- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01524484
Quality of Quality Data (QoQ)
Quality of Quality Data - A Retrospective Study on Routine Quality Data Reporting in Anesthesia
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Zürich, Svizzera, CH-8032
- Institute of Anesthesiology and Intensive Care, Klinik Hirslanden Zürich, Switzerland
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
- 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.
- anesthesia staff interviews: Physicians and nurses entering quality data into electronic anesthesia record
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Anesthesia staff Interviewees
Staff entering quality data into the electronic anesthesia record are interviewed regarding working conditions and record layout
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Anesthesia records
Anesthesia records (all types of procedures) are checked for correct reporting of defined events
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Event reporting rate
Lasso di tempo: 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.
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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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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.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Johannes Wacker, MD, IFAI, Klinik Hirslanden, Zürich, Switzerland
- Direttore dello studio: Georg Mols, MD, Prof., IFAI, Klinik Hirslanden Zürich, Switzerland
- Direttore dello studio: Reto Stocker, MD, Prof., IFAI, Klinik Hirslanden Zürich, Switzerland
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- KEK-ZH-Nr. 2011-0421
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .