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Changing outcome in inflammatory neuropathies: Rasch-comparative responsiveness.

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  • 1From the Department of Neurology (T.H.P.D., E.K.V., C.G.F., I.S.J.M.), University Medical Centre Maastricht; Department of Neurology (S.I.v.N., P.A.v.D.), Erasmus Medical Centre Rotterdam, the Netherlands; Department of Neurology (K.C.G.), St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, MA; Department of Neurology (W.L.V.d.P., N.C.N., L.H.v.d.B.), Rudolf Magnus Institute of Neuroscience University Medical Centre Utrecht, the Netherlands; Department of Neurological Sciences (E.N.-O.), Milan University, Humanitas Clinical Institute, Rozzano, Milan, Italy; Department of Neurology (J.M.L.), Hôpital de la Salpêtrière, Paris, France; Department of Neurology (P.Y.K.V.d.B.), Catholique University of Louvain, Belgium; Department of Clinical Neurosciences (G.L.), 3rd Neurology Unit, Milan, Italy; Department of Neurology (V.B., H.K.), Toronto General Hospital, Canada; Department of Neurology (M.P.T.L.), Centre for Neuromuscular Disease, National Hospital for Neurology and Neurosurgery, Queen Square, London, UK; Department of Neurology (J.P.), Centre de Référence des Maladies Neuromusculaires et de la SLA, Hôpital de La Timone, Marseille, France; Department of Neurology (A.J.v.d.K.), Academic Medical Centre, Amsterdam, the Netherlands; Department of Neurology (A.F.H.), London Health Science Center, London, Canada; Department of Neurology (D.R.C.), Johns Hopkins School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Spaarne Hospital, Hoofddorp, the Netherlands. tim.draak@mumc.nl.

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|November 8, 2014
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Summary

The patient-reported Inflammatory Rasch-built Overall Disability Scale (I-RODS) better captures meaningful improvements in Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) than the clinician-reported INCAT-ONLS scale.

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Area of Science:

  • Neurology
  • Clinical Trials
  • Patient-Reported Outcomes

Background:

  • Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), and IgM-monoclonal gammopathy of undetermined significance related polyneuropathy (IgM-MGUSP) are debilitating neurological conditions.
  • Accurate measurement of disability and treatment response is crucial for managing these polyneuropathies.
  • Existing clinician-reported scales may not fully capture patient-experienced changes.

Purpose of the Study:

  • To compare the responsiveness of the patient-reported Inflammatory Rasch-built Overall Disability Scale (I-RODS) against the clinician-reported Inflammatory Neuropathy Cause and Treatment-Overall Neuropathy Limitation Scale (INCAT-ONLS).
  • To evaluate the sensitivity of I-RODS and INCAT-ONLS in detecting clinically meaningful improvements in GBS, CIDP, and IgM-MGUSP patients.

Main Methods:

  • A cohort of 137 patients (55 GBS, 59 CIDP, 23 IgM-MGUSP) with new diagnosis or relapse were assessed using both I-RODS and INCAT-ONLS.
  • Longitudinal assessments were conducted at multiple time points (0-12 months) based on diagnosis.
  • Rasch analyses were performed to determine minimal clinically important difference (MCID) and responsiveness, defined as MCID-SE ≥1.96.

Main Results:

  • The I-RODS demonstrated a significantly higher proportion of meaningful improvement compared to INCAT-ONLS in GBS and CIDP patients.
  • Responsiveness was consistently higher for I-RODS when correlated with the EuroQoL thermometer.
  • The study could not clearly separate responsiveness for IgM-MGUSP due to limited data.

Conclusions:

  • The I-RODS is a more sensitive measure for capturing clinically meaningful changes over time in GBS and CIDP patients.
  • I-RODS shows a greater magnitude of change compared to INCAT-ONLS in these conditions.
  • The I-RODS is recommended for future clinical trials involving GBS and CIDP patients due to its enhanced sensitivity.