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Assessment of Hysteroscopy Skills With a New Assessment Tool

2026년 6월 23일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

24

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

      • Odense, 덴마크, 5000
        • Odense University Hospital
        • 연락하다:
        • 연락하다:
    • Ontario
      • Ottawa, Ontario, 캐나다, K1H 8L6
        • Department of Obstetrics, Gynecology and Newborn Care The Ottawa Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
HYSAT score
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Karen H Abrahamsen, MD, Odense University Hospital, University of Southern Denmark

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 22일

기본 완료 (추정된)

2026년 9월 22일

연구 완료 (추정된)

2026년 9월 22일

연구 등록 날짜

최초 제출

2026년 6월 11일

QC 기준을 충족하는 최초 제출

2026년 6월 23일

처음 게시됨 (실제)

2026년 6월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 23일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • S-20262000 - 78

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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