Risk of anti-TNF therapy on pregnancy, breastfeeding, live vaccines and related information in patients with inflammatory bowel disease: Real-world data from a nationwide study.

BACKGROUND: Anti-TNF are usually maintained during pregnancy in patients with inflammatory bowel disease (IBD) but safety is still a concern for them. AIMS: To provide data on management of anti-TNF agents during pregnancy, safety of live vaccines (BCG-MMR-rotavirus) and breastfeeding in newborns and dedicated information delivered to IBD women. METHODS: We performed an observational study in 25 centers from 2016 to 2018. We administered questionnaires to women with IBD receiving anti-TNF during pregnancy with newborn follow-up ≥ one year. RESULTS: Of 153 patients, 52 % maintained anti-TNF during the third trimester. Anti-TNF was shortly resumed in 79 % (58/73) after delivery. The rate of breastfeeding was 44 % (68/153) without any complication; 38 % of the mothers denied to breastfeed based on physician's advice. 26 % (34/129) of the newborns received live vaccines before 6 months-old (BCG:30 %; MMR:63 %; Rotavirus:8 %) and only 3 complications occurred (local BCGitis=1, fever=2). Information concerning anti-TNF during pregnancy/post-partum was delivered to 92 % of the patients, mainly by a gastroenterologist (97 %) who discussed with the obstetrician or the paediatrician in only 48 % and 25 %. CONCLUSION: In IBD patients, maintaining anti-TNF during pregnancy and breastfeeding is safe. Accidental live vaccines before 6 months did not lead to significant adverse events. The communication about these questions remains to improve.

Computer-based versus in-person interventions for preventing and reducing stress in workers.

BACKGROUND: Chronic exposure to stress has been linked to several negative physiological and psychological health outcomes. Among employees, stress and its associated effects can also result in productivity losses and higher healthcare costs. In-person (face-to-face) and computer-based (web- and mobile-based) stress management interventions have been shown to be effective in reducing stress in employees compared to no intervention. However, it is unclear if one form of intervention delivery is more effective than the other. It is conceivable that computer-based interventions are more accessible, convenient, and cost-effective. OBJECTIVES: To compare the effects of computer-based interventions versus in-person interventions for preventing and reducing stress in workers. SEARCH METHODS: We searched CENTRAL, MEDLINE, PubMed, Embase, PsycINFO, NIOSHTIC, NIOSHTIC-2, HSELINE, CISDOC, and two trials registers up to February 2017. SELECTION CRITERIA: We included randomised controlled studies that compared the effectiveness of a computer-based stress management intervention (using any technique) with a face-to-face intervention that had the same content. We included studies that measured stress or burnout as an outcome, and used workers from any occupation as participants. DATA COLLECTION AND ANALYSIS: Three authors independently screened and selected 75 unique studies for full-text review from 3431 unique reports identified from the search. We excluded 73 studies based on full-text assessment. We included two studies. Two review authors independently extracted stress outcome data from the two included studies. We contacted study authors to gather additional data. We used standardised mean differences (SMDs) with 95% confidence intervals (CIs) to report study results. We did not perform meta-analyses due to variability in the primary outcome and considerable statistical heterogeneity. We used the GRADE approach to rate the quality of the evidence. MAIN RESULTS: Two studies met the inclusion criteria, including a total of 159 participants in the included arms of the studies (67 participants completed computer-based interventions; 92 participants completed in-person interventions). Workers were primarily white, Caucasian, middle-aged, and college-educated. Both studies delivered education about stress, its causes, and strategies to reduce stress (e.g. relaxation or mindfulness) via a computer in the computer-based arm, and via small group sessions in the in-person arm. Both studies measured stress using different scales at short-term follow-up only (less than one month). Due to considerable heterogeneity in the results, we could not pool the data, and we analysed the results of the studies separately. The SMD of stress levels in the computer-based intervention group was 0.81 standard deviations higher (95% CI 0.21 to 1.41) than the in-person group in one study, and 0.35 standard deviations lower (95% CI -0.76 to 0.05) than the in-person group in another study. We judged both studies as having a high risk of bias. AUTHORS' CONCLUSIONS: We found very low-quality evidence with conflicting results, when comparing the effectiveness of computer-based stress management interventions with in-person stress management interventions in employees. We could include only two studies with small sample sizes. We have very little confidence in the effect estimates. It is very likely that future studies will change these conclusions.

