Prospective validation of classification of intraoperative adverse events (ClassIntra) : international, multicentre cohort study
Dell-Kuster, Salome (Department of Clinical Research, University of Basel, Basel, Switzerland)
Gomes, Nuno V (Department of Clinical Research, University of Basel, Basel, Switzerland)
Gawria, Larsa (Radboud University Medical Centre. Department of Surgery)
Aghlmandi, Soheila (University Hospital Basel (Basilea, Suïssa))
Aduse-Poku, Maame (Guy's and St Thomas' NHS Foundation Trust (Regne Unit))
Bissett, Ian (Department of Surgery, University of Auckland, Auckland, New Zealand)
Blanc, Catherine (Lausanne University Hospital)
Brandt, Christian (Department of Anaesthesiology, Bürgerspital Solothurn, Solothurn, Switzerland)
ten Broek, Richard B. (Radboud University Medical Centre. Department of Surgery)
Bruppacher, Heinz R. (Department of Anaesthesiology, Schulthess Clinic, Zurich, Switzerland)
Clancy, Cillian (Department of Surgery, Tallaght University Hospital, Dublin, Ireland)
Delrio, Paolo (Colorectal Surgical Oncology, Abdominal Oncology Department, Istituto Nazionale per lo Studio e la Cura dei Tumori, "Fondazione Giovanni Pascale" IRCCS, Naples, Italy)
Espin-Basany, Eloy (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Galanos-Demiris, Konstantinos (George Papanicolaou General Hospital (Tessalònica, Grècia))
Gecim, I Ethem (Department of Surgery, Ankara University Medical School, Ankara, Turkey)
Ghaffari, Shahbaz (Universitätskliniken der MedUni Wien)
Gié, Olivier (Lausanne University Hospital)
Goebel, Barbara (University Children's Hospital Basel (Basilea, Suïssa))
Hahnloser, Dieter (Lausanne University Hospital)
Herbst, Friedrich (Universitätskliniken der MedUni Wien)
Orestis, Ioannidis (George Papanicolaou General Hospital (Tessalònica, Grècia))
Joller, Sonja (University Children's Hospital Basel (Basilea, Suïssa))
Kang, Soojin (Guy's and St Thomas' NHS Foundation Trust (Regne Unit))
Martín, Rocio (Hospital Universitari Vall d'Hebron)
Mayr, Johannes (University Children's Hospital Basel (Basilea, Suïssa))
Meier, Sonja (Guy's and St Thomas' NHS Foundation Trust (Regne Unit))
Murugesan, Jothi (University of Sydney, Royal North Shore Hospital, Sydney, Australia)
Nally, Deirdre (Department of Surgery, Tallaght University Hospital, Dublin, Ireland)
Ozcelik, Menekse (Department of Anaesthesiology, Ankara University Medical School, Ankara, Turkey)
Pace, Ugo (Colorectal Surgical Oncology, Abdominal Oncology Department, Istituto Nazionale per lo Studio e la Cura dei Tumori, "Fondazione Giovanni Pascale" IRCCS, Naples, Italy)
Passeri, Michael (Department of Surgery, Carolinas Medical Centre, Charlotte, NC, USA)
Rabanser, Simone (Department of Anaesthesiology, Cantonal Hospital Graubünden, Chur, Switzerland)
Ranter, Barbara (Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria)
Rega, Daniela (Colorectal Surgical Oncology, Abdominal Oncology Department, Istituto Nazionale per lo Studio e la Cura dei Tumori, "Fondazione Giovanni Pascale" IRCCS, Naples, Italy)
Ridgway, Paul F. (Department of Surgery, Tallaght University Hospital, Dublin, Ireland)
Rosman, Camiel (Radboud University Medical Centre. Department of Surgery)
Schmid, Roger (Department of Surgery, Bürgerspital Solothurn, Solothurn, Switzerland)
Schumacher, Philippe (Department of Anaesthesiology, Bürgerspital Solothurn, Solothurn, Switzerland)
Solis-Pena, Alejandro (Hospital Universitari Vall d'Hebron)
Villarino, Laura (Hospital Universitari Vall d'Hebron)
Vrochides, Dionisios (Department of Surgery, Carolinas Medical Centre, Charlotte, NC, USA)
Engel, Alexander (University of Sydney, Royal North Shore Hospital, Sydney, Australia)
O'Grady, Greg (Department of Surgery, University of Auckland, Auckland, New Zealand)
Loveday, Benjamin (Department of Surgery, University of Auckland, Auckland, New Zealand)
Steiner, Luzius A. (Department of Clinical Research, University of Basel, Basel, Switzerland)
Van Goor, Harry (Radboud University Medical Centre. Department of Surgery)
Bucher, Heiner (Department of Clinical Research, University of Basel, Basel, Switzerland)
Clavien, Pierre-Alain (University Hospital Zurich (Suïssa))
Kirchhoff, Philipp (University Hospital Basel (Basilea, Suïssa))
Rosenthal, Rachel (Medical Faculty, University of Basel, Basel, Switzerland)
Universitat Autònoma de Barcelona

