PMID- 37616196
OWN - NLM
STAT- MEDLINE
DCOM- 20230828
LR  - 20230917
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 18
IP  - 8
DP  - 2023
TI  - What is a minimal clinically important difference for clinical trials in patients 
      with disorders of consciousness? a novel probabilistic approach.
PG  - e0290290
LID - 10.1371/journal.pone.0290290 [doi]
LID - e0290290
AB  - Over the last 30 years, there has been a growing trend in clinical trials towards 
      assessing novel interventions not only against the benchmark of statistical 
      significance, but also with respect to whether they lead to clinically meaningful 
      changes for patients. In the context of Disorders of Consciousness (DOC), despite 
      a growing landscape of experimental interventions, there is no agreed standard as 
      to what counts as a minimal clinically important difference (MCID). In part, this 
      issue springs from the fact that, by definition, DOC patients are either 
      unresponsive (i.e., in a Vegetative State; VS) or non-communicative (i.e., in a 
      Minimally Conscious State; MCS), which renders it impossible to assess any 
      subjective perception of benefit, one of the two core aspects of MCIDs. Here, we 
      develop a novel approach that leverages published, international diagnostic 
      guidelines to establish a probability-based minimal clinically important 
      difference (pMCID), and we apply it to the most validated and frequently used 
      scale in DOC: the Coma Recovery Scale-Revised (CRS-R). This novel method is 
      objective (i.e., based on published criteria for patient diagnosis) and easy to 
      recalculate as the field refines its agreed-upon criteria for diagnosis. We 
      believe this new approach can help clinicians determine whether observed changes 
      in patients' behavior are clinically important, even when patients cannot 
      communicate their experiences, and can align the landscape of clinical trials in 
      DOC with the practices in other medical fields.
CI  - Copyright: (c) 2023 Monti et al. This is an open access article distributed under 
      the terms of the Creative Commons Attribution License, which permits unrestricted 
      use, distribution, and reproduction in any medium, provided the original author 
      and source are credited.
FAU - Monti, Martin M
AU  - Monti MM
AUID- ORCID: 0000-0001-5511-3780
AD  - Department of Psychology, University of California Los Angeles, Los Angeles, 
      California, United States of America.
AD  - Department of Neurosurgery, Brain Injury Research Center, University of 
      California Los Angeles, Los Angeles, California, United States of America.
FAU - Spivak, Norman M
AU  - Spivak NM
AUID- ORCID: 0000-0002-2386-2987
AD  - Department of Neurosurgery, Brain Injury Research Center, University of 
      California Los Angeles, Los Angeles, California, United States of America.
AD  - UCLA-Caltech Medical Scientist Training Program, David Geffen School of Medicine, 
      UCLA, Los Angeles, California, United States of America.
FAU - Edlow, Brian L
AU  - Edlow BL
AUID- ORCID: 0000-0001-7235-8456
AD  - Department of Neurology, Center for Neurotechnology and Neurorecovery, 
      Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, 
      United States of America.
AD  - Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General 
      Hospital, Charlestown, Massachusetts, United States of America.
FAU - Bodien, Yelena G
AU  - Bodien YG
AD  - Department of Neurology, Center for Neurotechnology and Neurorecovery, 
      Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, 
      United States of America.
AD  - Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation 
      Hospital and Harvard Medical School Charlestown, Massachusetts, United States of 
      America.
LA  - eng
GR  - DP2 HD101400/HD/NICHD NIH HHS/United States
GR  - R21 NS109627/NS/NINDS NIH HHS/United States
GR  - RF1 NS115268/NS/NINDS NIH HHS/United States
GR  - R01 GM135420/GM/NIGMS NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20230824
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
SB  - IM
MH  - Humans
MH  - *Consciousness Disorders/diagnosis/therapy
MH  - *Minimal Clinically Important Difference
MH  - Benchmarking
MH  - Coma
MH  - Consciousness
MH  - Persistent Vegetative State/diagnosis
PMC - PMC10449161
COIS- The authors have declared that no competing interests exist.
EDAT- 2023/08/24 18:41
MHDA- 2023/08/28 06:43
PMCR- 2023/08/24
CRDT- 2023/08/24 13:33
PHST- 2023/04/13 00:00 [received]
PHST- 2023/08/03 00:00 [accepted]
PHST- 2023/08/28 06:43 [medline]
PHST- 2023/08/24 18:41 [pubmed]
PHST- 2023/08/24 13:33 [entrez]
PHST- 2023/08/24 00:00 [pmc-release]
AID - PONE-D-23-10843 [pii]
AID - 10.1371/journal.pone.0290290 [doi]
PST - epublish
SO  - PLoS One. 2023 Aug 24;18(8):e0290290. doi: 10.1371/journal.pone.0290290. 
      eCollection 2023.