Risankizumab Induction Therapy Achieves Early Symptom Improvements That Are Associated With Future Clinical and Endoscopic Outcomes in Crohn's Disease: Post Hoc Analysis of the ADVANCE, MOTIVATE, and FORTIFY Phase 3 Studies.

BACKGROUND AND AIMS: Crohn's disease (CD) symptoms are a main driver for impaired quality of life and fast relief is important for patient care. Stool frequency (SF) and abdominal pain score (APS) are patient reported outcomes (PROs) measuring symptom severity, which are supported as treatment targets by the STRIDE-II consensus. This post hoc analysis examined the efficacy of risankizumab (RZB), a humanised monoclonal antibody with high specificity for interleukin-23 p19, for providing early symptom relief, along with the prognostic value of early symptom relief for achieving future clinical and endoscopic endpoints. METHODS: Individual and combined measures of SF and AP at weeks 1, 2, and 3 were assessed in patients with moderate to severe CD who received 600 mg intravenous RZB or placebo (PBO) in the ADVANCE or MOTIVATE induction studies. Multivariate logistic regression was used to examine the predictiveness of early symptom improvement for clinical and endoscopic outcomes following RZB induction and maintenance. RESULTS: Higher rates of SF/APS clinical remission and enhanced clinical response were observed as early as week 1 with RZB versus PBO. A larger proportion of patients achieved clinical endpoints with RZB versus PBO, irrespective of prior bio-failure status. Early PRO improvement was associated with a greater likelihood of achieving clinical and endoscopic improvement following 12-weeks induction and 52-weeks maintenance RZB dosing. CONCLUSIONS: After the first intravenous RZB induction dose, significantly greater rates of symptom improvement versus PBO were achieved. Improvements could be observed as early as week 1 and were predictive of week 12 and 52 clinical and endoscopic improvement.

Improving the portability of predicting students' performance models by using ontologies.

One of the main current challenges in Educational Data Mining and Learning Analytics is the portability or transferability of predictive models obtained for a particular course so that they can be applied to other different courses. To handle this challenge, one of the foremost problems is the models' excessive dependence on the low-level attributes used to train them, which reduces the models' portability. To solve this issue, the use of high-level attributes with more semantic meaning, such as ontologies, may be very useful. Along this line, we propose the utilization of an ontology that uses a taxonomy of actions that summarises students' interactions with the Moodle learning management system. We compare the results of this proposed approach against our previous results when we used low-level raw attributes obtained directly from Moodle logs. The results indicate that the use of the proposed ontology improves the portability of the models in terms of predictive accuracy. The main contribution of this paper is to show that the ontological models obtained in one source course can be applied to other different target courses with similar usage levels without losing prediction accuracy.

Living With Inflammatory Bowel Disease: Online Surveys Evaluating Patient Perspectives on Treatment Satisfaction and Health-Related Quality of Life.

Background: The quality of life of persons living with inflammatory bowel disease (IBD) is impacted by the physical and psychosocial burdens of disease, as well as by their satisfaction with the quality of care they receive. We sought to better understand (1) the drivers of satisfaction with treatment, including treatment goals, treatment selection, and attributes of patient/health care professional (HCP) interactions, and (2) how IBD symptoms affect aspects of daily life and overall quality of life. Methods: Two online questionnaires were accessed via MyCrohnsAndColitsTeam.com. The Treatment Survey assessed desired treatment outcomes, past and present therapies, and experiences with the patient's primary treating HCP. The Quality of Life survey assessed respondents' most problematic IBD symptoms and their influence on family and social life, work, and education. Respondents had Crohn's disease (CD) or ulcerative colitis (UC), were 19 years or older, and resided in the United States. All responses were anonymous. Results: The Treatment Experience survey was completed by 502 people (296 CD, 206 UC), and the Quality of Life survey was completed by 302 people (177 CD, 125 UC). Reduced pain, diarrhea, disease progression, and fatigue were the most desired goals of treatment. Biologics and 5-aminosalicylates were reported as a current or past treatment by the greatest proportion of patients with CD and UC, respectively. A numerically lower proportion of respondents with UC than CD reported use of biologic or small molecule therapy; conversely, a numerically greater proportion of respondents with UC than CD reported these drugs to be very or extremely effective. The HCP was key in the decision to switch to, and in the selection of, biologic or small molecule therapy. Overall satisfaction with an HCP was greatly driven by the quality and quantity of the communication and of the time spent with the HCP. Troublesome abdominal symptoms most impacted aspects of social and family life. Emotional challenges associated with IBD were experienced by most respondents. Conclusions: Treatment goals of respondents seem to align with HCPs overall treatment goals, including control of gastrointestinal symptoms and prevention of disease progression. Persons with UC might be offered biologic and small molecule therapies less often, despite reported high efficacy by users. Feeling heard and understood by the HCP are key drivers of treatment satisfaction. Quality communication in the patient/HCP relationship enables a better understanding of the patients' goals, disease burden, and emotional needs, which are all key factors to consider when developing a personalized and comprehensive treatment plan and optimizing quality of life.

