About this trial
Objective To investigate validity of the hysteroscopy assessment tool (HYSAT) for assessment of competence in a clinical environment.
Methods Novices and experienced gynecologists are recruited from three hospitals and observed and assessed while performing hysteroscopy. Performances are assessed using the HYSAT tool by two independent raters. Validity evidence is gathered in accordance with Messick's framework: validity evidence for content was ensured in previously published Delphi study, response process is ensured by standardization of written rater instructions. Internal structure is explored using Cronbach's alpha for internal consistency reliability; inter-rater reliability and test-retest reliability are calculated as Pearson's r independently across all ratings. Relationship to other variables is investigated by comparing performances of the participants in each group. Consequences evidence is explored by calculating a pass/fail standard using the contrasting groups' standard setting method.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Medical doctors performing hysteroscopy
Novices during residency with no experience but permission to operate, and who rely on supervison
Experienced doctors with > 50 procedures
Assessment is done on procedures that are already planned. The evaluation does not change the treament of the patient in any way.
Disqualifiers
Intermediate experienced doctors
If complication arrise during the procedure, evaluation is no longer within the scope of the HYSAT tool.
Trial population
Participants will be enrolled from gynecology departments of all three locations: Odense, Odense University Hospital, Ottawa, Ottawa Hospital, Shanghai, Renji hospital. Participants are doctors who perform hysteroscopy. Novices during their residency, who rely on supervision and experts who have done more than 50 hysteroscopies. We aim to include 12 novices and 12 experienced operators and assess 2 procedures from each of them - resulting in 48 performed procedures and 96 completed assessments. Participation is voluntary. The following baseline demographics will be collected: years as a physician, age, sex at birth, years in gynecology, estimated number of performed hysteroscopies. Each participant will be informed of the aim of the study and how data will be used.
Trial design
Cohort
Prospective
Treatments tested in this trial
Evaluation score based on assessment tool
Other interventionAll hysteroscopies will be assessed by two raters. KHA will be one of the raters for all the procedures. The other rater will be a local physician who will receive a standard introduction to HYSAT. Raters are included from the departments based on their experience to ensure the most experienced raters possible. Two tablets will be used for assessment. All assessments will be immediately transferred to a secure server administered by the independent research support unit open patient data explorative network (OPEN) and deleted from the tablets. Each assessment will be assigned a unique identification number. Data will be pseudo-anonymized as correct pairings of test results/assessments and participants' level of experience will be essential.
Treatment groups
Trial outcomes
Primary outcomes
HYSAT score
HYSAT is an evaluation tool with 12 items. Scores range from 1-5. Minimum score is 12 maximum score is 60.
Sponsors and contacts
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Odense University Hospital
Lead sponsor
The Ottawa Hospital
Collaborator
University of Southern Denmark
Collaborator
Copenhagen Academy for Medical Education and Simulation
Collaborator
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