| 1 |
What is the primary function of AI in the medical imaging industry?
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To improve diagnostic accuracy and patient outcomes |
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The primary function of AI in the medical imaging industry is to enhance the precision and speed of diagnosing medical conditions. AI algorithms can analyze images such as X-rays, MRIs, and CT scans more efficiently and accurately than traditional methods. This improvement helps in early detection of diseases, reducing human error, and ultimately leading to better patient outcomes. |
This is grounded in the principles of Medical Informatics and Machine Learning in Healthcare, where AI technologies are used to support clinical decision-making by processing large datasets and identifying patterns that may not be visible to human eyes (Topol, 2019). The concept of Augmented Intelligence emphasizes AI as a tool to enhance human decision-making rather than replace it. |
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| 2 |
Which of the following is a key benefit of AI in radiology noted in the article?
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Acts as a second medical opinion |
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One of the key benefits of AI in radiology is its ability to provide a second opinion by assisting radiologists in interpreting medical images. AI algorithms can detect patterns, anomalies, or subtle findings that may be overlooked by humans. This complementary role helps reduce diagnostic errors and enhances confidence in diagnosis, ultimately improving patient care. |
This benefit is rooted in the concept of Decision Support Systems (DSS) in healthcare, where AI acts as an aid to human experts by analyzing complex data and offering recommendations. The role of AI as a second opinion aligns with the idea of Augmented Intelligence, emphasizing collaboration between human professionals and AI tools. |
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| 3 |
What does AI literacy refer to according to the article?
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Understanding and knowledge of AI technology |
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AI literacy refers to the ability to understand and have knowledge of how AI technology works, its capabilities, limitations, and implications. It empowers individuals to critically assess AI applications, make informed decisions, and interact effectively with AI systems. This goes beyond just using AI tools; it involves comprehending the underlying principles and ethical considerations. |
This concept is grounded in digital literacy and technology acceptance models, emphasizing the importance of understanding technology to use it effectively and responsibly. AI literacy is often linked to computational thinking and critical thinking in the context of emerging technologies. |
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| 4 |
Which factor is NOT listed as influencing the acceptability of AI among healthcare professionals?
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The color of the AI machines |
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The acceptability of AI among healthcare professionals is influenced by practical and cognitive factors such as trust in AI systems, how well AI integrates with existing workflows, understanding of the AI system, and the professionals' receptiveness to technology. The color of AI machines is unrelated to their acceptance or usability and is therefore not a factor listed as influencing acceptability. |
This aligns with Technology Acceptance Model (TAM) and Unified Theory of Acceptance and Use of Technology (UTAUT) frameworks, which focus on perceived usefulness, ease of use, and trust as key determinants of technology acceptance, rather than superficial attributes like color. |
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| 5 |
What role does social influence play in AI acceptability in healthcare according to the article?
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Affects healthcare professionals’ decisions to use AI |
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Social influence impacts how healthcare professionals perceive and decide to use AI technologies. When peers, leaders, or the broader professional community endorse or adopt AI, it increases acceptance and willingness to integrate AI into clinical practice. This social dynamic shapes attitudes and behavioral intentions towards AI adoption in healthcare. |
This is grounded in the Unified Theory of Acceptance and Use of Technology (UTAUT) model, where social influence is a key construct influencing users’ behavioral intention to use technology. |
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| 6 |
What is a perceived threat regarding AI usage in healthcare settings?
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Concerns about replacing healthcare professionals |
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One major perceived threat of AI in healthcare is the fear among healthcare professionals that AI might replace their roles or reduce their job security. Although AI aims to assist rather than replace, this concern impacts the acceptance and integration of AI technologies within healthcare settings.
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This concern can be explained by Technology Acceptance Model (TAM) and Job Displacement Theory. According to TAM, perceived risk (including job security concerns) affects users' acceptance of new technology. Job Displacement Theory discusses fears related to automation replacing human labor. |
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| 7 |
According to the article, what is essential for increasing AI acceptability among medical professionals?
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Designing human-centred AI systems |
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The acceptability of AI among medical professionals depends greatly on how well AI systems are designed to meet human needs and workflows. Human-centred AI ensures that the systems support healthcare professionals in their tasks without disrupting established routines or adding complexity. This approach fosters trust, usability, and integration, which are key for acceptance. |
This concept is rooted in Human-Centred Design (HCD) and Technology Acceptance Model (TAM). HCD emphasizes designing technology with a focus on human users’ needs and context. TAM highlights perceived usefulness and ease of use as critical factors influencing technology adoption. |
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| 8 |
What does the 'system usage' category of AI acceptability factors include according to the article?
