Prospektive Kohortenstudie bei stationären augenchirurgischen Patienten für die Validierung der ClassIntra-Klassifikation für unerwünschte intraoperative Ereignisse

Zusammenfassung

Hintergrund Gemäß unserer Literaturrecherche gibt es kein validiertes System für die standardisierte Erfassung von unerwünschten intraoperativen Ereignissen (iAEs) in der Augenchirurgie. ClassIntra wurde neu entwickelt, um chirurgie- oder anästhesiebezogene Abweichungen vom idealen intraoperativen Verlauf zu klassifizieren. Ziel der Studie ist die Validierung und die Praktikabilitätserfassung von ClassIntra in der Augenchirurgie.

Methoden In diese prospektive, monozentrische Kohortenstudie wurden nur stationäre, augenchirurgische Patienten eingeschlossen. Die iAEs wurden gemäß ClassIntra klassifiziert und entsprechend den therapeutischen Konsequenzen und den Symptomen des Patienten in 5 Schweregrade unterteilt. Ein 2-wöchiges Follow-up wurde durchgeführt, um alle postoperativen Komplikationen gemäß der Clavien-Dindo-Klassifikation zu erfassen. Primärer Endpunkt war die risikokorrigierte Assoziation zwischen dem schwersten ClassIntra-Grad und der Summe aller postoperativen Komplikationen (Comprehensive Complication Index, CCI) innerhalb des Follow-ups. Außerdem wurden Ophthalmologen und Anästhesisten gebeten, einen Onlinefragebogen auszufüllen, der eine Zuordnung der 5 ClassIntra-Schweregrade zu 10 fiktiven klinischen Fallszenarien erforderte. Die Reliabilität wurde durch den Vergleich der Bewertungen durch die Kliniker mit den vordefinierten Bewertungen des Studienteams geschätzt.

Ergebnisse Es wurden 100 stationäre Patienten im mittleren Alter von 64 Jahren (SA 15) eingeschlossen. Die Mehrheit der Patienten waren ASA II (n = 53, 53%) oder ASA III (n = 42, 42%). Es wurden 32 iAEs in 22 Patienten erfasst (17 × Grad I, 12 × Grad II, 3 × Grad III). Postoperativ traten 94 Komplikationen in 50 Patienten auf (44 × Grad I, 36 × Grad II, 14 × Grad IIIa). Für den primären Endpunkt zeigte sich eine mittlere Differenz im CCI von 2,1 (95%-Konfidenzintervall [KI] − 2,5 – 6,8) pro Zunahme im ClassIntra-Schweregrad. 50 Ophthalmologen und Anästhesisten haben den Onlinefragebogen vollständig ausgefüllt (Antwortrate 54%). Der Intraklassenkorrelationskoeffizient betrug 0,79 (95%-KI 0,64 – 0,94).

Schlussfolgerung Die Anwendung von ClassIntra während der täglichen Routine in der Augenchirurgie erwies sich als praktikables Tool, um iAEs standardisiert zu erfassen. Obwohl sich die Konstruktvalidität nicht nachweisen ließ, unterstreicht die hohe Kongruenz der Umfrageergebnisse eine gute Handhabung der neu entwickelten Klassifikation auch in der Augenchirurgie.

Abstract

Background To the best of our knowledge, there is no validated classification to assess intraoperative adverse events (iAEs) in ophthalmic surgery. ClassIntra is a newly developed classification for surgery- and anaesthesia-related iAEs that has been recently validated in various surgical disciplines, but not in ophthalmic surgery. We aim to assess the validity and practicability of ClassIntra in patients undergoing ophthalmic surgery.

Methods A consecutive sample of in-hospital patients undergoing any type of ophthalmic surgery was included in this single-centre prospective cohort study. iAEs were classified using ClassIntra, consisting of 5 severity grades according to the symptoms of the patient and the required treatment. All patients were followed for two weeks to record all postoperative adverse events according to Clavien-Dindo. The primary endpoint was the risk-adjusted association between the most severe iAE and the weighted sum of all postoperative adverse events within the two-week follow-up using the Comprehensive Complication Index (CCI). In addition, ophthalmologists and anaesthesiologists were asked to complete an online survey assessing the severity of iAEs for 10 fictitious clinical case scenarios. Reliability was assessed by comparing the cliniciansʼ ratings to the prespecified benchmark rating of the study team.

Results In this study, 100 in-hospital patients with an average age of 64 years (SD 15) were included. The majority of all patients were ASA II (n = 53, 53%) or III (n = 42, 42%). Thirty-two iAEs were recorded in 22 patients (17 grade I, 12 grade II, 3 grade III). Ninety-four postoperative adverse events occurred in 50 patients (44 grade I, 36 grade II, 14 grade IIIa). We found a mean difference in CCI of 2,1 (95% confidence interval [CI] − 2,5 to 6,8) per one unit increase in severity grades of ClassIntra. Fifty ophthalmologists and anaesthesiologists completed the online survey (response rate 54%). The intraclass correlation coefficient was 0,79 (95% CI 0,64 to 0,94).

Conclusions The application of ClassIntra during daily routine in ophthalmic surgery showed the usefulness and practicability of this classification for the standardised assessment of intraoperative adverse events. Although construct validity could not be demonstrated, the good reliability in the surveyʼs rating underlines the criterion validity of this newly developed classification in ophthalmic surgery.

Schlüsselwörter

unerwünschte intraoperative Ereignisse - Augenchirurgie - Klassifikation - Validierung - Checkliste Sichere Chirurgie - Sicherheitskultur

Key words

intraoperative adverse events - ophthalmic surgery - classification - validation - surgical safety checklist - safety culture

Publication History

Received: 23 September 2020

Accepted: 09 March 2021

Article published online:
30 April 2021

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