Antireflux 'barriers': problems with patient recruitment for a new endoscopic antireflux procedure.

BACKGROUND: Most first-generation endoscopic antireflux procedures (EARPs) have been withdrawn because of variable success rates, economic considerations, and/or complications.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. AIMS: 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. CONCLUSION: The EARP market seems to be much smaller than anticipated, partially because of skepticism of referring physicians, and partially because of strict selection criteria.