PMID- 29469951
OWN - NLM
STAT- MEDLINE
DCOM- 20190911
LR  - 20190911
IS  - 1097-0142 (Electronic)
IS  - 0008-543X (Print)
IS  - 0008-543X (Linking)
VI  - 124
IP  - 10
DP  - 2018 May 15
TI  - The minimal clinically important difference of the Richmond Agitation-Sedation 
      Scale in patients with cancer with agitated delirium.
PG  - 2246-2252
LID - 10.1002/cncr.31312 [doi]
AB  - BACKGROUND: The Richmond Agitation-Sedation Scale (RASS) is commonly used to 
      assess psychomotor activity; however, to the authors' knowledge, its minimal 
      clinically important difference (MCID) has not been determined to date. The 
      objective of the current study was to identify the MCID for RASS using 2 
      anchor-based approaches. METHODS: The current study was a secondary analysis of a 
      randomized controlled trial to compare the effect of lorazepam versus placebo as 
      an adjuvant to haloperidol for persistent agitation in patients with delirium. 
      The primary outcome was change in RASS (10-point numeric rating scale ranging 
      from -5 [unarousable] to +4 [combative]) from baseline to 8 hours after treatment 
      administration. The sensitivity-specificity and within-patient change methods 
      were used to identify the MCID, with the anchor being patient comfort after the 
      study intervention as perceived by caregivers and nurses. RESULTS: A total of 90 
      patients were randomized and 58 (64%) received the study medication for 
      restlessness/agitation (mean baseline RASS, 1.6). A total of 23 caregivers (61%) 
      and 23 nurses (55%) perceived that the patient was more comfortable after 
      treatment. Using the sensitivity-specificity method, the optimal RASS reduction 
      was >/=4 points according to both caregivers (sensitivity of 61% and specificity of 
      80%; area under the curve, 0.71) and nurses (sensitivity of 73% and specificity 
      of 84%; area under the curve, 0.78). The RASS cutoff value based on the 
      within-patient change method was similar (-4.2 for caregivers and -4.0 for 
      nurses). CONCLUSIONS: For patients with persistent restlessness/agitation, a 
      reduction of >/=4 points in RASS was considered to be the MCID for both nurses and 
      caregivers. These preliminary findings may have implications for sample size 
      calculation and the interpretation of treatment effect in future delirium trials. 
      Cancer 2018;124:2246-52. (c) 2018 American Cancer Society.
CI  - (c) 2018 American Cancer Society.
FAU - Hui, David
AU  - Hui D
AUID- ORCID: 0000-0003-2733-6607
AD  - Department of Palliative Care, Rehabilitation and Integrative Medicine, The 
      University of Texas MD Anderson Cancer Center, Houston, Texas.
AD  - Department of General Oncology, The University of Texas MD Anderson Cancer 
      Center, Houston, Texas.
FAU - Hess, Kenneth
AU  - Hess K
AD  - Department of Biostatistics, The University of Texas MD Anderson Cancer Center, 
      Houston, Texas.
FAU - Dibaj, Seyedeh S
AU  - Dibaj SS
AD  - Department of Biostatistics, The University of Texas MD Anderson Cancer Center, 
      Houston, Texas.
FAU - Arthur, Joseph
AU  - Arthur J
AUID- ORCID: 0000-0002-9185-6108
AD  - Department of Palliative Care, Rehabilitation and Integrative Medicine, The 
      University of Texas MD Anderson Cancer Center, Houston, Texas.
FAU - Dev, Rony
AU  - Dev R
AUID- ORCID: 0000-0002-7283-0519
AD  - Department of Palliative Care, Rehabilitation and Integrative Medicine, The 
      University of Texas MD Anderson Cancer Center, Houston, Texas.
FAU - Dalal, Shalini
AU  - Dalal S
AD  - Department of Palliative Care, Rehabilitation and Integrative Medicine, The 
      University of Texas MD Anderson Cancer Center, Houston, Texas.
FAU - Reddy, Suresh
AU  - Reddy S
AD  - Department of Palliative Care, Rehabilitation and Integrative Medicine, The 
      University of Texas MD Anderson Cancer Center, Houston, Texas.
FAU - Bruera, Eduardo
AU  - Bruera E
AD  - Department of Palliative Care, Rehabilitation and Integrative Medicine, The 
      University of Texas MD Anderson Cancer Center, Houston, Texas.
LA  - eng
GR  - P30 CA016672/CA/NCI NIH HHS/United States
GR  - R01 CA214960/CA/NCI NIH HHS/United States
GR  - R21 CA186000/CA/NCI NIH HHS/United States
GR  - R21 NR016736/NR/NINR NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20180222
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
RN  - 0 (Tranquilizing Agents)
RN  - J6292F8L3D (Haloperidol)
RN  - O26FZP769L (Lorazepam)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Delirium/*diagnosis/drug therapy/psychology
MH  - Drug Therapy, Combination/methods
MH  - Female
MH  - Haloperidol/therapeutic use
MH  - Humans
MH  - Lorazepam/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - *Minimal Clinically Important Difference
MH  - Neoplasms/*complications/psychology
MH  - Palliative Care/methods
MH  - Prospective Studies
MH  - Psychometrics/methods
MH  - Psychomotor Agitation/*diagnosis/drug therapy/psychology
MH  - Tranquilizing Agents/*therapeutic use
PMC - PMC5935554
MID - NIHMS943320
OTO - NOTNLM
OT  - delirium
OT  - minimal clinically important difference
OT  - neoplasms
OT  - palliative care
OT  - patient outcome assessment
OT  - randomized controlled trial
COIS- Disclosure: The authors have declared no conflicts of interest.
EDAT- 2018/02/23 06:00
MHDA- 2019/09/12 06:00
PMCR- 2019/05/15
CRDT- 2018/02/23 06:00
PHST- 2017/12/13 00:00 [received]
PHST- 2018/01/12 00:00 [revised]
PHST- 2018/02/03 00:00 [accepted]
PHST- 2018/02/23 06:00 [pubmed]
PHST- 2019/09/12 06:00 [medline]
PHST- 2018/02/23 06:00 [entrez]
PHST- 2019/05/15 00:00 [pmc-release]
AID - 10.1002/cncr.31312 [doi]
PST - ppublish
SO  - Cancer. 2018 May 15;124(10):2246-2252. doi: 10.1002/cncr.31312. Epub 2018 Feb 22.