title: The STRokE DOC trial technique: 'video clip, drip, and/or ship'.
abstract: BACKGROUND
  To describe the clinical trial methods of a site-independent telemedicine system used in stroke.
  
  
  OBJECTIVE
  A lack of readily available stroke expertise may partly explain the low rate of rt-PA use in acute stroke. Although telemedicine systems can reliably augment expertise available to rural settings, and may increase rt-PA use, point-to-point systems do require fixed base stations. Site-independent systems may minimize delay. The STRokE DOC trial assesses whether site-independent telemedicine effectively and efficiently brings rt-PA to a remote population.
  
  
  METHODS
  STRokE DOC is a 5-year, 400-participant, noninvasive trial, comparing two consultative techniques at four remote sites. Participants are randomized to acute 'STRokE DOC telemedicine' or 'telephone' consultations. Treatment decision accuracy is adjudicated at two time points, using three levels of data availability and an independent auditor.
  
  
  RESULTS
  The primary outcome measure is whether there was a 'correct decision to treat or not to treat using rt-PA' at each of three adjudication levels (primarily at Level #2). Secondary outcomes include the number of thrombolytic recommendations, intracerebral hemorrhage, and 90-day outcomes. Using the STRokE DOC system (or telephone evaluation), medical history, neurologic scales, CT interpretations, and recommendations have been completed on over 200 participants to date. Of the initial 11, nonrandomized, 'run-in' patients, six (65%) were evaluated wirelessly, and five (45%) were evaluated with a site-independent LAN or cable modem. Three (27%) received rt-PA. The adjudication methodology was able to show both agreements and disagreements in these 11 cases. It is feasible to perform site-independent stroke consultations, and adjudicate those cases, using the STRokE DOC system and trial design. Telemedicine efficacy remains to be proven.
authors.affiliation: Department of Neurosciences, UCSD School of Medicine, San Diego, CA 92103-8466, USA. bcmeyer@ucsd.edu
authors.forename: B C
authors.initials: BC
authors.lastname: Meyer
authors.forename: R
authors.initials: R
authors.lastname: Raman
authors.forename: R
authors.initials: R
authors.lastname: Rao
authors.forename: R D
authors.initials: RD
authors.lastname: Fellman
authors.forename: J
authors.initials: J
authors.lastname: Beer
authors.forename: J
authors.initials: J
authors.lastname: Werner
authors.forename: J A
authors.initials: JA
authors.lastname: Zivin
authors.forename: P D
authors.initials: PD
authors.lastname: Lyden
mesh_terms: D002985:Clinical Protocols; D003657:Decision Making; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006297:Health Services Accessibility; D006801:Humans; D020407:Internet; D011994:Recombinant Proteins / Q000627:therapeutic use; D012107:Research Design; D012424:Rural Population; D020521:Stroke / Q000188:drug therapy*; D017216:Telemedicine / Q000295:instrumentation / Q000458:organization & administration* / Q000706:statistics & numerical data; D013689:Telephone; D015912:Thrombolytic Therapy; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use; D016896:Treatment Outcome; D014741:Video Recording
chemical_list: D005343:Fibrinolytic Agents; D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator