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Assessment of Hysteroscopy Skills With a New Assessment Tool

2026年6月23日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

24

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Ontario
      • Ottawa、Ontario、カナダ、K1H 8L6
        • Department of Obstetrics, Gynecology and Newborn Care The Ottawa Hospital
      • Odense、デンマーク、5000
        • Odense University Hospital
        • コンタクト:
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
HYSAT score
時間枠: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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Karen H Abrahamsen, MD、Odense University Hospital, University of Southern Denmark

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月22日

一次修了 (推定)

2026年9月22日

研究の完了 (推定)

2026年9月22日

試験登録日

最初に提出

2026年6月11日

QC基準を満たした最初の提出物

2026年6月23日

最初の投稿 (実際)

2026年6月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月26日

QC基準を満たした最後の更新が送信されました

2026年6月23日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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