title: Community consultation for prehospital research: experiences of study coordinators and principal investigators.
abstract: OBJECTIVE
  To assess principal investigators' and study coordinators' views and experiences regarding community consultation in a multicenter trial of prehospital treatment for status epilepticus conducted under an exception from informed consent for research in emergency settings.
  
  
  METHODS
  Principal investigators and study coordinators at all 17 hubs for the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) were invited to complete a web-based survey regarding community consultation at their site for RAMPART. Major domains included 1) perceived goals of community consultation, 2) experiences with and views of community consultation methods used, 3) interactions with IRB regarding community consultation, and 4) general satisfaction and lessons learned. Descriptive statistics were tabulated for Likert scale data; relevant themes were reported for text-based data.
  
  
  RESULTS
  Twenty-eight individuals (16 coordinators and 12 investigators) representing all 17 RAMPART hubs completed the survey. Respondents considered multiple community consultation goals to be important, with least support for the role of community consultation in altering study design. All sites used multiple methods (median = 5). The most widely used, and generally favored, method was attending previously scheduled meetings of existing groups. Respondents expressed frustration with low attendance and responsiveness at open public meetings.
  
  
  CONCLUSIONS
  Coordinators and investigators in this trial viewed community consultation efforts as successful but reported real challenges generating public interest. Individuals with the condition under study were found to be more engaged and supportive of the trial. Respondents endorsed numerous potential goals of the community consultation process and often combined methods to achieve these goals.
authors.forename: Neal W
authors.initials: NW
authors.lastname: Dickert
authors.forename: Prasanthi
authors.initials: P
authors.lastname: Govindarajan
authors.forename: Deneil
authors.initials: D
authors.lastname: Harney
authors.forename: Robert
authors.initials: R
authors.lastname: Silbergleit
authors.forename: Jeremy
authors.initials: J
authors.lastname: Sugarman
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Weinfurt
authors.forename: Rebecca D
authors.initials: RD
authors.lastname: Pentz
mesh_terms: D000927:Anticonvulsants / Q000008:administration & dosage / Q000627:therapeutic use; D001291:Attitude of Health Personnel; D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence / Q000379:methods*; D017326:Clinical Trials, Phase III as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D003256:Community Participation / Q000331:legislation & jurisprudence / Q000379:methods*; D003159:Community-Institutional Relations; D003625:Data Collection; D004632:Emergency Medical Services / Q000941:ethics / Q000331:legislation & jurisprudence / Q000379:methods*; D017144:Focus Groups; D006801:Humans; D015337:Multicenter Studies as Topic; D012108:Research Personnel / Q000523:psychology / Q000706:statistics & numerical data; D013226:Status Epilepticus / Q000188:drug therapy; D020458:Third-Party Consent / Q000941:ethics / Q000331:legislation & jurisprudence*; D014481:United States
chemical_list: D000927:Anticonvulsants