Author: Sonya Sutton

IMPACT Health Equity Team

Posted on by Sonya Sutton

The Health Equity Team (HET) focuses on developing and implementing strategies to address diversity and inclusion in the conduct of ePCTs for people living with dementia (PLWD) and their care partners to ensure the IMPACT Collaboratory is a national resource for all Americans afflicted with dementia. Learn more about how the HET is working to increase health equity in dementia care from Core Leader Ana Quiñones, PhD, MS.

 

 

 

 

The IMPACT Collaboratory Health Equity Team from NIA IMPACT Collaboratory on Vimeo.

IMPACT Ethics and Regulation Core

Posted on by Sonya Sutton

The Ethics and Regulation Core (previously known as the Regulation and Ethics Core) focuses on clarifying the balance among the competing priorities of conducting ePCTs in people living with dementia (PLWD) and their care partners, protecting the interests of participants, and assuring health care systems that regulatory issues are addressed. Learn more about the core's work from Core Leader Jason Karlawish, MD.

 

 

 

 

The IMPACT Collaboratory Regulation and Ethics Core from NIA IMPACT Collaboratory on Vimeo.

 

Modifications and Waivers of Informed Consent in Pragmatic Clinical Trials

Posted on by Sonya Sutton

February 2020 – In Grand Rounds 4, Dr. Karlawish discusses waivers and alterations of written informed consent in pragmatic clinical trials (ePCTs). He provides two case studies of ePCTs to determine whether or not it is appropriate to permit a modification or a waiver of research informed consent.

Speaker

Jason Karlawish, MD

Jason Karlawish, MD
Core Leader, Ethics & Regulation Core

Professor of Medicine, Medical Ethics and Health Policy, and Neurology
Co-Director, Penn Memory Center, University of Pennsylvania

Download Webinar Slides

Learning Objectives

  • Identify how consideration of ethical and regulatory issues in the design phase of an ePCT with PLWD can help make the study more pragmatic.
  • Review the regulatory requirements for a waiver or alteration of informed consent and discuss related ethical considerations.
  • Apply what we’ve covered to two case studies.

 

Podcast

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Podcast Transcript: Download the transcript here.

Additional Resources

  • 45 CFR 46 – Protection of Human Subjects
  • Scott Kim and Frank Miller. “Waivers and alterations to consent in pragmatic clinical trials: Respecting the principle of respect for persons.” IRB: Ethics and Human Research. January-February 2016, Vol 38, issue 1.
  • January 31, 2008 SACHRP letter to HHS Secretary: Recommendations related to waiver of informed consent and interpretation of “minimal risk,” available at https://hhs.gov/ohrp/sachrp-committee/recommendations/2008-january-31-letter/index.html

New blog post on clustered randomized trials and the design effect

Posted on by Sonya Sutton

The latest blog post from Keith Goldfeld, DrPH, MS, MPA, member of the executive committee of the IMPACT Collaboratory Design and Statistics Core, discusses how the design effect could provide additional insight into cluster randomized trials in his most recent blog post. The ideas in this blog post were motivated in part by Goldfeld’s work with the IMPACT Collaboratory.

Gitlin’s Tailored Activity Program highlighted in Wall Street Journal

Posted on by Sonya Sutton

The Tailored Activity Plan (TAP),  a home-based occupational therapy intervention shown to reduce behavioral symptoms in people living with dementia and caregiver burden, was recently included in an article in the Wall Street Journal. The TAP program was developed by Laura Gitlin, PhD, FGSA, FAAN, Dean and distinguished professor at College of Nursing and Health Professions, at Drexel University and leader of the IMPACT Collaboratory Implementation Core and her colleagues. Read the full article at the Wall Street Journal at this link.

An Introduction to the NIA IMPACT Collaboratory

Posted on by Sonya Sutton

Richard J. Hodes, MD, Director of the National Institute of Aging and Partha Bhattacharyya, PhD, the IMPACT Collaboratory Project Officer and Program Director in the Division of Behavioral and Social Research, share their thoughts on the need for the IMPACT Collaboratory and the project goals.

 

 

An Introduction to the NIA IMPACT Collaboratory from NIA IMPACT Collaboratory on Vimeo.

Helping patients understand the results of an amyloid PET scan

Posted on by Sonya Sutton

SOKRATES (the Study of Knowledge and Reactions to Amyloid Testing), led by Emily Largent, PhD, and Jason Karlawish, MD from the IMPACT Collaboratory Ethics and Regulation Core, followed 80 cognitively unimpaired older adults for a year to understand the impact of learning the results of an amyloid PET scan, a common test used to determine the presence of brain amyloid, a biomarker for Alzheimer’s disease.  The results of the study were recently published in PLOS One.

Click here to read the full article at PLOS One.

Click here to read a news blog from the Penn Memory Center about the study.

Goldfeld discusses analyzing data from a stepped-wedge designed cluster randomized trial in a real-world context

Posted on by Sonya Sutton

Keith Goldfeld, DrPH, MS, MPA, member of the executive committee of the IMPACT Collaboratory Design and Statistics Core, recently discussed his work with the IMPACT Collaboratory on his blog, ouR data generation.

Goldfeld wrote about how to analyze data from a stepped-wedge designed cluster randomized trial. He said that this design can be an important tool to evaluate interventions in a real-world context, including research for the IMPACT Collaboratory in dementia and Alzheimers disease.

Read the full blog entry here: https://www.rdatagen.net/post/analyzing-the-open-cohort-stepped-wedge-trial-with-binary-outcomes/

Mitchell shares a look back at research in advanced dementia and links to her career

Posted on by Sonya Sutton

NIA IMPACT Collaboratory multiple principal investigator Susan Mitchell, MD, MPH, spoke at the February 4 Palliative and Advanced Illness Research (PAIR) Center Series at the Perelman School of Medicine at Pennsylvania University. Her talk, “Advanced Dementia: The Evolution of Research Informing Practice,” included a look at the overall body of work in advanced dementia and the evolution of her own research.

Mitchell described her research to date in three phases: Retrospective, Prospective, and Interventional, and described studies in each phase and how they contributed to the overall body of knowledge about advanced dementia. Mitchell concluded her talk with an introduction to the NIA IMPACT Collaboratory, describing how effectiveness and efficacy research continue the evolution of research in advanced dementia care.

To view the entire talk, please go to the PAIR Series site here: https://mediasite.med.upenn.edu/mediasite/Play/61d9013c63a24554bad8fa2506d1dfdd1d and begin the video at the 13:12 mark.