Antireflux 'barriers': problems with patient recruitment for a new endoscopic antireflux procedure.
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Antireflux 'barriers': problems with patient recruitment for a new endoscopic antireflux procedure. / Eckardt, Alexander J; Pinnow, Gernot; Pohl, Heiko; Wiedenmann, Bertram; Rösch, Thomas.
in: EUR J GASTROEN HEPAT, Jahrgang 21, Nr. 10, 10, 01.10.2009, S. 1110-1118.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Antireflux 'barriers': problems with patient recruitment for a new endoscopic antireflux procedure.
AU - Eckardt, Alexander J
AU - Pinnow, Gernot
AU - Pohl, Heiko
AU - Wiedenmann, Bertram
AU - Rösch, Thomas
PY - 2009/10/1
Y1 - 2009/10/1
N2 - BACKGROUND: Most first-generation endoscopic antireflux procedures (EARPs) have been withdrawn because of variable success rates, economic considerations, and/or complications.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.
AB - BACKGROUND: Most first-generation endoscopic antireflux procedures (EARPs) have been withdrawn because of variable success rates, economic considerations, and/or complications.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.
KW - Adult
KW - Germany
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Middle Aged
KW - Aged, 80 and over
KW - numerical data
KW - Young Adult
KW - Patient Selection
KW - Attitude to Health
KW - Attitude of Health Personnel
KW - Clinical Trials, Phase II as Topic methods
KW - Fundoplication contraindications
KW - Gastroesophageal Reflux surgery
KW - Gastroscopy contraindications
KW - Multicenter Studies as Topic methods
KW - Referral and Consultation statistics
KW - Adult
KW - Germany
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Middle Aged
KW - Aged, 80 and over
KW - numerical data
KW - Young Adult
KW - Patient Selection
KW - Attitude to Health
KW - Attitude of Health Personnel
KW - Clinical Trials, Phase II as Topic methods
KW - Fundoplication contraindications
KW - Gastroesophageal Reflux surgery
KW - Gastroscopy contraindications
KW - Multicenter Studies as Topic methods
KW - Referral and Consultation statistics
U2 - 10.1097/MEG.0b013e32832937c2
DO - 10.1097/MEG.0b013e32832937c2
M3 - SCORING: Journal article
C2 - 19300273
VL - 21
SP - 1110
EP - 1118
JO - EUR J GASTROEN HEPAT
JF - EUR J GASTROEN HEPAT
SN - 0954-691X
IS - 10
M1 - 10
ER -
