Archive for the ‘Public Health’ Category
In November, the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) released for public comment two proposals to increase the transparency of clinical trials via information submitted to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine. One is a Notice of Proposed Rulemaking (NPRM) that describes proposed regulations for registering and submitting summary results of certain clinical trials to ClinicalTrials.gov in compliance with Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). A major proposed change from current requirements is the expansion of the scope of clinical trials required to submit summary results to include trials of unapproved, unlicensed, and uncleared products. The second proposal is a draft NIH policy that would extend the similar registration and reporting requirements to all clinical trials funded by NIH, regardless of whether they are subject to FDAAA. Both proposals aim to improve public access to information about specified clinical trials, information that is not necessarily available from other public sources.
The public may comment on any aspect of the NPRM or proposed NIH Policy. Written comments on the NPRM should be submitted to docket number NIH-2011-0003. Commenters are asked to indicate the specific section of the NPRM to which each comment refers. Written comments on the proposed NIH Policy should be submitted electronically to the Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, via email; mail at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892; or by fax at 301-496-9839, by March 23, 2015.
The HHS Office of Adolescent Health (OAH) has issued a Funding Opportunity Announcement (FOA) with the purpose of funding an organization that will support the maintenance, operation, and re-launch of a national HIV/AIDS resource center. The Resource Center will promote practical strategies to assist in the implementation of evidence-based and evidence-informed interventions and best practices targeted to adolescent youth, in particular adolescents at high risk and African American and Hispanic/Latino adolescents. Funding for this project comes from the HHS Secretary’s Minority AIDS Initiative (MAI). OAH anticipates funding one grantee with an annual budget of up to $350,000 per year for a three-year project period. Applications are due by Friday, April 10, 2015.
The National Library of Medicine (NLM) LiverTox resource is a free website providing up-to-date, comprehensive and unbiased information about drug-induced liver injury caused by prescription and nonprescription drugs, herbals, and dietary supplements. LiverTox represents a collaborative effort by medical and scientific specialists to provide a central repository of clinical information in support of clinical and basic research on the prevention and control of drug-induced liver injury. The site also provides guidance to clinicians and healthcare providers on the diagnosis and management of this important cause of liver disease. LiverTox contains approximately 850 drug and herbal records. It is a joint effort of the Liver Disease Research Branch of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Division of Specialized Information Services (SIS) of NLM.
Look for these LiverTox updates in the coming months:
- Addition of about 100 new records.
- New histopathologic imaging (microscopic structure of diseased tissue) from the National Cancer Institute (NCI) included in drug records.
- Section providing public access to reference cases, initially populated with clinical cases from the Drug-Induced Liver Injury Network, a consortium of eight academic medical centers throughout the United States. This repository will allow for statistical analyses of trends in drug-induced liver disease, as well as better characterization of clinical patterns of injury.
According to recent studies, and despite new private insurance coverage over the past year, many people do not understand the very terms and concepts necessary to make informed choices. A new Alliance for Health Reform Toolkit, Health Literacy and Health Insurance Literacy: Do Consumers Know What they are Buying? addresses the extent and significance of both health literacy and health insurance literacy for Americans buying and using health insurance.
A few highlights from the Toolkit:
- Nearly nine out of ten adults have difficulty using health information to make informed decisions about their health.
- Half of Americans don’t understand such basic health insurance terms as premium, deductible and copay.
- Thirty-seven percent of marketplace enrollees did not know their deductible, and 47% of those receiving subsidies did not know the amount of federal assistance they were getting.
- The cost of low health literacy in the United States currently represents between 7% and 17% of all personal health care expenditures.
Contents of the Toolkit include:
- An overview of problems associated with health literacy as well as studies analyzing their impact.
- Links to reports and news articles explaining and analyzing the issue.
- Contact information for leading experts on the issue.
The National Library of Medicine’s (NLM) Alternatives to Animal Testing (ALTBIB) portal provides access to PubMed/MEDLINE citations relevant to alternatives to the use of live vertebrates in biomedical research and testing. The ALTBIB topics and subtopics are aligned with current U.S. and international approaches. For example, information is provided on in silico, in vitro, and refined or improved animal testing methods. Strategies that incorporate validated methods and other approaches are also covered. In addition to the topic areas for PubMed searches, the ALTBIB portal includes a searchable bibliographic collection of alternatives to animal testing, including citations from published articles, books, book chapters, and technical reports published from 1980 to 2000.
The Hazardous Substances Data Bank (HSDB), part of NLM’s Toxicology Data Network (TOXNET), now includes subheadings (“/alternative/ and /in vitro tests/”) in the Human and Non-Human Toxicity Excerpts fields. These subheadings allow users to locate data from in vitro and other alternative methods. For example, users can search “ALTERNATIVE IN VITRO TESTS” to locate records with this data. Coverage includes results from methods validated by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the European Union Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM).
