Research and Evidence Studies

BEST ENT - Become part of the BEST ENT Network! Introducing the BEST ENT Network, developed to expand and improve the evidence base for treatment options in otolaryngology by analyzing the current best evidence. You can be a part of this exciting new network made possible by the generous support of Schering-Plough.

SLEEP STUDY - This is a prospective observational study of adults to evaluate the effectiveness of uvulopalatopharyngoplasty (UPPP) in improving sleep apnea-related quality of life and symptoms.

To TREAT STUDY - Learn more about "Tonsillitis Outcomes: Towards Reaching Evidence in Adults and Tots." The study examines the disease-specific improvements in quality of life for adults and children with chronic or recurrent tonsillitis. 

NOSE STUDY
See the NOSE Study Results & download the NOSE Scale Instrument

ACUTE BACTERIAL RHINOSINUSITIS - Another study from the AAO-HNS NCPRO

EVIDENCE-BASED MEDICINE
Do you want to learn more about evidence-based medicine? Wonder what the Academy is up to in EBM? Learn more here.

CLINICAL TRIALS INFORMATION AND RESOURCES - Learn more about clinical trials.

OUTCOMES RESEARCH
Check out our Outcomes Research Primer. 

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A Message from Jonas Johnson, MD (from the July, 2003 Bulletin)

“Intersection of the Business of Medicine with Biomedical Research”

A little over 18 months ago, I was asked to address the Board of Directors of this Academy regarding my goals for the upcoming years. “Research,” I said. “We’ve got to do a better job in contributing to the advancement of our field.” Shortly thereafter, a dear colleague took me aside and pointed out that in a recent survey, over 85 percent of our members indicated that their number one concern was “socioeconomic.” Medicare undervalues our work. Insurance companies denigrate the independent importance of some procedures and bundle them for reduced payment. Everywhere around us, we see “scope of practice issues” threaten our specialty. Audiologists want to diagnose and treat diseases of the ear; dentists purport to do soft tissue surgery of the head and neck; allergists claim to be the primary physicians of the sinonasal tract; and oncologists treat an ever-expanding percentage of head and neck cancer patients without surgeons. Our anguished cries of distress are unheard.

Ladies and gentlemen, I submit to you that the answer lies in research. The community of otolaryngologists must work together to provide the evidence, substantiating the value of otolaryngologic care. We must document the efficacy of our recommendations. We must demonstrate the value of our discipline. In short, we must collect and present the supporting documentation, which justifies the claims we make. Namely otolaryngologic services are efficient, effective, and of good value. This is what the American public, the government, and eventually the insurance companies must hear. It is only through your personal participation that we can persevere and prevail. Some of you may serve as investigators and authors. Many of you can participate by allowing your clinical experience and your patient to be aggregated and studied. All of you can contribute your hard-earned dollars to help support our ongoing need for research in otolaryngology. It is more than academic; it is essential for the future of your career.

Jonas Johnson, MD

SLEEP Study

S.L.E.E.P.:

Studying Life Effects and Effectiveness of Palatopharyngoplasty
(closed to enrollment)

Why the "SLEEP" Study?

UPPP, the most common surgical treatment for sleep apnea, significantly improves physiologic abnormalities in selected patients. The procedure often does not, however, cure sleep apnea. Consequently, UPPP appears undervalued as a treatment modality for selected sleep-apnea patients.

Recent studies support that UPPP provides clinically important outcomes such as reduced motor vehicle accidents, mortality and incidence of cardiovascular disease. Moreover, health-related quality of life, possibly the most important outcome to patients, barely has been evaluated in UPPP patients. A multi-site, community-based study will adequately demonstrate the treatment effects of UPPP.

Study Aims

(Adults 18 and over)

• To determine whether UPPP improves sleep-related quality of life, measured in Functional Outcomes of Sleep Questionnaire
• To establish whether UPPP affects sleep apnea-related symptoms: snoring, sleepiness or morning headache
• To validate the UPPP Prognostic Staging system (Friedman) for quality-of-life outcomes (measured with Functional Outcomes of Sleep Questionnaire) in UPPP patients.
• To compare quality of life outcomes of UPPP alone versus UPPP with tongue procedure(s) in Friedman Stage II & III patients.

Procedure

The surgeon recruits eligible UPPP patients (most will be eligible) and completes brief eligibility and examination forms within 10 days before surgery. The surgeon has no further responsibilites after mailing the forms to the data coordinating center. The patient completes a baseline questionnaire and home blood pressure measurements within 10 days before surgery. The patient will receive a follow up questionnaire from the coordinating center 3 and 6 months after surgery.

