ArticleJournal of the American Geriatrics Society2020
Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia.
Article in Journal of the American Geriatrics Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 15 citations in OpenAlex.
- Pragmatic Trial of Personalized Music for Agitation and Antipsychotic Use in Nursing Home Residents With Dementia.Journal of the American Medical Directors Association · 2022Trial
- Open science in dementia care embedded pragmatic clinical trials.Psychology and aging · 2022Trial
- Designing Consent Processes for Research With Older Adults Who May Lack Decisional Capacity: A Guide for Investigators.Journal of the American Geriatrics Society · 2026Article
- Ethics From the Outset: Incorporating Ethical Considerations into the Artificial Intelligence and Technology Collaboratories for Aging Research Pilot Projects.The journals of gerontology. Series A, Biological sciences and medical sciences · 2025Article
- Algorithmic identification of persons with dementia for research recruitment: ethical considerations.Informatics for health & social care · 2024Article
- Feasibility of conducting qualitative research with persons living with dementia and their caregivers during a home-delivered meals pilot trial.Pilot and feasibility studies · 2023Article
- Ethical analysis of vulnerabilities in cluster randomized trials involving people living with dementia in long-term care homes.Journal of the American Geriatrics Society · 2023Article
- Design Considerations for Embedded Pragmatic Clinical Trials of Advance Care Planning Interventions for Persons Living With Dementia.Journal of pain and symptom management · 2023Review
- Article
- Home-delivered meals for people with dementia: Which model delays nursing home placement? - Protocol for a feasibility pilot.Contemporary clinical trials · 2022Article
- Ethical considerations within pragmatic randomized controlled trials in dementia: Results from a literature survey.Alzheimer's & dementia (New York, N. Y.) · 2022Article
- Coronavirus disease 2019 and clinical research in U.S. nursing homes.Journal of the American Geriatrics Society · 2021Article
- Public Attitudes toward Consent When Research Is Integrated into Care-Any "Ought" from All the "Is"?The Hastings Center report · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 2 countries.
Funding
Abstract
Embedded pragmatic clinical trials (ePCTs) present an opportunity to improve care for people living with dementia (PLWD) and their care partners, but they also generate a complex constellation of ethical and regulatory challenges. These challenges begin with participant identification. Interventions may be delivered in ways that make it difficult to identify who is a human subject and therefore who needs ethical and regulatory protections. The need for informed consent, a core human subjects protection, must be considered but can be in tension with the goals of pragmatic research design. Thus it is essential to consider whether a waiver or alteration of informed consent is justifiable. If informed consent is needed, the question arises of how it should be obtained because researchers must acknowledge the vulnerability of PLWD due in part to diminished capacity and also to increased dependence on others. Further, researchers should recognize that many sites where ePCTs are conducted will be unfamiliar with human subjects research regulations and ethics. In this report, the Regulation and Ethics Core of the National Institute on Aging Imbedded Pragmatic Alzheimer's disease (AD) and AD-related dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory discusses key ethical and regulatory challenges for ePCTs in PLWD. A central thesis is that researchers should strive to anticipate and address these challenges early in the design of their ePCTs as a means of both ensuring compliance and advancing science. J Am Geriatr Soc 68:S37-S42, 2020.
Indexed as
Identifiers
What OpenQuestion holds
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.