The Clinical Research Steering Committee, with representatives from COM, Arts & Sciences, Engineering, and Health and Human Services, was formed to administer a $134,144 grant from the 1804 Fund and the Research Challenge program to support interdisciplinary clinical research projects at Ohio University. The intent of this program is to provide seed money for projects that will enable the investigators to generate competitive proposals to external granting agencies. Through early 1998, ten proposals were funded for a total of $96,000. In November, the following projects were approved for funding:
Each of the fourteen research teams funded through this program is expected to submit at least one external grant proposal. If these efforts are successful, there will be a significant increase in external support and greater cooperation among many departments and colleges in the university in clinical and health-related research.
Paula J. Pheley, R.N., C.N.R.N., joined the staff of the Office of Research in September as the Clinical Research Coordinator. Paula received her B.S.N. from St. Olaf College in Minnesota. She completed coursework for a Master's in Health and Human Services from St. Mary's College in Minnesota.
Her clinical focus in nursing has been in the area of Neurosciences. It was as a staff nurse at the University of Minnesota that she became involved in clinical research. She has been involved in the development and coordination of clinical trials at The Johns Hopkins Hospital, the University of Minnesota and Hennepin County Medical Center in Minnesota. Her work has included coordination of the multicentered Nimodipine drug trial and the NIH program project evaluating the effectiveness of hyperbaric oxygen in severe traumatic brain injury.
Paula brings expertise in the organization and development of research proposals and the coordination and day-to-day needs of a clinical research project. Her primary role in the Office of Research is to assist in the development of research at OU-COM.
Al Pheley, Ph.D., Director for Research Development, has received a grant from the Brentwood Foundation in Cleveland to support a year-long project designed to enhance interest in research among OU-COM personnel throughout the CORE system. The program, set to begin in February, 1999, will be a series of monthly, two-hour sessions. Each session will begin with a keynote address by an individual who is well known for research in a particular area, or is an end-user of research data for clinical, policy, or insurance purchasing purposes. These individuals will share their keys to success and discuss areas in which additional health research data is needed. During the second hour, Al and other investigators will provide seminars on basic research methods, linking them to the topics addressed by the keynote speakers.
The Brentwood Foundation grant will support the development and conduct of this program in the Northeast CORE. All sessions will be conducted in Cleveland and will be simulcast to other CORE sites over the COM distance learning network. Proceedings of the series will be published at the end of the project. Northeast CORE faculty, staff, residents, and students will be sent more information on the project during January. If you would like additional information now, please call Al Pheley at 740-593-2411 or pheley@ohiou.edu.
The migraine trial that has been ongoing since May 1997 is coming to a successful close. The last subject visit is scheduled for the middle of January. Research subjects are anxiously awaiting FDA approval of this medication. According to the pharmaceutical company, the trialšs information has been submitted to the FDA for consideration.
A Type II diabetes trial is ongoing, and the enrollment period is complete. A large diabetic population was identified at UOMC. However, it was difficult to find Type II diabetics who were on diet/exercise management with elevated blood glucose -- a sign of good medical practice at UOMC. The information gathered during the enrollment period for this study was helpful in further identifying our diabetic population for future studies.
Ohio University College of Osteopathic Medicine is also participating in a multi-site clinical research trial of a new drug treatment for migraine headaches. On this study primary investigator is Jack Brose, D.O., with Dale Pratt-Harrington, D.O., as sub-investigator.
This current trial is an open label study scheduled to last six months. Subjects participating in this study receive medication to treat migraine headaches as well as physical examinations, laboratory testing before treatment and throughout the treatment period at no charge. The study subjects keep a diary of the effectiveness of the study medication. Other medication is available to the subjects if the study medication is not effective.
The study is funded through a leading pharmaceutical company. Enrollment for this study is currently closed. However, a second study with this medication is expected to begin enrollment in February 1999
For additional information about these studies and the clinical research unit, contact Lori Arnott, R.N., at 740-593-2410 or arnott@ohiou.edu.
by Al Pheley
The National Institutes of Health recently issued a request for applications (RFA) entitled "Chiropractic and Osteopathic Clinical Trial Pilot Grants." The purpose of this request is to "establish the feasibility and strengthen the scientific rationale" of these techniques prior to conducting large scale randomized clinical trials. These projects should be conceptualized as preliminary in nature, providing evidence that will enable reliable and valid studies to be conducted in the future.
The RFA provides several types of pilot examples, including:
The NIH will provide up to $150,000 per year, for up to five years to support pilot grants funded through this announcement. OU-COM will be submitting three applications for the February 1, 1999 application deadline, and another three for the June 1, 1999 deadline. If you have an idea that you would like to submit for June, please call Al Pheley at 740-593-2411 or pheley@ohiou.edu. If you would like to read the full RFA, it is available on the web at:
http://www.nih.gov/grants/guide/pa-files/PA-99-013.html
...and don't forget your institutional review board...
by John Dooley
Last quarter we discussed the Pearson and Spearman correlation coefficients. In this issue we will present one of the most commonly used statistics, the chi-square test
The chi-square test is one of the many non-parametric tests used in research. Non-parametric means that there are few assumptions made about the distribution of the data. That is, most data used in non-parametric analyses do not have a bell-shaped distribution, and measures of central tendency (mean, median, mode) are not the adequate descriptors.
The chi-square test is most often used in comparing categorical data, for example, current smoking status (yes/no) by respondent gender (male/female). Data are organized in a row-by-column (r x c) table. In most cases this will be a 2 x 2 table, with the observed counts entered in each cell:
The analysis will address the pre-study determined null hypothesis that there is no difference between proportion of current smokers between the two genders, and the alternative hypothesis that there is a difference between current smoking status of males and females. In this particular case, the chi-square test value is 9.09 and P=0.003. Since P is less than 0.05, we reject the null hypothesis and accept the alternative hypothesis, providing statistical support suggesting that males in the sample have a current smoking rate twice that of females.
When using r x c tables with more than 2 categories for any one variable present a more complex analysis if the overall chi-square test is statistically significant. If the example above had included three categories, e.g., never smoked, former smoker, current smoker, and the analysis found a statistically significant overall chi-square, additional analyses would be required to determine which groups differed from others. Pairwise comparisons would be conducted on three sets of 2 x 2 tables to address this question (never vs. former, never vs. current, former vs. current).
One final word of caution when using the chi-square test. When any one cell of the r x c table becomes too small (an expected value of 5 or less), the chi-square analysis becomes unstable. In this situation, a test known as the Fisher's Exact Test is more appropriate.
If you have any questions related to the chi-square test or other statistics, please call John Dooley (330-468-4500 ext. 224) or Dr. Al Pheley (740-593-2411).
Contact Judi Rioch at 740-593-2336 or rioch@ohiou.edu for details
Restricted to diabetes-related research. There is also a separate fund desinated for research relating to the diagnosis, treatment and cure of diabetes in children.
Deadline: March 1, 1999
Notified: May 1999
Awarded: June 1, 1999
Amount: $35,000
Faculty Research & Graduate Studies: promotes research and scholarly activities and innovations in graduate education
Deadlines:
March 15 -- preliminary discussions with Carol Blum, Interim VP for Research
April 15 -- full proposals due
Awarded: August 1999
Term: Two years
