnaire used to assess coping responses is the Brief COPE; however, different factorial structures were found in a variety of samples. This study aimed to examine across outpatients with substance use disorders the factor structure of the short dispositional French version of the Brief Coping Orientation to Problem Experienced (COPE) inventory. The French version of the Brief COPE was administered in a sample of 318 outpatients with alcohol or opioid substance use disorder. A clustering analysis on latent variables (CLV) followed by a confirmatory factorial analysis (CFA) was conducted to examine the factor structure of the scale. The internal consistency of the Brief COPE and its subscales were also studied. The analysis revealed a nine-factor structure with a revised 24-item version consisting of functional strategies (four items), problem-solving (four items), denial (two items), substance use (two items), social support seeking (four items), behavioral disengagement (two items), religion (two items), blame (two items), and humor (two items) that demonstrated a good fit to the data. This model explained 53% of the total variance with an overall McDonald's omega (ω) of 0.96 for the revised scale. The present work offers a robust and valid nine-factor structure for assessing coping strategies in French outpatients with opioid or alcohol substance use disorder. This structure tends to simplify its use and interpretation of results for both clinicians and researchers.


Subject(s)
Alcoholism , Opioid-Related Disorders , Humans , Analgesics, Opioid , Outpatients , Adaptation, Psychological , Surveys and Questionnaires , Reproducibility of Results , Psychometrics
13.
Clin Gastroenterol Hepatol ; 21(3): 771-788.e10, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36152897

ABSTRACT

BACKGROUND AND AIMS: There is a need to evaluate the benefit-risk ratio of current therapies in inflammatory bowel disease (IBD) patients to provide the best quality of care. The primary objective of I-CARE (IBD Cancer and serious infections in Europe) was to assess prospectively safety concerns in IBD, with specific focus on the risk of cancer/lymphoma and serious infections in patients treated with anti-tumor necrosis factor and other biologic monotherapy as well as in combination with immunomodulators. METHODS: I-CARE was designed as a European prospective longitudinal observational multicenter cohort study to include patients with a diagnosis of Crohn's disease, ulcerative colitis, or IBD unclassified established at least 3 months prior to enrollment. RESULTS: A total of 10,206 patients were enrolled between March 2016 and April 2019, including 6169 (60.4%) patients with Crohn's disease, 3853 (37.8%) with ulcerative colitis, and 184 (1.8%) with a diagnosis of IBD unclassified. Thirty-two percent of patients were receiving azathioprine/thiopurines, 4.6% 6-mercaptopurine, and 3.2% methotrexate at study entry. At inclusion, 47.3% of patients were treated with an anti-tumor necrosis factor agent, 8.8% with vedolizumab, and 3.4% with ustekinumab. Roughly one-quarter of patients (26.8%) underwent prior IBD-related surgery. Sixty-six percent of patients had been previously treated with systemic steroids. Three percent of patients had a medical history of cancer prior to inclusion and 1.1% had a history of colonic, esophageal, or uterine cervix high-grade dysplasia. CONCLUSIONS: I-CARE is an ongoing investigator-initiated observational European prospective cohort study that will provide unique information on the long-term benefits and risks of biological therapies in IBD patients. (EudraCT, Number: 2014-004728-23; ClinicalTrials.gov, Number: NCT02377258).


Subject(s)
Biological Products , Colitis, Ulcerative , Crohn Disease , Inflammatory Bowel Diseases , Female , Humans , Cohort Studies , Colitis, Ulcerative/diagnosis , Crohn Disease/diagnosis , Immunologic Factors/adverse effects , Immunosuppressive Agents , Inflammatory Bowel Diseases/chemically induced , Necrosis , Prospective Studies , Tumor Necrosis Factor-alpha
14.
J Clin Med ; 11(23)2022 Nov 25.
Article in English | MEDLINE | ID: mdl-36498541

ABSTRACT

Introduction: Data about the safety of vedolizumab and ustekinumab are lacking in older patients with inflammatory bowel disease. The objective was to compare the safety of vedolizumab and ustekinumab therapies in older patients (>60 years) with inflammatory bowel disease. Methods: This retrospective study included patients with Crohn's disease or ulcerative colitis initiating vedolizumab, ustekinumab or anti-TNF therapy at >60 years of age. We examined the occurrence of adverse events within one year after therapy. Results: This study included 182 patients: 53 were treated with vedolizumab (22 patients with Crohn's disease and 31 with ulcerative colitis), 31 with ustekinumab (30 Crohn's disease and one ulcerative colitis) and 98 with anti-TNF (63 Crohn's disease and 35 ulcerative colitis). At one year, there was no difference in terms of safety in patients with Crohn's disease between vedolizumab and ustekinumab considering the number of adverse events per year of follow-up (p = 0.258). For ulcerative colitis and Crohn's disease, the occurrence of adverse events per year of follow-up was similar between vedolizumab and anti-TNF (p = 0.274 and p = 0.876, respectively). Conclusions: Safety was similar between vedolizumab and ustekinumab in older patients with inflammatory bowel disease.

15.
Article in English | MEDLINE | ID: mdl-36361238

ABSTRACT

Billions of children/adolescents experienced unprecedented changes in their daily lives that impacted their health-related quality of life (HRQoL) during the first wave of the coronavirus disease 2019. The purpose of this study was to describe child-parent discrepancies in reporting on HRQoL and explore factors associated with such discrepancies at the end of the first lockdown in France. A cross-sectional study was conducted among French school-aged children from 8 to 18 years and their parents living in the Grand Est region in France during the first wave of the epidemic. The impact of individual, self-reported health status and environmental data on discrepant parent-child reports of HRQoL was assessed by multinomial multivariable logistic regression models. A total of 471 parent-child pairs were included. Among 50% of the discordant pairs, parents underestimated HRQoL more frequently than they overestimated it. Home location, social support score, children's education level, parents' education level, tensions and conflicts with neighbors reported by children, whether they had access to a garden, and parents' professional activity were significantly associated with parental overestimation (adjustedOR from 2.08 to 11.61; p < 0.05). Factors associated with parental underestimation were children's education level, SF12 score, home location, the child's gender, parent's level of education, the presence of noise in the residence reported by children, whether a household member was infected with COVID-19, whether they had access to a garden, and family structure (adjustedOR from 1.60 to 4.0; p < 0.05). This study revealed differences between child-reported and parent-reported HRQoL. The COVID-19 pandemic accentuated the discrepancies in observable dimensions and attenuated them in unobservable dimensions of HRQoL but did not impact the directional discrepancy; parents underestimated their child's HRQoL more. These discrepancies appear to be explained by parent and child sociodemographic factors.


Subject(s)
COVID-19 , Quality of Life , Humans , Adolescent , Child , COVID-19/epidemiology , Surveys and Questionnaires , Pandemics , Cross-Sectional Studies , Communicable Disease Control
16.
Article in English | MEDLINE | ID: mdl-36078712

ABSTRACT

The COVID-19 pandemic has led to widespread social isolation. This study aimed to determine anxiety levels among parents of school-aged children and investigate the associated factors. Data on sociodemographic characteristics, living and working conditions, family relationships, social support (MSPSS) and health status (SF-12) were collected from French parents through an online survey. The Generalized Anxiety Disorder Scale (GAD-7) was used to assess anxiety. Logistic regression analysis was performed to identify the factors associated with moderate to severe anxiety. Among 698 parents, 19.2% experienced moderate to severe anxiety. A low level of resilience (OR = 4.3, 95% CI: 2.7-6.7) and confirmed COVID-19 cases involving hospitalization (OR = 3.8, 95% CI: 2.0-7.3) among individuals in one's household or in the family circle were found to be the main risk factors for moderate to severe anxiety. Other factors were also identified: a level of education less than high school (OR = 2.1, 95% CI: 1.3-3.2), conflicts at home (OR = 2.3, 95% CI: 1.4-3.7), noises outside the home (OR = 2.0, 95% CI: 1.0-3.9), confirmed cases not involving hospitalization (OR = 1.8, 95% CI: 1.0-3.1) and suspected cases (OR = 1.9, 95% CI: 1.0-3.8). Family support was a protective factor. These findings suggest some need for support programs to help parents cope with public health crises and work-family challenges.


