Evidence map›Paper›PMID 24388124›Full record

ReviewJournal of pain and symptom management2014

Ethical challenges and solutions regarding delirium studies in palliative care.

Lisa Sweet, Dimitrios Adamis, David J Meagher, Daniel Davis, David C Currow, Shirley H Bush, Christopher Barnes, Michael Hartwick, Meera Agar, Jessica Simon and 3 more

Registry-linked trialAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Journal of pain and symptom management, 2014. 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, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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, 1 synthesis or guideline pooled it.

  1. Drug therapy for delirium in terminally ill adults.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Article
  3. Review
  4. Article
  5. Observational
  6. Article
  7. Article
  8. 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

13 authors.

Lisa SweetDivision of Palliative Care, University of Ottawa, Ottawa, Ontario, Canada; Bruyère Research Institute, Ottawa, Ontario, Canada.
Dimitrios AdamisResearch and Academic Institute of Athens, Athens, Greece. Electronic address: dimaadamis@yahoo.com.
David J MeagherDepartment of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada; Cognitive Impairment Research Group, Department of Psychiatry, Graduate Entry Medical School, University of Limerick, Limerick, Ireland.
Daniel DavisDepartment of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.
David C CurrowDiscipline of Palliative and Supportive Services, Bedford Park, South Australia, Australia; Flinders Centre for Clinical Change, Flinders University, Bedford Park, South Australia, Australia.
Shirley H BushDivision of Palliative Care, University of Ottawa, Ottawa, Ontario, Canada; Bruyère Research Institute, Ottawa, Ontario, Canada; Palliative Care Unit, Bruyère Continuing Care, Ottawa, Ontario, Canada.
Christopher BarnesDivision of Palliative Care, University of Ottawa, Ottawa, Ontario, Canada; Palliative Care Unit, Bruyère Continuing Care, Ottawa, Ontario, Canada.
Michael HartwickDivision of Palliative Care, University of Ottawa, Ottawa, Ontario, Canada; Division of Critical Care, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada; Critical Care Response Team, The Ottawa Hospital, Ottawa, Ontario, Canada.
Meera AgarDiscipline of Palliative and Supportive Services, Bedford Park, South Australia, Australia; Department of Palliative Care, Braeside Hospital, HammondCare, Sydney, New South Wales, Australia; South West Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Jessica SimonDivision of Palliative Medicine, Department of Oncology and Department of Internal Medicine, University of Calgary, Calgary, Alberta, Canada.
William BreitbartDepartment of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA; Department of Psychiatry, Weill Medical College of Cornell University, New York, New York, USA.
Neil MacDonaldDepartment of Oncology, McGill University, Montreal, Quebec, Canada.
Peter G LawlorDivision of Palliative Care, University of Ottawa, Ottawa, Ontario, Canada; Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada; Bruyère Research Institute, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

Funding

Wellcome Trust 090661
6 · The paper itself

Abstract

contextDelirium occurs commonly in settings of palliative care (PC), in which patient vulnerability in the unique context of end-of-life care and delirium-associated impairment of decision-making capacity may together present many ethical challenges.

objectivesBased on deliberations at the Studies to Understand Delirium in Palliative Care Settings (SUNDIPS) meeting and an associated literature review, this article discusses ethical issues central to the conduct of research on delirious PC patients.

methodsTogether with an analysis of the ethical deliberations at the SUNDIPS meeting, we conducted a narrative literature review by key words searching of relevant databases and a subsequent hand search of initially identified articles. We also reviewed statements of relevance to delirium research in major national and international ethics guidelines.

resultsKey issues identified include the inclusion of PC patients in delirium research, capacity determination, and the mandate to respect patient autonomy and ensure maintenance of patient dignity. Proposed solutions include designing informed consent statements that are clear, concise, and free of complex phraseology; use of concise, yet accurate, capacity assessment instruments with a minimally burdensome schedule; and use of PC friendly consent models, such as facilitated, deferred, experienced, advance, and proxy models.

conclusionDelirium research in PC patients must meet the common standards for such research in any setting. Certain features unique to PC establish a need for extra diligence in meeting these standards and the employment of assessments, consent procedures, and patient-family interactions that are clearly grounded on the tenets of PC.

Indexed as

Biomedical ResearchCultureDeliriumHumansInformed ConsentInternationalityPalliative CareVulnerable PopulationsdeliriumEthicspalliative careresearch

Identifiers

PMID24388124
PMCPMC4082407

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.