week 4 - clinical effectiveness Flashcards
What are the 4 underlying principles of good clinical effectiveness assessment?
- seeking information
- asking relevant questions
- understanding differences
- valuing differences
What is “seeking information” in clinical effectiveness assessment?
use clinical info to estimate the outcomes patients might experience when given a new health tech
How can they seek info for clinical effectivness assessment 3 different ways?
- review existing evidence
2 . conduct a new study to gather and evaluate info in real world setting - Ask clinicians and patients (“experts”) their expectations
What 3 things do they evaluate for “asking relevant questions” in clinical effectiveness assessment?
- Cause and effect
- Health improvements and harms identified
- Uncertainties
What are the two gold standard for every circumstance of strong evidence?
- RCT
- blinded trial
What is “safety” in clinical effectiveness consist of?
- condition of being protected against consequences of failure, error, or anything non-desirable
- it is the MEDICAL RISK to the patient
- assess in clinical trial
Can unitended consequences arise when trying to enhance a patient’s safety in a new health tech?
YES!
Are all unintended consequences negative?
NO!
some can be positive
example: bariatric surgery for weight loss in obese patients –> lead to curing type 2 diabetes
What are the 3 most common ways we can measure health outcomes?
- mortality (death rate)
- Morbidity (disease rate)
- Adverse Health events (harmful side effects)
What is a “clinical endpoint”? provide an example
used to measure the impact of a treatment on how a patient feels, fxns or survives
could improve or worsen health status
ex: survival, death
What is a humane (clinical) endpoint?
any disease or sign that strongly motivates withdrawl of the patient from the trial
What is an intermediate endpoint?
measure of a function or of a symptom but is NOT the ultimate endpoint of disease
may be of value to the patient!
ex: rate of irreversible morbid events
What is a surrogate endpoint?
where there is good evidence that it PREDICTS the clinical endpoint
- used as a substitute for a clinical endpoint of interest
- used in clinical trials when it is impractical to measure the primary endpoint during course of trial
ex: using hypertension as a surrogate for clinical end point of a stroke
What is a biomarker?
measured variable or trait that is used as an indicator of a normal biological process, disease state, or effect of treatment
can a biomarker or an intermediate endpoint be used as surrogate endpoints?
YES!
What are measures of treatment effect and provide examples?
compare the probability of a given health outcome in the treatment group with the probability of the same outcome in a control group
ex: odds ratio, effect size, number needed to treat, absolute risk reduction
What is “understanding differences” in clinical effectiveness assessment?
- where you compare the outcomes of new tech with the standard of care that already exists for a health condition
- can be challenging because there outcomes can be measured different ways
What is “valuing differences” in clinical effectiveness assessment?
- understanding how to perceive and value the differences between the outcomes of new tech and already existing care
- qualitative (interviews) or quantitative (surveys)
make sure to study regulatory framework!
- understand the regulatory framework
- what is considered a device under the regulatory framework
- devices are regulated based on ____________
- know the difference between the manufacturer and the qualified investigator
- what are the 3 pillars of the regulatory framework for medical devices
- which agency is responsible for each pillar
- what are the pathways to authorization?
- what distinguishes each pathway?
