OPTIMISE: MS study protocol: a pragmatic, prospective observational study to address the need for, and challenges with, real world pharmacovigilance in multiple sclerosis.
OPTIMISE: MS study protocol: a pragmatic, prospective observational study to address the need for, and challenges with, real world pharmacovigilance in multiple sclerosis.
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DOI：
10.1136/bmjopen-2021-050176
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发表时间：
2021-11-25
期刊：
影响因子：
2.9
通讯作者：
Matthews PM
中科院分区：
文献类型：
--
作者：
Dobson R;Craner M;Waddingham E;Miller A;Cavey A;Webb S;Hemingway C;Hobart J;Evangelou N;Scolding N;Rog D;Nicholas R;Marta M;Blain C;Young CA;Ford HL;Matthews PM
“真实的世界”数据的力量，以提高我们对多发性硬化症（MS）的临床方面的理解开始实现。在英国，疾病修饰疗法（DMT）的使用是由国家处方指南驱动的。因此，英国提供了一个收集MS结果数据的理想国家。一项以药物警戒为重点的严格进行的观察性研究有可能提供重要数据，以告知临床医生和患者，同时测试关键试验估计值在英国患者中的可靠性。本研究的主要目的是确定接受DMT治疗的MS患者中严重不良事件的发生率并比较其风险。OPTIMISE：MS数据库支持电子数据采集和安全数据传输。在常规临床访视时，以协调的方式收集各研究中心的选定临床数据、临床病史和患者报告的结局。首例患者于2019年5月24日入组研究。截至2021年1月，已有1615人的基线数据记录;后续数据正在采集中，将适时上报。本研究已获得伦理许可（伦敦City and East;参考19/LO/0064）。通过将可识别数据与所有其他临床数据分离，并限制对任何可识别数据的访问，缓解了对数据存储和共享的潜在担忧。这项研究的结果将通过出版物传播。参与者同意将匿名数据共享用于进一步的研究用途，进一步提高研究的价值。
The power of ‘real world’ data to improve our understanding of the clinical aspects of multiple sclerosis (MS) is starting to be realised. Disease modifying therapy (DMT) use across the UK is driven by national prescribing guidelines. As such, the UK provides an ideal country in which to gather MS outcomes data. A rigorously conducted observational study with a focus on pharmacovigilance has the potential to provide important data to inform clinicians and patients while testing the reliability of estimates from pivotal trials when applied to patients in the UK. The primary aim of this study is to characterise the incidence and compare the risk of serious adverse events in people with MS treated with DMTs. The OPTIMISE:MS database enables electronic data capture and secure data transfer. Selected clinical data, clinical histories and patient-reported outcomes are collected in a harmonised fashion across sites at the time of routine clinical visits. The first patient was recruited to the study on 24 May 2019. As of January 2021, 1615 individuals have baseline data recorded; follow-up data are being captured and will be reported in due course. This study has ethical permission (London City and East; Ref 19/LO/0064). Potential concerns around data storage and sharing are mitigated by the separation of identifiable data from all other clinical data, and limiting access to any identifiable data. The results of this study will be disseminated via publication. Participants provide consent for anonymised data to be shared for further research use, further enhancing the value of the study.
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