PMID- 28931621
OWN - NLM
STAT- MEDLINE
DCOM- 20171026
LR  - 20180308
IS  - 1524-4628 (Electronic)
IS  - 0039-2499 (Linking)
VI  - 48
IP  - 11
DP  - 2017 Nov
TI  - Minimal Clinically Important Difference for Safe and Simple Novel Acute Ischemic 
      Stroke Therapies.
PG  - 2946-2951
LID - 10.1161/STROKEAHA.117.017496 [doi]
AB  - BACKGROUND AND PURPOSE: Determining the minimal clinically important difference 
      (MCID) is essential for evaluating novel therapies. For acute ischemic stroke, 
      expert surveys have yielded MCIDs that are substantially higher than the MCIDs 
      observed in actual expert behavior in guideline writing and clinical practice, 
      potentially because of anchoring bias. METHODS: We administered a structured, 
      internet-based survey to a cross-section of academic stroke neurologists in the 
      United States. Survey responses assessed demographic and clinical experience, and 
      expert judgment of the MCID of the absolute increase needed in the proportion of 
      patients achieving functional independence at 3 months to consider a novel, safe 
      neuroprotective agent as clinically worthwhile. To mitigate anchoring bias, the 
      survey response framework used a base 1000 rather than base 100 patient 
      framework. RESULTS: Survey responses were received from 122 of 333 academic 
      stroke neurologists, there were 23% women, 72.8% had >/=6 years of practice 
      experience, and neurovascular disease accounted for more than half of practice 
      time in >70%. Responder-nonresponder and continuum of resistance tests indicated 
      that responders were representative of the full expert population. Among 
      respondents, the median MCID was 1.3% (interquartile range, 0.8% to >2%). 
      CONCLUSIONS: Stroke expert responses to MCID surveys are affected by anchoring 
      and centrality bias. When survey design takes these into account, the 
      expert-derived MCID for a safe acute ischemic stroke treatment is 1.1% to 1.5%, 
      in accord with actual physician behavior in guideline writing and clinical 
      practice. This revised MCID value can guide clinical trial design and 
      grant-funding and regulatory agency decisions.
CI  - (c) 2017 American Heart Association, Inc.
FAU - Cranston, Jessica S
AU  - Cranston JS
AD  - From the Department of Neurology and Comprehensive Stroke Center, David Geffen 
      School of Medicine, University of California, Los Angeles (J.S.C., B.D.K., 
      J.L.S.); Department of Neuroscience, Duke University, Durham, NC (J.S.C.); and 
      Department of Kinesiology, University of Maryland, College Park (B.D.K.). 
      jessicascranston@gmail.com.
FAU - Kaplan, Brett D
AU  - Kaplan BD
AD  - From the Department of Neurology and Comprehensive Stroke Center, David Geffen 
      School of Medicine, University of California, Los Angeles (J.S.C., B.D.K., 
      J.L.S.); Department of Neuroscience, Duke University, Durham, NC (J.S.C.); and 
      Department of Kinesiology, University of Maryland, College Park (B.D.K.).
FAU - Saver, Jeffrey L
AU  - Saver JL
AD  - From the Department of Neurology and Comprehensive Stroke Center, David Geffen 
      School of Medicine, University of California, Los Angeles (J.S.C., B.D.K., 
      J.L.S.); Department of Neuroscience, Duke University, Durham, NC (J.S.C.); and 
      Department of Kinesiology, University of Maryland, College Park (B.D.K.).
LA  - eng
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20170920
PL  - United States
TA  - Stroke
JT  - Stroke
JID - 0235266
RN  - 0 (Neuroprotective Agents)
SB  - IM
MH  - Brain Ischemia/*therapy
MH  - Cross-Sectional Studies
MH  - Female
MH  - Humans
MH  - Male
MH  - Neuroprotective Agents/administration & dosage
MH  - Practice Guidelines as Topic
MH  - Stroke/*therapy
OTO - NOTNLM
OT  - device approval
OT  - sample size
OT  - stroke
OT  - treatment outcome
EDAT- 2017/09/22 06:00
MHDA- 2017/10/27 06:00
CRDT- 2017/09/22 06:00
PHST- 2017/03/27 00:00 [received]
PHST- 2017/07/21 00:00 [revised]
PHST- 2017/08/21 00:00 [accepted]
PHST- 2017/09/22 06:00 [pubmed]
PHST- 2017/10/27 06:00 [medline]
PHST- 2017/09/22 06:00 [entrez]
AID - STROKEAHA.117.017496 [pii]
AID - 10.1161/STROKEAHA.117.017496 [doi]
PST - ppublish
SO  - Stroke. 2017 Nov;48(11):2946-2951. doi: 10.1161/STROKEAHA.117.017496. Epub 2017 
      Sep 20.