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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

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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

Using a Pilot to Test and Refine Your Measurement Strategy

Posted on by Mia

January 2020 – In Grand Rounds 3, Dr. McCreedy presents a case example to describe how a pilot can be used to test the adequacy of existing data for evaluating an ePCT outcome. Dr. McCreedy also describes a potentially efficient ePCT design that accommodates under-detection in existing data while maintaining large-scale implementation and evaluation.

Speaker

Ellen McCreedy, PhD, MPH

Executive Committee, Technical Data Core

Assistant Professor, Brown University School of Public Health

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Learning Objectives

  • Describe how a pilot study can be used to test the adequacy of existing data sources for the purposes of evaluating your ePCT.
  • Give three reasons why existing administrative data may suffer from under-detection of behaviors in persons with dementia.
  • Discuss an alternative ePCT design that addresses potential under-detection in existing administrative data sources.

 

Podcast


Podcast Transcript: Download the transcript here.

Related Articles and Resources

McCreedy EM, Yang X, Baier RR, Rudolph JL, Thomas KS, Mor V. Measuring effects of nondrug interventions on behaviors: music & memory pilot study. Journal of the American Geriatrics Society. 2019 Oct;67(10):2134-8.

Stepped Wedge Cluster Randomized Trials: What, How, And When?

Posted on by Jodi Snare

December 2019 – In Grand Rounds 2, Dr. Taljaard describes the use of stepped wedge design in cluster randomized trials (SW-CRT), a novel research design embraced by clinical researchers.

Speaker

Monica Taljaard, PhDMonica Taljaard, PhD

Executive Committee, Design & Statistics Core

Senior Scientist, Ottawa Hospital Research Institute
Associate Professor, University of Ottawa

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Learning Objectives

  • Describe the key characteristics and main types of stepped wedge cluster randomized trials (SW-CRTs) with examples.
  • Explain the main approach to analysis and sample size calculation for SW-CRTs.
  • Discuss what is an appropriate justification for using a SW-CRTs.

 

Podcast

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Podcast Transcript: Download the transcript here.

Related Articles and Resources

  1. Kasza J1, Taljaard M2,3, Forbes AB1 Information content of stepped-wedge designs when treatment effect heterogeneity and/or implementation periods are present https://www.ncbi.nlm.nih.gov/pubmed/31321806
  2. Teerenstra S, Taljaard M, Haenen A, Huis A, Atsma F, Rodwell L, Hulscher M. Sample size calculation for stepped-wedge cluster-randomized trials with more than two levels of clustering. Clinical Trials. 2019; 16(3):225-236. doi: 10.1177/1740774519829053.
  3. R package ‘swCRTdesign’  http://faculty.washington.edu/jphughes/pubs.html
  4. R-Shiny (Hemming & Kasza) https://clusterrcts.shinyapps.io/rshinyapp/ 

Are you ready for a pragmatic trial? The RAPT model and implementation considerations

Posted on by dcridigital

November 2019 – Grand Rounds 1 focuses on using the Readiness Assessment for Pragmatic Trials (RAPT) model to assess an intervention’s readiness for an ePCT. RAPT includes 9 domains that reflect a range of considerations regarding the feasibility of successfully employing pragmatic methods and the prospect of an intervention’s widespread adoption, if proven effective.

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Laura Gitlin, PhD, FGSA, FAAN

Laura Gitlin, PhD, FGSA, FAAN

Core Leader, Implementation Core

Dean, Distinguished Professor, Drexel University
Adjunct Professor, Johns Hopkins University

Joe Gaugler, PhD

Joe Gaugler, PhD

Associate Core Leader, Implementation Core

Robert L. Kane Endowed Chair in Long-Term Care and Aging, Professor, University of Minnesota

Rosa Baier, MPH

Rosa Baier, MPH

Executive Committee, Implementation & Health Care Systems (HCS) Cores

Director, Center for Long-Term Care Quality & Innovation
Associate Professor, Health Services, Policy & Practice, Brown University School of Public Health

Eric Jutkowitz, PhD

Eric Jutkowitz, PhD

Executive Committee, Implementation Core

Assistant Professor, Brown University School of Public Health

Learning Objectives

  • Understand how RAPT complements and differs from PRECIS-2
  • Understand RAPT's domains and their relevance for conducting an ePCT
  • Learn how RAPT results can inform decisions about and preparation for proceeding to an ePCT
  • Be prepared to apply RAPT to interventions and use results to guide team discussion

Podcast

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Podcast Transcript: Download the transcript here.