viernes, 23 de junio de 2017

Preventing Hospital-Associated Venous Thromboembolism | Agency for Healthcare Research & Quality

Preventing Hospital-Associated Venous Thromboembolism | Agency for Healthcare Research & Quality

AHRQ--Agency for Healthcare Research and Quality: Advancing Excellence in Health Care





Cover of Preventing Hospital-Associated Venous Thromboembolism



Preventing Hospital-Associated Venous Thromboembolism

A Guide for Effective Quality Improvement

Pulmonary embolism resulting from deep vein thrombosis—collectively referred to as venous thromboembolism—is the most common preventable cause of hospital death. Pharmacologic methods to prevent venous thromboembolism are safe, effective, cost-effective, and advocated by authoritative guidelines, yet large prospective studies continue to demonstrate that these preventive methods are significantly underused. Based on quality improvement initiatives undertaken at the University of California, San Diego Medical Center and Emory University Hospitals, this guide assists quality improvement practitioners in leading an effort to improve prevention of one of the most important problems facing hospitalized patients, hospital-acquired venous thromboembolism.

Acknowledgments

The author would like to acknowledge those who contributed to the first version of the guide, most notably Dr. Jason Stein of Emory University. Dr. Maynard has also been inspired by all those who have engaged in collaborative improvement efforts using the previous version of this guide; these have greatly informed this updated and revised version.
In addition, many individuals contributed a great deal of their time and expertise to the development of the revised guide. For their expert input, the author gratefully acknowledges the following individuals from the Centers for Disease Control and Prevention (CDC):
  • Michele G. Beckman, M.P.H., Epidemiologist, National Center on Birth Defects and Developmental Disabilities;
  • Scott Grosse, Ph.D., Research Economist, National Center on Birth Defects and Developmental Disabilities; and
  • Lisa C. Richardson, M.D., M.P.H., Director of Division of Cancer Prevention and Control
From the Center for Quality Improvement and Patient Safety at AHRQ:
  • Barbara Bartman, M.D., M.P.H., Medical Officer and AHRQ VTE clinical expert advisor;
  • Jeff Brady, M.D., M.P.H., Rear Admiral, U.S. Public Health Service and Director, CQuIPS;
  • Eileen M. Hogan, M.P.A., Public Health Analyst.
Finally, AHRQ and the author acknowledge the patients and families who have shared their personal stories about the impact VTE had on their lives and their insights into the importance of prevention efforts.

Peer Reviewers

Before publication of the revised guide, AHRQ sought input from independent peer reviewers without financial conflicts of interest. Please note that the conclusions and information presented in this guide do not necessarily represent the views of individual reviewers. The list of peer reviewers follows:
Alpesh N. Amin, M.D.
Chair, Department of Medicine; School of Medicine, University of California, Irvine
Irvine, CA
David Garcia, M.D.
Professor, University of Washington School of Medicine, University of Washington
Seattle, WA
William Geerts, M.D.
Affiliate Scientist, Sunnybrook Health Sciences Centre
Toronto, ON
Elliott Richard Haut, M.D., Ph.D.
Fellowship Director, Trauma/Acute Care Surgery Fellowship and Associate Professor of Surgery, The Johns Hopkins Hospital
Baltimore, MD
Michael Gould, M.D., M.S.
Director for Health Services Research and Implementation Science, Kaiser Permanente Southern California
Pasadena, CA
Gary E. Raskob, Ph.D.
Dean and Regents Professor, College of Public Health, The University of Oklahoma Health Sciences Center
Oklahoma City, OK
Michael Streiff, M.D.
Medical Director, Anticoagulation Management Service and Outpatient Clinics and Associate Professor of Medicine, The Johns Hopkins Hospital
Baltimore, MD
Richard H. White, M.D.
Chief of General Medicine and Professor of Medicine, University of California, Davis
Center for Healthcare Policy and Research, Lawrence J. Ellison Ambulatory Care Center, General Medicine
Sacramento, CA
Neil A. Zakai, M.D., M.Sc.
Associate Professor of Medicine, Hematology/Oncology Division, Department of Medicine and Associate Professor of Pathology and Laboratory Medicine
University of Vermont College of Medicine, Colchester Research Facility
Colchester, VT  

