Patient adherence to and tolerability of self-administered interferon β-1a using an electronic autoinjection device: a multicentre, open-label, phase IV study

<p>Abstract</p> <p>Background</p> <p>Achieving good adherence to self-injected treatments for multiple sclerosis can be difficult. Injection devices may help to overcome some of the injection-related barriers to adherence that can be experienced by patients. We sought to assess short-term adherence to, and tolerability of, interferon (IFN) β-1a administered via electronic autoinjection device in patients with relapsing-remitting multiple sclerosis (RRMS).</p> <p>Methods</p> <p>BRIDGE (RebiSmart to self-inject Rebif serum-free formulation in a multidose cartridge) was a 12-week, multicentre, open-label, single-arm, observational, Phase IV study in which patients self-administered IFN β-1a (titrated to 44 μg), subcutaneously (sc), three times weekly, via electronic autoinjection device. Patients were assessed at baseline and 4-weekly intervals to Week 12 or early termination (ET) for: physical examinations; diary card completion (baseline, Weeks 4, 8 only); neurological examinations (baseline, Week 12/ET only); MS Treatment Concern Questionnaire (MSTCQ; Weeks 4, 8, 12 only); Convenience Questionnaire (Week 12 only); Hospital Anxiety and Depression Scale (HADS); and Paced Auditory Serial Addition Task (PASAT; baseline only). Adherence was defined as administration of ≥ 80% of scheduled injections, recorded by the autoinjection device.</p> <p>Results</p> <p>Overall, 88.2% (105/119; intent-to-treat population) of patients were adherent; 67.2% (80/119) administered all scheduled injections. Medical reasons accounted for 35.6% (31/87) of missed injections, forgetfulness for 20.6% (18/87). Adherence did not correlate with baseline Expanded Disability Status Scale (<it>P </it>= 0.821) or PASAT (<it>P </it>= 0.952) scores, or pre-study therapy (<it>P </it>= 0.303). No significant changes (baseline-Week 12) in mean HADS depression (<it>P </it>= 0.482) or anxiety (<it>P </it>= 0.156) scores were observed. 'Overall convenience' was the most important reported benefit of the autoinjection device. Device features associated with handling and ease of use were highly rated. Mean MSTCQ scores for 'flu-like' symptoms (<it>P </it>= 0.022) and global side effects (<it>P </it>= 0.002) significantly improved from Week 4-12. Mean MSTCQ scores for pain at injection site and injection pain increased from Week 4-12 (<it>P </it>< 0.001). Adverse events were mild/moderate. No new safety signals were identified.</p> <p>Conclusion</p> <p>Convenience and ease of use of the autoinjection device may improve adherence and, therefore, outcomes, in patients with RRMS receiving sc IFN β-1a.</p> <p>Trial registration</p> <p>EU Clinical Trials Register (EU-CTR; <url>http://www.clinicaltrialsregister.eu</url>): 2009-013333-24</p

Predictors of reading literacy for first and second language learners

In this study an attempt was made to construct a multi-factor model predicting the development of reading literacy in the upper grades of primary school in the Netherlands for subgroups of 729 first language (L1) learners and 93 second language (L2) learners. Following a longitudinal design, it was explored to what extent the variation in reading literacy development in L1 and L2 from grade 4 to grade 6 can be explained from children’s word decoding, language, mathematics and nonverbal reasoning skills, reading motivation and self confidence as well as their home reading resources. The results showed that L1 and L2 learners differed in reading literacy skills, language, mathematics, and reasoning skills. Structural equation modelling showed that the reading literacy development in both L1 and L2 learners could be explained from decoding, language, mathematics and reasoning skills, as well as their motivation and self-confidence. A striking difference was the fact that home reading resources had an impact on reading literacy in L1 learners but not in L2 learners

A pilot study of oral calcitriol (1,25-dihydroxyvitamin D3) for relapsing-remitting multiple sclerosis.

BACKGROUND: Epidemiological and ecological studies suggest links between vitamin D deficiency and increased multiple sclerosis (MS) prevalence. OBJECTIVE: To evaluate the safety and tolerability of oral calcitriol therapy in an open label pilot study. METHODS: 15 ambulatory patients with relapsing-remitting MS and at least one clinical relapse within the previous 12 months received oral calcitriol (target dose: 2.5 microg/d) for 48 weeks. Dietary calcium was restricted to 800 mg/d. Patients were monitored using frequent clinical and laboratory examinations, the expanded disability status scale (EDSS), and brain magnetic resonance imaging (MRI). RESULTS: Two patients withdrew because of symptomatic hypercalcaemia (serum calcium &gt;3.35 mmol/l in each case) resulting from persistent dietary indiscretion. Two diet compliant patients required temporary dose adjustments for mild asymptomatic hypercalcaemia. Diet compliant patients experienced mild adverse effects. The on-study exacerbation rate (27%) was less than baseline. Four patients experienced five clinical relapses but only one patient worsened by &gt;1 EDSS point. Brain MRI revealed enhancing lesions in five patients at baseline (33%) and in four (29%) at both 24 and 48 weeks. CONCLUSIONS: Oral calcitriol is safe and well tolerated for up to one year by diet compliant relapsing-remitting MS patients. Further study of vitamin D related mechanisms is warranted in MS

Ondansetron, a 5-HT3 antagonist, improves cerebellar tremor.

It has been previously shown that ondansetron, a 5-HT3 antagonist, can ameliorate vertigo in patients with acute brainstem disorders. A coincidental benefit was the improvement of cerebellar tremor in some patients with both vertigo and tremor. To further evaluate this effect, a placebo controlled, double blind, crossover study was conducted of a single dose of intravenous ondansetron in 20 patients with cerebellar tremor caused by multiple sclerosis, cerebellar degeneration, or drug toxicity. The principal outcome measures were the change in blind assessment of a writing task (spiral copying) and the timed completion of a nine hole peg test. Thirteen of 19 patients were deemed to have improved spiral copying after treatment with ondansetron when compared with baseline performance. One patient had a better response to the placebo compared with baseline performance (P = 0.00024). Patients completed the nine hole peg test in less time after ondansetron than after placebo (P = 0.08). Twelve patients thought that their tremor was functionally improved with the ondansetron treatment. None thought that the placebo gave improvement (P = 0.00098). The efficacy of orally administered ondansetron in tremor control is currently under study

Pertinence des descripteurs d'ambiance sonore urbaine - Application aux bruits des transports pendant les périodes sensibles

Analysis of the pertinence of descriptors of urban sound environment. An application has been done to the transportation noise in particular periods as durting the night-time, showing the inadequacy of the current indicators on describing people annoyanc

Report of the first annual Hawaii Asthma Research Consortium.

The first Hawaii Asthma Research Consortium was held on 7 May 2001 at Tripler Army Medical Center. Researchers investigating asthma-related problems and program directors of asthma projects were solicited statewide to present their projects. Ten lecturers focused on research and asthma projects in Hawaii in 20-minute presentations. An informal ten-minute discussion followed each presentation to encourage audience questions about the project and to discuss possible collaboration efforts between institutions. The institutions that were represented include: American Lung Association-Hawaii, Kaiser Permanente Center for Health Research Hawaii, Kapiolani Medical Center, Tripler Army Medical Center, University of Hawaii at Manoa, and Waianae Coast Comprehensive Health Center