PMID- 35135059
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220219
IS  - 2287-6391 (Print)
IS  - 2287-6405 (Electronic)
IS  - 2287-6391 (Linking)
VI  - 24
IP  - 1
DP  - 2022 Jan
TI  - The Challenge of Designing Stroke Trials That Change Practice: MCID vs. Sample 
      Size and Pragmatism.
PG  - 49-56
LID - 10.5853/jos.2021.02740 [doi]
AB  - Randomized controlled trials (RCT) are the basis for evidence-based acute stroke 
      care. For an RCT to change practice, its results have to be statistically 
      significant and clinically meaningful. While methods to assess statistical 
      significance are standardized and widely agreed upon, there is no clear consensus 
      on how to assess clinical significance. Researchers often refer to the minimal 
      clinically important difference (MCID) when describing the smallest change in 
      outcomes that is considered meaningful to patients and leads to a change in 
      patient management. It is widely accepted that a treatment should only be adopted 
      when its effect on outcome is equal to or larger than the MCID. There are however 
      situations in which it is reasonable to decide against adopting a treatment, even 
      when its beneficial effect matches or exceeds the MCID, for example when it is 
      resource- intensive and associated with high costs. Furthermore, while the MCID 
      represents an important concept in this regard, defining it for an individual 
      trial is difficult as it is highly context specific. In the following, we use 
      hypothetical stroke trial examples to review the challenges related to MCID, 
      sample size and pragmatic considerations that researchers face in acute stroke 
      trials, and propose a framework for designing meaningful stroke trials that have 
      the potential to change clinical practice.
FAU - Goyal, Mayank
AU  - Goyal M
AD  - Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada.
AD  - Department of Radiology, University of Calgary, Calgary, AB, Canada.
FAU - McDonough, Rosalie
AU  - McDonough R
AD  - Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada.
AD  - Department of Neuroradiology, University Medical Center Hamburg-Eppendorf, 
      Hamburg, Germany.
FAU - Fisher, Marc
AU  - Fisher M
AD  - Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
FAU - Ospel, Johanna
AU  - Ospel J
AD  - Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada.
AD  - Department of Radiology, University of Calgary, Calgary, AB, Canada.
AD  - Department of Neuroradiology, University Hospital Basel, Basel, Switzerland.
LA  - eng
PT  - Journal Article
DEP - 20220131
PL  - Korea (South)
TA  - J Stroke
JT  - Journal of stroke
JID - 101602023
PMC - PMC8829472
OTO - NOTNLM
OT  - Ischemia
OT  - Ischemic stroke
OT  - Sample size
EDAT- 2022/02/09 06:00
MHDA- 2022/02/09 06:01
PMCR- 2022/01/01
CRDT- 2022/02/08 23:51
PHST- 2021/08/03 00:00 [received]
PHST- 2021/10/13 00:00 [accepted]
PHST- 2022/02/08 23:51 [entrez]
PHST- 2022/02/09 06:00 [pubmed]
PHST- 2022/02/09 06:01 [medline]
PHST- 2022/01/01 00:00 [pmc-release]
AID - jos.2021.02740 [pii]
AID - jos-2021-02740 [pii]
AID - 10.5853/jos.2021.02740 [doi]
PST - ppublish
SO  - J Stroke. 2022 Jan;24(1):49-56. doi: 10.5853/jos.2021.02740. Epub 2022 Jan 31.