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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.
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 …
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.
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