Crayton Heidi, Sidovar Matthew, Wulf Stanley, Guo Amy
MS Center of Greater Washington, 8320 Old Courthouse Road, Suite 400, Vienna, VA, 22181, USA,
Patient. 2015 Jun;8(3):283-91. doi: 10.1007/s40271-014-0102-z.
Dalfampridine extended-release tablets (dalfampridine-ER; in Europe, prolonged-release fampridine, and elsewhere, fampridine modified or fampridine sustained release), 10 mg twice daily, are available for the treatment of improvement of walking in patients with multiple sclerosis, as demonstrated by an increase in walking speed. On-drug patient perspectives and experiences are valuable to understand and manage this patient population.
The objective of this study was to examine perspectives and experiences of patients receiving dalfampridine-ER in a real-world setting.
Step Together, an ongoing program that captures real-world patient experience with dalfampridine-ER treatment, consists of a survey administered at baseline (before dalfampridine-ER initiation) and at 30 (first follow-up) and 60 days (second follow-up) after initiation. The survey includes modified versions of the 12-item Multiple Sclerosis Walking Scale (mMSWS-12) and the Sheehan Disability Scale (mSDS) to assess walking ability and functional impairment, respectively.
As of September 2013, 2,248 patients participated in the baseline survey and 522 completed both follow-up surveys (completers). Among the completers, improvements in walking ability and function relative to baseline were significant at both follow-ups as measured by mMSWS-12 and mSDS scores, respectively. Notably, 69-74 % of completers at both follow-ups had improved mMSWS-12 scores, with scores greater than the range considered to be minimally clinically significant. Patients who completed the program expressed satisfaction with overall dalfampridine-ER treatment, and 69 % indicated that the survey would help them communicate better with their healthcare providers.
Results highlight the utility of patient-reported outcomes in the assessment of patient perspective and experience, providing a useful supplement to traditional objective measures used in clinical studies.
达氟吡啶缓释片(在欧洲为长效氨吡啶,在其他地方为改良型氨吡啶或氨吡啶缓释制剂),每日两次,每次10毫克,可用于改善多发性硬化症患者的行走能力,这已通过步行速度的提高得到证实。了解正在服药患者的观点和体验对于了解和管理这一患者群体很有价值。
本研究的目的是考察在现实环境中接受达氟吡啶缓释片治疗的患者的观点和体验。
“携手共进”是一项正在进行的项目,旨在收集患者使用达氟吡啶缓释片治疗的真实体验,包括在基线(开始使用达氟吡啶缓释片之前)、开始治疗后30天(首次随访)和60天(第二次随访)进行的一项调查。该调查包括12项多发性硬化症步行量表(mMSWS-12)和希恩残疾量表(mSDS)的修改版,分别用于评估步行能力和功能障碍。
截至2013年9月,2248名患者参与了基线调查,522名患者完成了两次随访调查(完成者)。在完成者中,通过mMSWS-12和mSDS评分分别测量,两次随访时相对于基线的步行能力和功能均有显著改善。值得注意的是,两次随访中69%-74%的完成者mMSWS-12评分有所改善,评分高于被认为具有最小临床意义的范围。完成该项目的患者对达氟吡啶缓释片的总体治疗表示满意,69%的患者表示该调查有助于他们更好地与医疗服务提供者沟通。
结果突出了患者报告结局在评估患者观点和体验方面的效用,为临床研究中使用的传统客观测量方法提供了有用的补充。