Derivation and Validation of a Novel Severity Classification for Intraoperative Adverse Events

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• 作者：Haytham M.A. Kaafarani ; MD ; MPH ; ^{hkaafarani@partners.org" class="auth_mail} ; Michael N. Mavros ; MD ; John Hwabejire ; MD ; MPH ; Peter Fagenholz ; MD ; Daniel D. Yeh ; MD ; FACS ; Marc Demoya ; MD ; David R. King ; MD ; FACS ; Hasan B. Alam ; MD ; FACS ; Yuchiao Chang ; PhD ; Matthew Hutter ; MD ; MPH ; FACS ; Donna Antonelli ; BS ; CPHQ ; Alice Gervasini ; RN ; PhD ; George C. Velmahos ; MD ; PhD ; FACS
• 刊名：Journal of the American College of Surgeons
• 出版年：June 2014
• 年：2014
• 卷：218
• 期：6
• 页码：1120-1128
• 全文大小：149 K

文摘

There is currently no systematic approach to evaluating the severity of intraoperative adverse events (iAEs).

Study Design

A 3-phase project was designed to develop and validate a novel severity classification scheme for iAEs. Phase 1 created the severity classification using a modified Delphi process. Phase 2 measured the classification's internal consistency by calculating inter-rater reliability among 91 surgeons using standardized iAEs scenarios. Phase 3 measured the classification's construct validity by testing whether major iAEs (severity class ≥3) correlated with worse 30-day postoperative outcomes compared with minor iAEs (severity class <3). This was achieved by creating a matched database using American College of Surgeons NSQIP and administrative data, querying for iAEs using the Patient Safety Indicator #15 (Accidental Puncture/Laceration), and iAE confirmation by chart review.

Results

Phase 1 resulted in a 6-point severity classification scheme. Phase 2 revealed an inter-rater reliability of 0.882. Of 9,292 patients, phase 3 included 181 confirmed with iAEs. All preoperative/intraoperative variables, including demographics, comorbidities, type of surgery performed, and operative length, were similar between patients with minor (n = 110) vs major iAEs (n = 71). In multivariable logistic analysis, severe iAEs correlated with higher risks of any postoperative complication (odds ratio [OR] = 3.8; 95% CI, 1.9−7.4; p < 0.001), surgical site infections (OR = 3.7; 95% CI, 1.7−8.2; p = 0.001), systemic sepsis (OR = 6.0; 95% CI, 2.1−17.2; p = 0.001), failure to wean off the ventilator (OR = 3.2; 95% CI, 1.2−8.9; p = 0.022), and postoperative length of stay ≥7 days (OR = 3.0; 95% CI, 1.5−5.9; p = 0.002). Thirty-day mortalities were similar (4.5% vs 7.1%; p = 0.46).

Conclusions

We propose a novel iAE severity classification system with high internal consistency and solid construct validity. Our classification scheme might prove essential for benchmarking quality of intraoperative care across hospitals and/or individual surgeons.