tPA: A Rural Network Experience
To the Editor:
We read with considerable interest the report of the Order of St Francis (OSF) Stroke Network in Peoria,1 discussing their early experience promoting the use of intravenous tissue plasminogen activator (IV tPA) in central Illinois. Since 1996 we have been somewhat differently organized in Minnesota for a similar phase IV assessment of this important therapy. Our initial report in 19982 presented 60 patients collected over 14 months, a quantity similar to the current OSF report. It was our judgment then, and our main criticism now of the OSF report, that such a limited number of patients precludes any meaningful statistical analysis of data and conclusions must be viewed with great reservation. Our most recent report3 of 151 patients accumulated over 34 months—now 252 patients over 43 months, as presented at the recent American Stroke Association 25th Annual Stroke Conference—still is limited by marginally adequate numbers. It has, however, provided us with sufficient data to apply multivariate analysis to questions about size, rural/urban location and academic affiliation of treating hospitals, specialty expertise of supervising physicians, pretreatment patient risk factors, accuracy of pretreatment CT interpretation, incidence and predictors of poor outcomes including symptomatic intracerebral hemorrhage (ICH) and ICH-related death. Our steering committee of volunteer stroke neurologists has reviewed CT images on every patient with a poor outcome; we obtained posttreatment CT scans on approximately 70% of patients and so know much about asymptomatic ICH. All CT images, regardless of clinical outcome, have been reviewed by a neuroradiologist blinded to all clinical details. This process has given us confidence that IV tPA in Minnesota has been reasonably safe over the last 3 years and not detectably different from the statistically robust National Institute of Neurological Diseases and Stroke study.4 Our initial and motivating concerns of 1996 have gradually been lightened, though we realize that our conclusions are yet tentative and can’t completely counter the skeptical concerns of many of our local colleagues. We will publish our data in full when we have accumulated 300 patients, later this year.
Our process has been different from the OSF effort. The OSF Network appears to be centrally directed, while our IV tPA treating hospitals have been independent after the initial orientation and nominal “training.” Our observation tools evolved over the first 2 years of our organization, and on behalf of those now organizing or implementing such clinical programs, we have some questions for the OSF authors: How were the widely distributed medical facilities recruited and organized, for this and other stroke projects? Were/are there CME education-presentations only, or more specific arrangements? Was a specific Stroke/tPA Champion named at each site? How is communication maintained between the various facilities? How are peripheral sites encouraged and given feedback about their performance in following the protocol? Who are the “certified staff” who perform National Institutes of Health Stroke Scale testing and collect data in the peripheral sites; how are they trained and their scoring validated? Who pays for the efforts at the peripheral sites?
This lengthy questionnaire still leaves many issues to be addressed. It seems likely to us that local factors of personnel availability, interest, and enthusiasm will determine the direction and depth of efforts at any facility, and so some unevenness will be inevitable in overall results of a given “center.” This inhomogeneity is itself worthy of documentation and analysis. As participants in the broad national effort to bring IV tPA therapy from the stroke center out into mainstream practice, we can only applaud the OSF group for their work and encourage the continuation and improvement of such practical demonstration projects.
- Copyright © 2000 by American Heart Association
Wang DZ, Rose JA, Honings DS, Garwacki DJ, Milbrandt JC. Treating acute stroke patients with intravenous tPA: the OSF Stroke Network experience. Stroke. 2000;31:77–81.
Hanson SK, Brauer DJ, Anderson DC, Koller RL, Davenport J, Ramirez-Lassepas M, Klassen AC, Altafullah IM, Brown RD. Stroke treatment in the community (STIC)-Intravenous rt-PA in community practice. Neurology. 1998;50(suppl 4):A155–156.
Hanson SK, Brauer DJ, Brown RD, Anderson DC, Davenport JG, Altafullah IM. Should use of tPA for ischemic stroke be restricted to specialized stroke centers? Stroke. 2000;31:313. Abstract.
National Institute of Neurological Diseases and Stroke rtPA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333:1581–1587.
