Interactive Response System Research Articles

Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial

Many antihyperglycaemic drugs, including insulin, are primarily cleared by the kidneys, restricting treatment options for patients with kidney disease. Dulaglutide is a long-acting glucagon-like peptide-1 receptor agonist that is not cleared by the kidneys, and confers a lower risk of hypoglycaemia than does insulin. We assessed the efficacy and safety of dulaglutide in patients with type 2 diabetes and moderate-to-severe chronic kidney disease. AWARD-7 was a multicentre, open-label trial done at 99 sites in nine countries. Eligible patients were adults with type 2 diabetes and moderate-to-severe chronic kidney disease (stages 3-4), with an HbA1c of 7·5-10·5%, and who were being treated with insulin or insulin plus an oral antihyperglycaemic drug and were taking a maximum tolerated dose of an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. Participants were randomly assigned (1:1:1) by use of a computer-generated random sequence with an interactive response system to once-weekly injectable dulaglutide 1·5 mg, once-weekly dulaglutide 0·75 mg, or daily insulin glargine as basal therapy, all in combination with insulin lispro, for 52 weeks. Insulin glargine and lispro doses were titrated as per an adjustment algorithm; dulaglutide doses were masked to participants and investigators. The primary outcome was HbA1c at 26 weeks, with a 0·4% non-inferiority margin. Secondary outcomes included estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR). The primary analysis population was all randomly assigned patients who received at least one dose of study treatment and had at least one post-randomisation HbA1c measurement. The safety population was all patients who received at least one dose of study treatment and had any post-dose data. This study is registered with ClinicalTrials.gov, number NCT01621178. Between Aug 15, 2012, and Nov 30, 2015, 577 patients were randomly assigned, 193 to dulaglutide 1·5 mg, 190 to dulaglutide 0·75 mg, and 194 to insulin glargine. The effects on HbA1c change at 26 weeks of dulaglutide 1·5 mg and 0·75 mg were non-inferior to those of insulin glargine (least squares mean [LSM] -1·2% [SE 0·1] with dulaglutide 1·5 mg [183 patients]; -1·1% [0·1] with dulaglutide 0·75 mg [180 patients]; -1·1% [0·1] with insulin glargine [186 patients]; one-sided p≤0·0001 for both dulaglutide doses vs insulin glargine). The differences in HbA1c concentration at 26 weeks between dulaglutide and insulin glargine treatments were LSM difference -0·05% (95% CI -0·26 to 0·15, p<0·0001) with dulaglutide 1·5 mg and 0·02% (-0·18 to -0·22, p=0·0001) with dulaglutide 0·75 mg. HbA1c-lowering effects persisted to 52 weeks (LSM -1·1% [SE 0·1] with dulaglutide 1·5 mg; -1·1% [0·1] with dulaglutide 0·75 mg; -1·0% [0·1] with insulin glargine). At 52 weeks, eGFR was higher with dulaglutide 1·5 mg (Chronic Kidney Disease Epidemiology Collaboration equation by cystatin C geometric LSM 34·0 mL/min per 1·73 m2 [SE 0·7]; p=0·005 vs insulin glargine) and dulaglutide 0·75 mg (33·8 mL/min per 1·73 m2 [0·7]; p=0·009 vs insulin glargine) than with insulin glargine (31·3 mL/min per 1·73 m2 [0·7]). At 52 weeks, the effects of dulaglutide 1·5 mg and 0·75 mg on UACR reduction were not significantly different from that of insulin glargine (LSM -22·5% [95% CI -35·1 to -7·5] with dulaglutide 1·5 mg; -20·1% [-33·1 to -4·6] with dulaglutide 0·75 mg; -13·0% [-27·1 to 3·9] with insulin glargine). Proportions of patients with any serious adverse events were similar across groups (20% [38 of 192] with dulaglutide 1·5 mg, 24% [45 of 190] with dulaglutide 0·75 mg, and 27% [52 of 194] with insulin glargine). Dulaglutide was associated with higher rates of nausea (20% [38 of 192] with dulaglutide 1·5 mg and 14% [27 of 190] with 0·75 mg, vs 5% [nine of 194] with insulin glargine) and diarrhoea (17% [33 of 192] with dulaglutide 1·5 mg and 16% [30 of 190] with 0·75 mg, vs 7% [14 of 194] with insulin glargine) and lower rates of symptomatic hypoglycaemia (4·4 events per patient per year with dulaglutide 1·5 mg and 4·3 with dulaglutide 0·75 mg, vs 9·6 with insulin glargine). End-stage renal disease occurred in 38 participants: eight (4%) of 192 with dulaglutide 1·5 mg, 14 (7%) of 190 with dulaglutide 0·75 mg, and 16 (8%) of 194 with insulin glargine. In patients with type 2 diabetes and moderate-to-severe chronic kidney disease, once-weekly dulaglutide produced glycaemic control similar to that achieved with insulin glargine, with reduced decline in eGFR. Dulaglutide seems to be safe to use to achieve glycaemic control in patients with moderate-to-severe chronic kidney disease. Eli Lilly and Company.

Treatment with volanesorsen (VLN) reduced triglycerides and pancreatitis in patients with familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (sHTG) vs placebo: Results of the approach and compass studies

Volanesorsen is an antisense oligonucleotide that targets hepatic apolipoprotein C-III synthesis and reduces plasma triglyceride concentration. The aim of this study was to explore the safety and efficacy of volanesorsen in patients with multifactorial chylomicronaemia syndrome.The COMPASS trial was a randomised, placebo-controlled, double-blind, phase 3 study done at 38 international clinical sites in Canada, France, Germany, the Netherlands, UK, and USA. Eligible patients were aged 18 years or older with multifactorial severe hypertriglyceridaemia or familial chylomicronaemia syndrome, who had a BMI of 45 kg/m2 or less and fasting plasma triglyceride of 500 mg/dL or higher. Patients were randomly assigned (2:1) with an interactive response system using an allocation sequence and permuted block randomisation to receive subcutaneous volanesorsen (300 mg) or a matched volume of placebo (1·5 mL) once a week for 26 weeks. After 13 weeks of treatment, dosing was changed to 300 mg of volanesorsen or placebo every 2 weeks for all patients, except those who had completed 5 months or more of treatment as of May 27, 2016. Participants, investigators, sponsor personnel, and clinical research staff were all masked to the treatment assignments. The primary outcome was percentage change from baseline to 3 months in fasting triglyceride in the full analysis set (all patients who were randomly assigned and received at least one dose of study drug and had a baseline fasting triglyceride assessment). This trial is registered with ClinicalTrials.gov, NCT02300233 (completed).Between Feb 5, 2015, and Jan 24, 2017, 408 patients were screened for eligibility. 294 were excluded and 114 randomly assigned to receive either volanesorsen (n=76) or placebo (n=38). One patient in the volanesorsen group discontinued before receiving the study drug. The total number of dropouts was 28 (four in the placebo group and 24 in the treatment group). Volanesorsen reduced mean plasma triglyceride concentration by 71·2% (95% CI −79·3 to −63·2) from baseline to 3 months compared with 0·9% (−13·9 to 12·2) in the placebo group (p<0·0001), representing a mean absolute reduction of fasting plasma triglycerides of 869 mg/dL (95% CI −1018 to −720; 9·82 mmol/L [–11·51 to −8·14]) in volanesorsen compared with an increase in placebo of 74 mg/dL (−138 to 285; 0·83 mmol/L [–1·56 to 3·22]; p<0·0001). In the key safety analysis, five adjudicated events of acute pancreatitis occurred during the study treatment period, all in three of 38 patients in the placebo group. The most common adverse events were related to tolerability and included injection-site reactions (average of 24% of all volanesorsen injections vs 0·2% of placebo injections), which were all mild or moderate. One participant in the volanesorsen group had a platelet count reduction to less than 50 000 per μL and one patient had serum sickness, both of which were regarded as serious adverse events.Volanesorsen significantly reduced triglyceride concentrations in patients with multifactorial chlyomicronaemia and might reduce acute pancreatitis events in these patients.Ionis Pharmaceuticals and Akcea Therapeutics.

EL USO DE LOS SISTEMAS DE RESPUESTA INTERACTIVA COMO HERRAMIENTA PARA FAVORECER EL APRENDIZAJE PROACTIVO EN INGENIERÍA

El desarrollo de las tecnologías de la información y la comunicación (TIC) ha permitido el surgimiento de herramientas didácticas en el campo de la educación, proporcionando herramientas prácticas para apoyar a las clases presenciales. En este contexto, los sistemas electrónicos de respuesta estudiantil pueden ser útiles para introducir un elemento tecnológico motivador en las lecciones, así como una nueva metodología. En este estudio, además del uso de los sistemas de respuesta interactiva o clickers, se ha introducido la tecnología de aprendizaje móvil mediante la elaboración de una metodología de uso de las herramientas Kahoot y Telegram en la asignatura "Fundamentos Físicos en la Ingeniería II" del Grado en Ingeniería Electrónica Industrial. El Departamento de Física Aplicada de la Universidad de Córdoba tiene una amplia experiencia en el uso de Clickers en clases teóricas con grupos grandes para diferentes grados universitarios, pero ahora el uso de tecnologías móviles de aprendizaje se ha introducido en grupos de tamaño medio para clases prácticas. Usando esta nueva metodología, los estudiantes de grupos medianos realizan un cuestionario durante la lección de resolución de problemas, donde utilizaron sus conocimientos adquiridos durante la clase. La realización del cuestionario permite a los profesores evaluar en tiempo real el nivel del estudiante y utilizar la retroalimentación para abordar los problemas iniciales y los malentendidos. Los resultados muestran que los sistemas de respuesta interactiva son altamente valorados por los estudiantes, que lo perciben como una herramienta para mejorar el aprendizaje y aumentar la competencia en el aula.

