I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease.

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).

Combination of serum and peritoneal 1.3-beta-D-glucan can rule out intra-abdominal candidiasis in surgical critically ill patients: a multicenter prospective study.

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).

Pholcodine exposure increases the risk of perioperative anaphylaxis to neuromuscular blocking agents: the ALPHO case-control study.

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.

Measuring COVID-19 related stress and its associated factors among the parents of school-aged children during the first lockdown in France.

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.

Child self-report and child-parent agreement regarding health-related quality of life under COVID-19 lockdown in the French Grand Est area.

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.

A Magnetic Resonance Imaging Index to Predict Crohn's Disease Postoperative Recurrence: The MONITOR Index.

BACKGROUND & AIMS: We developed and validated a magnetic resonance imaging-based index to predict Crohn's disease (CD) postoperative recurrence (POR). METHODS: Patients with CD who underwent a postoperative evaluation for recurrence (with colonoscopy and MRI no longer than 105 days apart) were included between 2006 and 2016 in University Hospital of Nancy, France. MRI items with good levels of intra-rater and inter-rater agreement (Gwet's coefficient ≥0.5) were selected. The MRI in Crohn's Disease to Predict Postoperative Recurrence (MONITOR) index's performance was assessed in terms of the area under the receiver operating characteristic curve (AUROC) and accuracy, by considering the Rutgeerts score as the gold standard. The MONITOR index was validated with a bootstrap method and an independent cohort. RESULTS: Seventy-three MRI datasets were interpreted by 2 radiologists. Seven items (bowel wall thickness, contrast enhancement, T2 signal increase, diffusion-weighted signal increase, edema, ulcers, and the length of the diseased segment) had a Gwet's coefficient ≥0.5 and were significantly associated with the Rutgeerts score, leading to their inclusion in the MONITOR index. All the items had a weighting of 1, except the "ulcers" item weighting 2.5, reflecting the higher adjusted odds ratio. The AUROC [95% confidence interval] for the prediction of endoscopic POR (Rutgeerts score >i1) was 0.80 [0.70-0.90]. The optimal threshold was a MONITOR index ≥1, giving a sensitivity of 79%, a specificity of 55%, a predictive positive value of 68%, and a predictive negative value of 68%. The bootstrap validation gave an AUROC of 0.85 [0.73-0.97]. In the validation cohort, a MONITOR index ≥1 gave a sensitivity of 87%, a specificity of 75%, a predictive positive value of 84.6%, and a predictive negative value of 75%. CONCLUSIONS: The MONITOR index is an efficient, reliable, easy-to-apply tool that can be used in clinical practice to predict the POR of CD.

Impact of HIV Infection on the Course of Inflammatory Bowel Disease and Drug Safety Profile: A Multicenter GETAID Study.

BACKGROUND AND AIMS: Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), and human immunodeficiency virus (HIV) both impact innate and adaptive immunity in the intestinal mucosa. As it is a rare situation, the intersection between HIV and IBD remains unclear, especially the impact of HIV infection on the course of IBD, and the drug safety profile is unknown. METHODS: We conducted a multicenter retrospective cohort study between January 2019 and August 2020. All adult patients with IBD and concomitant HIV infection were included. Each IBD patient with HIV was matched to two HIV-uninfected IBD patients. RESULTS: Overall, 195 patients with IBD were included, including 65 HIV-infected patients and 130 without HIV infection. Of the 65 infected patients, 22 (33.8%) required immunosuppressants and 31 (47.7%) biologics. In the HIV-infected group, the need for immunosuppressants (p = 0.034 for CD and p = 0.012 for UC) and biologics (p = 0.004 for CD and p = 0.008 for UC) was significantly lower. The disease course, using a severity composite criterion, was not significantly different between the two groups for CD (hazard ration (HR) = 1.3 [0.7; 2.4], p = 0.45) and UC (HR, 1.1 [0.5; 2.7], p = 0.767). The overall drug safety profile was statistically similar between the two groups. CONCLUSION: Although HIV-infected patients receive less treatments, the course of their IBD did not differ than uninfected, suggesting that HIV infection might attenuate IBD. The drug safety profile is reassuring, allowing physician to treat these patients according to current recommendations.

