ECCO Guidelines on Therapeutics in Ulcerative Colitis: Surgical Treatment

This is the second of a series of two articles reporting the European Crohn's and Colitis Organisation [ECCO] evidence-based consensus on the management of adult patients with ulcerative colitis [UC]. The first article is focused on medical management, and the present article addresses medical treatment of acute severe ulcerative colitis [ASUC] and surgical management of medically refractory UC patients, including preoperative optimisation, surgical strategies, and technical issues. The article provides advice for a variety of common clinical and surgical conditions. Together, the articles represent an update of the evidence-based recommendations of the ECCO for UC

ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment

hese recommendations summarise the current evidence on the medical management of adult patients with UC. Gaps were iden-tified during the analysis of the data, which should be addressed by further research. Where evidence is lacking or is very weak and evidence-based recommendations cannot be given, ECCO provides alternative tools, such as Topical Reviews28,95,153–158 or Position Papers.159–161 It is important that clinicians use these guidelines within the framework of local regulations, and seek to understand and address the individual needs and expectations of every patient. We recognise that constraints on health care resources are an im-portant factor in determining whether recommendations can be implemented for patients in many countries. The recommendations outlined here should be used to inform treatment decisions and form part of an overall multidisciplinary treatment plan for patients with UC, which may also encompass psychological, nutritional, and other non-pharmacological interventions

Potential neoplastic evolution of Vero cells: in vivo and in vitro characterization

Vero cell lines are extensively employed in viral vaccine manufacturing. Similarly to all established cells, mutations can occur during Vero cells in vitro amplification which can result in adverse features compromising their biological safety. To evaluate the potential neoplastic evolution of these cells, in vitro transformation test, gene expression analysis and karyotyping were compared among low- (127 and 139 passages) and high-passage (passage 194) cell lines, as well as transformed colonies (TCs). In vivo tumorigenicity was also tested to confirm preliminary in vitro data obtained for low passage lines and TCs. Moreover, Vero cells cultivated in foetal bovine serum-free medium and derived from TCs were analysed to investigate the influence of cultivation methods on tumorigenic evolution. Low-passage Vero developed TCs in soft agar, without showing any tumorigenic evolution when inoculated in the animal model. Karyotyping showed a hypo-diploid modal chromosome number and rearrangements with no difference among Vero cell line passages and TCs. These abnormalities were reported also in serum-free cultivated Vero. Gene expression revealed that high-passage Vero cells had several under-expressedand a few over-expressed genes compared to low-passage ones.Gene ontology revealed no significant enrichment of pathways related to oncogenic risk. These findings suggest that in vitro high passage, and not culture conditions, induces Vero transformation correlated to karyotype and gene expression alterations. These data, together with previous investigations reporting tumour induction in high-passage Vero cells, suggest the use of low-passage Vero cells or cell lines other than Vero to increase the safety of vaccine manufacturing

Quality and Quantity Revisited

Este trabajo se propone discutir el enfoque metodológico cualitativo de Jack Katz en su marco histórico de producción. De este modo, se pretende analizar la relevancia actual de estos debates y su impacto en la problematización de la dualidad "cualitativo-cuantitativo". Revisitar las ideas de Katz y complementarlas con algunos comentarios críticos sobre los límites, usos indebidos y los sesgos de las cuatro erres (representatividad, reactividad, fiabilidad y reproducibilidad) en la investigación cuantitativa supone una importante contribución a la comprensión del valor de la investigación cualitativa en sus propios términos. En muchos sentidos, las ideas metodológicas de Katz anticiparon desarrollos posteriores.This paper attempts to discuss the qualitative methodological approach of Jack Katz in its historical framework of production. In doing so, we aim to analyze the actual relevance of these discussions and their impact in the qualitative-quantitative dilemma. Revisiting Katz's ideas and complementing them with some critical remarks about the limits, misuses and biases of the four R's (representativeness, reactivity, reliability and replicability) in quantitative research implies a significant contribution to the understanding of qualitative research's value in its own terms. In many ways, Katz's methodological ideas anticipated later developments.Fil: Piovani, Juan Ignacio. Universidad Nacional de La Plata. Facultad de Humanidades y Ciencias de la Educación. Instituto de Investigaciones en Humanidades y Ciencias Sociales (UNLP-CONICET); Argentina

The Prognostic Performance of Rotational Thromboelastometry for Excessive Bleeding and Increased Transfusion Requirements in Hip Fracture Surgeries

Background Hip fracture surgeries are associated with considerable blood loss, while the perioperative coagulopathy is associated with the bleeding risk of these patients. We aimed to evaluate the ability of rotational thromboelastometry (ROTEM) to detect patients at high risk for excessive bleeding and increased transfusion requirements. Methods We conducted a prospective observational study of 221 patients who underwent hip fracture surgeries. ROTEM analysis was performed preoperatively and immediately postoperatively. Blood loss parameters including blood loss volume, number of transfused red blood cell (RBC) units, and drop in hemoglobin levels were recorded. ROTEM parameters were compared between patients with and without excessive bleeding, and between patients with and without increased transfusion requirements (i.e., >= 2 RBC units). Results The postoperative FIBTEM MCF value <= 15mm had 66.6% (95% confidence interval [CI]: 59.7-74.1%) sensitivity and 92.0% (95% CI: 80.7-97.7%) specificity to prognose excessive bleeding, and preoperative FIBTEM MCF value <= 15mm had 80.4% (95% CI: 73.5-86.2%) sensitivity and 91.2% (95% CI: 80.7-97.0%) specificity to prognose increased transfusion requirements. Preoperative FIBTEM MCF <= 11mm and postoperative FIBTEM MCF <= 15mm were associated with considerably increased risks of excessive bleeding (odds ratio [OR]: 44.8, 95% CI: 16.5-121.3, p <0.001; and OR: 23.0, 95% CI: 7.8-67.0, p <0.001, respectively). Conclusion ROTEM parameters demonstrated high prognostic accuracy for excessive bleeding and increased transfusion requirements. This can enable implementation of blood sparing strategies in high-risk patients, while blood banks could be better prepared to ensure adequate blood supply

