Help Find the Evidence-Clinicians Needed ASHA’s Clinical Trials Group Conducts Wide-Ranging Research Features
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Features  |   August 01, 2005
Help Find the Evidence-Clinicians Needed
Author Notes
  • Jeri A. Logemann, of Northwestern University and CSDRG is the principal investigator (PI) for CSDRG and serves as the PI on Protocol 201, co-PI investigator on the Shaker Study, and co-investigator on the child language project. For information on CSDRG and its projects, contact her at 847-491-2490, or by e-mail at j-logemann@northwestern.edu.
    Jeri A. Logemann, of Northwestern University and CSDRG is the principal investigator (PI) for CSDRG and serves as the PI on Protocol 201, co-PI investigator on the Shaker Study, and co-investigator on the child language project. For information on CSDRG and its projects, contact her at 847-491-2490, or by e-mail at j-logemann@northwestern.edu.×
  • Patricia Miller Gardner, is CSDRG project manager. For more information about the CSDRG’s work or about participating in a study, contact her by phone through the Action Center at 800-498-2071, ext. 4237, or by e-mail at pgardner@asha.org.
    Patricia Miller Gardner, is CSDRG project manager. For more information about the CSDRG’s work or about participating in a study, contact her by phone through the Action Center at 800-498-2071, ext. 4237, or by e-mail at pgardner@asha.org.×
Article Information
Swallowing, Dysphagia & Feeding Disorders / Research Issues, Methods & Evidence-Based Practice / ASHA News & Member Stories / Features
Features   |   August 01, 2005
Help Find the Evidence-Clinicians Needed
The ASHA Leader, August 2005, Vol. 10, 8-9. doi:10.1044/leader.FTR3.10102005.8
The ASHA Leader, August 2005, Vol. 10, 8-9. doi:10.1044/leader.FTR3.10102005.8
For a decade, ASHA has been helping the professions of audiology and speech-language pathology collect clinical trials data to provide evidence on the effectiveness of clinical services. In 1995, ASHA created the Communication Sciences and Disorders Clinical Trials Research Group (CSDRG) as the Association’s non-profit, clinical trials affiliate. In 1997, the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health (NIDCD/NIH) funded the CSDRG as the first cooperative group devoted solely to the development and conduct of trials by speech-language pathologists, audiologists, and speech, language, and hearing scientists.
CSDRG’s current and planned projects involve research in dysphagia, supplemental speech methods for dysarthria, and language stimulation. Those projects include:
Protocol 201.
CSDRG’s first clinical trial was launched in 1997, entitled “A Randomized Study of Two Interventions for Liquid Aspiration: Short- and Long-Term Effects.” The trial was funded by NIDCD/NIH. Also called Protocol 201, this trial is looking at methods of treatment for controlling liquid aspiration and preventing the occurrence of aspiration pneumonia and death in patients with Parkinson’s disease and/or dementia. It is being carried out under the direction of Jeri Logemann as principal investigator and JoAnne Robbins as study chair.
The two treatments being studied are the chin-tuck position and thickened liquids (both honey and nectar consistencies). There are two parts to this study, a short-term portion looking at the success of presenting an intervention during the videofluorographic (VFG) examination, and a long-term study looking at the success of the two treatments in preventing aspiration pneumonia in patients over a three-month period.
Throughout its years of data collection, the study has been conducted in over 125 facilities around the country, including sites in Wisconsin, Florida, New York, Massachusetts, Minnesota, Illinois, Texas, Ohio, Indiana, and Georgia. Clinicians at the participating sites are working with adults in nursing homes, acute care hospitals, home care, and outpatient facilities.
One of the study’s many long-term participating clinicians, Paula Sullivan, worked at the University of Miami and the William S. Middleton VA Medical Center in Madison, WI during the course of the research.
“Participating in Protocol 201 is not only an honor and privilege, but a professional responsibility,” Sullivan said.” Our profession, like others, can no longer continue to provide non-supported treatments because of lack of alternatives or evidence.
“Collecting this evidence is a Herculean task and will require the contribution of many clinicians,” she said. “These collective efforts will answer many questions and are necessary to support the value of our services and profession.”
The long-term part of the study is recruiting 580 subjects. Protocol 201 was designed as a “blinded” study, meaning that the investigators do not know the results of the study until data collection and analysis is complete. As a result, no outcome data will be published until the last subject is finished with the study treatment, probably in 2006.
The Shaker Study.
In 2001, the group launched a research project to investigate “A Comparison of Two Therapies for UES Dysphagia.” Known as the Shaker Study, this clinical trial compared traditional swallowing exercises with the Shaker exercise to determine the effectiveness of each treatment protocol in patients with upper esophageal sphincter (UES) dysphagia resulting from stroke or treatment for head and neck cancer. The study recently stopped enrolling new patients as of July 1, 2005.
In this study, patients were randomly assigned to either the traditional therapy arm or the Shaker exercise arm and received treatment for six weeks. Patients were evaluated with a VFG examination at intake and study exit to assess their abilities to take nutrition and hydration safely by mouth. Reza Shaker, a physician from the Medical College of Wisconsin, and Jeri Logemann from CSDRG and Northwestern University are co-principal investigators.
The study was conducted at 14 sites in Florida, Wisconsin, New York, Georgia, Illinois, Louisiana, and Washington, DC. Clinicians in this study all worked in acute care facilities providing inpatient and outpatient care. This project was funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the NIH.
Other Completed Studies.
The CSDRG also received a small grant in 1999 from the National Institute on Child Health and Human Development to collect pilot data on supplemental speech methods for dysarthria due to traumatic brain injury. This study, with David Beukelman at the University of Nebraska, Lincoln, collected data on alphabet supplementation, topic supplementation, clear speech, and combinations of these techniques.
Upcoming Projects.
Most recently, CSDRG has partnered with Leap Learning Systems to serve as the Data Management and Statistical Center for a randomized clinical trial comparing two language stimulation programs for 3- to 5-year-old African American children in the Chicago Public Schools.
Why Are Clinical Trials Important?
Clinical trials provide clear evidence of whether a test, medication, or treatment is effective, whether one treatment is more effective than another, or which treatment has a higher success rate with a particular type of patient.
“Clinical trials study the efficacy of the methods and procedures that may be useful for our patients. This aids our efforts to move from a trial and error approach to a more evidence-based practice,” said Donna Lundy of the University of Miami, a regional principal investigator on Protocol 201 who supervises clinician participants in the Florida area.
“While the process of completing a clinical trial may be long, certainly the opportunity to have proven methodologies with specific parameters of usefulness that have stood the test of research is better than jumping on the bandwagon of each new approach that arises,” Lundy said.
Clinical trials also help determine if a treatment, test, or medication is safe. Information from clinical trials allows clinicians to advise patients and their families to make informed decisions.
Investigators Needed
The CSDRG needs investigators with good ideas for clinical trials. Clinicians and researchers who are interested in working on a clinical trial are encouraged to contact the CSDRG. The CSDRG comprises the Cooperative Group Principal Investigator Jeri Logemann; an Executive Policy Board (EPB) made up of experts in the areas of child language, adult language, voice and swallowing, hearing and balance, statistics, and epidemiology; and the CSDRG project manager.
All proposed research ideas are handled confidentially and reviewed by experts in the subject area of the proposal and the EPB. When the idea is approved as a proposed trial, a working group is established to assist the investigator to further develop the idea and write a grant application to obtain funding.
Why I Participate in Clinical Trials

by Barbara Grande

It started with a phone call from JoAnne Robbins five years ago. Would I be interested in doing research in dysphagia with Parkinson’s patients? The research was being conducted by ASHA’s clinical trials affiliate, the Communication Sciences and Disorders Clinical Trials Research Group (CSDRG). This seemed to be just the opportunity I was waiting for.

At that point in my career, I had been in clinical work for at least 15 years. I thought of the countless patients moving through our department whose diagnoses, interventions, and outcomes were duly documented and filed away. I remembered with frustration and some guilt the many times I had heard, in seminars and lectures, that each patient was a potential research subject whose data should be collected to support a research question about clinical practice or outcomes. This data would provide the evidence-based practice information we should all be trying to accumulate.

It’s not that I hadn’t tried. But my efforts were largely unsuccessful for several reasons-my research designs seemed flawed; I couldn’t accrue sufficient numbers of patients in diagnostic, gender, and age groups without depending on other colleagues or other sites; collecting the data was cumbersome; and analyzing the data was beyond my time and expertise (my statistics classes were completed many years ago).

Participation in the project would bypass these obstacles. The research design was appealing, with no conflicts in withholding treatment or dilemmas in making recommendations. My collected data would become part of a large national pool. Experts in data collection and analysis would provide support, determine randomization, and maintain accuracy to assure a high standard of research. I was ready to sign on!

My enthusiasm for the project was an important ingredient in convincing my administrators that it was a worthy effort for our organization. They were pleased we would be seeing more patients and contributing to improved interventions based on clinical trials-the gold standard in human subject research.

Training was the first step in becoming part of this project. New clinician investigators traveled to a central site to spend two days learning the protocol, analyzing video swallow studies, and collecting the materials we would need to run our future subjects. We learned a great deal about research, as well as the discipline, consistency, and integrity required to participate in research.

We made new friends, launching relationships that would grow over the next several years. We shared excitement, anxiety, and the sense of importance in what we were about to do.

Since that first telephone call five years ago, I have had the great satisfaction of accruing many subjects to this national clinical trial. It has been an enriching experience. Learning came in many forms. I learned from my subjects/patients. It was a great challenge to “switch hats” from researcher to clinician, keeping in mind that the subject being examined is also the patient who deserves the same appropriate clinical care as any other patient would receive.

Continuing education units have been provided on an ongoing basis through participation in conference calls scheduled to discuss our experiences, ideas, and concerns about the research and for important presentations on a variety of timely subjects. Last year, many of us gathered in Madison, WI as privileged participants in a face-to-face meeting to learn more about dysphagia and geriatrics from an esteemed multi-disciplinary cohort of experts. Some of us even had the opportunity to present case studies.

There was still plenty of time to gather informally and enjoy the camaraderie of shared experiences and satisfaction in what we had accomplished. The opportunity to know these other participating investigators, as well as the skilled members of the Central Lab who analyze the videofluorographic (VFG) examinations we conduct in the field, may be one of the greatest benefits of all.

Since this first clinical trial, I have committed to a second one. I am eager to continue utilizing my improved skills in measurement, consistency of performance, and finely honed scrutiny of swallow studies. I feel a sense of responsibility to participate in this way.

ASHA’s CSDRG continues to explore new research opportunities, and as these become available for clinician participation we owe it to ourselves to consider giving back to the profession in this way. It is a way for us to have an impact, not only on the people we currently serve, but on those patients of the future whose faces we may never see, but whose lives can be forever improved by our efforts today.

Contributing to the development of our profession’s evidence base is challenging and rewarding, and it is our unique role to fulfill as speech-language pathologists.

Barbara Grande is the dysphagia rehabilitation specialist for Covenant Rehabilitation Services. She participates in two national clinical trials studying efficacy of swallowing treatment, and was an initial contributor of data to the Shaker Exercise Protocol. Grande also served on the Division 13 Subcommittee for Specialty Recognition in Dysphagia. Contact her atbgrande@covhealth.org.

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August 2005
Volume 10, Issue 10