Early Prediction of Student Learning Performance Through Data Mining: A Systematic Review.

BACKGROUND: Early prediction of students’ learning performance using data mining techniques is an important topic these days. The purpose of this literature review is to provide an overview of the current state of research in that area. METHOD: We conducted a literature review following a two-step procedure, looking for papers using the major search engines and selection based on certain criteria. RESULTS: The document search process yielded 133 results, 82 of which were selected in order to answer some essential research questions in the area. The selected papers were grouped and described by the type of educational systems, the data mining techniques applied, the variables or features used, and how early accurate prediction was possible. CONCLUSIONS: Most of the papers analyzed were about online learning systems and traditional face-to-face learning in secondary and tertiary education; the most commonly-used predictive algorithms were J48, Random Forest, SVM, and Naive Bayes (classification), and logistic and linear regression (regression). The most important factors in early prediction were related to student assessment and data obtained from student interaction with Learning Management Systems. Finally, how early it was possible to make predictions depended on the type of educational system.

Metodología para valorar y clasificar herramientas de evaluación de accesibilidad web / Methodology to valuate and classify web accessibility evaluation tools

Resumen Teniendo en cuenta que la accesibilidad Web es el arte de garantizar que los portales de la Internet puedan ser visitados y utilizados de forma satisfactoria por el mayor número posible de personas, es imprescindible evaluar sus contenidos empleando las herramientas adecuadas; por tal razón, esta investigación tiene como objetivo presentar un modelo metodológico para valorar estas herramientas automáticas y seleccionar, entre las existentes, las que tienen más criterios, contemplados en la WCAG 2.0. El modelo propuesto comprende una metodología cíclica y se denomina IPAC, por las siglas en inglés de sus cuatro etapas: Inspect-Plan-Assess-Categorize, que pretenden categorizar y/o recategorizar las herramientas de evaluación de accesibilidad Web, cuyas funciones incorporadas son cambiantes en el tiempo. La validación realizada de este modelo en julio de 2017 de dio como resultado la categorización de las cinco mejores herramientas de licencia libre por cada nivel de conformidad (A, AA y AAA).

Abstract Taking into account that Web accessibility is the art of ensuring that web portals can be visited and used satisfactorily by as many people as possible, it is indispensable to evaluate the Web contents using the appropriate tools, for this reason, this research work aims to present a methodological model to evaluate these automatic tools, and to select between the existing ones, the highest number of criteria (referred to in WCAG 2.0) can be assessed. The proposed model comprises a cyclic methodology and is called IPAC by the acronym in English of its 4 stages (inspect-plan-assess-categorize), the same ones that are intended to categorize and/or recategorize the Web Accessibility assessment tools, whose built-in functions are changed over time. The validation made in July 2017 of this model resulted in the categorization of the 5 best free license tools for each conformance level (A, AA and AAA).

