dissemination

December 15, 2020: A Year of Results and New Insights From the NIH Collaboratory

Posted on by Damon Seils

Collection of Journal CoversNIH Collaboratory researchers in 2020 reported study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced more than 3 dozen articles in the peer-reviewed literature, including the primary results of the PROVEN and LIRE trials, the study design of ACP PEACE, insights into the COVID-19 pandemic from TSOS and EMBED, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ACP PEACE NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

HiLo NIH Collaboratory Trial

LIRE NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

STOP CRC NIH Collaboratory Trial

TSOS NIH Collaboratory Trial

November 3, 2020: Disseminating Trial Results: We Can Have Faster and Better

Posted on by Karen Staman

Healthcare cover imageNIH Collaboratory investigators Drs. Greg Simon, Rachel Richesson, and Adrian Hernandez published an opinion piece in Healthcare arguing that clinical trials investigators should align their dissemination processes with industry-sponsored trials to favor speed, and that years-long delays in dissemination reduce the relevance of clinical research.

“Delays reduce the ability for researchers to apply trial findings to new research questions, impede clinicians from having the most up-to-date information, and perhaps most importantly, are a disservice to patients who could benefit from the information.”

The authors use experiences with pragmatic trials supported by the NIH Collaboratory to explore faster dissemination of results, and suggest the following solutions:

  • Real-time access to outcome data
  • Continuous data curation and cleaning
  • Immediate data analysis
  • Rapid reporting of trial results

Much change is needed to reach these goals. The authors suggest that by modeling processes after industry-sponsored trials, researchers may be able to improve the speed and quality of results reporting.

“Cultural incentives are aligned in industry sponsored trials to favor speed: readiness for generalizing topline results is considered valuable to shareholders, and the culture encourages a system where data are liquid, available, and continuously cleaned and curated, such that topline results can be reported within a timespan of two weeks rather than two years.”

As part of the NIH Collaboratory’s commitment to dissemination and sharing, all NIH Collaboratory Trials are expected to share data and resources, and topline results are reported in our weekly Grand Rounds Webinars.

 

August 6, 2020: New Living Textbook Section Describes Rapid Approach for Implementation Assessments

Posted on by Karen Staman

A new section of the Living Textbook’s Dissemination and Implementation chapter describes how the Trauma Survivors Outcomes & Support (TSOS) pragmatic trial research team developed a rapid approach to implementation process assessments: the Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE). Implementation assessments are typically time consuming and expensive, and the new approach embeds these procedures as part of the trial to increase efficiency and decrease cost.

Since its development within the NIH Health Care Systems Research Collaboratory, the RAPICE method has been used to address the Washington State COVID-19 outbreak to help rapidly identify primary and secondary COVID-19 prevention strategies that could be delivered using the TSOS care management platform.

For more information, see the April 19, 2019 Grand Rounds: Trauma Survivors Outcomes & Support (TSOS) Pragmatic Trial: Revisiting Effectiveness & Implementation Aims (Doug Zatzick, MD)

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.

March 30, 2020: New Living Textbook Chapter Describes Ways to Monitor Intervention Fidelity and Adaptations During the Conduct of ePCTs

Posted on by Gina Uhlenbrauck

The new Monitoring Intervention Fidelity and Adaptations chapter of the Living Textbook was developed to introduce how to evaluate changes that may be encountered while conducting an embedded pragmatic clinical trial (ePCT). For example, a health system might experience competing clinical initiatives; turnover in leadership, clinicians, or staff; changes in technologies; new clinical practice guidelines; or regulatory changes.

The chapter offers strategies for study teams to anticipate, monitor, and document adaptations to the intervention in order to support study analysis and set the stage for dissemination and implementation of successful interventions in other healthcare settings. The chapter was developed by experts from the Collaboratory’s Health Care Systems Interactions Core, along with principal investigators conducting ePCT Demonstration Projects.

Topics include:

  • Anticipating changes that might impact intervention fidelity
  • Frameworks to assist in monitoring fidelity and adaptations
  • Strategies and case examples from the NIH Collaboratory Demonstration Projects
  • Pointers to additional resources

We encourage you to explore this new content.

 

January 15, 2020: NIH Collaboratory Announces Data and Resource Sharing Page

Posted on by Karen Staman

The NIH Collaboratory Coordinating Center has published a new Data and Resource Sharing Page on the Living Textbook, which is designed to share the data and resources generated by the NIH Collaboratory Trials.

“As part of the Collaboratory’s commitment to sharing, all NIH Collaboratory Trials are expected to share data and resources, such as protocols, consent documents, public use datasets, computable phenotypes, and analytic code.”  —Data and Resource Sharing Page

The page holds links to datasets and data dictionaries, study tools, ethics and regulatory documentation, computable phenotypes and analytic code, data collection forms, study design papers, main outcomes papers, and other information that might be useful to others.

