Responsiveness of 2 Different Ability Outcome Measures in Guillain-Barré Syndrome.
Journal
The neurologist
ISSN: 2331-2637
Titre abrégé: Neurologist
Pays: United States
ID NLM: 9503763
Informations de publication
Date de publication:
04 Nov 2021
04 Nov 2021
Historique:
entrez:
4
11
2021
pubmed:
5
11
2021
medline:
9
11
2021
Statut:
epublish
Résumé
The most frequently used ability outcome measure in Guillain-Barré syndrome (GBS) is the GBS disability scale (GDS). Recently developed inflammatory Rasch-built overall disability (I-RODS) scale has been suggested to be used in inflammatory polyneuropathies. In the present study, we wanted to assess the comparative responsiveness of I-RODS and GDS in subjects who were diagnosed with GBS during a follow-up period of 6 months. Our prospective, multicentric study included 72 subjects. Patients were tested, using GDS and I-RODS, on day 14, day 28, month 3, and month 6 from the start of the symptoms. We defined improvement as a reduction for 1 or more points on GDS or improvement on I-RODS as defined by Draak (2014). Between days 14 and 28 there was an improvement in 28% of patients as measured with GDS and only in 10% patients as measured with I-RODS. At month 3 compared with day 14, we noticed an improvement in GDS score in 90% of GBS patients and I-RODS score in 65%. At month 6 improvements were noticed in 94% of patients measured by GDS and 78% according to I-RODS. Our findings support the use of GDS in an acute phase of GBS. I-RODS have their role mostly during a longer follow-up period when the majority of patients are ambulant and their other abilities besides walking are also of great importance.
Sections du résumé
BACKGROUND
BACKGROUND
The most frequently used ability outcome measure in Guillain-Barré syndrome (GBS) is the GBS disability scale (GDS). Recently developed inflammatory Rasch-built overall disability (I-RODS) scale has been suggested to be used in inflammatory polyneuropathies. In the present study, we wanted to assess the comparative responsiveness of I-RODS and GDS in subjects who were diagnosed with GBS during a follow-up period of 6 months.
METHODS
METHODS
Our prospective, multicentric study included 72 subjects. Patients were tested, using GDS and I-RODS, on day 14, day 28, month 3, and month 6 from the start of the symptoms. We defined improvement as a reduction for 1 or more points on GDS or improvement on I-RODS as defined by Draak (2014).
RESULTS
RESULTS
Between days 14 and 28 there was an improvement in 28% of patients as measured with GDS and only in 10% patients as measured with I-RODS. At month 3 compared with day 14, we noticed an improvement in GDS score in 90% of GBS patients and I-RODS score in 65%. At month 6 improvements were noticed in 94% of patients measured by GDS and 78% according to I-RODS.
CONCLUSION
CONCLUSIONS
Our findings support the use of GDS in an acute phase of GBS. I-RODS have their role mostly during a longer follow-up period when the majority of patients are ambulant and their other abilities besides walking are also of great importance.
Identifiants
pubmed: 34734901
doi: 10.1097/NRL.0000000000000341
pii: 00127893-202111000-00004
doi:
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
244-247Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The authors declare no conflict of interest.
Références
van den Berg B, Walgaard C, Drenthen J, et al. Guillain-Barré syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014;10:469–482.
Farmakidis C, Inan S, Milstein M, et al. Headache and pain in Guillain-Barré syndrome. Curr Pain Headache Rep. 2015;19:40.
Drory VE, Bronipolsky T, Bluvshtein V, et al. Occurrence of fatigue over 20 years after recovery from Guillain-Barré syndrome. J Neurol Sci. 2012;316:72–75.
Bersano A, Carpo M, Allaria S, et al. Long term disability and social status change after Guillain-Barré syndrome. J Neurol. 2006;253:214–218.
US Department of Health and Human Services FDA Center for Drug Evaluation and Research, US Department of Health and Human Services FDA Center for Biologics Evaluation and Research, US Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006;4:79–99.
