Inter-rater Reliability of the ASA Classification (In-ASK)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ASA PS Klassifikation

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 Type: Observational
• Enrollment (Anticipated): 683

Contacts and Locations

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60590
    • University Clinic Frankfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity rate	Clavien-Dindo-Klassifikation	90 days postoperative
Mortality rate		30 and 90 days postoperative

Collaborators and Investigators

• Sponsor: University Clinic Frankfurt
• Investigators: Principal Investigator: Georgios Makridis, Dr. med., University Clinic Frankfurt; Study Director: Wolf Otto Bechstein, Prof. Dr., University Clinic Frankfurt

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: December 11, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 16, 2016

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 12, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: general surgery; inter-rater reliability; ASA-PS classification
• Other Study ID Numbers: 405/16; U1111-1190-9648 (Other Identifier: WHO / UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No