RECURSOS TICS ORIENTADOS A MEJORAR LA CAPACIDAD DE RAZONAMIENTO CIENTÍFICO COMO ESTRATEGIA DE RESOLUCIÓN DE PROBLEMAS DE INGENIERÍA

En este proyecto se ha diseñado una nueva metodología docente de resolución de problemas en asignaturas científico-técnicas, basada en el uso de recursos TIC, con el objetivo de fomentar la adquisición de la competencia de razonamiento científico. Concretamente, por un lado, en las sesiones presenciales, se han utilizado los sistemas de respuesta interactiva cuyo éxito en el aula ya ha sido comprobado por los autores. Por otro lado, para el trabajo del alumnado fuera del aula, se ha integrado el uso de la herramienta interactiva online (web 2.0) elearningphysics, desarrollada por los autores que, mediante flujos de preguntas concatenadas, guía al estudiante durante la resolución de problemas ayudándole a razonar el porqué de los conceptos y leyes aplicados. Se ha comprobado que ambos recursos TICs contribuyen a que el alumnado adquiera la competencia de razonamiento científico aplicada a la resolución de problemas en asignaturas científico-técnicas, ya que le ayudan a relacionar los conceptos teóricos y prácticos a la vez que aumentan su nivel de motivación y participación en las actividades de resolución de problemas.

Teaching Management System with Applications of RFID and IoT Technology

Currently, Internet of Things (IoT) technologies are used in many areas, such as intelligent transportation, smart city, hospital, games, education. Earlier interactive response system uses infrared or radio frequency (RF) wireless communication technologies to transmit the students’ answer to teachers’ managerment system, where there exists high cost, inconvenient usage, difficult deployment. How to use IoT to improve the quality of higher education becomes a very important topic in the researh area of teaching. Radio Frequency Identification (RFID) is one of key technologies to implement IoT applications, and most of universities use the High Frequency (HF) RFID card as the students’ identification devices in China. In this paper, a kind of WiFi supported RFID reader (WiRF) is implemented using open source hardware platforms, such as Node MCU and RFID-RC522. Then the proposed WiRF system is used to assist teacher to perform automatic attendance record and students’ behavior record. In addition, Quick Response (QR) code is another technology to enable IoT. In this paper, QR code is designed to quickly access course video and perform real-time interactive response in the classroom, which will provide multidimensional learning and strengthen the motivation of students’ learning. This IoT system can improve the attendance of students, and give a positive impact on students’ learning process for higher education.

Interactive response system (IRS) for college students: individual versus cooperative learning

ABSTRACTIn this study, the researcher aimed to understand how students learned the targeted knowledge with an interactive response system (IRS) tool, and whether learners in two different learning modes: individual and group use of IRS, differed in their learning performance and knowledge retention after the IRS activity. These two kinds of IRS interaction were integrated into the course which included multiple choice questions for testing memorable knowledge and open-ended questions for enhancing organization and critical thinking ability via a methodology that involved 120 college students and included the analysis of tests, survey questionnaires and a course learning diary. Overall, the results were consistent with the consensus that students perceive the IRS as a positive addition to their classes, as its use increased course participation, fostered interaction, and promoted the general enjoyment of the class. The results revealed that the immediate learning performance of the learners who participated in the activity through group use of the IRS was better than that of the learners with individual IRS accounts; however, the individual IRS users seemed to have better learning retention of the learning contents, and showed significant improvement on the delayed tests. Furthermore, the study also confirmed that the IRS with collaborative work could promote the students’ academic and social-emotional performance because the collaborative learning allowed them to learn from peers’ opinions and to make judgments and co-examine the learning concepts again while finding the correct answer. This paper contributes data and analysis that highlight the pedagogical benefits of the implementation of an IRS, and supports the value of using the IRS for college education.

Continuous assessment and interactive response systems in higher education

There is evidence that the use of information and communication technologies (ICTs) has the potential to improve assessment methods, and therefore, learning process and results. This study compares the effect of two different types of assessment on the learning results of university students: traditional continuous assessment (TCA) and continuous assessment with the interactive response system Educlick (CAE). A quasi-experimental study with 364 students of the degree in Primary Education was conducted. Partial and final marks obtained with TCA and CAE were analysed and the influence of both assessments on the final examination (FE) was considered. It was also studied the different psychological variables that influence the assessment process, which were present in the intervention groups. To this aim, a descriptive analysis of data using the Mann-Whitney and Kruskal-Wallis non-parametric tests were developed through SPSS software. Results revealed a higher percentage of passes (81.5% compared to 74.5%), better marks and higher attendance of the first FE among students assessed with CAE (99.3%) as opposed to students assessed with TCA (91.7%). Findings underline the importance of implementing innovative technological methods, such as the interactive resource proposed in this paper, to develop new and improved skill-based competences in the teaching-learning process.

