patient-reported outcomes

July 24, 2020: TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial (Leslie J. Crofford, MD; Kathleen Sluka, PT, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Leslie J. Crofford, MD
Wilson Family Chair and Professor of Medicine
Vanderbilt University Medical Center

Kathleen Sluka, PT, PhD
Kate Daum Research Professor
Department of Physical Therapy and Rehabilitation Science
University of Iowa

Topic

TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial

Keywords

Fibromyalgia; Musculoskeletal pain; Neuropathic pain; Transcutaneous electrical nerve stimulation (TENS); Physical therapy; Nonpharmacologic pain treatment; PRISM; Patient-reported outcomes (PROs)

Key Points

  • Fibromyalgia (FM) is a condition of widespread pain that is worsened with physical activity. It involves chronic musculoskeletal and visceral pain and is often accompanied by fatigue, depression, or anxiety.
  • Transcutaneous electrical nerve stimulation (TENS) is a technique that uses a device to deliver an electric impulse through the skin. Treatment with TENS has been shown to improve resting and movement-evoked pain and fatigue.
  • While physical therapists generally are trained in the use of TENS, the technique remains underused in clinical practice.
  • The goal of the FM TIPS pragmatic trial is to determine, in a real-world clinical setting, whether physical therapy combined with TENS for patients with FM is more effective than physical therapy alone. The study is being piloted in 24 sites across 5 physical therapy health systems.

Discussion Themes

While COVID-19 has had an impact on piloting the FM TIPS study, some kind of physical therapy will be possible through telemedicine. Other challenges include that conducting embedded research in physical therapy clinics is new, and there are multiple different EHR systems in use across the partnering clinics.

The recently published results from Fibromyalgia Activity Study With TENS (FAST) showed that TENS can be safely used in addition to other treatments to improve pain and fatigue in women with fibromyalgia in the setting of a randomized controlled trial.

Read more about the Fibromyalgia TENS in Physical Therapy Study (FM TIPS) NIH Collaboratory Trial and watch a brief interview with the PIs of the study.

FM TIPS is one of the NIH HEAL Initiative’s PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) studies.

Tags

#pctGR, @Collaboratory1

July 27, 2020: ADAPTABLE Roundtable Produces Consensus Statement on Capturing Patient-Reported Health Data in Clinical Trials

Posted on by Damon Seils

A new report from an NIH Collaboratory roundtable discussion held in 2017 discusses considerations for the capture of patient-reported health (PRH) data in clinical trials. The report is part of an effort by the ADAPTABLE Supplement project team “to address best practices for capturing PRH data in pragmatic studies and optimal analytic approaches for integrating PRH with other data sources.”

The statement was published online ahead of print this month in Healthcare.

The new consensus statement is the second report from the ADAPTABLE roundtable. A statement published in February offered guidance for the analysis and integration of PRH data in clinical trials.

ADAPTABLE, the first major randomized comparative effectiveness trial conducted by the National Patient-Centered Clinical Research Network (PCORnet), seeks to determine the optimal dose of aspirin therapy for secondary prevention of atherosclerotic cardiovascular disease. The trial relies on both existing EHR data sources and PRH data.

This work was supported by a supplemental grant award to the NIH Collaboratory Coordinating Center from the National Center for Complementary and Integrative Health.

July 17, 2020: Living Textbook Grand Rounds Series: Choosing What to Measure and Making it Happen: Your Keys to Pragmatic Trial Success (Devon Check, PhD; Rachel Richesson, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Rachel Richesson, PhD, MPH
Associate Professor, Informatics
Duke University School of Nursing

Devon Check, PhD
Assistant Professor, Population Health Sciences
Department of Population Health

Topic

Choosing What to Measure and Making it Happen: Your Keys to Pragmatic Trial Success

Keywords

Measuring outcomes; Phenotypes; Data quality; Data linkage; Endpoints; Patient-reported outcomes (PROs)

Key Points

  • Endpoints and outcomes for embedded pragmatic clinical trials (ePCTs) should be meaningful to providers and patients and be relatively easy to collect as part of routine care. Endpoints and outcomes also should be clearly defined and reproducible.
  • Patient-reported outcomes (PROs) are often the best way to measure quality of life, but come with challenges in that they are not routinely or consistently used in clinical care nor are regularly recorded in the EHR.
  • To fully capture all care—complete longitudinal data—it is often necessary to link research and insurance claims data.

Discussion Themes

Data in EHRs are an important component of ePCTs. While ePCTs strive for efficiency, there remain tradeoffs. Sometimes it will be necessary to collect data outside of the EHR to ensure important and compelling results.

