April 17, 2018: New Podcast: Dr. George Hripcsak on OHDSI and Drawing Reproducible Conclusions From Observational Clinical Data

A new episode of the Grand Rounds podcast is now available, featuring Dr. George Hripcsak, Chair of the Bioinformatics Department at Columbia University. In this episode, Dr. Hripcsak discusses the Observational Health Data Sciences and Informatics (OHDSI) Program with moderator Dr. Adrian Hernandez, and describes the program’s vision to create accessible and reliable clinical evidence by analyzing the clinical data of millions of patients globally. Dr. Hripcsak also talks about how listeners can “Join the Journey” and become part of the OHDSI research network, helping to generate high-quality evidence needed to inform medical decision-making.

Listen to the episode here:

At least once a month, we will release interviews with Grand Rounds speakers that delve into their topic of interest and give listeners bonus time with these featured experts.

Please let us know what you think by providing your feedback through the podcast page. We also encourage you to listen and share the recordings with your colleagues!

April 13, 2018: OHDSI: Drawing Reproducible Conclusions from Observational Clinical Data

Speaker

George Hripcsak, MD, MS
Vivian Beaumont Allen Professor of Biomedical Informatics, Columbia University
Chair, Department of Biomedical Informatics, Columbia University
Director, Medical Informatics Services, NewYork-Presbyterian Hospital/Columbia

Topic

OHDSI: Drawing Reproducible Conclusions from Observational Clinical Data

Keywords

Clinical research; Observational research; Precision medicine; Electronic health records; OHDSI; Clinical data

Key Points

  • Observational Health Data Sciences and Informatics (OHDSI) was developed to improve health by empowering communities to collaboratively generate the evidence that promotes better health decisions and patient care.
  • Patient-level predictions for personalized evidence requires big data. OHDSI provides a global network of at least a billion open-source records on more than 400 million patients in 80 databases.
  • It is feasible to encode the world population in a single data model if results are shared through a multi-stakeholder, interdisciplinary approach.
  • Through access to observational data, researchers can look at multiple outcomes or treatments at once to produce large numbers of comparisons.

Discussion Themes

There are five steps in reproducible research:

  1. Address measured confounding variables
  2. Identify residual confounding variables
  3. Use multiple databases, locations, and practice types
  4. Publish hypotheses, parameters, and runs
  5. Generate evidence

Data dredging is not about what researchers do, but about what they throw out, so it should not be done in the literature. Every last parameter should be published so a study can be reproduced.

There is an “upside down” approach to the problem of multiple comparisons and selective publication, by telling researchers that all comparisons are required.

People get their care from multiple institutions, so OHDSI is looking for ways to ensure that outcomes are not left out. Administrative databases tend to be more complete in terms of longitudinal information.

NCDR cardiovascular registry data, certain labs, radiology/path notes, and sociodemographic information are all key elements that are being considered as sources to enrich observational research.

 

To learn more about OHDSI, visit http://ohdsi.org or follow @OHDSI on Twitter.

For information on electronic health record (EHR) phenotyping, visit The Living Textbook https://bit.ly/2Hk5pQ8.

Tags

@PCORI, @Columbia, #clinicaldata, #observationaldata, #PrecisionMedicine, #openscience, #jointhejourney, #pctGR

April 11, 2018: New Podcast: Dr. Robert Califf on Data Science in the Era of Data Ubiquity

The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Robert Califf, former FDA Commissioner and current Director of Duke Forge. In this episode, Dr. Califf discusses with moderator Dr. Adrian Hernandez how the vast amount of information now available to people through cell phones and other devices is both an opportunity and obstacle for the field of data science.  While improving technology provides the chance to equalize access to health resources and knowledge for people across the country, it is also creates the challenge of ensuring that this information is complete and accurate.

Listen to the episode here:

At least once a month, we will release interviews with Grand Rounds speakers that delve into their topic of interest and give listeners bonus time with these featured experts.

Please let us know what you think by providing your feedback through the podcast page. We also encourage you to listen and share the recordings with your colleagues!

April 6, 2018: Legal and Ethical Architecture for PCOR Data

Speakers

Jane Hyatt Thorpe, JD
Associate Professor
Department of Health Policy and Management
Milken Institute School of Public Health
George Washington University

Lara Cartwright-Smith, JD, MPH
Associate Research Professor
Department of Health Policy and Management
Milken Institute School of Public Health
George Washington University

Elizabeth Gray, JD, MHA
Research Scientist
Department of Health Policy and Management
Milken Institute School of Public Health
George Washington University

Topic

Legal and Ethical Architecture for PCOR Data

Keywords

Patient-centered outcomes research; PCOR; Data privacy and security; Research ethics

Key Points

  • The patient-centered outcomes research (PCOR) Privacy and Security Research Scenario Initiative supports the development of a legal, ethical architecture to enable robust and secure PCOR data.
  • The legal and ethical framework was created to foster stakeholder trust through compliance with federal and state privacy laws.
  • The framework is a visual decision tool highlighting key characteristics and considerations associated with the spectrum of data used for PCOR and the nature of the relationships between researchers and other stakeholders.
  • The framework directs stakeholders through considerations organized into relevant legal provisions according to 6 key data characteristics:
    • Identifiability and Content
    • Subject
    • Source
    • Access and Use/Purpose
    • Consent/Authorization
    • Security

Discussion Themes

While the PCOR framework is not intended to replace a conversation with individual counsel, it should provide guidance to researchers on the types of questions to ask about their data.

The framework’s appendix was created to organize issues that may have ambiguous or overlapping legal authority.

Ethical considerations were embedded in the document, rather than being broken out separately apart from legal considerations, as they often go hand in hand (e.g., informed consent considerations).

 

To see the full framework documents, visitHealthIT.gov https://bit.ly/2H2RLke 

For more about regulatory frameworks, visit The Living Textbook  https://bit.ly/2GG3sOr

Tags

@PCORI, @ @ONC_HealthIT, @HHSONC, @GWtweets, #PCOR, #stakeholderengagment, #pctGR

March 30, 2018: HHS-DoD-VA Pain Management Collaboratory

Speaker

Robert D. Kerns, PhD
Professor of Psychiatry, Neurology, and Psychology
Yale University

Topic

HHS-DoD-VA Pain Management Collaboratory

Keywords

Pragmatic clinical trials; Clinical research; Health and Human Services; Veterans Affairs, Department of Defense; Pain research

Key Points

  • Nearly one-third of the U.S. adult population reports chronic pain, and treating it costs the healthcare system nearly $500 billion per year.
  • Military service members and veterans are particularly vulnerable subgroups, with anywhere from 50%-75% of veterans experiencing persistent pain.
  • Guidelines from the Centers for Disease Control and Prevention (CDC) advise that opioids not be used in first-line or routine treatment for chronic pain.
  • The primary goal of the Health and Human Services-Department of Defense-Veterans Affairs (HHS-DoD-VA) Pain Management Collaboratory is to conduct pragmatic trials evaluating non-pharmacologic approaches to pain management in military and veteran healthcare organizations.

Discussion Themes

The VA healthcare system has the advantage of 20 years of data for pain intensity ratings that have been collected in routine care—the one exception being a measure of functioning.

What are the considerations for potential privatization of the VA and ensuring the same level of access to data?

Ideally the Pain Management Collaboratory initiative would provide leverage for researchers to promote improved access to electronic health record (EHR) data for researchers.

There is a lot of competition for the same participants within the area of military and veteran healthcare, which is a consideration for the Pain Collaboratory when moving from planning to implementation.

 

The PPACT Demonstration Project of the NIH Collaboratory is a pragmatic trial addressing chronic pain in primary care. Read more at The Living Textbook https://bit.ly/2IcsvoQ.

Tags

@PCORI, @PCTGrandRounds, @Yale, @HHSGov, @DeptofDefense, @DeptVetAffairs, #chronicpain, #collaborativecare, #pragmatictrials, #healthsystems, #qualityoflife, #pctGR

March 23, 2018: Data Science in the Era of Data Ubiquity

Speaker

Robert M. Califf, MD
Vice Chancellor for Health Data Science
Duke University
Advisor, Verily Life Sciences

Topic

Data Science in the Era of Data Ubiquity

Keywords

Pragmatic clinical trials; Clinical research; Data science; Data ubiquity; Duke Forge; Data curation; Public health; Learning health system; Electronic health records; Real world evidence; Precision medicine; Stakeholder engagement

Key Points

  • Healthcare and clinical trials have benefitted from progress in electronic health records (EHR) and geospatial insight, but major work remains to be done in stakeholder engagement, data curation, and developing cultural/ethical frameworks.
  • A county-level breakdown of health outcomes and life expectancy, with stark divides by income and geography, underscores the vital role played by social determinants of health.
  • National frameworks for developing real world evidence and precision medicine are helping to build needed infrastructure to support a learning health system (LHS).
  • Technology doesn’t limit our ability to provide good information about health and healthcare, but we need good policy based in evidence and informed by stakeholder needs.

Discussion Themes

When internet searching is a primary source of information about health and healthcare, fake news becomes a public health problem.
In a learning health system (LHS), research influences practice and practice influences research, through design, implementation, evaluation, and adjustment, followed by dissemination of results to stakeholders.

The All of Us Research Program is a great start in terms of collecting data on a large scale from patients, but it would be ideal to expand from one million to 50 million participants, as other countries are ahead of the United States in the health data race.

It is necessary to always return results from research, but challenges to return of results include the reading level of populations and the comprehension of complex data.

Health educators, pharmacy techs, and allied health professionals could have a reimagined role if we could agree on principles and evidence-based best practices.

 

Tags

@PCORI, @PCTGrandRounds, @califf001, @DukeForge, #publichealth, #realworldevidence, #EHR, #geospatial, #learninghealthsystems, #PrecisionMedicine, #stakeholderengagement, #pragmatictrials, #pctGR

March 22, 2018: New Podcast: Dr. Sean Tunis and Ellen Tambor on Clinicians’ Views on Participating in CER/PCOR

The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Sean Tunis and Ellen Tambor of the Center for Medical Technology Policy (CMTP). In this episode, the speakers discuss with moderator Dr. Kevin Weinfurt their findings on clinician attitudes towards research participation, and how and when to best engage them. They describe the need for involving clinicians in the planning of study design, and in closing feedback loops after studies are completed, in order to build clinicians’ trust that research does lead to quality improvement for their patients.

Listen to the episode here:

At least once a month, we will release interviews with Grand Rounds speakers that delve into their topic of interest and give listeners bonus time with these featured experts.

Please let us know what you think by providing your feedback through the podcast page. We also encourage you to listen and share the recordings with your colleagues!

March 21, 2018: Dr. Rob Califf to Speak on Data Science at March 23 Grand Rounds

Robert Califf, MD, former FDA Commissioner and current Vice Chancellor for Health Data Science at Duke University School of Medicine, will present at NIH Collaboratory Grand Rounds on Friday, March 23 at 1 pm ET. The webinar will be broadcast live and is open to the public. Following the presentation, Dr. Califf will answer questions from the Grand Rounds audience.

As Director of Duke Forge, Duke’s interdisciplinary center for actionable health data science, Dr. Califf is currently working on initiatives designed to harness biostatics, machine learning, and sophisticated informatics approaches to improve health and healthcare. Dr. Califf is also an adjunct professor of medicine at Stanford University and is employed by Verily Life Sciences as a scientific advisor. Verily, part of the Alphabet (Google) family of companies, is aimed at transforming the growth of health-related data into practical applications.

Dr. Califf has been a pioneer in the fields of clinical, translational, and outcomes research, and the NIH Collaboratory looks forward to hearing his thoughts on the pragmatic applications of data that will advance health and health care strategies and practice.

Topic: Data Science in the Era of Data Ubiquity

Date: Friday, March 23, 2018, 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=m1a4a0665a615ae0382440edecedbdd33

March 16, 2018: Straight from the Source: Clinicians’ Views on Participating in CER/PCOR

Speakers

Ellen Tambor, MA
Research Director
Center for Medical Technology Policy (CMTP)

Rachael Moloney, MHS
Research Manager
Center for Medical Technology Policy (CMTP)

Sean Tunis, MD, MSc
President and CEO
Center for Medical Technology Policy (CMTP)

Topic

Straight from the Source: Clinicians’ Views on Participating in CER/PCOR

Keywords

Pragmatic clinical trials; Clinical research; Comparative effectiveness research; Patient-centered outcomes research; Clinician engagement

Key Points

  • Qualitative, empirical evidence pertaining to clinician participation in comparative effectiveness and patient-centered outcomes research (CER/PCOR) is very limited.
  • Literature has shown that the biggest motivations for clinician involvement in research are improving patient care and contributing to clinical knowledge, rather than recognition or financial motives.
  • Early and ongoing engagement builds clinician trust, enthusiasm, confidence, and commitment in pragmatic trials.
  • Focus groups with clinicians made it clear that clinicians want to be involved in early stages of study design and want to protect their patients from feeling like “guinea pigs.”

Discussion Themes

Maintaining clinician and clinic staff engagement through booster trainings, and through recognizing their efforts, is key to the long-term success of a research project.

Engaging clinicians after a study also is important to ensure that the results are translated into better patient care by the people who provide that care.

There seems to be a difference in clinician perceptions of “quality improvement” versus “research,” because they are not used to seeing research results or a feedback loop for real change. Dissemination and implementation of research results are critical in seeing real changes in patient care.

 

For information on comparative effectiveness research (CER) and patient-centered outcomes research (PCOR), visit the Living Textbook http://bit.ly/2GviZNU. See also Perspectives on Clinician Engagement from the National Academy of Medicine http://bit.ly/2FGUuA7.

Tags

@PCORI, @PCTGrandRounds, @CMTP_Baltimore, @SeanTunis, #outcomesresearch, #clinicianengagement, #pragmatictrials, #pctGR

March 9, 2018: Closing the Loop in Research/Care-Delivery Partnerships: Communication and Dissemination in Learning Health Systems

Speakers

Eric B. Larson, MD, MPH
Vice President, Research and Health Care Innovation
Kaiser Foundation Health Plan of Washington
Executive Director and Senior Investigator
Kaiser Permanente Washington Health Research Institute

Paula Lozano, MD, MPH
Associate Medical Director for Research and Translation
Senior Investigator
Kaiser Permanente Washington Health Research Institute

Joan DeClaire
Director, Communications
Kaiser Permanente Washington Health Research Institute

Topic

Closing the Loop in Research/Care-Delivery Partnerships: Communication and Dissemination in Learning Health Systems

Keywords

Embedded pragmatic clinical trials; Learning healthcare systems; Kaiser Permanente Washington Health Research Institute; Investigator engagement; Research dissemination

Key Points

  • The ultimate goal of the Kaiser Permanente Washing Health Research Institute communications strategy is to return value that comes from embedding research in the learning healthcare system.
  • Kaiser Permanente uses its blog as a platform to give investigators a voice, and it is the central place stakeholders are directed through emails, newsletters, and social media posts.
  • Investigator engagement is key in making the strategy work, by sharing knowledge and resources with each other and key stakeholders, especially through use of social media.
  • The Learning Healthcare System (LHS) Program was launched to leverage research through analytics, evidence synthesis and design, implementation support, and assessment of impact.

Discussion Themes

Research stories make up 75% of Kaiser Permanente’s positive media mentions.

Content should be optimized with strong headlines and simple writing, and the use of videos can help engage audiences.

Kaiser Permanente aims to create a robust learning health system (LHS) through three key methods: Cultivating curiosity, creating a culture of science, and doing the right things in real-world implementation.

 

For information on Learning Health Systems (LHS), visit The Living Textbook http://bit.ly/2FvbS6F

Tags

@PCTGrandRounds, @KPWaResearch, #learninghealthcaresystem, #pragmatictrials, #pctGR