Assessment of Hysteroscopy Skills With a New Assessment Tool

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorOdense University Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Evaluation score based on assessment tool

    Other intervention

    All 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

24 Participants
are divided into 1 treatment group
Group A: Medical doctors.1 intervention

Trial outcomes

Primary outcomes

1

HYSAT score

HYSAT is an evaluation tool with 12 items. Scores range from 1-5. Minimum score is 12 maximum score is 60.

Time frame
The timeframe of the rating is while the hysteroscopic procedure is done. For some evaluations it might be necessary to complete the assessment imediately after the procedure.

Secondary outcomes

Other outcomes

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

This trial is not recruiting at the moment. You can still explore other options: