Prospective evaluation of an assessment tool for technical performance of duodenoscopes
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Prospective evaluation of an assessment tool for technical performance of duodenoscopes. / Bang, Ji Young; Rösch, Thomas; Kim, Hyungjin Myra; Thakkar, Shyam; Robalino Gonzaga, Ernesto; Tharian, Benjamin; Inamdar, Sumant; Lee, Linda S; Yachimski, Patrick; Jamidar, Priya; Muniraj, Thiruvengadam; DiMaio, Christopher; Kumta, Nikhil; Sethi, Amrita; Draganov, Peter; Yang, Dennis; Seoud, Talal; Perisetti, Abhilash; Bondi, Gayatri; Kirtane, Sachin; Hawes, Robert; Wilcox, C Mel; Kozarek, Richard; Reddy, D Nageshwar; Varadarajulu, Shyam.
In: DIGEST ENDOSC, Vol. 33, No. 5, 07.2021, p. 822-828.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Prospective evaluation of an assessment tool for technical performance of duodenoscopes
AU - Bang, Ji Young
AU - Rösch, Thomas
AU - Kim, Hyungjin Myra
AU - Thakkar, Shyam
AU - Robalino Gonzaga, Ernesto
AU - Tharian, Benjamin
AU - Inamdar, Sumant
AU - Lee, Linda S
AU - Yachimski, Patrick
AU - Jamidar, Priya
AU - Muniraj, Thiruvengadam
AU - DiMaio, Christopher
AU - Kumta, Nikhil
AU - Sethi, Amrita
AU - Draganov, Peter
AU - Yang, Dennis
AU - Seoud, Talal
AU - Perisetti, Abhilash
AU - Bondi, Gayatri
AU - Kirtane, Sachin
AU - Hawes, Robert
AU - Wilcox, C Mel
AU - Kozarek, Richard
AU - Reddy, D Nageshwar
AU - Varadarajulu, Shyam
N1 - © 2020 Japan Gastroenterological Endoscopy Society.
PY - 2021/7
Y1 - 2021/7
N2 - 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.
AB - 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.
U2 - 10.1111/den.13856
DO - 10.1111/den.13856
M3 - SCORING: Journal article
C2 - 33007136
VL - 33
SP - 822
EP - 828
JO - DIGEST ENDOSC
JF - DIGEST ENDOSC
SN - 0915-5635
IS - 5
ER -