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

Gogem Topcu Orcid Logo, Laura Smith Orcid Logo, Jacqueline R. Mhizha-Murira Orcid Logo, Nia Goulden Orcid Logo, Zoë Hoare Orcid Logo, Avril Drummond Orcid Logo, Deborah Fitzsimmons Orcid Logo, Nikos Evangelou Orcid Logo, Klaus Schmierer Orcid Logo, Emma C. Tallantyre Orcid Logo, Paul Leighton Orcid Logo, Kimberley Allen-Philbey Orcid Logo, Andrea Stennett Orcid Logo, Paul Bradley Orcid Logo, Clare Bale, James Turton Orcid Logo, Roshan das Nair Orcid Logo, (On behalf of the NEuRoMS Collective)

Pilot and Feasibility Studies, Volume: 8, Issue: 1

Swansea University Author: Deborah Fitzsimmons Orcid Logo

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DOI (Published version): 10.1186/s40814-022-01073-5

Abstract

BackgroundCognitive 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...

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Published in: Pilot and Feasibility Studies
ISSN: 2055-5784
Published: Springer Science and Business Media LLC 2022
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URI: https://cronfa.swan.ac.uk/Record/cronfa60288
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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.MethodsThe 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.DiscussionTimely 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.</abstract><type>Journal Article</type><journal>Pilot and Feasibility Studies</journal><volume>8</volume><journalNumber>1</journalNumber><paginationStart/><paginationEnd/><publisher>Springer Science and Business Media LLC</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic>2055-5784</issnElectronic><keywords>Multiple sclerosis, Cognition, Cognitive screening, Rehabilitation, Feasibility study, Randomised controlled trial</keywords><publishedDay>11</publishedDay><publishedMonth>6</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-06-11</publishedDate><doi>10.1186/s40814-022-01073-5</doi><url/><notes/><college>COLLEGE NANME</college><department>Health and Social Care School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HSOC</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>This report is an independent research funded by the National Institute for Health and Care Research (Programme Grants for Applied Research, neuropsychological evaluation and rehabilitation in multiple sclerosis &#x2014; developing, evaluating, and implementing a clinical management pathway (NEuRoMS), RP-PG-0218&#x2013;20002). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National institute for Health and Care Research, or the Department of Health and Social Care.</funders><lastEdited>2022-07-15T16:50:46.7574323</lastEdited><Created>2022-06-21T09:11:52.5594484</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">School of Health and Social Care - Public Health</level></path><authors><author><firstname>Gogem</firstname><surname>Topcu</surname><orcid>0000-0002-7400-5686</orcid><order>1</order></author><author><firstname>Laura</firstname><surname>Smith</surname><orcid>0000-0003-3275-1530</orcid><order>2</order></author><author><firstname>Jacqueline R.</firstname><surname>Mhizha-Murira</surname><orcid>0000-0002-1976-0195</orcid><order>3</order></author><author><firstname>Nia</firstname><surname>Goulden</surname><orcid>0000-0001-6511-3987</orcid><order>4</order></author><author><firstname>Zo&#xEB;</firstname><surname>Hoare</surname><orcid>0000-0003-1803-5482</orcid><order>5</order></author><author><firstname>Avril</firstname><surname>Drummond</surname><orcid>0000-0003-1220-8354</orcid><order>6</order></author><author><firstname>Deborah</firstname><surname>Fitzsimmons</surname><orcid>0000-0002-7286-8410</orcid><order>7</order></author><author><firstname>Nikos</firstname><surname>Evangelou</surname><orcid>0000-0003-2871-0672</orcid><order>8</order></author><author><firstname>Klaus</firstname><surname>Schmierer</surname><orcid>0000-0002-9293-8893</orcid><order>9</order></author><author><firstname>Emma C.</firstname><surname>Tallantyre</surname><orcid>0000-0002-3760-6634</orcid><order>10</order></author><author><firstname>Paul</firstname><surname>Leighton</surname><orcid>0000-0001-5208-0274</orcid><order>11</order></author><author><firstname>Kimberley</firstname><surname>Allen-Philbey</surname><orcid>0000-0003-1207-8625</orcid><order>12</order></author><author><firstname>Andrea</firstname><surname>Stennett</surname><orcid>0000-0003-0881-022x</orcid><order>13</order></author><author><firstname>Paul</firstname><surname>Bradley</surname><orcid>0000-0002-4060-9932</orcid><order>14</order></author><author><firstname>Clare</firstname><surname>Bale</surname><order>15</order></author><author><firstname>James</firstname><surname>Turton</surname><orcid>0000-0003-2681-0477</orcid><order>16</order></author><author><firstname>Roshan das</firstname><surname>Nair</surname><orcid>0000-0001-8143-7893</orcid><order>17</order></author><author><firstname>(On behalf of the NEuRoMS</firstname><surname>Collective)</surname><order>18</order></author></authors><documents><document><filename>60288__24616__1a85ad3486f74747b1e8913248ddc85f.pdf</filename><originalFilename>60288.pdf</originalFilename><uploaded>2022-07-15T16:49:04.6871628</uploaded><type>Output</type><contentLength>1696569</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>&#xA9; The Author(s) 2022. 