It is also important that the endpoint that is conveniently available will also be accepted as influential for stakeholders when the trial results are disseminated.

In the future, it is essential that more meaningful data as well as more patient-reported outcomes are routinely collected and incentivized.

Developing a robust data quality assessment plan will improve the value of data and detect and address data issues. Read more about how to do this in Assessing Data Quality for Healthcare Systems Data Used in Clinical Research.

To learn more about measuring outcomes, visit these Living Textbook chapters:

Tags

#pctGR, @Collaboratory1

June 30, 2020: Special Issue of JAGS Features NIA IMPACT Collaboratory’s Work on Embedded Pragmatic Trials and Dementia Care

Posted on by Karen Staman

Members of the National Institute on Aging (NIA) IMPACT Collaboratory (Imbedded Pragmatic Alzheimer’s Disease [AD] and AD-Related Dementias [AD/ADRD] Clinical Trials) recently contributed 10 articles to a special issue of the Journal of the American Geriatrics Society. The articles support the IMPACT Collaboratory’s mission to “build the nation’s capacity to conduct ePCTs within healthcare systems for people living with dementia and their caregivers.”

The NIA IMPACT Collaboratory was modeled after the NIH Collaboratory; it has Working Group Cores to help advance the mission and support pilot and NIH Collaboratory Trials. The Cores include Administration, Design and Statistics, Dissemination and Implementation, Health Care Systems, Health Equity, Patient/Caregiver Reported Outcomes, Pilot Studies, Regulation and Ethics, Stakeholder Engagement, Technical Data, and Training.

Each of the Cores contributed an article to the special issue to describe how they are working to improve the quality and effectiveness of ePCTs for people living with dementia and their care partners.

The full list of articles (below) also includes an introductory article by leadership of the NIA IMPACT Collaboratory, Drs. Susan Mitchell, Vincent Mor, Ellen McCarthy, and Jill Harrison.

  • Embedded Pragmatic Trials in Dementia Care: Realizing the Vision of the NIA IMPACT Collaboratory
  • Achieving Health Equity in Embedded Pragmatic Trials for People Living with Dementia and Their Family Caregivers
  • Building a National Program for Pilot Studies of Embedded Pragmatic Clinical Trials in Dementia Care
  • Training the Workforce to Conduct Embedded Pragmatic Clinical Trials to Improve Care for People Living with Dementia and Their Caregivers
  • Dissemination and Implementation of Evidence-Based Dementia Care Using Embedded Pragmatic Trials
  • Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia
  • Transforming Dementia Care Through Pragmatic Clinical Trials Embedded in Learning Healthcare Systems
  • Using Healthcare Data in Embedded Pragmatic Clinical Trials among People Living with Dementia and Their Caregivers: State of the Art
  • Selecting Outcomes to Ensure Pragmatic Trials Are Relevant to People Living with Dementia
  • Engaging Stakeholders in the Design and Conduct of Embedded Pragmatic Clinical Trials for Alzheimer’s Disease and Alzheimer’s Disease–Related Dementias
  • Statistical Considerations for Embedded Pragmatic Clinical Trials in People Living with Dementia

Drs. Mitchell and Mor are also co–principal investigators of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN), an NIH Collaboratory Trial. See the Living Textbook for more on the NIH Collaboratory Core Working Groups and NIH Collaboratory Trials.

June 4, 2020: New Chapter in the Living Textbook Describes the Uses and How-tos of Patient-Reported Outcomes

Posted on by Karen Staman

A new chapter in the Living Textbook describes how patient-reported outcomes (PROs) are used in different settings and how to choose and integrate PRO measures into an embedded pragmatic clinical trial.

The chapter also characterizes PRO use within the PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) of the NIH HEAL Initiative (Helping End Addiction Long-term Initiative). NIH Collaboratory Trials supported through the PRISM program include:

AcuOA: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
FM TIPS: Fibromyalgia TENS in Physical Therapy Study
NOHARM: Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management
OPTIMUM: Group-based mindfulness for patients with chronic low back pain in the primary care setting

The main topics of the chapter are:

The authors also include Core Outcome Sets for chronic pain, low back pain, musculoskeletal pain, and cancer.