Disclaimer and Copyright Information

The author discloses that he has acted as an expert in cases involving venous thromboembolism (VTE). Dr. Maynard also sits on an expert review panel for a phase 3 study on rivaroxaban for VTE prophylaxis in medical patients (Mariner study, Janssen Pharmaceuticals). He has no other affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock options, grants, patents received or pending, or royalties) that conflict with material presented in this guide.
This document is in the public domain and may be used and reprinted without special permission. Citation of the source is appreciated.
Suggested Citation: Maynard G. Preventing hospital-associated venous thromboembolism: a guide for effective quality improvement, 2nd ed. Rockville, MD: Agency for Healthcare Research and Quality; October 2015. AHRQ Publication No. 16-0001-EF.

Page last reviewed August 2016
Page originally created August 2008


Internet Citation: Preventing Hospital-Associated Venous Thromboembolism. Content last reviewed August 2016. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/professionals/quality-patient-safety/patient-safety-resources/resources/vtguide/index.html

Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update - Research Review - Final | AHRQ Effective Health Care Program

Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update - Research Review - Final | AHRQ Effective Health Care Program



AHRQ--Agency for Healthcare Research and Quality: Advancing Excellence in Health Care



Research Review - Final – Jun. 22, 2017

Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update

Formats

These reports are available in PDF only (final report [7.4 MB]; executive summary [279 kB]). People using assistive technology may not be able to fully access information in these files. For additional assistance, please contact us.

Purpose of Review

Assess venous thromboembolism (VTE) prevention interventions with total hip replacement (THR), total knee replacement (TKR), and hip fracture (HFx) surgeries. 

Key Messages

  • Few head-to-head treatment comparisons have sufficient evidence. Most studies evaluated low molecular weight heparin (LMWH), not low-risk interventions (such as aspirin and mechanical devices); most reported on total deep vein thrombosis (DVT), an outcome that includes asymptomatic DVT and is thus of unclear clinical value. 
  • In THR, LMWH has lower VTE and adverse event risks than unfractionated heparin; LMWH and aspirin have similar risks of VTE and major bleeding; direct thrombin inhibitors (DTI) have lower DVT risk than LMWH but higher major bleeding risk; and higher dose LMWH has lower DVT risk but higher major bleeding risk than lower dose. 
  • In TKR, vitamin K antagonists have higher DVT risk than LMWH but lower major bleeding risk; and higher dose DTI has lower DVT risk but higher major bleeding risk than lower dose.

Structured Abstract

Background

Major orthopedic surgeries, such as total knee replacement (TKR), total hip replacement (THR), and hip fracture (HFx) surgery, carry a high risk for venous thromboembolism (VTE)—deep vein thrombosis (DVT) and pulmonary embolism (PE). 

Methods

Updating a 2012 review, we compare interventions to prevent VTE after TKR, THR, and HFx surgery. We searched four databases and other sources through June 3, 2016, for randomized controlled trials (RCTs) and large nonrandomized comparative studies (NRCSs) reporting postoperative VTE, major bleeding, and other adverse events. We conducted pairwise meta-analyses, Bayesian network meta-analyses, and strength of evidence (SoE) synthesis. 

Results

Overall, 127 RCTs and 15 NRCSs met criteria. For THR: low molecular weight heparin (LMWH) has lower risk than unfractionated heparin (UFH) of various VTE outcomes (moderate to high SoE) and major bleeding (moderate SoE). LMWH and aspirin have similar risks of total PE, symptomatic DVT, and major bleeding (low SoE). LMWH has less major bleeding (low SoE) than direct thrombin inhibitors (DTI), but DTI has lower DVT risks (moderate SoE). LMWH has less major bleeding than vitamin K antagonists (VKA) (high SoE). LMWH and factor Xa inhibitor (FXaI) comparisons are inconsistent across VTE outcomes, but LMWH has less major bleeding (high SoE). VKA has lower proximal DVT risk than mechanical devices (high SoE). Longer duration LMWH has lower risk of various VTE outcome risks (low to high SoE). Higher dose LMWH has lower total DVT risk (low SoE) but more major bleeding (moderate SoE). Higher dose FXaI has lower total VTE risk (low SoE). For TKR: LMWH has lower DVT risks than VKA (low to high SoE), but VKA has less major bleeding (low SoE). FXaI has lower risk than LMWH of various VTE outcomes (low to moderate SoE), but LMWH has less major bleeding (low SoE) and more study-defined serious adverse events (low SoE). Higher dose DTI has lower DVT risk (moderate to high SoE) but more major bleeding (low SoE). Higher dose FXaI has lower risk of various VTE outcomes (low to moderate SoE). For HFx surgery: LMWH has lower total DVT risk than FXaI (moderate SoE). 

