PMID- 31641014
OWN - NLM
STAT- MEDLINE
DCOM- 20200204
LR  - 20231020
IS  - 1526-632X (Electronic)
IS  - 0028-3878 (Print)
IS  - 0028-3878 (Linking)
VI  - 93
IP  - 21
DP  - 2019 Nov 19
TI  - Evaluation of multiple sclerosis disability outcome measures using pooled 
      clinical trial data.
PG  - e1921-e1931
LID - 10.1212/WNL.0000000000008519 [doi]
AB  - OBJECTIVE: We report analyses of a pooled database by the Multiple Sclerosis 
      Outcome Assessments Consortium to evaluate 4 proposed components of a 
      multidimensional test battery. METHODS: Standardized data on 12,776 participants, 
      comprising demographics, multiple sclerosis disease characteristics, Expanded 
      Disability Status Scale (EDSS) score, performance measures, and Short Form-36 
      Physical Component Summary (SF-36 PCS), were pooled from control and treatment 
      arms of 14 clinical trials. Analyses of Timed 25-Foot Walk (T25FW), 9-Hole Peg 
      Test (9HPT), Low Contrast Letter Acuity (LCLA), and Symbol Digit Modalities Test 
      (SDMT) included measurement properties; construct, convergent, and known group 
      validity; and longitudinal performance of the measures individually and when 
      combined into a multidimensional test battery relative to the EDSS and SF-36 to 
      determine sensitivity and clinical meaningfulness. RESULTS: The performance 
      measures had excellent test-retest reliability and showed expected differences 
      between subgroups based on disease duration and EDSS level. Progression rates in 
      detecting time to 3-month confirmed worsening were lower for T25FW and 9HPT 
      compared to EDSS, while progression rates for LCLA and SDMT were similar to EDSS. 
      When the 4 measures were analyzed as a multidimensional measure rather than as 
      individual measures, progression on any one performance measure was more 
      sensitive than the EDSS. Worsening on the performance measures analyzed 
      individually or as a multidimensional test battery was associated with clinically 
      meaningful SF-36 PCS score worsening, supporting clinical meaningfulness of 
      designated performance test score worsening. CONCLUSION: These results support 
      the use of the 4 proposed performance measures, individually or combined into a 
      multidimensional test battery as study outcome measures.
CI  - Copyright (c) 2019 The Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of the American Academy of Neurology.
FAU - Goldman, Myla D
AU  - Goldman MD
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - LaRocca, Nicholas G
AU  - LaRocca NG
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Rudick, Richard A
AU  - Rudick RA
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Hudson, Lynn D
AU  - Hudson LD
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Chin, Peter S
AU  - Chin PS
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Francis, Gordon S
AU  - Francis GS
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Jacobs, Adam
AU  - Jacobs A
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Kapoor, Raj
AU  - Kapoor R
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Matthews, Paul M
AU  - Matthews PM
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Mowry, Ellen M
AU  - Mowry EM
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Balcer, Laura J
AU  - Balcer LJ
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Panzara, Michael
AU  - Panzara M
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Phillips, Glenn
AU  - Phillips G
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Uitdehaag, Bernard M J
AU  - Uitdehaag BMJ
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH.
FAU - Cohen, Jeffrey A
AU  - Cohen JA
AD  - From the University of Virginia (M.D.G.), Charlottesville; National Multiple 
      Sclerosis Society (N.G.L.), New York, NY; Biogen (R.A.R., G.P.), Cambridge, MA; 
      Critical Path Institute (L.D.H.), Tucson, AZ; Genentech (P.S.C.), South San 
      Francisco, CA; Independent Neurology Clinical Development Consultant (G.S.F.); 
      Premier Research (A.J.), Wokingham, UK; UCL Institute of Neurology (R.K.), 
      London, UK; Imperial College London and UK Dementia Research Institute (P.M.M.); 
      Johns Hopkins (E.M.M.), Baltimore, MD; New York University School of Medicine 
      (L.J.B.), NY; Wave Life Sciences (M.P.), Cambridge, MA; VU University Medical 
      Center (B.M.J.U.), Amsterdam, the Netherlands; and Cleveland Clinic (J.A.C.), OH. 
      cohenj@ccf.org.
CN  - Multiple Sclerosis Outcome Assessments Consortium
LA  - eng
GR  - MC_PC_17114/MRC_/Medical Research Council/United Kingdom
GR  - MR/N026934/1/MRC_/Medical Research Council/United Kingdom
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20191022
PL  - United States
TA  - Neurology
JT  - Neurology
JID - 0401060
SB  - IM
CIN - Neurology. 2019 Nov 19;93(21):919-920. PMID: 31641015
EIN - Neurology. 2021 Mar 9;96(10):504-505. PMID: 33579759
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Clinical Trials as Topic
MH  - Databases, Factual
MH  - Female
MH  - Humans
MH  - Male
MH  - Meta-Analysis as Topic
MH  - Middle Aged
MH  - Multiple Sclerosis/*physiopathology
MH  - *Outcome Assessment, Health Care
MH  - Reproducibility of Results
MH  - Young Adult
PMC - PMC6885577
EDAT- 2019/10/24 06:00
MHDA- 2020/02/06 06:00
PMCR- 2019/10/22
CRDT- 2019/10/24 06:00
PHST- 2019/02/19 00:00 [received]
PHST- 2019/06/24 00:00 [accepted]
PHST- 2019/10/24 06:00 [pubmed]
PHST- 2020/02/06 06:00 [medline]
PHST- 2019/10/24 06:00 [entrez]
PHST- 2019/10/22 00:00 [pmc-release]
AID - WNL.0000000000008519 [pii]
AID - NEUROLOGY2019976142 [pii]
AID - 10.1212/WNL.0000000000008519 [doi]
PST - ppublish
SO  - Neurology. 2019 Nov 19;93(21):e1921-e1931. doi: 10.1212/WNL.0000000000008519. 
      Epub 2019 Oct 22.