Prospective evaluation of an assessment tool for technical performance of duodenoscopes
| Autor: | Talal Seoud, Gayatri Bondi, Nikhil A. Kumta, Linda S. Lee, Hyungjin Myra Kim, Robert H. Hawes, Sumant Inamdar, Richard A. Kozarek, Thiruvengadam Muniraj, Priya A. Jamidar, D. Nageshwar Reddy, Shyam Varadarajulu, Patrick Yachimski, Amrita Sethi, Christopher J. DiMaio, Ji Young Bang, Sachin Kirtane, Dennis Yang, Benjamin Tharian, Abhilash Perisetti, Shyam Thakkar, Peter V. Draganov, Thomas Rösch, Ernesto S. Robalino Gonzaga, C. Mel Wilcox |
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| Rok vydání: | 2020 |
| Předmět: |
Cholangiopancreatography
Endoscopic Retrograde medicine.medical_specialty Endoscopic retrograde cholangiopancreatography medicine.diagnostic_test business.industry Duodenoscopes Gastroenterology Reproducibility of Results Prospective evaluation Technical performance Cronbach's alpha Patient age Humans Medicine Procedure Duration Radiology Nuclear Medicine and imaging Medical physics Prospective Studies business Reliability (statistics) |
| Zdroj: | Digestive Endoscopy. 33:822-828 |
| ISSN: | 1443-1661 0915-5635 |
| DOI: | 10.1111/den.13856 |
| Popis: | Objective While single-use and detachable-tip duodenoscopes have been recently developed to overcome risks of infection transmission, there are no reliable tools to objectively assess their technical performance. We evaluated the reliability and validity of a newly developed tool to assess the technical performance of reusable duodenoscopes. Methods An assessment tool was developed to measure duodenoscope performance based on three distinct criteria: maneuverability, mechanical/imaging characteristics and ability to perform requisite interventions. The assessment tool was tested prospectively on duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at nine academic medical centers over a 6-month period. The main outcome was reliability of the duodenoscope assessment tool, which was estimated using Cronbach's coefficient alpha (α). The secondary outcome was validity of the assessment tool. Results The assessment tool evaluated technical performance of reusable duodenoscopes in 1080 ERCP procedures. Indications were biliary in 92.8% and pancreatic in 7.2% procedures. The overall Cronbach's coefficient α for maneuverability was 0.81, assessment of mechanical/imaging characteristics was 0.92, and ability to perform requisite interventions was 0.87. On multiple linear regression analysis, prolonged procedure duration, older patient age and pancreatic interventions were significantly positively associated with higher (worse) scores. Conclusions The newly developed assessment tool appears reliable and valid for evaluating the technical performance of duodenoscopes. Registration: ClinicalTrials.gov Identifier: NCT04004533. |
| Databáze: | OpenAIRE |
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