On December 18, 2017, the National Library of Medicine (NLM) released a new set of updates to ClinicalTrials.gov as part of its ongoing effort to enhance the usability of the database. For a review of this project, visit ClinicalTrials.gov: First in a Series of Changes to Improve Usability for Stakeholders. Most of the features provided in the current release were previously available for public testing on the beta site starting in November 2017 (see New ClinicalTrials.gov Beta Version Available for Public Testing). Following are highlights of key features in the latest release. These changes were informed by user research with end-users representing various stakeholder groups and the NLM partnership with 18F, a federal government digital services consultancy. Information about future changes to ClinicalTrials.gov will be provided on a new What’s New page.
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world operated by NLM. The database contains information on over 261,000 clinical studies and expanded access (or “compassionate use”) to investigational new drugs. Summary results entries for over 29,000 of these studies are also posted in a tabular format on ClinicalTrials.gov. Information listed on ClinicalTrials.gov is provided and updated by the study sponsor or investigator, and listing does not mean it has been evaluated by the U.S. Federal Government.Updated ClinicalTrials.gov homepage
Updated Search on Homepage
The updated homepage includes a new way for users to limit their searches to studies that are currently recruiting or will be recruiting participants. Additionally, users can now search for studies located within a specified distance from a city. Together, these new features will help users find information about potential studies in which to participate.
Updated Modify Search on Results Page
After a query is submitted, the Search Results page displays the number of studies found in ClinicalTrials.gov, the user-entered query terms and filters, and related terms that are automatically searched. The Modify Search link allows users to refine the current search directly on the Search Results page. Note that the Modify Search fields are initially hidden to ensure that the list of study records found is visible on the screen. The Start Over link returns users to the homepage to conduct a new search. To refine a search, use Filters to add or remove limits and Modify Search to display and update the search fields and terms used in the current query.
In-Context Glossary Display
The new glossary feature allows users to look up definitions of terms used on ClinicalTrials.gov while continuing to view the page on which a term appears (i.e., in context). Terms linked to glossary entries are identified by an information icon (“i” in a blue circle) throughout the ClinicalTrials.gov site. Clicking on a term opens a glossary panel from the right side of the screen to display the description for that term. The search box at the top of the glossary panel allows users to find entries for other terms. Note that clicking the “x” next to the glossary search box clears the box and reveals a full list of glossary entries. This glossary feature will help users understand words and phrases frequently used on ClinicalTrials.gov. (Sponsors and investigators should refer to the ClinicalTrials.gov Data Element Definitions documents for help with the data items required during registration and results submission.)
Results Submitted Tab
Information submitted by a study sponsor or investigator undergoes a quality control (QC) review process before being displayed on ClinicalTrials.gov. NLM staff members review all submissions for apparent errors, deficiencies, or inconsistencies. If “major issues” are identified by ClinicalTrials.gov during QC review, the submission is returned to the study sponsor or investigator with comments. Submitted information is publicly displayed (i.e., posted) after all major issues have been corrected or addressed.
The new Results Submitted tab displays a table that helps users track the QC review status for submitted results information that are not yet posted on ClinicalTrials.gov. After a study sponsor or investigator initially submits results information, the No Results Posted tab on a study record is updated to Results Submitted.
Clicking on this tab displays a table of dates. Each submission of results information prior to first posting is shown in a table row that is identified by sequential numbers in the Submission Cycle column. The date on which results information is submitted to ClinicalTrials.gov within each cycle is listed in the second column. If at least one major issue is identified during QC review in a submission cycle, the date on which NLM returns results information to a study sponsor or investigator with QC review comments is listed in the third column. After all identified major issues have been corrected or addressed by a study sponsor or investigator and submitted, the results information will be posted as part of the study record on ClinicalTrials.gov and the tab label will be changed to “Results Posted.”
Key Record Dates
A listing of key dates for record-related milestones is accessible by clicking the Key Record Dates link at the bottom of a study record. The Key Record Dates page allows users to identify when registration and, if applicable, results information was first submitted to ClinicalTrials.gov by the sponsor or investigator and first posted on ClinicalTrials.gov, as well as the date of the first submission that met QC criteria. It also lists when the last update was submitted and posted, and the date of submission for the last update that met QC criteria.
Note that when the QC review process for submitted information requires only a single submission cycle (i.e., no major issues are identified after initial submission), the dates displayed for “submitted that met QC criteria” and “submitted” will be the same. In contrast, when the QC review process takes two or more submission cycles, the date displayed for “submitted that met QC criteria” will be later than the date for “submitted.” For descriptions of each key record date, see Glossary of Common Site Terms.
Updated Study Record Layout
The design and layout of the study record page was updated to make the most relevant information more prominent. “Go to” links allow users to access the major sections of a record more easily.
Comments, questions, and suggestions are welcome! To contact NLM, click on “Customer Support” in the footer of the ClinicalTrials.gov web site, which will take you to the NLM Customer Support page. Then click on Contact NLM at the top of the NLM Customer Support page.
The holiday season can be a time of joy, but it can also be a time of major stress. Financial worries, family expectations, and other causes of stress may lead to both mental and physical symptoms; such as depression, irritability, and digestive problems. Find ways to help relieve stress during the holidays with National Library of Medicine resources, including resources for the public on MedlinePlus and resources in multiple languages on HealthReach:
- For the Public: The MedlinePlus Health Topic on Stress includes resources on stress symptoms, treatment options, tips for living with stress, and information targeting children, teens, and women experiencing stress. Also check the Medical Encyclopedia on MedlinePlus to find an article about learning to manage stress.
- Multiple Languages: Find multilingual patient information about stress on HealthReach, such as Coping with Stress (14 languages), Health and Well-Being 1 – Stress (15 languages), Anxiety (An Introduction) (4 languages), and What Is Mental Distress (16 languages).
by Yamila El-Khayat
Outreach Services Librarian
Health Sciences Library
University of Arizona
The NIH All of Us Research Program traveling exhibit came to the University of Arizona’s Banner Health Hospital Campus on December 7, 2017. It provided an excellent opportunity to visit and learn more about the All of Us Program. At the entry, there was an introductory video that clearly and simply introduced the All of Us project. The video focused on two individuals of differing ethnicities and lifestyles, but with the same diagnosis. It focused on the importance of molding medicine to each individual because of their differences. It was a very creative way of simply defining the concept of precision medicine.
Next in the exhibit was an area to answer a couple of questions on a tablet computer. Then your picture was taken and you received a color identification from the spectrum of options. The picture was then shown framed in the identity color. No definitions were supplied regarding the colors, but I ended up being red, which according to the person giving us the tour was rare, and her first experience seeing that color. It was a further illustration of the differences in each of us. Finally, we were shown other activities and noises and had to identify what we thought they were and then shown what they really were. This was a way to learn about differing perceptions, again emphasizing the importance of uniqueness in individuals. All in all, the exhibit was an informative and entertaining way to learn more about the All of Us Research Program.All of Us Traveling Exhibit
The NLM Outreach and Special Populations Branch (OSPB) will be retiring the following pages and social media accounts in January 2018:
- Twitter Account @NLM_OSP: This account will be retired on January 1, 2018. For health information resources for specific populations, follow @NLM_SIS.
- NLM 4 Caregivers: The NLM 4 Caregivers project page and all related social media accounts (Twitter, Facebook, and Pinterest) will be retired on January 31, 2018. Visit the Caregivers Health Topics page on MedlinePlus for reliable health information resources for family caregivers.
California Governor Jerry Brown has declared a state of emergency in Ventura County due to the Thomas Fire, in San Diego County due to the Lilac Fire, and in Los Angeles County due to the Creek and Rye Fires.
The National Library of Medicine (NLM) Disaster Information Management Research Center (DIMRC) has compiled resources to assist with response and and recovery from the latest California wildfires. Information guides on disaster topics and the Disaster Lit® database provide access to curated, reliable information from vetted Federal, state, and local governments and organizations.