Conclusions

VTE prophylaxis after major orthopedic surgery trades off lowered VTE risk with possible adverse events—in particular, for most interventions, major bleeding. In THR, LMWH has lower VTE and adverse event risks than UFH, LMWH and aspirin have similar risks of VTE and major bleeding, DTI has lower DVT risk than LMWH but higher major bleeding risk, and higher dose LMWH has lower DVT risk but higher major bleeding risk than lower dose. In TKR, VKA has higher DVT risk than LMWH but lower major bleeding risk, and higher dose DTI has lower DVT risk but higher major bleeding risk than lower dose. In HFx surgery and for other intervention comparisons, there is insufficient evidence to assess both benefits and harms, or findings are inconsistent. Importantly, though, most studies evaluate “total DVT” (an outcome of unclear clinical significance since it includes asymptomatic and other low-risk DVTs), but relatively few studies evaluate PE and other clinically important outcomes. This limitation yields a high likelihood of selective outcome reporting bias. There is also relatively sparse evidence on interventions other than LMWH.

Citation

Balk EM, Ellis AG, Di M, Adam GP, Trikalinos TA. Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update. Comparative Effectiveness Review No. 191. (Prepared by the Brown Evidence-based Practice Center under Contract No. 290-2015-00002-I.) AHRQ Publication No. 17-EHC021-EF. Rockville, MD: Agency for Healthcare Research and Quality; June 2017. www.effectivehealthcare.ahrq.gov/reports/final.cfm. DOI: https://doi.org/10.23970/AHRQEPCCER191.

New AHRQ Evidence Report Compares Risks and Benefits of Blood Clot Prevention Approaches

New AHRQ Evidence Report Compares Risks and Benefits of Blood Clot Prevention Approaches



AHRQ--Agency for Healthcare Research and Quality: Advancing Excellence in Health Care



New AHRQ Evidence Report Compares Risks and Benefits of Blood Clot Prevention Approaches
Male Clinician with patient



A new report  from the Agency for Healthcare Research and Quality compares the effectiveness of venous thromboembolism (VTE) prevention among people getting hip or knee replacements, and among people being treated for hip fractures. Few studies provided direct comparisons between different types of blood thinners and mechanical interventions such as compression stockings or compression pumps. The authors noted the need for additional research to determine the most effective strategy for preventing harmful blood clots after hip or knee replacement and hip fracture surgeries.  AHRQ has previously done other work in this area, including development of a guide to assist health care organizations in reducing preventable blood clots.

New AHRQ Evidence Report Compares Risks and Benefits of Blood Clot Prevention Approaches

NIOSH Research Rounds - June 2017

NIOSH Research Rounds - June 2017

CDC



In This Issue



Volume 2, Number 12 (June 2017)

Inside NIOSH:
Preventing Heat Stress While Wearing Personal Protective Equipment

During severe disease outbreaks such as the 2014 Ebola virus epidemic in West Africa, wearing special gear can protect healthcare workers from exposure. This personal protective equipment covers the face and body to provide a physical barrier against germs. In addition, a respirator prevents the inhalation of airborne germs. Since many types of personal protective equipment worn during the Ebola response are made of heavy, fluid-resistant material, which can prevent sweat from evaporating and cooling the body, heat stress is a concern in hot weather.

Personal Protective Equipment Does Not Take the Heat Equally

After comparing three commonly used ensembles, NIOSH investigators found that different types of personal protective equipment were linked to increases in heart rate and body temperature during exertion.

Cooling Vests Linked to Fewer Signs of  Heat Stress

Study participants wearing special vests fitted with ice packs, phase-change materials, or water hoses under personal protective equipment had fewer signs of heat stress than participants who did not wear the cooling devices, according to a related study. These results highlight the importance of cooling vests for healthcare workers wearing personal protective equipment in hot, humid environments.

