August 10, 2018: STOP CRC Trial Finds Higher Rates of Colorectal Cancer Screening in Community Clinics Using an EHR-Based Outreach Tool

The primary results of the Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) trial, an NIH Collaboratory Demonstration Project, were published online this week in JAMA Internal Medicine. The analysis found that colorectal cancer screening rates were higher in community clinics that implemented a mailed fecal immunochemical test (FIT) outreach program than in clinics that practiced usual care. The improved screening rates occurred despite low and highly variable rates of implementation of the program among participating clinics.

Almost half of eligible adults in the United States are not up to date with recommended screening for colorectal cancer, the second leading cause of cancer-related deaths. Screening rates are especially low among racial/ethnic minority and low-income populations, including those served at federal qualified health center clinics.

The STOP CRC trial tested a program to improve colorectal cancer screening rates in 26 clinics within 8 federal qualified health centers. The intervention involved embedding a tool in the electronic health record to identify patients who were overdue for colorectal cancer screening, mailing a FIT kit and reminder letter to eligible patients, and implementing a practice improvement process at participating clinics. Of the 26 clinics in the study, 13 received the intervention and 13 practiced usual care.

Compared with clinics that practiced usual care, intervention clinics had a significantly higher proportion of participants who completed a FIT (3.4 percentage points) and any colorectal cancer screening (3.8 percentage points). The higher screening rates occurred despite another important finding of the study, that low rates of implementation of the intervention were common. Higher rates of implementation were correlated with higher rates of FIT completion.

The STOP CRC experience offers lessons on how to use electronic health records to improve guideline-based screening. In a recent NIH Collaboratory Grand Rounds, investigators Dr. Gloria Coronado and Dr. Beverly Green presented findings from the trial and lessons from the implementation of the intervention. Download a study snapshot about the STOP CRC trial.

Additional reading:

Read the press release from the Kaiser Permanente Center for Health Research: Community Health Centers Can Help Boost Rates of Colorectal Cancer Screening, Kaiser Permanente Study Shows

Read Dr. Beverly Green’s blog post on the Kaiser Permanente Washington Health Research Institute’s Healthy Findings blog: Community Health Centers Can Boost Colon Cancer Screening

July 30, 2018: Registration Open for 3rd Seattle Symposium on Health Care Data Analytics

Registration is open for the 3rd Seattle Symposium on Health Care Data Analytics. The symposium will bring together biostatisticians, health informaticists, epidemiologists, and other data scientists to discuss health research and methods that involve large health care databases.

Experts involved in national research initiatives that use large health care databases will discuss methodological challenges encountered in this setting and share ideas for addressing them. Speakers will share their research on:

  • statistical approaches to learning from electronic health care data;
  • methods for precision medicine; and
  • health policy.

Space is limited, and registration is required.

The event is sponsored by the Biostatistics Unit at Kaiser Permanente Washington Health Research Institute and the Department of Biostatistics at the University of Washington.

July 25, 2018: NIH Collaboratory Launches 5 New Demonstration Projects

The NIH Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative Demonstration Projects. The new research awards, which are supported by 6 NIH institutes, centers, and offices, total $4.15 million for an initial 1-year planning phase and an estimated $30.85 million for 4 years of study implementation.

NIH Collaboratory Demonstration Projects are multicenter, pragmatic trials that engage healthcare delivery systems in research partnerships to gather real-world evidence and answer clinical questions of major public health importance. Five Core Working Groups of experts, each focused on a specific topic related to the implementation of pragmatic clinical trials, support all of the Demonstration Projects. The Core Working Groups help the research teams address challenges of conducting research embedded in clinical care, and they collect and disseminate knowledge and best practices learned throughout the process.

In its first 5 years, the NIH Collaboratory successfully guided 10 complex Demonstration Projects through the planning phase, 9 of which proceeded to full study implementation.

The 5 new Demonstration Projects are supported by the National Center for Complementary and Integrative Health (NCCIH), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Aging (NIA), the National Institute on Drug Abuse (NIDA), the Office of Behavioral and Social Sciences Research (OBSSR), and the Office of Disease Prevention (ODP). They include:

Over the next 5 years, the new Demonstration Projects will extend the NIH Collaboratory’s mission to improve how clinical trials are conducted by creating a new infrastructure for implementing cost-effective, large-scale research studies that involve healthcare delivery organizations.

July 16, 2018: JAMA Editorial Highlights mSToPS Trial, Discusses Strengths and Challenges of Pragmatic Clinical Trials

recent editorial in JAMA highlights the mHealth Screening to Prevent Strokes (mSToPS) randomized clinical trial in a discussion of the strengths and challenges of pragmatic clinical trials. The mSToPS trial, which studied patients at increased risk of atrial fibrillation who used a self-applied electrocardiogram sensor patch, found that immediate monitoring, compared with delayed monitoring, led to a higher rate of diagnosis after 4 months.

