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Questionnaire Study Concerning Artificial Intelligence

3 de febrero de 2022 actualizado por: Maastricht University Medical Center

Questionnaire Study Concerning Artificial Intelligence and Its Application in (Gastrointestinal) Healthcare - Patients' and Physicians' Perspectives

This study aims to investigate the knowledge, experience, and opinion on AI among gastroenterology (GI) patients, gastroenterologists, and GI-fellows, particularly concerning implementation and application of AI (in assisting clinicians) in healthcare. The secondary aims are to investigate (dis)advantages of AI use in healthcare and the availability of technical facilities and infrastructures within endoscopy to implement and apply AI in Dutch hospitals.

Descripción general del estudio

Estado

Terminado

Condiciones

Desórdenes gastrointestinales

Intervención / Tratamiento

Otro: Questionnaire

Descripción detallada

In recent years, important developments have been made in the field of artificial intelligence (AI). These developments have led to the large-scale application of AI in our everyday lives and AI-research within healthcare. A potentially promising application of AI lies in imaging analysis. For example, within gastroenterology this means the detection and classification of colorectal polyps and Barrett's neoplasia, disease severity scoring of inflammatory bowel diseases, and differentiating pancreatic cancer from chronic pancreatitis.

Despite the investments in AI-research, there is a lack in knowledge concerning patients' and physicians' perspectives on AI in healthcare. This prospective questionnaire study investigates these perspectives, obtaining data from both gastroenterology (GI) patients and GI-physicians within the Netherlands. The questionnaires focus on the knowledge, experience, and opinion of AI, particularly concerning the implementation of AI in (gastroenterology) healthcare. Furthermore, the current (endoscopic) infrastructure within Dutch hospitals will be investigated for its readnessy for AI.

Tipo de estudio

De observación

Inscripción (Actual)

457

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Países Bajos
- Limburg
  - Maastricht, Limburg, Países Bajos, 6202AZ
    - Maastricht University Medical Center
- Noord-Brabant
  - Eindhoven, Noord-Brabant, Países Bajos, 5623 EJ
    - Catharina Ziekenhuis Eindhoven

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Gastroenterology patients who will have an outpatient appointment for an endoscopic procedure in the context of the national bowel cancer screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases, in one of two Dutch hospitals between April 2020 and September 2020.

Gastroenterologists and gastroenterology fellows working in Dutch hospitals.

Descripción

Inclusion Criteria:

Gastrointestinal (GI) patients with an outpatient appointment in the gastroenterology department for an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases (in one of the two participating hospitals);
Gastroenterologists working in Dutch hospitals;
Gastroenterology fellows working in Dutch hospitals;
Minimal age of 18 years old.

Exclusion Criteria:

No appropriate understanding of the Dutch language;
Not willing to sign informed consent;
Objection to participate in medical scientific research, reported in the medical file.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Número de grupos/cohortes

Cohortes e Intervenciones

Grupo / Cohorte	Intervención / Tratamiento
Gastroenterology patients Patient receiving an endoscopic procedure because of regular care will be considered eligible for inclusion. Patients receive an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases. Patients will be asked to complete a questionnaire concerning AI. No intervention will be administered.	Otro: Questionnaire Questionnaire concerning artificial intelligence and its implementation in healthcare. GI patients and GI physicians will be provided with slightly different questionnaires.
Gastroenterology physicians GI physicians (both gastroenterologists and gastroenterology fellows), participating in a yearly gastroenterology and hepatology training day, will be asked for their participation in this study. Physician will be asked to complete a questionnaire concerning AI. No intervention will be administered.	Otro: Questionnaire Questionnaire concerning artificial intelligence and its implementation in healthcare. GI patients and GI physicians will be provided with slightly different questionnaires.

Grupo / Cohorte

Intervención / Tratamiento

Gastroenterology patients

Patient receiving an endoscopic procedure because of regular care will be considered eligible for inclusion. Patients receive an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases.

Patients will be asked to complete a questionnaire concerning AI. No intervention will be administered.

Otro: Questionnaire

Questionnaire concerning artificial intelligence and its implementation in healthcare. GI patients and GI physicians will be provided with slightly different questionnaires.

Gastroenterology physicians

GI physicians (both gastroenterologists and gastroenterology fellows), participating in a yearly gastroenterology and hepatology training day, will be asked for their participation in this study.

Physician will be asked to complete a questionnaire concerning AI. No intervention will be administered.

Otro: Questionnaire

Questionnaire concerning artificial intelligence and its implementation in healthcare. GI patients and GI physicians will be provided with slightly different questionnaires.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
The knowledge on AI investigated by means of a questionnaire Periodo de tiempo: 6 months	The knowledge on AI in healthcare among gastroenterology patients and physicians, investigated by means of a questionnaire.	6 months
The experience with AI investigated by means of a questionnaire Periodo de tiempo: 6 months	The experience with AI (in healthcare) among gastroenterology patients and physicians, investigated by means of a questionnaire.	6 months
The opinion on AI investigated by means of a questionnaire Periodo de tiempo: 6 months	The oninion on AI in healthcare among gastroenterology patients and physicians, investigated by means of a questionnaire.	6 months

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Willingness of physicians to use AI in (gastroenterology) healthcare Periodo de tiempo: 6 months	The willingness to apply AI in (gastroenterology) healthcare among gastroenterology physicians.	6 months
Willingness to apply AI in (gastroenterology) healthcare Periodo de tiempo: 6 months	The willingness of gastroenterology patients for their physicians to apply AI in (gastroenterology) healthcare.	6 months
Advantages and disadvantages of AI use in (gastroenterology) healthcare Periodo de tiempo: 6 months	Important advantages and disadvantages of AI use in (gastroenterology) healthcare among gastroenterology patients and physicians.	6 months
Potential domains within gastroenterology and hepatology for AI use Periodo de tiempo: 6 months	Potential domains within gastroenterology and hepatology for AI use indicated by GI physicians.	6 months
Mandatory infrastructure for AI use in healthcare Periodo de tiempo: 6 months	The availability of technical facilities and infrastructures within endoscopy to implement and apply AI in Dutch hospitals.	6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Maastricht University Medical Center

Colaboradores

Catharina Ziekenhuis Eindhoven

Investigadores

Investigador principal: Ad Masclee, Prof Dr MD, Maastricht Universitair Medisch Centrum

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

8 de abril de 2020

Finalización primaria (Actual)

12 de agosto de 2021

Finalización del estudio (Actual)

12 de agosto de 2021

Fechas de registro del estudio

Enviado por primera vez

13 de enero de 2022

Primero enviado que cumplió con los criterios de control de calidad

26 de enero de 2022

Publicado por primera vez (Actual)

31 de enero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de febrero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

3 de febrero de 2022

Última verificación

1 de febrero de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

METC 2020-2281

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Data collected for the study, including individual participant data, will be made available upon request. This data includes deidentified participant data. Additional documents that will be made available are the study protocol, the statistical analysis plan, the questionnaires, and the informed consent forms. Data will be available following publication with no end date. Requests should be methodologically sound proposals with the purpose to achieve aims in the approved proposal. Researchers who request the data should direct the proposal to q.vanderzander@maastrichtuniversity.nl to gain access. Data requestors will need to sign a data access agreement after approval of a proposal.

Marco de tiempo para compartir IPD

Data will be available following publication with no end date.

Criterios de acceso compartido de IPD

Requests should be methodologically sound proposals with the purpose to achieve aims in the approved proposal. Data requestors will need to sign a data access agreement after approval of a proposal.

Tipo de información de apoyo para compartir IPD

PROTOCOLO DE ESTUDIO
SAVIA
CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Questionnaire Study Concerning Artificial Intelligence