Implementation of sedation guidelines in clinical practice in Italy: results of a prospective longitudinal multicenter study

Background and study aims: Following publication in 2000 of the Italian Guidelines for Sedation in Digestive Endoscopy, the authors carried out a dissemination program and an audit of the impact of the Guidelines in clinical practice. The primary aim was to evaluate any changes in sedation methods at the start of and during the study period (at 0, 6, and 12 months). Secondary study aims were detailed analyses of endoscopies regarding sedation, complications, and patient satisfaction.
Patients and methods: The prospective, observational, multicenter study was commenced in 60 centers (31 first- and 29 second-level) which opted to have seminars on the Guidelines; results concerning sedation practices in relation to endoscopic procedure, complications, and patient satisfaction were recorded at the start of the study (phase 0) and at 6 and 12 months. Over a 1-year period, 5261 sedated and unsedated patients undergoing endoscopic procedures were enrolled (with data collection between December 1999 and June 2002). The results were analyzed using the chi-squared test.

Results: Data were available for all three assessment time points from 29 of the 60 centers. The sedation rate, between phase 0 and 2, increased by 12.75 % in first-level centers and 0.73 % in second-level centers with midazolam use increasing from 34 % to 41 %. For colonoscopy, sedation usage increased from 52 % to 56 %. Adverse events occurred in 0.47 % of the patients, without long-term sequelae or death, and patient satisfaction was only slightly, but not significantly higher with sedation (90.4 % of sedated patients were “very satisfied” vs. 87 % of unsedated patients who were “satisfied”), but the examination was more likely to be complete in sedated patients and this difference was statistically significant (P < 0.001).
Conclusions: We conclude that if sedation is used as recommended by the Guidelines, it is possible to control clinical risk by using high quality endoscopic procedures.

References

• 1 SIED, SIAARTI, ANOTE. . Linee Guida per la Sedazione in Endoscopia digestiva.  Giorn Ital End Dig. 2000;  23 Suppl 21
• 2 AGREE Collaboration .Appraisal of Guidelines for Research & Evaluation (AGREE) Instrument. http://Available from: www.agreecollaboration.org
• 3 Helsinki Declaration. Available from: http://onlineethics.org/reseth/helsinki.html
• 4 Educational program Promotions of Forms and Measures. http://Available from: www.link-ita.com/default.aspx?area=medicina
• 5 Hung O r, Dyck J B, Varvel J. et al . Comparative absorption kinetics of intramuscular midazolam and diazepam.  Can J Anaesth. 1996;  43 450-455
• 6 Getting evidence into practice.  Effective Health Care. 1999;  5 1-16 http://Available from: www.york.ac.uk/inst/crd/ehc51.pdf
• 7 Garside P. Quality management.  Health Care. 1999;  8 1321
• 8 Weingarten S. Using practice guideline compendiums to provide better preventive care.  Ann Intern Med. 1999;  130 454-458
• 9 Grol R, Dalhuijzen J, Mokkink H. et al . Attributes of clinical guidelines that influence use of guidelines in general practice: observational study.  BMJ. 1998;  317 858-861
• 10 Freeman M L. Sedation and monitoring for gastrointestinal endoscopy.  Gastrointest Endosc Clin N Am. 1994;  3 475-499
• 11 Arrowsmith J B, Gerstman B B, Fleischer D E. et al . Results from the American Society for Gastrointestinal Endoscopy/US Food and Drug Administration collaborative study on complication rates and drug use during gastrointestinal endoscopy.  Gastrointest Endosc. 1991;  4 421-427
• 12 Froehlich F, Gonvers J J, Fried M. Conscious sedation, clinically relevant complications and monitoring of endoscopy: results of a nationwide survey in Switzerland.  Endoscopy. 1994;  26 231-234