多发性硬化症的神经心理学评估与康复（NEuRoMS）：一项混合方法、多中心可行性随机对照试验方案

Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial.

作者信息

Topcu Gogem, Smith Laura, Mhizha-Murira Jacqueline R, Goulden Nia, Hoare Zoë, Drummond Avril, Fitzsimmons Deborah, Evangelou Nikos, Schmierer Klaus, Tallantyre Emma C, Leighton Paul, Allen-Philbey Kimberley, Stennett Andrea, Bradley Paul, Bale Clare, Turton James, das Nair Roshan

机构信息

Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.

School of Psychology, Keynes College, University of Kent, Canterbury, Kent, UK.

出版信息

Pilot Feasibility Stud. 2022 Jun 11;8(1):123. doi: 10.1186/s40814-022-01073-5.

DOI:10.1186/s40814-022-01073-5

PMID:35690797

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9187894/

Abstract

BACKGROUND

Cognitive problems affect up to 70% of people with multiple sclerosis (MS), which can negatively impact mood, ability to work, and quality of life. Addressing cognitive problems is a top 10 research priority for people with MS. Our ongoing research has systematically developed a cognitive screening and management pathway (NEuRoMS) tailored for people with MS, involving a brief cognitive evaluation and rehabilitation intervention. The present study aims to assess the feasibility of delivering the pathway and will inform the design of a definitive randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of the intervention and eventually guide its clinical implementation.

METHODS

The feasibility study is in three parts. Part 1 involves an observational study of those who receive screening and support for cognitive problems, using routinely collected clinical data. Part 2 is a two-arm, parallel group, multicentre, feasibility RCT with a nested fidelity evaluation. This part will evaluate the feasibility of undertaking a definitive trial comparing the NEuRoMS intervention plus usual care to usual care only, amongst people with MS with mild cognitive problems (n = 60). In part 3, semi-structured interviews will be undertaken with participants from part 2 (n = 25), clinicians (n = 9), and intervention providers (n = 3) involved in delivering the NEuRoMS cognitive screening and management pathway. MS participants will be recruited from outpatient clinics at three UK National Health Service hospitals.

DISCUSSION

Timely screening and effective management of cognitive problems in MS are urgently needed due to the detrimental consequences of cognitive problems on people with MS, the healthcare system, and wider society. The NEuRoMS intervention is based on previous and extant literature and has been co-constructed with relevant stakeholders. If effective, the NEuRoMS pathway will facilitate timely identification and management of cognitive problems in people with MS.

TRIAL REGISTRATION

ISRCTN11203922 . Prospectively registered on 09.02.2021.

摘要

背景

认知问题影响多达70%的多发性硬化症（MS）患者，这会对情绪、工作能力和生活质量产生负面影响。解决认知问题是MS患者的十大研究重点之一。我们正在进行的研究系统地开发了一种专为MS患者量身定制的认知筛查和管理途径（NEuRoMS），包括简短的认知评估和康复干预。本研究旨在评估实施该途径的可行性，并为确定的随机对照试验（RCT）设计提供信息，以调查该干预措施的临床和成本效益，并最终指导其临床实施。

方法

可行性研究分为三个部分。第1部分涉及对那些接受认知问题筛查和支持的患者进行观察性研究，使用常规收集的临床数据。第2部分是一项双臂、平行组、多中心、具有嵌套保真度评估的可行性RCT。这部分将评估在轻度认知问题的MS患者（n = 60）中进行一项确定性试验的可行性，该试验比较NEuRoMS干预加常规护理与仅常规护理。在第3部分中，将对参与实施NEuRoMS认知筛查和管理途径的第2部分的参与者（n = 25）、临床医生（n = 9）和干预提供者（n = 3）进行半结构化访谈。MS参与者将从英国三家国民健康服务医院的门诊招募。