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spelling 2022-07-15T16:50:46.7574323 v2 60288 2022-06-21 Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial e900d99a0977beccf607233b10c66b43 0000-0002-7286-8410 Deborah Fitzsimmons Deborah Fitzsimmons true false 2022-06-21 HSOC BackgroundCognitive 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.MethodsThe 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.DiscussionTimely 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. Journal Article Pilot and Feasibility Studies 8 1 Springer Science and Business Media LLC 2055-5784 Multiple sclerosis, Cognition, Cognitive screening, Rehabilitation, Feasibility study, Randomised controlled trial 11 6 2022 2022-06-11 10.1186/s40814-022-01073-5 COLLEGE NANME Health and Social Care School COLLEGE CODE HSOC Swansea University This report is an independent research funded by the National Institute for Health and Care Research (Programme Grants for Applied Research, neuropsychological evaluation and rehabilitation in multiple sclerosis — developing, evaluating, and implementing a clinical management pathway (NEuRoMS), RP-PG-0218–20002). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National institute for Health and Care Research, or the Department of Health and Social Care. 2022-07-15T16:50:46.7574323 2022-06-21T09:11:52.5594484 Faculty of Medicine, Health and Life Sciences School of Health and Social Care - Public Health Gogem Topcu 0000-0002-7400-5686 1 Laura Smith 0000-0003-3275-1530 2 Jacqueline R. Mhizha-Murira 0000-0002-1976-0195 3 Nia Goulden 0000-0001-6511-3987 4 Zoë Hoare 0000-0003-1803-5482 5 Avril Drummond 0000-0003-1220-8354 6 Deborah Fitzsimmons 0000-0002-7286-8410 7 Nikos Evangelou 0000-0003-2871-0672 8 Klaus Schmierer 0000-0002-9293-8893 9 Emma C. Tallantyre 0000-0002-3760-6634 10 Paul Leighton 0000-0001-5208-0274 11 Kimberley Allen-Philbey 0000-0003-1207-8625 12 Andrea Stennett 0000-0003-0881-022x 13 Paul Bradley 0000-0002-4060-9932 14 Clare Bale 15 James Turton 0000-0003-2681-0477 16 Roshan das Nair 0000-0001-8143-7893 17 (On behalf of the NEuRoMS Collective) 18 60288__24616__1a85ad3486f74747b1e8913248ddc85f.pdf 60288.pdf 2022-07-15T16:49:04.6871628 Output 1696569 application/pdf Version of Record true © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License true eng http://creativecommons.org/licenses/by/4.0/
title Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial
spellingShingle Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial
Deborah Fitzsimmons
title_short Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial
title_full Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial
title_fullStr Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial
title_full_unstemmed Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial
title_sort Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial
author_id_str_mv e900d99a0977beccf607233b10c66b43
author_id_fullname_str_mv e900d99a0977beccf607233b10c66b43_***_Deborah Fitzsimmons
author Deborah Fitzsimmons
author2 Gogem Topcu
Laura Smith
Jacqueline R. Mhizha-Murira
Nia Goulden
Zoë Hoare
Avril Drummond
Deborah Fitzsimmons
Nikos Evangelou
Klaus Schmierer
Emma C. Tallantyre
Paul Leighton
Kimberley Allen-Philbey
Andrea Stennett
Paul Bradley
Clare Bale
James Turton
Roshan das Nair
(On behalf of the NEuRoMS Collective)
format Journal article
container_title Pilot and Feasibility Studies
container_volume 8
container_issue 1
publishDate 2022
institution Swansea University
issn 2055-5784
doi_str_mv 10.1186/s40814-022-01073-5
publisher Springer Science and Business Media LLC
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Health and Social Care - Public Health{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care - Public Health
document_store_str 1
active_str 0
description BackgroundCognitive 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.MethodsThe 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.DiscussionTimely 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.
published_date 2022-06-11T20:12:33Z
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