Subject(s)
COVID-19 , Anxiety/epidemiology , Anxiety/psychology , COVID-19/epidemiology , Child , Communicable Disease Control , Health Status , Humans , Pandemics , SARS-CoV-2
17.
J Clin Med ; 11(15)2022 Aug 04.
Article in English | MEDLINE | ID: mdl-35956153

ABSTRACT

Background: Extra-intestinal manifestations are frequent in inflammatory bowel disease (IBD). Ocular disorders are generally under diagnosed as they are challenging diagnosis. Aims: We assessed the prevalence of ophthalmological manifestations in patients with IBD, and investigated characteristics associated with ocular manifestations. Methods: We performed a retrospective study including patients followed for IBD and had an ophthalmologic visit from January 2013 to July 2020, among 1432 patients followed during this period. Two groups were considered: the first group included patients whose an ocular diagnosis was considered as "related to IBD", and the second group including patients whose an ocular diagnosis was considered "not related to IBD". Results: Among 1432 patients with IBD, eighty-seven (6.1%) patients had an ophthalmologic visit. Fifty-three patients (3.7%) were considered to have an ocular extra-intestinal manifestation or an iatrogenic effect of IBD treatment, and 34 diagnoses (2.4%) were considered not related to IBD. Inflammatory surface pathologies were the most frequent (33.2%), including 15 patients with dry eye (17.2%), 9 with blepharitis (10.3%), and 5 with chalazions (meibomian cyst) (5.7%). Uveitis was diagnosed in 13 patients (14.9%), episcleritis in 5 patients (5.7%), and scleritis in 2 patients (2.3%). Characteristics of patients with an ophthalmological diagnosis "related to IBD" versus "not related to IBD" were not statistically different. Conclusion: In our cohort, less than 5% of patients had ophthalmological extra-intestinal manifestation. The most frequent ocular diagnosis were dry eye and uveitis. No disease characteristics of IBD were found to be associated with ocular manifestations.

18.
Respir Care ; 67(9): 1154-1160, 2022 09.
Article in English | MEDLINE | ID: mdl-35820703

ABSTRACT

BACKGROUND: Arterial cannulation is an important procedure for hemodynamic monitoring and blood sampling. Traditional radial artery cannulation is performed by using anatomical knowledge and pulse palpation as a guide. Arterial cannulation using ultrasound (US) requires specific training, especially for new US users. We hypothesized that even for new US users, US guidance would facilitate the successful puncture by lower attempts before successful intraluminal cannulation of a simulation model of the radial artery. METHODS: A prospective randomized controlled crossover study was conducted with new US users on a gelatin phantom wrist. Three sessions of training were proposed: US-guided technique with low blood pressure (BP), palpation-guided technique with high BP, and one secondary comparison with low BP. For the 2 first sessions, all volunteers performed each technique but not in the same order. The main criterion was the number of attempts before successful catheterization of the model artery. A secondary criterion was the number of needle movements (the number of attempts plus the number of needle directional changes). RESULTS: Twenty new US users participated in the study. Numbers of attempts before successful catheterization were significantly lower when using the US technique: 1.1 (± 0.4) for US versus 1.6 (± 0.8) for palpation high BP (P = .02) versus 2.5 (± 1.4) for the secondary comparison, palpation low BP (P < .001). All of the participants achieved success after the 12th needle movement for US technique, after the 19th needle movement for palpation high BP, and after the 25th needle movement for the secondary comparison, palpation low BP. The total time before success was not significantly different between the 2 first sequences (US vs palpation high BP). CONCLUSIONS: US technique was more successful than traditional palpation technique for novice US users performing arterial cannulations for the first time. A study in the clinical practice is needed to confirm these results.