Vision-Based Mid-Air Unistroke Character Input Using Polar Signatures

Hand-gesture-based commands may replace touch and electromechanical input panels to make public interactive response systems (IRS) more accessible. This work presents a prototype framework for vision-based mid-air unistroke character input, which can be adapted as an interface for the IRS. At first, we developed an acquisition module that effectively spots the legitimate gesture trajectory by implementing pen-up and pen-down actions using depth thresholding and velocity tracking. The extracted trajectory is recognized through a novel, fast, and easy to implement the equipolar signature (EPS) technique. Apart from resistance to rotation, scale, and translation variations, EPS exhibits neutrality to stroking directions as well. On the three self-collected datasets comprising of digits, alphabets, and symbols, the EPS scheme obtains over 96.5% accurate results with an average of 30-ms running time. The proposed scheme is also validated on an open dataset DAIR (Dataset for AIR Handwriting), where it achieves 95.5% mean accuracy with 24.3-ms recognition time per gesture. The developed approach is compared with benchmark schemes to justify its accuracy and speed.

Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial

HER2-targeted treatments have improved outcomes in patients with HER2-positive breast cancer in the neoadjuvant, adjuvant, and metastatic settings; however, some patients remain at risk of relapse or death for many years after treatment of early-stage disease. Therefore, new strategies are needed. We did a phase 3 trial to assess a neoadjuvant regimen for HER2-positive breast cancer that replaces traditional systemic chemotherapy with targeted treatment. We did a randomised, open-label phase 3 KRISTINE trial in 68 Translational Research In Oncology centres (hospitals and specialty cancer centres in Asia, Europe, USA, and Canada). Eligible participants were aged 18 years or older with centrally confirmed HER2-positive stage II-III operable breast cancer (>2 cm tumour size), an Eastern Cooperative Oncology Group performance status of 0-1, and a baseline left ventricular ejection fraction of at least 55% (by echocardiogram or multiple-gated acquisition scan). We randomly assigned participants (1:1) to receive either trastuzumab emtansine plus pertuzumab or docetaxel, carboplatin, and trastuzumab plus pertuzumab. We did the randomisation via an interactive response system under a permuted block randomisation scheme (block size of four), stratified by hormone receptor status, stage at diagnosis, and geographical location. Patients received six cycles (every 3 weeks) of neoadjuvant trastuzumab emtansine plus pertuzumab (trastuzumab emtansine 3·6 mg/kg; pertuzumab 840 mg loading dose, 420 mg maintenance doses) or docetaxel, carboplatin, and trastuzumab plus pertuzumab (docetaxel 75 mg/m2; carboplatin area under the concentration-time curve 6 mg/mL × min; trastuzumab 8 mg/kg loading dose, 6 mg/kg maintenance doses) plus pertuzumab [same dosing as in the other group]). All treatments were administered intravenously. The primary objective was to compare the number of patients who achieved a pathological complete response (ypT0/is, ypN0), between groups in the intention-to-treat population (two-sided assessment), based on local evaluation of tumour samples taken at breast cancer surgery done between 14 days and 6 weeks after completion of neoadjuvant therapy. Safety was analysed in patients who received at least one dose of study medication. This trial is registered with ClinicalTrials.gov, number NCT02131064, and follow-up of the adjuvant phase is ongoing. Between June 25, 2014, and June 15, 2015, we randomly assigned 444 patients to neoadjuvant treatment with trastuzumab emtansine plus pertuzumab (n=223) or docetaxel, carboplatin, and trastuzumab plus pertuzumab (n=221). A pathological complete response was achieved by 99 (44·4%) of 223 patients in the trastuzumab emtansine plus pertuzumab group and 123 (55·7%) of 221 patients in the docetaxel, carboplatin, and trastuzumab plus pertuzumab group (absolute difference -11·3 percentage points, 95% CI -20·5 to -2·0; p=0·016). During neoadjuvant treatment, compared with patients receiving docetaxel, carboplatin, and trastuzumab plus pertuzumab, fewer patients receiving trastuzumab emtansine plus pertuzumab had a grade 3-4 adverse event (29 [13%] of 223 vs 141 [64%] of 219) or a serious adverse event (11 [5%] of 223 vs 63 [29%] of 219). The most common grade 3-4 adverse events in the trastuzumab emtansine plus pertuzumab group were decreased platelet count (three [1%] of 223 patients vs 11 [5%] of 219 with docetaxel, carboplatin, and trastuzumab plus pertuzumab), fatigue (three [1%] vs seven [3%]), alanine aminotransferase increase (three [1%] vs four [2%]), and hypokalaemia (three [1%] vs five [2%]). The most common grade 3-4 adverse events in the docetaxel, carboplatin, and trastuzumab plus pertuzumab group were neutropenia (55 [25%] of 219 vs one [<1%] of 223 with trastuzumab emtansine plus pertuzumab), diarrhoea (33 [15%] vs 2 [<1%]), and febrile neutropenia (33 [15%] vs 0). No deaths were reported during neoadjuvant treatment. Traditional neoadjuvant systemic chemotherapy plus dual HER2-targeted blockade (docetaxel, carboplatin, and trastuzumab plus pertuzumab) resulted in significantly more patients achieving a pathological complete response than HER2-targeted chemotherapy plus HER2-targeted blockade (trastuzumab emtansine plus pertuzumab); however, numerically more grade 3-4 and serious adverse events occurred in the chemotherapy plus trastuzumab and pertuzumab group. Further efforts to improve the efficacy of chemotherapy without imparting more toxicity are warranted. F Hoffmann-La Roche and Genentech.

Efficacy of topical dexamethasone-cyclodextrin microparticle eye drops compared with ranibizumab in diabetic macular edema: a phase II, multicenter, randomized controlled non-inferiority trial.

Background and Aim: Diabetic macular edema (DME) is one of the leading causes of visual impairment among working-aged people responsible for more than 10,000 new cases of blindness per year. Although there are some therapeutical options for this disease, most of them are invasive, expensive, subject to a range of side effects, and may not be accessible to the entire population. In addition, conventional eye drops are not able to adequately deliver the drug to the posterior chamber of the eye, where DME develops. In this setting, it has been suggested that topical dexamethasone-cyclodextrin microparticle eye drop (TDCME) formulation may be effective in treating DME. The aim of this manuscript is to describe a study protocol for evaluating the efficacy of this formulation, compared with intravitreal injection of ranibizumab. Design: Phase II, randomized, double-dummy, multicenter, controlled, non-inferiority clinical trial. Participants: Adults aged >18 year-old, diagnosed with controlled diabetes (type I or II), and refractory moderate to severe DME in at least one eye at the beginning of study. Measurements and procedures: Participants will be allocated to either the intervention or control group using block randomization, through a centralized off-site computer interactive response system. The treatment group will receive sham intravitreal injections plus TDCME, whereas the control group will receive intravitreal injection of ranibizumab (0.5 mg) plus Endura TM (artificial tears eye drops emulsion, used as placebo). While injections will be performed every month, eye drops will be given three times a day (every 8 hours). The primary efficacy outcome will be the change in best corrected visual acuity (BCVA) between baseline and at the end of the 12-month-follow-up time. Ethical aspects: This trial will be carried out according to the tenants of the Declaration of Helsinki and other international guidelines. Participants will be required to provide informed written consent prior to enrolling in the study. A Data Safety Monitoring Board will be established to follow the study.

Seladelpar (MBX-8025), a selective PPAR-δ agonist, in patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid: a double-blind, randomised, placebo-controlled, phase 2, proof-of-concept study

