Final Flashcards
What are additional concepts of the principles of ethics (other than Autonomy, Beneficence, Nonmaleficence, Justice) (6)
- Privacy
- Values and Priorities NEW
- Informed Choice
- Dignity
- Confidentiality
- Respect for Persons
What are the examples of concepts important for the values and priorities aspect of ethics related to spinal cord injury (SCI)? (7)
- Relationality: Importance of support from peers, family and health care workers for well being
- Access: Importance of accessible support and services
- Identity: Impact of SCI on roles in society
- Intersectionality: Variety of factors intersect to affect the experience of SCI
- Knowledge: Importance of accessible information and education about SCI affects a person’s experience
- Divergent values: Diverse and potentially conflicting priorities between patient and care-providers in care and rehab
- Independence: Ability to fulfill aspects of daily living and self-management without external aid
What are 8 aspects to consider in the ethics of clinical research?
- Voluntariness (no coercion)
- Informed Consent
- Right to withdraw
- Confidentiality
- Accessibility
- Values and priorities
- Follow-up (ensuring no adverse events + continued benefits)
- Safety
What are 4 facts about spinal cord injury?
- 250,000-500,00 cases each year
- $1.5 - 5 million lifetime cost in NA
- Increasing incidence in resource- restricted nations
- Aging demographics due to slips and falls
What are 3 types of spinal cord injury?
- Cervical (quadriplegia: all 4 limbs affected) (60% of SCI are at the neck)
- Thoracic (paraplegia)
- Lumbar (paraplegia) (most function)
What are 10 consequences of spinal cord injury?
- Paralysis - Loss of motor and sensory function
- Loss of control over bowel and bladder function
- Pain
- Susceptibility to infection
- Affects other physiological functions
- Loss of independence
- Limited employment opportunities
- Altered purpose/meaning of life
- Personal and financial burden on individual and caregiver
- Societal cost ~$2.7 billion (2013) in Canada
What are the 3 stages of the pathophysiology of SCI?
- Acute (injury ~2 days)
- Intermediate (injury <6 months)
- Chronic (injury >6 months)
What are the 4 stages of clinical trials?
- Safety (Safest tolerable dose, side effects, small population)
- Efficacy (Most effective dose, outcome measures. larger population)
- Confirmation (Compare to other treatments, adverse events, control group) - most trials don’t make it to this stage
- Follow-up (Market)
What are 3 reasons for failing a clinical trial?
- Financial: 100s of millions to billions of $
- Enrollment: Small population, strict criteria
- Low power (Insignificant results): Poor design, single site
What are 4 reasons to stop a clinical trial?
- Safety: adverse events
- Poor study design: low enrollment
- Efficacy: insignificant results
- Commercial reasons
What are 4 reasons to stop a clinical trial DUE TO COMMERICAL REASONS?
- Research budgets shrink
- Competitive products emerge
(that are more promising) - Supply failures (raw materials difficult to source)
- Pressures to end unproductive programs
What are 5 interventions for SCI, and what do they focus on?
- Drugs (Minocycline): Inflammation, Pain, Axon health
- Stem cells (ES, MSC, iPSC): Inflammation, Regeneration, Cell replacement
- Devices (Exoskeletons): Movement, Pain, Physical support
- Biomaterial (Bridges): Regeneration
- Surgical (Decompression): Limit damage, Relieve pressure, Nerve grafts
What are 4 safety concerns regarding the use of stem cells for SCI treatment?
- Source of cells
- Invasiveness
- Tumours (BIGGEST CHALLENGE)
- Lack of follow-up protocols
How do values and priorities change in regards to risk tolerance depending to the type of SCI?
- Chronic, cervical SCI: More risk averse
- Chronic, thoracic SCI: High tolerance to risk
What is the case study of the Geron Trial?
Geron was a company researching stem cell treatment. They ended up halting their first clinical trial because they decided to put financial gain before the patients. By making this decision, they destroyed trust.
What is medical tourism (in the context of stem cells)?
Travelling for stem cell treatment
What are 3 features, 3 examples, and 1 ethical issue regarding biomaterials?
Features:
- Biologically compatible
- Scaffold (for axon regen)
- Support stem cells (viability)
Examples:
- Collagen
- Fibrin
- Matrigel
Ethical Issues:
- Safety
What are 2 pros and 3 cons (regarding safety) of the INSPIRE TRIAL for SCI treatment?
Pros:
- Scaffold support for stem cell therapy
- Deliver combination treatments (slow releasing drugs, nanoparticles)
Cons:
- Safety: Invasive (cutting open spinal cord), Potentially requires a second surgery (due to decompress surgery), Worsens SCI
What are 3 features, 3 examples and 2 ethical issues regarding devices for SCI treatment?
Features:
- Support mobility
- Reduce pain
- Aids rehab
Examples:
- BCI (Neuralink)
- Exoskeletons
- Electrical stimulation (axon regen)
Ethical Issues:
- Safety
- Access
What are 3 costs to general society when clinical trials fail?
- Trial participants are abandoned: Violates the risk-benefit contract between patients and sponsors
- Loss of knowledge: Loss of public trust, scientific community
- Healthcare does not progress efficiently: Tax funded research doesn’t translate to societal benefits
What is a robot, and what is a social robot?
Robot: Cyber-physical system with sensors, actuators and mobility
Social robot: Robot that interacts with people
What are potential benefits of social robots on improving mental health outcomes in older adults? (5, with 1 caveat)
- Decrease in loneliness
- Decrease in anxiety
- Increased medication adherence
- Possibly lower need for neuropsychiatric medication in people living with advanced dementia (lower sedative drug use)
- Improved quality of life
CAVEAT: - Quality of evidence is low-medium due to low sample size and time span
What are potential benefits of social robots on improving mental health outcomes in children? (4, with 1 caveat)
- Improved social and communication skills of children on the autism spectrum
- Relief of acute stress and anxiety
- Decrease in depressive symptoms
- Decrease in acute distress
CAVEAT: - Quality of evidence is low, lower than adult studies
What are Asimov’s 3 Laws of Robotics (1950)?
- A robot may not injure a human being or, through inaction, allow a human being to come to harm.
- A robot must obey the orders given it by human beings except where such orders would conflict with the first law.
- A robot must protect its own existence as long as such protection does not conflict with the first or second law.