Sadovnick A Dessa, Carruthers Robert, Houtchens Maria, Schabas Alice, Smyth Penelope
Department of Medicine (Neurology), University of British Columbia, Vancouver, British Columbia, Canada.
Department of Medical Genetics, University of British Columbia, Vancouver, British Columbia, Canada.
Can J Neurol Sci. 2020 Jan;47(1):109-114. doi: 10.1017/cjn.2019.296. Epub 2019 Oct 29.
Multiple sclerosis (MS) is the most common cause of neurological disability, other than trauma, among young adults of reproductive age. In contrast to the past, today there is very little lag time from clinical onset to diagnosis. Disease-modifying therapies are also now available outside of clinical trials. However, there is very little evidence-based population data to help an individual with MS make informed decisions with respect to reproductive options.
The objective of this study is to develop a Canada-wide, prospective population-based registry of women with MS who are either trying to become pregnant and/or have become pregnant.
The study represents a "real-world" scenario. Women with MS are invited to participate, regardless of clinical course, therapy, disease duration, and/or disability. The methodology to develop such a registry is very complex making it imperative to understand the design and rationale when interpreting results for clinical purposes.
This paper is a comprehensive discussion of the study rationale and methodology.
The study is ongoing, with over 100 potential participants. Numerous future publications are envisioned as the study progresses. The present paper is thus designed to be the key referral paper for subsequent publications in which it will not be possible to provide the necessary detailed information on rationale and methodology.
多发性硬化症（MS）是育龄期年轻成年人中除创伤外导致神经功能障碍的最常见原因。与过去不同的是，如今从临床发病到诊断的延迟时间很短。疾病修正疗法如今在临床试验之外也已可用。然而，几乎没有基于证据的人群数据来帮助患有MS的个体就生育选择做出明智的决定。
本研究的目的是建立一个覆盖加拿大全国的、基于人群的前瞻性登记系统，登记正在尝试怀孕和/或已怀孕的患有MS的女性。
该研究代表了一种“真实世界”的情况。邀请患有MS的女性参与，无论其临床病程、治疗方法、疾病持续时间和/或残疾情况如何。建立这样一个登记系统的方法非常复杂，因此在为临床目的解释结果时，必须了解其设计和基本原理。
本文对研究的基本原理和方法进行了全面讨论。
该研究正在进行中，有超过100名潜在参与者。随着研究的推进，预计会有大量后续出版物。因此，本文旨在成为后续出版物的关键参考论文，后续出版物中将无法提供关于基本原理和方法的必要详细信息。