Ambulance Crash Tests Promote Prevention through Design

Quickly maneuvering to the side of the road to allow a lights-flashing, sirens-blaring ambulance to pass, we may wonder about the medical emergency unfolding inside the racing vehicle. “That could be me or one of my family members,” we may think, a bit nervously, glad that the patient in the ambulance is receiving medical attention. What we may not consider as we sit safely in our cars is that medical care occurring while the ambulance is moving could place both the patient and the emergency medical services (EMS) workers at additional risk in the event of a crash.

Respiratory Symptoms and Abnormal Lung Function High Among Latino Horse Farmworkers

Dust in and around horse and other livestock barns often contains substances such as animal dander, bacteria, sawdust,  and particles of metal and sand that can harm the lungs if accidentally inhaled. Dust masks such as the NIOSH-approved N95 can help reduce the risk, but workers do not always use them. To understand and prevent the risk among Latino horse farm-workers, the study recruited 80 (mostly male), Mexican, adult horse farm-workers. Between July and September 2014, participants completed 40-item questionnaires, in either English or Spanish, and underwent lung-function testing (spirometry). As part of the study, investigators also distributed educational health and safety materials to horse farm-workers, owners, and managers.

Fentanyl Exposure Risks for Law Enforcement and Emergency Response Workers | | Blogs | CDC

Fentanyl Exposure Risks for Law Enforcement and Emergency Response Workers | | Blogs | CDC

Centers for Disease Control and Prevention. CDC twenty four seven. Saving Lives, Protecting People



Fentanyl Exposure Risks for Law Enforcement and Emergency Response Workers

Posted on  by Jennifer Hornsby-Myers, MS, CIH; G. Scott Dotson, PhD, CIH; and Deborah Hornback, MS



Fentanyl is a powerful synthetic drug that is similar to morphine and heroin, but is 50 to 100 times more potent. Fentanyl and its analogs, such as carfentanil, can pose a potential hazard to law enforcement, emergency medical personnel, and firefighters who could come into contact with these drugs through the course of their work day. While there are important questions about the risks of different types of exposures (and resultant health effects) that might occur during law enforcement and emergency response activities, workers involved in these types of activities leading to potential exposures should take prudent precautions. NIOSH provides interim recommendations for routine law enforcement activities following an arrest or execution of a search warrant—such as evidence collection—that may lead to potential exposures to fentanyl or related compounds.
Exposure routes are likely to vary based on the form of fentanyl and the circumstances of the event. Exposure through the skin, inhalation, and ingestion are all possible routes of exposure. Inhalation exposures can quickly result in respiratory depression. Recent news reports point to law enforcement officers being exposed to fentanyl through skin absorption while on the job. Additional research is needed to better understand the possible routes of exposure and means to prevent those exposures. Fentanyl and its analogs do not have established occupational exposure limits (OELs).
Standard safe work practices must be applied to all operations where fentanyl or its analogs are known or suspected to be present, just as they are applied to any law enforcement operation involving potential narcotics, such as a methamphetamine lab or heroin. Law enforcement officers should not eat, drink, or smoke in the area of the suspected fentanyl and should wash their hands and inspect clothing for contamination after performing any activity potentially involving fentanyl. It is important that a job hazard analysis be performed to determine the most appropriate level and type of personal protective equipment (PPE) to protect against respiratory and dermal hazards for specific tasks. At a minimum, NIOSH recommends the use of a P-100 half-mask filtering facepiece respirator (or higher), gloves, eye protection, and protective clothing to protect against possible fentanyl exposure. In the event of a large spill or release of fentanyl, NIOSH recommends that law enforcement vacate the area and call a hazardous materials incident response team for support.
The U.S. Drug Enforcement Administration (DEA) recommends that law enforcement do not field test drugs if fentanyl is suspected (https://www.dea.gov/divisions/hq/2016/hq061016.shtml). Wearing the appropriate PPE, the suspected substance should be collected and sent to a laboratory for analysis.
Questions remain about the risks of exposures to fentanyl and its analogs. For example do dermal exposures represent a significant health risk for first responders, should an OEL be established for fentanyl, and are there other activities that would benefit from NIOSH providing best work practices?
Would your workplace benefit from a Health Hazard Evaluation specific to the issues surrounding fentanyl? The NIOSH Health Hazard Evaluation Program has previously conducted research on possible workplace hazards and provided recommendations to law enforcement and emergency responders to protect against possible drug-related exposures other than fentanyl. Below are a few examples of evaluations conducted with law enforcement. For more information on the Health Hazard Evaluation program including how to request an evaluation visit the website.
We would like to hear from law enforcement and emergency services personnel about the safety procedures and practices that you use when you suspect the presence of fentanyl or carfentanil. Do you have information on the effectiveness of your safety procedures and practices or other issues related to fentanyl that you’d like to share with the broader law enforcement community? Please provide your input in the comment section below and let us know if you’re interested in hearing more about the NIOSH Health Hazard Evaluation Program.