Inhibition of Toll-Like Receptor 4 Signaling Mitigates Microvascular Loss but Not Fibrosis in a Model of Ischemic Acute Kidney Injury.

The development of chronic kidney disease (CKD) following an episode of acute kidney injury (AKI) is an increasingly recognized clinical problem. Inhibition of toll-like receptor 4 (TLR4) protects renal function in animal models of AKI and has become a viable therapeutic strategy in AKI. However, the impact of TLR4 inhibition on the chronic sequelae of AKI is unknown. Consequently, we examined the chronic effects of TLR4 inhibition in a model of ischemic AKI. Mice with a TLR4-deletion on a C57BL/6 background and wild-type (WT) background control mice (C57BL/6) were subjected to bilateral renal artery clamping for 19 min and reperfusion for up to 6 weeks. Despite the acute protective effect of TLR4 inhibition on renal function (serum creatinine 1.6 ± 0.4 mg/dL TLR4-deletion vs. 2.8 ± 0.3 mg/dL·WT) and rates of tubular apoptosis following ischemic AKI, we found no difference in neutrophil or macrophage infiltration. Furthermore, we observed significant protection from microvascular rarefaction at six weeks following injury with TLR4-deletion, but this did not alter development of fibrosis. In conclusion, we validate the acute protective effect of TLR4 signal inhibition in AKI but demonstrate that this protective effect does not mitigate the sequential fibrogenic response in this model of ischemic AKI.

A French observational study of botulinum toxin use in the management of children with cerebral palsy: BOTULOSCOPE.

BACKGROUND: Dystonia and spasticity are common symptoms in children with Cerebral Palsy (CP), whose management is a challenge to overcome in order to enable the harmonized development of motor function during growth. AIM: To describe botulinum toxin A (BTX-A) use and efficacy as a treatment of focal spasticity in CP children in France. METHODS: This prospective observational study included 282 CP children mostly administered according to French standards with BTX-A in lower limbs. Realistic therapeutic objectives were set with parents and children together before treatment initiation and assessed using the Visual Analogue Scale (VAS). Child management was recorded and the efficacy of injections was assessed during a 12-month follow-up period by physicians (Modified Ashworth Scale, joint range of motion, Physician Rating Scale, Gillette Functional Assessment Questionnaire and Gross Motor Function Measure-66) and by patients/parents (Visual Analogue Scale). RESULTS: BTX-A treatment was administered in different muscle localizations at once and at doses higher than those recommended by the French Health Authorities. Children were treated in parallel by physiotherapy, casts and ortheses. Injections reduced spasticity and improved joint range of motion, gait pattern and movement capacity. Pain was reduced after injections. BTX-A administration was safe: no botulism-like case was reported. The log of injected children who were not included in the study suggested that a large population could benefit from BTX-A management. CONCLUSIONS: We showed here the major input of BTX-A injections in the management of spasticity in CP children. The results are in favor of the use of BTX-A as conservative safe and efficient treatment of spasticity in children, which enables functional improvement as well as pain relief.

Risk assessment analysis of the future technical unit dedicated to the evaluation and treatment of motor disabilities.

