Assessment of Knowledge and Perceptions of Artificial Intelligence in Solid Organ Transplantation

NCT ID: NCT05932030

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 6750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2023-12-01

Brief Summary

The increasing abundance of clinical, genetic, radiological, and metabolic data in transplantation has led to a growing interest in applying artificial intelligence (AI) tools to optimize immunosuppression and overall patient management.

However, the majority of these applications exist only in the preclinical state and the field of artificial intelligence remains unknown to the general public. In view of the potential applications of AI and the growing research interest in this topic, it is essential to assess the knowledge and perceptions of those directly involved in solid organ transplantation.

Primary Objective: To assess the knowledge and perceptions of solid organ transplant patients and healthcare professionals working in the field of solid organ transplantation

Primary endpoint:

• Analysis of verbatim and closed-ended questionnaire data
• Comparison of the averages obtained by the subgroups of patients and health professionals and analysis of the verbatim by grouping them by themes

Detailed Description

Solid organ transplantation is the treatment of last resort for end-stage organ disease. In France, 51860 patients receive transplants, and the number of candidates awaiting transplantation has doubled in 10 years. At the same time as considerable progress has been made in recent decades, new challenges have emerged. The growing disparity between demand and supply of organs calls for optimal selection and matching of patients and donors. Improving long-term graft and patient survival requires data-driven diagnosis and management of post-transplant complications. The increasing abundance of clinical, genetic, radiological and metabolic data in transplantation has led to growing interest in applying artificial intelligence (AI) tools to optimize immunosuppression and overall patient management.

However, the majority of these applications are still in the pre-clinical stage, and the field of artificial intelligence remains largely unknown to the general public. In view of the potential applications of AI and the growing research interest in the subject, it is essential to assess the knowledge and perceptions of those directly involved in solid organ transplantation.

This is a prospective, observational, multicenter study. The questionnaire will be submitted face-to-face to healthcare professionals working in solid organ transplantation and solid organ transplant patients at Grenoble Alpes University Hospital. It will be put online on the LimeSurvey platform and offered to healthcare professionals at France's various transplant centers via the federations of each organ specialty, as well as to all organ transplant patients in France via patient associations.

The data included will be collected from paper questionnaires and online on the LimeSurvey platform. They will be stored on a secure server at the TIMC research laboratory department. Data will be anonymized for inclusion in the database. An identifier will be assigned to each volunteer at the time of inclusion.

Categorical data will be reported as frequency, percentage, and continuous data as mean and standard deviation or median and interquartile range if they do not follow a normal distribution. The normality of quantitative variables will be tested by graphical verification.

Continuous variables will be compared using a Student's t test if the conditions of application are valid (or Mann-Whitney if applicable). Categorical variables will be compared using a Chi2 test (or Fisher's test if validity conditions are not met).

We consider p values <0.05 to be significant. Statistical analysis will be carried out using RStudio software (version 4.2.1).

Conditions

Solid Organ Transplantation; Artificial Intelligence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

patients and health professionals

The intervention is a survey administered to patients and health professional. The two questionnaires are identical, with only the socio-demographic section differing. The questionnaire is composed of closed questions, scale scores and short-answer questions.

Group Type: OTHER

Survey

Intervention Type: OTHER

Submission of a survey to solid organ transplant patients and health professionals working in transplantation to assess their knowledge and perception of the use of artificial intelligence in transplantation

Interventions

Survey

Submission of a survey to solid organ transplant patients and health professionals working in transplantation to assess their knowledge and perception of the use of artificial intelligence in transplantation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age greater than or equal to 18 years
• solid organ transplant patients or health professionals working in transplantation
• no opposition to the study

Exclusion Criteria

• subject under guardianship or deprived of liberty
• hematopoietic stem cell transplantation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierrick Bedouch, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Central Contacts

Pierrick Bedouch, Pr

Role: CONTACT

pbedouch@chu-grenoble.fr

04 76 76 79 56

Other Identifiers

2023-A00950-45

Identifier Type: -

Identifier Source: org_study_id