Published: July 8, 2014

History of the CHEER Clinical Research Coordinator Conference – ONLINE EXCLUSIVE

CHEER Practice-based Research Network is an NIDCD-funded network comprising 30 sites in 17 states, and includes more than 200 otolaryngologists, 100 audiologists, and 50 SLPs, along with other research professionals. The focus of CHEER is to educate sites on practice-based research and maintain regulatory and research process infrastructure so sites are “at-the-ready” to participate in appropriate research studies. The CHEER Annual Coordinators Conference is one of CHEER’s flagship resources. Taking place at the Academy offices, the conference brings together study coordinators from the network, along with interested PIs and research professionals. The seventh annual conference will occur August 7-9. This article highlights experiences from the sixth annual conference. If you have questions about CHEER or the conference, email Kristine Schulz at Kristine.schulz@duke.edu. Shaun A. Nguyen, MD, MA, CPI  The history of clinical research emphasizes the close relationship between clinical research and clinical care. The ethics of clinical research tend to focus on whether, and to what extent, the treatment of research subjects diverges from the norms of clinical care. Clinical research is often conducted with patients and is often performed by physicians and clinical research coordinators. Modern clinical research studies are accompanied by more rules, regulations, laws, and guidelines than ever governing research with human subjects. I am director of Clinical Research for the department of otolaryngology-head and neck surgery at the Medical University of South Carolina (MUSC), where we are training a new generation of otolaryngology physician investigators through our research fellowship program. In addition, through the collaboration with the Master of Science in Clinical Research Program at the Medical University of South Carolina, we are providing an internship program for clinical research coordinators with more than 30 investigator-initiated and corporate-sponsored clinical trials. MUSC research fellows and clinical research coordinators have attended the Annual CHEER Conference since its inception in 2008. The two-day Annual CHEER Coordinator’s Conference provides physician investigators and clinical research coordinators the knowledge and expertise to conduct clinical research studies and follow principles of good clinical practice (GCP). The conference delivers disease-specific education and an overview of the clinical research process: its function, history, and development. Physician-investigators, research fellows, and clinical research coordinators learn project management skills and clinical practice guidelines. They learn about research team member roles, typical study designs, and developmental phases of clinical trials. For the 6th Annual CHEER Conference, MUSC sent three research fellows and three students for training. Conference Overview P. Ryan Camilon The 6th annual CHEER conference differed from previous meetings by greater incorporation of disease-specific education among the usual clinical-trial focused lectures. Neurotologist Alan Langman, MD, provided an overview of the pathophysiology, evaluation, and treatment of Meniere’s disease in the context of the aspects currently being explored. Melissa Pynnonen, MD, explained several issues in the diagnosis and treatment of sinusitis as well as challenges that need to be tackled concerning sinusitis research. Laryngologist Joshua Schindler, MD, presented a summary of laryngeal pathology after voice therapist Donna Graville, PhD, discussed possible areas of investigation in voice management. Finally, neurotologist Debara Tucci, MD, MS, (Co-PI for CHEER) reviewed sudden sensorineural hearing loss and current treatment controversies. Typically, the CHEER conference focuses heavily on research-practical topics, which were still thoroughly addressed. David Witsell, MD, MHS, (CHEER PI) and Kris Schulz, MPH (Director of Research), summarized CHEER’s current clinical trials and discussed the growth of the network, which now consists of 28 sites in 18 states. Select CHEER research coordinators presented topics covering FDA investigator qualification, new methods of site monitoring, preparation for an FDA audit, and IRB regulatory documentation. Also new in this year’s conference was an emphasis on the open discussion of ideas and experiences between coordinators. This new theme proved to be rewarding. Small-group sessions on how to ethically get consent from patients and properly manage their information led to the sharing of troubleshooting tips and methods to improve researcher technique. This year, CHEER provided coordinators with a better understanding of ear, nose, and throat pathology in addition to covering the latest changes in the research regulatory landscape. By presenting coordinators with more medical information, we hope to ensure a greater understanding of how CHEER projects will improve the treatment of patients, and also foresight into what aspects of head and neck pathology may be explored down the road. Reflection on the Experience Colin Fuller, MD, MS While we were all excited to be invited to participate in the annual CHEER Conference, I admit that I was unsure what to expect from the meeting. As a research fellow coordinating clinical trials for the first time, I anticipated a top-down, hierarchical situation where PIs would dole out instructions on how to facilitate practice-based research in general, and how to conduct the joint CHEER trials specifically. Instead, we were invited to an open discussion with providers at every level (PIs, nurses, SLPs, audiologists, residents, and coordinators) speaking directly about the conduct of clinical research. From Dr. Witsell’s opening address on the first day, a collegial and friendly atmosphere permeated every lecture and discussion. We were encouraged to contribute to the development of specific research protocol for the CHEER network studies, which helped to make the data collection process as efficient and practical as possible. We also shared ideas for how to improve data collection and subject protection for all human research studies. These discussions were incredibly informative to us as newly minted research fellows. Dr. Witsell’s remarks urged us to strive to replicate the behaviors of the most successful among us—to be, or to emulate, the “positive deviant.” With the conference bringing to bear the experiences and resources of so many research professionals, the CHEER network will be well-served by this philosophy. In the near future, I am quite confident that other specialties will be emulating the CHEER network itself as that “positive deviant.” How Does this Prepare Me for the Future (As a Future PI)? Amit J. Sood In addition to direct clinical care, my future practice as an academic otolaryngologist will include contributing to advancements in patient care. Clinical research, as a vehicle for medical advancement, enables a provider to treat patients with cutting-edge technologies and the most up-to-date knowledge of disease processes. The CHEER conference offers many learning opportunities for those interested in clinical research. The CHEER network fosters an appreciation for clinically driven research in an informal setting for providers at every level, including aspiring PIs like myself. In addition to informative clinical presentations, the CHEER network discusses the inner workings of “what to expect” when undertaking a clinical trial from start to finish. Experienced coordinators explain concepts such as IRB process, protocol design, and funding, while others provide insight on the “pitfalls” of clinical trials such as FDA audits. The conference instills feelings of appreciation for clinically oriented research and a greater desire to perform clinical research to enhance patient care for the next generation of patients. Lastly, it provides specific tools, connections, and resources that are needed to help facilitate successful clinical trials for coordinators and future PIs alike. History of the CHEER Clinical Research Coordinator Conference CHEER Practice-based Research Network is an NIDCD-funded network comprising 30 sites in 17 states, and includes more than 200 otolaryngologists, 100 audiologists, and 50 SLPs, along with other research professionals. The focus of CHEER is to educate sites on practice-based research and maintain regulatory and research process infrastructure so sites are “at-the-ready” to participate in appropriate research studies. The CHEER Annual Coordinators Conference is one of CHEER’s flagship resources. Taking place at the Academy offices, the conference brings together study coordinators from the network, along with interested PIs and research professionals. The seventh annual conference will occur August 7-9. This article highlights experiences from the sixth annual conference. If you have questions about CHEER or the conference, please email Kristine Schulz at Kristine.schulz@duke.edu.


CHEER Practice-based Research Network is an NIDCD-funded network comprising 30 sites in 17 states, and includes more than 200 otolaryngologists, 100 audiologists, and 50 SLPs, along with other research professionals. The focus of CHEER is to educate sites on practice-based research and maintain regulatory and research process infrastructure so sites are “at-the-ready” to participate in appropriate research studies. The CHEER Annual Coordinators Conference is one of CHEER’s flagship resources. Taking place at the Academy offices, the conference brings together study coordinators from the network, along with interested PIs and research professionals. The seventh annual conference will occur August 7-9. This article highlights experiences from the sixth annual conference. If you have questions about CHEER or the conference, email Kristine Schulz at Kristine.schulz@duke.edu.

Shaun A. Nguyen, MD, MA, CPI 

The history of clinical research emphasizes the close relationship between clinical research and clinical care. The ethics of clinical research tend to focus on whether, and to what extent, the treatment of research subjects diverges from the norms of clinical care. Clinical research is often conducted with patients and is often performed by physicians and clinical research coordinators. Modern clinical research studies are accompanied by more rules, regulations, laws, and guidelines than ever governing research with human subjects.

I am director of Clinical Research for the department of otolaryngology-head and neck surgery at the Medical University of South Carolina (MUSC), where we are training a new generation of otolaryngology physician investigators through our research fellowship program. In addition, through the collaboration with the Master of Science in Clinical Research Program at the Medical University of South Carolina, we are providing an internship program for clinical research coordinators with more than 30 investigator-initiated and corporate-sponsored clinical trials. MUSC research fellows and clinical research coordinators have attended the Annual CHEER Conference since its inception in 2008. The two-day Annual CHEER Coordinator’s Conference provides physician investigators and clinical research coordinators the knowledge and expertise to conduct clinical research studies and follow principles of good clinical practice (GCP). The conference delivers disease-specific education and an overview of the clinical research process: its function, history, and development. Physician-investigators, research fellows, and clinical research coordinators learn project management skills and clinical practice guidelines. They learn about research team member roles, typical study designs, and developmental phases of clinical trials. For the 6th Annual CHEER Conference, MUSC sent three research fellows and three students for training.

Conference Overview

P. Ryan Camilon

The 6th annual CHEER conference differed from previous meetings by greater incorporation of disease-specific education among the usual clinical-trial focused lectures. Neurotologist Alan Langman, MD, provided an overview of the pathophysiology, evaluation, and treatment of Meniere’s disease in the context of the aspects currently being explored. Melissa Pynnonen, MD, explained several issues in the diagnosis and treatment of sinusitis as well as challenges that need to be tackled concerning sinusitis research. Laryngologist Joshua Schindler, MD, presented a summary of laryngeal pathology after voice therapist Donna Graville, PhD, discussed possible areas of investigation in voice management. Finally, neurotologist Debara Tucci, MD, MS, (Co-PI for CHEER) reviewed sudden sensorineural hearing loss and current treatment controversies.

Typically, the CHEER conference focuses heavily on research-practical topics, which were still thoroughly addressed. David Witsell, MD, MHS, (CHEER PI) and Kris Schulz, MPH (Director of Research), summarized CHEER’s current clinical trials and discussed the growth of the network, which now consists of 28 sites in 18 states. Select CHEER research coordinators presented topics covering FDA investigator qualification, new methods of site monitoring, preparation for an FDA audit, and IRB regulatory documentation. Also new in this year’s conference was an emphasis on the open discussion of ideas and experiences between coordinators. This new theme proved to be rewarding. Small-group sessions on how to ethically get consent from patients and properly manage their information led to the sharing of troubleshooting tips and methods to improve researcher technique.

This year, CHEER provided coordinators with a better understanding of ear, nose, and throat pathology in addition to covering the latest changes in the research regulatory landscape. By presenting coordinators with more medical information, we hope to ensure a greater understanding of how CHEER projects will improve the treatment of patients, and also foresight into what aspects of head and neck pathology may be explored down the road.

Reflection on the Experience

Colin Fuller, MD, MS

While we were all excited to be invited to participate in the annual CHEER Conference, I admit that I was unsure what to expect from the meeting. As a research fellow coordinating clinical trials for the first time, I anticipated a top-down, hierarchical situation where PIs would dole out instructions on how to facilitate practice-based research in general, and how to conduct the joint CHEER trials specifically.

Instead, we were invited to an open discussion with providers at every level (PIs, nurses, SLPs, audiologists, residents, and coordinators) speaking directly about the conduct of clinical research. From Dr. Witsell’s opening address on the first day, a collegial and friendly atmosphere permeated every lecture and discussion. We were encouraged to contribute to the development of specific research protocol for the CHEER network studies, which helped to make the data collection process as efficient and practical as possible. We also shared ideas for how to improve data collection and subject protection for all human research studies. These discussions were incredibly informative to us as newly minted research fellows.

Dr. Witsell’s remarks urged us to strive to replicate the behaviors of the most successful among us—to be, or to emulate, the “positive deviant.” With the conference bringing to bear the experiences and resources of so many research professionals, the CHEER network will be well-served by this philosophy. In the near future, I am quite confident that other specialties will be emulating the CHEER network itself as that “positive deviant.”

How Does this Prepare Me for the Future (As a Future PI)?

Amit J. Sood

In addition to direct clinical care, my future practice as an academic otolaryngologist will include contributing to advancements in patient care. Clinical research, as a vehicle for medical advancement, enables a provider to treat patients with cutting-edge technologies and the most up-to-date knowledge of disease processes.