Key National Resources
- NLM Fires and Wildfires Information Guide
- Content syndication—embed the content of this page on your own website, to get automatic updates and new resources
- NLM Coping with Disasters, Violence and Traumatic Events
- 2017 California Wildfires (Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response)
- Disaster Distress Helpline (Substance Abuse and Mental Health Services Administration)
- Call 1-800-985-5990 toll-free, 24/7
- Text TalkWithUs to 66746 to connect with a trained crisis counselor
Key California Resources
- California Office of Emergency Services Wildfires Resource & Information
- City of Los Angeles Creek Fire Emergency Updates and Information
- California Statewide Fire Map
- City of Los Angeles December 2017 Fires
- WIFIRE Firemap Research Project (including recent smoke concentrations, air quality)
- Air Quality: AirNow from the Environmental Protection Agency (Search by Zip Code or State)
- Search NLM Disaster Lit database
Join the NLM and NNLM Training Office for two upcoming training events in January, introducing you to 2018 MeSH and how to adjust to MeSH changes in PubMed searches and alerts.
NLM Webinar: 2018 MeSH Highlights
Date and time: Friday, January 5, 2018, 10:00 am PST
Join NLM staff for a highlights tour of the 2018 Medical Subject Headings (MeSH). A 20-minute presentation will feature will be followed by questions and answers.
NNLM Class: MeSH Changes and PubMed Searching
Date and time: Friday, January 19, 2019, 10:00 am PST
Every year, the Medical Subject Headings are updated. Find out how this affects your PubMed searches.
Recordings of both sessions will be posted after the events.
December 3-9 is National Influenza Vaccination Week, and the National Library of Medicine offers resources to learn about the flu vaccine on MedlinePlus and through resources available in multiple languages on HealthReach. Materials about flu vaccines on HealthReach include illustrated handouts to educate people about the seasonal flu, a poster in multiple languages on how to fight the flu, and vaccine information statements about the flu vaccine:
- Influenza (10 languages) – This six-page illustrated handout educates people about influenza, also called the flu or seasonal flu, which is an infection that starts in the nose, throat, and lungs, and is caused by a number of viruses. It explains how the flu virus is spread, and describes its signs and symptoms.
- Fight the Flu Poster (19 languages) – This poster uses illustrations to educate people about four steps they can take to stop the spread of flu. It shows covering a cough, hand washing, staying at home when sick, and getting vaccinated.
- Vaccine Information Statement (VIS) — Influenza (Flu) Vaccine (Inactivated or Recombinant): What You Need to Know (38 languages) – This two-page Vaccine Information Statement (VIS) educates people about the inactivated or recombinant influenza (flu) vaccine, which is injected.
- Vaccine Information Statement (VIS) — Influenza (Flu) Vaccine (Live, Intranasal): What You Need to Know (23 languages) – This two-page Vaccine Information Statement (VIS) educates people about the live attenuated influenza (flu) vaccine (LAIV), which is sprayed into the nose and may be given to healthy, non-pregnant people ages 2 through 49.
The National Library of Medicine Value Set Authority Center (VSAC) has announced a new user interface that displays program releases of value sets on the VSAC homepage. Additionally, the page has a sleek new look and intuitive filters for program-related value sets. All functionality and underlying data remain the same. The new user interface displays current program releases, Centers for Medicare & Medicaid Services electronic clinical quality measure (eCQM) Value Sets and Health Level Seven International Consolidated Clinical Document Architecture (HL7 C-CDA) Value Sets, and introduces the newest program release of value sets, CMS Hybrid Value Sets. Core Clinical Data Elements and Hybrid Measures use a set of core clinical data elements, clinical variables from electronic health records (EHRs), that are routinely collected and can be extracted for use in risk-adjusted hospital-level hybrid outcome measures.
Learn more about creating a program release of your value sets in VSAC, display your published value sets in a program release on the front page of VSAC, and enable easy search and download for your value set consumers! Send any questions and feedback to NLM Customer Support.
NIH Request for Information (RFI) on the Tribal Health Research Office (THRO) Strategic Plan (FY 2018-2022)
A Request for Information (RFI) has been issued to invite comments and suggestions on the first National Institutes of Health (NIH) Tribal Health Research Office (THRO) Strategic Plan, to solicit input from stakeholders, including members of the scientific, tribal, advocacy, and patient communities; basic, clinical, and translational scientists; as well as other interested members of the public. Feedback is requested on five strategic priorities under consideration for the first THRO Strategic Plan. These themes are intended to stimulate new research areas, priorities, and approaches to help put science to work to improve the health of tribal communities.
The National Institutes of Health (NIH) seeks to improve, promote and strengthen communication between NIH and American Indian/Alaska Native (AI/AN) communities, as well as communication among its Institutes, Centers and Offices (ICOs), on Indigenous health research and discoveries. The development of culturally-driven practice and research is vital to improve AI/AN health, build trust in the relationships between NIH and AI/AN communities, and facilitate further integration and collaboration among the AI/AN communities and the NIH ICOs as they develop research that will be accepted by and useful to AI/AN communities.
Responses should be submitted by January 8, 2018. Responses will be acknowledged with receipt of an electronic confirmation. All submissions will be considered but will not be confidential. Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. Inquiries should be directed to the Tribal Health Research Office.
NLM’s MedlinePlus team has announced the release of an enhancement that allows users to choose what they want to print from a health topic web page: just the summary text, or the full page including the summary and all links. Users need to click the grey printer button on the page to choose an option:
A dialog will open allowing the choice of “Topic Summary only” or “Full topic including all links.” This feature is available on both English and Spanish health topics.
NOTE: The browser File menu > Print option will print the full page without giving the user these options. This feature is only available via the grey Print button on the MedlinePlus web page.
In September, 2016, the National Library of Medicine began a new web archiving effort to identify and collect web content on the topic of HIV/AIDS. On World AIDS Day 2017 NLM began sharing its HIV/AIDS web archive collection with the public, making available an initial set of websites and social media archived to document HIV/AIDS in the early 21st century. More content will be added over time. The archive represents a snapshot of the current social, cultural, and biomedical world around HIV/AIDS, as it is represented on the Internet, so that future researchers can use this collection as a primary source to understand HIV/AIDS in the early 21st century.
Highlights of the collection include the organizational response to HIV/AIDS, including pages of state public health departments in the United States, which often post current HIV surveillance and epidemiological data. Federal sites in the collection include HIV-related pages at the Department of Health and Human Services, such as NIH, and the Centers for Disease Control and Prevention (CDC), and the Veteran’s Administration, as well as the PEPFAR site (the President’s Emergency Plan for AIDS Relief, started by George W. Bush, which provides funding for HIV treatment in resource-limited settings around the world). The collection also includes websites for local and regional nonprofit HIV/AIDS service organizations across the country. Many of these organizations originated in the 1980s-1990s AIDS activist era, when groups like ACT UP demanded better clinical care for opportunistic infections caused by their impaired immune systems and faster progress toward effective drugs against the HIV virus itself. Most of the collection focuses on the United States, but there are some international resources, such as international clinical trials groups, informational sites from the United Kingdom, the United Nations’ HIV/AIDS pages, and a few blogs from outside the U.S.
For additional information about the archive, visit NLM’s Circulating Now blog.
Check out the December issue of NIH News in Health, the monthly newsletter bringing you practical health news and tips based on the latest NIH research. In this issue:
- Managing Diabetes: New Technologies Can Make It Easier
Scientists are finding ways to automate technologies to help control diabetes and keep you healthy.
- Battling a Bulging Hernia: Don’t Ignore Your Groin Pain
Is standing, coughing, or jumping causing pain in your lower abdomen? It may be a hernia.
- Health Capsule: Your Family’s Health History
Get to know your family better this holiday season by talking about health. Knowing your family’s health history can help your health care team provide better care for you.
