IDSA News - March 2016
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Infections Associated with Heater-Cooler Devices

The following information was developed by the Society for Healthcare Epidemiology of America (SHEA) to raise awareness among healthcare providers of the possible association between Mycobacterium chimaera infections and use of heater-cooler devices. 
 
In October 2015, the Centers for Disease Control and Prevention (CDC) released a guidance identifying the need for increased vigilance for Non-tuberculous Mycobacterium (NTM) infections. That same month, the Food and Drug Administration (FDA) released a similar Safety Communication on Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices to address issues regarding the proper use and maintenance of these devices. The FDA communication stated that between January 2010 and August 2015, the FDA received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination. Twenty-five of these MDRs were reported to the FDA in 2015. Additionally, several hospitals within the SHEA membership are starting to report patients with past cardiothoracic surgery developing an infection due to Mycobacterium chimaera, an infection not typically found in humans. 
 
A research study "Prolonged Outbreak of Mycobacterium chimaera Infection After Open-Chest Heart Surgery" published in March 2015 in Clinical Infectious Diseases on an outbreak in Switzerland determined that the water used in the heater-coolers became contaminated by M. chimaera based on how the fan on the heater-cooler unit aerosolized the organism into the air. While the water never came in contact with the patient, the aerosol spread by the fan directly contaminated the surgical wound. The study also found that when the heater-cooler devices were in the operating room but not turned on during the surgery, the organism was not aerosolized. Of the reported cases in this study, most have manifested as prosthetic valve endocarditis or vascular graft infections. Study authors pointed out the possibility that there may be involvement of the bone marrow causing cytopenias as well as splenomegaly. The patients in the study – who were not immunocompromised – presented with nonlocalizing symptoms, such as fever, myalgias, arthralgias, fatigue and weight loss. The mortality rate was approximately 50%.
 
Additionally, SHEA has noted that on Dec. 29, 2015, the Food and Drug Administration (FDA) issued a warning letter to Sorin Group Deutschland GmbH specifically, in which the agency notified the firm of its intent to refuse importation of its Heater Cooler 3T device following inspections of manufacturing facilities. These violations reference undocumented and unapproved design changes made to the Heater Cooler 3T device, and complaints of patient deaths due to infection from non-tuberculosis mycobacteria (NTM), specifically Mycobacteria chimaera, dating back to January 2014. A recently filed lawsuit is tied to this device, but is still waiting arbitration. 
 
Testing for Mycobacterium chimaera is not standard protocol and due to the long incubation period can often present itself a significant time (i.e., years) after the surgery occurs. CDC and FDA alerts both suggest looking back 4 years for infections in patients who underwent open chest heart surgery. SHEA is working with CDC and FDA to see if updated guidance is needed and the role SHEA experts can serve. FDA is evaluating information about documented and potential infections from multiple sources, including published studies, medical device reports submitted to the FDA, and updates from public health agencies in the U.S. and abroad. The FDA encourages health care facilities to submit reports of heater-cooler device contamination or potential infection transmission associated with heater-cooler devices as the FDA continues its investigation. SHEA is in active communication with both organizations. 
 
The recommendation at this time is to ensure all heater-cooler devices are disinfected according to manufacturers' guidelines. SHEA volunteers and staff will continue to examine this issue.
 
If you have any questions or comments, please email info@shea-online.org
 
Sign Up for IDSA’s CDC/FDA Alerts
 
IDSA offers two email services to help members stay informed of updates from FDA and CDC. Content includes a range of topics, including drug warnings, recalls, and outbreak investigations. To subscribe, please click here (member log-in required). Recent alerts included:
 
 
 
 
 
 

HCV Guidance Website Updated to Reflect Latest Drug Developments

HCVguidelines.org, the website developed by IDSA and the American Association for the Study of Liver Diseases (AASLD) to provide up-to-date guidance on the treatment of hepatitis C (HCV), has released updates on several sections of the website based on newly available therapies and data. 
 
The latest release of the guidance reflects several important developments, including the recent approval of the second single-tablet fixed dose combination regimen (elbasvir/grazoprevir) for the treatment of HCV. Based on the approval of this regimen, the website now also includes guidance on the role of testing for resistance to some HCV medications that may exist in patients prior to starting therapy.  
 
While most sections of the guidance have been updated, the most significant changes have been made in the Initial Treatment of HCV Infection and Retreatment of Persons in Whom Prior Treatment Has Failed sections as well as the Unique Populations sections, which include patients living with HIV, kidney disease, and severe liver disease including those with severe liver dysfunction and those who have had a liver transplant. Updated references have been provided throughout the guidance.
 
Visit www.HCVguidelines.org for updates regarding the release of this and other sections of the guidance.
 

HIVMA Joins Leading Health and Healthcare Organizations in Choosing Wisely® Campaign

In early February, the HIV Medicine Association joined more than 70 medical specialty societies in partnering with the ABIM Foundation’s Choosing Wisely® campaign. HIVMA has identified five tests that physicians and patients should question as a basis for conversations between patients and their providers about evidence-based care. Developed through input from specialists in HIV care, and the most recent guidelines for HIV management, HIVMA’s Choosing Wisely List recommends:
 
  • Avoid Unnecessary CD4 Tests.
  • Don’t order complex lymphocyte panels when ordering CD4 counts.
  • Avoid quarterly viral load testing of patients who have durable viral suppression, unless clinically indicated.
  • Don’t routinely test for CMV IgG in HIV-infected patients who have a high likelihood of being infected with CMV.
  • Don’t routinely order testing for glucose-6-phosphate dehydrogenase (G6PD) deficiency for patients who are not predisposed due to race/ethnicity.

What’s Facing ID Specialists in the Health Care Payment Reform Landscape?

Join the IDSA and Hart Health Strategies Informational Webinar

IDSA, in collaboration with Hart Health Strategies will host a webinar on Monday, March 14 at 7 pm EST to discuss the payment reform changes as mandated by the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. 
 
Under MACRA, the Centers for Medicare and Medicaid Services (CMS) are required to develop a Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). The MIPS will combine certain parts of, and essentially replace, the Physician Quality Reporting System (PQRS), the Value-based Payment Modifier, and the Medicare Electronic Health Record (EHR) incentive program. The new quality program will be a single program based on quality, resource use, clinical practice improvement and the meaningful use of EHR. 
 
In addition to MIPS, there will be a discussion on APMs and how they may affect ID physicians. APMs, according to CMS, will provide new ways to pay health care providers for care provided to Medicare beneficiaries. Under APMs, CMS may consider paying providers a lump-sum incentive payment as well as increasing transparency of physician-focused payment models. Finally, starting in 2026, Medicare will provide higher annual payments to some APM participating health care practitioners. Alternative payment models include ACOs and Patient Centered Medical Homes.
 
There will also be a discussion on the use of prolonged services CPT® codes to report ID physician services and “incident to” services.
 
Register Today! Webinar ID: 119-030-779.
 

Deadline Extended to Avoid 2017 Medicare EHR Incentive Program Payment Penalties

The Center for Medicare and Medicaid Services (CMS) has extended the deadline for physicians to apply for hardship exceptions to avoid payment penalties for the 2017 Medicare Electronic Health Records (EHR) Incentive Program. The new deadline for hardship exception applications is now July 1, 2016. 
 
IDSA recommends that members who are eligible to participate in the Medicare Incentive Program apply for hardship exemption under the “EHR Certification/Vendor Issues” (option 2.2.d in the application). Due to the delay in publication of Medicare EHR Incentive Program regulations, this category will broadly apply to all physicians and CMS has stated that they will refrain from auditing physicians who apply under option 2.2d – EHR Certification/Vendor Issues. 
 
Please review the American Medical Association’s (AMA) recommendations and instructions for applying for hardship exception (AMA log-in required) as well as the CMS' Hardship Exception Application Instructions (PDF) for full details on approved circumstances of significant hardship, providers who need not apply, and how to fill out the Hardship Exception Application (PDF).  
 

Changes to CMS Sepsis Quality Measure Based on IDSA Input

In response to a discussion among IDSA members via the Emerging Infections Network (EIN), the following update is provided by Ron Nahass, MD, FIDSA, chair of the IDSA Quality Improvement Committee on the issue of the Sepsis Measure within the Centers for Medicare and Medicaid Service’s (CMS) Inpatient Quality Reporting Program.  
 
In June 2015, IDSA became aware of changes in the measure specification for the Sepsis Bundle Project performance measure (SEP-1) implemented in the National Hospital Inpatient Quality Reporting Program. Specifically, the SEP-1 measure specifications included a recommended list of broad-spectrum antibiotics for monotherapy, (see Appendix C, Table 5.0 of the Specifications Manual for National Hospital Inpatient Quality Measures, Version 5.0b (.zip) (Note: this link opens a zip file containing several reference documents related to the Sepsis Measure). The list included several antibiotics that were deemed by IDSA to be inappropriate and excluded several antibiotics that would be appropriate for many septic cases where a source of infection is suspected or known.  Based upon the specifications provided by CMS, hospitals would be penalized for appropriately treating patients with narrow-spectrum antibiotics.
 
In August 2015, IDSA led advocacy efforts to engage CMS, as documented in a formal joint letter, which recommended changes to CMS on how to best correct the issues with the SEP-1 measure specifications.  As a result of the comments provided by IDSA and other stakeholders, CMS instructed the Joint Commission to revise the specifications. The changes requested by IDSA and others are reflected in Specifications Manual for National Hospital Inpatient Quality Measures v.5.1 (.zip) (Note: several documents are contained within this zip file), released in December 2015, removing Augmentin, which is only available in oral formulation, and Tequin, which was removed from the market due to safety reasons.  
 
IDSA welcomes further member input on the issues with SEP-1 measure. Please feel free to contact Andres Rodriguez, arodriguez@idsociety.org or Thomas Kim, tkim@idsociety.org, for more information regarding IDSA’s work with SEP-1.   
 
Public Comment Period Open for Quality Measure: 72-hour Review of Sepsis Therapy 
 
To encourage the appropriate use of broad-spectrum antibiotics, a joint work group of IDSA and the Society for Healthcare Epidemiology of America (SHEA) developed a corollary quality measure concept to track 72-hour review of all sepsis cases. This measure would require providers to review all sepsis cases at or before 72-hours of administration of broad-spectrum antibiotics for possible de-escalation according to available blood culture, diagnostic, and susceptibility data. 
 
IDSA has opened a public comment period and welcomes public review of the 72-hour Review of Sepsis measure concept. The public comment period closes on March 22, 2016
 
Please visit the following link to submit your comment. https://www.surveymonkey.com/r/XMZWKBD
 

Hepatitis C Treatment Access Resources for Providers

HIVMA and IDSA have created a new online resource, HCVtreatmentaccess.org, to house tools to help providers improve access to hepatitis C treatment.  Available on the website are:  template letters for appealing adverse coverage decisions; clinical resources, including the IDSA and AASLD HCV clinical guidance and the IDSA HCV Maintenance of Certification module; and tools to facilitate engagement with state Medicaid programs and other third-party payers, including a recorded webinar on Improving Access to HCV Treatment in Your State
 

IDSA, HIVMA Join in Development of Core Quality Measures

As health care moves toward a more value-based system, there is increasing need for alignment among public and private payers on quality measures to support new patient-centered payment delivery system reforms. In a collaborative effort, the Centers for Medicare and Medicaid Services (CMS), America’s Health Insurance Plans (AHIP), primary care and physician specialty groups, including IDSA and HIVMA, and consumer and employer groups developed seven core quality measures that will support greater quality improvement and reporting across the health care system. 
 
