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American Journal of Bioethics publishes special issue, includes commentary on article by IMPACT member

Posted on by Jeannine Sato

July 14, 2023

A previously published article by IMPACT member Emily Largent, PhD, JD, RN, and Stephanie Morain, MD, was the subject of guest commentary in a special issue of The American Journal of Bioethics (AJOB). The special issue focused on pragmatic clinical trials (PCTs). In the issue, Largent and Morain’s target article exploring investigators’ ethical obligations to patients was discussed in several peer commentaries and by two guest editorials including one co-authored by Commissioner of the Food and Drug Administration (FDA), Robert Califf, MD.

 

Access the special issue including all commentaries and the original target article.

Article advocates for advancing comprehensive dementia care for patients and caregivers beyond pharmaceuticals

Posted on by Jeannine Sato

A new publication co-authored by IMPACT member Eric Larson, MD, MPH, reflects on the importance of non-pharmacological interventions that promote the wellbeing of people living with dementia and their care partners as integral to dementia care. Authors comment on the contributions made by IMPACT Collaboratory on insights into real-world implementation of dementia care interventions through multiple mechanisms. The article emphasizes the need for comprehensive dementia care beyond pharmaceutical solutions, considering patients, caregivers, and care partners.

Abstract

Millions of individuals across the United States and around the world are living with dementia. Persons living with dementia can lead rewarding and fulfilling lives, and to do so, they need medical care, physical quality of life, social and emotional quality of life, and access to services and supports. To meet these needs, persons living with dementia may comanage with or rely on care partners or caregivers for adequate care and support. Many care partners and caregivers report positive benefits from assuming that role. However, the potential for negative consequences for their health, relationships, and finances necessitates a system of supports and services for the care partner and caregiver as well.

The approvals of the drugs aducanumab in 2021 and lecanemabin in 2023 for the treatment of Alzheimer’s disease have garnered a great deal of attention within the dementia community. Press releases highlighting other drugs in development aiming to reduce amyloid plaques—which are thought to contribute to dementia symptoms—such as donanemab continue to raise hope for more curative treatments. The arrival of these new drugs continues the decades-long process in search of treatments and cures for Alzheimer’s disease and related dementias. However, available treatments have the potential to cause serious side effects, and it remains unclear whether a causal relationship exists between dementia symptoms and the amyloid plaques that the drugs target.

With recent advances in research methods and infrastructure, a future in which people can live well with dementia is coming into sharper focus.

Read the full article.

NIH Pragmatic Trials Collaboratory Chapter: ETHICAL CONSIDERATIONS OF DATA SHARING IN PRAGMATIC CLINICAL TRIALS

Posted on by Sonya Sutton

Published on the NIH Pragmatic Trials Collaboratory website April 3 2023, this new chapter of the living textbook presents the human subjects research regulations that may impact data sharing and examines the intersection of enabling critical ePCT research, and respecting the interest of patients who become ePCT participants.

The scientific motivations for data sharing are clear: health information can enable scientific discovery, as well as enhance transparency and reproducibility in trial results. However, the ethical considerations of sharing data from embedded pragmatic clinical trials (ePCTs) are less well defined, especially when data are collected with a waiver or alteration of informed consent, as is often the case in ePCTs. Therefore, in this chapter, we describe the human subjects research regulations that may impact such data sharing and examine the intersection of enabling critical ePCT research, and respecting the interests of patients who become ePCT participants.

Access the chapter: https://rethinkingclinicaltrials.org/chapters/ethics-and-regulatory/ethical-considerations-of-data-sharing-in-pragmatic-clinical-trials/introduction-to-ethical-considerations-of-data/ 

 

The Center for Aging and Serious Illness accepting applications for second cohort of participants in Dementia Palliative Care Clinical Trials Training Program

Posted on by Sonya Sutton

The Center for Aging and Serious Illness Dementia Palliative Care Clinical Trials Training Program provides a foundation in practical aspects involving the design and conduct of randomized clinical trials in dementia palliative care. The Program is appropriate for early career researchers or other mid-career researchers interested in developing competence in the planning, design, and execution of randomized clinical trials among persons with Alzheimer’s Disease or Related Dementias (ADRD) and their caregivers. The 10-month-long Program includes a combination of virtual small group sessions and a 5-day in-person Institute where learners will work together to design a trial and learners will develop their own grant application addressing ADRD. The research training team includes a diverse group of faculty members who are dedicated to developing investigators in dementia palliative care clinical trials research.

The Institute is scheduled for October 2 – 6, 2023 in Chapel Hill, North Carolina. It is critical that the candidate be able to attend the Institute in its entirety. To be eligible, participants must be US citizens, have a doctoral-level degree, and be at least two years from their terminal degree with a demonstrated commitment to geriatric palliative care or dementia research. International applicants are not eligible for this opportunity.

Applications are due May 15, 2023. Complete this form to apply for the program.

Advanced Dementia: Research Informing Practice

Posted on by Beth C

Advanced Dementia: Research Informing Practice

Slides from Dr. Susan Mitchell’s presentation at the National Academy of Medicine (NAM) Decadal Survey of Behavioral and Social Science Research on Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias Workshop 3 on “Nursing Home, Hospice, and Palliative Care for Individuals with Later-Stage Dementia: Making Health Systems More Responsive to Dementia.” You can view the full slide deck here.

Dementia as Disparity: Access to High Quality Long term Care in America

Posted on by Beth C

Dementia as Disparity: Access to High Quality Long term Care in America

Slides from Dr. Vince Mor’s presentation at the National Academy of Medicine (NAM) Decadal Survey of Behavioral and Social Science Research on Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias Workshop 3 on “Nursing Home, Hospice, and Palliative Care for Individuals with Later-Stage Dementia: Making Health Systems More Responsive to Dementia.” You can view the slide deck here.

Advance Care Planning During a Crisis: Key Information for Nursing Facility Staff

Posted on by Beth C

Advance Care Planning During a Crisis: Key Information for Nursing Facility Staff

April 2, 2020

A video for advance care planning for nursing home residents during the COVID-19 pandemic. This is an excellent resource from the Indiana University Center for Aging Research, Regenstrief Institute for people living with dementia (PLWD) and their caregivers in this setting during the COVID-19 crisis, and a reminder about the importance of advance care planning. Watch the video here.

Is Learning Worth the Trouble? — Improving Health Care System Participation in Embedded Research

Posted on by Beth C

Is Learning Worth the Trouble? — Improving Health Care System Participation in Embedded Research

July 1, 2021

A paper about the importance of embedded pragmatic clinical trials (ePCTs) in generating real-world evidence without the limitations associated with observational studies or the time, expense, and lack of generalizability that are barriers to conducting conventional randomized clinical trials. The authors’ experience working in the coordinating center of the National Institutes of Health (NIH) Health Care Systems Research Collaboratory has demonstrated the feasibility of conducting innovative multicenter ePCTs for various conditions. Read the full article here.