跳至主要内容
临床试验/NCT07074405
NCT07074405已完成不适用

Understanding the Acceptability of Artificial Intelligence as a Support for Healthcare Providers in the Diagnosis of Prostate Cancer - the Patient at the Heart of His Care

Centre Hospitalier Universitaire de Liege1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Perceived Benefits of using AI in the diagnosis of prostate cancer

研究概览

简要总结

This study investigates the acceptability of artificial intelligence (AI) as a diagnostic support tool among patients with localized prostate cancer and healthcare providers, as well as their willingness to share health data for AI development.

Background AI tools in healthcare show promising potential, especially in improving diagnosis accuracy and personalizing treatment. However, successful implementation depends not only on technical performance but also on the acceptability of AI among its users-both patients and professionals. Prior research has shown varied acceptability depending on context, disease severity, task performed by AI, and user population.

Objectives Assess patients' acceptability of AI as a diagnostic support in prostate cancer.

Explore patients' willingness to share health data for developing clinical AI.

Assess healthcare providers' acceptability of AI in this diagnostic context.

Methodology Design: A cross-sectional, mixed-method, multinational study (Belgium, Italy, Spain).

Quantitative Phase: Online questionnaire, using adapted theoretical frameworks (Value Perception Model, NASSS-AI, TFA).

Qualitative Phase: Will follow based on quantitative findings.

Participants: Adults diagnosed with localized prostate cancer. Recruitment via hospitals, social media, and patient associations.

Data Collected: Personal and health information, attitudes toward AI, willingness to share data.

Ethics Approved by ethics committees in each participating country.

Informed consent obtained digitally before participation.

Data anonymized and GDPR-compliant.

详细描述

1. Introduction 1.1. Acceptability of artificial intelligence 1.1.1. Artificial intelligence in healthcare Healthcare professionals are facing a multitude of growing and more and more complex challenges. The nature of health problems is changing, workloads are increasing, which leads to a more difficult management in care and requires also a constant update of knowledge. At the same time, the implementation of artificial intelligence (AI) tools in healthcare is exploding and offers a bright opportunity to meet the needs of the evolving medical sector.

Many studies have explored the feasibility of clinical AI by evaluating, among other things, the technical performance of AI systems. However, the technical nature of AI development is not the only challenge facing the implementation of clinical AI. Indeed, studies have shown that the acceptability of clinical AI by healthcare professionals and patients impacts the effective adoption of AI by these users. Ignoring this parameter could lead to a waste of resources, by not taking advantage of the available AI systems.

The acceptability of clinical AI by patients and healthcare professionals has been studied in different contexts but most studies concern the acceptability of AI in healthcare in general. This subject has already been systematically summarised and shows in majority good acceptability of AI. On the other hand, studies in specific health contexts are rarer and the AI acceptability in these contexts cannot be defined by simply extrapolating the AI acceptability in the healthcare. Indeed, the acceptability of AI differs according to the context (disease diagnosed, severity of the disease, consequences of the AI's decision, complexity of decision-making) but also to the tasks that the AI performs (diagnosis, choice of treatment, prognosis). In addition, AI acceptability factors differ depending on the population studied (patients, healthcare professionals, researchers and healthcare managers) due to differences in needs, preferences and the context of use. It is therefore important to study the AI acceptability into the precise context to which the study refers.

1.1.2. Acceptability of AI in the prostate cancer diagnosis process The implementation of AI tools in the prostate cancer diagnosis (PCa) process will improve information from medical images and creation of predictive models. This will represent a significant advance in optimizing diagnosis of PCa and predicting its aggressiveness, with the final objective of personalizing treatment by adaptation to the biological characteristics of the tumour. This will help reduce the need for prostate biopsies, thus increasing the individuals' compliance and encouraging them to get tested before the appearance of symptoms. Moreover, early detection of PCa dramatically improves the treatment success rate.

Given the opportunity of the implementation of AI in the PCa diagnosis process, it is essential to study the acceptability of this implementation for patients and healthcare professionals who would the final users of AI in the PCa context, and the conditions for this implementation. Although some studies have examined this acceptability, research in this area remains limited and requires further investigation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • over 18 years;
  • with diagnose of localized prostate cancer;
  • consent to the study.

排除标准

  • not speaking French;
  • diagnosed with metastatic cancer from the outset;
  • terminally ill;
  • people suffering from mental retardation, dementia or altered state of consciousness.

结局指标

主要结局

Perceived Benefits of using AI in the diagnosis of prostate cancer

时间窗: Baseline

They are latent measures and will be assessed in several questions: * Benefits: I believe that tools based on artificial intelligence can 'Improve the diagnosis of prostate cancer', 'Advance the prostate cancer diagnostic process', 'Provide an accurate diagnosis of prostate cancer', Reduce the costs of prostate cancer diagnosis'. Scale: "Strongly disagree", "Disagree", "Somewhat disagree", "Neither agree nor disagree", "Somewhat agree", "Agree", "Strongly agree"; 'Strongly agree' gives the highest value of benefit.

Perceived Risks of using AI in the prostate cancer diagnosis

时间窗: Baseline

Risks, scale "Very low", "Low", "Somewhat low", "Moderate", "Somewhat high", "High", "Very high". The questions are too long to include here but they access the percieved risks of using AI in the diagnosis and treatment of prostate cancer. The 'very high' risk is considered the worst.

Intention to use AI

时间窗: Baseline

Question: Would you like to use artificial intelligence-based tools to manage my prostate cancer diagnosis. Answers - yes, uncertain beacause and no; then there are concerns if they answer 'no' or 'yes because' and they evaluate these concerns on the scale from 0 to 10; 10 is the biggest concern.

Willingless to share personal data

时间窗: Baseline

Question: Willingless to share personal data; answers 'yes', 'no', yes with conditions; then they can describe their conditions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ekaterina Koshmanova

Scientifique R&D

Centre Hospitalier Universitaire de Liege

研究点 (1)

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