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Factors like value proposition and integration with workflows |
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Based on a scoping review titled "Understanding the factors influencing acceptability of AI in medical imaging domains among healthcare professionals," the 'system usage factors' explicitly entail "value proposition, self-efficacy, burden, and workflow integration." This directly matches the provided option. Other options like personal preferences, geographical location, age/experience of professionals, or type of medical insurance are not categorized under 'system usage' factors in the context of AI acceptability. |
The primary theoretical framework and reference for the answer regarding 'system usage' factors in AI acceptability comes from a recent scoping review. This review synthesizes existing literature to identify key factors. |
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| 9 |
How does ethicality impact AI acceptability among healthcare professionals?
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Affects views on AI based on compatibility with professional values |
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Ethicality plays a critical role in determining whether AI systems are accepted by healthcare professionals. When AI systems align with the professional values—such as patient safety, autonomy, beneficence, and confidentiality—they are more likely to be accepted and trusted. If AI violates these values, professionals may be hesitant or reject its use, regardless of technical capability. |
This aligns with principlism in medical ethics (Beauchamp & Childress, 2013) |
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| 10 |
What methodological approach did the article emphasize for future AI acceptability studies?
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Considering user experience and system integration deeply |
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The article emphasizes that future AI acceptability studies should go beyond technical performance and economic metrics. It highlights the importance of deeply understanding how healthcare professionals interact with AI systems and how well these systems are integrated into existing clinical workflows. Ignoring user experience and system compatibility can lead to resistance, even if the AI performs well technically. |
This aligns with principles of Human-Centered Design (HCD) and Sociotechnical Systems Theory, which suggest that for successful technology adoption, both technical functionality and human/social contexts must be considered (Norman, 2013; Baxter & Sommerville, 2011). |
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| 11 |
What is the primary objective of using human embryonic stem cells in treating Parkinson’s disease?
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To replace lost dopamine neurons. |
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The primary objective of using human embryonic stem cells in treating Parkinson’s disease is to replace the dopaminergic neurons that have been lost due to degeneration. Parkinson’s disease is characterized by the progressive death of dopamine-producing neurons in the substantia nigra region of the brain, which leads to motor symptoms like tremors, rigidity, and bradykinesia. Human embryonic stem cells can differentiate into dopamine neurons and potentially restore dopamine levels in the brain, alleviating symptoms and improving quality of life. |
This approach is based on the regenerative medicine principle and cell replacement therapy. Key references include:
Lindvall & Kokaia (2006): “Stem cells for the treatment of neurological disorders” – Nature
Barker et al. (2015): “The emerging field of stem cell therapy for Parkinson’s disease” – Trends in Neurosciences
The Lancet Neurology (2020): Reports on the success of stem cell-derived dopamine neuron transplantation in clinical trials
These studies support the use of stem cells as a viable method to replace lost neurons and restore motor function in Parkinson’s patients. |
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| 12 |
Which animal was used to test the STEM-PD product for safety and efficacy?
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Monkeys |
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The STEM-PD product, a stem cell-based therapy for Parkinson’s disease, was tested in monkeys to assess both safety and efficacy before moving into human clinical trials. Non-human primates like monkeys are commonly used in advanced preclinical studies of neurological diseases because their brain structure and function are more similar to humans compared to smaller animals like rats or mice. This makes them a more reliable model for predicting human outcomes in neurodegenerative therapies. |
The scientific rationale is grounded in translational medicine and comparative neuroanatomy, which emphasize the importance of testing in animal models that closely resemble human physiology before human trials. References include:
Kikuchi et al. (2017) – Nature: “Human iPS cell-derived dopaminergic neurons function in a primate Parkinson’s disease model.”
The Lancet Neurology (2020) – Discusses safety testing of stem cell-based therapies in non-human primates.
FDA Guidelines – Require testing in appropriate animal models that simulate human disease for safety/toxicology studies.
Using monkeys provides critical data on cell survival, integration, and functional improvement, key for moving toward clinical applications. |
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| 13 |
What was the duration of the preclinical safety study in rats mentioned in the article?
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12 months |
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The preclinical safety study in rats, as mentioned in the article, was conducted over a 12-month period. This extended duration is essential in evaluating the long-term safety and tumorigenicity of transplanted human stem cell-derived dopaminergic neurons. It allows researchers to observe delayed adverse effects, such as tumor formation, immune response, or integration issues of the transplanted cells, which may not manifest in shorter studies. |
The design of long-term preclinical studies is based on regulatory guidance from authorities like the FDA and ICH (International Council for Harmonisation), which recommend chronic toxicity studies spanning 6 to 12 months (or longer) for cell-based products before proceeding to human trials. |
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| 14 |
What is the name of the clinical trial phase mentioned for STEM-PD?