The National Agricultural Library (NAL) has unveiled PubAg, a user-friendly search engine that provides public enhanced access to research published by the U.S. Department of Agriculture (USDA) scientists. NAL is part of USDA’s Agricultural Research Service (ARS), and has one of the world’s largest and most comprehensive compilations of agricultural information available.
PubAg is a new portal for literature searches and full-text access of more than 40,000 scientific journal articles by USDA researchers, mostly from 1997 to 2014. New articles by USDA researchers will be added almost daily, and older articles may be added if possible. There is no access fee, and no requirement for a username, password or any other form of registration to use PubAg. Phase I of PubAg provides access for searches of 340,000 peer-reviewed agriculturally related scientific literature, mostly from 2002 to 2012, each entry offering a citation, abstract and a link to the article if available from the publisher. This initial group of highly relevant, high-quality literature was taken from the 4 million bibliographic citations in NAL’s database. Phase II of PubAg, planned for later in 2015, will include the remainder of NAL’s significant bibliographic records. PubAg has been specifically designed to be easy to use and to serve a number of diverse users including the public, farmers, scientists, academicians and students.
NLM’s HIV/AIDS Portal now offers the ability to search for multilingual content. The new Multilingual Search interface searches specifically for HIV/AIDS related topics from the multilingual and multicultural content of HealthReach (formerly RHIN). HealthReach offers easy access to quality health information to individuals for whom English is not the primary language. It is also an important resource for health professionals as well as public health administrators. Users can search by subject/topic, language, and format. The default for the search is always HIV/AIDS so there is no need for these terms to be included in the search. There is also an Advanced Search capability to further refine retrieval. The content is available in audio and video formats as well as text. For text documents there is a feature that allows viewing the document in a split screen with one side being English and the other being the language requested in the search.
Want to build your repertoire of evaluation skills? Check out this library of evaluation-related podcasts and webinars from the CDC’s Division of Heart Disease and Stroke Prevention. These are archived documents from 20-minute presentations about evaluation. The usual basic topics are represented, such as Making Logic Models Work for You and How Do I Develop a Survey? But a number of the presentations cover topics that are not standard fare. Here are a few titles that stand out:
Most presentations consist of PDFs of PowerPoint slides and talking points, but there are a few podcasts as well. All presentations seem to be bird’s-eye overviews, but the final slides offer transcripts of Q&A discussion and a list of resources for more in-depth exploration of the topic. It’s a great way to check out a new evaluation interest!
As part of the omnibus budget measure signed by President Obama in December 2014, Congress changed the name of NCCAM to the National Center for Complementary and Integrative Health, or NCCIH. The change was made to more accurately reflect the Center’s research commitment to studying promising health approaches that are already in use by the American public. Since the Center’s inception, complementary approaches have grown in use to the point that Americans no longer consider them an alternative to medical care. The name change is in keeping with the Center’s existing Congressional mandate and is aligned with the strategic plan currently guiding the Center’s research priorities and public education activities. The mission of the organization will remain unchanged.
Large population-based surveys have found that the use of “alternative medicine,” unproven practices used in place of conventional medicine, is actually rare. By contrast, integrative health care, which can be defined as combining complementary approaches into conventional treatment plans, has grown within care settings across the nation, including hospitals, hospices, and military health facilities. The goal of an integrative approach is to enhance overall health, prevent disease, and to alleviate debilitating symptoms such as pain and stress and anxiety management that often affects patients coping with complex and chronic disease.
The Office of Alternative Medicine (OAM) was established in 1992 within the Office of the Director, NIH, to facilitate the study and evaluation of complementary and alternative medical practices and to disseminate the resulting information to the public. In 1998, NCCAM was established by Congress, elevating OAM to the status of an NIH center. In February 2011, NCCAM released Exploring the Science of Complementary and Alternative Medicine: Third Strategic Plan 2011–2015, which continues to guide NCCIH’s work.
The National Library of Medicine (NLM) TOXMAP’s new Flash-based beta now includes 2013 coal emissions data published by the US EPA’s Clean Air Markets program. Data was obtained from the Air Markets Program Data (AMPD) tool, a publicly-available data system for searching and downloading data collected as part of EPA’s emissions trading programs. In 2013, about 2.1 billion metric tons of carbon dioxide emissions were attributable to electricity generated from coal.
TOXMAP is a Geographic Information System (GIS) from the National Library of Medicine (NLM) that uses maps of the United States to help users visually explore data from the EPA’s Toxics Release Inventory (TRI) and Superfund Programs.