Fecha:	2020
Resumen:	To prospectively assess the construct and criterion validity of ClassIntra version 1. 0, a newly developed classification for assessing intraoperative adverse events. International, multicentre cohort study. 18 secondary and tertiary centres from 12 countries in Europe, Oceania, and North America. The cohort study included a representative sample of 2520 patients in hospital having any type of surgery, followed up until discharge. A follow-up to assess mortality at 30 days was performed in 2372 patients (94%). A survey was sent to a representative sample of 163 surgeons and anaesthetists from participating centres. Intraoperative complications were assessed according to ClassIntra. Postoperative complications were assessed daily until discharge from hospital with the Clavien-Dindo classification. The primary endpoint was construct validity by investigating the risk adjusted association between the most severe intraoperative and postoperative complications, measured in a multivariable hierarchical proportional odds model. For criterion validity, inter-rater reliability was evaluated in a survey of 10 fictitious case scenarios describing intraoperative complications. Of 2520 patients enrolled, 610 (24%) experienced at least one intraoperative adverse event and 838 (33%) at least one postoperative complication. Multivariable analysis showed a gradual increase in risk for a more severe postoperative complication with increasing grade of ClassIntra: ClassIntra grade I versus grade 0, odds ratio 0. 99 (95% confidence interval 0. 69 to 1. 42); grade II versus grade 0, 1. 39 (0. 97 to 2. 00); grade III versus grade 0, 2. 62 (1. 31 to 5. 26); and grade IV versus grade 0, 3. 81 (1. 19 to 12. 2). ClassIntra showed high criterion validity with an intraclass correlation coefficient of 0. 76 (95% confidence interval 0. 59 to 0. 91) in the survey (response rate 83%). ClassIntra is the first prospectively validated classification for assessing intraoperative adverse events in a standardised way, linking them to postoperative complications with the well established Clavien-Dindo classification. ClassIntra can be incorporated into routine practice in perioperative surgical safety checklists, or used as a monitoring and outcome reporting tool for different surgical disciplines. Future studies should investigate whether the tool is useful to stratify patients to the appropriate postoperative care, to enhance the quality of surgical interventions, and to improve long term outcomes of surgical patients. ClinicalTrials. gov NCT03009929.
Nota:	Altres ajuts: The research was supported by grants from the Goldschmidt-Jacobson Foundation, University of Basel, Foundation for Research and Education in Anaesthesiology, Switzerland, and VSB fonds (Verenigde Spaar Bankenfonds), Netherlands.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Publicado en:	The BMJ, Vol. 370 (august 2020) , ISSN 1756-1833

DOI: 10.1136/bmj.m2917
PMID: 32843333

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