کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2823888 | 1161444 | 2012 | 8 صفحه PDF | دانلود رایگان |
![عکس صفحه اول مقاله: Patient-rated ease of use and functional reliability of an electronic autoinjector for self-injection of subcutaneous interferon beta-1a for relapsing multiple sclerosis Patient-rated ease of use and functional reliability of an electronic autoinjector for self-injection of subcutaneous interferon beta-1a for relapsing multiple sclerosis](/preview/png/2823888.png)
BackgroundFor patients with multiple sclerosis (MS), electronic autoinjectors may improve convenience and reduce discomfort associated with chronic injections.ObjectiveTo assess ease of use, patient satisfaction, and functional reliability of an investigational electronic autoinjector for self-injection of subcutaneous interferon beta-1a (IFNβ-1a).MethodsThis prospective, multicenter, open-label, single-arm, 12-week, Phase IIIb study enrolled patients aged 18–65 years with relapsing MS receiving IFNβ-1a 44 μg subcutaneously 3 times weekly for ≥12 weeks before enrollment. Thereafter, patients continued their regimen using an electronic autoinjector. The primary endpoint was the proportion of patients rating the autoinjector ‘easy to use’ or ‘very easy to use’ on a User Trial Questionnaire at week 12. Secondary endpoints included patient responses to questions regarding device reliability, patient satisfaction, and convenience.ResultsOf 103 patients enrolled, 88 completed the study. The primary objective was met, with most patients (78%) indicating the device was ‘easy to use’ or ‘very easy to use’ at week 12 (worst-case imputation). In an analysis of secondary endpoints, over 60% of patients responded favorably to each of the User Trial questions regarding device ease-of-use and their satisfaction with the device. Overall convenience was judged the most important benefit of the device. Adverse events reported were consistent with the known safety profile of IFNβ-1a, with injection site reactions the most frequently reported.ConclusionThese data show that patients found the electronic autoinjector for delivery of subcutaneous IFNβ-1a reliable and easy to use, suggesting the device may help patients with relapsing MS to administer self-injections.
► An investigational electronic autoinjector for s.c. IFNβ-1a injection was studied in patients with relapsing MS.
► Ease of use, patient satisfaction, and functional reliability were assessed.
► Patients found the autoinjector to be reliable and easy to use for self-injection.
Journal: Multiple Sclerosis and Related Disorders - Volume 1, Issue 2, April 2012, Pages 87–94