Many patients with primary biliary cholangitis have an inadequate response to first-line therapy with ursodeoxycholic acid. Seladelpar is a potent, selective agonist for the peroxisome proliferator-activated receptor-delta (PPAR-δ), which is implicated in bile acid homoeostasis. This first-in-class study evaluated the anti-cholestatic effects and safety of seladelpar in patients with an inadequate response to ursodeoxycholic acid. The study was a 12-week, double-blind, placebo-controlled, phase 2 trial of patients with alkaline phosphatase of at least 1·67 times the upper limit of normal (ULN) despite treatment with ursodeoxycholic acid. Patients, recruited at 29 sites in North America and Europe, were randomly assigned to placebo, seladelpar 50 mg/day, or seladelpar 200 mg/day while ursodeoxycholic acid was continued. Randomisation was done centrally (1:1:1) by a computerised system using an interactive voice-web response system with a block size of three. Randomisation was stratified by region (North America and Europe). The primary outcome was the percentage change from baseline in alkaline phosphatase over 12 weeks, analysed in the modified intention-to-treat (ITT) population (any randomised patient who received at least one dose of medication and had at least one post-baseline alkaline phosphatase evaluation). This study is registered with ClinicalTrials.gov (NCT02609048) and the EU Clinical Trials Registry (EudraCT2015-002698-39). Between Nov 4, 2015, and May 26, 2016, 70 patients were screened at 29 sites in North America and Europe. During recruitment, three patients treated with seladelpar developed fully reversible, asymptomatic grade 3 alanine aminotransferase increases (one on 50 mg, two on 200 mg), ranging from just over five to 20 times the ULN; as a result, the study was terminated after 41 patients were randomly assigned. The modified ITT population consisted of 12 patients in the placebo group, 13 in the seladelpar 50 mg group, and 10 in the seladelpar 200 mg group. Mean changes from baseline in alkaline phosphatase were -2% (SD 16) in the placebo group, -53% (14) in the seladelpar 50 mg group, and -63% (8) in the seladelpar 200 mg group. Changes in both seladelpar groups versus placebo were significant (p<0·0001 for both groups vs placebo), with no significant difference between the two seladelpar groups (p=0·1729). All five patients who received seladelpar for 12 weeks had normal alkaline phosphatase values at the end of treatment, based on a central laboratory ULN for alkaline phosphatase of 116 U/L. The most frequently reported adverse events were pruritus (16%; one patient on placebo, four on seladelpar 50 mg, and one on seladelpar 200 mg), nausea (13%; one patient on placebo, three on seladelpar 50 mg, and one on seladelpar 200 mg), diarrhoea (10%; two patients on placebo, one on seladelpar 50 mg, and one on seladelpar 200 mg), dyspepsia (8%; two patients on seladelpar 50 mg and one on seladelpar 200 mg), muscle spasms (8%; three patients on seladelpar 200 mg), myalgia (8%; one patient on placebo and two on seladelpar 200 mg), and dizziness (8%; one patient on placebo and two on seladelpar 50 mg). Seladelpar normalised alkaline phosphatase levels in patients who completed 12 weeks of treatment. However, treatment was associated with grade 3 increases in aminotransferases and the study was stopped early. The effects of seladelpar should be explored at lower doses. CymaBay Therapeutics.

The Effect of Student Collaboration in Solving Physics Problems Using an Online Interactive Response System

&lt;p style="text-align:justify"&gt;Advanced technology helps educational institutes to improve student learning performance and outcomes. In this study, our aim is to measure and assess student engagement and collaborative learning in engineering classes when using online technology in solving physics problems. The interactive response system used in this study is a collaborative learning tool that allows teachers to monitor their students’ response and progress in real time. Our results indicated that students have highly positive attitude toward using the interactive response system as a tool in education in order to improve collaborative learning and student engagement in classes. Consequently, student-learning performance has been improved considerably, and technology was successfully incorporated in engineering classes.&lt;/p&gt;

Assessment of Suicidal Ideation and Behavior: Report of the International Society for CNS Clinical Trials and Methodology Consensus Meeting.

To develop consensus recommendations for assessment of suicidal ideation/suicidal behavior (SI/SB) in clinical trials. Stakeholders from academia, industry, regulatory agencies, National Institutes of Health, National Institute of Mental Health, and patient advocacy organizations participated in a consensus meeting that was sponsored by the International Society for CNS Clinical Trials and Methodology and held November 17-18, 2015. Prior to the meeting, teams of experts identified key areas of consensus and dissent related to SI/SB. The most critical issues were presented and discussed in the consensus meeting. Literature reviews and a pre-meeting survey were conducted. Findings were discussed in pre-meeting working group sessions and at the consensus meeting. Five pre-meeting working groups reviewed (1) nomenclature and classification schemes for SI/SB, (2) detection and assessment of SI/SB, (3) analysis of SI/SB data, (4) design of clinical trials for new treatments of SI/SB, and (5) public health approaches to SI/SB. A modification of the RAND/UCLA Appropriateness Method was used to combine review of scientific evidence with the collective views of experts and stakeholders to reach the final consensus statements. After discussion, all attendees voted using an electronic interactive audience response system. Areas of agreement and areas of continuing dissent were recorded. All 5 working groups agreed that a major barrier to advancement of the field of SI/SB research and the development of new treatments for SI/SB remains the lack of a universally accepted standardized nomenclature and classification system. Achieving alignment on definitions and classification of suicide-related phenomena is critical to improving the detection and assessment of SI/SB, the design of clinical trials for new treatments, and effective public health interventions.

Using Interactive Response Systems in Economics: utility and factors influencing students’ attitudes

&lt;p class="Textoindependiente21"&gt;&lt;span lang="EN-US"&gt;The European Higher Education Area (EHEA) involves changing traditional methods to promote innovative teaching experiences. This paper has two main aims: a) to show evidence of the use of Interactive Response Systems (IRS) to identify gaps in the understanding of the course contents and b) to investigate factors influencing students’ attitudes towards the use of IRS. The experience was developed through a collective tutoring session in the subject of Economics using IRS. Economics is a first-year subject in the Degree of Business Administration and Management offered by the University of Cadiz, which includes contents of Microeconomics and Macroeconomics and uses economic models to explain the function of the economy and the behaviour of economic agents. Results show that IRS technique allows detecting gaps in learning and comprehension. From our econometric estimations, we also identify two strongly significant variables affecting students’ attitudes towards IRS: gender and received explanations regarding the use of IRS. Variables such as first enrolment in the subject and the number of hours devoted to studying have a positive and significant effect on the attitude to IRS, but at a lower level of significance (from 5% to 10%).&lt;/span&gt;&lt;/p&gt;

Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, double-blind, placebo-controlled phase 2 study

The interleukin-23 pathway is implicated genetically and biologically in the pathogenesis of Crohn's disease. We aimed to assess the efficacy and safety of risankizumab (BI 655066, Boehringer Ingelheim, Ingelheim, Germany), a humanised monoclonal antibody targeting the p19 subunit of interleukin-23, in patients with moderately-to-severely active Crohn's disease. In this randomised, double-blind, placebo-controlled phase 2 study, we enrolled patients at 36 referral sites in North America, Europe, and southeast Asia. Eligible patients were aged 18-75 years, with a diagnosis of Crohn's disease for at least 3 months, assessed as moderate-to-severe Crohn's disease at screening, defined as a Crohn's Disease Activity Index (CDAI) of 220-450, with mucosal ulcers in the ileum or colon, or both, and a Crohn's Disease Endoscopic Index of Severity (CDEIS) of at least 7 (≥4 for patients with isolated ileitis) on ileocolonoscopy scored by a masked central reader. Patients were randomised 1:1:1 using an interactive response system to a double-blind investigational product, and stratified by previous exposure to TNF antagonists (yes vs no). Patients received intravenous 200 mg risankizumab, 600 mg risankizumab, or placebo, at weeks 0, 4, and 8. The primary outcome was clinical remission (CDAI <150) at week 12 (intention-to-treat population). Safety was assessed in patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT02031276. Between March, 2014, and September, 2015, 213 patients were screened, and 121 patients randomised. At baseline, 113 patients (93%) had been previously treated with at least one tumour necrosis factor (TNF) antagonist (which had failed in 96 [79%]). At week 12, 25 (31%) of 82 risankizumab patients (pooled 41 patients in 200 mg and 41 patients in 600 mg arms) had clinical remission versus six (15%) of 39 placebo patients (difference vs placebo 15·0%, 95% CI 0·1 to 30·1; p=0·0489). Ten (24%) of 41 patients who received 200 mg risankizumab had clinical remission (9·0%, -8·3 to 26·2; p=0·31) and 15 (37%) of 41 who received the 600 mg dose (20·9%, 2·6 to 39·2; p=0·0252). 95 (79%) patients had adverse events (32 in the placebo group, 32 randomised to 200 mg risankizumab, 31 randomised to 600 mg risankizumab); 18 had severe adverse events (nine, six, three); 12 discontinued (six, five, one); 24 had serious adverse events (12, nine, three). The most common adverse event was nausea and most common serious adverse event was worsening of underlying Crohn's disease. No deaths occurred. In this short-term study, risankizumab was more effective than placebo for inducing clinical remission in patients with active Crohn's disease. Therefore, selective blockade of interleukin-23 via inhibition of p19 might be a viable therapeutic approach in Crohn's disease. Boehringer Ingelheim.

Interactive audience response systems in oral and maxillofacial radiology undergraduate lectures.

To evaluate the impact of audience response systems (ARS) on student participation (SP) during Oral and Maxillofacial Radiology (OMR) undergraduate lectures and on final examination scores (FES). Furthermore, an analysis of unanimity assessed the influence of ARS on students' responses. Students' perceptions were also assessed. A controlled crossover study was designed. Four lectures covering topics of OMR were each taught with ARS and without ARS (i.e. hand-raising method). SP and FES were compared between ARS and HR groups. Unanimity of answers was analyzed for both groups. Questionnaires assessed students' impressions about ARS. Mean SP of ARS and HR groups were 97.6% and 47.3%, respectively, and this difference was statistically significant (P<.05). Mean FES for the ARS group (77%) was slightly higher than HR group (75.1%), however, not statistically significant. There was positive correlation between SP and FES. With ARS, only 5.7% of the questions were unanimous, whilst 51.4% were unanimous with HR method. Most students reported that the use of ARS had positive influence on their attention (92%), participation (96%), classmates' participation (82.7%), interest (74.7%), and learning (86.7%). For the five-point scale ratings of the relevance of ARS features, anonymity had an average 3.6, whilst other items received an average 4.6 or higher. ARS significantly increased participation in OMR lectures; however, an increase in FES could not be associated with ARS by itself. Not taking into consideration which method was used to answer questions posed during lectures, higher participation correlated with higher scores. ARS is well-accepted and students believe that these devices positively influence their performance. Among the recognized advantages of ARS, anonymity was considered the least relevant.

