Power and Finesse: The NLM Board of Regents

Running an operation as large and complex as the National Library of Medicine is a big job, but I don’t do it alone. In addition to my leadership team, I am privileged to have the NLM Board of Regents to help me.

Established in 1956 by the same Act that created the Library, the Board of Regents advises me on matters ranging from the acquisition of materials for the Library to the scope, content, and organization of NLM’s services to the rules governing access to those materials and services. The Board also makes recommendations for funding research and training in bioinformatics and educational technologies, suggests demonstration projects, and proposes ways to expand or enhance the biomedical communications network of which we are a part.

In short, the Board helps guide the overall work of the Library.

Given the diverse work we do and the breadth of topics we address, the Board’s membership includes leaders from across the library and life sciences, including medicine, public health, and health communications technology. They are joined by nine ex officio members whose positions read like a Who’s Who in health and librarianship, including four Surgeons General (Public Health Service, Army, Navy, and Air Force) and two national library directors (Library of Congress and National Agricultural Library).

Being in the room with them is like driving a Ferrari—things are moving fast but with finesse. And the power under the hood? Phenomenal.

It’s a blast.

With their various areas of expertise and different perspectives, Board members raise questions, highlight issues, or suggest innovations we hadn’t previously considered. Clinicians typically advocate for improvements to information management and delivery. Researchers point us towards important unsolved challenges. Consumer representatives voice the concerns and interests of patients and caregivers. Delegates from business help us leverage cutting-edge solutions coming out of private industry. And our ex officio members, as Federal partners, connect us to other parts of the government whose problems and constraints are similar to our own.

But the value of the Board is more than the individual members’ perspectives.

It’s the synergy that builds by bringing them together three times a year. It’s the lively conversations their close collaboration sparks, as they discuss NLM’s programs, services, and research initiatives. It’s their careful, considered deliberation of our research investments. And, most recently, it’s their collective effort in crafting our strategic plan for the coming decade.

Last week, after 16 months of activities involving over 500 experts and stakeholders, the Board endorsed that plan, positioning NLM for its third century. The plan envisions NLM as a platform for data-driven discovery and data-powered health, built upon three pillars:

  1. Accelerating discovery and advancing health through data-driven research
  2. Reaching more people in more ways through enhanced dissemination and engagement
  3. Building a workforce for data-driven research and health

Now the hard work begins.

Implementing the strategic plan will require fresh perspectives, new talents, and expanded resources. We will need to build a model of trust and accountability among our 1,700 women and men, encouraging them to fully contribute their skills and ideas and to envision their work in novel ways. We will have to make tradeoffs and set priorities. And as we work to make NLM’s bright future a reality, we will need to advocate for and embrace boldness and risk-taking.

Fortunately, we have the NLM Board of Regents to guide the way.

As their work proves, multiple perspectives spur innovation and creative problem-solving; collegiality supports accountability; and respectful advocacy—whether to each other, to the NIH Director, or to the Secretary of Health and Human Services—can lead to tremendous change for the greater good.  What more could we need to accelerate the progress towards our third century?!

Matters of the Heart

The Library’s role in heart health and understanding

February is American Heart Month. Begun in 1964 by presidential proclamation, this annual event focuses the nation’s attention on the importance of heart health.

That focus is well-placed.

According to the CDC, heart disease remains the leading cause of death for both men and women, with about one in four deaths in the United States attributed to its many forms.

With numbers like that, it’s no wonder NLM takes an active role in advancing knowledge about the preservation, diagnosis, and treatment of heart disease and cardiovascular problems. Of course, we’re not doing heart surgery, but in ways great and small—whether through our research, our products, our collection, our funding, or our writing—we help people learn about the heart, how to treat it, and how to keep it healthy.

That knowledge, as with everything we do, is grounded in science and research, so let’s start there.

PubMed, our flagship database of peer-reviewed biomedical literature, delivers the latest findings on heart disease and its prevention.

Clinicaltrials.gov helps people interested in participating in research on heart diseases find a study. And that’s true regardless of how old you are. Over 15% of the nearly 2,900 active, recruiting clinical trials focused on heart disease are open to children.

NLM’s computational science contributed to CRISPR-cas, a revolutionary tool for editing DNA that researchers in Oregon used last year to fix a heart-damaging genetic defect in human embryos, and our medical illustrators have helped NIH’s Human BioMolecular Atlas Program (HuBMAP) create a 3-D visualization of cardiac tissue.

NLM takes an active role in advancing knowledge about the preservation, diagnosis, and treatment of heart disease and cardiovascular problems.

Elsewhere, our research funding supports others as they look to better understand and treat heart disease through data mining, machine learning, and bioinformatics. All across the country, NLM dollars help drive the science forward, funding Dr. Karina Davidson’s work at Columbia that will accelerate the design of personalized solutions to cardiovascular issues; supporting UCLA’s Corey Arnold, PhD, who is trying to help physicians manage heart disease by establishing an automated system to summarize patient records; and financing Dr. James Blum’s group at the University of North Carolina-Wilmington as they try to predict which patients are at risk for developing post-operative complications like atrial fibrillation. Together they—and other NLM grantees—are doing innovative work that is expected to make a difference in preventing, diagnosing, or treating heart disease.

NLM staff then leverage the findings of our grantees and other researchers to deliver the most current guidance to patients, families, and caregivers through MedlinePlusNIH MedlinePlus magazine, and HealthReach. Together, these consumer-oriented resources—available in English, Spanish, and sometimes in other languages—provide practical information to help lay people understand heart disease, learn about risks, diagnosis, and treatment, and find experts to guide them.

But our cardiac contributions don’t end there.

We also collect materials and share insights regarding how medicine’s understanding of the heart and the circulatory system, along with our treatment of heart disease, evolved over time.

Our History of Medicine Division‘s blog, Circulating Now, recently explored William Harvey’s ground-breaking anatomical discoveries published in his 1628 work Exercitatio anatomica de motu cordis et sanguinis in animalibus. Harvey, the personal physician to England’s King Charles I, presented experimental proof of blood’s circulation through the body, elucidating the complex and beautiful interplay between arteries, veins, lungs, and the heart.

And on a more contemporary note, NLM’s Profiles in Science collection shares the papers of notable physicians whose work has transformed the treatment of heart disease, including legendary heart surgeons Michael E. DeBakeyAdrian Kantrowitz, and Henry Swan.

These examples—which range from the 17th century to today—highlight just some of the ways NLM celebrates American Heart Month and encourages good hearth health throughout the year.

You can do your part, too. Take the #MoveWithHeart pledge and get moving. It all adds up to a healthy heart!

Reflections on Patient- and Family-Centered Care

Broadening our vision

Today I want to reflect on how the concept of patient- and family-centered care may guide the NLM to reach new users in new ways.

Over the past year in this blog, I have highlighted several ways that libraries have expanded to attract patrons and serve their needs. Fundamentally, each of us in the library field develops personas for our patrons, and uses these personas to guide the selection of materials and strategies for delivering those materials. Today I am asking you to reflect on what contributes to your ideas of family.

Despite common assumptions, families are not necessarily a resource of support for people facing health problems. Indeed, think of the kinds of resources that libraries would need to develop in support of family-centered care when the very concept of family could be fractured at any time.

Differences in culture or circumstance also impact families, with many families defined by selection and affiliation, not by blood. What does this mean to a library?

It challenges us to organize materials in a way sufficiently broad enough to encompass many definitions of family. For example, our MeSH heading for family includes phrases like “kinship networks” and “stepfamilies.”

It also challenges the very way we deliver that information.

Right now, most of our resources are designed to reach a single person. Even our strategies to improve access to those resources, such as training for health literacy or reducing presentation bias, presume the person reading and searching the literature will also interpret and act upon it.

But a limited, idealized view rarely squares with reality.

What’s more likely is that health literacy is a family resource, not an individual talent; that health information is shared, debated, and discussed without regard to strict legal lines of relationship; and that patients define their families in myriad ways—each equally legitimate.

These ideas underpin the practice of patient- and family-centered health care, which acknowledges that patients’ families look all sorts of ways, that patients are free to determine how their families (however defined) will participate in care and decision-making, and that the resulting partnership between patients, families, and health care providers promotes better outcomes.