The goals of the collaborative effort were to establish broadly agreed upon core quality measures that allow for less complexity in reporting for clinicians, decreased overall costburden for consumers and the health care system, and high-quality care for patients.
 
The core measure sets will be reviewed on an ongoing basis by the collaborative group. The seven core quality measures are in the following areas:
 
  • Accountable Care Organizations/Patient Centered Medical Homes/Primary Care
  • Cardiology
  • Gastroenterology
  • HIV/Hepatitis C
  • Medical Oncology
  • Orthopedics
  • Obstetrics and Gynecology
 
More information on the core measures is available from CMS here
 

Take 3 Minutes to Support Legislative Proposal to Appropriately Value ID Services

IDSA President, Johan Bakken, MD, FIDSA with Rep. Erik Paulsen (R-MN)
 
Despite the vital contributions ID physicians make to patient care, research and public health, their work continues to be undervalued. As you're likely aware, over 90% of the care provided by ID physicians is considered evaluation and management (E&M). These face-to-face encounters and post-encounter work are undervalued by current payment systems that much more generously reward procedures. This has created a significant compensation disparity between ID physicians and specialists who provide more procedure-based care, as well as primary care physicians who provide similar or identical E&M services but who have received payment increases simply because of their specialty enrollment designations as "primary care physicians." These salary concerns are contributing to an alarming decline in the number of physicians entering the field of ID. IDSA is urging Congress to instruct the Center for Medicare and Medicaid Services (CMS) to undertake research necessary to develop new E&M codes that more precisely describe the work in physician-patient encounters and allow for a more appropriate valuation of these services.  
 
IDSA President Johan Bakken and other Board members visited Capitol Hill last week to discuss the value of the ID physician and other issues. We need your help to raise this as a priority issue for your representative and senators. In just 3 minutes, you can send a message to your representative and senators using the IDSA Action Center!
 
 

IDSA Supports Senate Committee Effort to Address CRE Outbreaks from Duodenoscopes

Sen. Patty Murray (D-WA), lead Democrat on the Senate’s health committee, has released a report (PDF) on carbapenem-resistant Enterobacteriaceae (CRE) outbreaks associated with contaminated duodenoscopes. The report includes recommendations to provide a clear and timely path for reporting new infections that stem from medical devices. At the request of Sen. Murray’s staff, IDSA’s Public Health Committee provided feedback on the initial recommendations and subsequent bill.   
 
The legislation would require the Food and Drug Administration (FDA) to publish a list of reusable devices that would need to provide proposed cleaning instructions as part of a 510(k) pre-market submission process. Manufacturers of the devices on this list would also need to provide FDA with validation data showing that proposed cleaning instructions are effective. IDSA and several other organizations formally supported the bill, which the Senate health committee is considering as part of its biomedical innovations effort. The legislation was later approved by the committee, and committee leaders anticipate that it will move to the floor of the Senate later this year with other bills approved as a biomedical innovations package.
 

IDSA Comments on NSABB Draft Recommendations on Gain-of-Function Research

IDSA recently submitted comments on draft recommendations from the federal agency that is charged with developing a flexible, transparent regulatory framework to oversee so-called “gain-of-function” (GOF) research of concern on pathogens with pandemic potential. 
 
In late 2014, the White House Office of Science and Technology Policy issued a “pause” for all gain-of-function research, defined as “that which aims to increase the transmissibility, host-range, and/or pathogenicity of a pathogen,” so that the risks and benefits associated with such research can be more effectively assessed. The White House directed the National Science Advisory Board for Biosecurity (NSABB) to establish a framework by which this risk/benefit assessment can be undertaken. The NSABB undertook a risk benefit assessment of the paused research in the summer of 2015 to inform the development of its recommendations.  
 
At the time, IDSA submitted recommendations to the NSABB and followed up with a Journal of Infectious Diseases editorial.  
 
In its new comment letter, IDSA applauded the NSABB’s efforts to address IDSA’s earlier recommendations, including NSABB’s focus back to only the research of highest concern and its exclusion of seasonal influenza vaccine manufacturing and development. On the other hand, IDSA expressed concern that the NSABB’s latest recommendations will not provide the appropriate guidance needed to develop a streamlined mechanism that provides appropriate oversight of the risk and benefits of GOF research of concern.
 
Final recommendations are expected to be released by NSABB in May.
 

Science Speaks

Live from Boston
 
When researchers from around the world gathered in Boston at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) at the end of February, the IDSA Center for Global Health Policy Science Speaks blog joined them, to cover findings and developments in science confronting HIV and related infections globally. CROI 2016 news included:
Find all Science Speaks CROI coverage here.
 

ABIM Updates

The American Board of Internal Medicine (ABIM) recently discontinued offering its Practice Improvement Modules (PIMS), with the exception of the Clinical Supervision PIM. Physicians with active PIMS open on their home page will have until April 22 to complete them for Maintenance of Certification (MOC) points.
 
ABIM’s Approved Quality Improvement (AQI) program allows physicians to earn MOC points for quality improvement activities in which they may already be engaged. ABIM published new AQI Program guidelines in January.
 
ABIM has extended the policy announced on Feb. 3, 2015 and will not require Practice Assessment, Patient Voice and Patient Safety in its MOC program through the end of 2018.
 
Diplomates currently enrolled in the MOC program are required to earn a total of 100 points every five years. IDSA’s modules provide an opportunity to earn a significant number of points. MOC program details can be accessed via the ABIM website. IDSA continues to monitor the MOC program closely and provide input as ABIM considers needed changes. 
 

Free Hepatitis C Module and Other MOC Resources

IDSA’s Hepatitis C 2015 Maintenance of Certification (MOC) module is available – free of charge – to all IDSA members.  
 
The module consists of 45 case-based questions. American Board of Internal Medicine (ABIM) diplomates who successfully complete this activity are eligible to receive 15 points toward the self-evaluation of medical knowledge requirement. Participants may also earn a maximum of 2.0 AMA PRA Category 1 Credit(s)TM
 
This free offering was made possible by grant funding from the Agency for Healthcare Research and Quality. Non-IDSA members pay a reduced fee of $100.
 
IDSA offers six additional modules to help members earn MOC credits, including two new modules on Adult Vaccines 2015 and Travel and Tropical Medicine.
 
Visit http://idsa.knowledgedirectweb.com/ to log in or register to access the modules.

Apply Now for IDSA Fellow Advancement

Applications are now being accepted through April 1 for advancement to IDSA Fellow (FIDSA). IDSA Fellowship honors members who have achieved professional excellence and provided significant service to the profession. IDSA Fellows are recognized by their peers as leaders in the field, either nationally or locally, in their communities and in their hospitals. It is an honored rank that the Society reserves for its highest achievers. 
 
The advancement to Fellow application is available online. Each application must be accompanied by two letters of nomination by current IDSA Fellows. If you have any questions about the Fellows advancement process, please contact Member Services at membership@idsociety.org or (703) 299-0200.
 
IDSA Fellows qualify for special peer review track at Open Forum Infectious Diseases (OFID), IDSA’s online only, fully open-access journal. Although not a guarantee of publication, the FIDSA track results in faster editorial decisions and publication. For more information, see the OFID instructions for authors.
 

Nominate Your Colleague for an IDSA or HIVMA Award

REMINDER! DEADLINE APPROACHING! 
 
IDSA, HIVMA and the IDSA Education and Research Foundation (ERF) are now accepting nominations for the 2016 Society Awards and the HIVMA Awards, which honor outstanding achievement and up-and-coming leaders in the field. Award recipients will be honored at IDWeek in New Orleans, Oct. 26-30.
 
IDSA Awards: Deadline April 1
 
Help IDSA recognize those who make a difference. Nominate a colleague for the:
  • Alexander Fleming Award for Lifetime Achievement
  • Oswald Avery Award for Early Achievement
  • Clinical Teacher Award
  • Walter E. Stamm Mentor Award
  • Society Citation
  • Watanakunakorn Clinician Award 
Complete details about the awards, including how to submit nominations, are available on the IDSA website. For more information, please email awards@idsociety.org or call (703) 299-0200.

HIVMA Awards: Deadline May 1
 
HIVMA recognizes two members each year for outstanding achievements with the Clinical Educator and the HIVMA Research awards. Each awardee receives a $1,500 honorarium in addition to travel support to attend the ceremony. More information on these awards and how to nominate your colleagues is available on the HIVMA website.
 

Member Report

IDSA welcomes the following new members:
 
MEMBERS
 
Alami, Negar Niki, MD
Benson, Peter, MD
Bryant, Matthew, PharmD
Chattu, Vijay Kumar, MBBS, MD, MPH
Galinski, Mary, MSc, PhD
Horton, Ariana, NP
John, Jisha, MBBS, MD
Klein, Robyn, MD, PhD
Leslie, Jill, PharmD
Miller, Darlene, MPH
Osinusi-Adekanmbi, Olukemi, MBBS, MPH
Patel, Karisma, PharmD
Singh, Sarman, MD
Trehan, Indi, MD
Wilson, Eleanor, MD
Wood, Sandra, PhD
 
MEMBERS-IN-TRAINING
 
Ahmad, Riyadh, MBBS, MD
Almangour, Thamer, PharmD
An, Young Min, MD
Anjan, Shweta, MBBS, MD
Barger, Melissa, MD
Belga M. Pereira, Sara Maria, MD
Bertumen, J. Bradford, MD
Chen, Justin, MD
Irani, Faria, MBBS
Kupferman, Tania, MD
Mankame, Siddhi, MD
Murthy, Ruchi, MD
Rodriguez, Anamaria, MD
 
RESIDENTS
 
Ali, Mohamed, MD
Donato, Christian, MD
 
STUDENTS
 
Aguinaldo, Jeremy
Batiste, Rainier
Carneal-Frazer, Nicole 
Cash, Ayla
Lindmark, Augie
Ronit, Andreas
Tweddell, Joshua
Zhang, Tiange 
 
ASSOCIATES
 
Busky, Chris, MBA
Cirilo, Imelda Angelica, MD
Danelo, Jamie, PharmD
Draper, Ken, PhD
Ellenberger, Stephanie, FNP
Faizan, Mohammad, MSc
Hameed, Kamran, MBBS
Kannan, Latha, MD
Muharemovic, Belma, PharmD
Ouellette, Yves, MD
Pickeral, John, MD
 

Zika: Working Together as Specialists and a Society to End an Outbreak

As infectious diseases specialists, we must be prepared to answer questions from our patients and the public about what is known about the Zika virus, but also be aware of what is being done domestically and globally to prevent its spread. ID specialists around the world are working day and night to find answers to many critical questions surrounding this disease while at the same time working on the development of a vaccine. Meanwhile, IDSA is also working to address the necessary public health policy response to the outbreak.

In the last issue of IDSA News, we published a concise summary of current information about the outbreak of Zika virus in South America and the Caribbean, with several links to resources providing up-to-date information available from the Centers for Disease Control and Prevention. Through a feature box on the homepage of IDSA’s website, we continue to provide timely updates and alerts. As infectious diseases specialists, we must be prepared to answer questions from our patients and the public about what is known about the virus, but also be aware of what is being done domestically and globally to prevent its spread.
 
As a clinician I am fascinated, as I’m sure many of you are, to learn about the progression of knowledge about Zika virus as it spreads. There are many issues that have yet to be understood and are being clarified daily: How long does the period of Zika viremia last? In blood? In semen? Is Aedes aegypti (and related Aedes species) the only capable mosquito vector for Zika virus, or can other commonly occurring virus genera (such as Culex, which is a prevalent genus in most of the US) also become carriers? 
 