Afectación pancreática en infección por leptospirosis / Pancreatic involvement in leptospirosis infection

La leptospirosis en fase ictérica o enfermedad de Weil es una vasculitis zoonótica endémica de la Costa ecuatoriana. Sin embargo, la pancreatitis aguda como parte de esta entidad es una complicación rara vez documentada. En este reporte de caso se presenta a un adulto varón de 63 años con signos de falla multiorgánica y amilasa con rápido ascenso inicial. La leptospirosis no fue tomada como primera opción diagnóstica. El paciente fue tratado debido a un cuadro de SDRA como un shock séptico de foco pulmonar, con falla renal aguda que requirió hemodiálisis, permaneciendo en UCI con antibioticoterapia empírica. El objetivo de este caso es remarcar que la leptospirosis debe siempre estar considerada en el diagnóstico diferencial de ictericia y pancreatitis, sobre todo en nuestro medio.

The icteric presentation of Leptospirosis, also known as Weil's disease, is a zoonotic vasculitis endemic to Ecuador's coastal region. However, reports of pancreatic affection due to this entity are rarely documented. We chose to present the case of a 63 years old male with signs of catastrophic organic failure, associated with a rapid increase in serum amylase concentrations. Due to this presentation, Leptospirosis was not held as the primary culprit of the disease, and was treated at the ICU as septic shock of pulmonary origin with ARDS associated with acute kidney injury that required hemodialysis. Thus this case aims to highlight the importance of Leptospirosis as an important differential diagnosis in any patient hailing from a tropical region with jaundice and pancreatitis.

Subcutaneous peginterferon ß-1a injection-site reaction experience and mitigation: Delphi analysis of the ALLOW study.

AIM: The objective of this Delphi analysis was to obtain consensus on injection-site reaction (ISR) experience and mitigation strategies for patients with relapsing-remitting multiple sclerosis switching from nonpegylated interferons (IFNs) to peginterferon ß-1a in the ALLOW Phase IIIb trial using a three-step approach. METHODS: Study investigators and coordinators from investigative sites enrolling four or more patients in ALLOW participated in three rounds of questionnaires and interviews. RESULTS: Respondents (n = 37) agreed that the most common ISR, erythema, was not disruptive to daily activities. Patient education, as a conversation with a clinician about ISR potential, was recommended. CONCLUSION: The consensus of Delphi respondents on ISR experience and ISR management after switching from nonpegylated IFNs to peginterferon ß-1a can help inform treatment decisions and manage patient expectations.

Strategies for Successful Long-Term Engagement of Adults With Phenylalanine Hydroxylase Deficiency Returning to the Clinic

Abstract Nearly half of all patients diagnosed with phenylalanine hydroxylase (PAH) deficiency, also known as phenylketonuria, are lost to follow-up (LTFU); most are adults who stopped attending clinic after the age of 18 years. To understand why adult patients with PAH deficiency disengage from their clinic, a focus group of 8 adults with PAH deficiency who had been LTFU for 2 or more years was held in March 2016. Ten clinicians observed the focus group and discussed strategies for successfully reengaging adult patients and encouraging lifelong management of PAH deficiency. Four strategies were proposed: (1) create a safe, supportive environment, (2) acknowledge patients as partners in their care, (3) develop individualized management plans, and (4) provide patients with additional resources. These strategies provide a framework to motivate change in clinical practice to meet the unique needs of adults with PAH deficiency.

Gastrointestinal Tolerability of Delayed-Release Dimethyl Fumarate in a Multicenter, Open-Label Study of Patients with Relapsing Forms of Multiple Sclerosis (MANAGE).

BACKGROUND: In phase 3 trials, delayed-release dimethyl fumarate (DMF; also known as gastroresistant DMF) demonstrated efficacy in relapsing-remitting multiple sclerosis (MS). Gastrointestinal (GI) events were associated with DMF treatment. The single-arm, open-label MANAGE study examined the incidence, severity, duration, and management of GI events in adults with relapsing MS initiating DMF treatment in clinical practice in the United States shortly after marketing approval. PATIENTS AND METHODS: Patients (N = 233) took DMF for up to 12 weeks and recorded information regarding GI events using an eDiary and numerical rating scales. RESULTS: Overall, 54.1% of patients used symptomatic therapy and had GI symptoms. The incidence of GI events was highest in the first month of treatment. The duration of GI events varied by event type, and severity was generally mild to moderate. Decreased severity was seen in patients treated with antacids, bismuth subsalicylate, acid-secretion blockers, antidiarrheals, and antiemetics. Less than 10% of patients were using symptomatic therapy for GI events by week 12 of DMF treatment. A modest reduction in severe GI events was observed in patients who regularly took DMF with food compared with patients who did not. The incidence of GI-related events was comparable in patients with or without a history of GI abnormalities and in patients who did or did not use alcohol or tobacco. CONCLUSIONS: Gastrointestinal events associated with DMF are generally transient, mild to moderate in severity, and manageable. Symptomatic therapy and dosing with food may mitigate these events.

BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety.

BACKGROUND: Multiple sclerosis (MS) is a chronic inflammatory disease, affecting more than 2.5 million people worldwide with more 400,000 cases in the United States alone. There has been considerable improvement in the treatment of MS, with the introduction of disease-modifying drugs; however, new oral therapies may provide additional benefit by providing an alternative treatment modality and the potential for improved adherence by avoiding the injection-associated side effects and anxiety encountered with some first-line agents. BG-12 (dimethyl fumarate) is an oral agent approved in the United States for the treatment of relapsing forms of MS. SCOPE: We review published literature about what is known about the mechanism of action of BG-12, and key efficacy and safety findings from three clinical studies in patients with relapsing-remitting MS (RRMS). FINDINGS: Data from preclinical studies have demonstrated that BG-12 may promote anti-inflammatory and cytoprotective activities that are mediated, at least in part, by the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) antioxidant response pathway. Studies in animals have shown a protective effect of BG-12 on neuronal, axonal and myelin integrity. Results from a phase 2 study and two randomized double-blind placebo-controlled phase 3 studies, CONFIRM and DEFINE, have shown that BG-12 provides clinical and radiologic efficacy in patients with RRMS. At 2 years, BG-12 240 mg twice and three times daily reduced annualized relapse rate (CONFIRM primary endpoint) by 44% and 51% and the risk of relapse (DEFINE primary endpoint) by 49% and 50%, respectively, compared with placebo (all p < 0.001). BG-12 was generally well tolerated and had an acceptable safety profile, with a similar incidence of adverse events across treatment groups. CONCLUSIONS: BG-12 may have cytoprotective and anti-inflammatory properties that contribute to its efficacy among patients with RRMS. Findings from phase 2 and 3 studies further support BG-12 as an effective initial therapy. ClinicalTrials.gov ID: NCT00168701; NCT00420212: NCT00451451.

Estrategias de afrontamiento individual y familiar frente a situaciones de estrés psicológico / Individual and family copying strategies when facing psychological stress situations

El artículo presenta el recorrido teórico que sustentan las estrategias de afrontamiento individual y las estrategias de afrontamiento familiar, a partir de una investigación bibliográfica analítica sobre los mismos. Los resultados de esta investigación dan cuenta de la génesis social del afrontamiento, concebido desde un enfoque cognitivo fenomenológico que en coherencia con el interaccionismo simbólico nos explica, a partir de la estrecha relación interactiva entre el individuo y las instituciones a las que pertenece, el uso de dichas estrategias a nivel individual y familiar. Igualmente se destaca en los hallazgos la relación positiva del afrontamiento con la salud y la funcionalidad del sistema familiar.

This paper presents a theoretical summary of individual coping strategies and family coping strategies based on a review of the literature. The results of this study show the social genesis of coping, designed from a cognitive phenomenological approach consistent with the symbolic interactionist which explains, from the close interactive relationship between individuals and institutions to which it belongs, how to use these strategies to individual and family level. Also we highlighted the positive relationship of coping with health and functionality of the family system.