Jennifer Hornsby-Myers, MS, CIH, is a Senior Certified Industrial Hygienist in the NIOSH Emergency Preparedness and Response Office.
Scott Dotson, PhD, CIH is a Lead Health Scientist in the NIOSH Education and Information Division.
Deborah Hornback, MS, is a Health Communication Specialist in the NIOSH Education and Information Division.
Posted on  by Jennifer Hornsby-Myers, MS, CIH; G. Scott Dotson, PhD, CIH; and Deborah Hornback, MS

Vaccine Courses, Broadcasts, Webcasts and Self Study Training | CDC

Vaccine Courses, Broadcasts, Webcasts and Self Study Training | CDC



Centers for Disease Control and Prevention. CDC twenty four seven. Saving Lives, Protecting People



CDC has released a new Vaccine Administration e-Learn.
The e-Learn is a free, interactive, online educational program that serves as a useful introductory course or a great refresher on vaccine administration. The self-paced e-Learn provides comprehensive training, using videos, job aids, and other resources to accommodate a variety of learning styles, and offers a certificate of completion and/or Continuing Education (CE) for those that complete the training.
We encourage you to share information on the Vaccine Administration e-Learn with your members and health care professional community.
For more information, please contact nipinfo@cdc.gov.


logo for CDC Learning Connection

e-Learn: Vaccine Administration

Target Audience: Administrators, CHES Certified Health Educators, Physicians, Epidemiologists, LPNs, LVNs, Medical Assistants, Medical Students, NPs, Nurse Technicians, Other Health Educators, Pharmacists, PAs, Program Managers, RNs
Description: Appropriate vaccine administration is a critical component of a successful immunization program. Vaccine administration errors are potentially dangerous occurrences that many immunization
providers miss. This training addresses knowledge gaps in proper vaccine administration. It highlights common mistakes and is designed to train providers to avoid administration errors by applying the “Rights of Medication Administration” to each encounter when vaccines are administered.
Learning Objectives:
  1. Identify the Rights of Medication Administration for Vaccines.
  2. Define the steps for proper vaccine administration.
  3. Recognize the recommended routes and sites for vaccine administration.
  4. Identify recommended vaccine administration best practices.
  5. Describe best practices to prevent vaccine administration errors.
  6. Locate resources on current immunization administration practice.
  7. Implement disease detection and prevention health care services (e.g., smoking cessation, weight reduction, diabetes screening, blood pressure screening, immunization services) to prevent health problems and maintain health.
CME: Valid through February 22, 2018.
CE Details: e-Learn: Vaccine Administration course #WB2502

Testimony on the Fiscal Year 2018 Budget Request before the Senate Committee | National Institutes of Health (NIH)

Testimony on the Fiscal Year 2018 Budget Request before the Senate Committee | National Institutes of Health (NIH)