Health-related quality of life in outpatients with substance use disorder: evolution over time and associated factors.

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.

The effects of living and learning conditions on the health-related quality of life of children and adolescents during the COVID-19 lockdown in the French Grand Est region.

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.

Risk of Late Postoperative Recurrence of Crohn's Disease in Patients in Endoscopic Remission After Ileocecal Resection, Over 10 Years at Multiple Centers.

BACKGROUND & AIMS: The risk of recurrence of Crohn's disease (CD) from 1 to 10 years after surgery despite initial endoscopic remission (late post-operative recurrence) is not clear. METHODS: We performed a retrospective study, at 3 inflammatory bowel disease (IBD) centers in France and Belgium, of all patients with CD (n = 86) undergoing an ileocecal resection with curative intent from 2006 through 2016 who did not have endoscopic evidence for recurrence (Rutgeerts score less than i2) at their baseline assessment. Postoperative recurrence after baseline endoscopy was defined as a composite endpoint of at least 1 of the following: clinical recurrence, IBD-related hospitalization, occurrence of bowel damage, need for endoscopic balloon dilatation of the anastomosis, and need to repeat the surgery. Risk of mucosal disease progression was studied as a secondary outcome. RESULTS: The median time between surgery and baseline endoscopy was 7 months (IQR, 5.7-9.5 months); 40 patients (46.5%) received medical prophylaxis in this period. The median follow-up time was 3.5 years (IQR, 1.6-5.3 years). Thirty-five patients (40.7%) had a late post-operative recurrence of CD, with a median time to disease recurrence after baseline endoscopy of 14.2 months (IQR, 6.3-26.1 months). Recurrence status did not differ significantly between patients with Rutgeerts scores of i0 (20/55) or i1 (15/31) at baseline (P = .28) and was independent of medical prophylaxis (16/40 with prophylactic therapy vs 19/46 without prophylactic therapy; P = .90). Mucosal disease progressed in 29 of the 71 patients (40.8%) with available data. We did not identify risk factors for late post-operative recurrence of CD or mucosal disease progression. CONCLUSIONS: Among patients with CD treated by ileocecal resection, 40% of patients had a late recurrence, despite initial endoscopic remission, after a median follow-up time of 3.5 years. Tight monitoring of these patients is recommended beyond 18 months.

Incidence of and Risk Factors for Colorectal Strictures in Ulcerative Colitis: A Multicenter Study.

BACKGROUND & AIMS: Ulcerative colitis (UC) is increasingly recognized as a progressive disease and patients with long-standing disease can develop colorectal stricture. Few data about its incidence in UC are available, while risk factors for colorectal strictures in UC remain to be determined. We assessed the incidence of and risk factors for developing colorectal strictures in a large UC population. METHODS: All adult patients followed at Nancy University hospital and at the centre hospitalier de Luxembourg for UC, between January 2004 and July 2019, were eligible for inclusion in this multicenter retrospective cohort study. RESULTS: A total of 439 patients with UC were included. Median follow-up duration was 9.6 years. Incidence of colorectal stricture was 3.6%. The cumulative probability of developing this complication was 1% at 5 years and 2.3% at 10 years. Median age at stricture diagnosis was 47.9 years (41.0; 63.0), and median time from UC diagnosis to onset of stricture was 11.5 years (5; 15.3). Montreal A3 classification (age > 40 years) (P = .008) and steroids use (HR = 4.1; 95% CI, 1.1-16.1) were independent risk factors for stricture, whereas mesalamine-treated patients carried a lower risk (HR = 0.3; 95% CI, 0.1-0.9). Dysplasia was found in 6 patients with strictures (42.9%) and among them 5 developed a colorectal cancer (33.3%). CONCLUSIONS: Patients with Montreal A3 classification and those exposed to steroids have a higher risk for strictures, while use of mesalamine lowers this risk. These factors should be assessed in daily clinical practice to prevent stricture occurrence in these patients.

