Outcomes & Clinical Trials Research

The Outcomes and Clinical Trials Research Unit in the Department of Otolaryngology and Communication Sciences performs basic and clinical health services research, by studying the diagnosis, prognosis, treatment, and outcome of patients with a variety of conditions. These studies determine how the health system functions so that the health system performance can be improved. The studies are based on clinical research, biostatistics, and data processing.

The unit's mission is to provide support for faculty research activities. The focus is on patient-care issues, including patterns of treatment for particular diseases and the factors affecting direct outcomes (disease-free duration, survival probability, and quality of life).

Since the Unit's inception, July 2001, numerous projects have been initiated and are in various stages of development. The unit is dedicated to improving health and health care by promoting the science of outcomes measurement, and the development, evaluation, and distribution of standardized, high quality instruments that measure health and medical care outcomes. The Unit supports the use of these instruments with services and with medical journal publications.

Outcomes Research

The Department of Otolaryngology & Communication Sciences is actively involved in ongoing efforts to collect prospective quality of life outcomes data on patients presenting with head and neck disorders. Validated and reliable patient oriented outcomes instruments are being utilized to evaluate the effect of these disorders on the patient's perception of their quality of life. The impact of disease severity and various comorbidities are analyzed in the context of the patients' primary disease process. Understanding these critical issues will lead to enhanced outcomes and improved quality of care. A few of the studies are listed below.

"Long Term Prospective Outcomes Analysis of Pediatric Vocal Fold Paralysis"
Nalin J. Patel, MD and Joseph E. Kerschner, MD

"Obstructive Sleep Apnea and Tonsillectomy in Patients with Sickle Cell Disease"
Valerie A. Flanary, MD

"Mucin Gene Expression in Middle ear Epithelia"
Joseph E. Kerschner, MD

"The Use of Polysomnography in Pediatric Otolaryngology"
Valerie A. Flanary, MD

"Treatment of Fungal Otitis Externa"
Valerie A. Flanary, MD

Clinical Trials Research

The Department of Otolaryngology & Communication Sciences is actively involved in clinical trials research. This patient-oriented research infrastructure includes inpatients and outpatients, laboratories that perform analyses and procedures, computerized database management, and support personnel (research nurses, biostatisticians, etc.). Investigational studies focus on the cause, prevention, progression, control and cure of head and neck diseases that afflict individuals of all ages and ethnic backgrounds. Financial support is provided by the National Institutes of Health and by other federal, state and local agencies, and the private sector. A few of the studies are listed below.

"Role of Autonomic Nervous System Dysfunction in Head and Neck Disorders"
Principal Investigator: Todd A. Loehrl

"Somnoplasty vs. Continuous Positive Airway Pressure (CPAP) as Therapy for Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)"
Co-Principal Investigators: B. Tucker Woodson, MD and Timothy L. Smith, MD

"Prospective Randomized Trial of Proton Pump Inhibitor for Post Nasal Drip"
Co-Principal Investigators: Todd A. Loehrl, MD; Timothy L. Smith, MD, MPH; and Albert L. Merati, MD

"Picibanil Sclerotherapy: A Multi-Center Study"
Principal Investigator: Joseph E. Kerschner, MD

"Autonomic Dysfunction in Ménière's Disease"
Principal Investigator: David R. Friedland, MD, PhD and Robert J. Toohill, MD

"A Prospective Comparative Study of Otitis Media Risk Factor Knowledge Deficit in a Suburban and Urban Primary Care Environment"
Principal Investigator: Joseph E. Kerschner, MD

"Esophageal Motility and Airway Protective Function in Infants"
Co-Investigator: Joseph Kerschner, MD

"Pupillometry in Otolaryngologic Disorders"
Principal Investigator: David R. Friedland, MD, PhD

"A Prospective, Randomized, Comparative Study of Ofloxacin Otic Drops verses Cortisporin Otic Drops as Prophylaxis Against Post-Tympanostomy Tube Placement Otorrhea"
Co-Principal Investigators: Joseph E. Kerschner, MD; Stephen F. Conley, MD; Valerie A. Flanary, MD; and Tom M. Kidder, MD

This study will be evaluating the incidence, prognosis, and outcomes of patients with Vocal Fold Paralysis (VFP) at the Children's Hospital of Wisconsin. This is a long-term prospective study that is following the airway, clinical voice, and swallowing outcomes of pediatric vocal fold paralysis. Additionally, the efficacy of treatment will be studied in a prospective manner, and the incidence of VFP in at risk populations will be studied in a prospective manner.

"Enuresis and Sleep Disordered Breathing"
Joseph E. Kerschner, MD and Valerie A. Flanary, MD

"Quality of Life in Head & Neck Cancer"
Bruce H. Campbell, MD

This study evaluates the quality of life in head and neck cancer survivors five years after diagnosis and will explore subjects and objective data in an effort to determine areas of future intervention.

"The Effect of Adenotonsillectomy on Quality of Life in Pediatric Patients"
Valerie A. Flanary, MD; Joseph E. Kerschner, MD; Stephen F. Conley, MD; & Timothy L. Smith, MD, MPH

The objective of this study is to evaluate the relative quality of life of patients presenting with upper airway obstruction secondary to adenotonsillar hypertrophy (UAO) and obstructive sleep apnea (OSA) and to determine the effect of adenotonsillectomy on quality of life.

"Quality of Life in Obstructive Sleep Apnea Patients"
B. Tucker Woodson, MD

This is a review of sleep and snoring quality of life measurements, as part of routine clinical care on 1,000 patients.

"Botulinum a Toxin for Laryngeal Dystonia: MCW's 11-Year Experience"
Thomas M. Kidder, MD 

This study is a retrospective review of the clinic charts of patients evaluated for and diagnosed with laryngeal dystonia since the first use of Botox for this purpose here at the Medical College of Wisconsin. The review of this data will add to the body of knowledge about laryngeal dystonia. The Medical College is one of only three sites in Wisconsin where Botox is administered for the treatment of laryngeal dystonia disorder.

"Validation of the 10-item FACT Head and Neck Symptom Index (FHNSI) to Assess Symptom Experience in Advanced Head and Neck Caner Patient"
Bruce H. Campbell, MD

This study is assessing the reliability, validity, and sensitivity to change of the 10-item Head and Neck Symptom Index (FHNSI). This is a multi-institutional research effort which includes: Medical College of Wisconsin, Evanston Northwestern Healthcare, University of Chicago, and Northwestern Medical Faculty Foundation.