National Institutes of Health (NIH) - Turning Discovery into Health

Testimony on the Fiscal Year 2018 Budget Request before the Senate Committee

Witness appearing before the Senate Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies
Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health
Accompanied by:
Anthony S. Fauci, M.D.
Director, National Institute of Allergy and Infectious Diseases
Gary H. Gibbons, M.D.
Director, National Heart, Lung, and Blood Institute
Joshua A. Gordon, M.D., Ph.D.
Director, National Institute of Mental Health
Richard J. Hodes, M.D.
Director, National Institute on Aging
Douglas R. Lowy, M.D.
Acting Director, National Cancer Institute
Nora Volkow, M.D.
Director, National Institute on Drug Abuse
Good morning, Chairman Blunt, Ranking Member Murray, and distinguished Members of the Subcommittee.  I am Francis S. Collins, M.D., Ph.D., and I have served as the Director of the National Institutes of Health (NIH) since 2009.  It is an honor to appear before you today, and it was a pleasure to host many of you at NIH earlier this month.
Before I discuss NIH’s diverse investments in biomedical research and some of the exciting scientific opportunities on the horizon, I want to thank this Subcommittee for your Fiscal Year (FY) 2017 commitment to NIH.
As the nation’s premier biomedical research agency, NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems, and to apply that knowledge to enhance human health, lengthen life, and reduce illness and disability.  As some of you have witnessed first-hand on your visits to NIH, our leadership and employees believe passionately in our mission.  This extends equally to the tens of thousands of individuals whose research and training we support, located in every state of this great country, and where 81 percent of our budget is distributed.
I would like to provide just a few examples of the depth and breadth of the amazing research being supported across the Institutes and Centers of NIH.
The core of our mission remains basic biomedical science. Given the exploratory and, hence, unpredictable nature of fundamental discovery, basic science is generally not supported in the private sector – but it provides the critical foundation for advances in disease diagnosis, treatment, and prevention through future clinical applications. Virtually none of the substantial gains in reducing human suffering and extending longevity over the last century would have happened without basic science.  NIH’s emphasis on fostering innovation to understand fundamental biological processes has led to no fewer than 149 Nobel Prizes to our grantees, and is leading year by year to new and more effective ways to treat complex medical conditions.
As a current example, the emergence of “cryo-EM,” a new form of electron microscopy, has dramatically sped up the time needed to visualize the exquisite details of biological structures including protein-protein and protein-drug complexes. This is a major revolution in structural biology that already is transforming drug design.
Basic research is also fueling new advances in our understanding of the brain, which will be critically important for treating diseases such as Alzheimer’s disease, Parkinson’s disease, autism, epilepsy, traumatic brain injury, and others. Through the Accelerating Medicines Partnership (AMP), a public-private partnership between NIH, the Food and Drug Administration (FDA), 10 biotechnology companies, and nonprofit organizations, we have joined ranks across sectors to expand our understanding of Alzheimer’s disease.  In one component of AMP, researchers are analyzing large-scale molecular data from thousands of affected and unaffected human brain samples, including genomic, gene expression, and protein measures.  With this information, NIH and our partners are building new molecular pathways to understand the cause of Alzheimer’s, and charting a course for entirely new ways to detect and treat this devastating disease that go beyond the previous understanding of the amyloid and tau proteins.  By working with industry and sharing data widely in the scientific community, NIH aims to shorten the time between these discoveries and the development of new strategies for Alzheimer’s disease treatment and prevention.
Rare diseases also represent an area of great need and great opportunity, one which NIH continues to be uniquely positioned to address.  Though such diseases are individually rare, collectively an estimated 25 to 30 million Americans are affected. Great advances have been made through genomic science in uncovering the cause of rare diseases, and that has led to dramatic improvements in diagnosis.  But of the 6,500 identified rare and neglected diseases for which the molecular cause is now known, only about 500 have approved treatments.  The private sector generally finds it difficult to mount expensive initiatives for such small markets – the risks are too high.  Finding new treatments thus requires NIH to play a lead role – by investing in the early stage of therapeutic development to “de-risk” such projects.  While almost all Institutes and Centers at NIH work on rare diseases, the National Center for Advancing Translational Sciences (NCATS) has a particular focus on this area of opportunity.
As an example, autoimmune pulmonary alveolar proteinosis (aPAP) is a rare, potentially fatal disease marked by a build-up of lipids and proteins in the lungs, and leads to respiratory failure.  The current treatment for severe aPAP is whole-lung lavage, whereby both lungs are repeatedly filled and washed with a salt solution.  This procedure is complicated, dangerous, and must be repeated throughout a patient’s entire life.  NCATS has supported efforts to develop an inhaled treatment for aPAP, providing support and expertise to the basic research, pre-clinical research and testing, and early-phase clinical trials.