I am watching closely as more information comes about regarding the correlation between microcephaly and Zika during pregnancy in Brazil, and the total lack of such association in Colombia. The critical question is whether Zika virus disease alone can cause sever neurological disease (microcephaly consequent to in utero infections, Guillain Barre syndrome in infected nonpregnant persons) or whether cofactors are needed. 
 
Infectious diseases specialists around the world are working day and night to find answers to many critical questions surrounding this disease while at the same time working on the development of a vaccine. Meanwhile, IDSA is also working to address the necessary public health policy response to the outbreak.
 
IDSA’s Public Health Committee, with input from the Center for Global Health Policy, has developed policy recommendations on how best to address the outbreak both within the US and globally. The focus of these recommendations is to ensure adequate federal support to strengthen our public health prevention and control readiness, diagnostic development, medical countermeasures research and development, and global health activities. 
 
These recommendations were shared in a letter to the Senate Health, Education, Labor, and Pensions (HELP) Committee, which held a hearing in late February on the Zika virus outbreak. The letter also highlights the key role of ID physicians in responding to the outbreak. These recommendations will also be shared with the House Energy and Commerce Committee, which plans to hold a Zika virus hearing early this month. IDSA’s funding recommendations will also be shared with relevant appropriations subcommittees in Congress. 
 
The Obama Administration has requested a $1.8 billion emergency supplemental budget request to respond to the outbreak. In addition to resources needed to ramp up domestic preparedness and research and development, the request proposes $335 million for USAID to support mosquito control, public education and maternal health programs in affected countries. 
 
As with any outbreak of this kind, whether it be Ebola, West Nile, Dengue or Chikungunya virus, there is much we don’t yet know, and the unknown can be the source of a great deal of anxiety and fear among the public. I am heartened, and proud, to know that infectious diseases specialists—some of the brightest medical minds in the world—are working around the clock to find answers. 
 

What Comes to Mind When You Hear of New Orleans in October? Think IDWeek!

The 5th annual IDWeek will take place Oct. 26-30, 2016 at the New Orleans Ernest N. Morial Convention Center. Registration and housing opens for members only on Tuesday, March 22 and will be available to all on Tuesday, April 19. Here is a sneak peek at what’s planned.

The 5th annual IDWeek will take place Oct. 26-30, 2016 at the New Orleans Ernest N. Morial Convention Center. Registration and housing opens for members only on Tuesday, March 22 and will be available to all on Tuesday, April 19. Make sure your IDSA membership is up-to-date so you can take advantage of member discounts and advance registration.  
 
The IDWeek Program Committee has developed a robust program and the Preliminary Program Primer will debut later this month. Below is a sneak peak of what’s to come.  
 
ID365 – Every Day, Everywhere in the World an ID Expert is Needed” will be an overreaching theme at IDWeek 2016. It emphasizes how critical the role of ID is to human health and how vast are the topics the specialty encompasses.

IDWeek’s Special Opening Plenary will look back at the history of ID and how ID can move forward. Ambassador-at-Large Deborah L. Birx, MD, the US Global AIDS Coordinator and US Special Representative for Global Health Diplomacy at the US Department of State, will begin the plenary by taking us through the past 20 years of antiretroviral therapy.  Next, Thomas Frieden*, MD, MPH, the Director of the Centers for Disease Control and Prevention, will address "Antibiotic Resistance and Where We are Today.” David Relman, MD, FIDSA, the Thomas C. and Joan M. Merigan Professor in Medicine, and Microbiology & Immunology and Co-Director of the Center for International Security and Cooperation at Stanford University, will enlighten us on the “Future of ID’s Role in Medicine.”
 
 
New abstract categories have expanded to TB, stewardship, and hepatitis. The IDWeek Program Committee awards grants to support attendance and travel needs of candidates whose abstracts have been selected and who are scheduled to present their work at IDWeek. The deadline for both abstract submission and travel awards is on Tuesday, May 17 at 5 p.m. EDT
 
 
The Closing Plenary, “Hot, Dry, and Crowded,” will cover “Climate Change and ID,” “Displaced Persons and the Diseases that Follow,” and “Emerging Viruses as a Result of Change.” The keynote speakers are:
 
  • Jan Semenza, PhD, MPH, Head of Health Determinants Programme for the European Centre for Disease Prevention and Control in Stockholm, Sweden
  • Patricia Walker*, MD, DTM&H, Associate Program Director, Global Health Pathway, University of Minnesota and HealthPartners Travel and Tropical Medicine Center, St. Paul, MN
  • Malik Peiris*, MBBS, FRCPath, DPhil,  Director, School of Public Health and Co-Director, WHO H5 Reference Laboratory, University of Hong Kong, Hong Kong
 
Know of any potential IDWeek first timers?  Show them this IDWeek for Beginners video. It’s hosted on the IDWeek YouTube Channel where you can also watch interviews from top speakers and key players.
 
We hope you'll be joining us in New Orleans this fall! 
 
*tentative

Call for Committee Volunteers!

Applications are now being accepted for committee positions within IDSA. The success of the Society depends on members who volunteer their time to serve on key committees. While there are limited positions available, there are many ways to get involved in your Society.

The success of IDSA depends on the Society's members who volunteer their time to serve on key IDSA committees. The Volunteer Application is now available.
 
Our desire is to give as many members as possible an opportunity to participate in IDSA activities. We try to balance the need to bring in new faces while maintaining the continuity and experience necessary for the committees to function effectively. Every year, about 30-35 committee positions are open. We usually have many more volunteers than available slots. We are particularly interested in ensuring that the membership of the Committees represents the full diversity of the membership of IDSA, and encourage women and individuals under-represented in medicine to volunteer to serve the Society. 
 
Please review the form carefully and respond by April 8 if you are interested in volunteering for an IDSA committee position for the coming year. The form can be filled out online or downloaded and emailed to kcortez@idsociety.org; faxed to 703-299-0204; or mailed to IDSA Nominations Committee, 1300 Wilson Blvd., Suite 300, Arlington, VA 22209.
 
We encourage anyone interested to apply, and we appreciate your understanding that not all who do will be selected this year. Besides serving on a committee, there are many ways to support the mission of the Society. Click here to learn more about how you can get involved!
 

President’s Budget Request for FY 2017 is Out: What it Holds for ID and HIV

The president’s budget request for FY 2017 is out!  Find out how antimicrobial resistance efforts, NIH funding, CDC initiatives and HIV programs, both global and domestic, fared in this year’s budget. What can you do to help?

IDSA and HIVMA are urging members to contact Congress to support strong federal funding for ID and HIV programs in Fiscal Year (FY) 2017. Congressional offices value the recommendations of constituents when determining spending priorities.
 
The president’s budget request for FY 2017, which was released on Feb. 9, would increase the budget for the National Institutes of Health (NIH) by 2.5%--all of which would go to three programs: Cancer Moonshot, Precision Medicine Initiative, and the BRAIN Initiative. NIH institutes and centers not involved in the three initiatives would be level-funded. The proposal includes a 2.7% reduction in the Centers for Disease Control and Prevention (CDC).  
 
Funding for domestic HIV/AIDS programs is largely sustained at current levels. Particularly concerning is proposed flat funding for HIV research at NIH for the third year in a row and for the President’s Emergency Plan for AIDS Relief, which has been stagnant since 2010.  Please see statements from the HIVMA and the IDSA/HIVMA Center for Global Health Policy for further details. 
 
On a more positive note, the budget carries forward many of the increases provided in FY 2016 for IDSA priority areas such as antimicrobial resistance (AR). The president’s budget requests an increase of $43 million for antimicrobial resistance programs across the government (Health and Human Services, Department of Agriculture, Department of Defense, and Veterans Administration), which would bring the total to approximately $1.1 billion.  Most of the proposed increase, $40 million, would go to the CDC’s Antibiotic Resistance Solutions Initiative to expand AR prevention programs in all 50 states, six large cities, and Puerto Rico.  The Agency for Healthcare Research and Quality (AHRQ) is also slated for a small increase of $2 million for a total of $12 million in the president’s request for research on antibiotic stewardship practices.  The president also proposes continuing the 2016 funding level for AR initiatives at the Biomedical Advanced Research and Development Authority (BARDA) and Food and Drug Administration.
 
The president’s budget failed to make new investments in multidrug-resistant tuberculosis, just a few weeks after releasing the National Action Plan for Combating Multidrug-Resistant Tuberculosis. The Food and Drug Administration (FDA) is virtually level-funded, increasing 0.5% over FY 2016 from $2.728 billion to $2.743 billion.  
 
Separately, the administration is seeking $1.8 billion, primarily to the CDC, Centers for Medicare and Medicaid Services (CMS), and US Agency for International Development (USAID), and the Department of State to address the Zika virus.  A reluctant Congress is urging the administration to use funding leftover from the Ebola crisis to address Zika.
 
In the weeks ahead, Congress will hold hearings on the budget request with federal agency leaders and other stakeholders with the goal of advancing appropriations bills in the spring and summer.  However, the FY 2017 appropriations process is challenged by a shortened congressional calendar.  Congress will go into recess in mid-July for the Democratic and Republican national conventions.  The recess period will continue on through August and much of the fall to allow for members of Congress to campaign ahead of the November elections.  
 

Journal Club

Peer Comparison and Accountable Justification to Reduce Inappropriate Antibiotic Prescribing in Primary Care; Difficulties in Dosing Colistin; Strong Evidence Against Adjunctive Corticosteroids in HIV-Associated Cryptococcal Meningitis; Antibiotics May Not Always be Necessary for Treatment of Uncomplicated UTIs; A Change Two Decades in the Making: Redefining Sepsis and Septic Shock

In this feature, a panel of IDSA members identifies and critiques important new studies in the current literature that have a significant impact on the practice of infectious diseases medicine.

Click here for the previous edition of Journal Club. For a review of other recent research in the infectious diseases literature, see “In the Literature,” by Stanley Deresinski, MD, FIDSA, in each issue of Clinical Infectious Diseases.

Peer Comparison and Accountable Justification to Reduce Inappropriate Antibiotic Prescribing in Primary Care
Reviewed by Sheila Mitsuma, MD

Acute respiratory tract infection (ARTI) is the most common reason for acute outpatient physician office visits and antibiotic prescription in adults in the United States. A portion of these prescriptions, estimated at up to 50 percent, are inappropriate. To address this issue, authors from the Centers for Disease Control and Prevention and the American College of Physicians recently offered guidance on appropriate antibiotic use for ARTI in an article in Annals of Internal Medicine.

Changing behavior in practice, however, is often challenging. To help determine what strategies may be effective, investigators in Boston and Los Angeles performed a cluster randomized trial evaluating the effects of three different behavioral interventions on antibiotic prescribing in the primary care setting and published their results in the Journal of the American Medical Association. The trial included 249 physicians from 49 primary care practices within three health systems randomized to zero, one, two, or three behavioral interventions for an 18-month period. Three interventions were implemented either alone or in combination:

  1. Suggested alternatives (electronic order sets presented non-antibiotic alternatives)
  2. Accountable justification (electronic health records prompted entry of free-text justification for antibiotic use)
  3. Peer comparison (emails sent to providers comparing their prescription rates with “top performers,” i.e., those with the lowest prescription rates)

The primary outcome measured was the antibiotic prescription rate for antibiotic-inappropriate diagnoses, defined as care not concordant with guidelines. These diagnoses included upper respiratory tract infection, acute bronchitis, and influenza, as defined by ICD-9 code. A total of 31,712 visits (14,753 in the baseline period and 16,959 in the intervention period) met criteria for outcome evaluation.