The idea of patient- and family-centered care is not new, but it is becoming more common in today’s health care system. Now we need to find ways to infuse it across NLM’s health information systems as well.

We need to provide tools that make it easier to collect and share health information and to support family discussions and decision-making. We need to think about new roles, such as the “health ambassador,” who serves as the bridge between patients and their families and the health care team. And we need to think beyond the individual, looking system-wide for ways that patients and families—however they are defined—look for and use health data.

And with the strategic plan on the horizon, it’s a good time to think differently.

It’s time to throw off old presumptions, ferret them out from our design requirements, and make sure those who find our health information can make use of it in ways that fit their lives, not just what we think their lives to be.

Because NLM exists to serve all families—regardless of structure, definition, or size.

Connecting Computing Research with National Priorities

Guest post by Mark D. Hill from the Computing Community Consortium and the University of Wisconsin-Madison. The content originally appeared in The CCC Blog on January 23, 2018. It is reprinted with permission.

symposium panelists sit at a table
Jim Kurose talks to the audience about CS+X.

For weeks [The CCC Blog has] been recapping the Computing Community Consortium (CCC) Symposium from the perspective of the researchers and industry representatives who presented their work on each panel.

This week, we are getting a different perspective. The goal of the final panel, called Connecting Computing Research with National Priorities and moderated by CCC Vice Chair Mark D. Hill, was to get a perspective from people who have or are currently serving in government.

The panelists included:

  • Will Barkis, from Orange Silicon Valley, shared a Silicon Valley perspective and called for increasing investment in basic research and development to benefit society as well as support innovation in industry. He emphasized that collaboration between academia, the public sector, and the private sector is critical for long-term impact.
  • Patti Brennan, from the National Institutes of Health (NIH), talked about a number of healthcare issues in the country that we need to be aware of and start addressing, such as the accelerated mental health crisis. If we develop computational services and fine-grained access control we might be able to address some of these issues sooner rather than later.
  • Jim Kurose, from the National Science Foundation (NSF), discussed smart and connected communities and how it serves people in their communities. He also highlighted the importance of interdisciplinary work and gave the example of biologists and computer scientists coming together in the field of bioinformatics.
  • Bill Regli, from Defense Advanced Research Projects Agency (DARPA), explained the Heilmeier Catechism. George H. Heilmeier, a former DARPA director, crafted a set of questions to help Agency officials think through and evaluate proposed research programs.
symposium panelists sit at a table
Bill Regli explains the DARPA Heilmeier Catechism.

During the Q&A session, one audience member asked if we should have computational specialists in all science fields since many are becoming more interdisciplinary. Dr. Brennan said that if we put computation in all fields then we run the risk of losing its impact. She does think that some of the training programs are a start, but it takes time for it to run smoothly enough. Dr. Kurose praised a number of CS+X programs around the country. These programs are trying to reach out to a different set of students who are interested in computing but are currently in other disciplines. They understand that if they take computational classes in their discipline only more doors will open.

To read all the recaps from each panel, see below:

Intelligent Infrastructure for our Cities and Communities

AI and Amplifying Human Abilities

Security and Privacy for Democracy

Data, Algorithms, and Fairness Panel

See the videos from all panels here.

headshot of Mark HillMark D. Hill is the Computing Community Consortium (CCC) Vice Chair and the John P. Morgridge Professor and Gene M. Amdahl Professor of Computer Sciences at the University of Wisconsin-Madison. 

ClinicalTrials.gov Moves Toward Increased Transparency

Guest post by Kevin M. Fain, JD, MPH, DrPH, Senior Advisor for Policy and Research, ClinicalTrials.gov.

ClinicalTrials.gov is the largest public clinical research registry and results database in the world—and  the most heavily used. As of today, it contains registration information for more than 260,000 studies in 202 different countries and results information on more than 29,000 of those studies. Each week, the content grows by approximately 560 new registrations and 110 new results submissions. The system averages more than 162 million page views per month and 93,000 unique visitors daily.