May 29, 2020: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Experiences from the Collaboratory PCTs (Wendy Weber, ND, PhD, MPH; Jerry Jarvik, MD, MPH; Lynn DeBar, PhD, MPH; Doug Zatzick, MD; Vince Mor, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Guest Moderator
Wendy Weber, ND, PhD, MPH
Branch Chief, Clinical Research in Complementary and Integrative Health
Division of Extramural Research
National Center for Complementary and Integrative Health, NIH

Panel
Jeffrey (Jerry) G. Jarvik, MD, MPH
LIRE NIH Collaboratory Trials
Professor of Radiology, Neurological Surgery and Health Services
Adjunct Professor of Pharmacy and Orthopedics & Sports Medicine
Co-Director, Comparative Effectiveness, Cost and Outcomes Research Center
Director, UW CLEAR Center for Musculoskeletal Disorders
University of Washington School of Medicine

Lynn DeBar, PhD, MPH
PPACT NIH Collaboratory Trials
Senior Scientist
Kaiser Permanente Washington Health Research Institute

Doug Zatzick, MD
TSOS NIH Collaboratory Trial
Professor, Department of Psychiatry and Behavioral Sciences
University of Washington School of Medicine

Vince Mor, PhD
PROVEN NIH Collaboratory Trial
Florence Pirce Grant University Professor and Professor of Health Services, Policy and Practice
Brown University School of Public Health

Topic

Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Experiences from the Collaboratory PCTs

Keywords

EHRs; PCTs; Embedded PCTs; NIH Collaboratory; NIH Collaboratory Trial; PROVEN; LIRE; PPACT; TSOS; Patient-reported outcomes; PROs; Data collection

Key Points

  • Lessons and experiences from the NIH Collaboratory Trials include:
    • Pilot the intervention at the partnering health systems and work closely with site programmers who know the systems best.
    • Monitor the trial’s implementation at regular intervals to detect breakage.
    • Keep both the intervention and the outcomes as simple as possible.
    • Choose endpoints that matter to patients and providers and that are captured reliably as part of routine clinical care.
  • Enabling rapid outcome ascertainment in large pragmatic trials can be a game changer.
  • The Emergency Department Information Exchange (EDIE) in Washington state is an innovative technology platform that can help with the collection of population-level administrative data for acute care follow-up and ongoing care plans.
  • It might be better to uncouple some types of patient-reported outcome (PRO) data collection from the routine clinical care visit.

Discussion Themes

A common theme throughout all the NIH Collaboratory Trial PCTs is how dynamic and ever-changing health care delivery settings are. The reality is that the trial as planned is often not the trial as piloted or conducted.

What type of education is most effective about how to use a PRO to inform care plans and decision-making?

There is nothing like a crisis (eg, the coronavirus pandemic) for people to do things that were before thought impossible. Now, the concept of a “visit” is changing, and there will likely be more uncoupling.

Read more about all 19 of the NIH Collaboratory Trials.

Tags

#pctGR, @Collaboratory1

April 3, 2020: Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): Participant-Centered, Rapidly-Deployed, Digitally-Enabled Research (Harlan Krumholz, MD; Bala Hota, MD, MPH; Graham Nichol, MD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

Harlan M. Krumholz, MD
Harold H. Hines Jr. Professor of Medicine, Yale University
Director, Yale New Haven Hospital Center for Outcomes Research and Evaluation
Co-Founder Hugo Health

Bala Hota, MD, MPH
Professor of Internal Medicine, Rush University
Chief Analytics Officer, Rush University Medical Center

Graham Nichol, MD, MPH
Medic One Foundation Endowed Chair for Pre-hospital Emergency Care
Professor of Emergency Medicine
University of Washington

Other Panelists:

Jacqueline Rollin, Administrative Fellow
Rush University Medical Center

Wade Schulz, MD, PhD
Assistant Professor of Laboratory Medicine
Director, CORE Center for Computational Health

Matthew J. Thompson, MB, ChB, DPhil
Helen D. Cohen Endowed Professorship in Family Medicine
Professor of Global Health and Medicine, University of Washington

Deb R. Chromik, Participant Experience
Hugo Health

Dave Hutton, Product Lead
Hugo Health

Topic

Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): Participant-Centered, Rapidly-Deployed, Digitally-Enabled Research

Keywords

Coronavirus; Virus pandemic; INSPIRE Registry; COVID-19 directed research program; SARS-COV-2; Longitudinal data; Hugo Health digital research platform

Key Points

  • In the face of the coronavirus pandemic, there is an urgent need for rapid knowledge generation and actionable insights. Evidence needed includes:
    • The number of cases, including milder ones
    • Risk factors and timing of transmission
    • Severity and attack rate
    • Risk factors for infection and severe outcomes, including death
    • Infectiousness timing and intensity
  • Patients must be considered part of the team; involved, engaged, and respected, with agency over their data.
  • To better understand the experience of people with COVID-19, Rush University Medical Center and Hugo health are piloting the COVID INSPIRE registry. INSPIRE is a rapidly-deployed, digitally-enabled, participant-centered platform to collect longitudinal data and facilitate observational and experimental studies.