The editorial’s authors, Dr. Eric Peterson of Duke University and Dr. Robert Harrington of Stanford University, describe the mSToPS trial as an “innovative example of the potential (and challenges) inherent in a pragmatic IT trial.” The trial “scores quite high for its pragmatic approach” while offering lessons in the trade-offs that such an approach often requires.

The editorial notes that efforts like the NIH Collaboratory are bringing about innovations in health systems collaborations and clinical data platforms that “could provide the ideal setting to conduct highly pragmatic and efficient [randomized clinical trials] of the benefits, risks, and costs associated with novel health IT solutions.”

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 27, 2018: Collaboratory Investigators Pen Editorial Calling for Pragmatic Trials of Nonpharmacologic Dementia Interventions

NIH Collaboratory investigators Dr. Susan Mitchell and Dr. Vincent Mor coauthored an editorial for an upcoming issue of JAMDA highlighting the need for pragmatic trials of nonpharmacologic interventions in Alzheimer disease and related dementias. The editorial summarizes conclusions from a recent workshop at the National Institute on Aging (NIA), where experts discussed the state of the science for pragmatic trials to improve dementia care.

The goals of the NIA workshop were (1) to identify criteria for determining the readiness of dementia interventions for pragmatic trials, and (2) to describe the research infrastructure needed to support such trials.

Read the full editorial: Identifying and Supporting Nonpharmacological Dementia Interventions Ready for Pragmatic Trials: Results From an Expert Workshop

Drs. Mitchell and Mor are co-principal investigators of the NIH Collaboratory’s Pragmatic Trial of Video Education in Nursing Homes (PROVEN), which is evaluating the effectiveness of advance care planning video tools in nursing home settings. The editorial mentions that a supportive infrastructure for pragmatic research in dementia could be modeled after the NIH Collaboratory’s Coordinating Center, including Core Working Groups “focused on building investigator capacity, supporting pragmatic trial design, and maintaining the resource and knowledge base.”

Full citation: Baier RR, Mitchell SL, Jutkowitz E, Mor V. Identifying and supporting nonpharmacological dementia interventions ready for pragmatic trials: results from an expert workshop. J Am Med Dir Assoc. doi: 10.1016/j.jamda.2018.02.011.

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.

February 20, 2018: National Academies Release Workshop Summary on Real-World Evidence in Medical Product Development

The National Academies of Sciences, Engineering, and Medicine released a summary of the first workshop in a 3-part series on the development and use of real-world evidence in medical product development. The report, Examining the Impact of Real-World Evidence on Medical Product Development: I. Incentives, focuses on the role of incentives in supporting the collection and use of real-world evidence in product review, payment, and delivery.

In clinical research, data from observational studies, registries, claims, safety surveillance, and other sources are increasingly recognized as valuable supplements to randomized controlled trials. The 3-part workshop, sponsored by the US Food and Drug Administration, is intended to “advance discussions and common knowledge about complex issues relating to the generation and utilization of real-world evidence.”

NIH Collaboratory investigators Dr. Gregory Simon and Dr. Richard Platt served on the planning committee for the workshop series. Dr. Simon opened Workshop 1 by summarizing the core qualities of real-world evidence. Dr. Platt presented lessons from the Sentinel Initiative, an example of the successful use of real-world evidence to answer questions of efficacy and effectiveness.

The second workshop in the series, “Practical Approaches,” will explore what types of data are appropriate for which purposes and will recommend practical approaches for data collection. Registration for Workshop 2 is open now.

January 31, 2018: NIH Collaboratory Launches Monthly Email Newsletter

The NIH Collaboratory is pleased to announce the launch of its new monthly email newsletter. The newsletter offers a convenient monthly wrap-up of NIH Collaboratory news, along with featured stories and a look at what’s coming in the month ahead. Every newsletter will contain useful tips for investigators and links to resources for pragmatic clinical trials.

The inaugural January issue of the newsletter includes recent news about training opportunities and regulatory requirements, Grand Rounds and podcast highlights, a spotlight on the Trauma Survivors Outcomes and Support (TSOS) trial, and more.

Read the January newsletter and subscribe to future issues of the newsletter.

January 10, 2018: NCI Announces Training Institute in Dissemination and Implementation Research in Cancer

The National Cancer Institute’s Division of Cancer Control & Population Sciences is accepting applications for a Training Institute in Dissemination and Implementation Research in Cancer (TIDIRC). Designed for investigators at all levels who conduct dissemination and implementation research in cancer control, the training institute will consist of a 4-month online course and a 2-day in-person training.

There are no costs associated with the training institute, though applicants who are accepted into the program must cover travel-related expenses for the in-person meeting in Bethesda, Maryland.

This cancer-focused training program is adapted from a broader curriculum offered in previous years, the Training Institute in Dissemination and Implementation Research in Health (TIDIRH). Read an article in Implementation Science about the development of the program: “The U.S. Training Institute for Dissemination and Implementation Research in Health.”

The application window for the training institute will close on February 9, 2018. Read the announcement and submit an application: https://cancercontrol.cancer.gov/IS/training-education/tidirc/index.html.