Utilising accessible and reproducible neurological assessments in clinical studies: Insights from use of the Neurological Impairment Scale in the multi-centre COVID-CNS study

Ali M Alam¹, Glynn W Webb¹, Ceryce Collie¹, Sashini Mariathasan², Yun Huang¹, Orla Hilton¹, Rajish Shil¹, Katherine C Dodd³, James B Lilleker³, Craig J Smith⁴, Ava Easton⁵, Arina Tamborska¹, Rhys H Thomas⁶, Nicholas W S Davies⁷, Thomas M Jenkins⁸, Michael Zandi², Laura Benjamin², Mark A Ellul¹, Tom Solomon⁹, Thomas A Pollak¹⁰, Tim Nicholson¹¹, Gerome Breen¹², Daniel J van Wamelen¹³, Nicholas W Wood¹⁴, Benedict D Michael¹⁵; (on Behalf of the COVID-CNS Group)¹

Affiliations

¹ Infection Neuroscience Laboratory, Institute of Infection, Veterinary and Ecological Science, University of Liverpool, NIHR HPRU for Emerging and Zoonotic Infection, Liverpool, UK.
² National Hospital for Neurology and Neurosurgery, London, UK.
³ Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Manchester Academic Health Science Centre, Salford, UK.
⁴ Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Manchester Academic Health Science Centre, Salford, UK; Divsion of Cardiovascular Sciences, University of Manchester, Manchester, UK.
⁵ Infection Neuroscience Laboratory, Institute of Infection, Veterinary and Ecological Science, University of Liverpool, NIHR HPRU for Emerging and Zoonotic Infection, Liverpool, UK; Encephalitis International, Malton, UK.
⁶ Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
⁷ Department of Neurology, Charing Cross Hospital, London, UK.
⁸ Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Curtin University, Perth, Western Australia.
⁹ Infection Neuroscience Laboratory, Institute of Infection, Veterinary and Ecological Science, University of Liverpool, NIHR HPRU for Emerging and Zoonotic Infection, Liverpool, UK; The Pandemic Institute, Liverpool, UK.
¹⁰ Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
¹¹ Section of Cognitive Neuropsychiatry, Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
¹² Institute of Psychiatry, Psychology & Neuroscience; Social, Genetic & Developmental Psychiatry Centre, King's College London, London, UK.
¹³ Institute of Psychiatry, Psychology & Neuroscience, Department of Neuroimaging, King's College London, London, UK.
¹⁴ Department of Clinical and Movement Neurosciences, University College London, UCL Queen Square Institute of Neurology, London, UK.
¹⁵ Infection Neuroscience Laboratory, Institute of Infection, Veterinary and Ecological Science, University of Liverpool, NIHR HPRU for Emerging and Zoonotic Infection, Liverpool, UK. Electronic address: benmic@liverpool.ac.uk.

PMID: 39244036
PMCID: PMC11420440
DOI: 10.1016/j.clinme.2024.100241

Multicenter Study

Utilising accessible and reproducible neurological assessments in clinical studies: Insights from use of the Neurological Impairment Scale in the multi-centre COVID-CNS study

Ali M Alam et al. Clin Med (Lond). 2024 Sep.

. 2024 Sep;24(5):100241.

doi: 10.1016/j.clinme.2024.100241. Epub 2024 Sep 6.