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Phase I/IIa |
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The article mentions that the STEM-PD product entered a Phase I/IIa clinical trial. This combined phase is designed to assess both safety (Phase I) and preliminary efficacy (Phase IIa) in a small group of participants. It is common in the early stages of testing cell-based or gene therapies, where researchers aim to gather data on how the body responds to the treatment while also getting an early signal of its potential benefits. |
Clinical Trial Framework:
Clinical trials progress through Phase I to IV, with Phase I/IIa often used for innovative or high-risk therapies, such as stem cell-based interventions. These early combined phases allow researchers to reduce time and cost while collecting essential safety and efficacy data.
Regulatory Practice:
The EMA (European Medicines Agency) and FDA both recognize adaptive trial designs, such as Phase I/IIa, especially for advanced therapy medicinal products (ATMPs).
Reference Example:
The STEM-PD trial is registered and conducted as a Phase I/IIa trial, aiming to evaluate the safety, tolerability, and initial signs of efficacy in patients with Parkinson’s disease receiving stem cell-derived dopaminergic neurons. |
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| 15 |
How is the STEM-PD product manufactured?
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Under GMP-compliant conditions |
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The article explicitly states that the STEM-PD product is manufactured under Good Manufacturing Practice (GMP)-compliant conditions. This is a critical requirement for any therapeutic product entering clinical trials, especially those involving human stem cells, to ensure safety, consistency, and quality.
Producing the cells under GMP conditions ensures that the process follows strict protocols that control for contamination, reproducibility, and traceability—key when the therapy is intended for human use. |
Good Manufacturing Practice (GMP):
GMP is a set of guidelines enforced by regulatory bodies such as the FDA and EMA to ensure pharmaceutical-grade quality in the production of medical products. For cell-based therapies like STEM-PD, GMP conditions ensure:
Sterility of the product
Quality assurance and control
Batch-to-batch consistency
Full traceability of cells and reagents used
Regulatory Requirement for Clinical Trials:
According to international standards (e.g. ICH Q7, EMA ATMP guidelines), GMP-compliant production is mandatory before a product can be administered to humans in a clinical trial.
Scientific Best Practice:
Cell therapy products, especially for diseases like Parkinson’s, must meet high safety standards. Producing under GMP-compliant conditions reduces the risk of introducing harmful or uncharacterized variables into the treatment. |
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| 16 |
According to the article, what confirmed the safety of the STEM-PD product in rats?
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There were no adverse effects or tumor formation. |
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According to the article, the safety of the STEM-PD product was confirmed in preclinical studies using rats, where no adverse effects or tumor formation were observed after transplantation of the cell product. These results are a key indicator of safety in regenerative medicine, particularly for stem cell therapies, where the risk of tumorigenicity (e.g., teratoma formation) is a major concern.
The absence of these side effects demonstrates that the cells are well-differentiated, non-proliferative, and functionally integrated, thereby making the product suitable for advancement into human trials. |
Preclinical Safety Evaluation in Cell Therapy:
The International Society for Stem Cell Research (ISSCR) guidelines emphasize the need for animal studies to evaluate the potential for:
Tumor formation (tumorigenicity)
Immunogenicity
Ectopic tissue formation
Adverse physiological responses
In this case, the absence of tumor formation or adverse effects is considered a positive safety endpoint.
FDA & EMA Guidelines for ATMPs (Advanced Therapy Medicinal Products):
Both regulatory bodies require nonclinical safety data, including biodistribution, toxicity, and tumorigenicity studies in animals before human clinical trials begin.
Scientific Principle – Risk Minimization:
Cell-based products must be thoroughly evaluated to prevent uncontrolled growth, mutation, or immune complications. Observing no adverse outcomes in rodent models supports a favorable safety profile based on toxicology and pharmacodynamics studies. |
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| 17 |
What key finding was noted in the efficacy study of STEM-PD in rats?
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Transplanted cells reversed motor deficits in rats. |
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The key efficacy finding from the STEM-PD study in rats was that transplanted cells led to a reversal of motor deficits. This outcome strongly suggests that the transplanted dopaminergic progenitor cells survived, integrated, and functionally contributed to the restoration of dopaminergic signaling — a critical factor in Parkinson’s disease therapy.
In preclinical animal models of Parkinson’s disease, behavioral recovery — especially improvements in motor functions — is a primary indicator of functional efficacy of stem cell-derived dopamine neurons. These results suggest that the cells not only survived post-transplant but also differentiated correctly and restored motor circuitry. |
Principle of Functional Integration in Regenerative Medicine:
According to studies on stem cell therapy for Parkinson’s disease (e.g., Kriks et al., Nature 2011), efficacy is demonstrated when transplanted cells:
Differentiate into midbrain dopaminergic neurons
Restore dopamine release
Improve motor performance in animal models
Scientific Method – Behavioral Endpoints in Preclinical Testing:
Evaluation of cell therapy often includes behavioral assessments such as rotarod, stepping tests, or amphetamine-induced rotation to detect improvements in motor deficits. The reversal of symptoms confirms functional restoration.
