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Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study

30 de outubro de 2026 atualizado por: Laura Galarza, Hospital General Universitario de Castellón

Update of Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Consensus From the European Society of Intensive Care Medicine (ESICM)

This study using a Delphi methodology, and involving international experts, will help define a training curriculum for core competencies for general intensive care ultrasound practice.

Visão geral do estudo

Status

Ainda não está recrutando

Intervenção / Tratamento

Descrição detalhada

Intensive care ultrasound has become an integral component of modern intensive care practice. The previous ESICM Delphi consensus on core competencies in intensive care ultrasound was published in 2020. Since then, clinical practice, training standards and programs, technology, and the scope of ultrasound use in intensive care medicine have evolved substantially.

The ESICM General Intensive Care Ultrasound (GenIUS) Core Faculty therefore proposes to update the previous core competency framework through a structured international Delphi consensus process. The aim is to define which ultrasound competencies should be considered core, rather than ADVANCED, for general intensive care ultrasound practice.

The Delphi process is a well-established methodology to generate consensus on a particular topic using the "collective intelligence" of panel members. After reviewing the previous consensus, the steering committee members drafted the initial competencies and will conduct iterative Delphi rounds to generate consensus among the experts. Steering Committee (SC) members will not participate in the Delphi surveys. The study findings will be reported according to the ACCORD criteria.

The Delphi panel will comprise two participant groups: expert panelists and trainee panelists. Recruitment will aim to include at least 60 panelists overall, of whom at least 10% will be clinicians in training. The panel will be international, multidisciplinary, and balanced regarding geographical region, profession, clinical background, sex, ultrasound expertise, and level of training. Participants will be invited worldwide without country restrictions. To ensure representation of diverse healthcare and resource settings, at least 20% of panelists will be based in low- and middle-income countries (LMICs). Recruitment will also aim for broader representation across world regions. Including both experienced clinicians and clinicians in training is intended to ensure the resulting competency framework reflects the perspectives of both established experts and future users of the GenIUS curriculum.

Steps of the Delphi process

Step 1: Establishing a preliminary list of competencies. A focused literature review will be performed by the members of the SC and, based on their input, the steering committee will identify competencies, which will be used to draft Round One of the Delphi process. Prior to Round 1, the Delphi questionnaire will be pilot-tested with a small group of members from the SC.

Step 2: Preparation of the Delphi Round One Survey. The list of competencies will be sent to the Experts as a Delphi questionnaire. The anonymity of the Experts will be maintained until the end of the Delphi rounds. The Experts will be requested to answer questions related to the training curriculum based on their experience and knowledge of the subject. Questions will be based on a 5-point Likert scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). Experts can also provide opinions on additions, deletions, or changes to questions or choices through free text. The responses of experts will be collated during the analysis of results and shared in the following survey as controlled feedback.

Step 3: Subsequent Delphi Rounds. The steering committee will review the results of round one. The competencies listed will be modified, deleted, or added if found ambiguous based on the feedback and comments on the results. The remaining statements will continue in subsequent rounds until response stability is achieved. The cumulative results of round two will be presented to experts along with anonymized comments, and the survey process will be repeated with the modified questionnaire. The Delphi rounds will be continued until the desired consensus and stability are achieved for statements.

Step 4: Final Consensus. Only the competencies that achieved consensus and stability will be used to develop consensus statements. The results of the final survey, consensus statements, and the manuscript will be circulated among the experts for approval before submission for publication.

Statistics Consensus definitions

  • Consensus for inclusion: >=80% of panelists score the item 4-5 (strong consensus >=90% of them or median of 5 [interquartile range, IQR 0 or 1]).
  • Consensus for exclusion: >80% of panelists score the item 1-2 (strong consensus >=90% of them or median of 1 [IQR 0 or 1]).
  • No consensus: failure to meet either threshold after the final Delphi round or when stable non-consensus is reached.

Stability assessment Starting from Round 2, stability will be assessed between two consecutive rounds. An item will be considered stable if there is no statistically significant change in the distribution of responses between consecutive rounds. Wilcoxon signed-rank test will be used, with p ≥ 0.05 indicating significant variation and therefore instability

Statistical reporting For each competency and each round, the methodologist should report the number of respondents, response rate, median, interquartile range, percentage agreement for inclusion, percentage agreement for exclusion, consensus status, stability status, and final classification. Continuous variables will be summarized using the median and IQR. Analysis should be performed using validated statistical software such as R.

Tipo de estudo

Observacional

Inscrição (Estimado)

60

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

A diverse (geography, sex, country income) group of physicians meeting all of the inclusion criteria.

Descrição

Inclusion criteria for expert panellists (all criteria must apply):

  • Clinicians with expertise in point-of-care ultrasound (or ICU ultrasound), including echocardiography, thoracic or lung ultrasound, abdominal ultrasound, etc., with at least 5 years of clinical experience, of which >50% was in intensive care medicine.
  • Actively using intensive care ultrasound or point-of-care ultrasound in routine clinical practice.
  • Representation from ESICM sections, or nominated from national/regional professional societies related to intensive care medicine or working with recognized ultrasound networks.

Inclusion criteria for trainee panelists (all criteria must apply):

  • Clinicians currently enrolled in a recognized postgraduate training programme which includes intensive care medicine.
  • Actively using point-of-care ultrasound in routine clinical practice.
  • Demonstrated interest in ultrasound education or research by participating in courses or doing research in ultrasound.
  • Completion of a recent POCUS training programme (national or international) within the last 5 years.

Exclusion Criteria:

  • Inability to complete Delphi rounds in English.
  • Declared conflict of interest judged to be incompatible with participation.
  • Failure to participate in the first Delphi round.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: OTHER
  • Perspectivas de Tempo: PROSPECTIVE

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Experts

The expert panelists meeting the eligibility criteria. The Delphi process will be conducted with the recruited panelists.

The study uses a Delphi process to generate consensus statements from experts and trainees on the training requirements for physicians using ultrasound in critically ill patients.

Trainees

The clinicians in training meeting the eligibility criteria. The Delphi process will be conducted with the recruited panelists.

The study uses a Delphi process to generate consensus statements from experts and trainees on the training requirements for physicians using ultrasound in critically ill patients.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Consensus statements
Prazo: Through study completion, an average of 3 months

Consensus amongst the panel regarding training requirements for physicians using ultrasound in critically ill patients will be achieved using Delphi method which includes iterative rounds of questions.

Consensus will be considered reached when a statement achieves >=80% of votes for multiple-choice questions and likert-scale statements.

Through study completion, an average of 3 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Laura Galarza, Hospital Universitari General de Castellón

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

16 de novembro de 2026

Conclusão Primária (Estimado)

10 de janeiro de 2027

Conclusão do estudo (Estimado)

31 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

30 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de outubro de 2026

Primeira postagem (Real)

5 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • ESICM01

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

IPD is available to the contact person to preserve panelist identities and avoid a breach of anonymity.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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