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Consensus-based development of a causal attribution system for post-ERCP adverse events
  1. Nauzer Forbes1,
  2. B Joseph Elmunzer2,
  3. Rajesh N Keswani3,
  4. Robert J Hilsden4,
  5. Matt Hall5,
  6. John T Anderson6,
  7. Marianna Arvanitakis7,
  8. Yen-I Chen8,
  9. Anna Duloy9,
  10. Grace H Elta10,
  11. Jennifer L Maranki11,
  12. Klaus Mergener12,
  13. Bret T Petersen13,
  14. Amrita Sethi14,
  15. Peter D Siersema15,
  16. Zachary L Smith16,
  17. Jennifer J Telford17,
  18. Frances Tse18,
  19. Peter B Cotton2,
  20. Sachin Wani9
  1. 1 Department of Medicine, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada
  2. 2 Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA
  3. 3 Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
  4. 4 Department of Medicine, University of Calgary, Calgary, Alberta, Canada
  5. 5 Biostatistics, Children's Hospital Association, Overland Park, Kansas, USA
  6. 6 Department of Gastroenterology, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, Gloucestershire, UK
  7. 7 Department of Gastroenterology, Hepatopancreatology and Digestive Oncology. Erasme Hospital, Universite Libre de Bruxelles, Bruxelles, Bruxelles, Belgium
  8. 8 Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Québec, Canada
  9. 9 Division of Gastroenterology and Hepatology, University of Colorado - Anschutz Medical Campus, Aurora, Colorado, USA
  10. 10 Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan, USA
  11. 11 Division of Gastroenterology and Hepatology, Penn State Health Milton S Hershey Medical Center, Hershey, Pennsylvania, USA
  12. 12 Division of Gastroenterology, Department of Medicine, University of Washington, Seattle, Washington, USA
  13. 13 Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
  14. 14 Division of Digestive and Liver Diseases, Columbia University Medical Center, New York, New York, USA
  15. 15 Department of Gastroenterology and Hepatology, Radboud Universiteit Nijmegen, Nijmegen, The Netherlands
  16. 16 Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA
  17. 17 Department of Medicine, Division of Gastroenterology, The University of British Columbia, Vancouver, British Columbia, Canada
  18. 18 Department of Medicine, Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada
  1. Correspondence to Dr Nauzer Forbes, Medicine, University of Calgary, Calgary, AB T2N 4Z6, Canada; nauzer.forbes{at}ucalgary.ca

https://doi.org/10.1136/gutjnl-2022-328059

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    WHAT IS ALREADY KNOWN ON THIS TOPIC

    • Endoscopic retrograde cholangiopancreatography (ERCP) has a high rate of associated adverse events (AEs). No tool currently exists to help practitioners and researchers attribute causality of AEs to antecedent procedures.

    WHAT THIS STUDY ADDS

    • Using an international expert panel and a Delphi-based consensus process, we developed a series of definitions and criteria to attribute degrees of causality of all common post-ERCP AEs (pancreatitis, bleeding, perforation, cholangitis, cholecystitis, abdominal pain and non-gastrointestinal AEs), with possible outcomes being definite, probable, possible, unlikely, unrelated or unclassifiable. High levels of agreement were achieved.

    HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

    • Our novel causal attribution system will serve both as a schema for clinical quality assurance and as an important tool for outcomes-based research studies in ERCP.

    Message

    No tool currently exists to help practitioners and researchers attribute causality of adverse events (AEs) to antecedent endoscopic retrograde cholangiopancreatography (ERCP) procedures. After three rounds of iterative feedback from 15 international ERCP experts using the RAND/University of California, Los Angeles Appropriateness Method, definitions and relatedness criteria were drafted for pancreatitis, bleeding, perforation, cholangitis, cholecystitis, abdominal pain and non-gastrointestinal AEs. Inter-panellist agreement was high for all definitions and criteria at the end of the third round. Possible outcomes for relatedness were definite, probable, possible, unlikely, unrelated or unclassifiable. This novel system bridges the gap in attributing causality to an antecedent AE and will serve as a schema for clinical quality assurance and for outcomes-based research.

    In more detail

    Endoscopic retrograde cholangiopancreatography (ERCP) is known to have the highest serious adverse event (AE) rates among all commonly performed endoscopic procedures, with a collective incidence of AEs exceeding 10%.1 2 In 2010, the American Society for Gastrointestinal Endoscopy (ASGE) Lexicon defined and standardised endoscopic AEs in addition to characterising their timing and severity.3 However, important gaps still exist with regards to (1) defining ERCP-specific AEs and (2) attributing causality of an AE to an …

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    Footnotes

    • Twitter @ZachSmithGI

    • Contributors Conception and design: NF, SW, BJE, RNK, RJH and PC; analysis plan: NF, MH and SW; drafting of the article: NF; critical revision of the article for important intellectual content: all authors; final approval of the article: all authors. NF was the guarantor of the article.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests NF is a consultant for and has received speaker’s fees from Pentax Medical and Boston Scientific, is a consultant for Pendopharm and has received research funding from Pentax Medical. MA has received speaker’s fees from Olympus, Medtronic and Fujifilm and is a consultant for Ambu. Y-IC is a consultant for Boston Scientific and has received research funding from Boston Scientific. KM is a consultant for Sebela Pharmaceuticals, Pentax, Boston Scientific and Fujifilm and owns shares in Kate Farms and Virgo SVS. PDS has received research funding from Pentax Medical, The E-Nose company, MicroTech, Norgine and Motus GI, and is on the advisory board of Boston Scientific and Motus GI. ZLS is a consultant for STERIS Endoscopy. JJT has received research funding from Penodpharm and was on an advisory board for Pendopharm. SW is a consultant for Exact Sciences and Interpace, is on the Advisory Board for Cernostics and has received research funding from Lucid, Ambu and CDx. All other authors have no conflicts to declare.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; internally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.