Video Rating in Neurodegenerative Disease Clinical Trials: The Experience of PRION-1.

BACKGROUND/AIMS: Large clinical trials including patients with uncommon diseases involve assessors in different geographical locations, resulting in considerable inter-rater variability in assessment scores. As video recordings of examinations, which can be individually rated, may eliminate such var...

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Main Authors: Carswell, C, Rañopa, M, Pal, S, Macfarlane, R, Siddique, D, Thomas, D, Webb, T, Wroe, S, Walker, S, Darbyshire, J, Collinge, J, Mead, S, Rudge, P
Format: Journal article
Language:English
Published: 2012
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author Carswell, C
Rañopa, M
Pal, S
Macfarlane, R
Siddique, D
Thomas, D
Webb, T
Wroe, S
Walker, S
Darbyshire, J
Collinge, J
Mead, S
Rudge, P
author_facet Carswell, C
Rañopa, M
Pal, S
Macfarlane, R
Siddique, D
Thomas, D
Webb, T
Wroe, S
Walker, S
Darbyshire, J
Collinge, J
Mead, S
Rudge, P
author_sort Carswell, C
collection OXFORD
description BACKGROUND/AIMS: Large clinical trials including patients with uncommon diseases involve assessors in different geographical locations, resulting in considerable inter-rater variability in assessment scores. As video recordings of examinations, which can be individually rated, may eliminate such variability, we measured the agreement between a single video rater and multiple examining physicians in the context of PRION-1, a clinical trial of the antimalarial drug quinacrine in human prion diseases. METHODS: We analysed a 43-component neurocognitive assessment battery, on 101 patients with Creutzfeldt-Jakob disease, focusing on the correlation and agreement between examining physicians and a single video rater. RESULTS: In total, 335 videos of examinations of 101 patients who were video-recorded over the 4-year trial period were assessed. For neurocognitive examination, inter-observer concordance was generally excellent. Highly visual neurological examination domains (e.g. finger-nose-finger assessment of ataxia) had good inter-rater correlation, whereas those dependent on non-visual clues (e.g. power or reflexes) correlated poorly. Some non-visual neurological domains were surprisingly concordant, such as limb muscle tone. CONCLUSION: Cognitive assessments and selected neurological domains can be practically and accurately recorded in a clinical trial using video rating. Video recording of examinations is a valuable addition to any trial provided appropriate selection of assessment instruments is used and rigorous training of assessors is undertaken.
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spelling oxford-uuid:ded3b243-0466-4107-868f-0a158b7ebafb2022-03-27T09:34:59ZVideo Rating in Neurodegenerative Disease Clinical Trials: The Experience of PRION-1.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:ded3b243-0466-4107-868f-0a158b7ebafbEnglishSymplectic Elements at Oxford2012Carswell, CRañopa, MPal, SMacfarlane, RSiddique, DThomas, DWebb, TWroe, SWalker, SDarbyshire, JCollinge, JMead, SRudge, PBACKGROUND/AIMS: Large clinical trials including patients with uncommon diseases involve assessors in different geographical locations, resulting in considerable inter-rater variability in assessment scores. As video recordings of examinations, which can be individually rated, may eliminate such variability, we measured the agreement between a single video rater and multiple examining physicians in the context of PRION-1, a clinical trial of the antimalarial drug quinacrine in human prion diseases. METHODS: We analysed a 43-component neurocognitive assessment battery, on 101 patients with Creutzfeldt-Jakob disease, focusing on the correlation and agreement between examining physicians and a single video rater. RESULTS: In total, 335 videos of examinations of 101 patients who were video-recorded over the 4-year trial period were assessed. For neurocognitive examination, inter-observer concordance was generally excellent. Highly visual neurological examination domains (e.g. finger-nose-finger assessment of ataxia) had good inter-rater correlation, whereas those dependent on non-visual clues (e.g. power or reflexes) correlated poorly. Some non-visual neurological domains were surprisingly concordant, such as limb muscle tone. CONCLUSION: Cognitive assessments and selected neurological domains can be practically and accurately recorded in a clinical trial using video rating. Video recording of examinations is a valuable addition to any trial provided appropriate selection of assessment instruments is used and rigorous training of assessors is undertaken.
spellingShingle Carswell, C
Rañopa, M
Pal, S
Macfarlane, R
Siddique, D
Thomas, D
Webb, T
Wroe, S
Walker, S
Darbyshire, J
Collinge, J
Mead, S
Rudge, P
Video Rating in Neurodegenerative Disease Clinical Trials: The Experience of PRION-1.
title Video Rating in Neurodegenerative Disease Clinical Trials: The Experience of PRION-1.
title_full Video Rating in Neurodegenerative Disease Clinical Trials: The Experience of PRION-1.
title_fullStr Video Rating in Neurodegenerative Disease Clinical Trials: The Experience of PRION-1.
title_full_unstemmed Video Rating in Neurodegenerative Disease Clinical Trials: The Experience of PRION-1.
title_short Video Rating in Neurodegenerative Disease Clinical Trials: The Experience of PRION-1.
title_sort video rating in neurodegenerative disease clinical trials the experience of prion 1
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