We would like to acknowledge Davenport and colleagues for their comments on our work. Their efforts to bring acute stroke therapy to more patients in their area of Minnesota also deserve to be commended. We agree that one weakness of our study is the small number of patients that were followed up. However, the intent of our study was to examine whether intravenous rtPA can be safely given to patients at facilities other than a large regional medical center. The patient outcomes we observed in our study were similar to or perhaps slightly better than what was seen in the National Institute of Neurological Disorders and Stroke Trial, and no significant differences were seen between the “hub” facility and the other participating hospitals. Growing evidence from several studies examining the use of rtPA since approval in 1996 further supports the safety and efficacy of rtPA administration using the Food and Drug Administration guidelines, including the Minnesota experience by Hanson et al.R1 R2 R3 R4 R5
The organization of the OSF Stroke Network is, in fact, very different from the Minnesota group. The primary goal of our network was to provide support to small community hospitals (68 to 251 beds) so that they have the infrastructure in place to deliver up-to-date stroke care at their facilities. There is an uneven distribution of neurologists throughout most parts of rural areas in the United States. This lack of neuroscience support and expertise remains the biggest challenge to delivery of acute stroke therapies. It has become more evident that such support is critical to protocol compliance to ensure the success and good outcome of rtPA therapy. Protocol deviation is likely related to poor outcome.R6 Supporting small rural hospitals from a hub or regional medical center may be one model offering assistance to these facilities to safely deliver acute stroke care. A manuscript is currently being prepared on the organization of the OSF Stroke Network; however, we will briefly answer several questions by Davenport et al.
The OSF Stroke Network is now a 21-hospital organization facilitating a systematic team approach to provide stroke care in Central Illinois. The initial recruitment of potential facilities began with meetings with individual hospital administration and presentations to the medical staff at each rural hospital. A letter of agreement was developed for sites outlining requirements for participation. There are neither financial obligation nor required transfer of patients to the hub. Network hospitals were individually asked to determine the level of stroke care they felt they could provide. In the agreement, participating hospital administration agreed to support the development of a stroke program at the local institution (ranging from community education to acute treatment). One key person at each site is identified as the local champion to lead their stroke care program. Each network facility was provided with a resource manual, which contained stroke management protocols, CareMaps for patient management, outcome monitoring, and marketing tools. The hub, therefore, played a facilitative role to the participating sites. In addition, a standardized data collection form was developed and used by participating centers to follow their acute stroke patients. OSF Saint Francis Medical Center agreed to train the local staff, certify site personnel in the use of the National Institute of Health Stroke Scale, and provide neurology telephone consultation 24 hours a day. Quarterly network meetings are held for education and marketing and to gain feedback from the network hospitals regarding concerns, problems, and suggestions to improve the network.
During the process of developing the network, we have learned that one of the biggest challenges was to find a physician champion. It was often the physicians who were reluctant to support the local stroke effort. Physicians’ reluctance may be related to financial “turf” and the potential need to change their lifestyles for acute stroke assessment and care. We have also learned that the administration at nearly every hospital will support setting up a certain level of stroke program at their institution.
Setting up the network has been a challenging and rewarding experience for us. We have realized that the real difficulty lies in maintaining the enthusiasm and continuous effort to deliver up-to-date stroke care at each site. The Stroke Network infrastructure has made an impact on the ability of rural hospitals to deliver state of the art stroke care. How to perfect it and maintain the momentum remains to be assessed.
Albers GW, Bates VE, Clark WM, Bell R, Verro P, Hamilton SA. Intravenous tissue-type plasminogen activator for treatment of acute stroke: the Standard Treatment with Alteplase to Reverse Stroke (Stroke) Study. JAMA.. 2000;283:1145–1150.
Chiu D, Krieger D, Vollar-Cordova C, Kasner SE, Morgenstern LB, Bratina PL, Yatsu FM, Grotta JC. Intravenous tissue plasminogen activator for acute ischemic stroke: feasibility, safety, and efficacy in the first year of clinical practice. Stroke.. 1998;29:18–22.
Tanne D, Bates VE, Verro P, Kasner MD, Binder JR, Patel SC, Mansbach HH, Daley S, Schultz LR, Karanjia PN, Scott P, Dayno JM, Vereczkey-Porter K, Benesch C, Book D, Coplin WM, Dulli D, Levine SR, and the t-PA Stroke Survey Group. Initial clinical experience with IV tissue plasminogen activator for acute ischemic stroke: a multicenter survey. Neurology.. 1999;53:424–427.
Ground M, Stenzel C, Schmulling S, Rudolf J, Neveling M, Lechleuthner A, Schneweis S, Heiss WD. Early intravenous thrombolysis for acute ischemic stroke in a community-based approach. Stroke.. 1998;29:1544–1549.
Hanson SK, Brauer DJ, Anderson DC, Koller RL, Davenport J, Ramirez-Lassepas M, Klassen AC, Altafullah IM, Brown RD: Stroke Treatment in the Community (STIC): intravenous rt-PA in community practice. Neurology. 1998;50(suppl 4):A155–A156.
Katzan IL, Furlan AJ, Lloyd LE, Frank JI, Harper DL, Hinchey JA, Hammel JP, Qu A, Sila CA. Use of tissue-type plasminogen activator for acute ischemic stroke: the Cleveland Area experience. JAMA.. 2000;283:1151–1158.