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Most first-generation endoscopic antireflux procedures (EARPs) have been withdrawn because of variable success rates, economic considerations, and/or complications.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.

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.

• Authors: Alexander J Eckardt, Gernot Pinnow, Heiko Pohl, Bertram Wiedenmann, Thomas Rösch
• Journal: European journal of gastroenterology & hepatology (Eur J Gastroenterol Hepatol) Vol. 21 Issue 10 Pg. 1110-8 (Oct 2009) ISSN: 1473-5687 [Electronic] England
• PMID: 19300273 (Publication Type: Journal Article)

Topics

• Adult
• Aged
• Aged, 80 and over
• Attitude of Health Personnel
• Attitude to Health
• Clinical Trials, Phase II as Topic (methods)
• Contraindications
• Female
• Fundoplication (methods)
• Gastroesophageal Reflux (surgery)
• Gastroscopy
• Germany
• Humans
• Male
• Middle Aged
• Multicenter Studies as Topic (methods)
• Patient Selection
• Referral and Consultation (statistics & numerical data)
• Young Adult