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- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Karen H Abrahamsen, MD
- Número de telefone: +4523397753
- E-mail: karen.hogh.abrahamsen@rsyd.dk
Estude backup de contato
- Nome: Pernille Ravn, Professor
- E-mail: pernille.ravn@rsyd.dk
Locais de estudo
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Ontario
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Ottawa, Ontario, Canadá, K1H 8L6
- Department of Obstetrics, Gynecology and Newborn Care The Ottawa Hospital
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Odense, Dinamarca, 5000
- Odense University Hospital
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Contato:
- Karen Abrahamsen, MD
- E-mail: kha@rsyd.dk
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Contato:
- Pernille Ravn, Professor, MD
- E-mail: pernille.ravn@rsyd.dk
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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HYSAT score
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Karen H Abrahamsen, MD, Odense University Hospital, University of Southern Denmark
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- S-20262000 - 78
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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