PMID- 24810970 OWN - NLM STAT- MEDLINE DCOM- 20140527 LR - 20151119 IS - 1097-4598 (Electronic) IS - 0148-639X (Linking) VI - 49 IP - 5 DP - 2014 May TI - Minimal clinically important difference in myasthenia gravis: outcomes from a randomized trial. PG - 661-5 LID - 10.1002/mus.23988 [doi] AB - INTRODUCTION: The minimal clinically important difference (MCID) is the smallest outcome change that has clinical significance. Its use has not been established in the study of myasthenia gravis (MG). METHODS: Patients from a published intravenous immunoglobulin (IVIg) vs. placebo study were studied. One anchor-based and 3 distribution-based techniques were used to identify quantitative myasthenia gravis score (QMGS), repetitive nerve stimulation (RNS), and single-fiber electromyography (SFEMG) MCID cut-offs. Patients with a change-score exceeding MCID cut-offs were compared. RESULTS: MCID cut-offs were below a QMGS change of 3.0. Anchor-based and 1 x SEM cut-offs showed 58.3% vs. 30.7% responders (P = 0.017), (1/2) SD 54.2% vs. 19.2% responders (P = 0.018), and effect size 0.519 vs. 0.164 (P = 0.011) in IVIg vs. placebo. Anchor-based (P = 0.73) and effect-size (P = 0.41) MCID cut-offs did not show a difference between IVIg and placebo. MCID methods did not produce meaningful RNS cut-offs. CONCLUSIONS: QMGS MCID values provide clinically relevant information and are recommended in MG trials. MCID analysis shows that improvement in MG patients treated with IVIg reflects clinically meaningful changes. CI - Copyright (c) 2013 Wiley Periodicals, Inc. FAU - Katzberg, Hans D AU - Katzberg HD AD - University Health Network, Division of Neurology, Toronto General Hospital, 200 Elizabeth Street, 5ES-306, Toronto, Ontario, M5G 2C4, Canada. FAU - Barnett, Carolina AU - Barnett C FAU - Merkies, Ingemar S J AU - Merkies IS FAU - Bril, Vera AU - Bril V LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20140204 PL - United States TA - Muscle Nerve JT - Muscle & nerve JID - 7803146 RN - 0 (Immunoglobulins, Intravenous) RN - 0 (Immunologic Factors) SB - IM MH - Clinical Trials as Topic/methods MH - Electromyography MH - Female MH - Humans MH - Immunoglobulins, Intravenous/*therapeutic use MH - Immunologic Factors/*therapeutic use MH - Male MH - Middle Aged MH - Myasthenia Gravis/diagnosis/*drug therapy MH - ROC Curve MH - Surveys and Questionnaires MH - Treatment Outcome OTO - NOTNLM OT - MCID OT - QMGS OT - myasthenia gravis OT - neuromuscular junction OT - outcomes EDAT- 2014/05/09 06:00 MHDA- 2014/05/28 06:00 CRDT- 2014/05/10 06:00 PHST- 2013/08/01 00:00 [accepted] PHST- 2014/05/10 06:00 [entrez] PHST- 2014/05/09 06:00 [pubmed] PHST- 2014/05/28 06:00 [medline] AID - 10.1002/mus.23988 [doi] PST - ppublish SO - Muscle Nerve. 2014 May;49(5):661-5. doi: 10.1002/mus.23988. Epub 2014 Feb 4.