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Quality of Quality Data (QoQ)

21. oktober 2014 opdateret af: Johannes Wacker, MD

Quality of Quality Data - A Retrospective Study on Routine Quality Data Reporting in Anesthesia

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

255

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Zürich, Schweiz, CH-8032
        • Institute of Anesthesiology and Intensive Care, Klinik Hirslanden Zürich, Switzerland

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

  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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Event reporting rate
Tidsramme: 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.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Johannes Wacker, MD, IFAI, Klinik Hirslanden, Zürich, Switzerland
  • Studieleder: Georg Mols, MD, Prof., IFAI, Klinik Hirslanden Zürich, Switzerland
  • Studieleder: Reto Stocker, MD, Prof., IFAI, Klinik Hirslanden Zürich, Switzerland

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2011

Primær færdiggørelse (Faktiske)

1. marts 2012

Studieafslutning (Faktiske)

1. april 2012

Datoer for studieregistrering

Først indsendt

21. januar 2012

Først indsendt, der opfyldte QC-kriterier

1. februar 2012

Først opslået (Skøn)

2. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • KEK-ZH-Nr. 2011-0421

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Anæstesi

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