Bringing Research into the Classroom – The Citizen Science approach in schools.

The way science is approached in the classroom can be instrumental in dispelling negative stereotypes about science and scientific research in future generations. The present report looks at the Citizen Science approach as an opportunity to connect schools with the world of research to foster a better command of scientific processes in the young, raise their awareness of current issues faced in certain sectors and geographical regions, and help them make sense of the surrounding world. The purpose of this report is to provide a baseline for understanding the key conditions of successfully implementing citizen science activities in schools. This report is based on three main sources of information: (1) review of recent literature on Citizen Science and its applications in schools; (2) a collection of citizen science case studies selected by educational organisations in four countries (Belgium, Greece, Poland and Spain) and from the Scientix repository of resources; and (3) the discussions between project managers, project representatives and science educators participating in the 14th Science Projects Networking Event (SPNE14), organisedbyScientixwiththecollaborationoffour other organisations and projects – GFOSS, Jet Propulsion Theatre, EDU-ARCTIC and ERIS. The report includes three main sections. The first explores the current literature on citizen science, guided by three main questions: (1) how do we define citizen science, (2) what are the main actors involved in citizen science projects and how do they contribute, and (3) what are the particularities of citizen science activities run in the context of formal education. The second section illustrates 20 citizen science projects, indicating the target audiences and main areas of research covered, as well as a description of the activities, outlining which part of the scientific method is carried out by volunteers, and, when such information is available, descriptions of the roles and interactions between the researchers and citizen scientists. Finally, the third section presents a discussion on the case studies included in the report, with a focus on the main challenges and opportunities of bringing citizen science in schools. The main challenge of running citizen science activities in school which transpired from the literature review and the review of the case studies is the issue of balancing research and educational outcomes. For educational outcomes to be achieved, citizen science projects in schools need to go beyond engaging pupils only in data collection and simple analysis, and look to involving them in meaningful research practices, which will give them the opportunity to develop scientific inquiry skills. On the same line, if genuine science outcomes are to be met, the ‘novice’ scientists (teachers and their students) need to interact with the researchers in order to be exposed to the requirements of the scientific method, and be supported in implementing it. Research suggests that carefully designed projects, created in dialogue between schools (teachers) and researchers which take into consideration the needs and constraints of both groups can successfully achieve both goals.status: Published onlin

Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study

Background Complement is likely to have a role in refractory generalised myasthenia gravis, but no approved therapies specifically target this system. Results from a phase 2 study suggested that eculizumab, a terminal complement inhibitor, produced clinically meaningful improvements in patients with anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis. We further assessed the efficacy and safety of eculizumab in this patient population in a phase 3 trial. Methods We did a phase 3, randomised, double-blind, placebo-controlled, multicentre study (REGAIN) in 76 hospitals and specialised clinics in 17 countries across North America, Latin America, Europe, and Asia. Eligible patients were aged at least 18 years, with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of 6 or more, Myasthenia Gravis Foundation of America (MGFA) class II\ue2\u80\u93IV disease, vaccination against Neisseria meningitides, and previous treatment with at least two immunosuppressive therapies or one immunosuppressive therapy and chronic intravenous immunoglobulin or plasma exchange for 12 months without symptom control. Patients with a history of thymoma or thymic neoplasms, thymectomy within 12 months before screening, or use of intravenous immunoglobulin or plasma exchange within 4 weeks before randomisation, or rituximab within 6 months before screening, were excluded. We randomly assigned participants (1:1) to either intravenous eculizumab or intravenous matched placebo for 26 weeks. Dosing for eculizumab was 900 mg on day 1 and at weeks 1, 2, and 3; 1200 mg at week 4; and 1200 mg given every second week thereafter as maintenance dosing. Randomisation was done centrally with an interactive voice or web-response system with patients stratified to one of four groups based on MGFA disease classification. Where possible, patients were maintained on existing myasthenia gravis therapies and rescue medication was allowed at the study physician's discretion. Patients, investigators, staff, and outcome assessors were masked to treatment assignment. The primary efficacy endpoint was the change from baseline to week 26 in MG-ADL total score measured by worst-rank ANCOVA. The efficacy population set was defined as all patients randomly assigned to treatment groups who received at least one dose of study drug, had a valid baseline MG-ADL assessment, and at least one post-baseline MG-ADL assessment. The safety analyses included all randomly assigned patients who received eculizumab or placebo. This trial is registered with ClinicalTrials.gov, number NCT01997229. Findings Between April 30, 2014, and Feb 19, 2016, we randomly assigned and treated 125 patients, 62 with eculizumab and 63 with placebo. The primary analysis showed no significant difference between eculizumab and placebo (least-squares mean rank 56\uc2\ub76 [SEM 4\uc2\ub75] vs 68\uc2\ub73 [4\uc2\ub75]; rank-based treatment difference \ue2\u88\u9211\uc2\ub77, 95% CI \ue2\u88\u9224\uc2\ub73 to 0\uc2\ub796; p=0\uc2\ub70698). No deaths or cases of meningococcal infection occurred during the study. The most common adverse events in both groups were headache and upper respiratory tract infection (ten [16%] for both events in the eculizumab group and 12 [19%] for both in the placebo group). Myasthenia gravis exacerbations were reported by six (10%) patients in the eculizumab group and 15 (24%) in the placebo group. Six (10%) patients in the eculizumab group and 12 (19%) in the placebo group required rescue therapy. Interpretation The change in the MG-ADL score was not statistically significant between eculizumab and placebo, as measured by the worst-rank analysis. Eculizumab was well tolerated. The use of a worst-rank analytical approach proved to be an important limitation of this study since the secondary and sensitivity analyses results were inconsistent with the primary endpoint result; further research into the role of complement is needed. Funding Alexion Pharmaceuticals