Validation of a new optical diagnosis training module to improve dysplasia characterization in inflammatory bowel disease: a multicenter international study

Background and Aims: Inflammatory bowel disease (IBD) increases risk of dysplasia and colorectal cancer. Advanced endoscopic techniques allow for the detection and characterization of IBD dysplastic lesions, but specialized training is not widely available. We aimed to develop and validate an online training platform to improve the detection and characterization of colonic lesions in IBD: OPtical diagnosis Training to Improve dysplasia Characterization in Inflammatory Bowel Disease (OPTIC-IBD). Methods: We designed a web-based learning module that includes surveillance principles, optical diagnostic methods, approach to characterization, and classifications of colonic lesions using still images and videos. We invited gastroenterologists from Canada, Italy, and the United Kingdom with a wide range of experience. Participants reviewed 24 educational videos of IBD colonic lesions, predicted histology, and rated their confidence. The primary endpoint was to improve accuracy in detecting dysplastic lesions after training on the platform. Furthermore, participants were randomized 1:1 to get additional training or not, with a final assessment occurring after 60 days. Diagnostic performance for dysplasia and rater confidence were measured. Results: A total of 117 participants completed the study and were assessed for the primary endpoint. Diagnostic accuracy improved from 70.8% to 75.0% (P = .002) after training, with the greatest improvements seen in less experienced endoscopists. Improvements in both accuracy and confidence were sustained after 2 months of assessment, although the group randomized to receive additional training did not improve further. Similarly, participants’ confidence in characterizing lesions significantly improved between before and after the course (P < .001), and it was sustained after 2 months of assessment. Conclusions: The OPTIC-IBD training module demonstrated that an online platform could improve participants’ accuracy and confidence in the optical diagnosis of dysplasia in patients with IBD. The training platform can be widely available and improve endoscopic care for people with IBD. (Clinical trial registration number: NCT04924543.

The predictive value of ABCB1, ABCG2, CYP3A4/5 and CYP2D6 polymorphisms for risperidone and aripiprazole plasma concentrations and the occurrence of adverse drug reactions

We investigated in ninety Caucasian pediatric patients the impact of the main polymorphisms occurring in CYP3A, CYP2D6, ABCB1 and ABCG2 genes on second-generation antipsychotics plasma concentrations, and their association with the occurrence of adverse drug reactions. Patients with the CA/AA ABCG2 genotype had a statistically significant lower risperidone plasma concentration/dose ratio (Ct/ds) (P-value: 0.007) and an higher estimated marginal probability of developing metabolism and nutrition disorders as compared to the ABCG2 c.421 non-CA/AA genotypes (P-value: 0.008). Multivariate analysis revealed that the ABCG2 c.421 CA/AA genotype was found associated to a higher hazard (P-value: 0.004) of developing adverse drug reactions classified as metabolism and nutrition disorders. The ABCB1 2677TT/3435TT genotype had a statistically significant lower aripiprazole Ct/ds if compared with patients with others ABCB1 genotypes (P-value: 0.026). Information obtained on ABCB1 and ABCG2 gene variants may result useful to tailor treatments with these drugs in Caucasian pediatric patients

Response of alpine plant florwer production to temperature and snow cover fluctuation at the species range boundary

Surface temperatures have risen globally during the last 30 years, especially in alpine areas. It is recognized that these increases are influencing phenology, physiology and distribution of plants. However, few studies have addressed the effects of climate warming at the species range boundary, where plants are expected to be more stressed. We analysed 11-year data sets of inflorescence production of four alpine plants (Carex foetida, Leucanthemopsis alpina, Senecio incanus, Silene suecica) at the southern boundary of their distribution range in the N-Apennines (N-Italy), in relation to air temperature and snow cover persistence. Inflorescence production of all species fluctuated greatly and was significantly affected by the variation of the mean temperature of June/July. We found significant relationships also between species data series and the snow cover persistence. Moreover, species responded differently to such parameters. One species showed a significant decrease of the reproductive effort, whereas the other three showed a stable trend of inflorescence production. We have shown that some alpine species are favoured by increased temperature and reduced snow cover even at the boundary of their range, where they are thought to be particularly sensitive to warming. However, the aptitude to cope with climate change might be limited by competition against thermophilous species migrating from lower altitude and in some cases by the low altitude of mountain peaks that prevent species upward migration. The individualistic response of species to climate change found here, support the statement that the composition of plant communities might rapidly change in the future. © 2011 Springer Science+Business Media B.V