- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07672288
Assessment of Hysteroscopy Skills With a New Assessment Tool
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Karen H Abrahamsen, MD
- Puhelinnumero: +4523397753
- Sähköposti: karen.hogh.abrahamsen@rsyd.dk
Tutki yhteystietojen varmuuskopiointi
- Nimi: Pernille Ravn, Professor
- Sähköposti: pernille.ravn@rsyd.dk
Opiskelupaikat
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Ontario
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Ottawa, Ontario, Kanada, K1H 8L6
- Department of Obstetrics, Gynecology and Newborn Care The Ottawa Hospital
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Odense, Tanska, 5000
- Odense University Hospital
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Ottaa yhteyttä:
- Karen Abrahamsen, MD
- Sähköposti: kha@rsyd.dk
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Ottaa yhteyttä:
- Pernille Ravn, Professor, MD
- Sähköposti: pernille.ravn@rsyd.dk
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
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Medical doctors.
Novices and experienced hysteroscopists
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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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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HYSAT score
Aikaikkuna: 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.
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HYSAT is an evaluation tool with 12 items.
Scores range from 1-5.
Minimum score is 12 maximum score is 60.
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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.
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Karen H Abrahamsen, MD, Odense University Hospital, University of Southern Denmark
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Sukuelinten sairaudet
- Patologiset prosessit
- Naisten virtsa- ja sukupuolielinten sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Kohdun sairaudet
- Sukuelinten sairaudet, naiset
- Verenvuoto
- Kohdun verenvuoto
- Patologiset tilat, merkit ja oireet
- Metrorragia
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