Inter-rater Reliability of the ASA Classification

• Conditions: ASA PS Klassifikation

• Registration Number: NCT02995499
• Lead Sponsor: University Clinic Frankfurt

Brief Summary

The ASA-PS classification, a subjective classification system of the patients' preoperative health status, contains a certain problem concerning its interrater reliability. A comparison between anesthesiologic and surgical assessment of the preoperative patient condition has not yet been extensively investigated. The aim of this study is to examine the latter in a prospective, monocentric, observational study.

Detailed Description

Included will be prospectively all patients undergoing an operation under anesthesiologic treatment in the one-period-time from the study-beginning at the Department of General and Visceral Surgery of the University Clinic Frankfurt. The ASA-PS classification will be twice conducted and documented during the informed consent process: once by the consulting surgeon and once by the consulting anesthesiologist. The assigned class and the training status of the involved physician are anonymously documented on the study case report form. The pre-, peri- and postoperative patient data, in particular the demographic data (age, height, weight, BMI), comorbidities, type and duration of operation, as well as perioperative complications in a follow-up period of 90 days will be extracted from the electronic patient record. The patient data documentation concludes with a contact and, if necessary, examination of the patient (in hospital or by the family doctor) after the 90th postoperative day. Subsequently two study cooperation partners, a senior surgeon and a senior anesthesiologist, will assign a "recommended"-ASA-PS class to every pseudonymized patient based only on the documented preoperative examination, demographics and comorbidities without insight into the preoperative documented ASA-PS classifications or the postoperative course.

Primary Hypothesis:

The assessments of the preoperative state of health of general-surgical patients by means of the ASA-PS classification carried out independently by members of different disciplines result in a moderate interrater reliability of the latter.

Secondary Hypothesis:

The discrepancy between the abovementioned ASA-PS classification and that recommended by an interdisciplinary committee decreases with increasing professional experience.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-11
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-16
• Primary Completion: 2019-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-12
• Last Update Posted: 2022-02-15
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 683

Inclusion Criteria

• All patients undergoing an operation under anesthesiologic treatment in the one-period-time from the study-beginning at the Department of General and Visceral Surgery of the University Clinic Frankfurt.

Exclusion Criteria

• Patients with ASA-Class 6.
• Patients undergoing surgery more than twice in the same hospital stay (only two evaluations per patient case admitted).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interrater reliability of the ASA classification	through study completion, an average of 1 year	Expressed as Krippendorff's alpha and as a Fleiss' kappa

Secondary Outcome Measures

Name	Time	Method
Morbidity rate	90 days postoperative	Clavien-Dindo-Klassifikation
Mortality rate	30 and 90 days postoperative

Trial Locations

Locations (1)

University Clinic Frankfurt; 🇩🇪 Frankfurt am Main, Germany