Authors

Affiliations

¹ Infection Neuroscience Laboratory, Institute of Infection, Veterinary and Ecological Science, University of Liverpool, NIHR HPRU for Emerging and Zoonotic Infection, Liverpool, UK.
² National Hospital for Neurology and Neurosurgery, London, UK.
³ Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Manchester Academic Health Science Centre, Salford, UK.
⁴ Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Manchester Academic Health Science Centre, Salford, UK; Divsion of Cardiovascular Sciences, University of Manchester, Manchester, UK.
⁵ Infection Neuroscience Laboratory, Institute of Infection, Veterinary and Ecological Science, University of Liverpool, NIHR HPRU for Emerging and Zoonotic Infection, Liverpool, UK; Encephalitis International, Malton, UK.
⁶ Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
⁷ Department of Neurology, Charing Cross Hospital, London, UK.
⁸ Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Curtin University, Perth, Western Australia.
⁹ Infection Neuroscience Laboratory, Institute of Infection, Veterinary and Ecological Science, University of Liverpool, NIHR HPRU for Emerging and Zoonotic Infection, Liverpool, UK; The Pandemic Institute, Liverpool, UK.
¹⁰ Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
¹¹ Section of Cognitive Neuropsychiatry, Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
¹² Institute of Psychiatry, Psychology & Neuroscience; Social, Genetic & Developmental Psychiatry Centre, King's College London, London, UK.
¹³ Institute of Psychiatry, Psychology & Neuroscience, Department of Neuroimaging, King's College London, London, UK.
¹⁴ Department of Clinical and Movement Neurosciences, University College London, UCL Queen Square Institute of Neurology, London, UK.
¹⁵ Infection Neuroscience Laboratory, Institute of Infection, Veterinary and Ecological Science, University of Liverpool, NIHR HPRU for Emerging and Zoonotic Infection, Liverpool, UK. Electronic address: benmic@liverpool.ac.uk.

PMID: 39244036
PMCID: PMC11420440
DOI: 10.1016/j.clinme.2024.100241

Abstract

Reproducible and standardised neurological assessment scales are important in quantifying research outcomes. These scales are often performed by non-neurologists and/or non-clinicians and must be robust, quantifiable, reproducible and comparable to a neurologist's assessment. COVID-CNS is a multi-centre study which utilised the Neurological Impairment Scale (NIS) as a core assessment tool in studying neurological outcomes following COVID-19 infection. We investigated the strengths and weaknesses of the NIS when used by non-neurology clinicians and non-clinicians, and compared performance to a structured neurological examination performed by a neurology clinician. Through our findings, we provide practical advice on how non-clinicians can be readily trained in conducting reproducible and standardised neurological assessments in a multi-centre study, as well as illustrating potential pitfalls of these tools.

Keywords: COVID-19; Clinical study; Neurological assessment; Neurology; Outcome tool.

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Conflict of interest statement

Declaration of competing interest T.S. is the Director of The Pandemic Institute which has received funding from Innova and CSL Seqirus and Aviva and DAM Health. T.S. was an advisor to the GSK Ebola Vaccine programme and the Siemens Diagnostic Programme. T.S. Chaired the Siemens Healthineers Clinical Advisory Board. T.S. Co-Chaired the WHO Neuro-COVID task force and sat on the UK Government Advisory Committee on Dangerous Pathogens, and the Medicines and Healthcare Products Regulatory Agency (MHRA) Expert Working Group on Covid-19 vaccines. T.S. Advised to the UK COVID-19 Therapeutics Advisory Panel (UK-TAP). T.S. was a Member of COVID-19 Vaccines Benefit Risk Expert Working Group for the Commission on Human Medicines (CHM) committee of the Medicines and Healthcare products Regulatory Agency (MHRA). T.S. has been a member of the Encephalitis Society since 1998 and President of the Encephalitis Society since 2019.

Figures

**Fig. 1**
Study design showing how core and clinical assessments were undertaken.

**Fig. 2**
A screenshot of the educational video on conducting the COVID-CNS clinical assessment.

**Fig. 3**
Kappa co-efficient values in the different neurological assessment categories in Group 1 and Group 2.

See this image and copyright information in PMC

References

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Utilising accessible and reproducible neurological assessments in clinical studies: Insights from use of the Neurological Impairment Scale in the multi-centre COVID-CNS study

Affiliations

Utilising accessible and reproducible neurological assessments in clinical studies: Insights from use of the Neurological Impairment Scale in the multi-centre COVID-CNS study

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources