Patient engagement

September 24, 2021: Enabling Patient-Reported Outcome Measures (PROMs) in Clinical Trials, Exemplified by Cardiovascular Trials (Theresa Coles, PhD; Kevin Weinfurt, PhD)

Posted on by terren.green@duke.edu

Speakers

Theresa Coles, PhD
Assistant Professor
Department of Population Health Sciences
Duke University School of Medicine

Kevin Weinfurt, PhD
Professor and Vice Chair of Research
Department of Population Health Sciences
Duke University School of Medicine

Topic

Enabling Patient-Reported Outcome Measures (PROMs) in Clinical Trials, Exemplified by Cardiovascular Trials

Keywords

Patient-reported outcomes; PROM; Validity Theory; Patient engagement

Key Points

  • Patient-reported outcome scores have value and bring different measures of outcome, such as quality of life and burden of treatment into focus in a study.
  • PROMs, or Patient Reported Outcome Measures, are not routinely collected in clinical care so they are not readily available in the electronic health record.
  • Challenges of integrating PROMs into clinical trials include the culture of the health care system, budget, time, missing information, and unclear or uncertain interpretation of scores.
  • Modern Validity Theory refers to the validity of the interpretation of test scores for the proposed use of the test, not the validity of the score itself.
  • A repository for validity arguments may help avoid redundant research and provide examples of successful validity arguments.

Discussion Themes

How do we educate regulators and researchers about interpreting validity arguments?

Validating PROMs to ensure they are appropriate for use across different cultures and population groups requires historical evidence across many different validity arguments.

PROMs offered in different formats receive better response rates.

Read more about Dr. Coles and Dr. Weinfurt’s work with PROMs in their recent publication, “Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials.”

Tags

#pctGR, @Collaboratory1

Grand Rounds October 8: Lessons Learned and Patient Partnership in ADAPTABLE

Speakers:
Madelaine Faulkner Modrow, MPH
Program Director
Department of Epidemiology and Biostatistics
University of California, San Francisco

Schuyler Jones, MD
Associate Professor of Medicine
Duke University School of Medicine

Topic: Lessons Learned and Patient Partnership in ADAPTABLE

Date: Friday, October 8, 2021, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

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September 10, 2021: Effect of Salt Substitution on Cardiovascular Events and Death (Bruce Neal, MB ChB, PhD, FRCP, FAHA, FAHMS)

Posted on by terren.green@duke.edu

Speaker

Bruce Neal, MB ChB, PhD, FRCP, FAHA, FAHMS
Executive Director, George Institute Australia
Professor of Medicine, UNSW Sydney
Honorary Professor, Sydney Medical School, University of Sydney
Professor of Clinical Epidemiology, Imperial College London

Topic

Effect of Salt Substitution on Cardiovascular Events and Death

Keywords

Cluster randomized trial; Salt substitute; Stroke; Cardiovascular disease; SSaSS

Key Points

  • The SSaSS study is a pragmatic, cluster randomized trial on the effects of salt substitutes versus regular salt on stroke, major adverse cardiovascular events, and mortality.
  • The SSaSS study followed almost 21,000 people in 600 village clusters over 5 years. At the end of the 5 year study, 92% of the intervention group was still using salt substitute and 6% of control started using salt substitute.
  • Data from the study show evidence of lower blood pressure, lower risk of stroke, lower risk of major adverse cardiovascular events, and protection against premature death with no evidence of harm.
  • There was no evidence of any increased risk of hyperkalemia.

Discussion Themes

Successful recruitment approaches in this large, long-term trial required extensive engagement and networking with local health workers and community leaders.

Salt substitute as a method to lower stroke and cardiovascular risk is attractive because it looks and tastes the same as salt, and doesn’t ask people to change their behavior.

The use of salt substitutes to decrease the intake of discretionary sodium, the salt used in home cooking or sprinkled on food after cooking, may have more effect in developing countries.  Developed countries consume processed and packaged foods more often and have less discretionary sodium intake.  In developed countries, it may be necessary to encourage food manufacturers to decrease sodium and increase potassium in the processed and packaged foods they produce.

Many millions of lives could benefit from the effects of salt substitute if this could be implemented in developing countries around the world.