Mean antibiotic prescribing rates decreased from 24.1 percent at intervention start to 13.1 percent 18 months later, for an absolute difference of -11.0 percent for control (no intervention) practices. Compared to control practices, a statistically significant difference was found between the control group and the accountable justification and peer comparison groups, with an absolute difference of -18.1 percent in the accountable justification group and a -16.3 percent difference in the peer comparison group (p < 0.001). While a -16 percent difference was measured in the suggested alternatives group, this did not reach statistical significance. No significant differences in the proportion of ARTI diagnoses were seen between baseline and intervention periods.  

Although this study has limitations, particularly sample size and generalizability, it highlights that strategies derived from behavioral science and change management may aid in antimicrobial stewardship efforts.

(Harris et al. Ann Intern Med. 2016 Jan. 19.)

(Meeker et al. J Am Med. 2016;315(6):562-570.)

 
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Difficulties in Dosing Colistin
Reviewed by Christopher J. Graber, MD, MPH, FIDSA

In its first few decades of use after its introduction in the 1950s, dosing of colistin (polymyxin E), available as its prodrug colistimethate, was based on very limited pharmacologic data. With its re-emergence over the past decade, more data has become available that has informed dosing guidelines established by the U.S. Food and Drug Administration (FDA) in 2013 and the European Medicines Agency (EMA) in 2014. However, a recent report published in Clinical Infectious Diseases notes that dosing according to these guidelines (particularly FDA’s) may result in low rates of attainment of clinically relevant serum concentrations at differing levels of renal function.

The authors obtained pharmacokinetic data from 162 critically ill patients with a wide range of renal function who were receiving colistin in order to determine average steady-state concentrations that would be achieved if they received EMA- or FDA-recommended doses specific to their level of renal function. They then calculated the probability of achieving clinically relevant serum concentrations based on these dosing recommendations, most notably 2 mg/L (corresponding to the current susceptibility breakpoint of ≤ 2 mg/L established by the Clinical and Laboratory Standards Institute for Pseudomonas and Acinetobacter species). While EMA dosing recommendations were associated with a relatively high probability of achieving a steady-state concentration of 2 mg/L at lower levels of renal function (approximately 90 percent for creatinine clearance (CrCl) < 80 mL/min), FDA dosing recommendations were associated with much lower probabilities (less than 10 percent for CrCl < 30 mL/min and approximately 50-60 percent for CrCl 30-80 mL/min). Neither was associated with high probability of target attainment of 2 mg/L at CrCl ≥ 80 mL/min (EMA: 33 percent; FDA: less than 25 percent). 

While nephrotoxicity was not specifically addressed in this study, prior studies indicate that nephrotoxicity may be more prevalent at serum concentrations ≥ 2.5 mg/L and in patients with CrCl ≥ 80 mL/min. Thus, colistin likely has an exceedingly narrow therapeutic window, making appropriate dosing difficult, particularly at higher levels of renal function. This study adds to a growing list of concerns regarding the utility of colistin, including batch-to-batch variability of active drug, poor data to support breakpoint determination, poorly available therapeutic monitoring, and recently described plasmid-mediated resistance. While polymyxin B may offer more favorable pharmacokinetics, its efficacy data is even more limited.  Better drugs are clearly needed to treat infections caused by resistant Gram-negative bacteria.

(Nation et al. Clin Infect Dis. 2016;62(5):552-558.)

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Strong Evidence Against Adjunctive Corticosteroids in HIV-Associated Cryptococcal Meningitis
Reviewed by Brian R. Wood, MD

Cryptococcal meningitis remains one of the most common opportunistic infections in HIV-infected persons, causing significant mortality and morbidity, even with optimal antifungal therapy. Thus, there exists substantial need to investigate strategies that might improve outcomes. A previous study that examined optimal timing of antiretroviral therapy (ART) initiation in cryptococcal meningitis was stopped early due to worse outcomes with early ART. Now, a trial reported in the New England Journal of Medicine provides strong evidence that adjunctive corticosteroids provide no survival benefit and in fact confer harm.
 
Researchers enrolled adults with advanced HIV and confirmed cryptococcal meningitis at multiple sites in Asia and sub-Saharan Africa (about 60 percent on ART at enrollment) and randomized participants in double-blind fashion to dexamethasone (intravenous, weight-based dosing for two weeks, followed by tapering oral dosing for four weeks) or placebo. Induction antifungal therapy included amphotericin and high-dose fluconazole.
 
Investigators halted the trial after enrolling 451 patients due to evidence of harm in the dexamethasone arm. While this arm did experience greater reductions in  intracranial pressure in the first two weeks, data showed significantly higher disability at 10 weeks and adverse events at six months (including grade 3 or 4 infections) plus slower cerebrospinal fluid fungal clearance. There was a trend towards lower survival with dexamethasone compared to placebo (47 percent versus 41 percent at 10 weeks and 57 percent versus 49 percent at six months). The findings were consistent across all study sites and subgroups.
 
The authors conclude that adjunctive corticosteroids, at least at the dose and duration used, elicit harm. Several questions linger. Would a shorter course of dexamethasone change outcomes? There was some suggestion of benefit from dexamethasone in the first three weeks. What role do corticosteroids play in cryptococcal immune reconstitution inflammatory syndrome (IRIS)? The trial found no suggestion of benefit for suspected IRIS cases, but was not powered to answer that question. As the authors note, this is strong evidence against routine adjunctive corticosteroids in cryptococcal meningitis, and improving access to first-line antifungal agents like flucytosine must be a priority.
 
(Beardsley et al. N Engl J Med. 2016 Feb 11;374(6):542-54.)
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Antibiotics May Not Always be Necessary for Treatment of Uncomplicated UTIs
Reviewed by Manie Beheshti, MD

The recent paradigm shift in the approach to urinary tract infections (UTIs) has led to a better understanding of the most common bacterial infection in women. The appropriate clinical approach to UTIs and the need to treat uncomplicated UTIs has been recently questioned by some intriguing studies. 
 
