PMID- 33123069
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201031
IS  - 1664-2295 (Print)
IS  - 1664-2295 (Electronic)
IS  - 1664-2295 (Linking)
VI  - 11
DP  - 2020
TI  - The Minimal Clinically Important Difference for Achievement of Substantial 
      Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke 
      Treatment.
PG  - 524220
LID - 10.3389/fneur.2020.524220 [doi]
LID - 524220
AB  - Background and Purpose: Recent noninferiority clinical trials of novel 
      endovascular thrombectomy devices for acute ischemic stroke have used substantial 
      reperfusion as the primary outcome of achievement. Determining the minimal 
      clinically important difference (MCID) is an essential step for the design of 
      noninferiority clinical trials. Materials and Methods: We surveyed international 
      neuro-interventionalist and noninterventional vascular neurologist investigators. 
      The questionnaire included demographic characteristics, level of clinical 
      experience, and their MCID clinical scenario-based judgment regarding the MCID 
      for the outcome substantial reperfusion (thrombolysis in cerebral infarction 
      score 2b-3) within 3 passes. Results: Survey responses were received from 58 of 
      200 experts. Among responders, 75.9% were neuro-interventionalists (most commonly 
      interventional neuroradiologists and interventional neurologists, followed by 
      endovascular neurosurgeons), and 24.1% were noninterventional vascular 
      neurologists; 87.9% had been in practice for more than 5 years, and 67.3% devoted 
      more than half of their practice to stroke care. Responder-nonresponder and 
      continuum of resistance analysis indicated responders were representative of the 
      full expert population. Among experts, the median MCID for substantial 
      reperfusion was 3.1-5% (interquartile range 1.1-3% to 5.1-10%). MCID 
      distributions did not differ among neuro-interventionalists and noninterventional 
      vascular neurologists. Conclusions: Neuro-interventionl and noninterventional 
      stroke experts judged that the minimal clinically important difference in 
      comparing thrombectomy devices for achieving substantial reperfusion is 3.1-5%. 
      This MCID, lower than noninferiority margins used in several recent clinical 
      trials, can inform trial designs and clinical development.
CI  - Copyright (c) 2020 Lin and Saver.
FAU - Lin, Chun-Jen
AU  - Lin CJ
AD  - Neurological Institute, Taipei Veterans General Hospital and School of Medicine, 
      National Yang-Ming University, Taipei, Taiwan.
FAU - Saver, Jeffrey L
AU  - Saver JL
AD  - Comprehensive Stroke Center and Department of Neurology, David Geffen School of 
      Medicine, University of California, Los Angeles, Los Angeles, CA, United States.
LA  - eng
PT  - Journal Article
DEP - 20201005
PL  - Switzerland
TA  - Front Neurol
JT  - Frontiers in neurology
JID - 101546899
PMC - PMC7569750
OTO - NOTNLM
OT  - MCID (minimal clinically important differences)
OT  - device
OT  - ischemic stroke
OT  - technical efficacy
OT  - thrombectomy
EDAT- 2020/10/31 06:00
MHDA- 2020/10/31 06:01
PMCR- 2020/10/05
CRDT- 2020/10/30 05:53
PHST- 2020/01/08 00:00 [received]
PHST- 2020/08/17 00:00 [accepted]
PHST- 2020/10/30 05:53 [entrez]
PHST- 2020/10/31 06:00 [pubmed]
PHST- 2020/10/31 06:01 [medline]
PHST- 2020/10/05 00:00 [pmc-release]
AID - 10.3389/fneur.2020.524220 [doi]
PST - epublish
SO  - Front Neurol. 2020 Oct 5;11:524220. doi: 10.3389/fneur.2020.524220. eCollection 
      2020.