- Health Capsule: How Do Medical Scans Work?
NIH has a free app called “Understanding Medical Scans” to help answer questions about various medical scans: MRI, CT, ultrasound, PET, and X-Ray.
- Featured Website: Know the Science of Health
Know the Science has tools to help you better understand complex scientific topics that relate to health research so that you can be discerning about what you hear and read and make well-informed decisions about your health.
NIH News in Health is available online in both HTML and PDF formats. Additionally, you can get trusted, up-to-date health information from NIH News in Health added directly to your site via NIH content syndication. Print copies are available free of charge for offices, clinics, community centers, and libraries within the U.S. Visit the NIH News in Health Facebook page to suggest topics you’d like to see covered, or share what you find helpful about the newsletter!
On January 10-12, 2018, the NCBI will help with a bioinformatics hackathon hosted by San Diego State University. The hackathon will focus on advanced bioinformatics analysis of next generation sequencing data, proteomics, and metadata. This event is for researchers, including students and postdocs, who have already engaged in the use of bioinformatics data or in the development of pipelines for bioinformatics analyses from high-throughput experiments. Some projects are available to other non-scientific developers, mathematicians, or librarians. The event is open to anyone selected for the hackathon and willing to travel to SDSU. Applications are due Monday, December 11th, by 3:00 pm PST. For additional information, refer to NCBI Insights.
In the next NCBI Minute session on Wednesday, December 6th, 9:00-9:30 PST, NCBI staff will show you the most important ways to get notified of updates and changes at NCBI and the most efficient ways to find help with using NCBI resources effectively. After registering, you will receive a confirmation email with information about attending the webinar. After the live presentation, the webinar will be uploaded to the NCBI YouTube channel. You can learn about future webinars on the Webinars and Courses page.
As part of an effort to develop the NIH-wide Strategic Plan for Women’s Health Research, the NIH Office of Research on Women’s Health (ORWH) has announced a new Women’s Health Seminar Series, debuting December 7. This program will feature speakers presenting the latest information on scientific topics important to the health of women across the life span. The inaugural seminar will highlight the timely issue of pain and the opioid epidemic:
- Sex and Pain: What’s the Story?
- Date/Time: Thursday, December 7, 2017, 10am-1pm PST
- Location: Building 10, Masur Auditorium, Clinical Center, NIH Main Campus
- Keynote Speaker: Dr. Jeff Mogil, McGill University
MeSH is the National Library of Medicine (NLM) controlled vocabulary thesaurus that is updated annually. NLM uses the MeSH thesaurus to index articles from thousands of biomedical journals for the MEDLINE/PubMed database and for the cataloging of books, documents, and audiovisuals acquired by the library.
Overview of Vocabulary Development and Changes for 2018 MeSH:
- 474 Descriptors added
- 106 Descriptor terms replaced with more up-to-date terminology
- 7 Descriptors deleted
- 1 Qualifier (Subheading) deleted
Totals by Type of Terminology:
- 28,939 MeSH Descriptors
- 79 Qualifiers
- 116,909 Total Descriptor Terms
- 244,154 Supplementary Concept Records
Changes of Note for 2018:
The following changes are detailed in MEDLINE Data Changes—2018.
- The MeSH qualifier (subheading) /contraindications was deleted.
- Three new Publication Types are available for 2018; Adaptive Clinical Trial, Equivalence Trial, and Expression of Concern. Three new related MeSH headings were added; Adaptive Clinical Trials as Topic, Equivalence Trial as Topic, and Proof of Concept.
- Expanded and updated terminology areas include Isotopes and Radioisotopes, Smoking, Sugars, Viruses and new Supplementary Concept Record (SCR) class for Organisms.