Disease specific-quality of life will be measured with the Functional Outcomes of Sleep Questionnaire at enrollment and at three months post-operatively. Other measures include: global assessment in improvement in sleep apnea; disease-specific quality of life at six months post-procedure; and post-procedure change in secondary problems present at enrollment (sleepiness, snoring, headache, Nasal Obstruction and Septoplasty Effectiveness scale). Since many patients with sleep apnea have multiple sites of obstruction, subjects will be stratified by concomitant procedures with UPPP.

Notes

The SLEEP study is sponsored by the American Academy of Otolaryngology-Head and Neck Surgery Foundation and its National Center for the Promotion of Research in Otolaryngology, and supported by a generous grant from Schering-Plough. This research is coordinated by the Duke Clinical Research Institute at Duke University Medical Center in Durham, North Carolina.

The steering committee:

Edward M Weaver, MD, MPH, Co-PI
University of Washington

B. Tucker Woodson, MD, Co-PI
Medical College of Wisconsin

Michael G Stewart MD, MPH
Baylor College of Medicine

David Witsell, MD, MHS
Duke University

Maureen Hannley, PhD
AAO-HNSF

Timothy Smith, MD, MPH
Medical College of Wisconsin

Bevan Yueh, MD, MPH
University of Washington

BEST ENT Network

Building Evidence for Successful Treatments in Otolaryngology:
An Evidence-based Practice Network

Introduction

The BEST ENT program is a practice-based clinical research network of physicians interested in studying the effect of medical treatments and surgical interventions on the outcomes of diseases they treat. This research cooperative works to examine the efficacy and effectiveness of various treatment modalities through clinical research and measurement of patient outcomes. BEST ENT is not a contract research organization. It does not conduct or manage clinical trials. Its purpose is to provide a group of like-minded colleagues opportunities to participate in and shape clinical research. The Duke Clinical Research Institute (DCRI) collaborates with the AAO-HNS Foundation’s National Center for the Promotion of Research in Otolaryngology (NCPRO) to provide support to BEST ENT activities by staffing an administrative office and providing study coordinators and other support personnel for clinical research studies conducted through the BEST ENT network.

BEST ENT encourages the involvement of physicians from community, managed care, and academic practices to develop and participate in research studies. Multiple practice settings and patient populations will be essential in the general applicability of research results. The network cooperative will provide expertise in assisting member physicians with the development of ideas into mature and achievable research questions. Initial studies aim to evaluate the quality of life and satisfaction of patients seen in various practice settings. Future development of accurate and valid measurements for disease-specific quality of life will be essential in achieving these goals. Research by the cooperative may help develop evidence-based practice guidelines and clinical indicators applicable for use by both primary care and specialty care physicians.

Why create the BEST ENT Network?

Clinical research plays an increasingly important role in the careers of otolaryngologist - head and neck surgeons in all practice settings. The past decade has seen a growing emphasis on the importance of patient and medical outcomes research. Medicine is moving towards treatment decisions based on the published results of valid clinical research and patient preferences, in addition to the physician’s clinical judgement and experience. Otolaryngology - head and neck surgery has a long history of publishing clinical research, but the level of evidence supporting some common intervention options is uneven, and the “best evidence” available is not known in many cases. Therefore, the need exists to develop practice-based networks to provide data to document practice patterns, improve the quality of patient care, and demonstrate the effectiveness of their treatments.

Goals

1. To establish a national clinical and outcomes research cooperative network that facilitates the interaction and collaboration of primary care providers with specialty medical and surgical services in such a way as to facilitate the development of relationships and affiliations with government, academic, and private institutions.
2. To encourage participation in multicenter clinical studies ensuring quality data collection, management and interpretation of results. 
3. To promote the evaluation of new and existing therapies in otolaryngologic disease processes combining traditional research strategies with quality of life, patient satisfaction measurements, and health economic analyses and to expand and/or improve the level of evidence supporting otolaryngologic interventions. 
4. To facilitate the establishment of disease-specific priorities for future research and assist members in effectively competing for grant funding through the Agency for Healthcare Research and Quality (AHRQ), National Institutes of Health (NIH), American Academy of Otolaryngology - Head & Neck Surgery Foundation (AAO-HNSF), and private industry. 
5. To provide a platform for open dialogue between practitioners in the development of practice guidelines and clinical indicators that improve the quality of care delivered to patients, maximize the effectiveness of the health dollars, and educate patients about their diseases and specific therapies. 
6. To maintain an independent alliance by the participating members utilizing individual expertise of the membership to develop relationships and affiliations with government, academic, and private institutions. 
7. To provide data for and access to the Otolaryngology Collaborative National Database (OCND).

Membership

BEST-ENT membership is available to physicians with particular interests in the diagnosis, treatment, and management of diseases of the ear, nose, throat and related structures of the head and neck. BEST-ENT applicants must have a current license to practice medicine to be eligible for membership in the organization. Other health care providers or individuals with interest in cost analysis and health care policy development may petition the Board for Associate membership status in BEST-ENT. Membership implies a preferred relationship between the member and the cooperative for participation in clinical and outcomes research but is not an exclusive relationship.

