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RESEARCH PRODUCT

Tu1253 How Safe Is Sedation in Gastrointestinal Endoscopy? a Prospective Multicenter Trial: an Interim Analysis of 73,941 Endoscopies. Data From Prospective Registries of Complications Managed by Members of the Working Group of Leading Hospital Gastroenterologists (Algk)

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were those plausibly associated with the procedure and severe enough for the patient to seek medical attention. We compared the proportion of patients with adverse events associated with gastrointestinal endoscopy identified with direct patient contact to the proportion identified through our current infrastructure using the chi-square statistic. Results: During the study period, 11,710 endoscopic procedures were performed on 9,683 patients. Our study personnel made 3205 calls over a three month period and ultimately made contact with 1999 (17%; 84.5% of those called) patients. 28 (1.4%) adverse events were identified through direct patient contact. Our adverse event tracking infrastructure identified 93 (0.96%) events (p 0.0992).7(6.5%) events were detected by both methods; the direct patient contact method detected 21 unique cases and the multi-disciplinary infrastructure detected 86 unique cases. Together, the two methods identified 107 (1.1%) adverse events over the study period. Conclusions: This study shows that our low-cost multi-disciplinary infrastructure performs as well as the labor intensive method of directly contacting patients to identify adverse events; and overall identified more adverse events because direct patient contact was not required.