Considerations for using personal Wi-Fi enabled devices as “clickers” in a large university class

Interactive student response systems, commonly referred to as clickers, have increased in popularity in higher education classrooms as a means to improve engagement and enhance learning. Clicker systems come with handheld devices as well as a radio frequency receiver. A Wi-Fi connection to the receiver is possible, enabling students to use their personal smartphones, tablets, or laptops instead of the handheld device. The objective of this study was to determine the feasibility of students using their personal Wi-Fi enabled devices as clickers in a large university class. In addition, we sought to elicit student perceptions of clicker use in general. Overall, the majority of students preferred using their personal devices, thus saving several minutes of class time in distribution and collection. Students gave very positive feedback on the use of clickers; however, they did not like that clickers could be used to track attendance and participation.

The effectiveness of integrating teaching strategies into IRS activities to facilitate learning

AbstractPrevious studies on the interactive response system (IRS) have generally adopted the lecture method to facilitate teaching and learning, while few have made efforts to investigate the learning effects of instructional methods and IRS activities on learning and teaching. The purpose of the present study was therefore to explore whether the use of the IRS with two different teaching methods would affect students' learning performance. A quasi‐experimental design was employed, with the teacher conducting the course using the learner as leader strategy in the experimental group (E.G.) and the teacher leader strategy in the control group (C.G.). The experiment was conducted over a period of 15 weeks (a semester), and questionnaires were administered at the beginning, in the middle and after the experiment to elicit the learners' views on the IRS application. The results support previous research which found that using the IRS improved learners' engagement and interaction. They also provide further evidence that the use of the IRS with both teaching strategies not only had a short‐term learning effect but could also be a tool for sustaining students' learning motivation and self‐directed learning for long‐term learning purposes. Besides, the use of the learner as leader strategy contributed to enhancing discussion in groups, especially for the leading groups. The use of the IRS with the learner as leader strategy benefited those who acted as leaders in taking the initiative to learn the course content, and also engaged the students who acted as learners in concentrating on the course because it was their classmates who were leading.Lay DescriptionWhat is already known about this topic The interactive response system (IRS) facilitates course interaction, and increases course attendance and learning performance Most studies have integrated the IRS with lectures to facilitate teaching and learning What this paper adds The paper explored the effectiveness of using the IRS with two teaching methods on students' learning for a semester. The use of the learner as leader strategy with IRS benefited the learners who acted as leaders in taking the initiative to learn the course content, and engaged the students who acted as learners in concentrating on the course. Implications for practice and/or policy Students are benefited in taking the initiative to learn the contents through hosting the IRS activity. Teachers could adopt both lectures and learner as leader strategy with IRS to sustain students' learning motivation and self‐directed learning for long‐term learning purposes.

IEngage: Using Technology to Enhance Students’ Engagement in a Large Classroom

&lt;p class="JLDAbstract"&gt;This paper aims to answer how we can increase students’ engagement in a large class. We hypothesised that the use of KeyPad, an interactive student response system, can lead to enhanced student engagement in a large classroom. We tested a model of classroom technology integration enhancing the students’ engagement among first year undergraduate students (n=131). This study provides evidence of significant effect of positive attitude and social pressure on the intent to use KeyPads. In turn, the intent to use KeyPads leads to the actual use of KeyPads which is directly associated with the level of student engagement. In addition, we find evidence for the relationship between extraversion and level of engagement such that compared to extrovert students, introvert students felt more engaged.&lt;/p&gt;

An Analysis of the 3D Video and Interactive Response Approach Effects on the Science Remedial Teaching for Fourth Grade Underachieving Students

Elementary school remedial teaching has been promoted for many years in Taiwan but it has primarily been aimed at Chinese and mathematics with little attention being paid to natural sciences. Due to the current shortage of natural science teachers, along with limitations in school budget and manpower, it is difficult to put natural science remedial teaching into practice in elementary schools. This research attempts to establish a new model of remedial teaching that utilizes remote asynchronous video-based instruction to carry out centralized remedial teaching with 3D television and interactive response system. We focused on fourth graders whose science ranking was at the bottom quarter and examined if their grades have improved. Centralized remedial teaching was implemented once a week during school’s noon break and lasted for 40 minutes. The materials used, including the remedial 3D natural science lesson videos and interactive response test questions, were both produced by the university. They were transmitted through the Internet to elementary school teachers who played them on 3D television and students practiced and answered the questions in real time with plickers. Twenty fourth graders from different classes participated in remedial teaching for one semester; the average percentage of test grade ranking in natural science has progressed from 9.19% to 24.12% in their original classes. Previously, the average of T-score in natural science test was 35.80, and after remedial instruction, the T-score average was 42.39. The T-score average improvement is statistically significant (t=3.34, p = .003). The research revealed that this instructional model can improve learning outcome in natural science for underachieving fourth graders, and through the questionnaire, it was also known that the students liked this remedial teaching approach.