ClinicalTrials.gov enables users to: (1) search for clinical trials of drugs, biologics, devices, and other interventions; (2) obtain summary information about these studies (e.g., purpose, design, and facility locations); (3) track the progress of a study from initiation to completion; and (4) obtain summary results, often before they are published elsewhere.

In addition, the unique ClinicalTrials.gov identifier assigned to each registered trial (commonly referred to as the “NCT Number”) has become the de facto standard for referencing trials and is widely and routinely used in medical journal articles, MEDLINE citations, and the mass media.

Federal law underlies the ClinicalTrials.gov database requirements and content. NIH launched the database in 2000 after the Food and Drug Administration Modernization Act of 1997.  The FDA Amendments Act of 2007 then expanded the database’s scope and purpose by requiring registration and results reporting for certain clinical trials of FDA-regulated drugs, biological products, and medical devices. Importantly, the 2007 law included legal consequences for noncompliance, including civil monetary penalties.

More recently, in an effort to make information about clinical trials more widely available to the public, the US Department of Health and Human Services issued a final rule in September 2016 that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The rule’s final form was shaped by over 900 public comments.

The new rule, which became effective one year ago (January 18, 2017), clarifies and expands the reporting requirements for clinical trials, including trial results for drug, biologic, and device products not approved by FDA. At the same time, NIH issued a policy establishing the expectation that all investigators conducting clinical trials funded in whole or in part by NIH will ensure these trials are registered at ClinicalTrials.gov and that results information for these trials is submitted to ClinicalTrials.gov.

The expanded reporting requirements are expected to yield important scientific, medical, and public health benefits—from improving the clinical research enterprise itself to maintaining the public’s trust in clinical research. Having access to complete study results, including negative or inconclusive data, can help counteract publication bias, reduce duplication in research, improve the focus and design of future studies, and protect patients from undue risk or ineffective interventions. That additional information, in the context of other research, can also help inform health care providers and patients regarding medical decisions.

As a repository for study results, ClinicalTrials.gov helps deliver those benefits.

Recent research indicates that the results of many clinical trials—including those funded by NIH—are never published. And even when results are published, they can be limited, focusing on findings of most interest rather than all outcomes. In contrast, studies have found results reported in ClinicalTrials.gov are more complete than in the published literature. The new reporting requirements are expected to strengthen that characteristic and enhance the benefits ClinicalTrials.gov brings.

It is important to understand that listing a study on ClinicalTrials.gov does not mean it has been evaluated by the US Federal Government. The ClinicalTrials.gov website emphasizes this point for the public through prominent disclaimer statements, including one on the importance of discussing any clinical trial with a health care provider before participating.

ClinicalTrials.gov allows for the registration of any human biomedical study that conforms with prevailing laws and regulations, including an indication that recruiting studies were approved by an ethics review committee. As a result, the database is more comprehensive, which can better serve the public in critical ways. For example, potential participants can see the full range of studies being conducted, not just those funded or sponsored by NIH. Ethics committees, funders, and others can also view the wider scope of studies, which can help them more effectively oversee new research.

Aside from legislative and policy changes, ClinicalTrials.gov has also focused on enhancing the site’s usability, addressing design and layout issues and improving the ability to search, display, and review information about the studies registered on the site. The latest set of updates, released last month, included new search options (such as by recruitment status and distance from a geographic location), refinements to the display of search results, and additional information regarding study results and key record dates.  These changes, plus those brought about by the final rule, will help maximize the value of clinical trials, and by extension, advance knowledge and improve health.

From finding trials actively recruiting participants to identifying new experimental drugs or device interventions to analyzing study design and results, ClinicalTrials.gov delivers key benefits to patients, clinicians, and researchers and puts into action NIH’s core mission: turning discovery into health. It also reflects one more way NLM makes medical and health information available for public use and patient health.

headshot of Kevin FainKevin Fain, JD, MPH, DrPH, has served as senior advisor for policy and research at ClinicalTrials.gov since 2015. He was an attorney with the FDA from 1995-2010, specializing in clinical trial and drug regulatory matters. He earned his doctorate in epidemiology from Johns Hopkins University in 2015.