Effect of the COVID-19 outbreak and lockdown on mental health among post-secondary students in the Grand Est region of France: results of the PIMS-CoV19 study.

BACKGROUND: The COVID-19 epidemic has sent students around the world in to lockdown. This study sought to assess the prevalence of impaired self-perceived mental health and identify associated factors among French post-secondary students during the lockdown. METHODS: A cross-sectional study was conducted among French students living in the Grand Est area in France from May 7 to 17, 2020 during the first lockdown. An online survey was used to collect sociodemographic data, learning and teaching conditions, living conditions, and exposure to COVID-19, and self-perceived mental health was assessed with mental composite score (MCS) of the SF-12. RESULTS: Overall, 4018 were analyzed. Most participants were female (70.7%), and the mean age was 21.7 years (SD 4.0). The mean MCS score was 44.5 (SD 17.3). Impaired mental health, defined by a MCS < 1st Quartile, was mainly associated with female sex; decreased time for learning; not having access to the outside with a garden, a terrace or a balcony; difficulties with the living situation and having someone in the home affected by the SARS-COV2 requiring hospitalization or not. CONCLUSIONS: This study showed that living conditions during lockdown had a clear impact on the mental health of French post-secondary students. There is a need to improve prevention and to access distance education as well as an urgent need for measures to develop healthy coping strategies for students. This is significant challenge and will assist in moderating the risk for the development of further distress and mental health concerns.

Burnout profiles among French workers in health units for inmates: results of the EHCAU study.

BACKGROUND: Health care personnel who work in penitentiary environments are at risk of burnout due to a variety of factors. Latest research have brought forward a classification system consisting of five burnout profiles on a continuum between engagement and burnout. The objective of this study was to measure the prevalence of these profiles among professionals working in French health units providing health services for inmates according to the three levels of care and to investigate their characteristics to propose appropriate management and prevention approaches. METHODS: This study involved a cross-sectional analysis of data from the Evaluation of Health CAre in Units for inmates (EHCAU) study, a multicentric cohort study of professionals practising in health units for inmates in eastern France. Burnout was assessed by the Maslach Burnout Inventory (MBI) at the levels of emotional exhaustion, depersonalization and personal accomplishment. Job conditions and characteristics were measured using the Karasek Job Content Questionnaire and the Effort-Reward Imbalance Questionnaire. Data on sociodemographic characteristics and self-reported health status were also collected. Differences between MBI profiles were identified using Fisher's exact test and the Wilcoxon test. RESULTS: Of the 350 professionals surveyed, 150 responded (42.9%). The most frequent profiles were ineffective (36.9%) and engagement (34.8%). The burnout (7.8%), overextended (15.6%) and disengaged (5.0%) profiles made up the remaining quarter. Significant differences in the burnout profiles were observed in regard to professional occupation (p = 0.01), irregular eating hours (p = 0.04), history of complaint procedures (p = 0.05), anxiety (p < 0.0001), depression (p < 0.0001) and the mental component of self-reported quality of life (p < 0.0001). CONCLUSIONS: These results confirm that special attention should be given to professionals working in these challenging settings. The results have important implications for theory and research and for more customized approach interventions. TRIAL REGISTRATION: ID RCB: 2018-A03029-46.

A modified train-of-four ratio to assess recovery from depolarizing neuromuscular blockade after succinylcholine, a prospective observational study.

Succinylcholine is still used in clinical practice. Its duration is highly variable and neuromuscular monitoring is recommended to assess its recovery. Unfortunately, depolarizing neuromuscular block cannot be evaluated by train-of-four (TOF) as no fade occurs. Only single twitch (ST) allows to monitor depolarizing block. The TOFScan monitor proposes a modified TOF ratio (T4/Tref) not referring to fade within a TOF series. We hypothesized that the T4/Tref allows to assess recovery from succinylcholine. This observational study aims to compare recovery from depolarizing block simultaneously assessed with T4/Tref and ST. After Ethics Committee approval and written informed consent 45 patients receiving a single dose of succinylcholine were included. ST recovery, measured with TOF-Watch SX, and T4/Tref recovery, measured by TOFScan, were assessed simultaneously. Difference between measurements was compared using Mann-Whitney U test and overall concordance with the intraclass correlation coefficient (ICC). The ICC was 0.85 [95% CI 0.82-0.87]. The first T4/Tref ratio ≥ 90% was 97% [95% CI 93-101%] the corresponding ST value was 91% [95% CI 87-97%]. The first T4/Tref ratio ≥ 100% was 103% [95% CI 102-107%], the corresponding ST value was 104% [95% CI 100-106%]; median [95% confidence interval of the median]. Time to recovery to 90% and 100% of baseline did not differ between ST or T4/Tref. It was10.0 [8.0-13.0] min vs 10.0 [8.0-12.0] min, P = 0.307 and 10.0 [9.0-15.0] min vs 10.0 [8.0-15.0] min, P = 0.546; respectively; median [IQR]. Agreement between both parameters was excellent. The T4/Tref can be used accurately to measure recovery from depolarizing neuromuscular block.

Cost-effectiveness of four living-donor nephrectomy techniques from a hospital perspective.

BACKGROUND: In Europe, transplantation centres use different nephrectomy techniques: open surgery, and standard, hand-assisted and robot-assisted laparoscopies. Few studies have analysed the disparity in costs and clinical outcomes between techniques. Since donors are healthy patients expecting minimum pain and fast recovery, this study aimed to compare the cost-effectiveness of four nephrectomy techniques focusing on early surgical outcomes, an essential in the donation act. METHODS: A micro-costing approach was used to estimate the cost of implementation from a hospital perspective. Estimates took into account sterilization costs for multiple-use equipment, costs for purchasing single-use equipment, staff and analgesics. The study recruited donors in 20 centres in France. Quality of life by EuroQol-5D was assessed preoperatively, and 4 and 90 days post-operatively. Two effectiveness indicators were built: quality-of-life recovery and post-operative pain days averted (PPDA). The study was registered at ClinicalTrials.gov NCT02830568, on 10 June 2010. RESULTS: A total of 264 donors were included; they underwent open surgery (n = 65), and standard (n = 65), hand-assisted (n = 65) and robot-assisted laparoscopies (n = 69). Use of the nephrectomy techniques differed greatly in cost of implementation and immediate post-operative outcomes but not in clinical outcomes at 90 days. At 4 days, hand-assisted laparoscopy provided the lowest cost per quality-of-life recovery unit of effectiveness (%) and PPDA (days) (€2056/40.1%/2.3 days, respectively). Robot-assisted laparoscopy was associated with the best post-operative outcomes but with the highest cost (€3430/59.1%/2.6 days). CONCLUSION: Hand-assisted, standard and robot-assisted laparoscopies are cost-effective techniques compared with open surgery. Hand-assisted surgery is the most cost-effective procedure. Robot-assisted surgery requires more healthcare resource use but enables the best clinical outcome.

Automatic rib unfolding in postmortem computed tomography: diagnostic evaluation of the OpenRib software compared with the autopsy in the detection of rib fractures.

