2 ORGANIZATIONAL STRUCTURE AND FUNCTION 2.1 PATIENT MANAGEMENT The Director (Dr. Gantz) and Co-director (Dr. Hansen) will be responsible for all patient care management: providing medical care; surgically implanting cochlear prostheses in new subjects; and overseeing the wellbeing of the subject population for the duration of the research project. Dr. Gantz will devote 15% effort and Dr. Hansen will devote 5% effort to Core B. With the large patient population enrolled, and variety of projects and laboratories involved, Patient Coordinators are crucial for success of the Clinical Research Center. They efficiently schedule the time patients are at the Center for the multidimensional research programs' data collection. As a liaison between research teams and participants, a Patient Coordinator also assists with consenting the research subject. Marta Ross, our Adult Patient Coordinator for the past 12 years, has been actively involved with developing the proposed program. She manages the scheduling of adult implant subjects; ensures appropriate insurance reimbursement; and provides outreach education about cochlear implants. Ms Ross also is the IRB coordinator, updating and renewing local IRB consent forms as well as national IRB issues that are used in the adult clinical trials for the Hybrid SI2 and L24 devices, and the severe hearing loss protocol sponsored by Cochlear Corporation. She will also maintain the cochlear implant registry for adults and children. The Adult Patient Coordinator position requires 80% effort. A separate Children's Patient Coordinator, Elaine Allen, is necessary due to the number of children studied and the new subject accrual. Ms Allen has extensive experience with clinical trials and will devote 80% of her effort to Core B. Coordinator activity is not reimbursed by third party payors, and is essential to the entire research program. Preoperative audiologic evaluation of cochlear implant research candidates and postoperative programming and maintenance of devices are time consuming and require on experienced audiologists. The audiologists assist in obtaining research consents and explain the nature of the research to be performed. The project's success as a whole depends on carefully programming and monitoring the participants' devices to ensure accurate results. Audiologists will also administer audiologic tests (See Follow-up Data 4.3) to be used by all projects, and monitor hearing aid fitting for all subjects including the bimodal control group. Data collection for the various projects can take up to one full day of an audiologist's time. Ann Perreau and Beth MacPherson will work primarily with adult implant recipients. Beth MacPherson and Ann Perreau have extensive experience programming standard, bimodal, bilateral and the hybrid implant devices. Ms. MacPherson will contribute 50% effort and Ms Perreau will contribute 80% effort to Core B. We believe that this effort is required for the research protocols and is not reimbursable from insurance or Medicaid. Tanya Van Voorst and Stephanie Gogel will work primarily with pediatric cochlear implant recipients. Ms Van Voorst, the principal children's audiologist, has 8 years experience with programming and troubleshooting devices in children with cochlear implants. Stephanie Gogel is trained as a pediatric cochlear implant audiologist at our center and has worked closely with Ms Van Voorst. Both will continue to assist in all aspects of the children's preoperative and postoperative implant care, device set-up and hearing aid monitoring prior to data collection, and speech perception data collection. Ms Van Voorst and Ms Gogel will each devote 80% effort to Core B. Eighty-percent of both Ms Van Voorst and Gogel are essential to collect the audiologic data for all projects. They spend a significant effort on data collection for all projects using children. They will also verify the hearing aid fittings (See 4.3) on bimodal and severely hearing impaired children at each visit to be certain that all equipment is appropriately fit at the time of data collection. They will also check settings on the implant prior to each data collection session. Twenty-percent of their time will be assigned to duties that could possibly generate clinical revenue. Other audiologists are assigned to fitting and following cochlear implant patients who are not participating in our grant. Up to six implants per year will be donated by Cochlear Corporation for either adults or children without funding during the 5 year funding period. Insurance coverage is not available to cover costs associated with these implant subjects. Camille Dunn, PhD, will provide oversight for the core audiology and speech perception measures that are collected on all subjects and are essential for all projects. She will devote 20% effort to Core B. Ruth Bentler, PhD, oversee procedures for hearing aid verification and for procedures for quantifying the audibility of our Hybrid and bimodal users. Ruth Bentler, PhD, will oversee hearing aid verification and guidelines to quantify audibility with Hybrid, bimodal and severely hearing impaired populations. 2.2 TECHNICAL SUPPORT Technical support provided for all projects include statistical analysis, data management, computer programming and maintenance. 2.2.1 Statistical Support Statistical analysis and data management will be provided by Dr. Jacob Oleson, a PhD statistician. He will produce statistical tabulations, graphs, and analyses for all investigators. The projects vary in their complexity and statistical design. Some have large samples of longitudinal data but all have small sample sizes. The potential for missing data also adds to the small sample size problem. Dr. Oleson works with investigators to accommodate these difficulties using appropriate statistical methods. Dr. Oleson will be assisted by a PhD graduate research student in bio-statistics to be named later. Dr. Oleson will devote 20% effort and the graduate research assistant will devote 50% effort to Core B. 2.2.2 Data Management An experienced computer programmer will program, maintain and upgrade a relational research database implemented on a central SQL server. Ms. Ji has been responsible for our database for over 6 years and is a critical team-member. Data entry and access are implemented in MS Access. Data is recorded either manually by the subject or an investigator, or captured electronically by computer-driven testing software and entered manually into the database and verified by the data entry clerk. She will devote 100% effort to Core B. 2.2.3 Computer Programming and Maintenance The Center has developed several computer-assisted data collection and data analyses programs including: electrophysiological data acquisition and analysis; automated testing and training systems; speech digitizing and editing systems; statistical and database systems; applications development platforms; and a hardware maintenance workshops. Wenjun Wang has been the principal software development engineer responsible for hardware setup and maintenance for the past 7 years. The Center has a central research network integrating all research computers, staff, and investigator computers. The network is backed-up daily and stored in a College of Medicine Department of Otolaryngology server. The network connects to a campus-wide high-speed fiberoptic network to our research facilities. The University of Iowa has a vBNS connection allowing broadband connection to high performance computing research facilities. He will devote 100% effort to Core B.
Showing the most recent 10 out of 247 publications