The CHEER conference offers many learning opportunities for those interested in clinical research. The CHEER network fosters an appreciation for clinically driven research in an informal setting for providers at every level, including aspiring PIs like myself. In addition to informative clinical presentations, the CHEER network discusses the inner workings of “what to expect” when undertaking a clinical trial from start to finish. Experienced coordinators explain concepts such as IRB process, protocol design, and funding, while others provide insight on the “pitfalls” of clinical trials such as FDA audits. The conference instills feelings of appreciation for clinically oriented research and a greater desire to perform clinical research to enhance patient care for the next generation of patients. Lastly, it provides specific tools, connections, and resources that are needed to help facilitate successful clinical trials for coordinators and future PIs alike.

History of the CHEER Clinical Research Coordinator Conference

CHEER Practice-based Research Network is an NIDCD-funded network comprising 30 sites in 17 states, and includes more than 200 otolaryngologists, 100 audiologists, and 50 SLPs, along with other research professionals. The focus of CHEER is to educate sites on practice-based research and maintain regulatory and research process infrastructure so sites are “at-the-ready” to participate in appropriate research studies. The CHEER Annual Coordinators Conference is one of CHEER’s flagship resources. Taking place at the Academy offices, the conference brings together study coordinators from the network, along with interested PIs and research professionals. The seventh annual conference will occur August 7-9. This article highlights experiences from the sixth annual conference. If you have questions about CHEER or the conference, please email Kristine Schulz at Kristine.schulz@duke.edu.


