Clinical trial NCT02455570: Global Assessment of Endoscopic Ultrasound Performance Skills
Official title: Global Assessment of Endoscopic Ultrasound Performance Skills - a New Tool to Measure the Learning Curve and Technical Skills of Endosonografists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: E01.370.350.850.280
I02.399
J01.897.608
N06.850.135.060.075.399
F02.784.629.529.274
Keywords: Endoscopic Ultrasound
Quality Management
Education and training
Safety
Learning curve
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endosonographists in traning under experienced supervision at tertiary endoscopy centers.

Brief summary: Endoscopic ultrasound (EUS) is a mini-invasive diagnostic procedure in the work-up of various suspicious malignancies. The learning curve of EUS is regarded long but so far the literature of this topic is minimal. Few studies have been published and there are no standardized or validated methods to perform a systematic assessment of endosonographists in training. This study is an observational study dealing with the matter of assessing endosonographists in training.

Detailed description: Sahlgrenska Univeristy Hospital is tertiary university endoscopy center. At our endoscopy unit physicians/endoscopists train EUS under the supervision of an experienced endosonographist. Endosonographists examining patients referred for a routine, clinical EUS at the Sahlgrenska Univeristy hospital are candidates for being study subjects. Patients will not be examined by the study endosonographists if supervision is lacking.

External, collaborating centers will be invited to participte in the study given that the study inclusion criteria and ethical standard will be ensured.

The investigators of this study have developped a score sheet for the assessment of endosonographists in training to be used in a standard clinical setting. The score sheet is to be used by both the endosonographist in training (performer) for self-assessment and by the supervisor (observer) for assessment of the performer.

First, background data of the performer is recorded (pervious endoscopy experience etc). Then the performer starts the examination under the guidance of the observer. The observer performs continuous evaluation and assessment of the performer according to the skill parameters (N=5) of the Observer score sheet. Each parameter is ranked on a 1-5 scale (1=non-satisfactory performance, 5= excellent performance). Finally the observer is taking over, reevaluates the findings of the performer and finishes the examination.

After the examination the performer fullfills the Performer score sheet. Finally, both the performer and the observer record their preliminary diagosis of the lesion examined.

Adverse events and complications are recorded.

A follow-up of the medical records of the patient is performed 8 weeks after the EUS-examiantion with respect to the final diagnosis of the lesion of interest. The reference standard is set to best available combination of surgery, pathology and imaging reports. The performer´s assessment of the diagnosis is the categorized as CORRECT or FALSE. A correct diagnosis equals 3 Points and a false diagnosis equals 0 Points.

Results in terms of the total and mean score of all perfomers is calculated and collected in a study database. Feasibility of the study assessment sheet is evaluated. Statistical analysis of categorical data is finally applied for evaluating the results with respect to the progress and learning curve of the study participants.

Eligibility criteria: Inclusion Criteria:

* EUS-examination with or without sampling performed for clinical reasons at one of the participating centers
* The EUS-examination is to be performed by a physician in training as endosonographist OR a physician with a completed training as endosonographist
* The EUS-examination is to be supervised by an experienced endosonographist
* Oral and written consent of the patients examined (age\>18 years)

Exclusion Criteria:

* Physicians in EUS-traning without adequate supervision
* Experimental or therapeutic EUS outside the clinical setting

Primary outcomes:
measure: EUS performance
timeFrame: Imediate
Secondary outcomes:
measure: EUS diagnosis
timeFrame: 2 months
measure: Safety and complications
timeFrame: <48 hours
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital, Gothenburg
name: Riadh Sadik, Ass prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wani S, Cote GA, Keswani R, Mullady D, Azar R, Murad F, Edmundowicz S, Komanduri S, McHenry L, Al-Haddad MA, Hall M, Hovis CE, Hollander TG, Early D. Learning curves for EUS by using cumulative sum analysis: implications for American Society for Gastrointestinal Endoscopy recommendations for training. Gastrointest Endosc. 2013 Apr;77(4):558-65. doi: 10.1016/j.gie.2012.10.012. Epub 2012 Dec 20.
citation: Hedenstrom P, Marasco G, Eusebi LH, Lindkvist B, Sadik R. GAPS-EUS: a new and reliable tool for the assessment of basic skills and performance in EUS among endosonography trainees. BMJ Open Gastroenterol. 2021 Jun;8(1):e000660. doi: 10.1136/bmjgast-2021-000660.