patient-reported outcomes

March 17, 2021: Cultural and Linguistic Adaptations: Results of a Survey of PRISM NIH Collaboratory Trials

Posted on by Karen Staman

To better understand efforts at cultural and linguistic adaptions in clinical trials focused on pain, members of the NIH Collaboratory’s Patient-Centered Outcomes Core recently conducted a survey of the PRISM NIH Collaboratory Trials (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing), which are part of NIH’s Helping to End Addiction Long-term Initiative℠, or NIH HEAL Initiative℠.

"Having culturally valid patient-reported outcome instruments is extremely important to the conduct of embedded pragmatic trials. For the results to be valid, the intended audience needs to understand both the measure and what is being asked of them. This is critical for trials centered on pain because pain-related outcomes are best described by the person who is experiencing the symptoms."  —Emily O’Brien, PhD, Co-Chair of the Patient-Centered Outcomes Core

The results are published in the Cultural Adaptation and Linguistic Translation section of the Patient-Reported Outcomes Chapter in the Living Textbook.
For more information on the PRISM projects, study snapshots are accessible from each NIH Collaboratory Trial page and the links below:

  • BackInAction: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
  • FM TIPS: Fibromyalgia TENS in Physical Therapy Study
  • OPTIMUM: Group-based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care Setting
  • NOHARM: Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management

Note that the 2 newest PRISM projects, GRACE and BeatPain Utah, are still in the design phase and were not included in this round of interviews.

January 29, 2021: The COVID-19 Citizen Science Study (Gregory M. Marcus, MD, MAS)

Posted on by Gina Uhlenbrauck

Speaker

Gregory M. Marcus, MD, MAS
Professor of Medicine
University of California, San Francisco

Topic

The COVID-19 Citizen Science Study

Keywords

Eureka digital research platform; COVID-19 infections; Mobile health; Risk factors; Citizen science; Geolocation; Participant engagement

Key Points

  • Eureka is an NIH-supported digital research platform built to use mobile health technology to combat the novel coronavirus, focusing on identifying risk factors for infection, transmission, and severity of disease that may inform best practices.
  • Eureka is also intended to serve as a platform for collaborating investigators to answer their own research questions.
  • As a citizen science project, any adult with a smartphone can participate and contribute information. Nearly 50,000 participants have enrolled to date.

Discussion Themes

The COVID-19 Citizen Science website provides data visualizations that show how people answered the survey questions. A study blog through the app is used to translate key information to participants.

Will this project be collaborating with other entities that are potentially overlapping in terms of their COVID-19 applications?

Best practices in mHealth include keeping it simple, avoiding over-explaining, listening to participants, and providing a feedback pathway.

Learn more about the Eureka platform. The smartphone app is available under the name “UCSF Eureka Research.”

Tags

#pctGR, @Collaboratory1  

January 26, 2021: NIH Collaboratory COVID-19 Grand Rounds Continues With the COVID-19 Citizen Science Study

Posted on by Damon Seils

Dr. Gregory MarcusIn this week’s COVID-19 Grand Rounds session, Dr. Gregory Marcus of the University of California, San Francisco, will present “The COVID-19 Citizen Science Study.” The Grand Rounds session will be held on Friday, January 29, at 1:00 pm eastern. Join the online meeting.

The Citizen Science Study is using a smartphone-based research platform to engage “citizen scientists” in advancing understanding of COVID-19. By collecting information from tens of thousands of participants, researchers hope to gain insights into how the coronavirus is spreading, identify ways to reduce the number of new infections, and determine how COVID-19 is affecting individuals and populations.

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

January 8, 2021: HERO-TOGETHER: Building Vaccine Confidence With Long-Term Outcomes Data (Emily O’Brien, PhD)

Posted on by Gina Uhlenbrauck

Speaker

Emily O’Brien, PhD
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine
Department of Population Health Sciences

Topic

HERO-TOGETHER: Building Vaccine Confidence With Long-Term Outcomes Data

Keywords

Vaccine development; COVID-19; Pandemic: Vaccine hesitancy; HERO-TOGETHER; Healthcare workers; Clinical outcomes: Observational study

Key Points

  • According to the World Health Organization, vaccine hesitancy refers to the delay in acceptance of, or refusal of, vaccines despite availability of vaccination services.

  • Vaccine hesitancy is complex and context specific, varying across time, place, and vaccines. It is influenced by factors such as complacency, convenience, and confidence. Hesitancy occurs on a continuum, from acceptance of all vaccines, to acceptance but doubt, to vaccine delayers, refusers, and deniers.