OBJECTIVES: The main objective of this study was to evaluate the diagnostic performance of the OpenRib software against the gold standard of autopsy in the detection of rib fractures. The secondary objective was to measure inter-rater agreement between each radiological reader. MATERIALS AND METHODS: Thirty-six subjects who underwent postmortem CT and autopsy were included in this study. Rib fractures were first assessed during the autopsy by carefully dissecting and examining each rib. They were also independently evaluated by three readers using OpenRib software. This software produces from postmortem CT images a reformat of the rib cage and a display of all ribs in a single plane. Each reader was asked to determine if the rib was fractured and, if so, whether the fracture was single or multiple. RESULTS: After exclusions, 649 ribs were included in the statistical analysis. The two readers with a similar level of experience showed a satisfactory inter-rater agreement and a sensitivity of 0.73 and 0.83 with a specificity of 0.95 and 0.91. However, the experienced reader diagnosed significantly more fractures than the autopsy and the other two readers (p < 0.001). CONCLUSION: The use of automatic rib unfolding software in postmortem CT allows an efficient and accurate assessment of rib fractures and enables the diagnosis of fractures that cannot be detected during a standard autopsy. For now, this method seems to be the simplest that can be routinely performed; however, it requires training time in order to be sufficiently effective.

Patient's early satisfaction with care: a predictor of health-related quality of life change among outpatients with substance dependence.

BACKGROUND: Although research on health-related quality of life (HRQoL) has increased in the addiction field, few studies have focused on the determinants of HRQoL changes. This study aimed to describe dependent patients' HRQoL changes at a 3-month follow-up and to assess whether satisfaction with care can predict those changes among outpatients starting care for alcohol or opioid dependence. METHODS: HRQoL was measured with the SF-12 at baseline and 3 months later in a prospective cohort of dependent outpatients. Satisfaction was assessed with the EQS-C early after inclusion. Data on sociodemographics, clinical characteristics and patients' levels of anxiety and depression were also collected. A multivariable analysis was performed to identify factors associated with HRQoL changes in both the physical and mental component summary scores (PCS and MCS, respectively). RESULTS: Of the 172 patients included at baseline, a total of 136 patients assessed their satisfaction with care. The mean PCS and MCS scores were initially low, and HRQoL improvement was significant after 3 months for both the PCS and MCS. Never having been married (ß = 5.5; p = 0.001) and a lower baseline PCS score (ß = - 0.6; p < 0.0001) were associated with significant PCS improvement, whereas being legally compelled to undergo drug treatment (ß = - 5.9; p = 0.02) was associated with less PCS change. Higher early satisfaction with care (ß = 0.1; p = 0.02) and a lower baseline MCS score (ß = - 0.7; p < 0.0001) were associated with significant MCS improvement. CONCLUSION: The study supported the hypothesis that greater satisfaction with care may predict HRQoL improvement among dependent outpatients. Further studies are needed to understand the factors that affect patients' early satisfaction to identify areas of improvement and thus improve HRQoL.

Comparison of sTREM-1 and associated periodontal and bacterial factors before/after periodontal therapy, and impact of psychosocial factors.

AIM: The immune receptor triggering receptor expressed on myeloid cell-1 (TREM-1) is responsible for an amplification of the immuno-inflammatory response in inflammatory diseases. Its role in the aetiopathogenesis of periodontitis is underexplored. The aim of this case-control and before-after study was to determine the evolution of soluble form of TREM-1 (sTREM-1) concentrations after scaling and root planing (SRP), and its prognostic value and evaluate associated microbial, periodontal and psychosocial factors. METHODS: Gingival crevicular fluid was collected in two pathological sites (periodontal pocket depth (PPD) ≥ 5 mm) and one healthy site (PPD ≤ 3 mm) from thirty periodontitis patients (before/after SRP), and in one healthy site from thirty controls (patients without periodontal disease). Each patient filled-in stress/anxiety self-assessment questionnaires and provided a saliva sample. Diseased patients were followed for a total of 13-15 weeks in initial periodontal treatment. sTREM-1 and salivary cortisol levels were determined by ELISA and periodontopathogens by PCR. RESULTS: Before SRP, higher crevicular sTREM-1 levels were positively associated with some increased clinical parameters (Plaque Index, tooth mobility, bleeding on probing, p < .05) and inversely with Aggregatibacter actinomycetemcomitans abundance (p = .03). No correlation with psychological factors nor cortisol was found with salivary sTREM-1 concentrations. After SRP, crevicular sTREM-1 levels decreased (p < .001) and were not linked to a PPD decrease but remained higher in pathological than in healthy sites (p < .001). Higher concentrations were also found out in unimproved sites (no change or increase in PPD) compared to improved ones (p = .02). Higher sTREM-1 levels were associated with Porphyromonas gingivalis, Treponema denticola and Campylobacter rectus in pathological sites after SRP (p < .05). CONCLUSION: Crevicular sTREM-1 level decreased after SRP but did not appear to be a site outcome predictive factor of periodontal healing and remained an inflammatory parameter.

Relationships between coping, anxiety, depression and health-related quality of life in outpatients with substance use disorders: results of the SUBUSQOL study.

Previous research showed that coping strategies are associated with depressive symptoms and health-related quality of life (HRQoL) in patients with chronic somatic conditions. The aim of this study was to examine the coping strategies used in patients with substance use disorders and to assess the relationships between coping strategies, HRQoL, anxiety and depression. Coping was assessed in a prospective outpatient cohort by the Brief COPE. Additionally, sociodemographic and clinical data were collected, and questionnaires assessing HRQoL (SF-12) and states of anxiety and depression were completed. Cross-sectional analysis using Pearson correlations and multiple linear regression was performed. A total of 244 patients were included. Acceptance, planning and self-blame were the most used coping strategies. Strong correlations were found between anxiety, depression, coping strategies and HRQoL. On the MCS-12, better scores were associated with male gender, lack of anxiety or depression and coping styles based on less self-blame, on positive reframing, acceptance, and behavioral disengagement. Patients without depression or anxiety, and no comorbidity had better scores on the SF-12 PCS. Coping strategies of substance-dependent outpatients should be assessed, as they might be useful for identifying patients in need of support. Furthermore, interventions that improve coping capabilities might be helpful for improving HRQoL.

Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial.

BACKGROUND: There is a controversy in the literature whether deep compared with moderate neuromuscular block (NMB) improves surgical conditions for laparoscopic surgery. OBJECTIVES: The primary outcome measure was to examine whether switching from moderate to deep NMB improves surgical conditions for laparoscopic surgery in the obese; secondary outcome measures were changes in intra-abdominal pressure, time required to perform the gastrojejunal anastomosis and peri-operative surgical complications. DESIGN: A single-centre, randomised controlled study. Each patient was taken as their own control and examined twice: at the first evaluation (E1), all patients had a moderate NMB, thereafter patients were randomised to deep or moderate block and a second evaluation (E2) was performed within 10 min. Patients with excellent rating at E1 were excluded from E2, as their surgical condition could not be further improved. SETTING: University Hospital France. PATIENTS: Patients undergoing laparoscopic gastric bypass surgery under general anaesthesia were included. Main exclusion criteria were hypersensitivity to the drugs used and absence of written informed consent. INTERVENTIONS: According to the group assignment, patients received bolus doses of rocuronium or 0.9% saline. MAIN OUTCOME MEASURES: Surgical conditions were assessed with a 4-point rating scale. Intra-operative adverse events were assessed with the Kaafarani-classification and postoperative complications with the Clavien-Dindo classification. RESULTS: Eighty-nine patients were initially included and data from 85 could be assessed at E1; surgical rating was excellent in 20, good in 35, acceptable in 18, poor in 12. After excluding those with an excellent rating, the remaining 65 patients were randomly assigned to deep or moderate block. At E2, an improvement of surgical conditions was observed in 29 out of 34 patients with deep block and in four out of 31 with moderate block; P < 0.0001. Poor surgical conditions were more frequently associated with surgical complications (61.5 versus 15.3%; P < 0.001). CONCLUSION: Switching from moderate to deep block improves surgical conditions. Poor surgical conditions were associated with a higher incidence of surgical complications. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02118844.