Subject(s)
Catheterization, Peripheral , Hypotension , Simulation Training , Catheterization, Peripheral/methods , Cross-Over Studies , Humans , Palpation/methods , Prospective Studies , Radial Artery/diagnostic imaging , Ultrasonography, Interventional
19.
BMC Public Health ; 22(1): 517, 2022 03 16.
Article in English | MEDLINE | ID: mdl-35296280

ABSTRACT

INTRODUCTION: COVID-19 lockdown measures resulted in children and adolescents staying and learning at home. This study investigated health-related quality of life (HRQoL) and its associated factors among youth during the first lockdown. METHODS: A cross-sectional study was conducted among 8- to 18-year-olds from the French Grand Est region. Sociodemographic data and information on living and learning conditions were collected using an online survey. HRQoL was assessed using the KIDSCREEN-27. Multiple regression analysis was performed to explore factors related to low HRQoL in each dimension. RESULTS: In total, 471 children from 341 households were included. Difficulties isolating at home were associated with low HRQoL in the psychological well-being (OR = 2.2, 95% CI: 1.2-4.0) and parent relations and autonomy (OR = 2.1, 95% CI: 1.2-3.8) dimensions. Conflicts with dwelling occupants were related to increased ORs in the psychological well-being (OR = 2.9, 95% CI: 1.9-4.6), parent relations and autonomy (OR = 2.2, 95% CI: 1.4-3.4) and school environment (OR = 2.4, 95% CI: 1.5-3.7) dimensions. Living in an apartment (OR = 1.8, 95% CI: 1.1-3.1), never leaving home (OR = 2.6, 95% CI: 1.2-5.9), having indoor noise at home (OR = 2.3, 95% CI: 1.2-4.6), and having a parent with high anxiety (OR = 1.8, 95% CI: 1.1-3.1) were associated with low HRQoL in the social support and peers dimension. Children working less than 1 h/day on schoolwork had an increased OR of 3.5 (95% CI: 1.4-9.0) in the school environment dimension. CONCLUSION: Living and learning conditions were associated with low HRQoL among children and adolescents during the COVID-19 lockdown. Prevention and intervention programs are needed to support youth by facilitating their interactions and improving their coping and to prepare for future waves.


Subject(s)
COVID-19 , Quality of Life , Adolescent , COVID-19/epidemiology , Child , Communicable Disease Control , Cross-Sectional Studies , Humans , Quality of Life/psychology , Surveys and Questionnaires
20.
Health Qual Life Outcomes ; 20(1): 26, 2022 Feb 16.
Article in English | MEDLINE | ID: mdl-35172824

ABSTRACT

BACKGROUND: Health-related quality of life (HRQoL) is an important element of patient care and clinical research. The aim of this study was to describe HRQoL changes and identify associated factors during a 6-month follow-up of outpatients starting care for alcohol or opioid dependence. METHODS: HRQoL was measured at baseline and 3 and 6 months later using the SF-12. Data on the patients' sociodemographics, clinical characteristics and levels of anxiety and depression were collected using the Hospital Anxiety and Depression Scale (HADS). Repeated-measures analyses were performed to assess factors associated with global HRQoL differences and the evolution of HRQoL indicated by both physical and mental scores (PCS and MCS, respectively). RESULTS: The mean PCS and MCS scores were initially low at 45.4 (SD = 8.6) and 36.0 (SD = 10.9), respectively. The improvement in HRQoL was rapid in the first 3-month period and then slowed and remained stable over the subsequent 3-month period. Being employed (p = 0.012), having no comorbidities (p = 0.014) and having no depression (p = 0.004) were associated with significant differences in the average PCS scores at the 3 time points. Patients who had lower overall HRQoL MCS scores on average were those for whom a medication was initiated (p = 0.009), as was the case for patients with anxiety (p < 0.001) and depression (p < 0.001). Patients with depression at baseline were also those for whom a significantly greater increase in MCS score during the 6 months of follow-up was observed. CONCLUSION: Our findings highlight the importance of screening early psychological distress and considering other factors associated with HRQoL changes in outpatients after the first 3-month period of treatment for substance use disorder.


Subject(s)
Quality of Life , Substance-Related Disorders , Anxiety , Comorbidity , Humans , Outpatients , Quality of Life/psychology
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