Other transformative technologies are offering dramatic new approaches to achieving a truly molecular cure of rare diseases.  For example, experts are now testing genetic therapy in bone marrow stem cells as a curative treatment for sickle cell disease, the first human disease understood at the molecular level and the most common inherited blood disorder in the United States, affecting over one hundred thousand Americans at a yearly cost of hundreds of millions of dollars.
As a final example, consider how fundamental research over many years now promises to transform medicine for patients with advanced cancer: immunotherapy.  For decades, basic scientists have worked to understand how the immune system functions at the molecular level. Now, thanks to a series of dramatic advances, we can not only watch the immune system at work, we can instruct it – “send it to school.”  In a recent breathtaking example, a young woman with widely metastatic breast cancer, whose cancer had failed to respond to several rounds of chemotherapy, enrolled in an experimental protocol at the NIH Clinical Center as a last hope.
Her tumor genome was sequenced, and rare immune cells in her body with the potential to seek and destroy those cancer cells were identified. After those immune cells were massively expanded in the laboratory, and then unleashed to go after the cancer, her tumors started to recede within days.  Now more than a year later, there is no evidence of any remaining cancer in her body.  She is part of a revolution in cancer treatment, all made possible by years of dedicated basic research in fields like immunology and genomics.
So the future has never been brighter for advances in biomedical research than right now.
Imagine what this feels like for a talented and curious new investigator. Early-stage investigators are responsible for many of the advances I’ve told you about today, and our future depends on them and their bright ideas.  Those young men and women are thrilled by the prospect of exploration, and driven to help people.  NIH is responsible for training these scientists, and for making sure that our investment in their careers, and the potential advances they will bring to patients, are sustained into the next stage.  They are our most important resource.  If advances in medical research are to continue, if research is to lead to breakthroughs that can reduce health care costs, if the considerable economic return on research is to continue, and if America is to continue its global leadership in biomedicine, we need to be sure this next generation has the confidence that there will be support for them. This is a priority for me.
Two weeks ago, NIH announced the Next Generation Researchers Initiative, a focused approach to bolster support to early- and mid-career investigators comprised of four components. First, we are repurposing funds from NIH's base budget, beginning this fiscal year with about $210 million, and ramping to approximately $1.1 billion per year after five years to support additional meritorious early-stage investigators, as well as mid-career investigators (those with less than or equal to 10 years as a principal investigator who are about to lose all NIH funding or are seeking a second award for highly meritorious research). Second, we will track the impact of NIH Institute and Center funding decisions for early- and mid-career investigators with fundable scores to ensure this new strategy is effectively implemented in all areas of research.  Third, we will place greater emphasis on current NIH funding mechanisms aimed at early- and mid-career investigators, such as the NIH Common Fund New Innovator Awards the National Institute of General Medicine Sciences Maximizing Investigators’ Research Award (MIRA), the National Institute of Dental and Craniofacial Research Sustaining Outstanding Achievement in Research (SOAR) Award, and other special awards from specific institutes, with an aim of funding most early-career investigators with applications that score in the top 25th   percentile. Fourth, we will encourage multiple approaches to develop and test metrics that can be used to assess the impact of NIH grant support on scientific progress.
I have provided you with examples of how investments in bright new ideas in biomedical research are advancing human health, spurring innovations in science and technology, stimulating economic growth, and laying the groundwork for the future of the United States biomedical research enterprise.  We have never witnessed a time of greater promise for advances in medicine than right now.  Your support has been critical, and will continue to be.
The FY 2018 Budget provides $26.9 billion for NIH, which is $7.4 billion below the FY 2017 enacted level.  The FY 2018 Budget eliminates the Fogarty International Center while retaining a total of $25 million in mission-critical international research and research related activities within the Office of Director.  It includes $272 million in discretionary budget authority within NIH to preserve key research activities previously carried out by the Agency for Healthcare Research and Quality (AHRQ), including critical survey activities, support for the U.S. Preventive Services Task Force, evidence-based practice centers, patient safety, investigator-initiated grants, and researcher training grants.  NIH is engaged in many efforts to encourage good stewardship practices across all levels of the biomedical research enterprise. These include ways to streamline administrative processes for investigators, efforts to support new and early stage investigators, and a focus on cultivating a world-class biomedical research
workforce.  The FY 2018 Budget includes an indirect cost rate for NIH grants that will be capped at 10 percent of total cost (currently NIH expends approximately 28 percent of its extramural budget on indirect costs).  This approach would be applied to all types of grants with a rate higher than 10 percent.  In addition, Federal research requirements for grantees will be streamlined to reduce grantee burden through targeted approaches as proposed by NIH.
This concludes my testimony, and I look forward to answering your questions.