November 12, 2018: Participate in the NIH Office of Disease Prevention’s Research Expertise Survey

The National Institutes of Health (NIH) Office of Disease Prevention (ODP) needs your help to enhance the quality of research supported by the NIH. The ODP is building a directory of experts in research methods and study designs that can help NIH Scientific Review Officers identify the most appropriate reviewers for NIH research applications. Adding your name and expertise to the directory is easy – simply share your methodological and content area expertise by filling out the ODP’s Prevention Research Expertise Survey (PRES).


 

The survey covers 7 areas related (but not limited) to prevention research:

  • Study Design Topics
  • Research Methods
  • Content Topics
  • Settings
  • Populations
  • Regions
  • Income Categories

The PRES takes approximately 15-25 minutes and is strictly voluntary. Based on your skill set and interest, NIH or Department of Health and Human Services (HHS) staff may invite you to serve as a peer reviewer for research applications, or you may be asked to sit on a panel, committee, or workgroup; or to speak at a seminar or workshop. Your responses and information will not be shared with anyone outside of HHS.

The ODP believes the participation of highly qualified methods experts will enhance the quality of peer review; improve the rigor, reproducibility, and impact of research supported by the NIH; and ultimately lead to stronger clinical practice, health policy, and community health programs.

The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention and disseminating the results of this research to improve public health. For more information about the ODP and its work, visit the ODP website.

Thank you in advance for taking the survey – your participation helps improve the rigor, impact, and value of research supported by the NIH.

August 23, 2018: PROVEN Team Uses PRECIS-2 to Evaluate Ongoing Trial Implementation

A tool used to rate how the design of a pragmatic clinical trial will influence the real-world applicability of its results can also be used in real time to assess the impact of changes in trial implementation, a recent study published in Trials found.

When designing a pragmatic trial to test the effectiveness of an intervention under “real-world” conditions, researchers use the Pragmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) to assess how a variety of design features may affect the applicability of trial results for the intended users. A pragmatic trial differs from a traditional “explanatory” trial, which tests the efficacy of an intervention under ideal conditions. PRECIS-2 rates design features on a scale from “explanatory” to “pragmatic” within several domains. The end users of trial results, such as health care systems, may need the results to be more or less “pragmatic” on the explanatory–pragmatic spectrum in order to implement the intervention in their own care delivery settings.

In a novel effort, researchers with the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) used PRECIS-2 during the conduct of the trial to assess the effects of midtrial changes in implementation. PROVEN, an ongoing NIH Collaboratory Demonstration Project, is a pragmatic, cluster randomized trial evaluating the effectiveness of video-assisted decision support tools for advance care planning in nursing homes.

In the initial design of PROVEN, design features in the implementation-focused domains of PRECIS-2 were relatively pragmatic, especially in the domain measuring flexibility in the delivery of the intervention. As the trial progressed, adaptations in implementation that were necessary to address challenges in monitoring and protocol adherence led to more explanatory approaches. The investigators concluded that some pragmatic trials, such as those conducted in complex health care systems like nursing homes, “may benefit from a more dynamic approach to implementation which allows for fluidity between pragmatic and explanatory features.” PRECIS-2 can be useful in evaluating the impact of midtrial adaptations with these dynamic approaches to trial implementation.

PROVEN is one of the first large-scale pragmatic trials to be conducted in nursing homes. Learn more about PRECIS-2 in the Living Textbook.

June 7, 2018: NIH Releases First Strategic Plan for Data Science

On June 4, the National Institutes of Health (NIH) released its first Strategic Plan for Data Science. The plan outlines steps the agency will take to modernize research data infrastructure and resources and to maximize the value of data generated by NIH-supported research.

Data science challenges for NIH have evolved and grown rapidly since the launch of the Big Data to Knowledge (BD2K) program in 2014. The most pressing challenges include the growing costs of data management, limited interconnectivity and interoperability among data resources, and a lack of generalizable tools to transform, analyze, and otherwise support the usability of data for researchers, institutions, industry, and the public.

The goals of the NIH Strategic Plan for Data Science are to:

  • support an efficient, effective data infrastructure by optimizing data storage, security, and interoperability;
  • modernize data resources by improving data repositories, supporting storage and sharing of individual data sets, and integrating clinical and observational data;
  • develop and disseminate both generalizable and specialized tools for data management, analytics, and visualization;
  • enhance workforce development for data science by expanding NIH’s internal data science workforce and supporting expansion of the national research workforce, and by engaging a broader community of experts and the general public in developing best practices; and
  • enact policies that promote stewardship and sustainability of data science resources.

As part of the implementation of the strategic plan, the NIH will hire a chief data strategist. For information about the position, see the job announcement.

April 13, 2018: PCORI Launches Tool for Exploring Literature on Engagement in Health Research

Seeking to advance the study and practice of engagement in health research, the Patient-Centered Outcomes Research Institute (PCORI) recently launched the Engagement in Health Research Literature Explorer. Locating relevant research articles about engagement can be challenging because of a lack of standard terminology. The new tool searches a curated database of peer-reviewed literature on engagement. Articles are included in the database if they describe engagement experiences, report research findings on engagement practices, or present theories, concepts, or views on engagement. The database is updated monthly and is one way PCORI is helping to promote meaningful involvement of patients, caregivers, clinicians, and other healthcare stakeholders throughout the research process.

Read more information about the explorer tool and how it was developed.

You can also learn more about stakeholder engagement in the Living Textbook chapter.

January 19, 2018: New Research Methods Resources Website on Group- or Cluster-Randomized Studies

The National Institutes of Health (NIH) Office of Extramural Research has released new clinical trial requirements for grant applications and contract proposals due on or after January 25, 2018. In anticipation of these new requirements, the NIH modified the Application Guide and the Review Criteria to address methodological problems common to many clinical trials. As group- or cluster-randomization designs are increasingly common in both basic and applied research, the new Application Guide includes links to the new Research Methods Resources website, which provides resources for investigators considering these group- or cluster-randomized designs, including lists of NIH webinars, key references, and statements to help investigators prepare sound applications and avoid methodological pitfalls.

NIH & FDA seek feedback on new clinical trial protocol template


As part of their ongoing effort to improve the speed and efficiency of conducting clinical trials, the NIH-FDA Joint Leadership Council has created a draft clinical trial protocol template. The template contains instructional and sample text intended to assist NIH-funded investigators in writing protocols for phase 2 or 3 clinical trials that require Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. Feedback is sought from investigators, investigator-sponsors, institutional review board members, and other stakeholders involved in protocol development and review.

Our goal is to provide an organized way for creative investigators to describe their plans so that others can understand them. – Dr. Pamela McInnes, NIH

Details on the rationale and development of the protocol template are on these blog posts:

Notice Number: NOT-OD-16-043. Responses accepted through April 17, 2016.

You can access the template document as well as a template shell, comment form, and other resources at NIH’s Clinical Research Policy website.

New Lessons Learned Document Draws on Experiences of Demonstration Projects

The NIH Collaboratory’s Health Care Systems Interactions Core has published a document entitled Lessons Learned from the NIH Health Care Systems Research Collaboratory Demonstration Projects. The Principal Investigators of each of the Demonstration Projects shared their trial-specific experience with the Core to develop the document, which presents problems and solutions for initiation and implementation of pragmatic clinical trials (PCTs). Lessons learned are divided into the following categories: build partnerships, define clinically important questions, assess feasibility, involve stakeholders in study design, consider institutional review board and regulatory issues, and assess potential issues with biostatistics and the analytic plan.

Other tools available from the Health Care Systems Interactions Core include a guidance document entitled Considerations for Training Front-Line Staff and Clinicians on Pragmatic Clinical Trial Procedures and an introduction to PCTs slide set.

New Guidance Document on Training Front-Line Staff & Clinicians in PCTs


Tools for ResearchThe NIH Collaboratory’s Health Care Systems Interactions Core has published a guidance document entitled Considerations for Training Front-Line Staff and Clinicians on Pragmatic Clinical Trial Procedures. The purpose of this guidance is to help pragmatic clinical trial (PCT) teams plan training for study procedures that involve front-line clinicians and staff. The content was developed by drawing on trial-specific experience from the NIH Collaboratory Demonstration Projects. The document describes how training for PCTs will differ from training conducted for typical research studies, and includes a list of specific considerations, real-world examples, a checklist for PCT training design, and links to additional resources.

Other tools available from the Health Care Systems Interactions Core include an introduction to PCTs slide set.


New Biostatistical Guidance Document Available: Small-Sample Robust Variance Correction for GEE

Tools for ResearchThe NIH Collaboratory’s Biostatistics and Study Design Core has just published a new guidance document by Andrea Cook, PhD, of the Group Health Research Institute, on using small-sample robust variance correction for generalized estimating equations (GEE) for use in cluster-randomized trials. The document, which includes guidance on methods available in the SAS and Stata statistical analysis packages, is available directly from the NIH Collaboratory Knowledge Repository here (opens as PDF), or via the Biostatistical Guidance Documents page in the Living Textbook.

This guidance document is one in a series of research tools focused on detailed aspects of statistical design for conducting pragmatic clinical trials. Each document in this series provides a synthesis of current developments, discusses possible future directions, and, where appropriate, makes recommendations for application to pragmatic clinical research.


Mobile Health (mHealth) Research Platform to Launch


In recent health information technology news, the University of California, San Francisco (UCSF), has received a 5-year National Institutes of Health award to support its launch of a cardiovascular mHealth platform. The research platform, to be named Health ePeople, will build on the successes of UCSF’s Health eHeart Study, which began in 2013. That study, with more than 30,000 participants worldwide, uses the power of mobile technologies to collect cardiovascular data and patient-reported outcomes (PROs) from study participants.

The Health ePeople platform will advance mHealth by providing researchers with easy access to a large cohort of volunteers, along with a quick, affordable means for collecting their health data through mobile and wireless technologies. Though the platform will not be ready to enroll new participants for several months, people who want to participate in the cohort can sign up through the Health eHeart Study website.

For information and short videos on mHealth technologies, visit the Living Textbook’s chapter on mHealth and PROs.