Boosting enrollment in neurology trials with Local Identification and Outreach Networks (LIONs)
| Autor: | W N, Kernan, C M, Viscoli, D, Demarco, B, Mendes, K, Shrauger, J L, Schindler, J C, McVeety, A, Sicklick, D, Moalli, P, Greco, D M, Bravata, S, Eisen, L, Resor, K, Sena, D, Story, L M, Brass, K L, Furie, L, Gutmann, E, Hinnau, M, Gorman, A M, Lovejoy, S E, Inzucchi, L H, Young, R I, Horwitz, R, Cote |
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| Rok vydání: | 2009 |
| Předmět: |
medicine.medical_specialty
Neurology Accrual Alternative medicine Hospitals Community Placebo law.invention Random Allocation Randomized controlled trial law medicine Humans Multicenter Studies as Topic Clinical Trials as Topic Informed Consent business.industry Patient Selection Health Insurance Portability and Accountability Act Articles Stroke Clinical trial Outreach Connecticut Ischemic Attack Transient Family medicine Physical therapy Neurology (clinical) Insulin Resistance Nervous System Diseases business |
| Zdroj: | Neurology. 72:1345-1351 |
| ISSN: | 1526-632X 0028-3878 |
| DOI: | 10.1212/wnl.0b013e3181a0fda3 |
| Popis: | The randomized clinical trial is the preferred scientific strategy for measuring the effectiveness and safety of new therapies for stroke patients. Unfortunately, many recent trials in stroke have been hampered by slow patient accrual.1,2 Trials that are designed to last 3 to 4 years are taking much longer. Trials designed for one or two countries have grown into multinational efforts. Among the serious consequences of slow accrual are increased costs and delayed completion.3,4 The current paradigm for most large clinical trials in stroke includes recruitment from multiple, independent hospitals. Each hospital establishes and staffs its own research operation and seeks patients only within its own walls. Within this paradigm, reasons for slow accrual, other than exclusion factors,5 seem to include 1) inadequate numbers of eligible patients seeking care at a recruitment venue, 2) failure to identify and approach all eligible patients, 3) barriers to participation that result in patient refusal, and 4) lack of adequately trained research personnel. Many small and nonacademic hospitals cannot support this paradigm and do not participate in stroke trials. In this article, we describe a novel approach that addresses these basic reasons for slow accrual. The approach, termed Local Identification and Outreach Networks (LIONs), was first developed to improve recruitment for the Hemorrhagic Stroke Project6 during 1994–2000 and the Women's Estrogen for Stroke Trial during 1993–2001.7 It was reconstructed in 2004 for the Insulin Resistance Intervention after Stroke (IRIS) trial, which is examining the effectiveness of pioglitazone compared with placebo for prevention of stroke and myocardial infarction among patients with insulin resistance and a recent ischemic stroke or TIA. This article is based on our experience with the Connecticut LION in the IRIS trial. The Connecticut LION includes multiple collaborating hospitals. Each works within US federal guidelines governing human subjects research and the Health Insurance Portability and Accountability Act (HIPAA)8 to provide the names of patients with stroke or TIA to researchers at a central coordinating center. After obtaining permission from personal physicians, the researchers contact each patient to describe the study, screen for eligibility, and set up a home visit. Researchers from the center travel throughout the state to enroll and follow participants. |
| Databáze: | OpenAIRE |
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