OBJECTIVES: The National Hospital of Saint Maurice (HNSM) for Physical Medicine and Rehabilitation aims at strengthening its position as a pivot rehabilitation and physical therapy center. The opening in 2011 of a new unit for the evaluation and treatment of motor disabilities meets this objective. This project includes several parts: clinical, financial, architectural, organizational, applied clinical research as well as dealing with medical equipments and information system. This study focuses on the risk assessment of this future technical unit. METHODS: This study was conducted by a group of professionals working for the hospital. It started with the design of a functional model to better comprehend the system to be analyzed. Risk assessment consists in confronting this functional model to a list of dangers in order to determine the vulnerable areas of the system. Then the team designed some scenarios to identify the causes, securities barriers and consequences in order to rank the risks. RESULTS: The analysis targeted various dangers, e.g. political, strategic, financial, economical, marketing, clinical and operational. The team identified more than 70 risky scenarios. For 75% of them the criticality level was deemed initially tolerable and under control or unacceptable. The implementation of an action plan for reducing the level of risks before opening this technical unit brought the system down to an acceptable level at 66%. CONCLUSION: A year prior to opening this technical unit for the evaluation and treatment of motor disabilities, conducting this preliminary risk assessment, with its exhaustive and rigorous methodology, enabled the concerned professionals to work together around an action plan for reducing the risks.

Diagnostic accuracy of esophageal capsule endoscopy versus conventional upper digestive endoscopy for suspected esophageal squamous cell carcinoma.

BACKGROUND AND STUDY AIM: A video capsule similar to that used in small-bowel capsule endoscopy is now available for esophageal exploration. The aim of our study was to compare the accuracy of upper endoscopy (esophageal gastroduodenoscopy [EGE]) with esophageal capsule endoscopy (ECE) in patients at risk of esophageal squamous cell cancer (SCC). PATIENTS AND METHODS: 68 patients at risk of SCC secondary to a history of head and neck neoplasia were included in this comparison of techniques for detecting SCC and dysplasia. ECE was done using the first generation Pillcam ESO and EGE was performed in accordance with the usual practice of each center, followed by examination with 2 % Lugol staining and biopsy of unstained areas (39 neoplasia comprising 5 low grade dysplasia, 8 high grade dysplasia and 26 SCC). RESULTS: Compared with EGE with and without Lugol staining, the sensitivities of ECE for neoplasia diagnosis were 46 % and 54 %, respectively. On a per-patient basis, the sensitivity, specificity, and positive and negative predictive value of ECE were 63 %, 86 %, 77 % and 76 %, respectively, compared with EGE without staining, and 61 %, 86 %, 77 % and 73 % compared with EGE with iodine staining. Neither the ECE transit time nor the distance between the esopharyngeal line and the neoplastic lesion differed between the 21 false-negative and 18 true-positive cases diagnosed by ECE; the only difference was a smaller median diameter among false negatives ( P < 0.001). CONCLUSION: In a cohort at high risk for esophageal SCC, ECE is not sensitive enough to diagnose neoplastic lesions.

Endoscopic treatment of painful chronic pancreatitis: evaluation of a new flexible multiperforated plastic stent.

OBJECTIVES: Endoscopic stents are a validated treatment for painful chronic calcifying pancreatitis (CCP). Biliary-type stents are the most commonly used, but have certain drawbacks. The aim of this single-center retrospective study was to evaluate the feasibility, and the short- and medium-term efficacy of a new pancreatic stent (Johlin model, Cook) for pain relief. METHODS: Thirteen patients with painful CCP were treated with a Johlin stent. Stent specifications were studied as well as feasibility and efficacy. Success was defined as relief of pain. RESULTS: There was no placement failure with the initial stent, which was 13.4+/-2.1cm in length and 9.8+/-0.6 Fr in diameter. Immediate total pain relief following stenting occurred in 11 patients. The average follow-up time was 11+/-7 months (range 1.5-24 months). Stents were left in place for 4.5+/-3 months (range 0.5-13.5 months). At the end of follow-up, endoscopic treatment was considered effective in 12 patients. Endoscopic retrograde cholangiopancreatographic (ERCP) complications consisted of uncomplicated acute pancreatitis (10%). CONCLUSION: Pancreatic stenting using the Johlin stent (Cook) is feasible, has no particular adverse events and is effective for immediate as well as medium-term pain improvement.

Colorectal surgery in cirrhotic patients: assessment of operative morbidity and mortality.