Read more about Dr. Neal’s work with the SSaSS study.

Tags

#pctGR, @Collaboratory1

Grand Rounds October 22: The STAMP Trial: Increasing Engagement in Advance Care Planning and Lessons Learned from Partnering with Community Ambulatory Practices

Speaker:
Terri R. Fried, MD
Section Chief, Geriatrics
Professor of Medicine
Yale School of Medicine
Attending Physician
VA Connecticut Healthcare System

Topic: The STAMP Trial: Increasing Engagement in Advance Care Planning and Lessons Learned from Partnering with Community Ambulatory Practices

Date: Friday, October 22, 2021, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

To join the online meeting:
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Click ‘Connect to Audio”
Choose ‘Computer Audio’ or ‘I will call in’.
If using the ‘call in option’, follow the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.

Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 2622 682 0537
Meeting Password: 12345

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 2622 682 0537

NOTE: For Toll-free users, the call-back (call me) services are also available.

July 23, 2021: Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care (Diana Berrent, JD; Natalie Lambert, PhD; Nick Guthe)

Posted on by terren.green@duke.edu

Speakers

Diana Berrent, JD
Survivor Corps, Founder

Natalie Lambert, PhD
Associate Research Professor
Indiana University School of Medicine

Nick Guthe
Survivor Corps Member and Advisor

Topic

Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care

Keywords

Long-term COVID; COVID-19 symptoms; Survivor Corps; Patient-centered outcomes; Real-world evidence; Patient engagement

Key Points

  • Survivor Corps is a 170,000 member grassroots organization founded in 2020 to support and educate people with COVID-19 and those who continue to experience long-lasting symptoms of COVID-19.
  • People who experience long-term, after-effects of COVID-19 report feeling alone and desperate due to the difficult and dissatisfying medical care they receive and their medical provider’s lack of knowledge about long-term COVID.
  • Long-term COVID patients want to be heard and believed by medical professionals who are thorough in their examination and testing methods.
  • Survivor Corps advocates for crucial research to be done on the symptoms that cause the most human pain and suffering, and not just the symptoms that are experienced most frequently.
  • COVID-19 research can be done at a faster pace if we engage citizen-scientists and quickly release NIH research funding.
  • The life-or-death struggles of people with long-term COVID illustrate the need to treat this condition as an emergency medical situation—the same as we would treat an acute case of COVID-19.

Discussion Themes

The CDC guidelines are the first-step, interim guidance; however, no treatment options have been offered. Another iteration of these guidelines needs to be released soon.

We know from people who have experienced long-lasting effects of COVID-19 that the condition can be debilitating and devastating—patients are in urgent need of understanding and help.

Medical professionals should focus on real-word evidence to develop patient-centered outcomes.

Read more about Survivor Corps, Dr. Lambert’s research, the report from the Survivor Corps COVID-19 ‘Long Hauler’ Symptom Survey, and physician resources.

Tags

#pctGR, @Collaboratory1, @Survivor_Corps

Grand Rounds July 23: Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care

Speakers:
Diana Berrent, JD
Survivor Corps, Founder

Natalie Lambert, PhD
Associate Research Professor
Indiana University School of Medicine

Nick Guthe
Survivor Corps Member and Advisor

 

Topic: Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care
Date: Friday, July 23, 2021, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=m228b52a4666c1e24046e11c01ae7bd0d

You must log in to the URL first.
Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.

Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 120 909 9614
Meeting Password: 1234

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 120 909 9614

NOTE: For Toll-free users, the call-back (call me) services are also available.

February 1, 2019: Promoting Effective Advance Care Planning Communication in the Elderly: The ACP-PEACE Trial (James Tulsky, MD, Angelo Volandes, MD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

James Tulsky, MD
Chair, Department of Psychosocial Oncology and Palliative Care
Dana-Farber Cancer Institute
Professor of Medicine, Harvard Medical School
Chief, Division of Palliative Medicine
Brigham and Women’s Hospital

Angelo Volandes, MD, MPH
Associate Professor of Medicine
Massachusetts General Hospital
Harvard Medical School

Topic

Promoting Effective Advance Care Planning Communication in the Elderly: The ACP-PEACE Trial