To assist clinical investigators in planning for sharing these resources, NIH Collaboratory Trials are given a Data and Resource Sharing Informational Document and an Onboarding Data and Resource Sharing Questionnaire during the onboarding process.

These documents contain:

  • Questions designed to help investigators think through the unique concerns when sharing data and resources from embedded pragmatic trials
  • Data sharing requirements for the NIH Collaboratory, NIH, and medical journals
  • Examples from NIH Collaboratory Trials.
  • Descriptions of data sharing mechanisms, such as archives and enclaves
  • Examples of data sharing platforms
  • Examples of data sharing statements

At closeout, NIH Collaboratory Trials are provided a Closeout Data and Resource Sharing Checklist, and investigators from the completed projects use this checklist to provide a final data share package.

For more on data sharing, see the Living Textbook Chapter, Data Sharing and Embedded Research.

October 25, 2019: Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility Gap (Richard Willke, PhD)

Posted on by Gina Uhlenbrauck

Speaker

Richard Willke, PhD
Chief Science Officer
ISPOR

Topic

Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility Gap

Keywords

Real-world evidence; Non-interventional studies; Health economics; ISPOR; Transparency; Reproducibility

Key Points

  • ISPOR is an international, multistakeholder nonprofit dedicated to advancing health economics and outcomes research excellence to improve decision making for health globally.
  • Key characteristics of credible and useful real-world evidence include:
    • Careful data collection or curation
    • Appropriate analytic methods
    • Good procedural practices for transparent study process
    • Replicability and reproducibility
    • Informed interpretation
    • Fit-for-purpose application
  • For transparency, it is recommended that researchers declare their study to be an exploratory (hypothesis evaluation) study and post the study protocol and analysis plan on a public study registration site prior to conducting the study analysis.

Discussion Themes

A draft white paper, Improving Transparency in Non-Interventional Research, is available for comment until November 15, 2019.

Sharing all study implementation parameters and definitions provides clarity on what was actually done and enables reproduction with confidence.

Potential registries for non-interventional real-world evidence studies include:

Read more about ISPOR.

Tags
#pctGR, @Collaboratory1, @ISPORorg

Podcast October 1, 2019: Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for Researchers (Rebecca Li, PhD, Frank Rockhold, PhD)

Posted on by Gina Uhlenbrauck

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez sits down with Drs. Rebecca Li and Frank Rockhold to discuss clinical trial data sharing and re-use. In the discussion, Li and Rockhold highlight benefits, potential fears, and the future of data sharing and open science as well as Vivli, a global clinical research data sharing platform.

Click on the recording below to listen to the podcast.

Want to hear more? View the full Grand Rounds presentation.

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Read the transcript.

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September 11, 2019: Deadline Extended for Special Supplement Seeking Papers on Embedded Research

Posted on by Gina Uhlenbrauck

AcademyHealth

The submission deadline has been extended to October 28, 2019, for a special supplement on embedded health services research in Healthcare: The Journal of Delivery Science and Innovation, the partner journal of AcademyHealth. Embedded research is a critical part of the learning health system in mining and analyzing health system data to improve patient care while also providing generalizable findings to transform the health care system at large.

This special supplement is being supported by the Department of Veterans Affairs Health Services Research & Development and will be published in March 2020. It is expected to feature 10-12 peer-reviewed articles. Ultimately, the supplement will be a resource for those aiming to improve the relevance and use of health research to improve patient care.

For details on relevant topics and how to submit your paper online, visit the journal’s special issue page.

August 9, 2019: Open Science: Are we there yet? (Adrian Hernandez, MD)

Posted on by Gina Uhlenbrauck

Speaker

Adrian Hernandez, MD
Professor of Medicine
Vice Dean for Clinical Research
Duke University, School of Medicine

Topic

Open Science: Are We There Yet?

Keywords

Open science; Data sharing; Secondary analyses; Research collaboration

Key Points

  • Open science involves the responsible sharing of research data for the purpose of scientific advancement, integrity, and transparency.
  • Various stakeholders have made progress toward sharing clinical trial data, including:
  • Guiding principles of open science include appropriate access to research information; proper oversight with minimum barriers to data access; maintaining utility of data; an expectation that results of shared data will similarly be shared; and acknowledgment of those who contribute original data.
  • Despite efforts at supporting open science, no academic institution has an open science policy yet.

Discussion Themes

Open science remains an important goal to build trust and expand knowledge.

Data sharing is not a traditional measure of academic success. What incentives would need to change in order to support open science?

Tags

#OpenScience, #DataSharing, #pctGR, @Collaboratory1, @texhern