More from July 2014 - Vol. 33 No. 07

The Value of Clinical Practice Guidelines – ONLINE EXCLUSIVE
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A Cleft Repair Mission in Kijabe, Kenya – EXTENDED ONLINE VERSION
Jason A. Showmaker, MD Last October I traveled with World Medical Mission to Kenya to perform cleft lip and palate repairs at AIC-CURE International Children’s Hospital in Kijabe, Kenya.  Situated on a mountainside rimming the Great Rift Valley and 31 kilometers west of Nairobi, this geographically isolated hospital is a busy hub of craniofacial cleft repair. Teams travel there three times each year to allow for patient follow up and to provide much needed repairs for poor families and their affected children. Dr. Chang has been travelling there annually since 2005 and this year I was allowed to join him and two other otolaryngologists, Jeffrey Neal, MD, and Cameron Kirchner, MD, to learn the challenging but rewarding art of repairing clefts. I have been interested in humanitarian medicine for many years but this was my first opportunity to travel as a physician and provide much needed care. We operated out of CUREHospital which was staffed mostly by Kenyan nationals and a handful of missionary physicians from around the world. The hospital and operating rooms ran efficiently and required very little “pushing” on our end. The hospital had been broadcasting daily radio announcements of our arrival and the day we arrived our clinic was packed with parents and their children. Within an hour of arriving, we were already operating on patients who had arrived the night before, gotten lab work, and had been NPO in anticipation. We ran two operating rooms five days a week that out of necessity functioned with very little waste. The anesthesia machines were old but functioning and the cleft trays were well-used but complete. There was routine re-sterilization of non-reusable products such as electrocautery tips which had long since lost their Teflon coating. Endotracheal tubes and suction tubing were stained yellow from multiple sterilizations with betadine and frequently the suction tubing would collapse because the tubing walls were weakened by frequent use. If a suture was opened but not used it was placed in a sterile container in the corner of the room for use in a subsequent case. Surgical sponges were made of washable material which was sterilized along with the drapes. We brought our own IV antibiotics, oral amoxicillin and donated suture. Any suture approaching its expiration date was donated to the hospital. The hospital staff was glad to have us there and really made the experience enjoyable for us. There were two anesthesiologists, well-trained scrub techs, and compassionate nurses who were all Kenyans with years of experience working together at the hospital.  In the wards, a single large room with 20-plus beds, daily praise and worship led by the hospital staff filled the halls with beautiful music as we drank tea between cases. As welcoming as the hospital staff was, I was struck by how little emotion the parents showed after their children had their operations. At times it seemed to border on apathy and it really made me and the rest of our team wonder why they weren’t more excited.  I came on this trip to serve and learn. I really wasn’t seeking their gratitude but when there was such little outward evidence of their appreciation I have to say I was surprised. In speaking with the hospital staff we learned that in Kenya a sign of true strength is to be unwavering in one’s emotion. To scream, shout, clap, and dance is entirely out of character and actually laughable to them. Instead the mothers accepted their children back into their arms with solemn gratitude, their most honorable display of strength. The Kenyans showed their strength, and all the while I was getting mine back.  The hours were long but my energy and desire to serve increased throughout the trip. Five months later I still reflect on this trip and find renewal. I am a better resident and better physician today because of this trip. I want to sincerely thank the AAO-HNSF Humanitarian Efforts Committee for its grant that made this trip possible. These two weeks were a gift given to me that I will never forget.
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AMPATH Kenya Surgical Mission – EXTENDED ONLINE VERSION
Susan R. Cordes, MD Bruce H. Campbell, MD Debara L. Tucci, MD, MBA As part of the greater AMPATH Kenya Program, our nine-member team traveled to Eldoret in western Kenya, in February 2014 to deliver medical and surgical care and build on existing relationships in the program.  AMPATH (Academic Model for Providing Access to Healthcare) was initiated by Indiana University (IU) physicians in 1989 as a partnership between IU and Moi University School of Medicine. MoiUniversity and its hospital, Moi Teaching and Referral Hospital (MTRH) in Eldoret, provides the only academic medical center for over three million people. The partnership between IU and MoiUniversity has flourished and expanded to include multiple specialties including otolaryngology. One of the main tenets of AMPATH is to provide education and research but to always “Lead with Care.” With that concept in mind, otolaryngologist/head and neck surgeons have traveled to Kenya once or twice each year since 2009 to provide much-needed surgical care and education. Currently, otolaryngology has the longest waiting time for elective surgery at MTRH, and our team was able to perform 35 procedures and, in the process, teach surgical technique and enhance the already very solid partnership between the American and Kenyan otolaryngologists. The American team consisted of Susan Cordes, MD (Indiana University), Bruce Campbell, MD (Medical College of Wisconsin), Debara Tucci, MD (Duke University), and Jack Coleman, MD (former chair of plastic surgery at IU), as well as nurses and IU medical student (and otolaryngologist-to-be), Joel Franco. We had the privilege of working with MTRH otolaryngology colleagues Titus Sisenda, MMed, Henry Nono, MMed (AAO International Visiting Scholar 2012), and Denge Makaya, MMed, and performed a wide range of surgeries, including thyroidectomies, nasal/sinus surgeries, cleft lip repairs, excision of cystic hygromas, facial/neck flap reconstruction, Sistrunk procedures, and a total laryngectomy. In addition, Debara Tucci met with key individuals to explore initiation of a hearing healthcare program for the region. Based on our past experience with these trips, we brought most of the necessary supplies, but still ran out of some of the seemingly most basic of items (e.g., suction tubing connectors, Mastisol, steri strips, etc.). Though we wish we could have stayed until the last of the patients had been released from the hospital, we confidently left the care of the patients in the hands of our Kenyan colleagues and continue to receive regular updates on their progress. Looking to the future, we plan to continue these trips and perhaps increase the frequency. Our Kenyan colleagues are exploring whether they might develop an otolaryngology residency program, which would be the second in Kenya. Our first joint research project has been submitted for review at both institutions, and we will continue to raise funds to further the educational experiences for our Kenyan otolaryngology colleagues. Traveling to a distant land to perform surgery in a difficult environment is a challenge; however, the rewards of providing care that otherwise might not be possible far outweighs any hardship on our part. Experiences such as this trip really help crystallize what is important and valuable. It is so easy to get caught up in the pressures and frustrations of everyday life in the U.S.; however, in the greater world, there is more hardship than most of us can imagine, and the ability to affect the lives of these patients and our Kenyan colleagues is truly a gift. We are proud that so many otolaryngologists participate in these noble ventures and that the AAO is so supportive of humanitarian efforts. Anyone who has ever participated in one of these trips knows exactly what we mean, and for anyone who has not, we hope you take the opportunity.
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Improving Professional Development through a New Learning Management System
The American Academy of Otolaryngology—Head and Neck Surgery Continuing Professional Development (CPD) Program has been analyzing the education needs, demographics, and career stages of its target audience. The goal of this analysis has been to construct a user experience that is focused on the demands of the individual specialties, yet comprehensive enough to provide a broad curriculum for the entire medical specialty. In order to actively engage this learner audience, however, AAO-HNSF must first have the correct tools to enable the design of activity formats that are built to align with diverse learner preferences. Plans are in process to build a new a Learning Management System (LMS) which will provide such tools and act as a hub through which the Foundation will create and deliver learning opportunities. The LMS will allow members and others in the greater healthcare community to design a customized education portfolio that meets their individual needs. The objectives of our LMS implementation and operation are to: Consolidate the Academy’s education resources and services under one easily accessible site, maintained and serviced by a single vendor. Expand the Academy’s education library to include innovative new formats that engage the learner in a more interactive, individualized education experience. Grow the Academy’s course participation by engaging new target audiences and encouraging repeat use. A new LMS will offer many features that will enrich members’ learning experience. These include the ability to: Recommend courses to users based on their professional interests and background. Support certified education, specifically AMA PRA Category 1 Credit™. Support the development of communities of practice and enable AAO-HNSF to build online learning communities. Provide access to a library of high-quality education content on a variety of topics. Build courses with content authoring tools: images, videos, and other file-based content can be embedded directly in activities. Be viewed on any device and support the most recent releases of Chrome, IE, Safari, and Firefox. Integrate a search function that pulls keywords from all resources on the AAO-HNS/F website. In addition, a new LMS will support these key strategic education resources. On Demand Learning and Interactive Platforms—The Foundation will be able to design future education activities that are self-paced, engaging, interactive, and customizable to individual learners. Such activities include patient case scenarios, simulation/gamification, and point-of-care learning. Assessment Courses/Question Bank—The Foundation will be able to leverage its existing self-assessment resources and established question-writing processes to produce a question bank and other self-assessment modules. The primary target market for these products will be recertifying physicians and residents. Such items as a question-of-the-day, practice tests, and exam prep will be available. Assessment and Continuing Education for Print Products—The Foundation will be able to maintain a host of print products, many of which will also have a duplicate online “eBook” edition. In order to grant continuing education credit for the print products, the new LMS will be able to support the post-test requirement to grant credit. The LMS would use a unique course identification code printed in each book to allow those who purchase the print product to access the post-test and credit request online. There are numerous additional administrative benefits to a new LMS that will make our education activity planning and evaluation more robust and meaningful. These benefits include: Needs Assessment data can be generated through advanced reporting features that correlate pre-test/post-test assessment scores with current literature on practice gaps. Testing functionalities allow pre-test/post-test scoring along with automated CME/CE credit request and certificate distribution. Evaluation options for new approaches to collecting needs assessment and user satisfaction data including automatic evaluation distribution and polling/survey widgets. CME/CE Transcript Generation/Repository gives members the ability to access CME/CE certificates immediately upon completing a course and access to certificates from past activities. As you know, AAO-HNSF has recently conducted a multiyear member education needs assessment along with a committee-led review of all current activities. As a result of this analysis, along with the introduction of a powerful new LMS, the Foundation stands poised to launch a dynamic, personalized, and flexible professional development platform that will engage our membership as never before.
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AAO-HNS/F Position Statement Updates
Definition of a Position Statement: A Position Statement is used to designate a statement, policy, or declaration of the AmericanAcademy of Otolaryngology—Head and Neck Surgery, and Foundation (AAO-HNS/F) on a particular topic or topics. Statements are created to formalize the AAO-HNS/F position on a clinical procedure or medical service with third party payers, for use in state and federal regulatory or advocacy efforts, or to clarify the AAO-HNS/F approval or disapproval of certain practices in medicine. For information about the differences between Position Statements and other quality knowledge products, such as Clinical Practice Guidelines, view the AAO-HNS/F Guidance Documents fact sheet on the website (http://www.entnet.org/default/files/Guidance-Documents.pdf). How are AAO-HNS/F Position Statements Created and Approved? Have you ever wondered how a Position Statement is created and what is involved in the process of review and final approval by the Board of Directors? In response to questions like this one the Health Policy department and the Physician Payment Policy (3P) workgroup that oversees the review and maintenance of the Position Statements, published a guidance document for AAO-HNS/F committees with a step-by-step process on how to develop a Position Statement. Notably, this document defines a Position Statement, clarifies its process of development, and clarifies its purpose as an AAO-HNS/F resource. This guidance document can be found on the Academy’s website (http://www.entnet.org/sites/default/files/Position-Statement-Template.pdf). This article provides examples of how members use the resource as an advocacy tool or to clarify the AAO-HNS/F approval or disapproval of certain practices in medicine. How Are AAO-HNS/F Position Statements Used by Members as a Resource? Real Examples of how AAO-HNS/F Position Statements are used as a resource include: Position Statements can be used to advocate with payers regarding coverage policies and issues that members are experiencing with third party payers. Example: An otolaryngologist has difficulty getting approval for a surgery including uvulapalatopharyngoplasty (UPPP) and midline glossectomy as treatment of obstructive sleep apnea (OSA) in patients where continued positive airway pressure (CPAP) has failed as treatment. As rationale for the denial, the insurance reviewer states that there is a lack of literature supporting this approach. The physician appeals the denial using Academy position statements on UPPP, mid-line glossectomy, and surgical management of OSA. The insurer subsequently reviews the supporting documentation reinforced by peer-reviewed literature to determine whether or not to reverse the denial and approve payment of the claim. Position Statements are also used to promote the Academy’s position on specific medical procedures. Example: The Academy published a position statement noting that sinus ostial dilation is an appropriate therapeutic option for selected patients with sinusitis. The statement also includes a list of supporting literature to indicate why we support this procedure as an appropriate option for clinical management. The Academy has provided this Position Statement to dozens of private healthcare insurers and several have reversed their decision of experimental and investigational, and instead, allowed for coverage. What are the latest New or Revised Position Statements Approved by the AAO-HNS/F Board of Directors? After an extensive review by AAO-HNS/F committees, the Executive Committee, and Board of Directors, the AAO-HNS/F revised nine, and published three new, Position Statements. The AAO-HNS/F reviews all position statements on a rolling four-year basis. For a listing of the updated Position Statements [Communications insert standard language to drive members to Bulletin online.] The latest updates can be found on the AAO-HNS/F website at http://www.entnet.org/positionstatements. Any questions about position statements? Email the health policy team at healthpolicy@entnet.org.
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Stage 3 of MU Is on the Horizon and We’re Advocating for You!
During the past few years, the Health Policy team has actively worked not only to educate members on the Centers for Medicare & Medicaid’s (CMS) Quality Initiative programs, but also to advocate on behalf of you so your needs and experiences are represented within the programs. This is particularly true with the Electronic Health Records (EHR) Meaningful Use (MU) Incentive Program, and 2014 is no exception. This year is important for a variety of reasons, one being it is the year that CMS plans to publish the notice of proposed rulemaking (NPRM) regarding Stage 3 of EHR MU. For those members not fully up-to-speed on the EHR MU program, this article includes a brief overview of the program and highlights Academy advocacy efforts as CMS develops Stage 3. [Communications insert standard language to drive members to Bulletin online.] By continuing advocacy efforts, the Health Policy team hopes to help members sort through any confusion associated with the EHR MU program, prepare for increased requirements, avoid penalties, and successfully participate, so you can focus on what matters most: providing excellent patient care. Did You Know? Rulemaking is a process that federal government agencies, such as CMS, use when developing governmental regulations. This process requires the opportunity for public comment before final regulations may be made. The Academy submits comments to CMS, and other agencies, on priority issues that impact otolaryngology-head and neck surgeons nationally. Background As you may know, the EHR MU was designed by CMS to facilitate the use of EHRs in clinical settings, with the program goals being to promote greater efficiency in healthcare, decrease costs, and improve the communication of medical information as it is shared between providers, regulators, and public health agencies. To meet those goals, eligible professionals (EPs) are expected to demonstrate they are “meaningfully using” their EHRs in such a manner that improves overall quality of care and increases patients’ choice as defined by CMS. In other words, it’s not simply a matter of utilizing EHRs, but rather, EPs and other healthcare professionals are expected to meet a number of thresholds for several objectives, with the requirements increasing as the stages of the program (1, 2, and 3) progress. For the most part, all three stages retain the same basic structure: EPs must report the required number of MU objectives + required number of clinical quality measures (CQMs) + any other reporting requirements.1 For the individual requirements, MU objectives are divided into two types: CORE and MENU. EPs are expected to report on all CORE measures but can choose the required number of MENU measures from a list based upon what best suits that individual’s practice. In addition, the MU objectives vary depending upon which stage of the program an EP is currently participating in. The requirements of each stage are designed to advance that particular stage’s chief goal (i.e., data capturing and sharing, advanced clinical processes, and improved outcomes). Stage 2 is currently underway, but Stage 3 is on the horizon with many new changes likely to impact specialists. Stage 3            AAO-HNS Comments on HITPC Recommendations for New/Heightened MENU and CORE Measures The Health IT Policy Committee (HITPC) is the federal advisory committee that makes recommendations to the Secretary of Health and Human Services (HHS) regarding the EHR MU Incentive Program. In spring 2014, the HITPC made several recommendations to CMS regarding Stage 3 requirements, which included many new or heightened MENU and CORE measures. Unfortunately, many of the recommendations are either reliant upon EHR systems that are fully interoperable or are requirements that are poorly suited for specialists, like ENTs. Since CMS considers the HITPC recommendations when developing their proposed rule, the Academy, along with other specialty societies, worked with the AMA to provide comments to CMS in hopes of changing many of the recommendations. Below is an example of one of the comments submitted by the AAO-HNS on a new MENU measure proposed by the HITPC. AAO-HNS General Comments on Stage 3: Increasing Costs for Providers In addition to commenting on the specific measures, the AAO-HNS also noted that while it supports the continued integration of EHRs into the practices of otolaryngologists-head and neck surgeons, it remains extremely concerned that the new and expanded requirements under Stage 3 will be increasingly difficult for otolaryngologists to meet, especially in light of the increased costs associated with meeting the higher standards and the additional maintenance required without the possibility of receiving incentive payments in coming years. The AAO-HNS further commented that because providers are also responsible for the expenses associated with implementing the core, menu and clinical quality objectives, it is imperative that flexibility be built into the program, which is currently lacking. As many can agree, flexibility helps ensure not only the continued adoption of HIT, but also avoids hindrances to patients’ access to quality care. AAO-HNS Health Policy Team Provides Resources to Members As rulemaking continues, the AAO-HNS will continue to stay actively engaged in the process and will keep members apprised of all pertinent information relating to the program. Members are also encouraged to stay engaged. View invaluable tools created by the AAO-HNS Health Policy team (available at: http://www.entnet.org/Practice/ONC.cfm) to help you understand the program and prepare your practice: AAO-HNS EHR MU webpage AAO-HNS EHR MU Fact Sheet Members should also stay tuned in to the eNews, HP Update, Bulletin, website, and other outreach tools for any announcements on important changes, deadlines, or other key factors surrounding the program. 1. Please note: This article is designed to provide a brief overview of the EHR MU Incentive Program and does not describe many pertinent aspects, such as the CQM requirements or other requirements that are essential to successfully participating in the program. Because of such, members are encouraged to review the resources listed on the Academy’s EHR webpage to ensure they fully understand the program and its implications.
Halfway to the Finish Line—Join the Competition Today!
We are more than halfway through the 2014 Residents and Fellows-in-Training Advocacy Involvement Campaign, and things are heating up. Residency programs nationwide are honing their advocacy skills by completing various advocacy-related tasks, and thereby earning points for themselves and their training programs. At year’s end, the program with the most points will be rewarded with an exclusive networking event with top Academy members at the next Annual Meeting. To date, Louisiana State and SUNY Downstate are tied for the lead with 32 points. Have you used this opportunity to become more involved and act as an advocate on behalf of the specialty? Participation is easy, and in some instances, it takes only a minute or two to join this ongoing effort. Take part in these small activities to instantly earn points for yourself and your program. Join the ENT Advocacy Network and earn one point. Follow @AAOHNSGovtAffrs on Twitter, friend us on Facebook, and connect on LinkedIn. Each action is worth one point. (Send handle names to govtaffairs@entnet.org) Donate to ENT PAC and gain five points.* In addition to the grand prize, participants in the Campaign are eligible for “milestone” awards as their involvement increases. For example, participants earning at least seven points will receive an exclusive Advocacy Investor T-shirt. Training programs that achieve 100 percent participation (when each resident earns at least three points) and have an average of five points or more will receive a special breakroom treat. It is essential for residents and fellows-in-training to learn about the Academy’s advocacy efforts and become actively involved early in their careers. Don’t miss this opportunity to learn more about the Academy’s advocacy programs in a fun and competitive setting. Together, we will make a difference! For more information regarding the Campaign, its structure, and how to become more involved, visit the Resident and Fellows-in-Training webpage at www.entpac.org. *Contributions to ENT PAC are not deductible as charitable contributions for federal income tax purposes. Contributions are voluntary, and all members of the American Academy of Otolaryngology-Head and Neck Surgery have the right to refuse to contribute without reprisal. Federal law prohibits ENT PAC from accepting contributions from foreign nationals. By law, if your contributions are made using a personal check or credit card, ENT PAC may use your contribution only to support candidates in federal elections. All corporate contributions to ENT PAC will be used for educational and administrative fees of ENT PAC, and other activities permissible under federal law. Federal law requires ENT PAC to use its best efforts to collect and report the name, mailing address, occupation, and the name of the employer of individuals whose contributions exceed $200 in a calendar year.
Outcomes Research and Evidence Medicine Committee: A ‘Systematic Review’ – ONLINE EXCLUSIVE
Scott E. Brietzke, MD, MPH As my tenure on the Outcomes Research and Evidence Based Medicine (OREBM) committee soon comes to a close, I would like to take this opportunity to reflect and perform a “systematic review” of the many activities of the committee during the past several years. It has been an extraordinary privilege to serve on a committee with such talented and vibrant people who have selflessly donated their time and energy for the betterment of their fellow otolaryngologists and most importantly, for the betterment of our patients. As consistent with its formal charge, the committee has focused on activities to improve the overall evidence basis of our specialty as a whole. This has included primary research projects to address evidence gaps, meta-analyses, and other efforts to assist others in their research endeavors and their pursuit of an evidence-based practice. The results of the “systematic review” of the committee’s many recent activities are below. Studying Life Effects and Effectiveness of Palatopharyngoplasty (SLEEP) Principal investigator: Edward M. Weaver, MD, MPH SLEEP was a multisite, community-based study to demonstrate the quality of life (QoL) treatment effects of uvulopalatopharyngoplasty (UPPP). Up to the time of the study, sleep surgery procedures had only been measured in terms of polysomnography changes. Using a novel community-based research network approach, the study demonstrated that UPPP provides substantial and durable quality of life (QoL) improvements. Weaver EM, Woodson BT, Yueh B, Smith T, Stewart MG, Hannley M, Schulz K, Patel MM, Witsell D; the SLEEP Study Investigators. Otolaryngol Head Neck Surg. 2011 Apr;144(4):623-631. Epub 2011 Feb 10. Treatment of Advanced Laryngeal Cancer (TALC) Principal Investigator: Bevan Yueh, MD, MPH TALC is a prospective, multi-site study assessing how chemoradiation for patients with new tumors of the hypopharynx (T2, T3) and cartilage-invading larynx (T3, T4) impacts QoL, in particular, swallowing and speech. The immediate goals are to identify pre-treatment predictors of swallowing function after treatment, and to explore the relative impact of chemoradiation vs. laryngectomy on swallowing, with secondary analyses of outcomes such as self-reported health status, H&N-specific function, and speech. Enrollment closed December 31, 2013, and one year follow-up will be completed on December 31, 2014. Parental Response to Ear Disease In Children with and without Tubes (PREDICT) Principal Investigator: Judith E.C. Lieu, MD PREDICT is a multi-institutional study that explores the impact that ear disease has on the child and their family in terms of QoL. This study uses several QoL instruments, both disease-specific and general, and meets the Academy’s NIH PROMIS (Patient Reported Outcomes Measurement Information System) collaboration goals. The study showed that otitis media significantly decreases QoL and that ear tube placement was associated with significant increases in QoL. Grindler DJ, Blank SJ, Schulz KA, Witsell DL, Lieu JE. Impact of Otitis Media Severity on Children’s Quality of Life. Otolaryngol Head Neck Surg. 2014 Mar 13. Hoarseness Database Study Principal Investigator: Seth M. Cohen, MD, MPH The purpose of this study effort was to use a large national administrative claims database to evaluate the epidemiology, patient demographics, practice patterns, and outcomes of the treatment of dysphonia patients. These data proved to be very instructive and several associated studies were performed. Cohen SM, Kim J, Roy N, Asche C, Courey M. Prevalence and Causes of Dysphonia in a Large-Treatment Seeking Population. Laryngoscope. 2012;122:343-348. Cohen SM, Kim J, Roy N, Asche C, Courey M. The impact of laryngeal disorders on work-related dysfunction. Laryngoscope. 2012;122:1589–1594. Cohen SM, Kim J, Roy N, Asche C, Courey M. Direct health care costs of laryngeal diseases and disorders. Laryngoscope. 2012;122:1582–1588. Hypopharyngeal Obstructive Sleep Apnea (OSA) Surgery Survey Principal Investigator: Eric J. Kezirian, MD, MPH The purpose of this survey was to evaluate factors influencing evaluation of and treatment decisions for patients with obstructive sleep apnea (OSA). Multilevel sleep surgery including hypopharyngeal procedures has been shown to increase procedure success, yet few otolaryngologists perform hypopharyngeal procedures. This survey study sought to assess otolaryngologists’ perceptions and attitudes toward hypopharyngeal surgery. It showed that a lack of training and comfort with these procedures was the most common reason that hypopharyngeal surgeries were not more frequently utilized. Kezirian EJ, Hussey HM, Brietzke SE, Cohen SM, Davis GE, Shin JJ, Weinberger DG, Cabana MD. Hypopharyngeal surgery in obstructive sleep apnea: practice patterns, perceptions, and attitudes. Otolaryngol Head Neck Surg. 2012 Nov;147(5):964-71. Meta-Analysis of Macrolide Therapy for Chronic Rhinosinusitis Co-Investigtors: Melissa A. Pynnonen, MD, Greg E. Davis, MD, MPH, and Giri Venkatraman, MD, MBA The objective of this systematic review was to investigate the disease-specific QoL impact of long-term macrolide therapy, compared with any other treatment, for adults with chronic rhinosinusitis. It showed there is limited scientific evidence to support the use of long-term macrolide therapy for chronic rhinosinusitis. Pynnonen MA, Venkatraman G, Davis GE. Macrolide therapy for chronic rhinosinusitis: a meta-analysis. Otolaryngol Head Neck Surg. 2013 Mar;148(3):366-73. Systematic review of the use of specific neuromodulators in the treatment of chronic, idiopathic cough Co-Investigators: Seth M. Cohen, MD, MPH, and Stephanie Misono, MD, MPH The objective of this systematic review was to determine the role of specific neuromodulators (elavil, lyrica, neurotonin) in the treatment of chronic cough. It showed that the available evidence indicate that these medications indeed do provide measurable benefit for chronic cough patients. Cohen SM, Misono S. Use of specific neuromodulators in the treatment of chronic, idiopathic cough: a systematic review. Otolaryngol Head Neck Surg. 2013 Mar;148(3):374-82. Quality of Life Outcomes Tool Registry Scott E. Brietzke, MD, MPH This project was undertaken through the OREBM Committee to explore and compile the best available QoL instruments available for use in otolaryngology and to make them easily available on the Academy website as a resource to all members. The instruments are grouped by clinical focus and the pertinent details such as length and links to supporting validation publications are also included.  