TY - JOUR
T1 - Impairment measures versus inflammatory RODS in GBS and CIDP
T2 - A responsiveness comparison
AU - Vanhoutte, Els K.
AU - Draak, Thomas H P
AU - Gorson, Kenneth C.
AU - Van Nes, Sonja I.
AU - Hoeijmakers, Janneke G J
AU - Van Der Pol, W. Ludo
AU - Notermans, Nicolette C.
AU - Lewis, Richard A.
AU - Nobile-Orazio, Eduardo
AU - Léger, Jean Marc
AU - Van Den Bergh, Peter Y K
AU - Lauria, Giuseppe
AU - Bril, Vera
AU - Katzberg, Hans
AU - Lunn, Michael P T
AU - Pouget, Jean
AU - Van Der Kooi, Anneke J.
AU - Hahn, Angelika F.
AU - Van Doorn, Pieter A.
AU - Cornblath, David R.
AU - Van Den Berg, Leonard H.
AU - Faber, Catharina G.
AU - Merkies, Ingemar S J
PY - 2015/9/1
Y1 - 2015/9/1
N2 - This study aimed to 'define responder' through the concept of minimum clinically important differences using the individually obtained standard errors (MCID-SE) and a heuristic 'external criterion' responsiveness method in patients with Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). One hundred and fourteen newly diagnosed or relapsing patients (GBS: 55, CIDP: 59) were serially examined (1-year follow-up). The inflammatory Rasch-built overall disability scale (I-RODS), Rasch-transformed MRC sum score (RT-MRC), and Rasch-transformed modified-INCAT-sensory scale (RT-mISS) were assessed. Being-a-responder was defined as having a MCID-SE cut-off ≥1.96. Also, the correlations between patients' scores on each scale and the EuroQoL health-status 'thermometer' (external criterion) were determined (higher correlation indicated better responsiveness). In both diseases, the SEs showed a characteristic 'U'-shaped dynamic pattern across each scales' continuum. The number of patients showing a meaningful change were higher for the I-RODS > RT-MRC > RT-mISS and were in GBS higher than CIDP patients. The MCID-SE concept using Rasch-transformed data demonstrated an individual pattern of 'being-a-responder' in patients with immune-mediated neuropathies, and the findings were validated by the external criterion responsiveness method. The I-RODS showed greater responsiveness compared with the MRC and INCAT-sensory scales, and its use is therefore recommended in future trials in GBS and CIDP.
AB - This study aimed to 'define responder' through the concept of minimum clinically important differences using the individually obtained standard errors (MCID-SE) and a heuristic 'external criterion' responsiveness method in patients with Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). One hundred and fourteen newly diagnosed or relapsing patients (GBS: 55, CIDP: 59) were serially examined (1-year follow-up). The inflammatory Rasch-built overall disability scale (I-RODS), Rasch-transformed MRC sum score (RT-MRC), and Rasch-transformed modified-INCAT-sensory scale (RT-mISS) were assessed. Being-a-responder was defined as having a MCID-SE cut-off ≥1.96. Also, the correlations between patients' scores on each scale and the EuroQoL health-status 'thermometer' (external criterion) were determined (higher correlation indicated better responsiveness). In both diseases, the SEs showed a characteristic 'U'-shaped dynamic pattern across each scales' continuum. The number of patients showing a meaningful change were higher for the I-RODS > RT-MRC > RT-mISS and were in GBS higher than CIDP patients. The MCID-SE concept using Rasch-transformed data demonstrated an individual pattern of 'being-a-responder' in patients with immune-mediated neuropathies, and the findings were validated by the external criterion responsiveness method. The I-RODS showed greater responsiveness compared with the MRC and INCAT-sensory scales, and its use is therefore recommended in future trials in GBS and CIDP.
KW - immune-mediated neuropathies
KW - minimum clinically important difference
KW - outcome measure
KW - Rasch
UR - http://www.scopus.com/inward/record.url?scp=84942580375&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84942580375&partnerID=8YFLogxK
U2 - 10.1111/jns.12118
DO - 10.1111/jns.12118
M3 - Article
AN - SCOPUS:84942580375
VL - 20
SP - 289
EP - 295
JO - Journal of the Peripheral Nervous System
JF - Journal of the Peripheral Nervous System
SN - 1085-9489
IS - 3
ER -