Merkies IS, Lauria G. 131st ENMC International Workshop: selection of outcome measures for peripheral neuropathy clinical trials 10-12 December 2004, Naarden, The Netherlands. Neuromuscul Disord. 2006;16:149–156.
Forsberg A, Press R, Einarsson U, et al. Disability and health-related quality of life in Guillain-Barré syndrome during the first two years after onset: a prospective study. Clin Rehabil. 2005;19:900–909.
Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010;362:865–869.
Draak TH, Vanhoutte EK, van Nes SI, et al. Changing outcome in inflammatory neuropathies: Rasch-comparative responsiveness. Neurology. 2014;83:2124–2132.
van Nes SI, Vanhoutte EK, van Doorn PA, et al. Rasch-built Overall Disability Scale (R-ODS) for immune-mediated peripheral neuropathies. Neurology. 2011;76:337–345.
Vanhoutte EK, Faber CG, Merkies IS. 196th ENMC International Workshop: outcome measures in inflammatory peripheral neuropathies, 8–10 February 2013, Naarden, The Netherlands. Neuromuscul Disord. 2013;23:924–933.
Eftimov F, Bunschoten C, Rajabally Y, et al. Participants of the 231st ENMC Workshop. 231st ENMC International Workshop: International Standard for CIDP Registry and Biobank, Naarden, The Netherlands, 12-14 May 2017. Neuromuscul Disord. 2018;28:178–184.
Delmont E, Hiew FL, Cassereau J, et al. Determinants of health-related quality of life in anti-MAG neuropathy: a cross-sectional multicentre European study. J Peripher Nerv Syst. 2017;22:27–33.
Peric S, Bozovic I, Pruppers MHJ, et al. Validation of the Serbian version of inflammatory Rasch-built overall disability scale in patients with chronic inflammatory demyelinating polyradiculoneuropathy. J Peripher Nerv Syst. 2019;24:260–267.
Sejvar JJ, Kohl KS, Gidudu J, et al. Guillain-Barre syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2011;29:599–612.
Dimachkie MM, Barohn RJ. Guillain-Barré syndrome and variants. Neurol Clin. 2013;31:491–510.
Hughes RA, Newsom-Davis JM, Perkin GD, et al. Controlled trial prednisolone in acute polyneuropathy. Lancet. 1978;2:750–753.
Draak TH, Gorson KC, Vanhoutte EK, et al. Correlation of the patient’s reported outcome inflammatory-RODS with an objective metric in immune-mediated neuropathies. Eur J Neurol. 2016;23:1248–1253.
Leger JM, Viala K, Nicolas G, et al. Placebo-controlled trial of rituximab in IgM anti-myelin-associated glycoprotein neuropathy. Neurology. 2013;80:2217–2225.
Nobile-Orazio E, Cocito D, Jann S, et al. Intravenous immunoglobulin versus intravenous methylprednisolone for chronic inflammatory demyelinating polyradiculoneuropathy: a randomised controlled trial. Lancet Neurol. 2012;11:493–502.
Merkies IS, Schmitz PI, Van Der Meche FG, et al. Comparison between impairment and disability scales in immune mediated polyneuropathies. Muscle Nerve. 2003;28:93–100.
Draak TH, Gorson KC, Vanhoutte E, et al. Does ability to walk reflect general functionality in inflammatory neuropathies? J Peripher Nerv Syst. 2016;21:74–81.
Vanhoutte EK, Draak TH, Gorson KC, et al. Impairment measures versus inflammatory RODS in GBS and CIDP: a responsiveness comparison. J Peripher Nerv Syst. 2015;20:289–295.
Misawa S, Kuwabara S, Sato Y, et al. Safety and efficacy of eculizumab in Guillain-Barré syndrome: a multicentre, double-blind, randomised phase 2 trial. Lancet Neurol. 2018;17:519–529.
Djordjevic G, Stojanov A, Bozovic I, et al. Six-month prospective study of quality of life in Guillain-Barre syndrome. Acta Neurol Scand. 2020;141:236–241.