Outcomes and clinical research

The Division of Outcomes and Clinical Research in the Department of Otolaryngology-Head and Neck Surgery, led by Timothy L. Smith, M.D., M.P.H., Professor of Otolaryngology-Head and Neck Surgery, performs basic and applied clinical epidemiology health services research. We have a number of ongoing clinical trials, and are often in need of patients to participate. If you are interested in participating in a clinical trial, please check out our clinical trials page. 

Clinical epidemiology is the study of the diagnosis, prognosis, and evaluation of treatment. The scientific methodology of clinical epidemiology is based on the architecture of clinical research, biostatistics, and data processing. Part of this methodology is borrowed from public health epidemiology and is applied to the uniquely clinical situations that clinicians face. Clinical epidemiology, therefore, is a methodology that can be applied to the study of any and all human disease and illness. Health services research can be defined as efforts to determine how the health system functions so that its performance can be improved. This definition makes the field essentially activist in nature.

The Division of Outcomes and Clinical Research is a clinical research laboratory dedicated to the evaluation of outcomes for patients with a variety of conditions. The Division was initiated in August 2005 and numerous projects are underway. Its mission is to provide support for research activities of faculty across the Department and in related specialties. While working in tandem with the Divisions of Biostatistics and Epidemiology, the Division of Outcomes and Clinical Research focuses on patient-care issues, including patterns of treatment for particular diseases and patient-level and provider facility-level factors affecting direct outcomes such as disease-free duration, survival probabilities, and quality of life. The Division provides expertise in research design and statistical analysis as well as data base development and analysis. Expertise is also available in psychometrics and survey questionnaire design.

Since the Division's inception, numerous projects have been initiated or are in various stages of development, and primarily focus on quality of care and quality of life outcomes. One of these projects, in particular, has yielded preliminary data recently summarized in an NIH grant proposal that was subsequently funded. This grant focuses on the determinants of surgical outcomes in chronic rhinosinusitis. Along with this effort, several related studies examining quality of life in head and neck disorders are being pursued.

Goals of the Division

• Develop an appropriate infrastructure to support collection of prospective quality of life outcomes data in the clinical setting.
• Assure the development of high-quality instruments to measure health outcomes in patients with head and neck disorders.
• Establish a foundation for the continued investigation of quality of care and quality of life in patients with head and neck disorders by assuring the widespread availability of a comprehensive library of quality of life instruments to measure health outcomes.
• Utilize preliminary data for the purpose of securing grant funding which will enable long-term investigation of quality of life and quality of care.
• Advance applications technology for ease of use and interpretation of quality of life instruments for greater practical value in everyday medical practice.
• Measure quality of care and quality of life and to provide this critical data to third party payers to demonstrate improved quality of care.
• Develop interdisciplinary, collaborative investigations into complex problems encountered at a tertiary medical center.
• Integrate outcomes measurement with appropriateness, practical guidelines, and utility information (patient preferences) in systems of quality improvement.
• Become recognized as a national center of excellence in the arena of health services research, outcomes research and quality of life.

These goals demonstrate our Department's ongoing efforts to achieve excellence in clinical research while utilizing results to improve quality of care and to demonstrate improved quality of care.

Clinical Research at the Oregon Hearing Research Center
This program is located within the Oregon Hearing Research Center. It encompasses a wide variety of areas of study, including tinnitus, otoacoustic emissions, hearing conservation, public health outcomes and voice/laryngeal disorders.

Behavioral and pharmacological factors related to tinnitus severity. Approximately 40 million Americans have chronic tinnitus. For 10 million of these people, tinnitus can be a severely debilitating condition. Many patients with severe tinnitus experience a vicious cycle of symptoms that exacerbate one another. Identifying and treating insomnia, anxiety and depression with medications and/or psychotherapy/counseling will reduce tinnitus severity for most patients. In order to develop increasingly effective treatment programs, we continue to study the relationships between tinnitus and psychosocial factors that contribute to its perceived severity. Research interests center on the neurobiology of tinnitus. Our staff is looking into the brain's role in tinnitus. Research projects evaluating new techniques of treating tinnitus include studies of:

• Pharmacological treatment of tinnitus and development of CNS drug delivery systems
• Functional imaging of brain activity related to tinnitus
• Deep brain stimulation
• Tinnitus severity management
• Predictive indicators of treatment resistant tinnitus
• Epidemiology of tinnitus
• Transcranial magnetic stimulation
• Factors contributing to tinnitus severity
• The Tinnitus Functional Index (TFI) is a state-of-the-art evaluation tool for measuring the degree and changes in tinnitus severity (impact of tinnitus on an individual life). It is useful for both clinical and research purposes. It can be downloaded HERE.

Hearing Loss Prevention Education

Most cases of chronic tinnitus are associated with some degree of hearing loss. One type of hearing loss that is preventable is noise-induced hearing loss (NIHL). One way to encourage people to protect their ears from excessive noise exposure is to educate them about hearing, hearing loss and hearing conservation. The Oregon Hearing Research Center, in collaboration with the Multnomah Education Service District, the National Hearing Conservation Association, the Oregon Museum of Science and Industry, the American Tinnitus Association, the VA National Center for Rehabilitative Auditory Research, and Oregon Health & Science University, has developed a hearing loss prevention program for "kids" of all ages called, Dangerous Decibels. Our goal is to bring hearing conservation education to every K-12 student in the state of Oregon on a continuing basis. We hope that this program will ultimately reduce the prevalence of noise-induced hearing loss among children and adults.

The Dangerous Decibels Program also is involved in health promotion research in the area of hearing loss and tinnitus prevention. Studies include:

• Health communication theory applied to noise induced hearing loss and tinnitus prevention
• Human factors in noise induced hearing loss in children and adolescents
• Epidemiology of noise induced hearing loss
• Hearing loss prevention in Native American communities

Other Clinical Research Areas

• Cochlear physiology and otoacoustic emissions
• Pathophysiology and treatment of spasmodic dysphonia, laryngopharyngeal reflux and other voice disorders
• Deep brain electrical stimulation
• Head and Neck Cancer
• Pediatric disorders

Tinnitus functional index

The Tinnitus Functional Index (TFI) has documented validity both for scaling the severity and negative impact of tinnitus for use in intake assessment and for measuring treatment-related changes in tinnitus (responsiveness).  It provides comprehensive coverage of multiple tinnitus severity domains.  

The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. Ear Hear. 2012 Mar-Apr;33(2):153-76.  The TFI and scoring instructions can be downloaded HERE.