Neurology
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Correspondence:
Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when Correspondence are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Kernan, W. N.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Kernan, W. N.
Related Collections
Right arrow Stroke prevention
Right arrow All Clinical trials
Right arrow Clinical trials Methodology/study design
Right arrow Infarction
NEUROLOGY 2009;72:1345-1351
© 2009 American Academy of Neurology

Boosting enrollment in neurology trials with Local Identification and Outreach Networks (LIONs)

W. N. Kernan, MD, C. M. Viscoli, PhD, D. DeMarco, B. Mendes, RN, K. Shrauger, RN, J. L. Schindler, MD, J. C. McVeety, MD, A. Sicklick, MD, D. Moalli, MD, P. Greco, MD, D. M. Bravata, MD, S. Eisen, MD, L. Resor, MD, K. Sena, MD, D. Story, MD, L. M. Brass, MD, K. L. Furie, MD, L. Gutmann, MD, E. Hinnau, M. Gorman, MD, A. M. Lovejoy, PA-C, S. E. Inzucchi, MD, L. H. Young, MD, R. I. Horwitz, MD On behalf of the IRIS Trial Investigators*

From the Departments of Internal Medicine (W.N.K., C.M.V., D.D., B.M., K.S., E.H., A.M.L., S.E.I., L.H.Y.), Neurology (J.L.S., J.C.M., D.S., L.M.B.), and Orthopaedics and Rehabilitation (A.S.), Yale School of Medicine, New Haven, CT; Department of Medicine (R.I.H.), Stanford University School of Medicine, Palo Alto, CA; Richard L. Roudebush VAMC (D.M.B.), Indiana University School of Medicine, Indianapolis, IN; Department of Neurology (M.G.), University of Vermont, Burlington, VT; and Department of Medicine (K.L.F.), Harvard Medical School, Massachusetts General Hospital, Boston, MA; Lawrence and Memorial Hospital (D.M.), Groton, CT; St. Mary's Hospital (P.G.), Waterbury, CT; Waterbury Hospital (S.E.), Waterbury, CT; Stamford Hospital (L.R.), Stamford, CT; Bridgeport Hospital (K.S.), Bridgeport, CT; and National Institute of Neurological Disorders and Stroke (L.G.), NIH, Bethesda, MD.

Address correspondence and reprint requests to Dr. Walter N. Kernan, Suite 515, 2 Church St. South, New Haven, CT 06519 walter.kernan{at}yale.edu.

Objective: Our purpose was to develop a geographically localized, multi-institution strategy for improving enrolment in a trial of secondary stroke prevention.

Methods: We invited 11 Connecticut hospitals to participate in a project named the Local Identification and Outreach Network (LION). Each hospital provided the names of patients with stroke or TIA, identified from electronic admission or discharge logs, to researchers at a central coordinating center. After obtaining permission from personal physicians, researchers contacted each patient to describe the study, screen for eligibility, and set up a home visit for consent. Researchers traveled throughout the state to enroll and follow participants. Outside the LION, investigators identified trial participants using conventional recruitment strategies. We compared recruitment success for the LION and other sites using data from January 1, 2005, through June 30, 2007.

Results: The average monthly randomization rate from the LION was 4.0 participants, compared with 0.46 at 104 other Insulin Resistance Intervention after Stroke (IRIS) sites. The LION randomized on average 1.52/1,000 beds/month, compared with 0.76/1,000 beds/month at other IRIS sites (p = 0.03). The average cost to randomize and follow one participant was $8,697 for the LION, compared with $7,198 for other sites.

Conclusion: A geographically based network of institutions, served by a central coordinating center, randomized substantially more patients per month compared with sites outside of the network. The high enrollment rate was a result of surveillance at multiple institutions and greater productivity at each institution. Although the cost per patient was higher for the network, compared with nonnetwork sites, cost savings could result from more rapid completion of research.

Abbreviations: BMI = body mass index; HIPAA = Health Insurance Portability and Accountability Act; HOMA = homeostastis model assessment of insulin resistance; ICD-9 = International Classification of Diseases, 9th Revision; IRB = institutional review board; IRIS = Insulin Resistance Intervention after Stroke; LION = Local Identification and Outreach Network.

*See appendix for list of participating investigators.

{dagger}Died March 8, 2006.

Supported by the National Institute of Neurological Disorders and Stroke (U01 NS044876) and by a grant from Takeda Pharmaceuticals North America, Inc.

Disclosure: Dr. Inzucchi has received honoraria from Takeda Pharmaceuticals (manufacturer of pioglitazone) and other manufacturers of diabetic medications.

Received September 2, 2008. Accepted in final form February 5, 2009.






HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Copyright © 2009 by AAN Enterprises, Inc.