http://www.entnet.org/EducationAndResearch/outcomesTools.cfm Otolaryngology Research Database Registry Jennifer J. Shin, MD, SM, and Melissa A. Pynnonen, MD This resource provides a compilation and description of existing datasets that may be appropriate for otolaryngology research. Each dataset is unique, with its own advantages, disadvantages, and nuances. To help newcomers identify a dataset that may be relevant for a particular research question, a basic overview of each dataset, example publications, and links for obtaining further information is provided. Datasets for inclusion were selected based on recommendations from members of the OREBM Committee. http://www.entnet.org/EducationAndResearch/Research-Databases.cfm Redesign of the Maureen Hannley Research Grant John S. Rhee, MD, MPH, and Scott E. Brietzke, MD, MPH The committee worked extensively with the research activities board and the CORE grant group to restructure the Maureen Hannley CORE Grant to support (maximum award of $50,000) primary research by young investigators that targets specific evidence gaps within the specialty of otolaryngology. http://www.entnet.org/EducationAndResearch/upload/2014-AAOHNSF-Maureen-Hannley-Grant_FINAL.pdf Annual Meeting Miniseminars The OREBM committee has also been strongly committed to educational efforts to increase knowledge and awareness of the principles and benefits of an evidence-based practice. The committee has sponsored several educational miniseminars at the annual meeting during the past few years in a variety of subject areas: Pediatric OSAS: Guidelines, Evidence, and Nuance (Vancouver 2013) Sleep Surgery Treatment Outcomes & Policy (Washington, DC, 2012) Rapid Review: The Guidelines in Pediatric Otolaryngology (Washington, DC, 2012) Evidence-Based Approach to Treating Chronic Rhinosinusitis (San Francisco 2011) Landmark Randomized Clinical Trials in Otolaryngology (San Francisco 2011) Outcomes Research: Past, Present, and Future (San Francisco 2011) Sleep Surgery: Reviewing the Reviews (San Francisco 2011) Cochrane and Guidelines International Network Scholars Participation as a Cochrane scholar and/or a Guideline International Network (G-I-N) scholar provides a phenomenal educational experience either in the area of meta-analysis and systematic review or in guideline development. Selectees attend an international meeting, network with leaders in the field, and then develop their new skill set within otolaryngology by completing either a meta-analysis project or participating in a guideline development panel. Below are members of the OREBM committee who were selected as Cochrane and/or G-I-N scholars. All interested Academy members should strongly consider pursuing this opportunity! Jennifer J. Shin, MD, SM (Cochrane 2008, G-I-N 2013) Seth M. Cohen, MD, MPH (Cochrane 2011) Melissa A. Pynnonen, MD (Cochrane 2011, G-I-N 2012) Lisa E. Ishii, MD, MHS (Cochrane 2012, G-I-N 2012) Stephanie Misono, MD, MPH (Cochrane 2012) Scott E. Brietzke, MD, MPH (G-I-N 2013) As I conclude this “systematic review” of the OREBM committee’s recent efforts, I would like to acknowledge the marvelous support from the Academy that has made this body of work possible. Although the faces and names of those who have supported the committee throughout the years have changed, the answer was always “yes!” for any effort the committee wanted to undertake and the support the committee received was always tireless and outstanding! As Dr. Jennifer Shin takes over leadership of the OREBM committee, I have no doubt that the long-standing traditions of the OREBM committee that include productivity and service with a clear goal of improving our specialty and the care of our patients will certainly continue.
Thank You to the 2014 CORE Study Section
The AAO-HNS/F, CORE societies, foundations, sponsors, and partners would like to formally thank the 2014 CORE Study Section for their commitment to ensuring that research grants are awarded to the most meritorious grant applications. They provide written critiques to each applicant to assist our young investigators with strengthening their grant-writing skills and encouraging them to continue to pursue their research careers in otolaryngology-head and neck surgery. Dunia Abdul-Aziz, MDOliver F. Adunka, MDNishant Agrawal, MD Henry P. Barham, MD Carol M. Bier-Laning, MD Benjamin Saul Bleier, MD Jonathan M. Bock, MD Michael G. Brandt, BSc, MD Jason Brant, MD, MA Michael J. Brenner, MD Marisa Buchakjian, MD, PhD Trinitia Y. Cannon, MD Steven S. Chang, MD Dinesh Chhetri, MD Steven B. Chinn, MD, MPH Noam A. Cohen, MD, PhD Raj C. Dedhia, MD, MS Vaninder Dhillon, MD Gregory R. Dion, MD Charles S. Ebert, Jr, MD, MPH Daniel Faden, MD David O. Francis, MD David R. Friedland, MD, PhD John A Germiller, MD, PhD Nira A. Goldstein, MD Steven Goudy, MD Christine G. Gourin, MD John H. Greinwald, Jr, MD Rebecca Hammon, MD Marlan R. Hansen, MD Ronna Hertzano, MD, PhD Courtney Hill, MD Alexander T. Hillel, MDMichael E. Hoffer, MDMonica Hoy, MD Clifford R. Hume, MD, PhD Akira Ishiyama, MD Stacey L. Ishman, MD, MPH Mark J. Jameson, MD, PhD Taha Jan, MD Benjamin L. Judson, MD David H. Jung, MD, PhD Alexandra Kejner, MD Young Jun Kim, MD, PhD Adam J. Kimple, MD, PhD Ruwan Kiringoda, MD Andrew Lane, MD Corinna Levine, MD, MPH Timothy S. Lian, MD Judith E. C. Lieu, MD Philip Littlefield, MD Jeffrey C. Liu, MD Brenda L. Lonsbury-Martin, PhD Amber U. Luong, MD, PhD Stephen Maturo, Maj, USAF, MC, FS Bryan R. McRae, MD Eduardo Mendez, MD Stephanie Misono, MD, MPH Joshua Mitchell, MD Jeffrey S. Moyer, MD Cherie-Ann O. Nathan, MD Rick F. Nelson, MD, PhD Anh T. Nguyen Huynh, MD, PhD Carrie Nieman, MD, MPH Thomas J. Ow, MDAlbert H. Park, MD   Renee Park, MD, MPHAndrea Park, MD Jayant Pinto, MD Karen T. Pitman, MD Vijay R. Ramakrishnan, MD Murugappan Ramanathan, MD Claus-Peter Richter, MD, PhD Christina Runge PhD, CCC-A Rodney J. Schlosser, MD Nathan M. Schularick, MD Andrew Shuman, MD Andrew Sikora, MD, PhD Bhuvanesh Singh, MD, PhD Jonathan Skirko, MD, MPH, MHPA Matthew E. Spector, MD Maie St. John, MD PhD Gordon H. Sun, MD John B. Sunwoo, MD Amar C. Suryadevara, MD Bruce Tan, MD Jonathan Y. Ting, MD Travis T. Tollefson, MD Michael P. Underbrink, MD, MPH Ravindra Uppaluri, MD, PhD Steven J. Wang, MD Preston D. Ward, MD Edward M. Weaver, MD, MPH Debra G. Weinberger, MD Christopher Welch, MD, PhD Bradford A. Woodworth, MD Adam Mikial Zanation, MD Jing Zheng, PhD
Congratulations to the 2014 CORE Grantees
American Academy of Otolaryngic Allergy (AAOA) Foundation See ARS/AAOA Joint Clinical Research Award listed under the American Rhinological Society The Education and Research Foundation for the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) AAFPRS Leslie Bernstein Resident Research Grant PI: Sagar Patel, MD ($5,000) INSTITUTION: Wayne State University, Detroit, MI PROJECT: Biomechanics of the orbital floor fracture PI: Shaun Desai, MD ($5,000) INSTITUTION: Washington University, St. Louis, MO PROJECT: Complications of alloplastic and allograft implants following septorhinoplasty PI: Leslie Kim, MD, MPH ($5,000) INSTITUTION: The Ohio State University, Columbus, OH PROJECT: Fractionated CO2 laser resurfacing of radial forearm free flap donor site scars AAFPRS Leslie Bernstein Grant No meritorious applications received. AAFPRS Leslie Bernstein Investigator Development Grant No meritorious applications received. AAFPRS Research Scholar Award PI: Jon-Paul Pepper, MD ($29,675) INSTITUTION: University of Southern California – Keck School of Medicine, Los Angeles, CA PROJECT: Peripheral nerve grafts engineered from mature human fibroblasts American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) AAO-HNSF Resident Research Award PI: Marisa Buchakjian, PhD, MD ($10,000) INSTITUTION: The University of Iowa, Iowa City, IA PROJECT: Developing a conditional TP53/PTEN knockout mouse model of tongue cancer PI: William Carroll, MD ($10,000) INSTITUTION: Medical University of South Carolina, Charleston, SC PROJECT: Vitamin D3 deficiency and fibroblast proliferation in chronic sinusitis PI: Amelia Clark, MD ($8,000) INSTITUTION: Stanford University, Stanford, CA PROJECT: A randomized controlled trial of bevacizumab for HHT-related epistaxis PI: Daniel Faden, MD ($10,000) INSTITUTION: University of California, San Francisco, CA PROJECT: Whole genome/transcriptome sequencing of oral tongue carcinoma in non-smokers PI: Elisabeth Ference, MD ($9,999) INSTITUTION: Northwestern University, Chicago, IL PROJECT: Antibiotic prescriptions for upper respiratory tract infections in children PI: John Gleysteen, MD ($10,000) INSTITUTION: Oregon Health & Science University, Portland, OR PROJECT: Role of Wnt signaling in metastatic oral cavity squamous cell carcinoma PI: Adam Kimple, MD, PhD ($10,000) INSTITUTION: The University of North Carolina, Chapel Hill, NC PROJECT: Regulating mucociliary clearance PI: Eugene Sansoni, MD ($8,000) INSTITUTION: Oregon Health & Science University, Portland, OR PROJECT: Disease severity and vitamin D in patients with chronic rhinosinusitis PI: Priyanka Shah, MD ($10,000) INSTITUTION: Wayne State University, Detroit, MI PROJECT: Role of disulfiram in oxidative stress and OSCC xenograft burden PI: Travis Shiba, MD ($9,999) INSTITUTION: University of California, Los Angeles, CA PROJECT: In-vivo tissue engineered vocal fold cover layer replacement AAO-HNSF Saidee Keller Memorial Research Grant PI: Danan Deepa, MD, MBA ($10,000) INSTITUTION: University of Virginia, Charlottesville, VA PROJECT: The effect of adipose-derived stem cells on head and neck squamous cell carcinoma AAO-HNSF Percy Memorial Research Award PI: Maie St. John, MD, PhD ($25,000) INSTITUTION: University of California, Los Angeles, CA PROJECT: A novel modular polymer platform for the treatment of oral and head and neck squamous cell carcinoma AAO-HNSF Health Services Research Grant PI: Erin Kirkham, MD ($10,000) INSTITUTION: Seattle Children’s Hospital, Seattle, WA PROJECT: The association between snoring and high-risk carotid plaques: a pilot study AAO-HNSF Maureen Hannley Research Training Award No meritorious applications received. Rande H Lazar Health Services Research Grant PI: Raj Dedhia, MD ($9,871) INSTITUTION: University of Washington, Seattle, WA PROJECT: Assessing the validity of VOTE scoring for drug induced sleep endoscopy The Alcon Foundation/AAO-HNSF Resident Research Grant PI: Courtney Hill, MD ($10,000) INSTITUTION: Dartmouth Hitchcock Medical Center, Lebanon, NH PROJECT: Effect of tonsillectomy on taste acuity and BMI in children Cook Medical/AAO-HNSF Resident Research Grant PI: Xiaoyang Hua, MD ($10,000) INSTITUTION: University of Iowa Hospital, Iowa City, IA PROJECT: Nasal priming of lung innate immunity The Doctors Company/ AAO-HNSF Resident Research Grant No meritorious applications received. The Oticon Foundation/AAO-HNSF Resident Research Grant PI: Chad Ruffin, MD ($9,948) INSTITUTION: Indiana University, Indianapolis, IN PROJECT: Using the novel CISPA outcome measure to improve cochlear implants American Head and Neck Society (AHNS) AHNS/AAO-HNSF Translational Innovator Award PI: Seungwon Kim, MD ($25,000) INSTITUTION: University of Pittsburgh, Pittsburgh, PA PROJECT: Mechanism of perineural invasion in head and neck cancer AHNS/ AAO-HNSF Young Investigators Combined Grant PI: Joseph Curry, MD ($40,000) INSTITUTION: Thomas Jefferson University, Philadelphia, PA PROJECT: Multicompartment glycolytic metabolism in head and neck cancer AHNS Pilot Grant PI: Monika Freiser, BS ($10,000) INSTITUTION: Miller School of Medicine of the University of Miami, FL PROJECT: HNSCC disparities: identifying critical barriers and intervention targets AHNS Ballantyne Resident Research Grant PI: Jennifer Wang, MD ($10,000) INSTITUTION: University Health Network, Toronto, Ontario PROJECT: Chromatin remodeling and head and neck squamous cell carcinoma American Hearing Research Foundation (AHRF) AHRF Wiley H. Harrison Memorial Research Award PI: Kristy Truong, MD ($25,000) INSTITUTION: The University of Iowa, Iowa City, IA PROJECT: Biochemical and topographic guidance of spiral ganglion neurite growth American Laryngological Association (ALA) ALA-ALVRE Grant No meritorious applications received. ALA Seymour R. Cohen Research Grant PI: Christopher Johnson, MD ($19,560) INSTITUTION: Georgia Regents University, Augusta, GA PROJECT: Effect of sterilization on viability of murine tracheal cartilage grafts The American Laryngological, Rhinological, and Otological Society, Inc., aka The Triological Society Triological Research Career Development Award PI: Simon Best, MD ($40,000) INSTITUTION: Johns Hopkins University School of Medicine, Baltimore, MD PROJECT: Therapeutic DNA vaccine for recurrent respiratory papillomatosis PI: Matthew Bush, MD ($40,000) INSTITUTION: University of Kentucky Research Foundation, Lexington, KY PROJECT: Promoting early congenital hearing loss diagnosis with patient navigation PI: Jolie Chang, MD ($40,000) INSTITUTION: University of California, San Francisco, CA PROJECT: Plasticity of binaural integration in asymmetric sensorineural hearing loss PI: Aaron Moberly, MD ($40,000) INSTITUTION: The Ohio State University, Columbus, OH PROJECT: Personalizing aural rehabilitation for adults with cochlear implants PI: Jeremy Meier, MD ($40,000) INSTITUTION: University of Utah, Salt Lake City, UT PROJECT: Improving Value in Pediatric Tonsillectomy through Shared Decision Making PI: Stephanie Smith, MD ($40,000) INSTITUTION: Northwestern University, Chicago, IL PROJECT: Acute rhinosinusitis complications: risks and role of prior antibiotics American Neurotology Society (ANS) ANS/AAO-HNSF Herbert Silverstein Otology & Neurotology Research Award PI: Dylan Chan, MD, PhD ($25,000) INSTITUTION: University of California, San Francisco, CA PROJECT: Gap junctions in the cochlear response to sound and noise in vitro American Rhinologic Society (ARS) ARS/AAOA Joint Clinical Research Award PI: Zachary Soler, MD, MSc ($40,000) INSTITUTION: Medical University of South Carolina, Charleston, SC PROJECT: Sleep dysfunction in chronic rhinosinusitis ARS New Investigator Award PI: Justin Turner, MD, PhD ($24,750) INSTITUTION: Vanderbilt University Medical Center, Nashville, TN PROJECT: Regulation of inflammation by deubiquitinases in chronic rhinosinusitis ARS Resident Research Grants PI: Nyall London, MD, PhD ($8,000) INSTITUTION: Johns Hopkins University-School of Medicine, Baltimore, MD PROJECT: Targeting ARNO-Arf6 to stabilize barrier dysfunction in chronic rhinosinusitis PI: Elizabeth Cottrill, MD ($7,997) INSTITUTION: University of Pennsylvania, Philadelphia, PA PROJECT: Characterization of sinonasal solitary chemosensory cells American Society of Pediatric Otolaryngology (ASPO) ASPO Research Grant PI: Graham Strub, MD, PhD ($20,000) INSTITUTION: Seattle Children’s Hospital, Seattle, WA PROJECT: MicroRNA-mediated regression of infantile hemangioma by propanolol PI: Robert Morrison, MD ($20,000) INSTITUTION: University of Michigan, Ann Arbor, MI PROJECT: Computer-aided designed 3D-printed bioscaffold for auricular reconstruction ASPO Research Career Development Award PI: Emily Boss, MD ($40,000) INSTITUTION: Johns Hopkins University School of Medicine, Baltimore, MD PROJECT: Shared decision-making and outcomes in pediatric sleep disordered breathing ASPO Dustin Micah Harper Recurrent Respiratory Papillomatosis Research Grant PI: Simon Best, MD ($10,000) INSTITUTION: Johns Hopkins University School of Medicine, Baltimore, MD PROJECT: The PD-1 and PD-L1 pathway in recurrent respiratory papillomatosis Knowles Hearing Center at Northwestern University Knowles Center Collaborative Grant PI: Steven DeVries, MD, PhD ($30,000) INSTITUTION: Northwestern University, Chicago, IL PROJECT: Role of marshalin in signaling at ribbon synapses
CORE Grants 2014
The Centralized Otolaryngology Research Efforts (CORE) grants program plays a critical role in advancing the field of otolaryngology by providing support to research projects, research training, and career development. CORE aims to: (1) unify the research application and review process for the specialty; (2) encourage young investigators to pursue research in otolaryngology; and (3) serve as an interim step that may ultimately channel efforts for important NIH funding opportunities. The CORE grant program societies, foundations, sponsors, and partners have awarded more than 530 grants totaling just under $9.5 million since the program’s inception in 1985. In conjunction with the American Academy of Otolaryngology—Head and Neck Surgery Foundation (AAO-HNSF), societies, foundations, and sponsors are involved in funding one- to two-year non-renewable grants ranging from $5,000 to $70,000. The leadership of each participating specialty society is ultimately responsible for determining who is selected to receive funding each year. The scores and critiques provided by the CORE Study Section are simply recommendations to help in the decision process. The recipients of the grants sponsored by the Alcon Foundation, Cook Medical, Oticon Foundation, and The Doctors Company are determined by the AAO-HNSF leadership. This year the CORE Study Section reviewed 183 applications seeking $3,412,376 in research funding. The 2014 CORE Study Section subcommittees included: Head and Neck Surgery, chaired by Christine G. Gourin, MD; Otology, chaired by David R. Friedland, MD, PhD; and General Otolaryngology, chaired by Rodney J. Schlosser, MD. The 2014 CORE leadership (including the boards and councils of all participating societies) has approved a portfolio of 43 grants totaling $820,799.
Building the Evidence: Guidelines and Consensus Statements
Since 2006, the AAO-HNSF has developed quality knowledge products (QKPs), including clinical practice guidelines (CPGs) and clinical consensus statements (CCSs), to support evidence-based decisions in patient care. Since we reported last July, the AAO-HNSF has published two new QKPs: CPG: Bell’s Palsy (November 2013) and Update to CPG: Acute Otitis Externa (January 2014). Four additional QKPs are in development and will be submitted for publication by the end of 2014: CPG: Tinnitus; CCS: Pediatric Sinusitis; CPG: Allergic Rhinitis; and Update to CPG: Adult Sinusitis. Oversight: Guideline Task Force (GTF) The GTF oversees the development, dissemination, implementation, and prioritization of topics for AAO-HNSF CPGs and CCSs. The GTF is led by Seth R. Schwartz, MD, MPH, chair, and Richard M. Rosenfeld, MD, MPH, past-chair and current AAO-HNSF Senior Consultant for Quality and Guidelines. The GTF comprises subspecialty society representatives from the American Broncho-Esophagological Association, American Neurotology Society, American Rhinologic Society, American Head and Neck Society, American Laryngological Association, The American Laryngological, Rhinological, and Otological Society, Inc. (The Triological Society), American Otological Society, American Academy of Facial Plastic and Reconstructive Surgery, American Academy of Otolaryngic Allergy, American Society of Pediatric Otolaryngology, and representatives from the AAO-HNS Board of Governors, Association of Otolaryngology Administrators, American Board of Otolaryngology, and Society Otorhinolaryngology and Head-Neck Nurses. The AAO-HNS Physician Payment and Policy (3P) Workgroup also now has a representative on the GTF. The group meets biannually at the Academy’s headquarters and reviews guideline development methodology and progress and prioritizes upcoming products. All AAO-HNS/F Scientific and Education Committees are encouraged to submit topics to the GTF for consideration. Topics are presented and voted on at the fall/winter GTF meeting. Approved future CPG/CCS topics include: Clinical Consensus Statement: Septoplasty Clinical Practice Guideline: Rhinoplasty Clinical Practice Guideline: Evaluation of the Neck Mass in Adults Clinical Practice Guideline: The Surgical Management of Rhinosinusitis Coming Soon: Clinical Consensus Statement (CCS) Methodology Since 2010, the AAO-HNSF has published three CCSs. The fourth has been submitted to the journal. We are pleased to report that the CCS development manual is near completion and will be submitted for publication later this year. Harmonizing CPGs In June, the AAO-HNSF and the AmericanAcademy of Neurology (AAN) co-published a commentary in their respective journals, Otolaryngology–Head and Neck Surgery and Neurology, entitled Reconciling the Clinical Practice Guidelines on Bell’s Palsy from the AAO-HNSF and the AAN. The CPG on Bell’s Palsy, recently produced by the AAO-HNSF, followed closely on the heels of the guideline on Bell’s Palsy published by the AAN. In an effort to provide harmonization between these two guidelines for the end users, authors and staff from both CPGs worked together to develop the commentary. AAO-HNSF Partners with International Guideline Central Recently, the AAO-HNSF formed a partnership with International Guideline Central (IGC). IGC is a producer of evidence-based quick reference guides in both paper pocketcard and mobile and web application formats for healthcare professionals. AAO-HNSF has joined with IGC to help develop full text clinical guidelines into quick reference tools. The IGC relationship will allow AAO-HNSF to 1. increase the dissemination of its CPGs to a much broader audience and 2. provide quick reference tools in both the pocket card and app format to its members. The CPG guideline development group leadership, Foundation staff, and the IGC medical director collectively develop the content to be included in the pocketcard and app from the AAO-HNSF guidelines. The guideline apps and pocketcards feature diagnosis and assessment information, treatment options, including their associated levels of evidence, and other recommendations from the AAO-HNSF CPGs. The pocketcards and apps are a tool for providers for point-of-care decision-making and quality improvement. AAO-HNSF members can receive a 10 percent discount by entering “OTOCPG” at checkout. The following guidelines are now available: Bell’s Palsy, Tonsillectomy, Tympanostomy Tubes, Acute Otitis Externa and Sudden Hearing Loss. Learn more by visiting www.guidelinecentral.com/medical-society/american-academy-otolaryngology-head-and-neck-surgeons. Get Involved with Guidelines In an effort to foster involvement in guideline development and encourage participation in guideline development groups, the AAO-HNSF started the Guidelines International Network (G-I-N) Scholars program in 2012. In exchange for a travel grant to attend the G-I-N Annual Meeting, each scholar agrees to write a commentary for Otolaryngology–Head and Neck Surgery during the coming year related to one of the themes of the G-I-N meeting. This is part of our education efforts to help bring awareness and understanding about the development of clinical practice guidelines to our members. In addition, all G-I-N Scholars agree to serve on an upcoming AAO-HNSF clinical practice guideline panel. Sharing and Expanding our Knowledge In addition to sponsoring members to attend the 2014 G-I-N Conference, AAO-HNSF will also be presenting. Two posters have also been accepted: Clinical Practice Guideline Plain Language Summaries Help to Empower Patients, submitted by Leslie Caspersen, MBA, and Stephanie Jones; and Reference Rodeo, submitted by Gene Cunningham and Stephanie Jones.
History of the CHEER Clinical Research Coordinator Conference – EXTENDED ONLINE VERSION
Shaun A. Nguyen, MD, MA, CPI  The history of clinical research emphasizes the close relationship between clinical research and clinical care. The ethics of clinical research tend to focus on whether, and to what extent, the treatment of research subjects diverges from the norms of clinical care. Clinical research is often conducted with patients and is often performed by physicians and clinical research coordinators. Modern clinical research studies are accompanied by more rules, regulations, laws, and guidelines than ever governing research with human subjects. I am director of Clinical Research for the department of otolaryngology-head and neck surgery at the Medical University of South Carolina (MUSC), where we are training a new generation of otolaryngology physician investigators through our research fellowship program. In addition, through the collaboration with the Master of Science in Clinical Research Program at the Medical University of South Carolina, we are providing an internship program for clinical research coordinators with more than 30 investigator-initiated and corporate-sponsored clinical trials. MUSC research fellows and clinical research coordinators have attended the Annual CHEER Conference since its inception in 2008. The two-day Annual CHEER Coordinator’s Conference provides physician investigators and clinical research coordinators the knowledge and expertise to conduct clinical research studies and follow principles of good clinical practice (GCP). The conference delivers disease-specific education and an overview of the clinical research process: its function, history, and development. Physician-investigators, research fellows, and clinical research coordinators learn project management skills and clinical practice guidelines. They learn about research team member roles, typical study designs, and developmental phases of clinical trials. For the 6th Annual CHEER Conference, MUSC sent three research fellows and three students for training. Conference Overview P. Ryan Camilon The 6th annual CHEER conference differed from previous meetings by greater incorporation of disease-specific education among the usual clinical-trial focused lectures. Neurotologist Alan Langman, MD, provided an overview of the pathophysiology, evaluation, and treatment of Meniere’s disease in the context of the aspects currently being explored. Melissa Pynnonen, MD, explained several issues in the diagnosis and treatment of sinusitis as well as challenges that need to be tackled concerning sinusitis research. Laryngologist Joshua Schindler, MD, presented a summary of laryngeal pathology after voice therapist Donna Graville, PhD, discussed possible areas of investigation in voice management. Finally, neurotologist Debara Tucci, MD, MS, (Co-PI for CHEER) reviewed sudden sensorineural hearing loss and current treatment controversies. Typically, the CHEER conference focuses heavily on research-practical topics, which were still thoroughly addressed. David Witsell, MD, MHS, (CHEER PI) and Kris Schulz, MPH (Director of Research), summarized CHEER’s current clinical trials and discussed the growth of the network, which now consists of 28 sites in 18 states. Select CHEER research coordinators presented topics covering FDA investigator qualification, new methods of site monitoring, preparation for an FDA audit, and IRB regulatory documentation. Also new in this year’s conference was an emphasis on the open discussion of ideas and experiences between coordinators. This new theme proved to be rewarding. Small-group sessions on how to ethically get consent from patients and properly manage their information led to the sharing of troubleshooting tips and methods to improve researcher technique. This year, CHEER provided coordinators with a better understanding of ear, nose, and throat pathology in addition to covering the latest changes in the research regulatory landscape. By presenting coordinators with more medical information, we hope to ensure a greater understanding of how CHEER projects will improve the treatment of patients, and also foresight into what aspects of head and neck pathology may be explored down the road. Reflection on the Experience Colin Fuller, MD, MS While we were all excited to be invited to participate in the annual CHEER Conference, I admit that I was unsure what to expect from the meeting. As a research fellow coordinating clinical trials for the first time, I anticipated a top-down, hierarchical situation where PIs would dole out instructions on how to facilitate practice-based research in general, and how to conduct the joint CHEER trials specifically. Instead, we were invited to an open discussion with providers at every level (PIs, nurses, SLPs, audiologists, residents, and coordinators) speaking directly about the conduct of clinical research. From Dr. Witsell’s opening address on the first day, a collegial and friendly atmosphere permeated every lecture and discussion. We were encouraged to contribute to the development of specific research protocol for the CHEER network studies, which helped to make the data collection process as efficient and practical as possible. We also shared ideas for how to improve data collection and subject protection for all human research studies. These discussions were incredibly informative to us as newly minted research fellows. Dr. Witsell’s remarks urged us to strive to replicate the behaviors of the most successful among us—to be, or to emulate, the “positive deviant.” With the conference bringing to bear the experiences and resources of so many research professionals, the CHEER network will be well-served by this philosophy. In the near future, I am quite confident that other specialties will be emulating the CHEER network itself as that “positive deviant.” How Does this Prepare Me for the Future (As a Future PI)? Amit J. Sood In addition to direct clinical care, my future practice as an academic otolaryngologist will include contributing to advancements in patient care. Clinical research, as a vehicle for medical advancement, enables a provider to treat patients with cutting-edge technologies and the most up-to-date knowledge of disease processes. The CHEER conference offers many learning opportunities for those interested in clinical research. The CHEER network fosters an appreciation for clinically driven research in an informal setting for providers at every level, including aspiring PIs like myself. In addition to informative clinical presentations, the CHEER network discusses the inner workings of “what to expect” when undertaking a clinical trial from start to finish. Experienced coordinators explain concepts such as IRB process, protocol design, and funding, while others provide insight on the “pitfalls” of clinical trials such as FDA audits. The conference instills feelings of appreciation for clinically oriented research and a greater desire to perform clinical research to enhance patient care for the next generation of patients. Lastly, it provides specific tools, connections, and resources that are needed to help facilitate successful clinical trials for coordinators and future PIs alike.
PSQI Committee: Year in Review
The Patient Safety Quality Improvement Committee (PSQI) continues to research topics, conduct studies, write articles, and develop Annual Meeting programming to assist our members in the areas of clinical quality improvement and patient safety. This past year, PSQI led several prominent projects that have elevated our visibility despite the small size of our specialty. We received positive feedback on our quality focus and the work we have done throughout the years from officials at Centers for Medicare & Medicaid Services (CMS) who congratulated us at an in-person meeting for the numerous ongoing quality improvement initiatives in otolaryngology-head and neck surgery. There is ongoing work being conducted by the PSQI on behalf of the specialty including efforts to populate a patient safety web-based tool; effective representation of the specialty at national quality organizations; and survey and database studies to identify issues and build tools that can be utilized by members to mitigate risk. During the past year, PSQI focused primarily on the following projects. 1. AAO-HNSF 2013 Annual Meeting & OTO EXPOSM a. Miniseminar on Big Patients, Big Worries (Margaret L. Skinner, MD, and Daniel L. Wohl, MD) b. Miniseminar on In Office Safety: Avoiding Unsafe Office Practices (Berrylin J. Ferguson, MD, Jonathan C. Kopelovich, MD, and Patrick T. Hennessey, MD) 2. Five journal articles published a. Zhu H, Das P, Roberson DW, Skinner ML, Felton M, Yuan J, Berry J. Hospitalizations in Children with Pre-existing Tracheostomy: A National Perspective. Submitted to Laryngoscope 2013. b. Goldman JL, Baugh RF, Davies L, Skinner ML, Stachler RJ, Brereton J, Eisenberg LD, Roberson DW, Brenner MJ. Mortality and major morbidity after tonsillectomy: etiologic factors and strategies for prevention. Laryngoscope. 2013 Oct;123(10):2544-53. Epub 2013 Apr 17. c. Racoosin JA, Roberson DW, Pacanowski MA, Nielsen DR. New evidence about an old drug—risk with codeine after adenotonsillectomy. N Engl J Med. 2013 Jun 6;368(23):2155-7. Epub 2013 Apr 24. d. Robertson PJ, Brereton JM, Roberson DW, Shah RK, Nielsen DR. Choosing wisely: our list. Otolaryngol Head Neck Surg. 2013 Apr; 148(4):534-6. Epub 2013 Feb 28. 3. Adverse Event Reporting Tool was developed using multi-stakeholder input and allows members to confidentially report on near misses, adverse events, and medical errors in real-time. The purpose of the portal is to collect information on patterns and trends of patient safety events in otolaryngology and help inform the PSQI Committee’s work in this area. Once there is a larger sample of data, the committee will use these data to develop patient safety improvement interventions. 4. National Quality Organization representation a. National Quality Forum (NQF) b. Reviewed the proposed modifications to the NQF Measure Evaluation Guidance for Evidence and Measure Testing. c. Reviewed and voted on performance measures, rosters, and other applicable reports 5. Surgical Quality Alliance (SQA) a. Reviewed and provided feedback on performance measures, including the Patient-centered Surgical Risk Assessment and Communication Measure. Reviewed and provided comments on SQA’s consensus document on the public reporting of physician data 6. AMA-convened Physician Consortium for Performance Improvement® (PCPI) a. Reviewed and voted on performance measures, including but not limited to asthma, anesthesia/critical care, adult diabetes, preventive care, and hepatitis C measure sets 7. AQA (formerly known as the Ambulatory Care Quality Alliance) a. Staff and physician representative presented AAO-HNS quality initiatives to the AQA Measures and Improvement Workgroup History of the CHEER Clinical Research Coordinator Conference CHEER Practice-based Research Network is an NIDCD-funded network comprising 30 sites in 17 states, and includes more than 200 otolaryngologists, 100 audiologists, and 50 SLPs, along with other research professionals. The focus of CHEER is to educate sites on practice-based research and maintain regulatory and research process infrastructure so sites are “at-the-ready” to participate in appropriate research studies. The CHEER Annual Coordinators Conference is one of CHEER’s flagship resources. Taking place at the Academy offices, the conference brings together study coordinators from the network, along with interested PIs and research professionals. The seventh annual conference will occur August 7-9. This article highlights experiences from the sixth annual conference. If you have questions about CHEER or the conference, please email Kristine Schulz at Kristine.schulz@duke.edu.