ISSCR Guidelines & Translational Pathway:
The International Society for Stem Cell Research highlights that functional recovery in validated animal models is a key precondition before moving toward human trials. |
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| 18 |
What specific markers were used to assess the purity of the STEM-PD batch?
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LMX1A and EN1 |
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The specific markers LMX1A (LIM homeobox transcription factor 1 alpha) and EN1 (Engrailed-1) are used to assess the purity of midbrain dopaminergic progenitor cells, which are the key therapeutic component in the STEM-PD product.
These markers indicate that the stem cells have successfully differentiated into midbrain-specific dopaminergic neuronal lineage, which is essential for treating Parkinson’s disease. High expression of these markers confirms that the batch contains a pure and targeted population of cells suitable for transplantation, minimizing risks from contaminating or undifferentiated cell types. |
Developmental Biology and Lineage-Specific Markers Theory:
In the differentiation of human pluripotent stem cells into specific neural subtypes, LMX1A and EN1 are canonical markers of floor plate-derived midbrain dopaminergic progenitors (Kriks et al., Nature, 2011).
Stem Cell Quality Control Framework:
The International Society for Stem Cell Research (ISSCR) recommends that cell therapy products undergo rigorous marker-based characterization. Markers like LMX1A and EN1 provide evidence of proper regional specification and lineage identity, which is critical for therapeutic safety and efficacy.
Purity and Identity Testing in GMP Stem Cell Manufacturing:
In translational stem cell therapy, especially for Parkinson’s disease, batch purity is ensured through immunocytochemistry or flow cytometry detecting markers like LMX1A/EN1, ensuring the product meets quality assurance standards before clinical application. |
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| 19 |
What role do growth factors like FGF8b and SHH play in the manufacturing process of STEM-PD?
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They are used in cell patterning for specific neural fates. |
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In the manufacturing of the STEM-PD product, FGF8b (Fibroblast Growth Factor 8b) and SHH (Sonic Hedgehog) are essential morphogens used to guide the differentiation of pluripotent stem cells into midbrain dopaminergic neurons.
SHH is involved in ventralization, directing cells toward a floor plate identity.
FGF8b provides rostro-caudal patterning, particularly inducing midbrain identity, critical for producing dopaminergic neurons.
Together, these growth factors pattern the stem cells during differentiation to achieve the correct regional and cellular identity, ensuring the therapeutic cells mimic those lost in Parkinson’s disease. |
Developmental Biology / Morphogen Gradient Theory:
Morphogens like SHH and FGF8b create concentration gradients that specify neural identities along the neural tube, a concept established in vertebrate embryology.
Stem Cell Differentiation Protocols:
Studies such as Kriks et al., Nature (2011) and Parmar et al., Nature Reviews Neuroscience (2020), show that co-treatment with SHH and FGF8b successfully generates ventral midbrain dopaminergic neurons from hESCs/iPSCs.
cGMP Manufacturing Practices for Cell Therapy:
In GMP-compliant manufacturing (like STEM-PD), defined morphogens are used to reproducibly direct lineage-specific differentiation, ensuring safety, consistency, and therapeutic efficacy. |
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| 20 |
What was a key outcome measured in the preclinical trials for efficacy in rats?
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Recovery of motor function |
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A key outcome measured in the preclinical trials of the STEM-PD product in rats was the recovery of motor function, which is the primary symptom affected in Parkinson’s disease.
The rat models used in these studies typically have lesions in the nigrostriatal pathway (e.g., using 6-OHDA lesions), which mimic the dopamine neuron loss seen in human Parkinson’s disease. Following transplantation of stem cell-derived dopaminergic neurons, the motor behavior of the rats is tested using various assays such as:
Amphetamine-induced rotation tests
Cylinder tests
Stepping tests
Improved motor performance in these tests indicates functional integration and dopamine release from the transplanted cells, thus serving as a direct measure of efficacy.
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Parkinson’s Disease Model in Rodents:
The standard 6-hydroxydopamine (6-OHDA) lesion model is widely used to induce Parkinson-like motor deficits in rats for preclinical efficacy testing.
Behavioral Neuroscience Principle:
Motor function recovery is the gold standard outcome in animal models for testing the therapeutic relevance of dopaminergic neuron transplantation.
Supporting Literature:
Kriks et al., Nature (2011): Demonstrated motor improvement after human PSC-derived dopaminergic neuron transplantation in rats.
Parmar et al., Nature Reviews Neuroscience (2020): Describes motor recovery as a key metric of success in preclinical and clinical trials of cell therapies for Parkinson’s. |
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