With the concerning rise in bacterial resistance to antimicrobials and the critical need for limiting antimicrobial use, a recent study in The BMJ was designed to assess a novel strategy for reducing antibiotics for the treatment of uncomplicated UTIs. Investigators sought to determine if symptomatic versus antimicrobial treatment of uncomplicated UTIs would lead to fewer courses of antibiotics during the 28-day study period. Building on their smaller pilot study, this multi-center controlled trial in Germany randomized nearly 500 women aged 18-65 with symptoms of UTI to two blinded groups: fosfomycin 3-gram single dose versus ibuprofen 400 milligrams twice daily for three days. The primary endpoints were total antibiotic use in the 28-day study period and symptom burden as scored by reported daily symptoms.
 
Although the ibuprofen group had greater symptom burden during the 28-day study period, they used 64.7 percent fewer courses of antibiotics compared to the fosfomycin group (85 women in the ibuprofen group received antibiotics versus 243 women in the fosfomycin group). In a subgroup analysis of those with negative urine cultures, this reduction was even more pronounced at greater than 90 percent. Most notably, two-thirds of women in the ibuprofen group recovered without antibiotics.
 
While this study cannot support the use of ibuprofen, it does lend potentially critical data to the question of whether all UTIs warrant therapy. In the right setting, the authors noted, “lower antibiotic consumption [could be] ‘bought’ at the expense of a higher burden of symptoms … .” 
 
(Gágyor et al. BMJ. 2015;351:h6544.)
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A Change Two Decades in the Making: Redefining Sepsis and Septic Shock
Reviewed by Nirav Patel, MD

Sepsis has always presented a clinical management challenge due to a lack of a diagnostic gold standard. Historically, clinicians have depended on the Systemic Inflammatory Response Syndrome criteria to provide clinical parameters. However, in bedside care, these non-specific markers did not provide the necessary accuracy to meet clinical demands. In the Feb. 23 issue of the Journal of the American Medical Association, a series of articles by a multidisciplinary taskforce describes the result of a paradigm-shifting effort to redefine sepsis and septic shock.
 
Sepsis is defined as “life-threatening organ dysfunction caused by a dysregulated host response to infection.” Organ dysfunction is ascertained by a change in the Sequential Organ Failure Assessment (SOFA) by greater than or equal to two points, which reflects an approximate 10 percent risk of mortality. A new measure, qSOFA, requires two of the following three elements to be considered: respiratory rate greater than or equal to 22/min, altered mental status, and systolic blood pressure of less than or equal to 100 mm Hg. While not as robust as SOFA, the new measure requires no specialized testing, and can be performed serially and rapidly at bedside.  The predicative validity for hospital mortality in intensive care unit (ICU) patients for SOFA had an area under the receiver operating characteristic curve (AUROC) of 0.74, while qSOFA was 0.66. Furthermore, in non-ICU patients the AUROC for SOFA was 0.79 and qSOFA was 0.81, suggesting high utility in this setting.
 
Septic shock was more loosely defined than in the previous definitions: “a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality.” Clinically, this was defined as persistent hypotension requiring vasopressors to maintain mean arterial pressure greater than or equal to 65 mm Hg and a serum lactate greater than 2 mmol/L despite volume resuscitation. In the derivation study, risk-adjusted mortality of greater than 40 percent was noted in patients who met both criteria, 30.1 percent in those who only required vasopressors, and 25.7 percent in those with hyperlactatemia alone.
 
The task force utilized large data sets, all including patients from 2005 or more recent years, to derive these parameters. Sepsis was assessed using 1.3 million patient records in the University of Pittsburgh Medical Center (UPMC) system, including 148,907 patients with suspected infection, and four other data sets comprised of 706,399 encounters at 165 U.S. and non-U.S. hospitals. Septic shock was assessed in the UPMC data set, the Surviving Sepsis campaign database of 28,150 patients from 18 countries, and 1.9 million patients from Kaiser Permanente Northern California. 
 
The future challenge will be the prospective validation of the new definitions and the qSOFA score, as well as evaluation in more resource-limited settings. An accompanying editorial noted that sepsis is a “syndrome and not a specific disease.”  Further work will be needed to clarify the unique biochemical signature of individual disease states that are currently grossly defined as “sepsis”. Nonetheless, the definitional changes help clarify the epidemiological understanding of this complex disease process and pave the way for continued research efforts.
 
(Singer et al. JAMA. 2016;315(8):801-810.) 
(Seymour et al. JAMA. 2016;315(8):762-774.)
(Shankar-Hari et al. JAMA. 2016;315(8):775-787.)

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For a review of other recent research in the infectious diseases literature, see “In the Literature,” by Stanley Deresinski, MD, FIDSA, in each issue of Clinical Infectious Diseases:

March 15
  • Staphylococcus aureus Bacteremia: Risk of Hematogenous Infection of Joint Prostheses
  • Mucormycosis and Fusariosis in Allogenic Hematopoietic Stem Cell Recipients
March 1
  • Miltefosine May Be Losing Efficacy in the Treatment of Leishmaniasis
  • Fifteen Years of Remarkable Progress in Preventing Malaria in Africa, With Much Left to Do
  • Zika in the Western Hemisphere
February 15
  • Plague—Older Than We Knew
  • Trypanosoma cruzi Infection and Nonischemic Cardiomyopathy in California
  • Case Vignette: Staphylococcus aureus: It’s MSSA—No, It’s MRSA
February 1
  • Improving Attitudes Toward Vaccination: Accentuate the Consequences of Failing to Vaccinate Children
  • “Hey, You, Get Off of My Cloud”
  • The Skin Microbiome May Play a Role in Resistance to Infection
  • Case Vignette: Autoantibodies and Disseminated Mycobacterium haemophilum Infection
  • Case Vignette: High-Level Vancomycin Resistance in Methicillin-Susceptible Staphylococcus aureus