PURPOSE: The morbidity from colorectal surgery can be high and increases for patients with cirrhosis of the liver. This study was designed to assess morbidity, mortality, and prognostic factors for patients with cirrhosis undergoing colorectal surgery. METHODS: From 1993 to 2006, 41 cirrhotic patients underwent 43 colorectal procedures and were included. Both univariate and multivariate analyses were performed to identify variables influencing morbidity and mortality. RESULTS: Postoperative morbidity was 77 percent (33/43). Postoperative mortality was 26 percent (11/43) among whom six patients (54 percent) underwent emergency surgery. Four factors influenced mortality on univariate analysis: presence of peritonitis (P < 0.05), postoperative complications (P < 0.04), postoperative infections (P < 0.01), and total colectomy procedures (P < 0.02). On multivariate analysis, the only factor influencing mortality was postoperative infection (P < 0.04). The only factor influencing morbidity was the existence of preoperative ascites (P < 0.04). CONCLUSIONS: Colorectal surgery for cirrhotic patients has a high risk of morbidity and mortality. This risk is associated with the presence of infection, ascitic decompensation, and the urgent or extensive nature of the procedure. The optimization of patients through selection and preparation reduces operative risk.

Patients with sporadic duodenal adenoma are a high-risk group for advanced colorectal neoplasia: results of a case-control study.

AIM: To evaluate colorectal cancer risk among patients with sporadic duodenal neoplasia using a case-control protocol. METHODS: Cases were 35 patients referred for the management of sporadic duodenal adenoma and who underwent colonoscopy. Colonoscopy findings among cases were compared with those from a control group matched for age and sex (two controls per case) without duodenal adenoma. Colonoscopy findings were categorized as adenoma, advanced adenoma, cancer or advanced neoplasia. The two groups were compared using the chi-squared test. Odds ratio and 95% confidence intervals were calculated. RESULTS: Colorectal adenoma was present in 31% of cases vs. 24% of controls, advanced neoplasia in 29% vs. 4%, advanced adenoma in 23% vs. 3% and adenocarcinoma in 6% vs. 1%. The relative risks of advanced colorectal adenoma and advanced colorectal neoplasia in cases were 10.1 (95% CI: 1.8-100.1, P = 0.003) and 8.9 (95% CI: 2.1-53.3, P = 0.001), respectively. CONCLUSIONS: The relative risk of advanced colorectal adenoma and advanced neoplasia in cases was nine- to 10-fold that among controls. Patients with sporadic duodenal adenoma represent a high-risk group for advanced colorectal neoplasia and should therefore undergo complete colonoscopy.

Chronic ischemic gastritis: case report of a difficult diagnosis and review of the literature.

Chronic ischemic gastritis is an unusual entity that is rarely distinguished from other forms of intestinal ischemia. On the basis of a case encountered and a subsequent review of the literature, the main features of this rare condition are described here. A better understanding and awareness of the disease should improve the diagnosis and ultimately also the prognosis.

Venesection therapy of insulin resistance-associated hepatic iron overload.

BACKGROUND/AIMS: The association of hepatic iron overload with metabolic disorders has been coined as the insulin resistance-associated hepatic iron overload syndrome (IR-HIO). METHODS: Fifty-six IR-HIO patients were phlebotomized either weekly (n = 14) or bimonthly (n = 42) and compared with C282Y homozygotes and with ten IR-HIO patients treated by a low calorie diet alone. RESULTS: In venesected patients, the median amount of mobilized iron was 0.6 g in 2.8 months in females and 1.8 g in 5 months in males. Mobilized iron did not differ depending on the frequency of venesections or HFE genotype. When compared with C282Y homozygotes, IR-HIO patients had a similar amount of mobilized iron, but three-fold serum ferritin levels. The presenting symptoms (chronic fatigue and/or polyarthralgias) improved in 6/7 patients. Phlebotomies were well tolerated. In patients treated by a low calorie diet, serum ferritin levels remained stable. CONCLUSIONS: In IR-HIO patients, body iron stores are significantly increased, overestimated by serum ferritin, not modified by a low calorie diet, and safely removed by phlebotomies. Based on these data and on studies indicating that iron excess is associated with increased risk for hepatic fibrosis, cancer and cardiovascular disorders, venesection therapy can be recommended in IR-HIO patients.