Evidence map›Paper›PMID 29469951›Full record

Trial reportCancer2018

The minimal clinically important difference of the Richmond Agitation-Sedation Scale in patients with cancer with agitated delirium.

David Hui, Kenneth Hess, Seyedeh S Dibaj, Joseph Arthur, Rony Dev, Shalini Dalal, Suresh Reddy, Eduardo Bruera

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04750395 (Open-label Randomized Controlled Trial of Oral Transmucosal Haloperidol and Olanzapine in the Treatment of Terminal Delirium), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.8field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04750395 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

Open-label Randomized Controlled Trial of Oral Transmucosal Haloperidol and Olanzapine in the Treatment of Terminal Delirium

TypeinterventionalSponsorHCA Hospice CareRan2021 to 2024Enrolled80ConditionsDelirium, Terminal IllnessArmsHaloperidol Solution, Olanzapine Tablets
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Association among rescue neuroleptic use, agitation, and perceived comfort: secondary analysis of a randomized clinical trial on agitated delirium.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Trial
  5. Trial
  6. Review
  7. Review
  8. Calming the Agitated Patient: Providing Strategies to Support Clinicians.Medsurg nursing : official journal of the Academy of Medical-Surgical Nurses
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

David HuiDepartment of Palliative Care, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-2733-6607
Kenneth HessDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Seyedeh S DibajDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Joseph ArthurDepartment of Palliative Care, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-9185-6108
Rony DevDepartment of Palliative Care, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-7283-0519
Shalini DalalDepartment of Palliative Care, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Suresh ReddyDepartment of Palliative Care, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Eduardo BrueraDepartment of Palliative Care, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
A Randomized Controlled Trial of Dexamethasone for Dyspnea in Cancer PatientsR01CA214960 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI HUI, DAVID · 2017 to 2020
$1.6M
Palliative Therapies for Refractory Delirium in Advanced CancerR21NR016736 · NINR · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI HUI, DAVID · 2017 to 2018
$455k
Adjuvant Lorazepam for Agitated Delirium in the Palliative Care UnitR21CA186000 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI HUI, DAVID · 2015 to 2016
$399k
NCI NIH HHS P30 CA016672NCI NIH HHS R01 CA214960NCI NIH HHS R21 CA186000NINR NIH HHS R21 NR016736
6 · The paper itself

Abstract

backgroundThe 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.

methodsThe 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.

resultsA 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).

conclusionsFor 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. © 2018 American Cancer Society.

Indexed as

Minimal Clinically Important DifferenceAdultAgedAged, 80 and overDeliriumDrug Therapy, CombinationFemaleHaloperidolHumansLorazepamMaleMiddle AgedNeoplasmsPalliative CareProspective StudiesPsychometricsHaloperidolLorazepamTranquilizing Agentsdeliriumminimal clinically important differenceneoplasmspalliative carepatient outcome assessmentrandomized controlled trial

Identifiers

PMID29469951
PMCPMC5935554
OpenAlexW2793705815

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.