Assessment of Hysteroscopy Skills With a New Assessment Tool

NCT07672288 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2026-06-26

No results posted yet for this study

Summary

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.

Conditions

  • Hysteroscopy
  • Assessment Methods in Medical Training
  • Medical Education
  • Diagnostic Hysteroscopy
  • Operative Hysteroscopy
  • Abnormal Uterine Bleeding

Interventions

OTHER

Evaluation score based on assessment tool

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.

Sponsors & Collaborators

  • The Ottawa Hospital

    collaborator OTHER
  • University of Southern Denmark

    collaborator OTHER
  • Copenhagen Academy for Medical Education and Simulation

    collaborator OTHER
  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Karen H Abrahamsen, MD · Odense University Hospital, University of Southern Denmark

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-22
Primary Completion
2026-09-22
Completion
2026-09-22

Countries

  • Canada
  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07672288 on ClinicalTrials.gov