A Pivotal Year
John S. Rhee, MD, MPH, Research and Quality Improvement Coordinator This has been a pivotal year for Research and Quality Improvement as we continued to meet the specialty’s needs for quality knowledge products, expanded our efforts in implementation and dissemination of these products, revamped the CORE grants program, and researched plans for incorporating quality measurement development into the business unit to aid our members in meeting requirements for government and private payer quality programs and for Maintenance of Certification (MOC). The Patient Safety and Quality Improvement (PSQI) and Outcomes Research and Evidence Based Medicine (OREBM) Committees contribute greatly to these ongoing efforts. To improve implementation of clinical practice guidelines (CPGs) into practice, plain language summaries were developed on new guidelines. In addition, we partnered with an organization to provide pocket cards and apps for CPGs. Our dissemination and implementation efforts are not only focused on our specialty, but are geared also to other health professionals who treat patients with otolaryngology-head and neck surgery conditions. All of these activities require a tremendous volunteer effort and we now have a cohort of dedicated members who have developed expertise as chairs, co-chairs, panel members, methodologists, and implementation specialists for CPGs. We continue to be recognized within the national and international communities as a best practice organization in CPG development. Further details on our guidelines activity during the past year can be found in this issue of Bulletin. There will be an ongoing need for quality measures for our specialty in the foreseeable future. While changes based on the SGR are yet to be finalized, by all indications current quality programs requiring measure reporting at the individual physician level will continue to exist. However, for how long and what data exactly will be required is still not clear. Many private payers utilize programs such as Bridges to Excellence to create tiers of providers within their networks and these are also based on meeting specific quality measures. In addition, having quality measures for our specialty may assist physicians in meeting MOC requirements and are a natural outcome of the clinical practice guidelines process in terms of measuring adherence to guidelines. This past year, the Foundation has been in discussions with ABOto regarding the development of an otolaryngology-specific measure set utilizing existing measures in the Physician Quality Reporting System (PQRS) program. This would serve to reduce the reporting burden (less reporting is required if reporting on a measures group versus individual measures) and help our members get used to reporting to such programs. The latest data from CMS shows that about 36 percent of eligible otolaryngologists are reporting to PQRS. In the past, the Foundation has depended upon outside consortia, including the AMA-convened Physician Consortium for Performance Improvement® (PCPI), for the expertise to develop quality measures. This past year, a business plan outlining requirements for developing this expertise within the Research and Quality business unit was finalized and approved by the AAO-HNS/F Board. We continue to support a strong CORE grants program, which has provided numerous opportunities throughout the years for physician members to learn techniques for writing effective grant applications and to earn research grants. We are grateful to the many organizations that partner with us in these efforts. A review of the CORE grants program had not taken place since its inception at the Academy so this past year a board-level task force was appointed to review the program, to make sure we were still operating at optimal efficiency, and to identify areas for improvement. Based on the outcome of this work, some key changes were discussed with the funding organizations and changes will be incorporated for the 2015 grant cycle. A discussion of the CORE grants program, including this year’s grant recipients and a comprehensive list of the funding organizations, can be found on page 18. This marks the end of my term as the coordinator for Research and Quality Improvement and I want to formally welcome Lisa E. Ishii, MD, MHS, as the incoming coordinator. Lisa has the perfect background and skill set to help set the course as the Research and Quality Improvement business unit continues to evolve to meet the ongoing needs of our members.
Drs. House, Hitselberger, and Kroner
A Winning Team: William F. House, MD, and William E. Hitselberger, MD – ONLINE EXCLUSIVE
John W. House, MD Recently, medicine lost two great pioneers. William F. House, MD, died in December 2012, and William E. Hitselberger, MD, died in February 2014. Dr. House (“Dr. Bill,” as he was affectionately known) attended Whittier College and then the University of California during World War II, completing pre-dental requirements in two years, followed by his DDS. During his two years as a dental officer in the Navy, he decided to pursue medicine at the University of Southern California to become a maxillofacial surgeon. However, instead of a plastic surgery residency, he took the otolaryngology residency at Los AngelesCountyHospital, during which he became interested in otology through his brother, Howard House, MD. Upon completion of the residency in 1956, he joined his brother in practice. Much of what he learned in dentistry he applied to otology (e.g., dental drill, suction irrigation), but he soon became interested in solving the problems of the inner ear. Dr. Bill House began working on innovative approaches to acoustic neuromas in the early 1960s. One of his early patients was a young fireman with unilateral progressive hearing loss. Dr. House diagnosed an acoustic neuroma and sent the patient to a neurosurgeon, who said it was too early to operate given the risks of such surgery at the time. The patient ultimately had surgery when his tumor became larger, but did not survive. This caused Dr. House to conclude that early diagnosis and treatment were crucial to obtaining better outcomes. Howard had purchased one of the first microscopes for middle ear surgery, and Bill recognized its potential. He introduced the concept of using the operating microscope for neurosurgery, developing the middle cranial fossa and translabyrinthine approaches to safely remove the tumors in the cerebellopontine angle. He also recognized the need to have a neurosurgeon as a key part of his surgical team. However, the neurosurgeon with whom he had begun working, and others in the area, opposed the idea of an otologist removing acoustic tumors. It was in this arena that the “two Bills” met and together shaped the future of neurotology. Dr. Hitselberger (“Hits”) attended the University of Wisconsin where he played football and was Phi Beta Kappa. He completed his MD degree at HarvardMedicalSchool in 1956. After his internship at the University of Minnesota, he served two years in the U.S. Army Special Forces. Following his service, he completed a fellowship in neuropathology at the Mayo Clinic, completed his neurosurgery residency at Henry Ford in Detroit in 1963, and then arrived in Los Angeles. Dr. House was seeking a new neurosurgery colleague when their paths crossed. Dr. Hitselberger immediately saw the wisdom in Dr. House’s ideas and embraced them. He even suggested that they “cross-train,” and he worked with Dr. House in the morgue and lab to acquire his microscope and temporal bone skills. A lifelong bond was created. As the two doctors began to perform acoustic tumor removals at St. VincentHospital, the head of neurosurgery objected. This led to the infamous “showdown at St. Vincent” in which the neurosurgeon asked the Board of Directors and Sisters of the hospital to essentially forbid House and Dr. Hitselberger from doing the procedures, threatening to resign from the staff if the board did not do so. Dr. Howard House then threatened to resign if “the Bills” were not allowed to continue their work. The hospital sided with them and the neurosurgeon resigned. Together, Dr. Bill House and Dr. Hitselberger removed more than 5,000 acoustic neuromas and meningiomas, using the microscope and the approaches that Dr. House had perfected. After Dr. Bill House’s success with cochlear implants, “the Bills” conceived the idea in 1979 of placing an electrode on the brainstem of a patient with neurofibromatosis type 2 in an attempt to provide hearing after the tumor was removed. She had bilateral 8th nerve tumors and was to undergo the removal of her second tumor. After the doctors discussed this new concept with her, she agreed to have the electrode placed. The tumor removal went well, as did the placement of the electrode. They stimulated the electrode in the intensive care unit, as they were concerned about possible side effects when stimulating the brainstem. The patient heard sound without complications. To this day, she is still using her Central Electro-auditory Prosthesis as they called it (now known as an Auditory Brainstem Implant or ABI). Both directly and indirectly, Dr. House and Dr. Hitselberger trained hundreds of neurotologists from around the world. Their early work and perseverance has allowed the safe removal of acoustic tumors, reducing the mortality rate of such surgery in California from the 40 percent it was when they started to the less than 1 percent it is today. And, they pioneered the means to provide hearing to those deaf after removal of bilateral tumors. We all owe a great deal to these pioneers—a winning team.
Walter Messerklinger, MD
From Messerklinger to Kennedy – ONLINE EXCLUSIVE
Nikhila P. Raol, MD While trainees in the modern era of otolaryngology know the endoscopic technique to be the routine approach to sinus surgery, it was not long ago that an open-operative method was the most commonly used technique. Hirschman, in 1901, used a cystoscope to visualize the maxillary sinus through an oroantral fistula, while some years later, in 1922, Spielberg accessed the maxillary sinus using an athroscope via the inferior meatus. However, true advancement in the design of the scopes is what led to the revolution that lay ahead. Born in 1918 in Leicester, England, Harold Hopkins fell into a career in lens making following graduation, due to the limited number of jobs in his hometown. Eventually, he shifted his focus toward fiberoptics, and 1960 he patented the rod-lens system. Finding no takers for his work in Britain or in the United States, he presented his invention at an exhibition in Germany. Through a friend who was present at the exhibition, Karl Storz came to know about the technology and soon after, the Storz-Hopkins endoscopes became reality. Storz astounded the medical community with additional technology, the flexible fiberglass gastroscope, presented by the American gastroenterologist Hirschowitz. Combining these technologies, Storz quickly licensed the concept of a fiberoptic light transmission coupled with the rod-lens system. The advent of this technology made way for the fathers of modern day sinus surgery to implement these new tools in the field of otolaryngology. In the 1970s, Messerklinger used these endoscopes to visualize the mucociliary clearance patterns that ultimately changed the way sinus surgery was viewed, with the natural ostia of the sinuses found to play the most important role in maintaining the health of the sinuses. Because of this discovery, the need for external approaches to the sinuses became nearly obsolete, as the endoscopes became a mainstay of surgery. Another Austrian otolaryngologist, Stammberger, was able to translate these observations and descriptions into English and bring them to the United States via Kennedy at Johns Hopkins. By partnering further with Storz, these exceptional surgeons turned endoscopic sinus surgery into what it is today: an art form.
2014 Honorary Guest Lectures – EXTENDED ONLINE VERSION
Each year the Annual Meeting & OTO EXPOSM features invited lecturers to present on topics of value epitomizing the highest standards that our profession has to offer. This year is no different. Each lecture is unique in prospective and tone. This year we are honored to have four exemplary lectures included as part of the programming presented by individuals who exemplify the best of the best in otolaryngology. John Conley, MD Lecture on Medical Ethics The John Conley, MD Lecture on Medical Ethics was established in 1987. 8:30 am Sunday, September 21 (Opening Ceremony Keynote Speaker) Rosemary Gibson is senior advisor to The Hastings Center and an editor for JAMA Internal Medicine and author. At the Robert Wood Johnson Foundation in Princeton, NJ, she led national healthcare quality and safety initiatives for 16 years.  As chief architect of the foundation’s long-term strategy, she was developed the practice of palliative care in more than 1600 U.S. and  for this received Lifetime Achievement Award from the AmericanAcademy of Hospice and Palliative Medicine. Ms. Gibson worked with Bill Moyers and Public Affairs Television on the PBS documentary, “On Our Own Terms,” about how to provide better care for seriously ill patients and their families. She initiated a series in the Journal of the American Medical Association, “Perspectives on Care at the Close of Life.” Along with positions of leadership with the American Board of Medical Specialties Public Policy Committee and the Accreditation Council for Graduate Medical Education CLER Evaluation Committee acting to evaluate quality and patient safety in sponsoring institutions for residency training, Ms. Gibson belongs to the Consumers Union Safe Patient Project. Her publications often interpret the costs to individuals and more broadly to society of U.S. healthcare’s shortcomings, and have received acclaimed by peers and medical press. These titles include: Wall of Silence, the human story behind the Institute of Medicine report, To Err is Human; The Treatment Trap about overtreatment; The Battle Over Health Care: What Obama’s Health Care Reform Means for America’s Future; and Medicare Meltdown: How Wall Street and Washington Are Ruining Medicare and How to Fix It. AAO-HNS/F International Hearing Foundation/Michael M. Paparella, MD Endowed Lecture for Distinguished Contributions in Clinical Otology It recognizes outstanding achievements and significant sustained contributions to clinical otology and neurotology. Given biennially since 1992, the award is co-sponsored by the International Hearing Foundation. 9:30 am Monday, September 22 Richard A. Chole, MD, PhD, is a highly skilled clinician and surgeon, an outstanding administrator. After U.S.C. School of Medicine graduation, Dr. Chole and completed a residency and subsequent fellowship at the University of Minnesota School of Medicine.  