To Apply:

1.  Complete either the Practitioner or Practice Forms (located in the table below).  Upon completion and submission of the form, you are considered a member.
2.  Send the completed form to the AAO-HNS office as indicated on the form.
3.  You will be contacted when a study in your area of interest or expertise is developed.

Contact Information for the BEST ENT Network

Yes! Please contact me with more information!

Fill out and mail or fax membership application.

Conflict of Interest Policy

Members of the BEST-ENT clinical research network must abide by the conflict of interest guidelines of their affiliated institutions and disclose, on a study-by-study basis, any potential conflict of interest they may have related to any drug or device company which provides support for the study. All potential conflicts of interest will be reviewed by the Executive Committee to determine if the investigator may participate in the study and/or whether they can access the database from the study. The investigator may appeal the Executive Committee decision to the full Board. Investigators must complete a Conflict of Interest Statement for each study in which they plan to participate.

Member Benefits

1. All BEST-ENT physician members may request the expertise of the members and support staff for development and implementation of clinical research projects. Requests may include:

2. All BEST-ENT members may be considered for participation in ongoing practice based clinical research projects. Participants in clinical studies funded by private industry may be eligible for financial support or compensation. 
3. BEST-ENT is a unique opportunity for physicians to be involved in studies aimed at quality of life issues and the subsequent development of health care policy. Participation in the BEST-ENT network provides the setting for member input into important patient management issues in an environment of health resource restriction. 
4. BEST-ENT members will have first access to practice guidelines and policies recommended by the cooperative. 
5. BEST-ENT members will be provided access to educational opportunities (newsletter, conferences) and a platform to interact with colleagues across specialties.

Projects

SLEEP Study
To Treat Study
Nose Study Results
Acute Bacterial Rhinosinusitis

Sites

See our map of participating sites.

Staff

Key AAO-HNS staff include:

David Witsell, MD, MHS
Coordinator for Research

Tasha Carmon
Clinical Trials Manager
1-919-668-8385

The Evidence Machine

The Evidence Machine will serve as the system to expand and analyze evidence in otolaryngology. It is an integrated process designed to:

• Review the evidence supporting the existing clinical indicators
• Identify areas of deficiency
• Prioritize the procedures with respect to their overall significance to the AAO-HNSF membership
• Design and conduct practice-based clinical studies to eliminate the deficiencies and shape a higher level of evidence in the literature
• Institute an ongoing program of continuous quality improvement for evidence-based otolaryngology

Links

• Click here for more on evidence-based medicine

To TREAT Study    

T.O. T.R.E.A.T. Trial

Tonsillitis Outcomes: Towards Reaching
Evidence in Adults and Tots
(closed to enrollment)

As part of its commitment to evidence-based medicine, the AAO-HNS Foundation’s National Center for the Promotion of Research in Otolaryngology has launched a new treatment effectiveness and patient outcome study. Want to know more?

(click below for more information)

Protocol Overview
Study Aims
Frequently Asked Questions

Please contact Tasha Carmon for more information, 1-919-668-8385.

Acute Bacterial Rhinosinusitis

Evidence-based Standards for Diagnosis and Management of Acute Bacterial Rhinosinusitis

Generously supported by Aventis

Rhinosinusitis is one of the leading health complaints in the United States.  The Antimicrobial Treatment Guidelines for Acute Bacterial Rhinosinusitis have been accepted as the standard for antibiotics selection in the treatment of acute bacterial rhinosinusitis (ABRS).   ABRS is differentiated into three classes:  mild, moderate, and severe.  At this time, there is little or no evidence to support this scheme other than clinical judgment and the influence of host factors such as immune response, anatomic abnormalities, etc.  Therefore, the AAO-HNS NCPRO will work to develop an evidence-based decision matrix that can be used by both primary care and specialized physicians in the overall clinical management of complicated and uncomplicated ABRS.  The study will utilize meta-analysis and systematic reviews to assess the evidence in the diagnosis and management of community-acquired ABRS in adults.

Goals:

• Provide a set of objective, clinically useful definitions of disease severity of community-acquired disease severity;
• To conduct a comprehensive literature review to determine what information is available to support the proposed definitions and what information is lacking;
• To address issues of pathogenesis, bacterial resistance, complicated vs. uncomplicated ABRS, collateral damage of broad-spectrum antibiotics, and clinical failures as they impact the clinical decision process
• To construct a clinical management of complicated and uncomplicated ABRS
• To write and publish the results of this project in the form of a monograph or journal supplement that can be widely distributed to both primary care providers and specialists. 

For more information, contact Maureen Hannley, PhD, AAO-HNS Chief Research Officer