title: Antireflux 'barriers': problems with patient recruitment for a new endoscopic antireflux procedure.
abstract: BACKGROUND
  Most first-generation endoscopic antireflux procedures (EARPs) have been withdrawn because of variable success rates, economic considerations, and/or complications. As a result, subsequent methods may meet 'skepticism' by physicians and patients.
  
  
  OBJECTIVE
  To identify potential barriers to patient recruitment for a new EARP METHODS: We prospectively analyzed our recruitment for a phase 2 study of a transoral incisionless fundoplication procedure. We contacted 50 private practices and 23 hospitals for potential referrals, and placed three newspaper advertisements. All patient replies were followed up by a phone call. Patients were then invited for a personal interview, and eligible patients underwent further preprocedure testing. In addition, poststudy questionnaires regarding their opinions about EARPs were sent to referring physicians.
  
  
  RESULTS
  Of 134 interviewed patients, only 10% (n=13) were successfully recruited. Candidates mostly responded to newspaper advertisements (87%) or were referred from our own institution (7%). Primary exclusion criteria included failure of proton pump inhibitor response (34%), lack of proton pump inhibitor use (20%), atypical symptoms (18%), or a large hiatal hernia (17%). Seventy percent of the responding physicians did not believe that new EARPs would be superior to previous methods.
  
  
  CONCLUSIONS
  The EARP market seems to be much smaller than anticipated, partially because of skepticism of referring physicians, and partially because of strict selection criteria.
authors.affiliation: Central Interdisciplinary Endoscopy Unit, Department of Gastroenterology and Hepatology, Charité University Hospitals Berlin, Campus Virchow, Berlin, Germany. alexander.eckardt@charite.de
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Eckardt
authors.forename: Gernot
authors.initials: G
authors.lastname: Pinnow
authors.forename: Heiko
authors.initials: H
authors.lastname: Pohl
authors.forename: Bertram
authors.initials: B
authors.lastname: Wiedenmann
authors.forename: Thomas
authors.initials: T
authors.lastname: Rösch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001291:Attitude of Health Personnel; D001294:Attitude to Health; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D000075202:Contraindications; D005260:Female; D018662:Fundoplication / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D005773:Gastroscopy; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000379:methods; D018579:Patient Selection; D012017:Referral and Consultation / Q000706:statistics & numerical data; D055815:Young Adult