  • HERO-TOGETHER is a prospective, observational, multicenter cohort study of 20,000 adult U.S. healthcare workers who received a COVID-19 vaccine within the past 60 days. The study will collect data from participants that includes their experience with receiving the vaccine, medical history, unexpected medical care, safety events, and quality of life.

Discussion Themes

There is no universal best practice to address vaccine hesitancy in all its contexts. Locally tailored and multicomponent approaches will be needed.

How has the political environment influenced the hesitancy around receiving the COVID-19 vaccine?

What are your approaches to evaluating vaccine safety? What about safety for women during child-bearing years?

Read more about the HERO-TOGETHER study.

Tags

#pctGR, @Collaboratory1

January 5, 2021: New Video Collection Highlights Advances in Electronic Health Records for Pragmatic Research

Posted on by Damon Seils

We are pleased to announce our new collection of short educational videos that highlight advances in the use of electronic health records (EHRs) in pragmatic clinical trials.

The videos are drawn from our 2020 EHR Workshop Grand Rounds Series, “Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials.” The series highlighted advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials. Experts discuss the evolving regulatory context for EHRs, national policy priorities, and innovative uses of EHRs in several NIH Collaboratory Trials.

Video topics include:

Visit the EHR Workshop Video Modules page for access to all of the new videos.

November 5, 2020: NIH HEAL Initiative Common Data Elements Published in the Living Textbook

Posted on by Karen Staman

Logo for the NIH HEAL InitiativeThe Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, has created common data elements (CDEs) to facilitate cross-study comparisons for pain, improve interoperability of findings for patient-reported outcomes, and compare results across trials. The core CDEs were published recently in the NIH Collaboratory’s Living Textbook. They include CDEs for adult acute pain, adult chronic pain, and pediatric acute and chronic pain, and represent patient-reported outcomes that HEAL Initiative clinical trials are required to collect.

“Having common measures to capture the patient’s perspective regarding pain will enable researchers to compare meaningful data across pain conditions, in diverse populations, and in multiple research studies, including in pragmatic clinical research. This should greatly increase our understanding of pain and how best to treat it.”

      —Emily O’Brien, PhD, co–principal investigator of the NIH Collaboratory Patient-Centered Outcomes Core

The NIH Collaboratory serves as the resource coordinating center for 6 NIH Collaboratory Trials funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program, a component of the NIH HEAL Initiative:

Because the PRISM studies are pragmatic clinical trials embedded in healthcare systems, it may not be feasible for investigators to collect all the required CDEs, as the trials need to be incorporated into clinical workflow with as little burden as possible. The NIH Collaboratory’s Patient-Centered Outcomes Core Working Group will work with the NIH Collaboratory Trials to understand and document which patient-reported outcome measures are collected and the perceived burden associated with collecting them.

Learn more in the Choosing PRO Measures chapter of the Living Textbook.

October 30, 2020: Lessons from Virtual Trials in Time of a Pandemic: Minnesota Hydroxychloroquine Experience (David Boulware, MD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

David R. Boulware MD, MPH
Professor of Medicine
Infectious Disease & International Medicine
Department of Medicine
University of Minnesota

Topic

Lessons from Virtual Trials in Time of a Pandemic: Minnesota Hydroxychloroquine Experience

Keywords

COVID-19; Patient-reported outcomes (PROs); Hydroxychloroquine; Epidemiology; Virtual trials

Key Points

  • These virtual randomized controlled trials evaluated hydroxychloroquine as a post-exposure prophylaxis, pre-emptive early treatment, and pre-exposure prophylaxis for COVID-19.
  • The trial of post-exposure prophylaxis employed patient-reported outcomes around COVID-19 symptoms and severity as well as side effects of hydroxychloroquine.
  • Enrollment and screening of eligible participants was automated through a REDCap survey.

Discussion Themes

Being a virtual trial, were there concerns about practicing medicine “across state lines?”

There has been a mix of science and politics over the course of the COVID-19 pandemic. Because your trial had substantial media coverage, how did the publicity affect enrollment?

Many big strategy questions can be studied virtually. What changes do you see for trials during future pandemics?

Read reports of these virtual trials in New England Journal of Medicine, Annals of Internal Medicine, and the medRxiv preprint server.

Tags

#pctGR, @Collaboratory1

October 6, 2020: Four PRISM NIH Collaboratory Trials Awarded Continuation From Planning to Implementation Phase

Posted on by Gina Uhlenbrauck

The NIH Collaboratory is pleased to announce that the four PRISM NIH Collaboratory Trials received approval to transition from the planning phase to the implementation phase of their studies. These embedded PCTs (ePCTs) are directly addressing the U.S. opioid crisis and exploring fundamental questions of pain management using nonpharmacologic treatments.

Congratulations to the PIs and study teams for their excellent work!

BackInAction: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults

Karen Sherman, PhD, MPH
Photo of Lynn DeBar, principal investigator of PPACT
Lynn DeBar, PhD, MPH

BackInAction is conducting a three-arm pragmatic trial of older adults who have chronic low back pain to evaluate acupuncture versus usual care. The study will compare a standard 12-week course of acupuncture, an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course), and usual care to assess back-related function at 26 weeks.

 

 

 

 

FM TIPS: Fibromyalgia TENS in Physical Therapy Study

Kathleen Sluka, PT, PhD
Leslie Crofford, MD

The aim of FM TIPS is to demonstrate the feasibility of adding transcutaneous electrical nerve stimulation (TENS) to the treatment of patients with fibromyalgia in a real-world physical therapy setting, and to determine if adding TENS to physical therapy reduces pain, increases adherence to physical therapy, and allows patients with fibromyalgia to reach their specific functional goals with less medication use.

 

 

 

NOHARM: Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management

Photo of Andrea Cheville, co–principal investigator of NOHARM
Andrea Cheville, MD
Jon Tilburt, MD

NOHARM is a stepped-wedge cluster-randomized trial that is testing a sustainable system-wide strategy for perioperative pain management using nonpharmacologic options in a manner that preserves patient function, honors patient values, and maintains availability of opioids as a last resort.

 

 

 

 

OPTIMUM: Group-based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care Setting

Natalia Morone, MD

OPTIMUM aims to evaluate the impact of an innovative, group-based mindfulness program for patients with chronic low back pain in a real-life clinical setting. Mindfulness is effective for the treatment of chronic low back pain, yet remains underutilized as it has not been regularly woven into the outpatient clinical setting.

 

 

 

 

The PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) is a component of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The NIH Collaboratory serves as the PRISM Resource Coordinating Center and is supported by the National Center for Complementary and Integrative Health. Support is also provided by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

August 11, 2020: Grand Rounds Webinar Discusses the Democratization of Medical Research

Posted on by Gina Uhlenbrauck

A recent Grand Rounds webinar presented by C. Michael Gibson, MS, MD, described how open access, patient empowerment, social media, and digital health are transforming clinical trials. Dr. Gibson is a professor of medicine at Harvard Medical School and president and CEO of Baim and PERFUSE Research Institutes.

Among the key points:

  • The COVID-19 pandemic has been a call to arms to physicians to combat not only the virus but the misinformation.
  • As the internet is replacing the printing press, “copyleft” is replacing copyright in this new open-access era. It is a participatory community with bidirectional flow of information through social media.
  • Health data does not equal health care. Patients are looking to physicians to curate health information.
  • In this new world of clinical research, patients are enrolling in virtual trials via a phone app and will be followed up online through claims data and patient-reported outcomes.
  • Patient-empowered trials have the potential to provide more generalizable study results and to lead to patient-specific predictions through use of artificial intelligence.

Watch the complete webinar and download the slides.

Read more in The Democratization of Medical Research and Education Through Social Media: The Potential and the Peril (Gibson, JAMA Cardiology, 2017) and learn about the Heartline Study as an example of a “giga trial.”

August 7, 2020: The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research (C. Michael Gibson, MS, MD)

Posted on by Gina Uhlenbrauck

Speaker

C. Michael Gibson, MS, MD
Professor of Medicine
Harvard Medical School
President and CEO
Baim and PERFUSE Research Institutes

Topic

The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research

Keywords

Clinical research; Open access; Social media; Artificial intelligence; Heartline study; WikiDoc; WikiPatient

Key Points

  • As the internet is replacing the printing press, “copyleft” is replacing copyright in the open-access era. It is a participatory community with bidirectional flow of information through social media.
  • Health data does not equal health care. Patients are looking to physicians to curate health information from huge volumes of data.
  • Social media and open access during the COVID-19 pandemic has meant that physicians are citizen journalists, innovators, activists, and educators.
  • In this new world, patients are enrolling in virtual trials via a phone app and will be followed up online through claims data and patient-reported outcomes.

Discussion Themes

The COVID-19 pandemic has been a call to arms to clinicians to combat not only the virus but the misinformation. As educators we must set the path and not allow uninformed people to take control.

Enabling patient-empowered trials has the potential for more generalizable study results and can lead to patient-specific predictions through use of artificial intelligence.

How do we validate the quality of open-access data and reports that are not peer-reviewed?

How can we diminish the hazards of skewed research outcomes arising from trial participant conversations on social media?

Read more from C. Michael Gibson in The Democratization of Medical Research and Education Through Social Media: The Potential and the Peril (JAMA Cardiology 2017).

Tags

#pctGR, @Collaboratory1