On August 3, 2017, the NNLM New England Region (NER) sponsored the one-hour session Misperceptions and the Misused Language of Addiction: Words Matter, the first of four webinars in the Substance Use Disorders webinar series. In the webinar, Dr. Richard Saitz, Professor and Chair of Community Health Sciences, School of Public Health and Professor of Medicine, School of Medicine at Boston University, discussed how terminology used in both layperson and scientific publications is often inaccurate and stigmatizing. Efforts are underway to encourage the use of terminology that can improve accuracy, reduce stigma, and even improve patient care. You can view the webinar by visiting the NNLM NER Repository page or by clicking on the YouTube video player below.
The 30-minute online course, HIV/AIDS Information Resources from the National Library of Medicine, is designed to provide valuable health information resources from NLM and other reliable sources to increase awareness of the abundance of treatment information and educational materials that are available online. Resources covered inclue AIDSource, AIDSinfo®, ClinicalTrials.gov, MedlinePlus®, PubMed®/MEDLINE®, and Public Health Partners.
To receive a course certificate of completion, register for a free account and enroll using the following steps:
- Click Register Now
- Complete all information, using National Library of Medicine as the partition
- Click Register Account at the bottom right of the page
- Re-sign in to the system and select Enroll Now
- The HIV/AIDS Information Resources course will be highlighted, with a Launch button to the left
After finishing the course, complete the post-course survey.
NIH’s All of Us Research Program Partners with NNLM to Reach Target Communities Through Local Public Libraries
The NIH All of Us Research Program and the National Library of Medicine (NLM) have teamed up to raise awareness about the program, a landmark effort to advance precision medicine. Through this collaboration, the National Network of Libraries of Medicine (NNLM) has received a $4.5 million award to support community engagement efforts by public libraries across the United States and to improve participant access. According to Eric Dishman, director of the All of Us Research Program: “We want to reach participants where they are. For many people in the country, including those with limited internet access, one of those places is the local library. We’re excited to work with the National Library of Medicine to make more people aware of All of Us and the opportunity to take part.”
The partnership is a three-year pilot program, running through April, 2020. Program objectives include:
- To increase the capacity of public library staff to improve health literacy.
- To equip public libraries with information about the All of Us Research Program to share with their local communities.
- To assess the potential impact of libraries on participant enrollment and retention.
- To highlight public libraries as a technology resource that participants can use to engage with the program, particularly those in underserved communities affected by the digital divide.
- To establish an online platform for education and training about All of Us and precision medicine, with resources for members of the public, health professionals, librarians and researchers.
- To help identify best practices in messaging and outreach that lead to increased public interest and engagement in the program.
The All of Us Research Program aims to build one of the largest, most diverse datasets of its kind for health research, with one million or more volunteers nationwide who will sign up to share their information over time. Researchers will be able to access participants’ de-identified information for a variety of studies to learn more about the biological, behavioral and environmental factors that influence health and disease. Their findings may lead to more individualized health care approaches in the future.
Amanda J. Wilson, head of NLM’s National Network Coordinating Office (NNCO), and Dara Richardson-Heron, M.D., chief engagement officer of the All of Us Research Program, will lead the new partnership. Each NNLM region’s funding includes one FTE for an All of Us Point of Contact. Kelli Ham, formerly NNLM PSR Consumer Health Librarian, will fill the role in the Pacific Southwest Region. Her new title will be Community Engagement Librarian. Over the course of the pilot program, Kelli will focus her outreach efforts on various designated target geographic areas in the region, beginning with Sacramento, CA.
The All of Us Research Program is currently in beta testing. To learn more, sign up to receive updates. Precision Medicine Initiative, All of Us, the All of Us logo, and “The Future of Health Begins with You” are service marks of the U.S. Department of Health and Human Services.
NLM’s end-of-year activities are now complete, and daily MEDLINE updates to PubMed have resumed. MEDLINE/PubMed may be searched using 2018 MeSH vocabulary. For details on data changes, visit MEDLINE Data Changes — 2018. PubMed/MEDLINE citations and the MeSH translation tables have been updated to reflect 2018 MeSH with full searching functionality for Supplementary Concept Record (SCR) data and mapping in place. Citations newly indexed with 2018 MeSH since November 13 are now available for searching in PubMed.
Other pertinent articles: