- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07917988
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Laura Galarza, PhD
- Numéro de téléphone: (34)964725000
- E-mail: galarza_lau@gva.es
Lieux d'étude
-
-
-
Brussels, Belgique
- ESICM
-
Contact:
- Margauz Osselaer
- Numéro de téléphone: +32 2 559 03 50
- E-mail: education@esicm.org
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
A diverse (geography, sex, country income) group of physicians meeting all of the inclusion criteria.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Consensus statements
Délai: 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
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Laura Galarza, Hospital Universitari General de Castellón
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ESICM01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
IPD is available to the contact person to preserve panelist identities and avoid a breach of anonymity.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .