Construct Validity of a Diagnostic Hysteroscopy Training Model

Study Overview
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Brief Summary
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In a prospective case-control study, the investigators compare the Objective Structured Assessment of Technical Skills (OSATS) scores in medical students and gynecologic experts performing a hysteroscopy on a training model for diagnostic hysteroscopy. The investigators hypothesize that OSATS on a hysteroscopy training model has construct validity to discriminate between experts and novices.

Detailed Description
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In a prospective case-control study, 140 medical students (,novices') and 10 senior gynecologists (,experts') will watch a demonstration detailing how to perform a hysteroscopy on a training model. All probands will perform a hysteroscopy themselves within 1 hour after the demonstration. Their performance will be judged using an Objective Structured Assessment of Technical Skills (OSATS) assessment. Using metrical and non-metrical measurements, construct validity of the hysteroscopy training model to distinguish between experts and novices will be assessed. Secondary endpoints are differences in OSATS scores within the group of novices based on gender and handyness, as well as satisfaction of the novices with the learning experience.

Official Title
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Prospective Case-control Study to Assess the Construct Validity of a Diagnostic Hysteroscopy in a Pelvic Training Model Using an Objective Structured Assessment of Technical Skills (OSATS) Assessment

Conditions
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Menorrhagia

Intervention / Treatment
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* Procedure: hysteroscopy on a training model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medical Student no previous experience in gynecologic surgery no previous gynecologic surgery Training gynecologist with a personal history of at least 50 hysteroscopies) Exclusion Criteria: language barrier unwillingness to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experts<br>Surgically experienced gynecologists with a personal history of at least 50 hysteroscopy procedures will perform a hysteroscopy on a training model. | Procedure: hysteroscopy on a training model<br>* Diagnostic hysteroscopy on a diagnostic hysteroscopy training model using a pelvic dummy and all surgical instruments also used in the original procedure. The performance of all participants will be scored using an OSATS scoring sheet developed for assessing surgical proficiency.<br>|
| Experimental: Novices<br>Medical students will perform a hysteroscopy on a training model. | Procedure: hysteroscopy on a training model<br>* Diagnostic hysteroscopy on a diagnostic hysteroscopy training model using a pelvic dummy and all surgical instruments also used in the original procedure. The performance of all participants will be scored using an OSATS scoring sheet developed for assessing surgical proficiency.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Construct validity | Predefined OSATS scores (metrical and non-metrical items) will be compared between experts and novices | within 1 hour after demonstration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSATS scores according to gender | OSATS scores will be compared depending on gender | within 1 hour after demonstration | 
| OSATS scores according to handyness | OSATS scores will be compared depending on handyness (right- versus left-handed) | within 1 hour after demonstration |