Keywords

Pragmatic clinical trial; Advance care planning; ACP PEACE; Dana-Farber Cancer Institute; National Institute on Aging; Palliative care; Video declarations; Goal-concordant care; Patient preferences

Key Points

  • Many people with serious illness die without receiving goal-concordant care, and patients over the age of 65 with cancer experience this disproportionately. Helping patients engage in advance care planning (ACP) can empower them to express and record their goals so that their care can be aligned with their preferences.
  • The ACP PEACE NIH Collaboratory Trial is a pragmatic, stepped-wedge, randomized trial of a comprehensive ACP program in oncology clinics at 3 health systems. It will involve a combination of 2 evidence-based programs:
    • VitalTalk teaches clinicians important communication skills in having empathic conversations with seriously ill patients.
    • ACP Decisions uses videos to promote planning and decision-making by patients and families.
  • The ACP PEACE study will monitor long-term outcomes to evaluate whether patients received the care they planned for and wanted.

Discussion Themes

The last element of the ACP PEACE trial is a video declaration (ViDec), recorded by a subset of patients. In recording the ViDec, patients are prompted by questions assessing their confidence with their decision, satisfaction, decisional regret, and patient-provider experience.

The ACP PEACE study team has a scaling strategy in place if the intervention proves effective. Implementing the intervention as standard of care will involve a culture shift from what is currently expected in health systems.

Read more about the ACP PEACE NIH Collaboratory Trial in the Living Textbook.

Tags

#AdvanceCarePlanning, #pctGR, @Collaboratory1 @VitalTalk, @ACPDecisions

October 9, 2018: New Recommendations for Engaging Patients in Roles Other Than as Research Subjects

Posted on by Karen Staman

A panel funded by the Patient-Centered Outcomes Research Institute (PCORI) recently published recommendations for the oversight of patients who participate in research roles other than as “research subject.” Patients and caregivers participate in many roles, such as co-investigators, study personnel, and advisors in research studies, and this creates novel ethical and regulatory challenges. The panel provides a taxonomy for these roles and recommendations for appropriate oversight. The group also provides recommendations about identifying and engaging a diverse mix of patients and developing mechanisms to protect against possible conflicts of interest. Finally, given the ubiquity of mobile health and other emerging technologies for use by patients, the recommendations provide guidance about the inclusion of these technologies in patient-centered outcomes research, with specific attention to education, best practices, and appropriate privacy protections.

In an accompanying editorial, Dr. Robert Califf expressed his support for the panel’s efforts and their taxonomy for patients in patient-centered outcomes research:

“Given the persistent gap between the slow pace of research and the pressing need for high-quality evidence to guide practice in areas of clinical uncertainty on one hand, and the potential offered by more pragmatic, people-centered research methods on the other, we need positive approaches for making learning through research a routine part of clinical care rather than an exceptional event.”

 

March 14, 2018: Public Input on Patient-Reported Outcome Measures Due April 1

Posted on by Karen Staman

The Agency for Healthcare Research and Quality (AHRQ) is requesting information to help inform a competition in the fall to develop and implement user-friendly technical tools for the collection of patient-reported outcome (PRO) data. The AHRQ is interested in learning about experiences with physical function PRO measures that are currently in use in ambulatory care settings, including primary and secondary care, as well as the methods used to collect these data. The information will be used to select physical function measures for the competition, which aims to bolster collection and integration of PRO data in the electronic health record by developing and piloting new, user-friendly tools. Responses can be emailed to Janey.hsiao@ahrq.hhs.gov and are due April 1, 2018.

March 7, 2018: FDA Offers Workshop on Submitting Draft Guidance on Patient Experience Data

Posted on by Karen Staman

The FDA is conducting a public workshop on Monday, March 19, to obtain input from stakeholders—including patients, patient advocates, academic and medical researchers, expert practitioners, drug developers, and other interested persons—to inform the drafting of a patient-focused drug development guidance as required by the 21st Century Cures Act. Workshop attendees will discuss considerations for development and submission of a proposed draft guidance regarding patient experience data submitted by an external stakeholder. The guidance is intended to help stakeholders continue progress in developing new medicines to respond to patient’s needs.

Registration for the event, either in person or via a live webcast, ends March 12. More meeting details, including background materials, will be posted by FDA as available.