Discussion Themes

Even with social distancing, the coronavirus is in a rapid escalation phase; this rapid pace has our attention.

People are interested in participating in research now more than ever. The call to action is to build a human-connected system that treats patients compassionately and supports patients in real time.

Are there existing systems that could be built on or adapted for COVID-19? Are there potential for linkages to other systems?

Tags
#pctGR, @Collaboratory1, @HMKYale, @BalaHota, @GrahamNichol

April 6, 2020: Convening Pain Management Expertise in the Patient-Centered Outcomes Core: An Interview With Dr. Kevin Weinfurt

Posted on by Gina Uhlenbrauck

The Collaboratory recently interviewed Kevin Weinfurt, PhD, co-chair of the Patient-Centered Outcomes Core working group, to hear about the Core’s plans for supporting the PRISM Demonstration Projects. In this video, Dr. Weinfurt says one challenge for embedded trials of pain is in obtaining high-quality, complete patient-reported outcome data on pain intensity and functioning. Along with other national initiatives focused on pain research, such as the NIH-DoD-VA Pain Management Collaboratory, a chief task of the Core will be to look at efforts to harmonize pain outcomes across studies.

“The Core serves as a convener of expertise in pain management within the Collaboratory. We keep an eye on issues across the Demonstration Projects that might also be of interest to the broader pragmatic trial community.”

Read more about the work of the Patient-Centered Outcomes Core, and view other interviews about the HEAL Initiative and PRISM Demonstration Projects.

February 21, 2020: New Video Interviews Highlight Goals of the NIH HEAL Initiative and PRISM NIH Collaboratory Trials

Posted on by Gina Uhlenbrauck

Recently, the Collaboratory Coordinating Center conducted video interviews describing the critical work being done in the NIH HEAL Initiative program to address the national opioid crisis. As part of this program, the PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) NIH Collaboratory Trials present exciting new possibilities for answering important questions along with unique challenges.

Drs. Rebecca Baker and Wendy Weber discuss the aims of the HEAL Initiative, including:

  • Leveraging expertise across all NIH institutes and centers to enhance pain management and improve prevention and treatment strategies for opioid use disorder and addiction
  • Generating evidence to help clinicians and patients make the right treatment decisions

 

Drs. Meyers, Hernandez, and Weber discuss aspects of collaborating with the four PRISM NIH Collaboratory Trials, including:

  • Leveraging broad expertise in the Collaboratory program to support embedded healthcare systems research in pain management
  • Developing new understanding across different care models such as physical therapy, surgery, acupuncture therapy, and primary care settings
  • Learning about patient-reported outcomes that will be the most meaningful to establish best practices in pain management

Learn more about the PRISM NIH Collaboratory Trials on their webpages:

  • AcuOA: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
  • FM TIPS: Fibromyalgia TENS in Physical Therapy Study
  • NOHARM: Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management
  • OPTIMUM: Group-based mindfulness for patients with chronic low back pain in the primary care setting

February 11, 2020: ADAPTABLE Roundtable Produces Consensus Statement on Analysis and Integration of Patient-Reported Data in Clinical Trials

Posted on by Damon Seils

A roundtable discussion organized by the NIH Collaboratory in 2017 has produced consensus findings on the analysis and integration of patient-reported health (PRH) data in clinical trials. The report is part of an effort by the ADAPTABLE Supplement project team “to address best practices for capturing PRH data in pragmatic studies and optimal analytic approaches for integrating PRH with other data sources.”

The consensus statement was published online ahead of print this month in the Journal of the American Medical Informatics Association.

The report discusses strengths and limitations of PRH data, approaches for ascertaining and classifying study end points, and methods for addressing incompleteness, data alignment, and data concordance. Roundtable participants used experiences from the ADAPTABLE trial as a case study to inform their discussions.

ADAPTABLE, the first major randomized comparative effectiveness trial conducted by the National Patient-Centered Clinical Research Network (PCORnet), seeks to determine the optimal dose of aspirin therapy for secondary prevention of atherosclerotic cardiovascular disease. The trial relies on both existing EHR data sources and PRH data.

This work was supported by a supplemental grant award to the NIH Collaboratory Coordinating Center from the National Center for Complementary and Integrative Health.