CHEER: Providing a Working Foundation for Expedient Research and Translation
Kris Schulz, MPH, Debara L. Tucci, MD, MS, and David L. Witsell, MD, MHS “Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe ” …Those who sponsor, perform, and regulate therapeutic research need to find ways of making trials much simpler and much larger. Otherwise, the next 50 years of randomized evidence will not fulfill the promise of 50 years ago, when a properly randomized clinical trial was first published, transforming medical research by its method of generating unbiased answers to many therapeutic questions.” — Richard Peto Statistician, tobacco and cancer Oxford Clinical Trials Service Unit Creating Healthcare Excellence through Education and Research (CHEER) is a community-based research network currently funded by a National Institute on Deafness and Other Communication Disorders (NIDCD) R21/33 infrastructure grant, entering its fifth and final year of initial funding. (www.cheerresearch.org). The mission of the network is to become the national resource for practice-based clinical research in hearing and communicative sciences. In practical terms, CHEER provides the necessary infrastructure to accelerate clinical research in order to improve patient outcomes. The focus of CHEER is research education. By standardizing Research Coordinator education, sites are “at the ready” to participate, patients are protected and safe, and the integrity of gathered data is assured and maintained. David L. Witsell, MD, MHS, Duke University Medical Center, is the overall grant principal investigator (PI). Kris Schulz, MPH, chief research officer at the AAO-HNS/F, serves in a project leadership role for the grant including the fostering of relationships with AAO-HNSF members for site recruitment. Duke serves as the coordinating center for the network, which relies on a hub-and-spoke concept with five academic hub sites serving to mentor community sites. Community sites range from private practices of all sizes through academic sites without highly formalized research infrastructure. The five academic hubs and their associated PIs are: Duke, Debara L. Tucci, MD, MS; Massachusetts Eye and Ear Infirmary, Steven D. Rauch, MD; University of Michigan, Steven A. Telian, MD; University of Texas – Southwestern, Peter S. Roland, MD; and Oregon Health & Science University, Anh T. Nguyen-Huynh, MD, PhD. A Coordinator Advisory Board, consisting of coordinators from academic and community sites, was developed to ensure the coordinator’s voice is represented and that the practicality of proposed research projects is vetted among all site types and experience levels. This board was developed as it became clear that the coordinator was the crucial component to ensuring the day-to-day commitment of the practice to CHEER and the promotion of its studies and activities. The benefits of community-based research networks to expedient and translatable research include generalizability and representativeness of research findings; answering questions of importance to providers and the community-at-large; expanding the field of clinician-scientists and research coordinators; and facilitating the process of research translation.1 This last point is paramount, as many proven effective treatments do not become incorporated into everyday care.2 As quantified in one study, only 14 percent of findings from research filter into practice, and for those that do, it takes an average of 17 years.3 In its five years, CHEER has gone from a concept on paper to a network of 26 academic and community research sites throughout the country, 22 of which met higher level criteria (based on training, project participation, and annual conference attendance) established for “active sites.” We have sites in 16 states: Arizona, California, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Michigan, North Carolina, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas, and Washington. Highlights from the last year include: The Otology Data Collection (ODC) Project was launched in March 2010 and ran through November 2010 as a proof-of-concept initiative testing the network’s readiness to deploy a study. Approximately 1,500 patients were recruited across the sites in this highly successful study focusing on tinnitus and dizziness, both major areas in need of treatment guidance. Patients filled out validated questionnaires and background information for the appropriate condition(s) and physicians filled out an accompanying worksheet on exam and clinical information. A snapshot of this data is provided above. Since the first CHEER publication (Tucci DL, Schulz K, Witsell DL. Building a national research network for clinical investigations in otology and neurotology. Otol Neurotol. 2010 Feb; 31 (2): 190-5.), a second CHEER manuscript on network progress was accepted for publication in March 2011, and a third CHEER manuscript (on the ODC project) was submitted in March 2011. A grant focusing on tinnitus (developed from the CHEER Expert Panel on tinnitus) was submitted last year. Although not funded in the initial submission, it did qualify for resubmission, which is under way. A grant focusing on migrainous vertigo (a result of the CHEER Expert Panel on dizziness) is in development. A poster presentation on the successes of and lessons learned from CHEER was accepted and presented at the Association for Research in Otolaryngology Winter Meeting in February 2011. CHEER continues to host its Annual CHEER Coordinator’s Conference each August at the AAO-HNS/F offices where CHEER site research coordinators attend two days of research training, networking, and mentorship. The online Clinical Scholars program was revamped through CHEER and is a resource for any interested AAO-HNSF member. CHEER submitted an R24 limited competition “renewal grant” in March. The networking aspect of the CHEER Coordinator’s Conference allows for informal conversations, relationship building, and mentorship. CHEER benefits the AAO-HNS/F and its members through its ability to bring more private and community physicians into research. Ultimately the activities and projects, published manuscripts, and grants CHEER has submitted are relevant to both comparative effectiveness research and expedient and relevant research translation, all of which were top priorities indicated by the leadership representing members during the AAO-HNS/F strategic planning. For more information on CHEER, contact Kris Schulz at kschulz@entnet.org. References 1. Zerhouni EA. “Translational research: moving discovery to practice” Clin Pharmacol Ther 2007; 81:126Y8. 2. IOM report “Crossing the Quality Chasm” 3. Balas E et al. “Managing Clinical Knowledge for Healthcare Improvement. Yearbook of Medical Informatics 2000: Patient Centered Systems, Stuttgart, Germany: Schattauer; 2000
Kris Schulz, MPH, Debara L. Tucci, MD, MS, and David L. Witsell, MD, MHS
— Goethe
” …Those who sponsor, perform, and regulate therapeutic research need to find ways of making trials much simpler and much larger. Otherwise, the next 50 years of randomized evidence will not fulfill the promise of 50 years ago, when a properly randomized clinical trial was first published, transforming medical research by its method of generating unbiased answers to many therapeutic questions.”
— Richard Peto
Statistician, tobacco and cancer Oxford Clinical Trials Service Unit
Creating Healthcare Excellence through Education and Research (CHEER) is a community-based research network currently funded by a National Institute on Deafness and Other Communication Disorders (NIDCD) R21/33 infrastructure grant, entering its fifth and final year of initial funding. (www.cheerresearch.org).
The mission of the network is to become the national resource for practice-based clinical research in hearing and communicative sciences. In practical terms, CHEER provides the necessary infrastructure to accelerate clinical research in order to improve patient outcomes. The focus of CHEER is research education. By standardizing Research Coordinator education, sites are “at the ready” to participate, patients are protected and safe, and the integrity of gathered data is assured and maintained.
David L. Witsell, MD, MHS, Duke University Medical Center, is the overall grant principal investigator (PI). Kris Schulz, MPH, chief research officer at the AAO-HNS/F, serves in a project leadership role for the grant including the fostering of relationships with AAO-HNSF members for site recruitment. Duke serves as the coordinating center for the network, which relies on a hub-and-spoke concept with five academic hub sites serving to mentor community sites.
A Coordinator Advisory Board, consisting of coordinators from academic and community sites, was developed to ensure the coordinator’s voice is represented and that the practicality of proposed research projects is vetted among all site types and experience levels. This board was developed as it became clear that the coordinator was the crucial component to ensuring the day-to-day commitment of the practice to CHEER and the promotion of its studies and activities.
The benefits of community-based research networks to expedient and translatable research include generalizability and representativeness of research findings; answering questions of importance to providers and the community-at-large; expanding the field of clinician-scientists and research coordinators; and facilitating the process of research translation.1 This last point is paramount, as many proven effective treatments do not become incorporated into everyday care.2 As quantified in one study, only 14 percent of findings from research filter into practice, and for those that do, it takes an average of 17 years.3
In its five years, CHEER has gone from a concept on paper to a network of 26 academic and community research sites throughout the country, 22 of which met higher level criteria (based on training, project participation, and annual conference attendance) established for “active sites.” We have sites in 16 states: Arizona, California, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Michigan, North Carolina, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas, and Washington. Highlights from the last year include:
- The Otology Data Collection (ODC) Project was launched in March 2010 and ran through November 2010 as a proof-of-concept initiative testing the network’s readiness to deploy a study. Approximately 1,500 patients were recruited across the sites in this highly successful study focusing on tinnitus and dizziness, both major areas in need of treatment guidance. Patients filled out validated questionnaires and background information for the appropriate condition(s) and physicians filled out an accompanying worksheet on exam and clinical information. A snapshot of this data is provided above.
Since the first CHEER publication (Tucci DL, Schulz K, Witsell DL. Building a national research network for clinical investigations in otology and neurotology. Otol Neurotol. 2010 Feb; 31 (2): 190-5.), a second CHEER manuscript on network progress was accepted for publication in March 2011, and a third CHEER manuscript (on the ODC project) was submitted in March 2011.- A grant focusing on tinnitus (developed from the CHEER Expert Panel on tinnitus) was submitted last year. Although not funded in the initial submission, it did qualify for resubmission, which is under way.
- A grant focusing on migrainous vertigo (a result of the CHEER Expert Panel on dizziness) is in development.
- A poster presentation on the successes of and lessons learned from CHEER was accepted and presented at the Association for Research in Otolaryngology Winter Meeting in February 2011.
- CHEER continues to host its Annual CHEER Coordinator’s Conference each August at the AAO-HNS/F offices where CHEER site research coordinators attend two days of research training, networking, and mentorship.
- The online Clinical Scholars program was revamped through CHEER and is a resource for any interested AAO-HNSF member.
- CHEER submitted an R24 limited competition “renewal grant” in March.
- The networking aspect of the CHEER Coordinator’s Conference allows for informal conversations, relationship building, and mentorship.
CHEER benefits the AAO-HNS/F and its members through its ability to bring more private and community physicians into research. Ultimately the activities and projects, published manuscripts, and grants CHEER has submitted are relevant to both comparative effectiveness research and expedient and relevant research translation, all of which were top priorities indicated by the leadership representing members during the AAO-HNS/F strategic planning. For more information on CHEER, contact Kris Schulz at kschulz@entnet.org.
References
1. | Zerhouni EA. “Translational research: moving discovery to practice” Clin Pharmacol Ther 2007; 81:126Y8. |
2. | IOM report “Crossing the Quality Chasm” |
3. | Balas E et al. “Managing Clinical Knowledge for Healthcare Improvement. Yearbook of Medical Informatics 2000: Patient Centered Systems, Stuttgart, Germany: Schattauer; 2000 |