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Assessment of Hysteroscopy Skills With a New Assessment Tool

23 giugno 2026 aggiornato da: Odense University Hospital

Assessment of Hysteroscopy Skills in an International Multicenter Trial - Gathering Validity Evidence for a Hysteroscopy Assessment Tool

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.

Panoramica dello studio

Descrizione dettagliata

Abstract:

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 a prior Delphi study, response process is ensured by standardization of 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.

Introduction Hysteroscopy is an essential tool in gynecology for diagnosing and treating intrauterine pathology. The increasing use of hysteroscopy under local rather than general anesthesia has heightened both technical and communicative demands, as patient comfort is closely linked to procedural efficiency and operator skill. While complications rates are low among experienced clinicians, inadequate proficiency may compromise safety and lead to prolonged, incomplete, or painful procedures particularly in awake patients.

Training in hysteroscopy is typically based on supervised clinical exposure within suggested curricula, yet the apprenticeship model is limited by variability in case volume and lack of standardized assessment.

Current educational paradigms emphasize mastery-based learning, requiring trainees to meet predefined proficiency standards supported by assessment tools with validity evidence. However, existing literature highlights heterogeneity in training and assessment methods, underscoring the need for standardized, evidence-based approaches.

A structured, consensus-based assessment tool for hysteroscopy (HYSAT) has recently been developed by an international panel of experts through a three round Delphi process (KHA et al.). The instrument encompasses key domains of procedural competence.

Prior to clinical implementation, it is essential to gather validity evidence for HYSAT in a real-life setting. Unreliable interpretation of assessment outcomes may lead to under- or overestimation of trainee competence with potential consequences for both training progression and patient safety. Therefore, the application of HYSAT must be supported by robust validity evidence to ensure that score interpretations are meaningful and that derived decisions are justified.

Aims We aim to investigate the validity of the Hysteroscopy Assessment (HYSAT) tool for assessment of competence in a clinical environment.

  • To establish an international multi-site validity investigation to show if HYSAT can be used to assess procedural competence in hysteroscopy.
  • To gather validity evidence according to Messick's framework validity from the following sources: response process, internal structure, relationship to other variables, and consequences evidence.
  • To investigate if HYSAT can be used for both formative and summative assessment, and to establish a credible pass/fail score to help inform decision-making for certification.

Tipo di studio

Osservativo

Iscrizione (Stimato)

24

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Department of Obstetrics, Gynecology and Newborn Care The Ottawa Hospital
      • Odense, Danimarca, 5000

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Intermediate experienced doctors
  • If complication arrise during the procedure, evaluation is no longer within the scope of the HYSAT tool.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Medical doctors.
Novices and experienced hysteroscopists

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
HYSAT score
Lasso di tempo: 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.
HYSAT is an evaluation tool with 12 items. Scores range from 1-5. Minimum score is 12 maximum score is 60.
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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Karen H Abrahamsen, MD, Odense University Hospital, University of Southern Denmark

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

22 giugno 2026

Completamento primario (Stimato)

22 settembre 2026

Completamento dello studio (Stimato)

22 settembre 2026

Date di iscrizione allo studio

Primo inviato

11 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 giugno 2026

Primo Inserito (Effettivo)

26 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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