PMID- 20647554
OWN - NLM
STAT- MEDLINE
DCOM- 20101210
LR  - 20171114
IS  - 1468-330X (Electronic)
IS  - 0022-3050 (Linking)
VI  - 81
IP  - 11
DP  - 2010 Nov
TI  - Confirming the efficacy of intravenous immunoglobulin in CIDP through minimum 
      clinically important differences: shifting from statistical significance to 
      clinical relevance.
PG  - 1194-9
LID - 10.1136/jnnp.2009.194324 [doi]
AB  - BACKGROUND: The ICE trial demonstrated the efficacy of immune globulin 
      intravenous (IGIV-C) over placebo in chronic inflammatory demyelinating 
      polyradiculoneuropathy (CIDP). However, improving the interpretability of the 
      results by analysing the minimum clinically important difference (MCID) had not 
      been considered. OBJECTIVES: To identify MCID thresholds of various outcome 
      measures using different methods and to test treatment differences (IGIV-C vs 
      placebo) using these thresholds. METHODS: One anchor-based (Short Form-36 
      question 2) and three distribution-based ((1/2) SD, 1 SE of measurement, and effect 
      size) techniques were employed to identify MCID cut-offs for various impairments 
      (electromyographic parameters, Medical Research Council (MRC) sum score, grip 
      strength, inflammatory neuropathy cause and treatment (INCAT) sensory sum score), 
      disability (INCAT scale score, Rotterdam handicap scale (RHS) score) and quality 
      of life (SF-36). IGIV-C or placebo was administered every 3 weeks for up to 24 
      weeks to 117 CIDP patients. Patients who did not improve by >/=1 point on the INCAT 
      scale received alternate treatment. The proportion of patients with results 
      exceeding identified MCID thresholds was compared. Results MCID cut-offs for 
      outcomes were determined using each method. For the INCAT disability scale 
      (primary ICE-trial outcome), all MCID methods identified significantly more 
      responders with IGIV-C than placebo. Significant differences favouring IGIV-C 
      were also demonstrated for various nerve conduction parameters, MRC sum score, 
      grip strength, RHS score and SF-36 physical component summary score. CONCLUSION: 
      In addition to being statistically significant, all MCID analyses showed that 
      CIDP improvements with IGIV-C are clinically meaningful. Consideration of MCID is 
      recommended in future therapeutic trials. Trial Registration Number NCT00220740 
      (http://ClinicalTrials.gov).
FAU - Merkies, I S J
AU  - Merkies IS
AD  - Department of Neurology, Spaarne Hospital, Hoofddorp, The Netherlands. 
      imerkies@spaarneziekenhuis.nl
FAU - van Nes, S I
AU  - van Nes SI
FAU - Hanna, K
AU  - Hanna K
FAU - Hughes, R A C
AU  - Hughes RA
FAU - Deng, C
AU  - Deng C
LA  - eng
SI  - ClinicalTrials.gov/NCT00220740
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20100720
PL  - England
TA  - J Neurol Neurosurg Psychiatry
JT  - Journal of neurology, neurosurgery, and psychiatry
JID - 2985191R
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 0 (Placebos)
SB  - IM
MH  - Differential Threshold
MH  - Disability Evaluation
MH  - Hand Strength/physiology
MH  - Health Status
MH  - Humans
MH  - Immunoglobulins, Intravenous/*administration & dosage
MH  - Infusions, Intravenous
MH  - Neural Conduction/physiology
MH  - Placebos
MH  - Polyradiculoneuropathy, Chronic Inflammatory 
      Demyelinating/*physiopathology/*therapy
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic/*methods/*statistics & numerical data
MH  - Treatment Outcome
EDAT- 2010/07/22 06:00
MHDA- 2010/12/14 06:00
CRDT- 2010/07/22 06:00
PHST- 2010/07/22 06:00 [entrez]
PHST- 2010/07/22 06:00 [pubmed]
PHST- 2010/12/14 06:00 [medline]
AID - jnnp.2009.194324 [pii]
AID - 10.1136/jnnp.2009.194324 [doi]
PST - ppublish
SO  - J Neurol Neurosurg Psychiatry. 2010 Nov;81(11):1194-9. doi: 
      10.1136/jnnp.2009.194324. Epub 2010 Jul 20.