In tandem with this effort, he also finished a PhD in Otolaryngology Anatomy-Biochemistry track from the graduate school. Dr. Chole chose a position with the Department of Otolaryngology at University of California-Davis and later became a professor and chairman of the Otolaryngology Department from 1985-1998. In 1998, he became the Lindburg Professor and Head of the Department of Otolaryngology at Washington University School of Medicine. Here he also holds joint appointments as Professor in the Department of Molecular Biology and Pharmacology and in Audiology and Communication Sciences. His invitation to serve on the Advisory Council of the National Deafness and Other Communication Disorders (NIDCD) of the National Institutes of Health by the Secretary of Health and Human Services is an outstanding honor. Dr. Chole was appointed on the Board of Scientific Counselors at the NIH in 2005 and he was elected to the Board of Directors of the American Board of Otolaryngology in 2000. He has served as President of the Association for Research in Otolaryngology in 1999-2000, President of the American Otological Society, in 2001-2002. Dr. Chole is a member of numerous professional societies, as well as university committees and is a sought after speaker, both nationally and internationally. He has authored more that 200 scientific publications, book chapters and editorials. He has been continually funded (since 1979) as a Principal Investigator from the National Institutes of Health. Dr. Chole has served as Chief of Otolaryngology at Barnes-JewishHospital since 1998, Chief of Staff at Barnes-JewishHospital from 2005-2007 and has served on the Barnes-Jewish Hospital Board of Directors. He is a member of the St. LouisCenter for Bioethics and Culture since 2001 Eugene N. Myers International Lecture on Head and Neck Cancer Established in 1991, it was endowed by Leslie Nicholas, MD, in honor of his nephew, Eugene N. Myers, MD, Past President of the AAO-HNS/F. 9:30 am Tuesday, September 23 Sheng-Po Hao, MD, FICS, is professor and chairman of the Department of Otolaryngology of Shin Kong Wu Ho-Su Memorial Hospital and Fu Jen Catholic University in Taiwan. Dr. Hao is a specialist in both Head and Neck Cancer Surgery and Skull Base Surgery. After his residency at ChangGungMemorialHospital, he perused an International Fellowship in Head and Neck Surgery in Pittsburgh, USA with Dr. Eugene N. Myers. He has published hundreds of articles and book chapters on the subject. Dr. Hao has given numerous International lectures including the Keynote Lecture in Seoul IFOS in 2013. In addition, he has been asked to present at medical gatherings around the world. Yale, University of Pittsburgh, and SeoulNationalUniversity have hosted Dr. Hao as a visiting professor. As an editor and reviewer, for more than 20 medical journals Dr. Hao has contributed to the body of knowledge on head and neck and skull base detection and treatment. Specifically, he served on the Editorial Board of Laryngoscope from 2005–2012. Dr. Hao is the founding President of Taiwan Head and Neck Society, Taiwan Oral Cancer Prevention and Therapy Association and the past President of Taiwan Skull Base Society. He is also the founding President and currently the Secretary General of Asian Society of Head and Neck Oncology. Dr. Hao also serves in the Head and Neck Committee and Nominating Committee in the International Federation of Otolaryngology and Head and Neck Surgery and also the Taiwan representative in the International Federation of Head and Neck Oncological Society. H. Bryan Neel III MD, PhD, Distinguished Research Lecture Funded by the Neel family and friends, it was established to disseminate information on new developments in biomedical science to the otolaryngologic community. 9:30 am Wednesday, September 24 Carter Van Waes, MD, PhD, is clinical director and chief, Head and Neck Surgery branch, NIDCD, and senior investigator, Radiation Oncology Sciences Program, NCI. In 1987, He received an NIH Medical Scientist Training Program Award and earned his MD and PhD in Tumor Immunology from University of Chicago. During his doctoral thesis research with Hans Schreiber, he showed that cancer cells express unique tumor antigens recognized by specific helper T cells, retained during tumor progression and metastasis. He took his Otolaryngology-Head and Neck Surgery residency at University of Michigan. While there he completed an NIH supported postdoctoral fellowship in cancer 1988-90, discovering the integrin structure and laminin binding function of the A9 squamous cell carcinoma antigen. Dr Van Waes came to NIH as a Senior Staff Fellow in NIDCD, 1993/94, and was appointed as a tenure-track investigator and Acting Chief of the Tumor Biology Section, NIDCD in 1994. He established an NIDCD and inter-institute program with NCI and NIDCR in Head and Neck Cancer. Recently, Dr. Van Waes has contributed to broad understanding of the genetic alterations that contribute to HNSCC development, as part of The Cancer Genome Atlas NIH initiative. He served as Acting Clinical Director from 1995-2003, and has been Clinical Director and Chief, Head and Neck Surgery Branch, NIDCD since 2003. He is Director of NIDCD’s Otolaryngology Surgeon Scientist Career Development Program. Dr. Van Waes has served on the Editorial Boards of Cancer Research, Clinical Cancer Research, Molecular Cancer Therapeutics, Head and Neck and Oral Oncology. Among Dr. Van Waes’s awards are an NIH MSTP award, Leon Jacobson Prize for outstanding PhD thesis, and MD with honors from the University of Chicago. He received the Norwich Eaton Resident Research Award of the American Academy of Otolaryngology—Head and Neck Surgery in 1989, and is a Fellow of AAO-HNS and American Association of Cancer Research. He has received a Merit, Special Act and Clinical Center Director’s awards for the building of the clinical research program in NIDCD and inter institute Head and Neck Cancer Program. In 2013, he received an award from NIH Director Francis Collins for leadership in developing an NIH-FDAIntramuralCenter for Tobacco Regulatory Sciences. Mark Your Calendar The following will be presented at the AAO-HNSF 2014 Annual Meeting & OTO EXPOSM Miniseminar – AAO-HNSF Clinical Practice Guideline: Tinnitus                  10:30 am-11:50 am Sunday, September 21 Moderator: David E. Tunkel, MD Instruction Course – Understanding Clinical Practice Guidelines                                               12:30 pm-1:30 pm Sunday, September 21 Instructors: Richard M. Rosenfeld, MD, MPH, and Stephanie Jones Miniseminar – AAO-HNSF Clinical Consensus Statement: Chronic and Recurrent Pediatric Sinusitis        8:00 am-9:20 am Monday, September 22 Moderator: Scott E. Brietzke, MD, MPH Miniseminar – AAO-HNSF Clinical Practice Guideline: Allergic Rhinitis 9:30 am-10:20 am Monday, September 22 Moderator: Michael D. Seidman, MD
Ken Yanagisawa, MD, Vice Chair, BOG SEGR Committee
Quality…You Can Make a Difference
As new measures of medicine rapidly evolve and engulf us, Research and Quality Improvement reign high as parameters that shape and define our practices. We must incorporate new knowledge into our patient care, and remain vigilant about external expectations and grading schemes. The word “Quality” is tossed around frequently and freely in the medical arena. The stakes of adequate, or preferably, superior quality continue to rise with reimbursement and recognition tied into this precious seven letter word. And yet, what is quality? We all have a gestalt “feeling” about high quality service and products, yet defining the term proves to be a bit nebulous. Webster defines quality as “a high level of value or excellence.” Physician quality assessments are running amok with valuations based on price (regardless of disease severity), results (which may not be equally comparable), compliance (with rules imposed by non-medical entities), and even waiting room decor. Physicians recognize that high quality relates to developing and nurturing effective interpersonal relationships with our patients, creating successful outcomes based on our interventions and treatments, and maintaining our patients’ health through lifestyle modifications and early recognition of significant symptoms. Yet the quality measures upon which we are judged revolve around different parameters—meaningful use adherence in our EHR systems, PQRS reporting,  and cost and utilization reduction. Important? Perhaps. But directly related to our effectiveness and quality as healthcare providers? Not yet. Physicians must help define the measures by which we are judged. We are fortunate that able otolaryngologists across the nation have taken significant leadership roles in areas such as Clinical Practice Guidelines, and new appropriate PQRS measures. By engaging in the rule making process, we influence our own future directions and constraints. At the grassroots level, the BOG Socioeconomic and Grassroots (SEGR) Committee is tackling many of these quality related issues, and encourages all otolaryngologists to share their concerns about how we can improve the healthcare landscape that has been thrust upon us. The Regionalization Plan, dividing the country into 10 geographic regions—each with a regional representative leader serves to coordinate regional issues and becomes an avenue to interconnect all 50 states in an efficient and fluid fashion. By listening and learning from each other, we gain collective wisdom and strategies. The SEGR national polls during the past two years have provided excellent input into two hot issues—pediatric subcertification and clinical practice guidelines. Through these polls, membership has contributed valuable thoughts about how we can improve our care and our quality. Each annual poll will continue to address pertinent issues. Please take the time to complete and return these polls, we want to hear your voice. Physician grading based on quality and cost is not disappearing. It is incumbent on each and every otolaryngologist, from resident to young physician to seasoned practitioners, to participate in the discussions and the polls. Contact your regional rep with any local issues. Use ENTConnect, which now has pages devoted to each separate region. By taking the difficult steps in taking charge and responsibility for our own measures, we can help shape the playing field for ourselves, our patients, and our future. * Stay alert and connect: bog@entnet.org
David R. Nielsen, MD, AAO-HNS/F EVP/CEO
Integrate or Perish
Recently, someone asked me what the top three concerns affecting specialty societies were. While I was tempted to list healthcare delivery and payment reform; quality improvement and performance measurement; scope of practice; undergraduate and graduate medical education; continuous professional development; data registries and data management; electronic health records and interoperability; shared accountability…I realized that on any given day we are required to shuffle the list and alter the perspective. It occurred to me, however, that all physician organizations are faced with three huge problems: In this issue of the Bulletin we focus on research and quality. The burden on “research” has included basic science and clinical research goals, but has broadly extended to health services research and integrative processes to ensure the maximal benefit and widest positive effect of the new knowledge we gain. So as you read these pages, keep an eye on the challenge you face—to constantly know and learn more and find meaningful ways of applying this explosion of knowledge to improving patient care. On April 25, I was the guest of the American Board of Medical Specialties (ABMS) at its National Policy Conference entitled “Future of Practice: Implications for the ABMS Boards’ Certification System.” Preceding the main meeting, some associate member organizations shared reports and actions each group was taking. Each report focused on a particular challenge pertinent to its organization. Most of these discussions required the use of data acquired from health services, education, or clinical research to inform the debate and solutions. One of the most enlightening presentations of the conference came from the keynote speaker George Thibault, MD, president of the Josiah Macy Jr. Foundation, entitled “The Doctor of the Future.” In the future, physicians will no longer be distinguished by “what they know,” but more by how well they work in teams, how resilient they are, how developed (Continued on page 5) their critical thinking and analytical skills are, and their ability to use information. Further, excellent communication skills, new forms of leadership (and “followership”), and most importantly, change management skills will be required—integration. Current physician education will be replaced by inter-professional education focusing on delivering care in integrated, highly functioning teams. Longitudinal, community-based, and chronic disease-oriented integrated approaches will take precedence. For decades we have been too quick to embrace technology advances in clinical, therapeutic, and diagnostic methods, and too slow to embrace and implement integrated educational and information technology facilitators and tools. Erin Fraher, PhD, an expert in workforce data, reminded us in her presentation of the challenges of education systems lagging in reform processes. She challenges us, instead of asking how many of each specialty we need, to ask, “What are the needs of patients for healthcare, and how can the overlapping scopes of various specialties meet those needs?” A summary comment from one of the panels is worth noting: We have to find solutions with the teams we have, not with the team we wish we had. So while we continue our traditional research and gain new clinical skills, we must simultaneously apply research methods to improve our education systems, reform payment and delivery of care, and integrate what we know to build a new level of team function and effective patient care.
Richard W. Waguespack, MD AAO-HNS/F President
Research and Quality: Next Steps
The changing landscape of today’s healthcare environment includes an increased focus on reducing costs and improving the quality of care we provide to our patients, in a nutshell, adding value. Many federal quality programs, including the Physician Quality Reporting System (PQRS), Meaningful Use of Healthcare Technology (MU), and Value Based Modifier Program, assess physician performance through quality measurement. The AAO-HNS/F has historically relied on the AMA Physician Consortium for Performance Improvement® (PCPI®) to develop quality measures for otolaryngology-head and neck surgery. Otitis Media with Effusion (OME) and Acute Otitis Externa (AOE) as well as Adult Sinusitis measures were developed in partnership with the PCPI utilizing our Clinical Practice Guidelines (CPG). Moving forward, the PCPI will continue to provide these services to specialty societies but only on a consulting basis. The AAO-HNS/F Board of Directors recently approved as part of its strategic plan the Foundation’s development of future quality measures and the stewardship of existing measures. Similar to our process for CPG development, AAO-HNSF will form a quality measures task force which will work with volunteer experts and staff to identify best practices for quality measure development and for prioritizing medical conditions for which measure development is necessary. We will look to the specialty society leadership to help identify physician volunteers to serve on development panels. This is an exciting new endeavor for the AAO-HNSF and will ensure more meaningful quality measures for our members.. The first measures development project was completed recently with representatives from the American Board of Otolaryngology (ABOto) and Academy research and quality physician leaders and volunteers. The group came together with AMA facilitation, to develop two measures groups (AOE and Adult Sinusitis) utilizing existing measures. A measures group eases the reporting requirements for PQRS as a physician need only report on 20 individual Medicare patients rather than 80 percent of their Medicare patients, the requirement for reporting individual PQRS measures. Physician leaders and staff met with Dan Green, MD, CMS Medical Director to review these measure groups for the 2015 Medicare Physician Fee Schedule. We received favorable feedback and will find out with the fee schedule interim rule release, if the groups were approved. See updates on www.entnet.org.