TY - JOUR
T1 - Impairment measures versus inflammatory RODS in GBS and CIDP: 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 - Leger, 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
Y1 - 2015/9
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-Barre 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-Barre 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
U2 - 10.1111/jns.12118
DO - 10.1111/jns.12118
M3 - Article
C2 - 26114893
SN - 1085-9489
VL - 20
SP - 289
EP - 295
JO - Journal of the Peripheral Nervous System
JF - Journal of the Peripheral Nervous System
IS - 3
ER -