Quality of Quality Data (QoQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01524484
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : October 22, 2014
University of Zurich
University of Freiburg
Information provided by (Responsible Party):
Johannes Wacker, MD, Klinik Hirslanden, Zurich

Brief Summary:
Data on quality of clinical anesthesia are important for the improvement of both quality and patient safety in this field. Routine quality data are often collected by professionals busy with patient care. This study examines the reliability of routinely collected quality data by comparing the electronic anesthesia record with the respective reports on quality-indicating events, i.e. whether events during the anesthetic (e.g., drop of blood pressure, irregular heart rhythm, and others) were actually reported or not. Additionally, interviews with reporting staff (physicians and nurses) are performed to gain insight in possible obstacles to reporting during the working process.

Condition or disease

Detailed Description:

Reliable quality data are an important basis for attempts to improve quality and safety of patient care. For anesthetic practice in Switzerland, an "Absolute Minimal Data Set" (AMDS) of preoperative patient characteristics and intra- and postoperative quality indicators is provided by the Institute of Social and Preventive Medicine (IUMSP, University of Lausanne) in cooperation with the Swiss Society of Anaesthesiology and Reanimation (SGAR-SSAR). Data are electronically forwarded by the participating institutions to IUMSP, whereas primary collection can be achieved by traditional paper records or electronic records as part of anesthesia information management systems (AIMS).

In the investigator's institution, physician and nurse anesthetists are supposed to use a window in the electronic anesthesia record for this purpose. This form should be completed at the end of each case. If an event according to the AMDS definitions occurs at least once during anesthesia, the respective box (e.g., "intraoperative hypotension") should be ticked in the form. The anesthesia record cannot be closed unless the quality form is filled, which can notably be done even in advance "on the quick" by ticking "no events". Considering the numerous duties of anesthesia staff at the end of a case, the investigators questioned the reliability of data generated during this busy phase.

A pilot study of 50 consecutive unselected cases of the year 2010 revealed a low rate of reporting (10.8%) of selected perioperative events related to anesthesia (specifically: hypotensive, hypertensive, bradycardic, tachycardic, and hypoxemic episodes). Consequently, the current extensive study with more representative sample size was initiated. To gain insight into possible causes (among others: time pressure, unclear definitions, fear of litigation), interviews with anesthesia staff are performed and will hopefully provide a basis for possible improvements. For the time being and considering the common nature of possible causes, the investigators suspect that their results may not be specific for their institution. The incidence of perioperative events may be grossly underestimated if the process of data collection is not properly designed and monitored.

Study Type : Observational
Actual Enrollment : 255 participants
Time Perspective: Retrospective
Official Title: Quality of Quality Data - A Retrospective Study on Routine Quality Data Reporting in Anesthesia
Study Start Date : November 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Anesthesia staff Interviewees
Staff entering quality data into the electronic anesthesia record are interviewed regarding working conditions and record layout
Anesthesia records
Anesthesia records (all types of procedures) are checked for correct reporting of defined events

Primary Outcome Measures :
  1. Event reporting rate [ Time Frame: Outcome measure is assessed at the end of each included anesthetic. Event reporting rate comprises reporting rate of defined events occurring during the given anesthetic. Durations of anesthetics are approximately between 0.5 and 5 hours. ]
    For defined events (hypotensive, hypertensive, bradycardic, tachycardic, and hypoxemic episodes), occurrence documented in the electronic anesthesia record is compared with their actual reporting in the reporting section of the record. From this, reporting rate is calculated for the various event types.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  1. Anesthesia records: a) Pilot study: 50 consecutive cases of the year 2010. b) Main study: 200 cases of the year 2010, random sample (generated with a random number generator). All cases are of one hospital, no further restrictions.
  2. anesthesia staff interviews: Physicians and nurses entering quality data into electronic anesthesia record

Inclusion Criteria:

  • 50 consecutive cases for pilot study;
  • 200 anesthetic records of the year 2010 chosen as a random sample.
  • all staff entering the quality data into the electronic anesthesia record (physicians, nurses)

Exclusion Criteria:

  • participation of staff in this study,
  • participation in quality data processing or assessment,
  • longterm leave precluding the interview

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01524484

Institute of Anesthesiology and Intensive Care, Klinik Hirslanden Zürich, Switzerland
Zürich, Switzerland, CH-8032
Sponsors and Collaborators
Johannes Wacker, MD
University of Zurich
University of Freiburg
Principal Investigator: Johannes Wacker, MD IFAI, Klinik Hirslanden, Zürich, Switzerland
Study Director: Georg Mols, MD, Prof. IFAI, Klinik Hirslanden Zürich, Switzerland
Study Director: Reto Stocker, MD, Prof. IFAI, Klinik Hirslanden Zürich, Switzerland

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Johannes Wacker, MD, Principal Investigator, Klinik Hirslanden, Zurich Identifier: NCT01524484     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2011-0421
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014

Keywords provided by Johannes Wacker, MD, Klinik Hirslanden, Zurich:
Data quality
Quality assurance

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs